throbber
US007598878B2
`
`(12) United States Patent
`Goldreich
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7,598,878 B2
`Oct. 6, 2009
`
`(54) METHOD AND DEVICE FOR MEASURING
`PHYSIOLOGICAL PARAMETERS AT THE
`WRIST
`
`(76) Inventor: Rami Goldreich, 96 Ayalon Street,
`48621 Rosh Ha'ayin (IL)
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(*) Notice:
`
`4,819,860 A * 4, 1989 Hargrove et al. ............ 600,483
`4,952,928 A
`8, 1990 Carroll et al.
`5,045,839 A
`9, 1991 Ellis et al.
`5,410,471 A
`4/1995 Alyfuku et al.
`5,416,695 A
`5/1995 Stutman et al.
`5,462,051 A 10/1995 Oka et al.
`5,515,858 A * 5/1996 Myllymaki ................. 600/301
`5.544,649 A
`8, 1996 E. A.
`- I
`
`(21) Appl. No.:
`(22) PCT Filed:
`
`10/497,169
`Dec. 10, 2002
`
`(Continued)
`FOREIGN PATENT DOCUMENTS
`
`(86). PCT No.:
`
`PCT/ILO2/OO995
`
`DE
`
`10005526
`
`8, 2001
`
`S371 (c)(1),
`(2), (4) Date:
`
`Jun. 9, 2004
`
`(87) PCT Pub. No.: WO03/050643
`
`(65)
`
`PCT Pub. Date: Jun. 19, 2003
`Prior Publication Data
`US 2005/01 16820A1
`Jun. 2, 2005
`
`(51) Int. Cl.
`(2006.01)
`A6B 5/00
`(52) U.S. Cl. ................. 340/573.1; 340/517; 340/539.1;
`600/300; 600/323; 600/340; 600/382; 600/301;
`128/903
`(58) Field of Classification Search .............. 340/573.1;
`600/300, 345, 500, 585, 301,323,340, 382:
`128/903
`See application file for complete search history.
`References Cited
`
`(56)
`
`U.S. PATENT DOCUMENTS
`ck
`3,911,899 A 10/1975 Hattes ........................ 600/407
`4.331,154 A
`5, 1982 Broadwater et al.
`4,407.295 A 10, 1983 Steuer et al.
`4.418,700 A 12/1983 Warner
`4,784,152 A * 1 1/1988 Shinoda et al. ............. 600/503
`
`(Continued)
`OTHER PUBLICATIONS
`
`Yang et al., “Development of the Ring Sensor for Healthcare Auto
`mation'. Robotics and Autonomous Systems, 30:273-281, 2000.
`
`(Continued)
`Primary Examiner Daniel Wu
`Assistant Examiner—Son M Tang
`(74) Attorney, Agent, or Firm Kohn & Associates, PLLC
`
`(57)
`
`ABSTRACT
`
`A wrist-mounted device for measuring at least one physi
`ological parameterofa Subject. The present invention enables
`Such a measurement to preferably be transformed into clini
`cally useful information about the subject. Such information
`may then optionally be sent to medical personnel, for
`example at a contact and/or monitoring center, through a
`gateway device. The gateway device preferably communi
`Cates with the wrist-mounted device of the present invention
`through a wireless communication channel
`9.
`
`32 Claims, 6 Drawing Sheets
`
`User
`k
`
`118
`
`
`
`nic Pa
`
`Button
`
`ED
`display
`
`display
`
`Processing
`Unit
`
`8
`
`107
`
`2
`
`16
`
`Wearable evice
`
`Remote server
`
`13
`
`1
`
`APPLE 1061
`Apple v. AliveCor
`IPR2021-00972
`
`

