Belt with built-in stimulator

By integrating sensors and stimulators into a neck collar, the system analyzes and responds to the user's airway condition in real time, providing electrical stimulation to prevent and stop sleep apnea. This solves the problems of discomfort and high cost of existing systems, achieving a more comfortable and effective treatment for respiratory disorders.

CN114222605BActive Publication Date: 2025-12-30RESMED PTY LTD
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Patent Information

Application Number
CN202080057208.0
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2019-06-28
Filing Date
2020-06-26
Publication Date
2025-12-30
Estimated Expiration
2040-06-26

AI Technical Summary

Technical Problem

Existing systems for treating sleep apnea and related breathing disorders are often uncomfortable, difficult to use, and expensive, necessitating a more comfortable and effective alternative.

Method used

A system comprising a neck collar, a stimulator, sensors, a memory, and a control system is designed. The system collects data through sensors to analyze the user's airway condition and uses the stimulator to provide electrical stimulation to prevent or stop sleep apnea events. The stimulator is worn on the user's neck through the neck collar, near the airway muscles or nerves. The sensors generate airway-related data, and the control system analyzes the data and controls the operation of the stimulator.

Benefits of technology

It provides a comfortable and effective way to prevent and stop sleep apnea events, avoiding the discomfort and high cost of traditional systems and improving the user experience.

✦ Generated by Eureka AI based on patent content.

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Abstract

A system includes a collar to be worn around a user's neck. A stimulator is coupled to the collar such that the stimulator is positioned proximate to the user's airway. A sensor is coupled to the collar and is configured to generate data associated with the user's airway. A memory is coupled to the collar and stores machine-readable instructions. A control system is coupled to the collar and includes one or more processors configured to execute the machine-readable instructions to determine, based at least on an analysis of the generated data, that the user is currently experiencing an apnea event. In response to the determination, the control system causes the stimulator to provide electrical stimulation to one or more muscles proximate to the user's airway at a first intensity level to help stop the apnea event.
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Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 868,336, filed June 28, 2019, which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates to the treatment of respiratory-related disorders, and more specifically to systems and methods having a band having a stimulator for resolving one or more types of sleep apnea events. Background Technology

[0004] Various systems exist to assist users experiencing sleep apnea and related breathing disorders. Some of these systems rely on a mask worn by the user to help supply pressurized air into the user's airway. Some users find these systems uncomfortable, difficult to use, expensive, or unsightly.

[0005] Therefore, there is a need for alternative systems and methods for addressing sleep apnea and related breathing disorders. This invention aims to address these problems and other needs. Summary of the Invention

[0006] According to some embodiments of this disclosure, a method for assisting a user includes receiving data associated with the user's airway from one or more sensors. The method further includes analyzing the data to determine (i) whether the user is experiencing an apnea event, (ii) whether the user is about to experience an apnea event, (iii) whether the user is no longer experiencing an apnea event, (iv) or any combination thereof. The method also includes, in response to determining that (i) the user is experiencing an apnea event or (ii) the user is about to experience an apnea event, causing a stimulator to provide electrical stimulation to help stop or prevent the apnea event.

[0007] According to some embodiments of this disclosure, a system for assisting a user includes a neck collar, a stimulator, a sensor, a memory, and a control system. The neck collar is configured to be worn around the user's neck. The stimulator is coupled to the neck collar such that, when the neck collar is worn around the user's neck, the stimulator is positioned to provide electrical stimulation to (i) one or more muscles adjacent to the user's airway, (ii) one or more nerves associated with the one or more muscles, or (iii) both (i) and (ii). The sensor is coupled to the neck collar such that, when the neck collar is worn around the user's neck, the sensor is configured to generate data associated with the user's airway. The memory stores machine-readable instructions. The control system includes one or more processors configured to execute the machine-readable instructions to analyze the generated data to determine (i) whether the user is experiencing an apnea event, (ii) whether the user is about to experience an apnea event, (iii) whether the user is no longer experiencing an apnea event, (iv) or any combination thereof. In response to determining that (i) the user is experiencing an apnea event or (ii) the user is about to experience an apnea event, the control system causes the stimulator to provide electrical stimulation to help stop or prevent the apnea event.

[0008] According to some embodiments of this disclosure, a method for assisting a user includes receiving data associated with the user's airway from one or more sensors. The method further includes determining, at least in part, that the user is currently experiencing a sleep apnea event based on the data. The method also includes, in response to determining that the user is currently experiencing a sleep apnea event, causing a stimulator to provide electrical stimulation at a first intensity level to one or more muscles adjacent to the user's airway to help stop the sleep apnea event.

[0009] According to some embodiments of this disclosure, a system for assisting a user includes a neck collar, a stimulator, a sensor, a memory, and a control system. The neck collar is configured to be worn around the user's neck. The stimulator is coupled to the neck collar such that when the neck collar is worn around the user's neck, the stimulator is positioned adjacent to the user's airway. The sensor is coupled to the neck collar and configured to generate data associated with the user's airway. The memory is coupled to the neck collar and stores machine-readable instructions. The control system is coupled to the neck collar and includes one or more processors configured to execute machine-readable instructions to determine, at least based on analysis of the generated data, that the user is currently experiencing a sleep apnea event. In response to determining that the user is currently experiencing a sleep apnea event, the control system causes the stimulator to provide electrical stimulation at a first intensity level to one or more muscles adjacent to the user's airway to help stop the sleep apnea event.

[0010] According to some embodiments of this disclosure, a method for assisting a user's breathing during sleep includes receiving first data from a first sensor. The method also includes receiving second data from a second sensor. The method further includes analyzing the first data to determine whether the user is currently experiencing a first type of apnea event. The method also includes analyzing the second data to determine whether the user is currently experiencing a second type of apnea event, different from the first type. The method further includes, in response to the analysis based on the first data determining that the user is currently experiencing a first type of apnea event, causing a first stimulator to provide electrical stimulation to one or more muscles adjacent to the user's airway to help stop the first type of apnea event. The method further includes, in response to the analysis based on the second data determining that the user is currently experiencing a second type of apnea event, causing a second stimulator to provide electrical stimulation to the user's diaphragm to help stop the second type of apnea event.

