(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization .
`International Bureau
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`||||I|||||||||ll||||||||I|||||J||||||||||Ill|||||||||||||||I|||||||||||||I||I|||||||||||||||||
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`(43) International Publication Date
`11 January 2007 (11.01.2007)
`
`(51) International Patent Classification:
`AISIB 5/00 (3006.01)
`
`(21) International Application Number:
`PC'l‘fl B2t)t}Gt[)5 I994
`
`(22) International Filing Date:
`
`20 June 2006 (2[).t}ti.2[)[}6)
`
`(10) International Publication Number
`
`WO 2007/004089 A1
`
`(81) Designated States (miter.-.‘ otlterwite indicated‘. for every
`kind of mttional protection available}: Ali, AG, AL, AM,
`AT. AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA. CH, CN,
`(I0. CR, CU, CZ, DIE, DK, DM, l)Z, EC, lili, lit}, 15S, 1-‘I,
`GB, GD, GE, GI-l, GM, IIN, Il'R, I-IU, ID, IL, IN, IS, JP,
`KE. KG, KM, KN, KP. KR, KZ, LA, LC. LK, LR. LS, LT,
`I.U_. IN’, LY, MA, MD, MG, MK, MN, MW, MX, MZ, NA,
`NG, N1, NO. NZ, OM, PG, PH, PL, VI‘. RO. RS. Ru, SC,
`SD. S19], SG. SK, Sl.. SM, SY, TJ, TM, TN, TR, T1‘, TZ,
`UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
`
`Designated States (tmtess otherwise indicated. for every
`kind of regional protection available): ARIPO (BW, G] I,
`GM, K11. LS, MW, MZ. NA. SD. SL, SZ, "W3, UG, ZM.
`ZW). [Eurasian (AM, AZ, BY, KG, Ki/., Ml), RU, TJ, TM),
`European (AT, BE, BG, C11, CY, CZ, DE, DK, EE, ES, FI,
`FR, GB, GR, HU, IE, IS. IT. LT, LU, LV, MC, NL, PL, PT.
`RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA,
`GN, GQ, GW, ML, MR, N15, SN, TD, TG).
`Published:
`
`with international Search report
`before the expiration of the time tirnit for amending the
`.r:.lz.It'm.i' (ind to be t'epttb.lt'.s'hea' in the event of rer_'et'pt of
`rttnetidtnettts
`
`(25) Filing Language:
`
`Publication Language:
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`(26)
`
`(30)
`
`English
`
`English
`
`Priority Data:
`6UI695.'}'35
`(1(ll?7'i',5t'}2
`
`30 June 3005 (30.05.2005)
`28 l"ehrLIary 2006 (28.{)2.?.Dtl(i)
`
`US
`US
`
`Applicant {for all de.i'.t'gm.Ited States extrept US): KONIN-
`KLLIKE PHILIPS ELECTRONICS, N.V.
`INLINL];
`Grocnewoudseweg 1, NL—56'3l BA Eindhovcn (NLL
`
`Inventors; and
`I nventorsmpplicants (fin US only): NIELSEN. Larry
`IUSIUS];
`'1' Thisllc Road, Burlington, Massachusetts
`01803 (US). MORONEY, Richard, M. [US.-’US|: 3 Kans-
`inglon Court, Princeton. New Jersey 03540 (US). POUX,
`Christoplier, .l. IUSIUSI; S95 Miner Road, Cleveland,
`Ohio 44143 (US).
`
`Common Representative: KONINKLIJKE PHILIPS
`l11[.EC'I‘RONlCS, N.\".; (Ito Lnndin, Thomas, M. 595
`Miner Road, Cleveland, Ohio 44143 (US).
`
`refer to the "Guid-
`For two-letter codes and other fl'I3bf€l*iflfI0fl.)'.
`ance Noter on Code: and xtbbrevicttions " appearing at the begin-
`nittg riferttrlt regular tune ofthe PCT Gazette.
