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

• US 7,120,491 B1
• Filed: 03/12/2003
• Issued: 10/10/2006
• Est. Priority Date: 03/12/2003
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bailin, Steven, Kroll, Mark W.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US10/387,651
• Time in Patent Office: 1,308 Days
• Field of Search: 607 1-156
• US Class Current: 607/5
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• 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 pulse generator, including, for instance, antitachycardia pacing therapy or defibrillation shocks. Initially, the conditions, i.e., ventricular tachycardia or fibrillation, 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 morphology of the sensed ventricular signals.

Claims

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

a sense amplifier to sense intrinsic signals from the patient'"'"'s heart and to generate corresponding sense signals;

a memory circuit to store interval thresholds to determine the type of antiarrhythmic therapy to be applied to the patient'"'"'s heart for a range of heart rates defined by the interval thresholds;

a control and timing circuit coupled to the sense amplifier and the memory circuit to generate control signals responsive to the sense signals and the interval thresholds, the control signals to define one of a plurality of antiarrhythmic therapies, wherein the therapy is selected in accordance with the relationship of the sensed heart rate and the interval thresholds;

an interval threshold adjusting circuit to adjust the interval thresholds stored in the memory circuit in accordance with the response of the patient to the selected antiarrhythmic therapy; and

a morphology discrimination circuit coupled to the control and timing circuit, at least one of the interval thresholds modified in accordance with a morphology detection applied to the intrinsic signals;

wherein the interval thresholds define a very slow ventricular tachycardia zone, a slow ventricular tachycardia zone, and a fast ventricular tachycardia zone;

wherein the at least one of the interval thresholds is an interval threshold VT1I, and wherein the morphology discrimination circuit compares a QRS complex of the intrinsic signals with a stored template to verify the very slow ventricular tachycardia; and

wherein the QRS complex is compared with the stored template when a ventricular rate interval (VRI) is between 100% and 130% of the interval threshold VT1I.

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

3. The device of claim 1 wherein the interval thresholds define a very slow ventricular tachycardia zone, 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 very slow ventricular tachycardia zone and the slow ventricular tachycardia zone, and generates more aggressive antitachycardia therapy when the sensed heart rate corresponds to the fast ventricular tachycardia zone.

4. An implantable cardiac stimulation device to provide therapy to a patient'"'"'s heart, the device comprising:

a sense amplifier to sense intrinsic signals from the patient'"'"'s heart and to generate corresponding sense signals;

a memory circuit to store interval thresholds to determine the type of antiarrhythmic therapy to be applied to the patient'"'"'s heart for a range of heart rates defined by the interval thresholds;

a control and timing circuit coupled to the sense amplifier and the memory circuit to generate control signals responsive to the sense signals and the interval thresholds, the control signals to define one of a plurality of antiarrhythmic therapies, wherein the therapy is selected in accordance with the relationship of the sensed heart rate and the interval thresholds;

an interval threshold adjusting circuit to adjust the interval thresholds stored in the memory circuit in accordance with the response of the patient to the selected antiarrhythmic therapy;

a morphology discrimination circuit coupled to the control and timing circuit, at least one of the interval thresholds modified in accordance with a morphology detection applied to the intrinsic signals; and

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

wherein the therapeutic pulses comprises AntiTachycardia Pacing therapy (ATP), and wherein an interval threshold VT1I is increased when the ATP Is successful.

5. The device of claim 4 wherein the interval threshold VT1I is increased to (VRI_M+2σ

), wherein VRI_M is the mean ventricular rate interval and σ

is the standard deviation.

6. The device of claim 4 wherein the interval thresholds define ventricular rate ranges, each range corresponding to a cardiac condition, and wherein the control and timing circuit determines the cardiac condition based at least in part on a ventricular rate corresponding to one of the ranges.

7. The device of claim 4 wherein the interval thresholds 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.

8. The device of claim 4 wherein the control and timing circuit determines a cardiac condition of the patient based on the ventricular rate and the interval thresholds.

9. The device of claim 4 wherein the interval thresholds define ventricular rate ranges, each range corresponding to a cardiac condition, and wherein the control and timing circuit determines the cardiac condition based at least in part on a ventricular rate corresponding to one of the ranges.

10. The device of claim 9 wherein the control and timing circuit further determines the cardiac condition based on a secondary criteria.

