available under
`Document made
`Patent Cooperation Treaty (PCT)
`
`the
`
`International application number: PCT/US2009/036690
`
`International filing date:
`
`10 March 2009 (10.03.2009)
`
`Document type:
`
`Certified copy of priority document
`
`Document details:
`
`Country/Office: US
`Number:
`61/035,970
`Filing date:
`12 March 2008 (12.03.2008)
`
`Date of receipt at the International Bureau:
`
`21 March 2009 (21.03.2009)
`
`Remark:
`
`Priority document submitted or transmitted to the International Bureau in
`compliance with Rule 17.1(a) or (b)
`
`
`
`World Intellectual Property Organization (WIPO) - Geneva, Switzerland
`Organisation Mondiale de la Propriété Intellectuelle (OMPI) - Genéve, Suisse
`
`1
`
`APPLE 1006
`
`APPLE 1006
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`1
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`

`

`coon S125.
`
`
`
`
`
`SE) AUSANDWESSHEESTS EEESENS: SHI, COOSERS:
`
`UNITED STATES DEPARTMENTOF COMMERCE
`
`
`United States Patent and Trademark Office
`
`
`
`March 20, 2009
`
`
`
`
`
`
`
`
`THIS IS TO CERTIFY THAT ANNEXED HERETOIS A TRUE COPY FROM
`THE RECORDS OF THE UNITED STATES PATENT AND TRADEMARK
`OFFICE OF THOSE PAPERS OF THE BELOW IDENTIFIED PATENT
`APPLICATION THAT MET THE REQUIREMENTS TO BE GRANTED A
`FILING DATE.
`
`APPLICATION NUMBER:61/035,970
`FILING DATE: March 12, 2008
`
` THE COUNTRY CODE AND NUMBER OF YOUR PRIORITY
`APPLICATION, TO BE USED FOR FILING ABROAD UNDER THE PARIS
`CONVENTION,IS US61/035,970
`
`
`
`
`
`
`
`
`RELATED PCT APPLICATION NUMBER: PCT/US09/36690
`
`
`
`yeriaeyitesteeseditstateten
`
`eee
`
`
`Ne Wo bYecheo
`
`
`
`
`
`Certified by
`
`
`
`
`
`ey=
`Under Sceretary of Commerce
`for Intellectual Property
`aad Director of the United States
`Potent and Trademark Office
`
`2
`
`

`

`Application Data Sheet
`
`Application Information
`
`Application number::
`
`Unassigned
`
`Herewith (03/12/2008)
`
`Provisional
`
`Utility
`
`Heart Failure Decompensation Prediction based
`
`on Cardiac Rhythm
`
`026843-002100US
`
`No
`
`No
`
`9 Y
`
`es
`
`No
`
`No
`
`Inventor
`
`US
`
`Full Capacity
`
`Imad
`
`Libbus
`
`Saint Paul
`
`MN
`
`US
`
`1726 Stanford Avenue
`
`Saint Paul
`
`MN
`
`US
`
`Filing Date::
`
`Application Type::
`
`Subject Matter::
`
`Title::
`
`Attorney Docket Number::
`
`Request for Early Publication::
`
`Request for Non-Publication::
`
`Total Drawing Sheets:
`
`Small Entity?::
`
`Petition included?::
`
`Secrecy Order in Parent Appl.::
`
`Applicant Information
`
`Applicant Authority Type::
`
`Primary Citizenship Country::
`
`Status:
`
`Given Name::
`
`Family Name::
`
`City of Residence::
`
`State or Province of Residence::
`
`Country of Residence::
`
`Street of Mailing Address::
`
`City of Mailing Address::
`
`State or Province of mailing address::
`
`Country of mailing address::
`
`Page 1
`
`Initial 3/12/08
`
`3
`
`

