Apparatus and method of arrhythmia detection in a subcutaneous implantable cardioverter/defibrillator

• US 6,754,528 B2
• Filed: 11/21/2001
• Issued: 06/22/2004
• Est. Priority Date: 11/21/2001
• Status: Expired due to Term

• Current Assignee: Cameron Incorporated (Schlumberger NV)
• Original Assignee: Cameron Incorporated (Schlumberger NV)
• Inventors: Ostroff, Alan H., Rissmann, William J., Allavatam, Venugopal, Erlinger, Paul J., Bardy, Gust H.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/990,510
• Publication Number:
  US 20030097153A1
• Time in Patent Office: 944 Days
• Field of Search: 600/509, 600/515, 600/518, 600/516, 600/517, 600/510, 607/4, 607/5, 607/9
• US Class Current: 607/5
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• 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: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3931 Protecting, e.g. back-up systems
• CPC Class Codes: A61N 1/395 for treating atrial fibrillation
• 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

Abstract

In a subcutaneous implantable cardioverter/defibrillator, cardiac arrhythmias are detected to determine necessary therapeutic action. Cardiac signal information is sensed from far field electrodes implanted in a patient. The sensed cardiac signal information is then amplified and filtered. Parameters such as rate, QRS pulse width, cardiac QRS slew rate, amplitude and stability measures of these parameters from the filtered cardiac signal information are measured, processed and integrated to determine if the cardioverter/defibrillator needs to initiate therapeutic action.

Claims

1. A method for detecting arrhythmias with a non-transvenous implantable cardioverter/defibrillator comprising the steps of:

sensing cardiac signal information from two far field sensors implanted in a patient;

amplifying the sensed cardiac signal information;

filtering the amplified cardiac signal information;

measuring one or more parameters of the filtered cardiac signal information; and

processing and integrating the one or more parameters of the cardiac signal information.

2. The method of claim 1, wherein the non-transvenous implantable cardioverter/defibrillator further comprises an subcutaneous implantable cardioverter-defibrillator.

3. The method of claim 1, wherein the non-transvenous implantable cardioverter/defibrillator further comprises a unitary subcutaneous implantable cardioverter-defibrillator.

4. The method of claim 1, wherein the step of measuring the one or more parameters further comprises the step of measuring the one or more parameters from a group consisting of rate, cardiac QRS pulse width, cardiac QRS slew rate, amplitude and stability.

5. The method of claim 1, further comprising the step of modifying the one or more parameters measured on a periodic basis.

6. The method of claim 1, further comprising the step of modifying the one or more parameters measured on a continuous basis.

7. The method of claim 6, further comprising the step of modifying the one or more parameters based on positional or cardiac substrate changes.

8. The method of claim 7, further comprising the step of performing derivative processing.

9. The method of claim 1, further comprising the step of filtering the one or more parameters measured on a beat-to-beat basis using a moving average filter.

10. The method of claim 1, further comprising the step of filtering the one or more parameters measured on a beat-to-beat basis using an adaptive filter.

11. The method of claim 10, further comprising the step of measuring a time interval between two or more successive QRS complexes.

12. The method of claim 11, further comprising the step of analyzing the one or more parameters from a group consisting of QRS complex width, QRS peak amplitude, and QRS slew rate.

13. The method of claim 11, further comprising the step of performing additional processing to extract variability information of the one or more parameters.

14. The method of claim 11, further comprising the step of performing additional processing to extract derivative processing information.

15. The method of claim 1, further comprising the step of filtering the one or more parameters measured on a beat-to-beat basis by applying x out of y calculations.

16. The method of claim 15, further comprising the step of determining a variability between the two or more successive QRS complexes.

17. The method of claim 1, further comprising the step of identifying a timing of a QRS complex of the filtered cardiac signal information.

18. The method of claim 1, further comprising the step of converting the filtered cardiac signal information to a digital format.

19. The method of claim 1, further comprising the step of determining if therapeutic action needs to be initiated based on the processing and integrating of the one or more parameters.

