Systems and methods for using an implantable device to assist a user in breathing

Abstract

A method includes receiving, from a respiration monitoring device positioned in a user's body proximate to the user's thorax, respiration data associated with respiration of the user. The method also includes determining, based at least in part on the respiration data associated with the respiration of the user, a respiration signal of the user. The method also includes determining, based at least in part on the respiration signal, a predicted start time of a future inhalation of the user. The method also includes causing a stimulation device to provide electrical stimulation to one or more branches of a nerve of the user at the predicted start time, the stimulation device being located in the user's body proximate to a tongue of the user and physically separate from the respiration monitoring device.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 983,375, filed February 28, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention generally relates to systems and methods for assisting a user's breathing, and more specifically, to systems and methods for helping to prevent sleep apnea by stimulating one or more nerve branches at defined stimulation times. Background Technology

[0004] Many individuals suffer from sleep-related breathing disorders such as sleep-disordered breathing (SDB), obstructive sleep apnea (OSA), and Cheyne-Stokes respiration (CSR). These conditions are characterized by events such as apnea, hypoventilation, hyperventilation, and hypercapnia, in which an individual's breathing stops or is interrupted / restricted during sleep. Various systems exist to assist users experiencing sleep apnea and related breathing disorders. Some of these systems require the user to wear an interface (e.g., a mask) that helps supply pressurized air to the user's airway (e.g., a continuous positive airway pressure (CPAP) system). Some users find these systems uncomfortable, difficult to use, expensive, unsightly, etc. Other systems rely on implantable respiratory monitoring sensors and / or stimulators that stimulate nerves / muscles to open the airway. However, these systems require a wired connection between the sensor and stimulator (e.g., wires embedded in the skin) to provide power to the sensor and / or stimulator and to facilitate communication between them. This invention aims to address these problems and resolve other needs. Summary of the Invention

[0005] According to some embodiments of the present invention, a system for assisting a user's breathing includes a respiratory monitoring device, a stimulation device, a memory, and a control system. The respiratory monitoring device is configured to be located within the user's body adjacent to the user's chest cavity. The respiratory monitoring device includes sensors configured to generate data related to the user's breathing. The stimulation device is configured to be located within the user's body adjacent to the user's tongue. The stimulation device includes a stimulator configured to provide electrical stimulation to one or more branches of a user nerve adjacent to the user's tongue. The stimulation device is physically separated from the respiratory monitoring device. The memory stores machine-readable instructions. The control system includes one or more processors configured to execute the machine-readable instructions to determine a user's respiratory signal based at least in part on the generated data associated with the user's breathing. The control system is further configured to identify one or more inhalation portions and one or more exhalation portions within the respiratory signal, based at least in part on the identified one or more inhalation portions. The control system is further configured to determine a predicted start time for the user's future inhalation. The control system is further configured to cause the stimulation device to provide electrical stimulation to one or more branches of the nerve at a stimulation time at least in part based on the predicted start time of the user's future inhalation.

[0006] According to some embodiments of the present invention, a method includes receiving respiratory data associated with a user's breathing from a respiratory monitoring device positioned within the user's body adjacent to the user's chest cavity. The method further includes determining a user's respiratory signal based at least in part on the respiratory data associated with the user's breathing. The method also includes determining a predicted start time of a future inhalation of the user based at least in part on the respiratory signal. The method further includes causing a stimulating device to provide electrical stimulation to one or more branches of a nerve of the user at the predicted start time, the stimulating device being located within the user's body adjacent to the user's tongue and physically separated from the respiratory monitoring device.

[0007] According to some embodiments of the present invention, a system for assisting a user's breathing includes a respiratory monitoring device, a stimulation device, a memory, and a control system. The respiratory monitoring device is configured to locate the user's chest cavity adjacent to the user's body and includes a sensor configured to generate data associated with the user's breathing. The stimulation device is configured to be located within the user's body adjacent to the user's tongue and includes a stimulator configured to provide electrical stimulation to one or more branches of a user nerve adjacent to the user's tongue. The stimulation device is physically separated from the respiratory monitoring device. The memory stores machine-readable instructions. The control system includes one or more processors configured to execute the machine-readable instructions to determine the user's respiratory signal based at least in part on the generated data associated with the user's breathing. The control system is further configured to identify a first exhalation portion of the respiratory signal. The control system is further configured to identify the beginning of a first inhalation portion of the respiratory signal immediately following the first exhalation portion, the beginning of the first inhalation portion occurring at a start time. The control system is further configured to cause the stimulation device to provide electrical stimulation to one or more branches of the nerve at a stimulation time at least in part based on the start time.

[0008] According to some embodiments of the present invention, a method includes receiving respiratory data associated with a user's breathing from a respiratory monitoring device positioned within the user's body adjacent to the user's chest cavity. The method further includes determining a user's respiratory signal based at least in part on the respiratory data associated with the user's breathing. The method further includes identifying the start time of a first inhalation portion of the respiratory signal. The method further includes causing a stimulating device to provide electrical stimulation to one or more branches of a nerve of the user at a stimulation time (i) after the start time and (ii) before the first exhalation portion of the respiratory signal, the stimulating device being positioned within the user's body adjacent to the user's tongue and physically separated from the respiratory monitoring device.

[0009] According to some embodiments of the present invention, a system for assisting a user's breathing includes a respiratory monitoring device, a stimulation device, a memory, and a control system. The respiratory monitoring device is configured to be located within the user's body adjacent to the user's chest cavity and includes a sensor configured to generate data associated with the user's breathing. The stimulation device is configured to be located within the user's body adjacent to the user's tongue and includes a stimulator configured to provide electrical stimulation to one or more branches of a user nerve adjacent to the user's tongue. The stimulation device is physically separated from the respiratory monitoring device. The memory stores machine-readable instructions. The control system includes one or more processors configured to execute the machine-readable instructions to determine a user's respiratory signal based at least in part on the generated data associated with the user's breathing. The control system is further configured to identify a first portion of the exhaled portion of the respiratory signal. The control system is further configured to identify the beginning of a second portion of the exhaled portion of the respiratory signal, the beginning of the second portion of the exhaled portion occurring at a start time. The control system is further configured to cause the stimulation device to provide electrical stimulation to one or more branches of the nerve at a stimulation time at least in part based on the start time.

[0010] The above overview is not intended to represent every embodiment or aspect of the invention. Additional features and advantages of the invention will become apparent from the detailed description and accompanying drawings. Attached Figure Description

[0011] Figure 1A It is a diagram illustrating the general condition of the user's respiratory system;

[0012] Figure 1B This is an explanation Figure 1A A diagram of the user's upper airway;

[0013] Figure 2 This is a block diagram of a system for assisting a user (e.g., breathing) according to some embodiments of the present invention;

[0014] Figure 3A This is a schematic diagram of a respiratory monitoring device positioned in the user's body near the chest cavity and a stimulation device positioned in the user's body near the tongue, according to some embodiments of the present invention.

[0015] Figure 3B This is according to some embodiments of the present invention. Figure 3A A schematic diagram of a respiratory monitoring device and a stimulation device, including a first wearable and a second wearable;

[0016] Figure 4 This is a process flowchart of a method for assisting a user's breathing according to some embodiments of the present invention;

[0017] Figure 5An exemplary breathing signal of a user is shown according to some embodiments of the present invention;

[0018] Figure 6 This is a process diagram of a method for assisting a user's breathing according to some embodiments of the present invention;

[0019] Figure 7 An exemplary breathing signal of a user is shown according to some embodiments of the present invention;

[0020] Figure 8 This is a process diagram of a method for assisting a user's breathing according to some embodiments of the present invention; and

[0021] Figure 9 An exemplary breathing signal of a user is shown according to some embodiments of the present invention.

