WO2026020207A1 - Système et procédés de neurostimulation - Google Patents

Système et procédés de neurostimulation

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Publication number
WO2026020207A1
WO2026020207A1 PCT/AU2025/050797 AU2025050797W WO2026020207A1 WO 2026020207 A1 WO2026020207 A1 WO 2026020207A1 AU 2025050797 W AU2025050797 W AU 2025050797W WO 2026020207 A1 WO2026020207 A1 WO 2026020207A1
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WIPO (PCT)
Prior art keywords
stimulation
stimulation current
user
physiological data
responsive
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PCT/AU2025/050797
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English (en)
Inventor
Dinesh Ramanan
Faizan JAVED
Rudi VOON
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Resmed Pty Ltd
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Resmed Pty Ltd
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Publication date
Priority claimed from AU2024902315A external-priority patent/AU2024902315A0/en
Application filed by Resmed Pty Ltd filed Critical Resmed Pty Ltd
Publication of WO2026020207A1 publication Critical patent/WO2026020207A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024—Measuring pulse rate or heart rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/08—Measuring devices for evaluating the respiratory organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/1116—Determining posture transitions
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A61B5/4818—Sleep apnoea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3601—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of respiratory organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36031—Control systems using physiological parameters for adjustment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/3611—Respiration control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B7/00—Instruments for auscultation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0476—Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0484—Garment electrodes worn by the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/06—Electrodes for high-frequency therapy

Definitions

  • the present disclosure relates generally to systems and methods for treating medical disorders, including sleep-related respiratory disorders, using neurostimulation therapy.
  • the present disclosure relates more specifically, but not exclusively, to systems and methods for treating medical disorders using neurostimulation therapy to stimulate the hypoglossal nerve.
  • SDB Sleep- Disordered Breathing
  • OSA Obstructive Sleep Apnea
  • CSA Central Sleep Apnea
  • RLS restless legs syndrome
  • Some such disorders are characterized by events such as apneas, hypopneas, hyperpnea, and hypercapnia where the individual’s breathing stops or is disrupted/restricted during sleep.
  • Various systems exist for aiding users experiencing sleep apnea and related respiratory disorders.
  • Some such systems require the user to wear an interface (e.g., mask) that aids in supplying pressurized air to the airway of the user (e.g., a continuous positive airway pressure (CPAP) system).
  • CPAP continuous positive airway pressure
  • Some users find such systems to be uncomfortable, with the result that ongoing compliance with CPAP therapy suffers.
  • Other systems rely on a surgically implanted stimulator that stimulates nerves/muscles to open the airway.
  • Non-implant stimulator devices that directly stimulate nerves using topical electrodes placed on the skin are also known.
  • One category of such devices utilize Transcutaneous Electrical Nerve Stimulation (TENS) to stimulate the nerve.
  • TENS-based devices suffer from the deficiency of requiring high-amplitude currents to reach the target nerve. Such currents are reported as producing an unpleasant feeling in users. This may reduce therapy adherence for medical devices that are based on TENS.
  • Tl-based devices do not require high-amplitude currents, instead relying on frequencies in the kHz range beneficially interfering with each other in the region of the target nerve to modulate an electric field that stimulates the target nerve.
  • This depolarization of deep nerves with modulated electric fields does not activate the overlaying structures in a clinically observable way, seeing that the structures do not efficiently respond to frequencies in the kHz range.
  • Tl-based devices are thus able to selectively focus electric fields to activate target nerves.
  • Tl-based devices are still in their infancy, particularly in their application to stimulating the hypoglossal nerve to treat sleep-related respiratory disorders and other sleep disorders.
  • the present disclosure is directed to a neurostimulation system and method that provides more responsive Tl-based nerve stimulation compared to current devices.
  • the present disclosure is concerned with a neurostimulation system, comprising: a positioning structure housing at least two stimulating elements, the positioning structure configured to hold the at least two stimulating elements in proximity to the skin of a user, the at least two stimulating elements configured to receive a respective stimulation current profile signal and generate first and second stimulation currents in accordance therewith, the respective stimulation current profiles of the first and second stimulation currents being such that when combined, the first and second stimulation currents apply temporal interference stimulation to a target nerve of the user; a memory storing machine-readable instructions; and a control system including one or more processors configured to execute the machine-readable instructions to responsively apply temporal interference stimulation to the target nerve, by: receiving a physiological data signal from one or more sensors collecting physiological data from the user; processing the received physiological data signal to compute a responsive stimulation current profile for one or both of the at least two stimulating elements; and transmitting responsive stimulation current profile signals to one or both of the at least two stimulating elements, the responsive stimulation current profile signals containing the computed responsive stimulation current profile, wherein the
  • the present disclosure provides a non-implant neurostimulation system that is capable of delivering responsive temporal interference stimulation to a target nerve to account for physiological data that is therapeutically relevant to the neurostimulation therapy being applied.
  • the present disclosure allows parameters of the neurostimulation therapy to be adaptively adjusted during the course of therapy to improve its effectiveness.
  • control system is configured to responsively apply temporal interference stimulation to the target nerve as therapy for a sleep-related respiratory disorder.
  • the physiological data signal typically includes data pertaining to whether the user has fallen asleep or is lying in a particular body position, wherein the responsive stimulation current profile includes activation instructions to the plurality of stimulating elements to generate stimulation currents.
  • the physiological data signal may include data pertaining to whether the user has woken from sleep or moved from one body position to another body position, wherein the responsive stimulation current profile includes deactivation instructions to the plurality of stimulating elements to deactivate any active stimulation currents.
  • the physiological data signal may also include data pertaining to one or more of: sleep state, sleep quality, upper airway condition, a phase within an inhalation-exhalation cycle, breathing sounds, body position, heart rate, heart rate variability, impedance, tone of muscles proximate to the target nerve of the user, oxygen saturation, nasal airflow, respiratory flow, respiratory volume and neck impedance.
  • control system processes data pertaining to breathing sounds to determine an occurrence of an apnea event, computes an apnea-related responsive stimulation current profile and transmits a responsive stimulation current profile signal to the at least two stimulating elements.
  • the apnea-related responsive stimulation current profile may include stimulation activation instructions to the at least two stimulating elements to generate stimulation currents.
  • the control system may process the data pertaining to breathing sounds by comparing the data to a breathing profile associated with the user.
  • the breathing profile is computed from a physiological data signal that includes breathing sounds collected from the one or more sensors.
  • the one or more sensors may include a microphone, a boneconduction microphone, a vibration sensor and/or an accelerometer, for collecting the breathing sounds (individually or in combination).
  • control system determines the occurrence of an apnea event when the comparison between the data pertaining to breathing sounds and the breathing profile identifies inhalation and/or exhalation not coinciding with the breathing profile.
  • the physiological data signal typically includes data pertaining to a stimulation characterization of the target nerve.
