HEALTH MONITORING SYSTEMS AND METHODS

• US 20160302674A1
• Filed: 06/24/2016
• Published: 10/20/2016
• Est. Priority Date: 10/07/2012
• Status: Active Grant

• Current Assignee: RDS SAS
• Original Assignee: Rhythm Diagnostic Systems, Inc.
• Inventors: Moyer, Daniel Van Zandt, Golda, George Stefan, Marriott, Mark P., Eletr, Sam, O'Neil, Bruce
• Granted Patent: US 10,244,949 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2503/04 Babies, e.g. for SIDS detection
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• CPC Class Codes: A61B 2560/0295 adapted for recording user messages or annotations
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 2562/18 Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/02108 from analysis of pulse wave characteristics
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/02433 for infrared radiation
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/1135 by monitoring thoracic expansion
• CPC Class Codes: A61B 5/14546 : for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 : using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14552 : Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/259 : using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 : Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/318 : Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/335 : using integrated circuit memory devices
• CPC Class Codes: A61B 5/352 : Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/6823 : Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/7207 : of noise induced by motion artifacts
• CPC Class Codes: A61B 5/721 : using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
• CPC Class Codes: A61B 5/7214 : using signal cancellation, e.g. based on input of two identical physiological sensors spaced apart, or based on two signals derived from the same sensor, for different optical wavelengths
• CPC Class Codes: A61B 5/7246 : using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7275 : Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7278 : Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/746 : Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

Systems, methods and devices for reducing noise in health monitoring including monitoring systems, methods and/or devices receiving a health signal and/or having at least one electrode or sensor for health monitoring.

Claims

1. A method, device and/or system as described herein.

6. A method according to any of claims 1-5 wherein colors other than green or red or IR are used.

7. A method according to claim 6 wherein color selection is limited only by minimal effectiveness in either signal to noise ratio and/or reflectiveness related to oxygenation.

11. A method according to any of claims 1-10 further comprising:

recording the first PPG or ECG data in time-concordance with one or two or more additional photoplethysmographs of different light wavelengths;

detecting the heart beats in the first PPG or ECG signal, these heart beats allowing for definition of a frame of photoplethysmogram data for the time between two adjacent heart beats;

averaging two or more of these frames together at each point in time to create an average frame for the time interval;

wherein the photoplethysmograph signal is reinforced by this averaging because the photoplethysmogram is correlated with the heartbeat, and any motion artifact or other noise source that is uncorrelated in time with the heartbeat is diminished;

interpreting the signal-to-noise ratio of the average frame as typically higher than that of the individual frames;

using linear regression to estimate the gain between the two average frame signals;

estimating from this gain value one or more of the blood oxygen saturation or other components present in the blood such as hemoglobin, carbon dioxide or others.

12. A method according to any of claims 1-11 wherein the operations are repeated for additional light wavelengths in order to estimate from the gain value one or more of the blood oxygen saturation or other components present in the blood such as hemoglobin, carbon dioxide or others.

2. A method of beat detection, using ECG, using green, or using a weighted combination of wavelengths.

3. A method of generating one or more of a pulse shape template or a dataset representing a pulse shape, the method comprising;

using green wavelengths, an ensemble average of green over approximately the same amount of time as for either red or IR, an ensemble average of multiple wavelengths over approximately the same amount of time as for either red or IR, or an ensemble average of multiple wavelengths over significantly longer than the amount of time as for either red or IR.

4. A method for determining pulse oxygenation;

including;

generating one or more of a first pulse shape template or a dataset representing a first pulse shape, including using green wavelengths, an ensemble average of green over approximately the same amount of time as for either red or IR, an ensemble average of multiple wavelengths over approximately the same amount of time as for either red or IR, or an ensemble average of multiple wavelengths over significantly longer than the amount of time as for either red or IR;

or a long time average of a single wavelength of any color.

