111111
`
`1111111111111111111111111111111111111111111111111111111111111111111111111111
`US 20050059870Al
`
`(19) United States
`(12) Patent Application Publication
`Aceti
`
`(54) PROCESSING METHODS AND APPARATUS
`FOR MONITORING PHYSIOLOGICAL
`PARAMETERS USING PHYSIOLOGICAL
`CHARACTERISTICS PRESENT WITHIN AN
`AUDITORY CANAL
`
`(76)
`
`Inventor: John G regory 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, fi led o n Aug.
`25, 2003.
`
`(10) Pub. No.: US 2005/0059870 Al
`Mar. 17,2005
`(43) Pub. Date:
`
`Publication Classification
`
`Int. CI.7
`
`(51)
`
`•..• .............•.•.......••. A618 5/00; A61B 5/11;
`A61B 10/00
`(52) U.S. CI. .. ....................... 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 animal. Physiological parameters are measured by sens(cid:173)
`ing at least one physiological characteristic present within
`the auditory canal of the animal, the at least one physiologi(cid:173)
`cal characteristic associated with a physiological parameter,
`and processing the at least o ne sensed physiological c har(cid:173)
`acteristic at a device positioned remotely from the auditory
`cana.l to determine IJ1e physiological parameter.
`
`!V;V
`
`804
`
`CENTRAL
`PROCESSOR
`
`!V;V
`
`802a
`
`BOO a
`
`!V;v
`
`802c
`
`!V;v
`
`802b
`
`REMOTE
`DEVICE
`
`100
`
`;v ;v
`I
`
`Apple Inc.
`APL1047
`U.S. Patent No. 8,652,040
`
`0001
`
`

`

`Patent Application Publication Mar. 17, 2005 Sheet 1 of 7
`
`US 2005/0059870 Al
`
`~100
`
`104
`
`FIG. 1
`
`108
`
`102
`
`~ 1 00
`
`FIG. 2
`
`0002
`
`

`

`Patent Application Publication Mar. 17, 2005 Sheet 2 of 7
`
`US 2005/0059870 Al
`
`INTERNAL
`CLOCK
`
`~ TX/RX
`
`1
`314 320
`
`1 l-
`PROCESSOR
`
`1 336 V 302
`
`0.
`
`330,_..>... "'"""------.
`I 660nm LED ;.----l
`PTG
`332 ~====~
`il-------4
`+
`805nm LED
`334 j PHOTO DIODE il---t__:8
`2 .J
`P:_
`:_
`338
`' - - - - - - - -...... J ~04
`Q--CURRENT-
`BIO
`Q - - SOURCE-
`IMPEDENCE
`EKG
`
`DETECTOR
`
`340 J ACCELEROMETER ;
`342 .__/
`
`306
`I
`1 SIGNAL PROCESSOR r
`
`344 .....------.
`MICROPHONE i
`1 SIGNAL PROCESSOR :~--~---..____J
`346......:::::::?
`'
`~------------------------~ 308
`350.------..1352
`I
`VOICE ROM
`SPEAKER
`1u-~---'
`•
`1
`1
`1 - - - - - ' '--------------'
`
`312
`
`I THERMISTER
`
`~-----------~310
`il-----1---- - - - - - - '
`348
`
`C326
`
`316
`\
`ROM&RAM
`MEMORY
`
`.---------i.-----------.....-- 322
`DATA IN
`
`FIG. 3
`
`0003
`
`

`

`Patent Application Publication Mar. 17, 2005 Sheet 3 of 7
`
`US 2005/0059870 Al
`
`0
`
`co
`C)
`~
`
`0004
`
`

`

`Patent Application Publication Mar. 17, 2005 Sheet 4 of 7
`
`US 2005/0059870 Al
`
`0005
`
`

`

`Patent Application Publication Mar. 17, 2005 Sheet 5 of 7
`
`US 2005/0059870 Al
`
`C\J
`0
`L{)
`
`...;;t
`0
`lO
`
`0 o---1
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`0006
`
`

`

`Patent Application Publication Mar. 17, 2005 Sheet 6 of 7
`
`US 2005/0059870 Al
`
`N
`0
`LO
`
`0
`0
`LO
`
`0007
`
`