`

`Postal or Zip Code of mailing address::
`
`55105
`
`Applicant Authority Type::
`
`Primary Citizenship Country::
`
`Status::
`
`Given Name:
`
`Middle Name::
`
`Family Name::
`
`City of Residence::
`
`State or Province of Residence::
`
`Country of Residence::
`
`Street of Mailing Address::
`
`Inventor
`
`US
`
`Full Capacity
`
`Yatheendhar
`
`D.
`
`Manicka
`
`Woodbury
`
`MN
`
`US
`
`10544 Hawthorn Trail
`
`City of Mailing Address::
`
`Woodbury
`
`State or Province of mailing address::
`
`Country of mailing address::
`
`MN
`
`US
`
`Postal or Zip Code of mailing address::
`
`55129
`
`Applicant Authority Type::
`
`Primary Citizenship Country::
`
`Status::
`
`Given Name::
`
`Family Name::
`
`City of Residence::
`
`State or Province of Residence::
`
`Country of Residence::
`
`Street of Mailing Address:
`
`City of Mailing Address::
`
`State or Province of mailing address::
`
`Country of mailing address::
`
`Inventor
`
`US
`
`Full Capacity
`
`Badri
`
`Amurthur
`
`Los Gatos
`
`CA
`
`US
`
`218 Mattson Avenue
`
`Los Gatos
`
`CA
`
`US
`
`Postal or Zip Code of mailing address::
`
`95032
`
`Page 2
`
`Initial 3/12/08
`
`4
`
`

`

`Applicant Authority Type::
`
`Primary Citizenship Country::
`
`Status:
`
`Given Name::
`
`Family Name::
`
`City of Residence::
`
`State or Province of Residence::
`
`Country of Residence::
`
`Inventor
`
`US
`
`Full Capacity
`
`Scott
`
`Mazar
`
`Woodbury
`
`MN
`
`US
`
`Street of Mailing Address::
`
`10459 Glen Eagle Circle
`
`City of Mailing Address::
`
`State or Province of mailing address::
`
`Country of mailing address::
`
`Woodbury
`MN
`
`US
`
`Postal or Zip Code of mailing address::
`
`55129
`
`CorrespondenceInformation
`
`Correspondence Customer Number::
`
`20350
`
`Representative Information
`
`Representative Customer Number::
`
`20350
`
`Assignee Information
`
`Assignee Name::
`
`Corventis, Inc.
`
`Street of mailing address::
`
`1410 Energy Park Drive, Suite 1
`
`City of mailing address::
`
`State or Province of mailing address::
`
`Country of mailing address::
`
`St. Paul
`
`MN
`
`US
`
`Postal or Zip Code of mailing address::
`
`55108
`
`Page 3
`
`Initial 3/12/08
`
`5
`
`

`

`Attorney Docket No.: 026843-002 100US
`Chent Reference No.: DO7-25
`
`PROVISIONAL PATENT APPLICATION
`
`HEART FAILURE DECOMPENSATION PREDICTION BASED ON
`
`CARDIAC RHYTHM
`
`Inventor(s):—Imad Libbus, a citizen of The United States, residing at
`1726 Stanford Avenue
`
`Saint Paul, MN 55105
`
`Yatheendhar D. Manicka, a citizen of The United States, residing at
`10544 Hawthorn Trail
`
`Woodbury, MN 55129
`
`Badri Amurthur,a citizen of The United States, residing at
`218 Mattson Avenue
`
`Los Gatos, CA 95032
`
`Scott Mazar, a citizen of The United States, residing at
`10459 Glen Eagle Circle
`Woodbury, MN 55129
`
`Assignee:
`
`Corventis, Inc.
`1410 Energy Park Dr., Suite 1
`St. Paul, MN 55108
`
`Entity:
`
`Small business concern
`
`61270427 v1
`
`TOWNSENDand TOWNSENDand CREW LLP
`Two Embarcadero Center, Eighth Floor
`San Francisco, California 94111-3834
`Tel: 650-326-2400
`
`6
`
`

