WO2021188786A1

WO2021188786A1 - Systems and methods for using a sound-producing breathing device to perform breathing exercises, and/or determine pulmonary function

Info

Publication number: WO2021188786A1
Application number: PCT/US2021/022952
Authority: WO
Inventors: Gregory O'keeffe
Original assignee: Okeeffe Gregory
Priority date: 2020-03-18
Filing date: 2021-03-18
Publication date: 2021-09-23

Abstract

Systems, devices, and methods for determining a user's pulmonary function may employ a sound-producing breathing device and a recording device such as a microphone included in a processing device (e.g., smart phone or tablet computer). A user may inhale or exhale through the sound-producing breathing device, thereby producing a sound that is received by the microphone and communicated to a processor. The processor may analyze the received sound recording to determine one or more sound intensity values over, for example, the duration of the received sound and/or points in time within the sound recording. The sound intensity values may then be used to determine the user's pulmonary function.

Description

SYSTEMS AND METHODS FOR USING A SOUND-PRODUCING BREATHING DEVICE TO PERFORM BREATHING EXERCISES AND/OR

DETERMINE PULMONARY FUNCTION

RELATED APPLICATIONS

[0001]This patent application is an INTERNATIONAL/PCT application claiming priority to U.S. Provisional Patent Application No. 62/991 ,534, filed on 18 March 2020 and entitled “SYSTEMS, DEVICES, AND METHODS FOR USING A SOUND- PRODUCING BREATHING DEVICE AND HOLDER TO PERFORM BREATHING EXERCISES, IMPROVE LUNG FUNCTION, PERFORM PULMONARY

MONITORING, AND/OR DETERMINE LUNG CAPACITY AND PEAK EXPIRATORY FLOW,” and U.S. Provisional Patent Application No. 63/006,384, filed on 07 April 2020 and entitled “SYSTEMS, DEVICES, AND METHODS FOR USING A SOUND- PRODUCING BREATHING DEVICE AND HOLDER TO PERFORM BREATHING EXERCISES, IMPROVE LUNG FUNCTION, PERFORM PULMONARY

MONITORING, AND/OR DETERMINE PULMONARY FUNCTION THROUGH THE USE OF TIDAL VOLUMES AND EXPIRATORY FLOW RATES AND VOLUMES,” both of which are incorporated in their respective entireties herein.

FIELD OF INVENTION

[0002] The present invention is in the field of medical devices for pulmonology and, more particularly, relates to systems, devices, and methods for performing breathing exercises, determining pulmonary function through the use of spirometry and the measurement of inspiratory parameters such as tidal volumes (TV) and expiratory parameters such as forced expiratory volume in the first second of expiration (FEV1) and forced vital capacity (FVC).

BACKGROUND

[0003] Performing breathing exercises and receiving feedback as to a volume of air inhaled or exhaled and analyzed to determine the pulmonary function of a user, usually referred to as spirometry, typically requires the use of cumbersome and expensive equipment. Proper and regular use of traditional spirometry equipment is usually limited to clinical settings where patient engagement can be ensured under direct oversight. Once discharged, only a fraction of patients continue with their breathing exercises as instructed, exposing non-compliant patients to respiratory complications such as pneumonia. These limitations make the use of spirometry to assist in determining pulmonary function in at risk populations extremely difficult, and as a result, rare.

SUMMARY

[0004] Exemplary systems disclosed herein may include a sound-producing breathing device and a holder physically coupled to the sound-producing breathing device. The sound-producing breathing device may include a sound-producing mechanism (e.g., a reed, paper, whistle, etc.) configured to generate a sound responsively to a user inhaling or exhaling through the sound-producing breathing device.

[0005] The holder may include a microphone configured to convert sound produced when the user inhales or exhales through the sound-producing breathing device into a digital signal representing the sound produced when a user inhales or exhales through the sound-producing breathing device. The holder may also include a body configured to house the microphone and physically couple to the sound-producing breathing device so that, for example, a fixed distance between the microphone and the sound-producing breathing device and/or sound producing mechanism may be known or fixed. In some instances, the holder may include a sound-dampening material and/or a noise-cancelling mechanism such as a microphone configured to detect ambient noise.

[0006] In some embodiments, the system and/or holder may further include a transceiver configured to transmit the digital signal representing the sound produced when a user inhales or exhales through the sound-producing breathing device to a receiving device such as an external processor as may be resident in, for example, a user electronic device (e.g., smart phone or tablet computer), a cloud computing environment, and/or a third party computer system. On some occasions, the receiving device may be an antenna coupled to a processor and the antenna may be configured to receive the digital signal from the transceiver. Additionally, or alternatively, in some embodiments, the holder may be associated with an identifier (e.g., bar code, QR code, radio-frequency identifier) and the transceiver may be configured to communicate the identifier to the receiving device.

[0007] In some embodiments, the microphone may be a wireless microphone configured to transmit the digital signal representing the sound produced when a user inhales or exhales through the sound-producing breathing device to the receiving device.

[0008] In some embodiments, the system may further include a processor communicatively coupled to the microphone and configured to receive a digitized audio signal and/or file from the microphone. They may further be configured to have a set of instructions stored thereon which when executed by the processor cause the processor to receive the digital signal representing the sound produced when a user inhales or exhales through the sound-producing breathing device, determine an intensity of the sound included in the digital signal, determine a pulmonary function of the user based on the determined intensity, and facilitate provision of an indication of the pulmonary function to the user.

[0009] On some occasions, the sound recording from the microphone may be divided into a plurality of time intervals that may be, for example, 0.5 or 1 second in duration, and a sound intensity may be determined for each time interval. A processor (which may be, for example, resident in/on the holder and/or external to the system) may be configured to receive the sound recording divided into plurality of intervals and may be further configured to receive a distance between the sound-producing breathing device and the microphone, access a correlation table stored in a database communicatively coupled to the processor, the correlation table correlating sound intensity and air flow rates for the sound-producing breathing device and being specific to the distance between the sound-producing breathing device and the microphone and the type of sound-producing breathing device used to make the sound recording, determine an air flow rate corresponding to the intensity for each time interval using the correlation table, determine a volume of air inhaled or exhaled for each time interval, and determine a total volume of air inhaled or exhaled for all the time intervals included in the plurality of time intervals.

[00010] Exemplary methods included in the present invention include receiving a digital signal representing a sound produced when a user inhales or exhales through a sound-producing breathing device, determining a characteristic (e.g., intensity, frequency, and/or a duration of time (e.g., recording is 20 seconds, 10 seconds, etc.)) of the sound included in the digital signal, determining a pulmonary function of the user based on the determined characteristic, and facilitating provision of an indication of the pulmonary function to the user.

[00011] In some instances, determining the pulmonary function may include determining one or more of, for example, a tidal volume, a forced vital capacity, and a forced expiratory volume at one second.

[00012] In some embodiments, one or more previously received digital signals for the user and previously determined pulmonary function of the user may be stored in a database communicatively coupled to the processor. In these embodiments, a previously received digital signal for the user and previously determined pulmonary function of the user may be accessed and/or extracted from the database. The received digital signal and/or determined pulmonary function of the user may be compared with a currently determined received digital signal for the user and/or the determined pulmonary function of the user and a result of the comparison may be provided to the user.

[00013] At times, a pulmonary nomogram may be determined and/or stored in a database communicatively coupled to the processor and accessed. The accessed pulmonary nomogram may then be compared with the received digital signal for the user and the determined pulmonary function of the user and a result of the comparison may be provided to the user. The comparisons disclosed herein may be used to, for example, determine how the user’s pulmonary function changes over time.

[00014] In some embodiments, a set digital signals may be received and each of the digital signals in the set may be associated with a different user. Then, a pulmonary function value for each user associated with a digital signal may be determined and aggregated into a data set. This data set may then be communicated to a third party. Each user may be associated with one or more characteristics and the method may further comprise sorting the aggregated pulmonary function values in the data set according to the one or more characteristics and communicating the sorted pulmonary function values in the data set to the third party.

BRIEF DESCRIPTION OF THE DRAWINGS

[00015] The present invention is illustrated by way of example, and not limitation, in the figures of the accompanying drawings in which: [00016] FIG. 1 is a block diagram of an exemplary system, consistent with some embodiments of the present invention;

[00017] FIG. 2A is a front perspective view of an exemplary sound-producing breathing device laying on its side, consistent with some embodiments of the present invention;

[00018] FIG. 2B is a perspective view of the exemplary sound-producing breathing device when standing upright on an end, consistent with some embodiments of the present invention;

[00019] FIG. 2C provides a cross-sectional view of the exemplary sound- producing breathing device, consistent with some embodiments of the present invention;

[00020] FIG. 3A provides a side view of a first system including the exemplary sound-producing breathing device and a first holder, consistent with some embodiments of the present invention;

[00021] FIG. 3B provides a side view of a second system including the exemplary sound-producing breathing device and a second holder, consistent with some embodiments of the present invention;

[00022] FIG. 3C provides a side view of a third system including the exemplary sound-producing breathing device and a third holder, consistent with some embodiments of the present invention;

[00023] FIG. 3D provides a side view of a fourth system including the exemplary sound-producing breathing device and a fourth holder, consistent with some embodiments of the present invention;

[00024] FIG. 3E provides a side view of a fifth system including the exemplary sound-producing breathing device and a fifth holder, consistent with some embodiments of the present invention;

[00025] FIG. 3F provides a side view of a sixth system including the exemplary sound-producing breathing device and a sixth holder, consistent with some embodiments of the present invention;

[00026] FIG. 4A is a diagram providing a longitudinal cross-section of a first exemplary sound-producing breathing device, consistent with some embodiments of the present invention; [00027] FIG. 4B is a diagram providing a longitudinal cross-section of a second exemplary sound-producing breathing device, consistent with some embodiments of the present invention;

[00028] FIG. 5 is a flowchart illustrating an exemplary process for generation and/or updating of breathing exercise protocol, consistent with some embodiments of the present invention;

[00029] FIG. 6 is a flowchart depicting a process for determining pulmonary function of a user, peak air flow of inhalation and/or exhalation of a user, and/or a user’s state of health, consistent with some embodiments of the present invention; [00030] FIG. 7A is a flowchart depicting a process for determining pulmonary function of a user and/or a peak air flow rate and volumes of inhalation and/or exhalation of a user, consistent with some embodiments of the present invention; [00031] FIG. 7B depicts a graph plotting sound intensity as a function of air flow rate, consistent with some embodiments of the present invention;

[00032] FIG. 7C depicts a graph plotting sound intensity as a function of time for a UserX, consistent with some embodiments of the present invention;

[00033] FIG. 8A is a flowchart depicting a process for determining pulmonary function of a user and/or a peak air flow rate and volumes of inhalation and/or exhalation of a user, consistent with some embodiments of the present invention; [00034] FIG. 8B depicts a graph plotting sound frequency as a function of air flow rate, consistent with some embodiments of the present invention;

[00035] FIG. 8C depicts a graph plotting sound frequency as a function of time for a User Y, consistent with some embodiments of the present invention;

[00036] FIG. 9A provides a diagram of showing how sound intensity decreases with a distance from a point source of sound, consistent with some embodiments of the present invention;

[00037] FIG. 9B shows a graph of relative sound intensity as a function of distance from a point source of sound, consistent with some embodiments of the present invention;

[00038] FIGs. 10A-10D provide exemplary interfaces by which a user may use a sound-producing breathing device and make a sound recording, consistent with some embodiments of the present invention;

[00039] FIG. 10E provides an exemplary user-monitoring portal interface, consistent with some embodiments of the present invention; [00040] FIG. 11 is a block diagram showing exemplary components of a system in which computer readable instructions instantiating the methods of the present invention may be stored and executed, consistent with some embodiments of the present invention;

[00041] FIG 12. is a flowchart showing a process for determining a user’s analyzing pulmonary function, TV, FVC, and/or FEV1 , and/or performing a comparison of the user’s pulmonary function, TV, FVC, and/or FEV1 to known or historical values for the user and communicating same to a user, a third party computer, and/or a treatment provider, consistent with some embodiments of the present invention; and [00042] FIG. 13 is a flowchart showing a process for aggregating, categorizing, and/or analyzing pulmonary function, TV, FVC, FEV1 , and/or a comparison for a plurality of users and communicating same to a user, a third party computer, and/or a treatment provider, consistent with some embodiments of the present invention. [00043] Throughout the drawings, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components, or portions of the illustrated embodiments. Moreover, while the subject invention will now be described in detail with reference to the drawings, the description is done in connection with the illustrative embodiments. It is intended that changes and modifications can be made to the described embodiments without departing from the true scope and spirit of the subject invention as defined by the appended claims.

