Implantable stimulator with external device

Abstract

A system for assisting a user includes a stimulator, a sensor, a memory, and a control system. The stimulator is configured to be positioned at the user adjacent to the user's airway. The sensor is configured to generate data associated with the user's airway. The memory stores machine-readable commands. The control system includes at least one processor configured to execute machine-readable commands to determine, based on the analysis of at least the generated data, that the user is currently experiencing an apnea event. In response to the determination that the user is currently experiencing an apnea event, the control system causes the stimulator to provide electrical stimulation at a first intensity level to one or more muscles of the user adjacent to the airway to help stop the apnea event.

Description

Technology Field

[0001] Cross-reference of related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 855,487 filed on May 31, 2019, the entire contents of which are incorporated herein by reference.

[0003] Technology field

[0004] The present disclosure relates to a system and method for the treatment of respiratory-related disorders and, more specifically, for addressing one or more types of apnea events using an implantable stimulator and a corresponding external device. Background Technology

[0005] Various systems exist to assist users experiencing sleep apnea and related respiratory disorders. Some of these systems rely on the user wearing a mask that helps supply pressurized air to the airway. Some users find these systems uncomfortable, difficult to use, expensive, and aesthetically unappealing.

[0006] Therefore, there is a need for alternative systems and methods to address sleep apnea and related respiratory diseases. The present disclosure relates to solving these problems and addressing other needs. means of solving the problem

[0007] According to a portion of the present disclosure, a method for assisting a user comprises receiving data associated with the user's airway from one or more sensors. The method also comprises analyzing the data to determine whether the user is experiencing an apnea event, whether the user is about to experience an apnea event, whether the user is no longer experiencing an apnea event, or any combination thereof. The method further comprises, in response to a determination that the user is experiencing an apnea event or that the user is about to experience an apnea event, a stimulator provides electrical stimulation to a portion of the user to help stop or prevent the apnea event.

[0008] According to some embodiments of the present disclosure, a system for assisting a user comprises a housing, a stimulator, a receiver, a collar, a transmitter, a sensor, a memory, and a control system. The housing is configured to be positioned on the user adjacent to the user's airway. The stimulator is coupled to the housing. The receiver is coupled to the housing. The collar is configured to be worn around the user's neck. The transmitter is coupled to the collar and is configured to communicate with the receiver so that the stimulator selectively provides electrical stimulation to (i) one or more muscles of the user adjacent to the airway, (ii) one or more nerves associated with one or more muscles, or (iii) both (i) and (ii). The sensor is configured to generate data associated with the user's airway. The memory stores machine-readable commands. The control system includes one or more processors configured to execute machine-readable commands to analyze the generated data. The data analysis is intended 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, or (iv) any combination thereof. (i) In response to the user's decision to experience an apnea event or (ii) the user's decision to experience an apnea event, the control system causes the transmitter to communicate with the receiver to provide electrical stimulation to help the stimulator stop or prevent the apnea event.

[0009] According to a partial embodiment of the present disclosure, a method comprises receiving data associated with a user's airway from one or more sensors. The method also comprises determining, based at least partially on the received data, that the user is currently experiencing an apnea event. The method further comprises, in response to the determination that the user is currently experiencing an apnea event, causing a stimulator to provide electrical stimulation at a first intensity level to one or more muscles of the user adjacent to the airway to help stop the apnea event.

[0010] According to some embodiments of the present disclosure, a system for assisting a user comprises a stimulator, a sensor, a memory, and a control system. The stimulator is configured to be positioned at the user adjacent to the user's airway. The sensor is configured to generate data associated with the user's airway. The memory stores machine-readable commands. The control system includes at least one processor configured to execute machine-readable commands to determine, based on an analysis of the generated data, that the user is currently experiencing an apnea event. In response to the determination that the user is currently experiencing an apnea event, the control system causes the stimulator to provide electrical stimulation at a first intensity level to one or more muscles of the user adjacent to the airway to help stop the apnea event.

[0011] According to some embodiments of the present disclosure, a method comprises receiving data associated with a user from one or more sensors. The method also comprises analyzing the data to determine whether the user is currently experiencing a first type of apnea event and analyzing the data to determine whether the user is currently experiencing a second type of apnea event different from the first type of apnea event. The method further comprises, in response to the determination 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 of the user adjacent to the user's throat to help stop the first type of apnea event. The method further comprises, in response to the determination that the user is currently experiencing a second type of apnea event, causing a stimulator to provide electrical stimulation to the user's diaphragm to help stop the second type of apnea event.

[0012] According to some embodiments of the present disclosure, a system for assisting a user to breathe during sleep comprises a first stimulator, a second stimulator, one or more sensors, a memory, and a control system. The first stimulator is configured to be positioned on the user adjacent to the user's throat. The second stimulator is configured to be positioned on the user adjacent to the user's diaphragm. One or more sensors are configured to generate data. The memory stores machine-readable commands. The control system includes one or more processors configured to execute machine-readable commands to analyze generated data to determine whether the user is currently experiencing a first type of apnea event. The control system further analyzes generated 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 the determination that the user is currently experiencing a first type of apnea event, the control system causes the first stimulator to provide electrical stimulation to one or more muscles of the user adjacent to the user's throat to help stop the first type of apnea event. In response to the determination that the user is currently experiencing a Type 2 apnea event, the control system causes the second stimulator to provide electrical stimulation to the user's diaphragm to help stop the Type 2 apnea event.

[0013] The above and additional aspects and embodiments of the present disclosure will be apparent to those skilled in the art from the detailed description of various embodiments and / or embodiments made with reference to the drawings, and a brief description thereof is provided below. Brief explanation of the drawing

[0014] The aforementioned advantages and other advantages of the present disclosure will become apparent by reading the following detailed description and referring to the drawings. Figure 1a is a diagram illustrating an overview of a user's breathing system. Figure 1b is a diagram illustrating the upper respiratory tract of the user of Figure 1a. FIG. 2 is a block diagram of a system for assisting a user (e.g., when breathing during sleep) according to a partial implementation of the present disclosure. FIG. 3a is a perspective view of a system having a stimulator (positioned at the user) and a colored external device (unfolded) to assist the user (e.g., when breathing during sleep), according to a partial embodiment of the present disclosure. FIG. 3b is a perspective view of the system of FIG. 3a, where the external device is worn by the user. FIG. 4a is a perspective view of a system having two stimulators (positioned on the user) and two external devices worn by a user to assist the user (e.g., when breathing during sleep) according to a partial embodiment of the present disclosure, one external device is in the form of a collar and the other external device is in the form of a band / belt. According to a partial embodiment of the present disclosure, FIG. 4b is the system of FIG. 4a relating to a cross-sectional view of a user to better illustrate the arrangement of two stimulators of a user. While the present disclosure allows for various modifications and alternative forms, specific embodiments are illustrated in the drawings by way of example and will be described in detail herein. However, it should be understood that the present disclosure is not intended to be limited to the particular form disclosed. Rather, the present disclosure includes all modifications, equivalents, and alternatives that fall within the spirit and scope of the present disclosure as defined by the appended claims. Specific details for implementing the invention

[0015] Referring to FIG. 1a, an overview of the respiratory system (12) of a user (10) (e.g., a patient), generally comprising the nasal cavity, oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, alveoli, heart, and diaphragm is shown. More generally, the user (10) generally has a throat (20) that includes the region(s) of the user's (10) respiratory system (12) in the neck region of the user (10). The diaphragm of the user (10) is a sheet of muscle that extends across the lower end of the user's (10) thorax. The diaphragm generally separates the user's (10) thorax (30), which includes the heart, lungs, and ribs, from the user's (10) abdominal cavity (40). When the diaphragm contracts, the volume of the thorax (30) increases and air is drawn into the lungs.

