Reducing inappropriate delivery of therapy for suspected non-lethal arrhythmias

• US 7,930,024 B2
• Filed: 01/08/2004
• Issued: 04/19/2011
• Est. Priority Date: 01/08/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ousdigian, Kevin T.
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): Heller; Tammie K
• Application Number:
  US10/755,185
• Publication Number:
  US 20050154421A1
• Time in Patent Office: 2,658 Days
• Field of Search: 607/4, 607/5, 600515-518
• US Class Current: 607/5
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• 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

An implantable medical device (IMD) identifies suspected non-lethal ventricular arrhythmia, and takes one or more actions in response to the identification to avoid or delay delivery of a defibrillation or cardioversion shock. The IMD employs number of intervals to detect (NID) thresholds for detection of ventricular arrhythmias. When a NID threshold is met, the IMD determines whether the ventricular rhythm is a suspected non-lethal rhythm despite satisfying a NID threshold. In some embodiments, the IMD increases the NID threshold, i.e., extends the time for detection, in response to identifying a rhythm as a suspected non-lethal rhythm, and monitors subsequent ventricular beats to determine if the increased NID threshold is met before detecting a ventricular arrhythmia and delivering therapy. The IMD can determine whether a rhythm is a suspected non-lethal arrhythmia by, for example, comparing the median ventricular cycle length (VCL) to the median atrial cycle length (ACL).

Claims

1. A method of determining a status of a ventricular rhythm of a heart using an implantable medical device comprising a sensing electrode, a therapy electrode and a processor, comprising the steps of:

measuring a ventricular cycle length of a ventricular rhythm of a heart detected by said sensing electrode;

comparing with the processor a number of times the ventricular cycle length exceeds a ventricular cycle length threshold against a predetermined number of intervals to detect threshold (NID threshold) to obtain a comparison;

then

determining, with the processor and based on the comparison, if the ventricular rhythm is a lethal arrhythmia or a non-lethal arrhythmia; and

then

if the ventricular rhythm is a lethal arrhythmia, delivering a therapy to the heart using the therapy electrode;

if the ventricular rhythm is a non-lethal arrhythmia, withholding the therapy to the heart and increasing the NID threshold;

then

measuring a subsequent ventricular cycle length of the ventricular rhythm of the heart detected by said sensing electrode;

comparing with the processor an updated number of times the ventricular cycle length and the subsequent ventricular cycle length exceed the ventricular cycle length threshold against the NID threshold, as updated, to obtain an update of the comparison, the updated number of times additively incorporating an instance of the subsequent ventricular cycle length exceeding the ventricular cycle length threshold;

then

returning to the determining step; and

wherein the NID threshold is reset to the predetermined NID threshold by the processor upon a first predetermined condition and the number of times the ventricular cycle length exceeds a ventricular cycle length threshold is reset upon a second predetermined condition.

2. The method of claim 1, wherein the ventricular rhythm comprises one of ventricular fibrillation, ventricular tachycardia, and fast ventricular tachycardia, and the NID threshold comprises one of a ventricular fibrillation NID threshold, a ventricular tachycardia NID threshold, a fast ventricular tachycardia NID threshold, and a combined count NID threshold.

3. The method of claim 1, wherein the determining step comprises determining that the ventricular rhythm is non-lethal if the ventricular rhythm is one of a suspected supraventricular tachycardia and a monomorphic ventricular tachycardia.

4. The method of claim 1, wherein the comparison step comprises making a comparison of the ventricular cycle length to an atrial cycle length, wherein the ventricular cycle length is one of a median ventricular cycle length and a mean ventricular cycle length and the atrial cycle length is one of a median atrial cycle length and a mean atrial cycle length;

and

wherein the determining step comprises determining whether the ventricular rhythm is a non-lethal arrhythmia based on the comparison of the ventricular cycle length.

5. The method of claim 4, wherein the determining whether the ventricular rhythm step comprises determining whether the ventricular rhythm is non-lethal if the ventricular cycle length is greater than or substantially equal to the atrial cycle length.

6. The method of claim 5, wherein the determining whether the ventricular rhythm is non-lethal step comprises comparing a difference between the ventricular cycle length and the atrial cycle length to a suspect threshold value.

7. The method of claim 4, wherein increasing the NID threshold comprises selecting an amount by which the NID threshold is increased based on the comparison of the ventricular cycle length and the atrial cycle length.

8. The method of claim 1, wherein increasing the NID threshold comprises selecting an amount by which the NID threshold is increased based on one of a median ventricular cycle length and a mean ventricular cycle length.

9. The method of claim 1, wherein the determining step comprises determining whether the ventricular rhythm is the non-lethal arrhythmia if the ventricular cycle length exceeds a minimum ventricular cycle length threshold, and the ventricular cycle length is one of a median ventricular cycle length and a mean ventricular cycle length.

