Method and apparatus for detecting arrhythmias in a medical device

• US 8,435,185 B2
• Filed: 04/28/2006
• Issued: 05/07/2013
• Est. Priority Date: 03/29/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ghanem, Raja N., Stadler, Robert W., Zhang, Xusheng
• Primary Examiner(s): Porter Jr., Allen
• Application Number:
  US11/380,842
• Publication Number:
  US 20070239051A1
• Time in Patent Office: 2,566 Days
• Field of Search: 600/509
• US Class Current: 600/508
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/341 Vectorcardiography [VCG]
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• 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 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock
• CPC Class Codes: Y10S 128/901 Suppression of noise in electric signal
• CPC Class Codes: Y10S 128/902 Biological signal amplifier

Abstract

A method of detecting a cardiac event in a medical device that includes sensing cardiac signals from a plurality of electrodes forming a first sensing vector and a second sensing vector, determining whether a signal energy content metric of the sensed cardiac signals is within predetermined limits, determining whether a noise to signal ratio of the sensed cardiac signals is less than a signal to noise threshold, determining whether the sensed cardiac signals are associated with muscle noise, and determining whether a mean frequency corresponding to the sensed cardiac signals is less than a mean frequency threshold.

Claims

1. A method of detecting a cardiac event by a medical device, comprising:

sensing cardiac signals from a plurality of electrodes, the plurality of electrodes forming a first sensing vector and a second sensing vector;

separately identifying the first sensing vector and the second sensing vector as being corrupted by noise in response to determining a signal energy content metric of corresponding sensed cardiac signals not being within predetermined limits;

separately identifying the first sensing vector and the second sensing vector as being corrupted by noise in response to determining a noise to signal ratio of corresponding sensed cardiac signals not being less than a signal to noise threshold;

separately identifying the first sensing vector and the second sensing vector as being corrupted by noise in response to determining corresponding sensed cardiac signals being associated with muscle noise;

separately identifying the first sensing vector and the second sensing vector as being corrupted by noise in response to determining a mean frequency of corresponding sensed cardiac signals not being less than a mean frequency threshold;

otherwise, separately identifying the first sensing vector and the second sensing vector as not being corrupted by noise; and

delivering therapy via the device in response to the identifying.

2. The method of claim 1, wherein the method is performed for each of the first sensing vector and the second sensing vector during a predetermined window of the sensed cardiac signals.

3. The method of claim 1, wherein determining corresponding sensed cardiac signals being associated with muscle noise comprises:

determining inflections of the sensed cardiac signals;

generating a pulse amplitude threshold in response to the determined inflections;

determining whether the inflections are indicative of noise in response to the determined inflections and the generated pulse amplitude threshold; and

identifying the corresponding sensed cardiac signals as being associated with muscle noise in response to determining whether the inflections are indicative of noise.

4. The method of claim 3, wherein the inflections are determined during a predetermined window of the sensed cardiac signals, the method further comprising:

determining the number of sub-segments of the window having a predetermined number of inflections greater than a minimum pulse count threshold;

determining whether the number of sub-segments having the predetermined number of sub-segments is greater than or equal to a pulse count threshold; and

identifying the first sensing vector and the second sensing vector as being corrupted by noise and shockable in response to the number of corresponding sub-segments having the predetermined number of sub-segments greater than or equal to the pulse count threshold.

5. The method of claim 3, wherein generating a pulse amplitude threshold comprises:

determining a mean of the inflections during a predetermined window of the sensed cardiac signals; and

setting the pulse amplitude threshold equal to a predetermined portion of the determined mean of the inflections.

6. The method of claim 5, wherein generating a pulse amplitude threshold further comprises:

determining a maximum inflection of inflections determined during sub-segments of the predetermined window of the sensed cardiac signals;

determining local maximums of the inflections determined during the sub-segments of the predetermined window of the sensed cardiac signals; and

replacing the local maximums with the determined maximum inflection in response to the local maximums being less than a portion of the determined maximum inflection for the corresponding sub-segment.

7. The method of claim 6, wherein the inflections are determined during a predetermined window of the sensed cardiac signals, and wherein determining inflections further comprises:

determining a first maximum of the data pairs determined during the predetermined window of the sensed cardiac signals;

determining second maximums of data pairs determined during sub-segments of the predetermined window of the sensed cardiac signals; and

setting the second maximums equal to the first maximum in response to the second maximum being less than a predetermined portion of the first maximum.

8. The method of claim 7, wherein generating a pulse amplitude threshold comprises:

determining a mean of the second maximums during the predetermined window of the sensed cardiac signals; and

setting the pulse amplitude threshold equal to a predetermined portion of the determined mean of the second maximums.

9. The method of claim 3, wherein determining inflections comprises:

applying the sensed cardiac signals to a first order derivative to generate a derivative signal;

determining zero crossings of the derivative signal; and

storing a muscle noise count in response to the determined zero crossings.

10. The method of claim 9, wherein determining inflections further comprises:

determining data pairs corresponding to a first data point prior to the zero crossings and a second data point subsequent to the zero crossings; and

determining the smallest absolute values of the first data point and the second data point as the determined inflections to generate a rectified signal from the derivative signal.

11. The method of claim 3, wherein the plurality of electrodes are positioned non-intravenously.

12. The method of claim 3, further comprising determining, in response to identifying the corresponding signals as being associated with muscle noise, whether the corresponding sensed cardiac signals are both associated with muscle noise and shockable.

