00000
`
` M000A317
`
`aso) United States
`a2) Patent Application Publication (0) Pub. No.: US 2009/0131761 Al
`May 21, 2009
`MoroneyIIIet al.
`(43) Pub. Date:
`
`(54)
`
`DEVICE PROVIDING SPOT-CHECK OF
`VITAL SIGNS USING AN IN-THE-EAR PROBE
`
`(86)
`
`PCTNo.:
`
`PCT/IB2006/051994
`
`(75)
`
`Inventors:
`
`Richard M. MoroneyIII,
`Princeton, NJ (US); Larry Nielsen,
`Burlington, MA (US): Christopher
`J. Poux, Mercerville, NJ (US)
`
`Correspondence Address:
`PHILIPS INTELLECTUAL
`STANDARDS
`P.O. Box 3001
`BRIARCLIFF MANOR, NY 10510 (US)
`
`PROPERTY &
`
`(73)
`
`Assignee:
`
`KONINKLIJKE PHILIPS
`ELECTRONICS N. V., Eindhoven
`(NL)
`
`(21)
`
`Appl. No.:
`
`11/995,008
`
`(22)
`
`PCTFiled:
`
`Jun. 20, 2006
`
`§ 371 (c)(1),
`(2), (4) Date:
`
`Nov. 13, 2008
`
`Related U.S. Application Data
`
`(60)
`
`Provisional application No. 60/695,725, filed on Jun.
`30, 2005, provisional application No. 60/777,502,
`filed on Feb. 28, 2006.
`
`Publication Classification
`
`Int. Cl.
`(2006.01)
`AGIB 5/145
`(2006.01)
`AGIB 5/02
`OSs Qe ississisicsnerccesinncincacccccnnicnewcc OOOIIOL
`
`ABSTRACT
`
`(51)
`
`(52)
`
`(57)
`
`A portable physiological monitoring device (12) includes a
`receiver (22) that wirelessly receives physiological measure-
`ments from each ofa plurality of in-the-ear probes (14) upon
`entering a communication range of one of the in-the-ear
`probes (14). The portable physiological monitoring device
`(12) farther includes a display (30) for presenting the physi-
`ological measurements.
`
`18
`
`INTERMEDIARY
`COMPONENT
`
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`0001
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`Apple Inc.
`APL1055
`U.S. Patent No. 8,652,040
`
`Apple Inc.
`APL1055
`U.S. Patent No. 8,652,040
`
`0001
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`Patent Application Publication
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`May 21, 2009 Sheet 2 of 3
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`Patent Application Publication May 21,2009 Sheet 3 of 3
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`US 2009/0131761 Al
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`US 2009/0131761 Al
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`May21, 2009
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`DEVICE PROVIDING SPOT-CHECK OF
`VITAL SIGNS USING AN IN-THE-EAR PROBE
`
`[0001] The following relates to monitoring physiological
`parameters. It finds particular application as a portable device
`that receives physiological measurements such as blood pres-
`sure, 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 monitoring station.
`[0002]
`Physiological parameters have been measured from
`within the ear via an in-the-ear probe. One such probe
`includes a multi-parameter physiological measurementsys-
`temthat non-invasively measures blood pressure as well as
`respiration, perfusion, blood oxygen, pulse rate, body tem-
`perature, etc. from within the ear canal. This probe includes a
`series of in-the-ear sensors that interconnect to electronics
`
`and a battery pack that are mounted behind the ear or in
`connection with another location onthe patient(e.g., around
`the neck, wrist, etc.). A processor in the electronics analyzes
`the raw data and convertsit into measurements ofphysiologi-
`cal parameters that are wirelessly sent to a central monitoring
`station, whichis remote form the location ofthe subject being
`monitored.
`
`[0003] Typically, such physiological parameters are con-
`tinuously or periodically measured and conveyed to the cen-
`tral monitoring station. However, in some instances it is not
`convenient for a clinicianto 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 periodic conveyance ofsuch 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 band-
`width 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 data. In yet another
`example, the sensitivity of the information may dictate how
`oftenit is transmitted, ifat all.
`[0004]
`In one aspect, a portable physiological monitoring
`device is illustrated. The portable physiological monitoring
`device includes a receiver and a display. The receiver wire-
`lessly receives physiological measurements from each of a
`plurality of in-the-ear probes upon entering a communication
`range of one ofthe in-the-ear probes. The received physi-
`ological measurements are subsequently presented on the
`display.