[0022] While the invention is susceptible to various modifications and substitutions, its specific embodiments and implementations have been illustrated by way of example in the accompanying drawings and will be described in detail herein. However, it should be understood that this is not intended to limit the invention to the specific forms disclosed, but rather, the invention is intended to cover all modifications, equivalents, and substitutions falling within the spirit and scope of the invention as defined by the appended claims. Detailed Implementation

[0023] refer to Figure 1A This diagram illustrates an overview of the respiratory system 12 of user 10 (e.g., a patient), which typically includes the nasal cavity, oral cavity, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. More generally, user 10 has a larynx 20, which includes the area of ​​user 10's respiratory system 12 typically located in the neck region of user 10. User 10's diaphragm is a muscle that extends through the base of user 10's thoracic cavity. The diaphragm typically separates user 10's thoracic cavity 30, which contains the heart, lungs, and ribs, from user 10's abdominal cavity 40. As the diaphragm contracts, the volume of thoracic cavity 30 increases and air is drawn into the lungs.

[0024] As described herein, one or more stimulators of the present invention can be placed (e.g., by surgical implantation, by syringe injection, etc.) inside a user 10 to assist the user 10 in breathing, for example, during sleep. For example, one or more stimulators may be positioned within the user 10 body adjacent to the tongue 16 of the user 10. In another example, one or more stimulators may be positioned within the user 10 body adjacent to nerves (e.g., the hypoglossal nerve 18) and / or nerve branches. The hypoglossal nerve 18 is generally involved in controlling the movement of the tongue 16 and includes multiple nerve branches distributed to the external and internal muscles of the tongue 16.

[0025] Reference Figure 1BThe image shows a view of the upper airway 14 of user 10, which includes the nasal cavity, nasal bones, lateral nasal cartilage, greater alar cartilage, nostrils (one shown), supralipal, sublipal, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, esophagus, and trachea.

[0026] User 10's respiratory system 12 facilitates gas exchange. User 10's nose 50 and mouth 60 form the entrance to User 10's airway. Figure 1A As shown, the airway comprises a series of branching tubes, which 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 enter the venous blood from inhaled air and carbon dioxide to be expelled in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the airway tubes and do not participate in gas exchange. Further branching of the airway leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone.

[0027] There are a range of breathing disorders that may affect User 10. Some conditions are characterized by specific events (such as apnea, hypoventilation, hyperventilation, or any combination thereof). Examples of sleep-related and / or breathing disorders include periodic limb movement disorder (PLMD), restless legs syndrome (RLS), sleep-disordered breathing (SDB), obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity-related hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0028] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events during sleep involving closure or obstruction of the upper airway due to a combination of abnormally small upper airway and loss of normal muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls. More generally, apnea generally refers to the cessation of breathing caused by air blockage (obstructive sleep apnea) or cessation of respiratory function (often referred to as central apnea). Other types of apnea include hypoventilation, hyperventilation, and hypercapnia. Hypoventilation is typically characterized by slow or shallow breathing caused by a narrowed airway, rather than airway obstruction. Hyperventilation is typically characterized by an increase in respiratory depth and / or rate. Hypercapnia is typically characterized by an excess of carbon dioxide in the bloodstream and is usually caused by hypoventilation.

[0029] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a dysregulation of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as the CSR cycle. CSR is characterized by repetitive hypoxia and reoxidation of arterial blood. Due to the repetitive oxygen deprivation, CSR can be harmful. In some users, CSR is associated with repetitive awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload.

[0030] Respiratory failure is a term for a respiratory disorder in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the user's needs. Respiratory failure can encompass some or all of the following disorders. Users with respiratory insufficiency (a form of respiratory failure) may experience unusual shortness of breath during exercise.

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

[0032] Chronic obstructive pulmonary disease (COPD) includes any of the lower airway diseases that share certain common characteristics, such as increased resistance to air movement, 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 diseases (NMDs) encompass a wide range of conditions and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some users of 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 disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: 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, somnolence, morning headache, difficulty concentrating, and mood swings.

[0034] The chest wall is 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] These other sleep-related conditions are characterized by specific events that occur during an individual's sleep (e.g., snoring, sleep apnea, insomnia, restless legs, sleep disturbances, apnea, increased heart rate, difficulty breathing, asthma attacks, seizures, epilepsy, or any combination thereof). While these other sleep-related conditions can have symptoms similar to insomnia, distinguishing them from insomnia can be used to tailor effective treatment plans that may require different treatments. For example, fatigue is often a characteristic feature of insomnia, while excessive daytime sleepiness is a characteristic feature of other conditions (e.g., PLMD) and reflects a physiological tendency to fall asleep involuntarily.

[0036] The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea during sleep. The AHI is calculated by dividing the number of apnea and / or hypopnea events experienced by the AHI user during a sleep session by the total number of hours of sleep in the session. An event can be, for example, an apnea lasting at least 10 seconds. An AHI less than 5 is considered normal. An AHI greater than or equal to 5 but less than 15 is considered an indicator of mild sleep apnea. An AHI greater than or equal to 15 but less than 30 is considered an indicator of moderate sleep apnea. An AHI greater than or equal to 30 is considered an indicator of severe sleep apnea. In children, an AHI greater than 1 is considered abnormal. When the AHI is normal, or when the AHI is normal or mild, sleep apnea can be considered “controlled.” The AHI can also be used in conjunction with oxygen desaturation levels to indicate the severity of obstructive sleep apnea.

[0037] One or more of the conditions described herein can be treated with electrical stimulation. For example, a stimulator can deliver electrical and / or magnetic stimulation to a user (e.g., nerves, nerve branches, muscles, etc.) to help prevent a sleep apnea event that the user is about to experience. Electrical stimulation can help prevent sleep apnea by, for example, moving (e.g., contracting) one or more muscles and opening the user's airway before sleep apnea occurs. For example, a stimulator can electrically stimulate the hypoglossal nerve 18 ( Figure 1B Move the tongue 16 to help open the airway to allow for more inhalation and prevent sleep apnea.

[0038] In a typical stimulation system, the stimulator is placed (e.g., implanted) inside the user's body. A respiratory sensor is also placed inside or on the user and measures the user's breathing. The timing of stimulation is determined based on the respiratory data. In other words, the system needs to determine when to stimulate based on respiratory data, essentially in real time. Therefore, in these systems, the stimulator and respiratory sensor are electrically coupled via one or more leads and / or wires for communication (e.g., enabling the respiratory sensor to signal to the stimulator when to stimulate) and power supply (e.g., powering the respiratory sensor and / or stimulator). These leads / wires are typically embedded or pierced through the user's skin, and therefore often cause pain or inconvenience to the user. The leads / wires are also prone to breakage (e.g., if not sufficiently loosened, the wire may become stuck in the tissue or pull apart), potentially requiring another surgical procedure / operation to repair the connection. Wired connections also impose a practical limitation on the number of sensors and / or stimulators that can be used (e.g., for redundancy), as this would require additional wires / leads embedded in the user's skin.

