US. Patent No. 892394
`
`(57) Abstract: A physiological monitoring device
`{10) includes a device homing (I l ) shaped to fit he-
`hind an car (12) ol'a subject and a sensor (18, 28,
`30) attached to the device housing so as to sense a
`physiological characteristic ofthc subject at a loca-
`tion behind the ear. An earphone xpeaker (16} ex-
`tends from the device housing towards an ear canal
`of the subject and provides an audible communica-
`tion to the subject recponsively to the physiological
`characteristic.
`
`(54) Title: IiAR—MOUN’I'IED BIOSIENSOR
`
`1-1
`
`41
`u-
`
`mcm1
`
`-1
`a"‘--..
`
`APL103
`
`hcaN g
`
`(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`(43) International Publication Date
`1 February 2007 (01.02.2007)
`
`(51)
`
`International Patent Classification:
`A613 5’00 (2006.01)
`
`(21)
`
`(22)
`
`(25)
`
`(26)
`
`(30)
`
`(71)
`(72)
`
`(74)
`
`(81)
`
`International Application Number:
`PCTIIIIZOOGI’OOOSOS
`
`International Filing Date:
`
`25 April 1006 (25.04.2006)
`
`Filing Language:
`
`Publication Language:
`
`Priorin Data:
`60003.55?
`
`English
`
`English
`
`28 July 2005(28012005)
`
`US
`
`Applicant and
`Inventor:
`SCHWAR’I".. Boris [[lJll.I: H
`Street, 45350 l-lod Hasharon (11.).
`
`llaodern
`
`Agents: SANFORD T. COLE & CO. e1 alc. PO, Box
`2273. 76122 Rcllovol (IL).
`
`Designated States (unfair otherwise indicated. for every
`kind ofmitt’otm.’ protection ttwtttabie): AE, AG. AL, AM.
`
`||||l|ll||ll||||||||||||||||l|||l||||||llllllllllllllllllllllll
`
`|||||||l||||||||l||
`
`(10} International Publication Number
`
`WO 2007/013054 A]
`
`AT. AU. AZ, BA. BB. BG, BR. BW, BY. BZ.CA. CH. CN,
`CO, CR, CU, CZ, DE. DK. DM, DZ, EC. EE, EG, ES, FI,
`GB. GD. GE, GIL GM, “R, “U, ID, IL, IN, IS, JP, KII,
`KG. KM. KN. KP. KR. KZ. LC. LK. LR. LS. LT. LU. LV.
`LY, MA. MD. MG. MK. MN, MW. MX. MZ. NA. NG. NI.
`NO. NZ. OM, PG. PII, PL. PT. RO. RU. SC. SD. SE. SG.
`SK. SL. SM, SY. TJ, TM, TN, TR. TT, TZ. UA, UG, US,
`UZ. VC, VN. YU. ZA. ZM. ZW.
`
`Designated States (mites: otherwise indicated. for every
`kind of regiotmi protection attaiirtbie): ARIPO (BW. (311,
`GM. KE, LS. MW. MZ. NA. SD, SL. SZ. Tl, UG. ZM.
`ZW'J, Eurasian (AM. AZ. BY, KG.
`MI), RU. TJ, TM).
`European (AT. Eli, BG, CH, CY, CZ. I315. DK, lili. [[5, FI.
`FR. GB, GR. Hll. IE. IS. IT. LT, LU. IN, MC. NI... PL. PT.
`RO, $15.31, SK, TR), ()API (Bl-Z BJ, CF, CG, CI, CM, GA,
`GN, GQ, GW, ML. MR,
`SN, TD, TG).
`
`Published:
`— with international search report
`
`For two-letter code! and other abbreviations. mfer to the "Guid-
`ance Note}: at: Codes andxlbbreviatitms" appearing at the begin,
`ning afeactt regular issue of the PCT Gazette.
`
`Apple Inc.
`APL1037
`U.S. Patent No. 8,923,941
`
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`W0 2007f01305-l
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`PCTlIL2006.’[I 00505
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`EAR—MOUNTED BIOSENSOR
`
`CROSS—REFERENCE TO RELATED APPLICATION
`
`This
`
`application
`
`claims
`
`the
`
`benefit
`
`of
`
`0.3.
`
`Provisional Patent Application 60/703,557,
`
`filed on July
`
`28, 2005, which is incorporated herein by reference.
`
`FIELD OF THE INVENTION
`
`subject during
`
`saturation (Spoz). A PPS probe measures light transmitted
`
`The present
`
`invention relates generally to health
`
`care
`
`and
`
`specifically to methods
`
`and
`
`systems
`
`for
`
`monitoring subject well—being.
`
`BACKGROUND OF THE INVENTION
`
`Two known indicators of physical and psychological
`
`stress are Galvanic Skin Response (GSR) and heart rate.
`
`GSR
`
`(also known
`
`as
`
`electrodermal
`
`response,
`
`skin
`
`conductance response, or
`
`skin conductance level)
`
`is a
`
`measure of electrical conductivity of a subject’s skin.
`
`GSR may be determined by applying a small voltage between
`
`two electrodes affixed to the skin and measuring the
`
`generated current. Often, GSR is measured at the tip of a
`
`subject’s finger or on the palm of a hand. An example of
`
`a GSR sensor used in clinical settings is the Model V71—
`
`23
`
`Isolated Skin Conductance Coupler, distributed by
`
`Coulbourne Instruments of Allentown, Pennsylvania.
`
`Heart rate may be determined by photoplethysmography
`
`(PPG), which can also be uSed to measure variations in
`
`blood oxygen levels by pulse oximetry. Oximetry readings
`
`are generally made in terms of a percent of blood oxygen
`
`through
`
`or
`
`reflected
`
`from arterial
`
`blood.
`
`In
`
`transmission PPG,
`
`light is generally transmitted through
`
`a
`
`thin appendage of
`
`the body. U.S. Patent 4,301,808 to
`
`Taus,
`
`for
`
`example, whose disclosure
`
`is
`
`incorporated
`
`herein by‘
`
`reference, describes
`
`the use of
`
`transmission
`
`PPG to measure
`
`the pulse
`
`rate of
`
`a
`
`0002
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`FITBIT, Ex. 1037
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`

