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ACOUSTIC SENSOR AND VENTILATION MONITORING SYSTEM

20230123995 · 2023-04-20

    Inventors

    Cpc classification

    International classification

    Abstract

    A method of monitoring physiological conditions including an acoustic measurement device and a remote controller. The remove controller configured to measure physiological conditions; calculate absolute tidal volume, a direction of tidal volume, and a rate of change of tidal volume; correlate absolute tidal volume, a direction of tidal volume, and a rate of change of tidal volume to a risk score; calculate a direction trend and rate of change for each physiological condition; correlate the direction trend and rate of change for each physiological condition; detect predefined patterns in the direction trend and rate of change of the measured physiological condition at the predetermined interval; and generating at least one from the group consisting of an alert, an alarm, and a medical treatment if the risk score defined on the predefined scale exceeds a first predetermined risk score threshold and at least one predefined pattern is detected.

    Claims

    1. A method of monitoring physiological conditions using an acoustic measurement device, the method comprising: providing an acoustic measurement device; providing a remote controller having processing circuitry that is in communication with the acoustic measurement device, the processing circuitry being configured to: measure at least one physiological condition; calculate at least one selected from the group consisting of absolute tidal volume, a direction of tidal volume, and a rate of change of tidal volume; correlate the at least one selected from the group consisting of absolute tidal volume, a direction of tidal volume, and a rate of change of tidal volume to a risk score defined on a predefined scale; calculate a direction trend and rate of change for each physiological condition that is measured at a predetermined interval; correlate the direction trend and rate of change for each physiological condition that is measured at the predetermined interval with any predefined patterns in the direction trend and rate of change of the measured physiological condition; detect predefined patterns in the direction trend and rate of change of the measured physiological condition at the predetermined interval; and generating at least one from the group consisting of an alert, an alarm, and a medical treatment if the risk score defined on the predefined scale exceeds a first predetermined risk score threshold and at least one predefined pattern is detected.

    2. The method of claim 1, wherein the physiological condition consists of at least one from the group consisting of tidal volume, respiratory rate, pattern of breathing, degree of upper airway obstruction, body activity level, body coordination, body position, heart rate, temperature, number and duration of apnea episodes.

    3. The method of claim 1, wherein the method further comprises at least one medical device, wherein the processing circuitry is in communication with the at least one medical device.

    4. The method of claim 3, wherein the at least one medical device is an auto injector.

    5. The method of claim 1, wherein the acoustic measurement device further includes an accelerometer and a sound transducer.

    6. The method of claim 1, wherein acoustic measurement device further includes a temperature sensor.

    7. The method of claim 5, wherein the acoustic measurement device further includes a reflectance pulse oximeter and a plurality of electrodes.

    8. The method of claim 1, wherein the measurement of the at least one physiological condition occurs periodically.

    9. The method of claim 1, wherein the measurement of the at least one physiological condition occurs continuously.

    10. A method of monitoring physiological conditions using an acoustic measurement device, the method comprising: providing an acoustic measurement device; providing a remote controller having processing circuitry that is in communication with the acoustic measurement device, the processing circuitry being configured to: measure at least one physiological condition where the at least one physiological condition includes respiratory rate, tidal volume, body activity level, pattern of breathing, body coordination, body position, heart rate, temperature, number and duration of apnea episodes, snoring amount and degrees; calculate at least one selected from the group consisting of absolute tidal volume, a direction of tidal volume, and a rate of change of tidal volume; correlate the at least one selected from the group consisting of absolute tidal volume, a direction of tidal volume, and a rate of change of tidal volume to a risk score defined on a predefined scale; calculate a direction trend and rate of change for each physiological condition that is measured at a predetermined interval; correlate the direction trend and rate of change for each physiological condition that is measured at the predetermined interval with any predefined patterns in the direction trend and rate of change of the measured physiological condition; correlate the measured physiological condition to one of body activity, body position, body coordination, apnea number and duration, and snoring amount and degree to an estimate of sedation level; detect any predefined patterns in the direction trend and rate of change of the measured physiological condition at the predetermined interval; and generate one of an alert, an alarm, and a medical treatment if at least one of the group consisting of the risk score defined on the predefined scale exceeds a first predetermined risk score threshold, at least one predefined pattern is detected, and the estimated sedation level exceeds a sedation level threshold.

    11. The method of claim 10, wherein the acoustic measurement device includes a sound transducer and accelerometer, and a housing at least partially surrounding the sound transducer and the accelerometer.

    12. The method of claim 11, wherein the housing is made up of at least one sound insulation material, the sound transducer being coupled to the housing.

    13. The method of claim 11, wherein the sound transducer is suspended within the housing.

    14. The method of claim 10, wherein the method further comprises providing at least one medical device and wherein the processing circuitry is in communication with the at least one medical device.

    15. The method of claim 14, wherein the at least one medical device is an auto-injector.

    16. The method of claim 14, wherein the at least one medical device includes a plurality of electrodes configured to measure a cardiac electrogram.

    17. The method of claim 10, wherein the acoustic measurement device further includes a temperature sensor.

    18. The method of claim 10, wherein the measurement of the at least one physiological condition occurs periodically.

    19. The method of claim 10, wherein the measurement of the at least one physiological condition occurs continuously.

    20. A method of monitoring physiological conditions using an acoustic measurement device, the method comprising: providing an acoustic measurement device having a housing and at least one sensor substantially surrounded by the housing; providing a medical device; and providing a remote controller having processing circuitry that is in communication with the acoustic measurement device and the medical device, the processing circuitry configured to: measure at least one physiological condition where the at least one physiological condition includes respiratory rate, tidal volume, body activity level, body coordination, body position, heart rate, temperature, number and duration of apnea episodes, snoring amount and degrees; calculate at least one selected from the group consisting of absolute tidal volume, a direction of tidal volume, and a rate of change of tidal volume; correlate the at least one selected from the group consisting of absolute tidal volume, a direction of tidal volume, and a rate of change of tidal volume to a risk score defined on a predefined scale; calculating a direction trend and rate of change for each physiological condition that is measured at a predetermined interval; correlate the direction trend and rate of change for each physiological condition that is measured at the predetermined interval with any predefined patterns in the direction trend and rate of change of the measured physiological condition; correlate the measured physiological condition to at least one of body activity, body position, body coordination, apnea number and duration, and snoring amount and degree to an estimate of sedation level; detect any predefined patterns in the direction trend and rate of change of the measured physiological condition at the predetermined interval; and generate one of an alert, an alarm, and a medical treatment if at least one of the group consisting of the risk score defined on the predefined scale exceeds a first predetermined risk score threshold, at least one predefined pattern is detected, and the estimated sedation level exceeds a sedation level threshold.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0111] A more complete understanding of embodiments described herein, and the attendant advantages and features thereof, may be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings wherein:

    [0112] FIG. 1 is a cross-sectional view of embodiment of an acoustic sensor constructed in accordance with the principles of the present application and a view of the acoustic sensor coupled to a patient's body;

    [0113] FIG. 2 is a cross-sectional view of another embodiment of an acoustic sensor constructed in accordance with the principles of the present application;

    [0114] FIG. 3 is a cross-sectional view of another embodiment of an acoustic sensor constructed in accordance with the principles of the present application;

    [0115] FIG. 4 is a cross-sectional view of another embodiment of an acoustic sensor constructed in accordance with the principles of the present application;

    [0116] FIG. 5 is a cross-sectional view of another embodiment of an acoustic sensor constructed in accordance with the principles of the present application;

    [0117] FIG. 6 is another a cross-sectional view of embodiment of an acoustic sensor constructed in accordance with the principles of the present application;

    [0118] FIG. 7 is a flow chart showing exemplary steps of determining a patient's risk index score for an opioid overdose in accordance with an embodiment of the present application;

    [0119] FIG. 8 is a flow chart showing exemplary steps of determining a patient's risk index score to determine a patient's risk for heat stroke or heat exhaustion;

    [0120] FIG. 9 is a flow chart showing exemplary steps of determining a patient's fitness level based in part on minute ventilation (MV) in accordance with an embodiment of the present application;

    [0121] FIG. 10 is a flow chart showing exemplary steps of determining a patient's risk index score to determine a patient's risk of decompensation due to asthma and chronic obstructive pulmonary disease (COPD) in accordance with an embodiment of the present application;

    [0122] FIG. 11 is another cross-sectional view of embodiment of an acoustic sensor constructed in accordance with the principles of the present application and a top cross-sectional view of a coupling component of the present application;

    [0123] FIG. 12 is a cross-sectional view of another embodiment of an acoustic sensor constructed in accordance with the principles of the present application and a medical device; and

    [0124] FIG. 13 is a flow chart showing exemplary steps of determining a patient's risk index score as well as any patterns associated with certain physiological parameters and triggering an alert/alarm and/or medical therapy or treatments.

