`(12) Patent Application Publication (10) Pub. No.: US 2008/0208009 A1
`Shkarski
`(43) Pub. Date:
`Aug. 28, 2008
`
`US 20080208009A1
`
`(54) WEARABLE DEVICE, SYSTEMAND
`SE MEASURINGVITAL
`
`Related U.S. Application Data
`(60) Provisional application No. 60/586,241, filed on Jul.9,
`2004.
`
`(76) Inventor:
`
`Dror Shklarski, Yavne (IL)
`
`Publication Classification
`
`(51) Int. Cl.
`(2006.01)
`A6B 5/45.5
`(52) U.S. Cl. ......................................... 600/301; 600/324
`(57)
`ABSTRACT
`A wireless mobile device is provided for measuring pulse and
`blood oxygen saturation (SpO2). The device may include a
`SpO2 sensor, a pulse sensor, and a main controller to receive
`and process signals from the SpO2 and the Pulse sensors, and
`to enable reconfiguration of the SpO2 and the Pulse sensors
`by commands received from a remote server. The device may
`include a light measurement module to measure pulse param
`eters, and a light measurement module to measure SpO2
`parameters, the light measurement modules including an
`emitting/receiving unit and an electronic unit.
`
`Correspondence Address:
`EMPK & Shiloh, LLP
`116 JOHNST, SUITE 12.01
`NEW YORK, NY 10038 (US)
`
`(21) Appl. No.:
`
`11/631,947
`
`(22) PCT Filed:
`
`Jul. 10, 2005
`
`(86). PCT No.:
`S371 (c)(1),
`(2), (4) Date:
`
`
`
`PCT/ILOS/00732
`
`Dec. 26, 2007
`
`134
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`or
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`MEDCAL CENTER
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`144
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`134
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`105
`A1
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`116/118
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`124
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`130
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`142
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`BATTERY
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`138
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`134
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`FIG. 4A
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`FIG. 4B
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`FIG. 4E
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`FIG. 4F
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`FIG. 4H
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`FIG. 4
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`
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`MAN
`CONTROLLER
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`128
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`135
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`OXYGEN
`LEVEL
`coffer
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`506
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`OTHER
`CONTROLLER
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`520
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`BLOOD
`PRESSURE
`READER
`CONTROLLER
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`515
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`130
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`PULSE READER
`CONTROLLER
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`507
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`160
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`FIG. 5
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`WEARABLE DEVICE, SYSTEMAND
`METHOD FOR MEASURINGVITAL
`PARAMETERS
`
`FIELD OF THE INVENTION
`
`0001. The present invention relates to wearable devices,
`systems and methods for monitoring and evaluating physi
`ological and/or environmental parameters, and particularly,
`to devices, systems and methods for measuring pulse and
`blood oxygen saturation levels.
`
`BACKGROUND OF THE INVENTION
`0002 Continuously monitoring a patient's physiological
`condition generally requires the patient's hospitalization,
`usually at great cost, especially where longterm monitoring is
`required. In certain situations it is possible to monitor the
`physiology of patients who are physically outside of the hos
`pital, using wearable monitoring devices.
`0003. There are, for example, wrist-worn devices that may
`record a patient's physiological data, Such as the patient's
`ECG, during a predetermined recording time. These devices
`may include event recorders that may capture a patient's
`physiological data during a physiological "event. Such as a
`cardiac arrhythmia or an episode of patient discomfort. The
`event recording may be activated manually by the patient or
`automatically by determining when monitored physiological
`data meets predefined event criteria.
`0004 Wrist-worn devices typically may require that a
`patient return to a medical center periodically or remotely
`communicate with a medical center in order to transfer the
`recorded data for interpretation by a medical staff.
`
`SUMMARY OF THE INVENTION
`
`0005. A wireless mobile device is provided for measuring
`pulse and blood oxygen Saturation (SpO). The device may
`include a SpO sensor, a pulse sensor, and a main controllerto
`receive and process signals from the SpO, and the Pulse
`sensors, and to enable reconfiguration of the SpO and the
`Pulse sensors by commands received from a remote server.