`[0005] One advantageresides in locally displaying physi-
`ological signals measured with anin-the-ear probe.
`[0006] Another advantageis user validation of physiologi-
`cal signals measured with an in-the-ear probe.
`[0007] Another advantageis that spot-check monitoring of
`the physiological signals measured with anin-the-ear probe is
`facilitated,
`
`[0008] Another advantageis using the device as a continu-
`ous monitor for the physiological signals measured with an
`in-the-ear probe with or without the use of a central monitor-
`ing station.
`[0009]
`Still further advantages will become apparent to
`those of ordinary skill in the art uponreading and understand-
`ing the detailed description of the preferred embodiments.
`
`[0010] The drawings are only for purposesofillustrating
`embodiments and are not to be construed as limiting the
`claims.
`
`FIG. 1 illustrates an exemplary physiological moni-
`[0011]
`toring device that communicates with an in-the-ear physi-
`ological measurement probe and other physiological moni-
`toring equipment.
`[0012]
`FIG. 2 illustrates another exemplary physiological
`monitoring device that communicates with an in-the-ear
`physiological measurement probe and other physiological
`monitoring equipment.
`[0013]
`FIG. 3 illustrates an exemplary in-the-ear physi-
`ological measurement probe.
`[0014]
`FIG. 4 illustrates an in-the-ear physiological mea-
`surement probe connected to a behind-the-ear supporting
`device.
`
`FIG. 1 illustrates a physiological monitoring system
`[0015]
`(“system”) 10. The system 10 includes a physiological moni-
`toring device 12, whichis a mobile device that communicates
`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 moni-
`toring device 12 can be hand held or held by an ambulatory
`carrier. As described in detail below, the physiological moni-
`toring device 12 can be usedto intercept, display, validate and
`forward (via wire or wirelessly) physiological measurements
`continuously over a wireless network, or spot-check received
`physiological measurements obtained by anin-the-ear probe
`and communicate or download such measurements to a cen-
`tral monitoring station, send and receive information (e.g.,
`physiological measurements, patient history, medical history,
`messages, notifications, alarms, etc.) to an authorized indi-
`vidual, the central monitoring station, another physiological
`monitoring device 12, etc., as well as various otheractivities.
`[0016] As briefly discussed above,the physiological moni-
`toring device 12 is used in connection withother physiologi-
`cal monitoring equipment. For example, an in-the-ear probe
`14 (e.g., described in detail in connection with FIGS. 3-4
`below) may be used ata hospital, a home, anursing home, etc.
`to measure, record, and/or convey physiological parameters
`(e.g., non-invasive blood pressure, pulse, blood oxygen, tem-
`perature, perfusion, respiration, etc.) obtained by the probe 14
`from within anear ofan individual. In such environments, the
`physiological parameters may be wirelessly transmitted (e.g.,
`continuously, periodically at a predetermined rate, on-de-
`mand, upon occurrence of anevent, etc.) fromthe probe 14 to
`a central monitoring station 16, an intermediate device 18
`(e.g., a bedside monitor, a signal router, this physiological
`monitoring device 12 acting as a continuous bedside monitor,
`an input fora wired networkthat carries the measured param-
`eters 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, option-
`ally the intermediate device 18, and/or other devices such as
`a second intermediate component 20. Such communication
`can be through wired (e.g., Ethernet, USB, serial, parallel,
`FireWire, optical wave guides, telephone wire, coaxial cable,
`etc.) and/or wireless (e.g., radio frequency, infrared, optical,
`mechanical wave, magnetism, etc.) technologies.
`[0017] Communication between the physiological moni-
`toring device 12 and the probe 14 includes, but is notlimited
`to, reception and/orretrieval 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
`
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`perform and/or send a physiological measurements) 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 troubleshootthe probe 14,etc. In one instance, the forego-
`ing communication is directly between the physiological
`monitoring device 12 and the probe 14, while in another
`instance, such communication between the physiological
`monitoring device 12 and the probe 14 is facilitated by the
`intermediary component 18 and/or other components.
