IP Library Granted Patent US 12,089,914
Granted Patent B2
US 12,089,914 · App. 17/026,929 · Granted Sep 17, 2024

Enhanced physiological monitoring devices and computer-implemented systems and methods of remote physiological monitoring of subjects

Inventor: Kurt Stump (San Diego, CA)
A61B5/0022A61B5/0205A61B5/021A61B5/02444A61B5/11A61B5/14551A61B5/33A61B5/742A61B5/7475G16H50/30A61B5/72A61B2560/0257G16H40/20
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Quick Facts
Patent No.
US 12,089,914
App. No.
17/026,929
Filed
Sep 21, 2020
Granted
Sep 17, 2024
Kind
B2
Art Unit
3792
USPC
600/301
Abstract

Physiological sign monitoring devices, and systems and computer-implemented methods of remote physiological monitoring of subjects. A monitoring device includes a plurality of physiological sign monitoring portions. Each physiological sign monitoring portion of the device is configured for deployment on a different, respective surface of a subject including a surface on the back of an ear of the subject, a surface over a mastoid region of the neck of the subject, and a surface over another region of the neck of the subject. Each physiological sign monitoring portion of the device includes a plurality of physiological sensors, where each sensor is configured to generate a respective electronic signal based on a respective monitored physiological parameter of the subject. At least one physiological sensor in each physiological sign monitoring portion of the device is configured to generate a respective electronic signal based on the same monitored physiological parameter of the subject.

Claims (102)

1. A monitoring device, comprising:

a first physiological parameter monitoring portion

configured for deployment on a surface on the back of a respective ear of the subject, or a surface over a mastoid region of the neck of the subject; and

comprising a first plurality of physiological sensors, each of the first plurality of physiological sensors configured to periodically generate respective data based on one or more real-time monitored physiological parameters of the subject, wherein the real-time monitored physiological parameters by the first plurality of physiological sensors of the first physiological parameter monitoring portion comprise photoplethysmogram, electrocardiogram, ballistocardiogram, and at least one of skin conductance or skin resistance, wherein at least one of the first plurality of physiological sensors comprises green and infrared (IR) light emitters and a corresponding light receptor; and

a second physiological parameter monitoring portion:

configured for deployment on a surface over another region of the neck of the subject selected from the group consisting of:

a surface of the neck over top of the pocket formed between the trapezius and the sternocleidomastoid muscles of the subject and under the levator scapulae of the subject;

a surface of the neck over the pocket formed between the posterior scalene and the middle scalene muscles of the subject, and above the trapezius muscle of the subject; and

a surface of the neck over the pocket formed between the middle scalene and the anterior scalene muscles of the subject, and above the trapezius muscle of the subject;

comprising a second plurality of physiological sensors, each of the second plurality of physiological sensors configured to periodically generate respective data based on one or more real-time monitored physiological parameters of the subject, wherein the real-time monitored physiological parameters by the second plurality of physiological sensors of the second physiological parameter monitoring portion comprise electrocardiogram, ballistocardiogram, and at least one of skin conductance or skin resistance;

configured to receive the respective data, periodically generated by the first plurality of physiological sensors, from the first physiological parameter monitoring portion; and

further comprising a processor; and a non-transitory machine-readable storage medium encoded with program code executable by the processor for periodically generating respective values indicative of a plurality of real-time physiological signs for the subject using the received, periodically generated respective data from the first plurality of physiological sensors and the periodically generated respective data from the second plurality of physiological sensors.

2. The monitoring device of claim 1 , wherein the deployment surface of the first physiological parameter monitoring portion, and the deployment surface of the second physiological parameter monitoring portion, are at least three inches apart from each other on the subject.

3. The monitoring device of claim 2 , wherein:

the first physiological parameter monitoring portion is configured for deployment on the surface on the back of the respective ear of the subject; and

the second physiological parameter monitoring portion is configured for deployment on the surface of the neck over top of the pocket formed between the trapezius and the sternocleidomastoid muscles of the subject and under the levator scapulae of the subject.

