Physiological monitoring methods and apparatus

• US 9,289,135 B2
• Filed: 11/13/2014
• Issued: 03/22/2016
• Est. Priority Date: 02/25/2009
• Status: Active Grant

• Current Assignee: Valencell, Inc.
• Original Assignee: Valencell, Inc.
• Inventors: LeBoeuf, Steven Francis, Tucker, Jesse Berkley, Aumer, Michael Edward
• Primary Examiner(s): FULLER, RODNEY EVAN
• Application Number:
  US14/540,404
• Publication Number:
  US 20150073236A1
• Time in Patent Office: 495 Days
• Field of Search: 600/310
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• CPC Class Codes: A61B 2560/0425 Ergonomically shaped housings A61B2560/0418 takes precedence
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/0013 Medical image data A61B1/00011, A61B6/56, A61B8/56 take precedence
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0082 adapted for particular medical purposes
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• 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 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/02427 : Details of sensor
• CPC Class Codes: A61B 5/02433 : for infrared radiation
• CPC Class Codes: A61B 5/026 : Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/0261 : using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/0295 : using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/0816 : Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/091 : Measuring volume of inspired or expired gases, e.g. to determine lung capacity
• CPC Class Codes: A61B 5/11 : Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1107 : Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/1118 : Determining activity level
• CPC Class Codes: A61B 5/14532 : for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 : using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14551 : for measuring blood gases
• CPC Class Codes: A61B 5/165 : Evaluating the state of mind, e.g. depression, anxiety
• CPC Class Codes: A61B 5/369 : Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/411 : Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/415 : the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/418 : lymph vessels, ducts or nodes
• CPC Class Codes: A61B 5/4812 : Detecting sleep stages or cycles
• CPC Class Codes: A61B 5/4845 : Toxicology, e.g. by detection of alcohol, drug or toxic products A61B5/4848 takes precedence
• CPC Class Codes: A61B 5/4848 : Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/486 : Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/4866 : Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/4875 : Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/4884 : inducing physiological or psychological stress, e.g. applications for stress testing
• CPC Class Codes: A61B 5/6803 : Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61B 5/6815 : Ear
• CPC Class Codes: A61B 5/6816 : Ear lobe
• CPC Class Codes: A61B 5/6817 : Ear canal
• CPC Class Codes: A61B 5/6819 : Nose
• CPC Class Codes: A61B 5/6826 : Finger
• CPC Class Codes: A61B 5/6838 : Clamps or clips
• 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 5/7221 : Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/725 : using specific filters therefor, e.g. Kalman or adaptive filters A61B5/316 take precedence
• 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 5/7282 : Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7475 : User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: G02B 6/0001 : specially adapted for lighting devices or systems lighting or signalling on vehicles using light guides B60Q1/00; lighting devices for vehicle dashboards B60Q3/10; lighting devices for vehicle interior using light guides B60Q3/62; lighting devices mounted on the vehicle rear part using light guides F21S43/235; measuring arrangements having light conducting pointers G01D13/265; illumination of liquid crystal displays G02F1/1336; illuminated signs G09F13/00
• CPC Class Codes: G16H 20/30 : relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 30/40 : for processing medical images, e.g. editing
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: H04R 1/028 : associated with devices performing functions other than acoustics, e.g. electric candles
• CPC Class Codes: H04R 1/105 : Earpiece supports, e.g. ear hooks for stereophonic headphones H04R5/0335
• CPC Class Codes: H04R 1/1091 : Details not provided for in groups H04R1/1008 - H04R1/1083
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A monitoring device includes a housing configured to be attached to a body of a subject. An optical emitter, optical detector, and sensor for measuring motion noise are located within the housing. Light transmissive material is in optical communication with the optical emitter and detector and is configured to deliver light from the optical emitter to one or more locations of the body of the subject and to collect light external to the housing and deliver the collected light to the detector. A signal processor is configured to receive and process signals produced by the optical detector and the motion noise sensor, and to remove noise from the signals produced by the optical detector. The signal processor may generate physiological parameters for the subject such as heart rate, blood flow, blood pressure, VO_2max, heart rate variability, respiration rate, and blood gas/analyte level.

