as) United States
`a2) Patent Application Publication (0) Pub. No.: US 2014/0323829 Al
` LeBoeufetal. (43) Pub. Date: Oct. 30, 2014
`
`
`
`US 20140323829A1
`
`(54) PHYSIOLOGICAL MONITORING
`APPARATUS AND NETWORKS
`
`Publication Classification
`
`(71) Applicant: Valencell, Inc., Raleigh, NC (US)
`
`(72)
`
`Inventors: Steven Francis LeBoeuf, Raleigh, NC
`(US); Jesse Berkley Tucker, Knightdale,
`NC (US); Michael Edward Aumer,
`Raleigh, NC (US)
`
`(21) Appl. No.: 14/328,107
`(22)
`Filed:
`Jul. 10, 2014
`
`(51)
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A6IB 5/00
`A6IB 5/021
`AGIB 5/11
`AGIB 5/029
`(52) US.CL
`CPC veecesseeseees AG6IB 5/6817 (2013.01); A61B 5/029
`(2013.01); A67B 5/02] (2013.01); A6IB
`5/1126 (2013.01)
`USPC cecececcecceesesneeeeeesseeseeseseesecesceaeenecaeens 600/301
`
`(57)
`
`ABSTRACT
`
`Related U.S. Application Data
`(63) Continuation of application No. 14/063,669, filed on
`Wearable apparatus formonitoringvarious physiological and
`Nee Part'e4waeSe3007 ofappication
`8 652 040 _—
`oo
`, a environmental factors are provided. Real-time, noninvasive
`eee
`health and environmental monitors include a plurality of
`(60) Provisional application No. 60/905,761, filed on Mar.
`compact sensors integrated within small, low-profile devices,
`8, 2007, provisional application No. 60/876, 128, filed
`such as earpiece modules. Physiological and environmental
`on Dec. 21, 2006, provisional application No. 60/875,
`data is collected and wirelessly transmitted into a wireless
`606, filed on Dec. 19, 2006.
`network, where the data is stored and/or processed.
`
`
`
`APPLE 1080
`Apple v. Masimo
`IPR2022-01465
`
`1
`
`APPLE 1080
`Apple v. Masimo
`IPR2022-01465
`
`

`

`Patent Application Publication
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`Oct. 30,2014 Sheet 1 of 11
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`US 2014/0323829 Al
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`
`
` 105
`EARPIECE \
`ATTACHMENT
`COMPONENT
`
`107
`
`109
`
`2
`
`

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`Patent Application Publication
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`Oct. 30,2014 Sheet 2 of 11
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`US 2014/0323829 Al
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`a2
`
`PERSONAL
`
`1
`
`SYSTEM
`
`™ SECONDARY
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`MODULES saa (Cc,__PORTABLE
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`SENSOR MODULE
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`CS
`DATABASE TRANSMISSION
`
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`OZONE LEVEL
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`PHYSICALACTIVITY
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`REGION
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`KS
`
`PULSE RATE
`
`3
`
`

`

`Patent Application Publication
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`Oct. 30,2014 Sheet 3 of 11
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`US 2014/0323829 Al
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`400
`
`EXTERNAL ENERGY
`(DIRECTION 2)
`
`129
`
`EXTERNAL ENERGY
`(DIRECTION 3)
`
`SIOLOGICAL ENERGY
`
`
`4
`
`

`

`Patent Application Publication
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`Oct. 30, 2014 Sheet 4 of 11
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`US 2014/0323829 Al
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`VeeeeRRSpeeSsLor\602
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`614
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`625
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`FIG./
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`

`

`Patent Application Publication
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`Oct. 30,2014 Sheet 5 of 11
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`US 2014/0323829 Al
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`800 ‘
`
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`0.0
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`FIG. 8
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`10:
`
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`1.0|ENERGY SPECTRUM
`0.2|(RAW WAVEFORM)
`
`
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`172.
`0.0
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`14 ENERGY SPECTRUM
`(AFTER LOW PASS & SIMPLE NOISE CANCELING)
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`0.2
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`

