(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`(19) World Intellectual Property
`llllllllllllllllllllllllllllllllllllllllll^
`Organization
`International Bureau
`(10) International Publication Number
`WO 2012/140559 Al
`(43) International Publication Date
`18 October 2012 (18.10.2012) WIPO I PCT
`
`(51) International Patent Classification:
`A61B 5/024 (2006.01) A61B 5/1455 (2006.01)
`A61B 5/0404 (2006.01)
`(21) International Application Number:
`
`PCT/IB2012/051731
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`(22) International Filing Date:
`
`8 April 2012 (08.04.2012)
`English
`English
`
`(25) Filing Language:
`(26) Publication Language:
`(30) Priority Data:
`11 April 2011 (11.04.2011) US
`61/473,821
`(71) Applicant (for all designated States except US):
`MEDIC4AUU AG [CH/CH]; Aegeristrasse 27, 6300 Zug
`(CH).
`(72) Inventors; and
`(75) Inventors/Applicants (for US only): SHMUEUI, Ram
`[IL/IL]; 12 Nordau St., 47269 Ramat-Hasharon (IL).
`SANDLERMAN, Nimrod [IL/IL]; 44 Churgin St., 52346
`Ramat-Gan (IL).
`(74) Agent: SWIRSKY, Daniel J.; AlphaPatent Associates
`Ltd., 55 Reuven St., 99544 Beit Shemesh (IL).
`(81) Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`
`AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ,
`CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO,
`DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN,
`HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR,
`KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME,
`MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ,
`OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD,
`SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR,
`TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
`(84) Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ,
`UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU,
`TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE,
`DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU,
`LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK,
`SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ,
`GW, ML, MR, NE, SN, TD, TG).
`Published:
`— with international search report (Art. 21(3))
`before the expiration of the time limit for amending the
`—
`claims and to be republished in the event of receipt of
`amendments (Rule 48.2(h))
`
`(54) Title: PULSE OXIMETRY MEASUREMENT TRIGGERING ECG MEASUREMENT
`
`Fig· 7
`
`(57) Abstract: A method and a system for triggering the measurement of electrocardiogram (ECG) signal of a user. The system in-
`cludes a SpO2 measuring unit and an ECG measuring unit both embedded in a wrist-mounted device warren by the user. The method
`including the steps of: continuously measuring SpO2 at the wrist of the user, detecting an irregular heart condition from the SpO2
`measurement, notifying the user to perform an ECG measurement, and initiating the ECG measurement at least partially at the wrist.
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`PULSE OXIMETRY MEASUREMENT TRIGGERING ECG
`MEASUREMENT
`
`Cross-Reference to Related Applications
`This application claims the priority benefit of U.S. Provisional Patent Application
`No. 61473821 filed April 11, 2011, which is incorporated herein by reference.
`
`Field of the Invention
`The present invention relates to systems and methods for patient monitoring and,
`more particularly but not exclusively, to systems and methods for monitoring heart-related
`events using electrocardiogram (ECG).
`
`Background of the Invention
`Various heart diseases require the monitoring of events associated with electrical
`activity of the heart. The electrical activity is typically monitored by measuring an
`electrocardiogram (ECG). Some heart diseases are reflected in permanent irregularities of
`the ECG signal. Other heart diseases are reflected in transient, very short-time,
`irregularities of the ECG signal. Some heart diseases are reflected in events of irregular
`ECG signal.
`Measuring ECG typically requires connecting the patient to an ECG measuring
`device via a plurality of wires connected to the patient in predefined places of the body. If
`the heart-related event is short enough the patient does not have the time to find an ECG
`device, to properly wire the device to the body and then take the ECG measurement.
`One common solution is a telemetry ECG device that is wired to the patient and
`transmits the ECG signal to a near-by telemetry station. Such devices are used in hospitals
`where it is important to monitor the patients at all time and also enable them mobility
`within the hospital ward. However, this solution has the disadvantage of the
`communication range of the ECG monitoring device.
`Another common solution is a Holter device, which is practically a small ECG
`device connected to the patient for typically 24 hours, recording the ECG signal.
`Hopefully, the heart-related event occurs during the recording time. The Holter does not
`limit the mobility range of the patient but has a time limit of its operation. For events that
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`are not sufficiently frequent this solution does not work. Also important and highly
`disadvantageous is the Holter device uses electric contacts at the end of electric cables.
`Thus, the patient has to be constantly wired to the Holter device.
