(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2005/0177051A1
`Almen
`(43) Pub. Date:
`Aug. 11, 2005
`
`US 2005O177051A1
`
`(54) APPARATUS AND METHOD FOR
`MONITORING HEART RATE WARIABILITY
`(75) Inventor: Adam J. Almen, Minneapolis, MN
`(US)
`Correspondence Address:
`ALTERA LAW GROUP, LLC
`6500 CITY WEST PARKWAY
`SUTE 100
`MINNEAPOLIS, MN 55344-7704 (US)
`
`(73) Assignee: Quiescent, Inc.
`(21) Appl. No.:
`11/067,168
`1-1.
`(22) Filed:
`
`Feb. 25, 2005
`Related U.S. Application Data
`(63) Continuation-in-part of application No. 10/829,544,
`filed on Apr. 22, 2004.
`(60) Provisional application No. 60/464,762, filed on Apr.
`23, 2003.
`
`Publication Classification
`
`(51)
`
`Int. Cl. .............................................. A61 B 5/0402
`
`(52) U.S. Cl. .............................................................. 600/509
`
`(57)
`
`ABSTRACT
`
`A wrist-worn or arm band worn heart rate variability moni
`tor is provided. Heart rate variability (“HRV) refers to the
`variability of the time interval between heartbeats and is a
`reflection of an individual’s current health status. Over time,
`an individual may use the results of HRV tests to monitor
`either improvement or deterioration of Specific health issues.
`Thus, one use of the HRV test is as a medical motivator.
`When an individual has a poor HRV result, it is an indicator
`that they should consult their physician and make appropri
`ate changes where applicable to improve their health. If an
`individual's HRV results deviate significantly from their
`normal HRV, they may be motivated to consult their phy
`Sician. In addition, the inventive monitor is capable of
`monitoring the Stages of Sleep by changes in the heart rate
`variability and can record the sleep (or rest) sessions with the
`resulting data accessible by the user or other interested
`parties. Alternate embodiments of the invention allow assis
`tance in the diagnosis and monitoring of various cardiovas
`cular and Sleep breathing disorders and/or conditions. Other
`embodiments allow communication with internal devices
`such as defibrillators or drug delivery mechanisms. Still
`other embodiments analyze HRV data to assist the user in
`avoiding sleep.
`
`
`
`
`
`36
`
`APPLE 1062
`Apple v. AliveCor
`IPR2021-00970
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`Patent Application Publication Aug. 11, 2005 Sheet 1 of 24
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`Patent Application Publication Aug. 11, 2005 Sheet 7 of 24
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`US 2005/0177051A1
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`Patent Application Publication Aug. 11, 2005 Sheet 11 of 24
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`Analog circuit
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`Digital controller
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`Communications
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`Power supply
`and power
`management
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`Fig.11
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`Patent Application Publication Aug. 11, 2005 Sheet 12 of 24
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`Communications
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`Wireless link
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`infrared transceiver
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`Fig. 12
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`Patent Application Publication Aug. 11, 2005 Sheet 13 of 24
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`US 2005/0177051A1
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`Patent Application Publication Aug. 11, 2005 Sheet 14 of 24
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`US 2005/0177051A1
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`Enter timed sleep mode
`
`Program desired sleep duration and
`desired waking prompt
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`Calculate awake heart rate
`parameters
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`Continuously monitor heart rate for
`
`-
`Recognition of early stages of sleep
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`sleep entry sY
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`Initiate waking prompt timer
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`Continuously monitor heart rate
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`Waking prompt timer expires
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`Activate waking prompt
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`Fig. 14
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`Patent Application Publication Aug. 11, 2005 Sheet 15 of 24
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`Enter REM cycle timed sleep mode
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`Program desired REM sleep duration
`and desired waking prompt
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`Calculate awake heart rate
`parameters
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`Continuously monitor heart rate for
`awake exit and non-REM sleep entry
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`Recognition of awake exit and non
`REM sleep entry
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`Calculate non-REM sleep entry
`parameters
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`Continuously monitor heart rate for
`non-REM sleep exit, REM sleep entry
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`Recognition of non-REM sleep exit
`and REM sleep entry
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`Calculate REM sleep parameters
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`Continuously monitor heart rate for
`REM sleep cycle completion
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`Recognition of REM sleep cycle exit
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`Wakding prompt activated
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`Fig. 15
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`Patent Application Publication Aug. 11, 2005 Sheet 16 of 24