WRITTEN DESCRIPTION

[00044] Patients’ lack of access to information regarding their pulmonary function represents a significant problem on both an individual and a population level. At the individual level, at-home monitoring of single patients with respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), respiratory infections, lung cancer, and/or congestive heart failure (CHF), all which rapidly and critically affect pulmonary function and, on some occasions, may be instrumental in diagnosing the patient and/or predicting when a patient’s condition may worsen and/or when a patient may need an intervention (e.g., visit to the clinic or change in medication or treatment regimen) and/or experience a mortality event. At the population level, use of the present invention may allow for the gathering of pulmonary function data for a group of individuals, or population, that may allow for at home monitoring of the pulmonary function of individuals, communities, states, nations, and/or regions of the world (e.g., continents) as may be helpful when assessing the development of an epidemic or pandemic that is and/or is capable of spreading across the globe. In these settings, management of large scale pulmonary problems can often be paramount. This data, combined with data management algorithms may be used to, for example, map populations presenting a decline in pulmonary function, accurately project health system patient load and timing, and coordinate response planning for more efficient, and effective, public health crisis mitigation.

[00045] The present invention is related to using a system of a sound-producing breathing device and a holder that includes a microphone for detecting sound produced by the sound-producing breathing device. In some instances, the holder may physically couple to the sound-producing breathing device so that a distance between a sound-producing component (e.g., a reed and/or whistle opening) and the microphone of the holder is known and does not vary during the user’s use of the sound-producing breathing device. To use the system, the user breathes (e.g., inhales or exhales) through the sound-producing breathing device and the sound-producing breathing device produces a sound responsively to the air (i.e., user’s breath) flowing therethrough in a manner that may bear resemblance to a whistle, reed pipe, harmonica, and/or kazoo.

[00046] In some embodiments, the microphone resident within the holder is a wireless microphone that transmits a signal representing the sound detected by the microphone to a processor that may be resident in a computing device (e.g., smart phone, tablet computer, and/or laptop computer) and, in other embodiments, the microphone may be communicatively coupled to a transceiver that transmits the signal representing the sound detected by the microphone to the processor.

[00047] The signal received by the processor may be analyzed to determine, for example, the user’s pulmonary function, expiratory flow rate, expiratory volume, inhalation flow rate, inhalation volume, and/or general health. Additionally, or alternatively, the signal received by the processor may be analyzed to provide the user with feedback (e.g., exhale for a longer period or try to blow harder through the sound- producing breathing device) regarding breathing exercises he or she is performing using a system including the sound-producing breathing device and a holder for same. [00048] In some embodiments, the signals may be processed by a processor that is resident in a hand-held or mobile device (e.g., smart phone or tablet computer) that may, or may not, be present at the patient location when the signal is generated. Additionally, or alternatively, the signal may be transmitted to a processor that may be resident in and/or communicatively coupled to a cloud-based platform that processes the signal using, for example, machine learning data algorithms and/or artificial intelligence.

[00049] In some instances, the devices and systems disclosed herein may be used for performing breathing exercises to maintain or improve lung function, provide pulmonary monitoring, and/or determine a user’s pulmonary function. In many embodiments, the invention comprises a sound-producing breathing device of known configuration that, when inhaled and/or exhaled through, produces a sound of a known frequency or range of frequencies. The sound produced by the sound-producing breathing device is received and recorded by a microphone that is resident within a holder that is physically coupled to the sound-producing breathing device and communicated to a processor running a software program, or application that is configured to receive and analyze the recorded sound to for example, determine the user’s pulmonary function and/or state of health. The characteristics of the holder, microphone, and a distance between a sound-producing mechanism within the sound- producing breathing device and the microphone of the holder will be known prior to processing the signal that represents the sound made by the sound-producing breathing device that is communicated by the microphone to the processor.

[00050] In some embodiments, the invention may further include a back-end user-monitoring component that may, in some instances, be operated by, for example, a treatment provider (e.g., the user’s physician, nurse, and/or medical aide) and/or a third-party healthcare monitoring service that may be in communication with a user's treatment provider(s) and/or hospital but, may be a separate entity from the user's treatment provider(s) and/or hospital.

[00051] In some embodiments, the invention may further comprise a data machine learning algorithm which interprets the patient level data and analyzes it in relationship to population nomograms of pulmonary function. This may allow, for example, the algorithm to categorize data as being within the expected range for any specific patient or outside of this expected range.

[00052] In some embodiments, the invention may further comprise a data machine learning algorithm which interprets the patient level data and in a sequential fashion for patients with more than one reading, or measurement, recorded in the system. This may allow the algorithm to, for example, compare the newly received readings/measurements with historical readings/measurements and/or categorize the individual level data (e.g., one or more recently received readings/measurements) as being within the range of previously obtained data. In some instances, this may allow for the identification of any temporal change in individual pulmonary function (improvement or worsening) of a specific patient and/or the derivation/selection/preparation of a recommendation for the patient to use, for example, the breathing device and holder and/or systems as disclosed herein. [00053] In some embodiments, the invention may further share the results of the machine learning data analysis performed on the individual patient level with the patient themselves with or without recommendations derived from the algorithm. [00054] In some embodiments, results of the machine learning data analysis may be communicated to a treatment provider (e.g., the user’s physician, nurse, and/or medical aide) and/or a third-party healthcare monitoring service that may be in communication with a user's treatment provider(s) and/or hospital but may be a separate entity from the user's treatment provider(s) and/or hospital. Additionally, or alternatively, results of the machine learning data analysis may be communicated to a third-party public health agency or administration such as the Center for Disease Control (CDC), the U.S. Public Health Service Commissioned Corps (PHSCC), and state or local public heath offices. The parameters of this data sharing may be delivered based on, for example, privacy rules/regulations and/or preferences and/or pre-set filters for results delivery set by each individual recipient.

[00055] In some embodiments, the invention may further aggregate data obtained from a machine learning algorithm on individual patients and create population-level pulmonary function data. Additionally, or alternatively, the data may be categorized and/or evaluated according to one or more criteria including, but not limited to, whether the data indicates that pulmonary function is within an expected range for populations of known characteristics or geographic distribution.

[00056] In some embodiments, the invention may take created population level data and distribute this data to public health authorities charged with managing health resources in populations such as the Center for Disease Control (CDC), the U.S. Public Health Service Commissioned Corps (PHSCC), and state or local public heath offices.

[00057] At times, the present invention may be in communication with one or more measurement devices, including, but not limited to, a pulse oximeter, a thermometer, and/or a blood pressure monitor that may wirelessly transmit measurements (e.g., blood oxygen level, heart rate, blood pressure, body temperature, etc.), or other readings regarding various bodily functions to the processor for processing by the software application via a wireless communication protocol such as Bluetooth and/or Wi-Fi.

[00058] A purpose of the invention disclosed herein is to aid in maintaining or improving pulmonary function or function during an illness (e.g. a respiratory illness), during recovery from an illness, and/or following, for example, a treatment or surgery that that may be performed in a hospital or other medical facility. For instance, the invention disclosed herein may be employed to monitor a user for a defined period of time (e.g., 30 or 90 days), or perpetually, following, for example, a diagnosis (e.g., cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), pneumonia, asthma or other diseases of the lungs), recovery from a treatment, or discharge from the hospital following a treatment or surgery (e.g., thoracic surgery, cardiac surgery, joint replacement surgery, etc.). In some instances, the invention may be used to perform pulmonary monitoring which may act to reduce preventable hospital admissions or readmissions for users with compromised respiratory systems by monitoring their pulmonary function while they are discharged from the hospital to detect potential problems. In some instances, the invention may be used by healthy individuals and populations with normal pulmonary function but who may be at risk of pulmonary function deterioration due to, for example, a

[00059] In the previously mentioned case of an epidemic or pandemic, the invention disclosed herein may be used to maintain patients monitored in their own homes and community setting thereby preserving healthcare resources (e.g., clinics and hospitals) in situations where remote monitoring of patients is all that is needed (i.e., the patients do not need clinic or hospital-based care). Use of the invention in this way may, on the other hand, rapidly and reliably identify patients with a need to be treated for critical decline in pulmonary function in a clinic or hospital setting. This may assist with population management and the allocation of healthcare resources, which may be particularly helpful in times of stress (e.g., during an epidemic or pandemic) and may coincidentally decrease exposure to disease by way of limiting contagion because, for example, patients with a respiratory illness may be monitored at home without the need to travel to a clinic and potentially expose clinicians, caregivers, and transportation workers to the illness thereby reducing infection rates. [00060] In some instances, the invention disclosed herein may be used to monitor and/or calculate one or more aspects of the health or wellness (e.g., monitor pulmonary function) of a healthy person (e.g., an individual who has not undergone a surgery or other medical intervention) such as an athlete or musician for the exemplary purpose of increasing pulmonary function.

[00061] Another purpose of the invention is to reduce expenses related to medical care for users, healthcare providers, governmental agencies (e.g., Centers for Medicare and Medicaid Services (CMS)) and health insurance companies by, for example, facilitating early detection of lung conditions, other complications, and/or problems with a user’s health or treatment recovery via monitoring of pulmonary function.

[00062] FIG. 1 provides a block diagram of an exemplary system 100 that may be configured and/or used to implement one or more methods disclosed herein to, for example, conduct breathing exercises, improve user pulmonary function, determine user pulmonary function, determine a peak air flow rate, determine an air volume for the inhalation and/or exhalation of a user, and/or perform pulmonary monitoring of a user. System 100 may include a treatment provider computer system 105, a third- party computer system 110, a user data store 115, a communication network 120, a processing device 125, a caregiver device 130, a sound-producing breathing device 140, a holder 300, a third-party data store 155, and a cloud computing platform 160. In some embodiments, the invention may be embodied in a system that includes fewer components than system 100. For example, in some embodiments, system 100 may include only a processing device 125 and a sound-producing breathing device 140 and, in other embodiments, system 100 may include only a processing device 125, third-party computer system 110, and sound-producing breathing device 140.

[00063] In some instances, communication between two or more components of system 100 may be subject to one or more security protocols (e.g., encryption) to protect, for example, user-specific information and/or medically relevant information as may be required by, for example, HIPAA. Access to one or more components of system 100 may be limited by security protocols (e.g., passwords or identity verification protocols) designed to limit access to system 100 components to individuals who should access the component or components.

[00064] Treatment provider computer system 105 may be any computer system(s) associated with/operated by a treatment provider, including, but not limited to, physicians, surgeons, nurses, pharmacists, and administrative staff for a treatment provider as may be associated with, for example, a doctor’s office or hospital. Third- party computer system 110 may be any computer system operated by a third party (i.e., not the treatment provider or patient/user). Exemplary third parties include, but are not limited to, healthcare monitoring services. In some instances, treatment provider computer system 105, cloud computing platform 160, and third-party computer system 110 may be protected by a firewall and/or security protocols. On some occasions, third-party computer system 110 may be a public health reporting and/or computer system operated by, for example, a public health agency or administration such as the CDC, the PHSCC, and national, state, provincial, or local public heath offices.

[00065] Cloud computing platform 160 may be any platform that combines the processing power of one or more processors or computers to execute one or more methods disclosed herein. In some cases, cloud computing platform 160 may utilize artificial intelligence (Al), machine learning, and/or neural networks, to execute the steps of sophisticated algorithms using data it receives. In some embodiments, cloud computing platform 160 may be configured to perform one or more machine learning processes to analyze data received from one or more users of system 100, sound- producing breathing device 140, and/or holder 300 in order to, for example, perform pulmonary monitoring, and/or determine pulmonary function of one or more users through the use of, for example, tidal volumes, expiratory flow rates, and/or expiratory flow volumes. Cloud computing platform 160 may be coupled to, for example, processing device 125, third-party computer system 110, and/or treatment provider computer system 105 via, for example, communication network 120.