[0011] According to some embodiments of this disclosure, a system for assisting a user's breathing during sleep includes a first band, a first stimulator, a second band, a second stimulator, a first sensor, a second sensor, a memory, and a control system. The first band is configured to be worn around the user's neck. The first stimulator is coupled to the first band such that, when the first band is worn around the user's neck, the first stimulator is positioned to provide electrical stimulation to one or more muscles adjacent to the user's airway. The second band is configured to be worn around the user's chest or abdomen. The second stimulator is coupled to the second band such that, when the second band is worn around the user's chest or abdomen, the second stimulator is positioned to provide electrical stimulation to the user's diaphragm. The first sensor is coupled to the first band and configured to generate first data. The second sensor is coupled to the second band and configured to generate second data. The memory stores machine-readable instructions. The control system includes one or more processors configured to execute the machine-readable instructions to: (i) analyze the generated first data to determine whether the user is currently experiencing a first type of apnea event, and (ii) analyze the generated second data to determine whether the user is currently experiencing a second type of apnea event different from the first type of apnea event. In response to determining that the user is currently experiencing a Type I apnea event, the control system causes a first stimulator to deliver electrical stimulation to one or more muscles adjacent to the user's airway to help stop the Type I apnea event. In response to determining that the user is currently experiencing a Type II apnea event, the control system causes a second stimulator to deliver electrical stimulation to the user's diaphragm to help stop the Type II apnea event.

[0012] Given the detailed description of various embodiments and / or implementations with reference to the accompanying drawings, the foregoing and additional aspects and implementations of this disclosure will be apparent to those skilled in the art, and a brief description of the drawings is provided below. Attached Figure Description

[0013] The foregoing and other advantages of this disclosure will become apparent from reading the following detailed description and referring to the accompanying drawings.

[0014] Figure 1A It is a diagram showing an overview of the user's respiratory system;

[0015] Figure 1B It is shown Figure 1A A diagram of the user's upper airway;

[0016] Figure 2 This is a block diagram of a system for assisting a user (e.g., during breathing during sleep) according to some embodiments of this disclosure;

[0017] Figure 3A This is a front view plan of a system (unfolded) in the form of a strap / neck collar for assisting a user (e.g., during breathing during sleep) according to some embodiments of this disclosure;

[0018] Figure 3B yes Figure 3A The rear plan view of the system (expanded);

[0019] Figure 3C It is worn / worn by the user. Figure 3A A perspective view of the system; and

[0020] Figure 4 This is a cross-sectional view of a user wearing a system according to some embodiments of the present disclosure, the system including two straps for assisting the user (e.g., during breathing during sleep).

[0021] While this disclosure allows for various modifications and alternatives, specific embodiments are illustrated by way of example in the accompanying drawings and will be described in detail herein. However, it should be understood that this disclosure is not intended to be limited to the specific forms disclosed. Rather, this disclosure will cover all modifications, equivalents, and substitutions falling within the spirit and scope of this disclosure as defined by the appended claims. Detailed Implementation

[0022] refer to Figure 1AThis diagram illustrates an overview of the respiratory system 12 of a user 10A (e.g., a patient), which typically includes the nasal cavity, oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. More generally, the user 10A has a larynx 20A that encompasses the region of the user 10A's respiratory system 12, typically located in the neck region of the user 10A. The diaphragm of the user 10A is a muscular sheet that extends across the bottom of the user 10A's ribcage. The diaphragm typically separates the thoracic cavity 30A, containing the heart, lungs, and ribs, from the abdominal cavity 40A of the user 10A. When the diaphragm contracts, the volume of the thoracic cavity 30A increases and air is drawn into the lungs.

[0023] As described in more detail below, one or more stimulators of this disclosure may be positioned on user 10A (e.g., via one or more straps / neck collars / bands, etc.) to assist user 10A in breathing, for example, during sleep. For example, one or more stimulators may be located on or near the larynx 20A of user 10A (e.g., adjacent to one or more nerves of the muscles innervating the neck / larynx and / or diaphragm, and / or adjacent to one or more muscles in the neck / larynx 20A of user 10), on or near the thoracic cavity 30A and / or abdominal cavity 40A (e.g., adjacent to the diaphragm of user 10), or any combination thereof.

[0024] refer to Figure 1B The image shows a view of the upper airway 14 of user 10A, which includes the nasal cavity, nasal bones, external nasal cartilages, greater alar cartilages, nostrils (one shown), supralipal and sublipal regions, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0025] User 10A's respiratory system 12 facilitates gas exchange. User 10A's nose 50 and mouth 60 form the entrance to user 10A's airway. Figure 1A As best illustrated, the airways consist of a series of branching tubes that become narrower, shorter, and more numerous as they penetrate deeper into the user's lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into the venous blood and allowing carbon dioxide to move in the opposite direction. The trachea divides into the left and right main bronchi, which eventually further divide into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar regions of the lungs are where gas exchange occurs and are called the respiratory zones.

[0026] There are a range of breathing disorders that can affect user 10A. Some conditions are characterized by specific events (such as apnea, hypoventilation, hyperventilation, or any combination thereof). Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity-induced hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0027] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. OSA is caused by a combination of abnormally small loss of normal upper airway and muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. The condition causes affected patients to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. OSA often leads to excessive daytime sleepiness and can cause cardiovascular disease and brain damage. The syndrome is common, especially in middle-aged overweight men, but those affected may not be aware of the problem.

[0028] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is an impairment of the user's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as the CSR cycle. CSR is characterized by repeated deoxygenation and reoxidation of arterial blood. CSR can be harmful due to repetitive hypoxia. In some users, CSR is associated with recurrent awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload.

[0029] Respiratory failure is a broad term encompassing respiratory disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the user's needs. Respiratory failure may cover some or all of the following conditions.

[0030] Users with respiratory insufficiency (a form of respiratory failure) may experience unusual shortness of breath during exercise.

[0031] Obesity hyperventilation syndrome (OHS) is a combination of severe obesity and chronic hypercapnia at wakefulness, without any other known cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0032] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These include increased air resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0033] Neuromuscular disease (NMD) is a broad term encompassing many conditions and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some patients with NMD are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular diseases can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive diseases: characterized by muscle damage that worsens over months and leads to death within years (amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive diseases: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, difficulty swallowing, shortness of breath during and at rest, fatigue, drowsiness, morning headaches, difficulty concentrating, and mood swings.

[0034] Chest wall disorders are a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0035] According to some embodiments of this disclosure, a system (e.g., system 100, 200, 300) is provided to assist a user (e.g., a patient) experiencing a breathing event (e.g., apnea) during sleep. Apnea typically occurs when a user's airflow drops below a predetermined threshold for a period of time (e.g., 10 seconds). A first type of apnea event is called obstructive apnea. Obstructive apnea typically occurs when, despite the user's effort to breathe, some obstruction in the airway prevents airflow. A second type of apnea event is called central apnea. Central apnea typically occurs when apnea is detected, and this apnea is due to a reduced or absent breathing effort, even though the airway is open (e.g., open). A third type of apnea event is called mixed apnea. Mixed apnea typically occurs when a reduced or absent breathing effort occurs simultaneously with an obstructed airway.

