# US 8,795,174 B2 · Adherent device with multiple physiological sensors

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- Number: US 8,795,174 B2
- Document ID: US8795174B2
- Status: Granted
- Kind: B2
- Application number: 13/598,238
- Filed: 2012-08-29
- Published: 2013-04-04
- Granted: 2014-08-05
- Earliest claimed: 2007-09-14
- Assignees: Corventis, Inc.
- Applicants: Yatheendhar D. Manicka; Badri Amurthur; Mark J. Bly; Kristofer J. James; Imad Libbus; Scott T. Mazar; Jerry S. Wang
- Inventors: Yatheendhar D. Manicka; Badri Amurthur; Mark J. Bly; Kristofer J. James; Imad Libbus; Scott T. Mazar; Jerry S. Wang
- Web page: https://patentgrep.com/patent/US8795174B2

## CPC

- G16H 40/63: for local operation
- A61B 5/0006: {ECG or EEG signals}
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/02055: {Simultaneously evaluating both cardiovascular condition and temperature}
- A61B 5/02405: {Determining heart rate variability}
- A61B 5/0535: Impedance plethysmography (for measuring blood flow A61B5/0295)
- A61B 5/0537: Measuring body composition by impedance, e.g. tissue hydration or fat content
- A61B 5/0806: {by whole-body plethysmography}
- A61B 5/086: {by impedance pneumography}
- A61B 5/11: Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb {(A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721)}
- A61B 5/1118: {Determining activity level}
- A61B 5/282: Holders for multiple electrodes (for introduction into the body A61B5/287)
- A61B 5/308: for electrocardiography [ECG]
- A61B 5/361: Detecting fibrillation
- A61B 5/363: Detecting tachycardia or bradycardia
- A61B 5/366: Detecting abnormal QRS complex, e.g. widening
- A61B 5/443: {Evaluating skin constituents, e.g. elastin, melanin, water}
- A61B 5/4869: {Determining body composition}
- A61B 5/4875: {Hydration status, fluid retention of the body}
- A61B 5/6801: {specially adapted to be attached to or worn on the body surface}
- A61B 5/6833: {Adhesive patches}
- A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61B 7/00: Instruments for auscultation
- A61N 1/046: {Specially adapted for shock therapy, e.g. defibrillation}
- A61N 1/0476: {Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)}
- A61N 1/0492: {Patch electrodes (A61N1/0412, A61N1/0428 take precedence)}
- G16H 50/30: for calculating health indices; for individual health risk assessment
- G16Z 99/00: Subject matter not provided for in other main groups of this subclass
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/02438: {with portable devices, e.g. worn by the patient}
- A61B 5/02455: {provided with high/low alarm devices}
- A61B 5/053: Measuring electrical impedance or conductance of a portion of the body
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 5/1116: {Determining posture transitions}
- A61B 7/003: {Detecting lung or respiration noise}
- A61B 2560/0412: Low-profile patch shaped housings
- A61B 2562/0215: Silver or silver chloride containing
- A61N 1/36521: {the parameter being derived from measurement of an electrical impedance}
- A61N 1/36535: {controlled by body position or posture}
- A61N 1/36542: {controlled by body motion, e.g. acceleration}
- A61N 1/36592: {controlled by the heart rate variability}
- G16H 15/00: ICT specially adapted for medical reports, e.g. generation or transmission thereof
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR

## Abstract

An adherent device to monitor a patient comprises an adhesive patch to adhere to a skin of the patient. At least four electrodes are connected to the patch and capable of electrically coupling to the patient. Impedance circuitry is coupled to the at least four electrodes to measure a hydration signal of the patient. Electrocardiogram circuitry is coupled to at least two of the at least four electrodes to measure an electrocardiogram signal of the patient. An accelerometer can be mechanically coupled to the adhesive patch to generate a signal in response to at least one of an activity or a position of the patient.

