111111
`
`1111111111111111111111111111111111111111111111111111111111111
`US008989830B2
`
`c12) United States Patent
`LeBoeuf et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,989,830 B2
`*Mar. 24, 2015
`
`(54) WEARABLE LIGHT-GUIDING DEVICES FOR
`PHYSIOLOGICAL MONITORING
`
`USPC .......................................................... 600/310
`See application file for complete search history.
`
`(71) Applicant: Valencell, Inc., Raleigh, NC (US)
`
`(56)
`
`References Cited
`
`(72)
`
`Inventors: Steven Francis LeBoeuf, Raleigh, NC
`(US); Jesse Berkley Tucker, Knightdale,
`NC (US); Michael Edward Aumer,
`Raleigh, NC (US)
`
`(73) Assignee: Valencell, Inc., Raleigh, NC (US)
`
`U.S. PATENT DOCUMENTS
`
`3,595,219 A
`4,240,882 A
`
`7/1971 Friedlander eta!.
`12/1980 Ang eta!.
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`EP
`GB
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`7/2009
`2 077 091 A2
`9/2005
`2 411 719 A
`(Continued)
`
`OTHER PUBLICATIONS
`
`(21) Appl. No.: 14/484,585
`
`(22) Filed:
`
`Sep.12,2014
`
`(65)
`
`Prior Publication Data
`
`US 2015/0032009 AI
`
`Jan.29,2015
`
`Related U.S. Application Data
`
`(63)
`
`Continuation of application No. 14/184,364, filed on
`Feb. 19, 2014, now Pat. No. 8,886,269, which is a
`continuation of application No. 12/691,388, filed on
`Jan.
`21,
`2010,
`now Pat. No.
`8,700,111.
`
`(Continued)
`
`(51)
`
`(52)
`
`(58)
`
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A61B 5100
`A61B 511455
`U.S. Cl.
`CPC ............. A61B 510082 (2013.01); A61B 516838
`(2013.01); A61B 51418 (2013.01); A61B
`511455 (2013.01); A61B 516803 (2013.01)
`USPC .......................................................... 600/310
`Field of Classification Search
`CPC ..................................................... A61B 5/0082
`
`FiTrainer "The Only Trainer You Need"; http://itami.com; Down(cid:173)
`loaded Feb. 26, 2010; © 2008 FiTrainer™; 2 pages.
`(Continued)
`
`Primary Examiner- Rodney Fuller
`(74) Attorney, Agent, or Firm- Myers Bigel Sibley &
`Sajovec
`
`ABSTRACT
`(57)
`A monitoring device configured to be attached to the body of
`a subject includes an outer layer and an inner layer secured
`together. The inner layer includes light transmissive material
`and has inner and outer surfaces. A base is secured to at least
`one of the outer and inner layers and includes an optical
`emitter and optical detector. A layer of cladding material is
`positioned near the outer surface of the inner layer, and at
`least one window is formed in the layer of cladding material
`that serves as a light-guiding interface to the body of the
`subject. The light transmissive material delivers light from
`the optical emitter to the body of the subject along a first
`direction and collects light from the body of the subject and
`delivers the collected light in a second direction to the optical
`detector. The first and second directions are substantially
`parallel.
`
`20 Claims, 21 Drawing Sheets
`
`14
`
`~~e ~ {)(
`
`-.::::__-:.._
`
`~~
`
`--::::_=
`
`38
`
`36
`
`20
`
`10
`
`\... 18
`
`40
`
`34b
`
`19 r
`
`30
`
`Apple Inc.
`APL1001
`U.S. Patent No. 8,989,830
`
`0001
`
`FITBIT, Ex. 1001
`
`

`

`US 8,989,830 B2
`Page 2
`
`Related U.S. Application Data
`
`(60) Provisional application No. 61/208,567, filed on Feb.
`25, 2009, provisional application No. 61/208,574,
`filed on Feb. 25, 2009, provisional application No.
`61/212,444, filed on Apr. 13, 2009, provisional appli-
`cation No. 61/274,191, filed on Aug. 14, 2009.
`
`(56)
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`FITBIT, Ex. 1001
`
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`

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`Suppl. 2, pp. S19-S23, 2003.
