Methods and apparatus for assessing physiological conditions

• US 8,961,415 B2
• Filed: 02/22/2010
• Issued: 02/24/2015
• 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): Thomson, William
• Assistant Examiner(s): Archer, Marie
• Application Number:
  US12/709,977
• Publication Number:
  US 20100217099A1
• Time in Patent Office: 1,828 Days
• Field of Search: 600300-301, 600363-365, 600372-384, 600386-394, 600/407, 600/412, 600/415, 600/418, 600/485, 600/474, 600/475, 600479-481, 600500-503, 600/508, 600515-519, 600529-534, 600544-547, 600/549, 600587-595
• US Class Current: 600/301
• 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

Monitoring apparatus and methods are provided for assessing a physiological condition of a subject. At least two types of physiological information are detected from a subject via a portable monitoring device associated with the subject, and an assessment of a physiological condition of the subject is made using the at least two types of physiological information, wherein each type of physiological information is individually insufficient to make the physiological condition assessment. Environmental information from a vicinity of a subject also may be detected, and an assessment of a physiological condition of the subject may be made using the environmental information in combination with the physiological information. Exemplary physiological information may include subject heart rate, subject activity level, subject tympanic membrane temperature, and subject breathing rate. Exemplary environmental information may include humidity level information in the vicinity of the subject. An exemplary physiological condition assessment may be subject hydration level.

Claims

1. A method of assessing a physiological condition of a subject, the method comprising:

collecting data over a period of time by a wearable sensor module attached to the subject, wherein the sensor module comprises at least one physiological sensor for measuring the following physiological parameters;

body temperature, heart rate, and sweat rate, and wherein the sensor module comprises at least one physical activity sensor for measuring the physical activity of the subject;

analyzing data to identify at least one time-dependent change in at least one of the physiological parameters during at least one less-active period and during at least one more-active period for the subject comprising determining whether at least one of the physiological parameters exhibits a time-dependent change that precedes or lags with respect to at least one other the physiological parameters; and

making an assessment of a physiological condition of the subject via at least one algorithm factoring the at least one time-dependent change in context of the physical activity of the subject, wherein the assessment comprises one or more of the following;

VO₂, VO_2max, thermoregulatory functioning, metabolic information, active calories burned, total calories burned, hydration status, heart rate variability, cardiac response, stress level, warm up time, recovery time, activity performance level;

wherein the analyzing data and making an assessment steps are performed by at least one processor.

2. The method of claim 1, wherein the at least one physiological sensor is configured to measure one of the following parameters:

breathing rate, hydration status, blood flow, blood pressure, blood oxygen, or a blood gas level.

3. A method of assessing a physiological condition of a subject wearing a sensor module, the method comprising:

collecting data over a period of time by a wearable sensor module attached to the subject, wherein the sensor module comprises at least one humidity sensor and at least one physical activity sensor for measuring physical activity of the subject;

identifying a time period of low subject activity via the at least one physical activity sensor;

analyzing data collected by the sensor module during the time period of low subject activity to identify natural humidity of the subject'"'"'s environment and ambient humidity of the subject'"'"'s environment during the time period of low subject activity;

identifying a subsequent time period of increased subject activity via the at least one physical activity sensor;

analyzing data collected by the sensor module during the time period of increased subject activity to identify a change in the ambient humidity of the subject'"'"'s environment during the time period of increased subject activity;

making an assessment of a physiological condition of the subject via at least one algorithm factoring the change in the ambient humidity of the subject'"'"'s environment;

wherein the identifying, analyzing data, and making an assessment steps are performed by at least one processor.

4. The method of claim 3, wherein the at least one physical activity sensor comprises at least one of the following:

a motion sensor, an accelerometer, a microelectromechanical systems (MEMS) device, a pedometer, a gyroscope, and a physiological sensor.