  • the stimulation characterization may be a frequency of oscillation of the target nerve evoked by the combined first and second stimulation currents.
  • the stimulation characterization may also be an extent of movement of a muscle or an organ connected to the target nerve evoked by the combined first and second stimulation currents.
  • the respective stimulation current profiles of the first and second stimulation currents comprise respective frequencies of such levels and a frequency difference between the respective frequencies that when combined, the first and second stimulation currents apply temporal interference stimulation to the target nerve of the user.
  • control system computes a responsive stimulation current profile by: receiving an initial physiological data signal including data pertaining to an initial stimulation characterization; computing an initial responsive stimulation current profile on the basis of the initial stimulation characterization; receiving a subsequent physiological data signal including data pertaining to a responsive stimulation characterization; and computing the responsive stimulation current profile on the basis of a comparison of the initial stimulation characterization and the responsive stimulation characterization.
  • control system computes a responsive stimulation current profile by: receiving an initial physiological data signal including data pertaining to an initial measurement of a physiological data parameter; computing an initial responsive stimulation current profile on the basis of the initial measurement of the physiological data parameter; receiving a subsequent physiological data signal including data pertaining to a subsequent measurement of the physiological data parameter; and computing the responsive stimulation current profile on the basis of a comparison of the initial measurement of the physiological data parameter and the subsequent measurement of the physiological data parameter.
  • the target nerve may be the hypoglossal nerve.
  • the positioning structure houses first and second pairs of spaced apart stimulating elements and is shaped and configured such that the first and second pairs of stimulating elements are positionable in proximity to the skin of the user to apply temporal interference stimulation to both hypoglossal nerves.
  • the stimulation characterization may comprise a degree of protrusion centralization of the tongue evoked by the temporal interference stimulation of both hypoglossal nerves.
  • the present disclosure provides a neurostimulation method for controlling a neurostimulation device to responsively apply temporal interference stimulation to a target nerve of a user
  • the neurostimulation device comprising a positioning structure housing at least two stimulating elements, the positioning structure configured to hold the at least two stimulating elements in proximity to the skin of the user, each stimulating element configured to receive a respective stimulation current profile signal and generate first and second stimulation currents in accordance therewith, the respective stimulation current profiles of the first and second stimulation currents being such that when combined, the first and second stimulation currents apply temporal interference stimulation to the target nerve
  • the method comprising a control system including one or more processors, executing machine-readable instructions to: receive a physiological data signal from one or more sensors collecting physiological data from the user; process the received physiological data signal to compute a responsive stimulation current profile for one or both of the at least two stimulating elements; and transmit responsive stimulation current profile signals to one or both of the at least two stimulating elements, the responsive stimulation current profile signals containing the computed responsive stimulation current profile, wherein the responsive
  • the present disclosure provides a neurostimulation system, comprising: a positioning structure housing at least two stimulating elements, the positioning structure configured to hold the at least two stimulating elements in proximity to the skin of a user, the at least two stimulating elements configured to receive a respective stimulation current profile signal and generate first and second stimulation currents in accordance therewith, the respective stimulation current profiles of the first and second stimulation currents being such that when combined, the first and second stimulation currents apply temporal interference stimulation to a target nerve of the user; a memory storing machine-readable instructions; and a control system including one or more processors configured to execute the machine-readable instructions to apply temporal interference stimulation for aiding the user in breathing, by: receiving a physiological data signal from one or more sensors collecting physiological data from the user; processing the received physiological data signal to compute a responsive stimulation current profile for one or both of the at least two stimulating elements; and transmitting responsive stimulation current profile signals to one or both of the at least two stimulating elements, the responsive stimulation current profile signals containing the computed responsive stimulation current profile, wherein the responsive
  • the present disclosure provides a neurostimulation method for controlling a neurostimulation device to responsively apply temporal interference stimulation for aiding the user in breathing, a positioning structure housing at least two stimulating elements, the positioning structure configured to hold the at least two stimulating elements in proximity to the skin of the user, each stimulating element configured to receive a respective stimulation current profile signal and generate first and second stimulation currents in accordance therewith, the respective stimulation current profiles of the first and second stimulation currents being such that when combined, the first and second stimulation currents apply temporal interference stimulation to the target nerve, the method comprising a control system including one or more processors, executing machine-readable instructions to: receive a physiological data signal from one or more sensors collecting physiological data from the user; process the received physiological data signal to compute a responsive stimulation current profile for one or both of the at least two stimulating elements; and transmit responsive stimulation current profile signals to one or both of the at least two stimulating elements, the responsive stimulation current profile signals containing the computed responsive stimulation current profile, wherein the responsive stimulation current profile includes stimulation current parameters including
  • FIG. l is a diagram that illustrates an overview of a respiratory system of a user
  • FIG. 2 is a diagram that illustrates an upper airway of the user of FIG. 1A;
  • FIGs 3 and 4 are schematic illustrations of a neurostimulation system according to an embodiment of the present disclosure in place around the neck of a user;
  • FIG. 5 is a schematic illustration of a neurostimulation system according to a further embodiment of the present disclosure.
  • FIG. 6 is a schematic illustration of a neurostimulation system according to a yet further embodiment of the present disclosure.
  • FIG 7 is a block diagram of a stimulation system according to an embodiment of the present disclosure.
  • FIG 8 is a block diagram of a stimulation system according to a further embodiment of the present disclosure.
  • FIG. 9 is a process flow diagram of computing operations performed by a stimulation system according to an embodiment of the present disclosure.
  • a respiratory system 12 of a user 10 (e.g., patient) is shown, which generally includes a nasal cavity, an oral cavity, a larynx, vocal folds, an oesophagus, a trachea, a bronchus, lungs, alveolar sacs, a heart, and a diaphragm. More generally, the user 10 has a throat 20, which includes a region(s) of the respiratory system 12 of the user 10 generally in the neck area of the user 10. The diaphragm of the user 10 is a sheet of muscle that extends across the bottom of the rib cage of the user 10.
  • the diaphragm generally separates the thoracic cavity 30 of the user 10, which contains the heart, lungs, and ribs, from the abdominal cavity 40 of the user 10. As the diaphragm contracts, the volume of the thoracic cavity 30 increases and air is drawn into the lungs.
  • FIG. 2 a view of an upper airway 14 of the user 10 is shown, which includes the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils (one shown), a lip superior, a lip inferior, the larynx, a hard palate, a soft palate, an oropharynx, a tongue, an epiglottis, the vocal folds, the esophagus, and the trachea.
  • the respiratory system 12 of the user 10 facilitates gas exchange.
  • the nose 50 and mouth 60 of the user 10 form the entrance to the airways of the user 10.
  • the airways include a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs of the user 10.
  • the prime function of the lungs is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and carbon dioxide to move in the opposite direction.
  • the trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles.
