Implantable cardiac stimulation system and method for automatic capture verification calibration

• US 6,731,985 B2
• Filed: 10/16/2001
• Issued: 05/04/2004
• Est. Priority Date: 10/16/2001
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Poore, John W., Florio, Joseph J., Bradley, Kerry, Bornzin, Gene A., Sloman, Laurence S.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/981,555
• Publication Number:
  US 20030083708A1
• Time in Patent Office: 931 Days
• Field of Search: 607/4-28
• US Class Current: 607/28
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold

Abstract

An implantable cardiac stimulation device and associated method perform an automatic calibration procedure for evaluating whether automatic capture verification can be recommended. The calibration procedure calculates and displays a number of variables for use by a medical practitioner in programming automatic capture operating parameters. An average paced depolarization integral (PDI) is determined from the cardiac signals following delivery of multiple stimulation pulse below and above capture threshold such that both pure lead polarization signals and evoked response signals may be analyzed. From the paced depolarization integral data, a capture threshold, a stimulation response curve, a minimum evoked response, a maximum lead polarization, an evoked response sensitivity, an evoked response safety margin, and a polarization safety margin are determined. Based on these variables, the calibration procedure determines if automatic capture verification can be recommended. If so, the stimulation device calculates a capture detection threshold. The automatic capture verification recommendation and the estimated calibration variables are displayed.

Claims

1. A method of calibrating an automatic capture verification feature for use in an implantable cardiac stimulation device, comprising:

collecting cardiac signal data and calculating a paced depolarization integral, for a plurality of stimulation output settings;

determining a capture detection threshold; and

comparing the capture detection threshold to a computed value based on the paced depolarization integral, for determining if automatic capture verification is recommended.

2. The method of claim 1, wherein the step of collecting cardiac signal data includes collecting cardiac signal data for an output setting for an evoked response at which capture occurs, and at least one output setting at which loss of capture occurs.

3. The method of claim 2, wherein the step of determining the capture detection threshold includes using a unipolar or bipolar electrode configuration.

4. The method of claim 2, wherein the step of determining the capture detection threshold includes setting a temporary capture detection threshold.

5. The method of claim 4, wherein the step of setting the temporary capture detection threshold includes calculating the temporary capture detection threshold as a sum of an average characteristic value for a minimum stimulation output plus half the difference between an average characteristic value for a maximum stimulation output and an average characteristic value for a minimum stimulation output.

6. The method of claim 4, wherein the step of setting the temporary capture detection threshold includes determining the difference between a characteristic value for sequentially decreasing stimulation output settings.

7. The method of claim 6, wherein the step of setting the temporary capture detection threshold includes determining capture threshold as a lowest output setting at which the difference between an average characteristic value and the average characteristic value for the next lower stimulation output setting equals or exceeds a temporary capture detection threshold.

8. The method of claim 2, wherein the step of collecting the paced depolarization integral includes sampling a cardiac signal following the delivery of a stimulation pulse.

9. The method of claim 8, wherein the step of collecting the paced depolarization integral further includes integrating a sampled cardiac signal following the delivery of the stimulation pulse to obtain a paced depolarization integral for the sampled cardiac signal.

10. The method of claim 9, wherein the step of collecting the paced depolarization integral further includes setting an integration window following the delivery of the stimulation pulse during which signal samples are integrated.

11. The method of claim 10, wherein the step of integrating the sampled cardiac signal includes integrating only negative signal samples.

12. The method of claim 11, wherein the step of integrating the sampled cardiac signal includes integrating only negative signal samples less than an integration baseline.

13. The method of claim 12, wherein integrating only negative signal samples less than the integration baseline includes determining the integration baseline by averaging a specified number of signal samples.

14. The method of claim 12, wherein integrating only negative signal samples less than the integration baseline includes determining the integration baseline by averaging a number of signal samples occurring relative to a post-pulse fast recharge period.

15. The method of claim 2, wherein the step of collecting cardiac signal data includes collecting characteristic values of cardiac signals for each of a predetermined number of stimulation pulses, at each of a predetermined number of stimulation output settings.

16. The method of claim 15, further including statistically analyzing the characteristic values for each of the stimulation output settings.

17. The method of claim 16, wherein the step of statistically analyzing includes determining an average and standard deviation of a characteristic value for each of the stimulation output settings.

18. The method of claim 17, further including storing the average characteristic cardiac signal value and the standard deviation for each of the stimulation output settings.

19. The method of claim 2, wherein the step of collecting cardiac signal data includes automatically adjusting a gain setting.

