Systems, devices, and methods for performing active auscultation and detecting acoustic signals and / or sonic energy measurements

A wearable device for monitoring lung health through acoustic signal projection and analysis addresses the challenge of daily, untrained monitoring of air trapping, enabling early detection of COPD exacerbations and improving patient care.

JP2026000928APending Publication Date: 2026-01-06SAMAY INC
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Patent Information

Application Number
JP2025142253
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2021-07-19
Filing Date
2025-08-28
Publication Date
2026-01-06

AI Technical Summary

Technical Problem

Current methods for monitoring air trapping in lungs, a key indicator of chronic obstructive pulmonary disease (COPD), require trained professionals and expensive equipment, making daily monitoring difficult and ineffective.

Method used

A wearable device that projects sound waves into the body, detects and measures acoustic signals using microphones, and communicates with external devices to analyze lung health, allowing for continuous monitoring of air pockets and lung function.

Benefits of technology

Enables daily monitoring of lung health without specialized personnel, detecting early signs of COPD exacerbations and providing timely interventions to improve patient outcomes.

✦ Generated by Eureka AI based on patent content.

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Abstract

A device for performing active auscultation.SOLUTION: A main body, a body mounting structure, and one or more wings, wherein the main body comprises a memory, a battery, an IMU, a transceiver, and a DSP; Wherein the one or more wings comprise a microphone wing and a speaker wing, wherein the microphone wing comprises one or more microphones, wherein the speaker wing comprises a speaker, wherein the one or more wings comprise a temperature sensor, wherein the main body is configured to engage with the body attachment structure, and wherein the body attachment structure is configured to engage with the main body on a first side and an animal body on a second side.SELECTED DRAWING: Figure 3A
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Description

[Technical Field]

[0001] Related Applications This application is an international patent application and claims priority to U.S. Provisional Patent Application No. 63 / 222,506, filed July 19, 2021, entitled "SYSTEMS, DEVICES, AND METHODS FOR PERFORMING ACTIVE AUSCULTATION AND DETECTING SONIC ENERGY MEASUREMENTS," which is incorporated herein in its entirety.

[0002] The present disclosure relates to systems, devices, and methods for performing active auscultation to determine the condition of an organ within an animal's body, typically the heart or lungs. [Background technology]

[0003] Many people have health problems related to the function of their internal organs. In particular, changes to a person's internal air compartment, observable as air trapping, can provide important insight into when treatment may be needed. Air trapping, defined as an abnormal increase in the volume of air remaining in the lungs after exhalation, is a key characteristic of chronic obstructive pulmonary disease (COPD). Numerous studies have now shown that air trapping is an earlier and more sensitive marker of pulmonary dysfunction than traditional spirometry measures. For example, air trapping can be detected in people with normal spirometry and no COPD symptoms who are diagnosed with COPD years later.

[0004] Auscultation is used to determine the condition of an animal's internal organs, typically the heart or lungs. A signal is introduced into the body, usually by tapping lightly with the hand on the chest or back. After interacting with the organ of interest (typically the lungs), this signal is detected by a stethoscope and interpreted by a medical practitioner. By analyzing the detected signal, the condition of the organ can be determined.

[0005] Importantly, accurate monitoring of air entrapment currently requires active monitoring by a medical practitioner or other person trained to determine abnormal air entrapment, which is particularly problematic as it makes daily monitoring of a slowly worsening condition extremely difficult. Summary of the Invention [Means for solving the problem]

[0006] The present disclosure is directed to a device configured to measure air pockets contained within an individual's body and / or tissue (e.g., lung tissue). In one embodiment, a signal, such as a sound wave of one or more frequencies, may be projected into the individual, and the responsive acoustic signal may be detected and measured by a microphone, whereby, for example, the refraction and reflection of the incident signal may be measured or otherwise determined. In some embodiments, this may allow for the measurement and monitoring of air pockets within the individual's body. In some embodiments, the device may also be configured to receive and store measurements related to signal emission, reflection, and refraction. In some embodiments, the device may comprise a power source and a memory module sufficient to record data for a set period of time, the set period of time corresponding to the time between data uploads / downloads to an external device, as described herein below.

[0007] In some embodiments, a device of the present disclosure may be in electronic communication with a separate or external electronic device, such as by wireless electronic communication methods. Some wireless electronic communication methods may include Bluetooth, Wi-Fi communication, and other radio signals. In one embodiment, the external electronic device may be a smartphone, tablet, or other smart device. In some embodiments, a device of the present disclosure may communicate with the external electronic device via the Internet, an intranet, or any other network communication protocol.

[0008] One embodiment may be a device for performing active auscultation comprising: a main body, a body mounting structure, and one or more wings, wherein the main body comprises a memory, a battery, an IMU, a transceiver, and a DSP, wherein the one or more wings comprise a microphone wing and a speaker wing, wherein the microphone wing comprises one or more microphones, wherein the speaker wing comprises a speaker, and wherein the one or more wings comprise one or more sensors and / or devices, such as a temperature sensor, an electrocardiogram device, a blood oxygen sensor, an oximeter, a tissue oxygen sensor, a skin conductivity sensor, etc., wherein the main body is configured to engage with the body mounting structure, and the body mounting structure is configured to engage the main body on a first side and an animal's body on a second side.

[0009] In some embodiments, a device for performing active auscultation may be affixed to an individual's body and may periodically record high-resolution and / or low-resolution data measurements. In some embodiments, data recorded by the device for performing active auscultation may be transmitted via wireless communication methods to a separate electronic device, such as a mobile phone. In preferred embodiments, the device may record as much data as possible and with as high quality as may be acceptable based, for example, on the capacity of the battery and memory unit.

[0010] In some embodiments, sensor data about the wearer may be collected over time, and subsequently detected sensor data may be compared to previously detected sensor data to determine differences therebetween that may indicate, for example, an improvement or worsening of the wearer's medical condition. Additionally or alternatively, one or more characteristics of the sensor data may be determined, and these characteristics may be compared to each other and / or predetermined values ​​for characterization to determine how the wearer's characteristics compare to other characteristics, for example, to infer similarities or patterns that may be used to diagnose the wearer and / or predict when the wearer is likely to experience an adverse event.

[0011] Additionally or alternatively, in some cases, the duration, intensity, and / or frequency contained within the signal may be adjusted, for example, in response to determined characteristics of the received acoustic signal and / or the lack of a sufficiently clear received acoustic signal.

[0012] A device for performing active auscultation may include a microphone wing housing, a speaker wing housing, and a main body housing. A surface of the microphone wing housing, the speaker wing housing, and / or the main body housing may be configured to mechanically and / or acoustically couple to a patient's skin via, for example, adhesive, elastic bands, a sleeve, and / or a garment (e.g., the device is integrated into the fabric of a shirt or bra).

[0013] The speaker wing housing may house a speaker or speaker array configured to project one or more acoustic signals into the patient's skin toward a target tissue, such as a lung or region of the lung, in response to receiving commands and / or electrical signals from the controller.

[0014] The microphone wing housing may house a microphone or microphone array configured to detect detected acoustic signals emanating from the patient's skin and underlying target tissue and communicate the detected acoustic signals to a controller.

[0015] The main body housing may be physically, electrically, and / or communicatively coupled to the microphone wing housing and / or components housed therein via a first flexible coupling, and / or may be physically, electrically, and / or mechanically coupled to the speaker wing housing and / or components stored therein via a second flexible coupling. The main body housing may include a transceiver, a memory, a controller, and a battery.

[0016] The transceiver may be communicatively coupled to the controller and memory and may be configured to communicate the detected acoustic signal to an external device and receive instructions from the external device. The memory may be communicatively coupled to the controller and transceiver and may be configured or programmed to receive instructions from the transceiver, store a set of instructions for execution by the controller, and store one or more measurements taken by the device and / or its components. The controller may be configured or programmed to generate an electrical signal in response to instructions stored in the memory, communicate the electrical signal to the speaker, receive the detected acoustic signal from the microphone, and communicate the detected acoustic signal to the transceiver. In some embodiments, the controller is further configured to pre-process the detected acoustic signal, for example, to remove noise before transmission to the transceiver. A battery may be electrically coupled to the speaker, microphone, transceiver, memory, and controller and configured to provide power thereto.

[0017] Systems, devices, and / or methods for performing active auscultation disclosed herein may be configured or programmed to receive a first detected acoustic signal or set of detections (dets) that may correspond to a first incident acoustic signal projected into the thorax of a wearer of an active auscultation device that includes at least one speaker and one microphone. Optionally, an indication that the wearer has moved may be received, and performance of a calibration sequence for the active auscultation device (e.g., the microphone and / or speaker included within the active auscultation device) may be initiated in response to receiving the indication that the wearer has moved. User movement may be detected, for example, by a motion sensor or inertial motion unit within and / or coupled to the active auscultation device. Movement includes, but is not limited to, the wearer's breathing, walking, or changing position (e.g., turning over in bed).

[0018] A second detected acoustic signal may also be received. The second detected acoustic signal may correspond to a second incident acoustic signal projected into the thorax of a wearer of the active auscultation device. The second detected acoustic signal and the second incident acoustic signal may be different from the first detected acoustic signal and the first incident acoustic signal, respectively, due to performance of a calibration sequence.

[0019] The first and second detected acoustic signals may be processed and / or analyzed to determine one or more characteristics of the wearer's lungs, lung regions, and / or both lungs based on the analysis. A display of the characteristics may then be provided to the user, for example, via a display on a computing device. In some embodiments, the characteristics may be compared to predetermined characteristics of the same or different types of the wearer's lungs to determine differences therebetween. The predetermined characteristics may have been determined at any previous time (e.g., 10 seconds, 20 minutes, or a year ago), so that the characteristics of the wearer's lungs can be compared to each other to assess changes therein. Because these changes may occur every second, every minute (e.g., before and after performing respiratory therapy or exercise), daily, monthly, and / or yearly (e.g., as part of an annual physical), the wearer's lungs may be monitored at a frequency / schedule that may result in meaningful assessment, monitoring, and / or diagnosis of the wearer's lung and / or respiratory health over time and / or in different situations and / or from different angles.

[0020] Exemplary determined and / or predetermined characteristics of the wearer's lungs include an acoustic lung signature, a volume of trapped air within the wearer's lungs, a number of pockets of trapped air present within the wearer's lungs, a size of one or more pockets of trapped air present within the wearer's lungs, and a location of one or more pockets of trapped air present within the wearer's lungs.

[0021] The present invention is illustrated by way of example and not by way of limitation in the accompanying figures. [Brief explanation of the drawings]