[0036] refer to Figure 2A block diagram of a system 100 for assisting a user (e.g., user 10A) is shown. System 100 can assist user 10A in (i) breathing while asleep, (ii) breathing while awake, (iii) opening the user's airway, (iv) initiating or increasing respiratory function (e.g., diaphragmatic contraction), (v) or any combination thereof. In some embodiments, system 100 assists user 10A by causing contractions of one or more muscles of user 10A to (i) open the user's airway, (ii) induce the user 10A to inhale air (e.g., breathing effort), or (iii) both.

[0037] System 100 includes one or more of the following: a strap 102 (e.g., a neck collar, chest strap, torso strap, waist belt, band, etc.), a stimulator 104, a motion sensor 112, a microphone 116, a conductivity sensor 118, a heart rate sensor 120, a photoplethysmography (PPG) sensor 124, one or more other sensors 126 (e.g., an EKG sensor, an EEG sensor, an EMG sensor, a blood flow sensor, a respiration sensor, a pulse sensor, etc.), a memory 128, a control system 130, a battery 132, a docking station 150, or any combination thereof. That is, system 100 may include any part and any combination of these elements, and these elements may be combined in a variety of different arrangements (e.g., physical and / or wireless) and / or housings.

[0038] According to some embodiments of this disclosure, a portion of these elements of system 100 is coupled to and / or built into belt 102, such that during use of system 100, user 10A wears / worn system 100 (e.g., or a portion of system 100) by positioning belt 102 around a portion of user 10A's body (e.g., user 10A's neck, user 10A's chest, user 10A's abdomen, user 10A's torso, etc.). In some embodiments, all elements of system 100, except docking station 150, are coupled to or built into belt 102 and worn by user 10A during use of system 100.

[0039] The stimulator 104 is coupled to and / or built into the band 102. Thus, when the band 102 is worn around the neck of the user 10A, one or more electrical leads 105 of the stimulator 104 are positioned adjacent to one or more muscles of the user 10A and / or connected to one or more nerves of the user 10A to one or more muscles of the user 10A.

[0040] In some embodiments, the one or more electrical leads 105 include a first electrical lead 105 positioned to stimulate a first of the one or more muscles and / or a first of the one or more nerves. Similarly, a second electrical lead 105 is positioned to stimulate a second of the one or more muscles and / or a second of the one or more nerves. In some such embodiments, the first electrical lead 105 is positioned on a first side of the airway of the user 10A, and the second electrical lead 105 is positioned on a second opposite side of the airway of the user 10A.

[0041] In some embodiments, the first electrical lead 105 provides electrical stimulation at a first frequency, and the second electrical lead 105 provides electrical stimulation at a second frequency different from the first frequency. In some embodiments, the first electrical lead 105 provides electrical stimulation at a first intensity, and the second electrical lead 105 provides electrical stimulation at a second intensity different from the first intensity.

[0042] In some alternative embodiments, the stimulator 104 is leadless. In such alternative embodiments, the stimulator 104 is coupled to and / or built into the band 102, such that one or more ends of the body of the stimulator 104 protrude from the band 102 to contact the skin of the user 10A and serve as electrodes.

[0043] Once the band 102 is worn around the neck of the user 10A, the stimulator 104 is able to deliver electrical and / or magnetic stimulation to the user 10A to help induce contraction of one or more muscles in the user 10A. Contraction of one or more muscles in the user 10A can help open the user 10A's airway. This contraction can alternatively or additionally help the user 10A to have a breathing effort (e.g., causing the diaphragm to inhale / exhale air).

[0044] Electrical stimulation can be applied directly (e.g., through the skin of user 10A) to one or more muscles of user 10A (e.g., muscles in the throat 20A of user 10A, muscles around and / or near the airway of user 10A, the diaphragm of user 10A, etc., or any combination thereof) and / or directly (e.g., through the skin of user 10A) to one or more nerves connected to one or more muscles. Directing electrical stimulation to one or more nerves (as opposed to directing it to one or more muscles) allows the application of relatively low-intensity electrical stimulation (e.g., voltage, ampere, etc., or any combination thereof) to induce contraction of one or more muscles (connected to one or more nerves).

[0045] Stimulator 104 includes or is an electrical conductor (e.g., one or more conductive wires with or without electrically insulating portions). Stimulator 104 includes one or more electrical leads 105 capable of carrying and / or flowing current and delivering the current to one or more muscles and / or one or more nerves of user 10A. The current may be supplied by battery 132 or other power sources directly and physically connected to stimulator 104. Battery 132 may be rechargeable. In some embodiments, battery 132 may be recharged by docking station 150 in a wired or wireless manner (e.g., when system 100 is not worn / used by user 10A). Alternatively, or in addition to stimulator 104 including battery 132, in some embodiments, current is supplied via a wired connection (e.g., a wire connecting system 100 to a wall power outlet, etc.).

[0046] In some embodiments, the stimulator 104 comprises only one or more conductive wires, with or without portions being electrically insulated. In some such embodiments, the stimulator 104 has a length between about 1 mm and about 100 cm; between about 1 mm and about 100 mm; between about 1 mm and about 10 mm; or any length in between. Furthermore, in some such embodiments, the stimulator 104 has a diameter between about 0.01 mm and about 5 mm; between about 0.1 mm and about 2 mm; between about 0.1 mm and about 1 mm; or any diameter in between. The size and shape of the stimulator 104 can be selected such that the stimulator 104 can be integrated into the band 102.

[0047] In addition to the stimulator 104 being coupled to and / or built into the band 102, a number of other components of the system 100 may be coupled to and / or built into the band 102 and worn around the neck of the user 10A. For example, in some embodiments, a motion sensor 112, a microphone 116, a conductivity sensor 118, a heart rate sensor 120, a photoplethysmography (PPG) sensor 124, other sensors 126, a memory 128, a control system 130, a battery 132, or any combination thereof may be coupled to and / or built into the band 102 along with the stimulator 104. Coupling to and / or being built into the band 102 means that the component is completely encapsulated within the band 102, attached to the outer surface of the band 102, partially protruding from one or more openings in the band 102, directly or indirectly attached to the band 102, or any combination thereof.

[0048] System 100 may include one or more of various sensors. These sensors may generate data that can be analyzed by control system 130 and / or by one or more other systems (e.g., mobile phone, computer, server, cloud-based device, etc.). Data analysis is used to determine information and / or make decisions regarding the application and / or cessation of electrical stimulation to user 10A via stimulator 104.