    DETAILED DESCRIPTION

    [0125] Before describing in detail exemplary embodiments, it is noted that the embodiments reside primarily in combinations of apparatus components and processing steps related to an acoustic sensor system and related method thereof. Accordingly, the system and method components have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that may be readily apparent to those of ordinary skill in the art having the benefit of the description herein.

    [0126] As used herein, relational terms, such as “first” and “second,” “top” and “bottom,” and the like, may be used solely to distinguish one entity or element from another entity or element without necessarily requiring or implying any physical or logical relationship or order between such entities or elements. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the concepts described herein. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It may be further understood that the terms “comprises,” “comprising,” “includes” and/or “including” when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

    [0127] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It may be further understood that terms used herein should be interpreted as having a meaning that is consistent with their meaning in the context of this specification and the relevant art and may not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

    [0128] In embodiments described herein, the joining term, “in communication with” and the like, may be used to indicate electrical or data communication, which may be accomplished by physical contact, induction, electromagnetic radiation, radio signaling, infrared signaling or optical signaling, for example. One having ordinary skill in the art may appreciate that multiple components may interoperate and modifications and variations are possible of achieving the electrical and data communication.

    [0129] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

    [0130] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPLAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

    [0131] With reference to FIGS. 1-6, an acoustic measurement device or TSD 10 is depicted which is sized and configured to be releasably affixed to the skin of a mammal by an adhesive or an adjustable elastic band. The device 10 includes a housing 12 defining an at least partially enclosed chamber 14 therein. In one configuration, the housing 12 defines a width of 3.5 cm or less, and a length of 2.5 cm or less. For example, the housing 12 may be substantially cube shaped having a width of 3.5 cm or less, such as between 0.5 cm to 3.5 cm, a sphere or disc having a diameter of 3.5 cm or less, or another shape suitable for affixing to the patient.

    [0132] The housing 12 may be composed of one or more materials, such as a lightweight plastic, metal, ceramic, or composite having integrated or added sound insulation material 16 on an exterior thereof, lining the interior of the chamber 14, or both, to attenuate ambient sound. The walls of the housing and lining may be separated by an air-filled space designed to attenuate ambient sound. The housing 12 may be manufactured from materials and structure that attenuates transmission of ambient sound into the chamber 14. In one configuration, an airtight seal is formed between the housing 12 and skin surface to isolate the inside of the TSD 10 from the external environment. In an alternative configuration, the housing 12 may be porous or have an external opening such that sound may penetrate the housing 12 from an ambient environment, depending on the application. In one configuration, the housing 12 defines a single opening 18 to provide access to the chamber 14; however, the number and size of the openings 18 are not limited to a particular number and size. The sound insulation material 16 may surround the housing 12 in all areas with the exception of around the opening 18. The housing 12 may define a dome shape, bell shape, (FIG. 6) or any shape such that the chamber 14 is isolated from external sounds and optimized to measure the sounds of air movement within the trachea.

    [0133] One or more sound transducers 20 may be affixed, either permanently or removably, within the chamber 14 of the housing 12 for measuring at least one of a respiratory rate and a tidal volume of the patient. The sound transducer 20 may be one or more microphones, for example, in the 20-2000 Hz range, configured to measure sound energy within the chamber 14 and transduce an acoustic signal into a digital signal. The miniature electronic microphones (electric, piezoelectric, or MEMS) transduce the mechanical vibrations caused by airflow within the proximal trachea during inhalation and exhalation with a high signal-to-noise ratio. In one configuration, the sound transducer 20 is located at an end of the housing 12 opposite an end of the housing 12 defining the opening 18 and may be suspended within the chamber 14 using, for example, an elongate rod or other suspension element (not shown) extending from the interior surface of the chamber 14 such that the sound transducer 20 is not in contact with the interior walls of the housing 12.

    [0134] A flexible diaphragm 22 may be disposed within the opening 18 that is coextensive or slightly recessed within a surface of the housing 12. The diaphragm 22 may be a thin flexible material that resonates in response to sound energy, for example airflow through the trachea of a mammal, in a manner similar to a pediatric stethoscope head. In one configuration, the diaphragm 22 is electrically coupled to the sound transducer 20 such that when the diaphragm 22 resonates, the sound vibration is directly measured by the sound transducer 20. In other configurations, rather than being coupled to the diaphragm 22, the sound transducer 20 is in close proximity to the diaphragm 22, for example, immediately adjacent thereto to minimize any ambient sound measured by the sound transducer 20. In other configurations, the diaphragm 22 is the actual diaphragm of the sound transducer 20 and is directly coupled to an electromagnetic coil, capacitor, or piezoelectric crystal of the sound transducer 20. In one configuration, the interior of the housing 12 may define a curved semi-circle, dome, or other shape to focus the sound energy transduced from the diaphragm 22 on the skin surface directly into the sound transducer 20. For example, the sound transducer 20 and diaphragm 22 may be angled and positioned in a manner to measure sounds of the airflow as it enters and exits the larynx. In other configurations, the sound transducer 20 and the diaphragm 22 are aimed toward the airflow through the trachea. In one configuration, the sound transducer 20 is a piezoelectric film with adhesive that adheres to the skin surface adjacent or proximal to the trachea.

    [0135] Continuing to refer to FIGS. 1-6, a wireless transmitter 24 may be coupled to the housing 12, which is in communication with the sound transducer 20. The wireless transmitter 24, which may transmit and receive, is configured to transmit the transduced acoustic signal measured by the sound transducer 20. In one configuration, the wireless transmitter 24 is included as part of a processing circuitry having one or more processors included within the housing 12. For example, the wireless transmitter 24 may transmit the measurement of the respiratory rate, the tidal volume, the heart rate, or other vital sign data, to a remote controller 26 which forms the AVMS 27 in combination with the TSD 10. The remote controller 26 may be in the form of a smartphone, tablet, smartwatch, Echo™ device, Alexa™ device, cable box, or other mobile communication device configured to be held, coupled to, or in proximity to the patient, that communicates with the device 10 by Bluetooth® low-energy (BLE) or WiFi®, or another electronic handshake such that acoustic information may be relayed to the controller 26 for real-time processing. The controller 26 may further include processing circuitry with one or more processors to process the data received from the TSD 10. The results of such processing may be displayed on the display of the controller 26 or transmitted by the controller 26 to a remote location for further processing and/or analysis.

    [0136] The wireless transmitter 24 and the sound transducer 20 may be powered by a same rechargeable power source 28, for example, a rechargeable battery. Although the power source 28 is shown in FIGS. 1-6 as being smaller size wise relative to some other components of device 10 disclosed herein, it is noted that the illustrated size of the power source 28 is merely exemplary and may be any shape or size. In one embodiment (not shown), the TSD 10 may be recharged within a dedicated housing unit that includes a rechargeable power source. When in the dedicated housing unit, the TSD 10 may be in electrical communication with the rechargeable power source such that TSD 10 may be rechargeable using inductive coupling or wired connection via a cable to a Universal Serial Bus (USB) port. A battery of the TSD 10 that lasts five or more days may be disposable.

    [0137] Referring back to FIG. 1, the TSD 10 may include an adjustable elastic band or adhesive 30 adhered to the patient's skin proximate one of the tracheal notch or a lateral neck region of the patient to measure sound and/or vibrations associated with the patient's breathing. The adhesive 30 may also at least partially surround the opening 18. The adhesive 30 may be a double-sided tape or pad or other removable adhesive which allows the TSD 10 to be releasably adhered to the skin of the patient after remaining affixed to the patient for a predetermined period of time, for example, 1 hour-14 days. In one configuration, the adhesive 30 surrounds the opening 18 on the surface of the housing 12 without occluding or otherwise blocking the opening 18 to avoid interfering with sound waves entering the chamber 14. When in contact with the skin surface, the adhesive 30 provides an airtight seal for enhanced passive noise suppression from ambient sounds.