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`Enter timed sleep mode
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`Calculate awake heart rate
`parameters
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`Continuously monitor heart rate for
`awake exit and non-REM sleep entry
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`-
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`Recognition of awake exit and non
`REM sleep entry
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`Calculate non-REM sleep entry
`parameters
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`Continuously monitor heart rate for
`non-REM sleep exit, REM sleep entry
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`Recognition of non-REM sleep exit
`and REM sleep entry
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`Activate waking prompt
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`Fig. 16
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`Patent Application Publication Aug. 11, 2005 Sheet 17 of 24
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`Enter sleep timer/heart rate
`recording mode
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`Calculate awake heart rate
`parameters
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`Continuously monitor heart rate for
`sleep entry
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`Recognition of early stages of sleep
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`Begin sleep timer and heart rate
`recorder
`
`Calculate sleep heart rate
`parameters
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`
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`Continuously monitor heart rate for
`sleep exit
`
`Recognize sleep exit
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`Stop sleep timer and heart rate
`recording
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`Fig. 17
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`Patent Application Publication Aug. 11, 2005 Sheet 18 of 24
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`Enter sleep apnea mode
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`Calculate aWake heart rate
`parameters
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`Continuously monitor heart rate for
`sleep entry
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`Recognition of early stages of sleep
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`624
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`Begin sleep timer and heart rate
`recorder
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`Calculate sleep heart rate
`parameters
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`Continuously monitor heart rate for
`sleep apnea event(s)
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`Optional waking prompt when apnea
`event recognized
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`Recognize sleep exit
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`Stop sleep timer and heart rate
`recording
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`Fig. 18
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`Patent Application Publication Aug. 11, 2005 Sheet 19 of 24
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`integrate heart rate monitor with home
`control unit and central home computer
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`Enter remote home control node
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`Calculate awake heart rate
`parameters
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`Continuously monitor heart rate for
`sleep entry
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`Recognition of early stages of sleep
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`71.6
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`Transmit signal to home control receiver(s)
`and, in turn to central horne Computer
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`Central home computer places home
`in sleep mode
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`Calculate sleep heart rate
`parameters
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`Continuously monitor heart rate for
`sleep exit
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`Recognize sleep exit
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`Transmit wake signal to home control receiver(s)
`and, in turn, to central home Computer
`
`Central home computer places home
`in wake node
`
`Fig. 19
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`Patent Application Publication Aug. 11, 2005 Sheet 20 of 24
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`Enter HRV test mode
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`Enter user's personal physical
`information
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`Program HRV beats per minute
`threshold
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`Continuously monitor heart rate
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`HRV beats perminute threshold
`exceeded
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`Initiate heartbeat recorder and HRV
`
`Conclude HRV test and heartbeat
`recording stopped
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`Prooess data
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`Display, store and/or transfer HRV
`test results
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`Fig. 20
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`Patent Application Publication Aug. 11, 2005 Sheet 21 of 24
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`Fig. 21
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`Patent Application Publication Aug. 11, 2005 Sheet 22 of 24
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`US 2005/0177051A1
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`DATA EMITTED TO DEVICE
`FROM INTERNAL DEVICE
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`930
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`931
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`DATA RECEIVED BY DEVICE
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`932
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`DATA DISPLAYED ON
`DEVICE DISPLAY
