`
`(19) World Intellectual Property Organization {
`International Bureau
`
`(43) International Publication Date
`11 January 2007 (11.01.2007)
`
`(51) International Patent Classification:
`AGIB 5/00 (2006.01)
`
` 2)0
`
`(10) International Publication Number
`WO 2007/004089 Al
`
`(21) International Application Number:
`PCT/IB2006/05 1994
`
`(22) International Filing Date:
`
`20 June 2006 (20.06.2006)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`60/695,725
`60/777 ,502
`
`30 June 2005 (30.06.2005)
`28 February 2006 (28.02.2006)
`
`US
`US
`
`(71) Applicant (for all designated States except US): KONIN-
`KLIJKE PHILIPS ELECTRONICS, N.V.
`[NL/NL];
`Groenewoudseweg 1, NL-5621 BA Eindhoven (NL).
`
`(72)
`(75)
`
`Inventors; and
`Inventors/Applicants (for US only): NUELSEN, Larry
`[US/US];
`7 Thistle Road, Burlington, Massachusetts
`01803 (US). MORONEY,Richard, M. [US/US]; 3 Kens-
`ington Court, Princeton, New Jersey 08540 (US). POUX,
`Christopher, J. [US/US]; 595 Miner Road, Cleveland,
`Ohio 44143 (US).
`
`(81) Designated States (unless otherwise indicated, for every
`kind of national protection available): AF, AG, AL, AM,
`AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN,
`CO, CR, CU, CZ, DE, DK, DM, DZ, EC, HE, EG, ES, FI,
`GB, GD, GE, GH, GM, HN, HR, HU, ID, IL, IN, IS, JP,
`KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT,
`LU, LV, LY, MA, MD, MG, MK, MN, MW, MX, MZ, NA,
`NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS, RU, SC,
`SD, SE, SG, SK, SL, SM, SY, TJ, TM, TN, TR, TT, TZ,
`UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
`
`(84) Designated States (unless otherwise indicated, for every
`kind ofregional protection available): ARIPO (BW, GH,
`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM,
`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`European (AT, BE, BG, CH, 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, NE, SN, TD, TG).
`Published:
`
`— with international search report
`before the expiration of the time limit for amending the
`claims and to be republished in the event of receipt of
`amendments
`
`(74) Common Representative: KONINKLIJKE PHILIPS
`ELECTRONICS, N.V.; C/o Lundin, Thomas, M. 595
`Miner Road, Cleveland, Ohio 44143 (US).
`
`For two-letter codes and other abbreviations, refer to the "Guid-
`ance Notes on Codes and Abbreviations" appearing at the begin-
`ning of each regular issue of the PCT Gazette.
`
`(54) Title: DEVICE PROVIDING SPOT-CHECK OF VITAL SIGNS USING AN IN-THE-EAR PROBE
`
`18
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`2007/004089A.IINTININNNNIMNTNIIITITANIUMHMMTAY
`
`CENTRAL
`_| MONITORING
`PHYSIOLOGICAL MONITORING
`STATION
`4DEVICE
`a5
`RECIEVER||TRANSMITTER
`
`40
`30
`[ POWER
`STORAGE
`
`34
`
`44
`
`DISPLAY
`26
`PROCE:
`R
`OSESEO)
`28
`CONTROLS38
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`(57) Abstract: A portable physiological monitoring device (12) includes a receiver (22) that wirelessly receives physiological mea-
`surements from each ofa plurality of in-the-ear probes (14) upon entering a communication range of oneof the in-the-ear probes (14).
`The portable physiological monitoring device (12) farther includes a display (30) for presenting the physiological measurements.
`
`5
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`0001
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`Apple Inc.
`APL1044
`U.S. Patent No. 8,923,941
`
`Apple Inc.
`APL1044
`U.S. Patent No. 8,923,941
`
`0001
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`
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`WO 2007/004089
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`PCT/1B2006/051994
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`DEVICE FOR PROVIDING SPOT-CHECK OF
`VITAL SIGNS USING AN IN-THE-EAR PROBE
`
`DESCRIPTION
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`The following relates to monitoring physiological parameters.
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`It finds particular
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`application as a portable device that 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 ear 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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`10
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`rate, body temperature, etc. from within the car canal. This probe includesa series of in-the-
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`ear 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,
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`in some instances it 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 and/or
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`20
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`periodic conveyance of such information is not desirable. For example, spot-check 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 ... 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 mayresult in delays and/or lost
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`25
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`data.