[0022] [Figure 1A] 1 is a scanned image of a relatively healthy lung with a small amount of air trapped inside, shown in image 101 as a dark spot, according to some embodiments of the present invention. [Figure 1B]1 is a scanned image of a lung affected by COPD containing multiple pockets or volumes of trapped air, according to some embodiments of the present invention. [Figure 1C] 1A-1C are model diagrams of exemplary ways in which the left and right lungs may be modeled or approximated, according to some embodiments of the present invention. [Figure 2A] FIG. 1 is a block diagram illustrating exemplary components of a networked system in which computer-readable instructions that instantiate the methods of the present invention may be stored and executed, consistent with some embodiments of the present invention. [Figure 2B] FIG. 1 is a block diagram illustrating exemplary components of a system in which computer-readable instructions that instantiate the methods of the present invention may be stored and executed, consistent with certain embodiments of the present invention. [Figure 2C] FIG. 1 is a block diagram illustrating exemplary components of an exemplary active auscultation device, consistent with certain embodiments of the present invention. [Figure 2D] 1 is a block diagram of a first exemplary microphone array according to some embodiments of the present invention. [Figure 2E] FIG. 10 is a block diagram of a second exemplary microphone array, according to some embodiments of the present invention. [Figure 2F] FIG. 10 is a block diagram of a third exemplary microphone array, according to some embodiments of the present invention. [Figure 2G] FIG. 10 is a block diagram of a fourth exemplary microphone array, according to some embodiments of the present invention. [Figure 2H] 1 is a block diagram of a first exemplary speaker array according to some embodiments of the present invention. [Figure 2I] FIG. 2 is a block diagram of a second exemplary speaker array according to some embodiments of the present invention. [Figure 2J] FIG. 10 is a block diagram of a third exemplary speaker array according to some embodiments of the present invention. [Figure 3A] FIG. 1 is a top view of an exemplary active auscultation device, according to some embodiments of the present invention. [Figure 3B] FIG. 3B is a side view of the exemplary active auscultation device of FIG. 3A, according to some embodiments of the present invention. [Figure 3C] FIG. 10 is a top view of another exemplary active auscultation device without the detachable main body seated in the cradle, according to some embodiments of the present invention. [Figure 3D] FIG. 3D is a side view of the active auscultation device of FIG. 3C, according to some embodiments of the present invention. [Figure 3E] FIG. 10 is a bottom view of a removable main body housing according to some embodiments of the present invention. [Figure 3F] FIG. 3D is a side view of the active auscultation device of FIG. 3C with the removable main body seated in the cradle, according to some embodiments of the present invention. [Figure 3G] FIG. 1 illustrates a top view of an exemplary hinged active auscultation device, according to some embodiments of the present invention. [Figure 3H] FIG. 3H is a side view of the hinged active auscultation device of FIG. 3G, according to some embodiments of the present invention. [Figure 3I] FIG. 10 is a top view of another exemplary hinged active auscultation device, according to some embodiments of the present invention. [Figure 3J] FIG. 3I is a side view of the hinged active auscultation device of FIG. 3I, according to some embodiments of the present invention. [Figure 4A] 1A-1C are diagrams of an exemplary wearer with an active auscultation device attached to the chest below the pectoral muscles, according to some embodiments of the present invention. [Figure 4B] FIG. 1 is a diagram of components of an exemplary active auscultation system being used to measure acoustic energy / waves emerging from the vicinity of a wearer's lungs, according to some embodiments of the present invention. [Figure 5A] 1A-1C are illustrations of spectrograms of detected acoustic signals from the lungs of a wearer who does not have COPD, according to some embodiments of the present invention. [Figure 5B]FIG. 5B is a spectrogram of energy change or energy generation over time for the wearer of FIG. 5A, according to some embodiments of the present invention. [Figure 5C] FIG. 5B is a diagram of a smoothed spectrogram showing the detected acoustic signal for the wearer of FIG. 5A as the wearer increases their breathing rate to 12 breaths per minute, according to some embodiments of the present invention. [Figure 5D] FIG. 10 is another spectrogram illustration of an exemplary reduced dynamic range of energy occurrence for a detected acoustic signal, according to some embodiments of the present invention. [Figure 6A] FIG. 1 is a diagram of a smoothed spectrogram of a detected acoustic signal from a wearer's lungs when the wearer is breathing at a rate of about 12 breaths per minute and the lungs have severe COPD, according to some embodiments of the present invention. [Figure 6B] 6B is a spectrogram illustrating the reduced dynamic range [−4:1] dB of the wearer's lungs from FIG. 6A in accordance with some embodiments of the present invention. [Figure 6C] 6B is a spectrogram illustrating the detected acoustic signal as the breathing rate of the wearer of FIG. 6A increases, according to some embodiments of the present invention. [Figure 6D] FIG. 6B is a spectrum diagram illustrating the detected acoustic signal for the wearer of FIG. 6A when the wearer's breathing rate slows to 10 breaths per minute, according to some embodiments of the present invention. [Figure 7] 10A-10C are scatter plots comparing labeled respiratory cycles and estimated respiratory events according to some embodiments of the present invention. [Figure 8] FIG. 1 is a flow diagram providing steps of an exemplary process for performing active auscultation, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0023] Throughout the figures, 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 present invention will now be described in detail with reference to the figures, it is done so 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 invention as defined by the appended claims.

[0024] detail COPD is an umbrella term for heterogeneous diseases or medical conditions affecting the lungs. Patients diagnosed with COPD can have a variety of different phenotypes (clinical characteristics) and endotypes (physiopathological causes) that can give rise to an operational definition of COPD. COPD is typically diagnosed when a patient has pulmonary infarction, as indicated by spirometry measurements of the ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) values ​​of 0.7 or less, a response to relevant exposures to pollutants (tobacco, household air), and / or respiratory symptoms (dyspnea, cough, sputum production). Because COPD can encompass such a wide range of symptoms and causes, patients can have a wide range of disease severity, with widely different functional status, quality of life loss, clinical needs, and prognosis, despite having similar backgrounds, exposure histories, and / or spirometric affectations.

[0025] COPD exacerbations can be defined as a clinically evident, persistent increase in symptom severity that necessitates a change and / or additional need for one or more medical treatments and / or interventions. COPD exacerbations are fairly common in COPD patients and are associated with a deterioration in short- and long-term patient outcomes, as well as a deterioration in the patient's respiratory health and overall well-being. Additionally, treating exacerbations accounts for a significant portion of the total cost of care for COPD patients when hospitalization is required. Furthermore, exacerbations can exist even in patients with mild obstruction / mild COPD, and can be defined as patients with two or more episodes of exacerbation or patients requiring hospitalization after one year. Exacerbation patients may behave like a stable phenotype, amenable to, for example, treatable trait approaches.

[0026] Currently, there are no clinically available biomarkers that can accurately predict the onset and / or occurrence of COPD exacerbations early. Spirometry is the most widespread respiratory function test used to identify obstructive pulmonary disease, but it has many caveats and drawbacks. For example, for spirometry to provide an accurate measure of lung function or obstruction, it typically needs to be performed in a respiratory function testing laboratory or clinic by well-trained personnel and may require the use of expensive equipment. Therefore, spirometry measurements are difficult to perform at home, even with a trained professional administering the test, and are not a suitable tool for frequent (e.g., daily or weekly) lung function testing. Additionally, the measured values ​​for FEV1 provided by conventional spirometry methods are insufficient for correlation (if any) with dyspnea, treatment efficacy, COPD exacerbations, and / or mortality, and cannot detect or predict the early onset of exacerbations or declines in lung function. Therefore, additional measures of lung function (body mass index, airway obstruction, dyspnea, and exertion index (BODE), age, dyspnea and obstruction index (ADO) index, and / or Global Initiative for Chronic Obstructive Pulmonary Disease Staging (GOLD) staging) are often required to accurately monitor COPD or respiratory patients.

[0027] However, other biomarkers of lung health, such as measurements and / or analysis of physiological variables and / or image-based measurements, can serve as surrogates for prognosis and symptoms. One biomarker of interest is pulmonary hyperinflation (LH), which is often caused by air trapping. Air trapping can be understood as the volume of air remaining in the lungs after a complete exhalation. Trapped air can be contained in discrete pockets of lung tissue after a patient has completely exhaled. Most COPD patients, regardless of COPD severity, endotype, or phenotype, suffer from / have some air trapping, and sometimes air trapping can precede symptoms or spirometric changes in diagnosed / exposed individuals. Therefore, monitoring trapped air in a patient's lungs can provide valuable information regarding disease status, respiratory health, and / or patient well-being.

[0028] In many cases, air trapping is a heterogeneous process intertwining at least two anatomical and physiological components: 1) partially irreversible, progressive gas trapping in damaged lung tissue or emphysema, and 2) more dynamic, potentially reversible gas trapping caused by peripheral airway dysfunction. These components (and the volume of trapped air within pockets throughout the lung tissue) are affected at different rates in each patient by, for example, successive attacks, aging, medications, exercise, and exacerbations.

[0029] Air trapping can be caused by a variety of phenomena. For example, in some cases, air trapping can be caused by loss of lung parenchyma elastic recoil associated with tissue destruction in emphysema and / or narrowing of peripheral airways, as seen in chronic bronchitis. Some patients have air trapping without emphysema, while others have air trapping with predominant emphysema. Within the latter group (air trapping and emphysema), two basic phenotypes exist: homogenous emphysema and upper lobe predominant emphysema.

[0030] In most cases, air trapping in COPD patients is heterogeneous in terms of anatomical phenotype (e.g., upper lobe-predominant emphysema vs. homogenous emphysema) and physiology (associated with emphysema and / or peripheral airway disease), and the pattern of air trapping and / or trapped air pockets occurring in COPD patients can be used to roughly determine the prognosis of these patients. In other cases, air trapping (or trapped air pockets) may be diffusely present throughout the lung anatomy.

[0031] In some cases, air trapping can be defined as an enhanced relationship between residual volume and total lung capacity (RV / TLC), which are traditionally measured using techniques that are even more complex and costly than spirometry, such as plethysmography, gas dilution techniques, and chest computed tomography. However, the complexity and financial cost of using these techniques limits their availability to select individuals who can visit specialized health care centers and are rarely available to the majority of patients and the general public.

[0032] In addition, air trapping correlates well with dyspnea at rest and during exercise, and it also appears early in the course of an exacerbation. Thus, measures of air trapping can be correlated with dyspnea and disease progression in COPD.

[0033] Thus, there is an urgent need for practical physiological biomarkers that can overcome the noted limitations of spirometry and serve as guidelines for personalized treatment. Furthermore, there is also a need for instruments that can act as early predictors of exacerbations to avoid mortality, deterioration in function and quality of life, and also to reduce the economic costs associated with COPD patient care, particularly the treatment of exacerbations within the COPD population. These needs may be met, inter alia, by the systems, devices, and methods disclosed herein that are configured to monitor trapped air volume in a wearer's lungs over short durations (e.g., minutes or hours) and long durations (e.g., hours, days, weeks, or months) without requiring expensive equipment or highly trained personnel to operate the device / system. The systems and devices disclosed herein may be used, for example, to determine short-term and / or long-term air trapping trends and other lung health measures, for example, in response to external stimuli and / or physical exertion undertaken by a patient, and to provide early, e.g., daily, warning of deviations in trends so that, for example, COPD can be proactively managed in certain populations and / or COPD exacerbations can be avoided.

[0034] Acoustic resonance is the ability of an object or system (e.g., a physical object such as an individual's body, a body part (e.g., lungs), or a portion thereof) to amplify sound waves at frequencies that match one or more of the system's natural vibrational frequencies. When an object is excited by energy at a frequency unrelated to its natural vibrational frequencies, the energy quickly dissipates. However, when the excitation approximates one of the object's natural vibrational frequencies, the object resonates at this frequency and begins to vibrate strongly. An object's resonant frequency is generally identified by exciting the object with a broadband signal (i.e., noise consisting of many frequencies), a pseudo-randomly generated frequency or range of frequencies, a chip signal (an acoustic signal of high intensity and short duration), and / or a white noise signal. In most cases, the object resonates at its lowest natural frequency or an integer multiple thereof.

[0035] Air trapping or trapped air may be defined as an abnormal increase in the volume of air remaining in the lungs, sometimes in discrete pockets of lung tissue, after exhalation has ended, which is a key characteristic of COPD. Numerous studies now show that air trapping is an earlier and more sensitive marker of pulmonary dysfunction than traditional spirometry measures of conditions such as COPD. For example, air trapping can be detected in people with normal spirometry and no COPD symptoms who are diagnosed with COPD years later. The degree or volume of air trapped in the wearer / user's lungs may be referred to herein as the air trapping index.

[0036] Figure 1A provides a scanned image 101 of a relatively healthy lung having a small amount of air trapped in an internal pocket, shown in image 101 as a dark spot 110. Figure 1B provides a scanned image 102 of a lung affected by COPD, containing multiple pockets or volumes of trapped air, shown in image 102 as multiple dark spots 110. Images 101 and 102 include a 1 cm scale bar to indicate the size of the dark spots / trapped air pockets 110.

[0037] FIG. 1C provides a diagram of model 103 of an exemplary manner in which left lung 105A and right lung 105B may be modeled or approximated. Model 103 represents the bronchi with multiple tubes 120 having one or two open ends and represents trapped air volumes as circles 125, which may represent spherical or nearly spherical trapped air volumes / pockets (which may be referred to herein as “air pockets”). A model such as model 103 may be generated without dividing the lungs into one or more lobes. Additionally or alternatively, a model such as model 103 may be generated by dividing the lungs into two or more lobes and / or by grouping the tubes and spheres by lobe or location within the lung. The model shown in FIG. 1C may be based on images such as images 101 and / or 102 showing trapped air pockets and / or other information about the lungs, such as multiple X-rays, MRI images, CT scans, PET scans of the lungs taken from different angles. In model 103, the naturally occurring resonant frequencies of lungs 105A and / or 105B and / or trapped air volume 125 may occur within the range of 2,000 Hz to 30,000 Hz, with the majority of these being within the range of 6,000 Hz to 15,000 Hz.

[0038] Disclosed herein are systems, devices, and methods that use acoustic energy / signals to measure, store, and / or report information regarding the response of tissue and gases within the tissue (e.g., air trapped or trapped within discrete pockets of tissue) to the acoustic energy / signals. In many cases, acoustic energy is projected into an individual's body (typically the thorax) via an emitter such as a speaker, and the resulting acoustic waves / energy are detected by a detector such as a microphone. The detected acoustic waves / energy are analyzed to determine characteristics (e.g., quantity, size, volume, composition, location) of pockets of gas / air trapped within lung and other organ tissue.

[0039] In some cases, the acoustic waves / energy projected into the body may be of a specific frequency or set of frequencies (e.g., a narrowband or broadband spectrum). The set of frequencies for projection into the body may be selected randomly and / or pseudo-randomly. Sometimes, the acoustic energy may be a set of frequencies corresponding to low-frequency ultrasound, which, in cases of COPD and / or air trapping, may result in a more accurate assessment of lung health and / or air trapping than the standard of care for monitoring lung health (e.g., plethysmography). In some cases, the devices and methods disclosed herein may be configured to detect and / or monitor air pockets or trapped air volumes that are too small to be detected by standard methods of assessing lung health. For example, in some situations, lungs and / or patients with early-stage COPD may be able to compensate for the reduced lung capacity caused by early-stage COPD by breathing deeper and / or faster. In these situations, standard methods of assessing lung health may not detect small amounts of trapped air that could lead to early-stage COPD and / or undiagnosed COPD and / or the administration of effective early intervention treatments.