`The device may include a light measurement module to mea
`Sure pulse parameters, and a light measurement module to
`measure SpO parameters, the light measurement modules
`including an emitting/receiving unit and an electronic unit.
`0006. According to some embodiments of the present
`invention, a system is provided for measuring pulse and
`SpO, comprising a wireless mobile monitoring device
`including an array of sensors; and a medical center server
`enabled to remotely initiate measurements of pulse and SpO.
`levels of a patient using the monitoring device, wherein the
`mobile monitoring device includes a light measurement mod
`ule, the light measurement model having an emitting/receiv
`ing unit and an electronic unit.
`0007 According to some embodiments of the present
`invention, a method is provided for measuring pulse and
`SpO, the method comprising transmitting commands to a
`wireless monitoring device, from a medical center server, to
`remotely measure pulse and SpO of a patient using the moni
`toring device, wherein the mobile monitoring device includes
`a light measurement module to measure pulse parameters,
`and a light measurement module to measure SpO param
`eters.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0008. The principles and operation of the system, appara
`tus, and method according to the present invention may be
`better understood with reference to the drawings, and the
`following description, it being understood that these draw
`ings are given for illustrative purposes only and are not meant
`to be limiting, wherein:
`0009 FIG. 1 is a schematic illustration of a medical moni
`toring system according to some exemplary embodiments of
`the present invention;
`0010 FIGS. 2A, 2B, and 2C are schematic illustrations of
`external top, bottom, and side view layouts, respectively, of a
`wearable monitoring device according to Some exemplary
`embodiments of the present invention:
`0011
`FIGS. 3A and 3B are schematic illustrations of a
`SpO, sensor and a pulse sensor, respectively, according to
`Some exemplary embodiments of the present invention;
`0012 FIGS. 4A-4I are schematic illustrations of nine sen
`Sor configurations incorporating SpO sensors and pulse sen
`sors, according various exemplary embodiments of the
`present invention; and
`0013 FIG. 5 is a schematic illustration of an internal lay
`out of a wearable monitoring device, according to some
`exemplary embodiments of the present invention.
`
`DETAILED DESCRIPTION OF THE INVENTION
`0014. The subject matter regarded as the invention is par
`ticularly pointed out and distinctly claimed in the concluding
`portion of the specification. The invention, however, both as
`to organization and method of operation, together with
`objects, features and advantages thereof, may best be under
`stood by reference to the following detailed description when
`read with the accompanied drawings.
`0015. It will be appreciated that for simplicity and clarity
`of illustration, elements shown in the figures have not neces
`sarily been drawn to scale. For example, the dimensions of
`Some of the elements may be exaggerated relative to other
`elements for clarity. Further, where considered appropriate,
`reference numerals may be repeated among the figures to
`indicate corresponding or analogous elements.
`0016. In the following description, various aspects of the
`invention will be described. For purposes of explanation,
`specific configurations and details are set forth in order to
`provide a thorough understanding of the invention. However,
`it will also be apparent to one skilled in the art that the
`invention may be practiced without the specific details pre
`sented herein. Furthermore, well-known features may be
`omitted or simplified in order not to obscure the invention.
`0017. Unless specifically stated otherwise, as apparent
`from the following discussions, it is appreciated that through
`out the specification discussions utilizing terms such as “pro
`cessing.” “computing. "calculating.” “determining.” or the
`like, refer to the action and/or processes of a computer or
`computing system, or to a similar electronic computing
`device, that manipulates and/or transforms data represented
`as physical. Such as electronic quantities within the comput
`ing system's registers and/or memories into other data simi
`larly represented as physical quantities within the computing
`system's memories, registers or other Such information stor
`age, transmission or display devices.
`0018. The processes and displays presented herein are not
`inherently related to any particular apparatus. Various gen
`eral-purpose systems may be used with programs in accor
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`dance with the teachings herein, or it may prove convenient to
`construct a more specialized apparatus to perform the desired
`method. The desired structure for a variety of these systems
`will appear from the description below. In addition, embodi
`ments of the present invention are not described with refer
`ence to any particular programming language. It will be
`appreciated that a variety of programming languages may be
`used to implement the teachings of embodiments of the
`invention as described herein.