`

`PATENT
`
`Attorney Docket No.: 026843-002100US
`Client Reference No.: DO7-25
`
`HEART FAILURE DECOMPENSATION PREDICTION BASED ON
`
`CARDIAC RHYTHM
`
`CROSS-REFERENCES TO RELATED APPLICATIONS
`
`[0001] NOT APPLICABLE
`
`10
`
`15
`
`20
`
`25
`
`BACKGROUND OF THE INVENTION
`
`[0002]
`
`The present invention relates to patient monitoring, and more specifically to patient
`
`monitoring to detect and/or avoid impending cardiac decompensation. Although embodiments
`
`make specific reference to monitoring impedance and electrocardiogram signals with an adherent
`
`patch, the system methods and device described herein may be applicable to many applications
`
`in which physiological monitoring is used, for example wireless physiological monitoring with
`
`implantable devices for extended periods.
`
`[0003]
`
`Patients are often treated for diseases and/or conditions associated with a compromised
`
`status of the patient, for example a compromised physiologic status such as heart disease.
`
`In
`
`some instances a patient may have suffered a heart attack and require care and/or monitoring
`
`after release from the hospital. While such long term care may beat least partially effective,
`
`many patients are not sufficiently monitored and eventually succumb to cardiac decompensation
`
`or other heart failure. Decompensation is failure of the heart to maintain adequate blood
`
`circulation. Although the heart can maintain at least some pumping of blood, the quantity is
`
`inadequate to maintain healthy tissucs. Several symptoms can result from decompensation
`
`including pulmonary congestion, breathlessness, faintness, cardiac palpitation, edemaofthe
`
`extremities, and enlargementof the liver. Cardiac decompensation can result in slow or sudden
`
`death. Sudden Cardiac Arrest (hercinafter "SCA"), also referred to as sudden cardiac death, is an
`
`abrupt loss of cardiac pumping function that can be caused by a ventricular arrhythmia, for
`
`example ventricular tachycardia and/or ventricular fibrillation. Although decompensation and
`
`SCAcanbe related in that patients with heart failure are also at an increased risk for SCA,
`
`decompensation is primarily a mechanical dysfunction caused by inadequate blood flow, and
`
`SCAis primarily an electrical dysfunction caused by inadequate and/or inappropriate electrical
`
`signals of the heart.
`
`7
`
`

`

`[0004]
`
`Patients who have cardiac decompensation may be incorrectly diagnosedinitially in at
`
`least some instances, as the symptoms may makethe patient appear to suffer from another
`
`ailment. For example, pulmonary congestion resulting from cardiac decompensation may appear
`
`as a lung disorder.
`
`In addition, work in relation to embodiments of the present invention
`
`suggests that measurement devices and techniques to detect an impending sudden cardiac death
`
`may not be appropriate for detecting an impending cardiac decompensation.
`
`[0005] Many devices have been developed to monitor patients. One example of a device that
`
`may be used to monitor a patient is the Holter monitor, or ambulatory electrocardiography
`
`device. Although such a device may beeffective in measuring electrocardiography, such
`
`measurements may not be sufficient to reliably detect and/or avoid an impending cardiac
`
`decompensation. In addition to measuring heart signals with electrocardiograms, known
`
`physiologic measurements include impedance measurements. For example, transthoracic
`
`impedance measurements can be used to measure hydration and respiration. Although
`
`transthoracic measurements can be useful, such measurements may use electrodesthat are
`
`positioned across the midline of the patient, and may be somewhat uncomfortable and/or
`
`10
`
`15
`
`cumbersomefor the patient to wear.
`
`In at least some instances, devices that are worn by the
`
`patient may be somewhat uncomfortable, which may lead to patients not wearing the devices and
`
`not complying with direction from the health care provider, such that data collected may be less
`
`than ideal. Although implantable devices may be used in someinstances, many of these devices
`
`20
`
`can be invasive and/or costly, and may suffer at lcast some of the shortcomings of known
`
`wearable devices. As a result, at least some patients are not adequately monitored.
`
`[0006]
`
`Therefore, a need exists for improved patient monitoring and detection of impending
`
`cardiac decompensation. Ideally, such improved patient monitoring would provide reliable
`
`detection of an impending cardiac decompensation and avoid at least some of the short-comings
`
`25
`
`ofthe present methods and devices.
`
`BRIEF SUMMARYOF THE INVENTION
`
`[0007] Embodiments of the present invention provide systems and methods for the detection of
`
`an impending cardiac decompensation. Decompensationis a failure of the heart to maintain
`
`adequate blood circulation, such that may pulmonary congestion. Therefore, determining the
`
`30
`
`risk of impending decompensation can decrease traumato the patient and maysave the patient's
`
`life by allowing delivery of therapy in response to an clevated risk of impending
`
`decompensation.
`
`In many embodiments, the impending decompensation can be detected early
`
`8
`
`

