Electrical stimulation synchronized with the patient's breathing

Abstract

A method of providing electrical stimulation to a patient to treat a disorder the patient suffers from includes the steps of detecting the patient's respiration with a sensor and repeatedly delivering electrical stimulation to a target site of the patient. Preferably, the repeated delivery of electrical stimulation is automatically synchronized with the patient's respiration as detected by the sensor. An apparatus for providing electrical stimulation to a patient to treat a disorder the patient suffers from includes a sensor to be worn by the patient, the sensor detecting the respiration of the patient to which it is worn, and a power supply, the power supply controlled to provide electrical signals to the electrodes such that the repeated electrical stimulation is automatically delivered to the target site of the patient via the electrodes in synchronization with the patient's respiration as detected by the sensor.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) Priority claims and cross-references This application claims the benefit of U.S. Provisional Application No. 63 / 202,299, filed June 4, 2021, which is incorporated by reference in its entirety.

[0002] background The following relates to medical technology, which finds particular application in the treatment of functional gastrointestinal disorders (FGIDs) and / or other similar conditions in human patients, and some preferred embodiments disclosed herein will be described with reference to the present specification from time to time. In particular, some embodiments described herein relate to methods and / or devices for treating FGIDs or other similar conditions in patients via suitable electrical stimulation that is automatically synchronized with the patient's breath. Alternatively, the subject matter described herein may be applicable to the treatment of other disorders and / or conditions as well. [Background technology]

[0003] For example, FGIDs such as functional dyspepsia, irritable bowel syndrome, and functional heartburn can affect a significant portion of the general population worldwide and can result in significant medical costs, reduced health-related quality of life for patients, and the like. Other health conditions that may similarly affect patients include, but are not limited to, gastroesophageal reflux disease (GERD), dysphagia, bloating, abdominal pain and discomfort, nausea, vomiting, gastroparesis, gas burbulence, intestinal pseudo-obstruction, postoperative ileus, fecal or urinary incontinence, constipation, diarrhea, pancreatitis, ulcerative colitis, Crohn's disease, menstrual cramps, spastic and interstitial cystitis and ulcers, obesity, anorexia nervosa, and bulimia nervosa. FGIDs such as functional dyspepsia and irritable bowel syndrome are common disorders diagnosed by gastroenterologists. Diagnosis of FGIDs has evolved in response to recent research on diagnostic algorithms. FGIDs can be recognized by the coexistence of multiple morphological and physiological abnormalities, including motility disorders, visceral hypersensitivity, altered mucosal and immune function, altered gut microbiota, and altered central nervous system processing. For example, some significant pathophysiological abnormalities involved in FGIDs are gastrointestinal (GI) motility disorders, visceral hypersensitivity, altered autonomic function, and abnormal central nervous system processing. Some common therapies for FGIDs focus on dietary and / or lifestyle modifications and / or interventions. However, such dietary and / or lifestyle modifications / interventions may have limited therapeutic efficacy and / or be otherwise less than satisfactory. In addition, available drug therapies for patients suffering from FGIDs may lack sufficient efficacy and / or result in various undesirable side effects.

[0004] Thus, in general, there remains a desire to have an effective treatment option for patients suffering from FGIDs and / or other similar conditions, which, for example, is more efficacious than conventional methods and / or which may be effective in improving the motor disorders and paresthesia of FGIDs and in improving the symptoms suffered by patients. Accordingly, inventive methods, devices, and / or systems to address the concerns identified above are described herein. Summary of the Invention [Means for solving the problem]

[0005] Short Description This brief description is provided to introduce concepts relevant to the present specification. It is not intended to identify essential features of the claimed subject matter, nor is it intended for use in determining or limiting the scope of the claimed subject matter. The exemplary embodiments described below are not intended to be exhaustive or to limit the claims to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art can appreciate and understand the principles and practices of the subject matter presented herein.

[0006] In one preferred embodiment, a method of providing electrical stimulation to a patient to treat a disorder from which the patient suffers includes detecting the patient's respiration with a sensor and repeatedly delivering electrical stimulation to a target site on the patient. Preferably, the repeated delivery of the electrical stimulation is automatically synchronized with the patient's respiration as detected by the sensor.

[0007] In another preferred embodiment, an apparatus for providing electrical stimulation to a patient to treat a disorder from which the patient suffers includes a sensor to be worn by the patient, the sensor detecting the respiration of the patient to which it is worn, and a power supply controlled to provide electrical signals to the electrodes such that repeated electrical stimulation is automatically administered to a target site on the patient via the electrodes in synchronization with the patient's respiration detected by the sensor.

[0008] In yet another preferred embodiment, a medical treatment device for providing electrical stimulation to a user includes a sensor that monitors a user's respiratory cycle; electrodes that administer electrical stimulation to a target site of the user, the target site being one of a nerve of the user and one of an organ of the user, the electrodes comprising one of a transdermal pad positioned on the user's skin, a percutaneous needle inserted through the user's skin, and a lead implanted within the patient; and a power supply electrically coupled to the electrodes, the power supply controlled to provide an electrical signal to the electrodes such that repeated electrical stimulation is administered to the target site of the user via the electrodes in automatic synchronization with the user's respiratory cycle as monitored by the sensor.

[0009] Numerous benefits and advantages of the subject matter disclosed herein will become apparent to those of ordinary skill in the art upon reading and understanding this specification. It should be understood, however, that the detailed descriptions of various embodiments and specific examples, while indicating preferred and / or alternative embodiments, are given by way of illustration and not limitation. [Brief description of the drawings]

[0010] The following detailed description refers to figures in the accompanying drawings. However, the subject matter disclosed herein may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating certain exemplary and / or preferred embodiments and are not to be construed as limiting. Additionally, it is understood that the drawings may not be to scale.

[0011] [Figure 1] FIG. 1 diagrammatically illustrates a medical treatment device and / or apparatus according to some embodiments disclosed herein.

[0012] [Diagram 2]2 shows a graph plotting an example respiratory signal provided by a respiratory sensor according to some embodiments disclosed herein. The y-axis is unitless and indicates the magnitude of the respiratory signal. The x-axis is time.

[0013] [Diagram 3] FIG. 3 is an illustration showing a stimulation signal that is automatically synchronized with the user's breathing cycle, and in particular with the start of the user's inspiration and / or exhalation.

[0014] [Figure 4] FIG. 4 is a flow chart illustrating a method of administering electrical stimulation to a patient according to some embodiments disclosed herein.