`

`US 7,598,878 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`7/1997 Lepkofker
`5,652,570 A
`5,669,392 A * 9/1997 Ljungstrom ................. 600,510
`5,771,001 A
`6/1998 Cobb
`5,772,586 A
`6, 1998 Heinonen et al.
`5,778,882 A
`7, 1998 Raymond et al. ........... 600,513
`5,807,267 A
`9/1998 Bryars et al. ................ 600,500
`5,853,005. A 12/1998 Scanlon
`5,862,803 A
`1/1999 Besson et al.
`5,877,675 A
`3, 1999 RebStock et al.
`5,899,928 A
`5, 1999 Sholder et al.
`5,917,415 A
`6, 1999 Atlas
`5,942.979 A * 8/1999 Luppino ..................... 340,576
`6,046,761 A
`4/2000 Echerer
`6,134,504 A 10/2000 Douglas et al.
`6,139,494 A 10, 2000 Cairnes
`6, 160,478 A * 12/2000 Jacobsen et al. ....... 340/.530.12
`6,327.495 B1
`12/2001 Iwabuchi et al.
`6,348,867 B1 *
`2/2002 Myllymaki .............. 340,573.1
`6,353,396 B1* 3/2002 Atlas ....................... 340.6939
`6,413,233 B1
`7/2002 Sites et al.
`6,443,890 B1
`9, 2002 Schulze et al.
`6,491.647 B1 * 12/2002 Bridger et al. .............. 600,585
`6,494,829 B1* 12/2002 New et al. ................... 600/300
`6,616,613 B1
`9, 2003 Goodman
`6,694, 180 B1
`2/2004 Boesen ....................... 600/547
`6,840,904 B2 *
`1/2005 Goldberg ....
`600,300
`6,893,396 B2 * 5/2005 Schulze et al. .
`... 600/300
`7,044,911 B2 *
`5/2006 Drinan et al. .....
`... 600/300
`7.285,090 B2 * 10/2007 Stivoric et al. .............. 600/300
`2001/0012916 A1
`8, 2001 Deuter
`2002fOO45808 A1
`4/2002 Ford et al.
`2003.01.07487 A1
`6/2003 Korman et al.
`2004/0204635 A1 * 10, 2004 Scharf et al. ................ 600/323
`
`
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`DE
`
`10009882
`20119965
`
`10, 2001
`4/2002
`
`O770349
`EP
`1070479
`EP
`O876790
`EP
`2003276
`GB
`WO96,01585
`WO
`WO99,04685
`WO
`WOOOf 4014.5
`WO
`WOO1? 15056
`WO
`WOO1,976.86
`WO
`WOO3,050642
`WO
`WOO3,050643
`WO
`WO WO2004/047633
`
`5, 1997
`1, 2001
`2, 2003
`3, 1979
`1, 1996
`2, 1999
`T 2000
`1, 2001
`12/2001
`6, 2003
`6, 2003
`6, 2004
`
`OTHER PUBLICATIONS
`Rhee et al., “Artifact resistant Power-Efficient Design of Finger
`Ring Plethysmographic Sensors”, IEEE Transactions. On Biomedical
`Enginering, 48(7):795-805, 2001.
`-
`Yang etal, "A Twenty-Four Hour Tele-Nursing System Using a Ring
`Sensor”, Proc. Of 1998 Int. Conf. On Robotics and Automation,
`Leuven, Belgium, pp. 387-392, 1998.
`Rhee et al. “The Ring Sensor: A New Ambulatory Wearable Sensor
`for Twenty-Four Hour Patient Monitoring”. Proceedings of the 20th
`Annual International Conference of the IEEE Engineering in Medi
`cine and Biology Society, Hong Kong, 1998.
`Mascaro, S.A., “Photoplethymograph Fingernail Sensors for Measur
`ing Finger Forces Without Haptic Obstruction", IEEE Transactions
`On Robotics and Automation, 17(5):698-708, 2001.
`Yang etal, "Cuffless Continuous Monitoring of Beat-to-Beat Blood
`Pressure Using Sensor Fusion', available through http://web.mit.
`edu/Zyi/www.pdf IEEETRans2000.pdf as of Dec. 9, 2001.
`Yang, et al. “Sensor Fusion for Noninvasive Continuous Monitoring
`of Pulsating Blood Pressure Based on an Arterial Hemodynamic
`Model”, available through http://www.mit.edu/afs/athena.mit.edu/
`user/zly/Zyi/www/pdf ASME99.pdf.
`Zhang et al. "A Telemedical Multilevel Server Network System'.
`Chinese Journal of Medical Instrumentation, 25(1): 30-33, 2001. In
`Chinese, Abstract in English.
`* cited by examiner
`
`2
`
`

`

`U.S. Patent
`U.S. Patent
`
`Oct. 6, 2009
`
`Sheet 1 of 6
`
`US 7,598,878 B2
`US 7,598,878 B2
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`U.S. Patent
`U.S. Patent
`
`Oct. 6, 2009
`Oct. 6, 2009
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`Sheet 2 of 6
`Sheet 2 of 6
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`US 7,598,878 B2
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`

