Systems and methods for triggering sound to shield against noise from the respiratory system and its components.

Abstract

A system includes a ventilator device, a mask, a microphone, a speaker, and a control system. The ventilator device is configured to supply pressurized air. The mask is coupled to the ventilator device and is configured to engage a user during sleep to help direct the supplied pressurized air to the user. The microphone is configured to generate audio data. The speaker is configured to emit sound. The control system is configured to analyze the audio data to determine whether noise associated with leaking air from the mask is occurring. Responsive to (i) the analysis resulting in a determination that noise associated with leaking air from the mask is occurring, (ii) the ventilator device determining that air is leaking from the mask, or (iii) both (i) and (ii) being present, causing the speaker to emit sound to help mask the noise associated with leaking air from the mask.

Description

[0001] Divisional application statement

[0002] This application is a divisional application of Chinese Patent Application No. 202080060054.0, which was filed on June 26, 2020 (PCT International Application No. PCT / US2020 / 039992) and entered the Chinese national phase on February 24, 2022. The invention is entitled "System and method for triggering sound to shield noise from the respiratory system and its components".

[0003] Cross-reference to related applications

[0004] This application claims the benefits and priorities of U.S. Provisional Application No. 62 / 868,465, filed June 28, 2019, and U.S. Provisional Application No. 62 / 890,918, filed August 23, 2019, each of which is incorporated herein by reference in its entirety. Technical Field

[0005] This invention relates to the treatment of respiratory-related conditions, and more particularly to systems and methods for detecting and mitigating the effects of noise caused by ventilator equipment and its components. Background Technology

[0006] Various systems exist to help users experiencing sleep apnea and related breathing disorders. A range of breathing disorders can affect users. Some conditions are characterized by specific events (such as apnea, hypoventilation, hyperventilation, or any combination thereof). Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity-induced hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall disorders. People with breathing disorders may also have sleep disturbances, but systems designed to alleviate the physical symptoms of breathing disorders do not address the underlying issues beyond the symptoms of the disorder itself that allow people to maintain good sleep.

[0007] Therefore, alternative systems and methods are needed to address treatment-related sleep disorders. This invention aims to solve these problems and address other needs. Summary of the Invention

[0008] According to some embodiments of the invention, a method includes receiving first audio data from a first microphone. The first audio data is analyzed to determine whether noise is present that is associated with air leakage from the mask. The mask is connected to a ventilator device supplying pressurized air, and the mask is configured to engage with the user during sleep to help direct the supplied pressurized air into the user's airway. Based at least in part on the results of the analysis of the first audio data, a speaker is caused to emit sound.

[0009] According to some embodiments of the present invention, a method includes receiving audio data from a microphone. The audio data is analyzed to determine (i) the presence of background noise associated with one or more background devices, and (ii) the occurrence of operational noise associated with the operation of a ventilator device, a mask, a tube, or any combination thereof. The mask is coupled to the ventilator device via a tube. The mask is configured to engage with the user during sleep to help direct supplied pressurized air into the user's airway. In response to the analysis of the audio data leading to the determination (i) the presence of background noise and (ii) the occurrence of operational noise, a speaker is caused to emit sound to help mask the operational noise, the sound emitted by the speaker having a plurality of characteristics, at least a portion of which is at least partially based on one or more characteristics of the background noise.

[0010] According to some embodiments of the invention, a method includes causing an air source to deliver air into a humidifier chamber, causing bubbles to form and float through water stored in the humidifier chamber, thereby producing a bubbling sound. The humidifier chamber is coupled to a ventilator device and configured to store water. A mask is coupled to the ventilator device via tubing and configured to engage with a user during sleep to help direct the supplied pressurized air into the user's airway.

[0011] According to some embodiments of the present invention, a system for masking noise generated during the use of a ventilator is provided. The system includes a ventilator, a mask, a microphone, a speaker, a memory, and a control system. The ventilator is configured to supply pressurized air. The mask is coupled to the ventilator and configured to engage with the user during sleep to help direct the supplied pressurized air into the user's airway; the microphone is configured to generate audio data. The speaker is configured to emit sound. The memory is configured to store machine-readable instructions. The control system includes one or more processors configured to execute machine-readable instructions to: analyze the audio data to determine if there is noise associated with air leakage from the mask; and in response to (i) the analysis resulting in a determination that noise associated with air leakage from the mask is occurring, (ii) the ventilator determining that air is leaking from the mask, or (iii) both (i) and (ii) being present, cause the speaker to emit the sound to help mask the noise associated with air leakage from the mask.

[0012] According to some embodiments of the present invention, a system for masking noise generated during the use of a ventilator is provided. The system includes a ventilator, a mask, a first microphone, a second microphone, a speaker, a memory, and a control system. The ventilator is configured to supply pressurized air. The mask is coupled to the ventilator and configured to engage with the user during sleep to help direct the supplied pressurized air into the user's airway; the first microphone is configured to generate first audio data; the second microphone is configured to generate second audio data; the speaker is configured to emit sound; and the memory is configured to store machine-readable instructions. The control system includes one or more processors configured to execute machine-readable instructions to: analyze first audio data to determine whether there is noise associated with air leakage from the mask; and in response to (i) the analysis of the first audio data leading to a determination that noise associated with air leakage from the mask is occurring, (ii) the ventilator device determining that air is leaking from the mask, or (iii) both (i) and (ii) are present, analyze second audio data to determine whether the user's bed partner is currently being disturbed; and in response to the analysis of the second audio data leading to a determination that the bed partner is currently being disturbed, cause the speaker to emit sound.

[0013] According to some embodiments of the present invention, a system includes a ventilator, a mask, a speaker, a memory, and a control system. The ventilator is configured to supply pressurized air. The mask is coupled to the ventilator and configured to engage with the user during sleep to help direct the supplied pressurized air into the user's airway; the speaker is configured to emit sound. The memory is configured to store machine-readable instructions. The control system includes one or more processors configured to execute machine-readable instructions to cause the speaker to emit sound in response to the ventilator determining that air is leaking from the mask, thereby helping to mask noise associated with the leaking air from the mask.

[0014] According to some embodiments of the present invention, a system includes a ventilator device, a mask, a microphone, a speaker, a memory, and a control system. The ventilator device is configured to supply pressurized air. The mask is coupled to the ventilator device and configured to engage with a user during sleep to help direct the supplied pressurized air into the user's airway; the microphone is configured to generate audio data. The speaker is configured to emit sound. The memory is configured to store machine-readable instructions. The control system includes one or more processors configured to execute machine-readable instructions to: analyze the audio data to determine if there is noise associated with air leakage from the mask; and in response to the analysis causing a determination of noise associated with air leakage from the mask, cause the speaker to begin emitting sound to help mask the noise associated with air leakage from the mask.

[0015] According to some embodiments of the present invention, a system for masking noise generated during the use of a ventilator includes a ventilator, a mask, a microphone, a speaker, a memory, and a control system. The ventilator is configured to supply pressurized air. The mask is coupled to the ventilator via a tube and configured to engage with the user during sleep to help direct the supplied pressurized air into the user's airway. The microphone is configured to generate audio data. The memory stores machine-readable instructions. The control system includes one or more processors configured to execute the machine-readable instructions to analyze the audio data. The analysis of the audio data determines (i) the presence of background noise associated with one or more background devices and (ii) whether operational noise is occurring associated with the operation of the ventilator, the mask, the tube, or any combination thereof. In response to the analysis leading to the determination that (i) background noise is present and (ii) operational noise is occurring, the control system causes the speaker to emit sound to help mask the operational noise. The sound emitted by the speaker has multiple characteristics. At least a portion of the multiple characteristics is at least partially based on one or more characteristics of the background noise.

