111111
`
`1111111111111111111111111111111111111111111111111111111111111111111111111111
`US 20050059870Al
`
`(19) United States
`(12) Patent Application Publication
`Aceti
`
`(54)
`
`J>ROCESSlNG METHODS AND AI>PARATUS
`FOR MON IT ORING PHYSIOLOGICAL
`PARAMETERS USTNG PHYSIOLOGICAL
`CHARACTERISTlCS PRESENT WITHIN AN
`AUDITO RY CANAL
`
`(76)
`
`Inventor: Jo hn G regory Aceti, West Windsor, NJ
`(US)
`
`Correspondence Address:
`RAT NERPRESTIA
`P.O. BOX 980
`VALLEY FORGE, PA 19482-0980 (US)
`
`(21) Appl. No.:
`
`10/925,765
`
`(22)
`
`riled:
`
`Aug. 25, 2004
`
`R elated U.S. Application Data
`
`(60) Provisio nal application No. 60/497,890, lilecl o n Aug.
`25, 2003.
`
`(10) Pub. No.: US 2005/0059870 Al
`Mar. 17, 2005
`(43) Pub. Date:
`
`Publication C lassification
`
`(51)
`
`Int. C l.7
`
`.............................. A61B 5/00; A61B 5/ 11;
`A61B l0/00
`(52) U.S. C l. . ........................ 600/340; 600/595; 600/549;
`600/551; 128/903
`
`(57)
`
`ABSTRACT
`
`Methods and apparatus for monitoring at least one physi(cid:173)
`ological parameter of an animal from one or more physi(cid:173)
`ological characteristics present within an auditory canal of
`the anjm al. Phys io logical parameters are measured by sens(cid:173)
`ing at least onc physiological characteristic present within
`the audjtory canal of the animal, the at least o ne physiologi(cid:173)
`cal characteristic associated with a physiological parameter,
`and pror.:essi ng the at least o ne sensed physiological char(cid:173)
`acteristic at a device positioned remotely from the auditory
`canal to determine the physiological parameter.
`
`I'I;V
`
`804
`
`CENTRAL
`PROCESSOR
`
`/'l ;v
`
`802a
`
`800a
`
`/'l;v
`
`802c
`
`/'l;v
`
`802b
`
`REMOTE
`DEVICE
`
`;V ;V
`
`100
`
`;-
`
`001
`
`Apple Inc.
`APL1047
`U.S. Patent No. 9,289,135
`
`

`

`Patent Application Publication Mar. 17, 2005 Sheet 1 of 7
`
`US 2005/0059870 A1
`
`~100
`
`104
`
`FIG. 1
`
`108
`
`102
`
`~ 100
`
`FIG.2
`
`002
`
`

`

`Patent Application Publication Mar. 17, 2005 Sheet 2 of 7
`
`US 2005/0059870 Al
`
`~110
`
`330,
`I 660nm LED
`332
`805nm LED ~
`3~ j PHOTO DIODE i
`
`;
`
`02
`1 336 V 3
`
`318__..
`
`PTG
`+
`Sp02
`
`INTERNAL
`CLOCK
`
`/'ltv
`
`r
`
`o--cuRRENT-
`o--soURCE-
`D
`
`DETECTOR
`
`810
`IMPEDENCE
`EKG
`
`340
`_1 ACCELEROMETER I
`342
`
`306
`I
`1 SIGNAL PROCESSOR J-
`
`338
`J
`304
`/~
`~
`PROCESSOR r
`I
`
`~ TX/RX
`I
`320
`
`314
`
`,!,
`
`.i
`
`"'
`
`... ~
`
`~
`
`344
`
`MICROPHONE i
`1 SJGNAL PROCESSOR :
`346-...=:;?
`
`350
`
`SPEAKER
`
`352-...
`I • f VOICE ROM
`•----- -- -------·
`
`I
`I
`
`~
`308
`
`312
`
`I THERMISTER
`
`I
`I
`
`B
`
`316
`\
`ROM&RAM
`MEMORY
`
`v-310
`
`348
`
`/326
`
`I POWER REGULATOR I
`
`~324
`
`~322
`
`DATA OUT
`
`DATA IN
`
`FIG. 3
`
`003
`
`

