(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property
`Organization
`International Bureau
`
`(43) International Publication Date
`24 November 2005 (24.11.2005)
`
` (10) International Publication Number
`
`WO 2005/110238 Al
`
`(51) International Patent Classification’:
`05/08
`
`A61B 05/02,
`
`(21) International Application Number:
`PCT/I1.2004/000417
`
`(22) International Filing Date:
`
`16 May 2004 (16.05.2004)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`except US):
`(for all designated States
`(71) Applicant
`MEDIC4ALL A.G [CH/CH]; Alpenstrasse 1, CH-6304
`ZUG (CH).
`
`AT, AU, AZ, BA, BB, BG, BR, BW,BY, BZ, CA, CH, CN,
`CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI,
`GB, GD, GE, GH, GM, HR, HU,ID, IL,IN,IS, JP, KE,
`KG,KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MA, MD,
`MG, MK, MN, MW,MX, MZ, NA,NI, NO, NZ, OM,PG,
`PH,PL, PT, RO, RU, SC, SD, SE, SG, SK, SL, SY, TJ, TM,
`TN,TR, TT, TZ, UA, UG, US, UZ, VC, VN, YU, ZA, ZM,
`ZW.
`
`(84) Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KT, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, 7M,
`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`European (AI, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI,
`FR, GB, GR, HU,IE, IT, LU, MC, NL,PL, PT, RO,SE,SI,
`SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ,
`GW, MI., MR, NE, SN, TD, TG).
`
`(81) Designated States (unless otherwise indicated, for every
`kind of national protection available): AB, AG, AL, AM,
`
`For two-letter codes and other abbreviations, refer to the "Guid-
`ance Notes on Codes and Abbreviations" appearing at the begin-
`ning of each regular issue of the PCT Gazette.
`
`(54) Titles METHOD AND DEVICE FOR MEASURING PHYSIOLOGICAL PARAMETERS AT THE HAND
`
`100
`
`Published:
`(72) Inventor; and
`(75) Inventor/Applicant (for US only): GOLDREICH, Rami
`—_with international search report
`[ILAIL]; 96 Ayalon St., 48621 Rosh-Ha’ayin (IL).
`
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`
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`103
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`
`
`an Processing
`Unit
`
`
`Memory
`
`."
`Wearable Device
`101
`
`<
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`
`Analog
`Front-End
`
`NJ
`
`Vibration
`Sensor
`
`Real-Time
`Clock
`
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`106
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`114
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`(57) Abstract: A wrist-mounted device (100) for measuring at least one physiological parameterof the user. The present invention
`cnables such a measurementto preferably be transformed into clinically uscful information about the user. Such information may
`© then optionally be sent to medical personnel, for example at a contact and/or monitoring center. The measuring parameters may
`include blood pressure, ECG, location. The present invention can perform a Holter process over more than one physiological pa-
`5
`rameter.
`
`APPLE 1064
`Apple v. AliveCor
`IPR2021-00972
`
`
`
`
`
`2005/110238Ad.IMVTININAIEIMUININATIMTOUTONTACOTAYA
`
`1
`
`APPLE 1064
`Apple v. AliveCor
`IPR2021-00972
`
`

`

`WO 2005/110238
`
`PCT/IL2004/000417
`
`METHOD AND DEVICE FOR MEASURING PHYSIOLOGICAL
`
`PARAMETERSAT THE HAND
`
`FIELD OF THE INVENTION
`
`The present invention is ofa method and device for measuring 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,
`
`10
`
`and which may then be used to monitor the subject through measurement of the
`
`physiological parameter.
`
`BACKGROUND OF THE INVENTION
`
`Currently, a number of different types of devices are available for monitoring
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`15
`
`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. Such equipmentis very expensive, limiting its use to hospitals and other
`
`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
`
`20
`
`personnel, thereby significantly altering the normal readings for these patients.
`
`However,
`
`there are many different
`
`situations
`
`in which non-invasive
`
`monitoring of a human subjectis 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 deterioration of the physiological condition of the subject
`
`25
`
`before a concomitant deterioration in the health ofthe subject b ecomesnoticeable.