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`In yet another example, the sensitivity of the information may dictate how often it is
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`transmitted, if at all.
`
`0002
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`0002
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`WO 2007/004089
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`PCT/IB2006/051994
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`In one aspect, a portable physiological monitoring device is illustrated. The portable
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`physiological monitoring device includes a receiver and a display. The receiver wirelessly
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`receives physiological measurements from each of a plurality of in-the-car probes upon
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`entering a communication range of one of the in-the-ear probes. The received physiological
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`measurements are subsequently presented on the display.
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`One advantage resides in locally displaying physiological signals measured with an in-
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`the-car probe.
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`Another advantage is user validation ofphysiological signals measured with an in-the-
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`ear probe.
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`Another advantage is that spot-check monitoring of the physiological signals measured
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`with an in-the-ear probe is facilitated.
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`Another advantage is using the device as a continuous monitor for the physiological
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`signals measured with an in-the-ear probe with or without the use of a central monitoring
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`station.
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`Still further advantages will become apparent to those of ordinary skill in the art upon
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`reading and understanding the detailed description ofthe preferred embodiments.
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`20
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`The drawings are only for purposes ofillustrating embodiments and are not to be
`
`construedaslimiting the claims.
`
`FIGURE 1
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`illustrates
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`an exemplary physiological monitoring
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`device
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`that
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`communicates with an in-the-ear physiological measurement probe and other physiological
`
`monitoring equipment.
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`ZS
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`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.
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`FIGURE3 illustrates an exemplary in-the-ear physiological measurementprobe.
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`FIGURE4illustrates an in-the-car physiological measurement probe connected to a
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`30
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`behind-the-ear supporting device.
`
`wan Downe
`
`0003
`
`0003
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`
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`WO 2007/004089
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`PCT/IB2006/051994
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`FIGURE1illustrates a physiological monitoring system (“system”) 10. The system 10
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`includes a physiological monitoring device 12, which is a mobile device that communicates
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`with physiological measuring equipment(e.g., an in-the-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 handheld or held by an ambulatory carrier. As described in detail below, the
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`physiological monitoring device 12 can be usedto intercept, display, validate and forward (via
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`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-car probe and communicate
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`or download such measurements to a central monitoring station, send and receive information
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`(e.g., physiological measurements, patient history, medical history, messages, notifications,
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`alarms, etc.) to an authorized individual, the central monitoring station, another physiological
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`monitoring device 12, etc., as well as various otheractivities.
`
`Asbriefly discussed above,
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`the physiological monitoring device 12 is used in
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`connection with other physiological monitoring equipment. For example, an in-the-car probe
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`14 (e.g., described in detail
`
`in connection with FIGURES 34 below) may be used at a
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`hospital, a home, a nursing home, etc.
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`to measure, record, and/or convey physiological
`
`parameters (e.g., non-invasive blood pressure, pulse, blood oxygen, temperature, perfusion,
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`20
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`respiration, etc.) obtained by the probe 14 from within an ear of an individual.
`
`In such
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`environments, the physiological parameters may be wirelessly transmitted (c.g., continuously,
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`periodically at a predetermined rate, on-demand, upon occurrence of an event, etc.) from the
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`probe 14 to a central monitoring station 16, an intermediate device 18 (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
`
`ZS
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`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, and/or other devices such as a second intermediate component 20.
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`Such
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`communication can be through wired (e.g., Ethernet, USB,serial, parallel, FireWire, optical
`
`ras fou
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`0004
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`0004
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`WO 2007/004089
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`PCT/IB2006/051994
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`wave guides,
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`telephone wire, coaxial cable, etc.) and/or 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
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`includes, but is not limited to, reception and/or retrieval via a receiver 22 of physiological
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`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 and/or 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
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`identification, software/firmware upgrades for
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`the probe 14, diagnostic applications to
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`troubleshoot the probe 14, etc.
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`In one instance, the foregoing communication is directly
`
`between the physiological monitoring device 12 and the probe 14, while in another instance,
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`such communication between the physiological monitoring device 12 and the probe 14 is
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`facilitated by the intermediary component18 and/or other components.