  • the bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli
  • the alveolated region of the lungs is where the gas exchange takes place, and is referred to as the respiratory zone.
  • a range of respiratory disorders exist that can impact the user 10. Certain disorders are characterized by particular events (e g., apneas, hypopneas, hyperpneas, or any combination thereof).
  • sleep-related and/or respiratory disorders include Periodic Limb Movement Disorder (PLMD), Restless Leg Syndrome (RLS), Sleep-Disordered Breathing (SDB) including Obstructive Sleep Apnea (OSA) and Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and chest wall disorders.
  • PLMD Periodic Limb Movement Disorder
  • RLS Restless Leg Syndrome
  • SDB Sleep-Disordered Breathing
  • OSA Obstructive Sleep Apnea
  • CSR Cheyne-Stokes Respiration
  • respiratory insufficiency Obesity Hyperventilation Syndrome
  • COPD Chronic Obstruct
  • Obstructive Sleep Apnea is a form of Sleep Disordered Breathing (SDB), and is characterized by events including occlusion or obstruction of the upper air passage during sleep resulting from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall. More generally, an apnea generally refers to the cessation of breathing caused by blockage of the air (Obstructive Sleep Apnea) or the stopping of the breathing function (often referred to as central apnea). Other types of apneas include hypopnea, hyperpnea, and hypercapnia.
  • Hypopnea is generally characterized by slow or shallow breathing caused by a narrowed airway, as opposed to a blocked airway. Hyperpnea is generally characterized by an increase depth and/or rate of breathing. Hypercapnia is generally characterized by elevated or excessive carbon dioxide in the bloodstream, typically caused by inadequate respiration.
  • CSR Cheyne-Stokes Respiration
  • CSR cycles rhythmic alternating periods of waxing and waning ventilation known as CSR cycles.
  • CSR is characterized by repetitive deoxygenation and re-oxygenation of the arterial blood. It is possible that CSR is harmful because of the repetitive hypoxia. In some users, CSR is associated with repetitive arousal from sleep, which causes severe sleep disruption, increased sympathetic activity, and increased afterload.
  • Respiratory failure is an umbrella term for respiratory disorders in which the lungs are unable to inspire sufficient oxygen or exhale sufficient CO2 to meet the user’s needs. Respiratory failure may encompass some or all of the following disorders.
  • a user with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath on exercise.
  • Obesity Hyperventilation Syndrome is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation Symptoms include dyspnea, morning headache and excessive daytime sleepiness.
  • COPD Chronic Obstructive Pulmonary Disease
  • COPD encompasses any of a group of lower airway diseases that have certain characteristics in common, such as increased resistance to air movement, extended expiratory phase of respiration, and loss of the normal elasticity of the lung.
  • Examples of COPD are emphysema and chronic bronchitis.
  • COPD is caused by chronic tobacco smoking (primary risk factor), occupational exposures, air pollution and genetic factors. Symptoms include: dyspnea on exertion, chronic cough and sputum production.
  • Neuromuscular Disease encompasses many diseases and ailments that impair the functioning of the muscles either directly via intrinsic muscle pathology, or indirectly via nerve pathology. Some users suffering from NMD are characterized by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, swallowing difficulties, respiratory muscle weakness and, eventually, death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive disorders: characterized by muscle impairment that worsens over months and results in death within a few years (e.g.
  • amyotrophic lateral sclerosis ALS
  • duchenne muscular dystrophy in teenagers
  • variable or slowly progressive disorders characterized by muscle impairment that worsens over years and only mildly reduces life expectancy (e g. limb girdle, Facioscapulohumeral and myotonic muscular dystrophy).
  • Symptoms of respiratory failure in NMD include: increasing generalized weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, morning headache, and difficulties with concentration and mood changes.
  • Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the thoracic cage.
  • the disorders are usually characterized by a restrictive defect and share the potential of long term hypercapnic respiratory failure.
  • Scoliosis and/or kyphoscoliosis may cause severe respiratory failure.
  • Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, repeated chest infections, morning headaches, fatigue, poor sleep quality and loss of appetite.
  • insomnia sleep-related disorders
  • sleep-related disorders may have similar symptoms as insomnia
  • distinguishing these other sleep-related disorders from insomnia is useful for tailoring an effective treatment plan distinguishing characteristics that may call for different treatments. For example, fatigue is generally a feature of insomnia, whereas excessive daytime sleepiness is a characteristic feature of other disorders (e.g., PLMD) and reflects a physiological propensity to fall asleep unintentionally.
  • the Apnea-Hypopnea Index is an index used to indicate the severity of sleep apnea during a sleep session.
  • the AHI is calculated by dividing the number of apnea and/or hypopnea events experienced by the user during the sleep session by the total number of hours of sleep in the sleep session The event can be, for example, a pause in breathing that lasts for at least 10 seconds.
  • An AHI that is less than 5 is considered normal.
  • An AHI that is greater than or equal to 5, but less than 15 is considered indicative of mild sleep apnea.
  • An AHI that is greater than or equal to 15, but less than 30 is considered indicative of moderate sleep apnea.
  • An AHI that is greater than or equal to 30 is considered indicative of severe sleep apnea. In children, an AHI that is greater than 1 is considered abnormal. Sleep apnea can be considered “controlled” when the AHI is normal, or when the AHI is normal or mild. The AHI can also be used in combination with oxygen desaturation levels to indicate the severity of Obstructive Sleep Apnea.
  • stimulating elements can provide electrical and/or magnetic stimulation to the user to aid in preventing an apnea event about to be experienced by the user.
  • the electrical stimulation is able to aid in preventing apneas by, for example, causing the one or more muscles to move (e.g., contract) and open the airway of the user prior to an apnea occurring.
  • stimulating elements can electrically stimulate the hypoglossal nerve 18 (FIG. 2) to move the tongue 16 to aid in opening the airway to prevent apneas from occurring.
  • a neurostimulation system 100 that comprises a positioning structure 35 that houses a plurality of stimulating elements, which in the illustrated embodiment comprise a right electrode array 132 housing electrodes 132A-132D and a left electrode array 134 housing electrodes 134A- 134D.
  • Neurostimulation system 100 further comprises a control system 110 (FIG 7) that is communicatively coupled to the positioning structure 35.
  • communicative coupling of control system 110 with positioning structure 35 facilitates the responsive control of the electrode arrays 132 and 134 to enable highly selective and responsive stimulation of target nerves.
  • positioning structure 35 takes the form of a generally c- shaped, elongated body member 37.
  • the electrode arrays 132 and 134 are respectively housed proximal to the left 39 and right 41 free ends of the arms of the body member 37. In this way, as shown in Figure 4, when user 10 positions the positioning structure 35 around their neck, the electrode arrays 132 and 134 are held in proximity to the skin of the neck.
