Implantable cardioversion device with a self-adjusting threshold for therapy selection

• US 6,445,949 B1
• Filed: 01/05/2000
• Issued: 09/03/2002
• Est. Priority Date: 01/05/2000
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Kroll, Mark W.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US09/478,300
• Time in Patent Office: 972 Days
• Field of Search: 607/4, 607/5, 607/14, 607/27, 607/30, 600/515, 600/518, 600/519
• US Class Current: 607/4
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

In an implantable cardioversion device, the condition of the patient'"'"'s heart is determined from an intrinsic ventricular parameter, such as the ventricular rate, and therapy is provided with a shock or pulse generator, including, for instance, antitachycardia pacing therapy or defibrillation shocks. Initially, the conditions, i.e., ventricular tachycardia or fibrillation/flutter, are determined using predetermined values for a set of thresholds defining the various conditions. Thereafter, the thresholds are changed by increasing or decreasing the therapy thresholds from the predetermined values based on the success rate of the corresponding therapy.

Claims

1. An implantable cardiac stimulation device for providing therapy to a patient'"'"'s heart, the device comprising:

a sense amplifier that senses signals from the patient'"'"'s heart and generates signals related to the patient'"'"'s heart rate;

a memory circuit for storing threshold settings for determining the type of antiarrhythmic therapy to be applied to the patient'"'"'s heart for a range of heart rates defined by the stored threshold settings;

a control and timing circuit coupled to the sense amplifier and the memory circuit that generates control signals responsive to the sense signals and the threshold settings, the control signals defining one of a plurality of antiarrhythmic therapies, wherein the therapy is selected in accordance with the relationship of the sensed heart rate and the stored threshold settings;

a pulse generator that generates therapeutic pulses to the patient'"'"'s heart in response to the control signals; and

a rate threshold adjusting circuit being adapted to adjust the threshold settings stored in the memory circuit in accordance with the response of the patient to the selected antiarrhythmic therapy.

2. The device of claim 1 wherein the patient'"'"'s heart beats at a ventricular rate and the threshold settings are related to the ventricular rate of the patient'"'"'s heart.

3. The device of claim 1 wherein the threshold settings define a ventricular tachycardia zone and a ventricular fibrillation zone, and wherein the pulse generator generates antitachycardia pacing therapy pulses when the sensed heart rate corresponds to the ventricular tachycardia zone and defibrillation shocks when the sensed heart rate corresponds to the ventricular fibrillation zone.

4. The device of claim 1 wherein the control and timing circuit determines a cardiac condition of the patient based on the ventricular rate and the stored threshold settings.

5. The device of claim 1 wherein the threshold settings define ventricular rate ranges, each range corresponding to a cardiac condition, and wherein the control and timing circuit determines the cardiac condition based on a ventricular rate corresponding to one of the ranges.

6. The device of claim 5 wherein the control and timing circuit further determines the cardiac condition based on a secondary criteria.

7. The device of claim 6 wherein the secondary criteria comprises sudden onset, wherein the control and timing circuit determines that physiological sinus rhythm is present when the sudden onset criteria is not met, and determines that a pathological rhythm is present when the sudden onset criteria is met.

8. The device of claim 6 wherein the secondary criteria comprises an indication that the patient is exercising.

9. The device of claim 6 wherein the secondary criteria comprises a mean ventricular rate interval (VRI_M) within a respective zone.

10. The device of claim 6 wherein the secondary criteria comprises a success rate of converting the patient'"'"'s rhythm to a normal rhythm.

11. The device of claim 6 wherein the control and timing circuit adjusts the threshold in the direction of the mean ventricular rate interval (VRI_M) within a respective zone.

12. The device of claim 10 wherein the control and timing circuit determines that a threshold adjustment is needed when the success rate is low, and determines that a threshold adjustment is not needed when the success rate is high.

13. The device of claim 1 wherein the memory circuit additionally stores a plurality of rules, wherein the threshold adjusting circuit adjusts the threshold setting using the stored rules.

14. The device of claim 1 wherein the threshold settings define a slow ventricular tachycardia zone and a fast ventricular tachycardia zone, and wherein the pulse generator generates less aggressive antitachycardia therapy when the sensed heart rate corresponds to the slow ventricular tachycardia zone, and generates more aggressive antitachycardia therapy when the sensed heart rate corresponds to the fast ventricular tachycardia zone.

15. The device of claim 1 wherein the threshold settings define a normal sinus rhythm zone and a ventricular tachycardia zone, and the pulse generator generates no therapy when the sensed heart rate corresponds to the normal sinus rhythm zone, and generates antitachycardia therapy when the sensed heart rate corresponds to the ventricular tachycardia zone.