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`The
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`receiver 22 and/or
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`the
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`transmitter 24 can communicate over various
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`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
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`measuring physiological parameters, the intermediary component 18, another physiological
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`monitoring device 12, etc. The central monitoring station 16 may communicate over a
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`20
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`networklocal to the facility, regional within the facility, and/or global to the community. The
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`network may be part of or communicate with one or more larger networks such asa 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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`and/or private networks. The central monitoring station 16 may communicate this selected
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`information to the physiological monitoring device 12.
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`ZS
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`A processor 26 controls the receiver 22 and the transmitter 24. For instance, upon
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`entering a communication range of the probe 14, the processor 26 can automatically invoke
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`the receiver 22 to detect and capture information emitted by the probe 14, automatically
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`invoke the transmitter 24 to send a request to the probe 14 for information stored therein,
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`automatically invoke the transmitter 24 to perform measurements, establish a secure
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`30
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`communication link with the probe 14, etc. Such requests may indicate which ofa plurality of
`
`--4--
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`0005
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`0005
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`
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`WO 2007/004089
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`PCT/IB2006/051994
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`possible physiological parameters (e.g., blood pressure, blood oxygen, heart rate, respiration
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`rate,
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`temperature, etc.)
`
`to measure.
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`The processor 26 can also automatically invoke
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`conveyanceof such information via the transmitter 24 to the central monitoring station 16 or
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`the intermediary component20.
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`Controls 28 provide various knobs, buttons, switches, sliders, audio receivers, tactile
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`transducers, etc. to receive/send control commands from 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 and/or 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 and/or
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`the intermediary component20.
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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 segmentdisplays, 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 information 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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`20
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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 (c.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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`ZS
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`intermediary component 20 and/or 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 transferred/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
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`30
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`corresponding port, afier manually selecting information to store within the portable storage
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`oe
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`0006
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`0006
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`WO 2007/004089
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`PCT/IB2006/051994
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`34, etc. The portable storage 36 can then be removed andinserted into a suitable port of the
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`intermediary component 20 and/orthe central monitoring station 16. The information 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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`software/firmware, 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 ofthe
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`physiological monitoring device 12. The power component 40 can include one or more of a
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`rechargeable and/or 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, and/or the like.
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`In one instance, the ear probe 14 continuously transmits/emits information to the
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`central monitoring station 16. When a user enters an area (e.g., a room) with the physiological
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`20
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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 component30.
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`The user can view the information, validate the monitored vital signs,
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`infer whether the
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`monitored signals are accurate (c.g., by assessing signal quality, by comparing the information
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`with previously stored information, ranges for typical information, ctc.), etc.
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`If a reading
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`ZS
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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 instrament. Whenall readings appear
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`to be correct, the user can provide the information and/ora 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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`30
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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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`oe
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`0007
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`WO 2007/004089
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`PCT/IB2006/051994
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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 orstored vital signs
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`using a low power
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`short-range communication,
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`such as Bluctooth, 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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`powertransmission 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 meansto the central monitoringstation 16.
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`In another instance,
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`the physiological monitoring device 12 performs the above-
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`discussed functions and further assumes additional functions that were previously performed
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`by other devices.
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`For example,
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`the physiological monitoring device 12 may be able to
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`communicate with staff members.
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`In addition to communicating with other physiological
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`monitoring devices 12 being used by other staff members, the physiological monitoring device
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`12 maybeableto interact with personaldata assistant, cell phones, beepers, telephones, email,
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`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, information,
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`alarms, paging, etc. to a care-giver, a guardian,etc.
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`20
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`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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`ZS
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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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`30
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`suggest treatments, etc.
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`In addition, the analyzer 42 provides processing capabilities to
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`oa Fen
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`WO 2007/004089
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`PCT/IB2006/051994
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`process the received physiological measurements information. Suitable processing includes
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`combining, averaging, weighting, etc. data. The raw and/or processed data can be presented to
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`the user via alpha-numeric symbols, graphs, plots, audio, icons, trends, projections, historical
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`comparisons,etc. on the display 30 and/or the central processing station 16.
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`The analysis can also be usedto 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.
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`Physiological
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`measurements having insufficient signal quality, or that fall outside of expected physiological
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`ranges may invoke the physiological monitoring device 12 to request re-transmissions of the
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`information, request performance of new measurements, and/or sound an alarm. Such alarm
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`may be a visual and/or audio alarm within the physiological monitoring device 12, an alarm at
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`the central monitoring system, and/or other alarms.