10. The method of claim 1, wherein the determining step is further based on determining whether the ventricular rhythm is a non-lethal arrhythmia based on analyzing at least one of regularity of a plurality of ventricular cycle lengths, regularity of a morphological feature of the ventricular rhythm, A-V association, and rate of onset of at least one of atrial cycle lengths, ventricular cycle lengths, and A-V interval lengths.

11. The method of claim 1, wherein the determining step is further based on determining whether the ventricular rhythm is a non-lethal arrhythmia based on analyzing one of an intracardiac pressure, respiration, and an activity level of a patient.

12. The method of claim 1, wherein increasing the NID threshold comprises increasing the NID threshold to a first value, the method further comprising:

determining if the ventricular rhythm is a slow non-lethal arrhythmia; and

increasing the NID threshold to a second value based on the slow non-lethal arrhythmia.

13. The method of claim 12, wherein determining whether the ventricular rhythm is a slow non-lethal arrhythmia comprises determining whether one of a median ventricular cycle length and a mean ventricular cycle length is greater than or equal to a threshold value.

14. The method of claim 1, further comprising after the comparing step, identifying at least one of cardiac and non-cardiac oversensing, and further comprising, after the identifying step, determining whether the ventricular rhythm is a non-lethal arrhythmia based on the identifying step.

15. The method of claim 14, wherein identifying at least one of cardiac and non-cardiac oversensing comprises determining whether one of a median ventricular cycle length and a mean ventricular cycle length is less than or equal to an oversensing threshold value.

16. The method of claim 1, wherein the therapy comprises delivering a withheld scheduled therapy only if the withheld scheduled therapy has been previously withheld.

17. The method of claim 16, wherein the withheld scheduled therapy is obtained by applying a first change to a scheduled therapy, the method further comprising:

determining whether the ventricular rhythm is a slow non-lethal arrhythmia; and

then

applying a second change to the therapy based on the slow non-lethal arrhythmia.

18. The method of claim 1, wherein increasing the NID threshold comprises increasing the NID threshold by a first amount based upon a first determination that the ventricular rhythm is a non-lethal arrhythmia, and wherein a subsequent increasing the NID threshold comprises increasing the NID threshold by a second amount based upon a second determination that the ventricular rhythm is a non-lethal arrhythmia.

19. The method of claim 1, wherein a clinician programs the predetermined NID threshold and an amount by which the NID threshold is increased in the increasing the NID threshold step.

20. An implantable medical device for a patient having a heart which generates a ventricular rhythm, comprising:

a sensing electrode sensitive to the ventricular rhythm;

a therapy electrode configured to deliver a therapy to the heart;

a processor, operatively coupled to the sensing electrode and the therapy electrode, configured to;

measure a ventricular cycle length of the ventricular rhythm;

compare a number of times the ventricular cycle length exceeds a ventricular cycle length threshold against a predetermined number of intervals to detect threshold (NID threshold) to obtain a comparison;

then perform a determine operation, based on the comparison, comprising determining if the ventricular rhythm is a lethal arrhythmia or a non-lethal arrhythmia; and

then

if a lethal arrhythmia, deliver a therapy to the heart with the therapy electrode;

if a non-lethal arrhythmia, withhold the therapy to the heart and increase the NID threshold;

then

measure a subsequent ventricular cycle length of the ventricular rhythm of the heart;

compare an updated number of times the ventricular cycle length and the subsequent ventricular cycle length exceed the ventricular cycle length threshold against the NID threshold, as updated, to obtain an update of the comparison, the updated number of times additively incorporating an instance of the subsequent ventricular cycle length that exceeds the ventricular cycle length threshold;

then

return to the determine operation; and

wherein the processor resets the NID threshold to the predetermined NID threshold upon a first predetermined condition and the number of times the ventricular cycle length exceeds a ventricular cycle length threshold is reset upon a second predetermined condition.

21. The device of claim 20, wherein the ventricular rhythm comprises one of ventricular fibrillation, ventricular tachycardia, and fast ventricular tachycardia, and the NID threshold comprises one of a ventricular fibrillation NID threshold, a ventricular tachycardia NID threshold, a fast ventricular tachycardia NID threshold, and a combined count NID threshold.

22. The device of claim 20, wherein the determine operation determines that the ventricular rhythm is non-lethal if the ventricular rhythm is one of a suspected supraventricular tachycardia and a monomorphic ventricular tachycardia.

23. The device of claim 20, wherein the determine operation determines that the ventricular rhythm is a non-lethal rhythm by comparing a ventricular cycle length to an atrial cycle length and determining whether the ventricular rhythm is a non-lethal arrhythmia based on the comparison, and wherein the ventricular cycle length is one of a median cycle length and the atrial cycle length is one of the median cycle length and the mean cycle length.

24. The device of claim 23, wherein the determine operation determines that ventricular cycle length is greater than or substantially equal to the atrial cycle length.

25. The device of claim 24, wherein the determine operation determines that the ventricular cycle length is greater than or substantially equal to the ventricular cycle length by comparing a difference between the ventricular cycle length and the atrial cycle length to a suspect threshold value.