[0040] The devices disclosed herein may include one or more acoustic energy emitters or speakers, which may be, for example, low-frequency sound emitters, and one or more acoustic detectors or microphones, which may be in a chest-worn housing or housings as shown in FIG. 4A and discussed below. The speakers disclosed herein may be configured to create acoustic resonance within an animal's body (e.g., a human's lungs, trapped air pockets within a human's lungs), preferably with reduced or minimal distortion that may be caused as the sound travels through the body. The devices disclosed herein may be configured to communicatively couple to an external processing device, such as a smartphone or computer, for example, via a wired and / or wireless communication protocol and / or a communication network, such as the Internet or a Wi-Fi network. The external processing device may store a software program / application configured, for example, to receive detected sounds from the one or more microphones, analyze the detected sounds for the presence of resonant frequencies, and / or determine a pulmonary resonance signature (LRS) for the wearer's body, lungs, or portions thereof.

[0041] As the wearer is monitored over time, the software program may be further configured to compare measurements taken at different times (e.g., every few hours, days, weeks, or months) to determine changes to characteristics of the wearer's body, lungs, or portions thereof. This may be useful, for example, to monitor the wearer's disease progression over time to determine how the wearer's behavior and / or treatment may affect the wearer's condition and / or to determine when the wearer's condition is worsening and intervention (e.g., supplemental oxygen, medication, etc.) may be necessary, for example, to prevent further deterioration, make the wearer more comfortable, and / or otherwise improve the wearer's quality of life. In some embodiments, the systems, devices, and methods disclosed herein may be used to reliably monitor lung function and detect lung function deterioration early in the deterioration cycle so that minimally invasive, inexpensive treatments can be used to reverse or slow the deterioration, thereby, for example, improving the wearer's outcome, slowing lung deterioration, and avoiding fatal events. For example, during a COPD exacerbation, it is known that air trapping within a wearer's lungs increases, e.g., by a change in the size and / or volume of one or more trapped air pockets and / or an increase in the number of trapped air pockets within the lungs, which can further alter the wearer's LRS. Thus, by continuously and / or periodically monitoring a wearer's LRS, the systems, devices, and methods disclosed herein can be configured to detect changes in lung function and alert the wearer and / or the patient's caregiver (e.g., a doctor, nurse, etc.) upon the occurrence of deterioration, preferably in time for appropriate medical intervention before the wearer needs to be admitted or readmitted to a hospital or an invasive procedure needs to be administered. Additionally or alternatively, by monitoring real-time and / or long-term trends in lung performance, the systems, devices, and methods disclosed herein may also help wearers, caregivers, and healthcare providers identify disease triggers, plan daily activities, and assess the efficacy of medications and other treatments.In some cases, such real-time and / or long-term monitoring of pulmonary performance or other physiological systems may utilize local and / or cloud-based processing and / or storage of acoustic data detected by one or more detectors / microphones.

[0042] In some embodiments, the LRS may be combined with other aspects and / or characteristics of the wearer to develop a physiological profile of the wearer. Exemplary wearer characteristics include, but are not limited to, age, sex, diagnosis, disease state, weight, resting heart rate, blood pressure, hemoglobin oxygen saturation level, endurance, treatments administered, the wearer's medication compliance, the wearer's known allergies, and known lung function deterioration triggers (e.g., air pollution, stress, etc.) specific to the wearer and / or known for wearers with a similar diagnosis to the specific wearer.

[0043] 2A provides a system diagram of an exemplary system 201 that may be used to implement one or more methods disclosed herein. System 201 includes a cloud computing platform 21, a communication network 22, a computer system 23, an active auscultation device 203, a database 25, a wearer computing device 27, and an acoustic spectrograph 28. It will be understood that in some embodiments, system 201 may not include all of the components shown in FIG. 2A and / or may include additional components other than those shown in FIG. 2A.

[0044] In some cases, communication network 22 is the Internet. Additionally or alternatively, communication network 22 may be, for example, a private network within an institution (e.g., a hospital or system of medical treatment facilities). Components of system 201 may be coupled together via wired and / or wireless communication links. In some cases, wireless communication of one or more components of system 201 may be enabled by using short-range wireless communication protocols (e.g., Bluetooth, Near Field Communication (NFC), Radio Frequency Identification (RFID), and Wi-Fi) designed to communicate over relatively short distances, for example, with a computer or personal electronic device (e.g., a tablet computer or smartphone) as described below. In most cases, communication between components of system 201 may adhere to one or more security protocols, regulations, and / or policies that may protect sensitive personally identifiable and / or health care data.

[0045] The cloud computing platform 21 may be any cloud computing platform 21 configured to receive and / or store information and / or execute one or more of the processes disclosed herein. Exemplary cloud computing platforms include, but are not limited to, Amazon Web Services (AWS), Rackspace, and Microsoft Azure.

[0046] Computer system 23, active auscultation device 203, and / or wearer computing device 27 may be configured to act as a communications terminal to cloud computing platform 21, for example, via communications network 22, and may transmit (directly and / or indirectly) measurements taken and / or data collected by active auscultation device 203 to cloud computing platform 21. Exemplary computer systems 23 and / or wearer computing devices 27 include desktop and laptop computers, servers, tablet computers, personal electronic devices, mobile devices (e.g., smartphones), etc. In some cases, computer system 23 may include a display device.

[0047] Computer system 23, active auscultation device 203, and / or wearer computing device 27 may be communicatively coupled to database 25, which may be configured to store a set of instructions for computer system 23 and / or cloud computing platform 21. Acoustic spectrograph 28 may be a spectrograph that may be capable of analyzing an acoustic signal or set of acoustic signals and generating, e.g., time, frequency, and / or intensity of the acoustic signal or set of acoustic signals in two or three dimensions to generate a spectrograph, such as the spectrograph images shown in Figures 5A-5D and / or 6A-6D.

[0048] One or more components (e.g., database 25, computer system 23, wearer computing device 27, active auscultation device 203, and / or cloud computing platform 21) may store and / or receive machine-readable instructions, for example, via communications network 22, which, when executed by a processor (e.g., processor of computer system 23, wearer computing device 27, active auscultation device 203, and / or cloud computing platform 21), may perform one or more methods, processes, and / or method steps and / or generate measurement data disclosed herein.

[0049] 2B provides an example of a system 202 that may represent any of the computing systems discussed herein (e.g., cloud computing platform 21, computer system 23, wearer computing device 27, active auscultation device 203, and / or audio spectrograph 28). Examples of system 202 may include a smartphone, a desktop computer, a tablet computer, a laptop, an embedded system, etc. It should be noted that not all of the various computer systems disclosed herein have all of the characteristics of system 202. For example, certain of the computer systems discussed above may not include a display, as the display functionality may be provided by a client computer communicatively coupled to the computer system or may be unnecessary. Such details are not important to the present invention.

[0050] The system 202 includes a bus 202 or other communication mechanism for communicating information and a processor 204 coupled to the bus 202 for processing information. The computer system 202 also includes a main memory 206, such as a random access memory (RAM) or other dynamic storage device coupled to the bus 202, for receiving and / or storing information and instructions to be executed by the processor 204. The main memory 206 may also be used for storing temporary variables or other intermediate information during execution of instructions to be executed by the processor 204. The computer system 202 further includes a read-only memory (ROM) 208 or other static storage device coupled to the bus 202 for storing static information and instructions for the processor 204. A storage device 210, such as a hard disk, a flash memory-based storage medium, or other storage medium readable by the processor 204, is provided and coupled to the bus 202 for storing information and instructions (e.g., an operating system, an application program, etc.).

[0051] Computer system 202 may be coupled via bus 202 to a display 209, such as a flat panel display, for displaying information to a computer user. Input devices 214, such as a keyboard including alphanumeric and other keys, a mouse, a trackpad, and / or a touch screen, may be coupled to bus 202 for communicating information, instruction sets, command selections, directional information, gestures, and cursor movement / control input by a user to processor 204.

[0052] The processes referred to herein may be implemented by processor 204 executing appropriate sequences of computer-readable instructions contained in main memory 206. Such instructions may be read into main memory 206 from another computer-readable storage medium, such as storage device 210, and execution of the sequences of instructions contained in main memory 206 causes processor 205 to perform the associated actions. In alternative embodiments, hardwired circuitry or firmware-controlled processing units may be used in place of, or in combination with, processor 204 and its associated computer software instructions to implement the invention. Computer-readable instructions may be rendered in any computer language.

[0053] In general, all process descriptions provided herein are meant to encompass any set of logical steps performed sequentially to achieve a given purpose, which is the distinguishing feature of any computer-executable application. Unless specifically stated otherwise, throughout the description of the present invention, the use of terms such as "processing," "calculating," "figuring out," "determining," "displaying," "receiving," "transmitting," and the like, will be understood to refer to the actions and processes of a suitably programmed computer system, such as computer system 202 or a similar electronic computing device, that manipulates and converts data represented as physical (electronic) quantities in its registers and memory into other data similarly represented as physical quantities in its memory or registers or other such information storage, transmission, or display device.

[0054] Computer system 202 also includes a communications interface 218 coupled to bus 202. Communications interface 218 may provide a two-way data communications channel with a computer network, thereby providing connectivity to and among the various computer systems discussed above. For example, communications interface 218 may be a local area network (LAN) card that provides a data communications connection to a compatible LAN, which is itself communicatively coupled to the Internet through one or more Internet service provider networks. The exact details of such communications paths are not important to the present invention. What is important is that computer system 202 can send and receive messages and data through communications interface 218 and, in this way, can communicate with hosts accessible via the Internet. It is noted that the components of system 202 may be located within a single device or may be located within multiple devices that are physically and / or geographically dispersed.

[0055] 2C is a block diagram of an exemplary set of components 203 that may be included within one or more of the active auscultation devices disclosed herein. A set of components 203 may also be referred to herein as an active auscultation device 203. The set of components that make up active auscultation device 203 includes a set of main body components 224 housed within main body housing 211, a set of microphone wing components 205 housed within microphone wing housing 222, and a set of speaker wing components 207 housed within speaker wing housing 227.

[0056] The set of microphone wing components 205 and the microphone wing housing 222 may be mechanically, communicatively, and / or electrically coupled to the set of main body components 224 and / or the main body housing 211 via a first flexible coupling 213A, which may be physically and / or mechanically attached to both the microphone wing housing 205 and the main body housing 211, and which may electrically and / or communicatively couple one or more components of the set of microphone wing components 205 to the set of main body components 224, for example, via leads embedded within the first flexible coupling 213A. The set of speaker wing components 207 and the speaker wing housing 227 may be mechanically, communicatively, and / or electrically coupled to the set of main body components 224 and / or the main body housing 211 via a second flexible coupling 213B, which may be physically and / or mechanically attached to both the speaker wing housing 207 and the main body housing 211, and which may electrically and / or communicatively couple one or more components of the set of speaker housing components 207 to the set of main body components 224 via leads embedded within the second flexible coupling 213B, for example. First and / or second flexible couplings 213A and 213B may be configured to allow first and / or speaker wing housings 227 and 227 to articulate in one or more directions relative to main body housing 211, for example, to allow the overall shape of active auscultation device 203 to bend so that active auscultation device 203 may adhere to curved or uneven portions of a wearer's body (e.g., the chest or sides). First and / or second flexible couplings 213A and 213B may comprise any flexible material, including, but not limited to, cord, mesh, plastic, and / or vinyl cable covering.In some embodiments, the first and / or second flexible couplings 213A and 213B may be expandable, for example, by spools and / or expandable materials (e.g., springs or expandable foam) within the microphone wing housing 222, the speaker wing housing 227, and / or the main body housing 211.

[0057] The active auscultation device 203 may be configured to be wearable by a wearer for short (e.g., 5 to 20 minutes) and / or long (days or weeks) durations. The underside of the active auscultation device 203 may include an attachment mechanism (e.g., adhesive or flexible material) or mechanism components (e.g., attachment mechanisms configured to cooperate with straps, sleeves, harnesses, and / or garments) for attachment to the wearer's skin, as shown in FIG. 2B , for example, and are discussed below. Sometimes, the attachment mechanism may be a sound dampener and / or isolator configured to insulate the components of the active auscultation device 203 from externally generated sound. Exemplary dimensions of the active auscultation device 203 are a width of 1 to 5 cm, a length of 2 to 20 cm, and a height of 0.3 to 2 cm. The set of microphone wing components 205 and the set of speaker wing components 207 may be mechanically, electrically, and / or communicatively coupled to the set of main body components 224. In some embodiments, one or more portions of the active auscultation device 203 may be removable and / or replaceable with similar or different components.