20. The method of claim 1, wherein the step of amplifying the cardiac signal information further comprises the step of amplifying the cardiac signal information to a CMRR value of at least approximately 80 dB.

21. A non-transvenous implantable cardioverter/defibrillator comprising:

two far field electrodes spaced from each other;

an amplifier coupled to the far field electrodes;

at least one filter coupled to the amplifier;

a timing detector coupled to the at least one filter;

a converter coupled to the at least one filter;

at least one parameter detector coupled to the converter; and

a parameter integrator.

22. The non-transvenous implantable cardioverter/defibrillator of claim 21 further comprising an subcutaneous implantable cardioverter-defibrillator.

23. The non-transvenous implantable cardioverter/defibrillator of claim 21 further comprising a unitary subcutaneous implantable cardioverter-defibrillator.

24. The non-transvenous implantable cardioverter/defibrillator of claim 21, wherein the amplifier further comprises a CMRR value of at least approximately 70 db.

25. The non-transvenous implantable cardioverter/defibrillator of claim 21, wherein at least one filter further comprises a narrow-band filter with corners set at approximately 10 Hz and 30 Hz.

26. The non-transvenous implantable cardioverter/defibrillator of claim 21, wherein the at least one filter further comprises a wide-band filter with corners set at approximately 1 Hz and 50 Hz.

27. The non-transvenous implantable cardioverter/defibrillator of claim 21, wherein the at least one parameter detector further comprises a parameter detector from the group consisting of a QRS width detector, a peak amplitude detector, and a QRS slew rate detector.

28. The non-transvenous implantable cardioverter/defibrillator of claim 27 further comprising at least one additional post processor coupled to the at least one parameter detector.

29. The non-transvenous implantable cardioverter/defibrillator of claim 28 wherein the at least one additional post processor further comprises derivative processing.

30. The non-transvenous implantable cardioverter/defibrillator of claim 28 wherein the at least one additional post processor further comprises analysis of variability of the at least one parameter detector.

31. The non-transvenous implantable cardioverter/defibrillator of claim 27, further comprising a QRS width stability detector coupled to the QRS width detector.

32. The non-transvenous implantable cardioverter/defibrillator of claim 27, further comprising a peak amplitude stability detector coupled to the peak amplitude detector.

33. The non-transvenous implantable cardioverter/defibrillator of claim 27, further comprising a QRS slew rate stability detector coupled to the QRS slew rate detector.

34. The non-transvenous implantable cardioverter/defibrillator of claim 21, wherein the timing detector further comprises a QRS detector and a timer.

35. The non-transvenous implantable cardioverter/defibrillator of claim 34, further comprising an R-R interval rate detector.

36. The non-transvenous implantable cardioverter/defibrillator of claim 34, further comprising an R-R interval stability detector.

37. The non-transvenous implantable cardioverter/defibrillator of claim 34, further comprising at least one additional post processor.

38. The non-transvenous implantable cardioverter/defibrillator of claim 37, wherein the at least one additional post processor further comprises derivative processing.

39. The non-transvenous implantable cardioverter/defibrillator of claim 21 wherein the at least one parameter detector further comprises at least one register for modifying at least one parameter on a periodic basis.

40. The non-transvenous implantable cardioverter/defibrillator of claim 21 wherein the at least one parameter detector further comprises at least one register for modifying at least one parameter on a dynamic basis.

41. The non-transvenous implantable cardioverter/defibrillator of claim 40, wherein the at least one register modifies the at least one parameter based on body positional changes.

42. A non-transvenous implantable cardioverter/defibrillator comprising:

two far field electrodes disposed at a predetermined distance from each other;

sensing means for sensing a cardiac signal through the two far field electrodes;

amplifying means for amplifying the sensed cardiac signal;

filtering means for filtering the amplified cardiac signal;

measuring means for measuring at least one parameter of the cardiac signal; and

integrating means for integrating the at least one parameter of the cardiac signal information.

43. The non-transvenous cardioverter/defibrillator of claim 42 further comprising an subcutaneous implantable cardioverter-defibrillator.

