as) United States
`a2) Patent Application Publication co) Pub. No.: US 2005/0059870 Al
`Mar.17, 2005
`Aceti
`(43) Pub. Date:
`
`US 20050059870A1
`
`(54) PROCESSING METHODS AND APPARATUS
`FOR MONITORING PHYSIOLOGICAL
`PARAMETERS USING PHYSIOLOGICAL
`CHARACTERISTICS PRESENT WITHIN AN
`AUDITORY CANAL
`
`(76)
`
`Inventor:
`
`John Gregory Aceti, West Windsor, NJ
`(US)
`
`Correspondence Address:
`RATNERPRESTIA
`P.O. BOX 980
`VALLEY FORGE, PA 19482-0980 (US)
`
`(21) Appl. No.:
`
`—-10/925,765
`
`(22)
`
`Filed:
`
`Aug. 25, 2004
`
`Related U.S, Application Data
`
`(60)
`
`Provisional application No. 60/497,890, filed on Aug.
`25, 2003.
`
`Publication Classification
`
`Tait? accsssscssensnccssessscaccistn, A61B 5/00; A61B 5/11;
`A61B 10/00
`tet 600/340; 600/595; 600/549;
`600/551; 128/903
`
`ABSTRACT
`
`(51)
`
`(52)
`
`G7)
`
`Methods and apparatus for monitoring at least one physi-
`ological parameter of an animal from one or more physi-
`ological characteristics present within an auditory canal of
`the animal. Physiological parameters are measured by sens-
`ing at least one physiological characteristic present within
`the auditory canal of the animal, the at least one physiologi-
`cal characteristic associated with a physiological parameter,
`and processing the at least one sensed physiological char-
`acteristic at a device positioned remotely from the auditory
`canal to determine the physiological parameter.
`
`MN
`
`804
`
`CENTRAL
`PROCESSOR
`
`800b
`
`100
`
`
`
`DEVICE 800c
`
`802c
`
`REMOTE
`
`001
`
`Apple Inc.
`APL1031
`U.S. Patent No. 8,923,941
`FITBIT, Ex. 1031
`
`Apple Inc.
`APL1031
`U.S. Patent No. 8,923,941
`
`001
`
`FITBIT, Ex. 1031
`
`

`

`Patent Application Publication Mar. 17,2005 Sheet 1 of 7
`
`US 2005/0059870 Al
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`

`

`Patent Application Publication Mar. 17,2005 Sheet 2 of 7
`
`US 2005/0059870 Al
`
`302
`
`660nm LED
`
`805nm LED
`
`PHOTO DIODE
`
`318
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`314 320
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`304
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`SOURCE
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`CURRENT
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`alo
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`IMPEDENCE
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`= DETECTOR
`
`
`ACCELEROMETER
`
`SIGNAL PROCESSOR
`
`344
`
`MICROPHONE
`
`SIGNAL PROCESSOR
`
`346
`
`SPEAKER
`
`VOICE ROM
`
`308
`
`312
`
`310|CE 326
`
`
`316
`
`POWER REGULATOR
`
`
`
`MEMORY
`
`394
`
`322
`
`FIG. 3
`
`003
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`

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`Patent Application Publication Mar. 17,2005 Sheet 3 of 7
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`Patent Application Publication Mar. 17,2005 Sheet 4 of 7
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`US 2005/0059870 Al
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`Patent Application Publication Mar. 17,2005 Sheet 5 of 7
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`US 2005/0059870 Al
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`Patent Application Publication Mar. 17,2005 Sheet 6 of 7
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`Patent Application Publication Mar. 17,2005 Sheet 7 of 7
`
`US 2005/0059870 Al
`
`NNV
`
`802b
`
`NN
`
`804
`
`CENTRAL
`
`PROCESSOR
`
`REMOTE
`DEVICE
`
`800a
`
`800b
`
`MN
`LO
`
`100 FIG. 8
`
`PASS PHYSIOLOGICAL CHARACTERISTIC(S) TO PROCESSING DEVICE POSITIONED
`BETWEEN AURICLE OF THE EAR AND THE HEAD OF THE ANIMAL.