[0039] Reference Figure 2 The present invention describes a system 100 according to some embodiments thereof. System 100 includes a control system 110, a memory device 114, a respiratory monitoring device 120, a stimulation device 130, one or more transmitters 140 (hereinafter, transmitter 140), one or more receivers 142 (hereinafter, receiver 142), a magnetic field generator 144, a wearable device 146, one or more external sensors 150, and an external device 180.

[0040] Control system 110 includes one or more processors 112 (hereinafter, processor 112). Control system 110 is typically used for various components of control system 100 and / or for analyzing data acquired and / or generated by components of system 100. Processor 112 may be a general-purpose or special-purpose processor or a microprocessor. Although one processor 112 is shown in Figure 1, control system 110 may include any suitable number of processors (e.g., one processor, two processors, five processors, ten processors, etc.), which may be located in a single housing or remotely to each other. Control system 110 may be coupled to and / or located within, for example, the housing of external device 180, the housing 124 of respiratory monitoring device 120, the housing 136 of stimulation device 130, or any combination thereof. Control system 110 may be centralized (within one such housing) or distributed (within two or more physically different such housings). In this embodiment, which includes two or more housings containing control system 110, such housings may be located close to and / or far from each other.

[0041] Memory 114 stores machine-readable instructions executable by processor 112 of control system 110. Memory device 114 can be any suitable computer-readable storage device or medium, such as random or serial access storage, hard disk drive, solid-state drive, flash memory, etc. Although one memory device 114 is shown in Figure 1, system 100 may include any suitable number of memory devices 114 (e.g., one storage device, two storage devices, five storage devices, ten storage devices, etc.). Memory device 114 may be coupled to and / or located within the housing of respiratory monitoring device 120, within the housing 136 of stimulation device 130, or any combination thereof. Similar to control system 110, memory device 114 can be centralized (within one such housing) or distributed (within two or more physically different such housings).

[0042] In some embodiments, memory device 114 (FIG. 1) stores a user profile associated with a user. The user profile may include, for example, user-associated demographic information, user-associated biostatistics, user-associated medical information, self-reported user feedback, user-associated sleep parameters (e.g., sleep-related parameters recorded from one or more earlier sleep sessions), or any combination thereof. Demographic information may include, for example, information indicating the user's age, gender, family history of insomnia or sleep apnea, employment status, education level, socioeconomic status, or any combination thereof. Medical information may include, for example, information indicating one or more medical conditions associated with the user, medication use, or both. Medical information data may further include Multisleep Latency Test (MSLT) results or scores and / or Pittsburgh Sleep Quality Index (PSQI) scores or values. Self-reported user feedback may include information indicating self-reported subjective sleep scores (e.g., poor, average, excellent), user's self-reported subjective stress levels, user's self-reported subjective fatigue levels, user's self-reported subjective health status, recent life events experienced by the user, or any combination thereof.

[0043] Although the control system 110 and the memory device 114 are in Figure 2 While described and shown as separate and distinct components of system 100, in some embodiments, the control system 110 and / or memory device 114 are integrated into external device 180, respiratory monitoring device 120, and / or stimulation device 130. Alternatively, in some embodiments, the control system 110 or a portion thereof (e.g., processor 112) may reside in the cloud (e.g., integrated into a server, integrated into an Internet of Things (IoT) device, connected to the cloud, subjected to edge cloud processing, etc.), or in one or more servers (e.g., remote server, local server, etc., or any combination thereof).

[0044] Some components of system 100 are located within user 10 (e.g., implanted within user 10), while other components of system 100 are located outside user 10 (e.g., worn / worn by user 10). One or more components of system 100 located within user 10 can be so located by injection into user 10 using a syringe, for example, with a hypodermal injection needle attached thereto. Alternatively or additionally, one or more components of system 100 located within user 10 can be so located by surgical placement therein (e.g., by making an incision in the skin and positioning the component therein and then suturing the skin closed).

[0045] The respiratory monitoring device 120 includes one or more sensors 122, a housing 124, and a power supply 126. As described herein, the respiratory monitoring device 120 may be placed (e.g., surgically) inside a user's body (e.g., in or near the user's chest cavity), and the one or more sensors 122 generate data associated with the user's breathing to determine the user's respiratory signal.

[0046] One or more sensors 122 may include any suitable sensors for generating data from which a user's breathing signals (e.g., signals indicating inhalation and / or exhalation) can be determined. In some embodiments, one or more sensors 122 include a barometric pressure sensor (e.g., an atmospheric pressure sensor, a pressure gauge, an absolute sensor, etc.) that generates data indicating a user's breathing (e.g., inhalation and / or exhalation). The pressure sensor may be, for example, a capacitive sensor, an electromagnetic sensor, a piezoelectric sensor, a strain gauge sensor, an optical sensor, a potentiometric sensor, or any combination thereof. In some embodiments, one or more sensors 122 include an airflow sensor that generates data indicating a user's breathing (e.g., inhalation and / or exhalation). In some embodiments, one or more sensors 122 include a motion sensor that generates motion data indicating a user's breathing (e.g., inhalation and / or exhalation). In some embodiments, one or more sensors 122 include an acoustic sensor (e.g., including a microphone and / or a speaker) that generates data indicating a user's breathing (e.g., inhalation and / or exhalation). In other embodiments, one or more sensors 122 include an electromyography (EMG) sensor that generates data indicating a user's breathing (e.g., inhalation and / or exhalation). In some embodiments, one or more sensors 122 include photoplethysmography (PPG) sensors that generate data indicating a user's breathing (e.g., inhalation and / or exhalation). In other embodiments, one or more sensors 122 include oxygen sensors that generate data indicating blood oxygen levels or oxygen saturation (SpO2), which in turn indicate a user's breathing (e.g., inhalation and / or exhalation).

[0047] In some embodiments, one or more sensors 122 of the respiratory monitoring device 120 are directly positioned within the user 10. In this manner, a housing 124 is not required. Alternatively, the sensor 122 or a portion thereof is coupled to the housing 124 (e.g., at least partially positioned therein), and the housing 124 (to which the sensor 122 is coupled) is positioned within the user 10. The housing 124 may have an elongated pill shape (or any other shape) that facilitates injection into the user 10 using, for example, a syringe with a hypodermic needle attached thereto. In some embodiments, the housing 124 electrically insulates at least a portion of the sensor 122 from the surrounding tissues of the user 10.

[0048] Sensor 122 may be powered by power source 126. Power source 126 may be, for example, a battery (e.g., a rechargeable battery). In some embodiments, battery 126 may be recharged or powered by magnetic field generator 144 and / or external device 180. As an alternative to the respiratory monitoring device 120 including power source 126, in some embodiments, power for the sensor is directly and wirelessly supplied to the electrical sensor by magnetic field generator 144 (which may be included in external device 180).

[0049] Besides sensor 122 and power supply 126 being coupled to or integrated into housing 124, many other components of system 100 can be coupled to housing 124 and placed in user 10. Attachment to housing 124 means that the component attached to housing 124 is completely encapsulated within housing 124, attached to the outer surface of housing 124, partially protruding from one or more openings in housing 124, directly or indirectly connected to housing 124, or any combination thereof. For example, in some embodiments, one or more of transmitters 140 and / or one or more of receivers 142 can be coupled to housing 124 or integrated into housing 124.