[0016] According to some embodiments of the present invention, a system for masking noise generated during the use of a ventilator includes a ventilator, a humidifier, a mask, a memory, and a control system. The ventilator is configured to supply pressurized air. The humidifier is coupled to the ventilator and configured to store water therein. The mask is coupled to the ventilator via tubing and configured to engage the user during a sleep session to help direct the supplied pressurized air into the user's airway. The memory stores machine-readable instructions. The control system includes one or more processors configured to execute machine-readable instructions such that an air source delivers air into the humidifier, causing bubbles to form and float through the water stored in the humidifier, thereby producing a bubbling sound.

[0017] Given the detailed description of various embodiments and / or implementations with reference to the accompanying drawings, the foregoing and additional aspects and embodiments of the present invention will be apparent to those skilled in the art, and a brief description of the drawings is provided below. Attached Figure Description

[0018] The foregoing and other advantages of the present invention will become apparent from reading the following detailed description and referring to the accompanying drawings.

[0019] Figure 1 A bedroom with a user, a bed partner, and a respiratory system is described according to some embodiments of the present invention;

[0020] Figure 2 This is according to some embodiments of the present invention. Figure 1 A perspective view of a respiratory system mask or mask assembly;

[0021] Figure 3 This is a block diagram of a system for mitigating noise generated by the respiratory system and / or its components, according to some embodiments of the present invention.

[0022] Figure 4 This is a flowchart illustrating, according to some embodiments of the present invention, a method for generating sound from a loudspeaker in response to noise from the respiratory system and / or its components;

[0023] Figure 5 This is a flowchart illustrating, according to some embodiments of the present invention, a method for generating sound from a loudspeaker in response to noise from the respiratory system and / or its components;

[0024] Figure 6 Exemplary placement of components for mitigating noise from the respiratory system and / or its components in a bedroom environment, according to some embodiments of the present invention; and

[0025] Figure 7 A perspective view is shown of a mask or mask assembly according to some embodiments of the present invention, which can be used with a respirator to mitigate the effects of noise from the respiratory system and / or its components.

[0026] While the present invention is susceptible to various modifications and substitutions, its specific embodiments have been illustrated by way of example in the accompanying drawings and will be described in detail herein. However, it should be understood that the invention is not limited to the specific forms disclosed. 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

[0027] Figure 1 An environment for mitigating the effects of noise from a ventilator device, system, and / or any of its components (e.g., mask, motor, water tank, pump, etc.) is illustrated according to some embodiments of the present invention. This environment is a bedroom environment comprising a ventilator user 104 and a bed partner 102 lying in bed, a mattress 136, pillows 138a and 138b, and a headboard 134. Near the bed are two bedside tables 132a and 132b, and a light 130 on bedside table 132b. The ventilator user 104 wears a user interface (e.g., mask 100) connected to the ventilator or ventilator device 108 via an air circuit or conduit (e.g., tube or conduit 106). The mask 100, air circuit or conduit 106, and ventilator 108 may be collectively referred to as respiratory system 10. In some embodiments, respiratory system 10 includes a humidifier tank 109, which may be used to store water and generate humidity in the air supplied to the ventilator user 104.

[0028] The respiratory system 10 can be used as, for example, a positive airway pressure (PAP) system, a continuous positive airway pressure (CPAP) system, an automated positive airway pressure (APAP) system, a bilevel or variable positive airway pressure (BPAP or VPAP) system, a ventilator, or any combination thereof. A CPAP system delivers a predetermined pressure (e.g., determined by a sleep physician) to the user. An APAP system automatically changes the pressure delivered to the user based on, for example, breathing data relevant to the user. A BPAP or VPAP system is configured to deliver a first predetermined pressure (e.g., inspiratory positive airway pressure or IPAP) and a second predetermined pressure lower than the first predetermined pressure (e.g., expiratory positive airway pressure or EPAP).

[0029] The ventilator user 104 may suffer from obstructive sleep apnea and relies on a mask 100 to deliver pressurized air via a tube 106 from a ventilator device 108. The ventilator device 108 may be a CPAP machine, which increases the air pressure in the ventilator user 104's larynx to prevent airway closure and / or narrowing during sleep. For a person with sleep apnea, her airway can narrow or collapse during sleep, reducing oxygen intake and forcing her to wake up and / or otherwise disrupting her sleep. The CPAP machine prevents airway narrowing or collapse, thereby minimizing awakenings or disturbances due to reduced oxygen intake.

[0030] The ventilator device 108 strives to maintain medically prescribed air pressure during sleep, but in some cases, the mask 100 may move or reposition while the ventilator user 104 is asleep. Movement of the mask 100 may cause and / or allow air from the ventilator device 108 to leak at the interface between the mask 100 and the face of the ventilator user 104. For example, the ventilator user 104 may be advised to sleep on her back with the mask 100 open, but during the night, the ventilator user 104 may unconsciously change position so that her cheek is flush with the pillow 138a. In this new position, the mask 100 may move from a snug fit that prevents air leakage to a new position that allows air to leak from the ventilator device 108. The pressurized air leaking from the mask 100 may generate audible noise that disturbs the ventilator user 104 and / or bed partner 102, thereby interfering with and / or negatively impacting the sleep process of both parties.

[0031] Other sources of air leakage are also possible at the interface between the mask 100 and the face of the respirator user 104. For example, over time, the mask 100 or a portion thereof may wear down, making the seal at the interface less complete than when the mask 100 was new. As another example, the strap segments 205a, 205b, and 205c of the mask 100 (… Figure 2 It can loosen over time, leading to a poor seal that may cause air leakage.

[0032] See Figure 2 The image shows a face mask 201 for use with a ventilator (e.g., ventilator 108) according to some embodiments of the invention. The face mask 201 and... Figure 1 The mask 100 is identical or similar. The mask 201 includes an inflation chamber 202, a positioning or stabilizing structure 204 with strap segments 205a, 205b, and 205c, a pad 206, an electronic interface 208, a connection portion 210, and a connection port or coupling mechanism 212. The positioning or stabilizing structure 204 allows the respirator user (e.g., respirator user 104) to secure the inflation chamber 202 to her face. The pad 206 is disposed between the respirator user 104's face and the inflation chamber 202 to improve wearer comfort and also serves as a seal or conformal membrane to prevent pressurized air leakage from the inflation chamber 202 at the interface between the respirator user 104's face and the inflation chamber 202. The pad 206 may be made of silicone.

[0033] Connection portion 210 allows connection port 212 to connect to inflation chamber 202. Connection port 212 mates with a tube (e.g., tube 106) for receiving pressurized air from ventilator device 108. Connection portion 210 can be rotatable, allowing connection port 212 to be rotated to a desired position. Connection portion 210 may also provide a controlled ventilation port to allow exhaled carbon dioxide and other gases from ventilator user 104 to escape from inflation chamber 202. The controlled ventilation port allows continuous ventilation flow from inside inflation chamber 202 to the environment while the pressure within inflation chamber 202 is positive relative to the environment. The controlled ventilation port at connection portion 210 is configured such that the ventilation flow rate is sufficient to reduce rebreathing of exhaled carbon dioxide by ventilator user 104 while maintaining therapeutic pressure in inflation chamber 202.

[0034] In some implementations, the mask 201 includes one or more assistance ports that allow access to the volume within the inflation chamber 202. These assistance ports may allow a clinician or physician to probe or approach the gas characteristics within the inflation chamber 202. For example, the assistance ports may help determine the pressure within the inflation chamber 202.

[0035] Electronic interface 208 provides connectivity to electronic sensors and other devices that can be embedded in mask 201. While strap segments 205a, 205b, and 205c are configured to allow a sliding fit between mask 201 and respirator user 104, movement or changes in sleeping position by respirator user 104 during sleep can disrupt this sliding fit, allowing pressurized air to leak from mask 201. Pressurized air can generate noise, which can disturb nearby sleepers (e.g., ...). Figure 1 The bed partner shown is 102.

[0036] See Figure 3 A block diagram of a system 300 for mitigating the effects of noise from a ventilator device 302 (or from a mask 310 attached to the ventilator device 302 via a tube 306) according to some embodiments of the invention is shown. For simplicity of discussion, the singular form will be used where appropriate. Figure 3 All components are identified in the text, but the use of the singular does not limit the discussion to only one of each such component.