4. The monitoring device of claim 2 , wherein:

the first physiological parameter monitoring portion is configured for deployment on the surface over the mastoid region of the neck of the subject; and

the second physiological parameter monitoring portion is configured for deployment on the surface of the neck over top of the pocket formed between the posterior scalene and the middle scalene muscles of the subject, and above the trapezius muscle of the subject.

5. The monitoring device of claim 1 , wherein at least one of the first and second physiological parameter monitoring portions further comprises a snap button configured to receive a disposable electrode.

6. The monitoring device of claim 1 , wherein the plurality of real-time physiological signs for the subject comprise motion-corrected pulse oximetry, at least one of motion-corrected respiratory rate or subject activity level, at least one of motion-corrected heart rate or motion-corrected heart rate variability, at least one of cuffless mean arterial blood pressure, cuffless systolic blood pressure, cuffless diastolic blood pressure or pre-ejection period, and at least one of hydration level, stress level, galvanic skin response, bioimpedance, or carbon dioxide in the subject's blood.

7. The monitoring device of claim 6 , wherein the program code executable by the processor of the second physiological parameter monitoring portion for periodically generating values indicative of the plurality of real-time physiological signs for the subject further comprises:

program code for periodically generating the values indicative of motion-corrected pulse oximetry for the subject using:

the periodically generated ballistocardiogram data from each of the first and second physiological parameter monitoring portions;

the periodically generated green light data from the at least one of the plurality of physiological sensors of the first physiological parameter monitoring portion; and

the periodically generated infrared light data from the at least one of the plurality of physiological sensors of the first physiological parameter monitoring portion as a motion reference.

8. The monitoring device of claim 6 , wherein the program code executable by the processor of the second physiological parameter monitoring portion for periodically generating values indicative of the plurality of real-time physiological signs for the subject further comprises:

program code for periodically generating the respective values indicative of the at least one of motion-corrected respiratory rate or subject activity level for the subject using:

the periodically generated ballistocardiogram data from the second physiological parameter monitoring portion;

the periodically generated electrocardiogram data, or the periodically generated at least one of skin conductance or skin resistance data, from each of the first and second physiological parameter monitoring portions; and

the periodically generated photoplethysmogram data from the first physiological parameter monitoring portion; and

program code for periodically generating the respective values indicative of the at least one of motion-corrected heart rate or motion-corrected heart rate variability for the subject using:

if motion-corrected heart rate for the subject, the periodically generated ballistocardiogram data from each of the first and second physiological parameter monitoring portions, the periodically generated green light data from the at least one of the plurality of physiological sensors of the first physiological parameter monitoring portion, and the periodically generated infrared light data from the at least one of the plurality of physiological sensors of the first physiological parameter monitoring portion as a motion reference; and

if motion-corrected heart rate variability for the subject, the periodically generated ballistocardiogram data from each of the first and second physiological parameter monitoring portions, and the periodically generated electrocardiogram data from each of the first and second physiological parameter monitoring portions.

9. The monitoring device of claim 6 , wherein the program code executable by the processor of the second physiological parameter monitoring portion for periodically generating values indicative of the plurality of real-time physiological signs for the subject further comprises:

program code for periodically generating the respective values indicative of the at least one of cuffless mean arterial blood pressure, cuffless systolic blood pressure, cuffless diastolic blood pressure or pre-ejection period for the subject using:

if cuffless mean arterial blood pressure, cuffless systolic blood pressure, or cuffless diastolic blood pressure, the periodically generated ballistocardiogram data from at least one of the first and second physiological parameter monitoring portions, the periodically generated electrocardiogram data from the at least one of the first and second physiological parameter monitoring portions, and the periodically generated photoplethysmogram data from the first physiological parameter monitoring portion; and

if pre-ejection period, the periodically generated electrocardiogram data from each of the first and second physiological parameter monitoring portions.

