(12) INTERNATIONAL APPLICATION P UBLISHED UNDE R THE PATENT COO PE RATION TREATY (PCT)
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`IIIIIIIIIIIUIIIIIIIIIIIIWIIIIIIImiiiiiiiiiiiUIIIUIIIIIIIIIIIIUIIIIIIII
`
`(43) InternationaJ Publication Date
`11 January 2007 (11.01.2007)
`
`PCT
`
`(10) International Publication Number
`WO 2007/004089 Al
`
`(51) International P a tent Classification:
`A6 1 B 5100 (2006.0 1)
`
`(21) interna tion al Ap p lication Num ber:
`PCf/182006/051994
`
`(22) Internation al Filing Da te:
`
`20 June 2006 (20.06.2006)
`
`(25) F iling Lan guage:
`
`(26) P ublication Language:
`
`English
`
`English
`
`(30) Priority Da ta:
`60/695,725
`60n77,502
`
`30 June 2005 (30.06.2005) US
`28 Pebruary 2006 (28.02.2006) US
`
`(71) Applicant (for aLL desig11ated States except US): KONIN(cid:173)
`KLLJKE P HILIPS ELECTRONICS, N.V. [NLINL];
`Grocnewoudseweg 1, NL-5621 BA Eindhoven (NL).
`
`(72) In ventors; a nd
`(75) Inven tors/Applicants (for US onLy): NIE LSEN, La rry
`(US/US]; 7 Thistle Road , Burlington, Massachuseus
`01803 (US). M ORONEY, Rich ard, M. [US/US]; 3 Kens(cid:173)
`ingtOn Coun, Princeton, New Jersey 08540 (US). POUX,
`C hris topher, J. [US/US]; 595 Miner Road, Cleveland,
`Ohio 44143 (US).
`
`(81) Designated States (unless orhenvise indicated. for every
`kind of national protection available): AE, 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, EE, EG, ES, fit,
`GB, GD, GE, Gil, GM, HN, IIR, llU, ID, IL, IN, IS, JP,
`KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT,
`LU, LV, LY, MA, MD, MG, Ml<., MN, MW, MX, MZ, NA,
`NG, NT, NO, NZ, OM, PG, PH, PL, PI: 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 orhenvise indicated. for every
`kind of regional protection available): ARII'O (BW, Gil,
`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, IfU, IE, IS, ff, LT, LU, LV, MC, NL, PL, JYl:
`RO, SE, Sf, SK, TR), OAPI (BF, BJ, CF, CG, Cl, CM, GA,
`GN, GQ, GW, ML, MR, NE, SN, TD, TG).
`
`Publish ed:
`with imemational search report
`before the expiration of rite time limit for amending Lhe
`clnims a11d to be repubLished in the eve111 of receipt of
`amendments
`
`--
`--
`
`(74) Common Representa tive: K ONINKLI.JKE PHILIPS
`ELECTRON ICS, 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(cid:173)
`ance Notes on Codes and Abbreviations" appearing attire begin(cid:173)
`lling of each regular issue oftiJe PCT Gazelle.
`
`--- --------------------------------------------------------------------------------------
`
`_
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`(54) Tille: DEVICE PROVIDING SPOT-CHECK OF VITAL SIGNS USING AN IN-THE-EAR PROBE
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`16
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`PHYSIOLOGICAL MONITORING
`DEVICE
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`_________________________ J _____________ .
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`0 (57) Abstract: A portable physiological monitoring device (12) includes a receiver (22) that wirelcssly receives physiological mea(cid:173)
`> surements from each of a plurality of in-the-car probes (14) upon enlering a communication range of one of the in-the-ear probes ( 14).
`
`~ The ponable physiological moni toring device ( 12) farther includes a display (30) for presenting the physiological measurements.
`
`Apple Inc.
`APL1208
`U.S. Patent No. 9,289,135
`
`001
`
`