[0037] Ventilator equipment 302, mask 310 and tube 306 and Figure 1 The ventilator device 108 (e.g., a CPAP machine), mask 100, and tubing 106 shown and described herein are the same as or similar to those described herein. The ventilator device 302 may include a humidifier 309, which is similar to the humidifier 109 ( Figure 1 The mask 310 is the same as or similar to the mask 201 and / or mask 100. The mask 310 may be worn or placed on the respirator by the user 104. Figure 1 The ventilator device 302 can be configured to generate an airflow to be delivered to the airway of the ventilator user 104. The ventilator device 302 can deliver an airflow ranging from -20 L / min to 150 L / min while maintaining a positive pressure of at least 6 cm H2O, or at least 10 cm H2O, or at least 20 cm H2O. The ventilator device 302 may include a housing having one or more panels and handles.

[0038] The ventilator device 302 may also include an inlet air filter, an inlet silencer, a pressure generator for supplying air at positive pressure, an outlet silencer, and one or more transducers, such as pressure sensors and flow sensors. The ventilator device 302 may have a power supply, one or more input devices (e.g., buttons, dial pads, switches, touchscreens, etc.), and a central controller. In some embodiments, the ventilator device 302 includes a humidifier and an anti-backflow valve that reduces the flow of water from the ventilator device 302 to the ventilator user 104 (e.g., via...). Figure 1 The risk of the tube 106 shown.

[0039] The ventilator device 302 may further include a wired or wireless data communication interface for communicating with electronic components or sensors on the mask 201. In some embodiments, the tube 106 not only carries pressurized air but also includes wires for connecting the data communication interface on the ventilator device 302 to sensors and / or one or more electronic components (e.g., sensors, speakers, microphones, cameras, memory, control systems, etc., or any combination thereof), which are integrated into and / or coupled to the mask 310.

[0040] System 300 may further include a microphone 320 for sensing sounds in its vicinity. The microphone 320 may be wired or wireless and may be located anywhere in a room, for example... Figure 1 The microphone 320 may also be located on or within the ventilator device 302, mask 310, or both.

[0041] System 300 may further include a speaker 330 for generating one or more sounds. In some embodiments, the speaker 330 generates sound based on the detection by microphone 320 of air leakage from the inflation chamber of mask 310. The speaker 330 may generate soothing sounds, white noise, shaped white noise, pink noise, brown noise, or any other sound or combination of sounds, such as those described herein.

[0042] In some embodiments, system 300 includes a plurality of speakers 330 to provide localized sound emission. Speakers 330 may include in-ear speakers, over-ear speakers, adjacent in-ear speakers, earplugs, in-ear earplugs, or any combination thereof. Speakers 330 may be wired or wireless speakers (e.g., headphones, bookshelf speakers, floorstanding speakers, television speakers, wall speakers, ceiling speakers, etc.). In some embodiments, speakers 330 are worn by the respirator user 104 and / or bed partner 102. In some such embodiments, the provided speakers 330 may provide noise masking without affecting the bed partner, as sound will be localized by the type of speaker 330. In this embodiment, a corresponding localized speaker 330 may be provided for the respirator user and / or bed partner.

[0043] In some embodiments, the speaker 330 is attached to strap segments 205a, 205b, and 205c of the face mask 310. Figure 2 One or more of the following. For example, the speaker may be located at positions 720a, 720b of the mask 701 (e.g., Figure 7(As shown). Therefore, the ventilator user 104 and / or bed partner 102 have the option to perceive a relatively flat-shaped white noise or a noise signal with a quieter (lower level and / or low-pass filtered) shape. Some variations of flat white noise are referred to as pink noise, brown noise, purple noise, etc. In some such implementations, higher frequency sounds / noise (e.g., “more jarring” sounds) are reduced while still providing masking sound to ambient noise. System 300 can select an optimized set of fill sound frequencies to achieve the target noise distribution. For example, if certain components of the sound are already present in the spectrum (e.g., associated with a box fan in the room, a CPAP blower motor, etc.), system 300 can select fill sounds with sound parameters / characteristics that fill a quieter frequency band, for example, reaching a target amplitude level. Therefore, system 300 is able to adaptively attenuate higher and / or lower frequency components using active adaptive masking and / or adaptive noise cancellation, making the perceived sound more pleasant and relaxing to the ear (the latter being better suited for slower-changing and predictable sounds).

[0044] The speaker 330 may support audio profiles, enabling a wireless network interface (e.g., built into the ventilator device 302 or other smart home devices) to be used to synchronize the speaker 330 with one or more other devices in the system 300.

[0045] In some embodiments, instead of using speaker 330 to generate one or more sounds, or in addition to using speaker 330 to generate one or more sounds, system 300 may use humidifier 309 to produce bubbling sounds, wave sounds, and / or any other water-related sounds (e.g., sounds generated by the movement and / or manipulation of water). That is, humidifier 309, which typically stores water during use of ventilator device 302 to humidify pressurized air delivered to the ventilator user via mask 310, may bubble and / or move the water within it to intentionally produce water-related sounds. Water-related sounds can be used for the same reasons as the sounds produced by speaker 330 discussed herein. In some such embodiments, air is added, delivered, and / or injected into humidifier 309 such that the air bubbles upward through the water stored therein to produce bubbling sounds. Alternatively or additionally, air may be added to humidifier 309 to induce one or more water waves therein, thereby producing wave sounds. The air added to the humidifier 309 may be supplied by a pump included in the ventilator device 302 for supplying pressurized air to the mask 310 and / or by a different pump and / or fan. In some embodiments, the humidifier 309 includes one or more vents (e.g., on the top surface) to help allow water-related sounds to exit the humidifier 309 and be audible to the ventilator user and / or bed partner.

[0046] In some embodiments, instead of using a loudspeaker 330 to generate one or more sounds, or in addition to using a loudspeaker to generate one or more sounds, system 300 may cause an intentional leak of pressurized air in ventilator device 302 or any component of ventilator device 302, tubing 306, mask 310, humidifier 309, or any combination thereof. In some such embodiments, system 300 includes one or more valves that can be selectively actuated by control system 390 to cause an intentional leak of pressurized air. One or more valves may be coupled to and / or adjacent to tubing 306, mask 310, humidifier 309, ventilator device 302, or any part thereof. One or more valves may be controlled (e.g., open, close, partially open, modulate, etc.) to shape the sound (caused by leaked air through one or more valves) to a desired frequency, amplitude, pitch, etc. In some embodiments, the intentionally leaked air causes a sound shaped as white noise, pink noise, brown noise, soothing sound, etc., or any combination thereof. In some embodiments, at least a portion of the one or more valves is coupled to pipe 306, and the regulation of such valves is modified by control system 390 at least in part based on the orientation of pipe 306. Specifically, pipe 306 is flexible and can take various positions, shapes, etc. Therefore, control system 390 is configured to monitor the position / or orientation of pipe 306 and / or monitor the generated sound and modify the modulation of at least a portion of one or more valves such that the generated sound is as expected / desired by system 300 (e.g., to approximate or generate white noise, pink noise, brown noise, soothing sound, etc., or any combination thereof). The position / orientation of pipe 306 can be determined by system 300 by analyzing image data associated with pipe 306 generated by one or more cameras (e.g., camera 340, infrared camera 342, etc., or any combination thereof).

[0047] As described above, ventilator devices 108, 302 generate pressurized air, and in some cases, normal operation of ventilator devices 108, 302 can cause noise that system 300 can mitigate by generating one or more sounds (e.g., soothing sounds, white noise, pink noise, brown noise, etc., or any combination thereof). In some embodiments, the orientation and / or placement of ventilator devices 108, 302 on and / or near specific surfaces (bedside tables, desks, floors, etc.) and / or objects can cause and / or contribute to the generation of noise perceived as unpleasant to the ventilator user and / or bed partner by ventilator devices 108, 302 and / or one of their components (e.g., blower motor, etc.). Furthermore, in some embodiments, the generated noise can develop and / or intensify over time, for example, due to normal wear and tear and / or placement of ventilator devices 108, 302. In some such embodiments, system 300 can generate masking sounds as described herein to mitigate and / or obscure these noises.