10. The monitoring device of claim 9 , wherein at least one of the second plurality of physiological sensors comprises a multi-axis accelerometer, wherein the plurality of real-time physiological signs for the subject further comprise at least two of cuffless mean arterial blood pressure, cuffless systolic blood pressure, or cuffless diastolic blood pressure, and wherein the program code for periodically generating the respective values indicative of the at least two of cuffless mean arterial blood pressure, cuffless systolic blood pressure, or cuffless diastolic blood pressure, further performs a weighted averaging of the respective resulting waveforms from each of:

a pulse wave velocity technique using the periodically generated ballistocardiogram data from the at least one of the first and second physiological parameter monitoring portions and the periodically generated photoplethysmogram data from the first physiological parameter monitoring portion; and

at least three of five pulse transit time techniques, wherein the five pulse transit time techniques respectively determine pulse transit time using:

an R-wave peak of the waveform from the periodically generated electrocardiogram data from the at least one of the first and second physiological parameter monitoring portions, and a peak of the waveform from the periodically generated photoplethysmogram data from the first physiological parameter monitoring portion;

an R-wave peak of the waveform from the periodically generated electrocardiogram data from the at least one of the first and second physiological parameter monitoring portions, and a peak of the waveform from the periodically generated ballistocardiogram data from the at least one of the first and second physiological parameter monitoring portions;

a pulse wave arrival time periodically generated by the multi-axis accelerometer of the at least one of the second plurality of physiological sensors, and an R-wave peak of the waveform from the periodically generated electrocardiogram data from the at least one of the first and second physiological parameter monitoring portions;

a pulse wave arrival time periodically generated by the multi-axis accelerometer of the at least one of the second plurality of physiological sensors, and a peak of the waveform from the periodically generated photoplethysmogram data from the first physiological parameter monitoring portion; and

a peak of the waveform from the periodically generated ballistocardiogram data from the at least one of the first and second physiological parameter monitoring portions, and a peak of the waveform from the periodically generated photoplethysmogram data from the first physiological parameter monitoring portion.

11. The monitoring device of claim 6 , wherein the program code executable by the processor of the second physiological parameter monitoring portion for periodically generating values indicative of the plurality of real-time physiological signs for the subject further comprises:

program code for periodically generating the respective values indicative of the at least one of hydration level, stress level, galvanic skin response, or bioimpedance for the subject, or of carbon dioxide in the subject's blood, using:

if galvanic skin response, bioimpedance, or hydration level for the subject, the periodically generated at least one of skin conductance data or skin resistance data from each of the first and second physiological parameter monitoring portions; and

if stress level for the subject,

the periodically generated electrocardiogram data, or the periodically generated at least one of skin conductance or skin resistance data, from each of the first and second physiological parameter monitoring portions; and

the periodically generated photoplethysmogram data from the first physiological parameter monitoring portion; and

if carbon dioxide in the subject's blood, the periodically generated values indicative of motion-corrected respiratory rate;

the periodically generated values indicative of motion-corrected pulse oximetry; and

the periodically generated photoplethysmogram data from the first physiological parameter monitoring portion.

12. The monitoring device of claim 11 , wherein the real-time monitored physiological parameters by the second plurality of physiological sensors of the second physiological parameter monitoring portion further comprise at least one of sweat chemistry or sweat composition; wherein the plurality of real-time physiological signs for the subject further comprise at least one of hydration level or stress level for the subject;

and wherein the program code executable by the processor of the second physiological parameter monitoring portion for periodically generating the respective values indicative of the at least one of hydration level or stress level further respectively uses the periodically generated at least one of sweat chemistry data or sweat composition data from the second physiological parameter monitoring portion.