[0016] As described in more detail below, one or more stimulators of the present disclosure may be placed inside the user (10) (e.g., implanted via surgery, injected via syringe, etc.) to assist the user (10), for example, to assist breathing during sleep. For example, one or more stimulators may be placed in the user's (10) throat (20), thoracic cavity (30) and / or abdominal cavity (40) (e.g., adjacent to and / or in contact with the user's (10) diaphragm), or a combination thereof (e.g., stimulating muscles of the neck / throat and / or diaphragm, or adjacent to one or more nerves in contact with the user's (10) throat / throat (20)).

[0017] Referring to FIG. 1b, a view of the upper respiratory tract (14) of a user (10) is shown, which includes the nasal cavity, nasal bone, lateral nasal cartilage, alar cartilage, nostrils (one is shown), upper lip, lower lip, larynx, hard palate, soft palate, pharynx, tongue, epiglottis, vocal cords, esophagus and trachea.

[0018] The user's (10) respiratory system (12) facilitates gas exchange. The user's (10) nose (50) and mouth (60) form the entrance to the user's (10) airway. As best illustrated in FIG. 1a, the airway contains a series of branching tubes that become narrower, shorter, and more numerous as they penetrate deeper into the user's (10) lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into venous blood and carbon dioxide to exit in the opposite direction. The trachea divides into the right and left main bronchi, which further eventually divide into terminal bronchioles. The bronchi constitute the conducting airway and do not perform part of the gas exchange. Further division of the airway leads to respiratory bronchioles, which eventually lead to the alveoli. The alveolated region of the lung is where gas exchange occurs and is referred to as the respiratory zone.

[0019] There are various respiratory diseases that can affect the user (10). A specific disease is characterized by a specific event (e.g., apnea, hypopnea, hyperpnea, or any combination thereof). Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disease.

[0020] Sleep Disordered Breathing (SDB) is a form of Obstructive Sleep Apnea (OSA) characterized by events involving the obstruction and / or blockage of the upper airway during sleep. OSA results from a combination of a normal loss of muscle tone in the small upper airway and the regions of the tongue, soft palate, and posterior oropharyngeal wall during sleep. This condition causes affected patients to stop breathing 200 to 300 times a night, typically for periods lasting 30 to 120 seconds. OSA leads to excessive daytime sleepiness, which can result in cardiovascular disease and brain damage. Although affected individuals may be unaware of these issues, this disorder is common, particularly among overweight middle-aged men.

[0021] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the user's respiratory regulator characterized by a rhythmic alternating cycle of waxing and waning ventilation known as the CSR cycle. CSR is characterized by the repetitive deoxygenation and reoxygenation of arterial blood. Due to repetitive hypoxia, CSR can be harmful. In some users, CSR is associated with repetitive awakenings, which result in severe sleep disturbance, excessive emotional activity, and increased afterload.

[0022] Respiratory failure is a comprehensive term for respiratory disorders in which the lungs are unable to inhale sufficient oxygen or exhale sufficient CO2 to meet the user's needs. Respiratory failure may include some or all of the following disorders.

[0023] Users with respiratory failure (a form of respiratory failure) may experience abnormal difficulty breathing during exercise.

[0024] Obesity Hyperventilation Syndrome (OHS) is characterized by severe obesity and awake chronic hypercapnia, but no further causes for hyperventilation are known. These symptoms include dyspnea, morning headaches, and excessive daytime sleepiness.

[0025] Chronic Obstructive Pulmonary Disease (COPD) encompasses any group of lower respiratory tract diseases that share some common characteristics. These include increased resistance to air movement, a prolonged expiratory phase of breathing, and a loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by smoking (a primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: difficulty breathing, chronic coughing, and the production of sputum.

[0026] Neuromuscular Disease (NMD) is a broad term encompassing many diseases and conditions that cause impairment in muscle function, either directly through intrinsic muscle pathology or indirectly through neuropathology. Some patients with NMD are characterized by progressive muscle impairment leading to loss of gait resulting in wheelchair dependence, dysphagia, respiratory muscle weakness, and ultimately, death due to respiratory failure. Neuromuscular disorders can be classified into rapidly progressive and slow-progressive types: (i) Rapidly progressive disorders: Characterized by muscle disorders that worsen on a monthly basis and lead to death within a few years (e.g., Amyotrophic Lateral Sclerosis (ALS) and Duchenne Muscular Dystrophy (DMD) found in teenagers); (ii) Variable or slow-progressive progressive disorder: Characterized by muscular disorders that worsen over the course of years and reduce life expectancy (e.g., limb girdle, facioscapulohumeral, and myotonic muscular dystrophy). Respiratory failure in NMD includes: increasing generalized weakness, dysphagia, difficulty breathing during activity and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and manic-depressive disorder.

[0027] Thoracic disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the thorax. These disorders are typically characterized by restrictive defects and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis may also cause severe respiratory failure. Symptoms of respiratory failure include: difficulty breathing during activity, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0028] According to some embodiments of the present disclosure, a system (e.g., system (100, 200, 300)) is provided to assist a user (e.g., patient) who experiences a breathing event (e.g., an apnea event) during sleep. Apnea typically occurs when the user's airflow falls below a predetermined threshold for a certain period (e.g., 10 seconds). A first type of apnea event is referred to as obstructive apnea. Obstructive apnea typically occurs when air does not flow due to partial obstruction of the airway despite the user's efforts to breathe. A second type of apnea event is referred to as central apnea. Central apnea typically occurs when apnea is detected due to a reduction or absence of breathing effort, despite the airway being open (e.g., open). A third type of apnea event is referred to as mixed apnea. Mixed apnea typically occurs when a reduction or absence of breathing effort occurs simultaneously with airway obstruction.

[0029] Referring to FIG. 2, a block diagram of a system (100) for assisting a user (e.g., user (10) of FIG. 1a and FIG. 1b) is shown. The system (100) can assist the user (10) in (i) breathing while sleeping, (ii) breathing while awake, (iii) opening the user's airway, (iv) initiating or increasing breathing function (e.g., diaphragm), (v) or any combination thereof. In some implementations, the system (100) assists the user (10) by contracting one or more muscles of the user (10) to (i) open the user's (10) airway, (ii) inhale air (e.g., breathing effort), or (iii) both.

[0030] The system (100) comprises: a housing (102), a stimulator (104), a receiver (108), a transmitter (110), a motion sensor (112), a magnetic field generator (114), a microphone (116), a conductance sensor (118), a heart rate sensor (120), an airflow sensor (122), 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), an external device (150), or one or more of any combination(s) thereof. That is, the system (100) may include any part and any combination of these elements, and the elements may be combined into various different arrangements (e.g., physical and / or wireless) and / or housings.

