Granted Patent B2

US 12,527,491 · App. 14/921,114 · Granted Jan 20, 2026

Inventor: Michael Stahl (Somerville, MA)

Assignee: XHALE ASSURANCE, INC.

A61B5/0806A61B5/02416A61B5/0295A61B5/08A61B5/7235A61B5/0059

Abstract

Claims (47)

1 . A microprocessing device configured to:

receive, in real time from a photoplethysmography (PPG) sensor, a raw PPG signal obtained from an individual, wherein the individual is spontaneously breathing and non-intubated;

isolate, in real time, a DC component signal stream, from the raw PPG signal by interpolating peaks of the raw PPG signal to generate an interpolated peak line, interpolating troughs of the raw PPG signal to generate an interpolated trough line, and averaging the interpolated peak line and the interpolated trough line to produce the DC component signal stream;

generate, in real time, a plot that represents the raw PPG signal and the DC component signal stream overlying each other, wherein the raw PPG signal is a waveform that intersects the DC component signal stream at midpoints of the raw PPG signal between the peaks and the troughs a plurality of times in the plot,

wherein a first curve of the DC component signal stream on the plot intersects a first midpoint of the midpoints of the raw PPG signal at a first end of the first curve and intersects a second midpoint of the midpoints of the raw PPG signal at a second end of the first curve, and is above a first curve of the raw PPG signal on the plot, and

wherein a second curve of the DC component signal stream on the plot intersects a third midpoint of the midpoints of the raw PPG signal at a first end of the second curve and intersects a fourth midpoint of the midpoints of the raw PPG signal at a second end of the second curve, and is below a second curve of the raw PPG signal on the plot;

calculate, in real time, one or more waveform parameters from the isolated DC component signal stream and the raw PPG signal to produce at least one waveform parameter data stream, wherein the one or more waveform parameters comprises a Top Area bounded by the second curve of the DC component signal stream on the plot and the second curve of the raw PPG signal on the plot, and a Bottom Area bounded by the first curve of the DC component signal stream on the plot and the first curve of the raw PPG signal on the plot, wherein the Bottom Area is an area under the first curve of the DC component signal stream on the plot and above the first curve of the raw PPG signal on the plot, and wherein the Top Area is an area above the second curve of the DC component signal stream on the plot and below the second curve of the raw PPG signal on the plot;

determine, in real time, whether a respiratory event has occurred in the individual by analyzing the produced at least one waveform parameter data stream and based on an Area Ratio that is the Top Area divided by the Bottom Area; and

report, in real time, the respiratory event to a caregiver substantially at the same time that the respiratory event occurs.

2 . The device of claim 1 , wherein the raw PPG signal stream is obtained from light emitted at an IR wavelength.

3 . The device of claim 1 , wherein the raw PPG signal stream is obtained from light emitted at a red wavelength.

4 . The device of claim 1 , wherein the at least one waveform parameter is calculated for substantially every cardiac peak in the raw PPG signal stream.

5 . The device of claim 1 , wherein the PPG signal stream is obtained from a central source site of the individual.

6 . The device of claim 5 , wherein the central source site is a nasal alar, nasal septum or nasal columella.

7 . The device of claim 1 , wherein the at least one waveform parameter is used to determine respiratory rate, respiratory effort, or both.

8 . The device of claim 1 , wherein the at least one waveform parameter is calculated from both a PPG signal stream obtained from light emitted in an IR wavelength and from a PPG signal stream obtained from light emitted at a red wavelength.

9 . The device of claim 8 , wherein a waveform parameter calculated from a red PPG signal stream is compared with a waveform parameter calculated from an IR PPG signal stream, and a confidence metric regarding whether a respiratory event occurred is generated based on the red waveform parameter and the IR waveform parameter.

10 . A system comprising a device of claim 1 and the PPG sensor.

11 . The system of claim 10 , further comprising a secondary respiration sensor, wherein the secondary respiration sensor is not a PPG sensor.

12 . The system of claim 11 , wherein the microprocessing device is further configured to:

receive, from the secondary respiration sensor, a raw respiration sensor signal;

calculate one or more waveform parameters from the received raw respiration sensor signal to produce a second waveform parameter data stream;

determine whether a respiratory event has occurred in the individual by analyzing the second waveform parameter data stream;

compare the respiratory event determined from the PPG signal to the respiratory event determined by from the respiration sensor signal; and

determine a confirmed respiratory event when the respiratory event determined from the PPG signal matches the respiratory event determined by from the respiration sensor signal.

13 . The device of claim 1 , wherein determining whether the respiratory event has occurred in the individual by analyzing the produced at least one waveform parameter data stream comprises analyzing a change in slope of the waveform over time, wherein the change in slope of the waveform indicates a breath.

14 . The device of claim 1 , wherein determining whether the respiratory event has occurred in the individual by analyzing the produced at least one waveform parameter data stream comprises a zero crossings method, wherein a breath is identified when the waveform parameter data stream crosses a zero point twice.