`

`Patent Application Publication Mar. 17, 2005 Sheet 3 of 7
`
`US 2005/0059870 Al
`
`0
`
`co
`0
`~
`
`004
`
`

`

`Patent Application Publication Mar. 17, 2005 Sheet 4 of 7
`
`US 2005/0059870 Al
`
`005
`
`

`

`Patent Application Publication Mar. 17, 2005 Sheet 5 of 7
`
`US 2005/0059870 Al
`
`C\J
`C>
`l{)
`
`«::t
`C>
`lO
`
`C>
`C> ---.~
`U')
`
`C\J
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`..--
`
`006
`
`

`

`Patent Application Publication Mar. 17, 2005 Sheet 6 of 7
`
`US 2005/0059870 Al
`
`0
`0
`1.0
`
`007
`
`

`

`Patent Application Publication Mar. 17,2005 Sheet 7 of 7
`
`US 2005/0059870 Al
`
`!V;v
`
`804
`
`CENTRAL
`PROCESSOR
`
`!V;v
`
`802a
`
`800a
`
`!V;v
`
`802c
`
`!V;v
`
`802b
`
`REMOTE
`DEVICE
`
`100
`
`;v ;v
`I
`
`FIG. 8
`
`~900
`
`SENSE PHYSIOLOGICAL CHARACTERISTIC($) PRESENT
`-902
`WITHIN AUDITORY CANAL OF AN EAR OF AN ANIMAL.
`...
`/
`PASS PHYSIOLOGICAL CHARACTERISTIC($) TO PROCESSING DEVICE POSITIONED
`•
`BElWEEN AURICLE OF THE EAR AND THE HEAD OF THE ANIMAL.
`
`904
`
`906
`
`/
`
`PROCESS PHYSIOLOGICAL CHARACTERISTIC(S) AT PROCESSING DEVICE
`POSITIONED BETWEEN AURICLE OF THE EAR AND THE HEAD OF
`THE ANIMAL TO DETERMINE PHYSIOLOGICAL PARAMETER($).
`i'
`I GENERATE EMERGENCY ALERT. ~
`...
`
`FIG. 9
`
`STORE PHYSIOLOGICAL CHARACTERISTIC($)
`AND/OR PHYSIOLOGICAL PARAMETER(S).
`
`I-- 910
`
`908
`
`008
`
`