[0031] Some of the elements of the system (100) are located on the user (10) (e.g., implanted in the user (10)), and other elements of the system (100) are located outside the user (10) (e.g., worn by the user (10)). One or more of the elements of the system (100) located on the user (10) may be located in such a way by being injected into the user (10), for example, using a syringe equipped with a subcutaneous injection needle. Alternatively or additionally, one or more of the elements of the system (100) located on the user (10) may be located in such a way by being surgically placed therein (e.g., by making an incision in the skin, placing the element(s) therein, and suturing the skin).

[0032] A stimulator (104) is positioned on the user (10) such that one or more electric leads (105) of the stimulator (104) are positioned adjacent to one or more muscles of the user (10) and / or one or more nerves of the user (10) connected to one or more muscles of the user (10). In some embodiments, one or more electric leads (105) include a first electric lead (105) positioned to stimulate a first muscle among one or more muscles and / or a first nerve among one or more nerves. Similarly, a second electric lead (105) is positioned to stimulate a second muscle among one or more muscles and / or a second nerve among one or more nerves. In some embodiments, the first electric lead (105) provides electrical stimulation at a first frequency and the second electric lead (105) provides electrical stimulation at a second frequency different from the first frequency. In some embodiments, the first electric lead (105) provides electrical stimulation at a first intensity, and the second electric lead (105) provides electrical stimulation at a second intensity different from the first intensity. Alternatively, the stimulator (104) may not have leads, and the stimulator body is conductive and the end of the body acts as an electrode.

[0033] When the stimulator (104) is positioned on the user (10), the stimulator (104) may deliver electrical and / or magnetic stimulation to the user (10) to help one or more of the user's (10) muscles contract. The contraction of one or more of the user's (10) muscles may help open the user's (10) airway. Alternatively, the contraction may help the user (10) make a breathing effort (e.g., causing the diaphragm to inhale / take in air).

[0034] The electrical stimulation may be applied directly to one or more muscles of the user (10) (e.g., muscles of the user (10)’s occipital region (20), muscles around and / or adjacent to the user (10)’s airway, the user (10)’s diaphragm, etc., or any combination thereof) and / or one or more nerves connected to one or more muscles. Directing the electrical stimulation to one or more nerves (as opposed to directing it to one or more muscles) causes a relatively lower intensity of the electrical stimulation (e.g., voltage, current, etc., or any combination thereof) to be applied, thereby causing one or more muscles (connected to one or more nerves) to contract.

[0035] The stimulator (104) comprises an electrical conductor (e.g., one or more electrically conductive wires with or without electrically insulated parts) or is an electrical conductor. The stimulator (104) comprises one or more electrical leads (105) capable of carrying and / or flowing and delivering an electric current to one or more muscles and / or one or more nerves of the user (10). The current may be supplied by a battery (132) or another power source physically connected directly to the stimulator (104). The battery (132) is rechargeable. In some embodiments, the battery (132) may be recharged by a magnetic field generator (114) and / or an external device (150). Alternatively to the stimulator (104) comprising the battery (132), in some embodiments, the current is supplied wirelessly directly to the electrical conductor(s) by a magnetic field generator (114) (which may be included in the external device (150)).

[0036] In some embodiments, the stimulator (104) comprises only one or more electrically conductive wires with or without electrically insulated portions. In some of these embodiments, the stimulator (104) / wire has: about 1 millimeter to about 100 centimeters; about 1 millimeter to about 100 millimeters; a length of about 1 millimeter to about 10 millimeters; or any length in between. Also, in some such embodiments, the stimulator (104) / wire has about 0.01 millimeter to about 5 millimeters; about 0.1 millimeter to about 2 millimeters; a diameter of about 0.1 millimeter to about 1 millimeter; or any diameter in between. The size and shape of the stimulator (104) may be selected so that the stimulator (104) can be injected into the user (10) through a syringe to which a subcutaneous injection needle is attached.

[0037] In some implementations, the stimulator (104) is positioned directly on the user (10). In such implementations, the housing (102) is not required. Alternatively, the stimulator (104) or a part thereof is coupled to the housing (102) (e.g., at least partially located inside) and the housing (102) (to which the stimulator (104) is coupled) is positioned on the user (10). The housing (102) may have the shape of an elongated pill (or any other shape) that helps to be injected into the user (10) using a syringe with a subcutaneous injection needle attached, for example. In some implementations, the housing (102) electrically insulates at least a part of the stimulator (104) (e.g., the entire stimulator (104) excluding one or more electric leads (105) or conductive ends) from the surrounding tissues of the user (10).

[0038] In addition to the stimulator (104) being coupled to the housing (102), a number of other elements of the system (100) may be coupled to the housing (102) and placed within the user (10). For example, in some implementations, a receiver (108), a motion sensor (112), a microphone (116), a conductance sensor (118), a heart rate sensor (120), an airflow sensor (122), a photoplethysmography (PPG) sensor (124), other sensor(s) (126), a memory (128), a control system (130), a battery (132), or any combination thereof may be coupled to the housing (102) and placed within the user (10) together with the stimulator (104). Being coupled to the housing (102) means that the element coupled to the housing (102) is completely inside the housing (102), attached to the outer surface of the housing (102), partially protruded from one or more openings of the housing (102), attached directly or indirectly to the housing (102), or any combination thereof.

[0039] For example, the stimulator (104) and the receiver (108) are coupled to the housing (102) and located on the user (10). In another example, the stimulator (104), the receiver (108), and the PPG sensor (124) are coupled to the housing (102) and located on the user (10). In yet another example, the stimulator (104), the receiver (108), the PPG sensor (124), the memory (128), and the control system (130) are coupled to the housing (102) and located on the user (10). Various other combinations of elements coupled to the housing (102) and located on the user (10) are considered.

[0040] In some implementations, the receiver (108) is coupled to the housing (102) and / or the stimulator (104). The receiver (108) may receive communication (e.g., a signal) from the transmitter (110). The transmitter (110) may be coupled to and / or located within the external device (150). The communication received by the receiver (108) may cause the stimulator (104) to provide electrical stimulation to one or more muscles of the user (10) and / or one or more nerves of the user (10). In some implementations, the receiver (108) and the transmitter (110) enable wireless communication between the stimulator (104) and the external device (150). In some implementations, the communication represents a command that causes the stimulator (104) to deliver electrical stimulation. In some implementations, the receiver (108) and / or the transmitter (110) are referred to as wireless control elements (e.g., wireless control elements (235)).

[0041] Various sensors may be included in the system (100) to generate data that can be analyzed by a control system (130) and / or one or more other systems (e.g., mobile phone, computer, server, cloud-based device, etc.) to determine information and make a decision regarding the application and / or discontinuation of electrical stimulation to be applied to the user (10) through the stimulator (104).

[0042] In some such implementations, the 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) may be used to generate motion data indicating breathing or lack of breathing by the user (10).

