I 1111111111111111 11111 1111111111 111111111111111 1111111111111111 IIII IIII IIII
`US009649042B2
`
`c12) United States Patent
`Albert et al.
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 9,649,042 B2
`*May 16, 2017
`
`(54) HEART MONITORING SYSTEM USABLE
`WITH A SMARTPHONE OR COMPUTER
`
`(71) Applicant: AliveCor, Inc., San Francisco, CA (US)
`
`(72)
`
`Inventors: David Albert, Oklahoma City, OK
`(US); Bruce Richard Satchwell,
`Carrara (AU); Kim Norman Barnett,
`Mt. Tamborine (AU)
`
`(73) Assignee: ALIVECOR, INC., San Francisco, CA
`(US)
`
`(58) Field of Classification Search
`CPC ...... A61B 5/024; A61B 5/0245; A61B 5/0404
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,717,857 A
`3,731,311 A
`
`2/ 1973 Evans
`5/1973 Williams
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 239 days.
`
`CH
`CN
`
`10/1990
`675675 AS
`9/2010
`101828915 A
`(Continued)
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`OTHER PUBLICATIONS
`
`(21) Appl. No.: 13/964,490
`
`(22) Filed:
`
`Aug. 12, 2013
`
`(65)
`
`Prior Publication Data
`
`US 2013/0331663 Al
`
`Dec. 12, 2013
`
`Related U.S. Application Data
`
`(62) Division of application No. 12/796,188, filed on Jun.
`8, 2010, now Pat. No. 8,509,882.
`
`(51)
`
`Int. Cl.
`A61B 5104
`A61B 510402
`
`(2006.01)
`(2006.01)
`(Continued)
`
`(52) U.S. Cl.
`CPC .......... A61B 510402 (2013.01); A61B 510404
`(2013.01); A61B 516898 (2013.01);
`(Continued)
`
`Adidas miCoach Pacer Review: Like Nike+, Only Better; printed
`from website http:/ /gizmodo.com/5479456/adidas on Mar. 4, 2010;
`5 pgs.
`
`(Continued)
`
`Primary Examiner - Edward Moran
`Assistant Examiner - Elizabeth K So
`or Firm - Wison
`(74) Attorney,
`Agent,
`Goodrich & Rosati
`
`Sonsini
`
`ABSTRACT
`(57)
`A personal monitoring device has a sensor assembly con(cid:173)
`figured to sense physiological signals upon contact with a
`user's skin. The sensor assembly produces electrical signals
`representing the sensed physiological signals. A converter
`assembly, integrated with, and electrically connected to the
`sensor assembly, converts the electrical signals generated by
`the sensor assembly to a frequency modulated physiological
`audio signal having a carrier frequency in the range of from
`about 6 kHz to about 20 kHz.
`
`14 Claims, 4 Drawing Sheets
`
`APPLE 1001
`
`1
`
`

`

`US 9,649,042 B2
`Page 2
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`(51)
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`Int. Cl.
`A61B 510404
`A61B 5100
`A61B 5/055
`(52) U.S. Cl.
`CPC
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`A61B 5/055 (2013.01); A61B 2505/07
`(2013.01); A61B 2560/045 (2013.01); A61B
`2560/0468 (2013.01)
`
`(56)
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`FOREIGN PATENT DOCUMENTS
`
`CN
`CN
`CN
`DE
`DE
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`FR
`GB
`GB
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`201918016 U
`102347804 A
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`2181554 A
`2408105 A
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`3/2009
`6/2010
`2/2012
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`4
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`

`

`US 9,649,042 B2
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`KR
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`WO
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`S59122032 A
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`10/2005
`7/2006
`8/2008
`8/2010
`3/2012
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`
`OTHER PUBLICATIONS
`
`Australian Design Awards; Heartplus Micro; printed from website
`http://www.designawards.com/au on Apr. 12, 2002; 6 pgs.
