(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization |
`International Bureau
`
`ND NOYAA
`
`11 January 2007 (11.01.2007) (10) International Publication Number
`
`(43) International Publication Date
`
`(51) International Patent Classification:
`AGIB 5/00 (2006.01)
`:
`.
`(21) International Application Number:
`RCTAB2ONGNS 1994
`20 June 2006 (20.06.2006)
`
`(22) International Filing Date:
`
`English
`ss
`age
`English
`
`(25) Filing Language:
`.
`er
`(26) Publication Language:
`(30) Priority Data:
`60/695.725
`6
`90/777,502
`
`30 June 2005 (30.06.2005)
`-
`:
`28 February 2006 (28.02.2006)
`
`US
`a
`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) Inventors; and
`(75) Inventors/Applicants (for US only): NIELSEN, 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).
`
`WO 2007/004089 Al
`
`(81) Designated States (unless otherwise indicated, for every
`kind af 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, BE, 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.
`.
`essere
`(84) Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`ss
`4
`-
`‘
`ie gic
`he
`GM, KE, LS, MW, MZ, NA, SD, SL, $Z, TZ, UG, 7M,
`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,TE, 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 ofeach regular issue ofthe PCT Gazette.
`
`(54) Title: DEVICE PROVIDING SPOT-CHECK OF VITAL SIGNS USING AN IN-THE-EAR PROBE
`
`INTERMEDIARY
`COMPONENT
`
`
`ib
`
`CENTRAL
`_| MONITORING
`PHYSIOLOGICAL MONITORING
`22
`24
`STATION
`5 DEVICE
`RECIEVER||TRANSMITTER
`40
`30
`POWER
`
`DISPLAY
`
`2007/004089AIIMITIINIUMIINATANTIRNUNTANAMMtA
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`
`
`
`
`
`
`
`-o----=====
`
`
`Lifeseserect
`
`32
`STORAG!iE
`34
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`
`
`#
`OCPROCESSOR
`28
`
`34
`
`:
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`(57) Abstract: A portable physiological monitoring device (12) includes a receiver (22) that wirelessly receives physiological mea-
`surements from each of a pluralityof in-the-ear probes (14) upon entering a communication range of oneofthe in-the-ear probes (14).
`The portable physiological monitoring device (12) farther includes a display (30) for presenting the physiological measurements.
`
`0001
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`Apple Inc.
`APL1044
`U.S. Patent No. 8,923,941
`FITBIT, Ex. 1044
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`Apple Inc.
`APL1044
`U.S. Patent No. 8,923,941
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`0001
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`WO 2007/004089
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`PCT/IB2006/051994
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`DEVICE FOR PROVIDING SPOT-CHECK OF
`VITAL SIGNS USING AN IN-THE-EAR PROBE
`
`DESCRIPTION
`
`The following relates to monitoring physiological parameters.
`
`It finds particular
`
`application as a portable device that receives physiological measurements such as blood
`
`pressure, respiration, perfusion index, blood oxygen, pulse rate, body temperature, etc. from
`
`an in-the-ear probe, displays the physiological measurement, and conveys the physiological
`
`measurement to a monitoringstation.
`
`Physiological parameters have been measured from within the car via an in-the-car
`
`probe. One such probe includes a multi-parameter physiological measurement system that
`
`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 includesa series of in-the-
`
`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
`
`processor in the electronics analyzes the raw data and converts it into measurements of
`
`physiological parameters that are wirelessly sent to a central monitoring station, which is
`
`15
`
`remote form the location of the subject being monitored.
`
`Typically, such physiological parameters are continuously or periodically measured
`
`and conveyed to the central monitoring station. However,
`
`in some instances it is not
`
`convenient for a clinician to have to view the parameters at the central monitoring station,
`
`which is located away from the patient. In addition, instances exist wherein continuous and/or
`
`20
`
`periodic conveyance of such information is not desirable. For example, spot-check or on-
`
`demand monitoring may be more desirable with patients having their vital signs checked only
`
`every one, two, four ... hours.
`
`In another example, the network used for such conveyance
`
`may have limited bandwidth that is shared with other wireless monitoring devices. Such
`
`devices may have to compete for available bandwidth, which may result in delays and/or lost
`
`25
`
`data.
`
`In yet another example, the sensitivity of the information may dictate how often it is
`
`transmitted, if at all.
`
`ee ea
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`WO 2007/004089
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`In one aspect, a portable physiological monitoring device isillustrated. The portable
`
`physiological monitoring device includes a receiver and a display. The receiver wirelessly
`
`receives physiological measurements from each of a plurality of in-the-ear probes upon
`
`entering a communication range of one of the in-the-ear probes. The received physiological
`
`measurements are subsequently presented on the display.