[0043] In some implementations, the motion sensor (112) may be coupled to the housing (102) and positioned on the user (10). Alternatively, the motion sensor (112) may be detached from the housing (102) and / or the stimulator (104) and positioned on the user (10). In such an implementation where the motion sensor (112) is positioned on the user (10), the motion sensor (112) may be positioned adjacent to the user's (10) airway to generate data associated with movement or lack of movement of the airway indicating breathing or lack of breathing. The placement of the motion sensor (112) is in the user's (10) throat (20) (Figs. 1a and 1b), thoracic cavity (30), abdominal cavity (40), or a combination thereof.

[0044] In some other implementations, the motion sensor (112) may be attached to an external device (150) (e.g., a collar, a band / belt, etc., or any combination thereof) and worn by the user (10). In an implementation where the external device (150) is a collar configured to be worn / covered around the user (10)'s neck and / or throat (20), the motion sensor (112) may be attached to the external device (150) such that when the external device (150) is worn / covered around the user (10)'s neck / throat (20), the motion sensor (112) is positioned adjacent to a portion of the user (10)'s airway. In this way, the motion sensor (112) is positioned to generate motion data indicating breathing or lack of breathing by the user (10) (e.g., movement, expansion, contraction, etc. of the neck / throat (20) adjacent to the airway indicates breathing).

[0045] Similarly, in an implementation where the external device (150) is a band and / or belt configured to be worn around the chest and / or abdomen of the user (10), a motion sensor (112) may be coupled to the external device (150) such that the motion sensor (112) is positioned adjacent to the chest and / or abdomen of the user (10) when the external device (150) is worn by the user (10). In this way, the motion sensor (112) is positioned to generate motion data indicating breathing or lack of breathing by the user (10) (e.g., movement, expansion, contraction of the chest and / or abdomen, etc., indicate breathing).

[0046] In addition to or instead of the motion sensor (112), the system (100) may include a microphone (116), a conductance sensor (118), a heart rate sensor (120), an airflow sensor (122), a PPG sensor (124), other sensor(s) (126), or any combination thereof, wherein such sensor or part thereof is in the user (10) and / or is coupled to an external device (150) in the same or similar manner as described above for the motion sensor (112).

[0047] For example, in some implementations, the system (100) includes a PPG sensor (124) coupled to the external device (150) such that when the external device (150) is worn / clothed by the user (10) as a collar, the PPG sensor (124) is positioned adjacent to the user (10)’s throat (20) or on the neck. In such implementations, the PPG sensor (124) may generate data indicating the user’s blood flow adjacent to the airway, the user’s blood oxygen level adjacent to the airway, the user’s heart rate, an apnea event currently experienced by the user, an apnea event likely to be experienced by the user in the future, or any combination thereof.

[0048] In another example, in some implementations, the system (100) includes a microphone (116) coupled to an external device (150) such that when the external device (150) is worn by the user (10) as a collar, the microphone (116) is positioned adjacent to the user's (10) throat (20) and / or neck. In such implementations, the microphone (116) may generate data (e.g., sound data) indicating snoring, suffocation, an apnea event currently experienced by the user, an apnea event likely to be experienced by the user in the future, or any combination thereof.

[0049] In another example, in some implementations, the system (100) includes a speaker (117) coupled to an external device (150). In such an implementation, the microphone (116) and the speaker (117) may be coupled to an acoustic sensor, for example, as described in WO 2018 / 050913, which is incorporated herein by reference in its entirety. In such an implementation, the speaker (117) generates or emits sound waves at predetermined intervals, and the microphone (116) detects reflections of sound waves emitted from the speaker (117). The sound waves generated or emitted from the speaker (117) have a frequency that is inaudible to the human ear (e.g., less than 20 Hz or greater than around 18 kHz) so as not to disturb the sleep of the user (10) or a companion. Based at least partially on data from the microphone (116) and / or speaker (117), the control system (130) can determine the movement of the user (10) as described herein and / or determine whether the user is experiencing or is about to experience apnea.

[0050] In another example, in some implementations, the system (100) includes a heart rate sensor (120) coupled to an external device (150) such that the heart rate sensor (120) is positioned adjacent to the user's (10) chest when the external device (150) is worn by the user (10) as a band / belt. In such an implementation, the heart rate sensor (120) can generate data indicating the user's (10) heart rate and / or pulse.

[0051] In another example, in some implementation, the system (100) includes an airflow sensor (122) coupled to the housing (102) such that when the housing (102) is positioned on the user (10), the airflow sensor (122) is positioned adjacent to and / or at least partially within the user's (10) airway. In this implementation, the airflow sensor (122) can generate data indicating the airflow in the user's (10) airway.

[0052] Other sensor(s) (126) included in the system (100) and located at the user (10) and / or coupled to an external device (150) include, for example, a blood oxygen sensor, a blood flow sensor, a pulse sensor, a respiration sensor, an EKG sensor, an EMG sensor, an EEG sensor, a strain gauge, an accelerometer, a capacitive sensor, a strain gauge sensor, an analyte sensor, a moisture sensor, a camera, an infrared (IR) sensor, an ultrasonic oxygen sensor, an electro-oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, a blood pressure sensor, an oxygen measurement sensor, an electro-skin response (GSR) sensor, or any combination thereof. Each of these other sensor(s) (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 determine information regarding the application and / or discontinuation of electrical stimulation to be applied to the user (10) through the stimulator (104).

[0053] The memory (128) may include one or more physically separated memory devices, so that one or more memory devices may be coupled to the housing (102) and / or an external device (150). The memory (128) acts as a non-transient computer-readable storage medium in which machine-readable instructions that can be executed by the control system (130) and / or one or more other systems are stored. The memory (128) may also store data generated by the sensors of the system (100) (transiently and / or permanently). In some implementations, the memory (128) includes non-volatile memory, battery-powered static RAM, volatile RAM, EEPROM memory, NAND flash memory, or any combination thereof. In some implementations, the memory (128) is a removable form of memory (128) (e.g., a memory card).

[0054] Similar to the memory (128), the control system (130) may be coupled to the housing (102) and / or an external device (150). The control system (130) is coupled to the memory (128) and configured to execute machine-readable instructions stored in the memory (128). The control system (130) includes one or more processors (131) and / or one or more controllers. In some implementations, the one or more processors (131) include one or more x86 INTEL processors, one or more processors based on ARM Holdings' ARM® Cortex®-M processors, such as ST MICROELECTRONIC's STM32 series microcontrollers, or any combination thereof. In some implementation examples, one or more processors (131) include a 32-bit RISC CPU, such as the ST MICROELECTRONICS STR9 series microcontroller, or a 16-bit RISC CPU, such as the processor of the MSP430 family microcontroller manufactured by TEXAS INSTRUMENTS.

[0055] In some implementations, the control system (130) is a dedicated electronic circuit. In some implementations, the control system (130) is a custom integrated circuit. In some implementations, the control system (130) includes individual components.

[0056] The control system (130) may receive input(s) (e.g., signals, generated data, commands, etc.) from any other element of the system (100) (e.g., sensors, etc.). The control system (130) may provide output signal(s) 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 (10)) (e.g., through the transmitter (110), through the magnetic field generator (114), through the external device (150), etc.).