  • the positioning structure 35 is manufactured from a suitably lightweight and flexible material to enable the user 10 to wear the structure around their neck when they sleep. This enables the neurostimulation system 100 to be used as a therapy for the sleep-related respiratory and other disorders described herein. Any surfaces that contact the user’s skin (such as the electrode arrays 132 and 134) are typically covered with a suitable film or gel to prevent skin irritation and enhance electrical coupling. Positioning structure 35 further includes a retaining structure 41 that retains the body member 37 in place around the user’s neck.
  • each electrode array 132 and 134 houses two pairs of electrodes that each deliver a current of a specified frequency.
  • electrode arrays 132 and 134 are oriented to be aligned with the hypoglossal nerve 18 (FIG 2). Stimulation currents are applied through the pairs of electrodes.
  • each electrode array 132 and 134 delivers two high-frequency stimulation currents.
  • electrode array 132 delivers stimulation currents Fi and F2 that each traverse a current path respectively defined by electrodes 132A and 132D, and 132B and 132C.
  • electrode array 134 delivers stimulation currents F3 and F4 that each traverse a current path respectively defined by electrodes 134A and 134D, and 134B and 134C.
  • the frequencies of the stimulation currents are:
  • each electrode array 132 and 134 differ by a specified difference frequency Af.
  • the difference frequency is 50Hz.
  • the frequency difference between the stimulation currents causes the stimulation currents to temporally interfere with each other and generate an electric field at the location of the hypoglossal nerve 18 (FIG 2).
  • the generated electric fields evoke a sympathetic oscillatory response from the hypoglossal nerve 18.
  • each hypoglossal nerve is simultaneously stimulated by electrode arrays 132 and 134.
  • This bilateral temporal interference stimulation may provide for more selective targeting of the hypoglossal nerves, as well as inducing a more centralised protrusion of the tongue 16 (FIG 2), compared with purely lateral stimulation of a single hypoglossal nerve.
  • the neurostimulation system 100 of the present disclosure controls the stimulation currents delivered by the electrode arrays 132 and 134 using stimulation current profiles.
  • Stimulation current profiles are data structures that encapsulate relevant parameters of the stimulation currents such as: the number of stimulation currents that the electrode arrays deliver, the activation status of each stimulation current, the frequency of each stimulation current, frequency difference (Af) between two stimulation currents, amplitude of each stimulation current, waveform shape of each stimulation current (such as a sine-wave, square wave and the like) and waveform width of each stimulation current (namely on-off timings of the stimulation current).
  • the electrode arrays 132 and 134 deliver four stimulation currents, other numbers of stimulation currents and electrode arrays are possible.
  • waveforms of the stimulation current are illustrated schematically in FIG 4 and that the teachings of the present disclosure extend to a spectrum of stimulation current waveforms, including sine-wave, square wave, triangle wave, sawtooth wave and pulse wave.
  • the neurostimulation system 100 of the present disclosure also utilizes physiological data taken from the user 10 to responsively control aspects of the stimulation that the electrode arrays 132 and 134 deliver. This responsive control is similarly facilitated by way of stimulation current profiles.
  • the neurostimulation system 100 of the present disclosure receives physiological data (typically from sensors) that is indicative of various physiological states of the user that are relevant to whether nerve stimulation is occurring and/or whether the relevant condition is being successfully treated by the nerve stimulation.
  • Examples of physiological data that the neurostimulation system 100 receives includes data pertaining to whether the user 10 has fallen asleep, data pertaining to whether the user 10 has woken from sleep and data pertaining to one or more of: sleep state, sleep quality, upper airway condition, a phase within an inhalation-exhalation cycle, breathing sounds, body position, heart rate, heart rate variability, impedance, tone of muscles proximate to the target nerve of the user, oxygen saturation, nasal airflow, respiratory flow, respiratory volume and neck impedance.
  • the physiological data includes data pertaining to a characterization of the nerve that is being targeted for stimulation (referred to hereinafter as a “stimulation characterization”).
  • a stimulation characterization For example, as discussed above, temporal interference stimulation of the hypoglossal nerve is characterized by the nerve oscillating at a proportionate frequency to the frequency difference (Af) between two stimulation currents.
  • the physiological data includes data pertaining to whether the hypoglossal nerve is indeed oscillating, and if so, the frequency of that oscillation.
  • Stimulation characterizations also typically include aspects of the extent of movement of an organ or muscle connected to the target nerve that is evoked by the stimulation currents and related electric fields.
  • the extent of tongue movement is a relevant item of physiological data.
  • the neurostimulation system 100 processes the physiological data (typically by way of a suitable algorithm, lookup table or machine learning model) and computes a stimulation current profile that is responsive to the received physiological data (referred to hereinafter as a “responsive stimulation current profile”). For example, if the physiological data indicates that the target nerve is being under stimulated or overstimulated, the neurostimulation system 100 computes a responsive stimulation current profile that includes parameters (such as frequency, amplitude, frequency difference, wave shape and wave width) that addresses the under or over stimulation. In this scenario, the responsive stimulation current profile may include increased or decreased frequency applied globally across all stimulation currents, a modified frequency difference between the stimulation currents comprised in stimulation current pairs, increased or decreased amplitude, different wave shape or width, or combinations thereof.
  • a responsive stimulation current profile that includes parameters (such as frequency, amplitude, frequency difference, wave shape and wave width) that addresses the under or over stimulation.
  • the responsive stimulation current profile may include increased or decreased frequency applied globally across all stimulation currents, a modified frequency difference between the stimulation currents
  • the neurostimulation system 100 computes suitable responsive stimulation current profiles to respond to a wide range of phenomena that the physiological data indicates is occurring. For example, in the case where the physiological data indicates that the user 10 has fallen asleep, the neurostimulation system 100 computes a responsive stimulation current profile that includes instructions to the electrode array to commence generating a stimulation current. These instructions (referred to hereinafter as “activation instructions”) typically also modify the status of the relevant stimulation current to “active” from “inactive. Similarly, in the case where the physiological data indicates that the user 10 has woken from sleep, the neurostimulation system 100 computes a responsive stimulation current profile that includes deactivation instructions to the electrode array to deactivate any active stimulation currents.
  • activation instructions typically also modify the status of the relevant stimulation current to “active” from “inactive.
  • the neurostimulation system 100 computes a responsive stimulation current profile that includes deactivation instructions to the electrode array to deactivate any active stimulation currents.
  • This functionality allows the neurostimulation system 100 to selectively and automatically activate the electrode arrays 132 and 134 when the user 10 falls asleep to commence neurostimulation therapy. Likewise, the functionality allows the neurostimulation system 100 to selectively and automatically deactivate the electrode arrays 132 and 134 when the user wakes from sleep to cease the neurostimulation therapy. Moreover, during the course of neurostimulation therapy, the feedback loop of receiving and processing physiological data and computing suitable responsive stimulation current profiles allows the neurostimulation system 100 to respond in real time and make appropriate modifications to neurostimulation therapy parameters. For example, neurostimulation system 100, in response to receiving specified physiological data computes a responsive stimulation current profile to either tonically or phasically stimulate the target nerve.