[0050] In such an implementation, transmitter 140 and / or receiver 142 allow respiratory monitoring device 120 to wirelessly communicate with control system 110, stimulation device 130, external device 180, or any combination thereof (e.g., using Bluetooth, WiFi, or any other suitable RF communication protocol) (e.g., transmitting data generated by sensor 122 for analysis by control system 110). If Bluetooth is used, the wireless communication frequency is in the MHz range, with a breakover frequency of approximately 15 Hz. Therefore, data from respiratory monitoring device 120 can be wirelessly transmitted (e.g., to control system 110) before the user's next inhalation and / or exhalation.

[0051] The stimulation device 130 includes a stimulator 132, a housing 136, and a power source 138. As described herein, the stimulation device 130 may be placed (e.g., surgically) inside a user's body (e.g., adjacent to the user's tongue) to stimulate one or more branches of a nerve (e.g., the hypoglossal nerve) at a defined stimulation time.

[0052] The stimulator 132 is positioned in the user 10 such that one or more electrical leads 134 of the stimulator 132 are located 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, the one or more electrical leads 134 include a first electrical lead positioned to stimulate a first muscle among one or more muscles and / or a first nerve among one or more nerves. Similarly, a second electrical lead 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 electrical lead provides electrical stimulation at a first frequency, and the second electrical lead provides electrical stimulation at a second frequency different from the first frequency. In some embodiments, the first electrical lead provides electrical stimulation at a first intensity, and the second electrical lead provides electrical stimulation at a second intensity different from the first intensity. Alternatively, the stimulator 132 may be leadless, with the stimulator body being conductive and the ends of the body serving as electrodes.

[0053] Once the stimulation device 130 is positioned in the user 10, the stimulator 132 is able to deliver electrical and / or magnetic stimulation to the user 10 to help induce contraction of one or more muscles of the user 10. Contraction of one or more muscles of the user 10 can help open the user 10's airway. Contraction may alternatively or additionally contribute to the user 10 having a respiratory effort (e.g., causing the diaphragm to inhale / take in air). Electrical stimulation may be applied directly to one or more muscles of the user 10 (e.g., muscles in the user 10's tongue, muscles around and / or near the user 10's tongue, neck muscles, laryngeal muscles, palate, other soft tissues typically in or around the user's airway, etc.) and / or directly 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).

[0054] Stimulator 132 includes or is an electrical conductor (e.g., one or more conductive wires with or without electrically insulating portions). Stimulator 132 includes one or more electrical leads 134 capable of carrying and / or flowing current and delivering the current to one or more muscles and / or one or more nerves of user 10. The current may be provided by power source 138. Power source 138 may be, for example, a battery (e.g., a rechargeable battery). In some embodiments, power source 138 may be recharged or powered by magnetic field generator 144 and / or external device 180. Alternatively, for stimulator 132 including power source 138, in some embodiments, the current is directly and wirelessly provided to the electrical conductor by magnetic field generator 144 (which may be included in external device 180).

[0055] In some embodiments, the stimulator 132 comprises only one or more conductive wires, some or none of which are electrically insulated. In some such embodiments, the stimulator 132 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 132 / wire 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 132 can be selected to allow the stimulator 130 to be injected into the user 10 via a syringe with a connected hypodermal needle.

[0056] In some embodiments, the stimulator 132 is positioned directly within the user 10. In this manner, a housing 136 is not required. Alternatively, the stimulator 132 or a portion thereof is coupled to the housing 136 (e.g., at least partially positioned therein), and the housing 136 (to which the stimulator 132 is coupled) is positioned within the user 10. The housing 136 may have an elongated pill shape (or any other shape) that facilitates injection into the user 10 using a syringe, for example, with a hypodermic needle attached thereto. In some embodiments, the housing 136 electrically insulates at least a portion of the stimulator 132 (e.g., the entire stimulator 132 except for one or more electrical leads 134 or conductive ends) from the surrounding tissues of the user 10.

[0057] In addition to the stimulator 132 being coupled to the housing 136, multiple other components of the system 100 may be coupled to the housing 136 and placed in the user 10. Attachment to the housing 136 means that the component attached to the housing 136 is completely enclosed within the housing 136, coupled to the outer surface of the housing 136, partially protruding from one or more openings in the housing 136, directly or indirectly connected to the housing 136, or any combination thereof. For example, in some embodiments, one or more of the transmitters 140 and / or one or more of the receivers 142 may be coupled to or integrated into the housing 136. In this embodiment, the transmitters 140 and / or receivers 142 allow the respiratory monitoring device 120 to wirelessly communicate with the control system 110, the respiratory monitoring device 120, or any combination thereof (e.g., using Bluetooth, WiFi, or any other suitable RF communication protocol) (e.g., transmitting a signal to activate the stimulator 132 to deliver electrical stimulation). In other embodiments, the transmitters 140 and receivers 142 are combined as a transceiver.

[0058] In some embodiments, the stimulation device 130 may be configured to automatically stimulate the user even if the respiratory monitoring device 120 malfunctions (e.g., the respiratory monitoring device 120's battery is depleted or it no longer receives power from the magnetic field generator 144). In this embodiment, the stimulation device 130 may be configured to stimulate the tongue at a 50% duty cycle to continue stimulating the tongue and help keep the airway clear during inhalation. While stimulation may not occur at the optimal time and may consume more power in the stimulation device 130, the user will receive at least some benefit from automatic stimulation. Any malfunction (e.g., a malfunction of the respiratory monitoring device 120) can be alerted to the user via an external device 180.

[0059] Although system 100 is described herein as including a single respiratory monitoring device 120, system 100 may more generally include any suitable number of respiratory monitoring devices (e.g., 2, 3, 5, 10, etc.) that are the same as or similar to respiratory monitoring device 120. Having multiple respiratory monitoring devices can be advantageous, for example, by providing redundancy in the event of a failure in another respiratory monitoring device (e.g., battery or power depletion), and by providing more respiratory data to more accurately determine the respiratory signal. The respiratory monitoring devices may be positioned together in the same implant within the user's body, or implanted individually in the same area.

[0060] Wearable device 146 may be worn by a user and is typically used to position magnetic field generator 144 near respiratory monitoring device 120 and / or stimulation device 130 to provide power as described herein. Wearable device 146 may include straps, collars, patches (e.g., adhesive patches), clothing, sleeves, bracelets, necklaces, watches, or any combination thereof. Magnetic field generator 144 may be embedded in and / or removable from wearable device 146.

[0061] One or more external sensors 150 of system 100 can be used to validate data from respiratory monitoring device 120 and / or generate or acquire different physiological data associated with the user. In some embodiments, one or more external sensors 150 may be used instead of respiratory monitoring device 120 to generate data associated with the user's breathing. One or more external sensors 150 may include oxygen sensor 152, motion sensor 154, camera 156, acoustic sensor 158, radio frequency (RF) sensor 164, PPG sensor 170, capacitive sensor 172, force sensor 174, strain gauge sensor 176, EMG sensor 178, and electrocardiogram (ECG) sensor 179, or any combination thereof. Data from sensors 150 may be received and stored in memory device 114 or one or more other memory devices.

[0062] Oxygen sensor 152 outputs oxygen data indicating the oxygen concentration of a gas (e.g., in a user's blood). Oxygen sensor 152 can be, for example, a pulse oximeter sensor, an ultrasonic oxygen sensor, an electrical oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, or any combination thereof.