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`
`0004
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`Mar. 24, 2015
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`Sheet 1 of 21
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`US 8,989,830 B2
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`38
`
`22
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`24
`
`36
`
`20
`
`10
`~
`
`34b
`
`19 r
`
`30
`
`100
`~
`
`FIG. 1
`
`F/6.2
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`U.S. Patent
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`Mar. 24, 2015
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`Sheet 2 of 21
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`US 8,989,830 B2
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`30
`~
`
`30
`~
`
`FIG. 3
`
`FIG. 4A
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`U.S. Patent
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`Mar.24,2015
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`Sheet 3 of21
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`US 8,989,830 B2
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`30 \
`
`E
`
`_)
`
`18
`
`24
`
`FIG. 48
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`U.S. Patent
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`Mar.24,2015
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`Sheet 4 of21
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`US 8,989,830 B2
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`30 \
`
`50
`
`E
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`
`21
`
`FIG. 4(
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`U.S. Patent
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`Mar.24,2015
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`Sheet 5 of21
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`US 8,989,830 B2
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`30 \
`
`50
`
`21
`
`FIG. 4D
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`U.S. Patent
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`Mar.24,2015
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`Sheet 6 of21
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`US 8,989,830 B2
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`30
`~
`
`30
`~
`
`FIG. 5
`
`0010
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`U.S. Patent
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`Mar. 24, 2015
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`Sheet 7 of 21
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`US 8,989,830 B2
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`30
`\.
`
`FIG. lA
`
`FIG. 78
`
`30 \ 19 26
`
`24
`
`21
`FIG. BA
`
`FIG. 88
`
`0011
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`U.S. Patent
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`Mar.24,2015
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`Sheet 8 of21
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`US 8,989,830 B2
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`26
`
`16a
`
`34b
`
`'tlll
`
`26
`
`FIG. 8(
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`U.S. Patent
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`Mar. 24, 2015
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`Sheet 9 of 21
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`US 8,989,830 B2
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`16a
`
`FIG. BD
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`0013
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`U.S. Patent
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`Mar.24,2015
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`Sheet 10 of 21
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`US 8,989,830 B2
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`9B
`I
`
`50
`
`111
`
`26
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`98
`FIG. 9A
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`FOSSA
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`
`FIG. 10
`
`0014
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`U.S. Patent
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`Mar.24,2015
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`Sheet 11 of 21
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`US 8,989,830 B2
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`30
`~
`
`24
`
`19
`
`FIG. 9(
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`U.S. Patent
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`Mar.24,2015
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`Sheet 12 of 21
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`US 8,989,830 B2
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`U.S. Patent
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`Mar. 24, 2015
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`Sheet 13 of 21
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`US 8,989,830 B2
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`30 \
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`FIG. 118
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`FIG. 12A
`
`27
`
`FACING EARBUD
`FIG. 128
`
`0017
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`U.S. Patent
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`Mar. 24, 2015
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`Sheet 14 of 21
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`US 8,989,830 B2
`
`200
`~
`
`201
`'-----.-
`.........