`

`U.S. Patent
`
`Oct. 6, 2009
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`Sheet 3 of 6
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`US 7,598,878 B2
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`

`

`U.S. Patent
`
`Oct. 6, 2009
`
`Sheet 4 of 6
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`US 7,598,878 B2
`
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`
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`Len
`indicates the number of data bytes that the message contains (0 to n + 2
`bytes).
`
`Lens 0 - No command.
`
`Len F 1 - command only; the message not include data(0) through
`data(n)
`
`Len >2 - the message includes command and data.
`status bits (1 byte)
`Flag
`Addr the user ID of the bracelet, 24bits (0 to16777216).
`CMD command description.
`Data(n) the data of the message.
`CRC the CRC (2 bytes) for the message beginning from STX byte to
`Data(n) byte
`
`ETX
`
`End of TX indicates the end of the message (7B hex)
`
`6
`
`

`

`U.S. Patent
`U.S. Patent
`
`Oct. 6, 2009
`Oct. 6, 2009
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`Sheet 5 of 6
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`US 7,598,878 B2
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`U.S. Patent
`U.S. Patent
`
`Oct. 6, 2009
`Oct. 6, 2009
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`Sheet 6 of 6
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`US 7,598,878 B2
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`

`

`US 7,598,878 B2
`
`1.
`METHOD AND DEVICE FOR MEASURING
`PHYSIOLOGICAL PARAMETERS AT THE
`WRIST
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`
`This application is a National Phase Application of PCT/
`IL02/00995 having International Filing date of 10 Dec. 2002,
`which claims priority from U.S. patent application Ser. No.
`10/006,357 filed Dec. 10, 2001 entitled, “Method and Device
`for Measuring Physiological Parameters at the Wrist, the
`subject matter of which is incorporated herein by reference.
`
`FIELD OF THE INVENTION
`
`10
`
`15
`
`The present invention is of a method and device for mea
`Suring at least one physiological parameter of a subject at the
`wrist, preferably for extracting clinically useful information
`thereof. More specifically, the present invention is of a device
`which may be worn at the wrist of the subject with a strap or
`other fastening article, and which may then be used to moni
`tor the Subject through measurement of the physiological
`parameter.
`
`BACKGROUND OF THE INVENTION
`
`25
`
`2
`easy to use. The equipment would then be able to monitor at
`least one physiological parameter of the user, without requir
`ing the user to perform any complicated actions and/or to
`operate complex devices. Indeed, it would be highly preferred
`for the equipment to be incorporated as part of the regular
`daily living routine of the Subject, since the requirement for
`any additional or special actions on the part of human Subject
`is likely to result in decreased compliance. In addition, the
`equipment should be robust yet inexpensive.
`One example of such a device incorporates a wristband to
`attach a physiological sensor to the wrist of the Subject. Cur
`rently, a number of different types of such wristband devices
`are available, most of which are intended to be used as stand
`alone devices to provide information about the subjects own
`physical condition, mainly for heart rate and blood pressure.
`Most of these devices obtain Such measurements by using an
`inflating cuff, which is bulky and awkward for the subject.
`Wrist-mounted heart rate monitors are knownto the art and
`have been disclosed, for example, in the patent to Orr et al.
`U.S. Pat. No. 3,807.388, wherein the duration of a heartbeat
`is measured by counting electrical pulses recurring at a
`known frequency. The duration of the heartbeat is then related
`to a particular average heartbeat rate. However, the disclosed
`measurement system does not directly measure the heart rate
`and, therefore, is subject to inaccuracies of measurement due
`to the instability of heartbeat duration over brief intervals of
`time.
`A blood pressure measuring device is disclosed in the
`patent to Petzke et al, U.S. Pat. No. 3,926,179, in which a
`probe is applied adjacent to the radial artery of a wrist. A
`pressure-sensitive transducer on the probe generates electri
`cal signals corresponding to the blood pressure pulses of the
`radial artery. The electrical pulses are applied to analog cir
