Wearable ambulatory medical device with multiple sensing electrodes

• US 8,706,215 B2
• Filed: 05/17/2011
• Issued: 04/22/2014
• Est. Priority Date: 05/18/2010
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Kaib, Thomas E., Volpe, Shane, Macho, John D.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US13/109,382
• Publication Number:
  US 20110288605A1
• Time in Patent Office: 1,071 Days
• Field of Search: None
• US Class Current: 607/5
• CPC Class Codes: A61B 2562/04 Arrangements of multiple sensors of the same type
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• 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 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• 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 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/35 by template matching
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6804 Garments; Clothes
• CPC Class Codes: A61B 5/6805 Vests
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts
• CPC Class Codes: A61B 5/7221 : Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61N 1/046 : Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/0484 : Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/3904 : External heart defibrillators [EHD]
• CPC Class Codes: A61N 1/3987 : characterised by the timing or triggering of the shock

Abstract

An ambulatory medical device including a plurality of electrodes configured to be disposed at spaced apart positions about a patient'"'"'s body, an electrode signal acquisition circuit, and a monitoring circuit. The acquisition circuit has a plurality of inputs each electrically coupled to a respective electrode of the plurality of electrodes and is configured to sense a respective signal provided by a plurality of different pairings of the plurality of electrodes. The monitoring circuit is electrically coupled to an output of the acquisition circuit and is configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the acquisition circuit to select at least one of the plurality of different pairings to monitor based on at least one of the quality of the respective signal, a phase difference between the respective signal and that of other pairings, a position of electrodes relative to the patient'"'"'s body, and other criteria.

Claims

1. An ambulatory medical device, comprising:

a plurality of electrodes configured to be disposed at spaced apart positions about a body of a patient;

an electrode signal acquisition circuit having a plurality of inputs, each respective input of the plurality of inputs being electrically coupled to a respective electrode of the plurality of electrodes, the electrode signal acquisition circuit being configured to sense a respective signal provided by a plurality of different pairings of the plurality of electrodes; and

a monitoring circuit, electrically coupled to an output of the electrode signal acquisition circuit, the monitoring circuit being configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select at least one of the plurality of different pairings to monitor based upon a quality of the respective signal provided by the selected at least one of the plurality of different pairings and a phase difference between the respective signal provided by the selected at least one of the plurality of different pairings and the respective signal provided by another selected at least one of the plurality of different pairings.

2. The ambulatory medical device of claim 1, further comprising a garment that is configured to be worn about the body of the patient, wherein the plurality of electrodes are integrated into the garment.

3. The ambulatory medical device of claim 2, wherein the plurality of electrodes are ECG sensing electrodes, and wherein the monitoring circuit is a cardiac monitoring and arrhythmia detection circuit.

4. The ambulatory medical device of claim 3, wherein the plurality of ECG sensing electrodes includes at least three ECG sensing electrodes.

5. The ambulatory medical device of claim 4, wherein the plurality of ECG sensing electrodes are not all located in a common plane.

6. The ambulatory medical device of claim 3, further comprising:

a plurality of therapy electrodes integrated into the garment and configured to deliver a defibrillating shock to the body of the patient in response to detection of a treatable cardiac arrhythmia by the cardiac monitoring and arrhythmia detection circuit.

7. The ambulatory medical device of claim 1, wherein the monitoring circuit is configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select at least three of the plurality of different pairings to monitor based upon the quality of the respective signal provided by each of the selected at least three of the plurality of different pairings, the phase difference between the respective signal provided by each of the selected at least three of the plurality of different pairings, and the position of the respective electrodes of the selected at least three of the plurality of different pairings relative to the body of the patient.

8. The ambulatory medical device of claim 1, further comprising a garment that is configured to be worn about the body of the patient, wherein the plurality of electrodes are integrated into the garment, and wherein the plurality of electrodes includes at least four ECG sensing electrode that are not all located in a common plane.

9. The ambulatory medical device of claim 1, wherein the monitoring circuit is configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select at least three of the plurality of different pairings to monitor based upon the quality of the respective signal provided by the selected at least one of the plurality of different pairings, the phase difference between the respective signal provided by each of the selected at least three of the plurality of different pairings, and the plane defined by the respective electrodes of the selected at least three of the plurality of different pairings.

10. The ambulatory medical device of claim 1, wherein the monitoring circuit is configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select at least three of the plurality of different pairings to monitor based upon the quality of the respective signal provided by the selected at least one of the plurality of different pairings, the phase difference between the respective signal provided by each of the selected at least three of the plurality of different pairings, and the position of the respective electrodes of the selected at least three of the plurality of different pairings relative to the body of the patient and the cardiac cycle of the heart of the patient.

