Method and apparatus for detecting arrhythmias in a medical device

• US 7,734,336 B2
• Filed: 04/28/2006
• Issued: 06/08/2010
• 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): Layno; Carl H
• Assistant Examiner(s): Behringer; Luther G
• Application Number:
  US11/380,823
• Publication Number:
  US 20070239049A1
• Time in Patent Office: 1,502 Days
• Field of Search: 600509-512, 600/515, 600/518, 600/519, 600/521, 600/505, 607/14, 607/120, 607/5, 607/9
• US Class Current: 600/517
• 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 inflections of the sensed cardiac signals, generating a pulse amplitude threshold in response to the determined inflections, determining whether the sensed cardiac signals are corrupted by noise in response to the determined inflections and the generated pulse amplitude threshold, and determining, in response to the sensed cardiac signals being corrupted by noise, whether the sensed cardiac signals are both corrupted by noise and shockable.

Claims

1. A method of detecting a cardiac event with a medical device comprising a plurality of electrodes forming a first sensing vector and a second sensing vector, comprising:

sensing cardiac signals from the plurality of electrodes;

determining a first number of inflections of the sensed cardiac signals sensed along the first sensing vector during a predetermined window;

determining a second number of inflections of the sensed cardiac signals sensed along the second sensing vector during the predetermined window;

generating a first pulse amplitude threshold in response to the first number of inflections and a second pulse amplitude threshold in response to the second number of inflections;

identifying the first sensing vector as one of noisy and not noisy based, at least in part, on the first number of inflections and the first pulse amplitude threshold;

identifying the second sensing vector as one of noisy and not noisy based, at least in part, on the second number of inflections and the second pulse amplitude threshold;

identifying the first sensing vector as being available for therapy delivery based, at least in part, on the first sensing vector being at least one of not noisy, and both noisy and shockable;

identifying the second sensing vector as being available for therapy delivery based, at least in part, on the second sensing vector being at least one of not noisy, and both noisy and shockable; and

delivering therapy based, at least in part, on at least one of the first sensing vector and the second sensing vector being identified as available for therapy delivery.

2. The method of claim 1, wherein the sensing cardiac signals step occurs during the predetermined window;

and

wherein the identifying the first sensing vector as being available therapy delivery step comprises the steps of;

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

determining the first sensing vector is noisy and shockable in response to the mean rectified amplitude for the predetermined window of the sensed cardiac signals being greater than the predetermined;

threshold; and

wherein the identifying the second sensing vector as being available for therapy delivery step comprises the steps of;

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

determining the second sensing vector is noisy and shockable in response to the mean rectified amplitude for the predetermined window of the sensed cardiac.

3. The method of claim 2, wherein determining whether a mean rectified amplitude of the sensed cardiac signals during the predetermined window is greater than a predetermined threshold comprises:

determining a maximum amplitude of the cardiac signals during an entirety of the predetermined window;

determining, for each individual one of the plurality of sub-segments of the cardiac signals, a maximum amplitude of the sub-segment, wherein, for each individual one of the plurality of sub-segments, the maximum amplitude of the sub-segment is set to the maximum amplitude of the cardiac signals during the entirety of the predetermined window if the maximum amplitude of the sub-segment is less than a predetermined percentage of the maximum amplitude of the cardiac signals during the entirety of the predetermined window;

determining a mean amplitude for each individual one of the plurality of sub-segments;

determining a normalized mean amplitudes amplitude for each individual one of the plurality of sub-segments based, at least in part, on the maximum amplitude and the mean amplitudes; and

setting the mean rectified amplitude for the entirety of the predetermined window of the sensed cardiac signals equal to a sum of the normalized mean amplitude for each individual one of the plurality of sub-segments divided by a total number of the plurality of sub-segments.

4. The method of claim 1, wherein the determining the first number of inflections step and the determining the second number of inflections step are determined during the predetermined window of the sensed cardiac signals, the predetermined window of the sensed cardiac signals having plurality of sub-segments, and further comprising the steps of:

determining a number of the sub-segments of the predetermined window having a predetermined number of first inflections corresponding to the first sensing vector greater than a minimum pulse count threshold;

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

identifying the first sensing vector as one of noisy and not noisy based, at least in part, on the number of first sub-segments having the predetermined number of first inflections corresponding to the first sensing vector being greater than or equal to a pulse count threshold; and

identifying the second sensing vector as one of noisy and not noisy based, at least in part, on the number of second sub-segments having the predetermined number of second inflections corresponding to the second sensing vector being greater than or equal to the pulse count threshold.