`[0018] The receiver 22 and/or the transmitter 24 can com-
`municate over various communication mediums. For
`instance, the probe 14 mayreside within a body area network
`60. In this instance, the physiological monitoring device 12
`can communicate within such network to interact with the
`probe 14, one or more physiological sensors 62 positioned on
`the patient, one or more emitters 64 positioned onthepatient,
`local measurement devices measuring physiological param-
`eters, 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 maybepart ofor communicate with one or more
`larger networks such as a large area network (LAN), a wide
`area network (WAN), including the Internet, as well as other
`public and/or private networks. The central monitoring sta-
`tion 16 may communicate this selected information to the
`physiological monitoring device 12.
`[0019] 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 emit-
`ted by the probe 14, automatically invokethe transmitter 24 to
`send a requestto the probe 14 for information stored therein,
`automatically invoke the transmitter 24 to perform measure-
`ments, establish a secure communication link with the probe
`14, etc, Such requests may indicate which of a plurality of
`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 informationvia the transmitter 24 to the
`central monitoring station 16 or the intermediary component
`20.
`
`[0020] Controls 28 provide various knobs, buttons,
`switches, sliders, audio receivers, tactile transducers, etc. to
`receive/send control commands froma user. For example, the
`controls 28 may include a mechanismwith whichthe user can
`employ to invoke reception of information from the probe 14
`and/or the intermediary component 18 by the receiver 22 or
`transmissionofstored or received information by the trans-
`mitter 24 to the central monitoring station 16 and/or the
`intermediary component 20.
`[0021] A display 30 visually presents received physiologi-
`cal measurements, or information from the central monitor-
`ing 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 segmentdisplays, a liquid
`crystal display,a flat panel display, a graphical user interface,
`etc. The controls 28 provide a user with a means forselecting
`information to present by the display 30 and configuring how
`the information is presented by the display 30.
`[0022]
`Information, applications, etc. can be stored within
`the physiological monitoring device 12 in a storage compo-
`
`nent 32, which may include resident storage 34 and portable
`storage 36. Both the resident andthe portable storages 34 and
`36 can include various types of memory including volatile
`(e.g., various flavors of random access memory (RAM)) and
`non-volatile (e.g., various flavors of read only memory
`(ROM), flash memory, magnetic RAM (MRAM), non-vola-
`tile RAM (NVRAM), etc.) memory. The portable storage 36
`can be used to transfer informationstored therein from the
`physiological monitoring device 12 to the intermediary com-
`ponent 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 residentstorage 34 to the portable storage 36. This can be
`achieved automatically uponinserting the portable storage 36
`into a corresponding port, after manually selecting informa-
`tion to store within the portable storage 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 fromthe portable storage 36. In another
`instance, the portable storage 36 can inserted into a suitable
`port of the intermediary component 20, the central monitor-
`ing station 16, etc. and applications, software/firmware, and/
`or other information can be loaded tothe portable storage 36.
`The portable storage 36 can then be removed therefrom and
`inserted into a suitable port ofthe 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.
`[0023] The physiological monitoring device 12 may also
`include one or moreports 38 for communicating information.
`The transmitter 24 can transmit informationthroughthe ports
`38 to the central monitoring station, the intermediary compo-
`nent 20, etc. Suitable wired ports include, but are not limited
`to, Ethernet, USB,serial, parallel, FireWire, optical, and the
`like.
`
`[0024] A power component40 provides power to power the
`various components of the 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/orthe like.
`
`Inoneinstance, the ear probe 14 continuously trans-
`[0025]
`mits/emits information to the central monitoring station 16.
`Whena user enters an area (e.g., a room) with the physiologi-
`cal monitoring device 12,
`the physiological monitoring
`device 12 receives real-time signals emitted by the probe 14
`and presents a corresponding display via the display compo-
`nent 30. The user can view the information, validate the
`monitoredvital signs, infer whether the monitored signals are
`accurate (e.g., by assessing signal quality, by comparing the
`information with previously stored information, ranges for
`typical information,etc.), etc. fa reading appears suspicious,
`the user can wait for signal quality to improve, take actionto
`improve signal quality, or check the measurement with
`another instrument. Whenall readings appear to be correct,
`the user can provide the information and/ora validation indi-
`cation to the central monitoring station 16.