`
`Bajaj, M.D.; Event Recording in Ambulatory Patients with Synco(cid:173)
`pal Events; University of Kansas; Wichita, Kansas; (no date); pp.
`15-18; printed on or before Apr. 14, 2010.
`Bluetooth; Headset Profile (HSP); printed from website http://
`bluetooth.corn/English/Technology/Works/Pates/HSP.aspx, printed
`May 12, 2010; 1 pg.
`Bramanti et al., Multichannel telemetric system for biomedical
`signals via switched telephone lines; Medical and Biological Engi(cid:173)
`neering and Computing, Sep. 1982, vol. 20, No. 5, pp. 653-656.
`Vitaphone; Telemedicine since 1999: Modern health management is
`our special subject; 3 pgs; retrieved Mar. 19, 2014 from the internet
`(http:/ /www. vi taphone .de/ en/ company/hi story-o f-vitaphone/).
`Albert et al.; U.S. Appl. No. 14/217,032 entitled "Systems and
`methods for processing and analyzing medical data," filed Mar. 17,
`2014.
`Albert, David E.; U.S. Appl. No. 14/252,044 entitled "Cardiac
`performance monitoring system for use with mobile communica(cid:173)
`tions devices," filed Apr. 14, 2014.
`Macfarlane et al.; Resting 12-lead ECG electrode placement and
`associated problems; SCST Update 1995; 15 pgs.; printed Feb. 18,
`2014 from www.scst.org.uk/resources/RESTING_l2.pdf? (year of
`pub. sufficiently earlier than effective US filed and any foreign
`priority date).
`Galloway et al.; U.S. Appl. No. 14/076,076 entitled "Electrocar(cid:173)
`diogram Signal Detection," filed Nov. 8, 2013.
`Albert et al.; U.S. Appl. No. 14/149,242 entitled "Methods and
`systems for electrode placement," filed Jan. 7, 2014.
`Burke, A Micropower Dry-Electrode ECG Preamplifier; IEEE
`Transactions on Biomedical Engineering, Feb. 2000, vol. 47, No. 2,
`pp. 155-162.
`Card Guard; CG-6108 ACT Ambulatory Cardiac Telemetry Bro(cid:173)
`chure; Card Guard, The Telemedicine Company: Switzerland; (year
`of publication is sufficiently earlier than the effective U.S. filing date
`and any foreign priority date) 2006; 2 pgs.
`Cardiocomm Solutions; GEMS Air (PC based ECG management);
`printed from website http://www.cardiocommsolutions/com on
`Mar. 19, 2010; 1 pg.
`Charuvastra; T ranstelephonic Cardiac Event Recording for Arrhyth(cid:173)
`mia Surveillance; printed from website http:/ /tchin.org/resource_
`roorn/c_art on Mar. 26, 2010; 2 pgs.
`Cheng, Allen C.; Real-Time Cardiovascular Diseases Detection on
`a Smartphone; printed Apr. 14, 2010.
`Company-Bosch et al.; ECG Front-End Design is Simplified with
`MicroConverter; Analog Dialogue; Nov. 2003; vol. 37(11); pp. 1-5.
`Creative; PC-SOB Portable ECG Monitor w/sd card extension slot;
`printed from website www.amazon.com/Portable-Monitor-exten(cid:173)
`sion-leather-shipping/dp/BOOlOjWKUE on Feb. 4, 2010; 3 pgs.
`Deveau, Health care eyes smart phones to heal ills (posted Sep. 15,
`2009); printed from website http://www.theQiobeandmail.com on
`Sep. 17, 2009, 4 pages.
`Dobrev, et al.; Bootstrapped two-electrode biosignal amplifier; Med
`Biol Eng Comput; vol. 46(6); Jun. 2008, pp. 613-619.
`Elert, Glenn (Editor); Frequency Range of Human Hearing; The
`Physics Factbook; web version as of Mar. 29, 2010; 2 pgs.; printed
`Jun. 6, 2012 (http://web.archive.org/web/20100329141847 /http://
`hypertextbook.corn/facts/2003/ChrisDAmbrose.shtrnl).