`

`W0 20071013054
`
`PCTJ'ILZOIMIOIJIJSOS
`
`physical exercise. Tans states that PPG readings be made
`
`through an appendage such as the ear,
`
`the nose septum, or
`
`the web between the forefinger and the thumb.
`
`Reflective pulse oximetry' measures
`from arteries beneath the
`surface of
`
`light reflected
`the
`skin. U.S.
`
`Patent
`
`6,553,242
`
`to
`
`Sarussi,
`
`whose
`
`disclosure
`
`is
`
`incorporated herein by reference, describes the use of
`
`reflective pulse oximetry to measure heart rate, as well
`
`as
`
`indications of
`
`apnea
`
`in sleeping infants. Sarussi
`
`identifies several means of affixing an oximetry sensor
`
`to a
`
`subject’s body,
`
`including a wristband,
`
`an ankle
`
`band,
`
`a Sock, and a headband for making measurements at
`
`the subject’s forehead.
`
`U.S. Patent 6,783,501 to Takahashi et al., Whose
`
`disclosure is incorporated herein by reference, describes
`
`the use of pulse oximetry to measure heart
`
`rate from
`
`various
`
`locations
`
`on
`
`the
`
`head
`
`during
`
`exercise.
`
`individual’s well—being are available on the market. For
`
`include the
`locations described by Takahashi
`Measurement
`forehead and the ear canal. Heart rate feedback to the
`
`exerciser may be provided by an audio indication, which
`
`may be provided through an earphone, or by
`
`a visual
`
`indication, which may be provided on a screen attached to
`
`glasses Worn by the exerciser.
`
`U.S. Patent 6,760,610 to Tschupp et al., Whose
`
`disclosure is incorporated herein by reference, describes
`
`the use of pulse oximetry to measure blood oxygenation in
`
`combination with a measurement of blood carbon dioxide
`
`levels.
`
`U.S. Patent Publication 2005/0033131 to Chen et al.,
`
`whose disclosure is incorporated herein by
`
`reference,
`
`describes
`
`an
`
`ear
`
`sensor
`
`assembly
`
`that
`
`supports
`
`an
`
`oximetry sensor
`
`in the ear concha, using an extension
`
`that clips onto the ear lobe.
`Wearable
`medical
`devices
`
`that
`
`monitor
`
`an
`
`0003
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`FITBIT, Ex. 1037
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`