`[0026]
`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 not continuously broadcast information. Rather, each
`
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`time the user wants to viewvital signs, the physiological
`monitoring device 12 requests and receives the current or
`stored vital signs using a low powershort-range communica-
`tion, such as Bluetooth, body coupled communications, and
`the like. Oncethe user has validated the readings, the physi-
`ological monitoring device 12 conveys the readings to the
`central monitoring station 16 with a higher power transmis-
`sion with longer range. This conveyance can be achieved in
`real time by a radio frequency signalor the like, or the physi-
`ological monitoring device 12 can store the readings of one or
`more individuals in the storage component 32 and subse-
`quently transfer the readings via a wireless or wired means to
`the central monitoring station 16.
`[0027]
`In another instance, the physiological monitoring
`device 12 performs the above-discussed functions and further
`assumesadditional functions that were previously performed
`by other devices. For example, the physiological monitoring
`device 12 may be able to communicate with staffmembers. In
`addition to communicating with other physiological monitor-
`ing devices 12 being used by other staff members, the physi-
`ological monitoring device 12 may be able to interact with
`personal data assistant, cell phones, beepers,
`telephones,
`email, etc. directly or throughthe central station 16. Through
`such devices, the physiological monitoring device 12 may be
`able to receive and deliver messages, notifications, medica-
`tion schedules, documented delivery of medication, chart
`highlights, vitals validation, information, alarms, paging,etc.
`to a care-giver, a guardian, etc.
`[0028] The physiological monitoring device 12 can also be
`used to memorialize, document, chart, ete. activity. Such
`activity can include, but is not limited to, physiological mea-
`surements and data derived thereform, the delivery of medi-
`cations or medical assistance, the individual(s) administering
`the medications or medical assistance, the time such medica-
`tions and assistance was given, scheduled procedures, medi-
`cal history, unique identification, patient name, health insur-
`ance provider, family history, treating physicians,test results,
`ete.
`
`FIG. 2 illustrates the physiological monitoring
`[0029]
`device 12 further having an analyzer 42, a messaging com-
`ponent 44, and a security component 46. The analyzer 42
`analyzes information received from the probe 14 and gener-
`ates trends, predicate future health, suggest treatments, etc. In
`addition, the analyzer 42 provides processing capabilities to
`process the received physiological measurements informa-
`tion. 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 compari-
`sons, etc. on the display 30 and/or the central processing
`station 16.
`
`[0030] 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 monitor-
`ing device 12 to request re-transmissions ofthe information,
`request performance of new measurements, and/or sound an
`alarm. Such alarm may be a visual and/or audio alarm within
`the physiological monitoring device 12, an alarm at the cen-
`tral 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 limited to, another physiological moni-
`toring device 12, a personal dataassistant, a cell phone, beep-
`ers, a telephone, email, a beeper, a pager, etc.
`[0031] The messaging component 44 may also send gen-
`eral 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/orthat a physiological measurementhas 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.
`[0032] Thesecurity component 46 can be used to determine
`whetherthe user of the physiological monitoring device 12 is
`an authorized user. For instance, the physiological monitor-
`ing device 12 may require the user to enter a passwordorother
`identifying indicia that can be checked against predetermined
`authorized information. Likewise, security component 46 can
`validate the probe 14 to ensurethat the probe 14 is associated
`with the correct individual (e.g.. via unique identification
`entered by user or read from an RFIDtag), that the physi-
`ological monitoring device 12 is authorized to communicate
`with the probe 14 (e.g., by checking unique identification,
`serial number, etc.), set up an encoded communicationlink
`with the probe 16, etc. For unauthorized use or communica-
`tion, the physiological monitoring device 12 can lock the
`controls 28, dim the display 30, invoke the messaging com-
`ponent 44 to sound analarm, ete.
`[0033]
`FIG. 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 (e.g., blood pressure, pulse,
`blood oxygen, perfusion, temperature, respiration .. . ) from
`withinan ear canal. The probe 14 includesa structure 48that
`inserts into the ear canal. The structure 48 is suitably dimen-
`sioned toenter the ear canal to a suitable depth and adapts to
`various shaped ear canals (e.g., different curvatures). Thatis,
`the structure 48 is small in diameter compared to the diameter
`ofthe ear canal. In one instance,the structure 48 projects into
`the ear canal suchthat an end portionis positioned proximate
`to a bony regionof the ear or other relatively quiet zone of the
`ear canal.