`
`PARAMETER
`ESTIMATOR
`
`CHANNEl D
`
`CHANNEl C
`
`205
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`CHANNEl E
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`CHANNEl A
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`+
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`CHANNEl B
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`PARAMETER
`ESTIMATOR
`
`FIG. 13
`
`0018
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`U.S. Patent
`
`Mar. 24, 2015
`
`Sheet 15 of 21
`
`US 8,989,830 B2
`
`RAW SIGNAl IN lOW MOTION
`
`5020
`300o~5000~
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`FIG. 14A
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`11BlOCKED CHANNEl" IN lOW MOTION
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`:~~~c .. . . . . . . ·4
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`FIG. 148
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`
`300c~
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`7 4 7 5 7 6
`FIG. 14(
`11BlOCKED CHANNEl" IN HIGH MOTION
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`71
`72
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`75
`76
`77
`78
`79
`80
`FIG. 140
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`70
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`0019
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`U.S. Patent
`
`Mar.24,2015
`
`Sheet 16 of 21
`
`US 8,989,830 B2
`
`\. 200 ,..----,.--------,r------.--------,r-------.-------.,
`
`ADAPTIVE FILTER+ BEAT FINDER
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`FIG. 15
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`PRE-ADAPTIVE SIGNAL CONDITIONING
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`FIG. 16
`
`0020
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`U.S. Patent
`
`Mar.24,2015
`
`Sheet 17 of 21
`
`US 8,989,830 B2
`
`r-----------------,
`
`I
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`STEPS
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`PACE
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`AGIVITY
`INTENSITY INTEGRITY
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`BLOOD
`FLOW
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`HEART BREATHING BLOOD
`RATE
`RATE
`PRESSURE
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`BLOOD
`ANALYTE
`LEVELS
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`FIG. 18
`
`0021
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`U.S. Patent
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`Mar.24,2015
`
`Sheet 18 of 21
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`US 8,989,830 B2
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`70
`
`80
`~
`
`FIG. 19
`
`800 \
`
`~---------~---------------------------------------------,
`
`POWER
`REGULATION
`
`SENSORS
`
`SENSOR
`NOISE SOURCES
`
`SIGNAL
`PROCESSING
`
`INPUT/OUTPUT
`
`FIG. 20
`
`DIGITAL CONTROL
`
`0022
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`FITBIT, Ex. 1001
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`

`

`Oo w = = N
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`!
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`OPTIONAL L
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`' I
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`CONTAINS SENSOR SIGNAL
`PIC MICROCONTROLLER
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`0023
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`U.S. Patent
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`Mar.24,2015
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`Sheet 20 of 21
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`US 8,989,830 B2
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`0024
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`U.S. Patent
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`Mar.24,2015
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`Sheet 21 of 21
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`US 8,989,830 B2
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`US 8,989,830 B2
`
`1
`WEARABLE LIGHT-GUIDING DEVICES FOR
`PHYSIOLOGICAL MONITORING
`
`RELATED APPLICATIONS
`
`This application is a continuation application of pending
`U.S. patent application Ser. No. 14/184,364, filed Feb. 19,
`2014, which is a continuation application ofU.S. patent appli(cid:173)
`cation Ser. No. 12/691,388, filed Jan. 21, 2010, now U.S. Pat.
`No. 8,700,111, and which claims the benefit of and priority to
`U.S. Provisional Patent Application No. 61/208,567 filed
`Feb. 25, 2009, U.S. Provisional Patent Application No.
`61/208,574 filed Feb. 25, 2009, U.S. Provisional Patent
`Application No. 61/212,444 filed Apr. 13, 2009, and U.S.
`Provisional Patent Application No. 61/27 4,191 filed Aug. 14,
`2009, the disclosures of which are incorporated herein by
`reference as if set forth in their entireties.
`
`FIELD OF THE INVENTION
`
`The present invention relates generally to physiological
`monitoring and, more particularly, to physiological monitor(cid:173)
`ing devices.
`
`BACKGROUND OF THE INVENTION
`
`There is growing market demand for personal health and
`environmental monitors, for example, for gauging overall
`health and metabolism during exercise, athletic training, diet(cid:173)
`ing, daily life activities, sickness, and physical therapy. How(cid:173)
`ever, traditional health monitors and environmental monitors
`may be bulky, rigid, and uncomfortable-generally not suit(cid:173)
`able for use during daily physical activity. There is also grow(cid:173)
`ing interest in generating and comparing health and environ(cid:173)
`mental exposure statistics of the general public and particular 35
`demographic groups. For example, collective statistics may
`enable the healthcare industry and medical community to
`direct healthcare resources to where they are most highly
`valued. However, methods of collecting these statistics may
`be expensive and laborious, often utilizing human-based 40
`recording/analysis steps at multiple sites.
`As such, improved ways of collecting, storing and analyz(cid:173)
`ing physiological information are needed. In addition,
`improved ways of seamlessly extracting physiological infor(cid:173)
`mation from a person during everyday life activities, espe- 45
`cially during high activity levels, may be important for
`enhancing fitness training and healthcare quality, promoting
`and facilitating prevention, and reducing healthcare costs.