`
`One advantageresides in locally displaying physiological signals measured with an in-
`
`the-ear probe.
`
`Another advantage is user validation ofphysiological signals measured with an in-the-
`
`10
`
`ear 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-car probe with or without the use of a central monitoring
`station.
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`15
`
`Still further advantages will become apparent to those of ordinary skill in the art upon
`
`reading and understanding the detailed description ofthe preferred embodiments.
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`20
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`25
`
`The drawings are only for purposes of illustrating embodiments and are not to be
`
`construed aslimiting the claims.
`
`FIGURE 1
`
`illustrates
`
`an
`
`exemplary physiological monitoring
`
`device
`
`that
`
`communicates with an in-the-car physiological measurement probe and other physiological
`
`monitoring equipment.
`
`FIGURE 2 illustrates another exemplary physiological monitoring device that
`
`communicates with an in-the-ear physiological measurement probe and other physiological
`
`monitoring equipment.
`
`FIGURE3 illustrates an exemplary in-the-car physiological measurementprobe.
`
`FIGURE4illustrates an in-the-ear physiological measurement probe connected to a
`30
`
`behind-the-car supporting device.
`
`ee
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`FIGURE1illustrates a physiological monitoring system (“system”) 10. The system 10
`
`includes a physiological monitoring device 12, which is a mobile device that communicates
`
`with physiological measuring equipment(c.g., an in-the-ear probes, etc.) and devices (c.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 described in detail below,the
`
`physiological monitoring device 12 can be usedto intercept, display, validate and forward (via
`
`wire or wirelessly) physiological measurements continuously over a wireless network, or spot-
`
`10
`
`check received physiological measurements obtained by an in-the-ear probe and communicate
`
`or download such measurements to a central monitoring station, send and receive information
`
`(e.g., physiological measurements, patient history, medical history, messages, notifications,
`
`alarms, etc.) to an authorized individual, the central monitoring station, another physiological
`
`15
`
`20
`
`25
`
`monitoring device 12, etc., as well as various otheractivities.
`
`As briefly discussed above,
`
`the physiological monitoring device 12 is used in
`
`connection with other physiological monitoring equipment. For example, an in-the-car probe
`
`14 (e.g., described in detail
`
`in connection with FIGURES 3-4 below) may be used at a
`
`hospital, a home, a nursing home, etc.
`
`to measure, record, and/or convey physiological
`
`parameters (e.g., non-invasive blood pressure, pulse, blood oxygen, temperature, perfusion,
`
`respiration, etc.) obtained by the probe 14 from within an ear of an individual.
`
`In such
`
`environments, the physiological parameters may be wirclessly transmitted (c.g., continuously,
`
`periodically at a predetermined rate, on-demand, upon occurrence of an event, etc.) from the
`
`probe 14 to a central monitoring station 16, an intermediate device 18 (€.g., a bedside monitor,
`
`a signal router,
`
`this physiological monitoring device 12 acting as a continuous bedside
`
`monitor, an input for a wired network that carries the measured parameters to the central
`
`station 16, etc.), etc. The physiological monitoring device 12 communicates (uni or bi-
`
`directionally) with the probe 14, the central monitoring system 16, optionally the intermediate
`
`device 18, and/or other devices such as a second intermediate component 20.
`
`Such
`
`communication can be through wired (c.g., Ethernet, USB, serial, parallel, FireWire, optical
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`a= Sinn
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`wave guides,
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`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
`
`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
`
`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
`
`troubleshoot the probe 14, etc.
`
`In one instance, the foregoing communication is directly
`
`10
`
`between the physiological monitoring device 12 and the probe 14, while in another instance,
`
`such communication between the physiological monitoring device 12 and the probe 14 is
`
`facilitated by the intermediary component 18 and/or other components.
`The
`receiver 22 and/or
`the
`transmitter 24 can communicate over various
`
`communication mediums. For instance, the probe 14 may reside within a body area network
`
`15
`
`60.
`
`In this instance, the physiological monitoring device 12 can communicate within such
`
`20
`
`25
`
`network to interact with the probe 14, one or more physiological sensors 62 positioned on the
`
`patient, one or more emitters 64 positioned on the patient,
`
`local measurement devices
`
`measuring physiological parameters, the intermediary component 18, another physiological
`
`monitoring device 12, etc. The central monitoring station 16 may communicate over a
`
`network local to the facility, regional within the facility, and/or global to the community. The
`
`network maybe part of or communicate with one or more larger networks such asa large area
`
`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
`
`information to the physiological monitoring device 12.