`
`[0034] The end portion of the structure 48 residing in the
`ear canal may be fabricated with a spongy expandable mate-
`rial, or include an annular inflatable balloon 50. The spongy
`material or inflatable balloon 50 surroundsthe end portion of
`the structure 48 (as illustrated) or suitable portions thereof.
`The spongy material or inflatable balloon 50 ideally supports
`one or more sensors 52 that are operatively coupled to a
`surface ofthe spongy material or balloon 50 and that measure
`physiological signals. Suitable sensors include light emitting
`diodes (LEDs), an infrared (IR) source, light detectors, a
`pressure transducer, a microphone, a speaker, an accelerom-
`eter, and a thermistor, for example. The sensors 52 are stra-
`tegically positioned onthe spongy material or balloon 50. For
`example, a light detecting sensor typically is positioned to
`minimize or prevent absorptionoflight not indicative of the
`physiological process under measurement (e.g., light from
`outside the ear, light emitted from another sensor located on
`
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`the spongy material or balloon 50... ). Although depicted as
`circular, the one or more sensors 46 can be any shape. Alter-
`natively, the sensors could be mounted withinthe end portion
`of the structure 48 and could be moved into contact with the
`tissue once inserted into the ear.
`
`[0035] The inflatable balloon 50 is inflated to position, or
`the spongy material positions the one or more sensors 52
`proximate to appropriate tissue withinthe ear canal with ideal
`force and pressure to ensure close coupling of sensors with
`tissue but without causing decreased perfusion or blanching
`ofthe tissue. By way of example,the structure 48is inserted
`suchthat the end portion with the spongy material or balloon
`50 residing in the ear canalis ina bony regionofthe ear. The
`balloon 50 is inflated to position, or the spongy material
`positions the sensors 52 proximateto innerear tissue to sense
`signals indicative of physiological states, including blood
`pressure, temperature, pulse, respiration, and blood oxygen,
`for example.
`[0036]
`For adult humans, this includes inflating the bal-
`loon, or allowing the spongy material 50 to conform to the
`widely varying ear canal diameters from about 6 mmto about
`13 mm. For neonates and small pediatrics, where the ear canal
`diameter various from about 4 mm in diameter to about 7 mm
`in diameter, smaller and shorter ITE devices are used. Typi-
`cally, sensors for measuring blood oxygen are positioned
`proximate to ear canal tissue that is perfused with arterial
`blood supplied by branches of the External as well as the
`Internal Carotid Arteries,
`thus serving as a well perfused
`physiological site evenif the body is experiencing peripheral
`shutdown due to shock or other conditions. Such sensors
`include an energy emitting means(e.g., an LED, an IR source
`...) and an energy detecting means that detects energy
`transmission throughthe vascular tissue. In another example,
`a temperature sensor (e.g., a thermistor) 1s also positioned
`proximate to vascular tissue. In yet another example, sensors
`for sensing audio signals (e.g., a microphone) indicative of
`pulse pressure sounds, and/or respirations are suitably posi-
`tioned in relatively quite regions of the ear canal to mitigate
`sensing extraneous audio signals (noise).
`[0037] The inflatable balloon 50 must be usedtofacilitate
`non-invasively measuring blood pressure. For a non-invasive
`blood pressure measurement,
`the inflatable balloon 50 is
`inflated until it occludes blood flow in a portion ofthe ear
`proximate a blood pressure sensor(s) (€.g.,
`a pressure trans-
`ducer) operatively connected to the inflatable balloon 50. The
`pressure in the inflatable balloon 50 is then suitably released
`to deflate the inflatable balloon 50. A systolic and a diastolic
`blood pressure are obtained during inflation and/or deflation
`using an auscultatory approach(e.g., via a microphone opera-
`tively connected to the balloon 50) and/or an oscillometric
`approach (e.g., via optical sensing componentsattached to the
`balloon).
`[0038] A continuous non-invasive blood pressure is mea-
`sured by obtaining an initial blood pressure measure as
`describe above and thenre-inflating the balloon 50 to amean
`pressure. A servo mechanism periodically adjusts balloon
`pressure to locate a maximum pulse waveform amplitude
`indicative of mean blood pressure. As long as the derived
`meanpressureis relatively close to the initial pressure and/or
`the pulse waveform amplitudes are relatively close,
`the
`derived continuous systolic, diastolic, and mean blood pres-
`sure are calculated with high accuracy.