13. The method of claim 12, wherein the inflections are determined during a predetermined window of the sensed cardiac signals, and wherein determining whether the sensed cardiac signals are both corrupted by noise and shockable comprises:

determining whether a mean rectified amplitude for the predetermined window of the sensed cardiac signals is greater than a predetermined threshold; and

determining the sensed cardiac signals are both corrupted by noise and shockable in response to the mean rectified amplitude for the predetermined window of the sensed cardiac signals being greater than the predetermined threshold.

14. The method of claim 13, wherein determining whether a mean rectified amplitude for the predetermined window of the sensed cardiac signals is greater than a predetermined threshold comprises:

determining whether a maximum amplitude for each of a plurality of sub-segments of the predetermined window of sensed cardiac signals is less than a portion of a maximum amplitude for the entire predetermined window of sensed cardiac signals;

setting, for each sub-segment of the plurality of sub-segments, the corresponding maximum amplitude to the maximum amplitude for the entire predetermined window of sensed cardiac signals in response to the corresponding maximum amplitude being is less than the portion of the maximum amplitude for the entire predetermined window of sensed cardiac signals;

determining mean amplitudes for each sub-segment of the plurality of sub-segments;

determining normalized mean amplitudes for each sub-segment of the plurality of sub-segments in response to the maximum amplitude and the mean amplitudes; and

setting the mean rectified amplitude for the predetermined window of the sensed cardiac signals equal to the sum of the normalized mean amplitudes divided by the number of sub-segments corresponding to the plurality of sub-segments.

15. The method of claim 14, further comprising:

determining a metric of signal energy content associated with the sensed cardiac signal during the predetermined sensing window; and

determining the sensed cardiac signal during the predetermined sensing window is corrupted by noise in response to the metric of signal energy content being greater than a first signal energy content threshold corresponding to a value greater than a signal energy content associated with the detected cardiac event.

16. The method of claim 14, further comprising:

determining a metric of signal energy content associated with the sensed cardiac signal during the predetermined sensing window; and

determining the sensed cardiac signal during the predetermined sensing window is corrupted by noise in response to the metric of signal energy content being one of greater than a first signal energy content threshold and less than a second signal energy content threshold, the first signal energy content threshold corresponding to a value greater than a signal energy content associated with the detected cardiac event and the second signal energy content threshold corresponding to asystole episodes.

17. The method of claim 1, wherein identifying the first sensing vector and the second sensing vector as being corrupted by noise in response to determining a noise to signal ratio of corresponding sensed cardiac signals not being less than a signal to noise threshold comprises:

determining amplitudes of the sensed cardiac signal during a predetermined sensing window;

determining a noise to signal ratio corresponding to the determined amplitudes; and

determining the sensed cardiac signal during the predetermined sensing window is corrupted by noise in response to the determined noise to signal ratio being greater than a noise to signal ratio threshold.

18. The method of claim 17, wherein determining a noise to signal ratio comprises determining a ratio of a highpass mean rectified amplitude corresponding to the sensed cardiac signal during the predetermined sensing window to a lowpass mean rectified amplitude corresponding to the sensed cardiac signal during the predetermined sensing window.

19. The method of claim 18, further comprising:

determining an average of absolute values of lowpass sample amplitudes corresponding to the determined amplitudes as the lowpass mean rectified amplitude;

determining an average of absolute values of the determined amplitudes to generate a raw mean rectified amplitude; and

determining a difference between the raw mean rectified amplitude and the lowpass mean rectified amplitude as the highpass mean rectified amplitude.

20. A non-transitory computer readable medium having computer executable instructions for performing a method comprising:

sensing cardiac signals from a plurality of electrodes, the plurality of electrodes forming a first sensing vector and a second sensing vector;

separately identifying the first sensing vector and the second sensing vector as being corrupted by noise in response to determining a signal energy content metric of corresponding sensed cardiac signals not being within predetermined limits;

separately identifying the first sensing vector and the second sensing vector as being corrupted by noise in response to determining a noise to signal ratio of corresponding sensed cardiac signals not being less than a signal to noise threshold;

separately identifying the first sensing vector and the second sensing vector as being corrupted by noise in response to determining corresponding sensed cardiac signals being associated with muscle noise; and

separately identifying the first sensing vector and the second sensing vector as being corrupted by noise in response to determining a mean frequency of corresponding sensed cardiac signals not being less than a mean frequency threshold;

otherwise, separately identifying the first sensing vector and the second sensing vector as not being corrupted by noise; and

delivering therapy via the device in response to the identifying.

21. A medical device, comprising:

means for sensing cardiac signals from a plurality of electrodes, the plurality of electrodes forming a first sensing vector and a second sensing vector;

means for separately identifying the first sensing vector and the second sensing vector as being corrupted by noise in response to determining a signal energy content metric of corresponding sensed cardiac signals not being within predetermined limits;

means for separately identifying the first sensing vector and the second sensing vector as being corrupted by noise in response to determining a noise to signal ratio of corresponding sensed cardiac signals not being less than a signal to noise threshold;

means for separately identifying the first sensing vector and the second sensing vector as being corrupted by noise in response to determining corresponding sensed cardiac signals being associated with muscle noise;

means for separately identifying the first sensing vector and the second sensing vector as being corrupted by noise in response to determining a mean frequency of corresponding sensed cardiac signals not being less than a mean frequency threshold, and otherwise, separately identifying the first sensing vector and the second sensing vector as not being corrupted by noise; and

means for delivering therapy via the device in response to the identifying.