[00066] User data store 115 and/or third-party data store 155 may store information regarding users including, but not limited to, contact information, medical history of the user, pulmonary monitoring information, or pulmonary performance tests, any surgeries or medical procedures scheduled for the user, and previously determined pulmonary function, peak air flows, and/or states of health. Additionally, or alternatively, user data store 115 and/or third-party data store 155 may store data regarding one or more user care protocols recommended and/or required by, for example, a hospital and/or treatment provider. In some cases, user data store 115 and/or third-party data store 155 may store lung, and/or pulmonary, training instructions regarding how, when, and why to use system 100 or components thereof, goals for a user’s pulmonary performance, and so on. Some or all of the data stored on user data store 115 and/or third-party data store 155 may be communicated to and/or stored on processing device 125. Additionally, or alternatively, user data store 115 and/or third-party data store 155 may store data (e.g., an identifier, type, bar code number, or brand name) regarding a sound-producing breathing device 140 and/or holder 300 the user may be using.

[00067] Third-party computer system 110 may be a secure server, protected by one or more security protocols, to which only authorized individuals may have access privileges. Third-party computer system 110 may be configured to communicate with treatment provider computer system 105, cloud computing platform 160, third-party computer system 110, user data store 115, and/or third-party data store 155 to generate user care protocols, design pulmonary training regimes and/or testing specifications for one or more users according to, for example, one or more processes described herein.

[00068] Third-party computer system 110 may be configured to communicate, for example, a user care protocol, pulmonary training regimes, and/or pulmonary testing specifications to processing device 125 via communication network 120 and/or cloud computing platform 160 and may receive one or more measurements, readings, and/or responses from processing device 125. Communication network 120 may be any network configured to facilitate communication between the components of system 100, such as the Internet or a mobile communication network.

[00069] Processing device 125 may be any device configured to execute one or more processes (or portions thereof) disclosed herein and/or directly and/or indirectly communicate with third-party computer system 110 and the user of sound-producing breathing device 140 and/or a caregiver for the user of the sound-producing breathing device 140. Exemplary processing devices 125 include smart phones and tablet computers. In many instances, processing device 125 will have a software application stored thereon adapted to execute in part, or in whole, the processes explained herein. This software application may be downloaded from, for example, the third-party computer system 110 and/or a server external to system 100. In some instances, the software application may be downloaded from a software marketplace such as the APPSTORE offered by Apple or the GOOGLE PLAY store offered by Alphabet. In some instances, the software application may be a secure (e.g., protected by encryption) mobile application configured to run on processing device 125 and may feature modular elements that can be easily adapted for different use cases and presentation of different user interfaces to a user to facilitate, for example, the user’s use of system 100 and/or components thereof and understand testing or breathing exercise results.

[00070] In some embodiments, processing device 125 may be a device that was owned and/or operated by the user prior to receipt of user care protocol pulmonary training regimes, and/or pulmonary testing specifications from third-party computer system 110. This provides the advantage of a processing device 125 that the user has already purchased and is already familiar with using. In some instances, processing device 125 may include one or more measurement devices including, but not limited to, a microphone, a camera, a proximity sensor, an antenna, and/or a heart rate monitor.

[00071] In some instances, there may be two versions of the software/mobile application: one for the user (i.e., “the user version”) by which the user may enter measurements of biometric data, answer questions regarding his or her recovery, set targets or goals, and/or view statistics, clinical feedback, or instructions and one for a caregiver(s) to keep track of the user’s progress and needs and support or intervene as necessary. The software/mobile application may be a tool through which user data is collected and information is furnished to the user. The caregiver version of the application may be substantially similar to the user version of the software/mobile application; however, the caregiver may not be enabled to enter or access user data via the caregiver version of the application. Instead, the caregiver version of the application may provide an indication to the caregiver that the user has correctly entered the required data. In most cases, no user medical information is visible to the caregiver via the caregiver version of the application so as to, for example, protect the user’s privacy.

[00072] In some embodiments, the present invention may further include a secure web application user-monitoring portal to which the readings received by the mobile application are transmitted via, for example, password-protected or otherwise encrypted protocols. Users of the web application may include, but are not limited to, users, caregivers, physicians, and other clinical staff and medical professionals who may be responsible for and/or interested in viewing, monitoring, editing and/or otherwise managing the user’s care protocol. Access to the web application and/or features of the web application that a viewer may modify may be dependent on the viewer’s relationship to the user or patient. For example, a viewer may not be able to modify a user care plan via the web application, but may be able to view all of the information entered into the web application and a caregiver (e.g., friend or spouse of the user or a patient who is a user) may only be able to access information regarding whether or not the breathing exercises were completed by the user in a timely manner and may have no further access to medically-sensitive or personally-identifying information.

[00073] These users may access the web application via, for example, third- party computer system 110. In some instances, the web application may further generate reports for users and/or clinicians, and/or caregivers using the data recorded (e.g., user frequency of usage, pulmonary function volume measurements, changes in pulmonary function, etc.). In some instances, the data collected may be used by the third party operating third-party computer system 110 to, for example, flag users when concerning measurements, determinations, and/or trends are observed so that they may, for example, establish communication with a user to, for example, assess the user’s health and/or notify a treatment provider. In some instances, the collected data may be used by clinical staff to assist doctors and/or hospitals identify which users are in the greatest need of attention before, for example, reaching a physical state that requires a hospital admission or other medical intervention.

[00074] Sound-producing breathing device 140 may be any device through which a user may breathe via his or her mouth, nose, or both and that produces a sound responsively to the air flow of the user’s inhalation and/or exhalation such as a whistle, a reed, or a pipe. In some embodiments, the sound-producing breathing device 140 may be a nose piece or a mask covering the nose and/or nose and mouth designed to encourage the user to breathe (e.g., inhale or exhale) using his or her nose rather than his or her mouth. In other embodiments, sound-producing breathing device 140 may be a mouthpiece adapted for insertion into the user’s mouth so that the user may breathe (e.g., inhale or exhale) using his or her mouth rather than his or her nose. An example of this embodiment of a sound-producing breathing device 140 is shown in FIGs. 2A-2C, 4A, 4B, and 7 and discussed below.

[00075] In some instances, sound-producing breathing device 140 may be adapted/configured so that a first tone/sound, or set of tones/sounds, may be specific to inhaling air through the sound-producing breathing device 140 and a second tone/sound, or set of tones/sounds, may be specific to exhaling through sound- producing breathing device 140 so that tones/sounds, or set of tones/sounds made by inhaling may be distinguishable from tones/sounds, or set of tones/sounds made by exhaling. In some instances, sound-producing breathing device 140 may create a sound due to turbulent airflow produced by a pressure differential near a sound- producing mechanism (e.g., a reed or whistle-like opening) present in sound- producing breathing device 140.

[00076] Sound-producing breathing device 140 may be made from any appropriate material (e.g., plastic, metal, wood, and combinations thereof), may configured in any number of shapes and/or sizes, and may produce sound in one or a range of differing frequencies and/or intensities. In some instances, a sound- producing breathing device 140 may be configured to generate a first tone or range of tones when the user is inhaling and a second tone or range of tones when the user is exhaling. Additionally, or alternatively, a first sound-producing breathing device 140 may be configured so that it is harder to breathe through than a second sound- producing breathing device 140 so that, for example, the user may increase, or decrease, the amount of resistance they encounter when inhaling or exhaling while doing a breathing exercise and/or test.

[00077] One exemplary sound-producing breathing device 140 is shown in FIGs. 2A-2C, where FIG. 2A provides a front perspective view of an exemplary sound- producing breathing device 140 laying on its side, FIG. 2B provides a top perspective view of the exemplary sound-producing breathing device 140 when standing upright on an end, and FIG. 2C provides a cross-sectional view of the exemplary sound- producing breathing device 140 shown in FIGs. 2A and 2B. The exemplary sound- producing breathing device 140 of FIGs. 2A-2C includes a first end 205, a first orifice 210, a second end 215, a housing for a sound-producing mechanism 220, a second orifice 225, a tunnel 230, a sound-producing mechanism 235, and an optional microphone. First end 205 is configured to face away from a user and towards a microphone of a holder holding sound-producing breathing device 140 when in use. Second end 215 is configured to abut and/or be inserted into a mouth of the user so that the user may inhale air into first orifice 210, through tunnel 230, and into the user’s mouth through second orifice 225 and/or so that the user may exhale air into first orifice 210, when it is blown through tunnel 230, and out through the second orifice 225. [00078] Housing 220 is positioned on sound-producing breathing device 140 between first and second ends 205 and 215, respectively. In some embodiments, sound-producing mechanism 235 may be positioned within housing 220 proximate to tunnel 230 so that when air travels between the first and second orifices 210 and 225, respectively, the air flow contacts sound-producing mechanism 235, which produces a corresponding sound. Additionally, or alternatively, air may be pulled through an orifice in housing 220 and past sound-producing mechanism 235 thereby creating a sound. Air may be pulled through sound-producing mechanism 235 via, for example, an air pressure difference in tunnel 230 facilitated by the construction of sound- producing breathing device 140. Exemplary sound-producing mechanisms include, but are not limited to, reeds, paper, whistles, and the like.

[00079] In some embodiments, sound-producing breathing device 140 may produce sound of different frequencies depending on a flow rate of air through the sound-producing breathing device. For example, a sound-producing breathing device 140 may be configured to produce sound that increases in frequency proportionally or disproportionally to an increase in a flow rate of air through the sound-producing breathing device.

[00080] In some embodiments, the sound-producing mechanism may be configured to produce sound of a first known frequency, or first set of known frequencies, when in contact with air inhaled through first/second orifice 210/225 and produce sound of a second known frequency, or a second set of known frequencies, when in contact with air exhaled through first/second orifice 210/225.

[00081] In many cases, the dimensions and features of the sound-producing breathing device 140 and/or sound-producing mechanism 235 are consistent across units so that each one has the same proportions and dimensions and/or sound- producing mechanisms produce sound of a known. This enables the software/mobile application operating on the processor to receive and analyze sound made by sound- producing breathing device 140 when the user inhales or exhales such that the only variable in the system is the volume of air the user inhales or exhales over time. [00082] Exemplary sound-producing breathing device 140 may be made of metal, plastic, or any other appropriate material (e.g., a composite or a combination of different materials). In some cases, a sound-producing breathing device 140 may also have a handle and/or an adapter or attachment for coupling to the processing device (e.g., a port on the processing device such as a microphone jack). [00083] The present invention may be used/practiced by, for example, users diagnosed with respiratory or pulmonary medical conditions and/or are recovering from a treatment and/or surgery that may impact their capacity to breath to, for example, track the user’s pulmonary health or medical condition, pulmonary function, blood oxygen levels, and/or overall health. In some situations, the present invention may be used by users who, for a variety of reasons, are bed-ridden to diagnose pneumonia or other respiratory conditions at an early stage so that they may be treated with minimum intervention and discomfort to the user.

[00084] In some cases, the present invention may be used to provide feedback to a user who is performing breathing exercises or is otherwise attempting to improve his or her breathing capacity. Exemplary uses for the present invention in non-medical contexts include those wishing to improve their breathing capacity such as swimmers, free divers, or athletes and/or those wishing to improve the evenness with which they inhale or exhale as may be useful to musicians who play, for example, wind instruments, or vocalists.

[00085] In many instances, the user will use his or her own processing device 125. This facilitates both ease of use (because the user is already familiar with how to use his or her device) and cost efficiency because the purchasing of a recording device or device that can provide access to a user account device is unnecessary. [00086] FIGs. 3A-3F are side views of exemplary systems that include a sound- producing breathing device 140A and a holder 300A-300F, respectively. Each of holders 300A-300F includes a body 305 configured to house, for example, a power source 335, a microphone 310, and/or a transceiver 315. In some embodiments, the microphone 310 and transceiver 315 are combined into a wireless microphone powered by power source 335. When a holder only includes a microphone 310 and transceiver 315, transceiver 315 may transmit an analog sound/audio file as received by microphone 310 and, on some occasions, may act as a transceiver only. In some embodiments, transceiver 315 may be configured to receive one or more instructions and/or sets of instructions regarding the operation of one or more components of holder(s) 300A-300F.