`Favorite Plus; Handheld Easy ECG Monitor; (Product ID: FP180);
`printed from website www.favoriteplus.com/easy-ecg-handheld(cid:173)
`monitor-fpl 80 on Feb. 4, 201 0; 2 pgs.
`Favorite Plus; Handheld ECG Monitor-Handheld EKG Monitor at
`Favoriteplus.com (Products: FP180, FP-RMH and FP-ICH); printed
`from website www.favoriteplus.com/handheld-ecg-ekg-monitor.
`php on Feb. 4, 2010; 3 pgs.
`Favorite Plus; Handheld EKG Monitor InstantCheck; (Product ID:
`FP-ICH); printed
`from website http://www.favoriteplus.com/
`instanchcheck-hand held-ecg-ekg-monitor on Feb. 4, 2010; 2 pgs.
`Ferrick, M.D., Holter Monitoring and Cardiac Event Recording in
`Assessing Symptomatic Patients; Albert Einstein College of Medi(cid:173)
`cine; Bronx, New York; (no date); pp. 11-14; printed on or before
`Apr. 14, 2010.
`Fulford-Jones, et al., A Portable, Low-Power, Wireless Two-Lead
`EKG System; Proc. of the 26th Ann. Int. Conf. IEEE EMBS; San
`Francisco, CA, USA; Sep. 1-5, 2004, pp. 2141-2144.
`
`5
`
`

`

`US 9,649,042 B2
`Page 6
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`
`Gillette, M.D.; Diagnosis of Pediatric Arrhythmias with Event
`Recording; Medical University of South Carolina; Charleston,
`South Carolina; (no date); pp. 25-32; printed on or before Apr. 14,
`2010.
`Grier, James W.; How to use I-lead ECG recorders to obtain 12-lead
`resting ECGs and exercise ("stress") ECGs; printed from website
`http://www.ndsu.edu/pubweb/grier on Jun. 7, 2010; 13 pgs.
`Hannaford, Kat; How to Turn Your iPhone Into A Laser, Fan or
`Flashlight; printed from website http://m.gizmodo.com/5534904;
`printed Feb. 3, 2011.
`Hayes, M.D., Approaches to Diagnosing Transient Arrhythmias(cid:173)
`An Overview; Mayo Clinic; Rochester, Minnesota; (no date); pp.
`7-10; printed on or before Apr. 14, 2010.
`Hearing Loss Assoc. of Kentuckiana; Decibel Ratings/Hazardous
`Time Exposures of Common Noise (excerpt from Survivor's
`Manual); web version as of Oct. 5, 2008; 2 pgs.; printed Jun. 6, 2012
`(http://web.archive.org/web/2008 l 00 5143856/http:/ /www.
`hearinglo ssky.org/hlasurvival I .html).
`Huang, Tina; Age-related hearing loss; Minnesota Medicine;
`90(10); pp. 48-50; Oct. 2007; printed Jun. 6, 2012 from: http://
`www.minnesotamedicine.com/Pastissues/Pastissues2007 /Octo(cid:173)
`ber2007 /Clinca!HuangOctober2007 .aspx ).
`IMEC News; IMEC extends flexible ECG patch to enable arrhyth(cid:173)
`mia detection; printed from website http://www2.imec.be/imec on
`Aug. 18, 2009; 1 pg.
`Instromedix; Cardiac Event Recording FAQs; Instromedix: A Card
`Guard Company, San Diego, CA; printed from website www.
`instromedix.corn/pdf/products/cardiac; printed on or before Apr. 14,
`2010.
`Instromedix; The Arrhythmia Monitoring System; King of Hearts
`Express AF Recorder Brochure; from Instromedix; A CardGuard
`Company; Rosemont IL; (year of publication is sufficiently earlier
`than the effective U.S. filing date and any foreign priority date)
`2004; 3 pgs.