`

`wo 2007/004089
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`PCT/I82006/051994
`
`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 that receives physiological measurements such as blood
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`pressure, respiration, perfusion index, blood oxygen, pulse rate, body temperature, etc. from
`
`5
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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
`
`10
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`rate, body temperature, etc. from within the ear canal. This probe includes a series of in-the(cid:173)
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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
`
`15
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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
`
`and conveyed to the central monitoring station. However, 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(cid:173)
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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. 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 and/or lost
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`25
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`data. In yet another example, the sensitivity of the infonnation may dictate how often it is
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`transmitted, if at all.
`
`-- 1 --
`
`002
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`

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`wo 2007/004089
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`PCT/lli2006/051994
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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
`
`5
`
`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(cid:173)
`
`the-ear probe.
`
`Another advantage is user validation of physiological signals measured with an in-the-
`
`1 0
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`car probe.
`
`Another advantage is that spot-check monitoring of the physiological signals measured
`
`with an in-the-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
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`15
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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 of the preferred embodiments.
`
`20
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`The drawings are only for pwposes of illustrating embodiments and are not to be
`
`construed 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
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`monitoring equipment.
`
`25
`
`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 illustrates an exemplary in-the-ear physiological measurement probe.
`
`FIGURE 4 illustrates an in-the-car physiological measurement probe connected to a
`
`30
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`behind-the-ear supporting device.
`
`--2--
`
`003
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`

`

`wo 2007/004089
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`PCT/lli2006/051994
`
`FIGURE 1 illustrates a physiological monitoring system ("system") 1 0. The system 10
`
`includes a physiological monitoring device 12, which is a mobile device that communicates
`5 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
`
`device 12 can be hand held or held by an ambulatory carrier. As descnbed 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-
`
`1 0
`
`check received physiological measurements obtained by an in-the-ear 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,
`
`alarms, etc.) to an authorized individual, the central monitoring station, another physiological
`
`monitoring device 12, etc., as well as various other activities.
`
`15
`
`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
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`14 (e.g., described in detail in connection with FIGURES 3-4 below) may be used at a
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`hospital, a home, a nursing home, etc. to measure, record, and/or convey physiological
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`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.
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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.) 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, this physiological monitoring device 12 acting as a continuous bedside
`
`25 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(cid:173)
`
`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. Such
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`communication can be through wired (e.g., Ethernet, USB, serial, parallel, FircWirc, optical
`
`-- 3--
`
`004
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`wo 2007/004089
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`PCT/lli2006/051994
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`wave guides, telephone wire, coaxial cable, etc.) and/or wireless (e.g., radio frequency,
`
`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 and/or retrieval via a receiver 22 of physiological
`5 measurements obtained by the probe 14, requests transmitted by a transmitter 24 to the probe
`
`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
`
`identification, software/firmware 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
`
`10
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`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
`
`facilitated by the intermediary component 18 and/or other components.
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`The receiver 22 and/or 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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`15
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`60. 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, local measurement devices
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`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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`20
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`network local 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 as a large area
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`network (LAN), a wide area network (WAN), including the Internet, as well as other public
`
`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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`25
`
`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 information emitted by the probe 14, automatically
`
`invoke the transmitter 24 to send a request to the probe 14 for information stored therein,
`
`automatically invoke the transmitter 24 to perform measurements, establish a secure
`
`30
`
`communication link with the probe 14, etc. Such requests may indicate which of a plurality of
`
`--4--
`
`005
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`

`

`wo 2007/004089
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`PCT/lli2006/051994
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`possible physiological parameters (e.g., blood pressure, blood oxygen, heart rate, respiration
`
`rate, temperature, etc.) to measure. The processor 26 can also automatically invoke
`
`conveyance of such information via the transntitter 24 to the central monitoring station 16 or
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`the intermediary component 20.
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`5
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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 transntitter 24 to the central monitoring station 16 and/or
`
`10
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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
`device 12. 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,
`
`15
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`a Hat 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(cid:173)
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`volatile (e.g., various flavors of read only memory (ROM), flash memory, magnetic RAM
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`(MRAM), non-volatiJe 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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`25
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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
`
`corresponding port, after manual1y selecting information to store within the portable storage
`
`-- 5--
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`006
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`