`

`Patent Application Publication Mar. 17, 2005 Sheet 7 of 7
`
`US 2005/0059870 Al
`
`!V;v
`
`802b
`
`REMOTE
`DEVICE
`
`100
`
`;v ;v
`I
`
`!V;v
`
`804
`
`CENTRAL
`PROCESSOR
`
`!V;v
`
`802a
`
`800a
`
`!V;v
`
`802c
`
`FIG. 8
`
`904
`
`906
`
`~900
`SENSE PHYSIOLOGICAL CHARACTERISTIC(S) PRESENT r--902
`WITHIN AUDITORY CANAL OF AN EAR OF AN ANIMAL
`...
`/
`PASS PHYSIOLOGICAL CHARACTERISTIC(S) TO PROCESSING DEVICE POSITIONED
`BETWEEN AURICLE OF THE EAR AND THE HEAD OF THE ANIMAL
`i
`PROCESS PHYSIOLOGICAL CHARACTERISTIC(S) AT PROCESSING DEVICE v
`POSITIONED BETWEEN AURICLE OF THE EAR AND THE HEAD OF
`THE ANIMAL TO DETERMINE PHYSIOLOGICAL PARAMETER(S).
`'t
`r GENERATE EMERGENCY ALERT. l
`i
`STORE PHYSIOLOGICAL CHARACTERISTIC(S) ~910
`AND/OR PHYSIOLOGICAL PARAMETER(S).
`
`FIG. 9
`
`908
`
`0008
`
`

`

`US 2005/0059870 A1
`
`Mar. 17,2005
`
`1
`
`PROCESSING METHODS AND AP PARATUS FOR
`MONITORING PHYSIOLOGICAL l~ARAMETERS
`USING PHYSIOLOG ICAL C HARACTERISTlCS
`PRESENT WITHIN AN AUDITORY CANAL
`
`CROSS REFERENCE TO RELPJED
`APPLICATION
`[0001] This application claims the benefit of U.S. Provi(cid:173)
`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(cid:173)
`ratus for monitoring physiological parameters and, more
`particularly, to processing methods and apparatus for moni(cid:173)
`toring physiological parameters using physiologica l c harac(cid:173)
`teristics present within an auditory canal o( an animal.
`
`BACKGROUND OF THE JNVENTION
`[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-TilE(cid:173)
`EAR MONlTORING INSTRUMENT AND METHOD OF
`MANU FACTURER. These instruments incorporate minia(cid:173)
`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(cid:173)
`iaturized components, however, are typically more expen(cid:173)
`sive than larger component, and small batteries tend to have
`rei alive! y short I ife spans.
`[0004) There is an ever-present desire for less expensive
`medical instruments having
`longer battery life spans.
`Accordingly, improved methods and apparatus are needed
`[or monitoring physiological parameters tbat are not subject
`to the above Limitations. T he present invention addresses this
`need among otbers.
`
`SUMMARY OF THE INVENTION
`
`[0005)
`lbe present invention is embodied in metbods and
`apparatus for monitoring at least one physiological param(cid:173)
`eter of an animal from one or more physiological 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 characteristic at a device
`positioned remotely from the auditory canal to determine tbe
`physiological parameter.
`
`BRIEF DESCRIPTION OF TilE DRAWINGS
`
`[0006]
`lbe invention is best understood from the follow(cid:173)
`ing detailed description when read in connection with the
`accompanying drawings, with like elements having the same
`reference numerals. When 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 the ele(cid:173)
`ments collectively or to a non-specific one or more of tbe
`
`elements, the small leuer designation may be dropped. This
`emphasizes that, according to common practice, the various
`features of the drawings are not drawn to scale. On the
`contrary, the dimensions of the various fea tures 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 the exemplary monitoring device of
`F IG. 1 positioned on the bead of an an.ima l;
`[0009) FIG. 3 is a block diagram of exemplary compo(cid:173)
`nents w itbin the exemplary monitoring device in accordance
`witb tbe present invention;
`[0010] F IG. 4 is a cross-sectional view of a section of a
`conducto r portion of the monitoring device configured for
`positioning within the auditory canal in accordance with the
`present invention;
`
`[0011) FIG. 5 is an illustratio n of a sheath for covering at
`least a portion of a monitoring device io accordance with the
`present invention;
`
`[00 12) FIG. 6 is an illustration of a sheath partially
`positioned to cover a portion of the monitoring device in
`accordance with the present invention;
`[0013) FIG. 7 is an illustration of a s heath (lilly positioned
`to cover a portion of the monitoring device in accordance
`with the present invention;
`
`[0014) FIG. 8 is a block diagram of a monitoring system
`in accordance with the present invention; and
`[0015) F IG. 9 is a flow chart of exemplary steps for
`determining physiological parameters in accordance with
`the present invention.
`
`DETAILED DESCRIPTION OF THE
`INVENTI ON
`
`[0016] FIG. 1 and FIG. 2 are useful for providing a
`general overview of the present invention. FIG. 1 depicts an
`exemplary monitoring dev.ice 100 in accordance with the
`present invention. The monitoring device 100 includes a
`processor portion 102 and a conductor portion 104. In an
`exemplary embodiment, the conductor portion 104 is
`removably coupled to tbe 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(cid:173)
`nents 110 may be found within the conductor portion 104.
`T be conduc tor portion 104 includes a first end 112 config(cid:173)
`ured for insertion at least partially within the auditory canal
`of an animal and a second end 114 coupled to the processor
`portion 102.
`
`In use, the first end 112 of tbe conductor portion is
`[0018)
`positioned at least partially witbin the auditory canal of the
`animal to detect one or more physiological characteristics
`and pass the detected physiological characteristics through
`the conductor portion 104 from tbe first end U2 to tbe
`second e nd 114 for processing by tbe processor portion 102
`
`0009
`
`