`All such solutions require uncomfortable fixed wiring of the patient to the ECG
`device at all time. Solutions require uncomfortable fixed wiring are therefore inappropriate
`for monitoring infrequent events of irregular ECG. There is thus a widely recognized need
`for, and it would be highly advantageous to have, a method and a system for measuring the
`ECG signal associated with an intermittent irregular heart-related event, devoid of the
`above limitations.
`The following patents and patent applications are believed to represent the most
`relevant prior art: US patents 5,176,137, 7,598,878, and 7650176; US patent applications
`20020095092, 20030229276, 20070038050, 20090247848, and 20090326356; and PCT
`applications W02001017420, and W02009074985.
`
`Summary of the Invention
`According to one aspect of the present invention there is provided a method for
`triggering measurement of electrocardiogram (ECG) signal of a subject, the method
`including the steps of: continuously measuring SpO2 at least one of a wrist and a finger of
`the subject, detecting an irregular heart condition from the SpO2 measurement, notifying
`the subject to perform an ECG measurement, and initiating ECG measurement at least
`partially at the wrist.
`According to another aspect of the present invention there is provided a method for
`triggering ECG measurement where the step of notifying the subject to perform an ECG
`measurement includes at least one of the acts of: notifying the subject to perform an ECG
`measurement repeatedly until the ECG measurement detects an ECG signal, stopping the
`notification to the subject to perform an ECG measurement when the ECG measurement
`detects an ECG signal, notifying the subject when the ECG signal is first detected,
`notifying the subject that the ECG signal is being detected, notifying the subject as long as
`the ECG signal is detected, and notifying the subject that the ECG measurement has
`stopped.
`According to still another aspect of the present invention there is provided a
`method for triggering ECG measurement additionally including the steps of: performing
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`the SpO2 measurement while performing the ECG measurement, identifying a correlation
`between the SpO2 measurement and the ECG measurement, and using the correlation in
`the step of detecting an irregular heart condition from the SpO2 measurement.
`Yet according to another aspect of the present invention there is provided a method
`for triggering ECG measurement where the correlation is particular to the subject.
`Also according to another aspect of the present invention there is provided a
`method for triggering ECG measurement where the ECG measurement is stopped upon
`detecting at least one of the conditions of: the irregular heart condition stopped, heart
`condition returned to normal, a predefined period elapsed, and a predefined number of
`heart beats counted.
`Further according to another aspect of the present invention there is provided a
`method for triggering ECG measurement where the SpO2 measurement includes using
`reflective SpO2 measurement.
`Yet further according to another aspect of the present invention there is provided a
`method for triggering ECG measurement where the ECG measurement additionally
`includes the steps of: providing at least two separate conductive areas configured to
`measure electrical activity of the subject, performing at least one of the steps of: contacting
`a first conductive area to at least a portion of the wrist, and a second conductive area to a
`finger of a second hand of the subject, contacting a first conductive area to at least a
`portion of the wrist, and a second and a third conductive areas to two fingers of a second
`hand of the subject, and contacting a first and a second conductive areas to at least a
`portion of the first hand and a third conductive area to a second hand of the subject;
`extracting an ECG signal from the conductive areas by using one conductive area as a
`reference and amplifying the differential voltage between at least two other conductive
`areas; and continuously converting the at least one measurement to form medical
`information.
`Still further according to another aspect of the present invention there is provided a
`method for triggering ECG measurement where the ECG measurement additionally
`includes the step of: communicating at least one of the SpO2 measurement, the ECG
`measurement, and the medical information to at least one of a gateway and a remote
`server.
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`According to yet another aspect of the present invention there is provided a wrist-
`mounted physiological parameters measuring device including: an SpO2 measuring unit
`attached to a wrist of a subject the SpO2 measuring unit being operative to continuously
`measure SpO2 at the wrist of the subject, an ECG measuring unit attached to the wrist of
`the subject for measuring ECG signal at least partially at the wrist, and a processor
`operative to control both the SpO2 measuring and the ECG measuring unit, where the
`processor is operative to detect an irregular heart condition from the SpO2 measurement,
`to notify the subject to perform an ECG measurement upon detecting the irregular heart
`condition the, and to initiate the ECG measurement.