44. The non-transvenous cardioverter/defibrillator of claim 42 further comprising a unitary subcutaneous implantable cardioverter-defibrillator.

45. The non-transvenous implantable cardioverter/defibrillator of claim 42, wherein the amplifying means further comprises a CMRR value of at least approximately 80 db.

46. The non-transvenous implantable cardioverter/defibrillator of claim 42, wherein the filtering means further comprises a narrow band filter with corners set at approximately 10 Hz and 30 Hz.

47. The non-transvenous implantable cardioverter/defibrillator of claim 42, wherein the filtering means further comprises a wide band filter with corners set at approximately 1 Hz and 50 Hz.

48. The non-transvenous implantable cardioverter/defibrillator of claim 42, further comprising converter means coupled to the filtering means for converting an analog signal to a digital signal.

49. The non-transvenous implantable cardioverter/defibrillator of claim 48, wherein the measuring means further comprises at least one of a QRS width detector, a peak amplitude detector, and a QRS slew rate detector.

50. The non-transvenous implantable cardioverter/defibrillator of claim 42, wherein the measuring means further comprises a QRS detector.

51. The non-transvenous implantable cardioverter/defibrillator of claim 50, further comprising an R-R interval rate detector coupled to the QRS detector.

52. The non-transvenous implantable cardioverter/defibrillator of claim 51, further comprising an R-R interval stability detector coupled to the R-R interval rate detector.

53. The non-transvenous implantable cardioverter/defibrillator of claim 42, further comprising post processing means for derivative processing of the at least one parameter.

54. The non-transvenous implantable cardioverter/defibrillator of claim 42, wherein the integrating means further comprises an integration block that is implemented with a statistical classifier approach in n-dimensions.

55. The non-transvenous implantable cardioverter/defibrillator of claim 42, wherein the integrating means further comprises an integration block that is implemented with a statistical classifier approach in one dimension.

56. The non-transvenous implantable cardioverter/defibrillator of claim 42, wherein the integrating means further comprises an integration block that is implemented with a statistical classifier approach in two dimensions.

57. The non-transvenous implantable cardioverter/defibrillator of claim 42, wherein the integrating means further comprises an integration block that is implemented with a statistical classifier approach in three dimensions.

58. The non-transvenous implantable cardioverter/defibrillator of claim 42, wherein the integrating means further comprises an integration block.

59. The non-transvenous implantable cardioverter/defibrillator of claim 58, wherein the integration block is implemented using an artificial narrow network.

60. The non-transvenous implantable cardioverter/defibrillator of claim 59, wherein the artificial neural network employs a multiplayer perceptron structure.

61. The non-transvenous implantable cardioverter/defibrillator of claim 58, wherein the integration block is implemented using an artificial neural network and employing a backpropagation algorithm.

62. A method for treating a patient with a nontransvenous implantable cardioverter/defibrillator, comprising the steps of:

sensing cardiac information of the patient on a continuous basis through two far field electrodes spaced from each other;

performing additional analysis of the cardiac information; and

delivering appropriate therapy to the patient according to the analysis performed.

63. The method of claim 62, wherein the non-transvenous implantable cardioverter/defibrillator further comprises an subcutaneous implantable cardioverter-defibrillator.

64. The method of claim 62, wherein the non-transvenous implantable cardioverter/defibrillator further comprises a unitary subcutaneous implantable cardioverter-defibrillator.

65. The method of claim 62, wherein the step of sensing cardiac information further comprises using at least one far field electrode.

66. The method of claim 62, wherein the step of sensing cardiac information further comprises the step of sensing additional patient information on a continuous basis.

67. The method of claim 66, wherein the additional patient information further comprises impedance information that can be used to extract ventilation rate.

68. The method of claim 66, wherein the additional patient information includes impedance information that can be used to extract minute ventilation.

69. The method of claim 66, wherein the additional patient information further comprises activity information on the patient'"'"'s position.

