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`US 20090234410Al
`
`c19) United States
`c12) Patent Application Publication
`Libbus et al.
`
`c10) Pub. No.: US 2009/0234410 Al
`Sep. 17, 2009
`(43) Pub. Date:
`
`(54) HEART FAILURE DECOMPENSATION
`PREDICTION BASED ON CARDIAC
`RHYTHM
`
`(75)
`
`Inventors:
`
`Imad Libbus, Saint Paul, MN (US);
`Yatheendhar D. Manicka,
`Woodbury, MN (US); Badri
`Amurthur, Los Gatos, CA (US);
`Scott T. Mazar, Woodbury, MN
`(US)
`
`Correspondence Address:
`TOWNSEND AND TOWNSEND AND CREW,
`LLP
`TWO EMBARCADERO CENTER, EIGHTH
`FLOOR
`SAN FRANCISCO, CA 94111-3834 (US)
`
`(73) Assignee:
`
`Corventis, Inc., San Jose, CA (US)
`
`(21) Appl. No.:
`
`12/402,318
`
`(22) Filed:
`
`Mar. 11, 2009
`
`Related U.S. Application Data
`
`(60) Provisional application No. 61/035,970, filed on Mar.
`12, 2008.
`Publication Classification
`
`(51)
`
`Int. Cl.
`A61N 11365
`(2006.01)
`A61B 510464
`(2006.01)
`(52) U.S. Cl. ............ 607/17; 600/518; 600/515; 600/513
`ABSTRACT
`(57)
`
`Systems and methods of detecting an impending cardiac dec(cid:173)
`ompensation of a patient measure an electrocardiogram sig(cid:173)
`nal of the patient. An incidence of cardiac arrhythmias is
`determined from the electrocardiogram signal. A risk of
`impending decompensation is determined in response to the
`incidence of cardiac arrhythmias. In many embodiments, the
`impending decompensation can be detected early enough to
`avoid, or at least delay, the impending decompensation, such
`that patient trauma and/ or expensive I CU care can be avoided.
`Although embodiments make specific reference to monitor(cid:173)
`ing electrocardiogram and other physiological signals with an
`adherent patch, the system methods and devices are appli(cid:173)
`cable to many applications in which physiological monitor(cid:173)
`ing is used, for example wireless physiological monitoring
`with implanted sensors for extended periods.
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`Sep. 17,2009
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`HEART FAILURE DECOMPENSATION
`PREDICTION BASED ON CARDIAC
`RHYTHM
`
`CROSS-REFERENCES TO RELATED
`APPLICATIONS
`
`[0001] The present application claims the benefit under 35
`USC 119( e) of U.S. Provisional Application No. 61/035,970
`filed Mar. 12, 2008; the full disclosure of which is incorpo(cid:173)
`rated herein by reference in its entirety.
`
`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 embodi(cid:173)
`ments 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 implant(cid:173)
`able devices for extended periods.
`[0003] Patients are often treated for diseases and/or condi(cid:173)
`tions 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 be at least par(cid:173)
`tially effective, many patients are not sufficiently monitored
`and eventually succumb to cardiac decompensation or other
`heart failure. Decompensation is failure of the heart to main(cid:173)
`tain adequate blood circulation. Although the heart can main(cid:173)
`tain at least some pumping of blood, the quantity is inad(cid:173)
`equate to maintain healthy tissues. Several symptoms can
`result from decompensation including pulmonary conges(cid:173)
`tion, breathlessness, faintness, cardiac palpitation, edema of
`the extremities, and enlargement of the liver. Cardiac decom(cid:173)
`pensation can result in slow or sudden death. Sudden Cardiac
`Arrest (hereinafter "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 ventricu(cid:173)
`lar tachycardia and/or ventricular fibrillation. Although dec(cid:173)
`ompensation and SCA can be related in that patients with
`heart failure are also at an increased risk for SCA, decompen(cid:173)
`sation is primarily a mechanical dysfunction caused by inad(cid:173)
`equate blood flow, and SCA is primarily an electrical dys(cid:173)
`function caused by inadequate and/or inappropriate electrical
`signals of the heart.
`[0004] Patients who have cardiac decompensation may be
`incorrectly diagnosed initially in at least some instances, as
`the symptoms may make the patient appear to suffer from
`another ailment. For example, pulmonary congestion result(cid:173)
`ing from cardiac decompensation may appear as a lung dis(cid:173)
`order. 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 dec(cid:173)
`ompensation.