`According to still another aspect of the present invention there is provided a wrist-
`mounted physiological parameters measuring device where the processor is additionally
`configured to perform at least one of the procedures selected from the group including of: a
`procedure for notifying the subject to perform an ECG measurement repeatedly until the
`ECG measurement detects an ECG signal, a procedure for stopping the notification to the
`subject to perform an ECG measurement when the ECG measurement detects an ECG
`signal, a procedure for notifying the subject when the ECG signal is first detected, a
`procedure for notifying the subject that the ECG signal is being detected, a procedure for
`notifying the subject as long as the ECG signal is detected, and a procedure for notifying
`the subject that the ECG measurement has stopped.
`Further according to another aspect of the present invention there is provided a
`wrist-mounted physiological parameters measuring device where the processor is
`additionally configured to perform at least one of the procedures selected from the group
`including of: a procedure performing the SpO2 measurement while performing the ECG
`measurement, a procedure for identifying a correlation between the SpO2 measurement
`and the ECG measurement, and a procedure for detecting the irregular heart condition
`from the SpO2 measurement using the correlation.
`Still further according to another aspect of the present invention there is provided a
`wrist-mounted physiological parameters measuring device where the correlation is
`particular to the subject.
`Yet further according to another aspect of the present invention there is provided a
`wrist-mounted physiological parameters measuring device where the processor is
`additionally configured to stop the ECG measurement upon detecting at least one of the
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`conditions of: the irregular heart condition stopped, heart condition returned to normal, a
`predefined period elapsed, and a predefined number of heart beats counted.
`Even further according to another aspect of the present invention there is provided
`a wrist-mounted physiological parameters measuring device the SpO2 measuring unit
`includes reflective SpO2 measurement device.
`Additionally according to another aspect of the present invention there is provided
`a wrist-mounted physiological parameters measuring device where the ECG measurement
`unit includes at least two separate conductive areas configured to measure electrical
`activity of the subject, where the at least three conductive areas arranged in one of the
`following configurations: a first conductive area configured to be in contact with at least a
`portion of the wrist, and second conductive area configured to be touched by a finger of a
`second hand of the subject, a first conductive area configured to be in contact with at least
`a portion of the wrist, and second and third conductive areas configured to be touched by
`two fingers of a second hand of the subject, and a first and a second conductive areas
`configured to be in contact with at least a portion of the first hand and a third conductive
`area configured to be touched by a second hand of the subject, where the ECG signal is
`extracted from the three conductive areas by using the signal of one conductive area as a
`reference and amplifying the differential voltage between the other two conductive areas,
`and where the processor is operative to continuously convert the ECG signal to form
`medical information.
`Also according to yet another aspect of the present invention there is provided a
`wrist-mounted physiological parameters measuring device additionally including a
`communication unit operative to communicate at least one of the SpO2 measurement, the
`ECG measurement, and the medical information to at least one of a gateway and a remote
`server.
`
`Unless otherwise defined, all technical and scientific terms used herein have the
`same meaning as commonly understood by one of ordinary skill in the art to which this
`invention belongs. The materials, methods, and examples provided herein are illustrative
`only and not intended to be limiting.
`Implementation of the method and system of the present invention involves
`performing or completing certain selected tasks or steps manually, automatically, or a
`combination thereof. Moreover, according to actual instrumentation and equipment of
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`preferred embodiments of the method and system of the present invention, several selected
`steps could be implemented by hardware or by software on any operating system of any
`firmware or a combination thereof. For example, as hardware, selected steps of the
`invention could be implemented as a chip or a circuit. As software, selected steps of the
`invention could be implemented as a plurality of software instructions being executed by a
`computer using any suitable operating system. In any case, selected steps of the method
`and system of the invention could be described as being performed by a data processor,
`such as a computing platform for executing a plurality of instructions.
`
`Brief Description of the Drawings
`The invention is herein described, by way of example only, with reference to the
`accompanying drawings. With specific reference now to the drawings in detail, it is
`stressed that the particulars shown are by way of example and for purposes of illustrative
`discussion of the preferred embodiments of the present invention only, and are presented in
`order to provide what is believed to be the most useful and readily understood description
`of the principles and conceptual aspects of the invention. In this regard, no attempt is made
`to show structural details of the invention in more detail than is necessary for a
`fundamental understanding of the invention, the description taken with the drawings
`making apparent to those skilled in the art how the several forms of the invention may be
`embodied in practice.