    [0138] In an exemplary configuration, the controller 26 is configured to compare the measurement of at least one of the respiratory rate and the tidal volume to a respective predetermined threshold, which may be a range or value, or patient baseline with the RIS discussed above. For example, the average respiratory rate for a sedentary person is approximately 12-15 breaths per minute. A typical inhalation (inspiration) period is approximately 1 second, followed by a 2 second pause, followed by a 2 second period of exhalation (expiration). The period of exhalation is always longer than the period of inhalation. Faster respiratory rates decrease the amount of time during each period of the respiratory cycle. The pause between breaths may become shorter with a rapid respiratory rate.

    [0139] In contrast to the rapid respiratory rate, the amount of time during each inhalation and exhalation period increases with a slow respiratory rate, and the pause may become longer. A typical tidal volume, the amount of air moved into the body during inhalation and out of the body during exhalation, at rest, is approximately 500 ml/breath. Thus, at rest, a typical person has a minute ventilation of approximately 6000 ml/minute (12 breaths/min×500 ml tidal volume/breath=6 L/min). Physiologists have determined the normal range of respiratory rate, tidal volume, and minute ventilation at rest and during activity for neonates, children, adolescents, adults, and geriatric adults based on height, weight, age, and gender. Based on these predetermined known parameters, the controller 26 is configured to determine an adverse event, such as hypoventilation caused by a drug overdose, in real time, if the measurement of at least one of the respiratory rate and the tidal volume falls outside of a respective predetermined range by a predetermined amount.

    [0140] For example, controller 26 may establish an adverse event risk index score (RIS), which may be a predetermined range, based on the percentage change, absolute change, rate of change, or the duration of time that the measured respiratory rate or tidal volume deviates (above or below) from a normal or predetermined range, from predetermined known parameters or baseline. For example, the percentage change may be between 5%-50%, or more, from the predetermined known parameters. Such a percentage is merely exemplary and may be set by a clinician based on the patient's own tidal volume and/or respiratory rate measurements when active and when at rest and the controller 26 may be configured to change the patient's baseline based on observed breathing patterns. For example, the controller 26 may employ algorithms (machine-learning, deep learning, artificial intelligence, and/or neural networks) to recognize a distinct pattern from the patient's usual baseline pattern. In one example, hypoventilation may cause higher levels of arterial carbon dioxide, which in turn produces greater sedation, less movement, snoring, head bobbing, uncoordinated movements, which can be detected by an activity sensor/accelerometer, described in more detail below. For example, a risk index score of “30” could produce an alert, a risk index score of “40” could produce a warning, and a risk index score >“50” could produce an alarm and/or an automated injection of an opioid reversal medication (for example, Naloxone or Narcan). Also, for example, the TSD 10 could produce a low alert with a 20-30% change of RR and/or TV suggesting impending hypoventilation, a medium alert with a 30-50% change, and a red alert/alarm with >50% change from baseline. The AVMS 27 may have threshold alerts/alarms and predictive alerts/alarms that warn the patient and/or clinician of an increased risk for an adverse event and/or a serious adverse event with a negative clinical outcome.

    [0141] As mentioned above, adverse events may include hypoventilation, which is defined as an elevated partial pressure of carbon dioxide in the blood (PaCO2 >45 mm Hg) due to insufficient minute ventilation relative to the metabolic production of CO2. In addition, such adverse events may include hyperventilation which is defined as a decreased partial pressure of carbon dioxide in the blood (PaCO2 <35 mm Hg) due to excessive minute ventilation relative to the metabolic production of CO2, hypopnea which is defined as overly shallow breathing or an abnormally low respiratory rate, bradypnea which is defined as abnormally slow respiratory rate, hyperpnea which is defined as an increased depth and rate of breathing, tachypnea which is defined as an abnormally rapid respiratory rate, and apnea which is defined as a pause in breathing where there is no movement of the muscles of inhalation and the volume of the lungs remain unchanged.

    [0142] The controller 26 may apply a low pass filter, a high pass filter, or an adaptive filter to the measured data to filter out anomalous data and ambient noise. An external microphone may be used for ambient noise suppression and noise cancelling. In one configuration, tracheal sounds may be analyzed by the controller 26 using frequency versus time curves and amplitude versus time curves to diagnose a normal pattern of inhalation and a normal pattern of exhalation (i.e., clear uninterrupted sound patterns) relative to abnormal inhalation/exhalation sounds or sound patterns. Sleep apnea and other pathological conditions of the brain and upper airway commonly cause intermittent upper airway obstruction that can lead to hypoventilation, hypoxemia, arrhythmias, pulmonary hypertension, and heart failure. Opioids, alcohol, illegal drugs, or medications that cause sedation, relax the upper airway muscles, leading to mild, moderate, or severe upper airway obstruction (snoring and obstructive apnea). As such, analysis of the partially obstructed upper airway sound patterns can be used to diagnose the progression of airway muscle relaxation as an estimate of the severity of sleep apnea or the degree of central nervous system sedation.

    [0143] Continuing to refer to FIGS. 1-6, the TSD 10 may further include an accelerometer 32, a temperature sensor 34, and/or a reflectance pulse oximeter 36, which may be positioned within the housing 12 and coupled to the power source 28 in communication with the controller 26. The 3-axis accelerometer 32 may be configured to measure a relative x-y-z position and a movement of the patient, such as the amount and pattern of head bobbing, body movement, body coordination, and body position in real-time to further estimate, in the case of a drug overdose, the degree of sedation and the trends of sedation over time. The accelerometer 32 also senses chest wall movement to monitor the onset/timing of inhalation and exhalation. The temperature sensor 34 may be integrated within the housing and used to detect a decrease or increase in body temperature. The reflectance pulse oximeter 36 may be configured to monitor percent hemoglobin oxygen saturation and the photoplethysmograph waveform, whether continuously, intermittently, or when the algorithm detects/predicts the onset of hypoventilation or a change in health. The pulse oximeter's waveform can be analyzed in real-time to estimate heart rate, heart rate variability, stroke volume, stroke volume variability, pre-load, myocardial contractility, systemic vascular resistance, cardiac output, and systemic blood pressure. In other configurations, the device 10 may use a gyroscope to monitor body position in real-time to further estimate, in the case of a drug overdose, the degree of sedation and the trends of sedation over time.

    [0144] In one configuration, the device 10 may also measure the patient's cardiac electrogram or electrocardiogram to determine the real-time heart rate and heart rhythm. For example, the device 10 may include a plurality of electrodes 38 (FIG. 11) positioned on, for example, a portion of the housing 12 in contact with the patient's skin to measure the patient's electrocardiogram. The method of pulse-transit time can utilize the electrocardiogram signal and the pulse oximeter 36 plethysmograph signal to calculate the systemic blood pressure. The electrocardiogram and pulse oximeter signals measured by the TSD 10 worn on the body may communicate wirelessly with the ambulatory patient's smart watch that also contains skin electrodes that measure the electrocardiogram and pulse oximeter signals at the wrist, to enhance the signal-to-noise ratio and clinical performance. In another configuration, the electrocardiogram and pulse oximeter signal may also communicate wirelessly with an electrocardiogram and pulse oximeter signal on the ambulatory patient's smart wrist watch to enhance the signal-to-noise ratio and clinical performance.

    [0145] Referring now to FIG. 5, in another configuration, the sound transducer 20 may include a vibration sensor (electric, piezoelectric, or MEMS) configured to measure vibrations as a result of air flowing into and out of the trachea or lungs. The sound transducer 20 may be substantially planar with the skin of the patient to increase mechanical coupling and sensitivity. The vibration sensor accelerometer 32 and the power source 28 may be integrated into the housing 12. For example, a MEMS device may be integrated within a first chamber 38 of the housing 12 separated from the sound transducer 20. The MEMS device may further be configured to process information from one or more of the sensors disclosed herein which may be included in this configuration. The MEMS device may be included in any of the embodiments discussed above.