`0019. It should be appreciated that according to some
`embodiments of the present invention, the method described
`below may be implemented in machine-executable instruc
`tions. These instructions may be used to cause a general
`purpose or special-purpose processor that is programmed
`with the instructions to perform the operations described.
`Alternatively, the operations may be performed by specific
`hardware that may contain hardwired logic for performing
`the operations, or by any combination of programmed com
`puter components and custom hardware components.
`0020. Although the scope of the present invention is not
`limited in this respect, the wearable device disclosed herein
`may be implemented in any suitable wired or wireless device
`that may be a handheld, worn, or other suitable portable
`communications device. By way of example, the wearable
`devices may include wireless and/or cellular telephones,
`Smart telephones, personal digital assistants (PDAs), wrist
`worn devices, and other suitable wearable devices or any
`parts of them. Alternatively, according to other embodiments
`of the present invention, the system and method disclosed
`herein may be implemented in computers.
`0021 Embodiments of the present invention are directed
`to an improved wearable device, a system, and a method for
`monitoring medically relevant parameters and/or processing
`data related to medically relevant parameters and/or alerting
`a patient and/or medical facility regarding a medical condi
`tion. For example, devices, systems and methods may be
`provided for monitoring physiological and/or environmental
`parameters, sending alerts to a Medical Center (MC) and/or to
`a patient, processing sensed data, and updating device param
`eters and/or functions and/or its software. The wearable
`device, according to Some embodiments of the present inven
`tion, may enable measurement of pulse and blood oxygen
`saturation (SpO) from one or more locations in or on a user's
`body. In other embodiments, additional physiological and/or
`environmental parameters, or combinations of parameters
`may be measured.
`0022. The wearable device, according to some embodi
`ments, may independently transfer a patient's physiological
`and/or environmental data, and/or other suitable data to, for
`example, the MC. For example, when certain parameters are
`above or below predetermined ranges or thresholds that may
`be defined according to the particular needs of a patient, Such
`data and/or signals or messages associated with the data may
`be sent to the MC. In some embodiments, the wearable device
`may also transfer the data to the MC if the parameters are
`within predetermined thresholds or ranges. In some embodi
`ments, the MC may receive, via a communications channel, a
`patient's physiological data and additional information, Such
`as, for example, the location of the patient, directly from the
`wearable device. A person or persons associated with the MC
`may remotely update, for example, the ranges or thresholds
`for determining the status of vital parameters of an individual
`patient, at the discretion of the staff, for example, medical
`staff, information technology staff and/or technical/engineer
`
`ing staff in the MC, or a device associated with the MC’s
`server, may automatically update various parameters. Addi
`tionally, the MC server may remotely update operational
`features, for example, changing modes of operation, adding
`new features, updating the device's software and/or part
`thereof etc. for a wireless device of an individual patient or for
`a group of patients. Any wearable or remote device for moni
`toring, measuring, communicating etc. Vital parameter or
`other data of a patient to the MC may be used.
`0023 Reference is now made to FIG. 1, which schemati
`cally illustrates a medical monitoring system 100 in accor
`dance with some exemplary embodiments of the present
`invention. Medical monitoring system 100 may include, for
`example, at least one wearable device 105 that may commu
`nicate with a medical center (MC) server 110. Wearable
`device 105 may have a bi-directional communication link
`with MC server 110, which may be associated with, for
`example, a clinic, hospital, remote center, medical profes
`sional, or any other suitable provider of suitable medical
`services. For example, wearable device 105 may communi
`cate with MC server 110 using a serial communication port, a
`parallel connection, USB, a modem, network card (e.g.,
`ADSL, Cable, satellite) or other data communications tech
`nologies. For example, wearable device 105 may communi
`cate with MC server 110 using wireless data communication,
`for example, using cellular communication (e.g., General
`Packet Radio Service (GPRS)), satellite communications
`technology, wireless LAN technology, infrared technology,
`Wireless Fidelity (WiFi), Bluetooth, ZigBee, or other suitable
`wireless communications technologies. Data may be trans
`ferred between wearable device 105 and MC server 110 using
`the above or other suitable means.