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`933
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`ALARMACTIVATED UPON
`SIGNIFICANT EVENT DETECTEDh-934
`BY INTERNAL DEVICE/DEVICE
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`DATA TRANSMITTED TO
`INTERNAL DEVICE/INVENTIVE
`DEVICE CONCEPTING
`DETECTED EVENT
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`3
`935
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`Fig. 22
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`Patent Application Publication Aug. 11, 2005 Sheet 23 of 24
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`US 2005/0177051A1
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`940
`Y
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`941
`DEVICE PUT INTO SAFE MODE,
`DEACTIVATE INTERNAL DEVICE
`942
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`INTERNAL DEVICE COMMUNICATES
`SIGNIFICANT EVENT TO DEVICE
`943
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`DEVICES ALARMACTIVATED
`AND DECISION DISPLAY
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`944
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`947
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`USER CHOOSES YES THROUGH
`INPUT BUTTON ON DEVICE
`945
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`USER CHOOSES NO THROUGH
`INPUT BUTTON ON DEVICE
`948
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`DEVICE TRANSMITS YES
`SELECTION TO INTERNAL DEVICE
`946
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`DEVICE TRANSMITS NO
`SELECTION TO INTERNAL DEVICE
`949
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`INTERNAL DEVICE RECEIVES
`YES SELECTION
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`INTERNAL DEVICE RECEIVES
`NO SELECTION
`950
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`INTERNAL DEVICE RECQUESTS
`DELAYED ACTION, REQUESTS
`NEW"YES, NO" DECISION,
`STARTS ACTION COUNTDOWN
`Fig. 23
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`Patent Application Publication Aug. 11, 2005 Sheet 24 of 24
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`US 2005/0177051A1
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`ENTER SLEEP AVODANCE MODE
`VIA INPUT BUTTONS(S)
`
`970
`
`DEVICE BEGINS INTERMINTED
`SEARCH FOR BEGINNING STAGES
`OF SLEEP OR FAILING ASLEEP
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`RECOGNITION OF USER
`FALING ASLEEP
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`ACTIVATION OF AUDIO
`AND VEBRATE ALARM FOR
`PERIOD OF TIME
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`ALARM ALTERNATION
`BETWEEN AUDIO AND WIBRATE
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`ALARM SHUT OFF VIA
`INPUT BUTTON
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`Fig. 24
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`971
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`972
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`974
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`975
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`US 2005/0177051A1
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`Aug. 11, 2005
`
`APPARATUS AND METHOD FORMONITORING
`HEART RATE WARIABILITY
`
`RELATED APPLICATIONS
`0001. This application is a Continuation-In-Part to U.S.
`patent application Ser. No. 10/829,544, filed Apr. 22, 2004
`which claims priority to U.S. provisional patent application
`No. 60/464,762 filed Apr. 23, 2003.
`
`FIELD OF THE INVENTION
`0002 This invention relates generally to monitoring heart
`rate variability using a wrist worn monitor.
`
`BACKGROUND OF THE PRESENT
`INVENTION
`0003) Heart rate variability refers to the variability of the
`time interval between heartbeats and may be mathematically
`defined as the one-sigma Standard deviation of the heart rate
`about the mean heart rate value. A heart rate variability test
`is a reflection of a person's current health Status. By taking
`heart rate variability tests over time, an individual is able to
`gauge improvement or deterioration in their health Status.
`Such improvements or deterioration of health may result
`from a number of Sources including, e.g., changes in lif
`estyle Such as Smoking cessation, Starting an exercise pro
`gram, Surgery recovery, Stressor additions or removals, diet
`changes. Thus, in this context, the HRV test may be used as
`a medical motivator. The HRV test may also be used as an
`early indicator diagnostic tool. For example, the HRV test
`has been demonstrated to have prognostic associations with
`future coronary disease and events.
`0004 Human sleep is described as a succession of recur
`ring Stages, including, inter alia, an awake Stage, non-REM
`Stages and the REM stage. The awake Stage in this context
`is actually the phase during which a perSon begins the
`process of falling asleep. Sleep quality changes with the
`transition from one Sleep Stage into another. Significantly for
`purposes of this invention, the transition from Stage to Stage
`is marked with observable, though Subtle, changes in bodily
`function, including heart rate variability.
`0005 Analysis of 24-hour HRV typically shows a noc
`turnal increase in the Standard deviation of heart beat
`intervals. The heart rate is further known to decrease rela
`tively rapidly as a person transitions from the awake Stage to
`the non-REM stages. As the individual eventually transitions
`from the non-REM sleep stages to REM sleep, the heart rate
`becomes more erratic and the variability increases. There are
`Several Stages of REM sleep, each marked by changes in
`heart rate variability. The first REM stage typically lasts
`about 10 minutes, with each recurring REM stage length
`ening, with the final Stage lasting about one hour. The
`inventive monitor is capable of detecting the heart rate
`variability within each Sleep Stage as well as the transition
`from one Sleep Stage to the next, i.e., the transition from
`awake to non-REM sleep, the transition from non-REM
`sleep to REM sleep, the completion of an REM sleep stage
`and Subsequent transition to the next REM sleep Stage, and
`the deep slow wave stages (also referred to as delta wave or
`deep sleep) within non-REM sleep.