`

`that measures level of exertion during exercise.
`
`Psychological
`
`stress
`
`among
`
`employees
`
`can
`
`have
`
`a
`
`significant
`
`impact
`
`on
`
`their
`
`job effectiveness
`
`and can
`
`lead to accidents,
`
`absenteeism,
`
`and employee
`
`turnover.
`
`According to an article by
`
`the American Institute of
`
`Stress,
`
`available at www.stress.org/job.htm and whose
`
`stress
`
`increases
`
`business
`
`costs
`
`in
`
`the U.S.
`
`by
`
`approximately $300 billion per year. Whrkplace testing of
`
`employees
`
`for indications of wellebeing is known in the
`
`art. For example, U.S. Patent 6,352,516 to Pozos, et al.,
`
`whose disclosure is incorporated herein by reference,
`
`describes
`
`a method for monitoring employee
`
`fatigue by
`
`W0 200 no I 3054
`
`PCT!I L20061000505
`
`example,
`
`the SenseWear@ Armband, distributed by Bodymedia
`
`of Pittsburgh, Pennsylvania,
`
`employs
`
`an
`
`accelerometer
`
`that
`
`records body movement,
`
`a
`
`temperature sensor
`
`that
`
`detects
`
`changes
`
`in skin temperature,
`
`and a GSR sensor
`
`disclosure is incorporated herein by reference, workplace
`
`measuring the force of fingers striking a keyboard.
`
`0004
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`PC TflLZOOfi/[IDOSflS
`
`SUMMARY OF THE INVENTION
`
`Embodiments
`
`of
`
`the
`
`present
`
`invention
`
`provide
`
`apparatus
`
`and methods
`
`for monitoring
`
`one
`
`or more
`
`physiological parameters from a location behind the ear.
`
`A sensor mounted to an earphone and positioned behind the
`
`ear
`
`is configured to sense the physiological parameters
`
`in a convenient, comfortable, and non—obtrusive manner.
`
`Photoplethysmography (PPG) of arterial blood either
`
`in the scalp behind the ear or in the ear itself may be
`
`used.
`
`to determine heart rate and/or oxygen saturation.
`
`(GSR) measurements may also be
`Galvanic Skin Response
`made from the location behind the ear.
`
`to
`used
`be
`may
`parameters
`physiological
`The
`determine stress and other health indicators while an
`
`individual being monitored is performing activities in a
`
`non—medical setting,
`
`such as activities related to work
`
`or
`
`leisure. These
`
`indicators may be provided to the
`
`individual and/or to a health care institution, such as a
`
`remotely based hospital. The earphone to which the sensor
`
`is nmunted may be utilized to provide an indication of
`
`responsively to the physiological characteristic.
`
`the sensed parameters, as well as to provide additional
`functions that enhance the convenience of use.
`
`There is therefore provided,
`
`in accordance with an
`
`embodiment of
`
`the present
`
`invention,
`
`a physiological
`
`monitoring device,
`
`including:
`
`a device housing shaped to fit behind an ear of
`
`a
`
`subject;
`
`a sensor attached to the device housing'
`
`so as
`
`to
`
`senss a physiological characteristic of the subject at a
`
`location behind the ear; and
`
`an
`
`earphone
`
`speaker
`
`extending
`
`from the
`
`device
`
`housing towards an ear canal of the subject and operative
`
`to provide
`
`an
`
`audible
`
`communication
`
`to the
`
`subject
`
`0005
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`

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`PCTHLZflOfi/OIJDSUS
`
`The location may be on at
`
`least one of
`
`a scalp of
`
`the subject and a pinna of
`
`the subject,
`
`and the sensor
`
`may
`
`be
`
`operative
`
`to
`
`sense
`
`the
`
`physiological
`
`characteristic on.both the scalp and the pinna.
`
`In
`
`some
`
`embodiments,
`
`the
`
`device
`
`includes
`
`a
`
`(PPG) probe, which is adapted to
`photoplethysmographic
`sense
`a characteristic
`of arterial
`blood
`flow.
`The
`
`characteristic of arterial blood flow may include heart
`
`rate, blood oxygen saturation (SpOE), or respiration rate.
`
`The device may additionally or alternatively include
`
`a Galvanic Skin Response (GSR)
`
`sensor operative to sense
`
`a characteristic of
`
`skin.
`
`The GSR
`
`sensor
`
`typically
`
`includes two electrodes, which are positioned so as
`contact the skin.
`
`to
`
`In some embodiments,
`
`the device includes a control
`
`unit, which
`
`is
`
`housed in the device housing and is
`
`operative to calculate a level of stress of the subject
`
`responsively to the physiological characteristic.
`
`The device may also include a transmitter, which is
`
`housed in the device housing and is Operative to transmit
`
`to an external
`
`receiver
`
`a
`
`signal
`
`indicative of
`
`the
`
`physiological characteristic.
`
`and
`
`The earphone speaker- may be operative to play at
`least one of music and work—related communications.
`
`There is further provided,
`
`in accordance with an
`
`embodiment
`
`of
`
`the present
`
`invention,
`
`a
`
`system for
`
`monitoring physiological parameters,
`
`including:
`
`a physiological monitoring device,
`
`including:
`
`a device housing shaped to fit behind an ear of
`
`a subject:
`
`a sensor attached to the device housing so as
`
`to sense
`
`a physiological characteristic of
`
`the
`
`subject at a location behind the ear;
`
`an earphone.speaker.extending from the device
`
`housing towards
`
`an ear canal of
`
`the subject
`
`0006
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`