`cuitry that generates a systolic signal corresponding to the
`integrated Voltage at the peak of the electrical pulse signal and
`a diastolic signal corresponding to the Voltage at the low point
`of the pulse signal. The analog device of Petzke etal requires
`a substantial amount of power to operate and, therefore, is not
`Suitable for use in a small, compact stand-alone device for
`being worn on the wrist.
`A blood pressure and a heart rate measuring wrist watch is
`also disclosed in the patent to Broadwater, U.S. Pat. No.
`4.331,154, in which a digital watch is employed to measure
`systolic and diastolic blood pressure as well as heart rate. The
`band of the watch Supports a piezoelectric transducer that is
`held in contact with the wrist adjacent to the radial artery
`when a switch on the band is activated. The absolute values
`required for this method to evaluate blood pressure cause the
`device to be subject to inaccurate readings, since the tissues of
`the hand and wrist may be expected to expand and contract
`according to such factors as the time of day, and the condition
`of the external environment such as the atmospheric pressure.
`Such expansion or contraction may cause different degrees of
`tension on the wrist-mounted device, which is therefore not
`suitable for use without daily calibrations.
`Other wrist-mounted devices are for wireless panic alarm
`systems, mainly for elderly people who live alone. These
`devices are usually shaped as a wristbandora pendant. When
`ever the user becomes distressed, the user presses a panic
`button located on the device. The device then sends a digitally
`coded wireless message to a gateway device located nearby,
`usually in the same room, by using a unidirectional wireless
`data communication link. The gateway device then contacts a
`manually operated contact center, for example with a land
`based or cellular telephone connection. A particular identifier
`for the user is usually sent first, after which the human opera
`tor is allowed to talk to the user through a speaker and to listen
`
`30
`
`40
`
`45
`
`Currently, a number of different types of devices are avail
`able for monitoring human Subjects in a non-invasive manner.
`For example, heart function can be monitored in a user
`through the use of electrodes, which must be attached to the
`skin of the user. Although non-invasive, such equipment is
`nevertheless uncomfortable for the user, who is attached to a
`network of cables and wired sensors. In addition, Such equip
`ment is very expensive, limiting its use to hospitals and other
`35
`medical settings in which both the cost and the discomfort of
`the patient can be justified. Furthermore, patients may
`become anxious when examined by medical personnel,
`thereby significantly altering the normal readings for these
`patients. It should be noted that the terms “subject”, “patient’
`and “user are used interchangeably herein.
`However, there are many different situations in which non
`invasive monitoring of a human Subject is desired. For
`example, such monitoring could be very useful as part of the
`overall health maintenance of the human Subject, and could
`be used in order to detect a deterioration in the physiological
`condition of the subject before a concomitant deterioration in
`the health of the subject becomes noticeable. Examples of
`adverse physiological conditions which could be detected
`with regular non-invasive monitoring include but are not lim
`ited to excessive weight gain or less; arrhythmia and other
`heart conditions; incipient diabetes in the form of improper
`glucose metabolism; and loss of lung capacity or other prob
`lems with respiration.
`Heart rate and blood pressure are important factors in
`determining the state of a person’s health and the physical
`condition of a person’s body in response to physical or emo
`tional stress. Periodic monitoring of these physical param
`eters is particularly important for individuals having cardiac
`disease and/or lowered cardiac functioning, or high blood
`pressure. However, physically healthy individuals may also
`wish to periodically monitor their heart rate and blood pres
`Sure in stressful situations, for example when engaging in
`strenuous exercise.
`In order to support regular monitoring of human Subjects in
`their normal environment, such as in the home and at the
`office for example, the equipment must be non-invasive and
`
`50
`
`55
`
`60
`
`65
`
`9
`
`