16. An implantable cardioversion device generating antitachyarrhythmic therapy for a patient'"'"'s heart, the device comprising:

a sense amplifier receiving intrinsic signals indicative of ventricular activity and generating corresponding sense signals;

a condition detector receiving the sense signals and generating patient condition signals indicative of the condition of the patient based on the sense signals and a set of thresholds;

a threshold level setting circuit that generates the thresholds;

a timing and control circuit that generates command signals based on the patient condition signals and the sense signals, the command signals defining a therapy for the patient corresponding to the patient condition signals;

an output signal generator receiving the commands and responsively generating therapeutic pulses to revert the patient condition to a sinus state;

a therapy success detector that analyzes the therapeutic pulses to determine a success rate at which said therapeutic pulses have reverted the patient condition to a sinus state; and

wherein

the threshold setting circuit is coupled to the therapy success detector to adjust the threshold levels in accordance with the determined success rate.

17. The device of claim 16 wherein the condition detector detects the condition based on the ventricular rate.

18. The device of claim 17 wherein the condition detector further detects the patient'"'"'s condition based on a secondary criteria.

19. The device of claim 18 wherein the secondary criteria comprises sudden onset, wherein the control and timing circuit determines that physiological sinus rhythm is present when the sudden onset criteria is not met, and determines that a pathological rhythm is present when the sudden onset criteria is met.

20. The device of claim 18 wherein the secondary criteria comprises an indication that the patient is exercising.

21. The device of claim 18 wherein the secondary criteria comprises a mean ventricular rate interval (VRI_M) within a respective zone.

22. The device of claim 21, wherein the control and timing circuit adjusts the threshold in the direction of the mean ventricular rate interval (VRI_M) within a respective zone.

23. The device of claim 16 wherein the condition detector compares the ventricular rate to a plurality of sets of ranges to determine if the ventricular rate is within one of the sets of ranges, the ranges defining various tachyarrhythmia conditions for the patient'"'"'s heart.

24. The device of claim 16 wherein the condition detector compares the ventricular rate to a plurality of sets of ranges defining a sinus rhythm, a ventricular tachyarrhythmia and a ventricular fibrillation/flutter condition.

25. The device of claim 24 wherein the sets of ranges correspond to the levels set by the threshold setting circuit.

26. The device of claim 16 further comprising a memory storing a plurality of rules for determining the conditions under which the thresholds are changed, and wherein the threshold setting circuit is coupled to the memory to apply the rules to the current thresholds in accordance with the cardiac condition of the patient as determined by the condition detector and the success rate.

27. The device of claim 16 wherein the control and timing circuit determines that a threshold adjustment is needed when the success rate is low, and determines that a threshold adjustment is not needed when the success rate is high.

28. In an implantable cardioversion device which includes a sensor for sensing cardiac activity in a patient'"'"'s heart, a patient condition detector that identifies the patient'"'"'s cardiac condition based on the cardiac activity and a set of thresholds, and a pulse generator configured for generating antitachyarrhythmic signals in accordance with the output of the patient condition detector, a process of dynamically adjusting the set of thresholds comprising the steps of:

setting the set of thresholds to predetermined values;

operating the device using the predetermined values; and

adjusting the thresholds dynamically by changing the predetermined threshold values in accordance with the cardiac activity resulting in response to the antitachyarrhythmic signals.

29. The method of claim 28 wherein the thresholds define a sinus rhythm condition, a tachycardia condition and a fibrillation/flutter condition.

30. The method of claim 28 wherein the device includes a memory storing rules defining how the threshold values are changed and further comprising applying the rules for adjusting the threshold values.

31. The method of claim 28 further comprising determining a success rate indicative of whether a therapy dependent on the antitachyarrhythmic signals has successfully reverted the patient'"'"'s heart to a normal sinus rhythm.

32. The method of claim 31 wherein the step of adjusting the thresholds is dependent on the success rate.

33. The method of claim 28 wherein the sensed cardiac activity corresponds to the ventricular rate.

34. The method of claim 28 wherein the antitachyarrhythmic signals are selected from the set of cardioversion pacing pulses and defibrillation shocks.

35. The method of claim 28 wherein the step of adjusting the thresholds is dependent on sudden onset of the cardiac activity.

36. The method of claim 28 wherein the step of adjusting the thresholds is dependent on whether there is an indication that the patient is exercising.

37. The method of claim 28 wherein the step of adjusting the thresholds is dependent on a mean ventricular rate interval.

38. The method of claim 37 wherein the adjusting step comprises the step of adjusting the threshold in the direction of the mean ventricular rate interval (VRI_M) within a respective zone.

39. The method of claim 28 wherein the adjusting step comprises the step of adjusting the threshold when the success rate is low.