    [0146] Referring now to FIG. 7, as discussed above, the controller 26 may employ a method to assign a risk index score to a wearer of the device 10, such risks may include as discussed above an opioid overdose. The method includes continuously, intermittently, or continually measuring the RR and TV of the patient wearing the device 10. In one configuration, the controller 26 further measures at least one from the group consisting of the user's activity level (AL), body position (P), snoring sounds (S), body coordination (BC), heart rate (HR), and hemoglobin oxygen saturation (HS). The controller 26 may then further calculate the user's absolute RIS using the values for RR, TV TD, AL, P, S, BC, HR, and/or HS, the direction trend of each value over time, the rate of change of each value, the duration of change for each value, and the sum of all the values to establish a predictive score for an opioid overdose. The absolute RIS may be calculated and updated every 20 to 30 seconds, or any periodic or continual interval. Alerts and alarms may be based upon the absolute RIS number, the RIS direction of change, the RIS rate of change over time, and the RIS duration of change.

    [0147] For example, the AVMS may continuously measure the RR and TV and the controller 26 may calculate the averaged RR and TV over a predetermined period of time (x), for example each 20 to 30 second interval. The controller 26 may then assign a risk value represented as a value (F), to score that particular parameter based on a predefined scale and determine if an alert (warning) or an alarm (urgent) is to be generated. For example, as shown in TABLE 1, a respiratory rate (RR) of 15 to 14 breaths/minute is assigned an F value of zero to −4 (low risk), a RR of 7 to 6 breaths/minute is assigned an F value of +8 (high risk), and a RR of 6 to 5 breaths/minute is assigned an F value of +10 (higher risk). One potential reason as to why RR would decrease is owing to an increased number of opioid molecules attached to opioid receptors in the midbrain. Opioids cause the RR to decrease from an average 15±3 breaths/minute at rest. Opioids also cause the TV to decrease from an average 7 ml/kg at rest. Higher opioid receptor binding causes a more severe and progressive decrease in the RR and TV over time. An opioid overdose can occur quickly when a large amount of opioid reaches the midbrain opioid receptors quickly after a large oral dose or after an intravenous injection. In one example, the controller 26 may trigger an alert, which may indicate caution as the absolute value of RR rate drops to a first predetermined rate, or an alarm to trigger immediate action when the RR drops below a second predetermined rate.

    TABLE-US-00001 TABLE 1 Absolute RR in breaths/minute and the corresponding F value 15-14 14-13 13-12 12-11 11-10 10-9 9-8 8-7 7-6 6-5 5-4 4-3 3-2 2-1 1-0 0 −4 0 0 +1 +2 +3 +4 +5 +8 + 10 +12 + 16 +20 +30 +30 +30 Alert Alert Alert Alarm Alarm Alarm

    [0148] In addition to the absolute RR discussed above and the resulting F value, the controller 26 may further calculate the RR direction of change, symbolized by the up or down arrows in TABLE 2 below, and the rate of change of the RR, and multiply those F values with weighting factors. The controller 26 may automatically adjust the weighting factor over time in response the patient's previously analyzed RR trend data, to optimize the sensitivity and specificity for detecting and predicting the progression from mild, to moderate, to severe hypoventilation. For example, the F value for RR may comprise three factors, namely, change in absolute RR, the direction of RR, and the rate of change of RR. The direction and rate of change of RR optionally may have a weighting factor (W) on the score, for example, 2× or 3×, or any multiple. In one example, F.sub.RR=(F.sub.absolute RR+2F.sub.RR direction+3F.sub.RR rate of change). An increased number of opioid molecules attached to opioid receptors in the midbrain cause the RR to decrease from an average range of 15±3 breaths/minute. Higher opioid receptor binding causes a progressive decrease in the RR over time. An opioid overdose can occur quickly when a large amount of opioid reaches the midbrain receptors quickly after a large oral dose, an intravenous injection, or combined with alcohol, benzodiazepams, or other respiratory depressant medications. This may cause the RR to become more variable with a slow or fast rate of decrease over a longer period of time. The ingestion of alcohol and other drugs may worsen the respiratory and cardiovascular affects when combined with the opioids. Additionally, the F value for RR may also include a fourth factor, namely, the duration of time the RR or TV is above or below a normal or predetermined RR or TV range for the patient. For example, the longer the time the RR and TV is decreased following opioid use, the greater the degree of hypoventilation may be detected. In one embodiment, a large and fast decrease in RR and TV over a short time interval may indicate a high likelihood of opioid overdose. In another embodiment, a smaller and slower decrease in RR and TV over an extended interval of time may also indicate high likelihood of opioid overdose.

    [0149] The RIS for opioid induced hypoventilation has a more positive value (+ more risk) when there is a decrease in the RR over time. There is a higher risk during a rapid decrease in RR over time. The RIS for opioid induced hypoventilation has a more negative value (− less risk) when there is an increase in RR over time. There is a lower risk during a rapid increase in RR over time. There is a non-linear increase in risk points when the RR decreases into the clinically significant range. The controller 26 recognizes the vital sign pattern towards hypoventilation early enough to prevent a permanent injury or death due to respiratory acidosis and hypoxemia. The middle column of TABLE 2 may be used for adult patients with average sensitivity to opioid induced respiratory depression. The left column may be used for patients with low sensitivity to opioid induced respiratory depression. The right column may be used for patients with high sensitivity to opioid induced respiratory depression.

    TABLE-US-00002 TABLE 2 RR direction and rate of change and corresponding F values for three different patient sensitives to opioid induced respiration depression. Respiratory Rate (RR) Low Average High Direction and Rate of Sensitivity Sensitivity Sensitivity Change Points Points Points Rapid Decrease RR ↓↓ +4 +6 +8 Alarm Slow Decrease RR ↓ +2 +3 +4 Alert No Change RR .fwdarw. 0 0 0 Slow Increase RR ↑ −2 −3 −4 Rapid Increase RR ↑↑ −4 −6 −8

    Examples

    [0150] 1. RR that is rapidly decreasing (+4) from 9 to 8 breaths/minute (+2) increases the risk index score +6
    2. RR that is rapidly decreasing (+4) from 8 to 7 breaths/minute (+3) increases the risk index score +7
    3. RR that is slowly decreasing (+2) from 7 to 6 breaths/minute (+5) increases the risk index score+7
    4. RR that is rapidly increasing (−4) from 6 to 7 breaths/minute (+5) increases the risk index score+1
    5. RR that is slowly decreasing (+2) from 12 to 11 breaths/minute (+1) increases the risk index score+3

    [0151] In addition to scoring the patient's RR, the controller 26 further analyzes the patient's TV in a similar manner to that of RR rate. An increased number of opioid molecules attached to opioid receptors in the midbrain cause the TV to decrease from an average range of 500±50 ml/breath (˜7 ml/kg). Higher opioid receptor binding causes a progressive decrease in the TV over time. Hypoventilation and hypoxia owing to an opioid overdose can occur quickly when a large amount of opioid reaches the midbrain opioid receptors quickly after a large oral dose or an intravenous injection, especially with the synthetic opioids fentanyl and sufentanyl. The majority of opioid overdoses following the oral ingestion of opioids occur more slowly, over a one to two-hour period. The ingestion of alcohol and other drugs may worsen the respiratory and cardiovascular affects when combined with the opioids. TABLE 3 below shows the absolute F values for changes of TV of an example patient weighing 70 kg. The RIS for opioid induced hypoventilation has a more positive value (+ more risk) when a lower TV than normal is measured. The RIS for opioid induced hypoventilation has a more negative value (− less risk) when a higher TV is measured. Note the non-linear increase in risk points when the TV decreases into the clinically significant range. The algorithms recognize the vital sign pattern towards hypoventilation early enough to prevent a permanent injury or death due to respiratory acidosis and hypoxemia. The F values are merely exemplary and may change based on the weight, age, and opioid sensitivity of the patient.