`
`904
`
`PROCESS PHYSIOLOGICAL CHARACTERISTIC(S) AT PROCESSING DEVICE
`POSITIONED BETWEEN AURICLE OF THE EAR AND THE HEAD OF
`
`
`
`THE ANIMAL TO DETERMINE PHYSIOLOGICAL PARAMETER(S).
`
`906
`
`GENERATE EMERGENCYALERT.
`
`
`
`SENSE PHYSIOLOGICAL CHARACTERISTIC(S) PRESENT
`902
`WITHIN AUDITORY CANALOF AN EAR OF AN ANIMAL.
`
`
`
`
`
`
`FIG. 9
`
`STORE PHYSIOLOGICAL CHARACTERISTIC(S)
`AND/OR PHYSIOLOGICAL PARAMETER(S).
`
`
`
`
`
`
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`

`US 2005/0059870 Al
`
`Mar. 17, 2005
`
`PROCESSING METHODS AND APPARATUS FOR
`MONITORING PHYSIOLOGICAL PARAMETERS
`USING PHYSIOLOGICAL CHARACTERISTICS
`PRESENT WITHIN AN AUDITORY CANAL
`
`CROSS REFERENCE TO RELATED
`APPLICATION
`
`(0001] This application claims the benefit of U.S. Provi-
`sional Application No. 60/497,890, filed Aug. 25, 2003, the
`contents of which are incorporated herein by reference.
`
`FIELD OF THE INVENTION
`
`{0002] The present invention relates to methods and appa-
`ratus for monitoring physiological parameters and, more
`particularly, to processing methods and apparatus for moni-
`toring physiological parameters using physiological charac-
`teristics present within an auditory canal of an animal.
`BACKGROUNDOF THE INVENTION
`
`elements, the small letter designation may be dropped. This
`emphasizes that, according to commonpractice, the various
`features of the drawings are not drawn to scale. On the
`contrary,
`the dimensions of the various features are arbi-
`trarily expanded or reduced for clarity.
`Included in the
`drawings are the following figures:
`[0007] FIG. 1 depicts a partially exploded view of an
`exemplary monitoring device in accordance with the present
`invention;
`
`FIG.2 depicts the exemplary monitoring device of
`[0008]
`FIG. 1 positioned on the head of an animal;
`
`[0009] FIG. 3 is a block diagram of exemplary compo-
`nents within the exemplary monitoring device in accordance
`with the present invention;
`
`FIG.4 is a cross-sectional view of a section of a
`[0010]
`conductor portion of the monitoring device configured for
`positioning within the auditory canal in accordance with the
`present invention;
`
`{0003] Physiological parameters are routinely monitored
`in a wide range of medical applications. Instruments for use
`in the auditory canal to measure physiological parameters
`have been developed. See,
`for example, U.S. Pat. No.
`6,283,915 to Aceti et al,, entitled DISPOSABLE IN-THE-
`EAR MONITORING INSTRUMENT AND METHOD OF
`MANUFACTURER. These instruments incorporate minia-
`turized components for monitoring physiological parameters
`along with a small battery into a package that is configured
`for placement within the ear. Such instruments provide an
`unobtrusive way to monitor physiological parameters. Min-
`[0014] FIG.8is a block diagram of a monitoring system
`iaturized components, however, are typically more expen-
`in accordance with the present invention; and
`sive than larger component, and small batteries tend to have
`relatively short life spans.
`
`FIG. 5 is an illustration of a sheath for covering at
`[0011]
`least a portion of a monitoring device in accordance with the
`present invention;
`
`[0012] FIG. 6 is an illustration of a sheath partially
`positioned to cover a portion of the monitoring device in
`accordance with the present invention;
`
`FIG.7 is an illustration of a sheath fully positioned
`[0013]
`to cover a portion of the monitoring device in accordance
`with the present invention;
`
`flow chart of exemplary steps for
`[0015] FIG. 9 is a
`determining physiological parameters in accordance with
`the present invention.