`
`(54) Title: DEVICE PROVIDING SPOT-CHECK OF VITAL SIGNS USING AN l'N-THE-EAR PROBE
`
`INTERMEDIAFW -
`COMPONENT
`
`-
`
`. .
`
`PHYSIOLOGICAL MONITORING
`‘S
`‘DEVICE
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`DISPLAY
`2f:
`ESSOR
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`00
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`| POWER
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`3:
`STORAGE
`34
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`lo
`FITAB LE
`
`/—!fi
`
`CENTRAL
`_ MONITOFIING
`STATION
`
`---..-_............-_...--.g..
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`(57) Abstract: A portable physiological monitoring device (12) includes a receiver (22) that wirclcssly rcccives physiological moa-
`surcments from each ofa plurality ofin—1hc-car probes (I4) upon entering a com municalion range ofoncofthc in—tl1c—ear[)rohes (14).
`The portable physiological monitoring device ([2) farther includes a display (30) for presenting the physiological measurements.
`
`U.S. Patent No. 8 923 9
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`Apple Inc.
`APL1044
`U.S. Patent No. 8,923,941
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`0001
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`

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`W0 20lJ7J'00-I089
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`PCT!IB20l|6:"05l99-I
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`DEVICE FOR PROVIDING SPOT-CHECK OF
`VITAL SIGNS USING AN IN-THE-EAR PROBE
`
`DESCRIPTION
`
`The following relates to monitoring physiological parameters.
`
`It finds particular
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`application as a portable device t.hat receives physiological measurements such as blood
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`pressure, respiration, perfusion index, blood oxygen, pulse rate, body temperature, etc. from
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`an in-the-ear probe, displays the physiological measurement, and conveys the physiological
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`measurement to a monitoring station.
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`Physiological parameters have been measured from within the car via an in-the-ear
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`probe. One such probe includes a multi-parameter physiological measurement system that
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`non-invasively measures blood pressure as well as respiration, perfusion, blood oxygen, pulse
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`rate, body temperature, etc. fi'om within the ear canal. This probe includes a series of in-the-
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`car sensors that interconnect to electronics and a battery pack that are mounted behind the ear
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`or in connection with another location on the patient (e.g., around the neck, wrist, etc.). A
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`processor in the electronics analyzes the raw data and converts it into measurements of
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`physiological parameters that are wirelessly sent to a central monitoring station, which is
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`remote form the location of the subject being monitored.
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`Typically, such physiological parameters are continuously or periodically measured
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`and conveyed to the central monitoring station. However,
`
`in some instances it
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`is not
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`convenient for a clinician to have to view the parameters at the central monitoring station,
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`which is located away from the patient. In addition, instances exist wherein continuous andfor
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`periodic conveyance of such information is not desirable. For example, spot-cheek or on-
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`demand monitoring may be more desirable with patients having their vital signs checked only
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`every one, two, four
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`hours.
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`In another example, the network used for such conveyance
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`may have limited bandwidth that is shared with other wireless monitoring devices. Such
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`devices may have to compete for available bandwidth, which may result in delays andfor lost
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`data.
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`In yet another example, the sensitivity of the information may dictate how often it is
`
`transmitted, if at all.
`
`0002
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`

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`W0 2Gl|7:"00-I089
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`I’CT:"IB2l|06l'05l99-l-
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`In one aspect, a portable physiological monitoring device is illustrated. The portable
`
`physiological monitoring device includes a receiver and a display. The receiver wirelessly
`
`receives physiological measurements from each of a plurality of in-the-ear probes upon
`
`entering a communication range of one of the in-the-ear probes. The received physiological
`
`measurements are subsequently presented on the display.
`
`One advantage resides in locally displaying physiological signals measured with an in-
`
`the-ear probe.
`
`Another advantage is user validation of physiological signals measured with an in-the-
`
`ear probe.
`
`Another advantage is that spot-check monitoring of the physiological signals measured
`
`with an in-l.he—ear probe is facilitated.