[0015] [Diagram 5] FIG. 5 is a diagram illustrating an example of a surveillance system according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] Detailed Description For clarity and simplicity, the present specification shall refer to structural and / or functional elements, associated standards, algorithms, and / or protocols, and other components, methods, and / or processes that are generally known in the art without further detailed description of their configuration or operation, except to the extent that they have been modified or altered in accordance with the preferred and / or other embodiments presented herein, and / or to adapt them. Furthermore, the apparatus and methods disclosed herein are described in detail with reference to the figures for illustrative purposes. Unless otherwise specified, like numerals in the figures refer to the same, similar, or corresponding elements throughout the figures. It will be understood that modifications to the disclosed and described examples, arrangements, configurations, components, elements, apparatus, methods, materials, etc. may be made and may be desired for specific applications. In this disclosure, any specification of specific materials, techniques, sequences, etc., is either related to the specific examples presented or is merely a general description of such materials, techniques, sequences, etc. Specific details or specific examples are not intended to be construed as essential or limiting unless specifically designated as such, and should not be construed as such. Selected examples of the apparatus and method are disclosed and described in detail hereinafter with reference to the figures. Indeed, the following disclosure provides many different embodiments or examples for implementing different features of the provided subject matter. Specific examples of components and arrangements are described below to simplify the disclosure. These are, of course, merely examples and are not intended to be limiting. In addition, the disclosure may repeat reference numbers and / or letters in various examples. This repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and / or configurations discussed.

[0017] Additionally, spatially relative terms such as "left," "right," "side," "back," "rear," "front," "beneath," "below," "lower," "above," "upper," and the like, may be used herein for ease of description to describe the relationship of one element or feature to another, as illustrated in the figures. The spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. The device may be oriented differently (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein may likewise be interpreted accordingly.

[0018] Generally, this specification describes methods, systems, devices, and / or apparatus that provide automatically synchronized electrical stimulation to a user or patient to treat a disorder, illness, and / or medical condition that the user or patient may be suffering from. More specifically, the disclosed methods, systems, devices, and / or apparatus automatically deliver or otherwise provide intermittent, periodic, or other patterned electrical stimulation to a user or patient that is synchronized with the user's / patient's breath or respiration. In some preferred embodiments, the system, device, and / or apparatus may include one or more breath or respiration sensors that detect the breath or respiration of a user / patient; one or more stimulation controllers or equivalent that employ a suitable algorithm or equivalent to identify the time (i.e., at a given point in time) to deliver the electrical stimulation such that the electrical stimulation is automatically synchronized with the breath / respiration of the user / patient; one or more electrical regulators and / or controllers to control and / or manage parameters of the provided electrical stimulation such as, for example, the voltage, current, frequency, pulse width, duration, waveform, and / or other suitable parameters of the provided electrical stimulation; one or more power supplies to produce electrical signals, pulses, or the like in accordance with parameters set or otherwise established by the electrical regulators / controllers; and one or more electrodes operably connected to the generator for delivering and / or administering the electrical stimulation to one or more target sites.

[0019] In this respect, breathing involves cycles of inspiration and expiration. Inspiration, also known as inspiration, is the phase in which air enters the lungs. Exhalation, also known as expiration, is the phase in which air leaves the lungs.

[0020] In some preferred embodiments, monitoring and / or feedback features may also be provided. Such additional features may be implemented through or with the aid of one or more smart devices or computers or equivalents utilizing or supporting one or more suitable applications running thereon and / or executed by. In practice, these applications may be designed and / or arranged to perform a variety of functions, including collecting symptomatic and / or research data, performing sensor-assisted pathophysiological measurements, and / or providing biofeedback functions. In some embodiments, suitable smart devices may include any number of portable electronic devices, including, for example, but not limited to, smartphones, handheld tablets, laptop computers, desktop computers, and any other similar electronic devices or computers. In practice, the monitoring and / or feedback features may employ data collected or otherwise obtained to assess the effectiveness of previously provided electrical stimulation and provide feedback utilized by the stimulation controller and / or electrical regulator / controller to modify the synchronization, timing, pattern, parameters, and / or form of future provided electrical stimulation.

[0021] In general, the advantage of some embodiments disclosed herein is the potential for greater efficacy than conventional electrical stimulation alone, for example, without synchronization to the breath / breath of the user / patient. More specifically, this more effective stimulation has the potential to improve the primary pathology of FGIDs, such as, for example, bowel motility and paresthesia, thereby reducing the severity of symptoms and improving the quality of life in FGID patients. Some preferred embodiments herein may be applicable to various disease indications, including, but not limited to, FGIDs, gastroesophageal reflux disease (GERD), postoperative ileus, abdominal pain and discomfort, pancreatitis, ulcerative colitis, Crohn's disease, menstrual cramps, spastic and interstitial cystitis and ulcers, obesity, anorexia nervosa, and bulimia nervosa. Some embodiments described herein provide therapeutic treatment for and / or alleviate the symptoms of various medical conditions and / or disorders, including, for example, but not limited to, FGIDs, functional dyspepsia, irritable bowel syndrome, gastroesophageal reflux disease (GERD), heartburn, bloating, post-operative ileus, abdominal pain and discomfort, early satiety, epigastric pain, nausea, vomiting, gas burbulence, valvular insufficiency, intestinal pseudo-obstruction, fecal incontinence, gastroesophageal reflux disease, chronic constipation, gastroparesis, pancreatitis, ulcerative colitis, Crohn's disease, menstrual pain, spastic and interstitial cystitis and ulcers, obesity, anorexia nervosa, and bulimia nervosa.

[0022] In some preferred embodiments, electrical stimulation can be applied in various modalities to various target sites, including, but not limited to, any of the following: electrical stimulation of nerves (e.g., vagus nerve, spinal cord, peripheral nerves, nerve plexuses, etc.), electrical stimulation of organs (e.g., compartments such as the intestine, liver, pancreas, bladder, etc.), and combinations of nerve and organ stimulation. In some preferred embodiments, delivery and / or application of electrical stimulation can be via needle-free percutaneous routes (e.g., using non-invasive adhesive skin electrode pads), percutaneous routes (e.g., using needle electrodes), and / or implantable routes (e.g., using patient-implanted electrodes at and / or around the nerve or organ target sites). Preferably, any single modality and / or route and / or various combinations thereof can be used to achieve the desired stimulation. Preferably, other stimulation modalities and / or routes not mentioned herein can also be used to obtain the desired electrical stimulation.

[0023] In practice, various different configurations of stimulation electrodes, stimulation target sites, and / or stimulation parameters may be employed to treat a patient using one or more electrodes that are sequentially or otherwise attached to one or more electrical pulse or function generators or the like. For example, one or more electrodes, including but not limited to, percutaneous electrode pads, percutaneous needle electrodes, or implantable leads, may be used for electrical stimulation of one or more target sites, including but not limited to, nerves or organs. In some preferred embodiments, the desired electrical stimulation of a selected target site is achieved by selecting individual electrodes and setting and / or adjusting various stimulation parameters therefor. Examples of stimulation parameters include, but are not limited to, the shape of the stimulation waveform, the amplitude of current or voltage, pulse width, frequency, and anodal or cathodal stimulation, in addition to several other controllable parameters.