    TABLE-US-00003 TABLE 3 Absolute TV in ml/kg. change in TV over a defined period of time, and the corresponding F value Tidal Volume (TV) Tidal Volume (TV) Change in TV (ml/kg) (ml) (ml/kg) F value  10 ml/Kg × 70 Kg 700 ml  10 to 9.5 −10 9.5 ml/Kg 665 ml 9.5 to 9.0 −8 9.0 ml/kg 630 ml 9.0 to 8.5 −6 8.5 ml/kg 595 ml 8.5 to 8.0 −4 8.0 ml/kg 560 ml 8.0 to 7.5 −2 7.5 ml/kg 525 ml 7.5 to 7.0 0 7.0 ml/kg 490 ml 7.0 to 6.5 0 6.5 ml/kg 455 ml 6.5 to 6.0 +2 6.0 ml/kg 420 ml 6.0 to 5.5 +4 5.5 ml/kg 385 ml 5.5 to 5.0 +6 5.0 ml/kg 350 ml 5.0 to 4.5 +8 4.5 ml/kg 315 ml 4.5 to 4.0 +10 4.0 ml/kg 280 ml 4.0 to 3.5 +12 3.5 ml/kg 245 ml 3.5 to 3.0 +14 3.0 ml/kg 210 ml 3.0 to 2.5 +20 2.5 ml/kg 175 ml 2.5 to 2.0 +30 2.0 ml/kg 140 ml 2.0 to 1.5 +30 1.5 ml/kg 105 ml 1.5 to 1.0 +30 1.0 ml/kg  70 ml 1.0 to 0.5 +30 0.5 ml/kg  35 ml 0.5 to 0   +30   0 ml/kg  0 ml 0 +30

    TABLE-US-00004 TABLE 4 Absolute TV in ml/kg for an average adult male. Grouping of TV into 7 ranges based upon the clinical risk for developing hypoventilation due to opioid use, and the corresponding F values. For example, Multiply F values × 2 for duration in range >5 minutes. Multiply F values × 3 for duration in range >10 minutes. Multiply F values × 4 for duration in range >15 minutes. Tidal Volume (TV) Tidal Volume (TV) F (ml/kg) (ml) Tidal Volume Range value  10 ml/Kg × 70 Kg 700 ml Large TV Increase −16 9.5 ml/Kg 665 ml Moderate TV Increase −6 9.0 ml/kg 630 ml Moderate TV Increase −6 8.5 ml/kg 595 ml Normal TV Range 0 8.0 ml/kg 560 ml Normal TV Range 0 7.5 ml/kg 525 ml Normal TV Range 0 7.0 ml/kg 490 ml Small TV Decrease +4 6.5 ml/kg 455 ml Small TV Decrease +4 6.0 ml/kg 420 ml Moderate TV Decrease +8 5.5 ml/kg 385 ml Moderate TV Decrease +8 5.0 ml/kg 350 ml Moderate TV Decrease +8 4.5 ml/kg 315 ml Large TV Decrease +14 4.0 ml/kg 280 ml Large TV Decrease +14 3.5 ml/kg 245 ml Large TV Decrease +14 3.0 ml/kg 210 ml Very Large TV Decrease +24 2.5 ml/kg 175 ml Very Large TV Decrease +24 2.0 ml/kg 140 ml Very Large TV Decrease +24 1.5 ml/kg 105 ml Very Large TV Decrease +24 1.0 ml/kg  70 ml Very Large TV Decrease +24 0.5 ml/kg  35 ml Very Large TV Decrease +24   0 ml/kg  0 ml Very Large TV Decrease +24

    TABLE-US-00005 TABLE 5 Absolute TV in ml/kg for an average adult male. Grouping of TV into 5 ranges based upon the clinical risk for developing hypoventilation due to opioid use, and the corresponding F values. For example, Multiply F values × 2 for duration in range >5 minutes. Multiply F values × 3 for duration in range >10 minutes. Multiply F values × 4 for duration in range >15 minutes. Tidal Volume (TV) Tidal Volume (TV) F (ml/kg) (ml) Tidal Volume Range value  10 ml/Kg × 70 Kg 700 ml Large TV Increase −16 9.5 ml/Kg 665 ml Moderate TV Increase −6 9.0 ml/kg 630 ml Moderate TV Increase −6 8.5 ml/kg 595 ml Moderate TV Increase −6 8.0 ml/kg 560 ml Normal TV Range 0 7.5 ml/kg 525 ml Normal TV Range 0 7.0 ml/kg 490 ml Normal TV Range 0 6.5 ml/kg 455 ml Normal TV Range 0 6.0 ml/kg 420 ml Moderate TV Decrease +6 5.5 ml/kg 385 ml Moderate TV Decrease +6 5.0 ml/kg 350 ml Moderate TV Decrease +6 4.5 ml/kg 315 ml Moderate TV Decrease +6 4.0 ml/kg 280 ml Large TV Decrease +16 3.5 ml/kg 245 ml Large TV Decrease +16 3.0 ml/kg 210 ml Large TV Decrease +16 2.5 ml/kg 175 ml Large TV Decrease +16 2.0 ml/kg 140 ml Large TV Decrease +16 1.5 ml/kg 105 ml Large TV Decrease +16 1.0 ml/kg  70 ml Large TV Decrease +16 0.5 ml/kg  35 ml Large TV Decrease +16   0 ml/kg  0 ml Large TV Decrease +16

    [0152] In addition to the absolute TV discussed above and the resulting F value, the controller 26 further calculates the TV direction of change, symbolized by the up or down arrows in TABLE 6 below, and the rate of change of the TV, with weighting factors. The controller 26 may automatically adjust the weighting factor over time in response the patient's previously analyzed TV trend data, to optimize the sensitivity and specificity for detecting and predicting the progression from mild, to moderate, to severe hypoventilation. For example, the F value for TV may comprise three factors, namely, absolute TV, direction of TV, and rate of change of TV. The direction and rate of change of TV optionally may have a weighting factor (W) on the F value, for example, 2× or 3×, or any multiple. In one example, F.sub.TV=(F.sub.absolute TV+2F.sub.TV direction+3F.sub.TV rate of change).

    [0153] The middle column below may be used for adult patients with average sensitivity to opioid induced respiratory depression. The left column may be used for patients with low sensitivity to opioid induced respiratory depression. The right column may be used for patients with high sensitivity to opioid induced respiratory depression.

    TABLE-US-00006 TABLE 6 TV direction and rate of change and corresponding F values for three different sensitivities to opioid induced respiration depression. Tidal Volume (TV) Low Average High Direction and Rate of Sensitivity Sensitivity Sensitivity Change Points Points Points Rapid Decrease TV ↓↓ +4 +6 +8 Alarm Slow Decrease TV ↓ +2 +3 +4 Alert No Change TV .fwdarw. 0 0 0 Slow Increase TV ↑ −2 −3 −4 Rapid Increase TV ↑↑ −4 −6 −8 EXAMPLES: Points  1. TV that is slowly decreasing (+3) from 7 to 6.5 ml/Kg (0) +3  2. TV that is rapidly decreasing (+6) from 6.5 to 6 ml/Kg(+2) +8  3. TV that is rapidly decreasing (+6) from 5 to 4.5 ml/Kg +14   (+8)  4. TV that is rapidly decreasing (+6) from 4.5 ml to 4.0   mg/Kg(+10) +16  5. TV that is slowing increasing (−3) from 4.5 to 5 ml/Kg +5   (+8)  6. TV that is slowly increasing (−3) from 7 to 7.5 ml/Kg (0) −3  7. TV that is rapidly increasing (−6) from 7 to 7.5 ml/Kg (0) −6  8. TV that is not increasing/decreasing (0) around 7 ml/Kg 0   (0)  9. TV that is rapidly increasing (−6) from 7 to 7.5 ml/Kg (0) −6 10. TV that is rapidly increasing (−6) from 8.5 to 9 ml/Kg (6) −12 11. TV that is rapidly increasing (−6) from 9.5 to 10 ml/Kg −16   (10)

    [0154] An increasing opioid concentration in the brain produces an increasing level of sedation. Ambulatory people develop a progressive decrease in the amount of activity (body movement) due to an increasing level of sedation. An increasing level of sedation also causes a change from normal coordinated body movement to uncoordinated body movement. An increasing level of sedation also causes a pattern of head nodding. A rapid increase in the concentration of brain opioid can produce a rapid decrease in the amount of body movement, change from coordinated to uncoordinated movement, onset of head nodding, and a change from standing or sitting to the supine, lateral, or prone position.