[0048] System 340 may also include a camera 340, an infrared camera 342, a pressure sensor 350, a motion sensor 355, and other sensors 360 (e.g., electrocardiogram (EKG) sensors, electroencephalogram (EEG) sensors, electromyogram (EMG) sensors, blood flow sensors, respiration sensors, pulse sensors, photoplethysmography (PPG) sensors, oxygen sensors, analyte sensors, humidity sensors, lidar sensors, etc.). Camera 340 and infrared camera 342 may be positioned to capture changes in the motion and thermal characteristics of the ventilator user 104 and / or bed partner 102. Pressure sensor 350 may be located anywhere along the air loop from ventilator device 302 to mask 310. Pressure sensor 350 may be multiple pressure sensors positioned along the air loop to measure pressure at different points within the air loop (e.g., at the mask inflation chamber, along the tubing connecting the mask to the ventilator device, at either end of the tubing, at the ventilator device, etc.).

[0049] Motion sensor 355 can detect movement of the ventilator user 104 and / or bed partner 102. In some embodiments, motion sensor 355 cooperates with infrared camera 342 to determine changes and / or shifts in body temperature relative to ambient temperature, thereby determining whether the person is moving. In some embodiments, motion sensor 355 uses electromagnetic sensing in infrared wavelengths to detect movement and determines that the body temperature has slightly decreased during an individual's sleep, so that when the body temperature rises above a certain level based on infrared sensing, motion sensor 355 determines that the individual is waking up and moving. Other examples of motion sensor 355 include passive infrared sensors, radio frequency sensors such as pulsed continuous wave (CW) sensors, ultra-wideband (UWB) sensors, frequency modulated continuous wave (FMCW) sensors, sensors that emit ultrasonic signals and determine whether the reception of detected reflected ultrasonic signals indicates a changing pattern, gyroscopes and accelerometers embedded in pajamas or bedding, or any combination thereof.

[0050] Memory 380 may include one or more physically separate memory devices, such that the one or more memory devices can be coupled to and / or built into ventilator device 302, control system 390, and / or wirelessly and / or wiredly coupled to system 300 (e.g., mobile phone, computer, server, cloud-based device, etc.). Memory 380 serves as a non-transient computer-readable storage medium on which machine-readable instructions executable by control system 390 and / or one or more other systems are stored. Memory 380 is also capable of (temporarily and / or permanently) storing data generated by sensors of system 300. In some embodiments, memory 380 includes non-volatile memory, battery-powered static RAM, volatile RAM, EEPROM memory, NAND flash memory, or any combination thereof. In some embodiments, memory 380 is a removable form of memory (e.g., a memory card).

[0051] Similar to memory 380, network interface 370 can be connected to ventilator device 302, mask 310, control system 390, and / or one or more external devices. Network interface 370 is connected to memory 380, enabling control system 390 to communicate with one or more external devices or other components in system 300.

[0052] Similar to memory 380, control system 390 can be coupled to ventilator device 302, mask 310, and / or one or more external devices. Control system 390 is coupled to memory 380 such that control system 390 is configured to execute machine-readable instructions stored in memory 380. Control system 390 may include one or more processors and / or one or more controllers. In some embodiments, the one or more processors include: one or more x86 Intel processors, one or more processors based on ARM Holdings... -M processors, such as the STM32 series microcontrollers from STMicroelectronics, or any combination thereof. In some implementations, one or more processors include: a 32-bit RISC CPU such as the STR9 series microcontrollers from STMicroelectronics, or a 16-bit RISC CPU such as the MSP430 series microcontrollers from Texas Instruments.

[0053] In some embodiments, the control system 390 is a dedicated electronic circuit. In some embodiments, the central controller 390 is a dedicated integrated circuit. In some embodiments, the control system 390 includes discrete electronic components.

[0054] The control system 390 is capable of receiving inputs (e.g., signals, generated data, instructions, etc.) from any other element (e.g., sensors, etc.) of the system 300. The control system 390 is capable of providing output signals to cause one or more actions to occur in the system 300 (e.g., causing the speaker 330 to play sound, etc.).

[0055] Although the control system 390 and memory 380 are in Figure 3 While described and shown as separate and distinct components of system 300, in some embodiments, control system 390 and / or memory 380 are integrated into ventilator device 302. Alternatively, in some embodiments, control system 390 or a portion thereof (e.g., at least one processor of control system 390) 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 servers, local servers, etc., or any combination thereof).

[0056] Although system 300 is shown as including all the components described above, according to an implementation of the invention, more or fewer components may be included in the system for generating data and determining recommended notifications or actions for the user. For example, a first optional system includes a control system 390, a memory 380, and... Figure 3At least one of the sensors provided. As another example, the second alternative system includes a control system 390, a memory 380, a breathing system 302, and Figure 3 At least one of the sensors provided herein. Therefore, 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.

[0057] As used throughout this invention, the term leakage is understood to mean unintentional airflow from system 300 to the surrounding environment. For example, leakage may occur due to an incomplete seal between the mask 310 and the face of the respirator user 104. In another example, leakage may occur in a rotating bend (e.g., Figure 2 The connection port 212) or any part of the air circuit of system 300 is used for connection to the surrounding environment. In some embodiments, the mask 310 includes a connection section 210 ( Figure 2 The connection section includes a vent designed to allow exhaled gas to escape from the inflation chamber 202. Gas escaping from the inflation chamber 202 via the vent is not considered a leak because the gas includes the intended flow within the system 300. In some embodiments, air flowing through the vent of the system 300 may be referred to as a permissible leak.

[0058] See Figure 4 A flowchart illustrating a method for generating sound from a speaker 330 in response to noise from a system 300 (e.g., air leakage from a ventilator device 302, a mask 310, or any combination thereof) according to some embodiments of the present invention is shown. In step 402, the control system 390 (and / or the ventilator device 302 in some embodiments) receives sensor data. The sensor data may come from a microphone 320 that generates sound data (or audio data) while the ventilator user 104 is asleep. In some embodiments, the sensor data comes from one or more of the microphones 320, one or more of the pressure sensors 350, one or more of the infrared cameras 342, one or more of the cameras 340, and / or one or more of other sensors 360, one or more flow sensors, or any combination thereof.

[0059] In step 404, the control system 390 analyzes sensor data to determine whether noise associated with an air leak in system 300 is currently occurring. In some embodiments that do not use a microphone to determine an air leak, an assumption can be made that the detected air leak (e.g., by the ventilator device 302) produces sound. For example, if the control system 390 is embedded in the ventilator device 302, the ventilator device 302 can determine that air is currently leaking through pressure measurements and data analysis using one or more algorithms.

[0060] In some implementations, the control system 390 determines and / or measures one or more flow rates to help determine whether an air leak is occurring. The control system 390 may determine the flow rate of the ventilator device 302, which is the flow rate of air leaving the ventilator device 302. The control system 390 may further determine the total flow rate reaching the mask 310 via the air circuit, wherein the total flow rate is the flow rate of air introduced via any aid ports of the mask 310 and any aid gas reaching the mask 310 via the air circuit. The control system 390 may determine the ventilation flow rate, which is the flow rate of air leaving the ventilator opening to allow the expulsion of exhaled gases. The control system 390 may further determine the leakage flow rate, which is the leakage flow rate from the mask 310 and / or any other location on the air circuit. The control system 390 may also determine the breathing flow rate, which is the flow rate of air received into the breathing system of the ventilator user 104.

[0061] In some implementations, the control system 390 may use a pressure sensor and / or one or more flow sensors to determine the pressure, breathing flow rate, and leakage flow rate at the mask 310. The control system 390 may further estimate the leakage flow rate and breathing flow rate.

