(12) United States Patent
`Tarler
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7,206,630 B1
`Apr. 17, 2007
`
`USOO720663 OB1
`
`(54) ELECTRODE PATCH AND WIRELESS
`PHYSIOLOGICAL MEASUREMENT SYSTEM
`AND METHOD
`
`(75) Inventor: Matthew David Tarler, Westlake, OH
`(US)
`(73) Assignee: Cleveland Medical Devices, Inc.
`Cleveland, OH (US)
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 64 days.
`(21) Appl. No.: 10/879,666
`
`(*) Notice:
`
`Jun. 29, 2004
`
`(22) Filed:
`(51) Int. Cl.
`(2006.01)
`A6 IB5/04
`(2006.01)
`A6B 5/452
`(52) U.S. Cl. ...................... 600/509; 600/508; 600/372:
`600/393; 600/301; 128/903
`(58) Field of Classification Search ........ 600/508–509,
`600/545–546,393-396, 372-373,382–384,
`600/301; 128/903
`See application file for complete search history.
`References Cited
`
`(56)
`
`U.S. PATENT DOCUMENTS
`
`4, 1978 Howson
`4,082,087 A
`4,957,109 A * 9/1990 Groeger et al. ............. 600,391
`5,381,798 A
`1/1995 Burrows
`5,417,222 A
`5/1995 Dempsey et al.
`5,458,124 A 10, 1995 Stanko et al.
`5,511,553 A * 4/1996 Segalowitz ................. 600,508
`5,694,940 A 12/1997 Unger et al.
`5,724,984 A
`3, 1998 Arnold et al.
`5,862,803 A
`1/1999 Besson et al.
`5,957,854 A
`9, 1999 Besson et al.
`6,073,046 A
`6, 2000 Patel et al.
`
`6,162,101 A 12/2000 Fischer et al.
`6,238.338 B1* 5/2001 DeLuca et al. ............. 600/300
`6,289.238 B1
`9, 2001 Besson et al.
`6,363,274 B1
`3/2002 Scalisi et al.
`6,597,946 B2 * 7/2003 Avrahami et al. ............. 604/20
`6,643,541 B2 * 1 1/2003 Mok et al. ........
`... 600,546
`6,768,920 B2 *
`7/2004 Lange et al. ......
`... 600,545
`6,782.283 B2 * 8/2004 Schmidt et al. ...
`... 600,372
`6,865,409 B2 * 3/2005 Getsla et al. .....
`340,870.16
`6,897,788 B2* 5/2005 Khair et al. ......
`2002/0028991 A1* 3/2002 Thompson .................. 600,372
`7/2002 Harry et al. ...
`... 600,301
`20O2/OO99277 A1*
`2003, OO6951.0 A1*
`4/2003 Semler ....................... 600/509
`2004, OO15058 A1
`1/2004 Besson et al.
`
`- - - - - - 600,393
`
`
`
`OTHER PUBLICATIONS
`Miller, Jodie, Interview with James M. Sweeny, Chairman and
`CEO, Cardionet, EP Lab Digest, Jul/Aug. 2002, vol. 2, No. 4, pp.
`1-4.
`
`(Continued)
`Primary Examiner Robert Pezzuto
`Assistant Examiner Shevon Johnson
`(74) Attorney, Agent, or Firm—Brian M. Kolkowski
`(57)
`ABSTRACT
`
`A wireless electrode patch and system for measuring the
`physiological condition of a Subject, more particularly to an
`electrode patch for ECG monitoring, and a method of
`sensing, analyzing and/or transmitting or relaying a physi
`ological signal. The wireless electrode patch and system is
`lightweight, compact and reusable. The wireless electrode
`patch provides a low, power system for extended battery life
`and use. The wireless electrode patch and system allows for
`good reliable measurement of physiological signals from the
`Subject. The wireless electrode is simple enough to apply as
`a single patch but versatile enough to be reconfigured as
`more than one patch.
`
`18 Claims, 12 Drawing Sheets
`
`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 1
`
`

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`US 7,206,630 B1
`Page 2
`
`OTHER PUBLICATIONS
`
`LIFECOR, Inc., Photos of LifeVest. www.lifecor.com.