`
`{0004] There is an ever-present desire for less expensive
`medical
`instruments having longer battery life
`spans.
`Accordingly, improved methods and apparatus are needed
`for monitoring physiological parameters that are not subject
`to the abovelimitations. The present invention addressesthis
`need among others.
`
`SUMMARY OF THE INVENTION
`
`{0005] The present invention is embodied in methods and
`apparatus for monitoring al least one physiological param-
`eter of an animal from one or more physiological charac-
`lerislics present within an auditory canal of the animal.
`Physiological parameters are measured by sensing al least
`one physiological characteristic present within the auditory
`canal of the animal, the at least one physiological charac-
`teristic associated with a physiological parameter, and pro-
`cessing the sensed physiological characteristic at a device
`positioned remotely from the auditory canal to determine the
`physiological parameter.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`[0016] FIG. 1 and FIG. 2 are useful for providing a
`general overview of the present invention. FIG. 1 depicts an
`exemplary monitoring device 100 in accordance with the
`present
`invention. The monitoring device 100 includes a
`processor portion L102 and a conductor portion 104. In an
`exemplary embodiment,
`the conductor portion 104 is
`removably coupled to the processor portion 102 and is
`considered disposable.
`
`[0017] The illustrated processor portion 102 includes a
`housing 106 with a cover 108 removed therefrom to expose
`electrical and/or electronic components 110 contained
`therein. Additionally, electrical and/or electronic compo-
`nents 110 may be found within the conductor portion 104.
`The conductor portion 104 includes a first end 112 config-
`uredfor insertion at least partially within the auditory canal
`of an animal and a second end 114 coupled to the processor
`portion 102.
`
`{0006] The invention is best understood from the follow-
`ing detailed description when read in connection with the
`accompanying drawings,with like elements having the same
`[0018]
`In use, the first end 112 of the conductor portion is
`
`reference numerals. Whenaplurality of similar elements are positioned at least partially within the auditory canal of the
`present, a single reference numeral may be assigned to the
`animal to detect one or more physiological characteristics
`plurality of similar elements with a small letter designation
`and pass the detected physiological characteristics through
`referring to specific elements. When referring to the ele-
`the conductor portion 104 from the first end 112 to the
`ments collectively or to a non-specific one or more of the
`second end 114 for processing by the processor portion 102
`
`009
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`US 2005/0059870 Al
`
`Mar. 17, 2005
`
`to determine at least one physiological parameter. The one or
`more physiological characteristics are associated with the at
`least one physiological parameter and include, by way of
`non-limiting example,
`temperature,
`light
`intensity, and
`sound. The associated physiological parameters include, by
`way of non-limiting example, temperature, pulse, blood-
`oxygen content, and respiration rate. For example,
`the
`intensity of light transmitted through tissue of an auditory
`canal wall may be used in accordance with known pulse-
`oximetry techniques to determine pulse rate and blood-
`oxygen content. In addition, sounds within the auditory
`canal may be used to determine pulse and/or respiration rate.
`One or more physiological characteristics such as tempera-
`ture may be considered both a physiological characteristic
`and a physiological parameter, Other suitable physiological
`characteristics and parameters will be understood by those
`of skill in the art from the description herein.
`
`(0019] FIG. 2 depicts the exemplary monitoring device
`100 positioned relative to an ear 202 on the head 204 of an
`animal, The ear 202 includes an auricle 206 and an auditory
`canal 208 adjacent the auricle 206. In an exemplary embodi-
`ment, the processor portion 102 of the monitoring device
`100 is positioned at least partially between the auricle 206
`and the head 204 of the animal and thefirst end 112 of the
`conductor portion 104 is positionedatleast partially within
`the auditory canal 208. In an alternative exemplary embodi-
`ment,
`the processor portion 102 may be positioned in
`essentially any location remote to the auditory canal. The
`animal may be a human being, a domestic animal such as a
`cow, horse, dog, or cat, a wild animal such as a lion or
`elephant, or essentially any animal having an ear with an
`auditory canal.