[0062] In some implementations, the control system 390 uses a pressure sensor 350 and / or one or more flow sensors to determine the pressure at the mask 310. The pressure sensor 350 can provide the pressure exiting the ventilator device 302, and the flow sensor can provide the flow rate of air exiting the ventilator device 302. The control system 390 can then use the pressure exiting the ventilator device 302 to estimate the pressure drop in the entire air loop and / or one or more of its components. In the absence of any supplemental gas being introduced into the mask 310, the flow rate of the ventilator device 302 can be used as an estimate of the total flow rate reaching the mask 310.

[0063] In some implementations, the control system 390 can simulate the dependence of the pressure drop across the air circuit on the total flow rate to the mask 310 reaching a particular air circuit to determine pressure characteristics. The control system 390 can then use these pressure characteristics to determine an estimated pressure reaching the mask 310. For example, the pressure reaching the mask 310 can be determined as the ventilator device pressure minus the air circuit pressure drop.

[0064] In some implementations, the control system 390 uses the pressure reaching the mask 310 to determine the ventilation flow rate and estimate the ventilation flow rate in the mask 310. The dependence of the ventilation flow rate on the pressure reaching the mask 310 can be simulated a priori, and the control system 390 uses the simulated characteristics to determine a specific ventilation flow rate at a specific pressure reaching the mask 310.

[0065] In some implementations, the control system 390 estimates the leakage flow using the total flow rate and the ventilation flow rate. The leakage flow rate can be estimated by the control system 390 by calculating the average of the difference between the total flow rate and the ventilation flow rate over a sufficiently long time period that includes several respiratory cycles. This time period can be, for example, 5 seconds, 10 seconds, 20 seconds, 30 seconds, etc.

[0066] In some implementations, the control system 390 estimates the leakage flow rate using the total flow rate, the ventilation flow rate, and the estimated pressure reaching the mask 310. The leakage flow rate can be estimated by calculating the leakage conductivity and determining the leakage flow rate as a function of the leakage conductivity and the estimated pressure reaching the mask 310. The leakage conductivity can be calculated as the quotient of the difference between the total flow rate and the ventilation flow rate, divided by the low-pass filtered square root of the pressure reaching the mask 310, where the low-pass filter time constant has a sufficiently long value to encompass several breathing cycles. A breathing cycle can last approximately 10 seconds, 20 seconds, etc. The leakage flow rate can be estimated as the product of the leakage conductivity and the pressure reaching the mask 310.

[0067] In some implementations, the control system 390 estimates the respiratory flow rate via total flow rate, ventilation flow rate, and leakage flow rate. The respiratory flow rate can be determined by subtracting the ventilation flow rate and leakage flow rate from the total flow rate.

[0068] In some implementations, microphone 320 provides sound data (or audio data) analyzed in step 404 to control system 390 in step 402. At the start of sleep, microphone 320 may provide ambient noise levels to control system 390, and during sleep, if noise in the bedroom reaches a threshold exceeding the ambient noise level, control system 390 determines that an air leak exists. An ambient noise level is established at the start of sleep, for example, after ventilator user 104 turns on ventilator device 302, for the time it would be 10 seconds, 30 seconds, 2 minutes, etc.

[0069] In some implementations, the control system 390 analyzes the noise picked up by the microphone 320 to determine the noise profile. If the noise has certain frequency and / or amplitude characteristics similar to rapidly moving air, the control system 390 increases the confidence level that the noise is associated with air leakage from the air loop of the system 300. On the other hand, if the frequency and / or amplitude characteristics indicate a siren or some other noise with rapid frequency and / or amplitude characteristics, the control system 390 determines that there is no air leakage, even though the noise is above a threshold.

[0070] In some implementations, microphone 320 refers to more than one microphone arranged in several locations (e.g., two locations, three locations, five locations, etc.) throughout the bedroom or room. Using the positioning of different microphones, the origin of the sound can be determined, such that when a noise threshold is reached, the microphone arrangement can be used to determine whether additional sound adding to the noise level originates from the area around the bed or from elsewhere, such as ductwork wiring above the ceiling. If the sound is believed to originate from a location close to the location of the ventilator user 104 and / or system 300, the control system 390 can more reliably determine that the noise is associated with an air leak. Although multiple microphones have been described, a single microphone positioned near the bed, within and / or on the ventilator device 302, within and / or on the mask 310, or any combination thereof, can be used to increase the confidence that sound data above and / or meeting a specific threshold indicates an air leak in system 300. Since sound attenuates as it leaves its source, placing the microphone 320 on the ventilator device 302 or the mask 310 or near the bed allows for better monitoring of sounds near the ventilator user 104 during sleep.

[0071] In some implementations, infrared data may be combined with sound data (or audio data) to determine if there is a change in the heat around the respirator user 104, thereby increasing the confidence in the occurrence of noise associated with an air leak. Since the pressurized air from the ventilator device 302 can be heated so that the respirator user 104 does not breathe cold air that could disturb their sleep, the heat around the respirator user 104 may change when heated air escapes from the air circuit of system 300 in the event of a leak.

[0072] In some implementations, infrared data alone can be used to determine whether an air leak is currently occurring (e.g., from the interface between mask 310 and the face of ventilator user 104) in the absence of acoustic data. Control system 390 can analyze infrared data from infrared camera 342 to identify the location of ventilator device 302, mask 310, and the air loop shared between ventilator device 302 and mask 310. The analyzed infrared data can be labeled as baseline infrared data for comparison. During sleep, if an air leak occurs, heated pressurized air will escape, causing interference with infrared imaging, and a second infrared dataset received at control system 390 can be compared with the baseline infrared dataset to determine whether an air leak has occurred.

[0073] In some implementations, motion data from motion sensor 355 is combined with infrared data to reduce the computational load performed by control system 390. Infrared data can change over time because individuals are prone to movement and position changes while sleeping. To reduce constant comparisons of imaging data to determine if an air leak has occurred, motion data is first analyzed to determine if the respirator user 104 has moved. If the respirator user 104 has moved, control system 390 combines the direction of movement to analyze specific portions of the infrared data to determine whether the respirator user 104's movement alone can explain the changes in infrared data. If the movement alone does not account for changes in infrared data, control system 390 determines that an air leak is likely the cause.

[0074] In step 406, in response to determining that the noise originates from a currently occurring air leak, the control system 390 causes the speaker 330 to emit a sound. The sound emitted from the speaker can be used to mask noise associated with air leaks from the air circuit of the system 300 (e.g., from the mask 310, tubing connected to the ventilator device 302, etc.). The control system 390 may cause the speaker 330 to emit a sound at a first volume, and then gradually increase the volume from the first volume to a second volume over a period of time. For example, the speaker 330 may initially emit a sound at a relatively low volume, and then gradually increase the volume so as not to wake and / or disturb the ventilator user 104 and / or bed partner 102 due to the sudden introduction of a new sound. The time period for increasing the volume may be 1 second, 5 seconds, 10 seconds, 20 seconds, 30 seconds, etc., or any other amount of time.

[0075] In some embodiments, the control system 390 may cause the speaker 330 to emit sound at a first volume when the ventilator user and / or bed partner first fall asleep or are in a first type of sleep state (e.g., in light sleep, NREM, N1, N2, etc.) and at a second volume when the ventilator user and / or bed partner are asleep or in a second type of sleep state (e.g., in REM, N3, slow-wave sleep (SWS), etc.). In some such embodiments, the first volume is larger than the second volume. Thus, any noise and / or air leakage and / or other noise generated by the ventilator device 302 is unlikely to disturb the ventilator user and / or bed partner when falling asleep. Similarly, when the ventilator user and / or bed partner are asleep and / or in REM sleep, a relatively low volume of sound is unlikely to disturb (e.g., wake) the ventilator user and / or bed partner. The different volumes of the emitted sound can be adapted to urban environments and / or to bed partners and / or ventilator users who are relatively more sensitive to noise while sleeping. The system 300 can use a relatively low volume of sound when the ventilator user and / or bed partner fall asleep relatively quickly and are less disturbed by noise during this period.