  • neurostimulation system 100 in response to receiving physiological data from the motion sensor 154 and/or camera 156 (discussed below) indicating that the user is lying in a particular body position, computes a responsive stimulation current profile to account for the sensed body position.
  • the neurostimulation system 100 computes a responsive stimulation current profile to take this into account, such as by activating the electrode array to deliver stimulation currents.
  • the system 100 includes control system 110, a memory device 114, a respiration monitoring device 120, positioning structure 35, one or more transmitters 140 (hereinafter, transmitter 140), one or more receivers 142 (hereinafter, receiver 142), a magnetic field generator 144, a wearable 146, one or more external sensors 150, and an external device 180.
  • the control system 110 includes one or more processors 112 (hereinafter, processor 112).
  • the control system 110 is generally used to control (e.g., actuate) the various components of the system 100 and/or analyze data obtained and/or generated by the components of the system 100.
  • the processor 112 can be a general or special purpose processor or microprocessor. While one processor 112 is shown in FIG. 7, the control system 110 can include any suitable number of processors (e.g., one processor, two processors, five processors, ten processors, etc.) that can be in a single housing, or located remotely from each other.
  • the control system 110 can be coupled to and/or positioned within, for example, a housing of the external device 180, within a housing 124 of the respiration monitoring device 120, a housing 136 of the stimulation device 130, or any combination thereof.
  • the control system 110 can be centralized (within one such housing) or decentralized (within two or more of such housings, which are physically distinct). In such implementations including two or more housings containing the control system 110, such housings can be located proximately and/or remotely from each other.
  • the memory device 114 stores machine-readable instructions that are executable by the processor 112 of the control system 110.
  • the memory device 114 can be any suitable computer readable storage device or media, such as, for example, a random or serial access memory device, a hard drive, a solid state drive, a flash memory device, etc. While one memory device 114 is shown in FIG. 7, the system 100 can include any suitable number of memory devices 114 (e.g., one memory device, two memory devices, five memory devices, ten memory devices, etc ).
  • the memory device 114 can be coupled to and/or positioned within the housing of the respiration monitoring device 120, within the positioning structure 35, or any combination thereof.
  • the memory device 114 can be centralized (within one such housing) or decentralized (within two or more of such housings, which are physically distinct).
  • the memory device 114 stores a user profile associated with the user.
  • the user profile can include, for example, demographic information associated with the user, biometric information associated with the user, medical information associated with the user, self-reported user feedback, sleep parameters associated with the user (e.g., sleep-related parameters recorded from a sleep session), or any combination thereof.
  • the demographic information can include, for example, information indicative of an age of the user, a gender of the user, a race of the user, a family history of insomnia or sleep apnea, an employment status of the user, an educational status of the user, a socioeconomic status of the user, or any combination thereof.
  • the medical information can include, for example, information indicative of one or more medical conditions associated with the user, medication usage by the user, or both.
  • the medical information data can further include a multiple sleep latency test (MSLT) result or score and/or a Pittsburgh Sleep Quality Index (PSQI) score or value.
  • the self-reported user feedback can include information indicative of a self-reported subjective sleep score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, a recent life event experienced by the user, or any combination thereof.
  • control system 110 and the memory device 114 are described and shown in FIG. 7 as being a separate and distinct component of the system 100, in some implementations, the control system 110 and/or the memory device 114 are integrated in the external device 180, and/or in the respiration monitoring device 120.
  • the control system 110 or a portion thereof e.g., the processor 112 can be located in a cloud (e.g., integrated in a server, integrated in an Internet of Things (loT) device, connected to the cloud, be subject to edge cloud processing, etc.), located in one or more servers (e.g., remote servers, local servers, etc , or any combination thereof
  • the respiration monitoring device 120 includes one or more sensors 122, a housing 124, and a power supply 126.
  • the one or more sensors 122 generate data associated with respiration of the user and encode such data into a respiration signal for the user
  • the one or more sensors 122 can include any suitable sensor(s) for generated data from which a respiration signal of the user can be determined (e.g., a signal indicative of inhalation and/or exhalation of the user).
  • the one or more sensors 122 includes an air pressure sensor (e.g., barometric pressure sensor, gauge, absolute transducer, etc.) that generates data indicative of the respiration (e.g., inhaling and/or exhaling) of the user.
  • the pressure sensor can be, for example, a capacitive sensor, an electromagnetic sensor, a piezoelectric sensor, a strain-gauge sensor, an optical sensor, a potentiometric sensor, or any combination thereof.
  • the one or more sensors 122 includes an air flow sensor that generates data indicative the respiration (e g., inhaling and/or exhaling) of the user.
  • the one or more sensors 122 includes a motion sensor that generates motion data indicative the respiration (e.g., inhaling and/or exhaling) of the user.
  • the one or more sensors 122 includes an acoustic sensor (e.g., including a microphone and/or a speaker) that generates data indicative of the respiration (e.g., inhaling and/or exhaling) of the user.
  • the one or more sensors 122 includes an electromyography (EMG) sensor that generates data indicative of the respiration (e.g., inhaling and/or exhaling) of the user.
  • EMG electromyography
  • the one or more sensors 122 includes a photoplethysmograph (PPG) sensor that generates data indicative of the respiration (e.g., inhaling and/or exhaling) of the user.
  • PPG photoplethysmograph
  • the one or more sensors 122 includes an oxygen sensor that generates data indicative of a blood oxygen level or oxygen saturation (SpCh), which in turn are indicative of respiration (e.g., inhaling and/or exhaling) of the user.
  • SpCh blood oxygen level or oxygen saturation
  • the sensor(s) 122 can be powered by the power supply 126.
  • the power supply 126 can be, for example, a battery (e.g., a rechargeable battery). In some implementations, the power supply 126 can be recharged by the magnetic field generator 144 and/or the external device 180. Alternatively to the respiration monitoring device 120 including the power supply 126, in some implementations, power for the sensor(s) is supplied wirelessly by the magnetic field generator 144 (which can be included in the external device 180) directly to the electrical sensor(s). [0068] In addition to the sensor(s) 122 and power supply 126 being coupled to or integrated in the housing 124, a number of other elements of the system 100 can be coupled to the housing 124 and placed into the user 10.
  • coupled to the housing 124 it is meant that the element coupled to the housing 124 is completely incased within the housing 124, attached to an exterior surface of the housing 124, partially protruding from one or more openings in the housing 124, directly or indirectly attached to the housing 124, or any combination thereof.
  • one or more of the transmitters 140 and/or one or more of the receivers 142 can be coupled to or integrated in the housing 124.