5. A method for determining pulse oxygenation;

comprising;

a) detecting heart beats;

using ECG, using green or another wavelength, or using a weighted combination of wavelengths;

b) generating one or more of a first pulse shape template or a dataset representing a first pulse shape, including using green wavelengths, an ensemble average of green over approximately the same amount of time as for either red or IR, an ensemble average of multiple wavelengths over approximately the same amount of time as for either red or IR, or an ensemble average of multiple wavelengths over significantly longer than the amount of time as for either red or IR;

or a long time average of a single wavelength of any color;

c) obtaining a red pulse shape template or dataset representing same and an IR pulse shape template or dataset representing same, and compare each of these to the first pulse shape above; and

,

d) correlating via linear regression between red ensemble average with the first pulse shape template or dataset to the IR ensemble average with the first pulse shape or dataset, where the ratio of these correlations is then used as the AC ratio for oxygen saturation.

8. A method for health monitoring comprising:

determining from either or both a user'"'"'s ECG and/or a first photoplethysmogram PPG signal and/or a weighted combination of wavelengths when heart beats occur;

time averaging the first photoplethymogram PPG signal to generate a first pulse shape template or dataset;

time averaging each of two additional photoplethysmogram signals correlated to the beat locations;

one of the additional signals being red, the other additional signal being IR;

generating ensemble averages for each of the red and IR signals;

comparing each of the red and IR ensemble averages to the first pulse shape template or dataset;

using a linear regression of each of the red and IR ensemble average-comparisons to the first pulse template or dataset to determine the linear gain factor between the two signals;

determining from the gain factor the patient oxygen saturation.

9. A method according to claim 8 wherein the first PPG signal is one or more of:

green, non-red;

non-infrared and/or a weighted combination of wavelengths.

10. A method according to claim 8 wherein the two photoplethysmogram signals include one or more or all of green, red and infrared signals.

13. A method comprising:

selecting a possible gain value,

multiplying the average frame signal by it, and

determining the residual error with respect to an average frame of a different wavelength;

whereby the gain between red and infrared (IR) frame signals are found by;

generating one or more of green or other color PPG signals or a long time average of red/IR;

including the one or more of green or other color PPG signals or the long time average of red/IR with the red and IR frame signals to create two frames;

averaging the two frames together first to provide a signal with reduced noise;

performing linear regression of the red versus combined with green or long time average of red/IR and IR versus combined with green or long time average of red/IR;

or linear regression of red versus green or long time average of red/IR and IR versus green or long time average of red/IR;

or linear regression by combining green or long time average of red/IR with each of red and IR and using the ratio of these results; and

then finding the ratio of the two corresponding results.

14. A method according to claim 13 for determining depth and/or rate of respiration.

15. A method according to claim 14 wherein one or more of ECG data, PPG data, pulse oximeter data and/or accelerometer data is used to determine respiration rate and/or depth.

16. A method according to claim 15 including

generating, using the one or more of ECG data, PPG data, pulse oximeter data and/or accelerometer data, a respiration waveform.

17. A method according to claim 14 where Red or IR or green values over time are used.

18. A method according to claim 14 including

measuring IR or red or green reflection by the photodiode to estimate depth and/or rate of respiration.

19. A method according to claim 14 where one or both of maximum values and minimum values of a curve or waveform of the IR or red or green data represent the difference between the maximum and minimum values related to the depth of breath in an individual being monitored, and/or over time, the rate of respiration can be evaluated from the curve of maximum and minimum values over time.

20. A method according to claim 14 using PPG signals.

21. A method according to claim 20 including

generating the PPG signals when the chest expands and contracts during breathing, the motion hereof presenting as a wandering baseline artifact on PPG signals.

22. A method according to claim 20 including

isolating the respiration signal by filtering out the PPG data to focus on the breathing/respiration signal.

23. A method according to claim 20 wherein the PPG is chest-mounted.

24. A device using the method according to claim 13 wherein one or more of the signals are obtained from one or more of:

a wearable health monitoring device having;

a substrate;

a conductive sensor connected to the substrate, and

a double-sided composite adhesive having;

at least one conductive adhesive portion, and

at least one non-conductive adhesive portion;

the double-sided composite adhesive being attached to the substrate and the conductive sensor;

the at least one conductive adhesive portion being disposed in conductive communicative contact with the conductive sensor, and

being configured to be conductively adhered to the skin of the subject for conductive signal communication from the subject to the conductive sensor.