    [0155] The accelerometer 32 and controller 26 monitor body activity, body position, and body coordination as an estimate of sedation level. The pattern of body activity level is continuously analyzed to detect and predict the progression from mild to moderate to severe hypoventilation due to an opioid overdose. The controller 26 analyzes the decrease in body activity level, presence of head nodding, presence of uncoordinated body movement, and change from the standing or sitting position to the supine, lateral, or prone position to calculate an RIS for detecting/predicting opioid induced hypoventilation. For example, as shown in TABLE 7, the RIS for opioid induced hypoventilation has a more positive value (+ more risk) when a decreased amount of body activity, presence of head nodding, presence of uncoordinated movement, and change from the standing or sitting position to the lateral, supine, or prone position are detected. The RIS for opioid induced hypoventilation has a more negative value (− less risk) when an increased in amount of body activity is measured. The RIS can be updated every 20-30 seconds.

    TABLE-US-00007 TABLE 7 F values for body position. Body Position Points Lying Prone +8 Alert Lying Lateral +4 Lying Supine +2 Sitting 0 Standing −4 Walking −6

    [0156] In addition to the absolute body position discussed above and the resulting F value, the controller 26 and accelerometer 32 further calculates the body position/activity level direction of change, symbolized by the up or down arrows in TABLE 8 below, and the rate of change of the body position/activity level, with weighting factors. The controller 26 may automatically adjust the weighting factor over time in response to the patient's previously analyzed body position trend data, to optimize the sensitivity and specificity for detecting and predicting the progression from mild, to moderate, to severe hypoventilation. For example, the F value for body position/activity level may comprise three factors, namely, body position, direction of body position/activity from ambulatory to stationary, and rate of change of body position/activity. The direction and rate of change of body position/activity may have a weighting factor on the F value, for example, 2× or 3×, or any multiple. In one example, F.sub.body position/activity=(F.sub.absolute body position/activity level+2F.sub.body position/activity direction+3F.sub.body position/activity rate of change).

    TABLE-US-00008 TABLE 8 body position/activity, direction and rate of change and corresponding F values for three different sensitivities to opioid induced respiration depression. Body Activity (Amount of Movement) Low Average High Sensitivity Sensitivity Sensitivity Direction and Rate of Change Points Points Points Rapid Decrease in Activity ↓↓ +4 +6 +8 Alarm Slow Decrease in Activity ↓ +2 +3 +4 Alert No Change in Activity .fwdarw. 0 0 0 Slow Increase in Activity ↑ −2 −3 −4 Rapid Increase in Activity ↑↑ −4 −6 −8 No Body Motion +15 +15 +15 Alarm Uncoordinated Body Motion +4 +4 +4 Alert Head Nodding +4 +4 +4 Alert EXAMPLES: Points Rapid decrease in body activity (+6), no body motion (+15), +29 lying prone (+8) Rapid decrease in body activity (+6), uncoordinated motion +6 (+4), standing (−4) Rapid decrease in body activity (+6), head nodding (+4), +10 sitting (0) Slow decrease in body activity (+3), head nodding (+4), +3 standing (−4) Slow increase in body activity (−3), walking (−6) −9 Rapid increase in body activity (−6), walking (−6) −12

    [0157] An increasing opioid concentration in the brain produces an increasing level of sedation and relaxation of the upper airway muscles leading to partial and/or complete upper airway obstruction. An increasing level of sedation causes a change from talking to light snoring, moderate snoring, heavy snoring, and episodes of obstructive apnea (complete airway obstruction). The sound transducer 20, accelerometer 32, and controller 26 monitor the amount of upper airway obstruction (number and degree of snoring episodes) and the number and duration of apnea episodes. The controller 26 analyzes the degree of snoring and duration of apnea to calculate the RIS for detecting/predicting opioid induced hypoventilation.

    [0158] As shown in TABLE 9, the RIS for opioid induced hypoventilation has a more positive value (+ more risk) when an increase in snoring and number/duration of apnea episodes are measured. In addition to a characteristic decrease in RR and TV, opioids cause an increase in the number of apnea episodes of short or long duration. The RIS for opioid induced hypoventilation has a more negative value (− less risk) with normal breathing and talking. The real-time RIS is updated every 20-30 seconds. The controller 26 may recognize the vital sign pattern towards hypoventilation early enough to prevent a permanent injury or death due to respiratory acidosis and hypoxemia.

    TABLE-US-00009 TABLE 9 upper airway obstruction (snoring and apnea) and examples incorporating increases and decreases in body motion, activity, and direction Upper Airway Obstruction (Snoring and Apnea) Points Apnea > 20 seconds +20 Apnea > 15 seconds +10 Heavy Snoring +8 Moderate Snoring +4 Light Snoring +2 No Snoring 0 Talking −8 EXAMPLES: Points Rapid decrease activity (+6), head nodding (+4), lateral position +22 (+4), heavy snoring (+8) Rapid decrease activity (+6), prone position (+8), moderate +26 snoring (+4), apnea > 10 (+8) No motion (+15), lateral position (+4), heavy snoring (+8), +47 apnea > 20 sec (+20) Slow decrease activity (+3), uncoordinated motion (+4), lateral +11 position (+4) No change activity (0), sitting (0), no snoring (0), talking (−8) −8 Slow increase activity (−3), walking (−6), talking (−8) −17

    [0159] Continuing to refer to FIG. 7, the F values for each of the above measured and calculated physiological conditions are correlated against a predetermined scoring system to determine if an alert (minor warning) or alarm (major warning) are generated. For example, the controller 26 continually measures the physiological conditions of the mammal and calculates a new RIS after a predetermined period of time, for example, five seconds to a minute. The above F values for RR, TV, AL, P, S, BC, HR, and HS are merely exemplary and may change over times based on the normal baseline of the particular patient. Additionally, when the sum, multiplication, division, or subtraction, or other combination of the F values for RR, TV, AL, P, S, BC, HR, and HS are calculated (RIS.sub.T), and compared against a predetermined risk threshold, which may be a range or a value, the rate at which the (RIS.sub.T) changes and/or the trend direction (up or down) may also trigger an alert or an alarm. For example, if the RIS.sub.T is rapidly changing and/or trending in a direction away from the predetermined risk threshold by a predetermined value, range, or other threshold, an alarm or an alert may be triggered. Thus, in one configuration, in addition to trending and rate of change factoring into each individual RR, TV, AL, P, S, BC, HR, and HS F values, trending and rate of change of the calculated RIS.sub.T is also contemplated by the algorithm to determine the risk of an adverse event. Moreover, the disclosure contemplates that any one of the F values alone, or in combination with any of the other values of RR, AL, P, S, BC, HR, and HS may form the RIS. For example, correlating the measured sound from airflow through the trachea to TV alone against a predetermined range of TV ranges or threshold may detect an adverse event.

    [0160] Referring now to FIG. 8, in another method, the controller 26 is configured to predict the onset of heat exhaustion and/or heat stroke in, for example, athletes or military personnel using the RIS discussed above. The controller 26 may measure the patient's HR, RR, and/or TV as discussed above with respect to the method shown in FIG. 7, including the absolute value change, direction, rate of change, and duration of change of RR, TV, and/or HR. The controller 26 further measures the patient's temperature with temperature sensor 34 and calculates the temperature trend and rate of change of the measured temperature similar to the methods discussed above. In another words, the controller 26 assigns an F value to the absolute measured temperature and an F score, which may be weighted to the trend (higher or lower) of the measured temperature and the rate of change. The sum of these F values, and the F values from the patient's measured HR, RR, or TV, may be compared to a threshold, and when the RIS exceeds or otherwise deviates from the threshold an alert or alarm is sounded. For example, a soldier wearing heavy clothing and a backpack on a 20-mile march may develop an increased cellular metabolism, increased CO2 production, dehydration, and increased body temperature. Compensatory mechanism may be exceeded during the march in some soldiers, leading to a rapid rise in CO2 production, a rapid rise in lactic acid (metabolic acidosis), a rapid rise in minute ventilation, and a rapid rise in body temperature (heat exhaustion and/or heat stroke).

    [0161] Referring to FIG. 9, another embodiment and application of the AVMS 27 may be employed in fitness tracking and training. It is known that respiratory function is an indicator of physical fitness. The AVMS 27 can be used to track HR, RR, TV, and minute ventilation (MV) during mild, moderate, and heavy activity (exercise) of short or long duration. The body's response during the increased activity and during the recovery period after the activity are an estimate of health and physical fitness. These measured parameters may be paired to exercise or training time spent at optimal range, maximum minute ventilation (measure of exertion), and progress against goals among other potential analytical and statistical outputs. In other words, the measured minute ventilation, HR, RR, and TV may be compared to a goal of minute ventilation, HR, RR, and TV during and after the activity to determine if fitness goals are progressing. Heart rate trend measurements may be combined with MV, RR, TV, and body temperature trend measurements to enhance fitness monitor performance.