`
`{0020] The present invention is now described in detail.
`FIG. 3 depicts exemplary electrical and/or electronic com-
`ponents 110 (referred to herein as components 110) that may
`be located within the monitoring device 100 (FIG. 1). The
`illustrated components 110, which are described below with
`reference to FIGS, 1 and 2, include a presentation device
`312 (e.g., a speaker 350 and, optionally, a voice read only
`memory (ROM) 352), a memory 316, an internal clock 318,
`a transceiver 320 (or, optionally, a transmitter only), data
`input circuitry 322, data output circuitry 324, and one or
`more sensors (i.¢., five in the illustrated embodiment). The
`illustrated sensors include a pulse oximetry sensor 302, an
`electrocardiogram sensor 304, an accelerometer 306, a
`microphone 308, and a thermister 320, each of which will be
`described in further detail below.
`
`{0021] A processor 314 is configured to process signals
`from the sensors, present information (e.g., via the presen-
`tation device 312), and communicate information (¢.g., via
`the data input/output circuitry 322/324 and the transceiver
`320). Further,
`the processor 314 is configured to store
`information to the memory 316 and retrieve the information
`from the memory 316. The internal clock 318 provides the
`processor with real time and/or interval readings for use in
`processing the information from the sensors. A power regu-
`lator 326 is optionally included to regulate power to the
`electrical and/or electronic components 110. A suitable
`processor 314, memory 316, internal clock 318, transceiver
`320, data input circuitry 322, data output circuitry 324, and
`power regulator 326 will be understood by those of skill in
`the art from the description herein.
`
`[0022] One or more of the sensors may reside in the
`conductor portion 104 near the first end 112 to sense
`physiological characteristics within the auditory canal. In
`this embodiment, the sensors sense the physiological char-
`acteristics and generate electrical signals that are passed
`through the conductor portion to the processor 314 in the
`processor portion 102, ¢.g., via an electrically conductive
`wire (referred to here as a wire). Alternatively, one or more
`of the sensors may be positioned within the processor
`portion 102 with physiological characteristics within the
`auditory canal being passed through the conductor portion
`104, e.g., via acoustic tubes, fiber optic cables, or wires, as
`described in further detail below,
`
`[0023] Acoustic tubes communicate aural signals through
`the conductor portion 104 between the auditory canal and
`the processor portion 102. Acoustic tubes may be used to
`transfer sounds from the auditory canal, such as those due to
`respiration, to the processor portion 102 and/or to transfer
`aural messages from a speaker 350 in the processor portion
`102 to the auditory canal. Those of skill in the art of hearing
`aids have developed various tube configurations for deliv-
`ering sound to the auditory canal. Such tubes can also be
`used for receiving sounds from the auditory canal.
`
`[6024] Fiber optic cables communicate photonic signals
`through the conductor portion 104 between the auditory
`canal and the processor portion 102. Fiber optic cables may
`be used to transfer one or more wavelengths oflight gen-
`erated in the processor portion 102 to the auditory canal and
`to transfer one or more wavelengths oflight in the auditory
`canal (e.g., emanating from the auditory canal wall tissue) to
`the processor portion 102.
`
`signals
`electric/electronic
`communicate
`[0025] Wires
`through the conductor portion 104 between the auditory
`canal and the processor portion 102. Wires may be used to
`transfer clectric/electronic signals generatedin the processor
`portion 102 to the auditory canal or a sensor within the
`conductor portion 104 positioned in the auditory canal and
`to transfer electric/clectronic signals in the auditory canal
`(e.g., emanating from the auditory canal wall tissue or a
`sensor within the conductor portion 104 positioned in the
`auditory canal) to the processor portion 102. The wires may
`terminate with electrodes suitable for contact with auditory
`canal wall tissue. In an exemplary embodiment, the elec-
`trodes are mounted in an ear mold, which is described in
`further detail below.