`W0 20071013054
`
`PCTIILZDIIISIIJBOSOS
`
`operative to provide an audible communication to the
`
`subject; and
`
`a transmitter housed in the device housing and
`
`operative to transmit
`
`a
`
`signal
`
`indicative of
`
`the
`
`physiological characteristic; and
`
`a receiving device, separate from the physiological
`
`monitoring device and operative to receive and process
`
`the signal.
`
`of
`
`subject using the sensor at the location behind the ear;
`and
`
`In
`
`some
`
`embodiments,
`
`the
`
`receiving
`
`device
`
`is
`
`operative to transmit an indication of
`characteristic
`over
`a
`communication
`
`the physiological
`network
`to
`a
`
`monitoring center.
`
`The receiving device may be operative to transmit an
`
`audio signal to be played by the earphone speaker.
`
`In
`
`further
`
`embodiments,
`
`the
`
`indication of
`
`the
`
`physiological characteristic is an indicator of stress.
`
`Additionally,
`
`the physiological monitoring device
`
`may be included in a communication headset used by the
`
`subject in work—related communications.
`
`There
`
`embodiment
`
`is
`
`of
`
`also provided,
`
`in accordance with
`
`an
`
`the present
`
`invention,
`
`a method
`
`for
`
`monitoring physiological parameters including:
`
`fitting a physiological monitoring device behind an
`
`ear of a subject in such a manner that a sensor attached
`
`to the device housing is positioned behind the ear;
`
`sensing
`
`a
`
`physiological
`
`characteristic
`
`of
`
`the
`
`responsively to the physiological characteristic,
`
`providing an audible communication through an earphone
`
`Speaker attached to the housing and extending towards an
`
`ear canal of the Subject.
`
`In disclosed embodiments,
`
`sensing the physiological
`
`characteristic
`
`includes
`
`sensing
`
`a
`
`characteristic
`
`0007
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`WO 2007/013054
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`PCT/ILZOflfiJflUDSiIS
`
`arterial blood flow using a photoplethysmcgraphic (PPG)
`
`probe.
`
`Additionally or alternatively,
`
`the sensor includes a
`
`Galvanic Skin Response
`
`(GSR)
`
`sensor,
`
`the GSR
`
`sensor
`
`includes
`
`two electrodes,
`
`and.
`
`sensing the physiological
`
`characteristic includes applying a voltage between the
`
`two electrodes and measuring a current generated through
`
`the scalp.
`
`In some embodiments,
`
`the method includes calculating
`
`a
`
`level of stress of
`
`the subject
`
`responsively to the
`
`physiological characteristic.
`
`In
`
`further
`
`embodiments,
`
`the method
`
`includes
`
`transmitting a
`
`signal
`
`indicative of
`
`the physiological
`
`characteristic from the physiological monitoring device
`
`to an external receiving device. The transmission may be
`
`accordance with an embodiment of the present invention.
`
`made over a communication network to a monitoring center.
`
`In
`
`further
`
`disclosed
`
`embodiments,
`
`the method
`
`includes playing from the earphone speaker at
`
`least one
`
`of music and work—related communications.
`
`The present
`
`invention will be more fully understood
`
`from the
`
`following
`
`detailed
`
`description
`
`of
`
`the
`
`embodiments thereof,
`which:
`
`taken together with the drawings in
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Fig.
`
`l
`
`is a schematic, pictorial
`
`illustration of a
`
`monitoring
`
`device
`
`positioned
`
`behind
`
`the
`
`ear,
`
`in
`
`accordance with an embodiment of the present invention;
`
`Fig.
`
`2
`
`is a schematic side view of
`
`the monitoring
`
`device of Fig.
`
`l,
`
`in accordance with an embodiment of the
`
`present invention; and
`
`Fig.
`
`3
`
`is a schematic, pictorial
`
`illustration of
`
`a
`
`system for monitoring
`
`physiological
`
`parameters,
`
`in
`
`0008
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`