[0063] Motion sensor 154 outputs motion data indicating user movement. Control system 110 can use the motion data from motion sensor 154 to determine user movement (e.g., breathing). Camera 156 outputs image data reproducible as one or more images (e.g., still images, video images, thermal images, or combinations thereof) that can be stored in memory device 114. Control system 110 can use the image data from camera 156 to determine user movement (e.g., breathing).

[0064] Microphone 160 outputs sound data that can be stored in memory device 114 and / or analyzed by processor 112 of control system 110. Microphone 160 can be used to record sound to determine (e.g., using control system 110) the user's breathing signals. Speaker 162 outputs sound waves that are audible to the user of system 100. For example, speaker 162 can be used as an alarm clock or to play alarms or messages to the user.

[0065] In some embodiments, microphone 160 and speaker 162 may be combined into acoustic sensor 158, as described, for example, in WO2018 / 050913, which is incorporated herein by reference in its entirety. In this embodiment, speaker 162 generates or emits sound waves at predetermined intervals, and microphone 160 detects reflections of emitted sound waves from speaker 162. The sound waves generated or emitted by speaker 162 have frequencies inaudible to the human ear (e.g., below 20 Hz or above about 18 kHz). Based at least in part on data from microphone 160 and / or speaker 162, control system 110 may determine the user's movement (e.g., breathing).

[0066] RF transmitter 168 generates and / or transmits radio waves with a predetermined frequency and / or predetermined amplitude (e.g., in the high-frequency band, in the low-frequency band, long-wave signal, short-wave signal, etc.). RF receiver 166 detects the reflection of the radio waves emitted from RF transmitter 168, and this data can be analyzed by control system 110 to determine the user's movement. Although RF receiver 166 and RF transmitter 168 are... Figure 2 While shown as separate and distinct components, in some embodiments, the RF receiver 166 and the RF transmitter 168 are combined as part of the RF sensor 164. In some such embodiments, the RF sensor 164 includes control circuitry. The specific format of the RF communication may be WiFi, Bluetooth, etc.

[0067] In some implementations, RF sensor 164 is part of a mesh system. An example of a mesh system is a WiFi mesh system, which may include mesh nodes, mesh routers, and mesh gateways, each of which may be mobile / movable or fixed. In such implementations, the WiFi mesh system includes WiFi routers and / or WiFi controllers and one or more satellites (e.g., access points), each satellite including the same or similar RF sensor as RF sensor 164. The WiFi routers and satellites communicate continuously with each other using WiFi signals. The WiFi mesh system can be used to generate motion data based on variations in the WiFi signals between the routers and satellites (e.g., differences in received signal strength), said variations being caused by a moving object or person partially blocking the signal. The motion data may indicate movement, breathing, heart rate, gait, falls, behavior, etc., or any combination thereof.

[0068] The PPG sensor 170 outputs physiological data associated with the user, which can be used, for example, to determine heart rate, heart rate variability, cardiac cycle, respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, blood pressure parameters, or any combination thereof.

[0069] The outputs of capacitive sensor 172, force sensor 174, and strain gauge sensor 176 can be stored in memory device 114 and used by control system 110 to determine the user's movements (e.g., breathing). EMG sensor 178 outputs physiological data associated with the electrical activity generated by one or more muscles. ECG sensor 179 outputs physiological data associated with the electrical activity of the user's heart. In some embodiments, ECG sensor 179 includes one or more electrodes located on or around a part of the user.

[0070] Although shown separately in Figure 1, any combination of one or more sensors 130 may be integrated into and / or coupled to any one or more components of system 100, including respiratory monitoring device 120, stimulation device 130, control system 110, external device 180, or any combination thereof.

[0071] In some implementations, the one or more external sensors 150 also include one or more of a temperature sensor, an EEG (electroencephalogram) sensor, an analyte sensor, a humidity sensor, and a light detection and ranging (LiDAR) sensor. LiDAR sensors can be used for depth sensing. This type of optical sensor (e.g., a laser sensor) can be used to detect objects and construct a three-dimensional (3D) map of the surrounding environment (e.g., a living space). LiDAR typically utilizes pulsed lasers for time-of-flight measurements. LiDAR is also known as 3D laser scanning. In examples using such sensors, a fixed or mobile device (such as a smartphone) with a LiDAR sensor can measure and map an area extending 5 meters or more from the sensor. For example, LiDAR data can be fused with point cloud data estimated by an electromagnetic RADAR sensor. LiDAR sensors can also use artificial intelligence (AI) to automatically geofence RADAR systems by detecting and classifying features in space that may cause problems for the RADAR system, such as glass windows (which may be highly reflective to RADAR). For example, LiDAR can also be used to provide an estimate of a person's height, and how that height changes when the person sits down or falls. LiDAR can be used to form a 3D mesh representation of the environment. In a further application, for solid surfaces through which radio waves pass (e.g., transmissive materials), LiDAR can reflect off such surfaces, allowing for the classification of different types of obstacles.

[0072] External device 180 ( Figure 2The system 100 includes a display device 182. An external device 180 may be, for example, a mobile device such as a smartphone, tablet, laptop, etc. Alternatively, an external device 180 may be an external sensing system, a television (e.g., a smart TV), or another smart home device (e.g., a smart speaker such as Google Home, Amazon Echo, Alexa, etc.). In some embodiments, the external device 180 is a wearable device (e.g., a smartwatch). The display device 182 is typically used to display images including still images, video images, or both. In some embodiments, the display device 182 acts as a human-machine interface (HMI) including a graphical user interface (GUI) configured to display images and provide input interfaces. The display device 182 may be an LED display, OLED display, LCD display, etc. The input interface may be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense input made by a human user interacting with the external device 180. In some embodiments, the system 100 may use and / or include one or more external devices.

[0073] Although system 100 is shown as including all of the components described above, according to embodiments of the invention, more or fewer components may be included in the system for assisting a user (e.g., breathing). For example, a first alternative system includes a control system 110, a memory device 114, a respiratory monitoring device, and a stimulation device. As another example, a second alternative system includes a control system 110, a memory device 114, a respiratory monitoring device 120, a stimulation device 130, and an external device 180. As yet another example, a third alternative system includes a respiratory monitoring device 120 and a stimulation device 130. Thus, various systems can be formed using any part or multiple parts of the components shown and described herein and / or in combination with one or more other components.

[0074] refer to Figure 3A , with system 100 ( Figure 2 The same or similar system 300 includes a respiratory monitoring device 320 and a stimulation device 330 implanted in the user 10. The respiratory monitoring device 320 is similar to the respiratory monitoring device 120. Figure 2 (Identical or similar, and located in the thoracic cavity 30 of user 10. It should be understood that...) Figure 3A The relative position of the respiratory monitoring device 320 in the chest cavity 30 shown is merely exemplary, and the respiratory monitoring device 320 may be located in any suitable position in the chest cavity 30.

[0075] Stimulation device 330 and stimulation device 130 ( Figure 2The stimulation device 330 is the same as or similar to the tongue 16 of the user 10 and includes a stimulator 332, a first lead 334A, and a second lead 334B. As shown, the stimulation device 330 is typically positioned adjacent to the tongue 16 of the user 10, such that the stimulator 332 can stimulate (e.g., provide an electrical current to) one or more branches of the hypoglossal nerve to induce movement of the muscles in the tongue.