`0006. In addition, utilization of heart rate, heart rate
`variability, Sleep Stage patterns and pattern identification
`
`may be used to determine if the user is at risk of Suffering
`from a wide variety of maladies or conditions relating in
`general to cardiovascular diseases or conditions and Sleep
`breathing disorders or conditions. It would be highly desir
`able to have a device and method to identify certain mala
`dies, conditions or related events (1) before they occur, (2)
`during the occurrence of the malady, event or condition,
`and/or (3) after the malady, event and/or condition has
`occurred to allow the user and/or health care professional to
`examine the data, identify the particular malady, event
`and/or condition, and take appropriate action to correct the
`problem.
`0007. The present invention addresses these concerns.
`
`SUMMARY OF THE PRESENT INVENTION
`0008. A wrist-worn or arm band worn heart rate variabil
`ity monitor is provided. Heart rate variability (“HRV) refers
`to the variability of the time interval between heartbeats and
`is a reflection of an individual’s current health status. Over
`time, an individual may use the results of HRV tests to
`monitor either improvement or deterioration of Specific
`health issues. Thus, one use of the HRV test is as a medical
`motivator. When an individual has a poor HRV result, it is
`an indicator that they should consult their physician and
`make appropriate changes where applicable to improve their
`health. If an individual's HRV results deviate significantly
`from their normal HRV, they may be motivated to consult
`their physician. In addition, the inventive monitor is capable
`of monitoring the Stages of sleep by changes in the heart rate
`variability and can record the sleep (or rest) Sessions with the
`resulting data accessible by the user or other interested
`parties. Alternate embodiments of the invention allow assis
`tance in the diagnosis and monitoring of various cardiovas
`cular and Sleep breathing disorders and/or conditions. Other
`embodiments allow communication with internal devices
`such as defibrillators or drug delivery mechanisms. Still
`other embodiments analyze HRV data to assist the user in
`avoiding Sleep.
`0009. An object of the present invention is to provide a
`wrist worn heart rate variability monitor capable of perform
`ing a heart rate variability test.
`0010 Yet another object of the present invention is to
`provide a wrist worn heart rate variability monitor that
`allows recording of Sleep Sessions to determine and improve
`the quality and duration of the individual's Sleep.
`0011) Another object of the present invention is to pro
`vide a wrist worn or arm worn heart rate variability monitor
`that is capable of detecting and recording conditions leading
`to sleep apnea events and the events themselves.
`0012 Another object of the present invention is to pro
`vide a wrist worn heart rate variability monitor that is
`capable of detecting SIDS, Specifically the proceeding
`events that lead to SIDS (cardiomyopathy for example).
`0013 Another object of the present invention is to pro
`vide a wrist worn or arm worn heart rate variability monitor
`that is capable of communicating with an internal device
`(defibrillator, drug delivery, sleep/apnea monitor, cardio
`monitor).
`0014) Another object of the present invention is to pro
`vide a wrist worn or arm worn heart rate variability monitor
`
`26
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`Aug. 11, 2005
`
`that is capable of detecting certain cardiovascular conditions
`Such as arrhythmia and the onset of myocardial infarction
`and monitoring treatment of Same.
`0.015. Another object of the present invention is to pro
`vide a wrist worn or arm worn heart rate variability monitor
`that is capable of recording heart rate and expressing cardio
`work load in relation to exercise and calorie expenditure
`through heart rate data.
`0016 Yet another object of the present invention is to
`provide a wrist worn or arm worn heart rate variability
`monitor that is capable of monitoring HRV data to assist the
`user in avoiding sleep.
`0017 Still another object of the present invention is to
`provide a wrist worn or arm worn heart rate variability
`monitor that is capable of monitoring HRV data to assist the
`user in a timed rest period or nap.
`0.018. The foregoing objects and advantages of the inven
`tion will become apparent to those skilled in the art when the
`following detailed description of the invention is read in
`conjunction with the accompanying drawings and claims.
`Throughout the drawings, like numerals refer to Similar or
`identical parts.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0019 FIG. 1 is a top view of one embodiment of the
`Wrist worn monitor.