11. The ambulatory medical device of claim 1, wherein the monitoring circuit is configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select at least three of the plurality of different pairings to monitor based upon the quality of the respective signal provided by each of the selected at least three of the plurality of different pairings, the phase difference between the respective signal provided by each of the selected at least three of the plurality of different pairings, and at least one of the position of the respective electrodes of the selected at three of the plurality of different pairings relative to the body of the patient, the plane defined by the respective electrodes of the selected at least three of the plurality of different pairings, and the cardiac cycle of the heart of the patient.

12. The ambulatory medical device of claim 11, wherein the monitoring circuit is configured to instruct the electrode signal acquisition circuit to select at least two of the selected at least three of the plurality of different pairings to monitor during a first time interval and to select a different at least two of the selected at least three of the plurality of different pairings to monitor during a second time interval.

13. The ambulatory medical device of claim 1, wherein the plurality of electrodes are ECG sensing electrodes, and wherein the monitoring circuit is a cardiac monitoring and arrhythmia detection circuit.

14. The ambulatory medical device of claim 13, wherein the plurality of ECG sensing electrodes includes at least three ECG sensing electrodes.

15. The ambulatory medical device of claim 1, wherein the electrode signal acquisition circuit includes:

a plurality of differential amplifiers each having a pair of inputs and an output, the plurality of differential amplifiers including a respective differential amplifier for each unique pairing of the plurality of electrodes; and

a selection circuit configured to select at least one output of the plurality of differential amplifiers to provide to the monitoring circuit.

16. An ambulatory medical device, comprising:

a plurality of electrodes configured to be disposed at spaced apart positions about a body of a patient;

an electrode signal acquisition circuit having a plurality of inputs, each respective input of the plurality of inputs being electrically coupled to a respective electrode of the plurality of electrodes, the electrode signal acquisition circuit being configured to sense a respective signal provided by a plurality of different pairings of the plurality of electrodes; and

a monitoring circuit, electrically coupled to an output of the electrode signal acquisition circuit, the monitoring circuit being configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select at least one of the plurality of different pairings to monitor based upon a quality of the respective signal provided by the selected at least one of the plurality of different pairings and a plane defined by the respective electrodes of the selected at least one of the plurality of different pairings.

17. An ambulatory medical device, comprising:

a plurality of electrodes configured to be disposed at spaced apart positions about a body of a patient;

an electrode signal acquisition circuit having a plurality of inputs, each respective input of the plurality of inputs being electrically coupled to a respective electrode of the plurality of electrodes, the electrode signal acquisition circuit being configured to sense a respective signal provided by a plurality of different pairings of the plurality of electrodes; and

a monitoring circuit, electrically coupled to an output of the electrode signal acquisition circuit, the monitoring circuit being configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select at least one of the plurality of different pairings to monitor based upon a position of the respective electrodes of the selected at least one of the plurality of different pairings relative to the body of the patient and a cardiac cycle of the heart of the patient.

18. An ambulatory medical device, comprising:

a plurality of electrodes configured to be disposed at spaced apart positions about a body of a patient;

an electrode signal acquisition circuit having a plurality of inputs, each respective input of the plurality of inputs being electrically coupled to a respective electrode of the plurality of electrodes, the electrode signal acquisition circuit being configured to sense a respective signal provided by a plurality of different pairings of the plurality of electrodes; and

a monitoring circuit, electrically coupled to an output of the electrode signal acquisition circuit, the monitoring circuit being configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select at least one of the plurality of different pairings to monitor based upon at least one of a quality of the respective signal provided by the selected at least one of the plurality of different pairings, a phase difference between the respective signal provided by the selected at least one of the plurality of different pairings and the respective signal provided by another selected at least one of the plurality of different pairings, a position of the respective electrodes of the selected at least one of the plurality of different pairings relative to the body of the patient, a plane defined by the respective electrodes of the selected at least one of the plurality of different pairings, and a cardiac cycle of a heart of the patient;

wherein the electrode signal acquisition circuit includes a selection circuit having a plurality of inputs and a plurality of outputs, each respective input of the plurality of inputs of the selection circuit being electrically coupled to a respective one of the plurality of electrodes, and a plurality of differential amplifiers, each respective differential amplifier having a pair of inputs and an output, each respective input of the pair of inputs being electrically coupled to a respective one of the plurality of outputs of the selection circuit, each respective output of the plurality of differential amplifiers providing an output signal corresponding to a difference between the pair of inputs of the respective differential amplifier.

