Acoustic sensor and ventilation monitoring system

Inventors

Joseph, Jeffrey IHELMOND, Noud VanTORJMAN, Marc CDEVINE, Denise LDICCIANI, Nance KLOEUM, Channy

Assignees

Thomas Jefferson UniversityRTM Vital Signs LLC

Publication Number

US-11071476-B2

Publication Date

2021-07-27

Expiration Date

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Abstract

A method of monitoring respiration with an acoustic measurement device, the acoustic measurement device having a sound transducer, the sound transducer configured to measure sound associated with airflow through a mammalian trachea, the method includes correlating the measured sound into a measurement of tidal volume and generating at least one from the group consisting of an alert and an alarm if the measured tidal volume falls outside of a predetermined range.

Core Innovation

The disclosure relates to a method, device, and system for an acoustic ventilation monitoring system. The acoustic measurement device has a sound transducer configured to measure sound associated with airflow through a mammalian trachea, correlates the measured sound into a measurement of tidal volume and respiratory rate, and generates at least one from the group consisting of an alert and an alarm if the measured tidal volume or other measured parameters fall outside of a predetermined range. The acoustic measurement device and system include a housing with an opening and a diaphragm, a sound transducer disposed within a chamber opposite the opening, optional accelerometer, temperature sensor, pulse oximeter, wireless transmitter, and a remote controller configured to correlate measured sound energy into measurements of tidal volume and respiratory rate in real-time and to calculate a Risk-Index Score (RIS).

The background identifies that continuous and accurate monitoring of airflow into and out of the lungs during ambulation in the hospital or real-world environment has not been well established, and that existing methods such as tight-fitting chest bands, impedance pneumography, nasal cannula capnography, and pulse oximetry are cumbersome, easily dislodged, or detect abnormalities only after moderate to severe hypoventilation. The invention addresses the inability to continuously and accurately monitor and quantify ventilation (for example respiratory rate, tidal volume, and minute ventilation) and related patterns of breathing in ambulatory and hospitalized patients to detect hypoventilation, hyperventilation, airway obstruction, and other adverse respiratory events in real-time.

Claims Coverage

The provided claim set includes one independent claim with six main inventive features extracted below.

Tracheal acoustic measurement during exercise

Measuring sound emanating from airflow through an ambulatory mammal's trachea during exercise with an acoustic measurement device configured to releasably affix to the mammal's skin proximate the trachea.

Releasably affixable acoustic device with recessed sound transducer

An acoustic measurement device including a housing with an opening and a sound transducer recessed and substantially surrounded by the housing and positioned opposite the opening.

Wireless communication to a remote controller with processing circuitry

Communicating the measured sound to a remote controller having processing circuitry.

Correlation of sound into respiratory rate and tidal volume

The remote controller is configured to correlate the measured sound into a measurement of respiratory rate and a measurement of tidal volume.

Calculation of ventilation metrics and trends

Calculating at least one selected from the group consisting of minute ventilation (MV), absolute tidal volume, direction of tidal volume trend, and rate of change of tidal volume from measured respiratory rate and tidal volume.

Index assignment, threshold comparison, and fitness determination

Assigning an index value to at least one selected metric, comparing the assigned index values with a predetermined threshold, and determining the ambulatory mammal's fitness level based on the comparison.

The independent claim covers an acoustic device releasably affixable to the tracheal skin surface with a recessed sound transducer, wireless communication to a remote controller, real-time correlation of tracheal sound into respiratory rate and tidal volume, calculation of ventilation metrics and trends, assignment of index values and comparison to thresholds to determine fitness.

Stated Advantages

Continuous non-invasive real-time monitoring and quantification of respiratory rate, tidal volume, minute ventilation, airway patency, activity level, body position, and other physiological variables.

Early detection and prediction of adverse events (for example mild, moderate, and severe hypoventilation including opioid-induced respiratory depression, heat exhaustion/heat stroke, and decompensation from COPD/asthma) prior to a severe hypoventilation event.

Enhanced patient safety, improved clinical outcomes, and decreased costs through use of real-time MV, HR, activity, and temperature trend data for clinicians and caregivers.

Capability to automatically alert caregivers and emergency personnel and to trigger automated interventions (for example auto-injector delivery of an opioid reversal medication) with the potential of saving lives.

Enhanced signal-to-noise ratio for tracheal sound measurement using a diaphragm, chamber geometry, sound insulation, and optional ambient noise cancellation.

Documented Applications

Continuous monitoring of ambulatory and hospitalized patients' respiratory function and calculation of a Risk-Index Score (RIS) to detect and predict hypoventilation, hyperventilation, and unstable ventilation patterns in real-time.

Predicting opioid overdose and opioid-induced hypoventilation with staged alerts/alarms and potential automatic delivery of an opioid reversal medication (for example naloxone) via an auto-injector under a closed-loop control algorithm.

Predicting heat exhaustion or heat stroke by combining respiratory metrics and temperature measurements and generating alerts/alarms when combined risk values exceed predetermined ranges.

Tracking fitness and training by measuring respiratory rate, tidal volume, and minute ventilation during exercise and comparing minute ventilation to predetermined thresholds to determine fitness level.

Monitoring patients during anesthesia and sedation in clinical settings (for example OR, PACU, ICU, ER, radiology, and cardiac catheterization) to continuously monitor minute ventilation and airway patency.

Monitoring chronic respiratory and cardiac conditions such as COPD, asthma, congestive heart failure, and other disorders for early detection of decompensation via changes in minute ventilation, heart rate, activity level, and temperature.

Use by first responders and in industrial or hazardous environments to detect hyperventilation, hypoventilation, low O2 situations, or acute upper airway obstruction, and to identify potentially dangerous gases or chemicals affecting breathing.

Integration with patient smart devices and central monitoring stations for remote analysis, clinician notification, electronic medical record upload, and caregiver alerts by text, e-mail, or phone call.

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