System and method of classifying tachyarrhythmia episodes as associated or disassociated

• US 7,151,958 B2
• Filed: 08/02/2002
• Issued: 12/19/2006
• Est. Priority Date: 12/01/1999
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Lovett, Eric G., Sweeney, Robert J., Hsu, William
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US10/211,222
• Publication Number:
  US 20020198461A1
• Time in Patent Office: 1,600 Days
• Field of Search: 600/515, 600/518, 600/519, 600/521, 607/14, 607/9
• US Class Current: 600/518
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

A method and system for classifying tachyarrhythmia episodes as associated or disassociated. Primary and auxiliary depolarizations are detected from different cardiac regions during a tachycardia episode. A first time interval is positioned to surround each of one or more primary depolarizations, including auxiliary depolarizations that occur in the first time interval. The auxiliary depolarizations occurring in the first time interval are then counted. Based on the number and the location of the auxiliary depolarizations counted in the first time intervals, the one or more primary depolarizations and the auxiliary depolarizations of the tachycardia episode are classified as disassociated or associated.

Claims

1. A system, comprising:

control circuitry where the control circuitry receives a first cardiac signal and a second cardiac signal sensed during a cardiac episode, where the first cardiac signal includes indications of depolarizations in a first cardiac area and the second cardiac signal includes indications of depolarizations in a second cardiac area, the control circuitry including;

a first depolarization detector circuit to detect occurrence of primary depolarizations in the first cardiac signal;

a second depolarization detector circuit to detect occurrence of auxiliary depolarizations in the second cardiac signal;

a cardiac depolarization counting circuit coupled to the first depolarization detector circuit and the second depolarization detector circuit, where the cardiac depolarization counting circuit counts a first number (K) of auxiliary depolarizations occurring during a first portion of a first time interval surrounding each of one or more primary depolarizations of the primary depolarizations and counts a total number (N) of auxiliary depolarizations during the first time interval; and

a microprocessor coupled to the cardiac depolarization counting circuit, where the microprocessor calculates K/N and determines whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated or disassociated based on K/N.

2. The system of claim 1, where the first time interval has an approximate midpoint location positioned at each of the one or more primary depolarizations, where the first portion of the first time interval is substantially a first-half of the first time interval, and where the microprocessor determines that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated when K/N is equal to approximately one-half (0.5).

3. The system of claim 1, where the first time interval has an approximate midpoint location positioned at each of the one or more primary depolarizations, where the first portion of the first time interval is substantially a first-half of the first time interval, and where the microprocessor determines that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated when K/N is not equal to approximately one-half (0.5).

4. The system of claim 1, where the first time interval has an approximate midpoint location positioned at each of the one or more primary depolarizations, where the first portion of the first time interval is substantially a first-half of the first time interval, and where the microprocessor determines that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated when K/N is statistically different from one-half (0.5) at a predetermined confidence level and where the microprocessor determines that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated when K/N is not statistically different from one-half (0.5) at the predetermined confidence level.

5. The system of claim 4, where the microprocessor determines that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated when K is less than or equal to a first threshold value Klow or when K is greater than or equal to a second threshold value Khigh, and determines that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated when K is between Klow and Khigh.

6. The system of claim 1, where the first time interval has an approximate midpoint location positioned at each of the one or more primary depolarizations, where the first portion of the first time interval is substantially a first-half of the first time interval, and where the cardiac depolarization counting circuit counts a second number (J) of auxiliary depolarizations during substantially a second-half of the first time interval, and the microprocessor determines that the primary depolarizations and the auxiliary depolarizations are associated when K and J are statistically different at a predetermined confidence level.

7. The system of claim 6, where the microprocessor determines that the primary depolarizations and the auxiliary depolarizations are disassociated when K and J are not statistically different at the predetermined confidence level.