`0024. The communication may be performed over a com
`puter network, for example, the Internet or a local area net
`work (LAN), etc. There may be a plurality of bi-directional
`and/or uni-directional communication channels between MC
`server 110 and wearable device 105, and there may be a
`plurality of medical centers (MC), MC servers 110 and/or
`wearable devices 105.
`0025. In one embodiment the bi-directional communica
`tion channel between the MC server 110 and wearable device
`105 is a Short Message Service (SMS) channel that may
`enable communication of data via SMS transceiver 115 to
`and/or from the wearable device 105, via a cellular commu
`nications network. The SMS channel may enable transmis
`sion of messages from wearable device 105 to MC server 110.
`via SMS transceiver 115. In one embodiment the bi-direc
`tional communication channel between the MC server 110
`and wearable device 105 is an Internet Protocol (IP) based
`channel, that may enable communication of data via Internet
`server 120, for example, using File Transfer Protocol (FTP) or
`other Suitable data transfer protocols. In some embodiments a
`combination of communication networks may be used. For
`example, if the SMS channel is not available and/or not cho
`sen by the wearable device 105, wearable device 105 may
`communicate with MC server 110 using FTP. In other
`embodiments wearable device 105 may communicate with
`MC server 110 using, for example, SMS and Internet com
`munications. In some embodiments wearable device 105 may
`communicate with MC server 110, via a Web interface, for
`example, a Website, where data, commands, and/or requests
`etc. may be entered and/or received by wearable device 105
`and/or MC server 110.
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`0026. In one embodiment the bi-directional communica
`tion channel between the MC server 110 and wearable device
`105 may utilize TCP/IP protocol. In one embodiment a File
`Transfer Protocol (FTP) may be used to upload physiological
`data of the patient, e.g., sensed measurement data, from wear
`able device 105 to MC server 110, and to download data such
`as updates to software modules from MC server 110 to wear
`able device 105. Usage of FTP or any other suitable protocol
`may require the wearable device 105 to logon as an FTP client
`to the Internet server 120.
`0027. In some embodiments a voice channel, as described
`below, may be used to enable the staff at MC server 110, or a
`device or suitable software and/or hardware associated with
`the MC server 100, to communicate with the patient who is
`using wearable device 105 and/or to enable the patient using
`wearable device 105 to communicate with the staff of MC
`server 110 or the MC server 110 itself.
`0028. Reference is now made to FIGS. 2A, 2B, and 2C,
`which schematically illustrate examples of external top, bot
`tom, and side view layouts, respectively, of a wearable device
`105 in accordance with some exemplary embodiments of the
`present invention. Wearable device 105 may include, for
`example, input components such as functional buttons 112
`and 114 for inputting data or commands (e.g., approving or
`rejecting activities) to operate wearable device 105, emer
`gency buttons 116 and 118, that may be used to manually
`initiate an emergency mode (e.g., by pressing them together
`or pressing one of them), and an On/Off button 125 to switch
`wearable device 105 on or off. The on/Off button 125 may be
`unified with any of the other buttons, for example functional
`buttons 112 and 114. Wearable device 105 may include one or
`more electrodes, for example, an ECG RA (Right Arm) finger
`electrode 122, an ECG LA (Left Arm) wrist electrode 124
`(FIG.2B), and an ECG REF. (Reference) wrist electrode 126
`(shown in FIG. 2C). Electrodes 122 and 124 may be located
`at any suitable location or locations on wearable device 105.
`For example, electrode 124 may be located on the top-side of
`wearable device 105. In some embodiments, the ECG REF.