[00087] Optionally, a holder 300A-300F may include a processor or CPU 340 that may be configured to, for example, convert an analog audio signal received from microphone 310 into a digital signal that may be transmitted to an external processor like processing device 125, third-party computer system 110, cloud computing platform 160, and/or treatment provider computer system 105. Additionally, or alternatively, processor 340 may be configured to pre-process the digital and/or analog audio recording to, for example, compress the audio file and/or apply a noise cancellation algorithm thereto. Application of the noise cancellation algorithm to the audio file may include application of information received by noise-cancelling mechanism 320 as explained below. Exemplary processors 340 include, but are not limited to a central processing units (CPU), application specific integrated circuits (ASIC), and/or controllers. One or more components of a holder may be communicatively and/or electronically coupled together via a wired and/or wireless coupling. For example, microphone 310, transceiver 315, noise-cancelling mechanism 320, and/or processor 340 may be electrically coupled to power source 335. Power source 335 may be, for example, a battery, which may be rechargeable via, for example, a port and/or induction charging, and/or a port by which to electrically couple holder 300 to an electrical main power outlet.

[00088] Microphone 310 may be configured to receive and/or detect sound made by sound-producing breathing device 140A, convert the received/detected sound into a digital signal, and communicate same to transceiver 315 via, for example, a wired and/or wireless communicative coupling. Additionally, or alternatively, the analog audio signal received by microphone 310 may be converted into a digital signal by processor 340 and communicated to transceiver 315. Transceiver 315 may be configured to transmit the digital signal that includes information about and/or represents the sound received/detected by microphone 310 to an external receiving and/or processing device like processing device 125 using, for example, a near-field wireless communication protocol and/or cloud computing platform 160, third-party computer system 110, cloud computing platform 160, and/or treatment provider computer system 105 via a communication network like communication network 120. For example, microphone 310 may capture sound made by the user when he or she is using the sound-producing breathing device 140A and convert that sound into a digital signal that represents the received sound. This digital signal may be communicated to transceiver 315 which may then communicate the digital signal to an external receiving device like processing device 125.

[00089] In some embodiments, a holder 300A, 300B, 300C, 300D, 300E, and/or 300F may be associated with an identifier that may, for example, identify the type of holder 300 being used (e.g., 305A, 305B, 305C, 305D, 305E, or 305F, respectively), a feature of holder 300A-300F (e.g., a distance “r” between a sound-producing device of the sound-producing breathing device and microphone 310, wherein the “r” is shown as rA, rB, rC, rD, rE, and rF in FIGs. 3A, 3B, 3C, 3D, 3E, and 3F, respectively), whether holder 300A-300F includes any sound dampening properties or mechanisms (such as the presence of sound-dampening material), a body type or shape, and/or whether the system includes any noise cancelling mechanisms), a user of the holder 300A, 300B, 300C, 300D, 300E, and/or 300F, and/or a protocol the user is following when using a sound-producing breathing device 140A and holder 300A, 300B, 300C, 300D, 300E, and/or 300F system. This identifier may be part of the signal that includes information about the sound received/detected by microphone 310 that is transmitted by transceiver 315.

[00090] In some embodiments, a holder 300A, 300B, 300C, 300D, 300E, and/or 300F may include an optional noise-cancelling mechanism 320, such as an ambient noise microphone, configured to capture and/or detect sound, or noise, that is in the ambient atmosphere. This ambient noise may be converted into a digital ambient noise signal that is communicated to transceiver 315. Transceiver 315 may then communicate the digital ambient noise signal to the receiving device (e.g., processing device 125) so that a noise-cancelling mechanism (e.g., noise-cancelling algorithm) may be applied to the digital signal that represents the sound a user makes when inhaling or exhaling through sound-producing breathing device. Additionally, or alternatively, a digital ambient noise signal may be applied to the digital signal that represents the sound a user makes when inhaling or exhaling through sound- producing breathing device by processor 340. Additionally, or alternatively, processor 340 may be configured to compress, or otherwise reduce, the size of an audio file representing the digital signal that corresponding to the sound a user makes when inhaling or exhaling through sound-producing breathing device by, for example, application of a compression algorithm and/or a noise-cancelling algorithm.

[00091] Flolder 300A, 300B, 300C, 300D, 300E, and/or 300F may be configured to maintain a constant distance between the sound-producing breathing device 140A and the microphone 310 so that a distance “r” may be known and constant throughout the microphone’s 310 receipt of the sound from the sound-producing breathing device 140A. In some instances, the distance “r” established between the sound-producing end of the sound-producing breathing device 140A and the microphone may be responsive to the inverse square rule. Optionally, the holder 300A, 300B, 300C, 300D, 300E, and/or 300F may include a microphone 310 and/or transceiver 315 with known characteristics, which may be used by the receiving device to process the received signal according to, for example, one or more processes disclosed herein.

[00092] Holder body 305 may attach to sound-producing breathing device 140A via for example, a gravitational (e.g., sound-producing breathing device 140A may fit into an exemplary holder 300A, 300B, 300C, 300D, 300E, and/or 300F and be held in place by gravity), mechanical (e.g., a clip, a tongue and groove fitting, and/or a strap), and/or magnetic coupling.

[00093] Although microphone 310, transceiver 315, processor 340, and power source 335 are shown in FIGs. 3A-3F to be present in two different locations within the exemplary holder’s bodies 305A-305F, this need not always be the case. In some instances, one or more of these components may be part of the same unit, positioned proximate to one another (e.g., superimposed upon one another) or the transceiver may be located on the outside of the holder body 305.

[00094] In some embodiments, holder 300A, 300B, 300C, 300D, 300E, and/or 300F may include a noise cancelling mechanism 320 configured to detect ambient sound that may be transmitted by transceiver 315 to, for example, processing device 125 so that the ambient noise may be filtered, or otherwise cancelled, from the signal representing the sound detected by microphone 310.

[00095] Optionally, holder 300A, 300B, 300C, 300D, 300E, and/or 300F may also include a memory resident in and/or communicatively coupled to microphone 310, processor 340, and/or transceiver 315. The memory may be configured to, for example, store sound captured by microphone 310, a digitized audio file generated by processor 340, instructions for the operation of one or more components (e.g., processor 340) of holder 300A, 300B, 300C, 300D, 300E, and/or 300F, an identifier for the holder and/or sound-producing breathing device 140A and holder 300A, 300B, 300C, 300D, 300E, and/or 300F system, and/or a transmission history for transceiver 315.

[00096] Turning now to a more specific discussion of holders 300A, 300B, 300C, 300D, 300E, and/or 300F shown in FIGs. 3A-3F, respectively, holder 300A of FIG. 3A has a body 305A that is shaped substantially like an “L” that is oriented on its side with a horizontal portion that is coupled to the sound-producing breathing device 140A via a first vertically-oriented extension as shown on the left-side of the horizontal portion. A second vertically-oriented extension of body 305A extends from the horizontal portion and supports, or houses, microphone 310. The shape and size of holder body 305A allows for air to flow into and/or out of sound-producing breathing device 140A. [00097] Holder 300B of FIG. 3B has a body 305B that is shaped substantially like holder body 305B with a vertically-oriented extension positioned on the right side (as shown) of the holder body 305B that extends from the horizontal portion and supports, or houses, microphone 310. Unlike holder body 305, the horizontal portion of holder body 305B includes a support tray 325 in which the sound-producing breathing device 140A rests and/or is coupled to.

[00098] Holder 300C of FIG. 3C has a body 305C that is shaped like a cone or trapezoid that fits onto an end of sound-producing breathing device 140A and covers the end of sound-producing breathing device 140A.

[00099] Holder 300D of FIG. 3D has a body 305D that is shaped like a cone or trapezoid and is similar to holder 300C except that holder 300D fits over and couples to sound-producing breathing device 140A at the approximate vertical center point of sound-producing breathing device 140A. Holder body 305D covers the end of sound- producing breathing device 140A.

[000100] Holder 300E of FIG 3E has a body 305E that fits onto an end of sound- producing breathing device 140A. Body 305E includes two arms that are positioned at an angle (e.g., 10-40 degrees) from the end of sound-producing breathing device 140A. Each arm has a vertical extension that houses a microphone 310.

[000101] Holder 300F of FIG 3F has a body 305F that fits onto an approximate middle of sound-producing breathing device 140A. Body 305F includes two arms that are positioned at an angle (e.g., 10-40 degrees) from the end of sound-producing breathing device 140A. Each arm has a vertical extension that houses a microphone 310.

[000102] In some embodiments, microphone 310, transceiver 315, and/or noise cancelling mechanism 320 may be positioned within and/or on an outside surface of out a housing for sound-producing breathing device 140A, which is shown as microphone and/or transceiver 240 in FIGs. 2A and 2B.

[000103] FIG. 4A is a diagram providing a longitudinal cross-section of an exemplary sound-producing breathing device 140A that, by way of example and not limitation, is similar to the sound-producing breathing device 140A shown in FIGs. 2A- 2C, that is attached to a holder 300AA that sets a fixed distance, or “r” between the sound-producing portion of sound-producing breathing device 140A (in this case, the sound-producing mechanism 235) and microphone 310 that is resident in holder 300AA that, by way of example and not limitation, is similar to holder 300A.

[000104] The sound-producing breathing device 140A of FIG. 4A is shaped with a form factor similar to a kazoo where the user inhales through the larger end causing a pressure drop as the air travels from the narrow opening into a larger space below the reed, creating a low-pressure zone and turbulent airflow across the reed. More specifically, FIG. 4A shows how air may flow through tunnel 230 to produce or propagate sound that may be recorded by processing device 125. In the diagram of FIG. 4A, second end 215 of sound-producing breathing device 140A is inserted into a user’s mouth 410 (shown as an approximation) and the user is inhaling air through first end 205 into his or her mouth 410. The air flow created by the user’s inhalation is shown in the diagram as solid lines with an arrow showing the direction of air flow. As air enters tunnel 230 through first end 205, it is of a first pressure Pi and as the diameter of tunnel 230 increases along its length, the inhaled air is of a second pressure P2. The configuration of sound-producing breathing device 140A is such second pressure P2 is lower than first pressure Pi (i.e., Pi > P2) and this drop in pressure acts to draw air into an opening in housing 220 and through sound-producing mechanism 235 into tunnel 230 and produce or propagate sound, shown in FIG. 4 as dashed lines 405. The sound propagates from sound-producing mechanism 235 in all directions and some of the sound is recorded by processing device 125.

[000105] A distance r4A between microphone 310 resident of holder 300AA and sound-producing mechanism 235 may be known and may be used to determine an air flow rate though the sound-producing breathing device 140A and approximate pulmonary function as discussed in further detail below with regard to FIGs. 5, 6, 7A- 7C, and 8A-8C.

[000106] FIG. 4B is a diagram providing a longitudinal cross-section of another exemplary sound-producing breathing device 140B that is similar to a whistle a user blows air through. The sound-producing breathing device 140B of FIG. 4B is attached to a holder 300BB that sets a fixed distance, or “r4B,” between the sound-producing portion of sound-producing breathing device 140B (in this case, an opening in the sound-producing breathing device 140B that includes an edge configured to create sound when air passes over it) and microphone 310 that is resident in holder 300BB that, by way of example and not limitation, is similar to holder 300AA. [000107] FIG. 5 is a flowchart illustrating an exemplary process 500 for generating and/or updating of breathing exercise protocol for a user. Process 500 may be executed by a system like system 100, a sound-producing breathing device and holder combination like one or more of the sound-producing breathing device 140 (for the sake of brevity, sound-producing breathing devices 140, 140A, and/or 140B may be collectively referred to herein as “sound-producing breathing device 140”) and holder 300 (for the sake of brevity, holder(s) 300, 300A, 300B, 300C, 300D, 300E, 300F, 300AA, and/or 300BB may be collectively referred to herein as “holder 300”) combinations disclosed herein, and/or a component or a combination of components thereof. In some embodiments, process 500, or portions thereof, may be executed by a third-party service (i.e., not the user or user’s physician) who monitors the user’s lung/pulmonary health. This third-party service may provide monitoring information to, for example, a treatment provider and/or caregiver of the user on, for example, a continuous, as-needed/requested, and/or periodic basis via, for example, communication by third-party computer system 110 and/or third party data store 155 with treatment provider computer system 105.