`

`US 2005/0059870 Al
`
`Mar. 17, 2005
`
`1
`
`PROCESSING METHODS AND APPARATUS FOR
`MONITORING l'HYSIOLOGICAL l'ARAMETERS
`USING PHYSIOLOGI CAL C HARACTE RISTlCS
`PRESENT WITHIN AN AUDITORY CANAL
`
`CROSS REFERENCE TO RELATED
`APPLICATION
`
`[0001] Tbis application c laims tbe benefit of U.S. Provi(cid:173)
`sional Application No. 60/497,890, filed Aug. 25, 2003, the
`contents of wbicb arc incorporated herein by reference.
`
`FIELD OF THE INVENTION
`
`[0002) Tbc present invention relates to methods and appa(cid:173)
`ratus for monitoring physiological parameters and, more
`particularly, to processing methods and apparatus for moni(cid:173)
`toring physiological parameters using physiological charac(cid:173)
`teristics present within an auditory canal o[ an animal.
`
`BACKGROUND OF THE INVENTION
`
`[0003] Physiological parameters are routinely monitored
`in a wide range of medical applications. Instruments for use
`in the auditory canal to measure physiologica l parameters
`bave been developed. See, for example, U.S. Pat. No.
`6,283,915 to Aceti et al., entitled DISPOSABLE IN-TilE(cid:173)
`EAR MONlTORJNG INSTRUMENT AND ME1HOD OF
`MANUFACTURER. These instruments incorporate minia(cid:173)
`turized components for mo11itoriogphysiological 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(cid:173)
`iaturized components, however, are typically more expen(cid:173)
`sive than larger component, and small batteries tend to have
`relatively short liJe spans.
`
`(0004) Tbere is an ever-present desire for less expensive
`medical
`insLruments having
`longer battery life spans.
`Accordingly, improved methods and apparatus are needed
`for monitoring physiological parameters tbat are oot subject
`to the above limitations. ~l11e present invention addresses tbis
`need among others.
`
`SUMMARY OF THE INVENTION
`
`(0005)
`lbe present invention is embodied io methods and
`apparatus for monitoring at least one physiological param(cid:173)
`eter of an animal from one or more pbysiologjcal cbarac(cid:173)
`teristics present within an auditory canal of the animal.
`Physiological parameters are measured by sensing at least
`one physiological characteristic present within the auditory
`canal of the animal, the at least one physiological charac(cid:173)
`teristic associated with a physiological parameter, and pro(cid:173)
`cessing the sensed physiological cbaracteristic at a device
`positioned remotely from tbe auditory canal to cletennine the
`physiological parameter.
`
`BRIEF DESCRIPTION OF TilE DRAWINGS
`
`[0006] The invention is best understood from the follow(cid:173)
`ing detailed description when read in connection witb the
`accompanying drawings, wilb like elements baving tbe same
`reference numerals. Wben a plurality of similar clements are
`present, a single reference numeral may be assigned to tbe
`plurality of similar elements with a small letter designation
`referring to specific elements. When referring to tbe ele(cid:173)
`ments collectively or to a no n-specific one or more of the
`
`elements, Lhe small leller designation may be dropped. This
`emphasizes that, according to common practice, the various
`features of the drawings are not drawn to scale. On tbe
`contrary, the dimensions of the various features are arbi(cid:173)
`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 w ith the present
`invention;
`
`[0008] FIG. 2 depicts tbe exemplary monitoring device of
`F IG. 1 positioned on the bead of an animal;
`
`[0009] FIG. 3 is a block diagram of exemplary compo(cid:173)
`nents within tbe exemplary monitoring device in accordance
`with the present invention;
`
`[0010) FIG. 4 is a cross-sectional view of a section of a
`conductor portion of the monitoring device configured for
`posiLioning within the auditory canal in accordance with the
`present inve ntion;
`
`(0011] FIG. 5 is an illustratio n of a sheath for covering at
`least a portion of a monitoring device in accordance witb the
`present invention;
`
`[0012] FIG. 6 is an illustration of a sheath partially
`positioned to cover a portion of the monitoring device in
`accordance witb the present invention;
`
`(0013) FIG. 7 is an illustration of a sheath fully positioned
`to cover a portion of tbc monitoring device in accordance
`with the present invention;
`
`(0014) F IG. 8 is a block diagram of a monitoring system
`in accordance with the present invention; and
`(0015) FIG. 9 is a flow cbart of exemplary steps Jor
`determining physiological parameters in accordance with
`the present invention.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`[0016] FIG. l and FIG. 2 are useful fo r providing a
`general overview of the present invention. FIG. l depicts an
`exemplary monitoring device 100 in accordance with the
`present invention. The monitoring device 100 includes a
`processor portion 102 and a conductor ptmion 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 coma ined
`therein. Additionally, electrical and/or electronic compo(cid:173)
`nents no may be (ound within the conductor portion 104.
`The conductor portion 104 includes a t1rst end 112 config(cid:173)
`ured for insertion at least partially within tbe auditory canal
`of an animal and a second end 114 coupled to the processor
`portion 102.
`
`[0018]
`In use, the first end 112 of the conductor portion is
`positioned at least partially within the auditory canal of tbe
`animal to detect one or more pbysiological characteristics
`ar1d pass the detected physiological characteristics througb
`the conductor portion 104 from the first end 112 to the
`second e nd 114 (or processing by the processor portion 102
`
`009
`
`

