Digital AGC using separate gain control and threshold templating

• US 5,620,466 A
• Filed: 08/14/1995
• Issued: 04/15/1997
• Est. Priority Date: 08/14/1995
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Stockburger, Mark A., Haefner, Paul A., Linder, William J.
• Primary Examiner(s): Jaworski, Francis
• Assistant Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US08/514,612
• Time in Patent Office: 610 Days
• Field of Search: 128/696, 128/702, 128/704, 128/708, 607/4, 607/5, 607/25, 607/9, 607/13, 607/28
• US Class Current: 607/5
• CPC Class Codes: A61N 1/3704 Circuits specially adapted therefor, e.g. for sensitivity control

Abstract

A system and method automatically adjusts a sensing threshold in a cardioverter/defibrillator which receives electrical activity of the heart and delivers shock pulses in response thereto. An amplifier amplifies the electrical activity according to a variable gain. A detection circuit detects depolarizations in the amplified electrical activity and provides a detect signal representing a cardiac event indicative of a depolarization when the amplified electrical activity exceeds a variable sensing threshold. Slow gain control circuitry adjusts the variable gain in discrete steps based on stored peak history information representing peak values of the amplified electrical activity. Template generation circuitry responds quickly to set the variable sensing threshold to a level proportional to a peak value of the amplitude of the amplified electrical activity and then decreases the variable sensing threshold from the level in discrete steps until the variable sensing threshold is at a low threshold value.

Claims

1. A method of automatically adjusting a sensing threshold in a cardioverter/defibrillator which receives electrical activity of a heart and provides shock pulses in response thereto, the method comprising the steps of:

amplifying the electrical activity according to a variable gain;

detecting cardiac events representing depolarizations in the electrical activity which exceed a variable sensing threshold;

acquiring amplitudes of the amplified electrical activity;

adjusting the variable sensing threshold to a level proportional to an acquired amplitude of the amplified electrical activity of a current detected cardiac event;

decreasing the variable sensing threshold from the level in discrete steps until the variable sensing threshold is at a low threshold value; and

adjusting the variable gain based on amplitudes of the amplified electrical activity of at least three detected cardiac events.

2. The method of claim 1 wherein the step of adjusting the variable gain comprises the steps of:

increasing the variable gain if a first selected number (M) of peak values of the amplified electrical activity of a second selected number (N) of the at least three detected. cardiac events are below a selected low threshold, wherein M is less than or equal to N; and

decreasing the variable gain if M peak values of the amplified electrical activity of the N cardiac events are above a selected high threshold.

3. The method of claim 2 wherein the variable gain is increased in the increasing step if a stored peak value of the last cardiac event and M-1 peak values of the last N-1 cardiac events previous to the last cardiac event are below the selected low threshold and the variable gain is decreased in the decreasing step if the stored peak value of the last cardiac event and M-1 peak values of the last N-1 cardiac events previous to the last cardiac event are above the selected high threshold.

4. The method of claim 2 wherein M is at least 3 and N is at least 4.

5. The method of claim 2 further comprising the step of decreasing the variable gain if the peak values of the amplified electrical activity of a third selected number of cardiac events alternate between clipped peak values and non-clipped peak values.

6. The method of claim 5 wherein the third selected number is at least two more than N.

7. The method of claim 1 wherein said level is a percentage of a peak value of the acquired amplitude of the amplified electrical activity of the current detected cardiac event.

8. The method of claim 7 wherein said percentage is approximately 75%.

9. The method of claim 1 wherein the step of adjusting the variable sensing threshold to said level occurs prior to the end of a new sensed refractory period caused by a cardiac event.

10. The method of claim 1 wherein the method automatically adjusts the sensing threshold in a cardioverter/defibrillator having pacing capability, and wherein the step of adjusting the variable sensing threshold to said level occurs at the end of a paced/shock refractory period resulting from a pace or shock pulse.

11. The method of claim 1 wherein the step of decreasing is performed by decreasing the variable sensing threshold in step groups, wherein each step group comprises multiple discrete steps, and wherein each step group decreases the variable sensing threshold by a defined percentage.

12. The method of claim 11 wherein the defined percentage is approximately 50%.

13. The method of claim 11 wherein each step group includes at least 4 discrete steps.

14. The method of claim 1 wherein the step of decreasing includes the step of calculating an amount of drop for a discrete step using integer math.

15. The method of claim 1 wherein the variable sensing threshold is decreased in the decreasing step according to a decay rate and wherein the method further comprises the step of varying a time width of each discrete step based on operating conditions of the cardioverter/defibrillator to control the decay rate of the variable sensing threshold.

16. The method of claim 15 wherein the method automatically adjusts the sensing threshold in a cardioverter/defibrillator having pacing capability, and wherein the operating conditions of the cardioverter/defibrillator include bradycardia pacing, tachyrhythmia sensing, and normal sinus sensing.

17. The method of claim 16 wherein the time width is varied as a function of a bradycardia pacing rate when the cardioverter/defibrillator is operating under the bradycardia pacing conditions.