`In the drawings:
`Fig. 1A is a simplified illustration of a front view of a wrist-mounted heart
`monitoring device with two ECG sensors in the front side and one in the back side;
`Fig. IB is a simplified illustration of a back view of a wrist-mounted heart
`monitoring device with two ECG sensors in the front side and one in the back side;
`Fig. 2A is a simplified illustration of a front view of a wrist-mounted heart
`monitoring device with one ECG sensors in the front side and two in the back side;
`Fig. 2B is a simplified illustration of a back view of a wrist-mounted heart
`monitoring device with one ECG sensors in the front side and two in the back side
`Fig. 3 is a simplified illustration of the wrist-mounted heart monitoring device of
`Figs. 1A and IB warn and used by a subject;
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`Fig. 4 is a simplified illustration of the wrist-mounted heart monitoring device of
`Figs. 2A and 2B warn and used by a subject;
`Fig. 5 is a simplified illustration of the wrist-mounted heart monitoring device
`having a ring-mounted oximeter sensor warn and used by a subject;
`Fig. 6 is a simplified block diagram of the heart monitoring device; and
`Fig. 7 is a simplified flow chart of a software program preferably executed by the
`processor of the wrist-mounted heart monitoring device.
`
`Detailed Description of the Invention
`The principles and operation of a combined oximetry and electrocardiogram
`measuring system and a method according to the present invention may be better
`understood with reference to the drawings and accompanying description.
`Before explaining at least one embodiment of the invention in detail, it is to be
`understood that the invention is not limited in its application to the details of construction
`and the arrangement of the components set forth in the following description or illustrated
`in the drawings. The invention is capable of other embodiments or of being practiced or
`carried out in various ways. In addition, it is to be understood that the phraseology and
`terminology employed herein is for the purpose of description and should not be regarded
`as limiting.
`In this document, an element of a drawing that is not described within the scope of
`the drawing and is labeled with a numeral that has been described in a previous drawing
`has the same use and description as in the previous drawings. Similarly, an element that is
`identified in the text by a numeral that does not appear in the drawing described by the text
`has the same use and description as in the previous drawings where it was described.
`In this document, unless otherwise specified, the terms "oxygen saturation in the
`blood", "blood oxygen saturation", “pulse oximeter”, oximetry, SpO2, and
`photoplethysmography have the same meaning and may be used interchangeably, except
`for those places where a difference between such terms is described. Similarly, the terms
`ECG, EKG, electrocardiogram, and electrocardiograph have the same meaning and may be
`used interchangeably unless otherwise specified. Additionally, the terms user, subject and
`patient may refer to the same entity, unless otherwise stated.
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`Oximetry and ECG are well known techniques and there are various devices for
`measuring each. US patent 7650176 (Sarussi) teaches reflective measurement of Oxygen
`saturation in the blood. Sarussi describes a device mounted on the wrist of a human
`subject, or on an ankle of a baby with a reflective oximetry sensor mounted at the back
`side of the device and facing the skin of the subject. US patent application 20020095092
`(Kondo) also teaches reflective oximetry at the wrist. Additionally, US patent application
`20070038050 (Sarussi) teaches a wrist-worn measuring device with a finger-worn
`reflective oximetry sensor. PCT application W02001017420 (Lindberg) teaches a further
`method of reflective oximetry. None of these teaches the use of ECG measurements with
`oximetry.
`Deriving heart beat rate from oximetry, as well as other artifacts of the heart
`activity and blood flow, is also known in the art, as can be seen in US patent 5,176,137
`(Ericson) and US patent applications 20030229276 (Sarussi) and 20090247848 (Baker).
`US patent applications 20100268040 (Ben Oren) and 20090326356 (Kracker)
`discuss combination of oximetry and ECG measurements. Both documents assume that
`both the oximetry device and the ECG device are connected to the patient at all times.
`Thus a combined measurement is possible.
`US patent No. 7,598,878 (Goldreich) describes a wrist mounted device equipped
`with an ECG measuring device and a SpO2 measuring device. However, Goldreich does
`not teach interrelated measurements of ECG and SpO2.
`The prior art does not consider a requirement to enable a patient to perform ECG
`measurement as soon as an irregular heart activity develops and without requiring the ECG
`to be constantly wired to the patient.
`The present invention resolves this problem by providing a combined oximetry and
`electrocardiogram measuring system and a method in which the oximetry measurement is
`performed continuously and/or repeatedly, and the ECG measurement is triggered upon
`detection of an intermittent irregular heart-related event. The present invention preferably
`performs measurements of intermittent irregular heart-related events without requiring the
`fixed wiring of the ECG device to the patient.
`Reference is now made to Figs. 1A and IB, which are simplified illustrations of
`two views of a wrist-mounted heart monitoring device 10 according to a preferred
`embodiment of the present invention.