19. An ambulatory medical device, comprising:

a plurality of electrodes configured to be disposed at spaced apart positions about a body of a patient;

an electrode signal acquisition circuit having a plurality of inputs, each respective input of the plurality of inputs being electrically coupled to a respective electrode of the plurality of electrodes, the electrode signal acquisition circuit being configured to sense a respective signal provided by a plurality of different pairings of the plurality of electrodes; and

a monitoring circuit, electrically coupled to an output of the electrode signal acquisition circuit, the monitoring circuit being configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select at least one of the plurality of different pairings to monitor based upon at least one of a quality of the respective signal provided by the selected at least one of the plurality of different pairings, a phase difference between the respective signal provided by the selected at least one of the plurality of different pairings and the respective signal provided by another selected at least one of the plurality of different pairings, a position of the respective electrodes of the selected at least one of the plurality of different pairings relative to the body of the patient, a plane defined by the respective electrodes of the selected at least one of the plurality of different pairings, and a cardiac cycle of a heart of the patient;

wherein the electrode signal acquisition circuit includes an analog multiplexor having a plurality of inputs and an output, each of the plurality of inputs being electrically coupled to a respective one of the plurality of electrodes, and an analog-to-digital converter having an input electrically coupled to the output of the analog multiplexer.

20. The ambulatory medical device of claim 19, wherein the analog-to digital converter has a sampling rate that is at least N times a desired sampling rate of a signal provided by each of the plurality of electrodes, where N is the number of the plurality of electrodes that are to be monitored.

21. The ambulatory medical device of claim 19, wherein the monitoring circuit includes at least one processor configured to receive a first digital signal corresponding to a first electrode of the plurality of electrodes and a second digital signal corresponding to a second electrode of the plurality of electrodes, to invert one of the first and second digital signals and sum the inverted one of the first and second digital signals with the other of the first and second digital signals to analyze the respective signal provided by a pairing of the first electrode and the second electrode.

22. An ambulatory medical device, comprising:

a plurality of electrodes configured to be disposed at spaced apart positions about a body of a patient;

an electrode signal acquisition circuit having a plurality of inputs, each respective input of the plurality of inputs being electrically coupled to a respective electrode of the plurality of electrodes, the electrode signal acquisition circuit being configured to sense a respective signal provided by a plurality of different pairings of the plurality of electrodes; and

a monitoring circuit, electrically coupled to an output of the electrode signal acquisition circuit, the monitoring circuit being configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select at least one of the plurality of different pairings to monitor based upon at least one of a quality of the respective signal provided by the selected at least one of the plurality of different pairings, a phase difference between the respective signal provided by the selected at least one of the plurality of different pairings and the respective signal provided by another selected at least one of the plurality of different pairings, a position of the respective electrodes of the selected at least one of the plurality of different pairings relative to the body of the patient, a plane defined by the respective electrodes of the selected at least one of the plurality of different pairings, and a cardiac cycle of a heart of the patient;

wherein the electrode signal acquisition circuit includes a plurality of analog-to-digital converters, each respective analog-to-digital converter having a respective input that is electrically coupled to a respective one of the plurality of electrodes.

23. The ambulatory medical device of claim 22, wherein each of the plurality of analog-to-digital converters is connected to another of the plurality of analog-to-digital converters by a serial bus.

24. A method of monitoring ECG signals, the method comprising acts of:

selecting, from among a plurality of ECG sensors, a plurality of different pairings of ECG sensors;

analyzing a respective ECG signal provided by each of the plurality of different pairings;

identifying at least one of the plurality of different pairings to monitor based upon at least one of a quality of the respective ECG signal provided by the identified at least one of the plurality of different pairings, a phase difference between the respective ECG signal provided by the identified at least one of the plurality of different pairings and the respective ECG signal provided by another identified at least one of the plurality of different pairings, a position of respective ECG sensors of the identified at least one of the plurality of different pairings relative to a body of a patient, a plane defined by the respective ECG sensors of the identified at least one of the plurality of different pairings, and a cardiac cycle of a heart of the patient; and

monitoring the identified at least one of the plurality of different pairings;

wherein the act of identifying at least one of the plurality of different pairings to monitor is based upon the quality of the respective ECG signal provided by the identified at least one of the plurality of different pairings and the phase difference between the respective ECG signal provided by the identified at least one of the plurality of different pairings and the respective ECG signal provided by the other identified at least one of the plurality of different pairings.

25. The method of claim 24, wherein the act of selecting the plurality of different pairings of ECG sensors from among the plurality of ECG sensors includes an act of selecting, from among the plurality of ECG sensors, each unique pairing of ECG sensors;

and wherein the act of analyzing the respective ECG signal provided by each of the plurality of different pairings includes analyzing the respective ECG signal provided by each unique pairing of ECG sensors.

26. The method of claim 25, wherein the act of monitoring includes:

monitoring the identified at least one of the plurality of different pairings to detect a cardiac arrhythmia.

27. The method of claim 26, further comprising acts of:

detecting the cardiac arrhythmia responsive to the act of monitoring;

determining that the detected cardiac arrhythmia is a type of cardiac arrhythmia that can be treated by applying defibrillation to the body of the patient; and

applying at least one defibrillation pulse to the body of the patient.