[0076] exist Figure 3A In this embodiment, the respiratory monitoring device 320 and the stimulation device 330 are connected to the magnetic field generator 144 ( Figure 2 A similar or identical magnetic field generator 344 is powered. The magnetic field generator 344 can be located on a mattress, pillow, bed, or any other suitable location to power the respiratory monitoring device 320 and / or the stimulation device 330. Although in Figure 3A A magnetic field generator 344 is shown, but multiple magnetic field generators are conceivable. For example, a first magnetic field generator may be positioned approximately adjacent to the stimulation device 330 (e.g., positioned in a pillow), and a second magnetic field generator may be positioned approximately adjacent to the respiratory monitoring device 320 (e.g., positioned in a mattress).

[0077] In some embodiments, the respiratory monitoring device 320 communicates directly with the stimulation device 330. The respiratory monitoring device 320 and the stimulation device 330 can also communicate with an external device 380, which is related to the external device 180 described herein. Figure 2 The same or similar. In some embodiments, the respiratory monitoring device 320 communicates directly with the external device 180, which in turn communicates directly with the stimulation device 330. In this embodiment, the control system 110 described herein ( Figure 2 This can be in an external device 180. For example, data from a respiratory monitoring device 320 is transmitted to an external device 180, which determines the stimulation time, and then the external device 180 communicates (e.g., sends a signal) to a stimulation device 330 to induce stimulation.

[0078] See Figure 3B In some embodiments, system 300 includes wearable device 146 (as described herein) with system 100. Figure 2 The first wearable 346A and the second wearable 346B are identical or similar. As shown, the first wearable 346A is a loop that is typically positioned and secured around the user's neck (e.g., using a hook and loop fastener). The first wearable 346A includes a magnetic field generator 144 as described herein. Figure 2 The first magnetic field generator 344A is the same or similar. Because the first wearable device 346A is typically positioned near the stimulation device 330, the first magnetic field generator 344A can wirelessly provide power to the stimulation device 330.

[0079] The second wearable 346B is a strap that is typically positioned and secured (e.g., using hook and loop fasteners) around the user's chest or waist. The second wearable 346B includes a second magnetic field generator 344B, which is related to the magnetic field generator 144 described herein. Figure 2 (Identical or similar.) Because the second wearable device 346B is positioned generally adjacent to the breathing monitoring device 320, the second magnetic field generator 344B can wirelessly provide power to the breathing monitoring device 320.

[0080] In some embodiments, the control system 110 described herein ( Figure 2 It can also be connected to or integrated into the first wearable 346A and / or the second wearable 346B.

[0081] Reference Figure 4 This describes a method 400 for assisting a user's breathing according to some embodiments of the present invention. For example, method 400 can help prevent sleep apnea. One or more steps of method 400 can be used with the system 100 described herein (…). Figure 2 (to implement any element or aspect of)

[0082] Step 401 of method 400 includes receiving data associated with a user's breathing. For example, step 401 may include receiving data from a breathing monitoring device 120 located within the user's body (e.g., in the user's chest cavity). Figure 2 Data is received. In some embodiments, respiratory data can be transmitted from the respiratory monitoring device 120 and received by the memory device 114 for analysis by the control system 110. In other embodiments, respiratory data can be transmitted from the respiratory monitoring device 120 and received by an external device 180.

[0083] Step 402 of method 400 includes determining the user's breathing signal (step 401) based at least in part on data associated with the user's breathing. The breathing signal represents the user's breathing (e.g., inhalation and exhalation) and can be determined by, for example, control system 110 (…). Figure 2 (This is confirmed.) Refer to... Figure 5 This illustrates an example of a user's breathing signal 500.

[0084] Method 400 ( Figure 4 Step 403 includes identifying one or more inhalation portions and one or more exhalation portions of a breathing signal. The inhalation and exhalation portions may be controlled by the control system 110. Figure 2 Identification. (Refer to...) Figure 5The breathing signal 500 includes an inhalation portion 510 and an exhalation portion 520. Typically, the inhalation portion 510 corresponds to the user's inhalation (inhalation), while the exhalation portion 520 corresponds to the user's exhalation (exhalation). In some embodiments, the integral of the inhalation portion 510 of the breathing signal 500 is equal to the integral of the exhalation portion 520 of the breathing signal 500.

[0085] Step 404 of method 400 includes determining the predicted start time of the user's future inhalation. This can be achieved, for example, by control system 110 ( Figure 2 The predicted start time of future inhalation is determined. This can be determined at least in part based on data associated with the user's breathing (step 401) and / or historical breathing data. For example, a machine learning algorithm can be used to determine the predicted start time, trained to receive breathing data as input and determining the predicted start time of future inhalation as output. (See reference) Figure 5 An exemplary future inhalation 530 is illustrated. As shown, the future inhalation 530 is the next actual inhalation immediately following the first exhalation 520 after the first inhalation portion 510 identified during step 403. The future inhalation 530 has a predicted start time 501.

[0086] Step 405 of Method 400 Figure 4 This includes providing electrical stimulation to one or more branches of the user's nerves at a stimulation time that is at least partially based on the predicted start time of the user's future inhalation (e.g., using the stimulation device described herein) (step 404). For example, the stimulation timing may be determined by the control system 110 ( Figure 2 The control system is determined to wirelessly communicate with the stimulation device 130 to enable the stimulator 132 of the stimulation device 130 to stimulate one or more branches of the user's nerve (e.g., one or more branches of the user's hypoglossal nerve).

[0087] The stimulation time is before the predicted start time of the user's future inhalation. For example, the stimulation time can be at least about 50 milliseconds, at least about 100 milliseconds, at least about 200 milliseconds, or at least about 300 milliseconds before the predicted start time of the user's future inhalation. As another example, the stimulation time can be within 100 milliseconds, 200 milliseconds, or 300 milliseconds of the predicted start time of the user's future inhalation. Because the stimulation time is exactly before the predicted start time of the next inhalation, the stimulation will cause the tongue to move and clear the airway just before the future inhalation, thereby helping to prevent sleep apnea.

[0088] Reference Figure 6This describes a method 600 for assisting a user's breathing according to some embodiments of the present invention. For example, method 600 can help prevent sleep apnea. One or more steps of method 600 can be used with the system 100 described herein (…). Figure 2 (to implement any element or aspect of)

[0089] Step 601 of method 600 is the same as that of method 400 above. Figure 4 Step 401 is the same as or similar to that of the user's breathing and includes receiving data related to the user's breathing. For example, step 601 may include receiving data from a breathing monitoring device 120 located within the user's body (e.g., in the user's chest cavity). Figure 2 Data is received. In some embodiments, respiratory data can be transmitted from the respiratory monitoring device 120 and received by the memory device 114 for analysis by the control system 110. In other embodiments, respiratory data can be transmitted from the respiratory monitoring device 120 and received by an external device 180.

[0090] Step 602 of method 600 is the same as that of method 400 above. Figure 4 Step 602 is the same as or similar to step 602, and includes determining the user's respiratory signal (step 601) based at least in part on data associated with the user's breathing. (See reference) Figure 7 An example respiratory signal 700 is shown.

[0091] Method 600 ( Figure 6 Step 603 is similar to method 400 above. Figure 4 Step 403, and includes identifying the first exhalation portion of the determined user breathing signal (step 602). The control system 110 can be used. Figure 2 This is used to determine the first exhaled portion of the identified user's breathing signal. (Reference) Figure 7 An exemplary first exhalation portion 720 in the breathing signal 700 is shown.