5. The method of claim 1, wherein the generating a first pulse amplitude threshold step comprises:

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

setting the first pulse amplitude threshold equal to a predetermined percentage of the mean of the first inflections; and

wherein the generating a second pulse amplitude threshold step comprises;

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

setting the second pulse amplitude threshold equal to a predetermined percentage of the mean of the second inflections.

6. The method of claim 5, wherein the predetermined window of the cardiac signals has of sub-segments, and where the generating a first pulse amplitude threshold step further comprises:

determining a maximum inflection of the first inflections during each individual one of the plurality of sub-segments of the predetermined window of the sensed cardiac signals;

determining local maximums of the first inflections during each individual one of the plurality of sub-segments of the predetermined window of the sensed cardiac signals; and

replacing, for each individual one of the plurality of sub-segments, the local maximum of the sub-segment with the maximum inflection of the first inflections in response to the local maximums being less than a percentage of the maximum inflection;

wherein the generating the second pulse amplitude threshold step further comprises;

determining a maximum inflection of second inflections during each individual one of the plurality of sub-segments of the predetermined window of the sensed cardiac signals;

determining local maximums of the second inflections during each individual one of the plurality of sub-segments of the predetermined window of the sensed cardiac signals; and

replacing, for each individual one of the plurality of sub-segments, the local maximum of the sub-segment with the maximum inflection of the second inflections in response to the local maximums being less than a percentage of the maximum inflection.

7. The method of claim 1, wherein the determining the first number of inflections step comprises:

applying the cardiac signals sensed along the first sensing vector to a first order derivative to generate a first derivative signal; and

determining zero crossings of the first derivative signal; and

wherein the determining the number of second inflections step comprises;

applying the cardiac signals sensed along the second sensing vector to a first order derivative to generate a second derivative signal; and

determining zero crossings of the second derivative signal.

8. The method of claim 7, wherein the determining the first number of inflections step further comprises:

determining a data pair for each individual one of the zero crossings of the first derivative signals corresponding to a first data point prior to each individual one of the zero crossings of the first derivative signal and a second data point subsequent to each individual one of the zero crossings of the first derivative signal; and

determining a smallest absolute value of the first data point and the second data for the data pair for each individual one of the zero crossings of the first derivative signals; and

wherein determining the second number of inflections step further comprises;

determining a data pair for each individual one of the zero crossings of the second derivative signals corresponding to a first data point prior to each individual the zero crossings of the second derivative signal and a second data point subsequent to each individual one of the zero crossings of the second derivative signal; and

determining a smallest absolute value of the first data point and the second data for the data pair for each individual one of the zero crossings of the second derivative signals.

9. The method of claim 8, wherein the determining the first number of inflections step and the determining the second number of inflections step occur during the predetermined window of the cardiac signals, the predetermined window comprising a plurality of sub-segments, and wherein the determining the first number of inflections step further comprises:

determining a first maximum of the data pair for each individual one of the zero crossings of the first derivative signals;

determining a second maximum of the data pair for each individual one of the zero crossings of the first derivative signals corresponding to each individual one of the plurality of sub-segments of the predetermined window of the sensed cardiac signals; and

for each individual one of the second maximums, setting the individual one of the second maximums equal to the first maximum based, at least in part, on the individual one of the second maximums being less than a predetermined percentage of the first maximum; and

wherein the determining the second number of inflections step further comprises;

determining a first maximum of the data pair for each individual one of the zero crossings of the second derivative signals;

determining a second maximum of the data pair for each individual one of the zero crossings of the second derivative signals corresponding to each individual one of the plurality of sub-segments of the predetermined window of the sensed cardiac signals; and

for each individual one of the second maximums, setting the individual one of the second maximums equal to the first maximum based, at least in part, on the individual one of the second maximums being less than a predetermined percentage of the first maximum.

10. The method of claim 9, wherein the generating a first pulse amplitude threshold in response to the first number of inflections and a second pulse amplitude threshold in response to the second number of inflections step comprises:

determining a mean of the second maximum of the data pair for each individual one of the zero crossings of the second derivative signals corresponding to each individual one of the plurality of sub-segments of the predetermined window of the cardiac signals sensed along each of the first sensing vector and the second sensing vector; and

setting the first pulse amplitude threshold and the second pulse amplitude threshold equal to a predetermined percentage of the mean of the second maximums from the first sensing vector and the second sensing vector, respectively.