28. The method of claim 26, further comprising acts of:

detecting the cardiac arrhythmia responsive to the act of monitoring;

selecting at least one additional pairing of ECG sensors in response to detecting the cardiac arrhythmia and analyzing the respective ECG signal provided by the at least one additional pairing;

determining that the detected cardiac arrhythmia is also present on the respective ECG signal of the at least one additional pairing;

determining that the detected cardiac arrhythmia is a type of cardiac arrhythmia that can be treated by applying defibrillation to the body of the patient; and

applying at least one defibrillation pulse to the body of the patient.

29. The method of claim 26, further comprising acts of:

detecting the cardiac arrhythmia responsive to the act of monitoring;

selecting at least one additional pairing of ECG sensors in response to detecting the cardiac arrhythmia and analyzing the respective ECG signal provided by the at least one additional pairing;

determining that the detected cardiac arrhythmia is also present on the respective ECG signal of the at least one additional pairing; and

increasing a confidence level that the cardiac arrhythmia has been detected.

30. The method of claim 26, further comprising acts of:

detecting the cardiac arrhythmia responsive to the act of monitoring;

selecting at least one additional pairing of ECG sensors in response to detecting the cardiac arrhythmia and analyzing the respective ECG signal provided by the at least one additional pairing;

determining that the detected cardiac arrhythmia is not present on the respective ECG signal of the at least one additional pairing; and

decreasing a confidence level that the cardiac arrhythmia has been detected.

31. The method of claim 24, wherein the acts of selecting, analyzing, and identifying are repeated at periodic intervals.

32. The method of claim 24, wherein the plurality of ECG sensors are integrated in a garment that is worn about the body of the patient, and wherein the acts of selecting, analyzing, and identifying are performed each time the garment is placed about the body of the patient.

33. The method of claim 24, wherein the plurality of ECG sensors are integrated in a garment that is worn about the body of the patient, the method further comprising an act of:

detecting strenuous physical activity of the patient; and

repeating the acts of selecting, analyzing, and identifying in response to the act of detecting the strenuous activity of the patient.

34. The method of claim 24, further comprising acts of:

determining that the quality of the respective ECG signal provided by a first pairing of ECG sensors of the identified at least one of the plurality of different pairings is below a determined threshold;

selecting another paring of ECG sensors to replace the first pairing of ECG sensors; and

monitoring the other pairing of ECG sensors.

35. The method of claim 24, further comprising acts of:

determining, from the quality of the respective ECG signal provided by a first pairing of ECG sensors of the identified at least one of the plurality of different pairings, that one or more of the ECG sensors of the first pairing may have at least partially lost contact with the body of the patient;

selecting another paring of ECG sensors to replace the first pairing of ECG sensors; and

monitoring the other pairing of ECG sensors.

36. A method of monitoring ECG signals, the method comprising acts of:

selecting, from among a plurality of ECG sensors, a plurality of different pairings of ECG sensors;

analyzing a respective ECG signal provided by each of the plurality of different pairings;

identifying at least one of the plurality of different pairings to monitor based upon at least one of a quality of the respective ECG signal provided by the identified at least one of the plurality of different pairings, and a phase difference between the respective ECG signal provided by the identified at least one of the plurality of different pairings and the respective ECG signal provided by another identified at least one of the plurality of different pairings, a position of respective ECG sensors of the identified at least one of the plurality of different pairings relative to a body of a patient, a plane defined by the respective ECG sensors of the identified at least one of the plurality of different pairings, and a cardiac cycle of a heart of the patient; and

monitoring the identified at least one of the plurality of different pairings;

wherein the act of identifying at least one of the plurality of different pairings to monitor is based upon the quality of the respective ECG signal provided by the identified at least one of the plurality of different pairings and the plane defined by the respective ECG sensors of the identified at least one of the plurality of different pairings.

37. A method of monitoring ECG signals, the method comprising acts of:

selecting, from among a plurality of ECG sensors, a plurality of different pairings of ECG sensors;

analyzing a respective ECG signal provided by each of the plurality of different pairings;

identifying at least one of the plurality of different pairings to monitor based upon at least one of a quality of the respective ECG signal provided by the identified at least one of the plurality of different pairings, and a phase difference between the respective ECG signal provided by the identified at least one of the plurality of different pairings and the respective ECG signal provided by another identified at least one of the plurality of different pairings, a position of respective ECG sensors of the identified at least one of the plurality of different pairings relative to a body of a patient, a plane defined by the respective ECG sensors of the identified at least one of the plurality of different pairings, and a cardiac cycle of a heart of the patient; and

monitoring the identified at least one of the plurality of different pairings;

wherein the act of identifying at least one of the plurality of different pairings to monitor is based upon the position of respective ECG sensors of the identified at least one of the plurality of different pairings relative to the body of the patient and the cardiac cycle of the heart of the patient.