15 . The device of claim 1 , wherein determining whether the respiratory event has occurred in the individual by analyzing the produced at least one waveform parameter data stream comprises a band crossing method, wherein a breath is identified when the waveform parameter data stream crosses an amplitude band twice.

16 . The device of claim 15 , wherein the microprocessing device is further configured to determine whether an amplitude band crossing is statistically valid.

17 . At least one non-transitory computer readable storage medium, comprising a set of instructions, which when executed by a computing device, cause the computing device to:

receive, in real time from a photoplethysmography (PPG) sensor, a raw PPG signal obtained from an individual, wherein the individual is spontaneously breathing and non-intubated;

isolate, in real time, a DC component signal stream, from the raw PPG signal by interpolating peaks of the raw PPG signal to generate an interpolated peak line, interpolating troughs of the raw PPG signal to generate an interpolated trough line, and averaging the interpolated peak line and the interpolated trough line to produce the DC component signal stream;

generate, in real time, a plot that represents the raw PPG signal and the DC component signal stream overlying each other, wherein the raw PPG signal is a waveform that intersects the DC component signal stream at midpoints of the raw PPG signal between the peaks and the troughs a plurality of times in the plot,

wherein a first curve of the DC component signal stream on the plot intersects a first midpoint of the midpoints of the raw PPG signal at a first end of the first curve and intersects a second midpoint of the midpoints of the raw PPG signal at a second end of the first curve, and is above a first curve of the raw PPG signal on the plot, and

wherein a second curve of the DC component signal stream on the plot intersects a third midpoint of the midpoints of the raw PPG signal at a first end of the second curve and intersects a fourth midpoint of the midpoints of the raw PPG signal at a second end of the second curve, and is below a second curve of the raw PPG signal on the plot;

calculate, in real time, one or more waveform parameters from the isolated DC component signal stream and the raw PPG signal to produce at least one waveform parameter data stream, wherein the one or more waveform parameters comprises a Top Area bounded by the second curve of the DC component signal stream on the plot and the second curve of the raw PPG signal on the plot, and a Bottom Area bounded by the first curve of the DC component signal stream on the plot and the first curve of the raw PPG signal on the plot, wherein the Bottom Area is an area under the first curve of the DC component signal stream on the plot and above the first curve of the raw PPG signal on the plot, and wherein the Top Area is an area above the second curve of the DC component signal stream on the plot and below the second curve of the raw PPG signal on the plot;

determine, in real time, whether a respiratory event has occurred in the individual by analyzing the produced at least one waveform parameter data stream and based on an Area Ratio that is the Top Area divided by the Bottom Area; and

report, in real time, the respiratory event to a caregiver substantially at the same time that the respiratory event occurs.

18 . A method comprising:

receiving, in real time from a photoplethysmography (PPG) sensor, a raw PPG signal obtained from an individual, wherein the individual is spontaneously breathing and non-intubated;

isolating, in real time, a DC component signal stream, from the raw PPG signal by interpolating peaks of the raw PPG signal to generate an interpolated peak line, interpolating troughs of the raw PPG signal to generate an interpolated trough line, and averaging the interpolated peak line and the interpolated trough line to produce the DC component signal stream;

generating, in real time, a plot that represents the raw PPG signal and the DC component signal stream overlying each other, wherein the raw PPG signal is a waveform that intersects the DC component signal stream at midpoints of the raw PPG signal between the peaks and the troughs a plurality of times in the plot,

wherein a first curve of the DC component signal stream on the plot intersects a first midpoint of the midpoints of the raw PPG signal at a first end of the first curve and intersects a second midpoint of the midpoints of the raw PPG signal at a second end of the first curve, and is above a first curve of the raw PPG signal on the plot, and

wherein a second curve of the DC component signal stream on the plot intersects a third midpoint of the midpoints of the raw PPG signal at a first end of the second curve and intersects a fourth midpoint of the midpoints of the raw PPG signal at a second end of the second curve, and is below a second curve of the raw PPG signal on the plot;

calculating, in real time, one or more waveform parameters from the isolated DC component signal stream and the raw PPG signal to produce at least one waveform parameter data stream, wherein the one or more waveform parameters comprises a Top Area bounded by the second curve of the DC component signal stream on the plot and the second curve of the raw PPG signal on the plot, and a Bottom Area bounded by the first curve of the DC component signal stream on the plot and the first curve of the raw PPG signal on the plot, wherein the Bottom Area is an area under the first curve of the DC component signal stream on the plot and above the first curve of the raw PPG signal on the plot, and wherein the Top Area is an area above the second curve of the DC component signal stream on the plot but below the second curve of the raw PPG signal on the plot; and

determining, in real time, whether a respiratory event has occurred in the individual by analyzing the produced at least one waveform parameter data stream and based on an Area Ratio that is the Top Area divided by the Bottom Area; and

reporting, in real time, the respiratory event to a caregiver substantially at the same time that the respiratory event occurs.

Assignments (1)

Continuity (2)

References Cited (21)