`Editor, Seeing Signs in a New Way, Medical Device and Diagnostic
`Industry, Jun. 2003.
`Agilent Technologies, Telemetry Systems: integrated ccg and spO2,
`Jun. 5, 2001 5988-3214EN.
`Medtronic New Diagnostic Tool—Reveal Insertable Loop
`Recorder, www.medtronic.com/reveal/new.html.
`Friesen, Gary M., A Comparison of the Noise Sensitivity of Nine
`QRS Detection Algorithms, IEEE Transactions on Biomedical
`Engineering, vol. 37, No. 1. Jan. 1990, pp. 85-98.
`Trahanias, P.E. An Approach to QRS Complex Detection Using
`Mathematical Morphology, IEEE Transactions on Biomedical Engi
`neering, vol. 40, No. 2., Feb. 1993, pp. 201-205.
`Chu, Chee-Hung Henry, Impulsive Noise Suppression and Back
`ground Normalization .
`.
`.
`. IEEE Transactions on Biomedical
`Engineering, vol. 36, No. 2. Jan. 1989, pp. 262-273.
`
`Ambrose, Mary Lou, ECG Interpretation Made Incredibly Easy,
`1997, Springhouse Corporation, Springhouse, Pennsylvania.
`Dunn, Marvin I., Lipman-Massie Clinical Electrocardiography,
`1951, Year Book Medical Publishers, Inc, Chicago, London, Boca
`Raton.
`El-Sherif, Nabil ed., High Resolution Electrocardiology, 1992,
`ISBN: 0-87993-3658. Futura Publishing Company, New York.
`Lewis, John ed., Put On Your Private Paramedic, www.designnews.
`com, Jun. 3, 2003.
`Simonsen, Michael. Disease monitoring, minimally invasive
`therapy stimulate market. Cardiovascular Device Update, vol. 8.
`No. 7, Jul. 2002. pp. 1-16.
`
`* cited by examiner
`
`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 2
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`U.S. Patent
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`Apr. 17, 2007
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`Sheet 1 of 12
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`Fig 1
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`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 3
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`U.S. Patent
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`Apr. 17, 2007
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`FIG 2
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`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 4
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`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 5
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`FIG 4
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`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 6
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`U.S. Patent
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`Apr. 17, 2007
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`Sheet S of 12
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`Fig 5A
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`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 7
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`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 8
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`Ex. 1036, p. 9
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`Fig 6
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`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 10
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`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 10
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`U.S. Patent
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`Apr. 17, 2007
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`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 11
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`FIG 8
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`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 12
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`U.S. Patent
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`Apr. 17, 2007
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`Ex. 1036, p. 13
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`Electrical
`Pathways
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`Electrode
`Input
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`Signal
`Digitized
`
`Micro
`Processor
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`Radio
`Tranceiver
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`Power
`Supply
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`Fig 10
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`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 14
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`

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`US 7,206,630 B1
`
`1.
`ELECTRODE PATCH AND WIRELESS
`PHYSIOLOGICAL MEASUREMENT SYSTEM
`AND METHOD
`
`The U.S. Government has a paid-up license in this inven
`tion and the right in limited circumstances to require the
`patent owner to license others on reasonable terms provided
`for by the terms of grant number 5R44HL065024-03
`awarded by the National Institutes of Health.