`
`A processor 26 controls the receiver 22 and the transmitter 24. For instance, upon
`
`entering a communication range of the probe 14, the processor 26 can automatically invoke
`
`the receiver 22 to detect and capture 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 ofaplurality of
`
`sade
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`possible physiological parameters (c.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 transmitter 24 to the central monitoring station 16 or
`
`the intermediary component20.
`
`Controls 28 provide various knobs, buttons, switches, sliders, audio receivers,tactile
`
`transducers, etc. to receive/send control commands from a user. For example, the controls 28
`
`may include a mechanism with which the user can employ to invoke reception of information
`
`from the probe 14 and/or the intermediary component 18 by the receiver 22 or transmission of
`
`stored or received information by the transmitter 24 to the central monitoring station 16 and/or
`
`10
`
`the intermediary component 20.
`
`A display 30 visually presents received physiological measurements, or information
`
`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
`
`limited to, one or more light emitting diodes, seven segment displays, a liquid crystal display,
`
`15
`
`a flat panel display, a graphical user interface, etc. The controls 28 provide a user with a
`
`means for selecting information to present by the display 30 and configuring how the
`
`information is presented by the display 30.
`
`Information, applications, etc. can be stored within the physiological monitoring
`
`device 12 in a storage component 32, which may include resident storage 34 and portable
`
`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
`
`(MRAM), non-volatile RAM (NVRAM), etc.) memory. The portable storage 36 can be used
`
`to transfer information stored therein from the physiological monitoring device 12 to the
`
`intermediary component 20 and/or the central monitoring station 16 and vice versa. For
`
`instance, flash memory (e.g., a universal serial bus (USB) based memory stick) can be inserted
`
`into a suitable port on the physiological monitoring device 12.
`
`Information can then be
`
`directly stored thereto or transferred/copied from the resident storage 34 to the portable
`
`storage 36. This can be achieved automatically upon inserting the portable storage 36 into a
`
`corresponding port, after manually selecting information to store within the portable storage
`
`20
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`25
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`34, etc. The portable storage 36 can then be removed andinserted into a suitable port of the
`
`intermediary component 20 and/or the central monitoring station 16. The information can be
`
`automatically or manually retrieved from the portable storage 36.
`
`In another instance, the
`
`portable storage 36 can inserted into a suitable port of the intermediary component 20, the
`
`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,
`
`wherein the information stored within the portable storage 36 can be moved to the resident
`
`storage 34 of the physiological monitoring device 12.
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`10
`
`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
`
`to the central monitoring station, the intermediary component 20, etc. Suitable wired ports
`
`include, but are not limited to, Ethernet, USB,serial, parallel, FireWire, optical, and the like.
`
`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
`
`rechargeable and/or a non-rechargeable battery, a solar cell, a port for receiving DC from an
`
`AC to DC converter, an AC to DC converter, and/or the like.
`
`In one instance, the ear probe 14 continuously transmits/emits information to the
`
`central monitoring station 16. Whenauser enters an area (e.g., a room) with the physiological
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`30
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`monitoring device 12,
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`the physiological monitoring device 12 receives real-time signals
`
`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
`
`monitored signals are accurate (c.g., by assessing signal quality, by comparing the information
`
`with previously stored information, ranges for typical information, etc.), etc.
`
`If a reading
`
`appears suspicious, the user can wait for signal quality to improve, take action to improve
`
`signal quality, or check the measurement with another instrument. Whenall readings appear
`
`to be correct, the user can provide the information and/or a validation indication to the central
`
`monitoring station 16.
`
`In another instance, the physiological monitoring device 12 is used for on-demand
`
`monitoring or spot-checks.
`
`In this embodiment, the probe 14 is configured such that it does
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`not continuously broadcast information. Rather, each time the user wants to view vital signs,
`
`the physiological monitoring device 12 requests and receives the current or stored vital signs
`
`using a low power
`
`short-range communication,
`
`such as Bluetooth, body coupled
`
`communications, and the like. Once the user has validated the readings, the physiological
`
`monitoring device 12 conveys the readings to the central monitoring station 16 with a higher
`
`powertransmission with longer range. This conveyance can be achieved in real time by a
`
`radio frequency signal or the like, or the physiological monitoring device 12 can store the
`
`readings of one or more individuals in the storage component 32 and subsequently transfer the
`
`readings via a wireless or wired meansto the central monitoringstation 16.
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`10
`
`In another instance,
`
`the physiological monitoring device 12 performs the above-
`
`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
`
`communicate with staff members.
`
`In addition to communicating with other physiological
`
`monitoring devices 12 being used by other staff members, the physiological monitoring device
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`15
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`12 maybeable to interact with personal data assistant, cell phones, beepers, telephones, email,
`
`etc. directly or through the central station 16. Through such devices, the physiological
`
`monitoring device 12 may be able to receive and deliver messages, notifications, medication
`
`schedules, documented delivery of medication, chart highlights, vitals validation, information,
`
`alarms, paging, etc. to a care-giver, a guardian, etc.