`

`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( non-limiting example, temperature, pulse, blood(cid:173)
`oxygen content, and respiration rate. For example, the
`intensity of light transmiued through tissue of an auditory
`canal waU may be used in accordance 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 characteristics such as tempera(cid:173)
`ture may be considered both a physiological characteristic
`and a physiological parameter. Otber suitable pbysiological
`characteristics and parameters will be understood by those
`of skill in the an from the description herein.
`
`[0019] FIG. 2 depicts the exemplary monitoring device
`100 positioned relative to an ear 202 on the bead 204 of an
`animal. The car 202 includes an auricle 206 and an auditory
`canal208 adjacent the auricle 206. In an exemplary embodi(cid:173)
`ment, the processor portion 102 of the monitoring device
`100 is positioned at least partially between the auricle 206
`and the bead 204 of the animal and tbe first end 112 of the
`conductor portion 104 is positioned at least partially within
`the auditory canal 208. In an alternative exemplary embodi(cid:173)
`ment, the processor portion 102 may be positioned in
`essentially any localion 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(cid:173)
`ponents 110 (referred to herein as components 110) that may
`be located within tbe 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.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 tbe sensors, present information (e.g., via the presen(cid:173)
`tation device 312), and communicate information (e.g., via
`the data input/output circuitry 322/324 and the transceiver
`320). Further, the processor 314 is con.figured to store
`information to the 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 the sensors. A power regu(cid:173)
`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 here in.
`
`[0022) One or more of the sensors may reside in the
`conductor portion 104 near tbe first end 112 to sense
`physiological characteristics within the auditory canal. In
`Ibis embodiment, the sensors sense the physiological c har(cid:173)
`acteristics and generate electrical signals 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 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 s ignals through
`the conductor portion 104 between the auditory canal and
`the processor portion 102. Acoustic tubes may be used to
`transfer sounds from tbe 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 sk-ill in the art of bearing
`aids have developed various tube configurations for deliv(cid:173)
`ering sound to the auditory canal. Such tubes can also be
`used for receiving sounds from the auditory canal.
`
`[0024] Fiber optic cables communicate pbotonic 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 of light gen(cid:173)
`erated in tbc proces.sor portion 102 to the auditory canal and
`to transfer one or more wavelengths of light in the auditory
`canal (e.g., emanating from the auditory canal wall tissue) to
`the processor portion 102.
`
`[0025) Wires communicate electric/electronic signals
`through tbe conductor portion 104 between the auditory
`canal and the processor portion 102. Wires may be used to
`transfer electric/electronic signals generated in 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/electronic 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(cid:173)
`trodes are mounted in an ear mold, which is described in
`furtber detail below.
`
`In an exemplary embodiment, the conductor por(cid:173)
`[0026]
`tion 104 and the wires, acoustic tubes, and/or fiber optic
`cables extending through tbe 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 tbe 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
`erniuiog diode 330, a second light cmiuing diode 332, a
`photo detector 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 lining the auditory
`
`0010
`
`