[0076] In some embodiments, the speaker 330 is located within the pillow on the bed, thus allowing the sound to be emitted at a lower volume than if the speaker 330 were located further away from the respirator user 104. The emitted sound can be white noise and / or soothing sounds. Soothing sounds may include beach sounds, birdsong, waterfall sounds, flowing water sounds, wind sounds, or any combination thereof.

[0077] In some implementations, in response to the analysis at step 402 resulting in the determination that no noise associated with air leakage from the air circuit of system 300 has occurred and / or the ventilator device 302 determines that no air leakage has occurred from the air circuit, system 300 causes speaker 330 to emit a sound at a first volume during sleep. When no air leak is detected, speaker 330 emitting a sound at the first volume allows the speaker to set an ambient noise level such that when an air leak is detected at step 404, speaker 330 can emit a sound at a relatively high volume level to mask the noise associated with the air leak.

[0078] In some implementations, the noise associated with air leakage can be a temporary phenomenon. For example, the respirator user 104 may change position while sleeping, such that in a first position, when the respirator user 104 is lying supine, no air leakage occurs, while in a second position, air leakage occurs, generating associated noise. Air leakage and associated noise occur when the respirator user 104 moves from the first position to the second position, but not when the respirator user 104 moves back from the second position to the first position. This temporary phenomenon can be monitored, and the system 300 can respond differently. For example, if the respirator user 104 moves frequently, resulting in relatively short periods of air leakage and thus causing associated noise lasting for a short period (e.g., less than 10 seconds), in some such implementations, the system 300 may not cause the speaker 330 to respond with sound (e.g., because frequent on / off switching of the sound itself could be disruptive to the bed partner 102 and / or the respirator user 104).

[0079] In some embodiments, in response to causing speaker 330 to begin emitting sound, control system 390 continues to analyze sensor data to determine whether noise associated with mask leakage still exists. Control system 390 may examine the characteristics of the sound from speaker 330 and separate it from the characteristics of the sound in the room. Based on the sound in the room, control system 390 determines that noise is still occurring, and therefore control system 390 allows speaker 330 to continue emitting sound. When control system 390 determines that sound is no longer occurring, control system 390 may cause speaker 330 to stop emitting sound. In some embodiments, control system 390 causes speaker 330 to emit sound or stop emitting sound when the respirator user 104 changes position while sleeping, thereby affecting whether the air circuit of system 300 leaks. In some embodiments, control system 390 causes speaker 330 to emit sound at a lower volume when no air leak is detected, and at a higher volume when an air leak is detected.

[0080] In some implementations, to minimize the intrusion of sound from speaker 330 during sleep by excessively frequent cut-ins and cut-outs, control system 390 utilizes a minimum duration for which speaker 330 will emit sound. That is, once speaker 330 begins to emit sound, it must continue for a minimum duration before control system 390 stops emitting sound. The minimum duration may be pre-programmed or determined based on the level of disturbance experienced by ventilator user 104 or bed partner 102 when the sound is first emitted by speaker 330. Based on adaptive sensing of previous disturbances from previously occurring sounds generated during sleep, the minimum duration may vary during sleep or across multiple sleep periods. The minimum duration may be, for example, 10 seconds, 20 seconds, 30 seconds, 1 minute, 2 minutes, 5 minutes, 30 minutes, etc., or any other duration.

[0081] In one example of the invention, the control system 390 determines that noise associated with an air leak is occurring, and then causes the speaker 330 to emit sound, with a minimum duration of 30 seconds for playing the sound (in this example). After ten seconds, the control system 390 determines that no more noise has occurred. In such an example, the control system 390 then instructs the speaker 330 to stop playing the sound at the 30-second mark (assuming no new noise was detected during that interval). Thus, the minimum duration of the sound to be emitted, 30 seconds, is satisfied.

[0082] In another example of the invention, the control system 390 determines that noise associated with an air leak is occurring, then causes the speaker 330 to emit sound, and the minimum duration for playing the sound is 30 seconds. After forty seconds, the control system 390 determines that the noise has ceased. In such an example, when the minimum duration of 30 seconds for playing the sound has been met, the control system 390 instructs the speaker to immediately stop playing the sound.

[0083] In some implementations, the control system 390 uses one or more algorithms to determine and / or estimate one or more leakage flows. The leakage flow can be used to determine whether to emit a sound. For example, in some implementations, the control system 390 causes the speaker 330 to emit a sound if the determined leakage flow is above a threshold level (e.g., above 5 liters of air per minute, above 10 liters of air per minute, above 15 liters of air per minute, above 20 liters of air per minute, above 24 liters of air per minute, above 30 liters of air per minute, above 40 liters of air per minute, etc., or any other threshold level). In some such implementations, a sound is emitted only after the control system 390 also determines that noise associated with a leakage is currently occurring. In some such implementations, a sound is emitted only after the control system 390 also determines that the respirator user 104 and / or bed companion 102 are present.

[0084] In some embodiments, in addition to emitting a sound when a leak is detected and / or otherwise determined to be occurring, the control system 390 may generate an alarm and / or warning when the leak flow rate is determined to exceed an alarm threshold. Such an alarm or warning may notify the ventilator user 104, the prescribing physician, or any other third party that any component of the ventilator device 302, mask 310, and / or air circuit should be repaired, replaced, or otherwise maintained. In this embodiment, when the leak flow rate is below the alarm threshold, the control system 390 causes the speaker 330 to sound without generating an alarm and / or warning. In some such embodiments, the alarm threshold is 20 liters of air per minute, 24 liters of air per minute, 30 liters of air per minute, or any other threshold amount.

[0085] Figure 5 This is a flowchart of a method for generating sound from a speaker 330 in response to noise (e.g., air leakage from a ventilator device 302, air leakage from a mask 310, etc., or any combination thereof) according to some embodiments of the present invention. In step 502, the control system 390 (and / or the ventilator device 302 in some embodiments) receives sensor data. In step 504, the control system 390 analyzes the sensor data to determine whether noise associated with an air leak is currently present. Steps 502 and 504 are combined with the above. Figure 4Steps 402 and 404 are described as the same or similar.

[0086] In step 506, the control system 390 analyzes the sensor data to determine the bed partner (e.g., Figure 1 Whether the bed partner 102 (shown) is disturbed. In some embodiments, the control system 390 uses sound data from the microphone 320 to determine whether the bed partner 102 is disturbed. The control system 390 can use the sound data from the microphone 320 to determine that the sleep stage of the bed partner 102 has changed, and therefore determine that the bed partner 102 is being disturbed.

[0087] In some implementations, the control system 390 uses a motion sensor 355, a microphone 320, a camera 340, an infrared camera 342, or any combination thereof to determine that the bed partner 102 is moving, and determines that the bed partner 102 is being disturbed based on the movement of the bed partner 102. The motion sensor 355 can use electromagnetic signals (e.g., RF signals) to determine the movement of the bed partner 102.

[0088] In some implementations, the control system 390 uses a microphone 320 and a speaker 330 to determine if the bed partner 102 is moving by generating an inaudible sound with the speaker 330 and sensing the reflection of the inaudible sound waves with the microphone 320 over a period of time. Changes in the reflection of the inaudible sound waves over this period of time can be used to determine whether the bed partner 102 is moving, and if the bed partner 102 is moving, the control system 390 determines that the bed partner 102 is being disturbed.

[0089] In some implementations, microphone 320 can generate sound data, which is analyzed by control system 390 to determine the breathing pattern of bed partner 102, thereby determining the sleep stage of bed partner 102. If the sleep stage of bed partner 102 changes, control system 390 determines that bed partner 102 has been disturbed.