Claims

1. A method of monitoring a subject, the method comprising:

positioning an earbud within an ear of the subject, wherein the earbud includes a housing, at least one optical emitter within the housing, at least one window in the housing, and a cover at least partially surrounding the housing, wherein the cover comprises light transmissive material that forms at least one light-guiding region in the cover, wherein the earbud is positioned within the ear such that the at least one light-guiding region in the cover engages a non-ear canal region of the ear; and

delivering light from the at least one optical emitter through the at least one window and into the non-ear canal region via the at least one light-guiding region in the cover.

2. The method of claim 1, wherein the at least one light-guiding region in the cover includes a lens region, and wherein delivering light from the at least one optical emitter through the at least one window and into the non-ear canal region of the subject comprises focusing the light from the at least one optical emitter via the lens region.

3. The method of claim 1, wherein the at least one light-guiding region in the cover includes a light diffusion region, and wherein delivering light from the at least one optical emitter through the at least one window and into the non-ear canal region of the subject comprises diffusing the light from the at least one optical emitter via the diffusion region.

4. The method of claim 1, wherein the at least one light-guiding region in the cover includes a luminescence region, and wherein delivering light from the at least one optical emitter through the at least one window and into the non-ear canal region of the subject comprises converting at least a portion of the light to light having a different wavelength via the luminescence region.

5. The method of claim 4, wherein the luminescence region comprises phosphor.

6. The method of claim 1, wherein at least one environmental sensor is supported by the housing, and further comprising detecting and/or measuring environmental conditions in a vicinity of the subject via the at least one environmental sensor.

7. The method of claim 6, wherein a transmitter is supported by the housing, and further comprising transmitting signals produced by the at least one environmental sensor to a remote device via the transmitter.

8. A method of monitoring a subject, the method comprising:

positioning an earbud within an ear of the subject, wherein the earbud includes a housing, at least one optical detector within the housing, at least one window in the housing, and a cover at least partially surrounding the housing, wherein the cover comprises light transmissive material that forms at least one light-guiding region in the cover, wherein the earbud is positioned within the ear such that the at least one light-guiding region in the cover engages a non-ear canal region of the ear; and

collecting light external to the earbud housing and delivering the collected light through the at least one window to the at least one optical detector via the at least one light-guiding region in the cover.

9. The method of claim 8, wherein the at least one light-guiding region in the cover includes a lens region, and wherein delivering the collected light through the at least one window to the at least one optical detector comprises focusing the collected light via the lens region.

10. The method of claim 8, wherein at least one environmental sensor is supported by the housing, and further comprising detecting and/or measuring environmental conditions in a vicinity of the subject via the at least one environmental sensor.

11. The method of claim 8, wherein a transmitter is supported by the housing, and further comprising transmitting signals produced by the at least one optical detector to a remote device via the transmitter.

12. The method of claim 10, wherein a transmitter is supported by the housing, and further comprising transmitting signals produced by the at least one environmental sensor to a remote device via the transmitter.

13. The method of claim 8, wherein a motion sensor and a signal processor are supported by the housing, and further comprising:

measuring motion of the subject via the motion sensor; and

processing signals produced by the at least one optical detector, via the signal processor, to selectively remove effects from subject motion.

14. The method of claim 8, wherein a signal processor is supported by the housing, and further comprising executing an adaptive filter algorithm via the signal processor to remove noise from signals produced by the at least one optical detector.

15. The method of claim 8, wherein a motion sensor and a signal processor are supported by the housing, and further comprising:

measuring motion of the subject via the motion sensor; and

processing signals produced by the at least one optical detector and the motion sensor to generate a digital output string, wherein the digital output string includes a plurality of physiological and motion-related information.