`
`Another advantage is using the device as a continuous monitor for the physiological
`
`signals measured with an in-the-ear probe with or without the use of a central monitoring
`
`station.
`
`Still further advantages will become apparent to those of ordinary skill in the art upon
`
`reading and understanding the detailed description ofthe preferred embodiments.
`
`The drawings are only for purposes of illustrating embodiments and are not to be
`
`eonstmed as limiting the claims.
`
`FIGURE 1
`
`illustrates
`
`an exemplary physiological monitoring
`
`device
`
`that
`
`communicates with an in-the-ear physiological measurement probe and other physiological
`
`monitoring equipment.
`
`FIGURE 2 illustrates another exemplary physiological monitoring device that
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`communicates with an in-the~ear physiological measurement probe and other physiological
`
`monitoring equipment.
`
`FIGURE 3 ill uslrates an exemplary in-the-car physiological measurement probe.
`
`FIGURE 4 illustrates an in-the-ear physiological measurement probe connected to a
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`behind-the-ear supporting device.
`
`0003
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`

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`W0 2Gl|7t'00-I089
`
`I’CTt'IB2l|06l"05l99-l-
`
`FIGURE 1 illustrates a physiological monitoring system (“system”) 10. The system 10
`
`includes a physiological monitoring device 12, which is a mobile device that communicates
`
`with physiological measuring equipment (e.g., an in-t.he~ear probes, etc.) and devices (e.g., a
`
`central monitoring station, etc.) used in connection therewith. The physiological monitoring
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`device 12 can be hand held or held by an ambulatory carrier. As described in detail below, the
`
`physiological monitoring device 12 can be used to intercept, display, validate and forward (via
`
`wire or wirelessly) physiological measurements continuously over a wireless network, or spot-
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`check received physiological measurements obtained by an in-the-ear probe and communicate
`
`or download such measurements to a central monitoring station, send and receive information
`
`(e.g., physiological measurements, patient history, medical history, messages, notifications,
`
`alarms, etc.) to an authorized individual, the central monitoring station, another physiological
`
`monitoring device 12, etc., as well as various other activities.
`
`As briefly discussed above,
`
`the physiological monitoring device 12 is used in
`
`connection with other physiological monitoring equipment. For example, an in-the-ear probe
`
`14 (e.g., described in detail
`
`in connection with FIGURES 3-4 below) may be used at a
`
`hospital, a home, a nursing home, etc.
`
`to measure, record, andfor convey physiological
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`parameters (e.g., non-invasive blood pressure, pulse, blood oxygen, temperature, perfusion,
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`respiration, etc.) obtained by the probe 14 from within an ear of an individual.
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`In such
`
`environments, the physiological parameters may be wirelessly transmitted (e.g., continuously,
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`periodically at a predetermined rate, on-demand, upon occurrence of an event, etc.) fi'om the
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`probe 14 to a central monitoring station 16, an intermediate device l8 (e.g., a bedside monitor,
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`a signal router,
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`this physiological monitoring device 12 acting as a continuous bedside
`
`monitor, an input for a wired network that carries the measured parameters to the central
`
`station 16, etc.), etc. The physiological monitoring device 12 communicates (uni or bi-
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`directionally) with the probe 14, the central monitoring system 16, optionally the intermediate
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`device 18, andfor other devices such as a second intermediate component 20.
`
`Such
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`communication can be through wired (e.g., Ethernet‘, USB, serial, parallel, FireWire, optical
`
`0004
`
`

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`W0 2Gl|7l'00-I089
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`I’CT:"IB2l|06l"05l99-l-
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`wave guides,
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`telephone wire, coaxial cable, etc.) andfor wireless (e.g., radio frequency,
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`infrared, optical, mechanical wave, magnetism, etc.) technologies.