[0024] Referring to FIG. 1, a medical treatment device and / or apparatus 100 includes a respiratory sensor 10 that is attached to and / or worn by a patient / user 20 and measures, detects and / or monitors the breath and / or respiration of the patient / user 20.

[0025] In some preferred embodiments, the sensor 10 may include a flexible strap or other belt or equivalent that is (i) attached and / or worn around an upper side or region of the torso, torso, or chest of the patient / user 20, for example, to measure, detect, and / or monitor thoracic breathing (i.e., chest breath), or (ii) attached and / or worn around a lower side or region of the torso, torso, or abdomen of the patient / user 20, for example, to measure, detect, and / or monitor diaphragmatic breathing (i.e., stomach breath). Generally, breathing and / or respiration is generally accompanied by associated cycles of expansion and contraction of the individual's chest and / or abdomen. Preferably, the sensor 10 measures, detects, and / or monitors respiration and generates a corresponding signal in response to expansion and contraction of the patient / user's anatomy within the region or area in which the sensor is attached and / or worn. In other words, during inspiration or breathing in, the patient / user's torso or torso generally expands, thereby applying and / or gradually increasing a force or pressure on the sensor 10. During expiration or breathing in, the patient / user's torso or torso generally contracts, thereby relaxing and / or gradually reducing the force or pressure applied to the sensor 10. Preferably, the sensor 10 generates a voltage or other electrical signal that varies proportional to and / or otherwise in response to the pressure or force experienced by the sensor 10.

[0026] In some preferred embodiments, the sensor 10 may extract force information (f) during expansion and / or contraction of the patient / user's anatomy during a breath or respiration. For example, the sensor 10 may be a flexible force sensitive resistor (FSR) that produces a voltage change that correlates to pressure applied to the sensor 10 during expansion of the anatomy associated with an inhaled breath. In some embodiments, the sensor 10 may employ an electromechanical film, for example having a thin porous polypropylene structure, to form a capacitive pressure sensor that produces a voltage change proportional to anatomy movement associated with respiration (i.e., torso expansion and contraction). In some alternative embodiments, the sensor 10 may comprise a mask or equivalent worn and / or attached around the mouth and / or nose of the patient / user 20 to sense airflow therethrough associated with respiration. In some other embodiments, the sensor 10 may comprise an accelerometer positioned on the anatomy of the patient / user 20 to sense anatomy movement associated with respiration. In other embodiments, the sensor 10 may comprise a piezoelectric device that produces a signal in response to pressure and / or force applied thereto. In general, the sensor 10 may be any suitable respiratory sensor or combination of one or more suitable sensors that measure, detect, and / or monitor the breath and / or respiration of the patient / user 20 and output a signal in response and / or based thereon.

[0027] In practice, signals from the respiratory sensor 10 are preferably provided as inputs to a system controller 30 that coordinates and / or controls various operations and / or functions of the device or apparatus 100 to administer, for example, in real time or near real time, repeated electrical stimulation to a target site of the patient / user 20 that is automatically and / or otherwise synchronized with the respiration of the patient / user 20 as measured, detected and / or monitored by the sensor 10. In some preferred embodiments, signals obtained from the respiratory sensor 10 can be transmitted to the system controller 30 via an analog-to-digital converter (ADC).

[0028] 1, the system controller 30 includes a stimulation specifier 32. Preferably, the stimulation specifier 32 analyzes and / or evaluates the input signals from the sensor 10 to identify characteristic features and / or patterns therein that are indicative of a particular point of interest (POI) in the patient / user's respiratory cycle, such that the delivery of electrical stimulation can be synchronized and / or otherwise timed with reference to that particular POI in the respiratory cycle. For example, the stimulation specifier 32 determines the location of the start of inspiration and generates a command or signal indicative of the start point, which in turn can be forwarded or otherwise communicated to a stimulation controller or driver 34 that can be triggered to control and / or regulate a power supply 36 to deliver electrical stimulation to a target site of the patient / user 20 via electrodes 38 in accordance with one or more stimulation parameters. For example, the stimulation parameters may include, without limitation, the shape of the waveform for the electrical stimulation, the amplitude of the current for the electrical stimulation, the amplitude of the voltage for the electrical stimulation, the frequency of the electrical stimulation, the pulse width of the electrical stimulation, and the duration of the electrical stimulation.

[0029] 2, an exemplary respiratory signal 12 produced by the sensor 10 is shown plotted on a graph, with the vertical axis of the graph representing the magnitude of the signal 12 in arbitrary units and the horizontal axis of the graph representing time in seconds. As shown in FIG. 2, at various points along the plot, the slope of the signal 12 is positive, indicated by a plus sign "+" in FIG. 2. For example, the locations where the slope of the signal 12 is generally positive may correspond to an inhalation by the patient / user 20 as detected by the sensor 10. At various other points along the plot, the slope of the signal 12 is negative, indicated by a minus sign "-" in FIG. 2. For example, the locations where the slope of the signal 12 is generally negative may correspond to an exhalation by the patient / user 20 as detected by the sensor 10. At still other points along the plot, the slope of the signal 12 is zero, essentially zero, substantially flat, or of negligible significant magnitude, indicated by a zero "0" in FIG. 2. For example, these points may correspond to transitions between exhalation and inhalation and vice versa and / or pauses by the patient / user 20 as detected by the sensor 10.

[0030] In some preferred embodiments, the stimulus specifier 32 may analyze and / or evaluate the respiratory signal 12 input to the system controller 30 to determine its slope and identify characteristic features and / or patterns in the slope that are indicative of particular points of interest in the patient / user's respiration. For example, the stimulus specifier 32 may determine the start of inspiration by recognizing one or more points where the slope of the signal 12 is essentially zero, substantially flat, and / or of negligible magnitude, followed by a positive slope developing in the signal 12. When such a pattern in the slope of the respiratory signal 12 is recognized, the stimulus specifier 32 may communicate to the stimulation controller or driver 34 that inspiration has begun. More generally, after detecting and extracting breath or respiratory information from the sensor 10, a respiratory parameter vector may be created that is indicative of, for example, the slope or other suitable characteristics of the respiratory signal 12. The vector parameters can be periodically updated and communicated to a stimulation specifier 32, which recognizes and / or identifies characteristic features and / or patterns in the respiratory parameters that are indicative of particular POIs in the patient / user's respiration. Thus, the stimulation controller or driver 34 can be triggered by a signal or command or other communication received from the stimulation specifier 32, such that the stimulation controller / driver 34 controls and / or regulates the power source 36 to deliver electrical stimulation, via the electrodes 38, to target sites of the patient / user 20 that are automatically synchronized with and / or relatively timed to the POIs identified by the stimulation specifier 32.