[0058] In some cases, the active auscultation device may further include an on / off button (not shown) and an indicator display device 258, which may be, for example, a light source. The light source may be a light-emitting diode (LED) that emits light in one or more colors, and in some cases, the variable colors or patterns of light may correspond to different information provided by the active auscultation device 203 to an external observer (e.g., a red light may indicate that the memory 240 is almost full or that the battery 245 is almost discharged, while a green light may indicate that all components of the active auscultation device 203 are functioning properly). The on / off button may be configured to turn on, off, or trigger measurements by the active auscultation device 203.

[0059] In some embodiments, the active auscultation device 203 may be configured to be secured to the wearer's chest (e.g., below the pectoral muscles or above the lungs) or back. In some cases, the mechanical connection between the set of main body housing 211, microphone wing housing 222, and / or speaker wing housing 227 may be flexible so that the microphone wing housing 222 and / or speaker wing housing 227 can articulate relative to the main body housing 211 to accommodate, for example, the curvature of the wearer's torso and / or movement of the wearer's torso during breathing, achieving a skin-tight fit that inhibits noise from entering the active auscultation device from the environment and acoustic signals from leaking out of the active auscultation device to the environment.

[0060] In alternative embodiments, the microphone and speaker may be incorporated into the main body, and the wings may not be components of the active auscultation device. Additionally or alternatively, one or more wings or components of active auscultation device 203 may not be physically coupled to the main body, e.g., via first and / or second flexible couplings 213A and / or 213B. In these embodiments, a component or housing (e.g., microphone wing housing 222 and / or speaker wing housing 227) may not be physically attached to the main body housing, but may be communicatively coupled to one or more components of the set of main body components 224, e.g., via a near-field communication protocol (e.g., Bluetooth). In some cases, one or more components of active auscultation device 203 may be positioned within the wearer's body when not physically coupled to main body housing 211, e.g., to facilitate projecting acoustic signals into different regions of the wearer's body, detecting acoustic signals from those regions, and / or projecting acoustic signals at different angles to the wearer's body. In some cases, analysis of the detected acoustic signal may incorporate location analysis (e.g., triangulation) based on where the components projecting and / or detecting the acoustic signal are positioned on the wearer's body.

[0061] The set of main body components 224 may include a memory unit 240, a power supply 245 (electrically coupled to some or all of the components of the active auscultation device 203), a digital signal processor (DSP) 230, a transceiver 235, which in some cases may be a Bluetooth® low energy / microcontroller unit (BLE / MCU), a port 255, an indicator display device 258, an electrocardiogram (ECG) device 268, an FIR array 247, a DSP coefficient controller 249, an inertial motion unit (IMU) 250, and a temperature probe 225, all housed within the housing 211 as shown in FIG. 2B . The set of microphone wing components 205 may include a microphone array 220 of one or more microphones housed within the microphone wing housing 222. The set of speaker wing components 207 may include a speaker array including one or more speakers. In some embodiments, active auscultation device 203 may include sound-attenuating material (not shown), which may be configured, for example, to absorb sound from one or more speakers of speaker array 230 so that the sound is not audible to the wearer. Additionally or alternatively, the sound-attenuating material may be configured to insulate the microphones of microphone array 220 from external noise (e.g., ambient noise and / or noise generated by the wearer by, for example, breathing and / or coughing) and / or acoustically separate a first microphone of microphone array 220 from a second microphone of microphone array 220.

[0062] In some embodiments, all or a portion of active auscultation device 203, microphone wing housing 222, speaker wing housing 227, first flexible coupling 213A, and / or second flexible coupling 213B may be water-resistant or waterproof so that they are impervious to, for example, a wearer's sweat and / or water that may be exposed to, for example, when active auscultation device 203 is worn (e.g., when the wearer is showering) and / or when active auscultation device 203 is being washed or cleaned. In some embodiments, the set of main body components 224 may be removably attached to active auscultation device 203, such that, for example, the set of main body components 224 and / or main body housing 211 may be removed from active auscultation device 203, for example, to recharge power supply 245, and / or may be replaced with another set of main body components 224, for example, when replacing the set of main body components 224. In some embodiments, the set of main body components 224 may be temporarily removed before the wearer is exposed to water, for example, before showering or swimming. An example of a removable / replaceable main body component in the form of an exemplary removable main body housing 330 is shown in FIG. 3E and discussed below.

[0063] The speakers included in the speaker array 230 may be configured to emit acoustic energy and / or acoustic signals (sometimes referred to herein as emitted acoustic signals) when activated, for example, by the DSP / controller 230. The acoustic energy / signals may be, for example, of a particular frequency or set of frequencies, typically in the range of 100 Hz to 25 KHz. In some cases, the frequency of the acoustic energy may change over time, for example, in response to the wearer's interaction with the acoustic energy / signals and any resonant frequencies that may be detected. The set of frequencies emitted by the speakers of the speaker array 230 may be selected intentionally, randomly, and / or pseudo-randomly. Sometimes, the acoustic signals may be in the ultrasonic range. In some embodiments, the set of frequencies emitted by the speakers of the speaker array 230 may be responsive to characteristics of a particular wearer. For example, if the wearer is known to have a demonstrated resonance at one or more particular frequencies (or bands of frequencies) in the past, the speakers of speaker array 230 may be configured to emit acoustic signals at those frequencies when further or subsequent measurements of the wearer are taken, e.g., via commands and / or signals from an external device (e.g., computer system 23 and / or wearer's computing device 27) in communication with DSP / controller 230 and / or active auscultation device 203. In some embodiments, one or more of the speakers of speaker array 230 may be single-channel speakers. Additionally or alternatively, one or more of the speakers of speaker array 230 may be configured to emit sound on multiple (two, three, four, etc.) channels. An exemplary acoustic power range for the speakers of speaker array 230 is 80 to 110 dBA for a white noise stimulus measured on-axis and 20 cm away from the speaker.

[0064] One or more of the microphones of microphone array 220 may be configured to detect acoustic energy emerging from the wearer's body in response to sound transmitted within the wearer's body by one or more of the speakers of speaker array 230, and to provide the detected acoustic energy (also referred to herein as a "detected acoustic signal") to DSP / controller 230 and / or transceiver 235 for transmission to an external device (e.g., one or more of the components of systems 201 and / or 202). In some cases, the detected acoustic signal may be associated with a microphone identifier, thereby enabling, for example, DSP / controller 230 to determine which microphone of microphone array 220 the detected acoustic signal came from. This identifier may be used, for example, to determine the direction from which the detected acoustic signal came, so that, for example, the location of a resonating portion of the wearer's body (e.g., a pocket of trapped air) may be located. In some embodiments, DSP / controller 230 may determine which microphone in microphone array 220 the detected sound signal came from by analyzing the components of the detected sound signal. This analysis may be used to determine, for example, frequency components, start / stop times of the detected sound signal, and / or other characteristics of the detected sound signal (e.g., intensity, noise, etc.).

[0065] In some exemplary embodiments, when microphone array 220 includes two microphones, the first microphone and / or the second microphone may have a range for detecting acoustic signals from 500 Hz to 20 kHz, for example, with a frequency response of + / - 3 dB in the range of 5 kHz to 15 kHz. Sometimes, the first microphone may be pointed toward the wearer and the second microphone may be pointed away from the wearer, for example, to capture ambient noise, which may later be removed from the sound detected by the first microphone, for example, by applying a noise-canceling algorithm to the acoustic signal detected by the first microphone. The noise-canceling algorithm may be informed of and / or adjusted in response to one or more characteristics (e.g., frequency and / or intensity) of the ambient noise detected by the second microphone.

[0066] Temperature probe 225 may be configured to measure the temperature of active auscultation device 203 and / or the wearer. In some cases, when the temperature of active auscultation device 203 exceeds a threshold, a warning notification may be sent to the wearer and / or active auscultation device 203 may be powered off to prevent burns or discomfort to the wearer. Additionally or alternatively, when the wearer's temperature exceeds a threshold (which may indicate the wearer has a fever), active auscultation device 203 may be activated to take high-resolution measurements and / or take low-resolution measurements. In some embodiments, temperature probe 225 may be configured to measure the wearer's temperature periodically (e.g., every minute, every five minutes, every hour) and / or at intervals required in response to instructions from DSP / controller 230, which, for example, in some cases, may correspond to measurements taken by another component of active auscultation device 203.

[0067] In some embodiments, temperature measurements and / or changes in temperature measurements over time may trigger one or more actions by the active auscultation device 203, such as taking quick and / or lower resolution acoustic measurements, taking slower and / or higher resolution acoustic measurements, taking an ECG measurement, and / or activating one or more components of the active auscultation device to take additional measurements, and / or communicating with an external computing device. Exemplary communications include, but are not limited to, alarm conditions, measurements, and / or system malfunction notifications (events in which the active auscultation device 203 (and not the patient) becomes too hot). Exemplary measurements that may trigger action by the active auscultation device 203 include, but are not limited to, a change in wearer body temperature over time (e.g., a one degree increase in less than one hour) and / or when a temperature change is measured and there is no corresponding data from the IMU 250 indicating, for example, a change in activity level (e.g., exercise).

[0068] The temperature measurements may be recorded, for example, on memory 240 and, in some cases, may be time-stamped and / or correlated with the detected acoustic signal. Sometimes, temperature probe 225 may be configured to draw a relatively small amount of power from power source 245, e.g., so that the wearer's temperature may be continuously monitored without substantially adversely affecting battery life. For example, in some embodiments, transceiver 235 may be configured to periodically become active, or wake up, instruct temperature sensor 225 to measure the temperature, and interrogate IMU 250 to determine whether IMU 250 has recorded any new behavior of the wearer. In this manner, the active auscultation device 203 may be configured to operate in a low power or sleep state drawing a very small amount of current from the power source 245 for a fixed duration, and may be configured to power up or wake up at periodic intervals (e.g., every second, every 30 seconds, every minute, or every hour) to measure the wearer's temperature, and the transceiver 235 and / or DSP / controller 230 may determine whether to wake up one or more additional components of the active auscultation device 203 to take one or more additional measurements and / or return to a quiescent / sleep state without waking up in response to the temperature measurements.

[0069] One or more ports 255 may be configured as power ports through which power supply 245 may be charged. Additionally or alternatively, port 255 may be configured as a communication port through which active auscultation device 203, or components therein, may communicate with one or more external devices (e.g., computers or processors). Exemplary ports 255 include, but are not limited to, mini-USB, micro-USB, USB-C, or other data / power mechanisms. Power supply 245 may be configured to provide power to one or more components of active auscultation device 203 and may be a rechargeable or non-rechargeable (e.g., disposable) battery and / or port configured to draw energy from a power line. In some embodiments, power for active auscultation device 203 may be provided directly to port 255 via an electrical connection, for example, from an external battery pack (not shown) or a wall outlet coupled to power from the power line. Additionally or alternatively, power for the active auscultation device 203 may be provided directly via a conductive coil (not shown) positioned within and / or on the housing of the active auscultation device 203, configured to cooperate with a conductive power source (e.g., a magnet) external to the housing, for example, to charge a battery within the housing.

[0070] The indicator display device 258 may be configured to provide one or more indications regarding the operation or status of the active auscultation device 203, such as battery power level, memory capacity, when the active auscultation device 203 is communicating with an external device and / or when an error condition occurs. Exemplary indicator display devices 258 include, but are not limited to, light emitting diodes (LEDs), touch screen displays, and LCD display screens.

[0071] Memory 240 may be configured to receive and store detected acoustic signals emerging from the wearer's skin detected by one or more microphones of microphone array 220 and / or received from DSP / controller 230. In some embodiments, memory unit 240 may be further configured to store instructions regarding the operation of one or more components of active auscultation device 203, such as DSP / controller 230, speakers of speaker array 230, temperature probe 225, IMU 250, transceiver 235, and / or indicator display device 258. In some embodiments, instructions may be received, for example, via port 255 and / or transceiver 235. In some embodiments, DSP / controller 230 may be a microcontroller configured to control the operation of one or more components of active auscultation device 203. In some embodiments, DSP / controller 230 may include and / or be in communication with a timer module such that active auscultation device 203 may be activated after a specified time has elapsed.

[0072] The transceiver 235 may be a communications module, such as a Bluetooth® low energy communications module. In some embodiments, the active auscultation device 203 may be configured to communicate electrically with an external electronic device (e.g., computer system 23 and / or wearer computing device 27) that may execute a software application configured to communicate with, provide one or more instructions to, and / or receive information from the active auscultation device 203. In some embodiments, this communication may enable the wearer and / or user (e.g., a physician or caregiver) to remotely or semi-remotely operate the active auscultation device 203, transmit data from the active auscultation device 203 to the external electronic device, and / or transmit instructions and other data to the active auscultation device 203. In some embodiments, the external electronic device may then transmit the data to a third party, such as a medical practitioner, a company working with the medical practitioner, and / or to a cloud computing environment and / or cloud computing platform 21. In some embodiments, the software and / or firmware used by the active auscultation device 203 may be updated and / or modified via instructions received by the transceiver 235. At times, the transceiver 235 may be configured to communicate, for example, battery charge level, diagnostic information, and / or one or more measurements taken by the active auscultation device 203, to, for example, an external computing device (e.g., a wearer's smartphone or other computing device running a software application described herein).