13. The monitoring device of claim 6 , wherein the real-time monitored physiological parameters by the first plurality of physiological sensors of the first physiological parameter monitoring portion, and the real-time monitored physiological parameters by the second plurality of physiological sensors of the second physiological parameter monitoring portion, further comprise skin temperature; wherein the plurality of real-time physiological signs for the subject further comprise at least one of core body temperature or cranial temperature; and wherein the program code executable by the processor of the second physiological parameter monitoring portion for periodically generating the respective values indicative of the at least one of core body temperature or cranial temperature uses the periodically generated skin temperature data from each of the first and second physiological parameter monitoring portions and the periodically generated values indicative of subject activity level.

14. A system for remote physiological monitoring of subjects, comprising:

a plurality of monitoring devices, each monitoring device comprising:

a respective first physiological parameter monitoring portion

configured for deployment on a surface on the back of a respective ear of a respective subject, or a surface over a mastoid region of the neck of the respective subject; and

comprising a respective first plurality of physiological sensors, each of the first plurality of physiological sensors configured to periodically generate respective data based on one or more real-time monitored physiological parameters of the respective subject, wherein the real-time monitored physiological parameters by the first plurality of physiological sensors of the first physiological parameter monitoring portion comprise photoplethysmogram, electrocardiogram, ballistocardiogram, and at least one of skin conductance or skin resistance, wherein at least one of the first plurality of physiological sensors comprises green and infrared (IR) light emitters and a corresponding light receptor; and

a respective second physiological parameter monitoring portion:

configured for deployment on a surface over another region of the neck of the respective subject selected from the group consisting of:

a surface of the neck over top of the pocket formed between the trapezius and the sternocleidomastoid muscles of the subject and under the levator scapulae of the respective subject;

a surface of the neck over the pocket formed between the posterior scalene and the middle scalene muscles of the subject, and above the trapezius muscle of the respective subject; and

a surface of the neck over the pocket formed between the middle scalene and the anterior scalene muscles of the subject, and above the trapezius muscle of the respective subject;

comprising a respective second plurality of physiological sensors, each of the second plurality of physiological sensors configured to periodically generate respective data based on one or more real-time monitored physiological parameters of the respective subject, wherein the real-time monitored physiological parameters by the second plurality of physiological sensors of the second physiological parameter monitoring portion comprise electrocardiogram, ballistocardiogram, and at least one of skin conductance or skin resistance;

configured to respectively receive the respective data, periodically generated by the respective first plurality of physiological sensors, from the respective first physiological parameter monitoring portion of the respective monitoring device; and

further comprising a respective processor; and a respective non-transitory machine-readable storage medium encoded with program code executable by the respective processor for periodically generating respective values indicative of a plurality of real-time physiological signs for the respective subject using the received, periodically generated respective data from the respective first plurality of physiological sensors and the periodically generated respective data from the respective second plurality of physiological sensors.

15. The system of claim 14 , wherein the respective second physiological parameter monitoring portion of each monitoring device further comprises a transmitter configured to periodically transmit electronic signals over a network, the transmitted electronic signals comprising the periodically generated respective values indicative of the plurality of real-time physiological signs for the respective subject, the system further comprising:

a mobile communication and display device comprising:

a communications interface configured to be coupled to a network and to receive the periodically transmitted electronic signals over the network from each of the respective second physiological parameter monitoring portions of each of the plurality of monitoring devices; and

a processor coupled to the communications interface.

16. The system of claim 15 , the mobile communication and display device further comprising a non-transitory machine-readable storage medium encoded with program code executable by the processor for:

periodically generating a respective prognosis score for each of the subjects using the respective values indicative of the plurality of real-time physiological signs for the respective subject in the received, periodically transmitted electronic signals from each of the plurality of monitoring devices; and

periodically generating an alert for at least one of the subjects based on the periodically generated prognosis scores.

17. The system of claim 14 , wherein the plurality of real-time physiological signs for the respective subject comprise motion-corrected pulse oximetry, at least one of motion-corrected respiratory rate or subject activity level, at least one of motion-corrected heart rate or motion-corrected heart rate variability, at least one of cuffless mean arterial blood pressure, cuffless systolic blood pressure, cuffless diastolic blood pressure or pre-ejection period, and at least one of hydration level, stress level, galvanic skin response, bioimpedance, or carbon dioxide in the respective subject's blood.