20. The method of claim 19, wherein the step of automatically adjusting the gain setting includes adjusting the gain until a cardiac signal amplitude reaches a signal amplitude criterion.

21. The method of claim 20, wherein the step of automatically adjusting the gain setting includes adjusting the gain until the cardiac signal amplitude reaches a predetermined maximum amplitude value.

22. The method of claim 20, further including aborting the method of calibrating when a gain cannot be adjusted to meet the signal amplitude criterion.

23. The method of claim 1, wherein the step of collecting cardiac signal data includes automatically adjusting a fusion avoidance parameter.

24. The method of claim 23, wherein the step of automatically adjusting the fusion avoidance parameter includes determining if fusion is suspected.

25. The method of claim 24, wherein the step of determining if fusion is suspected includes determining a cardiac signal variability.

26. The method of claim 25, wherein the step of determining the cardiac signal variability includes determining a standard deviation of an average characteristic value of the cardiac signal.

27. The method of claim 25, wherein determining the cardiac signal variability includes determining a coefficient of variation defined as a quotient of a standard deviation of an average characteristic value divided by an average characteristic value for a stimulation output setting.

28. The method of claim 25, wherein the step of determining the cardiac signal variability includes comparing the cardiac signal variability to a predetermined maximum value.

29. The method of claim 28, wherein if the cardiac signal variability exceeds a predetermined maximum value, suspecting fusion.

30. The method of claim 24, wherein the step of adjusting the fusion avoidance parameter includes increasing a base stimulation rate when fusion is suspected.

31. The method of claim 1, further comprising determining the plurality of variables relating to the automatic capture verification feature.

32. The method of claim 31, wherein the step of determining the plurality of variables relating to the automatic capture verification feature further includes determining a slope of a stimulation response curve defined by a relation between a number of average characteristic cardiac signal values and corresponding stimulation output settings.

33. The method of claim 31, wherein the step of determining the plurality of variables relating to the automatic capture verification feature further includes determining an intercept of a stimulation response curve.

34. The method of claim 31, wherein the step of determining the plurality of variables relating to the automatic capture verification feature further includes determining a set of calibration variables.

35. The method of claim 34, wherein the step of determining the set of calibration variables includes:

setting a minimum evoked response;

setting a maximum lead polarization;

setting an evoked response sensing margin;

setting an evoked response sensitivity;

setting an evoked response safety margin; and

setting a polarization signal safety margin.

36. The method of claim 35, wherein the step of setting the minimum evoked response includes setting a minimum average characteristic cardiac signal value for a stimulation output equal to or greater than a capture threshold.

37. The method of claim 35, wherein the step of setting the maximum lead polarization includes setting a maximum average characteristic cardiac signal value for a stimulation output less than a capture threshold.

38. The method of claim 35, wherein the step of setting the evoked response sensing margin includes setting a difference between a minimum evoked response less twice its standard deviation and a maximum lead polarization plus twice its standard deviation.

39. The method of claim 35, wherein the step of setting the evoked response sensitivity includes setting a sum of one-third of the evoked response sensing margin and a maximum lead polarization plus twice its standard deviation.

40. The method of claim 39, wherein the step of setting the evoked response sensitivity includes identifying a cardiac signal exceeding an evoked response sensitivity as a capture signal.

41. The method of claim 35, wherein the step of setting the evoked response safety margin includes setting a quotient of a minimum average evoked response divided by an evoked response sensitivity.

42. The method of claim 35, wherein the step of setting the polarization safety margin includes setting a quotient of an evoked response sensitivity divided by a maximum lead polarization.

43. The method of claim 35, further including the step of using a set of calibration variables for programming automatic capture operating parameters.

44. The method of claim 2, wherein the step of determining the plurality of variables further includes displaying a variable relating to the operation of automatic capture verification.

45. The method of claim 2, wherein the step of comparing the capture detection threshold includes comparing the capture detection threshold to an acceptable minimum value, so that automatic capture is not recommended if the capture detection threshold is less than an acceptable minimum value.

46. The method of claim 2, wherein the step of comparing the capture detection threshold to a predetermined value includes comparing a lead polarization to an acceptable maximum, so that automatic capture is not recommended if a lead polarization signal is greater than an acceptable maximum value.

47. The method of claim 2, further including the step of not recommending automatic capture if a capture threshold is not determined.

48. The method of claim 2, wherein the step of comparing the capture detection threshold to a predetermined value includes comparing an evoked response safety margin to a minimum acceptable value, so that automatic capture is not recommended if the evoked response safety margin is less than an acceptable minimum value.

