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`International filing date:
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`14 March 2014 (14.03.2014)
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`APPLE 1027
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`UNTFED STATES DEPARTMENT OF COMMERCE
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`United States Patent and ‘Praderrark CMfice
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`January 04, 2015
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`APPLICATION NUMBER: 61/953,616
`FILING DATE: March 14, 2014
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`METHODS AND APPARATUS FOR TRIGGERING DISCRETE
`ELECTROCARDIOGRAM RECORDING FROM CONTINUOUS MONITORING OF
`HEART RATE
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`pate March 14, 2014
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`DOCKET NUMBER 12212-714.100
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`UNITED STATES PROVISIONAL PATENT APPLICATION
`
`METHODS AND APPARATUSFOR TRIGGERING DISCRETE
`ELECTROCARDIOGRAM RECORDING FROM CONTINUOUS MONITORING OF
`HEART RATE
`
`Inventors:
`
`Euan THOMPSON
`
`Ravi GOPALAKRISHNAN
`
`Fei WANG
`
`
`Shay Glenn LLP
`2755 CampusDrive, Suite 210
`San Mateo, CA 94403
`(650) 212-1700 Telephone
`(650) 212-7562 Facsimile
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`EFS-Web on March 14, 2014.
`MaryBucy [ussliet
`IO
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`ne
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`4
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`METHODS AND APPARATUSFOR TRIGGERING DISCRETE
`ELECTROCARDIOGRAM RECORDING FROM CONTINUOUS MONITORING OF
`HEART RATE
`
`INCORPORATION BY REFERENCE
`All publications and patent applications mentioned in this specification are herein
`[0001]
`incorporated by reference to the same extent as if each individual publication or patent
`application was specifically and individually indicated to be incorporated by reference.
`
`FIELD
`The systems, devices and methods described herein relate to the processing and
`[0002]
`analyzingof cardiac information,and in particular to processing and analyzing of continuous
`heart rate information from a wearable heart rate monitor to indicate when the wearer should
`
`record an ECG.
`
`BACKGROUND
`Wearable systems for monitoring heart rate are well known and are currently
`[0003]
`commercially available. For example, wearable monitors such as Garmin’s Vivofit Fitness
`Band,Fitbit, Polar Heart Rate Monitors, New Balance’s Balance Watch, Basis B1 Band, MIO
`Alpha, Withings Pulse, LifeCORE Heart Rate Monitor strap, and the like all provide continuous
`heart rate monitoring when worn. Other examples described in the patent literature may include
`US 5,876,350, US 2009/0048526 and US 2011/0230748. Such devices typically present a
`continuous and/or average heart rate measurement and maybe useful forfitnesstraining.
`[0004
`In addition to generalfitness training, wearable heart rate monitors have also been
`proposed as capable of determining when a subject wearing the device is experiencing heart
`failure. For example, US 2009/0048526describes a system and device in which heart failure
`maybe detected by continuous monitoring ofheart rate to detect heart rate variability. Similar
`descriptions may be found, for example, in US 8504143 and US 6532385. These references
`teach techniques for determining hearrate variability from hear rate monitoring.
`[0005]
`In the context of wearable heart rate monitors, however, such systems have proven
`ineffective, in part because ofthe difficulty in accurately interpreting cardiac distress based on
`heart rate information alone. In contrast, the gold standard measurementfor analyzing heart
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`dysfunction is the electrocardiogram (ECG). An ECG (or EKG)translates the heart’s electrical
`activity into line tracings that can be used bya trained expert, such as a cardiologist, to
`powerfully interpret what a subject is experiencing. Although continuous monitoring of ECG
`signals wouldprovide insight into the function of a subject’s heart, particularly subject’s at risk
`for cardiac disorders suchasfibrillation (e.g., atrial fibrillation or afib), heart attack, irregular
`heartbeat, etc., continuous monitoring for ECGsis difficult and impractical, in part because of
`the vast amounts ofdata that may be generated, the requirement for continuous goodcontact
`with the subject’s skin, and the potentially low frequency ofcardiac events.
`[0006]
`Ambulatory electrocardiogram (ECG) monitoring could be useful to detect transient
`cardiac abnormalities or problemsthat are difficult to detect using a standard ECG recording
`device. One type of device used for ambulatory ECG monitoring is an event recorder which can
`be worn orcarried by the user to record ECG data for typically a relatively short duration. The
`event recorder can continuously record ECG data while only storing the most recent ECG ona
`rolling basis, and/or the event recorder can be activated manually by the user to record ECG data.
`Conventionally, the ECG data from the event recorders are sent to a receiving center or the
`user’s physician where the ECG data can be interpreted by a specialist. Examples of ambulatory
`ECG monitoring devices may be found, for example in US 8301232, US8509882, US
`2013/0197320, US 2014/0050321, US 2013/0331663 and US 2011/0301439, each of whichis
`herein incorporated by referencein its entirety. US 8301232is attached hereto as an explicit
`example in Appendix A.
`{0007}
`Unfortunately,it is often difficult or impossible to accurately predict when a transient
`cardiac issue will occur, particularly in the early stages when it may occurless often and/or with
`less regularity. Thus, what is neededis a system or technique whereby a subject could use an
`ambulatory ECG monitoring apparatus to accurately record ECG signals at times when
`irregularities are being experienced or immediately thereafter. Thus, whatis needed are
`techniques and systemsthat combine the ease of a low-bandwidth heart rate measurements with
`the accuracy and high-bandwidth measurements of an ECG recorder. Described herein are
`apparatuses (including systems, devices, software, firmware and hardware) that may answer
`these needs.
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`SUMMARYOF THE DISCLOSURE
`Described herein are methods and apparatuses, including software, firmware and
`[0008]
`hardware (device and systems) for monitoring a subject to determine when to record and
`electrocardiogram (ECG). In general, these methods and apparatuses may use continuously
`monitored heart rate information(e.g., from a wearable heart rate monitor) to determine when a
`subject wearing the heart rate monitor is in cardiac distress based on analyzing the subject’s hear