[0092] Step 604 of Method 600 ( Figure 6 This includes identifying the start time of the first inhalation portion of the breathing signal following the identified first exhalation portion (step 603). The start time can be determined by the control system 110 ( Figure 2 The identification is based at least in part on the determined respiratory signals (step 602) and / or the received data associated with the user's breathing (step 601). [Reference] Figure 7 An exemplary first inhalation portion 710 of the breathing signal 700 is shown. As shown, the first inhalation portion 710 has a start time 701 that immediately follows the end of the first exhalation portion 720.

[0093] Step 605 of method 600 includes stimulating the user's nerves (e.g., using the stimulation device described herein) based on the stimulation time of the identified first inhalation portion (step 604). For example, the stimulation time may be determined by control system 110 (…). Figure 2 The control system is determined to wirelessly communicate with the stimulation device 130 to enable the stimulator 132 of the stimulation device 130 to stimulate one or more branches of the user's nerve (e.g., one or more branches of the user's hypoglossal nerve).

[0094] The stimulation time determined during the step can be within 50 milliseconds, 100 milliseconds, 200 milliseconds, or 300 milliseconds of the recognition start time of the first inhalation portion (step 604).

[0095] Reference Figure 8 This describes a method 800 for assisting a user's breathing according to some embodiments of the present invention. For example, method 800 can help prevent sleep apnea. One or more steps of method 800 can be used with the system 100 described herein (…). Figure 2 (to implement any element or aspect of)

[0096] Step 801 of method 800 is the same as that of method 400 described herein. Figure 4 Step 401 is the same as or similar to that of the user's breathing and includes receiving data related to the user's breathing. For example, step 801 may include receiving data from a breathing monitoring device 120 located within the user's body (e.g., in the user's chest cavity). Figure 2 Data is received. In some embodiments, respiratory data can be transmitted from the respiratory monitoring device 120 and received by the memory device 114 for analysis by the control system 110. In other embodiments, respiratory data can be transmitted from the respiratory monitoring device 120 and received by an external device 180.

[0097] Step 802 of method 800 is the same as that of method 400 described herein. Figure 4 Step 402 is the same as or similar to that of the previous step and includes determining the user's breathing signal. (See reference) Figure 9 An exemplary respiratory signal 900 is shown.

[0098] Step 803 of Method 800 Figure 8 This includes a first part (step 802) that identifies the exhaled portion of the determined breathing signal. The first part of the exhaled portion can be controlled by the control system 110. Figure 2 Identification. (Reference) Figure 5 The breathing signal 900 includes an exhalation portion 920. The exhalation portion 920 of the breathing signal 900 includes a first portion 922.

[0099] Step 804 of Method 800 Figure 8This includes identifying the start time of the second part of the exhalation portion of the determined breathing signal (step 802). The second part of the exhalation portion can, for example, use the control system 110 described herein (…). Figure 2 The second part of the call-out portion is identified. In some implementations, the second part of the call-out portion immediately follows the identified first part (step 803).

[0100] Reference Figure 9 The exhalation portion 920 of the breathing signal 900 includes a second portion 924. The first portion 922 and the second portion 924 together form the complete exhalation portion 920. The first portion 922 of the exhalation portion 920 may be, for example, at least about 10%, at least about 20%, at least about 30%, at least about 50%, at least about 60%, at least about 80%, etc. of the exhalation portion 920. Conversely, the second portion 924 of the exhalation portion 920 may be, for example, at least about 90%, at least about 80%, at least about 70%, at least about 50%, at least about 40%, at least about 20%, etc. of the exhalation portion 920.

[0101] Step 805 of Method 800 Figure 8 This includes providing electrical stimulation to one or more branches of the user's nerves (e.g., using a stimulation device described herein) during a stimulation time that is at least partially based on the start time of a recognized second portion of the exhalation portion of the respiratory signal. For example, the stimulation time may be determined by a control system 110 (…). Figure 2 The control system is determined to wirelessly communicate with the stimulation device 130 to enable the stimulator 132 of the stimulation device 130 to stimulate one or more branches of the user's nerve (e.g., one or more branches of the user's hypoglossal nerve).

[0102] The stimulation occurs after the start of the identified second part of the exhalation (step 804), but before the next inhalation (e.g., the user's next actual inhalation). The stimulation time can be, for example, within 50 milliseconds, 100 milliseconds, 200 milliseconds, or 300 milliseconds of the start of the second part of the exhalation. Because the stimulation occurs before the start of the next inhalation, it causes the tongue to move and clear the airway just before the future inhalation, thus helping to prevent sleep apnea.

[0103] In some embodiments, the methods 400, 600, and 800 described herein may further include analyzing data associated with a user's breathing to determine multiple events experienced by the user over a period of time (e.g., using control system 110). Figure 2Events may include, for example, apnea, hypoventilation, hyperventilation, or any combination thereof. Time periods may be, for example, 15 minutes, 30 minutes, 45 minutes, one hour, two hours, three hours, five hours, seven hours, etc.

[0104] In such implementations, the methods 400, 600, and 800 described herein may further include comparing a determined number of events with a threshold, and, in response to the determined number of events exceeding the threshold, causing the stimulating device to change one or more parameters of the electrical stimulation provided to one or more branches of the nerve. The threshold may be the number of events per hour (e.g., 3 events per hour, 5 events per hour, 10 events per hour, 20 events per hour, etc.). One or more parameters of the electrical stimulation may include, for example, the amount of time during which the electrical stimulation is provided during respiration, a percentage of the amount of time during which the electrical stimulation is provided during respiration, a percentage of the amount of time during which the electrical stimulation is provided during inhalation, a percentage of the amount of time during which the electrical stimulation is provided during exhalation, frequency, intensity, duration, dwell time, rise time in a pulse, the ratio of on time to off time, or any combination thereof.

[0105] One or more elements or aspects or steps or any part thereof from one or more of the claims may be combined with one or more elements or aspects or steps or any part thereof from one or more other claims or combinations thereof to form one or more additional embodiments of the invention.

[0106] While the invention has been described with reference to one or more specific embodiments or implementations, those skilled in the art will recognize that many changes can be made thereto without departing from the spirit and scope of the invention. Each of these embodiments and their obvious variations is considered to fall within the spirit and scope of the invention. Additional embodiments according to aspects of the invention are also contemplated, which may combine any number of features from any of the embodiments described herein.

Claims

1. A system for assisting a user's breathing, the system comprising: A respiratory monitoring device configured to be positioned within the user's body adjacent to the user's chest cavity, the respiratory monitoring device including sensors configured to generate respiratory data associated with the user's breathing; A stimulation device configured to be positioned within the user's body adjacent to the user's tongue, the stimulation device comprising a stimulator configured to provide electrical stimulation to one or more branches of the user's nerves adjacent to the user's tongue, the stimulation device being physically separate from and communicatively coupled to the respiratory monitoring device via a wireless communication protocol; An external sensor, configured to be positioned outside the user, is configured to generate physiological data; Memory that stores machine-readable instructions; as well as The control system includes one or more processors configured to execute the machine-readable instructions to: The validity of the generated physiological data related to the user's breathing is determined based on the generated physiological data. In response to determining that the generated data associated with the user's breathing is invalid, the stimulation device automatically provides electrical stimulation to the one or more branches of the nerve independently of the generated breathing data associated with the user's breathing; In response to determining that the generated data associated with the user's breathing is valid: The user's breathing signal is determined at least in part based on the generated breathing data associated with the user's breathing; Within the respiratory signal, one or more inhaled portions and one or more exhaled portions are identified; Analyze the generated respiratory data to determine the number of events experienced by the user over a period of time; Based at least in part on the number of said events, determine one or more parameters for electrical stimulation to be provided to one or more branches of said nerve; The predicted start time of the user's future inhalation is determined, at least in part, based on one or more identified inhalation sites; as well as The stimulation device provides electrical stimulation to one or more branches of the nerve at a stimulation time based at least in part on the predicted start time of the user's future inhalation, based at least in part on the one or more parameters.