`

`Patent Application Publication
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`Oct. 30,2014 Sheet 6 of 11
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`US 2014/0323829 Al
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`7
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`

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`Patent Application Publication
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`Oct. 30,2014 Sheet 7 of 11
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`US 2014/0323829 Al
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`1201
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`1202
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`1208
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`

`Patent Application Publication
`
`Oct. 30,2014 Sheet 8 of 11
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`US 2014/0323829 Al
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`1300
`
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`
`1306
`
`6.13
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`
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`FIG. 14A
`
`FIG. 14B
`
`9
`
`

`

`Patent Application Publication
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`Oct. 30,2014 Sheet 9 of 11
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`US 2014/0323829 Al
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`
`
`1600
`
`OS
`
`FIG. 16
`
`10
`
`10
`
`

`

`Patent Application Publication
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`Oct. 30,2014 Sheet 10 of 11
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`US 2014/0323829 Al
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`1710
`
`NS EARPIECE
`
`PULSE OXIMETRY
`
`1800
`
`1807
`
`FIG. 17
`
`EARLOBE
`181]
`
`11
`
`11
`
`

`

`Patent Application Publication
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`Oct. 30,2014 Sheet 11 of 11
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`US 2014/0323829 Al
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`
`
`
`
`SIDE VIEW
`SENSOR MODULE
`
`OFMOUNTEDMODULES
`
`SENSOR MODULE
`
`
`
`FRONTVIEW\
`SENSOR MODULE
`\_
`
`CIRCUIT BOARD
`
`SS
`
`EXTENDED SENSOR
`
`
`
`
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`XTALS|
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`CODEC
`
`FIG. 19
`
`
`ett (1) BLUECORE MODULE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`REAL-TIME SAMPLING RATE ENABLES 11 HOURS OF OPERATION
`ENDURANCES >12 HOURS WITH REDUCED MEASUREMENT FREQUENCY
`
`
`
`BODY TEMPERATURE
`
`[_] ACCELEROMETER
`
`BAROMETRIC PRESSURE
`
`CM] HUMIDITY & AMBIENT
`TEMPERATURE
`
`(WY AMBIENT LIGHTING
`
`&S AMPLIFIER CIRCUITRY
`
`=] A/D CONVERTERS
`
`
`
`
`
`
`12
`
`12
`
`