`rate information (including, but not limited to heart rate variability). The heart rate information
`may be analyzed by the heart rate monitor or by a separate device (¢.g., a device including a
`processorsuch as a smartphone, computer, pad, tablet, or the like). When the heart rate
`informationindicates a potential cardiac event has oris occurring, the heart rate monitor or
`device (e.g., smartphone) mayalter the subject to immediately (or within a short period oftime,
`such as seconds or minutes) record an ECGusing, for example, an ambulatory electrocardiogram
`(ECG) monitoring apparatus, such as those described, for example in US 8301232, US8509882,
`US 2013/0197320, US 2014/0050321, US 2013/0331663 and US 2011/0301439.
`[0009]
`For example, described herein are methods for monitoring a subject to determine
`when to record an electrocardiogram (ECG). A method for monitoring a subject to determine
`when to record an ECG mayincludethe steps of: continuously monitoring the subject’s hear rate
`using a wearable heart rate monitor to provide heart rate information; examining the subject’s
`heart rate information to determine if the subject’s heart rate displays one or more predetermined
`characteristics; and alerting the subject to perform an ECG recording using an ECG recording
`system when the subject’s heart rate displays the predetermined characteristics. Any of the
`methods mayalso includethe step of recording an ECGafteraltering the subject. In particular,
`the subject may be notified and may record their own ECG.
`[00010]
`For example, a method for monitoring a subject to determine whento record an ECG
`may include: continuously monitoring the subject’s hear rate using a wearable heart rate monitor
`to provide heart rate information; processing the subject’s heart rate information in a processor to
`determineif the subject’s heart rate displays one or more predetermined characteristics; alerting
`the subject to perform an electrocardiogram when the subject’s heart rate displays the
`predetermined characteristics; and recording the subject’s ECG using a personal ECG recording
`device operated by the subject.
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`[00011]|Any of these methods for monitoring a subject to determine when to record an ECG
`may include communicating(e.g. wirelessly) the subject’s heart rate information to a processor,
`such as a smartphone(e.g., Android™, iPhone, etc.), computer, laptop computer, tablet computer
`(e.g., iPad), wearable computer (Google Glass) or the like. The information may be wirelessly
`communicated using any appropriate modality, including electromagnet, ultrasound, optical,etc.
`[00012]
`Continuously monitoring may comprise monitoring a subject’s heart rate using a
`heart rate monitor worn onthe subject’s wrist, arm, chest, neck, head, hand, waist, leg, foot, arm,
`or shoulder. Any appropriate heart rate monitor maybe used, including currently commercially
`available heart rate monitors such as Polar™ heart rate monitors and Garmin™heart rate
`monitors. Such monitors may be configured to continuously transmit information about heart
`
`rate and/or to automatically analyze heart rate.
`[00013]
`In general, the heart rate information may be analyzed to determineif a subjectis
`experiencing a cardiac event worth examining by ECG recording and analysis. For example, an
`apparatus or method mayinclude analyzing the heart rate information to identify heart rate
`variability. Detection of heart rate variability may be made based on quantitative analysis,
`including the automated analysis of heart rate signals such as that described, for example, in US
`8504143, US 6532382 and WO 2010/077997. Alternatively or additionally, detection of a
`cardiac disorder may be made by comparing a pattern of heart rate information (e.g., a pattern of
`regionalintervals, such as R-R intervals,or the like) to a database of patterns correlated with
`cardiac disorders. For example, a subject’s pattern of R-R intervals from the subject’s heart rate
`information may be comparedto a library of R-R interval patterns characteristic of cardiac
`disorders. This library may be present ona local device or it may be acccssed from a remote
`
`location.
`As mentioned, any of these methods may also includerecording a subject’s ECG
`[00014]
`using a personal ECG recording device operated by the subject.
`[00015]
`Also described are non-transitory computer-readable storage medium storing a set of
`instructions capable of being executed by a processor, that when executed by the processor
`causes the processorto: receive continuousheart rate information from a heart rate monitor worn
`by a subject; process the subject’s heart rate information to determineif the subject’s hear rate
`displays one or more predeterminedcharacteristics; alert the subject to record an ECG using a
`personal ECG recording device operable by the subject.
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`For example, the processor maybepart of a smartphone, and the smartphone may
`[00016]
`receive the continuously monitored heart rate information and determine whento alert and/or
`instruct the subject to record an ECG(e.g., using an ambulatory ECG monitoring apparatus). In
`somevariationsthe set of instructions causes the processor to begin preparing to take and/or
`receive an ECG from the patient using an ambulatory ECG monitor.
`[00017]
`For example, a non-transitory computer-readable storage medium storing a set of
`instructions capable of being executed by a smartphone having a processor,that whenexecuted
`by the smartphone processor causes the smartphoneto: receive continuous heart rate information
`from a heart rate monitor worn bya subject; process the subject’s heart rate information to
`determineif the subject’s hear rate displays one or more predetermined characteristics by
`comparing a pattern ofthe subject’s heart rate information to a database ofpatterns characteristic
`of cardiac disorders; and alert the subject to record an ECG using a personal ECGrecording
`device operable by the subject. As mentioned, the set of instructions, when executed, may cause
`the processorto prepare to receive ECG information from the personal ECG recording device
`(e.g., an ambulatory ECG monitor). The set of instructions, when executed, may cause the
`processor to processthe subject’s heart rate information by comparing a pattern of the subject’s
`R-Rintervals to a database of patterns characteristic of a cardiac disorder.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG.1 is illustrates a methods monitoring a subject to determine whento record and
`[00018]
`electrocardiogram (ECG).
`
`DETAILED DESCRIPTION
`In general, described herein are apparatuses and method of monitoring a subject to
`[00019]
`determine whento record and electrocardiogram (ECG). For example, described herein are