8. A system, comprising:

control circuitry where the control circuitry receives a first cardiac signal and a second cardiac signal sensed during a cardiac episode, where the first cardiac signal includes indications of depolarizations in a first cardiac area and the second cardiac signal includes indications of depolarizations in a second cardiac area, the control circuitry including;

a first depolarization detector circuit to detect occurrence of primary depolarizations in the first cardiac signal;

a second depolarization detector circuit to detect occurrence of auxiliary depolarizations in the second cardiac signal;

a cycle length interval circuit coupled to the second depolarization detector circuit, where the cycle length interval circuit measures auxiliary cycle lengths between pairs of consecutively sensed auxiliary depolarizations in a measurement window interval;

a cardiac data analyzing circuit coupled to the cycle length interval circuit, where the cardiac data analyzing circuit calculates a first time interval based on an average value and an standard deviation value of the auxiliary cycle lengths and positions the first time interval to surround each of one or more primary depolarizations of the primary depolarizations;

a cardiac depolarization counting circuit coupled to the first depolarization detector circuit and the second depolarization detector circuit, where the cardiac depolarization counting circuit counts a number of auxiliary depolarizations occurring during the first time interval; and

a microprocessor coupled to the cardiac depolarization counting circuit, where the microprocessor determines whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated or disassociated based on the number of auxiliary depolarizations occurring during the first time interval.

9. The system of claim 8, wherein the cycle length interval circuit calculates an average value (XXavg) and an standard deviation value (XXsd) of the auxiliary cycle lengths, and where the cardiac data analyzing circuit calculates the first time interval equal to

(XXavg−

Y * XXsd),

where Y is a predetermined constant.

10. The system of claim 9, where the measurement window interval has a predetermined duration.

11. The system of claim 9, where the measurement window interval has a duration sufficient to detect a predetermined number of primary depolarizations.

12. The system of claim 9, where the cardiac depolarization counting circuit counts a first number (K) of auxiliary depolarizations that occur during a first portion of the first time interval, and where the microprocessor compares K to threshold values Klow and Khigh to determine when the determination of whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated or disassociated can be made with a predetermined confidence level and extends the measurement window interval when the relationship of K to Klow and Khigh shows that the determination of whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated or disassociated cannot be made with the predetermined confidence level.

13. The system of claim 12, where the microprocessor repeats the measurement window interval when the relationship of K to Klow and Khigh shows that the determination of whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated or disassociated cannot be made with the predetermined confidence level.

14. The system of claim 12, where the microprocessor stops the measurement window interval when the relationship of K to Klow and Khigh shows that the determination of whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated or disassociated can be made with the predetermined confidence level.

15. A system, comprising:

control circuitry where the control circuitry receives a first cardiac signal and a second cardiac signal sensed during a cardiac episode, where the first cardiac signal includes indications of depolarizations in a first cardiac area and the second cardiac signal includes indications of depolarizations in a second cardiac area, the control circuitry including;

a first depolarization detector circuit to detect occurrence of primary depolarizations in the first cardiac signal;

a second depolarization detector circuit to detect occurrence of auxiliary depolarizations in the second cardiac signal;

a cardiac data analyzing circuit coupled to the first depolarization detector circuit and the second depolarization detector circuit, where the cardiac data analyzing circuit positions a first time interval to surround each of one or more primary depolarizations of the primary depolarizations and a second time interval to surround each of one or more auxiliary depolarizations of the auxiliary depolarizations;

a cardiac depolarization counting circuit coupled to the cardiac data analyzing circuit, where the cardiac depolarization counting circuit counts the number of auxiliary depolarizations occurring during the first time interval and the number of primary depolarizations occurring during the second time interval; and

a microprocessor coupled to the cardiac depolarization counting circuit, where the microprocessor determines whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated or disassociated based on the number of primary depolarizations occurring during the second time interval and the number of auxiliary depolarizations occurring during the first time interval.

16. The system of claim 15, where the cardiac depolarization counting circuit counts a first number (K) of auxiliary depolarizations which occur during a first portion of the first time interval that at least substantially precedes each of the one or more primary depolarizations, counts a total number (N) of auxiliary depolarizations during the first time interval, counts a first number (L) of primary depolarizations which occur during a first portion of the second time interval that at least substantially precedes each of the one or more auxiliary depolarizations, and counts a total number (M) of primary depolarizations during the second time interval;

and

where the microprocessor makes a first determination of whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated or disassociated based on K and N, makes a second determination of whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated or disassociated based on L and M, and makes an overall determination of whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated or disassociated based on outcomes of the first determination and the second determination.