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`Such alarms may also include
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`transmission of alarms, messages, notifications, etc. by the messaging component 44 to
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`various individuals through various devices. Examplesofsuitable devices include, but are not
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`limited to, another physiological monitoring device 12, a personal data assistant, a cell phone,
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`beepers, a telephone, email, a beeper,a pager, etc.
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`The messaging component 44 mayalso send general messages, notifications, etc. to
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`such individuals and/or equipment. The general messages,notifications, etc. may indicate that
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`it is time to read a physiological measurement, administer a medication, replace or recharge a
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`20
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`battery, etc. and/or that a physiological measurementhas been acquired, a medication has been
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`administered, an identification of the medical professional performingthe activity, etc.
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`In one
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`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
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`a similar device, a cell phone,etc.
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`ZS
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`The security component 46 can be used to determine whether the user of the
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`physiological monitoring device 12 is an authorized user. For instance, the physiological
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`monitoring device 12 may require the user to enter a password orother identifying indicia that
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`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
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`30
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`individual (c.g., via unique identification entered by user or read from an RFID tag), that the
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`oe
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`0009
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`WO 2007/004089
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`PCT/1B2006/051994
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`physiological monitoring device 12 is authorized to communicate with the probe 14 (e.g., by
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`checking unique identification, serial number, etc.), set up an encoded communication link
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`with the probe 16, etc. For unauthorized use or communication, the physiological monitoring
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`device 12 can lock the controls 28, dim the display 30, invoke the messaging component 44 to
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`sound an alarm,etc.
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`FIGURE 3 illustrates an exemplary configuration of the probe 14.
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`In this
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`configuration, the probe 14 is an in-the-ear (ITE) physiological measurement apparatus for
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`measuring one or more physiological signals (e.g., blood pressure, pulse, blood oxygen,
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`perfusion, temperature, respiration...) from within an ear canal. The probe 14 includes a
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`structure 48 that inserts into the ear canal. The structure 48 is suitably dimensioned to enter
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`the ear canal to a suitable depth and adapts to various shaped ear canals (e.g., different
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`curvatures). That is, the structure 48 is small in diameter compared to the diameter of the ear
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`canal.
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`In one instance, the structure 48 projects into the ear canal such that an end portion is
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`positioned proximate to a bony region ofthe ear or otherrelatively quiet zoneoftheear canal.
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`The end portion of the structure 48 residing in the car canal may be fabricated with a
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`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 ofthe 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 surface of the spongy material or balloon 50 and
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`20
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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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`25
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`process under measurement(e.g., light from outside the ear, light emitted from 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 ofthe 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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`perfusion 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 car canal is in a bony
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`region of the ear. The balloon 50 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, for 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 (c.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, and/or respirations are suitably positioned in relatively quite regions ofthe 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 50 is inflated
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`until it occludes blood flow in a portion of the ear proximate a blood pressure sensor(s) (e.g., a
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`pressure transducer) operatively 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 and/or deflation using an
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`auscultatory approach (c.g., via a microphone operatively connected to the balloon 50) and/or
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`an oscillometric approach(c.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 aboveandthenre-inflating 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 and/or 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/deflating the balloon 50, and/or allow pressure inside
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`the ear to equalize with the environment during balloon inflation/deflation.
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`In one instance,
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`the structure 48 includes a channel for both housing sensor wiring and inflating/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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`and/or deflation. This channel mitigates pressure build-up in the ear during balloon inflation
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`and/or deflation and potential pain therefrom. The passageways can be variously shaped(e.g.,
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`oval, rectangular, irregular...) to be conduciveto the ear canal.
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`FIGURE4 illustrates the ITE probe 14 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 asa 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 behindthe ear and a battery 58 powers both devices. An optional
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`sheath (not shown)can be placed over the structure 48 and/or balloon 50 to protect the ear and
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`30
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`the structure/balloon/sensor 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 from oneside 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 structure/balloon/sensor assembly can be
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`disposable, washable, and/orsterilizeable.
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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 powersignals, 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 constructed as includingall
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`such modifications and alterations insofar as they come within the scope of the appended
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`claimsor the equivalents thereof.
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