(19) United States
`
`(12) Patent Application Publication (10) Pub. No.: US 2008/0154098 A1
`Morris et al.
`(43) Pub. Date: Jun. 26, 2008
`
`
`US 20080154098A1
`
`The invention relates to an earpiece form factor including
`tcclmology to monitor physiological, activity and environ-
`mental data on a user. The device includes a pulse oximeter
`unit to provide blood oxygenation level and beat-lo-beat tim-
`ing, a three-axis accelerometer to provide orientation and
`activity level, and a temperature sensor to provide a subject’s
`skin temperature. The device may also capture other forms of
`data for the user and the user’s surroundings. Captured data
`are transmitted Wirelessly to a mobile phone, PDA or other
`device that supports Wireless transmission, and enables moni-
`toring form another location.
`
`8,923,941
`
`Publication Classification
`
`(51 )
`
`Int. Cl.
`(2006.01)
`A613 5/00
`(52) U.S.Cl. ...................................................... .. 600/300
`
`(57)
`
`ABSTRACT
`
`(54)
`
`APPARATUS FOR MONITORING
`PHYSIOLOGICAL, ACTIVITY, AND
`ENVIRONMENTAL DATA
`
`(76)
`
`Inventors :
`
`Margaret NIorris, Portland, OR
`(US); Terry Dishongh, Portland,
`OR (US); Farzin Guilak,
`Beaverton, OR a}S)
`
`Correspondence Address:
`Intel Corporation
`c/0 DARBY & DARBY BC.
`PO. BOX 770, CHURCH STREET STATION
`NEW YORK, NY 10008-0770
`
`(21)
`
`Appl. No.:
`
`11/641,973
`
`(22)
`
`Filed:
`
`Dec. 20, 2006
`
`Apple Inc.
`APLl 065
`
`US. Patent No.
`
`Apple Inc.
`APL1065
`U.S. Patent No. 8,923,941
`
`I
`
`FITBIT, Ex. 1065
`
`

`

`Jun. 26, 2008 Sheet 1 0f 2
`
`Patent Application Publication
`
`US 2008/0154098 A1
`
`II
`
`FITBIT, Ex. 1065
`
`

`

`Jun. 26, 2008 Sheet 2 0f 2
`
`US 2008/0154098 A1
`
`PatentApplication Publication
`
`Eizzfgm '-
`
`Eligzgz‘c £3
`
`III
`
`FITBIT, Ex. 1065
`
`