`methods of monitoring a subject by correlating information from heart rate, which may be easily
`and continuously monitoring using a wearable heart rate monitoring device with a high degree of
`tolerability by a subject, to cardiac disorders such as certain arrhythmia diseases (e.g., atrial
`fibrillation), in orderto alter a subject to record, e.g., self-record, an ECG immediately or shortly
`thereafter. This may allow the subject to record a high-resolution ECG measurementat or
`around a time pointthat is of particular clinical significance. The recorded ECG may then be
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`transmitted, and/or stored for later transmission, to a physician and/or a reading/analysis service
`to provide the subject with further care and/or instructions, including further clinical
`
`examination.
`[00020]
`Thus, continuousheart rate (HR) monitoring maybe applied through a wearable heart
`rate monitor, or part of an implant, etc. By analyzing the heart rate monitor output (heart rate
`information); to identify a potential cardiac event/period, the user may be alerted to record
`further information at higher resolution (e.g., ECG information).
`[00021]
`For example, a continuous heart rate monitor may provide heart rate information that
`is received by a processor that determines when aninteresting cardiac event may be occurring.
`In somevariations the heart rate monitor mayitself analyze the heart rate. The heart rate
`information may be used to provide information about heart rate variability. The heart rate
`information maybedigital or analog information and mayincludeelectrical(¢.g., single lead), or
`optical (e.g., infrared, IR) or the like.
`[00022]
`In particular,variations in heart rate (HRV) may be determined by the application of
`a formula (e.g., examining beat-to-beat variability). In some variations, the heart rate
`information (or an extracted portion of HR information) may be used to compareto a database of
`similar information that has been correlated with cardiac events. For example, heart rate
`information may be compared to a database of HR information extracted for ECG recordings of
`patients known to be experimenting cardiac problems. Thus,patterns ofheart rate information
`taken from a subject may be comparedto patterns of cardiac information in a database. If there
`is a match (or a match within a reasonable closenessoffit), the patient may be instructed to
`record an ECG,e.g., using an ambulatory ECG monitor. This may then provide a more detailed
`view ofthe heart. This method maybeparticularly useful, as it may allow recording and/or
`transmission and/or analysis of detailed electrical information aboutthe heart at or near the time
`(or shortly thereafter) whena clinically significant cardiac event is occurring. Thus, the
`continuous monitoring may allow a subject to be alerted immediately upon an indication of the
`potential problem (¢.g., an increase in HRV suggestive of a cardiac dysfunction). This may
`allow the coupling of continuous HR monitoring with ECG recording and analysis for disease
`
`diagnosis and disease management.
`[00023]
`FIG.1 illustrates one variation of a method for monitoring a subject to determine
`whento record an electrocardiogram (ECG). In FIG.1, a subject 1 is wearing a continuous heart
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`rate monitor (configured as a watch 12, including electrodes 16), shown in Step 101. The heart
`rate monitor transmits (wirelessly 111) heart rate information that is received by the smartphone
`108, as shown in step 103. The smartphoneincludes a processor that may analyze the heart rate
`information 103, and when an irregularity is determined, may indicate 105 to the subject that an
`ECG should be recorded. In FIG. 1, an ambulatory ECG monitor 109 is attached (as a case
`having electrodes) to the phone 108. The user may apply the monitor as to their body (e.g., chest,
`between arms,etc.) 107 to record ECGsthat can then be saved and/or transmitted for analysis.
`[00024]
`Anyof the methodsan apparatuses described herein may also be adapted to
`automatically trigger recording of an ECG(e.g., switching between receiving/analyzing just
`heart rate information, which may be low-density data to higher resolution ECG recordings).
`Althoughthe application to homehealth care and self-managementof monitoring by subject’s is
`described andparticularly useful, these same apparatuses, methods and principles may be applied
`in hospital and/orclinical settings.
`[00025]
`The foregoing descriptions of specific embodiments of the present invention have
`been presented for purposesofillustration and description. They are not intended to be
`exhaustiveor to limit the invention to the precise forms disclosed, and obviously many
`modifications and variationsare possible in light of the above teaching. For example, features
`described in one embodiment can be used in another embodiment. The embodiments were
`chosen and described in order to best explain the principles of the invention andits practical
`application, to thereby enable others skilled in the art to best utilize the invention and various
`embodiments with various modifications as are suited to the particular use contemplated.
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`Whatis claimed is:
`
`CLAIMS
`
`1.
`
`A methodfor monitoring a subject to determine whento record an electrocardiogram
`
`(ECG), the method comprising:
`continuously monitoring the subject’s hear rate using a wearable heart rate
`monitor to provide heart rate information,
`examining the subject’s heart rate information to determineif the subject’s heart
`rate displays one or more predetermined characteristics; and
`alerting the subject to perform an ECG recording using an ECG recording system
`whenthe subject’s heart rate displays the predetermined characteristics.
`
`2.
`
`A method for monitoring a subject to determine whento record an electrocardiogram
`
`(ECG), the method comprising:
`continuously monitoring the subject’s hear rate using a wearable heart rate
`
`monitor to provide heart rate information;
`processing the subject’s heart rate information in a processor to determineif the
`subject’s heart rate displays one or more predeterminedcharacteristics;
`alerting the subject to perform an electrocardiogram whenthe subject’s heart rate
`displays the predetermined characteristics; and
`recording the subject’s ECG using a personal ECG recording device operated by
`
`the subject.
`
`3.
`
`The method of claim 1 or 2, further comprising wirelessly communicating the subject’s
`
`heart rate information to a processor.
`
`The method ofclaim | or 2, wherein continuously monitoring comprises monitoring a
`4.
`subject’s heart rate using a heart rate monitor worn on the subject’s wrist, arm, chest, neck, head,
`hand, waist, leg, foot, arm, or shoulder.
`
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`

