Wearable ambulatory medical device with multiple sensing electrodes

• US 9,462,974 B2
• Filed: 10/28/2015
• Issued: 10/11/2016
• 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 S., Macho, John D.
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US14/925,221
• Publication Number:
  US 20160045156A1
• Time in Patent Office: 349 Days
• Field of Search: 607/5, 600509-510
• US Class Current: 1/1
• 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 sensing electrodes configured to be disposed at spaced apart positions about a body of a patient;

one or more therapy electrodes configured to be disposed about the body of the 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 sensing electrode of the plurality of sensing electrodes, the electrode signal acquisition circuit being configured to sense a respective signal provided by each of a plurality of different pairings of the plurality of sensing electrodes; and

a monitoring and detection circuit, electrically coupled to an output of the electrode signal acquisition circuit, the monitoring and detection circuit including at least one processor configured to analyze the respective signal provided by each of the plurality of different pairings, instruct the electrode signal acquisition circuit to select at least one of the plurality of different pairings to monitor based upon at least a quality of the respective signal provided by the selected at least one of the plurality of different pairings, analyze the respective signal provided by the selected at least one of the plurality of different pairings, and initiate a therapy to the patient via the one or more therapy electrodes on the basis of the analysis.

2. The ambulatory medical device of claim 1, wherein the at least one processor is further configured to instruct the electrode signal acquisition circuit to select the at least one of the plurality of different pairings to monitor based upon at least one of 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 sensing 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 sensing electrodes of the selected at least one of the plurality of different pairings, and a cardiac cycle of a heart of the patient.

3. The ambulatory medical device of claim 1, wherein the at least one processor is configured to instruct the electrode signal acquisition circuit to select a different at least one of the plurality of different pairings to monitor in response to a detected event.

4. The ambulatory medical device of claim 3, wherein the detected event is strenuous physical activity of the patient.

5. The ambulatory medical device of claim 3, wherein the detected event is movement of the patient.

6. The ambulatory medical device of claim 3, wherein the detected event is expiration of a predetermined time interval.

7. The ambulatory medical device of claim 3, wherein the detected event is a cardiac arrhythmia.

8. The ambulatory medical device of claim 3, wherein the detected event is noise in the selected at least one of the plurality of different pairings.

9. The ambulatory medical device of claim 3, wherein the detected event is fall-off of at least one sensing electrode of the selected at least one of the plurality of different pairings.

10. The ambulatory medical device of claim 3, further comprising a garment that is configured to be worn about the body of the patient, wherein the plurality of sensing electrodes are attached to the garment, and wherein the detected event is re-positioning of the garment.

11. 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 sensing electrodes are formed from electrically conductive threads sewn into the garment.

12. The ambulatory medical device of claim 11, wherein at least one of the electrode signal acquisition circuit and the monitoring and detection circuit are integrated into the garment.

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

14. The ambulatory medical device of claim 13, wherein the plurality of ECG sensing electrodes are wireless ECG sensing electrodes.

15. The ambulatory medical device of claim 13, wherein the plurality of ECG sensing electrodes includes at least 3 ECG sensing electrodes.

16. The ambulatory medical device of claim 13, wherein the plurality of ECG sensing electrodes includes at least 4 ECG sensing electrodes.

17. The ambulatory medical device of claim 13, wherein the plurality of ECG sensing electrodes are adhesive ECG sensing electrodes.

18. 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 sensing electrodes; and

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

19. The ambulatory medical device of claim 1, 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 sensing 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 at least one processor is configured to receive a first digital signal corresponding to a first sensing electrode of the plurality of sensing electrodes and a second digital signal corresponding to a second sensing electrode of the plurality of sensing 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 sensing electrode and the second sensing electrode.