`

`US 2008/0154098 A1
`
`Jun. 26, 2008
`
`APPARATUS FOR MONITORING
`PHYSIOLOGICAL, ACTIVITY, AND
`ENVIRONMENTAL DATA
`
`
`
`FIELD OF INVENTION
`
`[0001] The invention relates to an apparatus for monitoring
`physiological, activity and environmental data.
`
`BACKGROUND
`
`
`
`Pulse Oximetry was developed by Nellcor Incorpo—
`[0002]
`rated in 1982, and introduced into the US operating room
`market in 1983. Prior to its introduction, a patient’s oxygen-
`ation was determined by a painful arterial blood gas, a single
`point measure which typically took a minimum of 20—30
`minutes processing by a laboratory. (In the absence of oxy-
`genation, damage to the brain starts in 5 minutes with brain
`death in another 10-15 minutes). In the US alone, approxi-
`mately $2 billion was spent annually on this measurement.
`With the introduction of pulse oximetry, a non—invasive, con—
`tinuous measure ofpatient’s oxygenation was possible, revo-
`lutionizing the practice of anesthesia and greatly improving
`patient safety. Prior to its introduction, studies in anesthesia
`joumals estimated US patient mortality as a consequence of
`undetected hypoxemia at 2,000 to 10,000 deaths per year,
`with no known estimate of patient morbidity.
`[0003] By 1987, the standard ofcare for the administration
`of a general anesthetic in the US included pulse oximetry.
`From the operating room, the use of pulse oximetry rapidly
`spread throughout the hospital, first in the recovery room, and
`then into the various intensive care units. Pulse oxirnetry was
`of particular value in the neonatal unit where the patients do
`not thrive with inadequate oxygenation, but also can be
`blinded with too much oxygen. Furthermore, obtaining an
`arterial blood gas from a neonatal patient is extremely diffi-
`cult.
`In 2005 Masimo Corporation introduced the first
`[0004]
`FDA—approved pulse oximeter to monitor carbon monoxide
`levels non-invasively. Several products currently exist that
`enable patients to monitor their exertion. For example,
`NoninTM has a Bluetooth enabled pulse oximeter, that straps
`to the subject’s wrist and has a clip on one fingertip connected
`to the main unit with a cable. The cumbersome form factor of
`this unit precludes its use during daily activities that require
`unencumbered availability of the hands or fingers (for
`example, it would be very di'ficult to type while wearing the
`Nonin oximeter). Also, the lack of activity or temperature
`sensors on the Nonin limits he range of applications. The
`Army Research Laboratory has developed a sensor to monitor
`physiologic and motor activities acoustically. The sensor con-
`sists of a hydrophone (piezo transducer) in a gel—filled small
`rubber pad. This sensor enables high SNR capture of cardiac,
`respiratory, voice, and other data. It is worn using a harness
`and can be placed on the torso, neck, or head.
`[0005] However, these products are limited in their use and
`cumbersome. These factors preclude use during daily activi—
`ties that require, for example, unencumbered availability of
`the hands or fingers (which would prevent, for example, typ-
`ing) and the range of applications is limited.
`
`FIG. 1. illustrates an exemplary high-level architec-
`[0007]
`ture in accordance with the invention.
`[0008]
`FIG. 2.
`illustrates an exemplary earpiece circuit
`board in accordance with the invention.
`[0009]
`FIG. 3. illustrates the exemplary earpiece of FIG. 2.
`with a custom enclosure.
`
`DETAILED DESCRIPTION
`
`[0010] A pulse oximeter is a medical device that indirectly
`measures the amount 0 oxygen in a patient’s blood and
`changes inblood volume in the skin, a photoplethysmograph.
`It is often attached to a medical monitor so staff can see a
`patient’s oxygenation at all times. Most monitors also display
`the heart rate.
`[0011] A blood-oxygen monitor displays the percentage of
`arterial hemoglobin in the oxyhemoglobin configuration.
`Acceptable normal ranges are from 95 to 100 percent. For a
`patient breathing room air, at not far above sea level, an
`estimate of arterial p02 can be made from the blood-oxygen
`monitor SpO2 reading.
`[0012]
`A pulse oximeter is a particularly convenient non-
`invasive measurement instrument. Typically it has a pair of
`small light-emitting diodes facing a photodiode through a
`translucent part ofthe patient’s body, usually a fingertip or an
`earlobe. One LED is red, with wavelength of 660 nm, and the
`other is infrared, 910 nm. Absorption at these wavelengths
`differs significantly between oxyhemoglobin and its deoxy—
`genated form, therefore from the ratio of the absorption of the
`red and infrared light the oxy/deoxyhemoglobin ratio can be
`calculated.
`
`[0013] The monitored signal bounces in time with the heart
`beat because the arterial blood vessels expand and contract
`with each heartbeat. By examining only the varying part of
`the absorption spectrum (essentially, subtracting minimum
`absorption from peak absorption), a monitor can ignore other
`tissues or nail polish and discern only the absorption caused
`by arterial blood. Thus, detecting a pulse is essential to the
`operation of a pulse oximeter and it will not function if there
`is none.
`
`[0014] Because oftheir simplicity and speed (they clip onto
`a finger and display results within a few seconds), pulse
`oximeters are of critical importance in emergency medicine
`and are also very useful for patients with respiratory or car-
`diac problems, as well as pilots operating in a non—pressurized
`aircraft above 10,000 feet (12,500 feet in the US), where
`supplemental oxygen is required. Prior to the oximeter’s
`invention, many complicated blood tests needed to be per-
`formed.
`
`[0015] The pulse oximeters could use digital signal pro-
`ces sing to make accurate measurements in clinical conditions
`that were otherwise impossible. These could include situa-
`tions of patient motion, low perfusion, bright ambient light,
`and electrical interference. Because of their insensitivity to
`non—pulsate signals, it is also possible to build reflectance
`probes that place the photodiode beside the LEDs and can be
`placed on any llat tissue. These can be used on non-translu-
`cent body parts, to measure pulses in specific body parts
`(useful in plastic surgery), or when more convenient sites are
`unavailable (severe burn victims). They could be applied to
`the forehead of patients with poor peripheral perfusion.
`[0016] Oximetry is not a complete measure of respiratory
`sufficiency. A patient suffering from hypoventilation (poor
`gas exchange in the lungs) given 100% oxygen can have
`
`
`
`
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0006] The invention is described below in more detail with
`reference to the exemplary embodiments and drawings, in
`which:
`
`FITBIT, Ex. 1065
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`