`

`enough to avoid, or at least delay, the impending decompensation, such that patient trauma
`
`and/or expensive emergency room (hereinafter "ER") and intensive care unit (hereinafter "ICU")
`
`care can be avoided. Embodiments of the present invention can determine the risk of impending
`
`decompensation based on measurement of the electrocardiogram signal from the patient.
`
`Although embodiments make specific reference to monitoring electrocardiogram and other
`
`physiological signals with an adherent patch, the system methods and device described herein
`
`may be applicable to many applications in which physiological monitoring is used, for example
`
`wireless physiological monitoring with implanted sensors for extended periods.
`
`[0008]
`
`Ina first aspect, embodiments of the present invention provide a method of detecting an
`
`impending cardiac decompensation of a patient. An electrocardiogram signal of the patientis
`
`measured. An incidence ofcardiac arrhythmias is determined from the electrocardiogram signal.
`
`A risk of impending decompensation is determined in response to the incidence of cardiac
`
`arrhythmias.
`
`[0009]
`
`In many embodiments, the electrocardiogram signal is measured for at least one week
`
`and the risk of impending decompensation is determined in response to the incidence of cardiac
`
`arrhythmias measured for the at least one week. The incidence of cardiac arrhythmias can be
`
`compared to an earlier baseline incidence of cardiac arrhythmiasfor the patient to determine the
`
`risk of impending decompensation.
`
`In some embodiments, the incidence of cardiac arrhythmias
`
`may be compared to an earlier baseline incidence of cardiac arrhythmias for a patient population
`
`to determine the risk of impending decompensation. The electrocardiogram signal may comprise
`
`at least one of a derived signal, a time averaged signal, a filtered signal or a raw signal.
`
`[0010]
`
`In many embodiments, the incidence of cardiac arrhythmias is combined with at least
`
`one ofa heart rate, a heart rate variability, a bioimpedance,an activity or a respiration ofthe
`
`patient to determinethe risk of impending decompensation. At least one of a weighted
`
`combination, a tiered combination or a logic gated combination, a time weighted combination or
`
`a rate of change can be used to combinethe incidence of cardiac arrhythmias with the at least
`
`one of the heart rate, the heart rate variability, the bioimpedance, the activity or the respiration of
`
`the patient. The incidence of cardiac arrhythmias can be determined with anatrial arrhythmia
`
`that comprises at least one of a bradycardia, an atrial fibrillation, an atrial tachycardia, or an
`
`atrial flutter. The incidence of cardiac arrhythmias may also be determined with a ventricular
`
`arrhythmia comprising at least one of a bradycardia, a sustained ventricular tachycardia, a non-
`
`sustained ventricular tachycardia or a premature ventricular contraction.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`9
`
`