`
`The physiological monitoring device 12 can also be used to memorialize, document,
`
`chart, etc. activity.
`
`Such activity can include, but
`
`is not
`
`limited to, physiological
`
`measurements and data derived thereform, the delivery of medications or medical assistance,
`
`the individual(s) administering the medications or medical assistance,
`
`the time such
`
`medications and assistance was given, scheduled procedures, medical history, unique
`
`identification, patient name, health insurance provider, family history, treating physicians,test
`
`results, etc.
`
`FIGURE 2 illustrates the physiological monitoring device 12 further having an
`
`analyzer 42, a messaging component 44, and a security component 46. The analyzer 42
`
`analyzes information reccived from the probe 14 and generates trends, predicate future health,
`
`suggest treatments, ctc.
`
`In addition, the analyzer 42 provides processing capabilities to
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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
`
`the user via alpha-numeric symbols, graphs, plots, audio, icons, trends, projections, historical
`
`comparisons, etc. on the display 30 and/or the central processing station 16.
`
`The analysis can also be used to validate that received physiological measurements are
`
`within pre-stored ranges. For example, the analyzer 42 can assess signal quality and compare
`
`received measurements with acceptable ranges stored in the storage 32.
`
`Physiological
`
`measurements having insufficient signal quality, or that fall outside of expected physiological
`
`ranges may invoke the physiological monitoring device 12 to request re-transmissions ofthe
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`10
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`information, request performance of new measurements, and/or sound an alarm. Such alarm
`
`maybe a visual and/or audio alarm within the physiological monitoring device 12, an alarm at
`
`the central monitoring system, and/or other alarms.
`
`Such alarms may also include
`
`transmission of alarms, messages, notifications, etc. by the messaging component 44 to
`
`various individuals through various devices. Examples of suitable devices include, but are not
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`15
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`limited to, another physiological monitoring device 12, a personal data assistant, a cell phone,
`
`beepers,a telephone, email, a beeper, a pager, etc.
`
`The messaging component 44 mayalso 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
`
`battery, 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
`
`instance, the messaging component 44 can be used as a walkie-talkie to allow the user to
`
`audibly communicate with an individual at the central monitoring station, an individual using
`
`a similar device, a cell phone, etc.
`
`The security component 46 can be used to determine whether the user of the
`
`physiological monitoring device 12 is an authorized user. For instance, the physiological
`
`monitoring device 12 may require the user to enter a password or other identifying indicia that
`
`can be checked against predetermined authorized information. Likewise, security component
`
`46 can validate the probe 14 to ensure that the probe 14 is associated with the correct
`
`individual (¢.g., via unique identification entered by user or read from an RFID tag),that the
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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
`
`device 12 can lock the controls 28, dim the display 30, invoke the messaging component 44 to
`
`sound an alarm,etc.
`
`FIGURE 3 illustrates an exemplary configuration of the probe 14.
`
`In this
`
`configuration, the probe 14 is an in-the-ear (ITE) physiological measurement apparatus for
`
`measuring one or more physiological signals (c.g., blood pressure, pulse, blood oxygen,
`
`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 car canal such that an end portion is
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`positioned proximate to a bony region ofthe earor other relatively quiet zone ofthe car canal.
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`The end portion ofthe 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 (asillustrated) or suitable
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`portions thereof. The spongy material or inflatable balloon 50 ideally supports one or more
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`10
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`15
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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 cxample, 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(c.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 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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`sree sc
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`0010
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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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`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 50is 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 car 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
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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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`20
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`25
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`experiencing peripheral shutdown duc 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 car canal to
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`mitigate sensing extrancous 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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`30
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`an oscillometric approach(c.g., via optical sensing components attached to the balloon).
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`a (Oem
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`WO 2007/004089
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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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`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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`10
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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 car 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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`15
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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 morefirst 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(c.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-car (BTE) device 54.
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`In one instance, the structure 48 and the BTE
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`device 54 are formed as a single unit, while in another instance the structure 48 and the BTE
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`device 54 are detachably connected (as illustrated).
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`Such attachment can be through a
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`fastening means including a threaded connector, a snap, a set screw, an adhesive,a rivet, etc.
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`An arm 56 provides support behind the 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 50to protect the ear and
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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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`20
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`25
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`30
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`semi-permeable to allow air flow, but prevent fluid from moving from oneside of the sheath
`
`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/balloon/sensor assembly can be
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`disposable, washable, and/orsterilizeable.
`
`In another embodiment, the in the car structure 48 houses a smaller battery, a low
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`poweredtransmitter, 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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`phy