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`As shown in Fig. 1A, the heart monitoring device 10 preferably includes a
`monitoring unit 11 and a wearing accoutrement 12 such as a band, a strap or a bracelet, for
`attaching the monitoring unit 11 to a wrist of the monitored subject. It is appreciated that
`the accoutrement 12 can be a flexible band or a band equipped with a fastening article such
`as a hook and loop fastener (Velcro™) strip or any other type of fastener. It is appreciated
`that the heart monitoring device 10 can be attached to other parts of the body such as the
`ankle.
`
`As shown in Figs. 1A and IB, the heart monitoring device 10 is preferably
`equipped with two types of sensing devices: and oximetry (SpCh) measuring unit and an
`ECG measuring unit. The oximetry measuring unit preferably includes an oximetry sensor
`13 mounted in the back side of the monitoring unit 11 and facing the skin of the subject.
`The ECG measuring unit preferably includes at least three areas 14, each providing
`electrical contact with the subject. As shown in Figs. 1A and IB, at least one of the
`electrical contacts 14 designated by the numeral 15 is mounted in the back side of the
`monitoring unit 11 and facing the skin of the subject, and at least two electrical contacts 14
`designated by the numeral 16 are mounted on the front side of the monitoring unit 11.
`It is appreciated that instead of, or in addition to, the oximetry (SpCh) measuring
`unit the heart monitoring device may include a unit for measuring CO2 content in the
`blood.
`
`It is further appreciated that the oximetry (SpCh) measuring unit can be mounted on
`the inner side of a ring or a clip worn on a finger of the hand wearing the heart monitoring
`device 10.
`It is further appreciated that it is possible to measure ECG signals with only two
`electrical sensors contacting the subject, for example, one contact touching the wrist and
`the other contact touched by a finger of the other hand.
`As shown in Figs. 1A, the heart monitoring device 10 may optionally include a user
`interface, preferably containing a display 17 and one or more buttons 18 for operating the
`device, and a sound producing device 19 for providing audible alerts to the user.
`Reference is now made to Figs. 2A and 2B, which are simplified illustrations of
`two views of a different version wrist-mounted heart monitoring device 20 of an
`alternative configuration according to a preferred embodiment of the present invention.
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`As shown in Figs. 2 A and 2B, a monitoring unit 21 of the heart monitoring device
`20 is similar to the monitoring unit 11 except that it preferably contains one ECG sensing
`contact 14 designated by the numeral 22 mounted in the front side and two ECG sensing
`contact 14 designated by the numeral 23 mounted in the back side.
`Reference is now made to Figs. 3 and 4, which are simplified illustrations of the
`wrist-mounted heart monitoring device warn and used by a subject according to a preferred
`embodiment of the present invention.
`As shown in Fig. 3, the heart monitoring device 10 is preferably warren on the
`wrist of the first hand of the subject. The oximetry sensor 13 (not shown) preferably faces
`the front side of the hand. One electrical contact (not shown) mounted on the back side of
`the heart monitoring device 10 touches the skin of the subject at the wrist, and two of the
`fingers of the second hand of the subject touch the two electrical contacts 14 on the front
`side of the heart monitoring device 10.
`Alternatively, the heart monitoring device 10 may be equipped with two electrical
`contacts, one electrical contact mounted in the back side of the heart monitoring device 10
`facing the wrist and touching the skin of the wrist, and the other electrical contact mounted
`in the front side of the heart monitoring device 10 to be touched by a finger of the opposite
`hand.
`
`As shown in Fig. 4, the heart monitoring device 20 is preferably warren on the
`wrist of the first hand of the subject. The oximetry sensor 13 (not shown) preferably faces
`the back side of the hand. Two electrical contacts (not shown) mounted on the back side of
`the heart monitoring device 10 touch the skin of the subject at the wrist, and one of the
`fingers of the second hand of the subject touches the electrical contact 14 on the front side
`of the heart monitoring device 10.
`It is appreciated that the heart monitoring device 20 can be warren facing the front
`side of the hand and the heart monitoring device 10 can be warren facing the back side of
`the hand.
`Reference is now made to Fig. 5, which is a simplified illustrations another version
`of the wrist-mounted heart monitoring device warn and used by a subject according to a
`preferred embodiment of the present invention.
`As seen, the wrist-mounted heart monitoring device 24 of Fig. 5 includes the
`oximeter (not shown) mounted inside a ring 25 warn on a finger of the hand wearing the
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`heart monitoring device 24. The oximeter in the ring 24 is preferably connected to the
`heart monitoring device 24, preferably by an electrical cable 26.