17. The system of claim 16, where the first time interval and the second time interval each include an approximate midpoint location, and the cardiac data analyzing circuit positions the first time interval with the approximate midpoint location of the first time interval at each primary depolarization of the one or more primary depolarizations and positions the second time interval with the approximate midpoint location of the second timer interval at each auxiliary depolarization of the one or more auxiliary depolarizations, and where the first portion of the first time interval is substantially a first-half of the first time interval, and the first portion of the second time interval is substantially a first-half of the second time interval.

18. The system of claim 16, where the microprocessor determines that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated when the outcomes of both the first determination and the second determination indicate that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated.

19. The system of claim 16, where the microprocessor determines that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated when the outcomes of both the first determination and the second determination indicate that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated.

20. The system of claim 16, where the microprocessor determines that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated when the outcome of either the first determination or the second determination indicates that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated.

21. The system of claim 16, where the microprocessor determines that the primary depolarizations and the auxiliary depolarizations in the cardiac episode as disassociated when the outcome of either the first determination or the second determination indicates that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated.

22. The system of claim 16, where the microprocessor calculates a statistical significance for each of the first determination and the second determination, and determines that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated when the first determination and the second determination produce different outcomes and the outcome indicating that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated has a higher statistical significance than the outcome indicating that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated.

23. The system of claim 16, where the microprocessor calculates a statistical significance for each of the first determination and the second determination, and determines that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated when the first determination and the second determination produce different outcomes and the outcome indicating that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated has a higher statistical significance than the outcome indicating that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated.

24. A method, comprising:

sensing at least one cardiac signal during a cardiac episode, where the at least one cardiac signal includes auxiliary depolarizations and primary depolarizations;

measuring auxiliary cycle lengths between pairs of consecutively sensed auxiliary depolarizations in a measurement window interval;

calculating an average value (XXavg) and a standard deviation value (XXsd) of the auxiliary cycle lengths;

calculating a first time interval, where the first time interval has a value equal to;

(XXavg−

Y * XXsd),

where Y is a predetermined constant;

positioning the first time interval to surround each of one or more primary depolarizations of the primary depolarizations;

counting auxiliary depolarizations over the first time interval; and

determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated based on a number of the auxiliary depolarizations counted over the first time interval.

25. The method of claim 24, including programming a predetermined duration for the measurement window interval.

26. The method of claim 24, including programming a predetermined number of primary depolarizations defining the measurement window interval.

27. The method of claim 24, where the first time interval includes a first portion, and counting auxiliary depolarizations during the first time interval includes counting a first number (K) of auxiliary depolarizations during the first portion of the first time interval.

28. The method of claim 27, where the first portion of the first time interval is substantially a first-half of the first time interval.

29. The method of claim 28, further including:

comparing K to threshold values Klow and Khigh to classify the primary and auxiliary depolarizations at a predetermined confidence level; and

extending the measurement window interval when the relationship of K to threshold values Klow and Khigh shows that primary and auxiliary depolarizations are not classified with the predetermined confidence level.

30. The method of claim 28, where determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated includes determining that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated when K is less than or equal to a first threshold value Klow or greater than or equal to a second threshold value Khigh.

31. The method of claim 28, where determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated includes determining that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated when K is between a first threshold value Klow and a second threshold value Khigh.

32. A method, comprising:

sensing at least one cardiac signal during a cardiac episode, where the at least one cardiac signal includes auxiliary depolarizations and primary depolarizations;

counting a total number (N) of auxiliary depolarizations over a first time interval surrounding each of one or more primary depolarizations of the primary depolarizations;

counting a first number (K) of auxiliary depolarizations over a first portion of the first time interval;

calculating K/N; and

determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated based on K/N.

33. The method of claim 32, where determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated includes determining that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated when K/N is equal to approximately one-half (0.5).

34. The method of claim 32, where determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated includes determining that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated when K/N is not equal to approximately one-half (0.5).