`[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 electrocardio(cid:173)
`graphy device. Although such a device may be effective in
`measuring electrocardiography, such measurements may not
`be sufficient to reliably detect and/or avoid an impending
`
`cardiac decompensation. In addition to measuring heart sig(cid:173)
`nals with electrocardiograms, known physiologic measure(cid:173)
`ments include impedance measurements. For example, tran(cid:173)
`sthoracic impedance measurements can be used to measure
`hydration and respiration. Although transthoracic measure(cid:173)
`ments can be useful, such measurements may use electrodes
`that are positioned across the midline of the patient, and may
`be somewhat uncomfortable and/or cumbersome for 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 comply(cid:173)
`ing with direction from the health care provider, such that data
`collected may be less than ideal. Although implantable
`devices may be used in some instances, many of these devices
`can be invasive and/or costly, and may suffer at least 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 moni(cid:173)
`toring 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 of the present
`methods and devices.
`
`BRIEF SUMMARY OF THE INVENTION
`
`[0007] Embodiments of the present invention provide sys(cid:173)
`tems and methods for the detection of an impending cardiac
`decompensation. Decompensation is a failure of the heart to
`maintain adequate blood circulation, such that may pulmo(cid:173)
`nary congestion. Therefore, determining the risk of impend(cid:173)
`ing decompensation can decrease trauma to the patient and
`may save the patient's life by allowing delivery of therapy in
`response to an elevated risk ofimpending decompensation. In
`many embodiments, the impending decompensation can be
`detected early enough to avoid, or at least delay, the impend(cid:173)
`ing decompensation, such that patient trauma and/or expen(cid:173)
`sive 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 electrocardio(cid:173)
`gram 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.
`In a first aspect, embodiments of the present inven(cid:173)
`[0008]
`tion provide a method of detecting an impending cardiac
`decompensation of a patient. An electrocardiogram signal of
`the patient is measured. An incidence of cardiac arrhythmias
`is determined from the electrocardiogram signal. A risk of
`impending decompensation is determined in response to the
`incidence of cardiac arrhythmias.
`In many embodiments, the electrocardiogram signal
`[0009]
`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 ear(cid:173)
`lier baseline incidence of cardiac arrhythmias for 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 arrhyth(cid:173)
`mias for a patient population to determine the risk of impend-
`
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`2
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`ing decompensation. The electrocardiogram signal may com(cid:173)
`prise 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 of a heart rate, a
`heart rate variability, a bioimpedance, an activity or a respi(cid:173)
`ration of the patient to determine the risk of impending dec(cid:173)
`ompensation. 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 combine the
`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 an atrial arrhyth(cid:173)
`mia that comprises at least one of a bradycardia, an atrial
`fibrillation, an atrial tachycardia, or an atrial flutter. The inci(cid:173)
`dence of cardiac arrhythmias may also be determined with a
`ventricular arrhythmia comprising at least one of a bradycar(cid:173)
`dia, a sustained ventricular tachycardia, a non-sustained ven(cid:173)
`tricular tachycardia or a premature ventricular contraction.
`[0011] The electrocardiogram signal can be measured in
`many ways. In specific embodiments, the electrocardiogram
`signal is measured with an adherent patch comprising elec(cid:173)
`trodes, the patch continuously adhered to the patient for at
`least one week. The electrocardiogram signal may be mea(cid:173)
`sured with electrodes injected and/or implanted into the
`patient.
`[0012]
`In many embodiments a therapy can be delivered to
`the patient in response to the risk of impending decompensa(cid:173)
`tion, for example cardiac rhythm management therapy.
`[0013]
`In many embodiments, the electrocardiogram signal
`is measured where the patient is located and the risk of
`impending decompensation is determined at a remote loca(cid:173)
`tion. 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 elec(cid:173)
`trocardiogram 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 ben(cid:173)
`efits 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 when the patch is adhered to the patient. The pro(cid:173)
`cessor 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 inter(cid:173)
`mediate 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 patient is 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 dec(cid:173)
`ompensation 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 deter(cid:173)
`mined with the processor supported by the patient in response
`to the instructions from the remote site.
`[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 dec(cid:173)
`ompensation of a patient. The system comprises circuitry to
`measure an electrocardiogram signal of the patient, and a
`processor system comprising a tangible medium in commu(cid:173)
`nication with the circuitry. The processor system is config(cid:173)
`ured to determine an incidence of cardiac arrhythmias from
`the electrocardiogram signal and determine a risk of impend(cid:173)
`ing decompensation in response to the incidence of cardiac
`arrhythmias.
`[0018]
`In many embodiments, the processor system is con(cid:173)
`figured to receive the electrocardiogram signal for at least one
`week and determine the risk of impending decompensation in
`response to the incidence of cardiac arrhythmias over the at
`least one week.