`

`US 2008/0154098 A1
`
`Jun. 26, 2008
`
`preceded by activity (as measured by the accelerometer) is
`
`sent from the sensor to the mobile device using Bluetooth
`teclmology. The sensor is an earpiece worn by the user. The
`data transmitted over the network is monitored at least one of
`the home server, workstation and storage server.
`[0024] A method of transmitting data acquired by a sensor
`worn by a user over a network, comprising acquiring data
`from the sensor using at least one of an oximeter unit, accel—
`erometer and temperature sensor located in the sensor; send-
`ing the data from the sensor to a mobile device ofthe user; and
`transmitting the data sent to the mobile device over the net-
`work. The network comprises a home server, a workstation
`and a storage server. The acquired data is sent from the sensor
`to the mobile device using Bluetooth technology. The sensor
`is an earpiece worn by the user. The data transmitted over the
`network is monitored at least one of the home server, work-
`station and storage server.
`[0025] The invention includes an earpiece form factor,
`similar to a “behind-the-ear” hearing aid or BluetoothTM tele-
`phone headset, including technologies to monitor physiologi-
`cal, activity, and environmental data on a user. The invention,
`in one embodiment, includes a pulse oximeter unit (providing
`blood oxygenation level and heart rate), a three—axis acceler—
`ometer (providing activity level), and temperature sensor
`(providing subj ect’s skin temperature). Other embodiments
`include technologies to capture other types of data from the
`body and its surroundings. Captured data are transmitted
`wirelessly to a cell phone, PDA. or other device that supports
`wireless radio and protocol implemented in the earpiece (for
`example, Bluetooth, Zigbee, or a proprietary system). This
`unit serves to process data and transmit it to servers for
`storage and/or further processing. It also provides for feed—
`back and actuation to the user.
`[0026]
`In another embodiment of the present invention,
`pulse oxirnetry is unplugged and embedded into a wireless
`earpiece of a mobile phone. Immediate feedback appears on
`the phone screen regarding exertion levels (including wam-
`ings to slow down) or a longitudinal view which plots cardio—
`vascular stress against activity level.
`[0027] Currently, there is no technology that allows moni—
`toring physiological, activity, and enviromnental data in a
`small, wearable, wireless fonn factor. The combination of
`these parameters allows for functionality not possible with
`current units that typically monitor a single parameter.
`[0028]
`FIG. 1 illustrates a high-level architecture of an
`embodiment
`in the invention. The depicted architecture
`includes subject-worn devices, such as an earpiece and
`mobile phone, a home server, a researcher workstation, a
`clinician workstation, and a server, each of which may be
`connected via a network, such as the Internet. As the descrip—
`tionbelow indicates, the earpiece is capable ofmonitoring the
`user to record physiological, activity and enviromnental
`information, and transmit or send such information to a
`mobile device worn by the user, for example Via Bluetooth
`teclmology. This information may be displayed on the user
`mobile device (e.g. cell phone) and/or transmitted via the
`network to a user’s home computer, a researcher workstation
`(such as a doctor’s office) or a server for storage.
`[0029]
`FIGS. 2 and 3 illustrate an earpiece circuit board and
`the custom enclosure of the earpiece, respectively. These
`illustrations are exemplary of the type of device that may be
`worn by the user.
`[0030]
`In one embodiment, this device allows monitoring
`the subject’s stress level: an increase in heart rate that is not
`