`Wrist electrode 126 may be located at any suitable location on
`the inner side of wearable device 105 or on the inner side of a
`strap 144. Wearable device 105 may be worn on a patient's
`left or right hand or arm, e.g., on the wrist, or on the left or
`right foot or leg, e.g., on the ankle, and the various compo
`nents may be appropriately located to enable measuring of
`parameters on the left and/or right hand and/or arm and/or
`foot and/or leg.
`0029. In some embodiments wearable device 105 may
`include at least one blood oxygen level (SpO) transceiver
`128 to measure the level of the oxygen in the patient's blood,
`and at least one pulse transceiver 130 (shown in FIG. 2B) to
`measure the patient's pulse. Blood oxygen Saturation level
`(SpO) transceiver 128 may be incorporated into, for
`example, electrode 122 and/or may be independent of elec
`trode 122. In some embodiments wearable device 105 may
`include a pulse transceiver or sensor 130. The location of
`pulse transceiver 130 within wearable device 105 may be
`appropriately positioned to enable sensing of the pulse of the
`patient. Pulse transceiver 130 may be incorporated into, for
`example, electrode 124 and/or may be independent of elec
`trode 124. In some embodiments, wearable device 105 may
`include one or more transceivers, electrodes, or sensors to
`enable measurement of SpO, ECG, pulse, blood pressure
`data, skin temperature data, respiration data, perspiration
`data, cardio impedance data, blood Sugar or glucose level.
`
`and/or other suitable data. The SpO, pulse and/or other
`parameters may be presented on a display area 134 of wear
`able device 105. The pulse and/or other parameters may be
`transferred to the MC server 110. Other sensor mechanisms
`may be used.
`0030 Wearable device 105 may include a speaker 136 to
`enable a patient to hear audio signals, for example from Voice
`communications initiated from MC server 110 or from other
`sources. When wearable device 105 is operated in a continu
`ous mode of operation, wearable device 105 may, for
`example, continuously or according to a pre-defined sched
`ule, read the pulse of the patient, using pulse transceiver 130.
`The location of pulse transceiver 130 within wearable device
`105 may be appropriately positioned to enable sensing of the
`pulse of the patient. Pulse transceiver 130 may be incorpo
`rated within electrode 124 or may be separate from electrode
`124. An indication of the pulse of the patient and/or other
`parameters may be presented on the display area 134 of
`wearable device 105. The pulse and/or other parameters may
`also be transferred to the MC server 110. Other sensor mecha
`nisms may be used.
`0031
`Display area 134 may display additional informa
`tion Such as, for example, medical parameters of the patient,
`messages received from MC server 110, operational instruc
`tions, date and time, parameters that are related to functional
`elements of wearable device 105 etc. Display area 134 may
`be, for example, a color display and/or a monochromatic
`display and may have any desired resolution, depending on
`the type of data to be displayed. In some embodiments, dis
`play area 134 may include an interactive display, for example,
`a touch sensitive display, and may have a Voice-activated
`circuit to control Display area 134. Display area 134 may
`display any combination of alphanumeric characters, and/or
`text and/or two-dimensional and/or three-dimensional graph
`ics and/or icons.
`0032. Additional elements in wearable device 105 may
`include one or more service connectors, for example, a ser
`vice connector 138 that may connect the wearable device 105
`to external units such as, for example, a computer that may
`help provide Software updates, testing, technical diagnostics
`etc., a testing unit that may enable testing the usability of
`device 105, an external medical device, for example, To mea
`Sure blood pressure, ECG etc., an external display unit, com
`munication unit, for example, a Bluetooth chip and circuitry,
`and/or other suitable external units. Wearable device 105 may
`include a charge connector 140 that may be used to connect
`wearable device 105 to a power source to enable charging of
`a battery 142 (FIG. 2B). A charger connector 140 may be
`included in service connector 138. Wearable device 105 may
`include optional strap 144 that may be used to attach wearable
`device 105 to the wrist or other location of the patient. Wear
`able device 105 may include various other suitable compo
`nents and/or devices, which may be implemented using any
`Suitable combination of elements and components and may
`incorporate hardware and/or software.