`

`US 2005/0059870 Al
`
`Mar. 17, 2005
`
`2
`
`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 o( no n-limiting example, temperature, pulse, blood(cid:173)
`oxygen content, and respiration ra te. For example, the
`intensity of light transmitted through tissue of an auditory
`canal wal.l may be used in acco rdance with known pulse(cid:173)
`oximetry techniques to determine pulse rate and blood(cid:173)
`oxygen content. In addition, sounds within the auditory
`canal may be used to determine pulse and/or respiration rate.
`One or more physiological characteris tics such as tempera(cid:173)
`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 bereio.
`
`[0019] FIG. 2 depicts the exemplary monitoring device
`100 positioned relative to an ear 202 on the bead 204 of an
`animal. T he car202 includes an auricle 206 and an auditory
`canal208 adjacent the auricle 206. to an exemplary embodi(cid:173)
`ment, the processor port ion 102 of the monitoring device
`100 is positioned at least partially between the auricle 206
`and the bead 204 of the animal and the first end ill of the
`conductor portion 104 is positioned at least partially within
`the auditory cana1208. In an alternative exemplary embodi(cid:173)
`ment, the processor portion 102 may be positioned in
`es.seotially 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 <toy animal having an ear with an
`auditory canal.
`
`[0020] Tbe present invention is now described in detail.
`FIG. 3 depicts exemplary electrical and/or electronic com(cid:173)
`ponents 110 (referred to herein as components 110) that may
`be located within the monitoring device 100 (FIG. 1). The
`illus trated 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, optionaUy, a transmitter only), data
`input circuitry 322, data output circttitry 324, and one or
`more sensors (i.e., 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 tbermister 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(cid:173)
`ta tion device 312), and communicate iuformation (e.g., via
`the data input/ou tput circuitry 3221324 and the transceiver
`320). Further, the processor 314 is configured to store
`information to tbe memory 316 and retrieve the information
`from the memory 316. T he internal clock 318 provides the
`processor with real time and/or interval readings for use in
`processing the information from tbe sensors. A power regu(cid:173)
`lator 326 is optionally included to regulate power to the
`electrical and/or electronic components 110. A st1itable
`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 deseription 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 C.'loal. In
`this embodiment, tbe sensors sense the physiological c har(cid:173)
`acteristics and generate electrical s ignals that are passed
`through the conductor portion to the processor 314 in the
`processor portion 102, e.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 th rough 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 U1e 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. T hose of skill in tbe art of bearing
`aids have developed various tube configurations for deliv(cid:173)
`ering sound to the auditory canal. Stich tubes can also be
`used for receiving sounds [rom the auditory canal.
`
`[0024) Fiber optic cables communicate photonic s ignals
`througb the conductor portion 104 between the auditory
`canal and the processor portio n 102. Fiber optic cables may
`be used to transfer one or more wavelengths of light gen(cid:173)
`erated in the processor portion 102to the auditory canal and
`to transfer one or more wavelengths of light in the auditory
`canal (e.g., emana ting from the auditory canal wall tissue) to
`the processor portion 102.
`
`[0025) Wires communicate electric/electronic signals
`through the conductor portion 104 between the auditory
`canal and the processor portion 102. Wires may be tL~ed to
`transfer electric/electronic signals generated in the processor
`portion 102 to the auditory canal or a sensor witbio the
`conducto r portion 104 positioned in the auditory canal aod
`to transfer electric/electronic signals in the auditory canal
`(e.g., emanating from the auditory canal waiJ tissue or a
`sensor within the conductor portion 104 positioned in the
`auditory canal) to the processor portion 102. The \vires may
`terminate with electrodes suitable for contact with auditory
`canal wall !~<;.sue . In an exemplary embodiment, the elec(cid:173)
`trodes are mounted in an ear mold, which is described in
`fwther detail below.
`
`In an exemplary e mbodiment, the conductor por(cid:173)
`[0026]
`tion 104 and the wires, acoustic tubes, and/or fiber optic
`cables extending through the conductor portio n 104 are
`flexibl e and/or moldable. This enables sensors w ithin the
`cond ucto r portion 104 to be at least partially mechanically
`separated from the processing portion 102 to preveot/reduce
`tbe lrans le r of motion of the processing device 102 to the
`sensors within the conductor portion 104, which could catLse
`erroneous signals. lo addition, tbis 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(cid:173)
`trated pulse oximetry sensor 302 includes a first light
`emiuing diode 330, a second light emilling diode 332, a
`photo de tector diode 334, and pulse oximetry circuitry 336.
`For pulse oximetry, lig ht from the first and second diodes
`330 and 332 are introduced to the tissue lin·ing the auditory
`
`010
`
`

