Adherent device with multiple physiological sensors

• US 8,795,174 B2
• Filed: 08/29/2012
• Issued: 08/05/2014
• Est. Priority Date: 09/14/2007
• Status: Expired due to Fees

• Current Assignee: Medtronic Monitoring, Inc. (Medtronic Plc)
• Original Assignee: Corventis
• Inventors: Manicka, Yatheendhar D., Amurthur, Badri, Bly, Mark J., James, Kristofer J., Libbus, Imad, Mazar, Scott T., Wang, Jerry S.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): Sands, Davin K
• Application Number:
  US13/598,238
• Publication Number:
  US 20130085347A1
• Time in Patent Office: 706 Days
• Field of Search: None
• US Class Current: 600/301
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/02455 provided with high/low alarm devices
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/0806 by whole-body plethysmography measuring blood flow using plethysmography A61B5/0295; impedance plethysmography A61B5/053; measuring volume of the body or parts thereof A61B5/1073
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/30 : Input circuits therefor
• CPC Class Codes: A61B 5/349 : Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/361 : Detecting fibrillation
• CPC Class Codes: A61B 5/363 : Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/366 : Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/443 : Evaluating skin constituents, e.g. elastin, melanin, water
• CPC Class Codes: A61B 5/4869 : Determining body composition
• CPC Class Codes: A61B 5/4875 : Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/6801 : specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/746 : Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 7/00 : Instruments for auscultation
• CPC Class Codes: A61B 7/003 : Detecting lung or respiration noise
• CPC Class Codes: A61N 1/046 : Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/0476 : Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0492 : Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/36521 : the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36535 : controlled by body position or posture
• CPC Class Codes: A61N 1/36542 : controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36592 : controlled by the heart rate variability
• CPC Class Codes: G16H 15/00 : ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

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

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.

2. 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.

3. 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.

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

5. 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.

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

7. 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.

8. 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.

9. 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.

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

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

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.

20. 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.

21. 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.

22. 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.

23. 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.

24. 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.

25. 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.

26. 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.