`
`In an exemplary embodiment, the conductor por-
`[0026]
`tion 104 and the wires, acoustic tubes, and/or fiber optic
`cables extending through the conductor portion 104 are
`flexible and/or moldable. This enables sensors within the
`conductor portion 104 to be at least partially mechanically
`separated from the processing portion 102 to prevent/reduce
`the transfer of motion of the processing device 102 to the
`sensors within the conductor portion 104, which could cause
`erroneous signals.
`In addition, this enables the conductor
`portion 104 to conform to the shape of the auditory canal,
`thereby improving comfort.
`
`[0027] The sensors are now described in detail. The illus-
`trated pulse oximetry sensor 302 includes a
`first
`light
`emitting diode 330, a second light emitting diode 332, a
`photo detector diode 334, and pulse oximetry circuitry 336.
`For pulse oximetry, light from the first and second diodes
`330 and 332 are introduced to the tissue lining the auditory
`
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`
`canal wallin the vicinity ofthe first end 112 of the conductor
`portion 104. The photo detector diode 334 detects light (i.-e.,
`a physiological characteristic) that passes through the tissue
`that was introduced by the light emitting diodes 330 and
`332. The pulse oximetry circuitry 336 monitors the pulses of
`light
`introduced by the LEDs 330 and 332 and the light
`received al the photo detector diode 334 to determine pulse
`rate and/or blood oxygenation levels (i.c., physiological
`parameters). In an exemplary embodiment, the pulse oxim-
`etry circuitry 336 may be positioned within the processor
`portion 102 and is connected via wires to the LEDs 330/332
`and the photo diode 334, which are positioned within the
`first end 112 of the conductor portion 104. In an alternative
`exemplary embodiment,the LEDs 330/332 and/or the photo
`detector diode 334 may be positioned within the processor
`portion 102 with light from the LEDs 330 and 332 and/or
`light detected by the photo diode 334 being passed therebe-
`tween via fiber optic cables extending through the conductor
`portion 104. The pulse oximetry circuitry 336 communicates
`pulse oximetry information to the processor 314 for pro-
`cessing in a mannerthat will be understood by one of skill
`in the art from the description herein.
`
`{0028] The electrocardiogram sensor 304 includes elec-
`trocardiogram circuitry 338 that acts as a current source and
`current detector. In an exemplary embodiment, the electro-
`cardiogram circuitry 338 may be positioned within the
`processorportion 102 with wires leading from the processor
`portion 102 through the conductor portion from the second
`end 114to the first end 112 where the wires contact tissue of
`
`the auditory canal wall. In an alternative exemplary embodi-
`ment, the electrocardiogram circuitry 338 may be positioned
`in the vicinity of the first end 112 and communicates signals
`via an electrical connection to the processor 314 in the
`processor portion 102,
`
`{0029] The accelerometer 306 detects motion of the moni-
`toring device 100, In an exemplary embodiment, the accel-
`erometer 306 may be positioned within the processor portion
`102. In an alternative exemplary embodiment, the acceler-
`ometer 306 may be positioned within the conductor portion
`104, e.g., near the first end 112, with signals from the
`accelerometer 306 passed to the processor portion 102 via a
`wire extending through the conductor portion 104. Signal
`processing circuitry 342 may process signals from the
`accelerometer 306 into signals suitable for processing by the
`processor 314.
`
`(0030] The microphone sensor 308 senses sound within
`the auditory canal. The microphone sensor 308 includes a
`microphone 344 and a signal processor 346. In an exemplary
`embodiment, the microphone 344 may be positioned in the
`processor portion 102 with audio signals from the micro-
`phone 344 being communicated from the auditory canal to
`the processor portion 102 through the conductorportion 104
`via an acoustic tube. The acoustic tube may be sized to
`enable passage of the voice communication band, e.g., 2 mm
`or more in diameter. In an alternative exemplary embodi-
`ment, the microphone 344 may be positioned within the
`conductor portion 104, e.g., near the first end 112 and
`electrical signals generated by the microphone 344 are
`communicated to the processor portion 102 via a wire
`extending through the conductor portion 104.