16. A method of monitoring a subject, the method comprising:

positioning a headset at an ear of the subject, wherein the headset includes a housing, at least one optical emitter within the housing, at least one optical detector within the housing, at least one window in the housing, and a cover at least partially surrounding the housing, wherein the cover comprises light transmissive material that forms at least one light-guiding region in the cover, wherein the headset is positioned at the ear such that the at least one light-guiding region in the cover engages a non-ear canal region of the ear;

delivering light from the at least one optical emitter through the at least one window and into the non-ear canal region via the at least one light-guiding region in the cover; and

collecting light external to the housing and delivering the collected light through the at least one window to the at least one optical detector via the at least one light-guiding region in the cover.

17. The method of claim 16, wherein the headset includes a transmitter, and further comprising transmitting signals produced by the at least one optical detector to a remote device via the transmitter.

18. The method of claim 16, wherein the headset includes a motion sensor and a signal processor, and further comprising:

measuring motion of the subject via the motion sensor; and

processing signals produced by the at least one optical detector, via the signal processor, to selectively remove effects from subject motion.

19. The method of claim 16, wherein the headset includes a signal processor, and further comprising executing an adaptive filter algorithm via the signal processor to remove noise from signals produced by the at least one optical detector.

20. The method of claim 16, wherein the headset includes a motion sensor and a signal processor, and further comprising:

measuring motion of the subject via the motion sensor; and

processing signals produced by the at least one optical detector and the motion sensor to generate a digital output string, wherein the digital output string includes a plurality of physiological and motion-related information.

21. The method of claim 16, wherein the housing is an earbud housing, and wherein positioning the housing at an ear of the subject comprises positioning the earbud housing within the ear such that the at least one light-guiding region in the cover engages the non-ear canal region of the ear.

22. A headset, comprising:

a housing configured to be supported by an ear of a subject, wherein the housing comprises at least one window;

an optical emitter supported by the housing and configured to emit light through the at least one window; and

a cover at least partially surrounding the housing, wherein the cover comprises light transmissive material that forms at least one light-guiding region in the cover, wherein the at least one light-guiding region in the cover is in optical communication with the optical emitter via the at least one window, and wherein the at least one light-guiding region in the cover is configured to deliver light from the optical emitter to the non-ear canal region.

23. A wearable device, comprising:

a housing comprising at least one window;

an electronic module supported by the housing, the electronic module comprising at least one PPG sensor, at least one motion sensor, and at least one signal processor configured to process signals from the at least one motion sensor and signals from the at least one PPG sensor to reduce motion artifacts from the PPG signals; and

non-air light transmissive material in optical communication with the at least one PPG sensor, wherein the at least one window optically exposes the at least one PPG sensor to a body of a subject wearing the device via the non-air light transmissive material.

24. The device of claim 23, wherein the non-air light transmissive material comprises at least one light guide in optical communication with the at least one PPG sensor and the window.

25. The device of claim 23, wherein the wearable device is an earbud.

26. The device of claim 23, wherein the wearable device is a headset.

27. The device of claim 23, wherein the at least one processor is configured to reduce motion artifacts by removing frequency bands from the signals that are outside of a range of interest using at least one band-pass filter to produce pre-conditioned signals.

28. The device of claim 23, wherein the at least one processor is configured to filter the preconditioned signals via at least one of the following:

FIR (Finite Impulse Response) filtering, IIR (Infinite Impulse Response) filtering, adaptive filtering, phase filtering, and frequency filtering.

29. The device of claim 23, wherein the subject motion artifacts comprises subject footstep-related motion artifacts.

30. The device of claim 23, wherein the at least one motion sensor comprises at least one of the following:

an optical sensor, an inertial sensor, an electrically conductive sensor, a capacitive sensor, an inductive sensor, an accelerometer, and a blocked channel sensor.

31. The device of claim 23, wherein the wearable device is configured to be worn at one or more of the following locations of the body of the subject:

head, ear, limb, nose, and digit.