`excellent blood oxygen levels while still suffering from res-
`piratory acidosis due to excessive carbon dioxide.
`[0017] Nor is it a complete measure of circulatory sulfi—
`ciency. Ifthere is insufficient bloodflow or insufficient hemo-
`globin in the blood (anemia), tissues can stiffer hypoxia
`despite high oxygen saturation in the blood that does arrive.
`[0018]
`It also should be noted that two-wavelength satura-
`tion level measurement devices can not distinguish carboxy—
`hemoglobin due to carbon monoxide inhalation from oxyhe-
`moblobin, which must be taken into account when diagnosing
`a patient in emergency rescue from, e.g., a fire in an apart-
`ment. A CO—oximeter measures absorption at additional
`wavelengths to distinguish CO from O2 and determine the
`blood oxygen saturation more reliably.
`[0019] Heart failure and other cardiac patients need to
`monitor their exertion. Exercise and other stimulation offer
`important benefit but are often avoided because they pose
`serious risks. Real time feedback would allow people to
`monitor and modulate exertion, and the ability to safely and
`confidently pursue activities with preventive value.
`[0020] The embodiments of the invention include devices
`that include consciousness monitors for anesthesia/sedation,
`which works by using a sensor that is placed on the patient’s
`forehead to measure electrical activity in the brain and trans-
`late it into a number between 100 (wide awake) and zero
`(absence of brain electrical activity). Another such example
`consists of an armband that monitors caloric expenditure and
`communicates to a web site for users/trainers. \Vireless trans-
`ceivers can communicate with a variety of third—party moni—
`tors. Transceiver data is sent to a wireless gateway or arm—
`band, and from there to a call center via Internet.
`[0021] A sensor device worn on a user to monitor physi-
`ological, activity and environmental data of the user, corri-
`prising an oximeter unit to measure oxygenation level and
`heart rate; an accelerometer to measure activity level; and a
`temperature sensor to measure a temperature level. The sen-
`sor device communicates with the mobile device using Blue-
`tooth technology. The sensor device is one of an earpiece,
`hearing aid or telephone headset. The sensor device commu-
`nicates to the phone via a Body Area Network (BAN)7a
`short-range wireless network to transmit monitored data. The
`cell phone securely transmits the data is through the Internet
`over a Wide Area Network (\VAN for storage on a back-end
`server. From there it can be accessed by home users, research-
`ers, clinicians, etc. through an authenticated, secure connec—
`tion.
`
`[0022] A method ofmonitoring physiological, activity, and
`environmental data of a user wearing a sensor device, corri-
`prising measuring oxygenation level and heart rate with an
`oximeter unit; measuring activity level with an accelerom-
`eter; and measuring a temperature level with a temperature
`sensor. The sensor device communicates with the mobile
`device using Bluetooth technology. The sensor device is one
`of an earpiece, hearing aid or telephone headset. The sensor
`device communicates via a network to transmit monitored
`data. The transmitted data is sent to one of a home computer,
`researcher workstation and storage server.
`[0023] A system to transmit data acquired by a sensor worn
`by a user, comprising a sensor to acquire using at least one of
`an oximeter unit, accelerometer and temperature sensor
`located in the sensor; a mobile device receiving the data from
`the sensor of the user; and a network to receive the data
`transmitted from the mobile device to at least one of a home
`server, workstation and storage server. The acquired data is
`
`FITBIT, Ex. 1065
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`