[0049] In some such embodiments, system 100 includes a motion sensor 112. The motion sensor 112 may include one or more accelerometers, one or more gyroscopes, or any combination thereof. The motion sensor 112 can be used to generate motion data indicative of breathing or insufficient breathing in user 10A. In some embodiments, the motion sensor 112 is coupled to and / or built into a strap 102, such that when the strap 100 wraps around the neck / throat 20A of user 10A… Figure 1A and Figure 1B When worn, the motion sensor 112 is positioned near the airway of the user 10A. In this way, the motion sensor 112 can generate data associated with the movement or lack of movement of the airway indicating breathing or lack of breathing (e.g., movement, expansion, contraction, etc. of the neck / larynx 20A adjacent to the airway indicating breathing).

[0050] Similarly, in some other embodiments, motion sensor 112 is coupled to and / or built into strap 102 such that when strap 100 is worn around the torso of user 10A (e.g., around the chest cavity 30A and / or abdominal cavity 40A), motion sensor 112 is positioned adjacent to the lungs and / or diaphragm of user 10A. In this way, motion sensor 112 is capable of generating data associated with movement or lack of movement of the lungs and / or diaphragm, indicating respiratory effort or lack of breathing (e.g., movement, expansion, retraction, etc., of user 10A's torso indicate breathing).

[0051] In addition to, or as an alternative to, motion sensor 112, system 100 may include microphone 116, conductivity sensor 118, heart rate sensor 120, PPG sensor 124, other sensors 126, or any combination thereof, wherein such sensors or portions thereof are coupled to and / or integrated into strip 102 in the same or similar manner as described above for motion sensor 112.

[0052] For example, in some embodiments, system 100 includes a PPG sensor 124 coupled to and / or built into the strap 102. Accordingly, when user 10A wears / wears the strap 102 (e.g., as a neck collar), the PPG sensor 124 is positioned adjacent to the throat 20A or on the neck of user 10A. In such embodiments, the PPG sensor 124 is capable of generating data indicative of blood flow in the user 10A's adjacent airway, blood oxygen levels in the user 10A's adjacent airway, the user 10A's heart rate, current apnea events experienced by the user 10A, potential future apnea events experienced by the user 10A, or any combination thereof.

[0053] In another example, in some implementations, system 100 includes a microphone 116 coupled to and / or built into a strap 102. Accordingly, when user 10A wears strap 102 (e.g., as a neckband, chest strap, waistband, etc.), microphone 116 is positioned near user 10A's throat 20A or torso. In such implementations, microphone 116 is capable of generating data (e.g., sound data) indicative of snoring, apnea, an apnea event currently being experienced by user 10A, an apnea event that user 10A may experience in the future, or any combination thereof.

[0054] In another example, in some implementations, system 100 includes a heart rate sensor 120 coupled to and / or built into the strap 102. Thus, when user 10A wears the strap 102 (e.g., as a neckband, chest strap, waistband, etc.), the heart rate sensor 120 is positioned near the user 10A's throat 20A or torso. In this implementation, the heart rate sensor 120 is capable of generating data indicating the user 10A's heart rate and / or pulse.

[0055] Other sensors 126 that may be included in and coupled to the band 102 and / or built into the band 102 include, for example, a blood oxygen sensor, a blood flow sensor, a pulse sensor, a respiration sensor, an EKG sensor, an EMG sensor, a strain gauge, an accelerometer, or any combination thereof. Each of these other sensors 126 may generate data that can be analyzed by the control system 130 and / or one or more other systems to determine information and / or make decisions regarding the application and / or cessation of electrical stimulation to be applied to the user 10A via the stimulator 104.

[0056] Memory 128 may include one or more physically separate memory devices, such that the one or more memory devices can be coupled to and / or integrated into one or more external devices (e.g., mobile phones, computers, servers, cloud-based devices, etc.) that are wirelessly connected to system 100 via 102. Memory 128 serves as a non-transient computer-readable storage medium on which machine-readable instructions executable by control system 130 and / or one or more other systems are stored. Memory 128 is also capable of (temporarily and / or permanently) storing data generated by sensors of system 100. In some embodiments, memory 128 includes non-volatile memory, battery-powered static RAM, volatile RAM, EEPROM memory, NAND flash memory, or any combination thereof. In some embodiments, memory 128 is a removable form of memory 128 (e.g., a memory card).

[0057] Similar to memory 128, control system 130 may be coupled to band 102 and / or one or more external devices. Control system 130 is coupled to memory 128 such that control system 130 is configured to execute machine-readable instructions stored in memory 128. Control system 130 may include one or more processors and / or one or more controllers. In some embodiments, the one or more processors include one or more x86 Intel processors, based on those from ARM Holdings. One or more processors, such as the STM32 series microcontrollers from ST Microelectronics, or any combination thereof. In some implementations, one or more processors include a 32-bit RISC CPU, such as the STR9 series microcontrollers from ST Microelectronics, or a 16-bit RISC CPU, such as a processor from the MSP430 series microcontrollers, manufactured by Texas Instruments.

[0058] In some embodiments, the control system 130 is a dedicated electronic circuit. In some embodiments, the control system 130 is a dedicated integrated circuit. In some embodiments, the control system 130 includes discrete electronic components.

[0059] The control system 130 is capable of receiving inputs (e.g., signals, generated data, instructions, etc.) from any other element (e.g., sensors, etc.) of the system 100. The control system 130 is capable of providing output signals to cause one or more actions to occur in the system 100 (e.g., causing the stimulator 104 to provide electrical stimulation to the user 10A, etc.).

[0060] The control system 130 is capable of analyzing data generated by any sensors of the system 100 to determine (i) whether the user 10A is experiencing a sleep apnea event, (ii) whether the user 10A is about to experience a sleep apnea event, (iii) whether the user 10A is no longer experiencing a sleep apnea event, (iv) the user 10A's current sleep state, (v) the tension of one or more muscles of the user 10A, (vi) or any combination thereof. Based on one or more of these determinations, the control system 130 is capable of causing the stimulator 104 to provide electrical and / or magnetic stimulation to the user 10A to (i) help stop a sleep apnea event that the user 10A is currently experiencing and / or (ii) help prevent a sleep apnea event that the user 10A is about to experience. In some such embodiments, the control system 130 sends signals (wired or wireless) to induce electrical stimulation of one or more muscles of the user 10A.