`The method of claim 1 or 2, wherein processing comprises comparing a subject’s pattern
`5.
`of R-Rinterval from the subject’s heart rate information to a library of R-R interval patterns
`
`characteristic of cardiac disorders.
`
`6.
`
`The methodofclaim 1, further comprising recording the subject’s ECG using a personal
`
`ECGrecording device operated by the subject.
`
`A non-transitory computer-readable storage medium storing a set of instructions capable
`7.
`of being executed by a processor, that when executed by the processor causes the processorto:
`receive continuousheart rate information from a heart rate monitor worn by a subject;
`
`processthe subject’s heart rate information to determine if the subject’s hear rate
`displays one or more predetermined characteristics; and
`alert the subject to record an ECG using a personal ECGrecording device operable by
`
`the subject.
`
`A non-transitory computer-readable storage medium storing a set of instructions capable
`8.
`of being executed by a smartphone having a processor, that when executed by the smartphone
`processor causes the smartphoneto:
`receive continuous heart rate information from a heart rate monitor worn by a subject;
`
`process the subject’s heart rate information to determineif the subject’s hear rate
`displays one or more predetermined characteristics by comparing a pattern ofthe
`subject’s heart rate information to a database of patterns characteristic of cardiac
`
`disorders; and
`alert the subject to record an ECG using a personal ECG recording device operable by
`
`the subject.
`
`9.
`
`The non-transitory computer-readable storage medium of claim 7, wherein the processor
`
`is part of a smartphone.
`
`SG Docket No.: 12212-714.100
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`- 10 of 12 -
`
`14
`
`14
`
`

