Wearable devices configured for facilitating diagnosis and/or assessment of pulmonary diseases, and corresponding methods

Abstract

Exemplary implementations may provide objective, continuous, and clinically useful assessment of asthma control in subjects including young children using a device that is compact, non-intrusive, and simple. The device may include a water-resistant, flexible patch that can be comfortably worn for two weeks or more. In some implementations, the patch may resemble a Band-Aid® that is placed on the suprasternal notch. The device may record respiratory sounds that can be analyzed to identify coughing and wheezing episodes. The device may operate in different modes including ones for assessment of nocturnal symptoms, exercise-induced asthma, and overall asthma control. The device may be useful for objectively assessing asthma control to aid clinical therapy, and for an improved way to diagnose exercise-induced asthma.

What is claimed is: 
     
         1 . A wearable device configured for facilitating diagnosis and/or assessment of a pulmonary disease, the device comprising:
 a flexible patch having a skin contact surface configured to contact human skin;   a water-resistant enclosure disposed upon or within the patch;   an acoustic sensor disposed within the enclosure, the acoustic sensor being configured to provide an acoustic signal conveying information associated with internal respiratory sounds, wherein the acoustic sensor is a contact accelerometer configured to sense tissue vibration;   a non-transitory computer-readable storage medium disposed within the enclosure, the storage medium being configured to store information and provide access to the stored information; and   one or more processors disposed within the enclosure, the one or more processors being configured by computer program instructions to:
 record onto the storage medium information conveyed by one or more signals including the acoustic signal, the information being analyzable to identify one or both of wheezing or coughing episodes. 
   
     
     
         2 . The device of  claim 1 , wherein the patch is configured to be worn proximate to a suprasternal notch of a human subject. 
     
     
         3 . The device of  claim 1 , wherein the patch is shaped to resemble an elongated adhesive bandage. 
     
     
         4 . The device of  claim 1 , further comprising a communications port disposed within the enclosure, the communications port being configured to facilitate communication between one or more components of the device and a computing platform that is physically separate and distinct from the device. 
     
     
         5 . The device of  claim 1 , further comprising a power source disposed within the enclosure, the power source being configured to provide electrical power to one or more components of the device. 
     
     
         6 . The device of  claim 5 , wherein the power source is configured to provide electrical power for more than two weeks. 
     
     
         7 . The device of  claim 1 , wherein the skin contact surface of the patch is covered with a hypoallergenic adhesive configured to adhere to human skin. 
     
     
         8 . The device of  claim 7 , further comprising a protective cover configured to protect the hypoallergenic adhesive covering the skin contact surface of the patch when the device is not in use. 
     
     
         9 . The device of  claim 8 , further comprising a switching mechanism configured to activate one or more components of the device responsive to the protective cover being removed from the skin contact surface of the patch. 
     
     
         10 . The device of  claim 1 , further comprising a switching mechanism configured to deactivate one or more components of the device responsive to the device ceasing to be worn. 
     
     
         11 . The device of  claim 1 , wherein the one or more processors are further configured by computer program instructions to control an operational mode of the device, the operational mode being selected from among two or more preprogrammed operational modes of the device. 
     
     
         12 . The device of  claim 11 , wherein the two or more preprogrammed operational modes include one or more of:
 (1) a nocturnal mode in which the device is dormant during daytime and activated during nighttime, wherein daytime and nighttime are defined by default time values or time values provided by a user;   (2) an exercise mode in which the device is activated from a dormant state responsive to a level of exercise being detected and remains activated for a duration after the level of exercise ceases, the duration being defined by a default duration value or a duration value provided by a user;   (3) a 24-hour mode in which the device remains activated during all times the device is being worn; or   (4) a before/after mode in which the device is activated during specific times before and after a therapeutic treatment, the specific times being defined by specific time values or specific time values provided by a user.   
     
     
         13 . The device of  claim 1 , wherein the one or more processors are further configured by computer program instructions to cause the device to record information during a fraction of the time during which the device is activated. 
     