[0057] The control system (130) analyzes data generated by any sensor of the system (100) to determine (i) whether the user (10) 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) the user's (10) current sleep state, (v) tension in one or more of the user's (10) muscles, (vi) or any combination thereof.

[0058] Based on one or more of these decisions, the control system (130) causes the stimulator (104) to provide electrical and / or magnetic stimulation to the user (10) to help (i) stop an apnea event currently experienced by the user (10) and / or (ii) help prevent an apnea event that the user (10) will experience. In some of these implementations, the control system (130) causes the transmitter (110) to transmit a signal to the receiver (108) to induce electrical stimulation of one or more muscles of the user (10). In some other implementations, the control system (130) causes an external device (150) and / or a magnetic field generator (114) to supply wireless power to the stimulator (104) to provide electrical stimulation to one or more muscles and / or one or more nerves of the user (10).

[0059] In addition to causing the stimulator (104) to provide electrical and / or magnetic stimulation, the control system (130) may change one or more parameters of the electrical stimulation provided by the stimulator (104). One or more parameters of the stimulation include frequency, intensity, duration, dwell time, rise time of the pulse, ratio of on time to off time, or any combination thereof.

[0060] In some implementations, one or more parameters of the stimulus are modified based on the measured response of one or more muscles to the stimulus (e.g., using one or more of the sensors of the system (100). In some implementations, modification of the parameters may be based on a continuous feedback loop in which the control system (130) continues to analyze data generated by one or more of the sensors of the system (100) (e.g., motion sensor (112), airflow sensor (122), PPG sensor (124), etc., or any combination thereof). In this way, the control system (130) may modify one or more of the parameters based on the continuous analysis (e.g., in real time, while the user experiences the same apnea event, after the user has experienced an apnea event but before the user experiences another apnea event, etc.).

[0061] For example, if continuous analysis of data generated from one or more sensors of the system (100) indicates that the user (10) is still experiencing an apnea event in the presence of the stimulus, the control system (130) may increase the intensity of the stimulus applied to the user (10) by the stimulator (104). In another example, if continuous analysis indicates that the user (10) is no longer experiencing an apnea event after the stimulus, the control system (130) may cause the stimulator (104) to stop providing the simulation to the user (10). In this way, the user (10) is less likely to become desensitized to the stimulus over time compared to a system that continuously applies the stimulus (even when the user is not experiencing an apnea event).

[0062] In some implementations, the control system (130) causes the stimulator (104) to automatically increase the intensity of the stimulation applied to the user (10). In this way, the intensity may reach a level that causes one or more muscles of the user (10) to contract without artificially setting the intensity high from the start of the stimulation.

[0063] As discussed above, the control system (130) may continuously monitor the generated data to determine whether the current level of automatically increased stimulation intensity has caused one or more muscles of the user (10) to contract. When the control system (130) determines that the current level has not caused one or more muscles of the user (10) to contract, the control system (130) may or may not allow the stimulator (104) to automatically continue increasing the stimulation intensity beyond the current level. Similarly, when the control system (130) determines that the current level has caused one or more muscles of the user (10) to contract, the control system (130) may stop the stimulator (104) from automatically increasing the stimulation intensity at the current level. In this way, an appropriate intensity for stimulation for the user (10) is reached (e.g., not an artificially high intensity that may be painful).

[0064] As described above, the external device (150) may be in the form of a collar, band, belt, or any combination thereof and may be worn / clothed by the user (10). In some of these implementations, the external device (150) includes a housing made wholly or at least partially of a stretchable material so that when worn, the external device (150) can be kept close to the user's (10) skin at least partially. For example, the collar (e.g., external device (150)) may include a stretchable material so that the collar fits snugly around the user's (10) neck (without suffocating the user (10). In this way, when the PPG sensor (124) is contained in the collar (e.g., external device (150)), the PPG sensor (124) can be kept in close contact with the user's (10) neck, which can help provide more accurate data from the PPG sensor (124).

[0065] In addition to or alternative to the collar, band, and belt form factors for the external device (150), the external device (150) may also include and / or be in the form of a patch that can be adhered to the skin of the user (10). The external device (150) may also include and / or be a headgear configured to be worn around the head of the user (10). Other form factors for the external device (150) are considered. For example, the external device (150) may include and / or be in the form of a scarf, shirt, pants, mobile phone, tablet, computer, or any combination thereof.

[0066] The external device (150) may include any number of elements of the system (100). For example, in some implementations, a transmitter (110), a motion sensor (112), a magnetic field generator (114), a microphone (116), a conductance sensor (118), a heart rate sensor (120), a photoplethysmography (PPG) sensor (124), other sensor(s) (126), a memory (128), a control system (130), a battery (132), or any combination thereof is coupled to the external device (150) and / or located within the external device (150). In some implementations, the external device (150) includes at least one of the sensors of the system (100), the magnetic field generator (114), the memory (128), the control system (130), and the battery (132). In some implementations, the external device (150) includes at least the transmitter (110), the memory (128), the control system (130), and the battery (132). In some implementations, the external device (150) is plugged directly into a power source (e.g., a wall outlet) so that the external device (150) does not require a battery (132).

[0067] As discussed above, the control system (130) may determine whether the user is experiencing or intends to experience one or more types of apnea and take one or more actions in response. Additionally, the control system (130) may determine whether the user is experiencing or intends to experience one or more other breathing events and / or breathing-related conditions and take one or more actions in response. Such other breathing events and / or breathing-related conditions as discussed herein include, for example, hypopnea, hyperpnea, sleep disturbance breathing, Cheyne-Stokes breathing, respiratory failure, obesity-induced hyperventilation syndrome, chronic obstructive pulmonary disease, neuromuscular disease, chest wall disease, or any combination thereof.

[0068] The control system (130) executes a breathing event determination algorithm to determine the presence of a breathing event (e.g., apnea, hypopnea, hyperpnea, etc.). In some implementations, the breathing event determination algorithm receives as input at least a portion of data generated from one or more sensors of the system (100) and provides as output a flag indicating that a breathing event (e.g., apnea, hypopnea, etc.) has been detected. In some implementations, the breathing event determination algorithm receives as input at least a portion of data generated from one or more sensors of the system (100) and provides as output a command to activate a stimulator (104) to provide electrical stimulation to the user (10). In some such implementations, the command includes a command to set at least a portion of one or more parameters of the electrical stimulation to be provided by the stimulator (104).

[0069] In some implementations of the system (100), a breathing event of apnea is detected when a function of breathing flow rate (e.g., at least partially determined using an airflow sensor (122)) falls below a flow rate threshold for a predetermined time period. This function may determine a peak flow rate, which is a relatively short average flow rate, or a flow rate that is an intermediate between the relatively short average and peak flows, e.g., an RMS flow rate. The flow rate threshold may be a relatively long-term measurement of the flow rate.

[0070] In some implementations of the system (100), a breathing event of hypopnea is detected when a function of breathing flow rate (e.g., determined at least partially using an airflow sensor (122)) falls below a second flow rate threshold for a predetermined time period. This function may determine a peak flow rate, which is a relatively short average flow rate, or a flow rate that is an intermediate between the relatively short average and peak flows, e.g., an RMS flow rate. The second flow rate threshold is greater than the flow rate threshold used to detect apnea.