[0090] In some implementations, the movement of the bed partner 102 is detected by the sound of the bedding caused by the movement of the bed partner, the bed partner starting to snore, the bed partner talking, the bed partner sighing, or any combination thereof.

[0091] In some implementations, the control system 390 can determine the confidence level of the bed partner disturbance. The confidence level can range from 0 to 10, where 10 represents the highest level of disturbance and 0 represents no disturbance. Different examples of bed partner movement can be placed in this confidence score. Detection of sleep cycle changes can be at the lower end of the confidence score. Detection of sighs and / or conversations of the bed partner 102 can be at the higher end of the confidence score.

[0092] In step 508, based on the detected noise disturbance to bed companion 102 associated with air leakage, control system 390 causes speaker 330 to emit sound. Several implementations described above under step 406 also apply to step 508, and will not be repeated here.

[0093] In some implementations, the control system 390 selects the sound emitted by the speaker 330 based on a confidence score. For example, white noise can be emitted from the speaker 330 with a confidence score of 2, while classical music can be emitted with a confidence score of 5. In another example, where different sounds can be substituted with different confidence levels, more than two options are available.

[0094] In some implementations, the control system 390 selects the sound emitted by the speaker 330 based on the ventilator user's profile and / or the bed partner's profile. In such implementations, the ventilator user and / or bed partner may set up and / or create a user profile for the system 300, which includes, in particular, preferences for sounds to be played to mask noise and / or mask leakage from the ventilator device 302. Furthermore, the ventilator user's profile may include historical data related to the volume of noise and / or sound mitigated by the system 300. Thus, the system 300 is able to compare current noise / sound with historical noise / sound. This comparison of current and historical data can be used to determine whether noise associated with, for example, an air leak is related to an air leak, which can be easily addressed by producing a masking sound compared to an air leak, which may indicate a more serious issue that should be addressed, for example, by replacing one or more components (e.g., a new mask, a new ventilator device, etc.) and / or by maintaining one or more components.

[0095] In some embodiments, the control system 390 adjusts or sets the volume of the sound emitted by the speaker 330 based on a confidence score. For example, a relatively low confidence score (e.g., a confidence score of 1) causes the control system 390 to emit sound from the speaker at a relatively low volume (e.g., 15 out of 100), while a relatively high confidence score (e.g., a confidence score of 8) causes the control system 390 to emit sound from the speaker at a relatively high volume (e.g., 75 out of 100). Where different volumes can be opened at different confidence levels, more than two options can be used. In some embodiments, the control system 390 adjusts or sets the duration of sound emission based on the confidence score in a similar manner. Different confidence scores can indicate different lengths associated with sound emission from the speaker 330.

[0096] In some embodiments where the speaker 330 emits white noise, the control system 390 can select different types of white noise or can pre-program the type of white noise emitted. The control system 390 can also monitor the bed partner 102 and / or the ventilator user 104 over time to determine which sound and / or white noise works best for the bed partner 102 and / or the ventilator user 104. This can be achieved by monitoring the confidence scores of one or both of the bed partner 102 and the ventilator user 104. The control system 390 can store in memory 380 a profile of how the confidence scores change in response to a particular sound and / or white noise. The emitted sound and / or white noise that historically caused the largest drop in confidence scores can then be selected as the sound and / or white noise used by the control system 390. Although white noise has been discussed, the sound emitted from the speaker 330 can be any of the examples described above, and thus a profile can be created for, for example, how beach sounds affect confidence scores.

[0097] In some implementations, the control system 390 may cause the speaker 330 to emit different sounds based on the sleep cycle and / or sleep stage of the ventilator user 104 and / or bed partner 102. For example, if both the ventilator user 104 and bed partner 102 are in REM sleep, no sound is emitted for a Type 1 leak (e.g., a short leak lasting less than 20 seconds). If both are in REM sleep, a sound is emitted for a Type 2 leak (e.g., a leak lasting longer than 20 seconds). If the bed partner 102 is not in REM sleep, a sound is emitted for all leaks. In some implementations, the determination of whether a leak is a Type 1 or Type 2 leak may be performed dynamically. Once the control system 390 determines that a leak exists, it defaults to classifying the leak as Type 1 and calculates and / or estimates how long the leak has lasted or is expected to last. If a counter or clock relied upon by the control system 390 reaches a threshold mark, such as 20 seconds, the leak is reclassified as a Type 2 leak.

[0098] In some implementations, the control system 390 may determine whether the ventilator user 104 or bed partner 102 is awake based on sensor data, and then cause the speaker 330 to emit a sound based on who is awake in the bedroom. In one example, the bed partner 102 goes to bed first, and the speaker 330 plays a first sound. Later, the ventilator user 104 goes to bed, and the control system 390 determines that the ventilator user 104 is asleep, then causes the speaker 330 to stop playing the first sound and start playing a second sound. In some implementations, the control system 390 determines that the ventilator user 104 is about to go to bed by detecting that the ventilator device 302 has been turned on via the microphone 320 and / or by the ventilator device 302 itself.

[0099] In one example, bed partner 102 goes to bed after ventilator user 104, and control system 390 uses video data from camera 340 or thermal data from infrared camera 342 to sense the sequence and cause speaker 330 to emit a second sound. While the specification mentions a first sound and a second sound, this can be extended to a first volume and a second volume, initially no sound being played, then a sound being played later, and combinations thereof. Furthermore, although the specification mentions playing a first sound, this also extends to playing a first sound when a leak is detected and / or when the bed partner is disturbed.

[0100] Reference Figure 6 According to some embodiments of the invention, exemplary placement of components for mitigating the effects of noise from a ventilator device 608, air leakage from a mask 600, or any combination thereof, in a bedroom setting is shown. The environment is a bedroom setting including a ventilator user 604, a bed partner 602, a bed with a mattress 636, pillows 638a and 638b, and a headboard 634. Near the bed are two bedside tables 632a and 632b, and a light 630 on bedside table 632b. The ventilator user 604 wears a mask 600 connected to the ventilator 608 via an air circuit or tube 606. A speaker may be placed at position 610, and a camera and / or microphone may be placed at positions 618 and 614. A microphone and / or camera may be placed at position 612 to monitor, for example, the bed partner 602. Various other locations for the components are possible. For example, one or more cameras may be mounted in the ceiling of the room. One or more microphones may be mounted to the headboard 634 and / or the walls of the room, etc.

[0101] See Figure 7 The image shows a perspective view of a face mask 701 according to some embodiments of the invention, which can be used with a respirator (e.g., ventilator device 608) to mitigate the effects of noise from the respirator. Face mask 701 and... Figure 2 The mask 201 is identical or similar. The mask 701 includes an inflation chamber 702, a positioning or stabilizing structure 704 with strap sections 705a, 705b, and 705c, a padding 706, an electronic interface 708, a connection portion 710, and a connection port 712. The mask 701 may include several locations for embedding sensors. For example, sensors may be positioned at locations 720a, 720b, and / or 722. Such sensors may include a microphone embedded in the mask for determining air leaks. Furthermore, one or more speakers may be included at locations 720a, 720b, and / or 722 for emitting sound.

[0102] While the above disclosure generally discusses the use of sound (e.g., white noise, pink noise, brown noise, soothing sounds, etc.) to help mask noise from sources such as air leaks at the mask interface of the respiratory system, ventilator equipment sounds, etc., it is contemplated that the same or similar sounds can be used to train and / or guide the breathing of a ventilator user (e.g., when attempting to fall asleep). Training and / or guiding the breathing of a ventilator user while receiving pressurized air therapy and attempting to fall asleep can help the ventilator user relax while attempting to fall asleep and / or using pressurized air therapy. Breathing training can be provided by sound (e.g., white noise, shaped white noise, modulated sounds (e.g., boo) etc.) to encourage the ventilator user to bring their breathing to the guided modulation (e.g., to help the ventilator user relax and eventually fall asleep). In some embodiments, the provided sound can help guide the ventilator user to lower their breathing and take deeper breaths, which can help the ventilator user fall asleep. In some embodiments, the provided sound can help the ventilator user exhale at a rate relatively slower than inhalation. In some embodiments, the provided sound can help the ventilator user control their breathing duration as the time between exhalation and inhalation. In some implementations, the provided sounds may be associated with and / or linked to the ramp settings of the breathing system to better optimize overall pressurized air therapy during the sleep initiation phase of a ventilator user's sleep. That is, in some implementations, the pressure setting of the pressurized air supplied to the ventilator user may be increased or raised over time as the ventilator user attempts to fall asleep, and sounds to aid relaxation and breathing control may be played during the same or similar time periods. The length of the period during which the ventilator user needs to fall asleep may be learned over time, and the ramp and / or sound settings may be customized over time based at least in part on data collected during the use of a sound-characteristic breathing system.