`

`US 2005/0059870 Al
`
`Mar. 17,2005
`
`3
`
`canal wall in the vicinity of the first end 112 oft he 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 LEOs 330 and 332 and the light
`received at the photo detector diode 334 to determine pulse
`rate and/or blood oxygenation levels (i.e., physiological
`parameters). In 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 3301332
`and the photo diode 334, which are positioned within the
`first end 1l2 of the conductor portion 104. In an alternative
`exemplary embodiment, the LEOs 3301332 and/or the photo
`detector diode 334 may be positioned within the 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 conduc tor
`portion 104. 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 from the description herein.
`
`[0028) The electrocardiogram sensor 304 includes elec(cid:173)
`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 w ith wires leading from the processor
`portion 102 through the conductor portion from the second
`end 114 to the first end 112 where the wires contact tissue of
`the auditory canal waU. In an alternative exemplary embodi(cid:173)
`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(cid:173)
`toring device 100. In an exemplary embodiment, the accel(cid:173)
`erometer 306 may be positioned within the processor portion
`102. In 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 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 proccs.sor 346. In an exemplary
`embodiment, the microphone 344 may be positioned in the
`processor portion 102 with audio signals from the micro(cid:173)
`phone 344 being communicated from the auditory canal to
`the processor portion 102 throug h the conductor ponion 104
`via an acoustic tube. T he 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(cid:173)
`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 vi a a wire
`extending through the conductor portion 104.
`
`[0031) The thermister sensor 310 senses temperature. In
`thermister sensor 310
`an exemplary embodiment, the
`
`includes a thermister 348. T he thermister 348 may be
`positioned within the first end 112 of the conductor portion
`104. Electrical signals generated by
`the thermister in
`response to temperature within the auditory canal at the fi rst
`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(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 an
`exemplary embodiment, the speaker 350 may be positioned
`within the processor portion L02 with audio sig nals pre(cid:173)
`sented by the speaker 350 being communicated to the
`auditory canal via an acoustic tu be. In an alternative exem(cid:173)
`plary embodiment, the speaker 350 may be positioned
`within the conductor portion 104, e.g., ncar the first end 112,
`with clectricaVelectronic 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 o( the first end 112 of the conductor portion 104. T he
`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 fi rst end
`112. In an exemplary embodiment, tbe 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 (FlG. 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. lbe first electrical. wire 404 may be coupled to a
`tbermister 3 48 embedded w ithin a thermally conductive
`elastomer 410, which allows the communication of tempera(cid:173)
`ture from the auditory canal wall tis.suc to the thermistcr 348.
`The second electrical wire 406 terminates in an electrically
`conductive elastomer 412, w hich 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(cid:173)
`bility, and ease of manufacture. S uitable materials for use
`within the first end 112 include acrylic, vinyl, silicone, 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 tbermister 348), an RF transceiver
`320, and connection means (not s hown) for connection to
`the electrical wires 406/408, acoustic tube 400, and fiber
`optic cables 402. Ia accordance with this embodiment, the
`conductor portion 104 includes the thermister 348, electrical
`wires 406/408, acoustic tube 400, and fiber optic cables 402,
`
`0011
`
`