`
`Communication between the physiological monitoring device 12 and the probe 14
`
`includes, but is not limited to, reception andfor retrieval via a receiver 22 of physiological
`
`measurements obtained by the probe 14, requests transmitted by a transmitter 24 to the probe
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`14 instructing the probe 14 to perform andfor send a physiological measurement(s) to the
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`receiver 22, security indicia, device information such as a probe or device serial number, user
`
`identification, softwareffirmware upgrades for
`
`the probe 14, diagnostic applications to
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`troubleshoot the probe 14, etc.
`
`In one instance, the foregoing communication is directly
`
`between the physiological monitoring device 12 and the probe 14, while in another instance,
`
`such communication between the physiological monitoring device 12 and the probe 14 is
`
`facilitated by the intermediary component 18 andfor other components.
`
`The
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`receiver 22 andfor
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`the
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`transmitter 24 can communicate over various
`
`communication mediums. For instance, the probe 14 may reside within a body area network
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`60.
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`In this instance, the physiological monitoring device 12 can communicate within such
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`network to interact with the probe 14, one or more physiological sensors 62 positioned on the
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`patient, one or more emitters 64 positioned on the patient,
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`local measurement devices
`
`measuring physiological parameters, the intermediary component 18, another physiological
`
`monitoring device 12, etc. The central monitoring station 16 may communicate over a
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`network local to the facility, regional within the facility, andfor global to the community. The
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`network may be part of or communicate with one or more larger networks such as a large area
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`network (LAN), a wide area network (WAN), including the Internet, as well as other public
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`andfor private networks. The central monitoring station 16 may communicate this selected
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`information to the physiological monitoring device 12.
`
`A processor 26 controls the receiver 22 and the transmitter 24. For instance, upon
`
`entering a communication range of the probe 14, the processor 26 can automatically invoke
`
`the receiver 22 to detect and capture inlbnnation emitted by the probe 14, automatically
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`invoke the transmitter 24 to send a request to the probe 14 for infonnation stored therein,
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`automatically invoke the transmitter 24 to perform measurements, establish a secure
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`communication link with the probe 14, etc. Such requests may indicate which of a plurality of
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`-..4--
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`0005
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`

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`W0 2Gl|7t'00-I089
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`I’CT:"IB2l|06r'05l99-l-
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`possible physiological parameters (eg, blood pressure, blood oxygen, heart rate, respiration
`
`rate,
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`temperature, etc.)
`
`to measure.
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`The processor 26 can also automatically invoke
`
`conveyance of such information via the transmitter 24 to the central monitoring station 16 or
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`the intermediary component 20.
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`Controls 28 provide various knobs, buttons, switches, sliders, audio receivers, tactile
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`transducers, etc. to receivelsend control commands irom a user. For example, the controls 28
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`may include a mechanism with which the user can employ to invoke reception of information
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`from the probe 14 andfor the intermediary component 18 by the receiver 22 or transmission of
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`stored or received information by the transmitter 24 to the central monitoring station 16 andfor
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`the intermediary component 20.
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`A display 30 visually presents received physiological measurements, or information
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`from the central monitoring station, for observance by a user of the physiological monitoring
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`device 12.
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`In order to facilitate displaying such data, the display 30 can include, but is not
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`limited to, one or more light emitting diodes, seven segment displays, a liquid crystal display,
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`a flat panel display, a graphical user interface, etc. The controls 28 provide a user with a
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`means for selecting infomtation to present by the display 30 and configuring how the
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`information is presented by the display 30.
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`Information, applications, etc. can be stored within the physiological monitoring
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`device 12 in a storage component 32, which may include resident storage 34 and portable
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`storage 36. Both the resident and the portable storages 34 and 36 can include various types of
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`memory including volatile (e.g., various "flavors of random access memory (RAM)) and non-
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`volatile (e.g., various flavors of read only memory (ROM), flash memory, magnetic RAM
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`(MRAM), non-volatile RAM (NVRAM), etc.) memory. The portable storage 36 can be used
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`to transfer information stored therein from the physiological monitoring device 12 to the
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`intermediary component 20 andfor the central monitoring station 16 and vice versa. For
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`instance, flash memory (e.g., a universal serial bus (USB) based memory stick) can be inserted
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`into a suitable port on the physiological monitoring device 12.