`

`[0011]
`
`The electrocardiogram signal can be measured in many ways.
`
`In specific
`
`embodiments, the clectrocardiogram signal is measured with an adherent patch comprising
`
`electrodes, the patch continuously adhered to the patient for at least one week. The
`
`electrocardiogram signal may be measured with electrodes injected and/or implanted into the
`
`patient.
`
`(0012]
`
`In many embodiments a therapy can be delivered to the patient in responseto the risk
`
`of impending decompensation, for example cardiac rhythm managementtherapy.
`
`[0013]
`
`In many embodiments, the clectrocardiogram signal is measured where the patientis
`
`located and the risk of impending decompensation is determined at a remote location. This can
`
`distribute the processing of information from the electrocardiogram signal to two or more
`
`locations and result in improved handling of the information from the electrocardiogram signal,
`
`for example by permitting smaller device for the patient and increasing the rate of transmission
`
`of information from the patient to the remote site and/or decreasing bandwidth requirements of
`
`the network. The benefits of this distributed processing can be realized with many embodiments.
`
`In some embodiments, an adherent patch that supports a processor may be adhered to the patient,
`
`and the incidence of cardiac arrhythmias can be determined with the processor whenthe patch is
`
`adhered to the patient. The processor can transmit the incidence of arrhythmias to the remote
`
`site to determine the risk of impending decompensation. Alternatively or in combination, the
`
`electrocardiogram signal can be transmitted to an intermediate device, for example a gateway, to
`
`determine the incidence of arrhythmias, and the incidence of arrhythmias can be transmitted
`
`from the intermediate device to the remote site where the risk of the impending cardiac
`
`decompensation is determined.
`
`[0014]
`
`In some embodiments, the electrocardiogram signal is measured where the patientis
`
`located, and the incidence of cardiac arrhythmias determined at the remote site.
`
`In specific
`
`embodiments, the electrocardiogram signal is transmitted to the remote site where the risk of the
`
`impending cardiac decompensation are determined. This transmission of the signal to the remote
`
`site may also allow further evaluation of the signal at the remote site, for example by a physician.
`
`[0015]
`
`In many embodiments, instructions are transmitted from a remote site to a processor
`
`supported with the patient, and the incidence of cardiac arrhythmias is determined with the
`
`processor in response to the instructions.
`
`In specific embodiments, the risk of impending
`
`decompensation is determined with the processor supported by the patient in response to the
`instructions from the remote site.
`
`10
`
`15
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`20
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`25
`
`30
`
`10
`
`10
`
`

`

`[0016]
`
`In many embodiments,a flag status is determined in response to the risk.
`
`[0017]
`
`In another aspect, embodiments of the present invention provide a system to detect
`
`impending cardiac decompensation of a patient. The system comprises circuitry to measure an
`
`electrocardiogram signal of the patient, and a processor system comprising a tangible medium in
`
`communication with the circuitry. The processor system is configured to determine an incidence
`
`of cardiac arrhythmias from the electrocardiogram signal and determine a risk of impending
`
`decompensation in responseto the incidence of cardiac arrhythmias.
`
`[0018]
`
`In many embodiments, the processor system is configured to reccive the
`
`electrocardiogram signal for at least one week and determinethe risk of impending
`
`decompensation in responseto the incidence of cardiac arrhythmias over the at least one week.
`
`[0019]
`
`In many embodiments, the processor system is configured to compare the incidence of
`
`cardiac arrhythmias to an earlier incidence of cardiac arrhythmias and determinethe risk of
`
`impending decompensation. The electrocardiogram signal may comprise at least one of a
`
`derived signal, a time averaged signal, a filtered signal or a raw signal. The processor system
`
`may be configured to combine the incidence of cardiac arrhythmias with at least one of a heart
`
`rate, a heart rate variability, a bioimpedance,an activity or a respiration of the patient to
`
`determinethe risk of impending decompensation.
`
`[0020]
`
`In many embodiments the system comprises an adherent patch comprising a breathable
`
`tape, electrodes and gel to measure the electrocardiogram signal. The breathable tape, the
`
`electrodes and the gel are arranged to adhere continuously to the patient for at least one week and
`
`measure the electrocardiogram signal for the at least one week.
`
`[0021]
`
`In many embodiments, the processor system is configured to determine the incidence of
`
`cardiac arrhythmias with anatrial arrhythmia comprising at least one of a bradycardia, an atrial
`
`fibrillation, an atrial tachycardia, or an atrial flutter. The processor system may be configured to
`
`determine the incidence of cardiac arrhythmias with a ventricular arrhythmia comprisingat least
`
`one of a bradycardia, a sustained ventricular tachycardia, a non-sustained ventricular tachycardia
`
`or a premature ventricular contraction.
`
`[0022]
`
`In many embodiments, electrodes are coupled to the circuitry to measure the
`
`electrocardiogram signal, and the electrodes are configured to be implanted and/or injected into
`
`the patient.
`
`10
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`15
`
`20
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`25
`
`11
`
`11
`
`