`

`US 7,598,878 B2
`
`3
`through a sensitive microphone located within the gateway.
`However, none of the above systems contains any physiologi
`cal measurement device within, in order to learn about the
`current physiological status of the user.
`In Such a situation as described above, the operator at the
`call center learns about the users condition only by speaking
`with the user. However, this is only possible if the user is
`actually able to speak. High levels of background noise may
`also prevent the user from being heard by the microphone of
`the gateway device.
`
`SUMMARY OF THE INVENTION
`
`10
`
`15
`
`4
`physiological parameters of the user. These measurements
`may be sent directly to the gateway, or alternatively may be
`analyzed in order to compute the medical information of the
`user before sending the results to the gateway. The human
`operator would then preferably be able to assess the user's
`medical condition from the received information.
`Most preferably, the alarm signal is transmitted automati
`cally upon measurement of one or more physiological param
`eters of the user, even if the user is unable to press the panic
`button. Optionally, the alarm signal may be given to the user,
`additionally or alternatively, for example by Sounding an
`audible alarm, more preferably from the wrist-mounted
`device itself.
`The device of the present invention also monitors, at least
`periodically or continuously, one or more physiological
`parameters of the user. Continuous monitoring would more
`easily enable the device to transmit the alarm signal if one or
`more physiological parameters are determined to be outside
`of predefined criteria, which may represent Such medical
`information as unstable or excessive heart rate, or very high or
`low blood pressure.
`According to an exemplary embodiment of the present
`invention, the wrist-mounted device features one or more
`sensors attached to a wristband or other fastening article. The
`sensor(s) may optionally be connected to a microprocessor,
`optionally by a wire but alternatively through a wireless con
`nection. The microprocessor may optionally also be located
`within the wristband, or otherwise attached to the wristband.
`The sensor(s) may optionally support automatic collection of
`the measurement of the at least one physiological parameter,
`while the microprocessor is able to execute one or more
`instructions for extracting medical information about the user
`from Such measurement(s).
`The microprocessor more preferably operates a software
`program to process and analyze the data which is collected, in
`order to compute medical information. The extracted infor
`mation, optionally also with the raw data, is then preferably
`transferred to the previously described gateway device. The
`gateway device may optionally relay Such information to a
`remote server, which more preferably is able to provide such
`information to medical personnel, for example as part of a
`contact center. Therefore, continuous monitoring of the medi
`cal information and/or physiological parameters of the user
`may optionally and more preferably be made, enabling better
`medical care for the user. According to the present invention
`there is provided a device for measuring at least one physi
`ological parameter of a Subject, comprising: (a) a fastening
`article for being fastened to a wrist of the user; (b) at least one
`sensor for measuring at least one physiological function of
`the user, the sensor may be in contact with at least a portion of
`the wristand the sensor being attached to the fastening article:
`and (c) a processor for receiving a signal from the sensor and
`for converting at least one measurement to form the at least
`one physiological parameter. Optionally, the data may be
`stored on a non-volatile memory for being downloaded later
`by the user or by an operator.
`According to another embodiment of the present invention,
`there is provided a system for measuring at least one physi
`ological parameter of a Subject, comprising: (a) a device for
`measuring the at least one physiological parameter, compris
`ing: (i) a fastening article for being fastened to a wrist of the
`user; (ii) a sensor for measuring at least one physiological
`parameter of the user, the sensor being in contact with at least
`a portion of the wrist and the sensor being attached to the
`fastening article; (iii) a communication unit for at least trans
`mitting data; and (b) a gateway device for receiving the trans
`mitted data for being monitored.
`
`The background art does not teach or Suggest a device
`which can conveniently, non-intrusively and autonomously
`measure one or more physiological parameters, in order to
`extract medical information Such as heart rate, breathing rate
`and blood pressure, and which may be worn on the wrist of the
`user. The background art also does not teach or Suggest Such
`a wrist-mounted device, which can measure Such parameters
`and then send the information to a contact center or other
`location containing medical personnel. The background art
`also does not teach or Suggest Such a wrist-mounted device
`which is compact, non-invasive, and light.
`The present invention overcomes these deficiencies of the
`25
`background art by providing a wrist-mounted device for mea
`Suring at least one physiological parameter of the user. The
`present invention enables such a measurement to preferably
`be transformed into medical information about the user, and/
`or displays the results on a LCD display. As used herein, the
`term "physiological parameter refers to the signal which is
`received from the sensor, while the term “medical informa
`tion” refers to the information which may be extracted or
`otherwise obtained by analyzing this signal and/or a combi