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`Information can then be
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`directly stored thereto or t.rans'ferredr'copied from the resident storage 34 to the portable
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`storage 36. This can be achieved automatically upon inserting the portable storage 36 into a
`
`corresponding port, alter manually selecting information to store within the portable storage
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`-..5--
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`0006
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`

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`W0 2t}l|7r"00-I089
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`I’CT:"IB2l|06l'05l99-l-
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`34, etc. The portable storage 36 can then be removed and inserted into a suitable port of the
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`intermediary component 20 andfor the central monitoring station 16. The infomtation can be
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`automatically or manually retrieved from the portable storage 36.
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`In another instance, the
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`portable storage 36 can inserted into a suitable port of the intermediary component 20, the
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`central monitoring station 16, etc. and applications,
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`so'Itware:"linnware, and/or other
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`information can be loaded to the portable storage 36. The portable storage 36 can then be
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`removed therefrom and inserted into a suitable port of the physiological monitoring device 12,
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`wherein the information stored within the portable storage 36 can be moved to the resident
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`storage 34 of the physiological monitoring device 12.
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`The physiological monitoring device 12 may also include one or more ports 38 for
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`communicating information. The transmitter 24 can transmit information through the ports 38
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`to the central monitoring station, the intermediary component 20, etc. Suitable wired ports
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`include, but are not limited to, Ethernet, USB, serial, parallel, FireWire, optical, and the like.
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`A power component 40 provides power to power the various components of the
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`physiological monitoring device 12. The power component 40 can include one or more of a
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`rechargeable andfor a non-rechargeable battery, a solar cell, a port for receiving DC from an
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`AC to DC converter, an AC to DC converter, andfor the like.
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`In one instance, the ear probe 14 continuously transmitsfemits information to the
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`central monitoring station 16. When a user enters an area (eg, a room) with the physiological
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`monitoring device 12,
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`the physiological monitoring device 12 receives real-time signals
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`emitted by the probe 14 and presents a corresponding display via the display component 30.
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`The user can view the information, validate the monitored vital signs,
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`inter whether the
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`monitored signals are accurate (e.g., by assessing signal quality, by comparing the in formation
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`with previously stored information, ranges for typical in'l'ormation, etc.), etc.
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`If a reading
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`appears suspicious, the user can wait for signal quality to improve, take action to improve
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`signal quality, or check the measurement with another instrument. When all readings appear
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`to be correct, the user can provide the information andfor a validation indication to the central
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`monitoring station 16.
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`In another instance, the physiological monitoring device 12 is used for on-demand
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`monitoring or spot-checks.
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`In this embodiment, the probe 14 is configured such that it does
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`-..5--
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`0007
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`

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`W0 2Gl|7:"00-I089
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`I’CT:"IB2l|06l'05l99-l-
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`not continuously broadcast information. Rather, each time the user wants to view vital signs,
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`the physiological monitoring device 12 requests and receives the current or stored vital signs
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`using a low power
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`short-range communication,
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`such as Bluetooth, body coupled
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`communications, and the like. Once the user has validated the readings, the physiological
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`monitoring device 12 conveys the readings to the central monitoring station 16 with a higher
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`power transmission with longer range. This conveyance can be achieved in real time by a
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`radio frequency signal or the like, or the physiological monitoring device 12 can store the
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`readings of one or more individuals in the storage component 32 and subsequently transfer the
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`readings via a wireless or wired means to the central monitoring station 16.
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`In another instance,
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`the physiological monitoring device 12 performs the above-
`
`diseussed functions and further assumes additional fimetjons that were previously performed
`
`by other devices.
`
`For example,
`
`the physiological monitoring device 12 may be able to
`
`communicate with staff members.