[0061] In addition to providing electrical and / or magnetic stimulation by stimulator 104, control system 130 is capable of changing one or more parameters of the electrical stimulation provided by stimulator 104. The one or more parameters of the stimulation include frequency, intensity, duration, dwell time, rise time in the pulse, on-time to off-time ratio, or any combination thereof.

[0062] In some implementations, one or more parameters of the stimulus are changed based on the measured response of one or more muscles to the stimulus (e.g., using one or more sensors of system 100). In some implementations, the modification of the parameters may be based on a continuous feedback loop of control system 130, which continues to analyze data generated by one or more sensors of system 100 (e.g., motion sensor 112, PPG sensor 124, etc., or any combination thereof). In this way, control system 130 is able to modify one or more parameters based on continued analysis (e.g., in real time, when user 10A is experiencing the same apnea event, after user 10A experiences an apnea event but before user 10A experiences another apnea event, etc.).

[0063] For example, if continued analysis of data from one or more sensors of system 100 indicates that user 10A is still experiencing an apnea event in the presence of stimulation, control system 130 can cause stimulator 104 to increase the intensity of the stimulation applied to user 10A. For another example, if continued analysis indicates that user 10A no longer experiences an apnea event after stimulation, control system 130 can cause stimulator 104 to stop providing a simulation to user 10A. Thus, compared to a system that continuously applies stimulation (even when user 10A is not experiencing an apnea event), user 10A is less likely to become desensitized to the stimulation over time.

[0064] In some implementations, the control system 130 causes the stimulator 104 to automatically increase the intensity of the stimulus applied to the user 10A. This makes it likely that the intensity will reach a level that causes contraction of one or more muscles in the user 10A, without having to manually set the intensity high from the start of the stimulus.

[0065] As described above, the control system 130 can continuously monitor the generated data to determine whether the current level of automatically increasing stimulus intensity has induced contraction of one or more muscles of user 10A. When the control system 130 determines that the current level has not induced contraction of one or more muscles of user 10A, the control system 130 causes and / or allows the stimulator 104 to continue automatically increasing the stimulus intensity beyond the current level. Similarly, when the control system 130 determines that the current level has induced contraction of one or more muscles of user 10A, the control system 130 causes the stimulator 104 to stop automatically increasing the stimulus intensity of the current level. In this way, an appropriate intensity of stimulus is achieved for user 10A (e.g., not an artificially high intensity, which could be painful).

[0066] The strap 102 may be in the form of a neck collar, strap, belt, chest strap, torso strap, etc., or any combination thereof, and is worn by the user 10A. In some such embodiments, the strap 102 is made wholly or at least partially of a stretchable material, such that the strap 102 remains at least partially close to the user 10A's skin when worn. For example, when the strap 102 is worn as a neck collar around the user 10A's neck / throat 20A, the strap 102 may include a stretchable material, such that the strap / neck collar 102 fits snugly around the user 10A's neck / throat 20A (without suffocating the user 10A). Accordingly, when the PPG sensor 124 is included in the strap / neck collar 102, the PPG sensor 124 can maintain a close relationship with the user 10A's neck / throat 20A, which can help provide more accurate data from the PPG sensor 124.

[0067] In addition to or as an alternative to shape factor 102, system 100 may be in the form of a patch capable of adhering to the skin of user 10A (e.g., adhering to the neck / throat area 20A of user 10A). Other shape factors of system 100 may be considered. For example, system 100 may be in the form of a scarf, etc.

[0068] As described above, the control system 130 is capable of determining whether the user is experiencing or will experience one or more types of sleep apnea, and takes one or more actions in response. Additionally, the control system 130 is capable of determining whether the user is experiencing or will experience one or more other respiratory events and / or respiratory-related disorders, and takes one or more actions in response to these. Such other respiratory events and / or respiratory-related disorders, as discussed herein, include, for example, hypoventilation, hyperventilation, sleep apnea, Cheyne-Stokes respiration, respiratory failure, obesity-related hyperventilation syndrome, chronic obstructive pulmonary disease, neuromuscular disorders, chest wall disorders, or any combination thereof.

[0069] The control system 130 executes a respiratory event determination algorithm to determine the presence of a respiratory event (e.g., apnea, hypoventilation, hyperventilation, etc.). In some embodiments, the respiratory event determination algorithm receives at least a portion of data generated from one or more sensors of the system 100 as input and provides a flag indicating that a respiratory event (e.g., apnea, hypoventilation, etc.) has been detected as output. In some embodiments, the respiratory event determination algorithm receives at least a portion of data generated from one or more sensors of the system 100 as input and provides an instruction to activate the stimulator 104 to provide electrical stimulation to the user 10A as output. In some such embodiments, the instruction includes instructions for setting at least a portion of one or more parameters of the electrical stimulation to be provided by the stimulator 104.

[0070] In some implementations of system 100, a respiratory event or apnea is detected when a function of respiratory flow rate falls below a flow rate threshold for a predetermined time period. This function can determine peak flow, relatively short-term average flow, or an intermediate flow between relatively short-term average and peak flow, such as RMS flow. The flow rate threshold can be a relatively long-term measure of flow.

[0071] In some implementations of system 100, a respiratory event or insufficiency is detected when a function of respiratory flow rate falls below a second flow rate threshold for a predetermined time period. This function may determine peak flow, relatively short-term average flow, or an intermediate flow between relatively short-term average and peak flow, such as RMS flow. The second flow rate threshold is greater than the flow rate threshold used to detect apnea.

[0072] In some embodiments of system 100, a respiratory event or apnea is detected when a function of blood flow rate (e.g., determined at least in part using PPG sensor 124) falls below a flow rate threshold for a predetermined time period. This function may determine peak flow, relatively short-term average flow, or an intermediate flow between relatively short-term average and peak flow. The flow threshold may be a relatively long-term measure of flow.

[0073] The control system 130 executes a snoring event determination algorithm to determine the presence of a snoring-related event (e.g., snoring, apnea, etc.). In some embodiments, the snoring event determination algorithm receives at least a portion of data generated from one or more sensors of the system 100 (e.g., microphone 116, motion sensor 112, etc.) as input and provides (i) a flag indicating that a snoring event (e.g., sleep apnea, hypopnea, etc.) has been detected, (ii) a measure of the degree of snoring, or (iii) both (i) and (ii) as output.

[0074] In some implementations of system 100, the snoring event determination algorithm can determine the intensity of the flow rate signal in the range of 30-300 Hz. Furthermore, the snoring event determination algorithm can filter the respiratory flow rate signal to reduce background noise.