`

`US 2014/0323829 Al
`
`Oct. 30, 2014
`
`PHYSIOLOGICAL MONITORING
`APPARATUS AND NETWORKS
`
`RELATED APPLICATION
`
`[0001] This application is a continuation application of
`pending U.S. patent application Ser. No. 14/063,669, filed
`Oct. 25, 2013, which is a continuation application of U.S.
`patent application Ser. No. 11/811,844, filed Jun. 12, 2007,
`now U.S. Pat. No. 8,652,040, and which claimsthe benefit of
`and priority to U.S. Provisional Patent Application No.
`60/905,761, filed Mar. 8, 2007, U.S. Provisional Patent Appli-
`cation No. 60/876,128, filed Dec. 21, 2006, and U.S. Provi-
`sional Patent Application No. 60/875,606, filed Dec. 19,
`2006, the disclosures of which are incorporated herein by
`referenceas if set forth in their entireties.
`
`FIELD OF THE INVENTION
`
`[0002] The present invention relates generally to health and
`environmental monitors and, more particularly, to wireless
`health and environment monitors.
`
`BACKGROUNDOF THE INVENTION
`
`[0003] Thereis growing market demandfor personal health
`and environmental monitors, for example, for gauging overall
`health and metabolism during exercise, athletic training, diet-
`ing, and physical therapy. However, traditional health moni-
`tors and environmental monitors may be bulky, rigid, and
`uncomfortable—generally not suitable for use during daily
`physicalactivity. There is also growinginterest in generating
`and comparing health and environmental exposurestatistics
`of the general public and particular demographic groups. For
`example, collective statistics 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 recording/analysis steps at mul-
`tiple sites.
`[0004] As such, improved waysofcollecting, storing and
`analyzing personal health and environmental information are
`needed. In addition, improved ways of distributing raw and
`analyzed personal health and environmental information are
`desirable to support efforts to enhance healthcare quality and
`reduce costs.
`
`SUMMARY
`
`In view ofthe above discussion, apparatus for moni-
`[0005]
`toring various physiological and environmental factors are
`provided. According to some embodiments of the present
`invention, real-time, noninvasive health and environmental
`monitors include a plurality of compact sensors integrated
`within small, low-profile devices. Physiological and environ-
`mental data is collected and wirelessly transmitted into a
`wireless network, where the data is stored and/or processed.
`[0006]
`In some embodimentsofthe invention, an earpiece
`functionsas a physiological monitor, an environmental moni-
`tor, and a wireless personal communicator. The earpiece can
`take advantage of commercially available open-architecture
`wireless paradigms, suchas Bluetooth®, Wi-Fi, or ZigBee. In
`some embodiments, a small, compact earpiece contains at
`least one microphone and one speaker, and is configured to
`transmit information wirelessly to a recording device such as,
`for example, a cell phone, a personaldigital assistant (PDA),
`and/or a computer. The earpiece contains a plurality of sen-
`
`sors for monitoring personal health and environmental expo-
`sure. Health and environmental information, sensed by the
`sensorsis transmitted wirelessly, in real-time, to a recording
`device, capable of processing and organizing the data into
`meaningful displays, such as charts. In some embodiments,
`an earpiece user can monitor health and environmental expo-
`sure data in real-time, and may also access records of col-
`lected data throughout the day, week, month, etc., by observ-
`ing charts and data through an audio-visual display.
`[0007]
`In some embodiments, an earpiece can integrate
`personal physiological and environmental exposure informa-
`tion with biofeedback and personal entertainment. In other
`embodiments of the present
`invention, earpiece monitor
`devices enable a variety of networks, applications, games,
`and business methods.
`
`In some embodiments of the present invention, a
`[0008]
`monitoring apparatus includes a housing configured to be
`attached to the body of a person, one or more physiological
`sensors and one or more environmental sensors supported by
`(within and/or on) the housing. Each physiological sensoris
`configured to detect and/or measure physiological informa-
`tion from the person, and each environmental sensor is con-
`figured to detect and/or measure environmental conditions in
`a vicinity of the person wearing the apparatus. The apparatus
`also includesa signal processorthat is configured to receive
`and process signals produced by the physiological and envi-
`ronmental sensors. A wireless transmitter is responsiveto the
`signal processor and is configured to wirelessly transmit
`physiological and environmental sensor signals as processed
`by the signal processor from the signal processor to a remote
`terminal in real-time.
`
`[0009] Each physiological sensor is configured to detect
`and/or measure one or moreofthe following types of physi-
`ological information: heart rate, pulse rate, breathing rate,
`blood flow, heartbeat signatures, cardio-pulmonary health,
`organ health, metabolism, electrolyte type and/or concentra-
`tion, physical activity, caloric intake, caloric metabolism,
`blood metabolite levels or ratios, blood pH level, physical
`and/or psychological stress levels and/or stress level indica-
`tors, drug dosage and/or dosimetry, physiological drug reac-
`tions, drug chemistry, biochemistry, position and/or balance,
`body strain, neurological functioning, brain activity, brain
`waves, blood pressure, cranial pressure, hydration level, aus-
`cultatory information, auscultatory signals associated with
`pregnancy, physiological response to infection, skin and/or
`core body temperature, eye muscle movement, blood volume,
`inhaled and/or exhaled breath volume, physical exertion,
`exhaled breath physical and/or chemical composition, the
`presence and/oridentity and/or concentration of viruses and/
`or bacteria, foreign matter in the body, internal toxins, heavy
`metals in the body, anxiety, fertility, ovulation, sex hormones,
`psychological mood,sleep patterns, hunger and/orthirst, hor-
`mone type and/or concentration, cholesterol, lipids, blood
`panel, bone density, organ and/or body weight,
`reflex
`response, sexual arousal, mental and/or physical alertness,
`sleepiness, auscultatory information, response to external
`stimuli, swallowing volume, swallowingrate, sickness, voice
`characteristics, voice tone, voice pitch, voice volume,vital
`signs, head tilt, allergic reactions, inflammation response,
`auto-immune response, mutagenic response, DNA,proteins,
`protein levels in the blood, water content of the blood, phero-
`mones, internal body sounds, digestive system functioning,
`cellular regeneration response, healing response, stem cell
`regeneration response
`
`13
`
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`