[0031] The automatic synchronization of the stimulation signal with the detected patient's breath is more specifically illustrated as a non-limiting example shown in FIG. 3. In this particular non-limiting example, the stimulation is automatically synchronized with the start of inspiration / breath as detected by the sensor. As shown in FIG. 3, the detected breathing cycle or signal (e.g., produced by the sensor 10) is represented by a sine wave, and the start of inspiration or breath occurs when the slope of the breathing waveform starts to go positive. Exhalation or breath follows, and the slope of the breathing waveform goes negative. The stimulation signal is illustrated here as a square wave, and the stimulation is applied at the start of inspiration. The stimulation is applied for approximately one-half of the inspiration portion of the breathing signal. As shown, the system can accurately determine the start of the inspiration breath, provide electrical stimulation that correlates with the breath, and provide a stimulation pattern that correlates with the user's breathing pattern.

[0032] In practice, the electrodes 38 may comprise one or more of a non-invasive electrode pad adhered or otherwise positioned on the skin of the patient / user 20 to deliver and / or administer electrical stimulation (e.g., acupuncture stimulation) to a target site via a needle-free percutaneous pathway, a needle electrode inserted through the skin of the patient / user 20 to deliver and / or administer electrical stimulation (e.g., electroacupuncture) to a target site via a percutaneous pathway, and / or a lead surgically or otherwise inserted into the patient / user 20 to deliver and / or administer electrical stimulation to a target site via an implantable pathway. Suitably, the target site may include a nerve or organ of the patient / user 20, and the electrodes 38 may be positioned and / or located in, at, adjacent to, on, or otherwise in therapeutic proximity to the same. Suitably, the electrodes 38 may be anodal or cathodal. As shown in FIG. 1 , the electrodes 38 are preferably coupled to and / or in electrical communication with a power supply 36 that selectively excites and / or provides electrical signals thereto under the direction of a stimulation controller / driver 34.

[0033] In some preferred embodiments, the stimulation controller / driver 34 is triggered by and / or otherwise responsive to signals and / or commands or other like communications received from the stimulation specifier 32 and controls and / or regulates the power source 36 which thus excites or otherwise provides electrical signals to the electrodes 38 operatively coupled to and / or in electrical communication with the power source 36, thereby providing electrical stimulation to the target site via the electrodes 38 that are automatically synchronized with and / or timed to the patient / user's respiration as detected by the sensor 20. In practice, the power source 36 may be an electrical pulse or function generator that provides and / or otherwise excites electrical signals to the electrodes 38 in accordance with determined, selected, set, and / or otherwise established stimulation parameters and / or under the control and / or regulation of the stimulation controller / driver 34. As previously described herein, the stimulation parameters may include, for example, without limitation, a waveform shape for the electrical stimulation, a current amplitude for the electrical stimulation, a voltage amplitude for the electrical stimulation, a frequency of the electrical stimulation, a pulse width of the electrical stimulation, and a duration of the electrical stimulation. Preferably, the stimulation controller / driver 34 may determine, select, set, and / or otherwise establish the stimulation parameters and control or adjust the power source 36 accordingly.

[0034] As shown in FIG. 1, the system controller 30 may further include a feedback module 40. In some preferred embodiments, the feedback module 40 may collect, receive, and / or otherwise obtain patient data from one or more suitable sources. For example, suitable sources of patient data may include, but are not limited to, one or more sensors that measure, detect, and / or otherwise monitor biophysiological data or the like, and manual entry or other similar input from the patient / user 20, a medical professional or technician, or other individual relating to, for example, symptoms suffered and / or changes thereto, eating habits, diet, sleep quality, patterns, and / or habits, and other lifestyle data of the patient / user 20, laboratory test data, test data obtained from biological samples, and the like. Preferably, the patient data may be recorded, updated, and / or maintained in a Patient Information Database (PIDB) 42. The PIDB 42 may further maintain a time-stamped or otherwise identified historical record of the patient data along with programs and / or details of any electrical stimulation administered during various time periods. For example, historical patient data may be stored and tracked against dates and / or times, such as by month, week, day, hour, and / or by custom date and / or time range, along with details of any electrical stimulation administered during a particular time period. Preferably, details of any electrical stimulation administered, including stimulation parameters employed according to various instances, target site designations, etc., may be noted by feedback module 40 and / or received from system controller 30 and / or stimulation controller / driver 34 at the time of administration.

[0035] In some preferred embodiments, the feedback module 40 may employ artificial intelligence, advanced machine learning, suitable algorithms, and / or the like, for example, to review and / or analyze patient data from the PIDB 42, evaluate the past effectiveness of certain electrical stimuli previously administered during a given period of time, and based thereon, select, adjust, recommend, and / or establish new stimulation parameters to be employed in connection with certain future administrations of electrical stimulation. In practice, the output of the feedback module 40 may be communicated to the stimulation controller / driver 34, such that the stimulation parameters employed by the stimulation controller / driver 34 are set, adjusted, and / or adjusted according to the instructions of the feedback module 40.

[0036] In some preferred embodiments, the feedback module 40 may be separate from and communicate wirelessly or otherwise with the system controller 30. For example, the feedback module 40 may be implemented via a suitable application or equivalent running and / or executing on a suitable smart device, smartphone, laptop, or computer.

[0037] In general, the feedback module 40 acts as a closed loop or other similar feedback mechanism for the device or apparatus 100 such that, for example, stimulation parameters may be automatically or otherwise adjusted or regulated for future administrations of electrical stimulation based on the recognition or detected effectiveness of previously administered electrical stimulation. In practice, the feedback module 40 may collect patient data, such as, for example, the patient's symptoms, blood, stool, and / or other pathophysiological measurements from the PIDB 42, and therefrom may calculate a score upon which a biofeedback function may be based (e.g., according to changes to the score), which represents the effectiveness and / or response to the treatment being administered at that time. For example, if the score is increasing, this may represent symptoms worsening over time, indicating a less than suitable response to the stimulation, and thus the feedback module 40 communicates with the system controller 30 and / or the stimulation controller / driver 34, such that another set of stimulation parameters is selected from the pool of stimulation administration plans. Conversely, if the score is decreasing, this may indicate that symptoms are easing, suggesting a positive effect of the stimulation, and thus the feedback module 40 would not communicate any changes in the stimulation parameters.

[0038] Referring now to FIG. 4, a method 200 according to some preferred embodiments is disclosed, by way of example, in the depicted flow chart.