11. The method of claim 1, the plurality of electrodes being positioned non-intravenously.

12. A method of detecting a cardiac event with a medical device comprising a plurality of electrodes forming a first sensing vector and a second sensing vector, comprising:

sensing cardiac signals from the plurality of electrodes;

determining a first number of inflections of the sensed cardiac signals sensed along the first sensing vector during a predetermined sensing window having a plurality of sub-segments;

determining a second number of inflections of the sensed cardiac signals sensed along the second sensing vector during the predetermined sensing window;

generating a first pulse amplitude threshold in response to the first number of inflections and a second pulse amplitude threshold in response to the second number of inflections;

determining an individual one of the plurality of sub-segments of the predetermined window sensed along the first sensing vector having a first maximum number of inflections;

determining an individual one of the plurality of sub-segments of the predetermined window of sensed cardiac signals sensed along the second sensing vector having a second maximum number of inflections;

comparing each of the first pulse amplitude threshold and the second pulse amplitude threshold to a pulse threshold to obtain a first pulse amplitude comparison and a second pulse amplitude comparison, respectively; and

comparing each of the first maximum number of inflections and the second maximum number of inflections to a noise pulse number threshold to obtain a first maximum number comparison and a second maximum number comparison, respectively;

identifying the first sensing vector as one of noisy and not noisy based, at least in part, on the first pulse amplitude comparison and the first maximum number comparison;

identifying the second sensing vector as one of noisy and not noisy based, at least in part, on the second pulse amplitude comparison and the second maximum number comparison;

identifying the first sensing vector as being available for therapy delivery based, at least in part, on the first sensing vector being at least one of not noisy, and both noisy and shockable;

identifying the second sensing vector as being available for therapy delivery based, at least in part, on the second vector being at least one of not noisy, and both noisy and shockable;

delivering therapy based, at least in part, on at least one of the first sensing vector and the second sensing vector being identified as available for therapy delivery.

13. The method of claim 12, wherein the sensing cardiac signals step occurs during the predetermined window;

and

wherein the identifying the first sensing vector as being available for therapy delivery step comprises the steps of;

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

determining the first sensing vector is noisy and shockable in response to the mean rectified amplitude for the predetermined window of the sensed cardiac signals being greater than the predetermined threshold; and

wherein the identifying the second sensing vector as being available for therapy delivery the step comprise the steps of;

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

determining the second sensing vector is noisy and shockable in response to the mean rectified amplitude for the predetermined window of the sensed cardiac.

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

determining a maximum amplitude of the cardiac signals during an entirety of the predetermined window;

determining, for each individual one of the plurality of sub-segments of the cardiac signals, a maximum amplitude of the sub-segment, wherein, for each individual one of the plurality of sub-segments, the maximum amplitude of the sub-segment is set to the maximum amplitude of the cardiac signals during the entirety of the predetermined window if the maximum amplitude of the sub-segment is less than a predetermined percentage of the maximum amplitude of the cardiac signals during the entirety of the predetermined window;

determining a mean amplitude for each individual one of the plurality of sub-segments;

determining a normalized mean amplitude for each individual one of the plurality of sub-segments based, at least in part, on the maximum amplitude and the mean amplitudes; and

setting the mean rectified amplitude for the entirety predetermined window of the sensed cardiac signals equal to a sum of the normalized mean amplitude for each individual one of the plurality of sub-segments divided by a total number of the plurality of sub-segments.

15. The method of claim 12, wherein the generating a first pulse amplitude threshold step comprises:

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

setting the first pulse amplitude threshold equal to a predetermined percentage of the mean of the first inflections; and

wherein the generating, a second pulse amplitude threshold step comprises;

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

setting the second pulse amplitude threshold equal to a predetermined percentage of the mean of the second inflections.

16. The method of claim 15, wherein the predetermined window of the cardiac signals has a plurality of sub-segments, and where the generating a first pulse amplitude threshold step further comprises:

determining a maximum inflection of the first inflections during each individual one of the plurality of sub-segments of the predetermined window of the sensed cardiac signals;

determining local maximums of the first inflections during each individual one of the plurality of sub-segments of the predetermined window of the sensed cardiac signals; and

replacing, for each individual one of the plurality of sub-segments, the local maximum of the sub-segment with the maximum inflection of the first inflections in response to the local maximums being less than a percentage of the maximum inflection; and

wherein the generating the second pulse amplitude threshold step further comprises;

determining a maximum ion of the second inflections during each individual one of the plurality of sub-segments of the predetermined window of the sensed cardiac signals;

determining local maximums of the second inflections during each individual one of the plurality of sub-segments of the predetermined window of the sensed cardiac signals; and

replacing, for each individual one of the plurality of sub-segments, the local maximum of the sub-segment with the maximum inflection of the second inflections in response to the local maximums being less than a percentage of the maximum inflection.