[000108] Initially, a user account may be created (step 505). The user account may be created using, for example, treatment provider computer system 105, third- party computer system 110, cloud computing platform 160, and/or processing device 125. The user account may be embodied as a software application running on the processing device and often times, the user will interact with his or her user account via processing device 125.

[000109] The user account may be created at the request of, for example, the user and/or a physician or other treatment provider. In many cases, the user account and/or information associated therewith may be resident on and/or accessible by the processing device 125, treatment provider computer system 105, and/or third-party computer system 110. In some instances, information regarding the user (e.g., demographic information, information from an electronic medical record of the user (e.g., treatment information, diagnosis information, etc.)) may be associated with the user account (e.g., downloaded to processing device 125) via, for example, computer software and/or a website provided by, for example, the treatment provider and/or a third party operating third-party computer system 110. The created user account may be linked to and/or accessible by the processing device 125, the treatment provider computer system 105, and/or third-party computer system 110. [000110] In step 510, instructions regarding a breathing exercise protocol and/or user goals regarding performance of the breathing exercises and/or breathing tests, and/or results thereof (e.g., breathing and/or pulmonary function targets) may be received. The instructions may pertain to, for example, how the user is to use a sound- producing breathing device to perform breathing exercises, a frequency of use, a duration of use, target volumes/intensities for produced sound, target durations for producing sound, features of a sound-producing breathing device 140 (e.g., dimensions, brand name, type, etc.) to be used by the user. Optionally, updates to user instructions and/or goals may also be received in step 510 following an affirmative decision at step 555 as will be discussed in greater detail below.

[000111] In some instances, the received instructions may relate to treatment provider and/or treatment facility preferences (e.g., scheduling of breathing exercises, target durations and/or volumes/intensities of sound produced when using a sound- producing breathing device 140, etc.) that may be consistent with a standard of care for a particular user or diagnosis associated with the user. These may be associated with the user account via active selection and/or by default.

[000112] Additionally, or alternatively, the received instructions may relate to user information (e.g., diagnosis, expected recovery times, age, etc.) and/or preferences (e.g., scheduling, reminder, and/or interface preferences).

[000113] Additionally, or alternatively, the received instructions may relate to equipment parameters of the sound-producing breathing device (e.g., type, manufacturer, size, frequency range, volume or intensity range, etc.) and/or user device (e.g., type, brand, version, operating system, microphone capability, screen size, screen capability, etc.).

[0100] In step 515, a routine for a breathing exercise protocol and/or breathing test may be generated responsively to the instructions received in step 510, information associated with the user account, and/or default information (e.g., general instructions for use of a sound-producing breathing device or performance of breathing exercises). [0101] In some embodiments, generation of the routine in step 515 may include, but is not limited to, determining a schedule for when the user should engage in breathing exercises and/or tests, determining one or more parameters for the breathing exercises and/or tests, specifying parameters (e.g., target breathing duration, target sound intensities, number of repetitions of the breathing exercise to perform, etc.) of the breathing exercises and/or tests, and/or analysis of tones/sound received from the sound-producing breathing device according to features and/or attributes of the sound-producing breathing device.

[0102] Often times, execution step 515 may also include receiving information regarding features of the sound-producing breathing device 140 and/or processing device 125 being used by the user. The protocol may be adapted, or otherwise adjusted, to for example, optimize the protocol for different configurations of, for example, sound-producing breathing devices and/or user devices, a distance between a particular sound-producing breathing device and a particular user device, and/or treatment provider and/or user information/preferences as may be received in steps 505 and/or 510.

[0103] In step 520, an indication of an activation of the user account may be received. In some instances, the indication may be the user signing into his or her user account and/or opening or activating a software application associated with the user account on the processing device 125 that may be running on, for example, the user’s electronic device.

[0104] In step 525, instructions for conducting the breathing exercise routine and/or test may be provided to the user via his or her processing device. In many instances, the instructions will include directions for how to use the sound-producing breathing device and where to position the sound-producing breathing device relative to the processing device. In one example, these instructions may include provision of a target range for sound intensity on a user interface of the processing device that may be used in conjunction with a camera on the processing device such that the target is superimposed upon a video of the user when using the sound-producing breathing device and the processing device. The target may inform the user where to position the processing device relative to the sound-producing breathing device. Exemplary user interfaces that show target ranges for sound intensity produced by a user are provided by user interfaces 1001-1004 of FIGs. 10A-10D.

[0105] In some embodiments, the instructions provided in step 525 may include an instruction to sit down in a chair with good posture (e.g., sit up as straight as possible), place the sound-producing breathing device 140 in his or her mouth, over his or her nose, or both (nose and mouth) and, in some cases, form a seal between sound- producing breathing device 140 and the user’s skin and/or lips. The user may be instructed to open the software/mobile application running/stored on his or her processing device, such as processing device 125 and position the open end of the sound-producing breathing device toward the processing device. The user may then be instructed to breathe (i.e., inhale and/or exhale) as slowly and deeply as possible so that the sound-producing breathing device begins, and continues to, make a sound. [0106] On some occasions, execution of step 525 may include provision of a user interface to a processing device that may provide, for example, a visual display of a preferred, or target, range for an inhaled and/or exhaled air volume, a flow rate for inhaled and/or exhaled air, a volume or intensity of sound produced by a sound- producing breathing device, a duration of sound production, and/or a type of sound (e.g., frequency or range of frequencies) to make using the sound-producing breathing device. This user interface may also provide an indicator (e.g., a graph or number) showing where the user’s inhalation/exhalation falls within the respective preferred or target range. In some instances, the user interface may further provide a goal for users regarding performing breathing exercises and a frequency (e.g., 2 times a day, 4 days a week, etc.) for doing so. Exemplary user interfaces are shown in FIGs. 10A- 10E, which are discussed below.

[0107] In some instances, execution of step 525 may include instructing the user on how to use the sound-producing breathing device and/or perform breathing exercises safely. In some cases, the instructions may tell the user to cough two or three times and/or blow his or her nose to clear secretions or congestion prior to beginning a breathing exercise or test and/or repeating them. Users who have an incision (e.g., post-surgery incision) may be directed to support their incision while coughing by, for example, placing a cushion (e.g., pillow or foam pad) firmly against it while using the sound-producing breathing device and/or performing breathing exercises.

[0108] Optionally, in step 530, it may be determined whether there are any error conditions present for the sound-producing device and/or receipt of a recording of same and, if so, an error mitigation may be executed and/or instruction for the execution of an error mitigation may be provided (step 540). In some embodiments, execution of step 530 may include determining whether the user is using the correct and/or a properly functioning sound-producing breathing device. For example, step 530 may be executed by, for example, the user inputting (e.g., typing, scanning, and/or taking a picture) an identifier (e.g., bar code, QR code, or alpha-numeric code) for the sound-producing breathing device he or she intends to use into the processing device and/or performing a sound check using the sound-producing breathing device. If the user is not using the correct sound-producing breathing device, then an instruction to recalibrate and/or replace the sound-producing breathing device may be provided to the user in step 540.

[0109] Additionally, or alternatively, execution of step 530 may include receiving an initially created sound from a sound-producing device that is coupled to a holder like holder 300, 300A, 300B, 300C, 300D, 300E, and/or 300F, determining whether the sound was received from a component of the holder and/or processing device (e.g., a microphone), and providing an indication (e.g., a tone or a change in status for a light (e.g., turning on or off) and/or a message) to the user that the sound was received and/or a status (e.g., sufficiently loud or clear) of the received sound.

[0110] Additionally, or alternatively, on some occasions, execution of step 530 may include determining whether ambient noise (as may be detected by, for example, a noise-cancelling mechanism 320 and/or a microphone present on an electronic device) may adversely interfere with the recording of a sound produced by sound- producing device. When the ambient noise is too loud, an indication of an error condition (e.g., a tone, a change in status for a light (e.g., turning on or off), and/or an error message provided by the electronic device) may be provided (step 540)to the user until, for example, the situation is resolved and the ambient noise is reduced to below a threshold level.

[0111] When execution of step 530 indicates, for example, the correct sound- producing breathing device is not being used, the ambient noise level is too high, and/or when the sound-producing breathing device is malfunctioning (e.g., out of tune (i.e., producing undesired or unrecognized frequencies)), then it may be further determined whether the breathing device needs to be replaced and/or recalibrated and/or the user needs to change locations to an area with lower ambient noise. If so, then the routine may be changed to, for example, accommodate the different sound- producing breathing device and/or instructions may be provided to the user regarding, for example, how to recalibrate the sound-producing breathing device to the user, adjust the routine, and/or replacement of the sound-producing breathing device (step 540).

[0112] In some instances, an error condition may be mitigated by the subsequent analysis of the sound produced by the sound-producing breathing device. For example, an error mitigation may include, but is not limited to, adjusting to how pulmonary function determinations are made using a received sound emanating from the sound-producing breathing device when the user inhales and/or exhales through the sound-producing breathing device. For example, if a breathing device is out of tune, the error mitigation of step 540 may include updating how pulmonary function determinations are made using the frequencies the sound-producing breathing device is using. Additionally, or alternatively, when ambient noise is present, error mitigation may include application of a noise-cancelling algorithm or process to a recording of sound produced by a sound-producing breathing device.

[0113] Following step 540, step 530 may be repeated to determine if there are any more error conditions present and, if so, step 540 may be repeated. When there are no error conditions present (step 530), in some embodiments, the user may be instructed to begin use of the sound-producing breathing device to, for example, perform a breathing assessment and/or breathing exercises (step 545) and/or the user may simply begin performance of a breathing assessment and/or breathing exercises without a prompt.

[0114]Then, in step of 550, a sound produced by the user when using the sound- producing breathing device may be received, recorded, and/or analyzed by, for example, the processing device and/or a remote processor (e.g., third-party computer system 110, cloud computing platform 160, and/or treatment provider computer system 105). In some instances, the receiving and recording of the sound produced by the user may be performed by the processing device, a recording of the sound may be communicated to the remote processor, and some, or all of the analysis of step 550 may be executed by the remote processor. The receiving and recording of the sound is commonly executed by a microphone (like microphone 310) included in a holder 300. The analysis may be done by the processing device and/or an external computer such as third-party computer system 110, cloud computing platform 160, and/or treatment provider computer system 105. The received/recorded sound may be analyzed to determine, for example, volume/intensity, duration, changes in tone, changes in volume/intensity, pulmonary function, volume of air inhaled, volume of air exhaled, lung volume, blood oxygen level, and so on. In some instances, warbling or variations in the tone of the sound made by the user when using the sound-producing breathing device may be used to assess for example, user health and/or pulmonary function.

[0115] In some embodiments, performing the analysis of step 550 may include calculating one or more factors relating to how the sound is received by a microphone that may be present in, for example, a holder like holder 300 and/or a the processing device. For example, when the distance to the processing device is not known, or fixed (e.g., changes over the course of receiving the sound from the sound-producing breathing device as may be measured by, for example an infrared sensor or camera included in the processing device), the distance of the sound-producing breathing device from the processing device, measurement device, and/or microphone therein may be calculated using, for example, a flow rate of the sound and a volume/intensity, or decibel level, of the sound at the flow rate. In some embodiments, the processing device may include a camera and the user may be imaged and/or videotaped while performing the breathing exercises and/or tests. The images and/or video tape of the user may then be analyzed to determine if the user is moving when producing the sound and a determination regarding how that movement may impact features of the recorded sound.