`[0019]
`In many embodiments, the processor system is con(cid:173)
`figured to compare the incidence of cardiac arrhythmias to an
`earlier incidence of cardiac arrhythmias and 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. The proces(cid:173)
`sor 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 determine the risk of impending decompensa(cid:173)
`tion.
`[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 con(cid:173)
`tinuously 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 con(cid:173)
`figured to determine the incidence of cardiac arrhythmias
`with an atrial arrhythmia comprising at least one of a brady(cid:173)
`cardia, 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 comprising at least one of a bradycardia, a sus(cid:173)
`tained 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.
`[0023]
`In many embodiments, the processor system com(cid:173)
`prises a local processor and a remote processor at a remote
`site. The local processor is 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 con(cid:173)
`figured to transmit the electrocardiogram signal to the remote
`site to determine the risk of impending decompensation.
`[0025]
`In some embodiments, the local processor is con(cid:173)
`figured to transmit the incidence of arrhythmias to the remote
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`site and the remote processor is configured to determine the
`risk of impending decompensation from the incidence of
`arrhythmias.
`[0026]
`In some embodiments, the local processor is con(cid:173)
`figured to determine the incidence of cardiac arrhythmias in
`response to the electrocardiogram signal. The remote proces(cid:173)
`sor is configured to determine the risk of impending decom(cid:173)
`pensation in response to the incidence of electrocardiogram
`signals determined with the local processor.
`[0027]
`In some embodiments, the remote processor is con(cid:173)
`figured to determine the incidence of cardiac arrhythmias of
`the patient in response to the electrocardiogram signal.
`[0028]
`In many embodiments, the processor system com(cid:173)
`prises a local processor connected to an adherent patch con(cid:173)
`figured to adhere to the skin of the patient, and the local
`processor is configured to determine the incidence of arrhyth(cid:173)
`mias from the electrocardiogram signal and determine the
`risk of impending decompensation in response to the inci(cid:173)
`dence of arrhythmias. The local processor may be configured
`to receive instructions transmitted from the remote site to
`configure the local processor to determine the risk ofimpend(cid:173)
`ing decompensation in response to the electrocardiogram
`signal.
`[0029]
`In many embodiments, the processor system is con(cid:173)
`figured to determine a flag status in response to the electro(cid:173)
`cardiogram 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 patient. A processor system comprises a tangible
`medium in communication with the circuitry, in which the
`processor system is configured to determine an incidence of
`cardiac arrhythmias from the electrocardiogram signal and
`determine a risk of impending decompensation in response to
`the incidence of cardiac arrhythmias.
`[0031]
`In another aspect, embodiments of the present
`invention provide a computer-readable storage medium com(cid:173)
`prising a set of instructions for a computer system to evaluate
`a risk of an impending cardiac decompensation of a patient.
`The set of instructions comprises an input routine, an output
`routine and a run 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 electrocardiogram data. The output routine is con(cid:173)
`figured to provide the risk of the impending decompensation
`available for external use outside the computer system.
`[0032]
`In many embodiments, the input routine, the run
`routine and the output routine are located on a server at a
`remote site.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0033] FIG. lA shows a patient and a monitoring system
`comprising an adherent device, according to embodiments of
`the present invention;
`[0034] FIG.1B shows a bottom view of the adherent device
`as in FIG. lA comprising an adherent patch;
`[0035] FIG. lC shows a top view of the adherent patch, as
`in FIG. lB;
`[0036] FIG. lD shows a printed circuit boards and elec(cid:173)
`tronic components over the adherent patch, as in FIG. lC;
`
`[0037] FIG. lD-1 shows an equivalent circuit that can be
`used to determine optimal frequencies for determining
`patient hydration, according to embodiments of the present
`invention;
`[0038] FIG. lE shows batteries positioned over the printed
`circuit board and electronic components as in FIG. lD;
`[0039] FIG. lF shows a top view of an electronics housing
`and a breathable cover over the batteries, electronic compo(cid:173)
`nents and printed circuit board as in FIG. lE;
`[0040] FIG. lG shows a side view of the adherent device as
`in FIGS. lA to lF;
`[0041] FIG. lH shown a bottom isometric view of the
`adherent device as in FIGS. lA to lG;
`[0042] FIG. 2A shows a method of predicting an impending
`cardiac decompensation, according to embodiments of the
`present invention; and
`[0043] FIG. 3A shows a simplified flow chart of a com(cid:173)
`puter-readable storage medium having a set of instructions
`that can be read by a computer system to detect an impending
`decompensation, according to embodiments of the present
`invention.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`[0044] Embodiments of the present invention provide sys(cid:173)
