Methods and systems for managing fusion and noise in cardiac pacing response classification

• US 8,831,727 B2
• Filed: 09/14/2012
• Issued: 09/09/2014
• Est. Priority Date: 04/28/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Stalsberg, Kevin John, Dong, Yanting, Meyer, Scott A., Voegele, John Michael, Bohn, Derek Daniel, Enrooth, Eric Keith, Foster, Clayton Scott, Yost, David William
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US13/618,486
• Publication Number:
  US 20130013020A1
• Time in Patent Office: 725 Days
• Field of Search: 607/27, 607/28
• US Class Current: 607/28
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7217 of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

Methods and systems for detecting noise in cardiac pacing response classification processes involve determining that a cardiac response classification is possibly erroneous if unexpected signal content is detected. The unexpected signal content may comprise signal peaks that have polarity opposite to the polarity of peaks used to determine the cardiac response to pacing. Fusion/noise management processes include pacing at a relatively high energy level until capture is detected after a fusion, indeterminate, or possibly erroneous pacing response classification is made. The relatively high energy pacing pulses may be delivered until capture is detected or until a predetermined number of paces are delivered.

Claims

1. A cardiac signal noise detection method, comprising:

sensing a cardiac signal in one or more classification windows following delivery of a pacing pulse;

using the cardiac signal sensed in the one or more classification windows to classify a cardiac response to the pacing pulse;

sensing the cardiac signal in a noise detection window, wherein the noise detection window is shifted relative to the one or more classification windows;

determining a signal level of the cardiac signal in at least one of the classification windows;

determining a noise level of the cardiac signal in the noise detection window;

comparing the classification window signal level to the noise detection window noise level; and

determining a measure of cardiac signal noise based at least in part on the comparison.

2. The method of claim 1, comprising computing an estimate of a signal-to-noise ratio based at least in part on a magnitude of the cardiac signal sensed during at least one of the classification windows and a magnitude of the cardiac signal sensed during the noise detection window.

3. The method of claim 2, comprising

comparing the signal-to-noise ratio to a threshold;

and

determining the measure of cardiac signal noise based at least in part on the signal-to-noise ratio exceeding the threshold.

4. The method of claim 1, wherein determining the measure of cardiac signal noise comprises:

comparing the noise detection window noise level to a threshold;

determining the measure of cardiac signal noise based at least in part on the noise level of the cardiac signal exceeding the threshold; and

determining the cardiac signal to be unusable for cardiac response classification in response to determining that detecting the noise level of the cardiac signal exceeds the threshold.

5. The method of claim 1, wherein a last classification window of the one or more classification windows corresponding to the pacing pulse is followed by a delay period, and the noise detection window follows the delay period.

6. The method of claim 1, wherein the noise detection window does not overlap in time at least one of the one or more classification windows.

7. The method of claim 1, further comprises:

forming the one or more classification windows, each of the one or more classification windows formed based on one or more cardiac signals representative of a particular type of cardiac pacing response; and

forming one or more noise detection windows, each of the one or more noise detection windows formed relative to a corresponding one of the classification detection windows.

8. The method of claim 7, wherein each of the one or more noise detection windows is formed following a corresponding one of the one or more classification windows.

9. The method of claim 1, wherein the noise detection window is shifted in time, amplitude and/or sign relative to the one or more classification windows.

10. A cardiac signal noise detection method, comprising:

sensing a cardiac signal in two or more classification windows following delivery of a pacing pulse;

using the cardiac signal sensed in the two or more classification windows to classify a cardiac response to the pacing pulse;

sensing the cardiac signal in each of two or more noise detection windows, wherein each of the two or more noise detection window is associated with a particular one of the two or more classification windows; and

detecting noise based on the cardiac signal sensed in at least one of the two or more classification windows and the cardiac signal sensed in at least one of the two or more noise detection windows.

11. A cardiac rhythm management device, comprising:

a pulse generator configured to deliver pacing pulses to a heart chamber;

a sensing circuit configured to sense cardiac signals of the heart chamber, the sensed cardiac signals respectively associated with the pacing pulses; and

a processor coupled to the sensing circuit and the pulse generator, the processor configured to;

sense a cardiac signal in one or more classification windows following delivery of a pacing pulse;

classify a cardiac response to the pacing pulse using the cardiac signal sensed in the one or more classification windows;

sense the cardiac signal in a noise detection window, wherein the noise detection window is shifted relative to the one or more classification windows; and

detect the noise by determining a signal level of the cardiac signal in at least one of the classification windows, determining a noise level of the cardiac signal in the noise detection window, comparing the classification window signal level to the noise detection window noise level, and detecting cardiac signal noise based at least in part on the comparison.

12. The device of claim 11, wherein the processor is configured to compute an estimate of a signal-to-noise ratio based at least in part on a magnitude of the cardiac signal sensed during at least one of the classification windows and a magnitude of the cardiac signal sensed during the noise detection window.

13. The device of claim 12, wherein the processor is configured to compare the signal-to-noise ratio to a threshold and detect cardiac signal noise based at least in part on the signal-to-noise ratio exceeding the threshold.

14. The device of claim 11, wherein the processor is configured to detect the noise by determining a noise level of the cardiac signal in the noise detection window and comparing the noise level to a threshold, detect cardiac signal noise based at least in part on the noise level of the cardiac signal exceeding the threshold, and determine the cardiac signal to be unusable for cardiac response classification when the noise level of the cardiac signal exceeding the threshold.

15. The device of claim 11, wherein a last classification window of the one or more classification windows is followed by a delay period, and the noise detection window follows the delay period.

16. A cardiac rhythm management device, comprising:

a pulse generator configured to deliver pacing pulses to a heart chamber;

a sensing circuit configured to sense cardiac signals of the heart chamber, the sensed cardiac signals respectively associated with the pacing pulses; and

a controller coupled to the sensing circuit and the pulse generator, the controller configured to;

sense a cardiac signal in two or more classification windows following delivery of a pacing pulse;

classify a cardiac response to the pacing pulse using the cardiac signal sensed in the two or more classification windows;

sense the cardiac signal in each of two or more noise detection windows, wherein each of the two or more noise detection window is associated with a particular one of the two or more classification windows and wherein each of the two or more noise detection window is shifted relative to the associated one of the two or more classification windows; and

detect noise based at least in part on a signal level of the cardiac signal sensed in the two or more noise detection windows.

17. The cardiac rhythm management device of claim 16, wherein the controller is further configured to not classify the cardiac response as capture if the noise detected by the controller is greater than a threshold noise amount.

18. The cardiac rhythm management device of claim 16, wherein the controller is further configured to not classify the cardiac response as capture or fusion if the noise detected by the controller is greater than a threshold noise amount.