`iRHYTHM; Zio(TM) Patch; printed from website http://www.
`irhythmtech.corn/zio-solution/zio-pach/, printed Apr. 12, 2010.
`Kim, et al., Detection of Atrial Fibrillation Episodes using Multiple
`Heart Rate Variability Features in Different Time Periods; Conf Proc
`IEEE Eng Med Biol Soc.; EMBS; 30th Ann. Int. Conf.; Aug. 20-25,
`2008, 5482-5485.
`Koerner; The Author's Metrics; Wired Magazine Article; New York,
`NY; Jul. 2009; pp. 93-126.
`Kumparak, Greg; Visa officially announces their case that turns your
`iPhone into a credit card (and we've got pies!); May 17, 2010;
`www.mobilecrunch.com; printed Feb. 3, 2011.
`Leijdekkers et al., Trial Results of a Novel Cardiac Rhythm Man(cid:173)
`agement System using Smart Phones and Wireless ECG Sensors;
`Proc. of the 7th Int. Conf. on Smart homes and health Telematics.,
`Tours, France; Jul. 1-3, 2009; 8 pgs.
`Levkov et al., Removal of power-line interference from the ECG: a
`review of the subtraction procedure; BioMedical Engineering
`Online; 4:50; Aug. 23, 2005; 18 pgs.; (printed from website http://
`www.biomedical-engineeringonline.com/content/4/l/50).
`M Med Choice; (company information page) Beijing Choice Elec(cid:173)
`tronic Technology Co., Ltd.; printed from website http://www.
`choicemmed.corn/lxwm .asp; printed Dec. 28, 2009; 1 page.
`M Med Choice; Handheld ECG Monitor Brochure; MDl00 Prod(cid:173)
`ucts; Beijing Choice Electronic Technology Co. Ltd.; 6 pgs; pub(cid:173)
`lished on or before Apr. 14, 2010.
`M Med Choice; Handheld ECG Monitor MDlO0Al; printed from
`website http://www.choicemmed.com/productshow.asp on Dec. 28,
`2009; 2 pgs.
`M Med Choice; Handheld ECG Monitor MDlO0B; printed from
`website http://www.choicemmed.com/productshow.asp on Dec. 28,
`2009; 2 pgs.
`Mauvila: Mauvila ECG Tutorial; Basic ECG Interpretation Tutorial;
`Sections 1-12; 2004; printed from website http://mauvila.com/ECG/
`ecg.htrn on Mar. 26, 2010; 57 pgs.
`
`Medgadget; Zio(TM) Patch Wins Medical Design Award;
`MedGadget internet journal of emerging medical technologies;
`printed from website http://medgadget.com/archives/2010/04/zio
`patch wins medial desian award I.html on Apr. 12, 2010; 1 pg.
`MiCardioMobile: Remote Wireless Cardiac Rehabilitation Moni(cid:173)
`toring printed from website; http://alivetec.cable.nu/cardiomobile; 1
`page; printed Apr. 14, 2010.
`Mobility Mind; Use your Treo 650 as a portable ECG monitoring
`device; Mobility Mind; Sep. 14, 2005, printed from website http://
`www.treotoday.net/200 5/ 09 I 14/use-your-treo-6 50-as-a-portable(cid:173)
`ecg-monitoring-device/ (accessed Mar. 26, 2010); 1 pg.
`Modem Protocols Explained; ftp://kermit.columbia.edu/kermit/cu/
`protocol.html; 5 pgs.; printed Oct. 2, 2013.
`Modem
`Tutorial;
`http://www.lsu.edu/OCS/its/unix/tutorial/
`ModemTutorial/ModemTutorial.htrnl; 2 pgs.; printed Oct. 2, 2013.
`Muench, Frederick PhD; HRV: The Manufacturers and Vendors
`Speak; The portable StressEraser Heart Rate Variability Biofeed(cid:173)
`back Device: Background and Research; Biofeedback; vol. 36, Iss.