17. The method of claim 12, wherein the determining the first number of inflections step comprises:

applying the cardiac signals sensed along the first sing vector to a first order derivative to generate a first derivative signal; and

determining zero crossings of the first derivative signal; and

wherein the determining the number of second inflections step comprises;

applying the cardiac signals sensed along the second sensing vector to a first order derivative to generate a second derivative signal; and

determining zero crossing of the second derivative signal.

18. The method of claim 17, wherein the determining the first number of inflections step further comprises:

determining a data pair for each individual one of the zero crossings of the first derivative signals corresponding to a first data point prior to each individual one of the zero crossings of the first derivative signal and a second data point subsequent to each individual one of the zero crossings of the first derivative signal; and

determining a smallest absolute value of the first data point and the second data for the data pair fear each individual of the zero crossings of the first derivative signals; and

wherein the determining the second number of inflections step further comprises;

determining a data pair for each individual one of the zero crossings of the second derivative signals corresponding to a first data point to each individual one of the zero crossings of the second derivative signal and a second data point subsequent to each individual one of the zero crossings of the second derivative signal; and

determining a smallest absolute value of the first data point and the second data for the data pair for each individual one of the zero crossings of the second derivative signals.

19. The method of claim 18, wherein the determining the first number of inflections step and the determining the second number of inflections step occur during the predetermined window of the cardiac signals, the predetermined window comprising a plurality of sub-segments, and wherein the determining first number of inflections step further comprises:

determining a first maximum of the data pair for each individual one of the zero crossings of the first derivative signals;

determining a second maximum of the data pair for each individual one of the zero crossings of the first derivative signals corresponding to each individual one of the plurality of sub-segments of the predetermined window of the sensed cardiac signals; and

for each individual one of the second maximums, setting the individual one of the second maximums equal to the first maximum based, at least in part, on the individual one of the second maximums being less than a predetermined percentage of the first maximum; and

wherein the determining the second number of inflections step further comprises;

determining a first maximum of the data pair for each individual one of the zero crossings of the second derivative signals;

determining a second maximum of the data pair for each individual one of the zero crossings of the second derivative signals corresponding to each individual one of the plurality of sub-segments of the predetermined window of the sensed cardiac signals; and

for each individual one of the second maximums, setting the individual one of the second maximums equal to the first maximum based, at least in part, on the individual one of the second maximums being less than a predetermined percentage of the first maximum.

20. The method of claim 19, wherein the generating a first pulse amplitude threshold in response to the first number of inflections and a second pulse amplitude threshold in response to the second number of inflections step comprises:

determining a mean of the second maximum of the data pair for each individual one of the zero crossings of the second derivative signals corresponding to each individual one of the plurality of sub-segments of the redetermined window of the cardiac signals sensed along each of the first sensing vector and the second sensing vector; and

setting the first pulse amplitude threshold and the second pulse amplitude threshold equal to a predetermined percentage of the mean of the second maximums from the first sensing vector and the second sensing vector, respectively.

21. A non-transitory computer readable medium having computer executable instructions for performing a method of detecting a cardiac event with a medical device comprising a plurality of electrodes forming a first sensing vector and a second sensing vector comprising:

sensing cardiac signals from the plurality of electrodes;

determining a first number of inflections of the sensed cardiac signals sensed along the first sensing vector during a predetermined window;

determining a second number of inflections of the sensed cardiac signals sensed along the second sensing vector during the predetermined window;

generating a first pulse amplitude threshold in response to the first number of inflections and a second pulse amplitude threshold in response to the second number of inflections;

identifying the first sensing vector as one of noisy and not noisy based, at least in part, on the first number of inflections and the first pulse amplitude threshold;

identifying the second sensing vector as one of noisy and not noisy based, at least in part, on the second number of inflections and the second pulse amplitude threshold;

identifying the first sensing vector as being available for therapy delivery based, at least in part, on the first sensing vector being at least one of not noisy, and both noisy and shockable;

identifying the second sensing vector as being available for therapy delivery based, at least in part, on the second sensing vector being at least one of not noisy, and both noisy and shockable; and

delivering therapy based, at least in part, on at least one of the first sensing vector and the second sensing vector being identified as available for therapy delivery.