[0071] In some implementations of the system (100), a breathing event of apnea is detected when a function of blood flow velocity (e.g., determined at least partially using a PPG sensor (124)) falls below a flow threshold for a predetermined time period. This function may determine a peak flow, which is a relatively short average flow, or a flow that is an intermediate between the relatively short average and peak flows. The flow threshold may be a relatively long-term measurement of the flow.

[0072] The control system (130) executes a snoring event determination algorithm to determine the presence of a snoring-related event (e.g., snoring, suffocation, etc.). In some implementations, the snoring event determination algorithm receives as input at least a portion of data generated from one or more sensors of the system (100) (e.g., microphone (116), motion sensor (112), etc.) and provides as output (i) a flag indicating that a snoring event (e.g., apnea, hypopnea, etc.) has been detected, (ii) a metric indicating the degree to which snoring is present, or (iii) both (i) and (ii).

[0073] In some implementations of the system (100), the snoring event determination algorithm can determine the intensity of a flow rate signal in the range of 30 to 300 Hz. Additionally, the snoring event determination algorithm can reduce background noise by filtering the breathing flow rate signal.

[0074] The control system (130) executes an airway patency algorithm for determining the patency (e.g., open) of the user's airway. In some implementations, the airway patency algorithm receives a respiratory flow signal (e.g., determined at least partially using an airflow sensor (122)) as input and determines the power of the signal in a frequency range of about 0.75 Hz to about 3 Hz. The presence of a peak in this frequency range indicates an open airway. The absence of a peak in this frequency range indicates a closed airway. In some implementations, the airway patency algorithm receives the respiratory flow signal as input and determines the presence or absence of a cardiac signal. The absence of a cardiac signal indicates a closed airway.

[0075] The control system (130) executes a treatment parameter algorithm to determine one or more parameters of the stimulator (104) (e.g., intensity, frequency, duration, etc.). In some such implementations, the treatment parameter algorithm receives as input the output(s) of one or more other algorithms described herein and outputs one or more values ​​for one or more parameters (e.g., intensity, frequency, duration, etc.) of the electrical stimulation provided by the stimulator (104).

[0076] Although the system (100) is illustrated as comprising one stimulator (104), one external device (150), and one battery (132), it is considered that the system (100) may comprise any number of stimulators (104) (e.g., 1, 2, 3, 5, 10, 50, etc.), the system (100) may comprise any number of external devices (e.g., 1, 2, 3, 5, 10, 50, etc.), and the system (100) may comprise any number of batteries (132) (e.g., 1, 2, 3, 5, 10, etc.). The ratio of stimulators to external devices may be one-to-one or other ratios. For example, in some implementations, two or more stimulators (104) may be controlled and / or communicated by one external device (150).

[0077] A method of using the system (100) to assist the user (10) when experiencing an apnea event is now described. The control system (130) (in an external device (150) or within the housing (102)) executes a breathing event determination algorithm to determine the presence of a breathing event in the user (10). In some such implementations, the breathing event determination algorithm is stored as a command in memory (128).

[0078] The control system (130) analyzes data generated by one or more sensors of the system (100) included in the external device (150) (e.g., motion sensor (112), PPG sensor (124), etc.) to determine whether the user (10) is currently experiencing an apnea event (e.g., obstructive apnea event). If the control system (130) determines that the user (10) is currently experiencing an apnea event, the control system (130) causes the stimulator (104) to provide stimulation. The stimulation may be provided to one or more muscles and / or one or more nerves of the user (10) adjacent to the user's (10) throat (20). The stimulation may help stop the apnea event (e.g., by causing one or more muscles of the throat (20) to constrict and open the user's (10) airway).

[0079] Referring to FIGS. 3a and 3b, a system (200) is illustrated for a user (10B), wherein, for a better example of the components of an external device (250), the external device (250) (in the form of a collar) is worn by the user (10B) in FIG. 3b and removed from the user (10B) in FIG. 3a. The system (200) is identical or similar to the system (100). The system (200) includes (i) a stimulator (204) located in the throat (20B) of the user (10B) and (ii) an external device (250).

[0080] The stimulator (204) is identical or similar to the stimulator (104) described herein in relation to FIG. 2. The stimulator (204) is illustrated with two electric leads (205) adjacent to one or more muscles of the user (10B), but any number of electric leads (205) is considered (e.g., one electric lead, three electric leads, five electric leads, ten electric leads, etc.). Likewise, the stimulator may not have leads due to the ends of the stimulator capsule acting as electrodes for delivering stimulation.

[0081] Although the stimulator (204) is illustrated without a housing for ease of illustration, like the stimulator (104), the stimulator (204) may be coupled to a housing and / or any other element described herein (e.g., a receiver, a sensor, a battery, a wireless control element (235)). The stimulator (204) is typically positioned in the throat (20B) of the user (10B) 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).

[0082] The external device (250) is in the form of a collar that can be worn by the user (10B) around the user's (10B) throat (20A) / neck. The external device (250) may be made of any type of material(s) suitable for being worn on the body (e.g., neck) (e.g., one or more types of plastic, one or more types of metal, nylon, one or more types of fabric, elastic fabric, etc., or any combination thereof).

[0083] The external device (250) includes any type of coupling mechanism (260) (Fig. 3a) to help attach the external device (250) 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 clasp, a snap connection, a ball clasp, a bead clasp, a barrel clasp, a fishhook clasp, a push button clasp, a spring clasp, a lobster claw clasp, a hook and loop clasp, etc., or any combination thereof.

[0084] In some implementations, the coupling mechanism (260) includes a loop at one end of the external device (250) that passes through and returns twice so that the opposing end of the external device (250) is secured to the outer surface of the external device (250), for example, using a hook and loop fastener. Various other methods of securing the external device (250) to the user (10B) are considered. In some implementations, the coupling mechanism (260) helps secure the external device (250) to the user (10B) in a tight fit. Alternatively, the coupling mechanism (260) helps secure the external device (250) to the user (10B) in a loose fit.

[0085] As best illustrated in FIG. 3a, the external device (250) includes a sensor (275), memory (228), a control system (230), and a battery (232). The sensor (275) is identical or similar to a motion sensor (112), a microphone (116), a conductance sensor (118), a heart rate sensor (120), a PPG sensor (124), other sensor(s) (126), or any combination thereof. The memory (228) is identical or similar to the memory (128) described herein in relation to FIG. 2. The control system (230) is identical or similar to the control system (130) described herein in relation to FIG. 2. The battery (232) is identical or similar to the battery (132) described herein in relation to FIG. 2.

[0086] The external device (250) (and / or stimulator (204)) may also include one or more wireless control elements (235) to enable the external device (250) and the stimulator (204) to communicate wirelessly with and / or power the stimulator (204). One or more wireless control elements (235) may be built into / included in the control system (230) and / or separated therefrom. For example, the external system (250) may include a transmitter identical or similar to the transmitter (110) (and the stimulator (204) may include a receiver identical or similar to the receiver (108)), a magnetic field generator (114), a wireless control module, or any combination thereof. In some implementations, the stimulator (204) itself (e.g., an electrically conductive wire forming at least part of the stimulator (204)) serves as a wireless receiver without requiring any other components. In some implementations, the wireless control element (235) of the stimulator (204) is a receiver (e.g., receiver (108)) or includes it, and the wireless control element (235) of the external device (250) is a transmitter (e.g., transmitter (110)) or includes it.