`
`{0031] The thermister sensor 310 senses temperature. In
`an exemplary embodiment,
`the thermister sensor 310
`
`thermister 348. The thermister 348 may be
`includes a
`positioned within the first end 112 of the conductor portion
`104. Electrical signals generated by the
`thermister
`in
`response to temperature within the auditory canalat the first
`end 112 may be communicated to the processor portion 102
`via a wire extending through the conductor portion 104, In
`alternative exemplary embodiments, other devices for sens-
`ing temperature such as a thermopile may be employed to
`sense temperature.
`
`[0032] The presentation device 312 presents audio signals
`within the auditory canal. The presentation device includes
`a speaker 350 and an optional voice ROM 352.
`In an
`exemplary embodiment, the speaker 350 may be positioned
`within the processor portion 102 with audio signals pre-
`sented by the speaker 350 being communicated to the
`auditory canal via an acoustic tube. In an alternative exem-
`plary embodiment,
`the speaker 350 may be positioned
`within the conductor portion 104,e.g., near the first end 112,
`with electrical/electronic signals being communicated from
`the processor portion 102 to the speaker 350 for conversion
`to audiosignals via a wire extending through the conductor
`portion 104. The voice ROM 353 may store predefined
`messages for presentation via the speaker 350 in response to
`signals received from the processor 314.
`[0033] FIG. 4 depicts an exemplary embodiment ofa
`section of the first end 112 of the conductor portion 104. The
`illustrated first end 112 includes an acoustic tube 400, fiber
`optic cables (represented by fiber optic cable 402), and wires
`(represented by a first electrical wire 404 and a second
`electrical wire 406).
`In the illustrated embodiment,
`the
`acoustic tube 400 extends through the center of the first end
`112. In an exemplary embodiment, the acoustic tube 400
`extends through the conductor portion 104 to the processor
`portion 102 coupled to the second end 114 (FIG. 1) of the
`conductor portion 104 (FIG. 1). The fiber optic cable 402
`terminates in an optically transparent elastomer of the first
`end 112 to allow the communication of light between the
`fiber optic cable 402 and the tissue of the auditory canal
`wall. The first electrical wire 404 may be coupled to a
`thermister 348 embedded within a thermally conductive
`elastomer 410, which allows the communication of tempera-
`ture from the auditory canal wall tissue to the thermister 348.
`‘The second electrical wire 406 terminates in an electrically
`conductive elastomer 412, which allows the communication
`of electrical signals to/from the auditory canal wall tissue. In
`an exemplary embodiment, the first end 112 may be sized
`such that when inserted within the auditory canal, the outer
`surface of the first end 112 (e.g., the optically transparent
`elastomer 408), the thermally conducting elastomer 410, and
`the electrically conducting elastomer 412 contact the wall of
`the auditory canal. In an exemplary embodiment, the first
`end 112 is configured for comfort, biocompatibility, dura-
`bility, and ease of manufacture. Suitable materials for use
`within the first end 112 include acrylic, vinyl, silicone, or
`polyethylene, for example.
`
`In an exemplary embodiment, the processor por-
`[0034]
`tion 102 (FIG. 1) includes a power source (not shown),
`sensors (except for the thermister 348), an RF transceiver
`320, and connection means (not shown) for connection to
`the electrical wires 406/408, acoustic tube 400, and fiber
`optic cables 402. In accordance with this embodiment, the
`conductor portion 104 includes the thermister 348,electrical
`wires 406/408, acoustic tube 400, and fiber optic cables 402,
`
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`US 2005/0059870 Al
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`Mar. 17, 2005
`
`and provides structural support therefore. This embodiment
`minimizes the cost of the conductor portion 104, making the
`conductor portion disposable.