[0075] The control system 130 executes an airway opening algorithm to determine the occupancy (e.g., degree of occupancy) of the user's airway. In some embodiments, the airway opening algorithm receives a respiratory flow signal as input and determines the signal power in a frequency range of approximately 0.75 Hz to approximately 3 Hz. The presence of a peak in this frequency range indicates airway opening. The absence of a peak in this frequency range indicates airway closure. In some embodiments, the airway opening algorithm receives a respiratory flow signal as input and determines the presence of a cardiac signal. The absence of a cardiac signal indicates a closed airway.

[0076] The control system 130 executes a treatment parameter algorithm for determining one or more parameters (e.g., intensity, frequency, duration, etc.) of the stimulator 104. In some such embodiments, the treatment parameter algorithm receives the output of one or more other algorithms described herein as input and outputs one or more values ​​of one or more parameters (e.g., intensity, frequency, duration, etc.) of the electrical stimulation provided by the stimulator 104.

[0077] Although system 100 is shown as including a band 102, a stimulator 104, and a battery 132, it is contemplated that system 100 may include any number of bands 102 (e.g., one, two, three, five, etc.), any number of stimulators 104 (e.g., one, two, three, five, ten, fifty, etc.), and any number of batteries 132 (e.g., one, two, three, five, ten, etc.). The ratio of stimulators 104 to bands 102 may be one to one or different ratios. For example, in some embodiments, two or more stimulators 104 may be coupled to a band 102 and / or integrated into a band 102.

[0078] According to some embodiments, system 100 includes a belt 102, wherein stimulator 104, PPG sensor 124, memory 128, control system 130, and battery 132 are all connected to belt 102. According to some embodiments, system 100 includes a belt 102, wherein stimulator 104, motion sensor 112, memory 128, control system 130, and battery 132 are all connected to belt 102.

[0079] According to some embodiments, system 100 includes a belt 102 to which stimulator 104, PPG sensor 124, and battery 132 are all coupled, and memory 128 and control system 130 are separate from and distinct from belt 102 (e.g., included in remote devices such as mobile phones, computers, servers, cloud computers, etc.). In such embodiments, the system includes a wireless communication module to allow data and / or instructions to be sent and received between control system 130 and components coupled to belt 102.

[0080] A method for using system 100 to assist user 10A in the event of a breathing apnea is now described. Control system 130 executes a breathing event determination algorithm to determine the presence of a breathing event in user 10A. In some such embodiments, the breathing event determination algorithm is stored as instructions in memory 128.

[0081] Control system 130 analyzes data generated by one or more sensors of system 100 (e.g., motion sensor 112, PPG sensor 124, etc.), which are coupled to and / or built into belt 102, to determine whether user 10A is currently experiencing an apnea event (e.g., obstructive apnea event). If control system 130 determines that user 10A is currently experiencing an apnea event, control system 130 causes stimulator 104 to provide stimulation. Stimulation may be provided to one or more muscles and / or one or more nerves of user 10A, adjacent to user 10A's larynx 20A, chest 30A, and / or abdomen 40A. Stimulation may help stop the apnea event (e.g., by causing one or more muscles in larynx 20A to contract and open user 10A's airway, by causing diaphragm contraction and eliciting respiratory function in user 10A, or both).

[0082] Reference Figure 3A and Figure 3B System 200 includes a strap 202 in the form of a neck collar. The strap 202 is shown unfolded to better illustrate the various aspects of system 200. Figure 3CSystem 200 is shown relative to user 10B, wherein a band 202 is worn as a neck collar around the neck / throat 20B of user 10B. System 200 is the same as or similar to system 100. System 200 typically includes band 202, stimulator 204, sensor 275, memory 228, control system 230, and battery 232.

[0083] like Figure 3A As shown, stimulator 204, sensor 275, memory 228, control system 230, and battery 232 are all coupled to and / or within strip 202. In some such embodiments, sensor 275 is integrated into strip 202 such that all or part of sensor 275 is shielded (e.g., hidden) by strip 202. Similarly, memory 228, control system 230, and battery 232 are integrated into strip 202 such that all or part of memory 228, control system 230, and battery 232 are shielded (e.g., hidden) by strip 202.

[0084] Sensor 275 is identical or similar to motion sensor 112, microphone 116, conductivity sensor 118, heart rate sensor 120, PPG sensor 124, other sensors 126, or any combination thereof. Memory 228 is incorporated herein. Figure 2 The memory 128 described herein is the same as or similar. The control system 230 is associated with this. Figure 2 The control system 130 described herein is the same as or similar. Battery 232 is associated with this. Figure 2 The battery described is the same as or similar to 132.

[0085] Stimulator 204 combined with this Figure 2 The described stimulator 104 is the same as or similar to it. Figure 3B As shown, the stimulator 204 is shown with two electrical leads 205 exposed at the rear of the band 202. Thus, when the band 202 is operated by user 10B (… Figure 3C When worn, the electrical leads 205 can directly engage (e.g., touch, contact, abut, or any combination thereof) the skin of the user 10B, which is adjacent to one or more muscles of the user 10B. Although the system 200 is shown as including two electrical leads 205, the system 200 may include any number of electrical leads 205 (e.g., one electrical lead, three electrical leads, five electrical leads, ten electrical leads, etc.).

[0086] In some alternative embodiments, the stimulator 204 is leadless (not shown). In such alternative embodiments, the stimulator 204 is coupled to and / or built into the band 202 such that one or more ends of the body of the stimulator 204 protrude from the band 202 to contact the skin of the user 10B and serve as electrodes.

[0087] The stimulator 204 is coupled to and / or built into the band 202, such that when the band 202 is wrapped around the neck / throat 20B of the user 10B ( Figure 3C When worn and aligned, the stimulator 204 is positioned to provide electrical stimulation to one or more muscles in the throat 20B and / or neck of the user 10B. In this way, the stimulator 204 can help open the airway of the user 10B. Alignment means that the circumferential position of the band 202 is within a predetermined position and / or position range relative to one or more portions of the user 10B's anatomy, surrounding the neck 20B of the user 10B.

[0088] In some embodiments, markings may be included on the band 202 to help the user 10B align the band 202 with one or more portions of the user 10B's anatomy. This allows the simulator 204, electrical leads 205, sensor 275, or any combination thereof to be properly positioned relative to the user 10B. For example, vertical line markings 280 may be included (e.g., printed) on the outer surface of the band 202. The vertical line markings 280 may indicate to the user 10B the position of the stimulator 204, one or more electrical leads 205, sensor 275, or any combination thereof, to be aligned with the user's anatomy (e.g., the midline of the larynx 20B, the user 10B's ear, the posterior edge of the user 10B's jawbone, the user 10B's chin, etc.).