`

`US 2014/0323829 Al
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`Oct. 30, 2014
`
`environmental sensors associated therewith to a gaming
`device. The monitoring apparatus may also be configured to
`receive feedback regarding monitored health and environ-
`mental parameters. As such, personal health and environmen-
`tal feedback can be an active componentof a game.
`[0015]
`In some embodiments, the apparatus is an earpiece
`modulethat is configured to be attachedto the ear of a person,
`and includes a speaker, microphone, and transceiver that is
`electronically connected to the speaker and microphone and
`that permits bidirectional wireless communications between
`the earpiece module and a remote terminal, such as a cell
`phone. The transceiver(e.g., a Bluetooth®, Wi-Fi, or ZigBee
`transceiver) is electronically connected to the signal proces-
`sor and is configured to transmit physiological and environ-
`mental sensor signals from the signal processor to the remote
`terminal. In some embodiments, the earpiece module may
`include an arm that is attached to the housing andthat sup-
`ports the microphone. The arm may be movable between a
`stored position and an extended, operative position. The arm
`may also include one or more physiological sensor and/or
`environmental sensors.
`
`[0010] Each environmental sensor is configured to detect
`and/or measure one or more of the following types of envi-
`ronmental information: climate, humidity, temperature, pres-
`sure, barometric pressure, soot density, airborneparticle den-
`sity, airborneparticle size, airborne particle shape, airborne
`particle identity, volatile organic chemicals (VOCs), hydro-
`carbons, polycyclic aromatic hydrocarbons (PAHs), carcino-
`gens,
`toxins, electromagnetic energy, optical
`radiation,
`X-rays, gamma rays, microwaveradiation, terahertz radia-
`tion, ultraviolet radiation, infrared radiation, radio waves,
`atomic energy alpha particles, atomic energy beta-particles,
`gravity, light intensity, light frequency, light flicker, light
`phase, ozone, carbon monoxide, carbon dioxide, nitrous
`oxide, sulfides, airborne pollution, foreign material in the air,
`viruses, bacteria, signatures from chemical weapons, wind,
`air turbulence, sound and/or acoustical energy, ultrasonic
`energy, noise pollution, human voices, animal sounds, dis-
`eases expelled from others, exhaled breath and/or breath con-
`stituents of others, toxins from others, pheromones from oth-
`ers, industrial and/or transportation sounds, allergens, animal
`hair, pollen, exhaust from engines, vapors and/or fumes, fuel,
`signatures for mineral deposits and/or oil deposits, snow,rain,
`In some embodiments of the present invention, an
`[0016]
`thermalenergy,hot surfaces, hot gases, solar energy, hail, ice,
`earpiece module that is configured to be attachedto the ear of
`vibrations, traffic, the number of people in a vicinity of the
`a person includesa first acoustical sensororiented in a direc-
`person, coughing and/or sneezing sounds from people in the
`tion towards a tympanic membraneofthe ear and is config-
`vicinity of the person,
`loudness and/or pitch from those
`ured to detect acoustical energy emanating from the tympanic
`membrane. A second acoustical sensoris oriented in a direc-
`speaking in the vicinity of the person.
`[0011]
`In some embodiments, the signal processor is con-
`tion away from the person. The signal processoris configured
`figured to process signals produced by the physiological and
`to utilize signals produced by the second acoustical signal to
`environmental sensors into signals that can be heard and/or
`extract environmental acoustical energy not emanating from
`viewedby the person wearing the apparatus. In some embodi-
`the tympanic membranefrom signals produced bythefirst
`ments, the signal processor is configuredto selectively extract