[0039] At step 210, electrodes (e.g., electrode 38, etc.) are applied to a patient (e.g., patient / user 20, etc.). For example, the electrodes may be pads that are adhered, stuck, or otherwise positioned on the patient's skin, needles that are inserted through the patient's skin, or leads that are surgically or otherwise implanted within the patient. In practice, the electrodes may be applied on, in, preferably near, or otherwise in therapeutic proximity to a desired or selected target site (e.g., nerve or organ, etc.) of the patient to which electrical stimulation is to be administered.

[0040] In step 220, a breath or respiration sensor (such as sensor 10) is attached to the patient. Although steps 210 and 220 are shown consecutively one after the other in the illustrated flowchart, it should be understood that in practice steps 210 and 220 may be performed in any order and / or in parallel.

[0041] In step 230, the sensor attached to the patient in step 220 measures, detects, and / or monitors the patient's breath and / or respiration. In practice, the sensor may output a signal in response to and / or based on the measured, detected, and / or monitored respiration of the patient.

[0042] In step 240, a POI within the patient's breath or respiration is recognized and / or identified from the breath measured, detected and / or monitored by the sensor attached to the patient in step 220, i.e., the POI is recognized and / or identified based on the signal output from the sensor attached to the patient in step 220. Preferably, the POI recognized and / or identified in step 240 is a periodic, intermittent or otherwise reoccurring point in the patient's respiratory cycle, such as, for example, the start of inspiration.

[0043] In step 260, a set of stimulation parameters is set, determined, adjusted, and / or otherwise established. For example, the set of stimulation parameters may include, but is not limited to, any one or more of the following: the shape of the waveform to be used for the electrical stimulation, the amplitude of the current to be used for the electrical stimulation, the amplitude of the voltage to be used for the electrical stimulation, the frequency to be used for the electrical stimulation, the pulse width to be used for the electrical stimulation, and the duration to be used for the electrical stimulation. Initially, the stimulation parameters are set to a baseline or nominal value or level, or may be otherwise selected as desired, such as by the patient, a medical professional, a technician, or other individual. In some embodiments, the initial baseline or nominal value or level may be pre-programmed or prepared, such as within the system controller 30 and / or the stimulation controller / driver 34.

[0044] In step 270, in synchronization with the patient's breathing and / or timed to the POI recognized and / or identified in step 240, the electrodes applied to the patient in step 210 are repeatedly excited and / or provided with electrical signals (e.g., by power supply 36) in accordance with the stimulation parameters established in step 260, thereby repeatedly applying electrical stimulation to the patient's target site in automatic synchronization with the patient's breathing and / or timed to the POI recognized and / or identified in step 240. For example, when a POI is recognized and / or identified in step 240 within the patient's respiratory cycle, electrical stimulation is applied to the patient's target site by exciting or providing electrical signals using the stimulation parameters established in step 260 to the electrodes applied to the patient in step 210, in real time or near real time with respect to and / or timed to the POI, while the patient's respiratory cycle is sensed by a sensor attached to the patient in step 220.

[0045] At step 280, patient information and / or data is collected. For example, the patient information and / or data may include past records of the severity of the patient's symptoms, biological, blood, stool, laboratory, and / or other test results, etc. over a given period of time, correlated with information and / or data regarding prior applications of electrical stimulation provided to the patient over that period of time. Preferably, the patient information and / or data may be maintained in the PIDB 42 and includes stimulation parameters used for prior applications of electrical stimulation provided to the patient.

[0046] At step 290, the patient information and / or data collected at step 280 is analyzed and / or evaluated to determine the effectiveness of the previously administered electrical stimulation over a given period of time, e.g., in treating the patient's medical condition (e.g., FGID, etc.) and / or reducing the severity of symptoms. At decision step 292, if it is determined at step 290 that the previously administered electrical stimulation was sufficiently effective, the method 200 branches to step 294; otherwise, if it is determined at step 290 that the previously administered electrical stimulation was not sufficiently effective, the method branches to step 296.

[0047] If, in step 294, it is indicated that the stimulation parameters should remain unchanged (i.e., because the previously used stimulation parameters resulted in a sufficiently effective treatment and / or symptom relief), then the method 200 loops back to step 260 where the set of stimulation parameters is accordingly re-established, i.e., without modification as indicated in step 294. Otherwise, if, in step 296, it is indicated that one or more of the stimulation parameters will be altered, adjusted, or modified (i.e., because the previously used stimulation parameters did not result in a sufficiently effective treatment and / or symptom relief), then the method 200 loops back to step 260 where the set of stimulation parameters is accordingly re-established, i.e., one or more of the stimulation parameters are altered, adjusted, and / or modified as indicated in step 296.

[0048] Referring back to FIG. 1, a single electrode 38 and power source 36 are shown herein for simplicity and / or clarity. Nevertheless, it should be understood that in practice, one or more similar electrodes and / or one or more similar power sources electrically coupled thereto may be similarly employed to administer electrical stimulation to one or more target sites in automatic synchronization with the respiration of the patient / user 20 as detected by the respiration sensor 10. In addition, while a single respiration sensor 10 is illustrated herein in FIG. 1 for simplicity and / or clarity, it should also be understood that in practice, multiple similar respiration sensors 10 may similarly be employed to measure, detect, and / or monitor the respiration of the patient / user 20, and signals from such multiple sensors may be combined or otherwise employed to establish or calculate a respiration model representative of the patient / user's respiration (e.g., a model that may take a form similar to the respiration signal 12 shown in FIG. 2).

[0049] As described herein, the various elements and / or components (e.g., the sensor 10, the system controller 30, the stimulus specifier 32, the stimulus controller / driver 34, the power supply 36, the electrodes 38, the feedback module 40, and the PIDB 42, etc.) exchange, transmit and / or receive various signals, commands, data, messages, information, and the like. In practice, such exchange, transmission, and / or reception may be accomplished via suitable wired or wireless connections established between the individual elements and / or components.

[0050] In some preferred embodiments, one or more user interfaces (UIs) may be provided, for example, in association with the device or apparatus 100. The UI may include one or more input and / or output devices that enable the patient / user 20, medical professional, or other individual to suitably interact with the device or apparatus 100. For example, the UI may be provided on a smartphone or other mobile device, for example, in wired or wireless communication with the system controller 30, or a laptop or other computer in operative communication with the device or apparatus 100. In some embodiments, the UI may selectively display and / or output a graphical representation of the patient / user's respiration as detected by the sensor 10, for example, in a graph such as that depicted in FIG. 2. In some preferred embodiments, the UI may selectively display and / or output a graphical representation of the administered electrical stimulation, for example, shown as a waveform superimposed or otherwise registered with the graphical representation of the patient / user's respiration. The UI may also allow for manual entry and / or other input of patient information and / or data maintained in the PIDB 42. The UI may also allow for output and / or review of patient information and / or data from the PIDB 42. In some preferred embodiments, stimulation parameters may be manually entered or otherwise input via the UI interface, for example, either as initial nominal values ​​or levels, or to manually select the same as otherwise desired. In some preferred embodiments, currently defined or otherwise established stimulation parameters may be displayed and / or otherwise output via the UI for review by the patient / user 20 or a medical professional or other individual.