35. A method, comprising:

sensing at least one cardiac signal during a cardiac episode, where the at least one cardiac signal includes auxiliary depolarizations and primary depolarizations;

positioning a first time interval having an approximate midpoint location to surround each of one or more primary depolarizations of the primary depolarizations such that the approximate midpoint location is positioned at each of the one or more primary depolarizations;

counting auxiliary depolarizations over the first time interval; and

determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated based on a number of the auxiliary depolarizations counted over the first time interval.

36. The method of claim 35, where the first time interval includes a first portion preceding the approximate midpoint location and a second portion which is subsequent to the approximate midpoint location, where counting the auxiliary depolarizations includes counting a first number of auxiliary depolarizations in the first portion of the first time interval, and a second number of auxiliary depolarizations in the second portion of the first time interval, and determining whether the first number and the second number are statistically different at a predetermined confidence level.

37. The method of claim 36, where determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated includes determining that the primary depolarizations and the auxiliary depolarizations are associated if the first number of auxiliary depolarizations and the second number of auxiliary depolarizations are statistically different at the predetermined confidence level.

38. The method of claim 36, where determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated includes determining that the primary depolarizations and the auxiliary depolarizations are disassociated if the first number of auxiliary depolarizations and the second number of auxiliary depolarizations are not statistically different at the predetermined confidence level.

39. The method of claim 36, including calculating the first portion and the second portion of the first time interval with an equation:

(XXavg−

Y * XXsd)/2,

where Y is a predetermined constant.

40. The method of claim 36, including:

counting a first number of primary depolarizations during a first portion of a second time interval surrounding the one or more auxiliary depolarizations;

counting a second number of primary depolarizations during a second portion of the second time interval; and

determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated based on the first number of primary depolarizations, the second number of primary depolarizations, the first number of auxiliary depolarizations and the second number of auxiliary depolarizations.

41. A method, comprising:

sensing at least one cardiac signal during a cardiac episode, where the at least one cardiac signal includes auxiliary depolarizations and primary depolarizations;

counting the auxiliary depolarizations over a first time interval surrounding each of one or more primary depolarizations of the primary depolarizations;

counting the primary depolarizations over a second time interval surrounding each of one or more auxiliary depolarizations of the auxiliary depolarizations; and

determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated based on a number of the auxiliary depolarizations counted over the first time interval and a number of the primary depolarizations counted over the second time interval.

42. The method of claim 41, comprising:

counting a first number (K) of auxiliary depolarizations over a first portion of the first time interval that precedes the each of one or more primary depolarizations;

counting a total number (N) of auxiliary depolarizations over the first time interval;

counting a first number (L) of primary depolarizations over a first portion of the second time interval that precedes each of the one or more auxiliary depolarizations;

counting a total number (M) of primary depolarizations over the second time interval;

making a first determination of whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated based on K and N;

making a second determination of whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated based on L and M; and

determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated based on outcomes of the first determination and the second determination.

43. The system of claim 42, where the first portion of the first time interval is substantially a first-half of the first time interval, and the first portion of the second time interval is substantially a first-half of the second time interval.

44. The method of claim 42, where determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated includes determining that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated when the outcomes of both the first determination and the second determination indicate that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated.

45. The method of claim 42, where determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated includes determining that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated when the outcomes of both the first determination and the second determination indicate that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated.

46. The method of claim 42, where determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated includes determining that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated when the outcome of either the first determination or the second determination indicates that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated.

47. The method of claim 42, where determining whether the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated or associated includes determining that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated when the outcome of either the first determination or the second determination indicates that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated.

48. The method of claim 42, including calculating a statistical significance for each of the results of the first determination and the second determination, and determining that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated when the first determination and the second determination produce different outcomes and the outcome indicating that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated has a higher statistical significance than the outcome indicating that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated.

49. The method of claim 42, including calculating a statistical significance for each of the results of the first determination and the second determination, and determining that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated when the first determination and the second determination produce different outcomes and the outcome indicating that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are disassociated has a higher statistical significance than the outcome indicating that the primary depolarizations and the auxiliary depolarizations in the cardiac episode are associated.