`BACKGROUND OF THE INVENTION
`
`10
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`2
`tests: ECG, Holter monitor; external loop recorder; implant
`able loop recorder; tilt table test; electrophysiology study:
`and a stress test. An ECG can be performed in a physicians
`office or a hospital setting. It is unlikely, however, a patient
`will undergo many of the symptoms associated with these
`conditions such as for example syncope or fibrillation in
`those few minutes. A Holter monitor is a device that mea
`sures and records heart rhythm, usually over 1 day but
`occasionally for 2 or more days. Holter monitors can miss
`recording a critical moment when a diagnosis could be made
`because the event doesn’t happen during the recording, or
`because the patient took the device off to sleep. This is
`particularly important where patients do not want to wear
`the device to work for fear of discrimination if their
`employer or fellow employees know they have a health
`problem. An external loop recorder is a device that monitors
`heart rhythm and rate for up to a month. During this test, the
`patient wears a device on the wrist, around the chest or in a
`pocket. The patient must press a button on the device to
`make a recording of the heart activity during the period the
`symptoms occur such as fainting. Unfortunately, this only
`occurs if the patient is sufficiently aware that the event took
`place. Furthermore, the information collected must be down
`loaded periodically making in more difficult for the patient
`to comply. Implantable loop recorders are relatively new
`devices. These devices suffer from these same drawbacks as
`well as the possibility of infection due to the invasive
`procedure used to implant the device. A tilt table test is used
`to simulate conditions that may cause fainting. It enables the
`physician to gauge how blood pressure, heart rate and
`rhythm respond to a change in position from lying down to
`standing. This test is expensive and is generally only done in
`a large or teaching hospital setting. An electrophysiology
`study is an expensive and invasive procedure. This proce
`dure threads a catheter into the heart to record the heart’s
`own electrical impulses and to assess the response to pacing
`and extra beats. Other tests such as cardiac stress tests are
`expensive and generally are performed in a hospital setting.
`Traditional tests leave large numbers of patients with
`recurrent, unexplained, undiagnosed cardiac problems after
`undergoing these tests. The primary reasons these tests fall
`short are: 1) They only monitor the heart for a relatively
`limited amount of time, or 2) They require the patient to
`wear a device in their daily living that is embarrassing and
`inconvenient to wear, and/or that requires them to perform
`a task after experiencing a symptom. Therefore, there is a
`need for a diagnostic tool that allows one to continuously
`monitor the heart’s rhythm and rate for long periods of time.
`on the order of several months or more, and requires no
`action by the patient at the time of fainting.
`While a number of technologies have been developed to
`allow for patient monitoring at home or on the go, each of
`these technologies suffer from one or more major draw
`backs. U.S. Pat. No. 5,458,124 to Stanko et al. describes an
`electrode and wireless transmitter system for use in mea
`suring the physiological condition of a subject. The system
`in Stanko due to the rigidity of the system doesn't allow for
`good electrode contact with the patient's skin. Furthermore,
`the system in Stanko doesn’t provide a good means for data
`error detection, nor in process adjustment by an external
`source. U.S. Pat. Nos. 5,862,803; 5,957,854; and 6,289.239
`to Besson et al. provides for a wireless electrode system for
`measuring various body conditions. This system, however,
`is cumbersome, overly complex and limiting in that among
`other things it requires separate electronics for each elec
`trode, as well as, a source of power external to the electrode.
`Because of the unique power requirements, this system
`
`15
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`
`1. Field of the Invention
`The present invention is related, in general, to an elec
`trode patch and/or a wireless system for measuring the
`physiological condition of a subject, and more particularly
`to an electrode patch for ECG monitoring. The present
`invention further includes a method of sensing and analyZ
`ing a physiological signal.
`2. Technical Background
`Monitoring one or more physiological conditions of a
`patient is well known. Medical patient monitoring systems
`are highly sophisticated utilizing telemetry systems at a
`central receiving and monitoring station. ECG monitoring
`has the greatest applications.
`According to present estimates, approximately 60 mil
`lions Americans have one or more types of cardiovascular
`disease including high blood pressure, coronary artery dis
`ease, stroke, rheumatic heart disease, congenital cardiovas
`cular defects and congestive heart failure. Cardiovascular
`disease claims approximately one million lives in the United
`States each year, or approximately forty percent of all
`deaths. Since 1990, cardiovascular disease has been the
`number one killer in the United States every year other than
`1918. More than 2,600 Americans die each day of cardio
`vascular disease, which is an average of 1 death every 33
`seconds.
`Because heart performance can deteriorate quickly, the
`key to effective cardiovascular disease management resides
`in early medical intervention. Patients often to not recognize
`40
`subtle changes in cardiovascular disease symptoms and may
`not appreciate the importance of quickly reporting such
`changes to their physician. To make early intervention
`possible and prevent rehospitalization, healthcare providers
`need daily access to accurate information about patients
`symptoms. There are many reasons a physician may want to
`monitor patients on a continuous or nearly continuous basis.
