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-11000212-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

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 is disclosed, wherein the measured sound is correlated into a measurement of tidal volume and at least one from the group consisting of an alert and an alarm is generated if the measured tidal volume falls outside of a predetermined range. The disclosure further describes an acoustic ventilation monitoring system (AVMS) that correlates measured sound energy into measurements of the patient's tidal volume and respiratory rate in real-time and updates a Risk-Index Score (RIS) to calculate the current and future risk of an adverse clinical event.

The background identifies a need for continuous and accurate monitoring of airflow and ventilation during ambulation and in hospitalized patients because existing monitors such as tight-fitting chest bands, impedance pneumography, nasal cannula capnography, and pulse oximeters are limited by wiring, displacement, false alarms, delayed detection, and are not suited to quantify upper airway function or level of ventilation impairment during ambulation. The disclosure addresses the inability to continuously and accurately monitor/measure airflow into and out of the lungs during ambulation in the hospital or real-world environment by providing a wearable Trachea Sound Device (TSD) and diagnostic algorithms to continuously quantify and analyze respiratory parameters and related physiological variables.

Claims Coverage

Overview: one independent claim is present and it contains five main inventive features.

Acoustic measurement of tracheal airflow sounds

An acoustic measurement device having a sound transducer and an accelerometer configured to measure sound vibrations associated with airflow through a mammalian trachea.

Correlation of measured sound into tidal volume

Correlating the measured sound vibrations into a measurement of tidal volume.

Calculation of tidal volume metrics

Calculating 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.

Assignment of risk index values

Assigning a risk index value to the at least one selected from the group consisting 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 a group consisting of a positive score and a negative score based on a predefined scale.

Alert generation based on risk threshold

Generating an alert if the assigned risk index value deviates from a predetermined risk score threshold.

The independent claim integrates acoustic tracheal sound measurement with tidal volume computation, calculation of tidal volume metrics, assignment of positive/negative risk index scores, and generation of alerts when the risk index deviates from a predetermined threshold.

Stated Advantages

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

Updating a Risk-Index Score (RIS) that calculates the current and future risk of an adverse clinical event and producing alerts and alarms when unstable patterns are detected.

Ability to detect and predict the onset and progression of mild, moderate, and severe hypoventilation and other ventilation abnormalities prior to severe events.

Improved clinical outcomes and decreased costs through real-time monitoring and clinician access to MV, HR, activity, and temperature trend data.

Enhanced patient safety and compliance by enabling automated alerts/alarms, caregiver notification, transmission to central monitoring, and post-discharge monitoring.

Capability to automatically trigger delivery of an opioid reversal medication (for example naloxone), described as saving lives.

Documented Applications

Predicting and detecting opioid-induced respiratory depression and opioid overdose by calculating an RIS based on respiratory rate, tidal volume, activity, position, snoring, and body coordination.

Continuous monitoring of hospitalized patients during monitored anesthesia care, in the OR, PACU, ICU, emergency room, radiology suite, cardiac catheterization laboratory, and general hospital floors.

Post-discharge monitoring of patients taking opioids at home with data transmitted to a software application on the patient's cell phone and to a central monitoring station.

Closed-loop integration with a wearable or implantable drug infusion pump or auto-injector to automatically deliver an opioid reversal medication based on real-time AVMS data.

Predicting heat exhaustion and heat stroke in ambulatory mammals, including athletes and military personnel, by combining respiratory measurements with temperature measurements.

Tracking fitness of ambulatory persons, athletes, and military personnel by measuring respiratory rate, tidal volume, and minute ventilation during exercise to evaluate and optimize performance.

Monitoring chronic respiratory diseases and detecting exacerbations in COPD and asthma by comparing measured RR and TV to patient or population baselines and assigning a RIS.

Use by first responders and in industrial or environmental settings to detect hyperventilation or hypoventilation conditions indicative of dangerous gases, low O2 situations, or other hazardous environments.

Monitoring in non-medical high-altitude and aerospace contexts such as aviation hypoxia and astronauts in space capsules or space suits.

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