11. The device of claim 10 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.

12. The device of claim 10 wherein the secondary criteria comprises an indication that the patient is exercising.

13. An implantable cardiac stimulation device to provide therapy to a patient'"'"'s heart, the device comprising:

a sense amplifier to sense intrinsic signals from the patient'"'"'s heart and to generate corresponding sense signals;

a memory circuit to store interval thresholds to determine the type of antiarrhythmic therapy to be applied to the patient'"'"'s heart for a range of heart rates defined by the interval thresholds;

a control and timing circuit coupled to the sense amplifier and the memory circuit to generate control signals responsive to the sense signals and the interval thresholds, the control signals to define one of a plurality of antiarrhythmic therapies, wherein the therapy is selected in accordance with the relationship of the sensed heart rate and the interval thresholds;

an interval threshold adjusting circuit to adjust the interval thresholds stored in the memory circuit in accordance with the response of the patient to the selected antiarrhythmic therapy; and

a morphology discrimination circuit coupled to the control and timing circuit, at least one of the interval thresholds modified in accordance with a morphology detection applied to the intrinsic signals;

wherein the interval thresholds define ventricular rate ranges, each range corresponding to a cardiac condition, and wherein the control and timing circuit determines the cardiac condition based at least in part on a ventricular rate corresponding to one of the ranges;

wherein the control and timing circuit further determines the cardiac condition based on a secondary criteria; and

wherein the secondary criteria comprises a mean ventricular rate interval (VRI_M) within a respective zone.

14. An implantable cardiac stimulation device to provide therapy to a patient'"'"'s heart, the device comprising:

a sense amplifier to sense intrinsic signals from the patient'"'"'s heart and to generate corresponding sense signals;

a memory circuit to store interval thresholds to determine the type of antiarrhythmic therapy to be applied to the patient'"'"'s heart for a range of heart rates defined by the interval thresholds;

a control and timing circuit coupled to the sense amplifier and the memory circuit to generate control signals responsive to the sense signals and the interval thresholds, the control signals to define one of a plurality of antiarrhythmic therapies, wherein the therapy is selected in accordance with the relationship of the sensed heart rate and the interval thresholds;

an interval threshold adjusting circuit to adjust the interval thresholds stored in the memory circuit in accordance with the response of the patient to the selected antiarrhythmic therapy; and

a morphology discrimination circuit coupled to the control and timing circuit, at least one of the interval thresholds modified in accordance with a morphology detection applied to the intrinsic signals;

wherein the interval thresholds define ventricular rate ranges, each range corresponding to a cardiac condition, and wherein the control and timing circuit determines the cardiac condition based at least in part on a ventricular rate corresponding to one of the ranges;

wherein the control and timing circuit further determines the cardiac condition based on a secondary criteria; and

wherein the secondary criteria comprises a success rate of converting the patient'"'"'s rhythm to a normal rhythm.

15. The device of claim 14 wherein the control and timing circuit determines that an interval threshold adjustment is needed when the success rate is low, and determines that an interval threshold adjustment is not needed when the success rate is high.

16. The device of claim 14 wherein the memory circuit additionally stores a plurality of rules, wherein the rate threshold adjusting circuit adjusts the interval threshold using the stored rules.

17. A method for providing therapy to a patient'"'"'s heart, the method comprising:

sensing intrinsic signals from the patient'"'"'s heart and generating corresponding sense signals;

storing interval thresholds to determine the type of antiarrhythmic therapy to be applied to the patient'"'"'s heart for a range of heart rates defined by the interval thresholds;

generating control signals responsive to the sense signals and the interval threshold, 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 interval thresholds; and

analyzing success rates of the antiarrhythmic therapies to convert the patient'"'"'s rhythm to a normal sinus rhythm and adjusting the interval thresholds in accordance with the success rates of the selected antiarrhythmic therapies, at least one of the interval thresholds modified in accordance with a morphology discrimination applied to the intrinsic signals.

18. The method of claim 17 wherein the interval thresholds define a very slow ventricular tachycardia zone, a slow ventricular tachycardia zone, and a fast ventricular tachycardia zone.

19. The method of claim 18 wherein the at least one of the interval thresholds is an interval threshold VT1I, and wherein the morphology discrimination comprises comparing a QRS complex of the intrinsic signals with a stored template to verify the very slow ventricular tachycardia.