[0051] In some preferred embodiments, the UI and / or corresponding application may activate, for example, a smartphone or other similar mobile device of the patient / user 20 to enable the patient / user to track their daily symptoms, sleep quality, and record their daily meals. The UI may optionally include a questionnaire interface used to input daily symptoms and sleep quality. In some embodiments, daily meals may be input and / or entered via the UI as a photo taken with the patient / user's mobile device or otherwise. Preferably, the mobile device, UI, and / or application may automatically assign and record a current date and timestamp to the meal entry so that any correlation of symptoms may be traced back to a particular meal. In some preferred embodiments, the UI may provide an interactive icon or button or link that may be selected by the patient / user 20 to input the time he or she goes to bed. Preferably, all data and / or information entered via the UI, mobile device, and / or application may be communicated to and / or maintained in the PIDB 42. In some preferred embodiments, the PIDB 42 is a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant medical records database that can be securely and remotely stored and / or accessed via a suitable data communications network, such as, for example, the Internet or the equivalent.

[0052] In some embodiments, a sensor-assisted customized monitoring system is provided, for example, for a user suffering from GERD. Preferably, the UI may display or otherwise output different features and / or options, noted with tabs, to visually display summary data based on analysis of past user-entered data and enable the ability to track symptom changes over time, sleep quality and length, and daily diet and nutrition information. In some embodiments, an analyzer may be embedded and / or otherwise employed within the system that provides a general analysis of the data and may determine any correlations between sleep, symptoms, and diet through visualization on the UI. In some preferred embodiments, the UI may allow the patient / user 20 to input daily symptoms through a data collection mechanism, such as, for example, a questionnaire. The questionnaire may be recorded with a date / timestamp that may be used in the future to chronologically refer back to the data and note any patterns that emerge over time. In some embodiments, another feature of the UI may allow the user to answer a few questions that may be used to determine an assessment of sleep quality. In yet further embodiments, another feature of the UI may allow the user to record daily dietary and nutritional information and upload photos of their meals through the use of the mobile device's camera. Optionally, one or more machine learning algorithms or equivalents are utilized to detect food types and estimate food quantities through image processing and data extraction. Another optional feature of the UI and / or application allows the patient / user 20 to input their sleep time by selecting the "Go to bed" option, which will then determine and record the user's sleep time. Preferably, various information and / or data collected via the UI may be maintained in the PIDB 42 and provided to a healthcare provider at a later time to enable correlation and determination of symptom diagnosis and potential treatment options.

[0053] 5 is an exemplary illustration of a monitoring system. The controller transmits stimulation signals to the electrodes and receives signals from the sensors, so that stimulation can be synchronized with the patient's breathing (particularly the start of inspiration). The controller can also collect symptoms, biophysiological data from other sensors, and research data from other measurements, such as from blood, stool, urine, tissue, endoscopy, other images, and the like. Biofeedback can be provided to the controller based on this other data.

[0054] Without being limiting, the following are some examples of suitable therapies and / or treatment options that may be provided, for example, using the medical treatment device and / or apparatus shown in FIG. 1 and / or the method shown in FIG. Electrical stimulation of the vagus nerve (or vagus nerve branches) with automatic synchronization to breath can be delivered through transcutaneous, percutaneous, or implantable pathways / electrodes for the treatment of inflammatory bowel disease, GI motility disorders, chronic abdominal pain, epilepsy, depression, stroke rehabilitation, or other diseases, including, for example, implantable vagus nerve stimulation with automatic synchronization to breath, transcutaneous auricular vagus nerve stimulation with automatic synchronization to breath, and / or transcutaneous cervical vagus nerve stimulation with automatic synchronization to breath. Spinal cord stimulation with automatic breath synchronization can be delivered through implantable, transcutaneous, or percutaneous pathways / electrodes for the treatment of chronic pain, GI motility disorders, or other conditions, including, for example, implantable spinal cord stimulation with automatic breath synchronization, transcutaneous spinal cord stimulation with automatic breath synchronization, and / or transcutaneous spinal cord stimulation with automatic breath synchronization. Sacral nerve electrical stimulation automatically synchronized with breath can be delivered through implantable, transcutaneous, or percutaneous pathways / electrodes for the treatment of fecal incontinence, inflammatory bowel disease, GI motility disorders, or other conditions, including, for example, implantable sacral nerve electrical stimulation automatically synchronized with breath, transcutaneous sacral nerve electrical stimulation automatically synchronized with breath, and / or transcutaneous sacral nerve electrical stimulation automatically synchronized with breath. Peripheral nerve electrical stimulation, such as, for example, tibial nerve electrical stimulation with automatic synchronization with breath, can be delivered through implantable, transcutaneous, or percutaneous pathways / electrodes for the treatment of urinary incontinence, GI motility disorders, or other conditions, including, for example, transcutaneous tibial nerve electrical stimulation with automatic synchronization with breath and / or transcutaneous tibial nerve electrical stimulation with automatic synchronization with breath. Organ electrical stimulation (e.g., bowel, bladder, pancreas, liver, or kidney) automatically synchronized with breath can be delivered through implantable, transcutaneous, or transcutaneous pathways / electrodes to treat GI disorders, esophageal disorders, diabetes, obesity, or other disorders, including, for example, implantable gastric electrical stimulation automatically synchronized with breath and / or transcutaneous gastric electrical stimulation automatically synchronized with breath. Implantable deep brain stimulation, automatically synchronized with breath, can be delivered through implantable pathways / electrodes to treat, for example, Parkinson's disease, essential tremor, dystonia, epilepsy, obsessive-compulsive disorder, chronic pain, cluster headaches, or other disorders. Transcranial / transcutaneous magnetic stimulation, automatically synchronized with breath, can be delivered through electromagnetic induction, in which a changing magnetic field is used to induce electrical currents in specific areas of the brain / organ, for example, this method can be used to treat various disease states, especially in the areas of FGIDs, neurological and mental health.