`0033 Reference is now made to FIGS. 3A and 3B, which
`schematically illustrate possible sensor configurations to per
`form the functions described above with reference to SpO.
`sensor 128 (FIG. 2A) and pulse sensors 130 (FIG. 2B),
`respectively. According to Some embodiments of the present
`invention, wearable device 105 may have one or more SpO.
`sensors 300 (FIG. 3A) and/or one or more pulse sensors 350
`(FIG. 3B). Each SpO sensor 300 may include at least one
`emitting/receiving unit 310 and at least one electronic unit
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`320 as well as other appropriate components. Emitting/re
`ceiving unit 310 may be located, for example, on the upper
`side of wearable device 105, e.g., to be reachable by at least
`one finger of the patient wearing the device 105, or in the
`inner side of strap 144. Electronics unit 320 may be connected
`to a main controller (e.g., controller 502 in FIG. 5 below) of
`wearable device 105, and may optionally receive power from
`battery 142 (FIG. 2B) or from a battery circuit. SpO sensor
`300 may enable measurement of blood oxygen saturation in
`the blood and/or a patient's pulse. Each pulse sensor 350 may
`include at least one emitting/receiving unit 360 and at least
`one electronic unit 370 as well as any other suitable compo
`nents. Emitting/receiving unit 360 may be located, for
`example, on the lower side of wearable device 105, e.g., to be
`in suitable contact with the wrist of the patient wearing the
`device, or on the upper side of wearable device 105. Electron
`ics unit 370 may be connected to the main controller (see 502
`in FIG.5) of wearable device 105, and may optionally receive
`power from battery 142 or from the battery circuit. Measure
`ments may be taken from each sensor at any time, and may be
`taken in series, in parallel, in response to a predefined trigger,
`continuously and/or according to other selected patterns.
`Sensors 300 and 350 may be located at other suitable posi
`tions. Other sensor types may be used in addition to or in place
`of sensors 300 and 350, for example, a blood pressure sensor
`SpA.
`0034. In accordance with some embodiments of the
`present invention, medical monitoring system 100 may oper
`ate in at least one of a keeper mode, an extended mode, and an
`emergency mode, or any other appropriate mode, as
`described below.
`0035. The keeper mode may be used as the default mode of
`wearable device 105, such that wearable device 105 may
`enter this mode when the device is switched on. Other modes
`may alternatively be used as the default mode. In the keeper
`mode, wearable device 105 may, for example, continuously
`or intermittently, read the pulse and/or another parameters of
`a patient. In one example of keeper mode functioning, wear
`able device 105 may display parameter data on display area
`134, may alert the patient with a message on display area 134,
`and/or may alert the patient using an audible signal via
`speaker 136, for example, by playing back predefined audio
`signals. In addition, wearable device 105 may transmit the
`measured parameters to MC server 110 for analyses or pro
`cessing of the measured parameters, for example, using a FTP
`channel and/or a SMS channel. In the event where the staffin
`MC server 110 determines that the patient’s pulse is abnor
`mal, according to predetermined criteria or ranges described
`in detail below, wearable device 105 may alert the patient.
`0036. According to some embodiments of the present
`invention wearable device 105 itself may determine when one
`or more parameters are abnormal or, for example, in a danger
`range, instead of or in addition to the staff in MC server 110.
`According to some embodiments of the present invention MC
`server 110 may automatically determine when one or more
`parameters are abnormal or, for example, in a danger range,
`instead of or in addition to the staff in MC server 110. Addi
`tionally, wearable device 105 may senda warning message to
`MC server 110, using, for example, the SMS channel, FTP
`channel etc. When wearable device 105 is operated in keeper
`mode, parameters such as pulse, SpO, and ECG may be
`monitored continuously and/or at selected intervals, for
`example, every twelve hours.