`tems and methods for the detection of an impending cardiac
`decompensation. Decompensation is a failure of the heart to
`maintain adequate blood circulation, such that pulmonary
`congestion results. Therefore, determining the risk of
`impending decompensation can save the patient's life by
`delivering therapy in response to an elevated risk of impend(cid:173)
`ing decompensation. In many embodiments, the impending
`decompensation can be detected early enough to avoid, or at
`least delay, the impending decompensation, such that patient
`trauma and/or expensive ICU care can be avoided. Embodi(cid:173)
`ments of the present invention can determine the risk of
`impending decompensation based on measurement of the
`electrocardiogram signal from the patient. Although embodi(cid:173)
`ments make specific reference to monitoring electrocardio(cid:173)
`gram and other physiological signals with an adherent patch,
`the system methods and device described herein may be
`applicable to many applications in which physiological moni(cid:173)
`toring is used, for example wireless physiological monitoring
`with implanted sensors for extended periods. In some
`embodiments, implanted sensors may be used, for example as
`described in U.S. Pat. Nos. 6,208,894; 6,315,721; 6,185,452;
`and U.S. Application No. 60/972,329, entitled "Injectable
`Device for Physiological Monitoring" (Attorney Docket No.
`00456-1004), filed on Sep. 14, 2007, with the same assignee
`as the present application; the full disclosures of which pat(cid:173)
`ents and applications are incorporated herein by reference.
`[0045] Decompensation encompasses failure of the heart to
`maintain adequate blood circulation, often resulting in pul(cid:173)
`monary congestion. 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 ventricu(cid:173)
`lar tachycardia and/or ventricular fibrillation. Although dec(cid:173)
`ompensation and SCA can be related in that patients with
`heart failure are also at an increased risk for SCA, decompen(cid:173)
`sation is primarily the result of mechanical dysfunction, and
`SCA is primarily an electrical dysfunction caused by inad(cid:173)
`equate and/or inappropriate electrical signals of the heart.
`[0046] FIG. lA shows a patient Panda monitoring system
`10. Patient P comprises a midline M, a first side Sl, for
`example a right side, and a second side S2, for example a left
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`side. Monitoring system 10 comprises an adherent device
`100. Adherent device 100 can be adhered to a patient P at
`many locations, for example thorax T of patient P. In many
`embodiments, the adherent device may adhere to one side of
`the patient, from which data from the one side can be col(cid:173)
`lected. Work in relation with embodiments of the present
`invention suggests that location on a side of the patient can
`provide comfort for the patient while the device is adhered to
`the patient.
`[0047] Monitoring system 10 includes components to
`transmit data to a remote center 106 at a location remote from
`the patient. The patient can be located in a first building and
`the remote center located at a second site in a second building,
`for example with both the first building and the second build(cid:173)
`ing located in the same town. The remote center and patient
`can be located much farther from each other, and the patient
`can be located on a first continent and the remote center
`located at a site on a second continent. Adherent device 100
`can communicate wirelessly to an intermediate device 102,
`for example with a single wireless hop from the adherent
`device on the patient to the intermediate device. Intermediate
`device 102 can communicate with remote center 106 in many
`ways. For example, intermediate device 102 may comprise a
`gateway device connected to the Internet. In many embodi(cid:173)
`ments, monitoring system 10 comprises a distributed process(cid:173)
`ing system with at least one processor on device 100, at least
`one processor 102P on intermediate device 102, and at least
`one processor 106P at remote center 106, each of which
`processors is in electronic communication with the other
`processors. At least one processor 102P comprises a tangible
`medium 102M, and at least one processor 106P comprises a
`tangible medium 106M. Remote center 106 can be in com(cid:173)
`munication with a health care provider 108A with a commu(cid:173)
`nication system 107 A, such as the Internet, an intranet, phone
`lines, wireless and/or satellite phone. Health care provider
`108A, for example a family member, can be in communica(cid:173)
`tion with patient P with a communication, for example with a
`two way communication system, as indicated by arrow 109A,
`for example by cell phone, email, landline. Remote center
`106 can be in communication with a health care professional,
`for example a physician 108B, with a communication system
`107B, such as the Internet, an intranet, phone lines, wireless
`and/or satellite phone. Physician 108B can be in communi(cid:173)
`cation with patient P with a communication, for example with
`a two way communication system, as indicated by arrow
`109B, for example by cell phone, email, landline. Remote
`center 106 can be in communication with an emergency
`responder 108C, for example a 911 operator and/or para(cid:173)
`medic, with a communication system 107C, such as the Inter(cid:173)
`net, an intranet, phone lines, wireless and/or satellite phone.