`
`In addition to communicating with other physiological
`
`monitoring devices 12 being used by other staff members, the physiological monitoring device
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`12 may be able to interact with personal data assistant, cell phones, becpers, telephones, email,
`
`etc. directly or through the central station 16. Through such devices, the physiological
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`monitoring device 12 may be able to receive and deliver messages, notifications, medication
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`schedules, documented delivery of medication, chart highlights, vitals validation, iniiormation,
`
`alarms, paging, etc. to a care-giver, a guardian, etc.
`
`The physiological monitoring device 12 can also be used to memorialize, document,
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`chart, etc. activity.
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`Such activity can include, but
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`is not
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`limited to, physiological
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`measurements and data derived thereform, the delivery of medications or medical assistance,
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`the individual(s) administering the medications or medical assistance,
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`the time such
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`medications and assistance was given, scheduled procedures, medical history, unique
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`identification, patient name, health insurance provider, family history, treating physicians, test
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`results, etc.
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`FIGURE 2 illustrates the physiological monitoring device 12 further having an
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`analyzer 42, a messaging component 44, and a security component 46. The analyzer 42
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`analyzes information received from the probe 14 and generates trends, predicate "Future health,
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`suggest treatments, etc.
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`In addition, the analyzer 42 provides processing capabilities to
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`-..7--
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`0008
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`W0 2Gl|7t'00-I089
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`I’CT:"IB2l|06l'05l99-l-
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`process the received physiological measurements information. Suitable processing includes
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`combining, averaging, weighting, etc. data. The raw andfor processed data can be presented to
`
`the user via alpha—numeric symbols, graphs, plots, audio, icons, trends, projections, historical
`
`comparisons, etc. on the display 30 andfor the central processing station 16.
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`The analysis can also be used to validate that received physiological measurements are
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`within pre-stored ranges. For example, the analyzer 42 can assess signal quality and compare
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`received measurements with acceptable ranges stored in the storage 32.
`
`Physiological
`
`measurements having insufficient signal quality, or that fall outside of expected physiological
`
`ranges may invoke the physiological monitoring device 12 to request re-transmissions of the
`
`information, request performance of new measurements, andlor sound an alarm. Such alarm
`
`may be a visual andfor audio alarm within the physiological monitoring device 12, an alarm at
`
`the central monitoring system, andfor other alarms.
`
`Such alarms may also include
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`transmission of alarms, messages, notifications, etc. by the messaging component 44 to
`
`various individuals through various devices. Examples of suitable devices include, but are not
`
`limited to, another physiological monitoring device l2, a personal data assistant, a cell phone,
`
`beepers, a telephone, email, abccper, a pager, etc.
`
`The messaging component 44 may also send genera] messages, notifications, etc. to
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`such individuals andfor equipment. The general messages, notifications, etc. may indicate that
`
`it is time to read a physiological measurement, administer a medication, replace or recharge a
`
`battery, etc. andfor that a physiological measurement has been acquired, a medication has been
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`administered, an identi lication of the medical professional performing the activity, etc.
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`In one
`
`instance, the messaging component 44 can be used as a walkie-talkie to allow the user to
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`audibly communicate with an individual at the central monitoring station, an individual using
`
`a similar device, a cell phone, etc.
`
`The security component 46 can be used to determine whether the user of the
`
`physiological monitoring device 12 is an authorized user. For instance, the physiological
`
`monitoring device 12 may require the user to enter a password or other identifying indicia that
`
`can be checked against predetermined authorized information. Likewise, security component
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`46 can validate the probe 14 to ensure that the probe 14 is associated with the correct
`
`individual (e.g., via unique identification entered by user or read from an RFID tag), that the
`
`-..3--
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`0009
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`

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`W0 20[|7J'lJ0-I089
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`PCT! 11320063051994
`
`physiological monitoring device 12 is authorized to communicate with the probe 14 (e.g., by
`
`checking unique identification, serial number, etc.), set up an encoded communication link
`
`with the probe 16, etc. For unauthorized use or communication, the physiological monitoring
`
`device 12 can lock the controls 28, dim the display 30, invoke the messaging component 44 to
`
`sound an alarm, etc.