`WO 2007/013054
`
`PCT/ILZOflfiJflUDSflS
`
`DETAILED DESCRIPTION OF EMBODIMENTS
`
`In the embodiments of the present invention that are
`
`described below, one or more physiological parameters are
`
`measured from a location that is on the scalp behind the
`ear.
`
`Fig.
`
`l
`
`is a schematic, pictorial
`
`illustration of
`
`a
`
`monitoring device 10 shaped to fit behind an ear 12 of a
`
`subject
`
`14,
`
`in accordance with an
`
`embodiment of
`
`the
`
`present
`
`invention. The device fits between the scalp and
`
`the
`
`pinna,
`
`i.e.,
`
`the
`
`cartilaginous
`
`portion
`
`of
`
`the
`
`external ear. Monitoring device 10 fits behind ear 12 in
`
`the manner of clip—on earphones known in the art SO as to
`
`sense
`
`physiological
`
`parameters
`
`in
`
`a
`
`convenient,
`
`comfortable, and unobtrusive manner.
`
`Sensors comprised in monitoring device 10 contact
`
`either a location on the scalp of subject 14 behind the
`
`ear 12 or a location on the back of the pinna, or both.
`The
`locations
`are
`chosen
`so
`as
`to overlie arteries
`
`daily
`
`beneath the skin,
`
`such as
`
`the occipital branch of
`
`the
`
`posterior auricular artery.
`
`Monitoring
`
`device
`
`10
`
`comprises
`
`one
`
`or more
`
`photoplethysmographic
`
`(PPG)
`
`sensors,
`
`described further
`
`hereinbelow (Fig. 2), which are used to make oximetry
`measurements
`at
`the
`locations
`behind
`the
`ear.
`
`Additionally or alternatively, Galvanic Skin Response
`
`{GSR} measurements may be made behind the ear by a GSR
`
`sensor comprised in monitoring device 10
`further hereinbelow.
`
`and described
`
`Monitoring device
`
`10
`
`also comprises
`
`an
`
`earphone
`
`speaker
`
`16 that extends
`
`from the nmnitoring device,
`
`in
`
`front of
`
`the ear,
`
`to the ear canal,
`
`thereby enabling
`
`subject
`
`14
`
`to receive an
`
`indication of
`
`the monitored
`
`parameters,
`
`as well as audio streams,
`
`such as music or
`
`work—related communications. Monitoring device 10 may be
`
`used while
`
`subject
`
`14
`
`is
`
`performing
`
`normal
`
`0009
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`W0 20071013054
`
`PCTHLZflOfi/OIJDSUS
`
`activities,
`
`such as work or
`
`leisure activities. When
`
`these
`
`activities
`
`require
`
`the
`
`use
`
`of
`
`an
`
`earphone,
`
`monitoring device 10
`
`is particularly unobtrusive.
`
`For
`
`example, device 10 may be part of headset apparatus used
`
`service representative (CSR)
`by a customer
`center environment.
`
`in a call
`
`Fig.
`
`2 is a schematic side view of monitoring device
`
`10,
`
`in accordance with an
`
`embodiment of
`
`the present
`
`invention. The monitoring device comprises
`
`a crescent“
`
`shaped housing 11 that fits between ear 12 and the scalp.
`
`For the sake of illustration, Fig.
`
`2 shows the front side
`
`of housing 11,
`
`to which sen50rs are affixed. The back
`
`side of housing 11, not shown, may mirror the design of
`
`,the front side and comprise similarly affixed sensors.
`
`Consequently, housing 11 may be placed behind either the
`
`left ear or the right ear of subject 14. Depending on the
`
`ear selected, one side of housing 11 is in contact with
`
`the scalp and the other
`
`side is
`
`in contact with the
`
`pinna. Alternatively, device 10 may be made with a sensor
`
`or sensors on only one side.
`
`For
`
`the sake of
`
`illustration in the description
`
`that follows,
`
`the front side shown in Fig.
`
`2
`
`is assumed
`
`this artery is noted by way of example
`
`to be in contact with the subject's scalp. A PPG sensor
`18 is affixed to the front side in Such a manner that the
`
`sensor contacts the scalp. Sensor
`
`18 comprises one or
`
`more
`
`light
`
`sources,
`
`such
`
`as
`
`a
`
`LED
`
`19,
`
`and
`
`further
`
`comprises
`
`a
`
`light detector 20. The device housing is
`
`opaque,
`
`thereby preventing ambient
`
`light
`
`front
`
`reaching
`
`the location and interfering with the light generated by
`
`LED
`
`19.
`
`The
`
`light generated by LED 19
`
`is
`
`sensed by
`
`detector
`
`20 after being reflected from arterial blood
`
`under
`
`the scalp,
`
`such as blood flow in the occipital
`
`branch of
`
`the posterior auricular artery.
`
`It
`
`is to be
`
`understood that
`
`0010
`
`FITBIT, Ex. 1037
`
`

`

`W0 200 no I 3054
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`PCT!I L20061000505
`
`and that another artery behind the ear may also be used
`for the PPG measurement.
`
`A signal,
`
`indicative of the light reflected from the
`
`arterial blood,
`
`is transmitted from detector
`
`20
`
`to a
`
`control unit 22.
`
`10
`
`any
`or by
`transmit by Bluetoothm wireless protocols,
`other wireless or wired means known in the art. Power for
`
`Control unit
`
`22 processes
`
`the received signal
`
`in
`
`order to determine the subject’s heart rate, as well as
`
`SpOz variation of arterial blood over time. Based on the
`
`received signal, control unit 22 may also determine the
`
`subject’s respiratory rate, as described,
`
`for example, by
`
`Leonard et al.,
`
`in “Standard Pulse Oximeters Can Be Used
`
`to Monitor Respiratory Rate," Emergency Madicine Journal
`
`20, pages 524—525 {2003), which is incorporated herein by
`
`reference. Control unit
`
`22 may
`
`provide
`
`an
`
`audible
`
`indication of one or more of the determined physiological
`
`parameters,
`
`including heart
`
`rate,
`
`respiratory rate, or
`
`SpOz
`
`level
`
`to subject 14 via speaker 16. The indication
`
`may,
`
`for example, be in the form of a synthesized speech
`
`signal or
`
`an
`
`alarm in case the value of
`
`a monitored
`
`parameter
`
`is
`
`outside
`
`a
`
`predetermined
`
`range.
`
`Alternatively or additionally,
`
`the control unit transmits
`
`a
`
`signal
`
`indicative of one or more of
`
`the determined
`
`physiological
`
`parameters
`
`to
`
`an
`
`external
`
`receiver
`
`described hereinbelow (Fig. 3). To transmit
`
`the signal,
`
`control unit 22 may utilize a transmitter 24, which may
`
`LED 19, detector 20, control unit 22, and transmitter 24
`
`is provided by a battery 26. Control unit 22 and battery
`
`26
`
`are
`
`typically comprised within
`
`the
`
`housing
`
`of
`
`monitoring device
`
`10
`
`and are
`
`therefore shown
`
`in the
`
`illustration within a out—away portion of the device.
`
`Additionally
`
`or
`
`alternatively,
`
`a
`
`GSR
`
`sensor,
`
`comprising a first electrode 28
`
`and a
`
`second electrode
`
`30, is also affixed to one or both sides of housing 11 so
`
`0011
`
`FITBIT, Ex. 1037
`
`