`Independently, the wrist-mounted heart monitoring device 24 includes a single
`electrical contact (not shown) mounted in the back side and a second electrical contact 14
`mounted in the front side of the heart monitoring device 24 and touched by a finger of the
`other hand.
`Reference is now made to Fig. 6, which is a simplified block diagram of the heart
`monitoring device 10, and/or 20 and/or 24, according to a preferred embodiment of the
`present invention.
`As shown in Fig. 6, the heart monitoring device preferably includes a power supply
`unit such as a battery 27, a memory unit 28, a processor 29, an oximetry measuring unit 30
`with the oximetry sensor 13, an ECG measuring unit 31 with three ECG contact sensors
`14, a user interface unit 32 preferably containing output devices such as a display 33 and a
`sound producing device 34, and a user input device 35 for example including buttons, and
`optionally a communication unit 36.
`The oximetry measuring unit 30 preferably uses reflective oximetry measuring
`technology. However, it is appreciated that other technologies for measuring SpC>2 such as
`transmittance oximetry can be used as well.
`The memory unit 28 preferably contains software program containing instructions
`to be executed by the processor 29, operational parameters, oximetry and ECG data
`collected from the oximetry measuring unit 30 and ECG measuring unit 31, etc.
`The software program contained in the memory unit 28 preferably contains various
`procedures such as:
`Procedures for operating the oximetry measuring unit 30 and ECG
`measuring unit 31 including procedures to continuously measure SpC>2 signal, and
`procedures to initiate ECG measurements.
`Procedures for operating the user-interface unit 32 and for interacting with
`the user including procedures for notifying the subject to perform an ECG measurement.
`Procedures for analyzing oximetry measurements to detect various irregular
`heart conditions, procedure for identifying correlations between SpC>2 measurement and
`ECG measurement of a particular subject to detect user-specific irregular heart conditions.
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`Using said correlation in said step of detecting an irregular heart condition
`from said SpCh measurement.
`Procedures for communicating with a gateway and/or a remote server for
`exchanging information such as operational parameters and/or SpCh and ECG
`measurements.
`Reference is now made to Fig. 7, which is a simplified flow chart of a software
`program preferably executed by the processor 29 of the wrist-mounted heart monitoring
`device according to a preferred embodiment of the present invention.
`As shown in Fig. 7, the software program starts in element 37 by measuring SpCh.
`The element of measuring SpCh (e.g. oxygen saturation in the blood). The SpCh
`measurement is preferably executed continuously as long as the heart monitoring device is
`operative. Preferably, the SpCh measurement is executed using the oximetry measuring
`unit 30 and the oximetry sensor 13.
`The software program proceeds to element 38 to derive from the SpCh
`measurement physiological parameters such as pulse rate, pulse amplitude, pulse shape,
`rate of blood flow, etc. Then, the software program scans the derived physiological
`parameters to detect various irregularities of the heart condition. The scanning for an
`irregular heart condition preferably uses heart-irregularity detection parameters (element
`39) stored in the memory unit 28. When an irregular heart condition is detected (element
`40) the software program continues to element 41. However, the SpCh measurement
`(element 37) preferably continues and optionally also the derivation of physiological
`parameters as well as the detection of irregular heart conditions (element 38).
`In element 41 the software program preferably initiates ECG measurement,
`preferably by operating ECG measuring unit 31. The software program preferably
`proceeds to element 42 to notify the user to perform an ECG measurement, preferably
`making use of the ECG monitoring device as described and illustrated with reference to
`Figs. 3 and 4. The software program preferably proceeds to element 43 to detect and ECG
`signal. Preferably, determining that the ECG signal is present and appropriately detected
`by the ECG measuring unit 31 is made using ECG detection parameters (element 44)
`stored in the memory unit 28. The user is preferably notified (element 45) until an ECG
`signal is properly detected (element 46), in which case the software program proceeds to
`element 47 to notify the user that the ECG signal is detected.
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`13
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`WO 2012/140559
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`PCT/IB2012/051731
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`13
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`The user notification features described with reference to elements 42, 45 and 47
`includes the following optional but preferable notifications:
`Repeatedly notifying the user to perform an ECG measurement until the
`ECG measurement detects an ECG signal.
`Stopping the notification (to perform the ECG measurement) when the ECG
`measurement detects an ECG signal.
`Notifying the user when the ECG signal is first detected.
`Notifying the user that the ECG signal is be