`
`auditory canal through the tip 502 of the sheath 500 when
`fully positioned on the monitoring device 100. In another
`alternative exemplary embodiment, the body of the sheath
`500 may expand to accommodate the first end 112 as the
`sheath 500 is positioned on the monitoring device 100 and
`the first end 112 may contact the wall of the auditory canal
`through the tip 504 of the sheath 500 when the sheath 500
`is fully positioned on the monitoring device 100. Various
`alternative embodiments will be understood by those of skill
`in the art from the description herein.
`In an exemplary
`embodiment, the integrated battery 506 includes a fastener
`508 for engaging a corresponding fastener 510 on the
`processor portion 102.
`
`{0035] The monitoring device 100 provides, by way of
`non-limiting example, enhanced comfort for some animals
`over devices positioned entirely within the auditory canal,
`better fil for a larger percentage of animals, easy configu-
`ration for extreme auditory canal sizes or shapes. Further,
`due to its larger size (as compared to a monitoring device
`that is designedto fit entirely within the auditory canal), the
`monitoring device 100 provides greater flexibility in battery
`selection (and, thus, battery life span), easier handling, and
`improved componentselection. For example, the larger size
`[0039] FIG.7depicts a fully assembled monitoring device
`allows more “off-the-shelf’ components to be utilized,
`100 with flexible sheath installed. In an exemplary embodi-
`thereby reducing potential component and development
`cost,
`ment, when monitoring a new patient,
`the battery and
`flexible sheath assembly may be removed from the moni-
`toring device and a new flexible sheath and battery assembly
`may be reattached to the monitoring device 100 in a single
`slep.
`
`{0036] FIG. 5 depicts a flexible sheath 500 that may be
`used to coverat least a portion of the conductor portion L04
`(FIG. 1). The flexible sheath 500 includes a tip 502 that is
`configured for insertion within the auditory canal and is
`sized to engage the auditory canal. It is contemplated that
`different flexible sheaths 500 with tips having various diam-
`eters, e.g., from 5 mm to 12 mm, may be provided to
`accommodate different auditory canal sizes. In an exemplary
`embodiment, the tip 502 may be acoustically, thermally,
`and/or optically transparent(either partially or completely).
`The tip may be acoustically,
`thermally, and/or optically
`transparent
`through the presence of holes (represented by
`hole 504) in the tip 502, the material of the tip, and/or the
`thickness of the material of the tip. In an exemplary embodi-
`ment,
`the holes 504 are sized to prevent cumen from
`entering the tip portion 502 and coming in contact with the
`conductor portion 104. The use of the flexible sheath 500
`enables reuse of the processor portion 102 and the conductor
`portion 104 with the flexible sheath 500 being disposed
`when using the monitoring device 100 (FIG, 1) with sub-
`sequent patients or at periodic intervals with the same
`patient.
`
`In an exemplary embodiment, the flexible sheath
`(0037]
`500 is coupled to an integrated battery 506. Integrating the
`battery 506 into the flexible sheath provides a fresh battery
`for supplying powerto the processor portion 102 whenever
`the flexible sheath 500 is exchanged.
`
`{0038] FIG. 6 depicts a monitoring device 100 with the
`sheath 500 partially positioned on the conductor portion
`104, The monitoring device 100 illustrated in FIG. 6
`includes an alternative exemplary first end 112a@ configured
`for positioning at
`least partially within the tip 502 of the
`sheath 500. In an exemplary embodiment, the first end 112a
`may include a speaker, microphone, thermister, light emit-
`ter(s) and/or light detector(s) (and/or wires,fiber optic cables
`and/or acoustic tubes for coupling to such components
`positioned in the processor portion 102), As seen in FIG, 6,
`the first end 112¢ of the conductor portion 104 has a
`diameter that is smaller than the diameter of the tip 502. In
`this embodiment, the tip 502 of the flexible sheath 500 may
`center the first end 112¢ within the auditory canal. In an
`alternative exemplary embodiment, a first end 112 such as
`depicted in FIG, 4 may be used with the first end 112
`deforming to fit the body of the sheath 500 as the sheath is
`positioned on the monitoring device 100 and expanding
`within the tip 502 of the sheath 500 to contact the wall of the
`
`[0040] FIG. 8 depicts a monitoring device 100 and one or
`more remote devices (represented by remote devices 800a,
`b, and c). Each remote device 800 includes a transceiver
`(represented by transceivers 802a, b, and c) for communi-
`cating with the monitoring device 100 via the transceiver
`320 (FIG. 3) of the monitoring device 100, The monitoring
`device 100 may communicate with one or more of the
`remote devices 800. The monitoring device 100 may attach
`an identification code to each communication with the
`remote devices 800 so that a particular monitoring device
`100 is distinguishable from other monitoring devices. In
`addition, each remote device 800 may attach a unique
`monitoring code to communications communicated from the
`monitoring device 100 through the remote devices 800 to a
`central processing device 804 in order to provide an indi-
`cation of the remote device 800 through which the moni-
`tored information was received.