`

`[0023]
`
`In many embodiments, the processor system comprises a local processor and a remote
`
`processorat a remote site. The local processoris connected to an adherent patch configured to
`
`adhere to the skin of the patient, and the local processor is configured to measure the
`
`electrocardiogram signal. The remote processor is configured to determine the risk of impending
`
`decompensation.
`
`[0024]
`
`In some embodiments,the local processor is configured to transmit the
`
`electrocardiogram signal to the remote site to determine the risk of impending decompensation.
`
`[0025]
`
`In some embodiments, the local processoris configured to transmit the incidence of
`
`arrhythmias to the remote site and the remote processoris configured to determine the risk of
`
`impending decompensation from the incidence of arrhythmias.
`
`[0026]
`
`In some embodiments, the local processoris configured to determine the incidence of
`
`cardiac arrhythmias in response to the electrocardiogram signal. The remote processor is
`
`configured to determine the risk of impending decompensation in response to the incidence of
`
`electrocardiogram signals determined with the local processor.
`
`[0027]
`
`In some embodiments, the remote processor is configured to determine the incidence of
`
`cardiac arrhythmias of the patient in response to the electrocardiogram signal.
`
`[0028]
`
`In many embodiments, the processor system comprises a local processor connected to
`
`an adherent patch configured to adhere to the skin of the patient, and the local processor is
`
`configured to determine the incidence of arrhythmias from the electrocardiogram signal and
`
`determinethe risk of impending decompensation in response to the incidence of arrhythmias.
`
`The local processor may be configured to receive instructions transmitted from the remotesite to
`
`configure the local processor to determine the risk of impending decompensation in response to
`
`the electrocardiogramsignal.
`
`10
`
`13
`
`[0029]
`
`In many embodiments, the processor system is configured to determine a flag status in
`
`25
`
`responseto the electrocardiogram signal.
`
`[0030]
`
`In another aspect, embodiments provide a system to detect impending cardiac
`
`decompensation of a patient. The system comprises circuitry to measure an electrocardiogram
`
`signal of the paticnt. A processor system compriscs a tangible medium in communication with
`
`the circuitry, in which the processor system is configured to determine an incidence of cardiac
`
`30
`
`arrhythmias from the electrocardiogram signal and determine a risk of impending
`
`decompensationin response to the incidence of cardiac arrhythmias.
`
`12
`
`12
`
`

`

`[0031]
`
`In another aspect, embodiments of the present invention provide a computer-readable
`
`storage medium comprising a set of instructions for a computer systemto evaluate a risk of an
`
`impending cardiac decompensation of a patient. The set of instructions comprises an input
`
`routine, an output routine and arun routine. The input routine is operatively associated with a
`
`source of electrocardiogram data from the patient. The run routine is configured to determine a
`
`risk of the impending cardiac decompensation of the patient with the source of clectrocardiogram
`
`data. The output routine is configured to provide the risk of the impending decompensation
`
`available for external use outside the computer system.
`
`In many embodiments, the input routine, the run routine and the output routine are
`[0032]
`located on a server at a remotesite.
`
`10
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0033]
`
`Figure 1A showsa patient and a monitoring system comprising an adherent device,
`
`according to embodiments of the present invention:
`
`[0034]
`
`Figure 1B shows a bottom view ofthe adherent device as in Figure 1A comprising an
`
`15
`
`adherent patch;
`
`[0035]
`
`Figure |C shows a top view of the adherent patch, as in Figure |B;
`
`[0036]
`
`Figure 1D showsa printed circuit boards and electronic components over the adherent
`
`patch, as in Figure 1C;
`
`[0037]
`
`Figure 1D-1 shows an equivalent circuit that can be used to determine optimal
`
`20
`
`frequencies for determining patient hydration, according to embodiments of the present
`
`invention;
`
`[0038]
`
`Figure 1E showsbattcrics positioned over the printed circuit board and clectronic
`
`components as in Figure 1D;
`
`[0039]
`
`Figure 1F showsa top view of an electronics housing and a breathable cover overthe
`
`25
`
`battcrics, clectronic components and printed circuit board as in Figure 1E;
`
`[0040]
`
`Figure 1G showsa side view of the adherent device as in Figures 1A to IF;
`
`[0041]
`
`Figure 1H shown a bottom isometric view of the adherent device as in Figures LA to
`
`1G; and
`
`13
`
`13
`
`