70. The method of claim 69, wherein the activity information is measured using a piezo-electric sensor.

71. The method of claim 69, wherein the activity information is measured using an accelerometer.

72. The method of claim 69, wherein the activity information is measured using a one dimensional accelerometer.

73. The method of claim 69, wherein the activity information is measured using a two dimensional accelerometer.

74. The method of claim 69, wherein the activity information is measured using a three dimensional accelerometer.

75. The method of claim 69, wherein the activity information is measured using an n-dimensional accelerometer.

76. The method of claim 69, wherein a mercury switch is used to determine the patient'"'"'s position.

77. The method of claim 62, wherein the cardiac information further compromises at least two rate zones.

78. The method of claim 77, wherein the at least two rate zones further comprises a rate zone that provides therapy for rates in the rate zone.

79. The method of claim 77, wherein the at least two rate zones further comprises a rate zone that provides therapy if the heart rate rhythm is sustained for a pre-determined time period.

80. The method of claim 77, wherein one of the at least two rate zones can be disabled to provide no therapy.

81. The method of claim 77, wherein the at least two rate zones further comprises a rate zone that provides therapy if the rate is in this zone and in the additional analysis determines therapy should be employed.

82. The method of claim 77, wherein the at least two rate zones further comprises a rate zone that does not provide therapy for rates in this zone.

83. The method of claim 62, wherein the step of performing additional analysis further comprises a step of determining a boundary condition in n-dimensions.

84. The method of claim 83, wherein the step of determining the boundary condition can be determined empirically or analytically.

85. The method of claim 84, wherein the boundary condition is determined in one dimension and is represented by a scaler value.

86. The method of claim 84, wherein the step of the boundary condition is determined in two dimensions and is represented by a straight line, polynomial or other non-linear function.

87. The method of claim 84, wherein the boundary condition is determined in three dimensions and is represented by a plane or three dimensional surface plot.

88. The method of claim 84, wherein the boundary condition is adaptable to long-term changes in the cardiac substrate.

89. A method for detecting arrhythmias with a non-transvenous implantable cardioverter/defibrillator comprising the steps of:

sensing cardiac signal information from two subcutaneous electrodes, at least one of the subcutaneous electrodes being positioned in the rib area, said subcutaneous electrodes being spaced from the heart;

amplifying the sensed cardiac signal information;

filtering the amplified cardiac signal information;

measuring one or more parameters of the filtered cardiac signal information; and

processing and integrating the one or more parameters of the cardiac signal information.

90. A non-transvenous implantable cardioverter/defibrillator comprising:

two subcutaneous electrodes, at least one the subcutaneous electrodes being disposed in the rib area;

an amplifier coupled to the two electrodes;

at least one filter coupled to the amplifier;

a timing detector coupled to the at least one filter;

a converter coupled to the at least one filter;

at least one parameter detector coupled to the converter; and

a parameter integrator.

91. A method for detecting arrhythmias with a non-transvenous implantable cardioverter/defibrillator comprising the steps of:

sensing cardiac signal information from one or more far field sensors implanted in a patient;

amplifying the sensed cardiac signal information;

filtering the amplified cardiac signal information;

measuring one or more parameters of the filtered cardiac signal information; and

processing and integrating the one or more parameters of the cardiac signal information;

wherein, the step of amplifying the cardiac signal information further comprises the step of amplifying the cardiac signal information to a CMRR value of at least approximately 80 dB.

92. A non-transvenous implantable cardioverter/defibrillator comprising:

at least one far field electrode;

an amplifier coupled to the at least one far field electrode;

at least one filter coupled to the amplifier;

a timing detector coupled to the at least one filter;

a converter coupled to the at least one filter;

at least one parameter detector coupled to the converter; and

a parameter integrator;

wherein the amplifier further comprises a CMRR value of at least approximately 70 db.

93. A non-transvenous implantable cardioverter/defibrillator comprising:

at least one far field electrode;

an amplifier coupled to the at least one far field electrode;

at least one filter coupled to the amplifier;

a timing detector coupled to the at least one filter;

a converter coupled to the at least one filter;

at least one parameter detector coupled to the converter; and

a parameter integrator;

wherein at least one filter further comprises a narrow-band filter with corners set at approximately 10 Hz and 30 Hz.