[0073] In some embodiments, the active auscultation device 203 may communicate with an external electronic device to transmit data regarding the status of the active auscultation device 203 (e.g., battery level and other diagnostic information such as the number of measurements currently in memory). In some embodiments, the active auscultation device 203 may be configured to transmit data continuously for short periods of time.

[0074] The IMU 250 is an inertial motion unit, or accelerometer, configured to detect wearer movement, such as may occur when the wearer is breathing and / or walking. In some embodiments, the IMU 250 may be configured to activate / deactivate the active auscultation device 203 when movement is detected and / or provide an indication to the DSP / controller 230 that may cause the DSP / controller 230 to activate the active auscultation device 203. In some embodiments, the IMU 250 may be configured to activate the active auscultation device 203 when movement, as measured by the IMU, exceeds a predetermined threshold. In some embodiments, the IMU 250 and / or the DSP / controller 230 in communication with the IMU 250 may be configured to recognize patterns in the wearer's movement, such as walking and / or coughing, and the active auscultation device 203 may be activated and / or deactivated in response to the detected patterns. The wearer's movement and / or activity may be measured periodically (e.g., every 1 minute, 5 minutes, or 10 minutes) and / or as needed (e.g., movement is detected and then the wearer is monitored for movement until no movement or a reduction in movement is detected) and stored for download from the active auscultation device 203. Additionally or alternatively, the movement and / or activity measurements may be sent to the DSP / controller 230, which may analyze the movement and / or activity measurements to determine whether there is a change in the movement and / or activity measurements and / or whether a threshold condition (e.g., movement similar to taking a deep breath in and / or out) has been reached, and if so, such a determination may be used to trigger the performance of other actions and / or measurements by the active auscultation device 203.

[0075] The ECG device 268 may be an electrocardiogram device that measures the wearer's heart rate and provides the wearer's heart rate to, for example, the DSP / controller 230 and / or the transceiver 235 for transmission to an external processing device. Variations in the wearer's heart rate measured by the ECG device 258 may trigger high-resolution and / or low-resolution measurements by, for example, an active auscultation device 203 as disclosed herein.

[0076] In some embodiments, active auscultation device 203 may include one or more finite impulse filters (FIRs), shown in FIG. 2C as FIR array 247, which may be physically, electronically, and / or communicatively coupled to one or more of the microphones of microphone array 220, DSP / controller 230, and / or transceiver 235. For example, in some embodiments, microphone array 220 may have first, second, and third microphones, and FIR array 247 may have a corresponding first FIR physically, electronically, and / or communicatively coupled to the first microphone, a second FIR physically, electronically, and / or communicatively coupled to the second microphone, and a third FIR physically, electronically, and / or communicatively coupled to the third microphone. In these embodiments, the first microphone 220B may communicate its detected first acoustic signal to the first FIR, the second microphone 220B may communicate its detected second acoustic signal to the second FIR 410B, and the third microphone may communicate its detected third acoustic signal to the third FIR 410C. The first, second, and / or third FIR may then process the detected signals to improve audio performance, e.g., in real time, by mixing one or more of the first, second, and / or third detected signals and / or by processing and / or filtering the respective first, second, and / or third detected acoustic signals using finite impulse response analysis and / or finite impulse response filters. In some cases, signals processed by the first, second, and / or third FIR may be communicated to the DSP / controller 230 for further processing and / or optimization, e.g., by application of one or more coefficients generated by the DSP coefficient controller 249. The optimized audio signal may then be communicated by DSP / controller 230 to external components and / or processing devices, for example, via transceiver 235 and / or port 255.

[0077] In some embodiments, one or more of the FIRs of FIR array 247 may have multiple coefficients (e.g., 10 to 65) for each FIR and / or for each microphone coupled to the FIR, which may be received, for example, from DSP coefficient controller 249 and / or DSP / controller 230. The coefficients may be applied to the detected acoustic signals to, for example, improve signal quality and / or measurement accuracy and / or analysis results determined using the detected acoustic signals. In some cases, the coefficients may be established and / or adjusted in response to, for example, one or more factors that may affect measurements taken by active auscultation device 203 and / or the quality of those measurements. Sometimes, these adjustments may be made in real time (or near real time) as the detected acoustic signals are received, which may enable adjustment and / or processing of the FIR coefficients in synchronization with the detected acoustic signals, which may, for example, improve signal quality (e.g., reduce noise, amplify desired portions of the signal, etc.) and / or strength. In some cases, adjusting one or more of the coefficients may include performing one or more calibration processes that may be performed, for example, to maximize the strength of the signal that the microphone is detecting and / or providing to its respective FIR of the FIR array 247.

[0078] Sometimes, one or more coefficients of the FIRs of FIR array 247 may be optimized, for example, to maximize the energy and / or power of the detected acoustic signals. This optimization may be done, for example, by determining whether the sum and / or mixture of detected acoustic signals transmitted and / or received by DSP / controller 230 has sufficient energy (e.g., intensity, power, etc.) and / or clarity (e.g., signal-to-noise ratio (SNR)), and if not, how to amplify and / or reduce noise within the detected acoustic signals. By optimizing the maximum energy of the detected acoustic signals among the FIRs in FIR array 247, the coefficients of each FIR may be adjusted and / or calibrated to create a uniformly (or nearly uniformly) strong signal across different microphones by adjusting the amplification across the array of microphones and / or the detected acoustic signals. For example, there may be one FIR coefficient per microphone that can adjust the power / intensity / volume of a particular detected acoustic signal and / or frequency across multiple microphones, so that each detected acoustic signal from each microphone may be given the same (or similar) weight in subsequent calculations.

[0079] In some cases, the coefficients of the FIRs may account for timing discrepancies in the receipt of detected acoustic signals, which may be caused, for example, by different microphone locations relative to the target tissue (e.g., lungs or trapped air pockets within the lungs). For example, if a first microphone in microphone array 220 is 4 cm closer to the source of the outgoing acoustic signal (e.g., a speaker in speaker array 230) than a fourth microphone in microphone array 220, the FIR corresponding to the fourth microphone may add more volume to the coefficients of fourth FIR 440D than the volume of the first microphone, which may act to amplify the delayed signal received by fourth microphone 220D and / or overlap the acoustic signal detected by fourth microphone 220D itself (thereby increasing the signal strength / power).

[0080] In some embodiments, one or more microphones of the microphone array 220 may be configured such that when the active auscultation device 203 is worn, one or more microphones face outward from the wearer's chest to capture ambient noise in the environment, and a subtraction factor (e.g., −1) may be applied to the detected acoustic signal from this microphone, thereby subtracting the ambient noise from the detected acoustic signals of the remaining microphones in the array.

[0081] Optionally, one or more surfaces of microphone wing housing 222, speaker wing housing 227, and / or main body housing 211 may have adhesive and / or sound insulating material 270 adhered thereto. In some embodiments, adhesive and / or sound insulating material 270 may be a substrate of the components of active auscultation device 203 and / or the underside surfaces of microphone wing housing 222, speaker wing housing 227, and / or main body housing 211. Adhesive and / or sound insulating material 270 may be configured to adhere to the wearer's skin for a period of time (e.g., 30 minutes to 4 weeks) and, in some cases, may be waterproof. Additionally or alternatively, adhesive and / or sound insulating material 270 may insulate the components of active auscultation device 203 from external acoustic noise and / or signal noise that may be generated by something other than the speakers of speaker array 230, such that the microphones of microphone array 220 are less likely to detect background noise. Exemplary materials that may be used for adhesive and / or sound insulating material 270 include, but are not limited to, silicone, glue, rubber, and plastic. Sometimes, adhesive and / or sound insulating material 270 may not cover the entire lower portion of microphone wing housing 222, speaker wing housing 227, and / or main body housing 211 so as not to interfere with the projection of acoustic signals into or detection of acoustic signals emerging from the wearer's body. In these embodiments, adhesive and / or sound insulating material 270 may be positioned around the lower exterior of microphone wing housing 222, speaker wing housing 227, and / or main body housing 211 and / or may surround microphone array 220 and / or speaker array 230, for example, in a ring-like manner that does not occlude them.

[0082] In some embodiments, the speakers in speaker array 230 and / or the microphones in microphone array 220 may be positioned in different positions within microphone wing housing 222 and speaker wing housing 227, examples of which are shown in Figures 2D through 2J. In particular, Figure 2D is a diagram of a first microphone array 220A including five microphones 221 arranged in a triangular shape within a corresponding first microphone wing housing 222A, Figure 2E is a diagram of a second microphone array 220B including four microphones 221 arranged in a diamond-like shape within a corresponding second microphone wing housing 222B, Figure 2F is a diagram of a third microphone array 220C including five microphones 221 arranged in a cross-like shape within a corresponding third microphone wing housing 222C, and Figure 2G is a diagram of a fourth microphone array 220D including six microphones 221 arranged in a rectangular shape and three microphones arranged in a triangular shape within a corresponding fourth microphone wing housing 222D.

[0083] The microphones included in one or more of microphone arrays 220A, 220B, 220C, and / or 220D may be oriented or focused in the same and / or different directions. For example, the microphones 221 in microphone arrays 220A, 220B, 220C, and / or 220D may be oriented away from the wearer, while the remainder of the microphones 221 in microphone arrays 220A, 220B, 220C, and / or 220D may be oriented toward the wearer. In some embodiments, all of the microphones 211 facing toward the wearer may be oriented in the same direction (e.g., parallel to the base of the microphone wing housing 220), while in other embodiments, one or more of the microphones 211 facing toward the wearer may be oriented in a different direction (e.g., between 5 and 85 degrees relative to the base of the microphone housing 220). The placement and / or orientation of microphones 221 in microphone arrays 220A, 220B, 220C and / or 220D may be configured to detect sounds coming from particular directions (e.g., towards and / or away from speaker array 230) and / or from particular locations on the wearer's body. It will be understood that the microphone arrays of Figures 2D through 2G are exemplary, and that microphone array 220 may include more or fewer microphones (e.g., 1 to 3, or 10 to 25) than the placement shown in Figures 2D through 2G.

[0084] With respect to the speaker arrays, FIG. 2H is a diagram of a first speaker array 230A including three speakers 231 arranged horizontally and generally parallel to one another within a first speaker wing housing 230A, FIG. 21 includes three speakers 231 arranged vertically and generally parallel to one another within a corresponding second speaker wing, and FIG. 2J is a diagram of a third speaker array 230C including five speakers 231 within a corresponding third speaker wing housing 227C, three arranged horizontally and generally parallel to one another, with two speakers 231 above and below (as shown in FIG. 2J) the three horizontally arranged speakers 231.

[0085] The speakers included within one or more of speaker arrays 230A, 230B, and / or 230C may face or be focused in the same and / or different directions. For example, in some embodiments, all of the speakers 231 in speaker array 230 may be pointed toward the wearer and oriented in the same direction (e.g., parallel to the base of speaker wing housing 230), while in other embodiments, one or more of the speakers 231 that face toward the wearer may be oriented in a different direction (e.g., 5 to 85 degrees relative to the base of speaker housing 230).

[0086] In some cases, activation of speakers and / or microphones included in speaker array 230 and / or microphone array 220 may be selective so that all microphones / speakers in the array are not on at the same time. Each speaker in the array may be configured to emit sound at a different time and / or at a different frequency or set of frequencies (e.g., multiplexed), for example, so that acoustic energy from different speakers in the speaker array can be distinguished from one another. In some embodiments, an acoustic signal may be emitted by one or more of the speakers in speaker array 230 and detected by one or more of the microphones in microphone array 220. The detected acoustic signal from each of the microphones may be analyzed to determine the optimal combination of speakers and / or microphones to use to perform active auscultation measurements.

[0087] In some embodiments, one or more speakers 231 of speaker array 230 may be configured to emit acoustic energy having a variety of frequencies to assess at which frequencies the wearer's body, organs, and / or trapped air pockets resonate and determine a set of frequencies to use for subsequent active auscultation. In some cases, the set of frequencies of the acoustic signals emitted by one or more of the speakers of speaker array 230 may be selected randomly and / or pseudo-randomly. Sometimes, analysis of the detected acoustic signals may then focus on one or more frequencies determined to resonate within the wearer's body, and in some cases, subsequent incident frequencies may be selected based on the frequencies determined to resonate within the wearer's body. Instructions to generate the acoustic signals may be received by speaker 231 and / or speaker array 230, for example, from DSP / controller 230.

[0088] 3A is a top view and FIG. 3B is a side view of exemplary active auscultation device 301 showing a set of main body components 224 housed within rectangular-shaped main body housing 211, a set of microphone wing components 205 housed within trapezoidal-shaped microphone wing housing 222, and a set of speaker wing components 207 housed within trapezoidal-shaped speaker wing housing 227. Microphone wing housing 222 is electrically, physically, and / or communicatively coupled to main body housing 211 via first flexible coupling 213A, and speaker wing housing 227 is electrically, physically, and / or communicatively coupled to main body housing 211 via second flexible coupling 213B. As can be seen in FIG. 3B, active auscultation device 301 includes an adhesive and / or sound insulating material 270 adhered to an underside, skin-facing surface (as oriented in FIG. 3B) of active auscultation device 301.