`These include the need to detect episodic arrhythmias, either
`to establish a diagnosis or to evaluate efficacy of therapy; the
`need to help evaluate syncope, in particular to detect any
`associated cardiac rhythm disorder or to assess therapy; the
`need to assess efficacy of therapy for atrial arrhythmias (this
`is especially important with atrial fibrillations in patients at
`risk for stroke or systemic embolism who can not take
`warfarin or similar drugs); the need in patients at increased
`risk for sudden arrhythmic death, particularly for example
`those patients with ventricular dysfunction who would ben
`efit from prolonged (6 weeks to 6 months) ECG monitoring
`after serious events such as a myocardial infarction, an
`episode of cardiac decompensation, recent cardiac Surgery
`or the onset of new therapy with an antiarrhythmic agent;
`and the need for providing patients with at home immediate
`access to 911 emergency help without patient action par
`ticularly for those patients who have had multiple myocar
`dial infarctions.
`A typical diagnostic process for any of these cardiovas
`cular conditions may include one or more of the following
`
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`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 15
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`

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`US 7,206,630 B1
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`3
`presumably doesn't allow for remote wireless monitoring at
`any great distance thereby creating an invisible tether to the
`receiver and limiting the versatility of the system.
`The wireless technologies outlined above are interesting,
`but are not applicable for the easy measurement physiologi
`cal signals and transmission over long periods of time. A
`compact, wireless physiological monitoring technology is
`needed for this purpose. It is therefore, an object of this
`invention to provide an electrode patch and wireless system
`for such a purpose. It is a further object of this invention to
`provide an electrode patch and wireless system with a
`feasible battery system. It is still a further object of this
`invention to provide an electrode patch and wireless system
`that allows for good measurement from two or more elec
`trodes. It is still further an object of this invention to provide
`an electrode patch and wireless system that provided for data
`error correction. It is still further an object of this invention
`to provide an electrode patch and wireless system, which
`utilizes dry physiological electrodes for detecting the physi
`ological signals.
`
`10
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`more electronic components to the base and electrically
`connecting the at least two electrical pathways to the one or
`more electronic components.
`In still another embodiment, the present invention
`includes an electrode patch for sensing a physiological
`signal from a subject, the electrode patch comprising a base
`having an upper and a lower Surface, the lower Surface of the
`base comprising at least two electrodes for placing on a
`Subjects skin and for sensing of a physiological signal from
`the Subject; and one or more electronic components for
`receiving the physiological signal from the at least two
`electrodes, transmitting a signal corresponding to the physi
`ological signal to a receiving unit or remote communication
`station, and receiving a signal from a remote transmitter, the
`one or more electronic components being attached to the
`base.
`In still another embodiment, the present invention
`includes a wireless system for monitoring at least one
`physiological condition of a Subject, the system comprising
`an electrode patch comprising a base having an upper and a
`lower Surface, the lower Surface of the base comprising at
`least two electrodes for placing on a Subjects skin and for
`sensing of a physiological signal from the Subject; and one
`or more electronic components for receiving the physiologi
`cal signal, transmitting a signal corresponding to the physi
`ological signal to a receiving unit or remote communication
`station and receiving a signal from a remote transmitter, the
`one or more electronic components being attached to the
`base; and a receiving unit or remote communication station
`for receiving, re-transmitting and/or processing the signal
`corresponding to the physiological signal, the receiving unit
`or remote communication station comprising a computer,
`processor and/or one or more electronic parts.
`In yet another embodiment, the present invention includes
`a method comprising the steps of sensing and analyzing a
`physiological signal comprising the steps of measuring a
`physiological signal from a subject; transmitting wirelessly
`the physiological signal from the Subject to a remote com
`munication station; and transmitting data formed in part
`from the physiological signal from the remote communica
`tion station wirelessly or via the internet to another computer
`or processor System.