2. The system of claim 1, wherein the stimulation time is the predicted start time of the user's future inhalation.

3. The system of claim 1, wherein the stimulation time is at least 50 milliseconds prior to the predicted start time of the user's future inhalation.

4. The system of claim 1, wherein the stimulation time is within 300 milliseconds of the predicted start time of the user's future inhalation.

5. The system of claim 1, wherein the stimulation time is at least 50 milliseconds prior to the start time of the user's next actual inhalation.

6. The system of any one of claims 1 to 5, wherein the stimulation time is within 300 milliseconds of the start time of the user's next actual inhalation.

7. The system of any one of claims 1 to 5, wherein the user's future inhalation is the user's next inhalation.

8. The system of any one of claims 1 to 5, wherein each of the one or more inhalation portions corresponds to the user's inhalation, and each of the one or more exhalation portions corresponds to the user's exhalation.

9. The system according to any one of claims 1 to 5, wherein the nerve is the hypoglossal nerve.

10. The system of any one of claims 1 to 5, wherein the control system is further configured to execute machine-readable instructions to: Compare the number of identified events with a threshold; and The determination of the one or more parameters is based at least in part on the number of determined events that exceed the threshold.

11. The system of claim 10, wherein the time period is one hour.

12. The system of claim 10, wherein the threshold is ten events per hour.

13. The system of claim 10, wherein the one or more parameters for the electrical stimulation include: Frequency, intensity, duration, dwell time, rise time in the pulse, ratio of on time to off time, amount of time during the respiratory period when the electrical stimulation is provided, percentage of the amount of time during the respiratory period when the electrical stimulation is provided, percentage of the amount of time during the inhalation period when the electrical stimulation is provided, percentage of the amount of time during the exhalation period when the electrical stimulation is provided, or any combination thereof.

14. The system of any one of claims 1 to 5, wherein the control system is coupled to a belt configured to be worn by a user.

15. The system of claim 14, further comprising a power source coupled to the band, the power source being configured to wirelessly power the respiratory monitoring device.

16. The system of any one of claims 1 to 5, wherein the respiratory monitoring device includes a built-in power supply.

17. The system of any one of claims 1 to 5, wherein the control system is communicatively coupled to the respiratory monitoring device and the stimulation device via the wireless communication protocol.

18. The system of claim 17, wherein the wireless communication protocol is Bluetooth.

19. A system for assisting a user's breathing, the system comprising: A respiratory monitoring device configured to be positioned within the user's body adjacent to the user's chest cavity, the respiratory monitoring device including sensors configured to generate respiratory data associated with the user's breathing; A stimulation device configured to be positioned within the user's body adjacent to the user's tongue, the stimulation device comprising a stimulator configured to provide electrical stimulation to one or more branches of the user's nerves adjacent to the user's tongue, the stimulation device being physically separate from and communicatively coupled to the respiratory monitoring device via a wireless communication protocol; An external sensor, configured to be positioned outside the user, is configured to generate physiological data; Memory that stores machine-readable instructions; as well as The control system includes one or more processors configured to execute the machine-readable instructions to: The validity of the generated physiological data related to the user's breathing is determined based on the generated physiological data. In response to determining that the generated data associated with the user's breathing is invalid, the stimulation device automatically provides electrical stimulation to the one or more branches of the nerve independently of the generated breathing data associated with the user's breathing; In response to determining that the generated data associated with the user's breathing is valid: The user's respiratory signal is determined at least in part based on the generated respiratory data associated with the user's breathing; Identify the first exhaled portion of the breathing signal; Analyze the generated respiratory data to determine the number of events experienced by the user over a period of time; Based at least in part on the number of events determined, one or more parameters for the electrical stimulation to be provided to one or more branches of the nerve are determined; The start of the first inhalation portion of the breathing signal immediately following the first exhalation portion is identified, and the start of the first inhalation portion occurs at the start time; as well as The stimulation device provides the electrical stimulation to the one or more branches of the nerve at a stimulation time based at least in part on the start time and at least in part on the one or more parameters.

20. The system of claim 19, wherein the stimulation time is within 300 milliseconds of the start time.

21. The system of claim 19 or claim 20, wherein the first exhalation portion corresponds to a user exhalation, and the first inhalation portion corresponds to a user inhalation.

22. A system for assisting a user's breathing, the system comprising: A respiratory monitoring device configured to be positioned within the user's body adjacent to the user's chest cavity, the respiratory monitoring device including sensors configured to generate respiratory data associated with the user's breathing; A stimulation device configured to be positioned within the user's body adjacent to the user's tongue, the stimulation device comprising a stimulator configured to provide electrical stimulation to one or more branches of the user's nerves adjacent to the user's tongue, the stimulation device being physically separate from and communicatively coupled to the respiratory monitoring device via a wireless communication protocol; An external sensor, configured to be positioned outside the user, is configured to generate physiological data; Memory that stores machine-readable instructions; as well as The control system includes one or more processors configured to execute the machine-readable instructions to: The validity of the generated physiological data related to the user's breathing is determined based on the generated physiological data. In response to determining that the generated data associated with the user's breathing is invalid, the stimulation device automatically provides electrical stimulation to the one or more branches of the nerve independently of the generated breathing data associated with the user's breathing; In response to determining that the generated data associated with the user's breathing is valid: The user's respiratory signal is determined at least in part based on the generated respiratory data associated with the user's breathing; Identify the first portion of the exhaled portion of the breathing signal; The start of the second portion of the exhalation portion of the breathing signal is identified, and the start of the second portion of the exhalation portion occurs at the start time; Analyze the generated respiratory data to determine the number of events experienced by the user over a period of time; Based at least in part on the number of events determined, one or more parameters for electrical stimulation to be provided to one or more branches of the nerve are determined; as well as The stimulation device provides the electrical stimulation to the one or more branches of the nerve at a stimulation time based at least in part on the start time and at least in part on the one or more parameters.

23. The system of claim 22, wherein the stimulation time is within 300 milliseconds of the start time.

24. The system of claim 22 or claim 23, wherein the first portion and the second portion form a complete single exhaled portion of the breathing signal.

25. The system of claim 24, wherein the first portion of the call-out portion is at least 80% of the call-out portion, and the second portion of the call-out portion is less than 20% of the call-out portion.

26. The system of claim 1, further comprising a second respiratory monitoring device, wherein data from the second respiratory monitoring device is combined with the generated respiratory data to determine the user's respiratory signal.

27. The system of claim 26, wherein both the second respiratory monitoring device and the respiratory monitoring device are housed in a separate housing and positioned within the user's body adjacent to the user's chest cavity.

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