20. The method of claim 19 wherein the QRS complex is compared with the stored template when a ventricular rate interval is between 100% and 130% of the interval threshold VT1I.

21. The method of claim 17 further comprising generating therapeutic pulses to the patient'"'"'s heart in response to the control signals.

22. The method of claim 21 wherein the therapeutic pulses comprises AntiTachycardia Pacing therapy (ATP), and wherein an interval threshold VT1I is increased when the ATP is successful.

23. The method of claim 22 wherein the interval threshold VT1I is increased to (VRI_M+2σ

), wherein VRI_M is the mean ventricular rate interval and σ

is the standard deviation.

24. The method of claim 21 wherein the interval thresholds define a very slow ventricular tachycardia zone, a slow ventricular tachycardia zone, and a fast ventricular tachycardia zone, and wherein the therapeutic pulses are less aggressive for antitachycardia therapy when the sensed heart rate corresponds to the very slow ventricular tachycardia zone and the slow ventricular tachycardia zone, and the therapeutic pulses are more aggressive for antitachycardia therapy when the sensed heart rate corresponds to the fast ventricular tachycardia zone.

25. The method of claim 24 wherein the interval thresholds define ventricular rate ranges, each range corresponding to a cardiac condition, and wherein determination of the cardiac condition is based on a ventricular rate corresponding to one of the ranges.

26. The method of claim 25 wherein the cardiac condition is based on a secondary criteria.

27. The method of claim 26 wherein the secondary criteria comprises sudden onset, wherein the presence of physiological sinus rhythm is determined when the sudden onset criteria is not met, and wherein the presence of a pathological rhythm is present when the sudden onset criteria is met.

28. The method of claim 26 wherein the secondary criteria comprises an indication that the patient is exercising.

29. The method of claim 26 wherein the secondary criteria comprises a mean ventricular rate interval (VRI_M) within a respective zone.

30. The method of claim 26 wherein the interval threshold is adjusted in the direction of the mean ventricular rate interval (VRI_M) within a respective zone.

31. The method of claim 17 wherein the patient'"'"'s heart beats at a ventricular rate and the interval thresholds are related to the ventricular rate of the patient'"'"'s heart.

32. The method of claim 17 wherein an interval threshold adjustment is needed when the success rate is low, and wherein an interval threshold adjustment is not needed when the success rate is high.

33. The method of claim 17 further comprising storing a plurality of rules, wherein the interval threshold is adjusted using the stored rules.

34. An implantable cardiac stimulation device to generate antitachyarrhythmic therapy for a patient'"'"'s heart, the device comprising:

a sense amplifier to receive intrinsic signals indicative of ventricular activity and to generate corresponding sense signals;

a condition detector to receive the sense signals and to generate 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 to generate the thresholds;

a timing and control circuit to generate 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 to receive the commands and to responsively generate therapeutic pulses to revert the patient condition to a sinus state; and

a therapy success detector to analyze the therapeutic pulses to determine a success rate at which the therapeutic pulses have reverted the patient condition to a sinus state, wherein the threshold setting circuit is coupled to the therapy success detector to adjust the thresholds in accordance with the determined success rate;

wherein the threshold setting circuit adjusts at least one of the thresholds in accordance with a morphology discrimination applied to the intrinsic signals.

35. The device of claim 34 wherein the thresholds define a very slow ventricular tachycardia zone, a slow ventricular tachycardia zone, and a fast ventricular tachycardia zone.

36. The device of claim 35 wherein the at least one of the interval thresholds is an interval threshold VT1I, and wherein the morphology detection comprises comparing a QRS complex of the intrinsic signals with a stored template to verify the very slow ventricular tachycardia.

37. The device of claim 36 wherein the QRS complex is compared with the stored template when a ventricular rate interval is between 100% and 130% of the interval threshold VT1I.

38. The device of claim 36 wherein the therapeutic pulses comprises AntiTachycardia Pacing therapy (ATP), and wherein the interval threshold VT1I is increased when the ATP is successful.

39. The device of claim 38 wherein the interval threshold VT1I is increased to (VRI_M+2σ

), wherein VRI_M is the mean ventricular rate interval and σ

is the standard deviation.