`
`2
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`

`

`WO 2003/110238
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`PCT/IL2004/000417
`
`Examples of adverse physiological conditions which could be detected with regular
`
`non-invasive monitoring include but are not limited to excessive weight gain or loss;
`
`arrhythmia and other heart conditions; incipient diabetes in the form of improper
`
`glucose metabolism; and loss of lung capacity or other problems with respiration.
`Heart rate, Breathing rate, body temperature, oxygen level in the blood
`
`and
`
`blood pressure are important factors in determining the state of a person's health and
`
`the physical condition of a person's body especially if exposed to physical or
`
`emotional stress. Periodic monitoring of these physical parameters is particularly
`
`important for individuals having cardiac disease and/or lowered cardiac functioning or
`
`10
`
`high blood pressure. However, physically healthy individuals may also wish to
`
`periodically monitor their heart rate and blood pressure in order to monitor changes in
`
`their personal vital signs.
`
`In order to support regular monitoring of human subjects in their normal
`
`environment, such as in the homeandat the office for example, the equipment must
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`15
`
`be non-invasive and easy to use. The equipment would then be able to monitorat
`
`least one physiological parameter of the user, without requiring 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
`
`20
`
`actions on the part of human subjectis 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. Currently, a numberof different types
`
`of such wristband devices are available, most of which are intended to be used as
`
`25
`
`stand-alone devices to provide information about
`
`the subject’s own physical
`
`3
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`

`WO 2003/110238
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`PCT/IL2004/000417
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`condition, mainly for heart rate and blood pressure. Most of these devices obtain such
`
`measurements by using an inflating cuff, which is bulky and awkwardforthe subject.
`
`Wrist-mounted heart rate monitors are known to the art and have been disclosed,
`
`for example, in the patentto Orr et al, U.S. Patent No. 3,807,388, wherein the duration
`
`of a heart beat is measured by counting electrical pulses recurring at a known
`
`frequency. The duration of the heartbeat is then related to a particular average heart
`
`beat 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 heart beat duration overbrief intervals of time.
`
`10
`
`A blood pressure measuring device is disclosed in the patent to Petzke et al, U.S.
`
`Patent 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 electrical signals
`
`corresponding to the blood pressure pulses of the radial artery. The electrical pulses
`
`are applied to analog circuitry that generates a systolic signal corresponding to the
`
`15
`
`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 et al 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 onthewrist.
`
`A blood pressure and a heart rate measuring wrist watch is also disclosed in the
`
`patent to Broadwater, U.S. Patent No. 4,331,154, in whichadigital watch is employed
`20
`
`to measure systolic and diastolic blood pressure as well as heart rate. The bandofthe
`
`watch supports a piezoelectric transducerthat 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
`
`25
`
`inaccurate readings, since the tissues of the hand and wrist may be expected to expand
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`4
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`WO 2003/110238
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`PCT/IL2004/000417
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`and c ontract according to such factors as the time of day, and the condition of the
`
`external environment such as the atmospheric pressure.
`
`Such expansion or
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`contraction may cause different degrees of tension on the wrist-mounted device,
`
`whichis therefore not suitable for use without daily calibrations.
`
`Other wrist-mounted devices are for wireless panic alarm systems, mainly for
`
`elderly people wholive alone. These devices are usually shaped as a wristband or a
`
`pendant. Whenever 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
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`10
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`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 operator is allowedto talk to the user through a speaker and to listen through a
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`sensitive microphone located within the gateway. However, none of the above
`
`15
`
`systems contains any physiological measurement device within,
`
`in order to learn
`
`about the current physiologicalstatus of the user.
`
`In such a situation as described above, the operator at the call center learns
`
`about the user’s 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
`
`20
`
`also prevent the user from being heard by the microphoneofthe gateway device.
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`5
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`PCT/IL2004/000417
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`SUMMARY OF THE INVENTION
`
`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 secured, automated databank (contact
`
`center) or call center containing medical personnel. The background art also does not
`
`teach or suggest such a wrist-mounted device which is compact, non-invasive, and
`
`10
`
`light.