[0055] In some preferred embodiments, the amount of time and / or parameters of electrical stimulation may be titrated while identifying targeted subtle changes in parasympathetic activity, heart rate, blood, and / or other monitored physiological parameters. In practice, the waveform of the stimulation and / or other electrical parameters may be selected and / or varied according to the type of therapy and / or treatment being provided. The waveform of the electrical stimulation may be direct current, alternating current, and / or pulsed current. For example, with respect to nerve and / or acupuncture point stimulation, such as the vagus nerve, sacral nerve, spinal cord, or acupuncture stimulation, the electrical stimulation may be delivered at or with one or more of the following parameters, without limitation: a frequency within the range of about 0.5 Hz to about 300 Hz, inclusive; a pulse width within the range of about 0.1 milliseconds (ms) to about 1.0 ms, inclusive; a current amplitude within the range of about 0.1 mA to about 10 mA, inclusive, with each pulse train applied for a duration within the range of about 1 second to about 120 seconds, inclusive, within the range of about every 10 seconds to about every 300 seconds, inclusive, for up to about 180 minutes. In another embodiment, for organ stimulation, such as gastric electrical stimulation, the frequency may be in the range of about 3 cycles to about 20 cycles per minute, inclusive, the pulse width may be in the range of about 0.1 ms to about 600 ms, inclusive, the current amplitude may be in the range of about 0.2 mA to about 10 mA, inclusive, and the stimulation is applied for up to about 60 minutes. In still other embodiments, such as with respect to deep brain stimulation, electrical stimulation of a relatively short pulse width (e.g., within the range of about 10 microseconds (μs) to about 300 μs, inclusive) may be employed with a somewhat lower voltage amplitude (e.g., up to about 4 V), electrical stimulation of a relatively short pulse width may be employed with a relatively high voltage amplitude (e.g., within the range of about 5 V to about 10 V, inclusive), or electrical stimulation of a relatively long pulse width (e.g., within the range of about 120 μs to about 450 μs, inclusive) may be employed with a relatively low voltage amplitude (e.g., within the range of about 0.1 V to about 2 V, inclusive).

[0056] In some preferred embodiments, treatment of functional dyspepsia (FD) may be achieved using the medical treatment device and / or apparatus shown in FIG. 1 and / or the method shown in FIG. 4. FD patients may present with common gastric symptoms without organic factors. FD may affect a significant portion of the population, leading to impaired quality of life and high annual costs to manage the disease. Electrical stimulation synchronized with breath is superior to similar treatments without breath synchronization and can improve important FD pathophysiology, including, for example, improving gastric adaptation that is attenuated in response to meals, normalizing gastric dysrhythmia, improving visceral hypersensitivity, and enhancing vagus nerve activity. However, manual breath synchronization, for example, requiring the patient to first sense the onset of the stimulation and manually adjust their breathing to follow the stimulation, may have some drawbacks and / or limitations. For example, such manual synchronization may generate very large delays and / or errors in synchronization, resulting in poor patient compatibility with chronic therapy and significantly impairing the effectiveness of the method. In some embodiments, to solve this problem and improve the effectiveness of electrical stimulation in treating FD, the novel non-invasive neuromodulation method disclosed herein automatically detects the user's respiratory waves, synchronizes electrical stimulation with the user's breath, and delivers them, for example, at acupuncture points via surface skin electrodes. With the automated synchronization employed by the device and / or apparatus disclosed herein, the patient can receive electrical stimulation treatment synchronized with inhalation and exhalation without interruption and with a normal breathing pace, greatly simplifying the treatment procedure, improving patient compliance, and improving the effectiveness of the method. The integrated effect of synchronized electrical stimulation on gastric motility and visceral hypersensitivity is based on the activation of the vagus nerve pathway. For example, these vagal pathways may include the lateral peroneal branch of the sacral nerve to the ST36 acupuncture point, and / or the median nerve between the palmaris longus tendon and flexor carpi radialis to the PC6 acupuncture point, which together elicit beneficial vagal-mediated effects on gastric motility and visceral hypersensitivity.In some embodiments, the targeted end-organ and associated functional modulation is as follows: the autonomic nervous system, for example, to produce vagus nerve activation; the stomach, for example, to improve gastric accommodation attenuation and gastric dysrhythmia, such as that induced by the Ensure task; and visceral hypersensitivity (afferent nerve sensitization), for example, to improve visceral hypersensitivity (FD syndrome), such as that induced by the Ensure task. In some preferred embodiments, the transcutaneous electrodes may have a relatively small diameter, for example, about 10 mm, for example, to provide focal stimulation at the acupuncture points of ST36 and / or PC6. In some preferred embodiments, a respiratory sensing system (including, for example, one or more sensors 10, such as the type disclosed herein) may be employed to measure the expansion / contraction of the user's chest for respiratory monitoring without skin contact. The respiratory sensing system may be preferably integrated into a harness or equivalent that can be easily put on and / or removed by the user, for example, for easy self-operation at home, improving patient compatibility. Advantageously, in some embodiments, the medical device / apparatus and / or method proposed herein can improve gastric compliance, normalize gastric dysrhythmia, and improve visceral hypersensitivity, which are mediated by enhanced vagus nerve activity. In some embodiments, for FD-specific treatment, for example, using acupuncture points ST36 and / or PC6, the electrical stimulation parameters may be as follows: pulse width of about 0.3 ms to about 0.6 ms (inclusive), frequency of about 1 Hz to about 100 Hz (inclusive), current amplitude of about 1 mA to about 10 mA (inclusive), and cycle of about 1 to 5 seconds on and about 1 to 5 seconds off. In certain embodiments, the on time is shorter than the off time in the cycle, such as about 2 seconds on and 3 seconds off.

[0057] In some embodiments, the various controllers, modules, units, and / or equivalents (e.g., system controller 30, stimulus specifier 32, stimulus controller / driver 34, feedback module 40, etc.) may be implemented via hardware, software, firmware, or combinations thereof. In particular, one or more controllers may be embodied by a processor, circuitry, computer, and / or other electronic data processing device configured and / or otherwise arranged to perform one or more of the tasks, steps, processes, methods, and / or functions described herein. For example, a processor, computer, server, or other electronic data processing device embodying a controller may be provided, supplied, and / or programmed with a suitable listing of code or other similar instructions or software or firmware (e.g., source code, interpreted code, object code, directly executable code, and the like) such that, when activated and / or executed by a computer or other electronic data processing device, one or more of the tasks, steps, processes, methods, and / or functions described herein are completed or otherwise performed. Preferably, the listing of code or other similar instructions or software or firmware is embodied as and / or recorded, stored, contained or included in and / or on a non-transitory computer and / or machine readable storage medium or media such that it can be provided to and / or executed by a computer or other electronic data processing device.For example, suitable storage media and / or media may include, but are not limited to, floppy disks, flexible disks, hard disks, magnetic tapes, or any other magnetic storage media or media, CD-ROMs, DVDs, optical disks, or any other optical media or media, RAM, ROM, PROM, EPROM, FLASH-EPROM, or other memory or chips or cartridges, or any other tangible media or media that a computer or machine or electronic data processing device can read and use. Substantially, as used herein, non-transitory computer-readable and / or machine-readable media and / or media comprises all computer-readable and / or machine-readable media and / or media except for transitory propagating signals.