`nation of signals. Such information may then optionally be
`sent to medical personnel (for example at a contact monitor
`ing center) and/or to a remote server, through a gateway
`device. The gateway device preferably communicates with
`the wrist-mounted device of the present invention through a
`wireless communication channel.
`The present invention has the option to display the medical
`information to the user on a local LCD display, such that the
`user is optionally and preferably able to read the result locally.
`Examples of medical information which may be extracted
`from the measured physiological parameter or parameters
`include, but are not limited to: heart rate; regularity in heart
`rate; breathing rate; arrhythmia of the heart (if any), as well as
`the general rhythm and functioning of the heart; blood pres
`Sure; presence of abnormal body movements such as convul
`sions for example, body position; general body movements;
`body temperature; presence and level of Sweat; oxygen Satu
`ration in the blood; and glucose levels in the blood.
`In addition to the physiological parameters, the present
`invention may measure other parameters that may affect the
`Subject’s physical condition, including but not limited to
`ambient temperature and humidity, lighting conditions,
`Smoke or other material in the air, distance from home etc.
`Optionally and more preferably, the present invention also
`features an alarm signal for being transmitted through the
`gateway device in order to indicate an emergency or other
`wise dangerous situation for the user. The alarm signal may
`optionally be transmitted according to a manual action of the
`user, Such as pressing a “panic button’ for example.
`Upon receipt of the manually activated alarm signal, the
`gateway would preferably initiate immediately a call to a
`human operated call center. Then the device would preferably
`automatically collect one or more current measurements of
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`5
`According to another embodiment of the present invention,
`there is provided a method for monitoring a physiological
`parameter of a user, comprising: providing a device for moni
`toring the physiological parameter, the device being attached
`to at least a portion of the user at a pulse point of the user;
`monitoring the physiological parameter through the pulse
`point; and if a level of the physiological parameter of the user
`is outside of an expected range, transmitting an alarm.
`According to still another embodiment of the present
`invention, there is provided a device for measuring at least
`one physiological parameter of a subject, comprising: (a) a
`fastening article for being fastened to a wrist of the user; (b) a
`piezoceramic sensor for measuring at least one physiological
`parameter of the user at a pulse point of the wrist and the
`sensor being attached to the fastening article; and (c) a pro
`cessor for receiving a signal from the sensor and for convert
`ing the at least one measurement to form medical informa
`tion.
`Hereinafter, the term “microprocessor includes, but is not
`limited to, general-purpose microprocessor, a DSP, a micro
`controller or a special ASIC designed for that purpose.
`The method of the present invention could be described as
`a process for being performed by a data processor, and as Such
`could optionally be implemented as software, hardware or
`firmware, or a combination thereof. For the present invention,
`a software application could be written in Substantially any
`Suitable programming language, which could easily be
`selected by one of ordinary skill in the art. The programming
`language chosen should be compatible with the computa
`tional device (computer hardware and operating system)
`according to which the software application is executed.
`Examples of suitable programming languages include, but
`are not limited to, Visual Basic, Assembler, Visual C, standard
`C, C++ and Java.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The invention is herein described, by way of example only,
`with reference to the accompanying drawings, wherein:
`FIG. 1 is a schematic block diagram of a system according
`to an exemplary embodiment of the present invention;
`FIG. 2 shows an exploded view of an exemplary device;
`FIG.3 describes a general state flow diagram;
`FIG. 4 describes a bi-directional message format between
`the device and the gateway;
`FIG. 5 shows an exploded view of an exemplary device
`with ECG option; and
`FIG. 6 is an exploded view of an exemplary device, which
`illustrates the installation of a SpO2 sensor.
`
`DESCRIPTION OF THE EXEMPLARY
`EMBODIMENTS
`
`The present invention is of a wrist-mounted device for
`measuring at least one physiological parameter of the user.
`The present invention enables Such a measurement to prefer
`ably be transformed into medical information about the user.
`Such information may then optionally be sent to medical
`personnel (for example at a contact monitoring center) and/or
`to a remote server, through a gateway device. The gateway
`device preferably communicates with the wrist-mounted
`device of the present invention through a wireless communi
`cation channel.
`Examples of medical information which may be extracted
`from the measured physiological parameter or parameters
`include, but are not limited to: heart rate; regularity in heart
`rate; breathing rate; arrhythmia of the heart (if any), as well as
`
`US 7,598,878 B2
`
`6
`the general rhythm and functioning of the heart; blood pres
`Sure; presence of abnormal body movements such as convul
`sions for example, body position; general body movements;
`body temperature; presence and level of Sweat; oxygen Satu
`ration in the blood; and glucose levels in the blood.