`acoustical sensor. In some embodiments, the earpiece module
`environmentaleffects from signals produced by a physiologi-
`may include an optical emitter that directs optical energy
`cal sensor and/or selectively extract physiological effects
`towards the tympanic membrane, and an optical detectorthat
`from signals produced by an environmental sensor.
`is configured to detect secondary optical energy emanating
`from the tympanic membrane. The signal processor is con-
`[0012]
`In some, embodiments of the present invention, a
`figured to extract selected optical energy from the secondary
`monitoring apparatus configured to be worn by a person
`optical energy emanating from the tympanic membrane. The
`includes a physiological sensorthat is oriented in a direction
`signal processor may also be configured to extract optical
`towards the person and an environmental sensorthatis ori-
`noise from the secondary optical energy emanating from the
`ented in a direction away from the person. A buffer materialis
`tympanic membrane. In some embodiments,
`the optical
`positioned between the physiological sensor and environ-
`detector may includeafilter configured to pass secondary
`mental sensors andis configuredto selectively reflect and/or
`optical energy at selective wavelengths.
`absorb energy emanating from the environment and/or the
`person.
`[0017]
`In some embodiments of the present invention, an
`earpiece module that is configured to be attachedto the ear of
`In some embodiments of the present invention, a
`[0013]
`a person includes an optical detector that is configured to
`monitoring apparatus may includea receiverthat is config-
`ured to receive audio and/or video information from a remote
`detect acoustically modulated blackbody IR radiation ema-
`nating from the tympanic membrane.
`terminal, and a communication module that is configured to
`store and/or process and/or play audio and/or video informa-
`[0018]
`In some embodiments of the present invention, an
`tion received from the remote terminal. In some embodi-
`earpiece module that is configured to be attachedto the ear of
`ments, the communication module maybe configuredto alert
`a person includesan optical emitterthatdirects optical energy
`(e.g., via audible and/or visible and/or physical alerts) a per-
`towards the tympanic membrane, and an optical detector
`son wearing the apparatus when a physiological sensor
`configured to detect secondary optical energy emanating
`detects certain physiological information from the person
`from the tympanic membrane. In some embodiments, the
`and/or when an environmentalsensor detects certain environ-
`signal processor maybe configured to extract selected optical
`energy and/or optical noise from the secondary optical energy
`emanating from the tympanic membrane. In some embodi-
`ments, the optical detector may includea filter configured to
`pass secondary optical energy at selective wavelengths.
`[0019]
`In some embodiments of the present invention, an
`earpiece module that is configured to be attachedto the ear of
`a person includesan ear hookthat is configured to attach to an
`ear of aperson. One or more physiological sensors and/or one
`or more environmental sensors may be supported by the ear
`
`mental information from the vicinity of the person. In some
`embodiments, the communication module is configured to
`audibly presentvital sign information to the person wearing
`the apparatus. In some embodiments, the communication
`module may be configured to store content generated by the
`person.
`In some embodiments of the present invention, a
`[0014]
`monitoring apparatus may include a transmitter that is con-
`figured to transmit signals produced by physiological and
`
`14
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`14
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`