[0058] In general, any one or more of the specific tasks, steps, processes, methods, functions, elements, and / or components described herein may be implemented on and / or embodied in one or more general purpose computers, special purpose computers, programmed microprocessors or microcontrollers and peripheral integrated circuit elements, hardwired electronic or logic circuitry such as ASICs or other integrated circuits, digital signal processors, discrete element circuits, programmable logic devices such as PLDs, PLAs, FPGAs, graphical card CPUs (GPUs), or PALs, or the like. In general, any device capable of implementing a finite state machine and thus capable of implementing the individual tasks, steps, processes, methods, and / or functions described herein may be used.

[0059] The foregoing outlines the features of some embodiments so that those skilled in the art may better understand aspects of the present disclosure. Those skilled in the art should understand that they may easily use the present disclosure as a basis for designing or modifying other processes and structures to accomplish the same purpose and / or achieve the same advantages of the embodiments introduced herein. Those skilled in the art should also recognize that such equivalent constructions do not depart from the spirit and scope of the present disclosure, and that those skilled in the art may make various changes, substitutions, and alterations herein without departing from the spirit and scope of the present disclosure.

Claims

1. A device for providing electrical stimulation to a patient for treating a disorder afflicting the patient, the device comprising: a sensor configured to automatically detect one or more respiratory cycles of the patient, the sensor being configured to be worn and attached around a lower side or torso of the patient, the sensor detecting physical expansion and contraction of the lower side or torso and generating an electrical signal representative of the expansion and contraction of the lower side or torso to provide the automatically detected one or more respiratory cycles; a controller configured to identify one or more points of interest (POIs) within the respiratory cycle by processing the detected one or more respiratory cycles; an electrode configured to repeatedly administer electrical stimulation to a target site of the patient, the electrical stimulation being applied to the target site while the patient inhales and exhales with an uninterrupted and normal respiratory cycle; comprising; wherein the repeated administration of the electrical stimulation is automatically synchronized with the respiratory cycle of the patient detected by the sensor, and the electrical stimulation is timed with reference to the one or more POIs.

2. The device according to claim 1, further comprising a feedback module, the feedback module being configured to acquire patient data during a period when a previous electrical stimulation is being administered; determine the effectiveness of the previous electrical stimulation administered during the period based on the acquired patient data; and adjust parameters of a future administered electrical stimulation in response to the determined effectiveness.

3. The device according to claim 2, wherein the parameter is one of a shape of a waveform of the electrical stimulation, an amplitude of a current of the electrical stimulation, an amplitude of a voltage of the electrical stimulation, a frequency of the electrical stimulation, a pulse width of the electrical stimulation, and a duration of the electrical stimulation.

4. The device according to claim 1, wherein the target site is one of a nerve of the patient and an organ of the patient.

5. The device according to claim 1, further comprising a power supply, the power supply being Providing an electrical signal to an electrode positioned relative to the target site of the patient such that the electrical stimulation is applied to the target site The device according to claim 1, which is configured to perform the above

6. The device according to claim 5, wherein the electrode is one of a transcutaneous pad positioned on the skin of the patient, a transcutaneous needle inserted through the skin of the patient, and a lead wire implanted within the patient

7. The device according to claim 1, wherein the symptoms of the disorder are improved by repeated administration of the electrical stimulation that is automatically synchronized with the respiratory cycle of the patient detected by the sensor

8. An apparatus for providing electrical stimulation to a patient for treating a disorder suffered by the patient, the apparatus comprising A sensor to be worn by the patient, the sensor detecting one or more respiratory cycles of the patient on which it is worn A power supply, the power supply being controlled to provide an electrical signal to the electrode such that repeated electrical stimulation is automatically applied to the target site of the patient via the electrode in synchronization with the respiratory cycle detected by the sensor while the patient is inhaling and exhaling with an uninterrupted and normal respiratory cycle The apparatus comprising the above

9. The apparatus according to claim 8, further comprising a controller operatively communicating with the sensor, the controller controlling the power supply in response to the respiratory cycle detected by the sensor

10. Further comprising a feedback module, the feedback module comprising at least one processor and at least one memory, the at least one memory including computer program code, the computer program code using the at least one processor to cause the feedback module to at least Obtain patient data during a period in which previous electrical stimulation has been applied according to stimulation parameters, the stimulation parameters being one of the shape of the waveform of the electrical stimulation, the amplitude of the current of the electrical stimulation, the amplitude of the voltage of the electrical stimulation, the frequency of the electrical stimulation, the pulse width of the electrical stimulation, and the duration of the electrical stimulation Determining the effectiveness of the previous electrical stimulation administered during the period based on the obtained patient data; Changing the stimulation parameters regarding future administered electrical stimulation in response to the determined effectiveness; The device according to claim 8, which is configured to perform the above.

11. The device according to claim 8, wherein the target site is one of the nerves and organs of the patient.

12. The device according to claim 8, wherein the electrode is one of a transcutaneous pad positioned on the patient's skin, a transcutaneous needle inserted through the patient's skin, and a lead wire implanted within the patient.

13. The device according to claim 8, wherein the disorder to be treated is a functional gastrointestinal disorder.

14. The device according to claim 8, wherein the symptoms of the disorder are improved by repeated automatic administration of the electrical stimulation synchronized with the detected respiratory cycle.

15. The device according to claim 8, wherein the sensor responds to at least one of the expansion and contraction of the patient's biological structure associated with the patient's respiration.

16. A medical treatment device that provides electrical stimulation to a user, the device comprising: A sensor that monitors the user's respiratory cycle; An electrode that administers electrical stimulation to the user's target site, wherein the target site is one of the user's nerves and organs, and the electrical stimulation is applied to the target site while the user inhales and exhales with an uninterrupted and normal respiratory cycle; A power supply electrically coupled to the electrode, wherein the power supply is controlled to provide an electrical signal to the electrode such that repeated electrical stimulation is administered to the user's target site through the electrode and is automatically synchronized with the respiratory cycle of the user monitored by the sensor; A device comprising the above.

17. The device according to claim 16, wherein the electrode comprises one of a transcutaneous pad positioned on the user's skin, a transcutaneous needle inserted through the user's skin, and a lead wire implanted within the user.

18. The device according to claim 16, wherein symptoms of the disorder suffered by the user are alleviated by repeated administration of the electrical stimulation that is automatically synchronized with the user's respiratory cycle monitored by the sensor. **Claim 19** Further comprising a controller, the controller comprising at least one processor and at least one memory, the at least one memory including computer program code, the computer program code causing the controller, using the at least one processor, to at least identify one or more points of interest within the respiratory cycle of the user monitored by the sensor; direct power supplied to provide an electrical signal to the electrodes at one or more determined times for the one or more identified points of interest The device according to claim 16, which is configured to perform.

Images