`

`The non-transitory computer-readable storage medium ofclaims 7 or 8, wherein the set
`10.
`of instructions, when executed, causes the processor to prepare to receive ECG information from
`
`the personal ECG recording device.
`
`The non-transitory computer-readable storage medium of claims7 or 8, wherein the set
`11.
`ofinstructions, when executed, causes the processorto process the subject’s heart rate
`information by comparing a pattern of the subject’s R-R intervals to a database of patterns
`
`characteristic of a cardiac disorder.
`
`SG Docket No.: 12212-714.100
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`15
`
`15
`
`

`

`METHODS AND APPARATUS FOR TRIGGERING DISCRETE
`ELECTROCARDIOGRAM RECORDING FROM CONTINUOUS MONITORING OF
`HEART RATE
`
`ABSTRACT
`
`Described herein are systems for receiving continuous heart rate (HR) monitoring
`
`information,e.g., from a wearable HR monitor that, based on HR variability and particularly the
`
`variability of the R-R segments determines when to recommendthat a subject take an ECG (e.g.,
`
`within a few second, minutes or hours of detection).
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`-12 of 12 -
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`SG Docket No.: 12212-714.100
`
`16
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`

`

`"METHODS AND APPARATUS FOR TRIGGERING DISCRETE ELECTROCARDIOGRAM RECORDING FROM CONTINUOUS MONITORING OF HEART RATE"
`Attorney No.: 12212-714.100 FILED VIAEFS Sheet 1 of 1
`
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`
`
`
`
`
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`LOTSOTcOT
`
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`
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`
`
`
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`
`piovay
`
`94
`
`60T
`
`17
`
`T‘Sls
`
`17
`
`
`