`0020 FIG. 2 is a bottom view of one embodiment of the
`wrist worn monitor with Sensor(s) and wires in phantom.
`0021
`FIG. 3A illustrates a capacitive micromachined
`ultrasound transducer in a normal State.
`0022 FIG. 3B illustrates a capacitive micromachined
`ultrasound transducer in a deformed State.
`0023 FIG. 4 is a side view of one embodiment of the
`wrist worn monitor closure.
`0024 FIG. 5 is a side view of one embodiment of the
`wrist worn monitor.
`0025 FIG. 6 is a bottom view of the wrist worn monitor
`illustrating possible two piece manufacture.
`0026
`FIG. 7 is a top view of the membrane attachment.
`0027 FIG. 8 illustrates the membrane attached to the
`wrist worn monitor.
`0028 FIG. 9A is a bottom view illustrating placement of
`the alarm elements.
`0029 FIG.9B is a top view illustrating placement of the
`alarm elements.
`0030 FIG. 10 is a view of one embodiment of the wrist
`worn monitor display.
`0031 FIG. 11 is a block diagram of the circuitry.
`0.032
`FIG. 12 is a block diagram of the communications
`unit with data transfer options.
`FIG. 13 is a graphical representation of the heart
`0033)
`rate.
`
`0034 FIG. 14 is a flowchart for using the wrist worn
`monitor to take a timed and recorded nap of Specified
`duration.
`0035 FIG. 15 is a flowchart for using the wrist worn
`monitor to take a timed and recorded nap with a Specified
`duration in REM sleep Stage.
`0036 FIG. 16 is a flowchart for using the wrist worn
`monitor to take a timed and recorded nap with alarmed exit
`when REM sleep Stage recognized.
`0037 FIG. 17 is a flowchart for using the wrist worn
`monitor to record Heart Rate Variability and time to analyze
`Sleep duration and quality.
`0038 FIG. 18 is a flowchart for using the wrist worn
`monitor to monitor for and record Heart Rate Variability for
`Sleep apnea events.
`0039 FIG. 19 is a flowchart for sending the heart rate
`variability data obtained by the wrist worn monitor to a
`central home computer to place the home in “sleep' and
`“awake' modes.
`0040 FIG. 20 is a flowchart for using the wrist worn
`monitor to perform a Heart Rate Variability (HRV) test.
`0041 FIG. 21 illustrates a user with the wrist worn
`monitor and an internal device.
`0042 FIG. 22 is a flowchart for using the wrist worn
`monitor to exchange data with an internal device.
`0043 FIG. 23 is a flowchart for using the wrist worn
`monitor to communicate and give commands to an internal
`device.
`0044 FIG. 24 is a flow chart for using the wrist worn
`monitor for sleep avoidance.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`0045. A wrist worn heart rate variability monitor for use
`in the above-mentioned conditions is desirable. Alterna
`tively, the inventive monitor may also be worn on the arm
`Secured by a band encircling the arm. An embodiment of the
`invention may used to assist the user with a timed nap. The
`heart rate variability data obtained through the invention is
`used to determine when the user has achieved sleep or a
`beneficial level of rest. When the heart rate itself is lowered
`to a target resting heart rate level, the device Starts a timed
`alarm to wake the user. Both the threshold target heart rate
`level and the duration of the Sleep Session may be deter
`mined by the user using input buttons to program the device.
`The user may also choose to be awoken by alarm before,
`during, or after Specific sleep Stages, Such as REM or deep
`Slow wave Sleep.
`0046) Another embodiment of the invention may use the
`heart rate to determine the duration and quality of a sleep
`Session. Users and health professionals may use the device
`at night in this manner to measure the overall duration of
`Sleep, time spent within a specific Sleep Stage or Stages, to
`assess the quality of their sleep. The measured data may be
`Stored in the device's memory and accessed either by the
`user through the device or by the user's physician. The
`Stored information may be related to the physician residing
`in a remote location via known wired or wireleSS data
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`transfer techniques. The results may be assessed for quality
`of Sleep by recognizing when the heart rate is above or
`below the preset threshold target level as well as variations
`in the intervals between heartbeats. Thus, the data may be
`used to determine whether or not the user is getting quality
`Sleep, or is waking during Sleep which is common in perSons
`Suffering from Sleep apnea and heavy Snoring. This infor
`mation may be used by the user as a motivator to See a
`physician and/or a Sleep Specialist. This information is also
`valuable to the user's physician in determining if treatment
`is necessary and what type of treatment would be most
`effective. Subsequent impact of the treatment may also be
`evaluated using heart rate variability information. The
`device may be further used in concert with a memory device
`Such as a mini flash drive or memory Stick. In this embodi
`ment, the inventive device would communicate with the
`memory device in ways that are well known in the art and
`not shown in the Figures. In one Such embodiment, the
`inventive monitor may have a port for communication with
`the memory device wherein the monitor's memory is trans
`ferred to the memory device. The memory device may then
`be connected to the user's computer for review of the data.