`

`US 2005/0059870 Al
`
`Mar. 17, 2005
`
`3
`
`canal wall in the vicinity of the first end U2 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 tbe light e mitting diodes 330 and
`332. The pulse oximetry circuitry 336 monitors the pul<;es of
`light introduced by the LEDs 330 and 332 and the light
`received at the photo detector diode 334 to determine pulse
`rate aod/or blood oxygenation levels (i.e., physiological
`parameters). [o an exemplary embodiment, the pulse oxim(cid:173)
`etry circuitry 336 may be positioned within the processor
`portion 102 and is connected via wires to the LEOs 330!332
`and the photo diode 334, which are positioned within the
`first cod 112 of the conductor portion 104. In an alternative
`exemplary embodiment, the LEOs 330!332 and/or the photo
`detector diode 334 may be positioned within tbe processor
`portion 102 with light from the LEOs 330 and 332 and/or
`Light detected by the photo diode 334 being passed therebe(cid:173)
`tween via fiber optic cables extending through the conductor
`portion L04. The pulse oximetry circuitry 336 communicates
`pulse oximetry information to the processor 314 for pro(cid:173)
`cessing in a manner that will be understood by one of skill
`in the art (rom the description herein.
`
`ll1e electrocardiogram sensor 304 includes elec(cid:173)
`[0028]
`trocardiogram circuitry 338 that acts as a current source and
`current detector. In an exemplary embodiment, the electro(cid:173)
`cardiogram circuitry 338 may be positioned within the
`processor portion 102 with wires leading from the processor
`portion 102 through the conductor portion from the second
`end 1L4 to the first end 112 where the wires contact tissue of
`the auditory canal waU. l o ao alternative exemplary embodi(cid:173)
`ment, the electrocardiogram circuitry 338 may be positioned
`in the vicinity of the first end ll2 and communicates signals
`via an electrical connection to the processor 314 in the
`processor portion 102.
`
`[0029] The accelerometer 306 detects motion o( the moni(cid:173)
`toring dev"ice 100. In an exemplary embodiment, the accel(cid:173)
`erometer 306 may be positioned within the processor portion
`102. [n an alternative exemplary embodiment, the acceler(cid:173)
`ometer 306 may be positioned within the conductOr portion
`104, e.g., near the fi rst end 112, with signals [rom the
`accelerometer 306 passed to the processor portion L02 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 sett'>Or 308 includes a
`microphone 344 and a signal proces.'>Or 346. In an exemplary
`embodimeot, the microphone 344 may be positioned in the
`processor portion 102 with audio signals from the micro(cid:173)
`phooc 344 being communicated rrom the auditory canal to
`tbe processor portion 102 through the conductor portion 104
`via an acoustic tube. T he acoustic tube may be sized to
`enable passage of tbe voice communication band, e.g., 2 mm
`or more in diameter. To an alternative exemplary embodi(cid:173)
`ment, the microphone 344 may be positioned within the
`conductor portion 104, e.g., near the first end ll2 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
`
`includes a thermister 348. The them1ister 348 may be
`positioned within the first end 112 of the conductor portion
`104. Electrical signals generated by the thermistcr in
`response to temperature wi1bio tbe auditory canal at the first
`end 112 may be communicated to the processor portion 102
`via a wire extending through tbe conductor portion 104. In
`alternative exemplary embodiments, other devices for sens(cid:173)
`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 ao
`exemplary embodiment, the speaker 350 may be positioned
`within tbe processor portion 102 with audio signals pre(cid:173)
`sented by tbe speaker 350 being communicated to tbe
`auditory canal via an acoustic tube. In an alternative exem(cid:173)
`plary embodiment, U1e speaker 350 may be positioned
`within the conductor portion 104, e.g., near the first cod 112,
`with electrical/electronic signals being communicated from
`the processor portion 102 to the speaker 350 for conversion
`to audio signals 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 of a
`section of the fi rst 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 \vires
`(represented by a l:irst electrical wire 404 and a second
`electrical wire 406). [n lhe illustrated embodiment, the
`acoustic tube 400 extends th rough 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
`cod 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(cid:173)
`lure from the auditory canal wall tissue to tbe tbermister 348.
`The second electrical wire 406 terminates in an electrically
`conductive elastomer 4ll, which allows the communication
`of electrical signals to/from the auditory canal wall tissue. In
`an exemplary embodiment, tbe 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 e lastomer 4ll contact the wall of
`the auditory canal. In an exemplary embodiment, the first
`end lll is configured for comfort, biocompatibility, dura(cid:173)
`bility, and ease of manuJacture. S uitable materials for use
`within the first end 112 include acrybc, vinyl, s ilicone, or
`polyethylene, for example.
`
`In an exemplary embodiment, the processor por(cid:173)
`[0034]
`tion 102 (FIG. 1) includes a power source (not shown),
`sensors (except for the thermister 348), ao RF transceiver
`320, aocl 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, tbe
`conductor portion 104 includes the thermister 348, electrical
`wires 406/408, acoustic tube 400, and fiber optic cables 402,
`
`011
`
`