`
`The present invention overcomes these deficiencies of the background art by
`
`providing a wrist-mounted device for measuring 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
`
`15
`
`LCD display. As used herein, the term “physiological parameter’ refers to the signal
`
`which is received from the sensor, while the term “medical information”refers to the
`
`information which may be extracted or o therwise obtained b y analyzing this signal
`
`and/or a combination of signals.
`
`Such information may then optionally be sent to
`
`medical personnel (for example at a contact monitoring call center) and/or to a remote
`
`20
`
`secured, automated databank server usually Web based, 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 display, such that the user is optionally and preferably able to read the
`
`25
`
`result locally. Examples of medical information which may be extracted from the
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`6
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`WO 2003/110238
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`PCT/IL2004/000417
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`measured physiological parameter or parameters include, but are not limited to: heart
`
`rate; variability in heart rate; breathing rate; arrhythmia of the heart (if any), as well as
`
`the general rhythm and functioning of the heart; blood pressure; presence of abnormal
`
`body movements such as convulsions for example; body position; general body
`
`movements; body temperature; presence and level of sweat; oxygen pressure 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 otherwise dangerous situation for the user. The alarm signal may
`
`10
`
`optionally be transmitted according to a manualaction ofthe 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 humanoperated call center. Then the
`
`device would preferably automatically collect one or more current measurements of
`
`15
`
`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.
`
`20
`
`Most preferably,
`
`the
`
`alarm signal
`
`is
`
`transmitted automatically upon
`
`measurement of one or more physiological parameters 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 deviceitself.
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`7
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`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 above 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,
`
`10
`
`optionally by a wire but alternatively through a wireless connection.
`
`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
`
`15
`
`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 information, optionally also with the raw data,
`
`is then preferably
`
`transferred to the previously described gateway device. The gateway device may
`
`20
`
`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 medical
`
`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
`
`25
`
`provided a device for measuring at least one physiological parameter of a subject,
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`8
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`

`

`WO 2003/110238
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`PCT/IL2004/000417
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`comprising: (a) a fastening article for being fastened to a wrist of the user; (b) a sensor
`
`for measuring at least one physiological function 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; 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 embodimentof the present invention, there is provided a
`
`system for measuring at least one physiological parameter of a subject, comprising:
`
`10
`
`(a) a device for measuring the at least one physiological parameter, comprising: (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 transmitting data; and (b) a gateway device for
`
`15
`
`receiving the transmitted data for being monitored.
`
`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 monitoring 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
`
`20
`
`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
`
`25
`
`piezoceramic sensor for measuring at least one physiological parameter of the user at
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`WO 2003/110238
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`PCT/IL2004/000417
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`a pulse point of the wrist and the sensor being attached to the fastening article; and (c)
`
`a processor for receiving a signal from the sensor and for converting the at least one
`
`measurement to form medical information.
`
`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.
`
`Hereinafter, the term “wrist” includes, but is not limited to, the lower forearm
`
`from the elbow to the hand, inclusive, unless otherwise noted.
`
`The method of the present invention could be described as a process for being
`
`10
`
`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 computational device
`
`15
`
`(computer hardware and operating system) according to which the software
`
`application is executed, E xamples of suitable programming languages include, but
`
`are not limited to, Visual Basic, Assembler, Visual C, standard C, C++ and Java.
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`10
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`WO 2003/110238
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`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 the present
`
`invention;
`
`FIG 2 shows an exploded view ofthe device;
`
`FIG 3 describes a general state flow diagram;
`
`FIG 4 describes a bi-directional message format between the device and the
`
`gateway;
`
`10
`
`FIG 5 shows an exploded view of an exemplary device with ECG option;
`
`FIG. 6 shows an exploded view of an exemplary device, which illustrates the
`
`installation of a SpO2 sensor;
`
`FIGS. 7A-7D show diagrams of external views of different parts of the
`
`illustrative blood pressure monitoring device according to the present invention;
`
`15
`
`FIG. 8 shows a schematic block diagram of a system according to the present
`
`invention featuring the blood pressure monitoring device of Figure 7;
`
`FIG. 9 is a flowchart of an exemplary method according to the present
`
`invention for performing an extended cardiac monitoring task; and
`
`FIG. 10 is a flowchart of an exemplary method according to the present
`
`20
`
`invention for synchronizing a medical care management function of the device
`
`according to the present invention with a central care facility.