`
`[0041] FIG. 9 depicts a flow chart 900 of exemplary steps
`for monitoring physiological parameters in accordance with
`the present invention. The exemplary steps are be described
`with reference to FIGS. 1, 2, and 3. Physiological param-
`elers may be monitored from one or more physiological
`characteristics present with an auditory canal of an animal.
`
`[0042] At block 902, the monitoring device 100 senses
`one or more physiological characteristics present within the
`auditory canal of the animal. In an exemplary embodiment,
`sensors within the monitoring device 100 such as a pulse
`oximetry sensor 302, EKG sensor 304, accelerometer 306,
`microphone 308, and thermister 310 sense the one or more
`physiological characteristics. The sensors may be located in
`the processing portion 102 and/or the conductor portion 104
`of the monitoring, device.
`
`[0043] At block 904, the physiological characteristics are
`passed from within the auditory canal to a processing device
`102 positioned remote to the auditory canal, e.g., at least
`partially between the auricle of the ear and the head of the
`animal for processing. In an exemplary embodiment,
`the
`physiological characteristics may be sensed by sensors posi-
`tioned in a conductor portion 104 of the monitoring device
`that
`is coupled to the processing device 102. Electrical
`signals representing the physiological characteristics may be
`generated by the sensors in the conductor portion 104 and
`
`012
`
`FITBIT, Ex. 1031
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`012
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`FITBIT, Ex. 1031
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`US 2005/0059870 Al
`
`Mar. 17, 2005
`
`may be communicated to the processing portion 102 for
`processing by the processor 314 via wires extending through
`the conductor portion 104.
`
`In an alternative exemplary embodiment, physi-
`(0044]
`ological characteristics present within the auditory canal
`may be passed directly to sensors within the processing
`device 102 for sensing, ¢.g., via wires, fiber optical cables,
`and/or acoustic tubes. In accordance with this embodiment,
`the step of block 904 is performed before the step of block
`902. More specifically, the physiological characteristics are
`passed from within the auditory canal
`to the processing
`device 102 positioned at least partially between the auricle
`of the ear where these physiological characteristics are then
`sensed.
`
`{0045] At block 906, the sensed physiological character-
`istics are processed at the processing portion 102 to deter-
`mine the at least one physiological parameter. In an exem-
`plary
`embodiment,
`the processor 314 processes
`the
`physiological characteristics. In an alternative exemplary
`embodiment, circuitry associated with the sensors performs
`the processing or assists in processing the physiological
`characteristics.
`
`{0046] Optionally, at block 908, an emergency alert is
`generated. In an exemplary embodiment, the processor 314
`generates an emergencyalert if a physiological characteris-
`tic or parameter is outside of a predefined range. The
`emergency alert may be communicated to the user wearing
`the monitoring device, e.g., by the processor 314 via the
`speaker 350 (optionally playing a predetermine message
`stored in the voice ROM 352). Alternatively, the emergency
`alert may be communicated by the processor 314 to a remote
`device 800 or central processing device 804 via the trans-
`ceiver 320.
`In an alternative exemplary embodiment,
`the
`emergency alert may be generated if the monitoring device
`is out of communication range with a remote device 800 or
`a central processing device 804, or is greater than