`

`US 2005/0059870 Al
`
`Mar. 17, 2005
`
`4
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`and provides s tructural support therefore. Tb~s embodimem
`minimizes the cost of the conductor portion 104, making the
`conductor portion disposable.
`
`[0035) The monitoring device 100 provides, by way of
`non-limiting example, enhanced comfort for some animals
`over devices positione-d entirely within the auditory canal,
`better fit for a larger percentage of animals, easy configu(cid:173)
`ration for extreme auditory canal sizes or shapes. Further,
`clue to its larger size (as compared to a monitoring device
`that is designed to fit entirely wi thin the auditory canal), the
`monitoring device 100 provides greater flexibility in battery
`selection (and, thus, battery life span), easier handling, and
`improved component selection. For example, the larger size
`allows more ·'off-the-shelf" components to be utilized,
`thereby reducing potential component and development
`cost
`
`[0036] FIG. 5 depicts a flexible sheath 500 that may be
`used to cover at least a portion of the conductor portion 104
`(FIG. l ). The flexible sheath 500 includes a lip 502 that is
`configured [or insertion wi thin the audito ry canal and is
`sized to engage the auditory canaL It is contemplated that
`different flexible sheaths 500 with tips having various diam(cid:173)
`eters, e.g., from 5 mm to 12 mm, may be provided to
`accommodate different auditory canal sizes. 1n an exemplary
`embodiment, the tip 502 may be acoustically, them1ally,
`and/or optically transpa rent (either partially or completely).
`The tip may be acoustically, the rmally, and/o r optically
`transparent through tbe presence of boles (represented by
`bole 504) in the tip 502, the ma terial of the tip, and/or the
`thickness of the material of the tip. In an exemplary embodi(cid:173)
`ment, the holes 504 are sized to prevent cumen from
`entering the Lip portion 502 and coming in contact wit h the
`conductor portion 104. T he use of the flexible s heath 500
`enables reuse of the processor portion 102 and the conductor
`portion 104 with the flexible sheath 500 being disposed
`when using tbe monitoring device 100 (FIG. 1) wi th sub(cid:173)
`sequent patients or at periodic intervals with the same
`patient.
`
`[0037]
`In an exemplary embodiment, the flexible s heath
`500 is coupled to an integrated battery 506. Iotcgratiog the
`ballery 506 into the flexible sheath provides a fresh ballery
`for supplying power to 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 coofigUied
`for positioning at least partially within the tip 502 of the
`sheath 500. In an exemplary embodiment, the first end ll2a
`may include a speaker, microphone, tbermister, light emit(cid:173)
`ter(s) and/or light detector(s) (and/or wires, fiber optic cables
`and/or acoustic tu.bes for coupling to such components
`positioned in the processor portion 102). As seen in FIG. 6,
`the first e nd U2a of the conductor portion 104 bas a
`diameter that is smaller than the diameter of the tip 502. In
`Ibis embodiment, the tip 502 of the flexible sheath 500 may
`center the first end U2a w ithin the auditory canal In an
`alternative exemplary embodiment, a first cod ll2 such as
`depicted in FIG. 4 may be used with the first cod 112
`deforming to fit the body of the sheath 500 as the sheath is
`positioned o n the monitoring device 100 and expanding