`

`[0042]
`
`Figure 2A shows a method ofpredicting an impending cardiac decompensation,
`
`according to embodiments of the present invention; and
`
`[0043]
`
`Figure 3A shows a simplified flow chart of a computer-readable storage medium
`
`havinga set of instructions that can be read by a computer system to detect an impending
`
`decompensation, according to embodimentsofthe present invention.
`
`DETAILED DESCRIPTION OF THE INVENTION
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`[0044] Embodiments of the present invention provide systems and methodsforthe detection of
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`an impending cardiac decompensation. Decompensationis a failure of the heart to maintain
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`adequate blood circulation, such that pulmonary congestion results. Therefore, determining the
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`risk of impending decompensation can save the patient's life by delivering therapy in response to
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`an elevated risk of impending decompensation.
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`In many embodiments, the impending
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`decompensation can be detected early enough to avoid, or at least delay, the impending
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`decompensation, such that patient trauma and/or expensive ICU care can be avoided.
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`Embodiments of the present invention can determine the risk of impending decompensation
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`based on measurementofthe electrocardiogram signal from the patient. Although embodiments
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`make specific reference to monitoring electrocardiogram and other physiological signals with an
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`adherent patch, the system methods and device described herein may be applicable to many
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`applications in which physiological monitoring is used, for example wireless physiological
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`monitoring with implanted sensors for extended periods.
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`In some embodiments, implanted
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`sensors may be used, for example as described in U.S. Pat. Nos. 6,208,894; 6,315,721;
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`6,185,452; and U.S. Application No. 60/__,_—_, entitled "Injectable Device for Physiological
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`Monitoring" (Attorney Docket No. 00456-1004), filed on September 14, 2007, with the same
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`assignee as the present application; the full disclosures of which patents and applications are
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`incorporated herein by reference.
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`[0045]
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`Decompensation encompassesfailure of the heart to maintain adequate blood
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`circulation, often resulting in pulmonary congestion. SCA,also referred to as sudden cardiac
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`death, is an abrupt loss of cardiac pumping function that can be caused by a ventricular
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`arrhythmia, for example ventricular tachycardia and/or ventricularfibrillation. Although
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`decompensation and SCAcanberelated in that patients with heart failure are also at an increased
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`risk for SCA, decompensation is primarily the result of mechanical dysfunction, and SCA is
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`primarily an clectrical dysfunction caused by inadequate and/or inappropriate electrical signals
`of the heart.
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`[0046]
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`Figure 1A shows a patient P and a monitoring system 10, Patient P comprises a
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`midline M, a first side S1, for example a right side, and a second side S2, for examplea left side.
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`Monitoring system 10 comprises an adherent device 100. Adherent device 100 can be adhered to
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`a patient P at many locations, for example thorax T of patient P.
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`In many embodiments, the
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`adherent device may adhere to one side ofthe patient, from which data from the one side can be
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`collected. Work in relation with embodiments of the present invention suggests that location on
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`a side of the patient can provide comfort for the patient while the device is adhered to the patient.
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`[0047] Monitoring system 10 includes components to transmit data to a remote center 106 at a
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`location remote from the patient. The patient can be located in a first building and the remote
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`center located at a secondsite in a second building, for example with both the first building and
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`the second building located in the same town. The remote center and patient can be located
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`much farther from each other, and the patient can be located on a first continent and the remote
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`centerlocated at a site on a second continent. Adherent device 100 can communicate wirelessly
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`to an intermediate device 102, for example with a single wireless hop from the adherent device
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`on the patient to the intermediate device. Intermediate device 102 can communicate with remote
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`center 106 in many ways. For example, intermediate device 102 may comprise a gateway device
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`connected to the Internet.
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`In many embodiments, monitoring system 10 comprises a distributed
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`processing system with at least one processor on device 100, at least one processor 102P on
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`intermediate device 102, and at least one processor 106P at remote center 106, each of which
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`processors is in electronic communication with the other processors. At least onc processor
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`102P comprises a tangible medium 102M, andat least one processor 106P comprises a tangible
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`medium 106M. Remote center 106 can be in communication with a health care provider LOSA
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`with a communication system 107A, such as the Internet, an intranet, phone lines, wireless