`

`W0 20071013054
`
`PCTIILZDHISIIJBOSQS
`
`as to contact
`
`the skin. Respective electrodes 28 and 30
`
`may be made of a conductive polymer, for example,
`
`thereby
`
`providing a good electrical contact with the scalp when
`
`the monitoring device is in place behind the ear. Control
`
`unit 22 passes a current between electrodes 28 and 30 in
`order to measure skin conductance between the electrodes.
`
`As
`
`in the case of
`
`the heart rate and SpOz measurements
`
`mentioned above, control unit
`
`22 may process
`
`the GSR
`
`sensor signal
`
`in order
`
`to determine a level of stress
`
`and/or exertion and may give
`
`the subject
`
`an audible
`
`indication of the level via speaker 16. Alternatively or
`
`additionally,
`
`the
`
`control
`
`unit
`
`transmits
`
`a
`
`signal
`
`indicative
`
`of
`
`the
`
`skin
`
`conductance
`
`to an
`
`external
`
`receiver described hereinbelow (Fig. 3). To transmit
`
`the
`
`signal, control unit 22 may utilize transmitter 24.
`
`In some
`
`embodiments of
`
`the present
`
`invention,
`
`the
`
`PPG and GSR measurements described above may be taken at
`
`the back of
`
`the pinna of ear
`
`l2 by sensors on the back
`
`side of housing 11 (not shown),
`
`instead of or in addition
`
`to the measurements made on the scalp. Measurements of
`
`ll
`
`physiological parameters at both the scalp and the back
`'of the pinna may‘ be made simultaneously by respective
`Sensors
`on
`each of
`the
`front
`and back sides of
`the
`
`housing. Circuitry in the housing,
`
`such as control unit
`
`22, may be configured to determine which of the scalp and
`
`ear
`
`locations provides
`
`a better
`
`signal—to—noise
`
`ratio
`
`(SNR). The parameters measured at
`
`the location with the
`
`better SNR may then be selected for further processing
`
`and transmission, as described below. Alternatively,
`
`the
`
`measurements may be averaged, or other selection criteria
`
`may be applied.
`
`Fig.
`
`3
`
`is a schematic, pictorial
`
`illustration of
`
`a
`
`system for monitoring
`
`physiological
`
`parameters,
`
`in
`
`accordance-with an embodiment of
`
`the present
`
`invention.
`
`While subject
`
`14 has device 10 in place behind his ear,
`
`0012
`
`FITBIT, Ex. 1037
`
`

`

`W0 20071013054
`
`PCTIILZDIIISIIJBOSOS
`
`he may
`
`perform normal
`
`daily
`
`activities,
`
`including
`
`activities related to his work or leisure.
`
`PPG and
`
`skin conductance
`
`data
`
`transmitted from
`
`monitoring device 10 may be used to determine a level of
`
`subject stress and changes
`
`in that
`
`level.
`
`Indicators of
`
`stress are,
`
`for example,
`
`increased heart rate,
`
`increased
`
`respiratory rate,
`
`and
`
`increased skin conductance.
`
`To
`
`report stress level, monitoring device 10 may transmit
`
`physiological data to a receiving device such as a cell
`
`phone,
`
`or
`
`a
`
`personal
`
`computer
`
`(PC)
`
`32.
`
`PC
`
`32
`
`configured
`
`to
`
`receive
`
`the
`
`signal
`
`transmitted
`
`is
`
`by
`
`transmitter 24 by wireless or wired means. when wireless
`
`means,
`
`such as Bluetooth transmission, are utilized,
`
`PC
`
`32 may receive such transmission by means of an antenna
`
`38. The PC may also return an audio signal
`
`to be played
`
`12
`
`programmed to automatically notify the subject and other
`
`through earphone speaker 16.
`
`The calculation of stress level
`
`from physiological
`
`parameters may be determined by device 10 or by PC 32.
`
`The PC may be configured to display a stress level to the
`
`subject. Alternatively,
`
`or
`
`additionally,
`
`PC
`
`32,
`
`or
`
`another receiving device,
`
`such as a cell phone, may be
`
`configured to transmit physiological parameters over
`
`a
`
`data network 34,
`
`to a monitoring center 36, which may be
`
`maintained by a health care provider or by the subject’s
`
`employer,
`
`for
`
`example.
`
`The monitoring center may
`
`be
`
`concerned parties,
`
`such as the subject's doctor or work
`
`supervisor, if changes in the level of stress, or Changes
`
`in other physiological indicators, warrant intervention.
`
`Although
`
`the
`
`embodiments
`
`described above
`
`relate
`
`specifically to the measurement of heart
`
`rate,
`
`SpDz,
`
`respiratory rate, and skin conductance,
`
`the principles of
`
`the present
`
`invention may also be applied to other types
`
`of measurements. indicative
`
`of
`
`subject well—being
`
`or
`
`stress.
`
`Furthermore,
`
`although
`
`these
`
`embodiments make
`
`0013
`
`FITBIT, Ex. 1037
`
`