`Such data may be subsequently provided to the user's health
`care professional(s) computer for analysis. This data transfer
`may be accomplished computer-to-computer via the internet
`or, alternatively, the user may save the data to a computer
`disk and bring the disk to the health care professional.
`Further, the user may provide the health care professional
`with the memory device itself for communication with the
`health care professional's computer.
`0047 Another embodiment may utilize the heart rate to
`perform a heart rate variability test (HRV). HRV tests are
`typically performed while the Subject is at rest or asleep or
`may be done over a user's normal 24-hour activities. User's
`can choose to have an HRV test performed using an input
`button. An HRV test may be performed in as little as ten
`Seconds, but the longer the test, the more accurate the
`results. Users can utilize the HRV option while taking a
`timed nap, during a resting period, or when Sleeping at night.
`0.048
`Still another embodiment enables the device to be
`used in concert with a home's electronicS control unit. Many
`homes are equipped with a controlling computer System.
`These homes have been referred to as 'Smart houses. The
`home's controlling computer or electronics control unit
`manages the functions of the home. These functions may
`include: television; personal computer; shower; home Secu
`rity System; lights, kitchen appliances, garage door and other
`functional features of a home. This invention is capable of
`working in concert with the home's controlling computer
`System and works to Synchronize the home's functions with
`the homeowner's functions. The user wears the device
`before bed and when the user's heart rate level and vari
`ability reach the threshold level, the wrist worn monitor
`Sends out a signal to the home's controlling computer which
`then prepares the home for the night, i.e., places the home in
`sleep mode. This may comprise functions Such as Shutting
`lights and televisions off, and ensuring the garage door is
`down, Setting the thermostat at an appropriate temperature
`for the night, etc. The opposite is done in the morning. When
`the user's heart rate level and variability rises above the
`threshold level, the monitor Sends a signal to the central
`home computer to prepare the home for the day, i.e., placing
`the home in awake mode. Thus, functions Such as turning
`on the lights, shower, coffee maker, alarm are accomplished.
`
`In addition to using the heart rate variability of the user to
`control the features of the home, the monitor may have a
`button that manually accomplishes the tasks without use of
`heart rate variability information.
`0049 Another embodiment of the device may recognize
`and/or assist in the diagnosis of the onset of maladies and/or
`conditions that cause Sudden Infant Death Syndrome (SIDS)
`and/or heart rate variability and Sleep Stage patterns com
`prising events associated with SIDS. Such recognition may
`occur proactively or predictively, concurrent with the
`malady or event, and/or retrospectively. In this embodiment
`the device may utilize heart rate, heart rate variability and
`Sleep Stage patterns and pattern identification to determine if
`the user is at risk of suffering from SIDS. In this embodi
`ment, thresholds and algorithms are applied to the heart rate
`for identification of events placing the user at risk of SIDS
`or recognition of when a SIDS even is occurring or has
`occurred. Pattern recognition and pre-event milestone rec
`ognition allow the device to alert the user, parent, or health
`care professional to an upcoming event or an event in
`progreSS. AS an example, cardiomyopathy or long Q-T
`syndrome may be identified by the inventive monitor, with
`Subsequent alerting of the user or an outside party (in this
`case perhaps the infant’s parents or healthcare professional)
`of the event. This may assist in a preliminary diagnosis. So
`that proper Steps toward treatment may begin. The devices
`alarm System may give parents or the user a chance to
`prevent the event from happening or continuing.