`In still yet another embodiment, the present invention
`includes a method comprising the steps of applying a
`wireless electrode patch to a subject; digitizing and/or
`analyzing a physiological signal measured from the Subject
`with the electrode patch; transmitting wirelessly from the
`electrode patch the digitized and/or analyzed physiological
`signal from the Subject to a remote communication station;
`and re-transmitting a signal based in part from the physi
`ological signal from the remote communication station
`wirelessly or via the internet to another monitor, computer or
`processor System.
`Additional features and advantages of the invention will
`be set forth in the detailed description which follows, and in
`part will be readily apparent to those skilled in the art from
`that description or recognized by practicing the invention as
`described herein, including the detailed description which
`follows, the claims, as well as the appended drawings.
`It is to be understood that both the foregoing general
`description and the following detailed description are merely
`exemplary of the invention, and are intended to provide an
`overview or framework for understanding the nature and
`character of the invention as it is claimed. The accompany
`ing drawings are included to provide a further understanding
`of the invention, and are incorporated in and constitute a part
`of this specification. The drawings illustrate various embodi
`
`SUMMARY OF THE INVENTION
`
`25
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`30
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`40
`
`The present invention is related, in general, to an elec
`trode patch and/or a wireless system for measuring the
`physiological condition of a Subject, and more particularly
`to an electrode patch for ECG monitoring. The present
`invention further includes a method of sensing, analyzing
`and/or transmitting or relaying a physiological signal.
`The wireless system and/or electrode patch of the present
`invention is preferably lightweight and compact. The elec
`trode patch preferably additionally provides a low, power
`system for extended battery life and use. The electrode patch
`35
`and wireless system of the present invention still further
`preferably allows for good and reliable measurement of
`physiological signals form the Subject. The electrode patch
`is still preferably simple to apply as a single patch, but
`versatile enough to be reconfigured as more than one patch.
`In one embodiment, the present invention includes an
`electrode patch for sensing a physiological signal from a
`Subject, the electrode patch comprising a base having an
`upper and a lower surface, the lower surface of the base
`comprising at least two electrodes for placing on a Subjects
`skin and for sensing of a physiological signal from the
`Subject; one or more electronic components for receiving the
`physiological signal and transmitting a signal corresponding
`to the physiological signal to a receiving unit or remote
`communication station, the one or more electronic compo
`nents being attached to the base; and at least two electrical
`pathways connecting the at least two electrodes to the one or
`more electronic components which are not used as a primary
`means to mechanically attach the one or more electronic
`components to the base.
`In another embodiment, the present invention includes an
`electrode patch for sensing a physiological signal from a
`Subject, the electrode patch comprising a base having an
`upper and a lower surface, the lower surface of the base
`comprising at least two electrodes for placing on a Subjects
`skin and for sensing of a physiological signal from the
`Subject; one or more electronic components for receiving the
`physiological signal and transmitting a signal corresponding
`to the physiological signal to a receiving unit or remote
`communication station, the one or more electronic compo
`nents; at least two electrical pathways connecting to the at
`least two electrodes; and a fastener for attaching the one or
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`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 16
`
`

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`5
`ments of the invention, and together with the description
`serve to explain the principles and operation of the inven
`tion.
`
`US 7,206,630 B1
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1. Plan cross-sectional view of the base of one
`embodiment of an electrode patch.
`FIG. 2. Plan cross-sectional view of the base of another
`embodiment of an electrode patch.
`FIG. 3. Plan cross-sectional view of an electrode patch
`utilizing base from FIG. 1.
`FIG. 4. Exploded view of base laminate from FIG. 2.
`FIG. 5. A), B), and C) are plan cross-sectional views of
`three embodiments of the reconfigurable electrical pathways
`of an electrode patches.
`FIG. 6. Plan cross-sectional view of another embodiment
`of a reconfigurable electrode of the present invention.
`FIG. 7. Plan cross-sectional view of another embodiment
`of the base of an electrode patch.
`FIG. 8. Plan cross-sectional view of one embodiment of
`a connector used with base laminate described in FIGS. 2
`and 4.
`FIG. 9. Schematic representation of one embodiment of a
`wireless monitoring system of the present invention.