[0089] Additionally, Figure 3B shows second flexible coupling 213B, speaker wing housing 227, and adhesive and / or sound insulating material 270 oriented at a first non-perpendicular angle 215A relative to the right side (as shown in Figure 3B) of main body housing 211 to accommodate the curvature of the wearer, for example, so that each component of active auscultation device 301 may be securely physically coupled to and / or directly abut the wearer's skin. Although second flexible coupling 213B, speaker wing housing 227, and adhesive and / or sound insulating material 270 are all shown in Figure 3B as being oriented at the same angle, this need not be the case. For example, the second flexible coupling 213B may be oriented at a first non-perpendicular angle 215A where the second flexible coupling 213B joins the main body housing 211, and the speaker wing housing 227 and adhesive and / or sound insulating material 270 may be oriented at a different angle (e.g., parallel to the main body housing 211 or at an angle of magnitude greater than or less than the first non-perpendicular angle 215A) where the second flexible coupling 213B joins the speaker wing housing 227. The first flexible coupling 213A may be flexible and oriented at an angle relative to the main body housing 211 in a similar manner as the second flexible coupling 213B.

[0090] In some embodiments, one or more portions of active auscultation device 203 may be removable from the active auscultation device, e.g., to facilitate cleaning and / or electrical recharging of one or more components thereof. Additionally or alternatively, one or more active auscultation device components may be removable, e.g., to facilitate downloading and / or uploading of information to / from memory 240, DSP / controller 230, DSP coefficient controller 240, and / or transceiver 235. Additionally or alternatively, one or more active auscultation device components may be removable, e.g., to facilitate exchange of one component (e.g., a main body housing) for another component (e.g., a replacement main body housing), whereby a first main body housing may be exchanged for a second main body housing, e.g., when components contained within the first main body housing (e.g., power supply 245) need to be charged, when information needs to be downloaded therefrom, and / or when a new or changed set of instructions must be uploaded to one or more components of the first main body housing.

[0091] An example of an active auscultation device with a detachable portion 302 is shown in Figures 3C through 3F, where Figure 3C provides a top view and Figure 3D provides a side view of the active auscultation device with a detachable portion 302 without the main body housing being disposed within the cavity 310 formed in the cradle 305. The active auscultation device with a detachable portion 302 includes a microphone wing housing 222, a speaker wing housing 227, a first flexible coupling 213A, and a second flexible coupling 213B. The first and / or second flexible couplings 213A and / or 213B of the active auscultation device 302 may be oriented at a non-perpendicular angle relative to the main body housing in a manner that may be similar to that described above with respect to the active auscultation device 301.

[0092] As can be seen in FIG. 3C, cradle 310 includes first port 315 and second port 320 by which removable main body housing 330 (shown in FIG. 3E) can be electrically, mechanically, and / or communicatively coupled to removable main body housing 330, a bottom view of which is shown in FIG. 3E. Removable main body housing 330 may thus accommodate most or all of the set of main body components 224 described herein and may include first coupling 316 configured to electrically, mechanically, and / or communicatively couple to first port 315 and second coupling 321 configured to electrically, mechanically, and / or communicatively couple to second port 320. FIG. 3F provides a side view of active auscultation device having removable portion 302, showing removable main body housing 330 seated within cradle 305 within cavity 310.

[0093] 3G provides a top view, and FIG. 3H provides a side view, of another exemplary embodiment of active auscultation device 303 including main body first portion 211A and main body second portion 221B mechanically, electrically, and / or communicatively coupled together by hinge 320. Main body first portion 211A may be configured to accommodate first portion 224A, or a subset, of the set of main body components, and main body second portion 221B may be configured to accommodate second portion 224B, or a subset, of the set of main body components. In some cases, the components allocated to first portion 224A and second portion 224B of the set of main body components may include components configured to interact with microphone array 222 and speaker array 227, respectively.

[0094] Hinge 320 may be configured to allow articulation of main body first portion 211A relative to main body second portion 221B, for example in the Z direction, and may include flexible materials and / or hinge-like components that allow for articulation. The articulation provided by hinge 320 may contribute to the overall flexibility of active auscultation device 303, allowing it to bend to fit the corresponding curvature of the wearer. Figure 3H shows one example of how main body second portion 211B may articulate relative to main body first portion 221A (in this case, upward as oriented in the figure) via hinge 320.

[0095] Figure 3H also shows main body housing second portion 211B oriented at angle 314A relative to main body housing first portion 211A to provide one example of how main body housing second portion 211B may articulate relative to main body housing first portion 211A. In addition, Figure 3H also shows second flexible coupling 213B, speaker wing housing 227, and adhesive and / or sound insulating material 270 oriented at a second non-perpendicular angle 215B relative to the right side of main body housing second portion 211B (as shown in Figure 3H) to accommodate the curvature of the wearer such that each component of active auscultation device 303 may be securely physically coupled to and directly abut the wearer's skin.

[0096] FIG. 3I provides a top view, and FIG. 3J provides a side view, of another exemplary embodiment of active auscultation device 304 including first body 350 and second body 355 mechanically, electrically, and / or communicatively coupled together via hinge 320. First body 350 may be configured to accommodate first portion 224A or a subset of main body component set and microphone wing component 205, and second main body 355 may be configured to accommodate second portion 224B or a subset of main body component set and speaker wing component 207. In some cases, the components allocated to first portion 224A and second portion 224B of main body component set of active auscultation devices 303 and 304 may be the same; in other cases, they may be different. FIG. 3J shows one example of how second body 355 may articulate relative to first body 350 via hinge 320 (in this case, upward as oriented in the figure).

[0097] Prior to use, any of the active auscultation devices (e.g., 203, 301, 302, 303, and / or 304) may be positioned at one or more locations (e.g., on the skin above / below the left lung, right lung, upper lobe of the lung, lower lobe of the lung, anterior and / or posterior side of the lung) on ​​the wearer's body (e.g., upper / lower chest, upper / lower back, left and / or right side of the torso, etc.) that may be selected, for example, in response to the wearer's physiological characteristics, gender, disease progression, disease localization, and / or trapped air pocket concentration location. In some cases, the position and / or orientation of active auscultation devices 203, 301, 302, 303, and / or 304 on the wearer's body may be selected by a medical professional (e.g., a pulmonologist, respiratory therapist, etc.) so that an area of ​​interest can be investigated and / or to achieve the strongest and / or least noisy detected acoustic signal and / or to avoid interfering factors (e.g., the diaphragm, fatty tissue, and / or other medical devices). The active auscultation devices may be attached to the wearer's body by any acceptable means, including but not limited to adhesives, straps, and / or tape. The active auscultation devices 203, 301, 302, 303, and / or 304 may be worn for any desired length of time (e.g., from 30 minutes to 3 weeks).

[0098] 4A is a diagram of an exemplary wearer 400 in which active auscultation devices 203, 301, 302, 303, and / or 304 are attached to the wearer's chest below the skin overlying the pectoral muscles, whereby, for example, acoustic energy / waves emerging from the wearer's second lung (detected by speaker array 230) may be analyzed, e.g., used, to generate a model of the wearer's lungs and / or air trapped therein, e.g., as modeled second lung 105B shown in FIG. 1C and discussed above, and one or more of whose spectrographs are shown in FIGS. 5A-5D or 6A-6D, and / or produce a result by execution of process 800. In some cases, wearer 400 may wear multiple active auscultation devices, which may be positioned at different locations on the wearer's body (e.g., left and right sides of the rib cage, chest and back of the wearer, etc.).

[0099] In some cases, a medical professional may select locations for placing the active auscultation devices on the body of the wearer 400 in response to determining which parts of the body are likely to produce clear and / or highly repeatable measurements (e.g., as measured by SNR). Sometimes, two or more active auscultation devices 203, 301, 302, 303 and / or 304 may be used to obtain measurements from a variety of different locations, which may facilitate obtaining measurements from representative portions of the wearer's lungs, thereby providing an idea of ​​overall lung health and / or disease progression. In one embodiment, active auscultation devices 203, 301, 302, 303, and / or 304 may be positioned centrally at the right and / or left rib cage of wearer 400, allowing conditions within multiple lung lobes and / or lung parenchyma to be measured simultaneously while avoiding the theoretical risk of overrepresenting upper lobe-predominant emphysema or lower lobe diaphragmatic interference, and thus allowing measurements to be interpreted as short-term and long-term trends relatively free of overrepresentation of upper lobe-predominant emphysema and interference from the diaphragm. In these embodiments, analysis of measurements from active auscultation devices 203, 301, 302, 303, and / or 304 may enable identification / determination of dynamic changes in measurements caused, for example, by exercise, medication efforts, and / or early COPD exacerbations. In some cases, these dynamic changes may be localized or associated, for example, with specific locations within the wearer's lungs or rib cage.

[0100] 4B is a diagram of representative components of exemplary active auscultation devices 203, 301, 302, 303 and / or 304 used to measure acoustic energy / waves emerging from an approximation (represented as an oval) of lungs 425 of a wearer 400. Lungs 425 include first, second, and third pockets 405A, 405B, and 405C, respectively, of trapped air, and air remains trapped within pockets 405A, 405B, and 405C even after wearer 400 has fully exhaled, as may often be the case when wearer 400 has COPD. 4B also shows the paths of first transmitted acoustic signal 410A, second transmitted acoustic signal 410B, and third transmitted acoustic signal 410C, all of which signals are transmitted by speakers 231 of speaker array 230 toward lung 425 and / or first pocket 405A, second pocket 405B, and third pocket 405C of trapped air. FIG. 4B also shows the paths of reflected acoustic signals that respond to first transmitted acoustic signal 410A, second transmitted acoustic signal 410B, and third transmitted acoustic signal 410C as first detected acoustic signal 415A (corresponding to a reflection of first transmitted acoustic signal 410A), second detected acoustic signal 415B (corresponding to a reflection of second transmitted acoustic signal 410B), and third detected acoustic signal 415C (corresponding to a reflection of third transmitted acoustic signal 410C).

[0101] Various techniques may be utilized to distinguish among the first transmitted acoustic signal 410A, the second transmitted acoustic signal 410B, and the third transmitted acoustic signal 410C from one another upon receipt by the microphone 221, so that, for example, characteristics of the first transmitted acoustic signal 405A, the second transmitted acoustic signal 405B, and / or the third transmitted acoustic signal 405C may be determined, for example, by one or more processes disclosed herein. For example, in some embodiments, the first transmitted acoustic signal 410A, the second transmitted acoustic signal 410B, and / or the third transmitted acoustic signal 410C may be transmitted simultaneously, for example, as part of a wideband large-field transmitted acoustic signal. Additionally or alternatively, the first transmitted acoustic signal 410A, the second transmitted acoustic signal 410B, and the third transmitted acoustic signal 410C may be transmitted at different times (e.g., multiplexed) so that the first transmitted acoustic signal 410A, the second transmitted acoustic signal 410B, and the third transmitted acoustic signal 410C may be differentiated from one another using the time of emission / detection. Additionally or alternatively, the first transmitted acoustic signal 410A, the second transmitted acoustic signal 410B, and the third transmitted acoustic signal 410C may be directed toward a target region of the lung 425 by adjusting the orientation of the speaker 221 to direct the first transmitted acoustic signal 410A toward the first pocket of trapped air 405A, the second transmitted acoustic signal 410B toward the second pocket of trapped air 405B, and the third transmitted acoustic signal 410C toward the third pocket of trapped air 405C. Additionally or alternatively, the first outgoing acoustic signal 410A, the second outgoing acoustic signal 410B, and the third outgoing acoustic signal 410C may be emitted from the speaker 231 such that each of the first outgoing acoustic signal 410A, the second outgoing acoustic signal 410B, and the third outgoing acoustic signal 410C has a different frequency and / or has a variable pulse signature. In some embodiments, the characteristics (e.g., frequency and / or intensity) of the outgoing acoustic signals may be a function of characteristics of the wearer and / or the location of the target tissue (e.g., trapped air pockets and / or distance between the speaker and / or microphone and the target tissue).For example, the second transmitted acoustic signal 410B may be transmitted at an intensity greater than that of the first transmitted acoustic signal 410A or the third transmitted acoustic signal 410C because the target tissue of the second transmitted acoustic signal 410B (i.e., the second air pocket 405B) is deeper within the lung 425 (i.e., further away from the speaker 231 and microphone 221) than the first air pocket 405A or the third air pocket 405C.