`
`FIGURE 3
`
`illustrates an exemplary configuration of the probe 14.
`
`In this
`
`configuration, the probe 14 is an in-the-ear (ITE) physiological measurement apparatus For
`
`measuring one or more physiological signals (c.g., blood pressure, pulse, blood oxygen,
`
`pcrfirsion, temperature, respiration...) from within an ear canal. The probe 14 includes a
`
`structure 48 that inserts into the ear canal. The structure 48 is suitably dimensioned to enter
`
`the ear canal to a suitable depth and adapts to various shaped ear canals (e.g., different
`
`curvatures). That is, the structure 48 is small in diameter compared to the diameter of the ear
`
`canal.
`
`In one instance, the structure 48 projects into the ear canal such that an end portion is
`
`positioned proximate to a bony region of the ear or other relatively quiet zone of the ear canal.
`
`The end portion of the structure 48 residing in the ear canal may be fabricated with a
`
`spongy expandable material, or include an annular inflatable balloon 50. The spongy material
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`or inflatable balloon 50 surrounds the end portion of the structure 48 (as illustrated) or suitable
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`portions thereof. The spongy material or inflatable balloon 50 ideally supports one or more
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`sensors 52 that are operatively coupled to a surlace of the spongy material or balloon 50 and
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`that measure physiological signals. Suitable sensors include light emitting diodes (LEDs), an
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`infrared (IR) source,
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`light detectors, a pressure transducer, a microphone, a speaker, an
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`accelerometer, and a thermistor, for example. The sensors 52 are strategically positioned on
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`the spongy material or balloon 50.
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`For example, a light detecting sensor typically is
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`positioned to minimize or prevent absorption of light not indicative of the physiological
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`process under measurement (e.g., light from outside the ear, light emitted liom another sensor
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`located on the spongy material or balloon 50...). Although depicted as circular, the one or
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`more sensors 46 can be any shape. Alternatively, the sensors could be mounted within the end
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`portion of the structure 48 and could be moved into contact with the tissue once inserted into
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`the ear.
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`The inflatable balloon 50 is inflated to position, or the spongy material positions the
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`one or more sensors 52 proximate to appropriate tissue within the ear canal with ideal force
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`and pressure to ensure close coupling of sensors with tissue but without causing decreased
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`perfiision or blanching of the tissue. By way of example, the structure 48 is inserted such that
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`the end portion with the spongy material or balloon 50 residing in the ear canal is in a bony
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`region of the ear. The balloon S0 is inflated to position, or the spongy material positions the
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`sensors 52 proximate to inner ear tissue to sense signals indicative of physiological states,
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`including blood pressure, temperature, pulse, respiration, and blood oxygen, lbr example.
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`For adult humans, this includes inflating the balloon, or allowing the spongy material
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`50 to conform to the widely varying ear canal diameters from about 6 mm to about 13 mm.
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`For neonates and small pediatrics, where the ear canal diameter various from about 4 mm in
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`diameter to about 7 mm in diameter, smaller and shorter ITE devices are used. Typically,
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`sensors for measuring blood oxygen are positioned proximate to ear canal
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`tissue that is
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`perfused with arterial blood supplied by branches of the External as well as the Internal
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`Carotid Arteries,
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`thus serving as a well perfused physiological site even if the body is
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`experiencing peripheral shutdown due to shock or other conditions. Such sensors include an
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`energy emitting means (e.g., an LED, an IR source...) and an energy detecting means that
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`detects energy transmission through the vascular tissue.
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`In another example, a temperature
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`sensor (e.g., a thermistor) is also positioned proximate to vascular tissue.
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`In yet another
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`example, sensors for sensing audio signals (e.g., a microphone) indicative of pulse pressure
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`sounds, andfor respirations are suitably positioned in relatively quite regions of the ear canal to
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`mitigate sensing extraneous audio signals (noise).