`within the tip 502 of the sheath 500 to contact the wall of the
`
`auditory canal th rough the tip 502 of the sheath 500 when
`fully positioned on the monitodng device 100. In another
`alternative exemplary embodiment, the body of the sheath
`500 may expand to accommodate the fust end 112 as the
`s heath 500 is positioned on the monitoring device 100 and
`the first end 112 may contact the wall of the auditory canal
`through tbe 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, tbe integrated bauery 506 includes a fastener
`508 for engaging a corresponding fastener 510 on the
`processor portion 102.
`[0039] FIG. 7 depicts a fully assembled monitoring device
`100 with llexible sheath installed. fa an exemplary embodi(cid:173)
`ment, w hen monitorLng a new patient, the bauery and
`flexible sheath assembly may be removed from the mo ni(cid:173)
`toring device and a new flexible sheath and battery assembly
`may be reallached to the monitoring device 100 in a single
`s tep.
`[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(cid:173)
`cating \vith tbe monitoring device 100 via the transceiver
`320 (FIG. 3) of the monitoring device 100. The monitoring
`device 100 may communicate with ooe or more of the
`remote devices 800. The monitoring device 100 may auacb
`an identification code to each communication with the
`remo te devices 800 so that a particular monitoring device
`100 is distinguishable from other moni toring devices. To
`addition, each remote device 800 may anach a unique
`moni toring 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(cid:173)
`cation of the remote device 800 th rough which the moni(cid:173)
`tored information was received.
`[0041] FIG. 9 depicts a liow chart 900 of exemplary steps
`for monitoring physiological parameters in accordance with
`the present invention. T he exemplary s teps are be described
`with reference to FIGS. 1, 2, and 3. Physiological paranl(cid:173)
`eters may be monitored from o ne or more physiological
`characteristics present with an auditory canal of ao animal.
`
`[0042) At block 902, the monitoring device 100 senses
`one or more physiological characteristics present '.'.rithin 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 lhe conductor portion 104
`of the moni toring 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 bead of the
`animal for processing. fa an exemplary embodiment, the
`physiological characteristics may be sensed by sensors posi(cid:173)
`tioned in a conductor portion 104 of the mortitoriog 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
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`US 2005/0059870 Al
`
`Mar. 17, 2005
`
`5
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`may be communicated to the proces.~ing portion 102 for
`processing by the processor 314 via wires extending th rough
`the conductor portion 104.
`[0044)
`ln an alternative exemplary embodiment, physi(cid:173)
`ological characteristics present within the auditory canal
`may be passed directly to sensors within the processing
`device 102 for sensing, e .g., via wires, fiber optical cables,
`and/or acoustic tubes. In accordance with this embodimem,
`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 tbc processing
`device 102 positioned at least partially between Lbe auricle
`of the ear where these physiological characteristics are then
`sensed.
`(0045) At