`l; pp. 35-39; Spring 2008.
`Murph; RedEye mini converts iPhone, iPad or iPod touch into
`IR-beaming universal remote; printed from website http://www.
`engadget.corn/2010/03/02/redeye on Mar. 2, 201 0; 2 pgs.
`Nam et al.; An Ultrasonic Sensor Based Low-Power Acoustic
`Modem for Underwater Communication in Underwater Wireless
`Sensor Networks; Computer Network Lab, Dept. of Elec. Eng.,
`Korea Univ.; pp. 494-504; Dec. 2007 (http://nesl.ee.ucla.edu/fw/
`torres/home/Dropbox/good_paper_mico_controller.pdf; 11 pgs.;
`printed Oct. 2, 2013).
`Neuroreille; Audiometry; web version as of Oct. 14, 2008; 1 pg.;
`printed Jun. 6, 2012 (http://www.neuroreille.com/promenade/eng(cid:173)
`lish/audiometry/audiometry.htm).
`Omron; Omron Portable ECG EKG Handheld HCG-801 Monitor;
`printed from website http://www.amazon.com/Omron-Portable(cid:173)
`Handheld-HCG-801-Monitor/dp/B0019WH3EO on Feb. 24, 2010;
`4 pgs.
`Omron; Omron Portable ECG Monitor; printed from website http://
`wvvw.target.corn/gp/detail.htrnl on Mar. 26, 2010; 1 pg.
`Oresko, et al., Detecting Cardiovascular Diseases via Real-Time
`Electrocardiogram Processing on a Smartphone; 2009 Workshop on
`Biomedicine in Computing: Systems, Architectures, and Circuits
`(BiC); Austin, TX; Jun. 2009; pp. 13-16.
`Perez, Sarah; No NFC? No Problem; New Startup Zoosh Provides
`Workaround Technology (Jun. 20, 2011); printed on or before Jun.
`27, 2011 from website; 2 pgs.; (http://www.readwriteweb.com/
`archives).
`Prystowsky, M.D., Chairmans Introduction; Duke University Medi(cid:173)
`cal Center; Indianapolis, Indiana; pp. 5-6; printed on or before Apr.
`14, 2010.
`Prystowsky, M.D., Chairmans Summary; Duke University Medical
`Center; Indianapolis Indiana; (no date); pp. 39-40; printed on or
`before Apr. 14, 2010.
`Prystowsky, M.D., The Clinical Application, Diagnostic Yield and
`Cost Considerations of Cardiac Event Recorders; Duke University
`Medical Center; Indianapolis Indiana; (no date); pp. 19-23• printed
`on or before Apr. 14, 2010.
`Puurtinen, et al., Best Electrode Locations for a Small Bipolar ECG
`Device: Signal Strength Analysis of Clinical Data, Annals of
`Biomedical Engineering, vol. 37, No. 2, Feb. 2009; pp. 331-336.
`Raju; Heart-Rate and EKG Monitor Using the MSP430FG439
`(Application Report); Texas Instruments; SLAA280-Oct. 2005-
`(Revised Sep. 2007); 11 pgs.
`Read-My-Heart; ECG Machine Handheld Read My Heart; (Product
`Item No. HH-3413); printed from website http://www.helioliving .
`corn/ECG-Machine-Handheld-ReadMyHeart on Feb. 4, 2010; 1 pg.
`Read-My-Heart; ReadMyHeart Personal Handheld ECG Monitor
`with Free Illustrator Book & Free Electrodes V2.2; printed from
`website http://www
`.amazon.corn/Readmyheart-Personai-Hand(cid:173)
`held-illustrator-Electrodes/dp/B0010AN63W on Mar. 26, 2010; 1
`pg.
`Ricker; Square payment dongle demoed for iPhone toting hippies
`and you (video); printed from website ht