`

`US 2014/0323829 Al
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`Oct. 30, 2014
`
`hook. In some embodiments, the hook may include a pinna
`coverthat is configured to contact a portion ofthe pinna of an
`ear. One or more physiological and/or environmental sensors
`may be supported by the pinna cover.
`
`In some embodiments of the present invention, an
`[0020]
`earpiece module mayinclude an arm that extends outwardly
`therefrom and that supports one or more physiological sen-
`sors and/or environmental sensors. For example, the arm may
`be configured to support physiological sensors configured to
`detect and/or measure jaw motion and/orarterial blood flow
`near the neck of a person wearing the earpiece module.
`
`In some embodiments of the present invention, an
`[0021]
`earpiece module may includean earpiecefitting configured to
`be inserted near or within the ear canal ofa person wearing the
`earpiece. The earpiecefitting may include one or more physi-
`ological sensors configuredto detect information from within
`the ear canal.
`
`In some embodiments of the present invention, an
`[0022]
`earpiece module mayinclude a transmittance pulse oximeter
`and/or reflectance pulse oximeter. For example, the earpiece
`module may include an earlobe clip having a transmittance
`pulse oximeter and/or reflectance pulse oximeter supported
`thereby. As another example,
`the earpiece module may
`include a transmitter pulse oximeter and/orreflectance pulse
`oximeter supported at the front or back of the ear.
`
`In some embodiments of the present invention, a
`[0023]
`monitoring apparatus is an earring. The earring may be con-
`figured to operate independently of other monitoring appara-
`tus, such as an earpiece module, or may operate in conjunc-
`tion with another monitoring apparatus. For example, an
`earring may include one or more physiological sensors con-
`figured to detect and/or measure physiological information
`from the person, and one or more environmental sensors
`configured to detect and/or measure environmental condi-
`tions in a vicinity of the person wearing the earring. The
`earring mayalso include a signal processorthat receives and
`processes signals producedby the physiological and environ-
`mental sensors, and a transmitterthat transmits physiological
`and environmental sensorsignals from the signal processor to
`a remote terminalin real-time.
`
`In some embodiments of the present invention, a
`[0024]
`monitoring apparatus configuredto be attachedto the ear of a
`person mayinclude a housing containing one or more physi-
`ological and environmental sensors wherein the housing is
`configured to be positioned in adjacent contacting relation-
`ship with the temple of the person.
`
`[0025] Monitoring apparatus, according to some embodi-
`ments of the present invention, may include various addi-
`tional devices/features. For example, a monitoring apparatus
`may include an air sampling system that samples air in a
`vicinity ofthe person wearing the apparatus. In some embodi-
`ments, one or more physiological sensors in a monitoring
`apparatus may be configured to detect drowsiness of the
`person wearing the apparatus. An alarm maybe providedthat
`is configured to alert the person in response to one or more
`physiological sensors detecting drowsiness. In some embodi-
`ments, a monitoring apparatus may include a user interface
`that provides user control over one or more ofthe physiologi-
`cal and/or environmental sensors. A user interface may be
`provided on the monitoring apparatus or may be included on
`a remote device in wireless communication with the moni-
`
`toring apparatus. In some embodiments, a monitoring appa-
`
`ratus may includea userinterface that is configured to allow
`the personto store a time mark indicating a particular point in
`time.
`
`[0026] Monitoring apparatus, according to some embodi-
`ments of the present invention, may be configured to send a
`signal to a remote terminal when one or more of the physi-
`ological and/or environmental sensorsare turned offby a user
`and/or when oneor moreofthe physiological and/or environ-
`mental sensors malfunction or fail. In some embodiments, a
`signal may be sent to a remote terminal when potentially
`erroneous data has been collected by one or more of the
`physiological and/or environmental sensors, such as when a
`person wearing a monitoring apparatus is surrounded by loud
`noises.
`
`[0027] Monitoring apparatus, according to some embodi-
`ments of the present invention, may be configured to detect
`damageto a portion of the body of the person wearing the
`apparatus, and may be configured to alert the person when
`such damage is detected. For example, when a person is
`exposed to sound abovea certain level that may be potentially
`damaging, the person is notified by the apparatus to move
`away from the noise source. As another example, the person