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`The inflatable balloon 50 must be used to facilitate non-invasively measuring blood
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`pressure. For a non-invasive blood pressure measurement, the inflatable balloon S0 is inflated
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`until it occludes blood How in a portion of the ear proximate a blood pressure sensor(s) (e.g., a
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`pressure transducer) opcratively connected to the inflatable balloon 50. The pressure in the
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`inflatable balloon 50 is then suitably released to deflate the inflatable balloon 50. A systolic
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`and a diastolic blood pressure are obtained during inflation andfor deflation using an
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`auscultatory approach (e.g., via a microphone operatively connected to the balloon S0) andfor
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`an oseillometric approach (e.g., via optical sensing components attached to the balloon).
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`A continuous non-invasive blood pressure is measured by obtaining an initial blood
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`pressure measure as describe above and then re—ini-lating the balloon 50 to a mean pressure. A
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`servo mechanism periodically adjusts balloon pressure to locate a maximum pulse waveform
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`amplitude indicative of mean blood pressure. As long as the derived mean pressure is
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`relatively close to the initial pressure andior the pulse waveform amplitudes are relatively
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`close, the derived continuous systolic, diastolic, and mean blood pressure are calculated with
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`high accuracy.
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`The structure 48 includes one or more passageways (not shown) that extend through
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`the structure 48. Such passageways house sensor data, power, and control wires, provide a
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`hermetically sealed channel for inflating/dellating the balloon 50, andfor allow pressure inside
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`the ear to equalize with the environment during balloon inllationfdellation.
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`In one instance,
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`the structure 48 includes a channel for both housing sensor wiring and inllating/deflating the
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`balloon 50. The channel
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`isolates the wires from the inner ear environment, mitigating
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`contamination of both the ear and the sensor wiring and provides a pressurized air conduit to
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`the balloon 50.
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`In another instance, the structure 48 includes separate channels for sensor
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`wiring and inflating/deflating the balloon 50; one or more first channels house sensor wiring
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`and a second channel provides the pressurized air conduit for inflating/deflating the balloon
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`50.
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`In yet another example, an optional channel provides an ear pressure stabilizing
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`mechanism that allows ear pressure to equalize with the environment during balloon inflation
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`andfor dellation. This channel mitigates pressure build-up in the car during balloon inllation
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`andfor deflation and potential pain therefrom. The passageways can be variously shaped (e.g.,
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`oval, rectangular, irregular. ..) to be conducive to the ear canal.
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`FIGURE 4 illustrates the ITE probe l4 mechanically and electrically coupled with an
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`exemplary behind-the-ear (BTE) device 54.
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`In one instance, the structure 48 and the BTE
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`device 54 are formed as a single unit, while in another instance the structure 48 and the BTE
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`device 54 are detachably connected (as illustrated).
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`Such attachment can be through a
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`fastening means including a threaded connector, a snap, a set screw, an adhesive, a rivet, etc.
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`An arm 56 provides support behind the car and a battery 58 powers both devices. An optional
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`sheath (not shown) can be placed over the structure 48 andfor balloon 50 to protect the ear and
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`the structurcfballoonfsensor assembly from contamination.
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`In one aspect, the sheath can be
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`semi-permeable to allow air flow, but prevent fluid from moving fi'om one side of the sheath
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`to the other side.
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`In another aspect, the sheath prevents substantially all matter from moving
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`from one side of the sheath to the other side. The structurefballoonfsensor assembly can be
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`disposable, washable, andfor sterilizeable.
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`In another embodiment, the in the ear structure 48 houses a smaller battery, a low
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`powered transmitter, a processor and the like. A separate unit carried by the patient houses a
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`receiver for the low power signals, a higher power transmitter which communicates with the
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`physiological monitor device 12, the central station 16, etc., a larger battery, and, optionally, a
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`processor, memory, and action appropriate components and software.
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`The invention has been described with reference to the preferred embodiments.
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`Modifications and alterations may occur to others upon reading and understanding the
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`preceding detailed description. It is intended that the invention be construct