18. A system for remote physiological monitoring of a subject, comprising:

a monitoring device comprising a plurality of physiological parameter monitoring portions, the plurality of physiological parameter monitoring portions comprising:

a first physiological parameter monitoring portion:

configured for deployment on a surface on the back of a respective ear of the subject, or a surface over a mastoid region of the neck of the subject; and

comprising a first plurality of physiological sensors, each of the first plurality of physiological sensors configured to periodically generate respective data based on one or more real-time monitored physiological parameters of the subject, wherein the real-time monitored physiological parameters by the first plurality of physiological sensors of the first physiological parameter monitoring portion comprise photoplethysmogram, electrocardiogram, ballistocardiogram, and at least one of skin conductance or skin resistance, wherein at least one of the first plurality of physiological sensors comprises green and infrared (IR) light emitters and a corresponding light receptor; and

a second physiological parameter monitoring portion:

configured for deployment on a surface over another region of the neck of the subject selected from the group consisting of:

a surface of the neck over top of the pocket formed between the trapezius and the sternocleidomastoid muscles of the subject and under the levator scapulae of the subject;

a surface of the neck over the pocket formed between the posterior scalene and the middle scalene muscles of the subject, and above the trapezius muscle of the subject; and

a surface of the neck over the pocket formed between the middle scalene and the anterior scalene muscles of the subject, and above the trapezius muscle of the subject; and

comprising a second plurality of physiological sensors, each of the second plurality of physiological sensors configured to periodically generate respective data based on one or more real-time monitored physiological parameters of the subject, wherein the real-time monitored physiological parameters by the second plurality of physiological sensors of the second physiological parameter monitoring portion comprise electrocardiogram, ballistocardiogram, and at least one of skin conductance or skin resistance;

configured to receive the respective data, periodically generated by the first plurality of physiological sensors, from the first physiological parameter monitoring portion; and

further comprising:

a processor;

a non-transitory machine-readable storage medium encoded with program code executable by the processor for periodically generating respective values indicative of a plurality of real-time physiological signs for the subject using the periodically generated respective data from the first plurality of physiological sensors and the periodically generated respective data from the second plurality of physiological sensors; and

a transmitter configured to periodically transmit electronic signals over a network, the transmitted electronic signals comprising the periodically generated respective values indicative of the plurality of real-time physiological signs for the subject; and

a mobile communication and display device comprising:

a communications interface configured to be coupled to the network and to receive the periodically transmitted electronic signals over the network from the second physiological parameter monitoring portion of the monitoring device; and

a processor coupled to the communications interface.

19. The system of claim 18 , the mobile communication and display device further comprising a non-transitory machine-readable storage medium encoded with program code executable by the processor for:

periodically generating a prognosis score for the subject using the respective values indicative of the plurality of real-time physiological signs for the subject in the received, periodically transmitted electronic signals from the transmitter of the second physiological parameter monitoring portion of the monitoring device; and

periodically generating an alert for the subject based on the periodically generated prognosis score.

20. The system of claim 18 , wherein the plurality of real-time physiological signs for the subject comprise motion-corrected pulse oximetry, at least one of motion-corrected respiratory rate or subject activity level, at least one of motion-corrected heart rate or motion-corrected heart rate variability, at least one of cuffless mean arterial blood pressure, cuffless systolic blood pressure, cuffless diastolic blood pressure or pre-ejection period, and at least one of hydration level, stress level, galvanic skin response, bioimpedance, or carbon dioxide in the subject's blood.

Continuity (6)
Continuation In Part 16593354 · Oct 4, 2019
Continuation In Part 15889992 · Feb 6, 2018
Continuation 14812696 · Jul 29, 2015
Provisional Application 62081185 · Nov 18, 2014
Provisional Application 62030314 · Jul 29, 2014
Related Publication 20210000347A1 · Jan 7, 2021