25. A method according to claim 14 wherein any one or more of PPG and/or accelerometer, methods are used discretely or in combination with each other and/or with the above-described ECG-based respiration estimation techniques.

26. A method according to claim 14 wherein using multiple methods improves accuracy when compared to estimates based on a single method.

27. A system using the device according to claim 26 further including a computer.

28. A device using the method of claim 26.

29. A device according to claim 28 using a wearable health monitoring device.

30. A method according to claim 13 using software and computer hardware to determine the oxygen saturation.

31. A method, device and/or system for temperature monitoring and/or measuring as described herein.

32. A method for temperature monitoring and/or measuring including:

disposing on an infant a temperature sensing device having at least first and second thermally isolated temperature sensors disposed therein, one on each of two opposing sides of the device;

obtaining one or more of a temperature difference between the two sensors, a first temperature reading from the first temperature sensor and a second temperature reading from the second temperature sensor.

33. A method according to claim 32 further including one or more of:

communicating one or more of the temperature difference, the first temperature reading and the second temperature reading to external data collection and/or processing devices;

generating an alarm upon an appropriate temperature sensing condition.

34. A method according to either of claims 32 and 33 further including:

one or more of thermally insulating the “

infant side”

sensor to reach equilibrium, and providing an accurate “

core temperature”

of the infant, and alternatively isolating the infant'"'"'s temperature reading from the mother'"'"'s or ambient; and

,

providing a temperature reading for the “

mother side”

sensor that is one of an accurate core temperature for the mother, or not an accurate core temperature for the mother but, sufficiently distinctive of mother temperature for differentiating whether or not the infant is in the correct direct contact with the mother'"'"'s skin.

35. An apparatus for dual temperature sensing, comprising:

a substrate disposed to contain

circuitry including

first and second temperature sensors disposed on alternative opposing sides of the apparatus;

the first and second temperature sensors disposed to obtain one or more of;

a temperature difference between the two sensors,

a first temperature reading from the first temperature sensor and

a second temperature reading from the second temperature sensor.

36. An apparatus according to claim 35 further comprising an adhesive, to one or both hold the apparatus to the infant or the parent/mother.

37. An apparatus according to claim 36 wherein the adhesive includes one or more of:

a composite adhesive;

a disposable adhesive;

a medical grade adhesive; and

a double-sided adhesive.

38. An apparatus according to claim 35, the electronics further comprising,

sensing relative X-Y-Z position;

and/or acceleration, and/or

Bluetooth or other wireless data/signal connectivity,

a replaceable and/or rechargeable battery for one or both extended use, or seven (7) days of continuous monitoring.

39. An apparatus according to claim 35 wherein the substrate is one or more of:

a small circuit board,

a flexible circuit board, and

twenty (20) mm×

thirty (30) mm.

40. An apparatus according to claim 35 wherein the first and second sensors are one or more of:

thermally isolated from each other,

one or more of waterproof, water tight or water resistant.

41. An apparatus according to claim 40 further comprising:

a thermally insulating or isolation layer that may provide the thermal isolation of the electronics and/or first and second sensors;

a spacer disposed through an insulating or isolating layer to provide a throughway for electronic communication of one or more sensors to other electronics;

a silicone bead for one or both isolating and assisting in giving a waterproof or water-resistant seal on the “

infant side”

; and

,

a silicone cover to provide a waterproof or waterproof barrier on the “

mother side”

.

42. An apparatus according to one of claims 35-41 wherein one or more of:

the sensor on the “

mother side”

or top or exterior side is slightly protruding relative to the cover;

the sensor on the “

mother side”

or top or exterior side has a thin/thinner layer of covering material and/or silicone thereover;

the sensor on the child side or patient or circuit side is protruding one or both of past, or through the substrate and/or adhesive; and

/or

the sensor on the child side or patient or circuit side is one or more of disposed exposed or also/alternatively covered with a thin protectant layer for water proofness, or tightness or resistance.

43. An apparatus according to one of claims 35-42 wherein the apparatus is configured for one or more of:

obtaining one or more of;

a temperature of an infant wearer;

the mother;

or

ambient air/environment;

or

a temperature difference between the two sensors,

a first temperature reading from the first temperature sensor and

a second temperature reading from the second temperature sensor.