  • the transmitter 140 and/or receiver 142 allow the respiration monitoring device 120 to wirelessly communicate (e.g., using a Bluetooth communication protocol, a WiFi communication protocol, or any other suitable RF communication protocol) with the control system 110, the stimulation device 130, the external device 180 or any combination thereof (e.g., to transmit data generated by the sensor(s) 122 for analysis by the control system 110).
  • a Bluetooth communication protocol e.g., a WiFi communication protocol, or any other suitable RF communication protocol
  • the wireless communication frequency is in the MHz range, whereas breaching frequency is about 15 Hz.
  • the data the respiration monitoring device 120 can be wirelessly transmitted (e.g., to the control system 110) before the next inhalation and/or exhalation of the user.
  • positioning structure 35 includes electrode arrays 132 and 134 as well as a power supply 138.
  • the electrode arrays 132 and 134 are capable of delivering temporal interference stimulation to the user 10 to aid in causing the one or more muscles of the user 10 to contract.
  • the contraction of the one or more muscles of the user 10 can aid in opening an airway of the user 10.
  • the contraction can alternatively or additionally aid in causing the user 10 to have breathing effort (e.g., causing the diaphragm to draw/suck in air).
  • the electrical stimulation can be applied to the one or more muscles of the user 10 (e.g., muscles in the tongue of the user 10, muscles surrounding and/or adjacent to the tongue of the user 10, neck muscles, throat muscles, the palate, other soft issue generally in or around the airway of the user, etc.) and/or directly to the one or more nerves that are connected to the one or more muscles. Directing the electrical stimulation to the one or more nerves (as opposed to the one or more muscles directly) allows for a relatively lower intensity (e g., voltage, amperage, etc. or any combination thereof) of the electrical stimulation to be applied to cause the one or more muscles (connected to the one or more nerves) to contract.
  • a relatively lower intensity e., voltage, amperage, etc. or any combination thereof
  • a number of other elements of the system 100 can be coupled to the housing 136.
  • coupled to the housing 136 it is meant that the element coupled to the housing 136 is completely encased within the housing 136, attached to an exterior surface of the housing 136, partially protruding from one or more openings in the housing 136, directly or indirectly attached to the housing 136, or any combination thereof.
  • one or more of the transmitters 140 and/or one or more of the receivers 142 can be coupled to or integrated in the housing 136.
  • the transmitter 140 and/or receiver 142 allow the respiration monitoring device 120 to wirelessly communicate (e.g., using a Bluetooth communication protocol, a WiFi communication protocol, or any other suitable RF communication protocol) with the control system 110, the respiration monitoring device 120, or any combination thereof (e.g., to transmit a signal to actuate the positioning structure 35 to deliver electrical stimulation).
  • the transmitter 140 and the receiver 142 are combined as a transceiver.
  • the positioning structure 35 can be configured to automatically stimulate the user even if the respiration monitoring device 120 has failed (e.g., the respiration monitoring device 120 has ran out of battery or is no longer receiving power from the magnetic field generator 144).
  • the positioning structure can be configured to stimulate at a 50% duty cycle to continue to stimulate the tongue and to aid in keeping the airway clear during inspiration. While the stimulation may not occur at the optimal stimulation time and this may consume more power in the positioning structure, the user will receive at least some benefit from the automatic stimulation. The user can be alerted to any failures (e.g., of the respiration monitoring device 120) by the external device 180.
  • the wearable(s) 146 can be worn by the user and are generally used to position the magnetic field generator 144 adjacent to the respiration monitoring device 120 and/or the positioning structure to provide power as described herein.
  • the wearable(s) 146 can include a belt, a collar, a patch (e.g., an adhesive patch), clothing, a sleeve, a bracelet, a necklace, a watch, or any combination thereof.
  • the magnetic field generator 144 can be embedded in the wearable 146 and/or removable from the wearable 146.
  • the one or more external sensors 150 of the system 100 can be used to generate or obtain different physiological data associated with the user, with the data utilized to compute stimulation current profiles for the electrode arrays 132 and 134 of the positioning structure 35.
  • the one or more external sensors 150 can be used instead of the respiration monitoring device 120 to generate data associated with respiration of the user.
  • the one or more external sensors 150 can include an oxygen sensor 152, a motion sensor 154, a camera 156, an acoustic sensor 158, a radio-frequency (RF) sensor 164, a PPG sensor 170, a capacitive sensor 172, a force sensor 174, a strain gauge sensor 176, an EMG sensor 178, and an electrocardiogram (ECG) sensor 179, or any combination thereof.
  • Data from the sensor(s) 150 can be received and stored in the memory device 114 or one or more other memory devices.
  • the oxygen sensor 152 outputs oxygen data indicative of an oxygen concentration of gas (e.g., in the blood of the user).
  • the oxygen sensor 152 can be, for example, a pulse oximeter sensor, an ultrasonic oxygen sensor, an electrical oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, or any combination thereof.
  • the motion sensor 154 outputs motion data that is indicative of movement of the user.
  • the motion data from the motion sensor 154 can be used by the control system 110 to determine movement of the user (e.g., respiration).
  • the camera 156 outputs image data reproducible as one or more images (e.g., still images, video images, thermal images, or a combination thereof) that can be stored in the memory device 114.
  • the image data from the camera 156 can be used by the control system 110 to determine movement of the user (e.g., respiration).
  • the microphone 160 outputs sound data that can be stored in the memory device 114 and/or analyzed by the processor 112 of the control system 110.
  • the microphone 160 can be used to record sound(s) to determine (e.g., using the control system 110) a respiration signal for the user.
  • the speaker 162 outputs sound waves that are audible to a user of the system 100.
  • the speaker 162 can be used, for example, as an alarm clock or to play an alert or message to the user.
  • the microphone 160 and the speaker 162 can be combined into an acoustic sensor 158, as described in, for example, WO 2018/050913, which is hereby incorporated by reference herein in its entirety.
  • the speaker 162 generates or emits sound waves at a predetermined interval and the microphone 160 detects the reflections of the emitted sound waves from the speaker 162.
  • the sound waves generated or emitted by the speaker 162 have a frequency that is not audible to the human ear (e.g., below 20 Hz or above around 18 kHz).
  • the control system 110 can determine movement of the user (e.g., respiration).
  • the RF transmitter 168 generates and/or emits radio waves having a predetermined frequency and/or a predetermined amplitude (e.g., within a high frequency band, within a low frequency band, long wave signals, short wave signals, etc .).
  • the RF receiver 166 detects the reflections of the radio waves emitted from the RF transmitter 168, and this data can be analyzed by the control system 110 to determine movement of the user. While the RF receiver 166 and RF transmitter 168 are shown as being separate and distinct elements in FIG. 2, in some implementations, the RF receiver 166 and RF transmitter 168 are combined as a part of an RF sensor 164. In some such implementations, the RF sensor 164 includes a control circuit. The specific format of the RF communication could be WiFi, Bluetooth, etc.