[0102] Exemplary techniques for distinguishing between the first detected acoustic signal 415A, the second detected acoustic signal 415B, and the third detected acoustic signal 415C include, but are not limited to, frequency analysis (which may be used in embodiments where the first detected signal 415A, the second detected signal 415B, and / or the third detected signal 415C include different frequencies of acoustic signals) and / or time domain analysis (which may be used, for example, in embodiments where the first outgoing acoustic signal 410A, the second outgoing acoustic signal 410B, and / or the third outgoing acoustic signal 410C are emitted at different times). Additionally or alternatively, the difference between the first outgoing acoustic signal 410A, the second outgoing acoustic signal 410B, and the third outgoing acoustic signal 410C may be responsive to, for example, the location (e.g., distance from the speaker 231) and / or size of the targeted trapped air pockets 405A, 405B, and / or 405C. In some embodiments, the differences between the first outgoing acoustic signal 410A, the second outgoing acoustic signal 410B, and the third outgoing acoustic signal 410C may be used, for example, by the DSP / controller 230 and / or an external processing device to distinguish between all signals received by the microphone 221. In some cases, the first detected signal 415A, the second detected signal 415B, and / or the third detected signal 415C may be distinguished from one another, for example, by the DSP / controller 230 and / or an external processor, via, for example, the time at which they were received (as may occur when each different outgoing acoustic signal is projected to the wearer at a different time) and / or the frequency and / or set of frequencies included within the detected signal. Additionally or alternatively, one or more of the outgoing acoustic signals may include a signature (e.g., a set of frequencies or the absence of an acoustic signal) embedded within the outgoing acoustic signal as that signal is transmitted over time, and this signature may be used to distinguish one outgoing acoustic signal from another.

[0103] It is expected that the distance from an emitter such as speaker 231 to trapped air positioned within air pockets such as first pocket 405A, second pocket 405B, and third pocket 405C of trapped air and back to a receiver such as microphone 221 will vary for each trapped air pocket, and that these differences in time may make it possible to distinguish between different trapped air pockets by estimating the time delay for each particular stimulus (or sound frequency).

[0104] In some embodiments, the transmitted acoustic signals may be generated using known frequencies, which in some cases may be and / or include a pseudo-randomly selected set of frequencies (e.g., a PN sequence). These known frequencies and / or sets of frequencies may facilitate matching of signals from a group or set of frequencies, making analysis of the detected acoustic signals easier, for example, by aligning the detected acoustic signals with one another, e.g., in time and / or frequency, and / or grouping the detected acoustic signals together for comparison. The analysis may be performed, for example, to detect and / or determine characteristics (e.g., size, volume, location) of one or more trapped air pockets within the wearer's lungs. In some cases, varying the characteristics of the pseudo-random noise included within the transmitted acoustic signals may facilitate fine-tuning and / or amplification of portions of corresponding detected acoustic signals received from different locations and / or entities within the body, such as trapped air pockets that may have different resonant cavity sizes. In some cases, a PN sequence may be represented as and / or correspond to a stream of 1s and 0s (or 1s and -1s) derived from a known formula, which outputs binary values ​​that may look and / or behave like random noise, but which have a known pattern if the initial state of its generation is known. To convert a PN sequence into acoustic noise, a known carrier signal (e.g., a sine wave and / or a set of sine waves at different frequencies) may be multiplied by the PN sequence, effectively introducing a 180-degree phase shift in the carrier signal at random intervals. To the average observer, the original signal appears like noise, but an observer who knows the PN sequence and the characteristics of the original carrier signal may be able to synchronize the detected acoustic signals with each other using the known components and / or compare the detected acoustic signals with the original modified carrier signal to determine one or more differences therebetween (e.g., losses at some frequencies and / or gains at other frequencies).The duration of each 1 and -1 can provide a better signal for nearby or distant air-trapping pockets, or make it easier to locate and / or detect air pockets. In some cases, having a shorter duration of 1 and -1 may provide better spatial resolution (e.g., for determining the location of a trapped air volume (i.e., air pocket)) because faster transitions allow more bits to be sent to the processor at the same time, thereby enabling higher spatial resolution. Because sound travels back and forth within the lungs or other animal tissue over time, in some cases using an outgoing acoustic signal with a higher density of bits being transmitted may allow for more accurate alignment of the detected acoustic signal. To achieve this spatial resolution, a high sampling frequency (e.g., above 48 kHz), typically beyond the audible range, may be required.

[0105] 4B shows only the first outgoing acoustic signal 410A, the second outgoing acoustic signal 410B, and / or the third outgoing acoustic signal 410C incident on a respective first pocket 405A, second pocket 405B, and third pocket 405C of trapped air, but this is not necessarily the case. In some embodiments, one or more of the first outgoing acoustic signal 410A, the second outgoing acoustic signal 410B, and the third outgoing acoustic signal 410C may be incident on multiple pockets of trapped air 405.

[0106] In some embodiments, the speaker 231 may emit the first transmitted acoustic signal 410A, the second transmitted acoustic signal 410B, and / or the third transmitted acoustic signal 410C in different trajectories and / or at different intensities (power levels) such that the acoustic signals are directed toward different target locations within the wearer (e.g., three trapped air pockets 405A, 405B, and / or 405C). This may serve to focus the transmitted acoustic signals onto one or more trapped air pockets 405A, 405B, and / or 405C. Additionally or alternatively, frequencies of the transmitted acoustic signals may be selected that have the potential to resonate with trapped air pockets positioned at different depths (i.e., distances between the speaker and the air pockets) of lung tissue, and when resonance is found at a frequency associated with a particular depth and / or location of tissue, the corresponding location of the trapped air pocket may be determined. In this manner, the locations and / or characteristics of various trapped air pockets within the wearer's lungs may be plotted or mapped.

[0107] In some embodiments, the active auscultation system 203, 301, 302, 303, and / or 304 may be configured to use the longest sequence to send to a single (or multiple) speaker / microphone pair. Matched filters may then be used to estimate resonance by distance and / or implement multi-resonance stimulation. The longest sequence may be a pseudo-randomly selected sequence of frequencies created using a repeatable generative process or generative parameters. In some cases, the longest sequences may have one or more special characteristics, and their frequency spectrum appears like broadband (or white) noise. Sometimes, two longest sequences with different generative parameters may have very similar average frequency spectra, but a filter matching each specific sequence can be created to enable detection of each individual sequence even in the presence of other signals and / or sequences with different parameters.

[0108] 5A through 5D and 6A through 6D, respectively, provide first and second sets of exemplary spectrograms of detected acoustic signals that may be generated / detected by a system such as system 201 and / or 202 and / or by an active auscultation device such as active auscultation devices 203, 301, 302, 303, and / or 304 when the acoustic signals are projected into the lungs. These spectrograms show frequency in Hz on the first y-axis (left as oriented in the figures), magnitude in decibels (dB) on the second y-axis (right as oriented in the figures), and frame x 10 on the x-axis. 4 5A through 5D and 6A through 6D may be used to determine and / or establish a lung signature of the wearer.

[0109] More specifically, Figures 5A through 5D provide spectrograms of lungs without COPD, where Figure 5A provides spectrogram 501 in which the instantaneous energy in each frame is represented by a grayscale bar or scale positioned to the right of the graph, and Figure 5B provides spectrogram 502 of energy change over time, or energy production, for a control subject without COPD at rest, breathing at a rate of 8.57 breaths per minute with a 7-second respiratory cycle. In some cases, spectrogram 502 in Figure 5B may serve as a baseline, and energy changes in other spectrograms for the same or different patients may be compared to the baseline in spectrogram 502 and plotted as differences from the baseline energy. The dynamic range of energy production shown in spectrogram 502 in Figure 5B is in the range of [-8:6] dB (14 dB). When the subject increases their breathing to a breathing rate of 12 breaths per minute, a smoothed spectrogram 503 is produced as shown in Figure 5C. Figure 5D provides a spectrogram 504 showing an exemplary reduced dynamic range of energy production, approximately 7 dB, with very steep and localized energy changes.

[0110] A first set of exemplary spectrograms 501-504 may be generated / detected by a system such as system 201 and / or 202 and / or an active auscultation device such as active auscultation devices 203, 301, 302, 303, and / or 304 when an acoustic signal is projected into a lung that does not have COPD, where spectrogram 501 shows a smoothed spectrogram and spectrogram 502 shows the energy evolution of the detected acoustic signal before the wearer exercises. Spectrograms 501 and 502 show a relatively large dynamic range of 14 decibels between a range of [-8:6] dB obtained when the wearer is breathing at a relatively slow rate of approximately 8.5 breaths per minute. Spectrogram 503 shows a smoothed spectrogram, and spectrogram 504 shows the energy evolution of the detected acoustic signal from spectrograms 501 and 502 when the wearer is breathing faster during exercise, demonstrating a reduced dynamic range compared to spectrograms 501 and 502, respectively, where spectrograms 503 and 504 show a dynamic range of 7 decibels between the [-5:2] dB range obtained when the wearer is breathing at a relatively fast rate of approximately 12 breaths per minute. In this manner, acoustic signatures of the wearer's lungs during variable breathing rates may be measured and / or established as a baseline for the acoustic signatures of control wearers (i.e., wearers not diagnosed with COPD).

[0111] 6A, 6B, 6C, and 6D provide a second set of exemplary spectrograms 601, 602, 603, and 604, respectively, of detected acoustic signals that may be generated / detected by a system such as system 201 and / or 202 and / or an active auscultation device such as active auscultation devices 203, 301, 302, 303, and / or 304 when the acoustic signals are projected into lungs with severe COPD (i.e., multiple trapped air pockets). More specifically, FIG. 6A provides a smoothed spectrogram 601 of the lungs when the wearer is breathing at approximately 12 breaths per minute. FIG. 6B provides a spectrogram 602 showing the energy evolution of the detected acoustic signal while the wearer is exercising and / or breathing at a relatively fast rate of approximately 12 breaths per minute, and also showing a reduced dynamic range [−4:1] dB, where the energy change remains fairly constant across the entire spectrum. Figure 6C provides a spectrogram 603 showing the detected signal when the wearer is exercising and the wearer's breathing rate increases, and Figure 6D provides a spectrogram 604 showing the detected signal when the wearer is resting after exercise and the wearer's breathing rate has slowed to 10 breaths per minute after exercise, but energy production remains in the [-4:1] dB or 5 dB dynamic range.

[0112] For example, active auscultation measurements performed by the active auscultation devices described herein may include powering a speaker and microphone and transmitting an acoustic signal toward a region of interest within the wearer's body, which may most likely be the lungs and / or a pocket or volume of trapped air within the lungs. The transmitted acoustic signal may be, for example, a single frequency, a set of frequencies, a broadband set of frequencies, and / or a white-noise-like broadband set of frequencies. In some cases, the acoustic signal may vary over time. For example, the acoustic signal may be modulated over time and / or may vary in frequency. The frequency variation may be random, pseudo-random, and / or continuous (e.g., increase and / or decrease at regular intervals (e.g., 10 Hz, 100 Hz, etc.)). Additionally or alternatively, the acoustic energy may have sufficient intensity / power to generate measurements. In some embodiments, the systems, devices, and methods herein may be configured such that the acoustic signal is not of sufficient intensity / power to be heard by the wearer and / or other individuals near the wearer.

[0113] Acoustic signals resulting from the outgoing acoustic signal (i.e., detected acoustic signals) may be detected by one or more microphones and converted to digital signals that may be stored and / or processed by a processor / memory configuration such as DSP / controller 230. The detected acoustic signals may be processed by DSP / controller 230 and stored in memory 240.

[0114] In some embodiments, the active auscultation devices disclosed herein may be configured to make measurements of variable duration and / or resolution, for example, measurements may be made at high, medium, and low resolution, and measurements may vary in time.

[0115] High-resolution measurements may be referred to as detailed measurements. In one embodiment, high-resolution measurements may have a duration of, for example, 3 to 10 minutes, with a data consumption rate of, for example, 203 to 300 kilobytes per minute. An exemplary data storage requirement for a high-resolution measurement may be, for example, 1.2 to 1.8 megabytes. In one embodiment, to perform high-resolution measurements, the active auscultation device may be required to be connected to an external processing device (e.g., computer system 23, wearer computing device 27, etc.) via a wireless and / or wired communication connection. In some cases, the external processing device may be running a software application configured to communicate with active auscultation devices such as active auscultation devices 203, 301, 302, 303, and / or 304, whereby, for example, the active auscultation devices may communicate measurements in real time as they are taken, thereby avoiding the need to store measurements in memory 240. Additionally or alternatively, measurements (e.g., low-resolution measurements stored on memory 240) may be communicated to an external processing device upon communicative coupling therewith. In some embodiments, high-resolution measurements may be triggered by an application, which may also guide the wearer through a series of steps to perform, for example, to perform certain measurements, and to initiate actions (e.g., breathing and / or exercise) to be taken by the wearer before, during, and / or after the measurements are made. Additionally or alternatively, the software application may ask the wearer one or more questions regarding, for example, the wearer's health status, the wearer's comfort / quality of life, and / or environmental conditions (e.g., temperature, humidity level, air quality level, etc.). Answers to these questions may be associated with measurements made by the active auscultation device and received by the external computing device. In some cases, high-resolution measurements may be transmitted to the application in real time.In some embodiments, the answers to these questions may be scored according to a scoring formula that may be associated with the questions (as in a patient-reported-outcome (PRO) instrument), for example, to quantify the answers and track patient answers to the same questions over time.