     
         14 . The device of  claim 13 , wherein the fraction of the time during which the device records is defined as the first ten seconds of every minute. 
     
     
         15 . The device of  claim 1 , wherein the one or more processors are further configured by computer program instructions to provide a report based on information recorded while the device is worn, the report comprising one or both of a table or a graph conveying one or more of:
 (1) an amount of time with nocturnal wheezing;   (2) an amount of time with daytime wheezing;   (3) an amount of sleep time with wheezing;   (4) an amount of day time with wheezing;   (5) an amount of nighttime coughs;   (6) an amount of daytime coughs;   (7) an amount of wheezing episodes during and/or after exercise; or   (8) an amount of moderate-vigorous physical activity (MVPA) associated with wheezing.   
     
     
         16 . The device of  claim 1 , further comprising a muscle activity sensor, the muscle activity sensor being configured to provide a muscle activity signal conveying information associated with contraction of a sternocleidomastoid (SCM) muscle. 
     
     
         17 . The device of  claim 16 , wherein the one or more processors are further configured by computer program instructions to determine an occurrence of clinically significant wheezing, the determination being based on information conveyed by the acoustic signal and the muscle activity signal. 
     
     
         18 . The device of  claim 1 , further comprising an ambient temperature sensor disposed within the enclosure, the ambient temperature sensor being configured to provide a temperature signal conveying information associated with an ambient temperature. 
     
     
         19 . The device of  claim 18 , wherein the one or more processors are further configured by computer program instructions to determine a presence of cold air triggered asthma exacerbation, the determination being based on information conveyed by the acoustic signal and the temperature signal. 
     
     
         20 . The device of  claim 1 , further comprising a motion sensor disposed within the enclosure, the motion sensor being configured to provide a motion signal conveying information associated with body motion. 
     
     
         21 . The device of  claim 20 , wherein the one or more processors are further configured by computer program instructions to determine a presence of poor asthma control indicated by wheezing during exercise, the determination being based on information conveyed by the acoustic signal and the motion signal. 
     
     
         22 . The device of  claim 20 , wherein the one or more processors are further configured by computer program instructions to determine a presence of exercise-induced asthma indicated by wheezing after exercise, the determination being based on information conveyed by the acoustic signal and the motion signal. 
     
     
         23 . The device of  claim 20 , further comprising a clock disposed within the enclosure, the clock being configured to provide a clock signal conveying information associated with a time of day. 
     
     
         24 . The device of  claim 23 , wherein the one or more processors are further configured by computer program instructions to determine whether a subject wearing the device is awake or sleeping, the determination being based on information conveyed by one or both of the motion signal or the clock signal. 
     
     
         25 . The device of  claim 23 , wherein the one or more processors are further configured by computer program instructions to determine a current activity level of a subject wearing the device, the determination being based on information conveyed by one or more of of the motion signal, a posture signal provided by the motion sensor and conveying information associated with posture of the subject, or the clock signal. 
     
     
         26 . The device of  claim 1 , wherein the one or more processors are further configured by computer program instructions to facilitate communication between the device and a computing platform that is physically separate and distinct from the device. 
     
     
         27 . The device of  claim 26 , wherein the computing platform is a mobile device configured to run an application by which the device can be programmed. 
     
     
         28 . The device of  claim 1 , wherein the pulmonary disease includes one or more of asthma, chronic obstructive pulmonary disease (COPD), emphysema, bronchitis, restrictive lung disease, pneumonia, atalectasis, or consolidation. 
     
     
         29 . A wearable device configured for facilitating diagnosis and/or assessment of a pulmonary disease, the device comprising:
 a flexible patch having a skin contact surface covered with a hypoallergenic adhesive configured to adhere to human skin;   a water-resistant enclosure disposed upon or within the patch;   an acoustic sensor disposed within the enclosure, the acoustic sensor being configured to provide an acoustic signal conveying information associated with internal respiratory sounds;   a muscle activity sensor disposed within the enclosure, the muscle activity sensor being configured to provide a muscle activity signal conveying information associated with contraction of an accessory respiratory muscle;   a non-transitory computer-readable storage medium disposed within the enclosure, the storage medium being configured to store information and provide access to the stored information; and   one or more processors disposed within the enclosure, the one or more processors being configured by computer program instructions to:
 record onto the storage medium information conveyed by one or more signals including the acoustic signal and the muscle activity signal, the information being analyzable to identify one or both of wheezing or coughing episodes; and 
 determine an occurrence of clinically significant wheezing, the determination being based on information conveyed by the acoustic signal and the muscle activity signal. 
   