`
`2
`headset at one or more predetermined locations and to collect
`light external to the earbud housing and deliver the collected
`light to the optical detector. The optical emitter, via the light(cid:173)
`guiding cover, directs optical energy towards a particular
`region of ear and the optical detector detects secondary opti(cid:173)
`cal energy emanating from the ear region. In some embodi(cid:173)
`ments, the optical detector may include an optical filter con(cid:173)
`figured to pass secondary optical energy at selective
`wavelengths. In some embodiments, the light transmissive
`10 material of the cover may be configured, for example via the
`use of cladding and/or light reflective material, such that the
`cover serves as a light guide that is coupled in parallel to the
`optical emitter and detector. In some embodiments, the light
`transmissive material of the cover may be configured, for
`15 example via the use of cladding and/or light reflective mate(cid:173)
`rial, such that the cover serves as a light guide that is coupled
`perpendicular to the optical emitter and detector.
`In some embodiments, the headset may include various
`electronic components secured to the base. For example, the
`20 headset may include one or more environmental sensors con(cid:173)
`figured to detect and/or measure environmental conditions in
`a vicinity of the headset. The headset may include a signal
`processor configured to receive and process signals produced
`by the optical detector. For example, in some embodiments, a
`25 signal processor may be configured to extract secondary opti(cid:173)
`cal energy and remove optical noise or environmental noise.
`The headset may include a signal processor configured to
`receive and process signals produced by the one or more
`environmental sensors. In addition, the headset may include a
`30 transmitter configured to transmit signals processed by the
`signal processor to a remote device in real time. Headsets
`according to embodiments of the present invention may uti(cid:173)
`lize, for example, Bluetooth®, Wi-Fi, ZigBee, or other wire(cid:173)
`less transmitters.
`In some embodiments, a housing is secured to and overlies
`the base so as to enclose and protect the speaker, optical
`emitter and optical detector, as well as other electronic com(cid:173)
`ponents secured to the base (e.g., sensors, processor, trans(cid:173)
`mitter etc.).
`The earbud housing is in acoustical communication with
`the speaker and has at least one aperture through which sound
`from the speaker can pass. The light-guiding cover surround(cid:173)
`ing the earbud housing also includes at least one aperture
`through which sound from the speaker can pass. The cover
`may be formed from a soft, resilient material, such as silicone
`which deforms when inserted within an ear canal of a subject.
`In some embodiments, the cover includes an alignment mem(cid:173)
`ber that facilitates alignment of the earbud housing within an
`ear canal of a subject.
`Light directed into the ear of a subject from a light emitter
`and the subsequent collection of light at a light detector,
`according to embodiments of the present invention, may be
`utilized for detecting and/or measuring, among other things,
`body temperature, skin temperature, blood gas levels, muscle
`55 tension, heart rate, blood flow, cardiopulmonary functions,
`etc.
`In some embodiments of the present invention, the light(cid:173)
`guiding cover may include a lens that is in optical communi(cid:173)
`cation with the optical emitter and/or optical detector. The
`60 lens may be configured to focus light emitted by the optical
`emitter and/or to focus collected light toward the optical
`detector. In some embodiments, multiple lenses may be
`incorporated into a light-guiding cover.
`In some embodiments, the light-guiding cover may include
`65 a light diffusion region in optical communication with the
`light transmissive material that diffuses light emitted by the
`optical detector.
`
`50
`
`SUMMARY
`
`It should be appreciated that this Summary is provided to
`introduce a selection of concepts in a simplified form, the
`concepts being further described below in the Detailed
`Description. This Summary is not intended to identify key
`features or essential features of this disclosure, nor is it
`intended to limit the scope of the invention.
`According to some embodiments of the present invention,
`a headset configured to be attached to the ear of a person
`includes a base, an ear bud housing extending outwardly from
`the base that is configured to be positioned within an ear of a
`subject, and a cover surrounding the earbudhousing. The base
`includes a speaker, an optical emitter, and an optical detector.
`The cover includes light transmissive material that is in opti(cid:173)
`cal communication with the optical emitter and the optical
`detector and serves as a light guide to deliver light from the
`optical emitter into the ear canal of the subject wearing the
`
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`US 8,9