[0087] As illustrated in FIG. 3b, when the user (10B) wears the external device (250) on the user's (10B) throat (20B) / neck, the external device (250) or a part thereof is in direct proximity to the stimulator (204). In this way, in some implementations, wireless communication and / or wireless charging / power supply between the external device (250) and the stimulator (204) becomes possible. Additionally, this placement of the external device (250) positions the sensor (275) in proximity to the user's (10B) airway.

[0088] In some implementations, markings may be included on the external device (250) to help the user align the external device (250) with one or more parts of the user's (10B) anatomical structure. In this way, the sensor (275) may be appropriately positioned relative to the user (10B). For example, a vertical line marking (280) may be included on the outer surface of the external device (250) (e.g., printed). The vertical line marking (280) may indicate to the user (10B) the location of the sensor (275) (which may be embedded in the external device (250) and / or otherwise hidden) to be aligned with the user's anatomical structure (e.g., the midline of the throat (20B)).

[0089] In another example, the external device (250) may include other features to help the user (10B) align the external device (250) when wearing the external device (250). For example, a cutout (285) of the external device (250) (e.g., circular, square, triangular, polygonal, or any combination thereof) may indicate a location of the external device (250) that must be aligned with a specific part of the user's anatomy (e.g., the midline of the throat (20B)) so that, for example, the sensor (275) is properly positioned relative to the user (10B).

[0090] Being properly positioned means that the sensor (275) is positioned in a location relative to the user (10B) so that the sensor (275) can generate reliable and / or available data. In some such implementations, the position of the sensor (275) depends on the type of sensor(s) included in the sensor (275). For example, if the sensor (275) is a motion sensor, the proper position for the sensor (275) may be in a first position, and if the sensor (275) is a PPG sensor, the proper position for the sensor (275) may be in a second position that is the same as or different from the first position.

[0091] Referring to FIG. 4a, a system (300) related to a user (10C) is illustrated. The system (300) is identical or similar to the system (100, 200). The system (300) includes a first external device (350A) worn on the throat (20C) of the user (10C) and a second external device (350B) worn on the chest (30C) of the user (10C). The first external device (350A) may be referred to as a collar and the second external device may be referred to as a chest band. The system (300) also includes a first stimulator (304A) located on the throat (20C) or neck of the user (10C) and a second stimulator (304B) located on the abdominal or thoracic cavity of the user (10C).

[0092] Both stimulators (304A and 304B) are identical or similar to the stimulators (104, 204) described herein in relation to FIGS. 2, FIGS. 3a and FIGS. 3b. External devices (350A and 350B) are identical or similar to the external devices (150, 250) described herein in relation to FIGS. 2, FIGS. 3a and FIGS. 3b. The system (300) differs primarily in that it includes two stimulators and two external devices that work together to assist the user (10C).

[0093] Referring to FIG. 4b, the system (300) is illustrated with respect to a cross-sectional view of the user (10C) to better illustrate the placement of the stimulator (304A, 304B) on the user (10C). Additionally, more details regarding the external devices (350a, 350B) are illustrated. As mentioned above, the first and second external devices (350A, 350B) are identical or similar to the external devices (150, 250). Specifically, each of the external devices (350A, 350B) includes a sensor (375), memory (328), control system (330), battery (332), coupling mechanism (360), and wireless control element (335), which are identical or similar to the sensor (275), memory (228), control system (230), battery (232), coupling mechanism (260), and wireless control element (235) of the system (200) described in relation to FIGS. 3A and 3B. The second external device (350B) differs in size primarily in relation to the first external device (350A) and the external device (250). That is, the second external device (350B) is larger so that it can be worn on the chest of the user (10C).

[0094] In some implementations, the first external device (350A) and the first stimulator (304A) operate independently of the second external device (350B) and the second stimulator (304B). In these implementations, the first external device (350A) and the first stimulator (304A) form a first subsystem of the system (300) that helps the user (10C) cope with a first type of apnea event (e.g., obstructive apnea) by, for example, causing the muscles of the throat (20C) to contract to open the airway. Similarly, in these implementations, the second external device (350B) and the second stimulator (304B) form a second subsystem of the system (300) that helps the user (10C) cope with a second type of apnea event (e.g., central apnea) by, for example, causing the user (10C)'s diaphragm to contract to assist the user (10C)'s breathing effort. In this implementation, both the first external device (350A) (collar) and the second external device (350B) (chest band) include their respective memory (328) and their respective control systems (330).

[0095] In some other implementations, the first and second external devices (350A, 350B) operate together and are combined (e.g., wireless and / or wired). In some of these implementations, only one of the first and second external devices (350A, 350B) includes a memory (328) and a control system (330). That is, for example, the second external device (350B) (chest band) includes a memory (328), a control system (330), a sensor (375), and a battery (332), and the first external device (350A) (collar) includes a sensor (375) and a battery (332). In another example, the first external device (350A) (collar) includes a memory (328), a control system (330), a sensor (375), and a battery (332), and the second external device (350B) (chest band) includes a sensor (375) and a battery (332).

[0096] It should be understood that the sensor (375) of the first external device (350A) and the sensor (375) of the second external device (350B) may be of the same type of sensor(s) or different sensor(s). For example, in some implementations, the sensor (375) of the first external device (350A) (collar) is a PPG sensor (e.g., PPG sensor (124)) and the sensor (375) of the second external device (350B) (chest band) is a motion sensor (e.g., motion sensor (112)).

[0097] Although the first and second stimulators (304A, 304B) are depicted as two separate and distinct stimulators, it is considered that the first and second stimulators (304A, 304B) may be physically and / or electrically linked. For example, a common housing (not shown) may be implanted in the user (10C) (e.g., the user's (10C) thoracic cavity). From the common housing, one or more electrical leads of the first stimulator (304A) may be extended to the user's (10C) neck to be adjacent to one or more muscles and / or one or more nerves in the user's (10C) neck. Additionally, from the common housing, one or more electrical leads of the second stimulator (304B) may be extended into the user's (10C) abdominal cavity and / or thoracic cavity to be adjacent to the user's (10C) diaphragm. In some such implementations, one or more batteries may be combined in a common housing to supply current to the first and second stimulators (304A, 304B).

[0098] A method of using the system (300) to assist a user (10C) when experiencing one or more types of apnea events is now described. A control system (330) (in the first external device (350A), the second external device (350B), or a combination thereof) executes a breathing event determination algorithm to determine the presence of a breathing event of the user (10C). In some such implementations, the breathing event determination algorithm is stored as a command in memory (328).

[0099] The control system (330) analyzes data generated by the sensor (375) of the first external device (350A) 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) of the second external device (350B) to determine whether the user (10C) is currently experiencing a second type of apnea event (e.g., central apnea event).