`maybe alerted upon damageto the tympanic membrane due
`to loud external noises.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a block diagram of a telemetric earpiece
`[0028]
`module for physiological and environmental monitoring and
`personal communication, according to some embodiments of
`the present invention.
`[0029]
`FIG. 21isablock diagram ofa telemetric network for
`health and environmental monitoring through portable tele-
`metric sensor modules, such as the earpiece module of FIG.1,
`according to some embodimentsof the present invention.
`[0030]
`FIG.3 illustrates a graphical user interface for dis-
`playing data, according to some embodimentsofthe present
`invention.
`
`FIG. 41s ablock diagram thatillustrates a method of
`[0031]
`extracting physiological and environmental
`information
`using a plurality of sensors and a signal processor, according
`to some embodiments of the present invention.
`[0032]
`FIG.5 illustrates an auscultatory signal extraction
`technique according to the methodologyillustrated in FIG.4.
`[0033]
`FIG. 6 illustrates an optical physiological signal
`extraction technique, according to some embodiments of the
`present invention, and wherein optical information scattered
`from the tympanic membrane is digitally compared with
`acoustical energy from the environment
`to generate an
`extracted signal containing cleaner physiological information
`than raw optical information scattered from the tympanic
`membrane.
`
`FIG.7 illustrates an optical source detector configu-
`[0034]
`ration, according to some embodimentsofthe present inven-
`tion, for the physiological signal extraction methodillustrated
`in FIG.6.
`
`FIG. 8 illustrates experimental auscultatory data
`[0035]
`obtained via the auscultatory signal extraction approach of
`FIG.5.
`
`FIG. 9 illustrates an earpiece module according to
`[0036]
`some embodiments of the present invention.
`[0037]
`FIG. 10 isa side view ofthe earpiece module of FIG.
`9 showing a placement ofphysiological sensors, according to
`some embodiments of the present invention.
`
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`or addition of one or more other features, integers, steps,
`operations, elements, components, and/or groups thereof. As
`used herein, the term “and/or” includes any andall combina-
`tions of one or moreof the associated listed items.
`
`FIG. 11 is a front view of the earpiece module of
`[0038]
`FIG. 9 showing a placement of environmental sensors,
`according to some embodimentsof the present invention.
`[0039]
`FIG. 12 is an exploded view of the earpiece module
`ofFIG. 9 showing a location ofvarious physiological sensors,
`according to some embodimentsof the present invention.
`[0040]
`FIG. 13 is a side view of a flexible substrate config-
`ured to place sensors in selected locationsin the vicinity ofthe
`ear, according to some embodiments ofthe presentinvention.
`[0041]
`FIGS. 14A4-14Billustrates an earpiece module with
`an adjustable mouthpiece for monitoring physiological and
`environmental
`information near the mouth, according to
`some embodiments of the present invention, wherein FIG.
`14A illustrates the mouthpiece in a stored position and
`wherein FIG. 14B illustrates the mouthpiece in an extended
`operative position.
`[0042]
`FIG. 15illustrates an earpiece module incorporating
`various physiological and environmental sensors, according
`to some embodiments of the present invention, and being
`worn by a user.
`[0043]
`FIG. 16 illustrates an earpiece module according to
`other embodiments of the present invention that includes a
`temple module for physiological and environmental monitor-
`ing.
`[0044] FIG.17 illustrates a pulse-oximeter configured to be
`attached to an ear ofa user and that may be incorporated into
`an earpiece module, according to some embodiments of the
`present invention. The illustrated pulse-oximeteris in trans-
`mission mode.
`[0045]
`FIG. 18 illustrates a pulse-oximeter configured to be
`integrated into an earpiece module, according to some
`embodiments of the present invention. Theillustrated pulse-
`oximeteris in reflection mode.
`
`DETAILED DESCRIPTION
`
`[0048] The present invention now is described more fully
`hereinafter with reference to the accompanying drawings, in
`which preferred embodiments of the invention are shown.
`This invention may, however, be embodied in manydifferent
`forms and should not be construedas limited to the embodi-
`
`ments set forth herein; rather, these embodiments are pro-
`vided so that this disclosure will be thorough and complete,
`and will fully convey the scope of the invention to those
`skilled in the art.
`
`[0051] Unless otherwise defined, all terms (including tech-
`nical and scientific terms) used herein have the same meaning
`as commonly understood by oneof ordinary skill in the art to
`which this invention belongs. It will be further understood