`

`US 2008/0154098 A1
`
`Jun. 26, 2008
`
`likely to be caused by increased stress. Similarly, an increase
`in skin temperature following activity may be a normal physi—
`ological response, but without activity may indicate illness.
`Features present on the cell phone device allow for audio,
`visual, and tactile feedback to the subject. The presence of a
`microphone enables capturing voice signals for analysis:
`there is research indicating that early detection and progres-
`sion of certain neurological diseases is possible through voice
`analysis. The presence of an earpiece allows for audio cueing
`and prompting to be provided to the subject. Audio cues are an
`active area of research in falls, which may assist prevention
`for in patients with certain neurological conditions. Audio
`reminders may be an effective means to remind subjects to
`perform necessary activities (like taking medication). Also,
`the compact form factor will allow researchers to gather data
`that may difficult to obtain otherwise. The earpiece is worn
`primarily for phone communication but also affords continu-
`ous, ecologically sensitive health monitoring. The earpiece is
`not stigmatizing and may appeal to people who are concerned
`about health and wellness, but do not want to almounce these
`concerns publicly.
`[0031] The invention provides integration ofphysiological,
`activity, and environmental monitors in a commonly-used
`form factor, which also is capable of providing real-time
`feedback to the wearer. This is particularly true because the
`point of sensor fusion and feedback is a single integrated unit.
`Essentially, the invention provides integration of the devices
`into a commonly used wearable platform to obtain pulse
`oximetry, heart rate, and temperature from one device to
`monitor for conditions such as: medication adherence, glyce-
`mic shock, and heart rate variability. The device may also
`combine sensors capable of tracking head motion with blood
`oxygen level as a leading indicator for preventing the occur-
`rence of falls. Additionally, the device may provide on-body
`feedback in response to monitored physiological signals.
`These can be used to affect changes in wearer’s behavior to
`benefit their health. An ear-wom device with motion sensors
`can also be used as a pedometer. Combining it with heart rate
`gives an indication of the effectiveness of physical activity,
`Adding a cell phone gives the ability to do location tracking to
`map measured distance traveled to caloric expenditure. The
`cell phone also allows us to capture, store, forward, and
`analyze data from the wearer.
`[0032]
`Physiological: Human physiology is the science of
`the mechanical, physical, and biochemical functions of nor-
`mal humans or human tissues or organs. The principal level of
`focus ofphysiology is at the level oforgans and systems. Most
`aspects of human physiology are closely homologous to cor—
`responding aspects of animal physiology, and animal experi-
`mentation has provided much of the foundation of physi-
`ological knowledge. Human physiology is one of the basic
`sciences ofmedical study, and as such is mo st often applied as
`medical care.
`
`tored data.
`
`arterial blood alone, factoring out venous blood, skin, bonc,
`muscle, fat, and even fingernail polish. Based upon the ratio
`of changing absorbances of the red and infrared light caused
`by the difference in color between oxygen-bound (bright red)
`and unbound (dark red or in severe cases blue) hemoglobin in
`the blood, a measure of oxygenation (the percent of hemo—
`globin molecules bound with oxygen molecules) can be
`made.
`[0035] Accelerometer: An accelerometer is a device for
`measuring acceleration. An accelerometer inherently mea-
`sures its own motion (locomotion), in contrast to a device
`based on remote sensing. One application for accelerometers
`is to measure gravity, wherein an accelerometer is specifically
`configured for use in gravirnetry. Such a device is called a
`gravimeter. Accelerometers are used along with gyroscopes
`in inertial guidance systems, as well as in many other scien-
`tific and engineering systems. One of the most connnon uses
`for micro electro-mechanical system (MEMS) accelerom-
`eters is in airbag deployment systems for modern automo-
`biles. In this case the accelerometers are used to detect the
`rapid negative acceleration of the vehicle to determine when
`a collision has occurred and the severity of the collision. An
`accelerometer is an instrument for measuring acceleration,
`detecting and measuring vibrations, or for measuring accel-
`eration due to gravity (inclination). Accelerometers can be
`used to measure vibration on vehicles, machines, buildings,
`process control systems and safety installations. They can
`also be used to measure seismic activity, inclination, machine
`vibration, dynamic distance and speed with or without the
`influence of gravity. Accelerometers are perhaps the simplest
`MEMS device possible, sometimes consisting of little more
`than a suspended cantilever beam or proof mass (also known
`as seismic mass) with some type of deflection sensing and
`circuitry. MEMS Accelerometers are available in a wide vari-
`ety of ranges up to thousands of gn’s. Single axis, dual axis,
`and three axis models are available.
`
`It is readily understood by the skilled artisan that the
`[003 6]
`embodiments disclosed herein are merely exemplary and are
`not intended to limit the scope of the invention.
`
`1. A sensor device worn on a user to monitor physiological,
`activity and environmental data of the user, comprising:
`an oximeter unit to measure oxygenation level and/or beat-
`to -beat timing;
`an accelerometer to detect orientation and to measure
`activity level;
`and a temperature sensor to measure a temperature level
`wherein the oximeter unit, the accelerometer and the tem-
`perature sensor are integrally combined within a single
`unit of the sensor device so as to allow simultaneous
`functionality of the oximeter unit, the three—axis accel—
`erometer and the temperature sensor.
`2. The sensor device according to claim 1, wherein the
`sensor device communicates wirelessly with a mobile device.
`3. The sensor device according to claim 2, wherein the
`sensor device communicates wirelessly with the mobile
`device.
`
`4. The sensor device according to claim 1, wherein the
`sensor device is one of an earpiece, hearing aid or telephone
`headset.
`
`5. The sensor device according to claim 1, wherein the
`sensor device communicates via a network to transmit moni-
`
`[0033] Environmental: Environmental physiology is a bio-
`logical discipline which studies the adaptation of organism’s
`physiology to environmental conditions.
`[0034] Oximetry: Pulse oximetry is a non—invasive method
`which allows health care providers to monitor the oxygen-
`ation of a patient’s blood. A sensor is placed on a relatively
`thin part of the patient’s anatomy, usually a fingertip or ear-
`lobe, or in the case of a neonate, across a foot, and red and
`infrared light is passed from one side to the other. Changing
`absorbance of each of the two wavelengths is measured,
`allowing determination of the ab sorbances due to the pulsing
`
`FITBIT, Ex. 1065
`
`