     
     
         30 . The device of  claim 29 , wherein the acoustic sensor includes one or both of a microphone configured to sense sound propagating in air or a contact accelerometer configured to sense tissue vibration. 
     
     
         31 . The device of  claim 29 , wherein the pulmonary disease includes one or more of asthma, chronic obstructive pulmonary disease (COPD), emphysema, bronchitis, restrictive lung disease, pneumonia, atalectasis, or consolidation. 
     
     
         32 . The device of  claim 29 , wherein the accessory respiratory muscle is a sternocleidomastoid (SCM) muscle. 
     
     
         33 . A method for facilitating diagnosis and/or assessment of a pulmonary disease using a wearable device, the wearable device comprising a flexible patch having a skin contact surface covered with a hypoallergenic adhesive configured to adhere to human skin and a water-resistant enclosure disposed upon or within the patch, the patch being configured to be worn proximate to a suprasternal notch of a human subject and being shaped to resemble an elongated adhesive bandage, the method comprising:
 obtaining an acoustic signal from an acoustic sensor disposed within the enclosure, the acoustic signal conveying information associated with internal respiratory sounds, wherein the acoustic sensor is a contact accelerometer configured to sense tissue vibration;   obtaining a muscle activity signal from a muscle activity sensor disposed within the enclosure, the muscle activity signal conveying information associated with contraction of an accessory respiratory muscle;   recording onto a non-transitory computer-readable storage medium disposed within the enclosure information conveyed by one or more signals including the acoustic signal and the muscle activity signal, the information being analyzable to identify one or both of wheezing or coughing episodes; and   determining an occurrence of clinically significant wheezing, the determination being based on information conveyed by the acoustic signal and the muscle activity signal.   
     
     
         34 . The method of  claim 33 , wherein the pulmonary disease includes one or more of asthma, chronic obstructive pulmonary disease (COPD), emphysema, bronchitis, restrictive lung disease, pneumonia, atalectasis, or consolidation. 
     
     
         35 . The method of  claim 33 , wherein the accessory respiratory muscle is a sternocleidomastoid (SCM) muscle. 
     
     
         36 . A method for treating a pulmonary disease, the method comprising:
 obtaining a diagnosis of the pulmonary disease using a wearable device, the device comprising:
 a flexible patch having a skin contact surface covered with a hypoallergenic adhesive configured to adhere to human skin; 
 a water-resistant enclosure disposed upon or within the patch; 
 an acoustic sensor disposed within the enclosure, the acoustic sensor being configured to provide an acoustic signal conveying information associated with internal respiratory sounds, wherein the acoustic sensor is a contact accelerometer configured to sense tissue vibration; 
 a non-transitory computer-readable storage medium disposed within the enclosure, the storage medium being configured to store information and provide access to the stored information; and 
 one or more processors disposed within the enclosure, the one or more processors being configured by computer program instructions to:
 record onto the storage medium information conveyed by one or more signals including the acoustic signal, the information being analyzable to identify one or both of wheezing or coughing episodes; and 
 
   administering a therapeutic agent effective in ameliorating the pulmonary disease.   
     
     
         37 . The method of  claim 36 , wherein the pulmonary disease includes one or more of asthma, chronic obstructive pulmonary disease (COPD), emphysema, bronchitis, restrictive lung disease, pneumonia, atalectasis, or consolidation. 
     
     
         38 . The method of  claim 36 , further comprising assessing a response to the administration of the therapeutic agent by evaluating symptoms using the device after the administration is performed.