[0116] Low-resolution measurements made by the systems and devices disclosed herein may also be referred to as rapid measurements. In one embodiment, a low-resolution measurement may have a duration of, for example, 0.5 to 5 minutes with an exemplary data consumption rate of 28 to 30 kilobytes per minute. An individual low-resolution measurement may have a maximum data storage requirement of 40 to 80 kilobytes. In one embodiment, the active auscultation device may store one or more low-resolution measurements in on-board memory. The stored measurements may then be uploaded to an external processing device, for example, upon synchronization of the active auscultation device with an external communication device. When the memory is full, a visual indication on the sensor and application may be displayed, and new measurements may not be possible until the application and memory are desynchronized.

[0117] In some cases, a noise reduction algorithm (e.g., a deterministic beamforming algorithm) may be applied to the detected acoustic signal, e.g., to improve the signal-to-noise ratio (SNR). The resulting audio stream may then be segmented into frames, e.g., of 2 to 30 milliseconds in duration, and a fast Fourier transform (FFT) may be applied to each segment. The segments may then be individually compared to each other and / or to a running average of recent segments, e.g., to find outlier or noise-producing segments. The segments may then be analyzed, e.g., to estimate the patient's LRS and / or track its fluctuations over time, e.g., using 0.5-, 10-, and 120-second moving averages.

[0118] In some embodiments, analysis of the LRS and / or segments may be used to determine, for example, lung volume change, lung and / or air pocket resonance, ventilation, etc., over the patient's respiratory cycle. Additionally or alternatively, the patient's LRS may be used to derive secondary features, such as the main spectral peak (MSP), which is the highest energy level over all spectral frames (see, e.g., FIGS. 5A-5D and 6A-6D). Other secondary features may be correlated with spectral energy evolution (e.g., the difference between the fast and slow averages). These features (LRS, lung volume change, secondary features, etc.) may be used to track cyclic changes in the patient's LRS during, for example, inhalation and exhalation. From here, respiratory events (inhalation and exhalation) may be marked when respiratory cycle estimation is performed and compared with manual labeling, such as may be done by visual observation of the patient. FIG. 7 provides a scatter plot 701 comparing the patient's labeled respiratory cycle in seconds observed as a function of the estimated respiratory cycle in seconds. The estimated respiratory cycle is determined by analysis of 16,000 frames selected from 100 test segments. The scatter plot 701 also provides a linear regression with R2=0.960.

[0119] Use of the systems, devices, and methods disclosed herein may be applicable to monitoring many respiratory conditions in addition to COPD and / or air trapping. For example, active auscultation and other measurements obtained by active auscultation devices 203, 301, 302, 303, and / or 304 may be used to monitor many different pulmonary conditions and / or lung health and / or diagnose one or more pulmonary conditions. For example, measurements obtained by active auscultation devices 203, 301, 302, 303, and / or 304 may be used to measure and / or diagnose disease and / or disease progression, with exemplary pulmonary diseases and / or conditions being bronchial inflammation, asthma, pneumonia, cancer, pulmonary embolism, and / or interstitial lung disease, which is characterized by hardening of lung tissue. Additionally or alternatively, active auscultation and other measurements obtained by active auscultation devices 203, 301, 302, 303 and / or 304 may be used to monitor pulmonary conditions over time, for example, to assess the effectiveness of treatments (e.g., medication, respiratory therapy, and / or exercise).

[0120] 8 is a flow diagram providing steps of an exemplary process 800 for performing active auscultation using, for example, an active auscultation device disclosed herein. Process 800 may be performed by one or more of the systems and / or system components disclosed herein, such as systems 201 and / or 202, and / or active auscultation devices, such as active auscultation devices 203, 301, 302, 303.

[0121] Optionally, in step 805, an indication of activation and / or trigger to begin projecting acoustic signals, such as outgoing acoustic signals 405A, 405B, and / or 405C acoustic signals, into the wearer's thorax may be received by a processor of the active auscultation device, such as, for example, DSP / controller 230. The activation and / or trigger may be, for example, an indication from an inertial motion unit, such as IMU 250, that the wearer has moved (e.g., inhaled, exhaled, started walking, etc.) and / or may be in response to instructions stored in a memory, such as memory 240, for example, that scheduled and / or periodic active auscultation measurements should be taken by the active auscultation device.

[0122] In step 810, an acoustic signal and / or set of acoustic signals may be projected into the wearer's thorax toward the wearer's lungs (e.g., lungs 425) by one or more speakers, such as, for example, speaker 231 of speaker array 230 as shown in FIG. 4B . In some embodiments, performance of step 810 may be responsive to performance of step 805. Then, in step 815, one or more detected acoustic signals that have passed through and / or reflected from the wearer's tissue (e.g., lung tissue) may be detected by one or more microphones, such as microphone 220, and communicated / received by a processor, such as DSP / controller 230 and / or processor 204. Optionally, in step 820, the received detected acoustic signals may then be pre-processed to remove noise, for example, filtering out undesirable sound frequencies (e.g., by applying a band-pass filter), and / or compressing the data that constitutes the detected acoustic signals. Additionally or alternatively, in step 820, the detected acoustic signal may be sampled, for example, at periodic intervals (eg, a 0.5 s sample every 3 seconds or a 1 s sample every 5 seconds).

[0123] Optionally, in step 825, it may be determined whether the signal quality of the detected acoustic signal is below a threshold (e.g., signal-to-noise ratio (SNR)) and / or whether movement of the active auscultation device used to perform process 800 and / or provide information that may be received during the performance of process 800 is detected. When determining whether the signal quality is below a threshold, step 825 may be performed by an on-board processor, such as, for example, DSP / controller 230 and / or external processor 204. When step 825 is performed by an external processor, execution of step 825 may include analyzing the received signal to determine whether it is correct and / or is being transmitted wirelessly without interference, for example, from the wearer's body (e.g., moisture). When the signal quality is below the threshold, a calibration sequence may be performed (step 830). In some cases, performing the calibration sequence may include transmitting an analysis of the detected acoustic signals from one or more speakers of a speaker array, such as speaker array 230, and / or received by one or more microphones of a microphone array, such as microphone array 220, to determine, for example, one or more speaker / microphone pairs that provide the clearest detected acoustic signals and / or detected acoustic signals above a threshold SNR.

[0124] When execution of step 825 indicates that no movement was detected, process 800 may proceed to step 835. When movement is detected, for example, by IMU 250, by the clinician's visual observation, and / or by a device communicatively coupled to the active auscultation device (e.g., a device that triangulates the position of the active auscultation device, such as computer system 23 and / or the wearer's computing device 27), a calibration process may be performed, for example, to optimize the operation of the microphone and / or speaker used by the active auscultation device to capture the detected acoustic signal, thereby optimizing one or more characteristics (e.g., SNR, intensity, power, etc.) of the detected acoustic signal.

[0125] In step 835, the detected acoustic signal, the sampled detected acoustic signal, and / or the pre-processed detected acoustic signal may be analyzed to determine one or more characteristics thereof, and the results of the analysis may be used to determine, for example, a lung signature of the wearer, a volume of trapped air in the wearer's lungs, a degree of respiratory function of the wearer, and / or an indication of the wearer's respiratory health (step 840). In step 845, the results of the analysis (e.g., spectrograph) of step 835 and / or an indication of the resonance signature of the wearer's lungs may be provided to a display device, such as display 209.

Claims

1. 1. A device for performing active auscultation, comprising: a speaker wing housing containing a speaker configured to project an acoustic signal into the patient's skin in response to an electrical signal received from the controller; a microphone wing housing containing a microphone configured to detect a detected acoustic signal emerging from the patient's skin and to communicate the detected acoustic signal to the controller; a main body housing physically and communicatively coupled to the microphone wing housing by a first coupling and physically and mechanically coupled to the speaker wing housing by a second coupling, the main body housing comprising: a transceiver communicatively coupled to the controller and memory, the transceiver configured to communicate the detected acoustic signal to an external device and to receive instructions from the external device; the memory is communicatively coupled to the controller and the transceiver, the memory configured to receive instructions from the transceiver and to store a set of instructions for execution by the controller; a transceiver, wherein the controller is configured to generate electrical signals in response to instructions stored in the memory, communicate the electrical signals to the speaker, receive the detected acoustic signals from the microphone, and communicate the detected acoustic signals to the transceiver; a main body housing comprising: a battery electrically coupled to the speaker, the microphone, the transceiver, the memory, and the controller, the battery configured to provide power to the speaker, the microphone, the transceiver, the memory, and the controller.

2. The device for performing active auscultation according to claim 1 , wherein the controller is further configured to pre-process the detected acoustic signal to remove noise.

3. 3. A device for performing active auscultation according to claim 1 or 2, wherein the speaker wing housing houses an array of multiple speakers.

4. 4. A device for performing active auscultation as recited in claim 1, 2, or 3, wherein the microphone wing housing houses an array of multiple microphones.

5. 5. A device for performing active auscultation according to any one of claims 1 to 4, wherein the main body housing includes a first section physically coupled to a second section by a flexible hinge.

6. 6. A device for performing active auscultation as described in any one of claims 1 to 5, wherein a surface of at least one of the microphone wing housing, speaker wing housing, and main body housing is configured to be acoustically coupled to the patient's skin by at least one of an elastic band, a sleeve, a garment, and an adhesive.

7. 7. A device for performing active auscultation according to any one of claims 1 to 6, wherein at least one of the first coupling and the second coupling is flexible, and the device is configured to bend due to the flexibility of the at least one of the first coupling and the second coupling.

8. 8. A device for performing active auscultation according to claim 1, wherein the memory is further configured to store the detected acoustic signals.

9. 9. A device for performing active auscultation according to any one of claims 1 to 8, further comprising a motion detector for detecting movement of the device.

10. The device of claim 9 , wherein the controller is further configured to perform calibration of the speaker and the microphone in response to receiving detected movement from the motion detector.

11. 1. A method for performing active auscultation, comprising: receiving, by a processor, a first detected acoustic signal, the first detected acoustic signal corresponding to a first incident acoustic signal projected into a thorax of a wearer of the active auscultation device; receiving, by the processor, an indication that the wearer has moved; initiating, by the processor, performance of a calibration sequence of the active auscultation device in response to receiving the indication that the wearer has moved; receiving, by the processor, a second detected acoustic signal, the second detected acoustic signal corresponding to a second incident acoustic signal projected into the wearer's thorax of the active auscultation device, the second detected acoustic signal and the second incident acoustic signal being different from the first detected acoustic signal and the first incident acoustic signal, respectively, due to performance of the calibration sequence; analyzing the first detected acoustic signal and the second detected acoustic signal by the processor; determining, by the processor, lung characteristics of the wearer using the analysis; and providing, by said processor, a representation of said characteristics to a user.

12. receiving, by the processor, predetermined characteristics of the wearer's lungs; comparing, by the processor, the characteristics of the wearer's lungs to the predetermined characteristics of the wearer's lungs; and providing, by the processor, a display of the comparison to the user.

13. The method of claim 11 , wherein the characteristic of the wearer's lungs is an acoustic lung signature.

14. The method of claim 11 , wherein the characteristic of the wearer's lungs is a volume of air trapped within the wearer's lungs.

15. 12. The method of claim 11, wherein the characteristic of the wearer's lungs is the number of trapped air pockets present in the wearer's lungs.

16. 12. The method of claim 11, wherein the characteristic of the wearer's lungs is the size of one or more pockets of trapped air present within the wearer's lungs.

17. 12. The method of claim 11, wherein the feature of the wearer's lungs is the location of one or more pockets of trapped air present within the wearer's lungs.

18. 14. The method of claim 13, wherein the predetermined characteristic of the wearer's lungs is a first acoustic lung signature and the characteristic of the wearer's lungs is a second acoustic lung signature.

19. 15. The method of claim 14, wherein the predetermined characteristic of the wearer's lungs is a first volume of air trapped in the wearer's lungs and the characteristic of the wearer's lungs is a second volume of air trapped in the wearer's lungs.

20. 16. The method of claim 15, wherein the predetermined characteristic of the wearer's lungs is a first number of trapped air pockets present in the wearer's lungs, and the characteristic of the wearer's lungs is a second number of trapped air pockets present in the wearer's lungs.

21. 17. The method of claim 16, wherein the predetermined characteristic of the wearer's lungs is a first size of one or more pockets of trapped air present in the wearer's lungs, and the characteristic of the wearer's lungs is a second size of one or more pockets of trapped air present in the wearer's lungs.

22. 18. The method of claim 17, wherein the predetermined characteristic of the wearer's lungs is a first location of one or more pockets of trapped air present within the wearer's lungs, and the characteristic of the wearer's lungs is the location of one or more pockets of trapped air present within the wearer's lungs.

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