`0050 Another embodiment of the device may assist in
`the recognition of Sleep Stages and Sleep disorders. The
`device is able to determine the user's sleep Stage and
`abnormalities, REM, non-REM, deep slow wave sleep, and
`Sleep apnea Syndrome through HRV, heart rate, algorithms,
`and the programming of patterns for recognition. Other
`Sleep disorders may be recognized based on data and pat
`terns recognized by the device and health care professionals
`reviewing the data and patterns as well as the user dissemi
`nating the information to determine a sleep problem. Various
`embodiments of the inventive device may incorporate an
`actigraph, pulse OXimetry, and a method for measuring
`peripheral arterial tone. These additional tools coupled with
`heart rate variability and heart rate may provide a means of
`croSS referencing and/or Secondary information Source
`needed to determine if the user is asleep, experiencing a
`Sleep disorder or other malady or event to assist in providing
`more accurate information for the user and health care
`professionals.
`0051. With reference to pulse oximetry, an infra-red
`Sensor may be used to obtain or measure the heart rate.
`Infra-red detection transmits infra-red light through the
`user's skin which is then reflected back to the sensor. This
`method picks up the pulsatile flow of blood through local
`capillaries producing an accurate heart rate measurement.
`Infra-red detection further allows for the measurement of
`oxygen levels in the blood. The oxygen levels in the blood
`are a reflection of respiration and may be used as an
`indicator of respiratory problems that may result from
`chronic obstructive pulmonary disease or obstructive Sleep
`apnea by way of example. Those skilled in the art will
`readily recognize a plurality of diseases or conditions that
`may be monitored, diagnosed or treated using pulse OXim
`etry and/or oxygen level measurement.
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`0.052 One exemplary condition that may be identified
`and monitored is Sleep apnea. Sleep apnea is a condition
`whereby afflicted individuals literally stop breathing repeat
`edly during Sleep, often for a minute or longer and as many
`as hundreds of times during a Single night's sleep. Very often
`individuals with Sleep apnea experience disrupted sleep and
`are prevented from reaching the later Stages of Sleep, Such as
`REM sleep, which the body requires for rest and replenish
`ment of Strength. Heart rate variability data can be used to
`assist the physician in diagnosing and monitoring the effi
`cacy of treatment regimens for Sleep apnea. The inventive
`monitor may be used to determine whether heart rate Vari
`ability indicates that Sleep is continually interrupted and
`whether a sufficient amount of REM sleep and deep slow
`wave sleep is being obtained. In addition to the recognition
`of Sleep apnea events, the inventive monitor provides an
`overall view of the users Sleep and Sleep patterns, including
`the identification of the users Sleep Stages, Stages one
`through five, allowing the user or health care professionals
`to identify abnormalities or other Sleep disorders.
`0053. The device may be outfitted with a transceiver to
`communicate with internal devices or with external devices.
`Internal devices Such as defibrillators, insulin pumps, drug
`delivery/pumps, apnea monitors, pulse transmitters, and
`heart rate monitors (monitoring for abnormalities or cardiac
`events). In this application the device can be used to display
`pertinent information for the user as well as transmit infor
`mation to the internal device. The internal device commu
`nicates information to the inventive monitor via the trans
`ceiver regarding a significant event. In the case of an internal
`defibrillator, the Significant event may be an impending
`stimulation from the defibrillator with the option to override
`the automatic System or delay it. In one embodiment, the
`inventive monitor's alarm alerts the user of the impending
`Significant event, in the example the defibrillation Stimula
`tion. Thus, if the user is driving a car they may choose to
`delay the Stimulation So they can pull over to the Side of the
`road. The user will be alerted by an audible or vibrate alarm
`to the impending Stimulation So they can prepare for it or
`they can use an input button to delay the Stimulation or use
`an input button to override the Stimulation all together So at
`a later and Safer time they can Stimulate themselves through
`an input button on our device. In the case of an insulin pump
`the user can receive information used for tailoring their diet
`and activities based on the timing and amount of insulin
`delivered. Alerting the user of this exemplary significant
`event, an insulin dosage, can also help the user prepare for
`the effects of the insulin. The same principles apply for drug
`delivery/pumps as with insulin pumps.
`0.054 The user will also be able to easily view informa
`tion gathered by the internal device on the inventive device's
`display. The internal device may, in an alternate embodiment
`be placed into a “decision mode” by an input on our device.
`The decision mode would prompt the internal device to
`transmit a signal to the inventive device's transceiver (exter
`nal) requesting perm