[0103] In some embodiments, the room using the respiratory system includes natural noise and / or sound sources that are the same as or similar to white noise, pink noise, brown noise, or any combination thereof. For example, the room may include and / or be adjacent to table fans, box fans, window fans, ceiling fans, stoves, air conditioners, washing machines, dryers, electrical appliances that generate electric buzzers, etc. Each of these existing sound sources can be supplemented by the system of the present invention to fill and / or complement the existing sound with additional sound. In some such implementations, the existing sound has existing sound characteristics that can be sensed by the system (e.g., by one or more sensors of the system, such as one or more microphones, one or more transducers, etc.). Existing sound characteristics may include frequency, amplitude, period, wavelength, wave velocity, pitch, dynamics, tone, timbre, duration, wave blocking, location, or any combination thereof. The system can supplement the existing sound with intermediate / complementary sounds having complementary sound characteristics. For example, complementary sounds may have frequencies and / or amplitudes between existing frequencies and / or existing amplitudes. In this way, the overall sound (e.g., including the existing sound and complementary sound of the system of the present invention) can provide a relatively more complete sound to mask noise.

[0104] One or more elements or aspects or steps or any part thereof from any one of claims 1-75 may be combined with one or more elements or aspects or steps or any part thereof from any other claims 1-75 or a combination thereof to form one or more additional implementations and / or claims of the present invention.

[0105] Although the invention has been described with reference to one or more specific embodiments, 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 implementations, and any obvious variations thereof, is considered to be within the spirit and scope of the invention as set forth in the following claims.

Claims

1. A method for masking background noise and operational noise associated with operation of a ventilator device, the method comprising: receiving audio data from a microphone; analyzing the audio data to determine (i) whether background noise associated with one or more background devices is present, and (ii) whether operational noise associated with operation of a ventilator device, a mask, a tube, or any combination thereof is occurring, the mask being coupled to the ventilator device via the tube, the mask being configured to engage a user during sleep to help direct supplied pressurized air to the user’s airway; and in response to the analysis of the audio data resulting in a determination that (i) the background noise is present and (ii) the operational noise is occurring, causing a speaker to emit sound to help mask the operational noise, the sound emitted by the speaker having a fill sound, the fill sound including increasing an amplitude of a relatively quiet frequency of the background noise to a target amplitude level to provide one or more characteristics of a relatively more complete background noise.

2. The method of claim 1, wherein, the operational noise including noise associated with air leaking from the mask, noise associated with operation of a pump of the ventilator device, or a combination thereof.

3. The method of claim 1 or 2, wherein the one or more background devices include a box fan, a ceiling fan, a table fan, a window fan, a furnace, an air conditioner, a washing machine, a dryer, an electrical device producing an electrical buzzing, or any combination thereof.

4. The method of claim 1, wherein the plurality of characteristics of the sound emitted by the speaker include frequency, amplitude, periodicity, wavelength, wave speed, pitch, dynamics, tone, timbre, duration, envelope, location, or any combination thereof.

5. The method of claim 1, further comprising: receiving second audio data from a second microphone; wherein causing the speaker to emit sound is further based at least in part on the analysis of the second audio data resulting in a determination that a bed partner of the user is currently disturbed.

6. The method of claim 5, wherein the second audio data indicates movement of the bed partner, a sound of bedding caused by movement of the bed partner, a change in breathing of the bed partner, a change in sleep stage of the bed partner, the bed partner starting to snore, the bed partner speaking, the bed partner sighing, or any combination thereof.

7. A system for masking noise produced during use of a ventilator device, the system comprising: a ventilator device configured to supply pressurized air; a mask coupled to the ventilator device and configured to engage a user during sleep to help direct the supplied pressurized air to the user’s airway; a microphone configured to produce audio data; a speaker configured to emit sound; a memory storing machine-readable instructions; and a control system comprising one or more processors configured to execute the machine-readable instructions to: analyze the audio data to determine whether background noise is present and whether noise associated with air leaking from the mask is occurring; and in response to the analysis resulting in a determination that the background noise is present and that (i) noise associated with air leaking from the mask is occurring, or (ii) the ventilator device determines that air is leaking from the mask, or (iii) both (i) and (ii) are present, causing the speaker to emit a sound, the sound having a fill sound that includes increasing an amplitude of a relatively quiet frequency of the background noise to a target amplitude level to provide one or more characteristics of a relatively more complete background noise to help mask the noise associated with air leaking from the mask.

8. The system of claim 7, wherein causing the speaker to emit the sound includes (i) causing the speaker to emit the sound at a first volume, and (ii) incrementally increasing the volume from the first volume to a second, higher volume over a first time period.

9. The system of claim 8, wherein the first time period is 20 seconds.

10. The system of claim 7, wherein the speaker is located in a pillow adjacent to the user.

11. The system of claim 10, wherein the pillow is used by a bed partner of the user and not by the user.

12. The system of any one of claims 7 to 11, wherein the sound emitted from the speaker includes at least a portion of a frequency spectrum of white noise, pink noise, brown noise, or any combination thereof.

13. The system of any one of claims 7 to 11, wherein the sound emitted from the speaker is a soothing sound.

14. The system of claim 13, wherein the soothing sound includes at least a portion of a frequency spectrum of a beach sound, a bird chirping sound, a waterfall sound, a running water sound, a wind sound, or any combination thereof.

15. The system of claim 7, wherein the control system is further configured to execute the machine-readable instructions to, in response to the analysis resulting in a determination that no noise associated with air leaking from the mask is occurring and that the ventilator device determines that no air is leaking from the mask, cause the speaker to emit the sound at a first volume during the sleep period.

16. The system of claim 15, wherein the speaker emits the sound at a second volume greater than the first volume in response to (i), (ii), or (iii).

17. The system of claim 7, wherein, the ventilator device determines that air is leaking based at least in part on an analysis of pressure generated by the ventilator device.

18. A system for masking background noise and operational noise associated with operation of a ventilator device, the system comprising: a ventilator device configured to supply pressurized air; a mask coupled to the ventilator device and configured to engage a user during sleep to help direct the supplied pressurized air to an airway of the user; a microphone configured to generate audio data; a speaker configured to emit a sound; a memory storing machine-readable instructions; and a control system including one or more processors configured to execute the machine-readable instructions to: analyzing the audio data to determine whether background noise is present; and in response to (i) the analysis resulting in a determination that the background noise is present, and (ii) the ventilator device determining that air is leaking from the face mask, causing the speaker to emit a sound, the sound having a fill sound, the fill sound including increasing an amplitude of a relatively quiet frequency of the background noise to a target amplitude level to provide one or more characteristics of a relatively more complete background noise to help mask noise associated with the air leaking from the face mask.

19. The system of claim 18, wherein the ventilator device determines that air is leaking from the face mask by a leak flow estimation algorithm.

20. The system of claim 19, wherein the leak flow estimation algorithm receives as input a total flow, a ventilation flow, a pressure at an interface between the face mask and the user, or any combination thereof.

21. The system of claim 20, wherein the leak flow estimation algorithm determines a leak flow by calculating an average of a difference between the total flow and the ventilation flow over a period of time.

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