`

`It will
`
`thus
`
`be
`
`appreciated
`
`that
`
`embodiments
`
`desoribed above are cited by way of example, and that the
`
`present
`
`invention is
`
`not
`
`limited to what
`
`has
`
`been
`
`particularly shown and described hereinabove. Rather,
`
`the
`
`hereinabove,
`
`as well
`
`as variations
`
`and modifications
`
`thereof which would occur
`
`to persons skilled in the art
`
`upon reading the foregoing description and which are not
`
`W0 2007f" 13054
`
`PCTJ'ILZOOGIOIIDSUS
`
`reference to certain types of active life settings and
`
`signaling methods,
`
`the
`
`principles
`
`of
`
`the
`
`present
`
`invention may likewise be applied in the context of other
`
`environments and other communications technologies.
`
`scepe of the present invention includes both combinations
`and subcombinations of
`the various
`featurES described
`
`disclosed in the prior art.
`
`0014
`
`FITBIT, Ex. 1037
`
`

`

`W0 2007f" 13054
`
`PCTJ'ILZOOGIOIIDSUS
`
`CLAIMS
`
`A physiological monitoring device, comprising:
`
`a device housing shaped to fit behind an ear of
`
`a
`
`. control unit, which is housed in the device housing and
`
`comprises two electrodes, which are positioned so as to
`contact the skin.
`
`subject;
`
`a sensor attached to the device housing so as
`
`to
`
`sense a physiological characteristic of the subject at a
`
`location behind the ear; and
`
`an
`
`earphone
`
`Speaker
`
`extending
`
`from the
`
`device
`
`housing towards an ear canal of the subject and operative
`
`to provide
`
`an
`
`audible
`
`communication
`
`to the
`
`subject
`
`responsively to the physiological characteristic.
`
`2.
`
`The device of claim 1, wherein the location is on at
`
`least one of
`
`a scalp of the subject and a pinna of
`
`the
`
`subject.
`
`3.
`
`The
`
`device
`
`of
`
`claim 2, wherein
`
`the
`
`sensor
`
`is
`
`operative to sense the physiological characteristic on
`
`both the scalp and the pinna of the subject.
`
`4.
`
`The device of any of claims 1—3, wherein the sensor
`
`comprises
`
`a photoplethysmographic (PPG) probe, which is
`
`adapted to sense a characteristic of arterial blood flow.
`
`5.
`
`The device of claim 4, wherein the characteristic of
`
`arterial blood flow comprises at least one of heart rate,
`
`blood oxygen saturation (Sp02}, and resPiration rate.
`
`6.
`
`The device of any of claims la3, wherein the sensor
`
`comprises a Galvanic Skin Response (GSR} sensor operative
`to sense a characteristic of skin.
`
`7.
`
`The device of
`
`claim 6, wherein the GSR
`
`sensor
`
`8.
`
`The device of any of claims
`
`1—3, and comprising a
`
`0015
`
`FITBIT, Ex. 1037
`
`

`

`W0 200m I 3054
`
`PCT!I L20061000505
`
`is operative to calculate a
`
`level of
`
`stress of
`
`the
`
`subject responsively to the physiological characteristic.
`
`9.
`
`The device of any of claims
`
`1—3,
`
`and comprising a
`
`transmitter, which is housed in the device housing and is
`
`operative to transmit
`
`to an external receiver
`
`a signal
`
`indicative of the physiological characteristic.
`
`10.
`
`The
`
`device
`
`of
`
`any of
`
`claims
`
`1-3, wherein
`
`the
`
`least one of
`
`is operative to play at
`earphone speaker
`music and work—related communications.
`
`15
`
`10
`
`ll.
`
`A system for monitoring physiological parameters,
`
`comprising:
`
`a physiological monitoring device, comprising:
`
`a device housing shaped to fit behind an ear of
`
`a subject;
`
`a sensor attached to the device housing so as
`
`to
`
`sense
`
`a physiological
`
`characteristic
`
`of
`
`the
`
`subject at a location behind the ear;
`
`an earphone speaker extending from the device
`
`housing towards
`
`an ear canal of
`
`the subject
`
`and
`
`operative to provide an audible communication to the
`
`subject; and
`
`a transmitter housed in the device housing and
`
`operative to transmit
`
`a
`
`signal
`
`indicative of
`
`the
`
`physiological characteristic: and
`
`a receiving device, separate from the physiological
`
`monitoring device and operative to receive and. process
`
`the signal.
`
`12.
`
`The system of claim 11, wherein the receiving device
`
`is
`
`operative
`
`to
`
`transmit
`
`an
`
`indication
`
`of
`
`the
`
`physiological characteristic over a communication network
`
`to a monitoring center.
`
`13.
`
`The system of claim 11, wherein the receiving device
`
`is operative to transmit an audio signal to be played by
`
`the earphone speaker.
`
`0016
`
`FITBIT, Ex. 1037
`
`

