Acoustic sensor and ventilation monitoring system

Inventors

Joseph, Jeffrey ITORJMAN, Marc CDEVINE, Denise LDICCIANI, Nance KLOEUM, Channy

Assignees

Thomas Jefferson UniversityRTM Vital Signs LLC

Publication Number

US-11000191-B2

Publication Date

2021-05-11

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 invention is a method, device, and system for an acoustic ventilation monitoring system in which an acoustic measurement device having a sound transducer measures sound associated with airflow through a mammalian trachea, the measured sound is correlated into measurements of respiratory rate and tidal volume, minute ventilation is calculated based on the measured respiratory rate and tidal volume, and at least one alert or alarm is generated if calculated or measured values deviate from predetermined ranges.

The background problem being solved is the inability to continuously and accurately monitor and quantify airflow into and out of the lungs during ambulation and in real-world environments using existing methods such as tight-fitting chest bands, impedance pneumography, nasal cannula capnography, temperature thermistors, and pulse oximetry, which are cumbersome, prone to false alarms, poorly suited to quantify upper airway function or ventilation impairment, and do not provide continuous, ambulatory, real-time ventilation measurement to detect hypoventilation or other ventilation abnormalities.

Claims Coverage

The claims include two independent claims and disclose six main inventive features.

Measuring tracheal airflow sound

Measuring sound emanating from an airflow through a mammalian trachea with a sound transducer disposed in an acoustic measurement device.

Correlating sound to respiratory rate and tidal volume

Correlating the measured sound into measurements of the mammal's respiratory rate and tidal volume.

Calculating minute ventilation

Calculating a minute ventilation based on the measured respiratory rate and tidal volume.

Measuring cardiovascular and temperature parameters

Measuring the mammal's heart rate, blood oxygen saturation, and temperature in conjunction with the acoustic measurements.

Assigning categorical risk scores and summing to a total risk score

Assigning a respective risk score for each measured or calculated parameter selected from categories including stable, increasing, and decreasing, and calculating a total risk score based on a sum of the respective risk scores.

Generating alerts based on predetermined thresholds

Comparing calculated minute ventilation and measured heart rate, blood oxygen saturation, and temperature against respective predetermined thresholds and generating at least one alert if the total risk score deviates from at least one predetermined total risk threshold for acute respiratory distress.

Controller communication and processing

A controller in communication with the acoustic measurement device and with a pulse oximeter and temperature sensor, the controller having processing circuitry configured to correlate measured sound into respiratory rate and tidal volume, calculate minute ventilation, assign respective categorical risk scores, calculate a total risk score, and generate alerts when the total risk score deviates from thresholds.

The independent claims cover an acoustic-based measurement of tracheal airflow correlated to respiratory rate and tidal volume, calculation of minute ventilation, concurrent measurement of heart rate, blood oxygen saturation, and temperature, assignment and summation of categorical risk scores into a total risk score, and generation of alerts by a controller when predetermined risk thresholds are exceeded.

Stated Advantages

Provides a non-invasive real-time monitoring system that continuously quantifies and analyzes respiratory rate, tidal volume, upper airway patency, body activity, body coordination, body position, heart rate, and temperature.

Detects and predicts the onset and progression of mild, moderate, and severe hypoventilation (including opioid induced hypoventilation) prior to a severe hypoventilation event with high sensitivity and specificity as contoured by the algorithms.

Generates progressive alerts and alarms to patients, caregivers, clinicians, and emergency personnel and can automatically communicate location and vital sign information.

Can improve clinical outcomes and decrease costs by providing continuous real-time minute ventilation and other vital sign trend data for inpatient and ambulatory management.

Can be integrated with automated delivery systems (for example an auto-injector or infusion pump) to automatically deliver an opioid reversal medication based upon real-time data to save lives.

Documented Applications

Continuous respiratory monitoring of ambulatory and hospitalized patients, including real-time calculation of a Risk-Index Score (RIS) for adverse clinical events.

Predicting and detecting opioid overdose and opioid induced hypoventilation, including outpatient monitoring and monitoring after hospital discharge.

Predicting heat exhaustion or heat stroke by combining respiratory measurements with temperature monitoring.

Fitness tracking and training by measuring respiratory rate, tidal volume, and minute ventilation during exercise to assess physical fitness and exertion.

Monitoring and early detection of decompensation in chronic respiratory diseases such as COPD and asthma.

Perioperative and procedural monitoring during monitored anesthesia care (MAC), in the OR, PACU, ICU, emergency room, radiology suite, and cardiac catheterization laboratory.

Integration with auto-injector or wearable infusion pump to deliver naloxone or other antidotes in response to detected high-risk conditions.

Use by athletes, the military, and first responders to detect overheating, exhaustion, hyperventilation, hypoventilation, or exposure to harmful gases and low oxygen situations in industrial or operational environments.

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