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`and/orsatellite phone. Health care provider 108A, for example a family member, can be in
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`communication with patient P with a communication, for example with a two way
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`communication system, as indicated by arrow 109A, for example by cell phone, email, landline.
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`Remote center 106 can be in communication with a health care professional, for example a
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`physician 108B, with a communication system 107B, such as the Internet, an intranet, phone
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`lines, wireless and/orsatellite phone. Physician 108B can be in communication with patient P
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`with a communication, for example with a two way communication system, as indicated by
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`arrow 109B, for cxample by ccll phonc, cmail, landline. Remote center 106 can be in
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`communication with an emergency responder 108C, for example a 911 operator and/or
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`paramedic, with a communication system 107C, such as the Internet, an intranet, phonelines,
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`wireless and/or satellite phone. Emergency responder 108C can travel to the patient as indicated
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`by arrow 109C. Thus, in many embodiments, monitoring system 10 comprises a closed loop
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`system in which patient care can be monitored and implemented from the remote center in
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`response to signals from the adherent device.
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`[0048]
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`In many embodiments, the adherent device may continuously monitor physiological
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`parameters, communicate wirelessly with a remote center, and provide alerts when necessary.
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`The system may comprise an adherent patch, which attaches to the patient’s thorax and contains
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`sensing clectrodes, battery, memory, logic, and wireless communication capabilities.
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`In some
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`embodiments, the patch can communicate with the remote center, via the intermediate device in
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`the patient’s home.
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`In the many embodiments, the remote center receives the data and applies
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`the prediction algorithm. Whena flag is raised, the center may communicate with the patient,
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`hospital, nurse, and/or physician to allow for therapeutic intervention to prevent decompensation.
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`[0049]
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`The adherent device may be affixed and/or adhered to the body in many ways. For
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`example, with at least one of the following an adhesive tape, a constant-force spring, suspenders
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`around shoulders, a screw-in microneedle electrode, a pre-shaped electronics module to shape
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`fabric to a thorax, a pinch ontoroll of skin, or transcutancous anchoring. Patch and/or device
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`replacement may occur with a keyed patch (e.g. two-part patch), an outline or anatomical mark, a
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`low-adhesive guide (place guide | remove old patch | place new patch | remove guide), or a keyed
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`attachment for chatter reduction. The patch and/or device may comprise an adhesiveless
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`embodiment (¢.g. chest strap), and/or a low-irritation adhesive model for sensitive skin. The
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`adherent patch and/or device can comprise many shapes, for example at least one of a dogbone,
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`an hourglass, an oblong, a circular or an oval shape.
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`[0050]
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`In many embodiments, the adherent device may comprise a reusable electronics module
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`with replaceable patches (the module collects cumulative data for approximately 90 days) and/or
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`the entire adherent component (electronics + patch) may be disposable.
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`In a completely
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`disposable embodiment, a “baton” mechanism may be used fordata transfer and retention, for
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`example baton transfer may include baseline information.
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`In some embodiments, the device may
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`have a rechargeable module, and may use dual battery and/or electronics modules, wherein one
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`module 101A can be recharged using a charging station 103 while the other module 101B is
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`placed on the adherent device.
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`In some embodiments, the intermediate device 102 may comprise
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`the charging module, data transfer, storage and/or transmission, such that one of the electronics
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`modules can be placed in the intermediate device for charging and/or data transfer while the
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`other electronics module is worn by the patient.
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`(0051]
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`In many embodiments, the system can perform the following functions: initiation,
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`programming, measuring, storing, analyzing, communicating, predicting, and displaying. The
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`adherent device may contain a subset of the following physiological sensors: bioimpedance,
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`respiration, respiration rate variability, heart rate (average, minimum, maximum), heart rhythm,
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`HRV, HRT, heart sounds(e.g. S3), respiratory sounds, blood pressure, activity, posture,
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`wake/slecp, orthopnea, temperature/heat flux, and weight. The activity sensor may be onc of the
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`following: ball switch, accelerometer, minute venti