`

`US 2005/0059870 Al
`
`Mar. 17,2005
`
`4
`
`and provides structural support therefore. This embodiment
`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 positioned 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,
`due to its larger size (as compared to a monitoring device
`that is designed to 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 component selection. For example, the larger size
`allows more "ofl'-tbe-sbelf'' 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 lea')! a portion of the conductor portion 104
`(FlG. l ). The flexible sheath 500 includes a tip 502 that is
`configured [or 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(cid:173)
`eters, e.g., from 5 rom to 12 rum, may be provided to
`accommodate different auditory canal sizes. 1n 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/o r optically
`transparent through the presence of boles (represented by
`bole 504) in the tip 502, the material of the tip, and/or the
`thickness of the material of the tip. In an exemplary embodi(cid:173)
`ment, the boles 504 are sized to prevent cumen from
`entering the Lip portion 502 and coming in contact with 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 llcxiblc shcatb 500 being disposed
`when using the monitoring device 100 (FIG. 1) with sub(cid:173)
`sequent patients or at periodic intervals witb the same
`patient.
`
`[0037]
`In an exemplary e mbodiment, the flexible sheath
`500 is coupled to an integrated battery 506. Integrating tbe
`battery 506 into tbe flexible s heatb provides a fresh battery
`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 au alternative exemplary first end 112a configu red
`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, tbermister, ligbt emit(cid:173)
`ter(s) and/or light detector(s) (ancVorwires, fiber optic cables
`and/or acoustic tubes for coupling to such components
`positioned in tbc processor portion 102). As seen in FIG. 6,
`the first e nd 112a 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 112a within the auditory canal. In an
`alternative exemplary embodiment, a first end ll2 such as
`depicted in FIG. 4 may be used with the first end 112
`deforming to fit tbe body of the sheath 500 as the s beatb 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 througb the lip 502 of the sheath 500 when
`fully positioned on the monitoring device 100. In another
`alternative exemplary embodiment, tbe body of the sbeath
`500 may expand to accommodate the first end 112 as the
`s heath 500 is positioned on the monitoring device 100 and
`the first end 112 may contact the wall of tbe auditory canal
`through tbe tip 504 of the sbcatb 500 wben the s bcath 500
`is fully positioned on the monitoring device 100. Various
`alternative embodiments will be understood by those of skill
`in the art from tbe description herein. In an exemplary
`embodiment, the integrated ballery 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 flexible sheath installed. In an exemplary embodi(cid:173)
`ment, when monitoring a new patient, the batlery and
`flex ible s beath assembly may be removed from the moni(cid:173)
`toring device and a new flexible sbeath and battery assembly
`may be reattacbed to the monitoring device 100 in a single
`step.
`[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) (or communi(cid:173)
`cating witb the monitoring device 100 via tbe transceiver
`320 (FIG. 3) of the monitoring device 100. The monitoring
`device 100 may communicate with one or more of tbe
`remote devices 800. The monitoring device 100 may allach
`an identification code to each communication with the
`remote devices 800 so that a particular monitoring device
`100 is distinguishable from otber monitOring devices. In
`addition, each remote device 800 may anach 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 ao indi(cid:173)
`cation of the remote device 800 through which the moni(cid:173)
`tored information was received.
`[0041] FIG. 9 depicts a flow chart 900 of exemplary steps
`for monitoring physiological parameters in accordance witb
`the present invention. T he exemplary steps are be described
`with reference to FIGS. 1, 2, and 3 . Physiological param(cid:173)
`eters may be monitored from o ne or more physiological
`characteristics present with an auditory canal of an animal.
`
`[0042) At block 902, the monitoring device 100 senses
`one o r more physiological characteristics present within the
`auditory canal of the animal. In an exemplary embodiment,
`sensors within tbe monitoring device 100 such as a pulse
`oximetry sensor 302, EKG sensor 304, accelerometer 306,
`mkrophone 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, tbe physiological characteristics arc
`passed Erom within the auditory canal to a processing device
`102 positioned remote to the auditory canal, e.g., at least
`partially between the au.ricle of the ear and the bead of the
`animal for processing. In an exemplary embodiment, the
`physiological characteristics may be sensed by sensors posi(cid:173)
`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
`
`0012
`
`

`

`US 2005/0059870 Al
`
`Mar. 17,2005
`
`5
`
`may be communicated to the processing portion 102 (or
`processing by the processor 314 via wires extending through
`the conductor portion 104.
`
`ln an alternative exemplary embodiment, physi(cid:173)
`[0044)
`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 opticaJ 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 phy