[0089] In another example, band 202 may include additional features to assist user 10B in aligning band 202 when wearing it. For example, cuts 285 in band 202 (e.g., having a circular shape, square shape, triangular shape, polygonal shape, etc., or any combination thereof) may indicate the position where band 202 should be aligned with a specific part of the user's anatomy (e.g., the midline of the larynx 20B), such that, for example, stimulator 204, one or more electrical leads 205, sensor 275, or any combination thereof, are properly positioned relative to user 10B. The cuts may be tactile, allowing user 10B to feel the cuts when wearing band 202 and to use the cuts to align band 202 (e.g., not necessarily in a mirror, in the dark, etc.). In some embodiments, band 202 includes multiple cuts (e.g., a circular cut aligned with user 10B's chin and two triangular cuts aligned with user 10B's ears).

[0090] Proper placement means, for example, (i) that the electrical lead 205 is positioned to apply electrical stimulation to the user 10B, causing one or more target muscles of the user 10B to contract and help open the user's airway, and (ii) that the sensor 275 is positioned relative to the user 10B, enabling the sensor 275 to generate reliable and / or usable data, or both. In some such embodiments, the position of the sensor 275 depends on the type of sensor included in the sensor 275. For example, if the sensor 275 is a motion sensor, the appropriate position of the sensor 275 may be a first position, while if the sensor 275 is a PPG sensor, the appropriate position of the sensor 275 may be a second position that is the same as or different from the first position.

[0091] As described herein, the band 202 is in the form of a choker that can be worn by user 10B around the throat 20A / neck of user 10B. The band 202 may be made of any type of material suitable for wearing on the human body (e.g., the neck) (e.g., one or more types of plastics, one or more types of metals, nylon, one or more types of fabrics, stretchable fabrics, etc., or any combination thereof).

[0092] Belt 202 may include any type of coupling mechanism 260 ( Figure 3A and Figure 3B This helps attach the strap 202 around the neck and / or throat 20B of the user 10B. For example, the coupling mechanism 260 may include a hook and loop fastener, a magnetic buckle, a snap-fit ​​connection, a ball buckle, a bead buckle, a barrel buckle, a hook buckle, a push-button buckle, a spring buckle, a lobster claw buckle, a hook and loop buckle, or any combination thereof.

[0093] In some embodiments, the coupling mechanism 260 includes a loop at one end of the belt 202, through which the opposite end of the belt 202 passes and folds back into the loop for securing to the outer surface of the belt 202 using, for example, hook-and-loop fasteners. Various other methods of securing the belt 202 around the user 10B are conceivable. In some embodiments, the coupling mechanism 260 facilitates securing the belt 202 to the user 10B in a close-fitting manner. Alternatively, the coupling mechanism 260 facilitates securing the belt 202 to the user 10B in a loose manner.

[0094] refer to Figure 4 The cross-sectional view relative to user 10C shows system 300. System 300 is the same as or similar to systems 100 and 200. The main difference of system 300 is that system 300 includes two stimulators and two bands, which work together to assist user 10C.

[0095] System 300 includes a first strap 302A that can be worn around the throat 20C of user 10C and a second strap 302B that can be worn generally around the torso 30C of user 10C (e.g., chest, abdomen, waist, etc.). The first strap 302A may be referred to as a neck collar, and the second strap 302B may be referred to as a chest strap. The first and second straps 302A and 302B are combined herein. Figure 2 , Figure 3A , Figure 3B and Figure 3C The descriptions of 102 and 202 are the same or similar.

[0096] The first band 302A is coupled to or includes a built-in first stimulator 304A, the first stimulator 304A having one or more electrical leads 305A, a sensor 375, a memory 328, a control system 330, a battery 332, and a coupling mechanism 360, which are combined with Figure 2-3C The stimulators 104 and 204, sensor 275, memory 128 and 228, control system 130 and 230, battery 132 and 232, and coupling mechanism 260 of the described systems 100 and 200 are the same or similar. The first strip 302A also includes a vertical line mark 380 (e.g., printed thereon) on the outer surface of the first strip 302A, which is the same or similar to the vertical line mark 280.

[0097] Similarly, the second band 302B is coupled to or includes a built-in second stimulator 304B with one or more electrical leads 305B, a sensor 375, a memory 328, a control system 330, a battery 332, and a coupling mechanism 360, which are combined with Figures 3A-3C The stimulators 104, 204, sensor 275, memory 128, 228, control system 130, 230, battery 132, 232, and coupling mechanism 260 of the described systems 100, 200 are the same or similar. The second band 302B differs primarily in size from the first band 302A. That is, the second band 302B is larger (e.g., longer) so that the second band 302B can be worn around the torso 30C of the user 10C.

[0098] In some embodiments, the first band 302A and the first stimulator 304A are operable independently of the second band 302B and the second stimulator 304B. In such embodiments, the first band 302A (and its associated components) forms a first subsystem of system 300 that assists user 10C in resolving a first type of apnea event (e.g., obstructive apnea). For example, the first subsystem causes the muscles in the larynx 20C to contract to open the airway. Similarly, in such embodiments, the second band 302B (and its associated components) forms a second subsystem of system 300 that assists user 10C in resolving a second type of apnea event (e.g., central apnea). For example, the second subsystem causes the diaphragm of user 10C to contract to assist user 10C's breathing effort. In this manner, both the first band 302A (neck collar) and the second band 302B (torso band) include their respective memory 328 and their respective control system 330. In some such embodiments, the first and second subsystems coordinate treatment such that the stimulation applied by the first and second subsystems is coordinated (e.g., simultaneously, alternately, etc.).

[0099] In some alternative embodiments, the first and second straps 302A and 302B cannot operate independently and are coupled together (e.g., wirelessly and / or wired). In such embodiments, only one of the first and second straps 302A and 302B includes a memory 328 and a control system 330. That is, for example, the second strap 302B (torso strap) includes a memory 328 and a control system 330, while the first strap 302A (neck collar) does not include a memory and a control system. Alternatively, the first strap 302A (neck collar) includes a memory 328 and a control system 330, while the second external device 350B (torso strap) includes neither a memory nor a control system.

[0100] It should be understood that the sensor 375 connected to the first band 302A and the sensor 375 connected to the second band 302B can be the same type of sensor or different sensors. For example, in some embodiments, the sensor 375 connected to the first band 302A (neckband) is a PPG sensor (e.g., like PPG sensor 124), and the sensor 375 connected to the second band 302B (torso band) is a motion sensor (e.g., like motion sensor 112). The sensor 375 of the first band 302A and / or the sensor 375 of the second band 302B can include any number of sensors (e.g., sensors of different types or more than one of the same type).