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`25
`
`11
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`11
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`DESCRIPTION OF THE PREFERRED 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
`
`measurementto preferably 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 communication channel.
`
`Examples of medical information which may be extracted from the measured
`
`10
`
`physiological parameter or parameters include, but are not limited to: heart rate,
`
`regularity in heart rate; breathing rate; I/E ratio; arrhythmia of the heart (if any), as
`
`well as the general rhythm and functioning of the heart; blood pressure; presence of
`
`abnormal body movements such as convulsions for example; body position; general
`
`body movements; body temperature; presence and level of sweat; oxygen saturation in
`
`15
`
`the blood; and glucoselevels 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 otherwise dangerous situation for the user. The alarm signal may
`
`optionally be transmitted according to a manual action of the user, such as pressing a
`
`20
`
`“panic button” for example.
`
`Most preferably,
`
`the
`
`alarm signal
`
`is
`
`transmitted automatically 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
`
`25
`
`alarm, more preferably from the wrist-mounted deviceitself.
`
`11
`
`12
`
`12
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`WO 2003/110238
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`PCT/IL2004/000417
`
`An exemplary embodiment of the present
`
`invention may measure also
`
`parameters that may affect the subject's physical condition, including but not limited
`
`to ambient temperature and humidity, lighting conditions, smoke and/or other material
`
`in the air, distance from homeetc.
`
`Uponreceipt of the manually/automatically 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 physiological
`
`measurements of the user. These measurements may be sent directly to the gateway,
`
`or alternatively may be analyzed in order to compute the medical parameters of the
`
`10
`
`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
`
`gateway. The humanoperator, 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.
`
`15
`
`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
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`are collected and analyzed by the microprocessor to form medical information, which
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`then could be determined to be above predefined criteria, such as unstable heart rate,
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`or very high or low blood pressure, for example.
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`According to a non-limiting exemplary embodimentof the present invention,
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`the wrist-mounted device features one or more sensors attached to a wristband or
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`other fastening article. The sensor(s) are preferably connected to a microprocessor,
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`optionally by a wire but alternatively through a wireless connection.
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`The
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`microprocessor may optionally also be located within the wristband, or otherwise
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`attached to the wristband. The sensor(s) preferably support automatic collection ofat
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`least one physiological measurement; more preferably, the microprocessor is able to
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`execute one or moreinstructions for extracting clinically useful information about the
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`user from such measurement(s).
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`The microprocessor more preferably operates a software program to process
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`and analyze the data which is collected, in order to compute medical information.
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`The extracted medical
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`information, optionally also with the raw data,
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`is then
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`preferably transferred to the previously described gateway device. The gateway
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`device then preterably relays such information to a remote server, which more
`preferably is able to provide such information to medical personnel, for example as
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`part of a call center. Therefore, continuous monitoring of the physiological parameters
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`of the user may optionally and more preferably be made, enabling better medical care
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`for the user.
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`A general, non-limiting example of suitable methods for measuring the heart
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`rate and/or other heart-related physiological parameters of a subject who is wearing
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`the device according to the present invention may be found in the article “Cuff-less
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`Continuous Monitoring of Beat-To-Beat Blood Pressure Using Sensor Fusion”, by
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`Boo-Ho Yang, Yi Zhang and H. Harry Asada — IEEE (also available through
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`http://web.mit.edu/zyi/www/pdf/IEEETrans2000.pdf as of December 9, 2001), hereby
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`incorporated by reference as if fully set forth herein, where systolic and diastolic
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`blood pressure are calculated using the pulse pressure shape per heartbeat. The
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`disclosure does not describe a device which has the functionality according to the
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`present invention, but the disclosed method is generally useful for determining blood
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`pressure from an external measurementof pressure from the pulse through the skin of
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`the subject.
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`According to exemplary embodiments of the present
`
`invention,
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`there is
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`provided a device for measuring at least one physiological parameter of a subject in
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`addition to blood pressure. The device preferably comprises a band for being fastened
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`to a wrist of the user, which is also associated with a blood pressure cuff. The device
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`also features at least one additional sensor for measuring at least one additional
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`physiological parameter of the user, as well as a processor for receiving a signal from
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`the sensor andasignal from the blood pressure cuff and for converting said signals to
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`form medical
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`information.