49. The method of claim 2, wherein the step of comparing the capture detection threshold to a predetermined value includes comparing a polarization safety margin to a minimum acceptable value, so that automatic capture is not recommended if the polarization safety margin is less than an acceptable minimum value.

50. The method of claim 2, wherein the step of comparing the capture detection threshold to a predetermined value includes comparing a slope of a response curve to a maximum acceptable value, so that automatic capture is not recommended if the slope of the response curve is greater than an acceptable maximum value.

51. The method of claim 2, further including displaying a message indicating that automatic capture verification is recommended if at least one predefined condition is met.

52. The method of claim 51, further including displaying a message indicating that automatic capture verification is not recommended if the predefined condition is not met.

53. The method of claim 2, further including determining a first set of variables relating to the operation of automatic capture if automatic capture is recommended, and determining a second set of variables relating to the operation of automatic capture if automatic capture verification is not recommended.

54. The method of claim 53 further including a step of prioritizing a plurality of conditions required for recommending automatic capture verification.

55. The method of claim 54, further including displaying the first set of variables if automatic capture is recommended and displaying the second set of variables if automatic capture is not recommended.

56. A cardiac stimulation device capable of calibrating an automatic capture verification feature, comprising:

a pulse generator that selectively generates stimulation energy;

a lead, connected to the pulse generator, that delivers the stimulation energy to one or more cardiac chambers;

a sensing circuit, coupled to the lead, that collects cardiac signal data for a plurality of stimulation output settings;

a calculator that calculates paced depolarization integrals from the cardiac signal data;

a control circuit, connected to the sensing circuit, that determines a capture detection threshold; and

wherein the control circuit compares the capture detection threshold to a computed value based on the paced depolarization integral, for determining if automatic capture verification is recommended.

57. The cardiac stimulation device of claim 56, wherein the cardiac signal data include cardiac signal data collected for an output setting for an evoked response at which capture occurs, and for an output setting at which loss of capture occurs.

58. The cardiac stimulation device of claim 57, wherein the lead has a unipolar configuration.

59. The cardiac stimulation device of claim 57, wherein the paced depolarization integral includes samples of a cardiac signal that follows the delivery of a stimulation pulse.

60. The cardiac stimulation device of claim 59, wherein the paced depolarization integral includes integrated samples of a cardiac signal following the delivery of the stimulation pulse.

61. The cardiac stimulation device of claim 60, further including a timing circuit that sets an integration window following the delivery of the stimulation pulse during which signal samples are integrated.

62. The cardiac stimulation device of claim 61, wherein integrated samples of the cardiac signal include only integrated negative signal samples.

63. The cardiac stimulation device of claim 61, wherein integrated samples of the cardiac signal include only integrated negative signal samples less than an integration baseline.

64. The cardiac stimulation device of claim 63, wherein the control circuit determines an integration baseline by averaging a predetermined number of signal samples.

65. The cardiac stimulation device of claim 63, wherein the control circuit determines an integration baseline by averaging a number of signal samples occurring during a post-pulse fast recharge period.

66. A cardiac stimulation device capable of calibrating an automatic capture verification feature, comprising:

means for collecting cardiac signal data and for calculating a paced depolarization integral, for a plurality of stimulation output settings;

means for determining a capture detection threshold; and

means for comparing the capture detection threshold to a computed value based on the paced depolarization integral, to determine if automatic capture verification is recommended.

67. The cardiac stimulation device of claim 66, wherein the cardiac signal data include cardiac signal data collected for an output setting for an evoked response at which capture occurs, and for an output setting at which loss of capture occurs.

68. The cardiac stimulation device of claim 67, further including means for delivering stimulation energy to one or more cardiac chamber having any of a unipolar configuration, a bipolar configuration, or a multipolar configuration.

69. The cardiac stimulation device of claim 68, wherein the paced depolarization integral includes samples of a cardiac signal that follows the delivery of a stimulation pulse.

70. The cardiac stimulation device of claim 69, wherein the paced depolarization integral includes integrated samples of a cardiac signal following the delivery of the stimulation pulse.

71. The cardiac stimulation device of claim 70, further including means for setting an integration window following the delivery of the stimulation pulse during which signal samples are integrated.

72. The cardiac stimulation device of claim 71, wherein integrated samples of the cardiac signal include only integrated negative signal samples less than an integration baseline.

73. The cardiac stimulation device of claim 72, wherein the integration baseline is determined by averaging a predetermined number of signal samples.

74. The cardiac stimulation device of claim 72, wherein the integration baseline is determined by averaging a plurality of signal samples that occur during a post-pulse fast recharge period.