  • the RF sensor 164 is a part of a mesh system.
  • a mesh system is a WiFi mesh system, which can include mesh nodes, mesh router(s), and mesh gateway(s), each of which can be mobile/movable or fixed.
  • the WiFi mesh system includes a WiFi router and/or a WiFi controller and one or more satellites (e.g., access points), each of which include an RF sensor that the is the same as, or similar to, the RF sensor 164.
  • the WiFi router and satellites continuously communicate with one another using WiFi signals.
  • the WiFi mesh system can be used to generate motion data based on changes in the WiFi signals (e.g., differences in received signal strength) between the router and the satellite(s) due to an object or person moving partially obstructing the signals.
  • the motion data can be indicative of motion, breathing, heart rate, gait, falls, behavior, etc., or any combination thereof.
  • the PPG sensor 170 outputs physiological data associated with the user that can be used to determine, for example, a heart rate, a heart rate variability, a cardiac cycle, respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, estimated blood pressure parameter(s), or any combination thereof.
  • the capacitive sensor 172, the force sensor 174, and the strain gauge sensor 176 output data that can be stored in the memory device 114 and used by the control system 110 to determine movement of the user (e.g., respiration).
  • the EMG sensor 178 outputs physiological data associated with electrical activity produced by one or more muscles.
  • the ECG sensor 179 outputs physiological data associated with electrical activity of the heart of the user.
  • the ECG sensor 179 includes one or more electrodes that are positioned on or around a portion of the user.
  • any combination of the one or more sensors 130 can be integrated in and/or coupled to any one or more of the components of the system 100, including the respiration monitoring device 120, the positioning structure 35, the control system 110, the external device 180, or any combination thereof.
  • the one or more external sensors 150 also include one or more of a temperature sensor, an EEG sensor, an analyte sensor, a moisture sensor, and a Light Detection and Ranging (LiDAR) sensor.
  • the LiDAR sensor can be used for depth sensing.
  • This type of optical sensor e g., laser sensor
  • LiDAR can generally utilize a pulsed laser to make time of flight measurements. LiDAR is also referred to as 3D laser scanning.
  • a fixed or mobile device such as a smartphone having a LiDAR sensor can measure and map an area extending 5 meters or more away from the sensor.
  • the LiDAR data can be fused with point cloud data estimated by an electromagnetic RADAR sensor, for example.
  • the LiDAR sensor(s) can also use artificial intelligence (Al) to automatically geofence RADAR systems by detecting and classifying features in a space that might cause issues for RADAR systems, such a glass windows (which can be highly reflective to RADAR).
  • LiDAR can also be used to provide an estimate of the height of a person, as well as changes in height when the person sits down, or falls down, for example.
  • LiDAR may be used to form a 3D mesh representation of an environment.
  • the LiDAR may reflect off such surfaces, thus allowing a classification of different type of obstacles.
  • the external device 180 includes a display device 182.
  • the external device 180 can be, for example, a mobile device such as a smart phone, a tablet, a laptop, or the like.
  • the external device 180 can be an external sensing system, a television (e.g., a smart television) or another smart home device (e.g., a smart speaker(s) such as Google Home, Amazon Echo, Alexa etc ).
  • the external device 180 is a wearable device (e.g., a smart watch).
  • the display device 182 is generally used to display image(s) including still images, video images, or both.
  • the display device 182 acts as a human-machine interface (HMI) that includes a graphical user interface (GUI) configured to display the image(s) and an input interface.
  • HMI human-machine interface
  • GUI graphical user interface
  • the display device 182 can be an LED display, an OLED display, an LCD display, or the like.
  • the input interface can be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the external device 180.
  • one or more external devices can be used by and/or included in the system 100.
  • system 100 is shown as including all of the components described above, more or fewer components can be included in a system for aiding a user (e.g., in breathing) according to implementations of the present disclosure.
  • a first alternative system includes the control system 110, the memory device 114, the respiration monitoring device, and the stimulation device.
  • a second alternative system includes the control system 110, the memory device 114, the respiration monitoring device 120, the stimulation device 130, and the external device 180.
  • a third alternative system includes the respiration monitoring device 120 and the stimulation device 130.
  • various systems can be formed using any portion or portions of the components shown and described herein and/or in combination with one or more other components.
  • FIGs. 5 and 6 Further embodiments of the present disclosure are illustrated in FIGs. 5 and 6.
  • the illustrated embodiments similarly include a positioning structure 50 that houses a plurality of stimulating elements.
  • the user 10 either wears an earpiece that incorporates a bone-conduction microphone 52, or a bone-conduction microphone 53 is integrated into the positioning structure 50.
  • Bone-conduction microphones are illustrated in FIGs. 5 and 6.
  • the earpiece 52 and 53 function as acoustic sensors in a similar way to the sensor 122 in the respiratory monitoring device 120 and the acoustic sensor 158 of the external sensor array 150 described above.
  • the earpiece holds the bone-conduction microphone 52 behind the user’s ear in contact with the skull.
  • the positioning structure 50 holds the bone-conduction microphone
  • the bone-conduction microphones 52 and 53 are configured to detect vibrations that are produced by anatomical sound sources (such as breathing sounds) and travel through the bones, typically through the bones in the skull. Upon detection of bone vibrations, the bone-conduction microphones’ 52 and 53 transducing elements convert the vibrations into an electrical signal. In this way, the bone-conduction microphones 52 and 53 are capable of producing a physiological data signal that includes data pertaining to the sound of the user’s breathing. In turn (as discussed below), the control system 110 can be configured to process the physiological data signal that the bone-conduction microphones 52 and 53 produce and compute responsive stimulation current profiles that take account of the recorded breathing sounds.
  • Bone-conduction microphone 52 can be placed in contact with other bones and bone structures apart from the skull and neck. Referring to FIG. 6, bone-conduction microphone 55 is placed in contact with the sternum. In this position, bone-conduction microphone 55 is adapted to detect vibrations produced by breathing sounds that originate in the lungs and travel through the skeletal structure to the sternum. [0090] Use of bone-conduction microphones 52, 53, 55 to capture sounds has a number of advantages over traditional air-conduction microphones. Principally, bone-conduction microphones are well suited to detect target breathing sounds and cancel out other sounds in the environment. In this regard, generally any airborne sounds that can be detected by the human ear can also be picked up by traditional air-conduction microphones.
  • neurostimulation system 100 operates (namely the user’s sleeping environment) sounds other than the user’s breathing sounds are often present.
  • additional sounds in this regard that are at risk of being detected by a traditional air-conduction microphone are the breathing and other sounds produced by the user’s 100 partner.
  • Utilizing a bone-conduction microphone to detect breathing sounds also provides flexibility over traditional air-conduction microphones in terms of choosing the position of the microphone relative to the user.