    [0162] In one configuration, physical fitness may also be based on the amount of MV at a specific level and duration of exercise or activity level, and the change in MV over time after a period of conditioning or deconditioning at the same level and duration of exercise or activity level such as, for example, (1) normal daily activities, (2) exercise warm up activities, (3) maximal exercise, and (4) exercise recovery. The level and duration of each exercise or activity at a specific time can also be determined by a quantitative activity monitor, or the average heart rate during the exercise or activity.

    [0163] Referring now to FIG. 10, similar to the algorithm shown in FIG. 7, a change from stable lung function in ambulatory patients with chronic obstructive pulmonary disease (COPD) and asthma to unstable or worsening lung function during an acute exacerbation of COPD and/or asthma may be determined by comparing known RR and TV flow rates of a particular patient or range of known values, against measured RR and TV flow rates. A RIS value that defines a clinically significant change in lung function may be assigned based on the percentage deviation from normal and the rate at which the deviation from the normal is increasing. Alarms or alerts may be generated when the RIS and the RIS trend deviates from predetermined ranges.

    [0164] Referring now to FIG. 11, in this configuration, the TSD 10 includes two internal microphones 20, one external microphone for noise cancelling, a reflectance pulse oximeter 36, a temperature sensor 34, ECG electrodes 38, and an accelerometer 32. The TSD 10 is releasably coupled to a coupling component 40 adhered to the patient's skin with a surrounding area of adhesive tape 30 to releasably connect the TSD 10 to the patient. The coupling component 40 may be adhered to the skin of the neck with the adhesive tape 30 (or an adjustable elastic band) for up to 2 weeks, while the TSD 10 may be removed after at least approximately 1-hour or every few days for recharging. In one configuration, the housing 12 may include a first connector 42, for example, a flange, hook, locking ring or other connectors to releasably couple the housing 12 to a corresponding second connector 44 of the coupling component 40. The adhesive tape 30 may at least partially surround the flexible diaphragm 22 (similar to a pediatric stethoscope head) for attachment to the skin surface of the neck. In one embodiment, the outer surface of coupling component's 40 flexible diaphragm 22 may be coated with an adhesive for robust attachment to the skin surface. Connecting the first connector 42 with the second connector 44 may form a single airtight unit that securely attaches to the skin of the neck above the tracheal notch or lateral to the larynx and excludes ambient sounds. The flexible diaphragm 22 and the bell-shaped chamber may enhance the signal-to-noise ratio of the sound signal measured by the TSD microphones 20. In one embodiment, the second connector 44 may be disposed around the circumference of the diaphragm 22 with the adhesive 30 that mechanically attaches the diaphragm 22 surface to the skin surface. The adhesive tape 30 may further be disposed around the circumference of the flexible diaphragm 22 to firmly secure the coupling component 40 to the skin surface. In another configuration, the center of the adhesive tape 30 may include an open center area between the skin surface and the TSD microphones 20. The open configuration (without a diaphragm) and the bell-shaped stethoscope head may enhance the signal-to-noise ratio of the sound signal measured by the TSD microphone 20.

    [0165] Although the above embodiments were discussed with respect to medical applications, it is further contemplated that any of the above embodiments may be used in non-medical settings. For example, the AVMS 27 may be used by first responders, whether firefighters, police, EMS, or hazmat teams when encountering potentially dangerous gases, chemicals, or weapons of mass destruction that may affect breathing or acute upper airway obstruction. The AVMS 27 can detect hyperventilation or hypoventilation conditions of first responders which may identify the presence of harmful and potentially dangerous gases or chemicals. In another embodiments, the AVMS 27 may be used to detect low O2 situations such as oil field, breweries, chemical manufacturing facilities, mining operations, dry ice manufacture, food processing and refrigeration/freezing facilities, as well as aviation hypoxia and high altitude; astronauts, space capsules, space suits, etc.

    [0166] Referring now to FIG. 12, the remote controller 26 of the device 10 may be in electrical communication with one or more medical devices 46 to form a system 47 including the remote controller 26, the device 10 and the medical device(s) 46 which can aid and assist in patient care, therapies, and treatment. The remote controller 26 may include one or more processors, and/or software modules containing instructions to provide for the automated operation and performance of the features, sequences, or procedures described herein. In one embodiment, the remote controller 26 includes one or more processors, and/or software modules containing instructions to provide for the automated operation and performance of the features, sequences, or procedures described herein. For example, the remote controller 26 includes processing circuitry 48 programmed or programmable to execute the automated or semi-automated operation and performance of the features, sequences, calculations, or procedures described herein.

    [0167] In one embodiment, for example, the remote controller 26 includes processing circuitry 48 with a memory and a processor. The memory is in electrical communication with the processor and includes instructions that, when executed by the processor, configure the processor to receive, process, or otherwise use signals from the device 10 and/or other system components. Still further, the remote controller 26 may include one or more user input devices, controllers, speakers, and/or displays 51 for collecting and conveying information from and to the user.

    [0168] For example, referring to FIG. 12, the remote controller 26 may include processing circuitry 48 configured to operate and control the various functions of the device 10 and the medical devices 46. In some configurations, the processing circuitry 48 may include a memory 50 and a processor 52. In particular, in addition to or instead of a processor 52, such as a central processing unit and memory, the processing circuitry 48 may comprise integrated circuitry for processing and/or control, e.g., one or more processors and/or processor cores and/or FPGAs (Field Programmable Gate Array) and/or ASICs (Application Specific Integrated Circuitry) adapted to execute instructions. The processor 52 may be configured to access (e.g., write to and/or read from) the memory 50, which may comprise any kind of volatile and/or nonvolatile memory, e.g., cache and/or buffer memory and/or RAM (Random Access Memory) and/or ROM (Read-Only Memory) and/or optical memory and/or EPROM (Erasable Programmable Read-Only Memory).

    [0169] The processing circuitry 48 may be configured to control any of the methods and/or processes described herein and/or to cause such methods, and/or processes to be performed, e.g., by the device 10 and/or the medical device 46. The processor 52 may correspond to one or more processors 52 for performing functions described herein. The memory 50 is configured to store data, programmatic software code and/or other information described herein. In some embodiments, the software may include instructions that, when executed by the processor 52 and/or processing circuitry 48 causes the processor 52 and/or processing circuitry 48 to perform the processes described herein with respect to controller 26 and/or the medical device 46. For example, processing circuitry 48 of the controller 26 may be configured to perform one or more functions described herein such as with respect to methods and systems described in more detail herein.

    [0170] The processing circuitry 48 of the device 10 is configured to receive data (for example, signals) from the accelerometer 32, the temperature sensor 34, the reflectance pulse oximeter 36, and/or the plurality of electrodes 38 of the device 10 and to convert that data into information that can be conveyed to the user, such as a visual display, an audio signal, or the like. Further, the processing circuitry 48 of the device 10 may be configured to compare data received from the accelerometer 32, the temperature sensor 34, the reflectance pulse oximeter 36, and/or the plurality of electrodes 38 to one or more reference values or ranges and generate an alert based on the comparison. For example, the processing circuitry 48 of the device 10 may compare data received from the accelerometer 32, the temperature sensor 34, the reflectance pulse oximeter 36, and/or the plurality of electrodes 38 to preset threshold or reference data. If the received data from the accelerometer 32, the temperature sensor 34, the reflectance pulse oximeter 36, and/or the plurality of electrodes 38 is within a threshold range, the processing circuitry 48 may then generate and communicate an alert (such as a visual display or audio tone) to the user to indicate the status of the patient.