`

`W0 2007f" 13054
`
`PCTJ'ILZOOGIOIIDSUS
`
`14.
`
`The system of claim 11 or 12, wherein the indication
`
`the physiological characteristic is an indicator of
`of
`stress.
`
`15.
`
`The
`
`system of
`
`claim 11
`
`or
`
`12, wherein
`
`the
`
`physiological monitoring
`
`device
`
`is
`
`comprised
`
`in
`
`a
`
`communication headset used by the subject in work—related
`communications.
`
`16
`
`16.
`
`A method
`
`for monitoring physiological parameters
`
`comprising:
`
`fitting a physiological monitoring device behind an
`
`ear of a subject
`
`in such a manner that a sensor attached
`
`to the device housing is positioned at a location behind
`
`the ear of the subject;
`
`Sensing a physiological characteristic using the
`
`sensor on the location; and
`
`responsively to the physiological characteristic,
`
`providing an audible communication through an earphone
`
`speaker attached to the housing and extending towards an
`
`ear canal of the subject.
`
`17.
`
`The method of claim 16, wherein the location is on
`
`at least one of a scalp of the subject and a pinna of the
`
`subject.
`
`18.
`
`The method
`
`of
`
`claim 17, wherein the
`
`sensor
`
`is
`
`operative to sense the physiological characteristic on
`
`both the scalp and the pinna of the subject.
`
`19.
`
`The method according to any of Claims 16—18, wherein
`
`the sensor comprises a photoplethysmographic (PPG) probe,
`
`and wherein
`
`sensing the physiological characteristic
`
`comprises sensing a characteristic of arterial blood flow
`
`using the PPG probe.
`
`20.
`
`The method of
`
`any of claims
`
`16—18, wherein the
`
`sensor comprises a.Galvanic Skin Response (GSR)
`
`sensor,
`
`wherein the GSR sensor
`
`comprises
`
`two electrodes,
`
`and
`
`0017
`
`FITBIT, Ex. 1037
`
`

`

`W0 2007f" 13054
`
`PCTJ'ILZOOGIOIIDSUS
`
`wherein
`
`sensing
`
`the
`
`physiological
`
`characteristic
`
`comprises applying a voltage between the two electrodes
`
`and measuring a current generated through the scalp.
`
`21.
`
`The method of
`
`any of claims
`
`16—18,
`
`and comprising
`
`calculating a level of stress of the subject responsively
`
`to the physiological characteristic.
`
`22.
`
`The method of any of claims
`
`16—18,
`
`and comprising
`
`transmitting a
`
`signal
`
`indicative of
`
`the physiological
`
`to an external receiving device.
`
`23.
`
`The method of claim 22, and comprising transmitting
`
`an indication of
`
`the physiological characteristic from
`
`the receiving device over
`
`a communication network to a
`
`monitoring center.
`
`24.
`
`The method of any of claims
`
`16—18,
`
`and comprising
`
`playing from the earphone speaker at
`
`least one of music
`
`characteristic from.‘the physiological monitoring device
`
`and work—related Communications.
`
`0018
`
`FITBIT, Ex. 1037
`
`

`

`W0 MOT/ll 13854
`
`PCTI'ILZIIEIGIOIHISIJS
`
`0019
`
`FITBIT, Ex. 1037
`
`

`

`E
`39
`g?ml
`
`2
`
`0020
`
`FITBIT, Ex. 1037
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`“mm” “PPM”? N“
`PCT/llflfimfl 505
`
`A.
`
`CLASSIFICATION OF SUBJECT MATTER
`AfilB smu( 2005.01}
`
`lPC:
`
`660i300,301,306.323,507
`USPC:
`According to International Patent Classification (IPC) 01' to both national classification and IPC
`
`.
`
`FIELDS SEARCHED
`
`Minimum documentalion Searched (classification system followu‘l by classification symbols)
`US. : 600500301305, 323,500,507
`
`Documentation searched other than minimum documentation to the extent that such documetfis are included in the fields searched
`
`Electronic data been consulted during the international search (name of data base and, where practicable, Search terms used)
`
`C.
`
`DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category ‘
`X
`
`Citation of document, with indication, where appropriate, ofthe relevant passages
`US 5,9?1331 A (RAFF) 26 Oclober 199996.10‘1999), figs. 2 & 3; col. 2, line Ill—col. 3,
`line 9.
`
`Relevant io clnim No.
`11,1345
`
`i-lO,lZ,16-24
`
`US 5,3?1,134 A (RICHARDSON) 13 December 1994 (13.12.1994), figs. 1-2; col. 4, lines 1-
`30.
`US 6,030,110 A (THORGERSEN) 2.7 June 2000 {27.06.2000} entire document
`
`Sec patent family annex.
`later dominant published 530: Ill: inknuiimml Elingdzte ct pfiwity data
`and not in amflicl wilh ma milk-alien but citedtu mm Illa
`principle ardiecry underbdngth: inth
`dew-mm cfpam'mJni-relevance; the claimed invmlinn Baum be
`considered novel or canon: be omnidu-adm inmlve aninmlive slap
`when tin: m1 is Iakan'alane
`
`dncnmanl ul‘pafliwlarmlnvmw, the claimed invention cannnl be
`onusidmdlo involve an inveolive step when the document is unkind
`with one arm other such dean-min, such omnhinalinn beingcbvimis
`In apsmon skillsdin the ad
`document member eff-he same patcnl Emily
`
`- phone No.
`
`(571) 272-3000
`
`Form