## Claims

### Claim 1

An adherent device to monitor a patient, the device comprising:
an adhesive patch configured to adhere to the skin of the patient continuously for at least seven days;
at least two electrodes connected to the patch and configured to electrically couple to the patient;
a processor system coupled to the at least two electrodes and configured to monitor a physiologic signal of the patient using the electrodes, wherein the physiologic signal includes an impedance signal related to the hydration of tissue of the patient and wherein the processor is further configured to, based at least in part on the impedance signal measured from the patient, detect an impending cardiac decompensation of the patient; and
wireless communications circuitry coupled to the processor, wherein the processor is further configured to communicate an alert via the wireless communications circuitry to a remote receiver in response to the detection of the impending cardiac decompensation.

### Claim 2 (depends on 1)

The adherent device of claim 1, wherein the processor is further configured to transmit data describing the physiologic signal via the wireless communications circuitry to the remote receiver.

### Claim 3 (depends on 1)

The adherent device of claim 1, wherein:
the physiologic signal is a first physiologic signal;
the processor system is further configured to monitor a second physiologic signal of the patient; and
the alert is based on a combination of the first and second physiologic signals.

### Claim 4 (depends on 3)

The adherent device of claim 3, wherein the second physiologic signal is monitored using the electrodes.

### Claim 5 (depends on 3)

The adherent device of claim 3, wherein the adherent device comprises a microphone, and the second physiologic signal is an audio signal from within the patient detected using the microphone.

### Claim 6 (depends on 5)

The adherent device of claim 5, wherein the audio signal includes an S3 heart sound.

### Claim 7 (depends on 1)

The adherent device of claim 1, wherein the processor system is further configured to, based at least in part on the physiologic signal measured from the patient:
calculate a risk of sudden cardiac death of the patient; and
transmit to the remote receiver via the wireless communications circuitry a report of the risk of sudden cardiac death.

### Claim 8 (depends on 7)

The adherent device of claim 7, wherein:
the processor is further configured to monitor an electrocardiogram (ECG) signal; and
the risk of sudden cardiac death is calculated based at least in part on an analysis of the ECG signal performed by the processor system.

### Claim 9 (depends on 8)

The adherent device of claim 8, wherein the risk of sudden cardiac death is calculated based on recognition by the processor system that the ECG signal indicates one or more conditions selected from the group consisting of pulsus alternans, T-wave alternans, and autonomic imbalance.

### Claim 10 (depends on 8)

The adherent device of claim 8, wherein the processor is further configured to continuously monitor a bradycardia of the patient.

### Claim 11 (depends on 8)

The adherent device of claim 8, wherein the processor is further configured to recognize that the ECG signal indicates one or more conditions selected from the group consisting of Brugada syndrome with an ST elevation and a short QT interval, and long-QT interval.

### Claim 12 (depends on 1)

The adherent device of claim 1, wherein the remote receiver is one of a plurality of remote receivers, and the processor system is configured to select the remote receiver from the plurality of remote receivers based at least in part on the severity of a detected cardiac event.

### Claim 13 (depends on 12)

The adherent device of claim 12, wherein the processor system is configured to:
alert an emergency responder in response to the detection of an event that is immediately life threatening;
alert a physician in response to the detection of an event that indicates a need for medical care but is not immediately life threatening; and
alert a family member of the patient or another caregiver in response to the detection of at least one kind of event that is not immediately life threatening and does not indicate a need for medical care.

### Claim 14 (depends on 13)

The adherent device of claim 13, wherein the processor system is further configured to alert a monitoring facility in response to the detection of at least one kind of event.

### Claim 15 (depends on 1)

The adherent device of claim 1, wherein:
the processor is configured to monitor an electrocardiogram (ECG) signal;
the processor is configured to monitor a respiration signal; and
the processor system is configured to analyze the ECG signal and the respiration signal and to transmit an alert of a life threatening cardiac event upon the detection of an arrhythmia with no respiration.

