Method and apparatus for detecting arrhythmias in a medical device

• US 7,761,142 B2
• Filed: 04/28/2006
• Issued: 07/20/2010
• 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:
  US11/380,802
• Publication Number:
  US 20070239048A1
• Time in Patent Office: 1,544 Days
• Field of Search: 600/409, 600/413, 600509-512, 600/515, 600/518, 600/519, 600/521, 600/505, 607/14, 607/120
• 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, and determining whether the inflections are indicative of noise in response to the determined inflections and the generated pulse amplitude threshold.

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;

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

generating a first pulse amplitude threshold based, at least in part, on the first number of inflections and a second pulse amplitude threshold based, at least in part, on 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; and

delivering therapy based, at least in part, on the identifying of the first sensing vector as one of noisy and not noisy and the identifying of the second sensing vector as one of noisy and not noisy.

2. The method of claim 1, wherein each of the determining the first number of inflections step and the determining the second number of inflections step are based on inflections which occur during a predetermined window comprising a plurality of sub-segments;

wherein the determining a first number of inflections step comprises determining a number of inflections of each of the plurality of sub-segments of the predetermined window;

wherein the determining a second number of inflections step comprises determining a number of inflections of each of the plurality of sub-segments of the predetermined window;

wherein the method further comprises the steps of;

determining, for each of the first sensing vector and the second sensing vector, a number of sub-segments of the window having a predetermined number of inflections greater than a minimum pulse count threshold; and

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

3. The method of claim 2, further comprising the steps of determining the first sensing vector is corrupted by noise based, at least in part, on the number of sub-segments having the predetermined number of inflections being greater than or equal to the pulse count threshold.

4. The method of claim 1, wherein the sensing step occurs during a predetermined window, and wherein generating a first pulse amplitude threshold step comprises:

determining a mean of the first inflections sensed during the predetermined window; 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.

5. The method of claim 4, wherein the predetermined window has a plurality of sub-segments, and wherein 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 inflection 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.

6. 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.

7. The method of claim 6, 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; and

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

8. The method of claim 7, wherein the determining the first number of inflections step and the determining the second number of inflections step occur during a 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.

9. The method of claim 8, 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 setting 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.

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

20. The method of claim 1, wherein the identifying the first sensing vector as one of noisy and not noisy step further comprises determining whether the first sensing vector is noisy and shockable;

and

wherein the identifying the second sensing vector as one of noisy and not noisy step further comprise determining, whether the sensed cardiac signals are both noisy and shockable, independently of determining whether the first sensing vector is noisy and shockable.

11. 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 comprising 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 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 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;

separately 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, and 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; and

delivering therapy based, at least in part, on the identifying of the, first sensing vector as one of noisy and not noisy and the identifying of the second sensing vector as one of noisy and noisy.

12. The method of claim 11, further comprising, before the delivering therapy step, the steps of:

comparing a number of the plurality of sub-segments of the predetermined window sensed along the first sensing vector having a predetermined number of inflections greater than a predetermined minimum threshold to a sub-segment pulse count threshold to obtain a first sub-segment comparison; and

comparing a number of the plurality of sub-segments of the predetermined window sensed along the second sensing vector having the predetermined number of inflections greater than the predetermined minimum threshold to the sub-segment pulse count threshold to obtain a second sub-segment comparison.

13. The method of claim 11, wherein the generating a first pulse amplitude threshold step comprises:

determining a mean of the first inflections during a 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.

14. The method of claim 13, wherein the generating a first pulse amplitude threshold and a second 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 sensed along the first sensing vector;

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

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

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

determining local maximums of the second inflections during each individual one of the plurality of sub-segments of the predetermined window sensed along the second sensing vector; 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 of the second inflections.

15. The method of claim 11, 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.

16. The method of claim 15, 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 signal 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 the zero crossings each individual one of; 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 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 prior 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.

17. The method of claim 16, 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.

18. The method of claim 17, 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.

19. 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;

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

generating a first pulse amplitude threshold based, at least in part, on the first number of inflections and a second pulse amplitude threshold based, at least in part, on 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; and

delivering therapy based, at least in part. on the identifying of the first sensing vector as one of noisy and not noisy and the identifying of the second sensing vector as one of noisy and not noisy.