18. The method of claim 1 wherein the method automatically adjusts the sensing threshold in a cardioverter/defibrillator having pacing capability, and wherein the method further comprises the steps of:

setting the variable sensing threshold after a pace or a shock pulse to a selected relatively high threshold value; and

holding the variable sensing threshold at the selected relatively high threshold value through a paced/shock refractory period resulting from the pace or shock pulse.

19. The method of claim 1 wherein the step of adjusting the variable gain includes the step of setting the variable gain to a selected relatively high sensitivity based on a certain condition occurring.

20. The method of claim 19 wherein the certain condition occurs when a cardiac event is not detected within a selected time period.

21. The method of claim 19 wherein the certain condition occurs after a shock pulse is delivered by the cardioverter/defibrillator.

22. The method of claim 19 wherein the method automatically adjusts the sensing threshold in a cardioverter/defibrillator having pacing capability, and wherein the certain condition occurs after a pacing pulse is delivered by the cardioverter/defibrillator.

23. The method of claim 19 wherein the step of adjusting the variable gain is performed in discrete steps and the selected relatively high sensitivity is at least one discrete step from a maximum sensitivity.

24. The method of claim 23 further comprising the step of decrementing the variable gain from the selected relatively high sensitivity by a selected number of discrete gain steps if the setting of the variable gain to the selected relatively high sensitivity creates a clipped peak value of the amplified electrical activity on the following detected cardiac event.

25. The method of claim 24 further comprising the step of further decrementing the variable gain by at least one discrete gain step if the peak value of the amplified electrical activity is still clipped on the second detected cardiac event following the setting of the variable gain to the selected relatively high sensitivity.

26. The method of claim 23 further comprising the step of decrementing the variable gain from the selected relatively high sensitivity by a selected number of discrete gain steps if the setting of the variable gain to the selected relatively high sensitivity does not create a clipped peak value of the amplified electrical activity on the following detected cardiac event and does create a clipped peak value of the amplified electrical activity on the second detected cardiac event following the setting of the variable gain to the selected relatively high sensitivity.

27. A system for automatically adjusting a sensing threshold in a cardioverter/defibrillator having a pulse circuit for generating shock pulses based on a detect signal representing cardiac events indicated in electrical activity of a heart, the system comprising:

an amplifier for amplifying the electrical activity of the heart according to a variable gain;

a cardiac depolarization detector for detecting depolarizations in the amplified electrical activity of the heart and providing the detect signal representing a cardiac event indicative of a depolarization when the amplified electrical activity exceeds a variable sensing threshold;

gain controller for adjusting the variable gain of the amplifier based on amplitudes of the amplified electrical activity of at least three detected cardiac events; and

threshold controller for acquiring amplitudes of the amplified electrical activity and for adjusting the variable sensing threshold to a level proportional to the acquired amplitude of the amplified electrical activity of a current detected cardiac event and for decreasing the variable sensing threshold from said level in discrete steps until the variable sensing threshold is at a low threshold value.

28. The system of claim 27 wherein the gain controller comprises:

storage means for storing peak history information representative of peak values of the amplified electrical activity of a first selected number (N) of the at least three detected cardiac events; and

adjusting means for adjusting the variable gain based on the stored peak history information.

29. The system of claim 28 wherein the adjusting means adjusts the variable gain only if a second selected number (M) of peak values of the N cardiac events are outside of a selected range, wherein M is less than or equal to N.

30. The system of claim 28 wherein the adjusting means increases the variable gain if a second selected number (M) of peak values of the N cardiac events are below a selected low threshold and decreases the variable gain if M peak values of the N cardiac events are above a selected high threshold, wherein M is less than or equal to N.

31. The system of claim 30 wherein the adjusting means increases the variable gain if a stored peak value of the last cardiac event and M-1 peak values of the last N-1 cardiac events previous to the last cardiac event are below the selected low threshold and decreases the variable gain if the stored peak value of the last cardiac event and M-1 peak values of the last N-1 cardiac events previous to the last cardiac event are above the selected high threshold.

32. The system of claim 30 wherein the storage means comprises a first group of storage locations which store peak history information indicating if the peak values are below the selected low threshold and a second group of storage locations which store peak history information indicating if the peak values are above the selected high threshold.

33. The system of claim 30 wherein M is at least 3 and N is at least 4.

34. The system of claim 28 wherein the storage means is capable of storing peak history information representative of peak values of the amplified electrical activity of a second selected number of cardiac events, and the system further comprises:

gain turndown means responsive to the stored peak history information to decrease the variable gain if the peak values of the amplified electrical activity of the second selected number of cardiac events alternate between clipped peak values and non-clipped peak values.

35. The system of claim 48 wherein the second selected number is at least two more than N.

36. The system of claim 28 wherein the peak history information from a previous cardiac event is updated at the beginning of a new sensed refractory period caused by a cardiac event.

37. The system of claim 27 wherein said level is a percentage of a peak value of the acquired amplitude of the amplified electrical activity of the current detected cardiac event.