`Optionally and more preferably, the present invention also
`features an alarm signal for being transmitted through the
`gateway device in order to indicate an emergency or other
`wise dangerous situation for the user. The alarm signal may
`optionally be transmitted according to a manual action of the
`user, Such as pressing a “panic button’ for example.
`Most preferably, the alarm signal is transmitted automati
`cally upon measurement of the one or more physiological
`parameters of the user, preferably even if the user is unable to
`press the panic button. Optionally, the alarm signal may be
`given to the user, additionally or alternatively, for example by
`Sounding an audible alarm, more preferably from the wrist
`mounted device itself.
`An exemplary embodiment of the present invention may
`measure also parameters that may affect the Subject's physi
`cal condition, including but not limited to ambient tempera
`ture and humidity, lighting conditions, Smoke and/or other
`material in the air, distance from home etc.
`Upon receipt of the manually/automatically activated
`alarm signal, the gateway would preferably initiate immedi
`ately a call to a human operated call center. Then the device
`would preferably automatically collect one or more current
`physiological measurements of the user. These measure
`ments may be sent directly to the gateway, or alternatively
`may be analyzed in order to compute the medical parameters
`of the user before sending the results to the gateway. The
`gateway may also analyze the measurement, for example
`when the measurements are transferred directly to the gate
`way. The human operator, at the medical center, would then
`preferably be able to assess the user's medical condition from
`the received information. It should be noted that the terms
`“medical center and “call center are used interchangeably
`herein.
`The device of the present invention may also monitor, at
`least periodically but more preferably continuously, the value
`or condition of one or more physiological parameters of the
`user. Continuous monitoring would more easily enable the
`device to transmit the alarm signal if measurements of one or
`more physiological parameters are collected and analyzed by
`the microprocessor to form medical information, which then
`could be determined to be above predefined criteria, such as
`unstable heart rate, or very high or low blood pressure, for
`example.
`According to a non-limiting exemplary embodiment of the
`present invention, the wrist-mounted device features one or
`more sensors attached to a wristband or other fastening
`article. The sensor(s) are preferably connected to a micropro
`cessor, optionally by a wire but alternatively through a wire
`less connection. The microprocessor may optionally also be
`located within the wristband, or otherwise attached to the
`wristband. The sensor(s) preferably Support automatic col
`lection of at least one physiological measurement; more pref
`erably, the microprocessor is able to execute one or more
`instructions for extracting clinically useful information about
`the user from Such measurement(s).
`The microprocessor more preferably operates a software
`program to process and analyze the data which is collected, in
`order to compute medical information. The extracted medical
`information, optionally also with the raw data, is then pref
`erably transferred to the previously described gateway
`device. The gateway device then preferably relays such infor
`mation to a remote server, which more preferably is able to
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`7
`provide Such information to medical personnel, for example
`as part of a contact center. Therefore, continuous monitoring
`of the physiological parameters of the user may optionally
`and more preferably be made, enabling better medical care
`for the user.
`A general, non-limiting example of Suitable methods for
`measuring the heart rate and/or other heart-related physi
`ological parameters of a Subject who is wearing the device
`according to the present invention may be found in the article
`“Cuff-less Continuous Monitoring of Beat-To-Beat Blood
`Pressure Using Sensor Fusion', by Boo-Ho Yang, Yi Zhang
`and H. Harry Asada—IEEE (also available through http://
`web.mit.edu/Zyi/www/pdf/IEEETrans2000.pdf as of Dec. 9,
`2001), hereby incorporated by reference as if fully set forth
`herein, where systolic and diastolic blood pressure are calcu
`lated using the pulse pressure shape per heartbeat. The dis
`closure does not describe a device which has the functionality
`according to the present invention, but the disclosed method
`is generally useful for determining blood pressure from an
`external measurement of pressure from the pulse through the
`skin of the subject.
`The principles and operation of a device and method
`according to the present invention may be better understood
`with reference to the drawings and the accompanying
`description.
`Referring now to the drawings, FIG. 1 is a schematic block
`diagram of a system according to the present invention. As
`shown, a system 100 features a wearable device 101 to be
`worn by a user, preferably as a wrist-mounted device, for
`example by being attached with a wristbandor other fastening
`article to the wrist of the user. Device 101 features at least one
`physiological sensor 102 for measuring at least one physi
`ological parameter of the user. The function of an exemplary
`sensor 102 is described in greater detail below.
`The device 101 may optionally feature a vibration sensor
`123, preferably a piezoceramic sensor, which is not in direct
`contact with the skin of the user. Sensor 123 measures the
`movement of the

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