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-10881330-B2

Publication Date

2021-01-05

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

A method of monitoring respiration with an acoustic measurement device having a sound transducer configured to measure sound associated with airflow through a mammalian trachea 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. The techniques of this disclosure generally relate to a method, device, and system for an acoustic ventilation monitoring system.

Current respiratory monitors such as tight-fitting chest bands, impedance pneumography, nasal cannula capnography, and pulse oximeters are described as cumbersome, invasive, easily dislodged, prone to false alarms, and not suited to continuously and accurately monitor/measure airflow into and out of the lungs during ambulation. The disclosure identifies the inability to continuously and accurately monitor tidal volume and minute ventilation in ambulatory and real-world environments as a problem in clinical diagnostics and patient safety.

An Acoustic Ventilation Monitoring System (AVMS) is configured to measure and analyze a pattern of variables such as respiratory rate, tidal volume, upper airway patency, body activity, body coordination, body position, heart rate, and temperature in ambulatory and hospitalized patients and to analyze these variables in real-time to update a Risk-Index Score (RIS). The AVMS comprises a wearable Trachea Sound Device (TSD) that transmits trachea sound and accelerometer data to a controller that correlates measured sound energy into measurements of tidal volume and respiratory rate in real-time, assigns likelihood values, calculates rates of change and trends, and generates alerts and alarms when summed risk values exceed predetermined thresholds.

Claims Coverage

One independent claim is presented; it discloses four main inventive features.

Correlating measured sound into a measurement of tidal volume

correlating the measured sound into a measurement of tidal volume;

Calculating tidal volume metrics

calculating an absolute tidal volume, a direction of tidal volume, and a rate of change of tidal volume;

Assigning risk index values to tidal volume metrics

assigning a risk index value to each of the absolute tidal volume, the direction of tidal volume, and the rate of change of tidal volume, each risk index value being one selected from the group consisting of a positive score and a negative score based on a predefined scale;

Summing risk index values and generating alerts or alarms

calculating a sum of the risk index values assigned to each of the absolute tidal volume, the direction of tidal volume, and the rate of change of tidal volume; and generating at least one selected from the group consisting of an alert and an alarm if the calculated sum exceeds a predetermined risk score threshold.

The independent claim focuses on transforming tracheal acoustic measurements into quantitative tidal volume metrics, assigning predefined risk index values to those metrics, summing the values, and generating alerts or alarms when the summed risk exceeds a predetermined threshold.

Stated Advantages

Continuous, non-invasive real-time monitoring and quantification of respiratory rate, tidal volume, minute ventilation, airway patency, body activity, body coordination, body position, heart rate, and temperature.

Early detection and prediction of mild, moderate, and severe hypoventilation and opioid induced respiratory depression prior to a severe hypoventilation event.

Alerts and alarms to notify the patient, caregivers, clinicians, and emergency personnel, with automatic communication (for example text, e-mail, phone call, or 911) when detecting or predicting increased risk for a serious adverse clinical event.

Enhanced patient safety, improved clinical outcomes, and decreased costs through continuous monitoring and timely clinician intervention.

Capability to integrate with closed-loop drug delivery such as automatic delivery of an opioid reversal medication (for example naloxone) to prevent death from opioid overdose.

Documented Applications

Continuous ambulatory and in-hospital monitoring of respiratory function including respiratory rate, tidal volume, minute ventilation, airway patency, heart rate, body activity, body position, and temperature.

Predicting and detecting opioid overdose and opioid induced hypoventilation by calculating a Risk-Index Score (RIS) from respiratory and motion-derived metrics and generating alerts/alarms when thresholds are exceeded.

Predicting heat exhaustion or heat stroke by combining measured respiratory metrics with body temperature to assign likelihood values and generate alerts/alarms when comparisons exceed predetermined ranges.

Fitness tracking and training by measuring respiratory rate, tidal volume, and minute ventilation during exercise and comparing minute ventilation to predetermined thresholds to assess fitness.

Monitoring patients during monitored anesthesia care and sedation in operating room, PACU, ICU, emergency room, radiology, and cardiac catheterization laboratory for continuous minute ventilation and airway patency assessment.

Post-discharge monitoring of patients taking opioids, and use in outpatient/inpatient drug rehabilitation (methadone) clinics to enhance safety and compliance.

Integration with an auto-injector or wearable/implantable drug infusion pump to automatically deliver an opioid reversal medication based upon real-time AVMS data using a closed-loop control algorithm.

Monitoring and early detection of decompensation in chronic respiratory and cardiac diseases such as congestive heart failure, COPD, asthma, pneumonia, and other pulmonary and cardiovascular disorders.

Use by first responders and industrial/military/aviation applications to detect hyperventilation, hypoventilation, low oxygen situations, overheating/exhaustion, and other environmental or operational respiratory hazards.

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