[0116] Additionally, or alternatively, performing the analysis of step 550 may include processing the sound recording to isolate frequencies of interest or otherwise remove ambient noise not being made by the sound-producing breathing device. This processing may include, but is not limited to, application of a filter to the sound recording to remove ambient noise, amplifying desired frequencies of the sound recording, using a lock-in amplifier and/or a band-pass filter to isolate desired frequencies of the sound recording, and so on.

[0117] Further details regarding the execution of step 550 are provided below with regard to process 600 shown in FIG. 6.

[0118] Then, in step 555, it may be determined whether the protocol, user goals, equipment (e.g., sound-producing breathing device and/or holder), and/or instructions may need to be updated responsively to, for example, the received, recorded and/or analyzed sound. If so, step 510 may be repeated and instructions to update the equipment, protocols, goals, and/or user instructions may be received. If not, process 500 may end.

[0119] FIG. 6 is a flowchart depicting a process 600 for determining the pulmonary function of a user, a peak air flow rate and volumes of inhalation and/or exhalation of a user, and/or a user’s state of health. Process 600 may be executed by a system like system 100 and/or a component or combination of components thereof. In some embodiments, process 600, or portions thereof, may be executed by a third-party service (i.e., not the user or user’s physician) who monitors the user’s lung/pulmonary health. This third-party service may provide monitoring information to, for example, a treatment provider and/or caregiver of the user on, for example, a continuous, as- needed/requested, and/or periodic basis via, for example, communication by third- party computer system 110, cloud computing platform 160, and/or third party data store 155 with treatment provider computer system 105.

[0120] Initially, in step 605, a digital signal representing sound generated by a user’s use of (e.g., inhaling or exhaling through) a sound-producing breathing device like sound-producing breathing device 140 over time may be received by a processor, like processing device 125. Additionally, information regarding a holder like holder 300 the user is using when breathing through the sound-producing breathing device may also be received by the processor in step 605. The digital signal and/or information about the holder may be received from a transceiver like transceiver 315. The information about the holder may, for example, provide information regarding the type of holder being used, a distance between a sound-producing mechanism of sound- producing breathing device and a microphone of the holder, whether the holder uses any noise cancelling or sound dampening mechanisms (such as sound-dampening material 325), and/or an identifier of the user of the holder/ sound-producing breathing device. In some embodiments, the information about the holder may include and/or may be conveyed by an identifier of the holder that is transmitted by the transceiver along with the digital signal.

[0121] In some cases, step 605 may be executed when the sound the user makes when using the sound-producing breathing device may be initially received and/or recorded by a microphone like microphone 310, communicated to transceiver 315, and transmitted by transceiver 315 to the processing device 125.

[0122] Optionally, in step 607, the digital signal may be processed in order to, for example, make the signal easier to analyze and/or use in the processes described herein. In some embodiments, the processing of step 607 may include noise cancelling using, for example, ambient noise information detected by noise-cancelling mechanism 320. Additionally, or alternatively, the digital signal may be processed in order to, for example, remove noise (e.g., sound from the signal that are not within the frequency range produced by the sound-producing breathing device) and/or amplify portions of the signal.

[0123] Optionally, in step 610, a duration of the sound recording may be determined by, for example, measuring a duration of the recording and/or how long the sound is of a particular frequency, volume, and/or intensity is present within the recording. [0124] In step 615, the sound recording may be analyzed using the holder information, and in particular using the distance between the sound-producing mechanism of the sound-producing breathing device and the microphone of the holder (i.e., “r”) to determine a pulmonary function of the user over, for example, the duration of the recording or portions thereof.

[0125] Optionally, in some embodiments, the user’s peak airflow rate during the sound recording for an inhalation and/or exhalation may be determined (step 620). In some embodiments, execution of step(s) 615 and/or 620 may include processing the sound recording to isolate frequencies of interest or otherwise remove ambient noise not being made by the sound-producing breathing device. This processing may include, but is not limited to, application of a filter to the sound recording to remove ambient noise, amplifying desired frequencies of the sound recording, using a lock-in amplifier to isolate desired frequencies of the sound recording, and so on.

[0126] Further details regarding how steps 615 and 620 may be executed are provided below regarding the discussions corresponding to FIGs. 7A-7C and 8A-8C.

[0127] Optionally, in step 625, the sound recording may be analyzed to determine a state of health and/or medical condition of the user. For example, if analysis of the recording indicates that the user cannot catch his or her breath, is coughing for a portion of the recording, is wheezing, or is making sounds that may indicate distress during the recording, then a determination that the state of the patient’s health is problematic, sub-optimal, and/or worse than may be expected for the particular user may be made.

[0128] In some embodiments, audio of the user using the sound-producing breathing device may be continuously recorded throughout a breathing exercise session and that recording may be received in step 605 as opposed to a recording of only when the sound-producing breathing device is being used. In these embodiments, the received recording may be analyzed to determine periods of inhalation (i.e., when the tone the sound-producing breathing device produces when the user inhales is recorded), periods of exhalation (i.e., when the tone the sound-producing breathing device produces when the user exhales is recorded), sounds present between periods of inhalation and/or exhalation (e.g., coughing, wheezing, verbal comments, etc.) and these portions of the recording may be analyzed to determine a user’s state of health and/or how he or she is feeling. [0129] In step 630, it may be determined whether an intervention based on the user’s pulmonary function, airflow rates and volumes, and/or state of health is desired and/or required and, if so, in step 635 it may be determined what type of intervention is desired or required. Then, performance of the intervention may be initiated and/or performed (step 640). Interventions may be something relatively simple like a message provided to the user providing encouragement or follow-up instructions, a notification of an analysis result to the user’s physician, etc. For example, data collected and/or determinations based thereon may be used to ‘flag’ or otherwise make a notation for the patient and/or a treatment provider for the patient in his or her medical record or user account indicating that treatment provider follow up is desired or required. The treatment provider follow up could take the form of, for example, a phone call, telehealth appointment, and/or office visit. In some cases, the intervention may involve using the onboard phone capabilities of the processing device to place a call to, for example, emergency services or a treatment provider. In some instances, the intervention may be the sending of a message via, for example, SMS or email to the user or the user’s treatment provider.

[0130] When no intervention is required, or step 640 has been performed, provision of an indication of pulmonary function, peak air flow rate, user’s state of health, and/or receipt of the recorded sound to the user, a treatment provider, and/or a third party that may be operating third-party computer system may be facilitated (step 645). [0131] FIG. 7 A is a flowchart depicting a process 700 for executing step 615, determining pulmonary function of a user and/or air flow rate and volumes of inhalation and/or exhalation of a user. Process 700 may be executed by a system like system 100 and/or a component or combination of components thereof.

[0132] Optionally, in step 705, a frequency of sound represented by the signal received in step 605 may be determined. Step 705 may be performed when, for example, the user is using a sound-producing breathing device 140 that is configured to produce sound of a first frequency or first range of frequencies when the user is inhaling and a second frequency or second range of frequencies when the user is exhaling to determine whether the user is inhaling or exhaling. In instances where such a determination is not necessary and/or when a frequency of the received signal is not necessary, step 705 may be omitted from process 700.

[0133] In step 710, distance between the sound-producing breathing device and/or sound-producing mechanism that generated the sound included in the signal received in step 605 and the microphone resident in the holder that received/recorded the sound may be determined using the holder information received in step 605. Optionally, in some embodiments, step 710 may also include determining a characteristic of a holder used with the sound-producing breathing device. These characteristics include, but are not limited to, whether the holder uses any noise cancelling or sound dampening mechanisms (such as sound-dampening material), whether the holder has any openings by which ambient air may enter the holder, whether the holder is likely to resonate at one or more frequencies, and how the holder (or a component thereof) may impact the frequency range of the sound represented by the received signal. The holder may impact the frequency range of the sound represented by the received signal when, for example, the microphone is tuned to pick up only certain frequencies which may correspond to frequencies of sound generated by the sound-producing breathing device.

In step 715, an intensity, or volume, of the sound represented by the received signal may be determined using, for example, the determined distance. Typically, the sound intensity is determined in decibels (dB). The intensity of the recorded sound may be determined for specific intervals of time within the sound recording (e.g., every second or portion thereof (e.g., 0.1 seconds, 0.5 seconds, etc.)), averaged over the duration of the sound recording, and/or may be continuously determined throughout the sound recording. Then, in step 720, an air flow rate, usually determined in liters per minute (LPM) corresponding to the determined intensity may be determined. Step 720 may be executed by using a correlation table that correlates sound intensity with air flow rates. The correlations provided by such tables may be experimentally determined based on the sound-producing breathing device and/or holder being used. In some embodiments, multiple correlation tables may be generated and/or available wherein each correlation table may be specific to 1) a type of sound-producing breathing device used and 2) a type of holder being used with the sound-producing breathing device, which may set a distance between the sound-producing breathing device and the microphone present in the holder. An example of a correlation table that correlates sound intensity (or power) in decibels (dB) with air flow rates for a sound-producing breathing device and holder combination wherein the sound-producing mechanism of the sound-producing breathing device is positioned 30cm from the microphone (i.e., r = 30cm) of the holder is provided in Table 1, provided below. The values of Table 1 indicate that a flow rate of at least 6 LPM per minute is required to produce a sound using the sound-producing breathing device used to generate the data provided by Table 1 and that when the flow rate is 34 LPM, or higher, the sound-producing breathing device does not make a relevant sound. A graph 701 showing the sound intensity (dB) values of Table 1 plotted against the flow rate (LPM) of Table 1 is provided in FIG. 7B.

TABLE 1

[0134] In some instances, a correlation table specific to a particular sound-producing breathing device and holder that sets a particular distance (r) may not be available and, in these instances, the correlations of sound intensity and airflow rates may need to be determined and/or approximated using, for example, the Inverse Square Law (reproduced below as Equation 1 ) and/or other equations describing fluid dynamics or aeroacoustics (e.g., the perfect gas equation of state, Navier-Stokes equations, etc.).

R/4pG² = I Equation 1

Where:

P = sound power r = a distance between the sound-producing breathing device and the microphone; and

I = recorded sound intensity.

[0135] The distance between the sound-producing device and the microphone as well as the determined intensity of the sound (from step 715) may be input as r and I, respectively, in Equation 1 to determine a sound power (which may be sometimes understood as intensity) for the sound represented by the signal received in step 605 and/or a time interval of the recording. This sound power determination may then be compared with experientially known correlations between sound power and air flow rates to determine the user’s pulmonary function. In some instances, these correlations may be specific to a particular type of sound-producing breathing device 140 and/or sound-producing breathing device 140 and holder 300 pair.

[0136] FIG. 9A provides a diagram of showing how sound power and/or intensity (I) decreases with a distance between the sound-producing breathing device 140/housing 220 (i.e., “r”) and the processing device and/or measurement device. In the diagram of FIG. 9A, representations of sound propagating from housing 220 are shown as lines 405 that spread out as they travel a distance r, 2r, 3r, etc. The intensity (I) of the sound is decreased according to the inverse square law (i.e., Equation 1) so that an intensity at a distance r is represented as “I,” an intensity at a distance of 2r is ¼ as intense, which is represented as I/4 on the diagram and an intensity at a distance of 3r is 1/9 as intense, which is represented as I/9 on the diagram.

[0137] FIG. 9B shows a graph of relative sound intensity as a function of distance of a recording device (microphone 310) from a point source of sound, such as sound- producing breathing device 140 and/or housing 220. The graph shows how sound intensity exponentially decreases as distance from a point source of a sound increases. For example, at a distance between a point source and a recording device of r, the relative sound intensity has a value of I, when a distance between the point source and the recording device is 2r, the relative sound intensity has a value of ¼ I, or (1/4), when a distance between the point source and the recording device is 3r, the relative sound intensity has a value of 1/9 I, or (I/9) and so on.

[0138]Then, in step 725, pulmonary function in, for example, liters of air, of the user may be determined. The pulmonary function of the user may be determined by, for example, using the flow rate and the duration of the sound recording and/or a portion of the sound recording used to determine the flow rate for that portion of the recording. [0139] Table 2 provides data for an exemplary sound recording of a user (referred to herein as User X) as may be received in step 605, which shows time in seconds (s) and sound intensity in dB. The sound recording was made by a user using the sound- producing breathing device used to make correlation Table 1 at a distance of 30cm from the microphone. The overall duration of the sound recording of Table 2 is 5.5 seconds and determinations of sound intensity are made every 0.5 seconds.