  • traditional microphones generally need to be located in proximity to the user’s 100 mouth or nose in order to acquire a breathing sound signal with an appropriate signal-to-noise ratio.
  • positioning structure 50 includes other sensors 56, battery 58, power management integrated circuit 61, microcontroller or microprocessor 62, charging circuit (inductive or wired) 64, wireless chip (typically Bluetooth Low Energy or WIFI) 66, storage 68, other circuits 70, electrical current generator 72 and skin electrodes 132.
  • FIG. 9 an embodiment of computing operations 200 performed by the processor 112 to compute responsive stimulation current profiles according to some implementations of the present disclosure is illustrated.
  • Step 201 of the operations 200 includes the control system 110 receiving an initial physiological data signal that includes data pertaining to an initial measurement of a physiological data parameter of the user 10.
  • step 201 can include receiving an initial physiological data signal from the respiration monitoring device 120 or from one or more of the other sensors (namely oxygen sensor 152, camera 156, acoustic sensors 158, bone conduction microphones 52, 53, 55, ppg sensor 170, capacitive sensor 172, force sensor 174, strain gauge sensor 176, EMG sensor 178 and ECG sensor 179(FIGs. 7 and 8).
  • the initial physiological data signal can be transmitted from the respiration monitoring device 120 or external sensors 150 and received by the memory device 114 for analysis by the processor 112 of control system 110.
  • the initial physiological data signal can be transmitted from the respiration monitoring device 120 and received by the external device 180.
  • Step 202 includes the processor 112 computing an initial responsive stimulation current profile on the basis of the initial measurement of the physiological data parameter.
  • processor 112 computes stimulation current profiles by processing the physiological data and computing a stimulation current profile that is intended to control the neurostimulation to account for the current measurement of the physiological data parameter.
  • processor 112 processes the physiological data to determine an occurrence of an apnea event and computes an apnea-related responsive stimulation current profile that accounts for the occurrence of the apnea event.
  • the apnea-related responsive stimulation current profile includes stimulation activation instructions that instruct the electrodes 132 to generate a stimulation current that stimulates the user’s hypoglossal nerve and thus terminates the apnea event.
  • Step 203 includes the control system 110 receiving a subsequent physiological data signal that includes data pertaining to a subsequent measurement of the physiological data parameter of the user.
  • Step 204 includes the control system 110 performing a comparison of the initial physiological data signal and the subsequent physiological data signal.
  • the signal comparison allows the control system to gain insight into the effectiveness of the initial responsive stimulation current profile that the electrode arrays 132 and 134 applied to the target nerve. For example, if the initial physiological data indicated that nerve stimulation was not occurring or that the condition being treated by the nerve stimulation was persisting (such as a closed airway leading to apnea events), a comparison with the subsequent physiological data provides insights into whether the initial responsive stimulation current profile resolved the issues.
  • the subsequent physiological data comprises data pertaining to breathing sounds detected after the application of a stimulating current. Processing the physiological data signal to determine whether further apnea events are occurring allows the system to gauge the effectiveness of the stimulation.
  • Step 205 includes the processor 112 computing a subsequent responsive stimulation current profile on the basis of the comparison of the initial measurement of the physiological data parameter and the subsequent measurement of the physiological data parameter.
  • the subsequent responsive stimulation current profile may be the same or differ from the initial responsive stimulation current profile.
  • the signal comparison indicates that the deficiencies in nerve stimulation or applied therapy have been resolved by the initial responsive stimulation current profile, then the subsequent responsive stimulation current profile is typically substantially the same as the initial responsive stimulation current profile.
  • the processor 112 computes a distinct subsequent responsive stimulation current profile with a view of addressing the identified deficiencies.
  • processor 112 can be configured to perform a comparison between the physiological data signal and a breathing profile that is generated for the user 10.
  • the breathing profile is typically generated from the user’s breathing sounds that are collected from the bone-conduction microphone 52, 53, 55.
  • the breathing profile encodes an “ideal” breathing cycle that would prevail in the absence of apnea events.
  • Such a breathing profile is a useful marker against which detected breathing sounds can be prepared and the occurrence of apnea events determined. For example, comparing detected breathing sounds against an ideal breathing profile provides insights into whether the actual inhalation and/or exhalation coincides with the ideal inhalation or exhalation.

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Abstract

La présente invention concerne un système de neurostimulation, comprenant : une structure de positionnement logeant au moins deux éléments de stimulation conçus pour recevoir un signal de profil de courant de stimulation respectif et pour générer des premier et second courants de stimulation en fonction de celui-ci, une mémoire stockant des instructions lisibles par machine ; et un système de commande qui applique, en réponse, une stimulation d'interférence temporelle au nerf cible, : en recevant un signal de données physiologiques, en traitant le signal de données physiologiques reçu ; et en transmettant des signaux de profil de courant de stimulation sensibles contenant le profil de courant de stimulation sensible calculé, le profil de courant de stimulation sensible comprenant des paramètres de courant de stimulation comprenant : le nombre de courants de stimulation et/ou la fréquence de chaque courant de stimulation et/ou la différence de fréquence entre deux courants de stimulation et/ou l'amplitude de chaque courant de stimulation et/ou la forme de forme d'onde de chaque courant de stimulation et/ou la largeur de forme d'onde de chaque courant de stimulation.
PCT/AU2025/050797 2024-07-25 2025-07-25 Système et procédés de neurostimulation Pending WO2026020207A1 (fr)

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AU2024902315 2024-07-25
AU2024902315A AU2024902315A0 (en) 2024-07-25 Neurostimulation system and method
AU2024903571 2024-11-01
AU2024903571A AU2024903571A0 (en) 2024-11-01 Neurostimulation system and method

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130204314A1 (en) * 2011-12-07 2013-08-08 Otologics, Llc Sleep Apnea Control Device
US20170333706A1 (en) * 2014-10-31 2017-11-23 Avent, Inc. Non-Invasive Nerve Stimulation System and Method
US20200297995A1 (en) * 2019-03-22 2020-09-24 Neurostim Technologies Llc Detection and Treatment of Obstructive Sleep Apnea
US20230271013A1 (en) * 2020-10-01 2023-08-31 Sunrise Sa Wearable device for decreasing the respiratory effort of a sleeping subject

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130204314A1 (en) * 2011-12-07 2013-08-08 Otologics, Llc Sleep Apnea Control Device
US20170333706A1 (en) * 2014-10-31 2017-11-23 Avent, Inc. Non-Invasive Nerve Stimulation System and Method
US20200297995A1 (en) * 2019-03-22 2020-09-24 Neurostim Technologies Llc Detection and Treatment of Obstructive Sleep Apnea
US20230271013A1 (en) * 2020-10-01 2023-08-31 Sunrise Sa Wearable device for decreasing the respiratory effort of a sleeping subject

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