[0100] When the control system (330) determines that the user (10C) is currently experiencing a first type of apnea event, the control system (330) causes the first stimulator (304A) to provide electrical stimulation. The electrical stimulation may be provided to one or more muscles and / or one or more nerves of the user (10C) adjacent to the user's (10C) throat (20C). The electrical stimulation may help stop the first type of apnea event (e.g., by causing one or more muscles of the throat (20C) to constrict and open the user's (10C) airway).

[0101] If the control system (330) determines that the user (10C) is currently experiencing a second type of apnea event, the control system (330) causes the second stimulator (304B) to provide electrical stimulation. The electrical stimulation may be provided to the diaphragm and / or one or more nerves connected to the user's (10C) diaphragm. The electrical stimulation may help stop the second type of apnea event (e.g., by contracting the diaphragm and causing the user (10C) to breathe / inhale air into the respiratory system).

[0102] Additionally, if the control system (330) determines that the user (10C) is currently experiencing a first type of apnea event and a second type of apnea event simultaneously, the control system (330) causes (i) the first stimulator (304A) to provide electrical stimulation to one or more muscles and / or one or more nerves of the user (10C) adjacent to the user (10C)'s neck (20C) and (ii) the second stimulator (304B) to provide electrical stimulation to the diaphragm and / or one or more nerves connected to the user (10C)'s diaphragm.

[0103] One or more elements, modes, or steps, or any part(s) thereof, from any one or more of the following claims 1 through 75 may be combined with one or more elements, modes, or steps, or any part(s) thereof, from any one or more of the other claims 1 through 75 or a combination thereof, to form one or more additional embodiments and / or claims of the present disclosure.

[0104] Although the present disclosure has been described with reference to one or more specific embodiments and embodiments, those skilled in the art will understand that many variations may be made without departing from the spirit and scope of the present disclosure. Each of these embodiments and embodiments and obvious variations thereof is considered to be within the spirit and scope of the present disclosure as set forth in the following claims.

Claims

Claim 1 A system for supporting a user comprises: a housing configured to be positioned on the user adjacent to the user’s airway; a stimulator coupled to the housing; a receiver coupled to the housing; and a collar configured to be worn around the user’s neck and configured to wirelessly power the stimulator, wherein the collar comprises: a transmitter coupled to the collar and configured to communicate with the receiver to enable the stimulator to selectively provide electrical stimulation to (i) one or more muscles of the user adjacent to the airway, (ii) one or more nerves associated with the one or more muscles, or (iii) both (i) and (ii); a sensor configured to generate data associated with the user’s airway; an indicator on the collar indicating the position of the sensor within the collar, wherein the indicator aligns the sensor with the anatomical features of the neck when the collar is worn around the user’s neck; and a memory for storing machine-readable commands. A control system comprising one or more processors configured to execute the machine-readable command, wherein the machine-readable command analyzes data generated 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; and, in response to the determination that (i) the user is experiencing an apnea event or (ii) the user is about to experience an apnea event, the transmitter communicates with the receiver to provide the electrical stimulation to help the stimulator stop or prevent the apnea event. Claim 2 A system according to claim 1, wherein the control system is further configured to execute the machine-readable command to analyze the generated data to determine the user's sleep state, the tension of one or more muscles, or both. Claim 3 A system according to claim 1 or 2, wherein the control system is further configured to execute the machine-readable command to change one or more parameters of the electrical stimulation, wherein the one or more parameters of the electrical stimulation include frequency, intensity, duration, dwell time, rise time of pulse, ratio of on time to off time, or any combination thereof, and wherein the one or more parameters of the electrical stimulation are changed based on the measured response of the one or more muscles to the electrical stimulation. Claim 4 A system according to claim 1, wherein the control system is further configured to execute the machine-readable command to automatically increase the intensity of the electrical stimulation when the stimulator provides the electrical stimulation, and to analyze the generated data to determine whether the current level of the automatically increased electrical stimulation intensity has contracted one or more muscles. Claim 5 In paragraph 4, the control system is further configured to execute a machine-readable command to: automatically continue increasing the intensity of the electrical stimulation beyond the current level in response to a determination that the current level has not contracted one or more muscles; and to stop the automatic increase in the intensity of the electrical stimulation at the current level in response to a determination that the current level has contracted one or more muscles. Claim 6 A system according to claim 1, wherein the stimulator comprises two or more leads protruding at least partially from the housing, wherein the first lead among the two or more leads is configured to stimulate a first muscle among the one or more muscles, and the second lead among the two or more leads is configured to stimulate a second muscle among the one or more muscles. Claim 7 In claim 1, the system wherein the sensor is a motion sensor configured to detect motion of the airway. Claim 8 A system according to claim 1, wherein the sensor is a photoplethysmography (PPG) sensor and the data represents the blood flow of the user adjacent to the airway, the blood oxygen level of the user adjacent to the airway, the heart rate of the user, an apnea event currently experienced by the user, an apnea event likely to be experienced by the user in the future, or any combination thereof. Claim 9 A system according to claim 1, wherein the sensor is a microphone and the data is sound data representing snoring, suffocation, apnea events, or any combination thereof. Claim 10 A system according to claim 1, wherein the sensor comprises a motion sensor, a photoplethysmography (PPG) sensor, a blood oxygen sensor, a blood flow sensor, a microphone, a skin conductance sensor, a pulse sensor, a respiration sensor, an EKG sensor, an EMG sensor, an airflow sensor, or any combination thereof. Claim 11 A system according to claim 1, further comprising a battery coupled to the housing and configured to supply power to the stimulator, wherein the collar is configured to wirelessly charge the battery. Claim 12 A system according to claim 1, wherein the one or more processors are further configured to execute machine-readable commands, the machine-readable commands: determine whether the user is currently experiencing an apnea event based on at least an analysis of generated data; and in response to the determination that the user is currently experiencing an apnea event, cause the stimulator to provide electrical stimulation at a first intensity level to one or more muscles of the user adjacent to the airway to help stop the apnea event. Claim 13 In paragraph 12, the control system is further configured to execute the machine-readable command to analyze the generated data to determine whether the first intensity level of the electrical stimulation intensity has contracted one or more muscles. Claim 14 In paragraph 13, the control system is further configured to execute a machine-readable command to: automatically increase the intensity of the electrical stimulation beyond the first intensity level in response to a determination that the first intensity level did not contract the one or more muscles; and stop the automatic increase in intensity of the electrical stimulation at the second intensity level in response to a determination that the second intensity level contracted the one or more muscles. Claim 15 A system according to claim 1, wherein the stimulator is an electrical conductor, has a length of 1 millimeter to 10 millimeters, and has a diameter of 0.1 millimeter to 2 millimeters. Claim 16 In claim 1, the system comprises a magnetic field generator configured to supply power to the stimulator. Claim 17 A system according to claim 1, further comprising a battery coupled to the housing, wherein the battery is positioned at the user when the housing is positioned at the user, is rechargeable by the collar, and is configured to supply power to the stimulator. Claim 18 A system according to claim 1, further comprising an additional sensor configured to generate data associated with the user's airway, and coupled to the housing such that the additional sensor is positioned on the user when the housing is positioned on the user. Claim 19 In paragraph 18, the system wherein the additional sensor comprises a motion sensor, an airflow sensor, or both. 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