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`wo 2007/004089
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`PCT/lli2006/051994
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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 and/or the central monitoring station 16. The information can be
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`automatically or manually retrieved from the portable storage 36. In another instance, the
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`portable storage 36 can inserted into a suitable port of the intermediary component 20, the
`
`5
`
`central monitoring station 16, etc. and applications, software/firmware, and/or other
`
`information can be loaded to the portable storage 36. The portable storage 36 can then be
`
`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.
`
`10
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`The physiological monitoring device 12 may also include one or more ports 38 for
`
`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, Fire Wire, 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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`15
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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 monitoring device 12, 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, infer whether the
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`monitored signals are accurate (e.g., by assessing signal quality, by comparing the information
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`with previously stored information, ranges for typical information, etc.), etc. If a reading
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`25
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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 and/or 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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`30 monitoring or spot-checks. In this embodiment, the probe 14 is configured such that it does
`
`--6--
`
`007
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`

`

`wo 2007/004089
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`PCT/lli2006/051994
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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 or stored vital signs
`
`using a
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`low power short-range communication, such as Bluetooth, body coupled
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`communications, and the like. Once the user has validated the readings, the physiological
`5 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.
`
`10
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`In another instance, the physiological monitoring device 12 performs the above-
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`discussed functions and further assumes additional functions that were previously performed
`
`by other devices. For example, 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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`15
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`12 may be able to interact with personal data assistant, cell phones, beepers, 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, 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 is not 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, the time such
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`medications and assistance was given, scheduled procedures, medical history, unique
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`25
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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
`
`-- 7--
`
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`wo 2007/004089
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`PCT/lli2006/051994
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`process the received physiological measurements information. Suitable processing includes
`
`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.
`
`5
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`The analysis can also be used to va1idate 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
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`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
`
`10
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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. Examples of suitable devices include, but are not
`
`15
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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 may also send general messages, notifications, etc. to
`
`such individuals and/or equipment The general messages, notifications, etc. may indicate that
`
`it is time to read a physiological measurement, administer a medication, replace or recharge a
`
`20
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`batt ery, etc. and/or that a physiological measurement has been acquired, a medication has been
`
`administered, an identification of the medical professional performing the activity, etc. 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
`
`a similar device, a cell phone, etc.
`
`25
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`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
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`can be checked against predetermined authorized information. Likewise, security component
`
`46 can validate the probe 14 to ensure that the probe 14 is associated with the correct
`
`30
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`individual (e.g., via unique identification entered by user or read from an RFID tag), that the
`
`--8--
`
`009
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`

`

`wo 2007/004089
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`PCT/I82006/051994
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`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
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`device 12 can lock the controls 28, dim the display 30, invoke the mes·saging component 44 to
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`5
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`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
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`measuring one or more physiological signals (e.g., blood pressure, pulse, blood oxygen,
`
`perfusion, temperature, respiration ... ) from within an ear canal. The probe 14 includes a
`
`10
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`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.
`
`15
`
`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
`
`or inflatable balloon 50 surrounds the end portion of the structure 48 (as illustrated) or suitable
`
`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 (LEOs), an
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`infrared (IR) source, 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. 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 ftom 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 car 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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`5
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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 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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`10
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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 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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`15 Carotid Arteries, 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. In another example, a temperature
`In yet another
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`sensor (e.g., a thermistor) is also positioned proximate to vascular tissue.
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`20
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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 of the car 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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`25
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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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`a·uscultatory approach (e.g., via a microphone operatively connected to the balloon 50) and/or
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`an oscillometric 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-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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`5
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`relatively close to the initial pressure and/or the pulse waveform amplitudes are relatively
`
`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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`10
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`hermetically scaled 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. 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 isolates the wires from the inner ear environment, mitigating
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`contamination ofboth the ear and the sensor wiring and provides a pressurized air conduit to
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`15
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`the balloon 50. 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
`
`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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`20
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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 conducive to the ear canal.
`FIGURE 4 illustrates the JTE probe 14 mechanically and electrically coupled with an
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`exemplary behind-the-ear (BTE) device 54. In one instance, the structure 48 and the BTE
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`25
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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). 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 bellind the 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. In one aspect, the sheath can be
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`semi-permeable to allow air flow, but prevent fluid from moving ftom one side of the sheath
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`to the other side. In another aspect, the sheath prevents substantially all matter from moving
`
`from one side of the sheath to the other side. The structure/ball