`
`0037. In the extended mode, wearable device 105 may be
`set to perform operations according to a pre-defined schedule,
`for example, to periodically measure oxygen levels in the
`patient's blood (SpO) and/or ECG. In this mode, wearable
`device 105 may display parameter data on display area 134,
`may alert the patient with a message on display area 134,
`and/or may alert the patient using an audible signal via
`speaker 136, for example, by playing back predefined audio
`signals. In addition, wearable device 105 may transmit the
`measured parameters and/or results from analyses or process
`ing of the measured parameters, to MC server 110, for
`example, using FTP channel and/or SMS channel. When
`wearable device 105 is operated in extended mode, vital signs
`such as pulse, SpO2, and ECG, may be monitored, for
`example, five times a day by default (e.g., the default may be
`at shorter or longer intervals, as required). If the staff at MC
`server 110 or the MC server 110 detect, for example, that the
`heart rate, oxygen level in the blood, and/or ECG records
`and/or other data are abnormal (e.g., according to pre-defined
`criteria or ranges as discussed below), wearable device 105
`may alert the patient by providing output signals in the dis
`play area 134 or via speaker 136. Additionally or alterna
`tively, wearable device 105 may send a message to MC server
`110, or to another destination, for example, using the FTP
`channel.
`0038. In emergency mode a patient may initiate operation
`of the medical monitoring system 100 by pressing, for
`example, any of the emergency buttons 116 or 118. When
`operating in emergency mode, wearable device 105 may send
`emergency messages to MC server 110 or to another destina
`tion using, for example, the FTP channel. Emergency mes
`sages may additionally or alternatively be sent to MC server
`110 or to another destination via the SMS channel, for
`example, in cases where the FTP channel is not available. In
`addition, when entering an emergency mode, measurement of
`SpO2 level, ECG level, and/or additional suitable parameters
`may be initiated. The staff of MC server 110 or the MC server
`110 itself may initiate a call to the patient of wearable device
`105, or may send a message etc.
`0039. According to some embodiments of the present
`invention, Software or device program updates (referred to
`herein as “software updates') may be implemented to enable
`individualized adaptation of operation parameters of device
`105. Customizable software updates may include, for
`example, customizing one or more modes of operation for
`each patient, customizing ranges or thresholds for monitoring
`of an individual patient's parameters, customizing timing of
`parameter measurements, customizing alert functions, deter
`mination of types of measurements to be monitored, custom
`izing diagnostic ranges, adding new features or Software
`improvements, deleting features that are not relevant for a
`particular patient's condition monitoring, customizing opera
`tional modes, correcting Software problems, and/or any other
`suitable modifications. The customized or individualized pro
`grams may be programmed directly into wearable device 105
`using wire based or wireless data communication, and/or may
`be remotely transferred to wearable device 105. In this way
`the timing parameters or other aspects of operation of wear
`able device 105 may be modified and updated, optionally
`remotely, by MC server 110, at the discretion of the MC staff
`or automatically using pre-defined criteria. For example, the
`MC may remotely initiate a certain mode of operation for
`wearable device 105, and/or may remotely change vital
`parameter ranges, etc., optionally for each patient individu
`
`-10-
`
`Masimo Ex. 1035
`IPR Petition - USP 10,942,491
`
`
`
`US 2008/0208009 A1
`
`Aug. 28, 2008
`
`ally. Customized or individualized programs may be pro
`grammed directly into a single wearable device 105 or into a
`group of wearable devices 105.
`0040. According to some embodiments of the present
`invention, measurements of SpO and/or pulse may be
`executed using reflected light. For example, light may be
`emitted by a light emitting component, e.g., a light emitting
`diode (LED) onto a suitable part of a patient's body, and the
`light reflected from the body may be detected by a light
`detecting component on wearable device 105. The patient's
`SpO, pulse, blood pressure, SpA. and/or other physiologi
`cal parameters and/or environmental parameters may be cal
`culated from the detected light. The light to be reflected may
`be emitted in one or more wavelength ranges, as is known in
`the art. In order to simplify and to clarify, the sub-system or
`Sub-systems for measuring the SpO may be described and
`illustrated herein as being composed, for example, of an
`emitting/receiving unit and an electronic unit. In the same
`manner the Sub-system or Sub-systems for measuring pulse
`may be described and illustrated herein as being composed,
`for example, of an emittin