`

`
`
`
`
`functionality of the oximeter unit. the three-axis accel-
`erometer and the temperature sensor.
`14. The system of claim 13, wherein the acquired data is
`sent wirelessly from the sensor to the mobile device.
`15. The system of claim 13, wherein the sensor is an ear-
`piece worn by the user.
`16. The system of claim 13, wherein data transmitted over
`the network is monitored by at least one of the home server,
`clinician workstation, researcher workstation and storage
`server.
`
`17. A method of transmitting data acquired by a sensor
`worn by a user over a wireless network, comprising:
`acquiring data from the sensor using at least one of an
`oximeter unit, accelerometer and temperature sensor
`located in the sensor;
`sending the data from the sensor to a mobile device ofthe
`user; and
`transmitting the data sent to the mobile device over the
`network
`wherein the oximeter Imit, the accelerometer and the teln-
`perature sensor are integrally combined within a single
`unit of the sensor device so as to allow simultaneous
`functionality of the oximeter unit, the three-axis accel-
`erometer and the temperature sensor.
`18. The method of claim 17, wherein the network com—
`prises a home server, a workstation and a storage server.
`19. The method of claim 17, wherein the acquired data is
`sent from the sensor to the mobile device.
`
`20. The method of claim 17, wherein the sensor is an
`earpiece worn by the user.
`21. The method of claim 18, wherein data transmitted over
`the network is monitored at least one of the home server,
`workstation and storage server.
`22. The sensor device of claim 1, wherein the device has a
`wearable, wireless form factor.
`*
`>I<
`=l<
`
`*
`
`US 2008/0154098 A1
`
`Jun. 26, 2008
`
`6. The sensor device according to claim 5, wherein the
`transmitted data is sent to one ofa home computer, researcher
`workstation, clinician workstation, and storage server.
`7. A method ofmonitoring physiological, activity and envi-
`ronmental data of a user wearing a sensor device, comprising:
`measuring oxygenation level and/or beat—to—beat timing
`with an oximeter unit;
`measuring activity level with an accelerometer; and
`measuring a temperature level with a temperature sensor
`wherein the oximeter unit the accelerometer and the tem-
`perature sensor are integrally combined within a single
`unit of the sensor device so as to allow simultaneous
`functionality of the oximeter unit, the three-axis accel-
`erometer and the temperature sensor.
`8. The method according to claim 1, wherein the sensor
`device communicates wirelessly with a mobile device.
`9. The method according to claim 8, wherein the sensor
`device communicates wirelessly with the mobile device,
`10. The method according to claim 7, wherein the sensor
`device is one ofan earpiece, hearing aid or telephone headset.
`11. The method according to claim 7, wherein the sensor
`device communicates via a network to transmit monitored
`data.
`12. The method according to claim 11, wherein the trans—
`mitted data is sent to one of a home computer, clinician
`workstation, researcher workstation and storage server.
`13 , A system to transmit data acquired by a sensor wom by
`a user, comprising:
`a sensor to acquire using at least one of an oximeter unit,
`accelerometer and temperature sensor located in the sen-
`sor;
`a mobile device receiving the data from the sensor of the
`user; and
`a network to receive the data transmitted from the mobile
`device to at least one of a home server, clinician work-
`station, researcher workstation and storage server
`wherein the oximeter unit, the accelerometer and the tem-
`perature sensor are integrally combined within a single
`unit of the sensor device so as to allow simultaneous
`
`*
`
`FITBIT, Ex. 1065
`
`