`[0039]
`Thestructure 48 includes one or more passageways
`(not shown) that extend throughthe structure 48. Such pas-
`
`sageways house sensor data, power, and control wires, pro-
`vide a hermetically sealed channel for inflating/deflating the
`balloon 50, and/or allow pressure inside the ear to equalize
`with the environment during balloon inflation/deflation. In
`one instance, the structure 48 includes a channel for both
`housing sensor wiring and inflating/deflating the balloon 50.
`The channel isolates the wires from the inner ear environ-
`ment, mitigating contaminationofboth the ear and the sensor
`wiring and provides a pressurized air conduit to the balloon
`50. In another instance, the structure 48 includes separate
`channels for sensor wiring andinflating/deflating the balloon
`50: one or more first channels house sensor wiring and a
`second channel provides the pressurized air conduit for inflat-
`ing/deflating the balloon 50. In yet another example, an
`optional channel provides anear pressure stabilizing mecha-
`nismthat allows ear pressure to equalize with the environ-
`ment during balloon inflation and/or deflation. This channel
`mitigates pressure build-up inthe ear duringballooninflation
`and/or deflation and potential pain therefrom. The passage-
`ways can be variously shaped(e.g., oval, rectangular, irregu-
`lar...) to be conduciveto the ear canal.
`[0040]
`FIG. 4 illustrates the ITE probe 14 mechanically and
`electrically coupled with an exemplary behind-the-ear (BTE)
`device 54. In one instance, the structure 48 and the BTE
`device 54 are formed as a single unit, while in another
`instance the structure 48 and the BTE device 54 are detach-
`ably connected (as illustrated). Such attachment can be
`througha fastening means including a threaded connector, a
`snap, a set screw, an adhesive,a rivet, etc. An arm 56 provides
`support behind the ear and a battery 58 powers both devices.
`An optional sheath (not shown) can be placed overthe struc-
`ture 48 and/or balloon 50 to protect the ear and the structure/
`balloon/sensor assembly from contamination. In one aspect,
`the sheath can be semi-permeable toallow air flow, but pre-
`ventfluid from moving fromone side ofthe sheathto the other
`side. In another aspect, the sheath prevents substantially all
`matter from moving fromoneside of the sheath to the other
`side. The structure/balloon/sensor assembly can be dispos-
`able, washable, and/orsterilizeable.
`[0041]
`In another embodiment, the in the ear structure 48
`houses a smaller battery, a low powered transmitter, a proces-
`sor and the like. A separate unit carried by the patient houses
`a receiver for the low powersignals, a higher powertransmit-
`ter which communicates with the physiological monitor
`device 12, the central station 16, etc., a larger battery, and.
`optionally, a processor, memory, and actionappropriate com-
`ponents and software.
`[0042] The invention has been described with reference to
`the preferred embodiments. Modifications and alterations
`may occur to others upon reading and understanding the
`preceding detailed description. It is intended that the inven-
`tion be constructed as including all such modifications and
`alterations insofar as they come within the scope of the
`appendedclaimsor the equivalentsthereof.
`1. A portable physiological monitoring device, compris-
`ing:
`a receiver that wirelessly receives physiological measure-
`ments from eachofa plurality of in-the-ear probes upon
`entering a communication range ofone ofthe in-the-ear
`probes: and
`a display that presents one or more ofthe physiological
`measurements.
`
`2. The physiological monitoring device asset forth in claim
`1, further including a transmitter for conveying the received
`
`0008
`
`0008
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`US 2009/0131761 Al
`
`May21, 2009
`
`receiving physiological parameters measured by an in-the-
`physiological measurementsto at least one ofa central moni-
`ear probe with the portable physiological monitoring
`toring station and an intermediary component.
`device:
`3. The physiological monitoring device as set forth in claim
`storing, processing and displaying the physiological mea-
`2, wherein the physiological measurements are conveyed by
`the transmitter throughat least one of a wireless port, a wired
`surements with the portable physiological monitoring
`device:
`port, and portable storage.
`transferring the physiological measurements to a monitor-
`4. The physiological monitoring device as set forth inclaim
`2, further including a messaging componentthat sendsatleast
`ing station either directly or through an intermediary
`component.
`one of analarm, a message, andanotificationtoat least one
`ofthe central monitoringstation, another physiological moni-
`17. The method as set forth in claim 16, further includ