`FIG. 10. Flow diagram of one embodiment of the one or
`more electronic components for the various devices and
`systems of the present invention.
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`DESCRIPTION OF THE PREFERRED
`EMBODIMENT
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`45
`
`The present invention is related, in general, to an elec
`trode patch and/or a wireless system for measuring the
`physiological condition of a Subject, and more particularly
`to an electrode patch for ECG monitoring. The present
`invention further includes a method of sensing and analyZ
`ing a physiological signal.
`The electrode patch and the wireless system of the present
`invention are preferably used for sensing or detecting a
`physiological signal from a Subject. The Subject from which
`a physiological signal is measured being a human or other
`form of animal. The electrode patch and the wireless system
`of the present invention can be used in a variety of appli
`cations including but not limited to electrocardiography
`(ECG), electroencephalography (EEG), electrical imped
`ance tomography (EIT), electromyography (EMG), and
`electro-oculography (EOG). Preferably, the electrode patch
`and the wireless system of the present invention is used for
`electrocardiography (ECG).
`The electrode patch, which is a part of the wireless system
`of the present invention comprises a base having an upper
`and lower surface. The lower surface of the base comprising
`at least two electrodes. The electrodes are used for sensing
`a physiological signal from a subject. The electrode patch
`further comprises one or more electronic components. The
`one or more electronic components are used to receive the
`physiological signal from the at least two electrodes. The
`one or more electronic components also transmit or store a
`signal corresponding to the physiological signal to a remote
`60
`receiving unit. Preferably, the one or more electronic com
`ponents can further receive signals from one or more remote,
`receiving units. In a number of embodiments, the electrode
`patch further comprises at least two electrical pathways
`connecting to the at least two electrodes to one or more
`electronic components for receiving the physiological sig
`nal.
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`The electrical pathways are preferably attached to the
`base. More preferably, the electrical pathways are a line of
`conductive ink, which is printed on the upper surface of the
`base. Even more preferably, the electrical pathways are
`printed on the upper Surface of the base and are drawn to a
`connector. This allows for separate production of the elec
`tronic components of the electrode patch and further for
`reuse or recycling of the electronic components. Also pref
`erably, any of the electronic components and their electrical
`connections can be printed on the base of the electrode
`patch. The electrical pathways of the present invention are
`preferably greater than about 0.25 inches in length, more
`preferably greater than about 0.5 inches in length, and most
`preferably greater than about 1.0 inches in length. Prefer
`ably, the electrical pathways are made from Some conductive
`ink or coating material.
`The subject(s) referred to in the present invention can be
`any form of animal. Preferably the subject(s) are mammal,
`and most preferably human. The base having an upper and
`a lower Surface can be made from any materials known to
`those skilled in the art. Preferably the base is made from a
`material which has the mechanical features necessary for the
`at least two electrodes and for attaching to the one or more
`electronic components. More preferably, the base is a lami
`nate. Even more preferably, the base incorporates Some type
`of foamed or cellular material that allows a certain flexibility
`and depth necessary for wells or depressions to hold con
`ductive electrode gels or pastes. Preferably, the base com
`prises a flexible spacer layer with a modulus of elasticity of
`less than about 500,000 psi, more preferably less than about
`100,000 psi, and most preferably less than about 30,000 psi.
`The spacer layer can be made from any polymer known to
`those skilled in the art. Preferably, the spacer layer is a foam
`or celled structure. Most preferably, the spacer layer is a
`closed cell structure, which doesn't allow for absorption of
`biological contaminants. Preferably the spacer layer of the
`base is between about 0.001 to about 0.3 inches thick, more
`preferably between about 0.01 to about 0.2 inches thick, and
`most preferably between about 0.03 to about 0.15 inches
`thick. If an adhesive is used to attach the electrode patch to
`the subject, preferably the adhesive is biologically compat
`ible to the subject. More preferably, a pressure sensitive
`adhesive is used. Even more preferably, a removable pres
`sure sensitive adhesive is used. The adhesives used include
`but are not limited to for example natural rubber, butyl,
`styrenic block copolymer, SBR, acrylics, and silicone based
`adhesives. Preferably, if a base laminate is used, the base
`laminate comprises a more rigid upper Surface wherein the
`upper Surface has an elastic modulus greater than that of the
`spacer layer. This allows for a better surface on which to
`attach the one or more electronic components of various
`embodiments of the present invention.