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`Therefore,
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`the device preferably combines
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`the
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`functionality of a portable blood pressure cuff with at
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`least one other type of
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`physiological measurement in order to assess the medical condition of the user.
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`Since the device is portable,
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`it may optionally be used for a number of
`
`different embodiments. For example, it may optionally and preferably be used for
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`performing a Holter monitoring process,
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`in which one or more physiological
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`measurements (preferably including at least one cardiac physiological parameter) are
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`measured over an extended period of time, such as 24 hours for example. Currently
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`available Holter devices are clumsy and difficult to use, and also may impede daily
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`living tasks of the user.
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`In addition, the present invention also preferably features
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`electronic input and/or display, which enables actions of the user (for example during
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`the Holter task) to be input by the user at least semi-automatically, for example
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`through selection from a menu shownonthe display. The display mayalso optionally
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`(additionally or
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`alternatively)
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`feature
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`such information as
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`reminders
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`about
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`appointments with medical personnel and/or times to take medication, and/oralerts to
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`the user (for example from a medical center).
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`Preferably, as described above, the device is also in communication with a
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`medical center, to pass the medical information collected about the user to the medical
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`center and also more preferably to transmit information from the medical center to the
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`user through the device.
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`For implementing the Holter task and/or other types of cardiac measurements,
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`preferably the at
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`least one additional sensor of the device includes an electro
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`cardiogram (ECG) sensor, which preferably at least one electrode associated with the
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`band of the device. Optionally, the band features at least a rigid portion and the
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`electrode is associated with the rigid portion. Also optionally and preferably, the at
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`least one electrode is organized into a set of two or more electrodes, such that only
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`one electrode is required to be in contact with the wrist of the user at any particular
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`time.
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`The device may also optionally and preferably feature a locator unit for
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`locating the device (and hence the user),
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`in the case that the user is unable to
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`communicate his or her location. The locator unit may optionally comprise a GPS
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`unit.
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`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
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`accompanying description.
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`Referring now to the drawings, Figure 1 is a schematic block diagram ofa
`
`system according to the present invention.
`
`As shown, a system 100 features a
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`wearable device 101 to be worn by a user, preferably as a wrist-mounted device, for
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`example by being attached with a wristband or other fasteningarticle to the wrist of
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`the user. Device 101 features at least one physiological sensor 102 for measuring at
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`least one physiological parameter of the user. The function of an exemplary sensor
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`102 is described in greater detail below.
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`The device 101 may optionally feature a vibration sensor 123, preferably a
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`piezoceramic sensor, which is not in direct contact with the skin of the user. Sensor
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`123 measures the movementof the wrist. The output of sensor 123 can be used by a
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`processing unit 103 to capture the movementof the wrist and to recover some noise
`
`received by sensor 102, which is caused by such movement.
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`Optionally, the output of vibration sensor 123 may record some breathing
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`movements thus enabling the processing unit 103 to calculate the breathing rate, when
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`the user’s wrist with the device 101 is placed over the user’s abdomenor chest for a
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`period of time.
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`Device 101 may include additional ambient sensors 130 or additional
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`measuring routines for measuring other parameters. For example, device 101 may
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`optionally have a humidity sensor for measuring the ambient humidity. An exemplary
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`humidity sensor may be the Humidity Gauge manufactured by Honeywell.
`
`In order to support processing of the measured physiological parameter or
`
`parameters, processing unit 103 may optionally include internal RAM and non-
`
`volatile program memory (not shown). Also processing unit 103 may optionally
`
`include an extended data memory 105 located externally to processing unit 103.
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`Processing unit 103 preferably executes at least one instruction for processing the data
`
`obtained by sensor 102.
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`Examples of such processing units 103 include but are notlimited to MSP430
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`by TI company, which contains some channels of 12 bit A/D converters, a 2K bytes of
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`internal RAM and 64K Bytesof non-volatile program memory.
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`Extended memory componen