### Claim 16 (depends on 1)

The adherent device of claim 1, wherein:
the processor is configured to monitor an electrocardiogram (ECG) signal;
the adherent device further comprises a patient activity sensor that produces a patient activity signal; and
the processor system is configured to analyze the ECG signal and the patient activity signal and to transmit an alert of a life threatening cardiac event upon the detection of an arrhythmia with no patient activity.

### Claim 17 (depends on 1)

The adherent device of claim 1, wherein:
the processor is configured to monitor an electrocardiogram (ECG) signal;
the processor system is configured to analyze the ECG signal and to transmit an alert of a life threatening cardiac event upon the detection of one or more events selected from the group consisting of a sustained ventricular tachycardia, a sustained ventricular fibrillation, and an asystole.

### Claim 18 (depends on 3)

The adherent device of claim 3, wherein the second physiologic signal is selected from the group consisting of an electrocardiogram signal of the patient, a respiration signal of the patient, and an activity signal of the patient.

### Claim 19

A method of monitoring a patient, the method comprising:
adhering an adherent device to the skin of the patient, the adherent device comprising an adhesive patch, at least two electrodes that contact the skin of the patient when the adherent device is adhered to the skin of the patient, a processor system, and wireless communications circuitry;
monitoring, using the processor system, a physiologic signal of the patient, the physiologic signal being measured using the at least two electrodes, the physiological signal comprising an impedance signal related to the hydration of tissue of the patient;
detecting, using the processor system, an impending cardiac decompensation of the patient based at least in part on the impedance signal; and
communicating an alert via the wireless communications circuitry to a remote receiver in response to the detection of the impending cardiac decompensation.

### Claim 20 (depends on 19)

The method of claim 19, wherein the adherent device further comprises a microphone, and the method further comprises monitoring an audio signal from within the patient detected using the microphone;
and wherein detecting the impending cardiac decompensation of the patient comprises detecting the impending cardiac decompensation based at least in part on a combination of the impedance signal and the audio signal.

### Claim 21 (depends on 20)

The method of claim 20, wherein the impending cardiac decompensation is detected based at least in part on the recognition of an S3 heart sound in the audio signal.

### Claim 22 (depends on 19)

The method of claim 19, further comprising:
calculating, using the processor, based at least in part on the physiologic signal, a risk of sudden cardiac death of the patient; and
transmitting to the remote receiver via the wireless communications circuitry a report of the risk of sudden cardiac death.

### Claim 23 (depends on 22)

The method of claim 22, wherein the method further comprises:
monitoring, using the processor system, an electrocardiogram (ECG) signal;
recognizing, by the processor, in the ECG signal, an indication of at least one condition selected from the group consisting of pulsus alternans, T-wave alternans, and autonomic imbalance; and
calculating the risk of sudden cardiac death based at least in part on the at least one condition.

### Claim 24 (depends on 22)

The method of claim 22, wherein the method further comprises:
monitoring, using the processor system, an electrocardiogram (ECG) signal; and
recognizing, by the processor, that the ECG signal indicates one or more conditions selected from the group consisting of Brugada syndrome with an ST elevation and a short QT interval, and long-QT interval.

### Claim 25 (depends on 19)

The method of claim 19, further comprising selecting the remote receiver from a plurality of remote receivers according to a tiered response scheme that includes:
alerting an emergency responder in response to the detection of a cardiac event that is immediately life threatening;
alerting a physician in response to the detection of a cardiac event that indicates a need for medical care but is not immediately life threatening; and
alerting a family member of the patient or another caregiver in response to the detection of at least one kind of event that is not immediately life threatening and does not indicate a need for medical care.

### Claim 26 (depends on 19)

The method of claim 19, wherein the method further comprises monitoring, by the processor system, an electrocardiogram (ECG) signal, and wherein detecting the impending cardiac decompensation of the patient comprises detecting the impending cardiac decompensation based at least in part on the combination of the physiologic signal and the electrocardiogram signal.