`The lower surface of the base, preferably, comprises at
`least two electrodes, more preferably more than at least three
`electrodes, and most preferably more than at least four
`electrodes. The at least two electrodes can be any type of
`electrode known to those skilled in the art for sensing a
`physiological signal. Preferably, the at least two electrodes
`of the present invention can be conventional electrodes
`known to those skilled in the art comprising a sensing
`element and a conductive gel for transmitting the signal
`between the Subjects skin and the sensing element; or dry
`electrodes comprising a penetrator for detecting physiologi
`cal signals below the Surface of the skin as a sensing
`element. Dry physiological recording electrodes of the type
`described in U.S. patent application Ser. No. 09/949,055 are
`herein incorporated by reference. Dry electrodes provide the
`
`Petitioner - Avation Medical, Inc.
`Ex. 1036, p. 17
`
`

`

`US 7,206,630 B1
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`10
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`15
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`7
`advantage that there is no gel to dry out, no skin to abrade
`or clean, and that the electrode can be applied in hairy areas
`Such as on an animal or on a male human's chest. Alterna
`tively, the Subject(s) skin may be mechanically abraded, or
`an amplified electrode may be used. Preferably, the at least
`two electrodes are one signal electrode and one reference
`electrode. The at least two electrodes don’t have to be of the
`same type, i.e., for example one could be a conductive gel
`electrode and the other a dry electrode. The at least two
`electrodes can be any shape known to be useful to those
`skilled in the art. For example the electrodes can be circular
`or non-circular in shape. Preferably, the at least two elec
`trodes are in close proximity with no more than 9 inches
`between each of their sensing elements or their closest
`sensing elements, more preferably with no more than 6
`inches between each of their sensing elements or their
`closest sensing elements, and most preferably with no more
`than 3 inches between each of their sensing elements or their
`closest sensing elements.
`The electrode patch is attached to the subject by any
`method or means known to those skilled in the art. By way
`of example but not limitation, the electrode patch may be
`attached to the subject by adhesive on the lower surface of
`the base, by adhesive on the electrodes on the lower surface
`of the base, by an elastomeric band that is attached to the
`based and about the subject, or some combination thereof.
`The electrode patch further comprises one or more elec
`tronic components for detecting the physiological signal
`from the at least two electrodes. While some of the elec
`tronic components such as the battery or antenna may be
`separate from the other electronic components, and in the
`case of the antenna may be printed right onto the base. One
`or more of the electronic components are mechanically
`attached to the base. Preferably, the one or more electronic
`components are mechanically attached to the upper Surface
`of the base. The one or more electronic components can be
`attached by any means known to those skilled in the art
`including but not limited to hooks, hangers, Velcro, clips and
`the like. The one or more electronic components are, how
`ever, preferably not attached to the base by the electrical
`40
`pathways. If, however, this is not possible preferably the one
`or more electronic components are attached with a connecter
`that incorporates at least two electrical pathways.
`The one or more electronic components for detecting the
`physiological signal from the at least two electrodes is a
`wireless device, which most preferably transmits the physi
`ological signals to a remote receiving unit. Preferably, the
`one or more electronic components also filter (and possibly
`amplify) the detected signal, and more preferably convert
`this detected physiological signal, which is in an analog
`form into a digital signal for transmission to the remote
`receiving unit. The one or more electronic components are
`attached to the subject as part of the electrode patch. Further
`preferably, the one or more electronic components can
`receive a signal from the remote receiving unit or other
`remote transmitters. The one or more electronic components
`may include circuitry for but are not limited to for example
`electrode amplifiers, signal filters, analog to digital con
`verter, RF output antenna, RF input antenna, RF output/
`input antenna, subcarrier VCO, transmitter VCO, tuning
`60
`crystal, phase-loc