TABLE 2

A graph 702 showing the sound intensity (dB) values of Table 2 plotted against the flow rate (LPM) of Table 2 is provided in FIG. 7C. The data of Tables 1 and 2 may then be combined (as show in Table 3, below) to determine a volume of air inhaled or exhaled for each interval of time (i.e., 0.5s, 1s, and/or 5.5s) and these determined values may be added together to determine a total volume of air inhaled or exhaled and/or an indication of pulmonary function. Stated differently, a volume of air inhaled or exhaled by the user using the sound-producing breathing device may be determined by calculating the area under a curve by integrating over time using the Sound Intensity vs. Flow Rate curve for distance r = 30 cm. The corresponding flow rate in liters per second (LPS) may be determined by dividing the corresponding flow rate in LPM by 60 seconds (thereby converting the LPM flow rate into a LPS flow rate). The volume of air inhaled or exhaled may then be calculated by, for example, averaging consecutive flow-rates over the time interval. For example, at time t = Os, the volume of air is 0. Then at the end of 0.5s, the beginning and end flow rates (0 and 0.40 LPS) may be averaged to determine a volume of air of 0.20LPS at t=0.5s. Additionally, or alternatively, the volume of air inhaled or exhaled may be determined by multiplying a flow rate (in LPS) for a time interval by a duration of the time interval (in this instance, 0.5 seconds) to determine the volume of air inhaled or exhaled in liters (L) for each time interval. The volume of air inhaled or exhaled in liters (L) for each time interval are then added together to determine the pulmonary function of the user in liters for the respective time interval.

TABLE 3

[0140] Optionally, in some embodiments, an air flow rate of the sound recording may be determined (step 730). This determination may be made by determining the highest sound intensity value of the sound recording and determining the air flow volume corresponding the highest sound intensity and/or selecting the highest air flow volume value from a plurality of determined air flow volumes. For User X, the peak air flow volume is 32 LPM, which corresponds to a sound intensity value of 84 dB.

[0141] FIG. 8A is a flowchart depicting a process 800 for executing step 615, determining a pulmonary function capacity of a user and/or a peak air flow rate of inhalation and/or exhalation of a user. Process 800 may be executed by a system like system 100 and/or a component or combination of components thereof such as a system including a sound-producing breathing device like sound-producing breathing device 140 and a holder like holder 300. Process 800 makes use of a sound- producing breathing device that emits sound of a particular frequency responsively to a flow rate of air through the sound-producing breathing device. Stated differently, the sound-producing breathing device used to produce sound that is analyzed according to process 800 produces sound of a frequency that varies responsively to the flow rate of air through the sound-producing breathing device.

[0142] Initially, in step 805, a frequency, or range of frequencies, of the sound for each interval (e.g., 1 second, 0.5 seconds, 0.1 seconds, etc.) in the sound recording may be determined. In some embodiments, the determination of step 805 through the sound-producing breathing device 805 may be made using information about the holder (e.g., recording range of the microphone, distance between the sound- producing device of the sound-producing breathing device and the microphone). The frequency of sound for each interval may then be used to determine an air flow rate for each interval (step 810) using, for example, a table correlating sound frequency with air flow rates. An example of such a table is provided by Table 4, reproduced below.

TABLE 4

[0143] The determined flow rates for each interval may then be used to determine a volume of air inhaled or exhaled during each interval, which corresponds to the user’s pulmonary function for the respective interval. The values of pulmonary function for each interval may then be added together to determine an overall pulmonary function for the user (step 815). Table 5 provides experimentally measured data for a User Y where a sound frequency for each time interval is determined via execution of step 805.

[0144] A plot of the data in Table 5 is provided by graph 801 shown in FIG. 8B. These determined frequencies may then be correlated with their associated air flow rates in LPM, which may then be converted into LPS as shown in Table 6, below. Then, the volume of air inhaled or exhaled for each time interval may be determined. In some embodiments, the volume of air inhaled or exhaled may be calculated by, for example, averaging consecutive flow-rates over the time interval. For example, at time t = Os, the volume of air is 0. Then at the end of 0.5s, the beginning and end flow rates (0 and 0.40 LPS) may be averaged to determine a volume of air of 0.20LPS at t=0.5s. Additionally, or alternatively, the volume of air inhaled or exhaled may be determined by multiplying a flow rate (in LPS) for a time interval by the duration of the time interval (in this instance 5s). These volumes may then be added together to determine a user’s pulmonary function over the duration of the recording, which in this example is 2.52 L.

TABLE 6

[0145] FIGs. 10A-10E provide screen captures of a user interface 1001 , 1002, 1003, 1004, and 1005, respectively, that may be provided to a user of, for example, a sound- producing breathing device like sound-producing breathing device 140, a holder like holder 300, and/or a processing device like processing device 125 when, for example, performing breathing exercises and/or a breathing and/or lung health assessment. User interfaces 1001, 1002, 1003, 1004, and/or 1005 may be provided by, for example, a web application and/or software/mobile application running on the processing device 125. User interfaces 1001 and 1002 correspond with processes 500, 600, and/or 700; user interfaces 1001 and 1002 correspond with processes 500, 600, and/or 800, and user interface 1005 corresponds with processes 500, 600, 700, and/or 800. User interface 1001 includes a sound intensity bar graph 1005 that graphically depicts a range of sound intensities that are too quiet (which may correspond with an air flow rate that is below a target range) 1020, a range of sound intensities that are too large (which may correspond with an air flow rate that is above the target range) 1010, and a target range (which may correspond with an airflow rate that at the target range) 1015. Interface 1001 may also include a sound intensity indicator 1010, which graphically represents whether the sound intensity produced by the user using the sound-producing breathing device is too loud, too quiet, or within the target range. Interface 1001 further includes a message window 1025 that may, for example, provide a user with instructions for using the sound-producing breathing device and/or holder. In the embodiment of FIG. 10A, the message shown in message window 1025 is “Attach sound-producing breathing device to holder and exhale completely. Then, inhale slowly and deeply. Try to keep the arrow within the target range.”

[0146] User interface 1002 of FIG. 10B is substantially similar to user interface 1001 with the exception that user interface 1002 further includes a first feedback window 1035 and a second feedback window 1030. Feedback windows 1030 and 1035 provide the user with feedback regarding how well they are doing with performance of their breathing exercises and whether or not they are on track with their breathing exercise routine. Provision of feedback within feedback windows 1030 and 1035 may be representations of the indication provided in step 645. In some instances, the feedback provided within feedback windows 1030 and 1035 may be points awarded for a particular inhalation or exhalation period, total points awarded as measured over a day, a week, a month, etc., and a number of goal points. The award of points to a user for using the sound-producing breathing device 140 may be an attempt to incentivize user to perform his or her breathing exercises or otherwise gamify the performance of breathing exercises for the user. In the embodiment of the FIG. 10B, the user has been awarded 90 points for a sound recording associated with a 6s interval and this information is provided in feedback window 1035.

[0147] User interface 1003 of FIG. 10C includes a frequency bar graph 1040 that graphically depicts a range of sound frequencies that have differing degrees of being below a target frequency. In bar graph 1040, depictions of the frequency ranges are ranked so that there are depictions of a target range 1045, a range one (1) degree below the target range 1050, a range two (2) degrees below the target range, and a range three (3) degrees below the target range. How many frequencies are encompassed within a range may vary based on the sound-producing breathing device being used by exemplary ranges include but are not limited to 50, 75, 100, or 125 Hz. In one embodiment where the target range is 600 Hz, a first degree below 600 Hz may be 550 Hz, a second degree below 600 Hz may be 500 Hz, and a third degree below 600 Hz may be 550 Hz.

[0148] Interface 1003 may also include a sound frequency indicator 1065, which graphically represents whether the sound frequency produced by the user using the sound-producing breathing device is within the target range. Interface 1001 further includes a message window. In the embodiment of FIG. 10B, the message shown in message window 1025 is “Inhale completely and then exhale through your mouth into sound-producing breathing device while it is attached to the holder as hard and for as long as you can.”

[0149] User interface 1004 of FIG. 10D is substantially similar to user interface 1003 with the exception that user interface 1004 further includes first feedback window 1035 and second feedback window 1030.

[0150] In some instances, user interfaces 1001 , 1002, 1003, and/or 1004 may be provided to the user via, for example, a display like display 1112 while the user is using the sound-producing breathing device and holder system and/or making a sound recording using the sound-producing breathing device and holder system. In this way, the user may receive instantaneous feedback about their performance of the breathing exercise. At times, movement of sound intensity indicator 1010 and/or frequency indicator 1065 may be representations of the indication provided in step 645.

[0151] The target ranges for bar graphs 1005 and/or 1040 may be standard target ranges that may, in some instances, be specific to a sound-producing breathing device and holder system being used, a correlation table or set of correlation tables being used, and/or may be specific to particular user. In some instances, the target ranges may be set by, for example, process 500 and/or execution of step(s) 510, 515, 530, and/or 555.

[0152] FIG. 10E provides an exemplary user-monitoring portal interface 1005 that may be displayed to a user and/or a treatment provider and may include user-identifying information, one or more options for a time period (week, month, year) over which data is to be viewed, and statistics analysis of sound recordings. In the embodiment of FIG. 10E, the time period being viewed is the previous week (i.e., “last week”). Exemplary statistics that may be provided by user interface 1005 include, but are not limited to, the average number of daily uses, average volume of exhaled air/pulmonary function, peak exhale volume over all sound recordings for the time interval selected, average exhale volume/pulmonary function, average exhale duration, peak exhalation flow rate, average exhalation flow rate, average volume of inhaled air/pulmonary function, peak inhale volume over all sound recordings for the time interval selected, average inhale volume/pulmonary function, average inhale duration, peak inhalation flow rate, and average inhalation flow rate.

[0153] FIG. 11 provides an example of a system 1100 that may be representative of any of the computing systems (e.g., processing device 125, caregiver device 130) discussed herein. Examples of system 1100 may include a smartphone, a desktop computer, a tablet computer, a laptop, an embedded system, etc. Note, not all of the various computer systems disclosed herein have all of the features of system 1100. For example, certain ones of the computer systems discussed above may not include a display inasmuch as the display function may be provided by a client computer communicatively coupled to the computer system or a display function may be unnecessary. Such details are not critical to the present invention.

[0154]System 1100 includes a bus 1102 or other communication mechanism for communicating information, and a processor 1104 coupled with the bus 1102 for processing information. Computer system 1100 also includes a main memory 1106, such as a random access memory (RAM) or other dynamic storage device, coupled to the bus 1102 for storing information and instructions to be executed by processor 1104. Main memory 1106 also may be used for storing temporary variables or other intermediate information during execution of instructions to be executed by processor 1104. Computer system 1100 further includes a read only memory (ROM) 1108 or other static storage device coupled to the bus 1102 for storing static information and instructions for the processor 1104. A storage device 1110, for example a hard disk, flash memory-based storage medium, or other storage medium from which processor 1104 can read, is provided and coupled to the bus 1102 for storing information and instructions (e.g., operating systems, applications programs and the like).

[0155] Computer system 1100 may be coupled via the bus 1102 to a display 1112, such as a flat panel display, for displaying information to a computer user. An input device 1114, such as a keyboard including alphanumeric and other keys, mouse, track pad, and/or a touch screen, may be coupled to the bus 1102 for communicating information, command selections, directional information, gestures, and controlling cursor movement of/input by the user to the processor 1104. [0156] Computer system 1100 may include a microphone 1122 configured to receive sound, which may be recorded in, for example, memory 1106, storage device 1110, and/or ROM 1108. Computer system 1100 may further include an antenna 1120 configured to receive signals from, for example, transceiver 315. Other user interface devices, such as speakers, devices to cause vibrations, etc. are not shown in detail but may be involved with the receipt of user input and/or presentation of output. [0157]The processes referred to herein may be implemented by processor 1104 executing appropriate sequences of computer-readable instructions contained in main memory 1106. Such instructions may be read into main memory 1106 from another computer-readable medium, such as storage device 1110, and execution of the sequences of instructions contained in the main memory 1106 causes the processor 1104 to perform the associated actions. In alternative embodiments, hard-wired circuitry or firmware-controlled processing units may be used in place of, or in combination with, processor 1104 and its associated computer software instructions to implement the invention. The computer-readable instructions may be rendered in any computer language.