`Emergency responder 108C can travel to the patient as indi(cid:173)
`cated by arrow 109C. Thus, in many embodiments, monitor(cid:173)
`ing system 10 comprises a closed loop system in which
`patient care can be monitored and implemented from the
`remote center in response to signals from the adherent device.
`[0048]
`In many embodiments, the adherent device may
`continuously monitor physiological parameters, communi(cid:173)
`cate wirelessly with a remote center, and provide alerts when
`necessary. The system may comprise an adherent patch,
`which attaches to the patient's thorax and contains sensing
`electrodes, battery, memory, logic, and wireless communica(cid:173)
`tion capabilities. In some embodiments, the patch can com(cid:173)
`municate with the remote center, via the intermediate device
`in the patient's home. In the many embodiments, the remote
`
`center receives the data and applies the prediction algorithm.
`When a flag is raised, the center may communicate with the
`patient, hospital, nurse, and/or physician to allow for thera(cid:173)
`peutic intervention to prevent decompensation.
`[0049] The adherent device may be affixed and/or adhered
`to the body in many ways. For example, with at least one of
`the following an adhesive tape, a constant-force spring, sus(cid:173)
`penders around shoulders, a screw-in microneedle electrode,
`a pre-shaped electronics module to shape fabric to a thorax, a
`pinch onto roll of skin, or transcutaneous anchoring. Patch
`and/or device replacement may occur with a keyed patch ( e.g.
`two-part patch), an outline or anatomical mark, a low-adhe(cid:173)
`sive guide (place guide I remove old patch I place new patch
`I remove guide), or a keyed attachment for chatter reduction.
`The patch and/or device may comprise an adhesiveless
`embodiment ( e.g. chest strap), and/or a low-irritation adhe(cid:173)
`sive model for sensitive skin. The adherent patch and/or
`device can comprise many shapes, for example at least one of
`a dogbone, an hourglass, an oblong, a circular or an oval
`shape.
`[0050]
`In many embodiments, the adherent device may
`comprise a reusable electronics module with replaceable
`patches (the module collects cumulative data for approxi(cid:173)
`mately 90 days) and/or the entire adherent component ( elec(cid:173)
`tronics+patch) may be disposable. In a completely disposable
`embodiment, a "baton" mechanism may be used for data
`transfer and retention, for example baton transfer may include
`baseline information. In some embodiments, the device may
`have a rechargeable module, and may use dual battery and/or
`electronics modules, wherein one module 101A can be
`recharged using a charging station 103 while the other mod(cid:173)
`ule 101B is placed on the adherent device. In some embodi(cid:173)
`ments, the intermediate device 102 may comprise the charg(cid:173)
`ing module, data transfer, storage and/or transmission, such
`that one of the electronics modules can be placed in the
`intermediate device for charging and/or data transfer while
`the other electronics module is worn by the patient.
`[0051]
`In many embodiments, the system can perform the
`following functions: initiation, programming, measuring,
`storing, analyzing, communicating, predicting, and display(cid:173)
`ing. The adherent device may contain a subset of the follow(cid:173)
`ing physiological sensors: bioimpedance, respiration, respi(cid:173)
`ration rate variability, heart rate (average, minimum,
`maximum), heart rhythm, HRV, HRT, heart sounds ( e.g. S3),
`respiratory sounds, blood pressure, activity, posture, wake/
`sleep, orthopnea, temperature/heat flux, and weight. The
`activity sensor may be one of the following: ball switch,
`accelerometer, minute ventilation, HR, bioimpedance noise,
`skin temperature/heat flux, BP, muscle noise, posture.
`[0052]
`In many embodiments, the patch wirelessly com(cid:173)
`municates with a remote center. In some embodiments, the
`communication may occur directly (via a cellular or Wi-Fi
`network), or indirectly through intermediate device 102.
`Intermediate device 102 may consist of multiple devices
`which communicate wired or wirelessly to relay data to
`remote center 106.
`[0053] FIG. 1B shows a bottom view of adherent device
`100 as in FIG. lA comprising an adherent patch 110. Adher(cid:173)
`ent patch 110 comprises a first side, or a lower side HOA, that
`is oriented toward the skin of the patient when placed on the
`patient. In many embodiments, adherent patch 110 comprises
`a tape HOT which is a material, preferably breathable, with
`an adhesive 116A. Patie