`that terms, such as those defined in commonly used dictio-
`naries, should be interpreted as having a meaning that is
`consistent with their meaning in the context of the specifica-
`tion and relevant art and should not be interpreted in an
`idealized or overly formal sense unless expressly so defined
`herein. Well-known functions or constructions may not be
`described in detail for brevity and/orclarity.
`is
`[0052]
`It will be understood that when an element
`referred to as being “on”, “attached” to, “connected” to,
`“coupled”with,“contacting”, etc., another element, it can be
`directly on, attached to, connected to, coupled with or con-
`tacting the other clementor intervening elements may also be
`present. In contrast, when an elementis referred to as being,
`for example, “directly on”, “directly attached”to, “directly
`connected”to, “directly coupled” with or “directly contact-
`ing” another element,
`there are no intervening elements
`present. It will also be appreciated by those of skill in theart
`that referencesto a structure or feature that is disposed “adja-
`cent” another feature may haveportionsthat overlap or under-
`lie the adjacent feature.
`[0053]
`Spatially relative terms, such as “under”, “below”,
`“lower”, “over”, “upper” and the like, may be used herein for
`ease of description to describe one element or feature’s rela-
`tionship to another element(s) or feature(s) as illustrated in
`the figures. It will be understood that the spatially relative
`[0046] FIG. 19 illustrates a sensor module havingaplural-
`
`termsare intended to encompassdifferent orientations of the
`ity of health and environmental sensors and mounted onto a
`device in use or operation in addition to the orientation
`Bluetooth headset module, according to some embodiments
`depicted in the figures. For example, if the device in the
`of the present invention.
`figures
`is
`inverted, elements described as “under” or
`“beneath” other elements or features would then be oriented
`[0047]
`FIG. 20 is a pie chart that graphically illustrates
`exemplary powerusage of an earpiece module for monitoring
`“over” the other elements or features. Thus, the exemplary
`health and environmental exposure, according to some
`term “under” can encompass both an orientation of “over”
`embodiments of the present invention.
`and “under”. The device may be otherwise oriented (rotated
`90 degrees or at other orientations) andthe spatially relative
`descriptors used herein interpreted accordingly. Similarly,the
`terms “upwardly”, “downwardly”, “vertical”, “horizontal”
`and the like are used herein for the purpose of explanation
`only unless specifically indicated otherwise.
`[0054] The term “earpiece module” includes any type of
`device that may be attached to or near the ear of a user and
`may have various configurations, without limitation.
`[0055] The term “real-time”is used to describe a process of
`sensing, processing, or transmitting information in a time
`frame which is equal to or shorter than the minimum times-
`cale at which the information is needed. For example, the
`real-time monitoring of pulse rate may result in a single
`average pulse-rate measurement every minute, averaged over
`30 seconds, because an instantaneouspulse rate is often use-
`less to the end user. Typically, averaged physiological and
`environmental information is more relevant than instanta-
`
`[0049] Like numbersrefer to like elements throughout. In
`the figures, the thickness of certain lines, layers, components,
`elements or features may be exaggerated forclarity.
`[0050] The terminology used herein is for the purpose of
`describing particular embodiments only and is not intended to
`be limiting of the invention. As used herein, the singular
`forms “a’’, “an” and “the” are intended to include the plural
`formsas well, unless the context clearly indicates otherwise.
`It will be further understood that the terms “comprises” and/
`or “comprising,” when usedin this specification, specify the
`presence of stated features, integers, steps, operations, ele-
`ments, and/or components, but do not preclude the presence
`
`neous changes. Thus, in the context of the present invention,
`signals may sometimesbe processed over several seconds, or
`even minutes, in order to generate a “real-time” response.
`[0056] The term “monitoring”refers to the act of measur-
`ing, quantifying, qualifying, estimating, sensing, calculating,
`interpolating, extrapolating, inferring, deducing, or any com-
`
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`
`bination ofthese actions. More generally, “monitoring”refers
`to a way of getting information via one or more sensing
`elements. For example, “blood health monitoring” includes
`monitoring bloodgaslevels, blood hydration, and metabolite/
`electrolyte levels.
`[0057] The term “physiological”refers to matter