[0158] In general, all of the process descriptions provided herein are meant to encompass any series of logical steps performed in a sequence to accomplish a given purpose, which is the hallmark of any computer-executable application. Unless specifically stated otherwise, it should be appreciated that throughout the description of the present invention, use of terms such as “processing”, “computing”, “calculating”, “determining”, “displaying”, “receiving”, “transmitting” or the like, refer to the action and processes of an appropriately programmed computer system, such as computer system 1100 or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within its registers and memories into other data similarly represented as physical quantities within its memories or registers or other such information storage, transmission or display devices.

[0159] Computer system 1100 also includes a communication interface 1118 coupled to the bus 1102. Communication interface 1118 may provide a two-way data communication channel with a computer network, which provides connectivity to and among the various computer systems discussed above. For example, communication interface 1118 may be a local area network (LAN) card to provide a data communication connection to a compatible LAN, which itself is communicatively coupled to the Internet through one or more Internet service provider networks. The precise details of such communication paths are not critical to the present invention. What is important is that computer system 1100 can send and receive messages and data through the communication interface 1118 and, in that way, communicate with hosts accessible via the Internet. It is noted that the components of system 1100 may be located in a single device or located in a plurality of physically and/or geographically distributed devices.

[0160] In some instances, one or more correlation tables as disclosed herein may be stored on user data store 115, third party data store 155, processing device 125, third- party computer system 110, cloud computing platform 160, and/or treatment provider computer system 105. In other instances, the correlation tables and/or correlations included therein may be generated as-needed via, for example, use of one or more mathematical relationships, experimentally determined relationships, and/or algorithms by, for example, processor 1104.

[0161] FIG. 12 is a flowchart showing a process 1200 for determining and/or analyzing a user’s pulmonary function, TV, FVC, and/or FEV1 , and/or performing a comparison of the user’s pulmonary function, TV, FVC, and/or FEV1 to known (e.g., standard known values for pulmonary function, TV, FVC, and/or FEV1) or historical values for the user and communicating same to the user, a third party computer, and/or a treatment provider, consistent with some embodiments of the present invention. Process 1200 may be executed by, for example, system 100 and/or any component or combination of components thereof.

[0162] In step 1205, a digital signal that represents sound generated by a user’s use of a sound-producing breathing device like sound-producing breathing device 140 that may be coupled to a holder like holder 300 may be received by a processor, like processing device 125 and/or a cloud-computing platform like cloud-computing- platform 160. In some embodiments, the signal and/or user may be associated with demographic or other patient information (e.g., treatments administered, diagnosis, body weight, etc.). In some embodiments, execution of step 1205 may resemble execution of step 605. In step 1210, the received signal may be analyzed to determine, for example, the user’s title volume (TV), forced vital capacity (FCV), and/or forced expiratory volume at one second (FEV1). In step 1215, one or more of these determine values may be used to determine the user’s pulmonary function.

[0163] Optionally, in step of 1220, the user’s pulmonary function, TV, FVC, and/or FEV1 may be compared with historically determined, or known, values for the user’s pulmonary function, TV, FVC, and/or FEV1. Additionally, or alternatively, execution of step 1220 may include comparing the user’s pulmonary function, TV, FVC, and/or FEV1 with known and/or expected values for the user’s pulmonary function, TV, FVC, and/or FEV1. At times, this comparison may be performed and/or analyzed using the user’s demographic are other patient information. For example, and an expected value for pulmonary function, TV, FVC, and/or FEV1 of a user who is a certain age may be known and execution of step 1220 may include comparing the user’s pulmonary function, TV, FVC, and/or FEV1 demographic to known values for pulmonary function, TV, FVC, and/or FEV1 for users who are the same age to, for example, to determine if for example, a pathology is present and/or track disease progression.

[0164] Instead of 1225, the user’s pulmonary function, TV, FVC, FEV1, and/or comparison results may be communicated to the user via a processing device like processing device 125, a third-party computer system like third-party computer system 110, a treatment provider via, for example, a treatment provider computer system like treatment provider computer system 105, and/or a cloud-computing platform like cloud-computing platform 160.

[0165] FIG. 13 is a flowchart showing a process for aggregating, categorizing, and/or analyzing pulmonary function, TV, FVC, FEV1 , and/or a comparison for a plurality of users and communicating same to a user, a third party computer, and/or a treatment provider. Process 1200 may be executed by, for example, system 100 and/or any component or combination of components thereof such as cloud-computing platform 160.

[0166] Optionally, in step 1305, a digital signal that represents sound generated by a user’s use of a sound-producing breathing device like sound-producing breathing device 140 that may be coupled to a holder like holder 300 for a plurality (e.g., 100; 100,000; 1 ,000,000 etc.) of users (which may also be referred to herein as a “population of users”) may be received by a processor, like processing device 125 and/or a cloud-computing platform like cloud-computing-platform 160. In some embodiments, some, or all, of the signals and/or users may be associated with demographic or other patient information (e.g., treatments administered, diagnosis, body weight, etc.). In some embodiments, execution of step 1305 may resemble execution of step 605. When step 1305 is executed, the received signals may be analyzed to determine, for example, the pulmonary function, TV, FCV, and/or FEV1, and/or comparison results for each user (step 1310). When step 1305 is not executed, the pulmonary function, TV, FCV, and/or FEV1, and/or comparison results may be received by, for example, a processor like processing device 125 and/or a cloud computing platform like cloud-computing-platform 160 (step 1310). Optionally, in step 1315, the received and/or determined pulmonary function, TV, FCV, and/or FEV1, and/or comparison results may be de-identified by, for example, stripping or deleting personally-identifiable information associated with the received and/or determined TV, FCV, and/or FEV1, and/or comparison results.

[0167] In step 1320, the received and/or determined pulmonary function, TV, FCV, and/or FEV1, and/or comparison results may be aggregated together, categorized according to, for example, a demographic characteristic (e.g., age, gender, location), and/or analyzed to determine pulmonary function, TV, FCV, and/or FEV1, and/or comparison results for the plurality, or population, of users.

[0168] Optionally, in step 1325, a recommendation for the plurality of users may be generated. Exemplary recommendations may be to analyze the pulmonary function, TV, FCV, and/or FEV1, and/or comparison results for a group of users in a particular location (e.g., county, state, or country) to see if, disease prevention measures are required and, if so, what type disease prevention measures maybe most affect at curbing spread a disease in a particular region.

[0169] In step 1330, the aggregated, categorized, and/or analyzed pulmonary function, TV, FCV, and/or FEV1, comparison results, and/or a recommendation may be communicated to one or more of the plurality of users, a third party computer system, and/or a treatment provider.

Claims

CLAIMS I claim:

1 . A system comprising: a sound-producing breathing device comprising: a sound-producing mechanism configured to generate a sound responsively to a user inhaling or exhaling through the sound-producing breathing device; a holder physically coupled to the sound-producing breathing device, the holder comprising: a microphone configured to convert sound produced when the user inhales or exhales through the sound-producing breathing device into a digital signal representing the sound produced when a user inhales or exhales through the sound- producing breathing device; and a body configured to house the microphone and physically couple to the sound- producing breathing device, the body being further configured to hold the microphone at a fixed distance from the sound-producing breathing mechanism.

2. The system of claim 1 , the holder further comprising: a transceiver configured to transmit the digital signal representing the sound produced when a user inhales or exhales through the sound-producing breathing device to a receiving device.

3. The system of claim 2, wherein the receiving device is an antenna coupled to a processor, the antenna being configured to receive the digital signal from the transceiver.

4. The system of claim 2, wherein the holder is associated with an identifier and the transceiver is configured to communicate the identifier to the receiving device.

5. The system of claim 1 , wherein the microphone is a wireless microphone configured to transmit the digital signal representing the sound produced when a user inhales or exhales through the sound-producing breathing device to a receiving device.

6. The system of claim 4, wherein the receiving device is an antenna coupled to a processor, the antenna being configured to receive the digital signal from the transceiver.

7. The system of claim 1 , wherein the holder further comprises a sound-dampening material.

8. The system of claim 1 , wherein the holder further comprises a noise-cancelling mechanism.

9. The system of claim 1, further comprising: a processor communicatively coupled to the microphone, the processor having a set of instructions stored thereon which when executed by the processor cause the processor to: receive the digital signal representing the sound produced when a user inhales or exhales through the sound-producing breathing device; determine an intensity of the sound included in the digital signal; determine a pulmonary function of the user based on the determined intensity; and facilitate provision of an indication of the pulmonary function to the user.

10. The system of claim 1, wherein the sound recording is divided into a plurality of time intervals and a sound intensity is determined for each time interval, the system further comprising: a processor communicatively coupled to the microphone, the processor having a set of instructions stored thereon which when executed by the processor cause the processor to: receive a distance between the sound-producing breathing device and the microphone; access a correlation table stored in a database communicatively coupled to the processor, the correlation table correlating sound intensity and air flow rates for the sound-producing breathing device and being specific to the distance between the sound-producing breathing device and the microphone and the type of sound- producing breathing device used to make the sound recording; determine an air flow rate corresponding to the intensity for each time interval using the correlation table; determine a volume of air inhaled or exhaled for each time interval; and determine a total volume of air inhaled or exhaled for all the time intervals included in the plurality of time intervals.

11. The system of claim 9 or 10, wherein the processor is a one or more processors resident within a cloud-computing platform.

12. The system of claim 9 or 11 , wherein determining the pulmonary function comprises determining at least one of a tidal volume, a forced vital capacity, and a forced expiratory volume at one second.

13. A method comprising: receiving, by a processor, a digital signal representing a sound produced when a user inhales or exhales through a sound-producing breathing device; determining, by the processor, a characteristic of the sound included in the digital signal; determining, by the processor, a pulmonary function of the user based on the determined characteristic; and facilitating, by the processor, provision of an indication of the pulmonary function to the user.

14. The method of claim 13, wherein the characteristic of the sound is at least one of an intensity, a frequency, and a duration of time.

15. The method of claim 13 or 14, wherein determining the pulmonary function comprises determining at least one of a tidal volume, a forced vital capacity, and a forced expiratory volume at one second.

16. The method of any of claims 13-15, wherein at least one of previously received digital signals for the user and previously determined pulmonary function of the user is stored in a database communicatively coupled to the processor, the method further comprising: accessing, by the processor, the at least one previously received digital signals for the user and previously determined pulmonary function of the user; comparing, by the processor, the at least one previously received digital signals for the user and previously determined pulmonary function of the user with at least one of the received digital signal for the user and the determined pulmonary function of the user; and providing a result of the comparison to the user.

17. The method of any of claims 13-16, wherein a pulmonary nomogram is stored in a database communicatively coupled to the processor, the method further comprising: receiving, by the processor, the pulmonary nomogram; comparing, by the processor, the pulmonary nomogram with at least one of the received digital signal for the user and the determined pulmonary function of the user; providing a result of the comparison to the user.

18. The method of claim 17, the method further comprising: determining, by the processor, whether the user’s pulmonary function is improving based on the comparison result.

19. The method of any of claims 13-18, further comprising: receiving, by the processor, a set digital signals, each of the digital signals in the set being associated with a different user; determining, by the processor, a pulmonary function value for each user associated with a digital signal; aggregating, by the processor, determined pulmonary function values into a data set; and communicating, by the processor, the data set to a third party.

20. The method of claim 19, wherein each user is associated with one or more characteristics, the method further comprising: sorting, by the processor, the aggregated pulmonary function values in the data set according to the one or more characteristics; and communicating, by the processor, the sorted pulmonary function values in the data set to the third party.

21. The method of any of claims 13-20, wherein the processor is a one or more processors resident within a cloud-computing platform.