[0101] A method for using system 300 to assist user 10C in the event of one or more types of sleep apnea events is now described. Control system 330 (in a first band 302A, a second band 302B, or a combination thereof) executes a breathing event determination algorithm to determine the presence of a breathing event in user 10C. In some such embodiments, the breathing event determination algorithm is stored as instructions in memory 328 (in the first band 302A, the second band 302B, or a combination thereof).

[0102] The control system 330 analyzes data generated by the sensor 375 connected to the first band 302A to determine whether the user 10C is currently experiencing a first type of apnea event (e.g., obstructive apnea event). The control system 330 also analyzes data generated by the sensor 375 connected to the second band 302B to determine whether the user 10C is currently experiencing a second type of apnea event (e.g., central apnea event).

[0103] If the control system 330 determines that the user 10C is currently experiencing a Type I apnea event, the control system 330 causes the first stimulator 304A to provide electrical stimulation via one or more electrical leads 305A. The electrical stimulation can be provided to one or more muscles and / or one or more nerves of the user 10C adjacent to the larynx 20C. The electrical stimulation can help stop the Type I apnea event (e.g., by causing one or more muscles in the larynx 20C to contract and open the airway of the user 10C).

[0104] If the control system 330 determines that the user 10C is currently experiencing a type II sleep apnea event, the control system 330 causes the second stimulator 304B to provide electrical stimulation via one or more electrical leads 305B. Electrical stimulation may be provided to the user 10C's diaphragm and / or one or more nerves connected to the diaphragm. Electrical stimulation can help stop the type II sleep apnea event (e.g., by causing the diaphragm to contract and allowing the user 10C to breathe / draw air into the respiratory system).

[0105] Furthermore, if the control system 330 determines that the user 10C is currently experiencing both a first type of apnea event and a second type of apnea event simultaneously, the control system 330 (i) causes the first stimulator 304A to provide electrical stimulation to one or more muscles and / or one or more nerves of the user 10C that are adjacent to the larynx 20C of the user 10C, and (ii) causes the second stimulator 304B to provide electrical stimulation to the diaphragm and / or one or more nerves connected to the diaphragm of the user 10C.

[0106] In some embodiments, the size and shape of the electrical leads 105, 205, 305A, 305B of this disclosure are determined to protrude from the straps 102, 202, 302A, 302B such that wearing the straps 102, 202, 302A, 302B causes the electrical leads 105, 205, 305A, 305B to be pressed into the skin of the user 10A, 10B, 10C. In some such embodiments, the leads 105, 205, 305A, 305B extend from the straps 102, 202, 302A, 302B by a distance of about 0.1 inch, about 0.25 inches, about 0.5 inches, about 0.75 inches, about 1 inch, or any distance in between.

[0107] One or more elements, aspects or steps or any part thereof from any one of claims 1-69 may be combined with one or more elements, aspects or steps or any part thereof or combinations thereof from any one of other claims 1-69 to form one or more additional embodiments and / or claims of this disclosure.

[0108] While this disclosure has been described with reference to one or more specific embodiments and implementations, those skilled in the art will recognize that many changes can be made thereto without departing from the spirit and scope of this disclosure. Each of these embodiments and implementations, and any obvious variations thereof, is considered to fall within the spirit and scope of this disclosure as set forth in the appended claims.

Claims

1. A system for assisting a user with breathing during sleep, the system comprising: a first strap configured to be worn around a neck of the user, the first strap comprising: a photoplethysmography (PPG) sensor coupled to the first strap and configured to generate first data associated with blood flow of the user; a first stimulator coupled to the first strap and configured to provide electrical stimulation to one or more muscles of the user proximate to an airway of the user; a second strap configured to be worn around a chest or abdomen of the user, the second strap comprising: a motion sensor, a strain gauge, an accelerometer, or any combination thereof coupled to the second strap and configured to generate second data associated with motion of the chest of the user, motion of the abdomen of the user, or motion of both; and a second stimulator coupled to the second strap and configured to provide electrical stimulation to a diaphragm of the user; a memory storing machine-readable instructions; and a control system comprising one or more processors configured to execute the machine-readable instructions to: analyze the generated first data and the generated second data; in response to the first data indicating that the user is currently experiencing an obstructive apnea event, cause the first stimulator to provide the electrical stimulation to the one or more muscles of the user proximate to the airway of the user to assist in stopping the obstructive apnea event; and in response to the second data indicating that the user is currently experiencing a central apnea event, cause the second stimulator to provide electrical stimulation to the diaphragm of the user to assist in stopping the central apnea event.

2. The system of claim 1, wherein the first strap is adjustable such that a length of the first strap is changeable when worn around a neck of a user.

3. The system of claim 1, wherein the second strap is adjustable such that a length of the second strap is changeable when worn around a chest or abdomen of the user.

4. The system of any one of claims 1-3, wherein the first strap, the second strap, or both are at least partially stretchable.

5. The system of any one of claims 1-3, wherein the memory and the control system are physically coupled to the second strap and configured to wirelessly control the first stimulator.

6. The system of any one of claims 1-3, wherein the memory and the control system are physically coupled to the first strap and configured to wirelessly control the second stimulator.

7. The system of any one of claims 1-3, wherein the control system is further configured to analyze the first data, the second data, or both to determine a sleep state of the user, a tension of the one or more muscles, or both.

8. The system of any one of claims 1-3, wherein the control system is further configured to change one or more parameters of the electrical stimulation.

9. The system of claim 8, wherein the control system is configured to change one or more parameters of the electrical stimulation based at least in part on the measured response of the one or more muscles to the electrical stimulation.

10. The system of claim 8, wherein the one or more parameters of the electrical stimulation comprise frequency, intensity, duration, dwell time, rise time in a pulse, ratio of on time to off time, or any combination thereof.

11. The system of any one of claims 1-3, wherein the one or more muscles of the user proximate to the user’s airway comprise one or more muscles of the user’s neck, one or more muscles of the user’s throat, or both.

12. The system of any one of claims 1-3, wherein the first data is associated with a blood flow rate of the user.

13. The system of claim 12, wherein the control system is configured to analyze the first data to determine whether the blood flow rate of the user has fallen below a blood flow rate threshold.

14. The system of claim 12, wherein the control system is configured to analyze the first data to determine whether the blood flow rate of the user has fallen below a blood flow rate threshold for a predetermined period of time.

15. The system of any one of claims 1-3, wherein determining that the user is currently experiencing the obstructive apnea event is based on only the first data, and wherein, determine that the user is currently experiencing the central apnea event based on the second data alone.

Citation Information

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