`

`APPENDIX A
`Attorney No.: 12212-714.100
`
`US008361232B2
`
`(12)
`
`(34)
`
`(75)
`
`(73)
`
`(*)
`
`(21)
`
`(22)
`
`(65)
`
`(63)
`
`(31)
`
`(52)
`(58)
`
`(56)
`
`*
`US 8,301,232 B2
`ao) Patent No:
`United States Patent
`Albertet al.
`(45) Date of Patent:
`Oct. 30, 2012
`
`
`WIRELESS, ULTRASONIC PERSONAL
`HEALTH MONITORING SYSTEM
`Inventors: David Albert, Oklahoma City, OK (US);
`Bruce Richard Satchwell, Carrara
`(AU); Kim Norman Barnett, Mt.
`Tamborine (AU)
`Assignee: AliveCor, Inc., OklahomaCity, OK (US)
`:
`:
`.
`.
`.
`Notice:
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`Appl. No.: 13/420,520
`Filed:
`Mar. 14, 2012
`
`5/1975 Kennedy
`3,885,552 A
`8/1975 Mandel etal.
`3,898,984 A
`9/1975 Trott, Jr. et al.
`3,909,599 A
`aiovg Comore etal.
`1083'366 ‘
`«6/1978 _Beachem etal.
`4,095,050 A
`2/1981 Grosskopf
`4,250,888 A
`8/1981 Duggan
`4,281,664 A
`10/1983 Dick
`4,409,984 A
`eee ISR. Lemegtak
`4,803,625 A
`2/1989 Fuetal.
`4,938,229 A
`71990 Bergelson etal.
`Continued
`(Continued)
`FOREIGN PATENT DOCUMENTS
`675675 AS
`10/1990
`(Continued)
`
`cli
`
`Prior Publication Data
`
`OTHER PUBLICATIONS
`
`US 2012/0172689 Al
`
`Jul. 5, 2012
`
`Related U.S. Application Data
`
`Continuation of application No. 13/108,738,filed on
`May 16, 2011, which is a continuation-in-part of
`application No. 12/796,188,filed on Jun. 8, 2010.
`Int. Cl.
`(2006.01)
`AGIB 5/04
`WLS. C1.
`ceccccesccccsseseserseecscessssersssesestcereveess 600/509
`Field of Classification Search .................. 600/509;
`455/557
`
`See application file for complete search history.
`References Cited
`
`U.S. PATENT DOCUMENTS
`3,717,857 A
`2/1973 Evans
`3,731,311 A
`5/1973 Williams
`3,768,014 A
`10/1973 Smith et al.
`3,782,367 A
`1/1974 Hochberg etal.
`3,882,277 A
`5/1975 DePedro etal.
`
`Oresko et al. “Detecting Cardiovascular Diseases via Real-Time
`Electrocardiogram Processing on a Smart Phone”, 2009 Workshop
`on Biomedicine in Computing: Systems, Architectures, and Circuits,
`pp. 13-16.*
`
`(Continued)
`
`Primary Examiner — Mark W Bockelman
`(74) Attorney, Agent, or Firm — Shay Glenn LLP
`
`ABSTRACT
`(57)
`A personal monitoring device has a sensor assembly config-
`ured to sense physiological signals upon contact with a user’s
`skin. The sensor assembly produceselectrical signals repre-
`senting the sensed physiological signals. A converter assem-
`bly, integrated with, and electrically connected to the sensor
`assembly, converts the electrical signals generated by the
`sensor assembly to a frequency modulated inaudible ultra-
`sonic soundsignal. The ultrasonic signal is demodulated from
`an aliased signal produced by undersampling,
`
`14 Claims, 11 Drawing Sheets
`
`
`
`EG
`MOHCTOR
`
`MOBILE PHONE OR OTHER COMPUTING DEVICE
`
`16,30
`
`
`
`
`18
`
`18
`
`

`

`APPENDIX A
`Attorney No.: 12212-714.100
`
`US 8,301,232 B2
`
`Page 2
`
`
`
`8/2010 Wolfe etal.
`30100217345 Al
`