    [0171] Also, the processing circuitry 48 may be configured to recognize various patterns received from data from the accelerometer 32, the temperature sensor 34, the reflectance pulse oximeter 36, and/or the plurality of electrodes 38 to various reference patterns that are preset in the processing circuitry. For example, there may be certain patterns which are detected in a patient's TV and/or TV variability which are known to correspond with certain medication overdoses or sensitivities. Additionally, the processing circuitry 48 may be programmed to recognize patterns of RR, HR, or other vital sign data, RR variability, HR variability, apnea patterns including apnea number per minute and/or the duration of apnea, and/or other vital sign variability patterns. For example, the TSD 10 may use the accelerometer 32 to determine sleep/awake cycles and estimate the level of sedation. The TSD 10 may include telemetry to a cell phone application and may be a dime-sized sensor (for example 1.0 cm diameter×0.675 cm height) to a quarter-sized sensor (for example 2.0 cm diameter×0.75 cm height).

    [0172] As shown in FIG. 12, the medical device 46, the medical device 8 may be an auto-injector and when certain preset parameters in the controller 26 are met, the auto-injector may deliver/inject a medication, like naloxone hydrocholoride, to try and reverse the effects of respiratory depression, sedation, and/or hypotension in a patient. Alternatively, the medical device 46 that is in communication with the controller 26 may be a medical device that is capable of delivering an electric shock to a patient when certain preset parameters are met. For example, if a patient stops breathing for a preset period time, the controller 26 may detect this and based upon these preset parameters a certain timed voltage of electric shock may be delivered to the patient to arise the patient from a state of sedation and to promote breathing. Also, as shown in FIG. 12, the medical device 46 may or may not include a diaphragm 22. As a nonlimiting example, the TSS may include a bell shape with an aperture at the concave focal point and a microphone may be placed in or near the aperture.

    [0173] The remote controller 26 of the device 10 may be configured to transmit data to a diagnostic software application on a cell phone of a patient, clinician, family member, friend, or care giver, or hospital monitor, for example in a central nursing station, that alerts/alarms when certain preset parameters are detected. For example, the controller 26 may be configured to detect preset parameter and when these preset parameters are met certain alerts/alarms may be activated on the hospital monitor or the cell phone so that others are alerted when a patient is not breathing enough, has stopped breathing, or shows other irregular and/or abnormal vital signs. As another example, when the system 47 is used in the hospital, the data collected from the system can be transmitted to a cell phone, like a nurse's cell phone, or a central nursing station and the system 47 may be configured to display 51 certain information and provide real-time alarms depending upon the data that is received by the system 47. When an alert is activated on the cell phone vibrations and/or an audible alarm on the cell phone may be activated. Additionally, the cell phone may be used to provide the patient with verbal commands like an instruction to “take a deep breath”.

    [0174] Similar to the algorithm as shown in FIG. 7, patients that receive an intravenous infusion of opioids, sedatives, and anesthetics, including fentanyl, may develop characteristic sleep patterns. Following the use of an intravenous injection or infusion of an opioid, a patient may experience apnea, which is a period where breathing is not occurring and this apnea may be caused by an upper airway obstruction due to the sedation. The controller 26 may be programmed to continuously, intermittently, or continually measure for any apnea that is detected and assign a risk index score to a wearer of the device 10. For example, the AVMS may continuously monitor for the duration and frequency of any apnea and the controller 26 may calculate the averaged apnea experienced by an individual over a predetermined period of time (x). The AVMS may include a wearable Trachea Sound Device (TSD) and the AVMS may also be generally referred to as a Respiratory Monitoring System (RMS). The TSD may also generally be referred to as a Trachea Sound Sensor (TSS). A point value may be assigned based upon the timing and duration of the apnea, for example as shown in Table 9. The controller 26 may then assign a risk value represented as a value (F) to score the parameter/pattern based upon a predefined scale to determine if an alert or an alarm will be generated. Also, based upon the value (F) that is assigned to the apnea that is detected in a patient, the controller 26 may be in contact the medical device 46 and if the controller 26 detects a preset parameter for the apnea, for example that shows the patient has stopped breathing, the controller 26 may communicate with the medical device 46 and the medical device 46 may deliver medication to the patient.

    [0175] Additionally, the controller 26 may be programmed to recognize certain patterns of apnea in a patient. The controller 26 will be configured to recognize certain preset patterns of apnea which have been programmed into the controller 26 and these patterns of apnea may be communicated along with the RIS score that is calculated to determine the status of the patient. Based upon the present parameters associated with the particular pattern of apnea detected as well as the RIS that was calculated, certain actions may be triggered by the processing circuitry 48. For example, if the patterns and apnea and RIS meet certain predefined parameters, then the controller 26 may be in communication with the medical device 46 to deliver certain treatments and/or therapies to the patient. For example, the patient may receive an electric shock to stimulate further breathing or may receive an injection to try and stimulate breathing as well. The patterns may include, but are not limited to, a pattern of normal TV, a pattern of decreased TV, a pattern of very decreased TV, and a period of apnea followed by deep breaths. This pattern may be repeated again and again such that the F value plus ten indicates an intermittent pattern and the F value plus twenty indicates a consistent pattern. Also, a duration of apnea for 15 second may equal the F value plus 15, a duration of apnea for 15-30 seconds may equal the F value plus 20, and a duration of apnea for more than 30 seconds may equal an F value plus 26 or more than 26.

    [0176] Also, a pattern may be detected in RR as well as the RIS associated with RR, for example, as shown in TABLE 2, may be detected using the device 10. When the pattern of the RR is progressively decreasing over a preset period of time and a particular RIS is detected, this pattern recognition along with certain RIS which is detected by the processing circuitry 48 can trigger an alarm or an alert. For example, if the RR shows a pattern of decreasing over a preset period of time from 8 breaths per minute, to 6 breaths per minute, to 4 breaths per minute to 0 breaths per minute, a preset pattern may be recognized by the processing circuitry 48 and an RIS may also be assigned to the RR which in turn can trigger an alarm or alert. Also, depending upon the present parameters in the processing circuitry 48, the RR pattern detected as well as the RIS may trigger the medical device 46 to deliver certain therapies and/or treatments to the patient.

    [0177] One pattern which may be associated with significant risk may be where there is a progressive decrease in RR and TV over a preset period of time along with an increase in sedation and snoring over the same preset period of time which may be followed by a period of apnea. When patients have become heavily sedated from certain medications this pattern may be detected and when associated with certain RIS and the processing circuitry 48 may trigger an alert, alarm, and/or certain treatments/therapies from the medical device 46.

    [0178] Referring now to FIG. 13, certain physiological conditions may be measured by the device 10. The device may be used to monitor and/or measure the patient's MV, oxygenation, airway patency, and breathing patterns. Also, the device 10 may be configured to measure at least one from the group consisting of RR, TV, minute ventilation (MV), MV variability, breathing pattern, degree of upper airway obstruction (talking/snoring), body activity level, body coordination, body position, heart rate, temperature, number and duration of apnea episodes, as well as other physiological conditions. S100. For example, changes in body position (going from upright to sitting to lying down), the sounds of air flowing through the patient's trachea during inhalation and exhalation (this may be converted into a measurement of air flow into and out of the body each minute (ml/minute), the timing of inhalation/exhalation (1:E ratio), patterns of breathing and/or lack of breathing, changes in snoring patterns (going from no snoring to mild/moderate/severe snoring), changes in body activity (going from walking to stationary), heart rate, and body coordination (going from normal ambulation to unstable) can be various parameters that are used to estimate the degree of sedation due to opioid use. These measurements may be taken continually, periodically, or continuously. In one exemplary embodiment, the measurements may be taken every 20 or 30 seconds by the device 10. Once certain measurements are taken by the device 10, the processing circuitry 48 may be configured to determine a RIS that defines a clinically significant change with a particular physiological parameter based upon what is being measured by the device. S110. The RIS may be assigned based on the percentage deviation from normal and the rate at which the deviation from the normal is increasing. The algorithms may use a RIS to accurately predict the onset of mild, moderate, and severe hypoventilation prior to a severe adverse event like a seizure, brain damage, heart attack and death, due to a mediation overdose (including medications like opioids, alcohol, benzodiazepam, etc.) or other serious medical events. Also, once certain measurements are taken by the device 10, the processing circuitry 48 may be configured to detect certain patterns associated with certain physiological functions. S120. Depending upon the RIS which is associated with what is being measured and/or depending upon any patterns which are detected based upon what is being measured, certain alarms or alerts may be generated when the RIS and/or the pattern deviates from predetermined ranges. S130.

    [0179] It may be appreciated by persons skilled in the art that the present embodiments are not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. A variety of modifications and variations are possible in light of the above teachings.