38. The system of claim 37 wherein said percentage is approximately 75%.

39. The system of claim 27 wherein the threshold controller adjusts the variable sensing threshold to said level prior to the end of a new sensed refractory period caused by a cardiac event.

40. The system of claim 27 wherein the system automatically adjusts the sensing threshold in a cardioverter/defibrillator having pacing capability, and wherein the threshold controller adjusts the variable sensing threshold to said level at the end of a paced/shock refractory period resulting from a pace or shock pulse.

41. The system of claim 27 wherein said discrete steps are grouped into step groups, wherein each step group decreases the variable sensing threshold by a defined percentage.

42. The system of claim 41 wherein the defined percentage is approximately 50%.

43. The system of claim 41 wherein each step group includes at least 4 discrete steps.

44. The system of claim 27 wherein the threshold controller calculates an amount of drop for a discrete step using integer math to achieve a piecewise linear approximation of a geometric progression.

45. The system of claim 44 wherein the geometric progression is an exponential decay curve.

46. The system of claim 27 wherein the threshold controller decreases the variable sensing threshold according to a decay rate and wherein the system further comprises decay rate control means for varying a time width of each discrete step based on operating conditions of the cardioverter/defibrillator to control the decay rate of the variable sensing threshold.

47. The system of claim 46 wherein the system automatically adjusts the sensing threshold in a cardioverter/defibrillator having pacing capability, and wherein the operating conditions of the cardioverter/defibrillator include bradycardia pacing, tachyrhythmia sensing, and normal sinus sensing.

48. The system of claim 47 wherein the decay rate control means varies the time width as a function of a bradycardia pacing rate when the cardioverter/defibrillator is operating under the bradycardia pacing conditions.

49. The system of claim 27 wherein the system automatically adjusts the sensing threshold in a cardioverter/defibrillator having pacing capability, and wherein the system further comprises:

means for setting the variable sensing threshold after a pace or a shock pulse to a selected relatively high threshold value and for holding the variable sensing threshold at the selected relatively high threshold value through a paced/shock refractory period resulting from the pace or shock pulse.

50. The system of claim 27 wherein the gain controller includes means responsive to the detect signal to set the variable gain to a selected relatively high sensitivity based on a certain condition occurring.

51. The system of claim 50 wherein the certain condition occurs when a cardiac event is not detected within a selected time period.

52. The system of claim 50 wherein the certain condition occurs after a shock pulse is delivered by the cardioverter/defibrillator.

53. The system of claim 50 wherein the system automatically adjusts the sensing threshold in a cardioverter/defibrillator having pacing capability, and wherein the certain condition occurs after a pacing pulse is delivered by the cardioverter/defibrillator.

54. The system of claim 50 wherein the gain controller adjusts the variable gain in discrete gain steps and the selected relatively high sensitivity is at least one discrete step from a maximum sensitivity.

55. The system of claim 54 further comprising means for decrementing the variable gain from the selected relatively high sensitivity by a selected number of discrete gain steps if the setting of the variable gain to the selected relatively high sensitivity creates a clipped peak value of the amplified electrical activity on the following detected cardiac event.

56. The system of claim 55 further comprising means for decrementing the variable gain by at least one discrete gain step if the peak value of the amplified electrical activity is still clipped on the second detected cardiac event following the setting of the variable gain to the selected relatively high sensitivity.

57. The system of claim 54 further comprising means for decrementing the variable gain from the selected relatively high sensitivity by a selected number of discrete gain steps if the setting of the variable gain to the selected relatively high sensitivity does not create a clipped peak value of the amplified electrical activity on the following detected cardiac event and does create a clipped peak value of the amplified electrical activity on the second detected cardiac event following the setting of the variable gain to the selected relatively high sensitivity.

58. A cardiac rhythm management device for generating electrical pulses and coupleable to an electrode for sensing electrical activity of a heart and carrying the electrical pulses to the heart, the device comprising:

an input/output terminal connectable to the electrode to receive the sensed electrical activity of the heart from the electrode and to provide the electrical pulses to the electrode;

a sense amplifier coupled to the input/output terminal and amplifying the electrical activity of the heart according to a variable gain;

a cardiac depolarization detector coupled to the sense amplifier and detecting depolarizations in the amplified electrical activity of the heart and providing a detect signal representing a cardiac event indicative of a depolarization when the amplified electrical activity exceeds a variable sensing threshold;

gain controller coupled to the sense amplifier and the cardiac depolarization detector to adjust the variable gain of the sense amplifier based on amplitudes of the amplified electrical activity of at least three detected cardiac events; and

threshold controller coupled to the sense amplifier and the cardiac depolarization detector to acquire amplitudes of the amplified electrical activity and to adjust the variable sensing threshold to a level proportional to the acquired amplitude of the amplified electrical activity of a current detected cardiac event and to decrease the variable sensing threshold from the level in discrete steps until the variable sensing threshold is at a low threshold value; and

a pulse circuit coupled to the input/output terminal and the cardiac depolarization detector for generating the electrical pulses based on the detect signal.