26. The device of claim 23, wherein the processor selects an amount by which the NID threshold is increased based on the comparison of the ventricular cycle length and the atrial cycle length.

27. The device of claim 23, wherein the processor selects an amount by which the NID threshold is increased based on one of a median ventricular cycle length and a mean ventricular cycle length.

28. The device of claim 20,

wherein the determine operation determines that a ventricular cycle length exceeds a minimum ventricular cycle length threshold, and determines that the ventricular rhythm is a non-lethal arrhythmia based on the determination that the ventricular cycle length exceeds a minimum ventricular cycle length threshold;

and

wherein the ventricular cycle length is one of a median ventricular cycle length and a mean ventricular cycle length.

29. The device of claim 20, wherein the determine operation is further based on determining if the ventricular rhythm is a non-lethal arrhythmia by analyzing at least one of the regularity of a plurality of ventricular cycle lengths, regularity of a morphological feature of the ventricular rhythm, A-V association, and rate of onset of at least one of atrial cycle lengths, ventricular cycle lengths, and A-V interval lengths.

30. The device of claim 20, further comprising a pressure sensor implanted within the patient to detect an intracardiac pressure, wherein the processor further determines that the ventricular rhythm is a non-lethal arrhythmia based on the intracardiac pressure.

31. The device of claim 20, further comprising a circuit to measure an intrathoracic impedance of a patient via the sensing electrode, wherein the determines operation determines that the ventricular rhythm is a non-lethal arrhythmia based on the intrathoracic impedance.

32. The device of claim 20, further comprising an activity sensor to detect a patient activity of the patient, and further comprising a determines operation further determines that the ventricular rhythm is a non-lethal arrhythmia based on the patient activity.

33. The device of claim 20, wherein increasing the NID threshold comprises increasing the NID threshold to a first value based upon a first determination that the ventricular rhythm is a slow non-lethal arrhythmia, and increasing the NID threshold to a second value based upon a second determination that the ventricular rhythm is a slow non-lethal arrhythmia.

34. The device of claim 33, wherein the determine operation determines that the ventricular rhythm is a slow non-lethal arrhythmia based on a determination that one of a median ventricular cycle length and a mean ventricular cycle length is greater than or equal to a ventricular cycle length threshold value.

35. The device of claim 20, wherein the determine operation determines that the ventricular rhythm is a non-lethal arrhythmia by identifying at least one of cardiac oversensing and non-cardiac oversensing.

36. The device of claim 35, wherein the determine operation identifies at least one of cardiac oversensing and non-cardiac oversensing by determining whether one of a median ventricular cycle length and a mean ventricular cycle length is less than or equal to an oversensing threshold value.

37. The device of claim 20, wherein the therapy is a withheld scheduled therapy only if the withheld scheduled therapy has been previously withheld.

38. The device of claim 37, wherein in response to the determine operation determining that the ventricular rhythm is a non-lethal arrhythmia the withheld scheduled therapy is changed by applying a first change to a scheduled therapy, determining that the ventricular rhythm is a slow non-lethal arrhythmia, and applying a second change to the scheduled therapy based on the determination of a slow non-lethal arrhythmia.

39. The device of claim 20, wherein the processor increases the NID threshold by a first amount based upon a first determination that the ventricular rhythm is a non-lethal arrhythmia, and increases the NID threshold by a second amount based upon a second determination that the ventricular rhythm is a non-lethal arrhythmia.

40. The device of claim 20, wherein a clinician programs the predetermined NID threshold and an amount by which the NID threshold is increased when the processor increases the NID threshold.

41. The device of claim 20, wherein the device is implantable within a patient.

42. The device of claim 20, wherein the device comprises one of a pacemaker and a pacemaker-cardiovertor-defibrillator.

43. An implantable medical device for determining a status of a ventricular rhythm of a heart, comprising:

means for measuring a ventricular cycle length of a ventricular rhythm of a heart;

means for comparing a number of times the ventricular cycle length exceeds a ventricular cycle length threshold against a predetermined number of intervals to detect threshold (NID threshold) to obtain a comparison;

means for determining, based on the comparison, if the ventricular rhythm is a lethal arrhythmia or a non-lethal arrhythmia;

means for delivering a therapy to the heart if the ventricular rhythm is a lethal arrhythmia,;

means for withholding the therapy to the heart and increasing the NID threshold if the ventricular rhythm is a non-lethal arrhythmia;

means for measuring a subsequent ventricular cycle length of the ventricular rhythm of the heart;

means for comparing an updated number of times the ventricular cycle length and the subsequent ventricular cycle length exceed the ventricular cycle length threshold against the NID threshold, as updated, to obtain an update of the comparison, the updated number of times additively incorporating an instance of the subsequent ventricular cycle length that exceeds the ventricular cycle length threshold;

means for returning to the means for determining; and

wherein the NID threshold is reset to the predetermined NID threshold upon a first predetermined condition and the number of times the ventricular cycle length exceeds a ventricular cycle length threshold is reset upon a second predetermined condition.

44. The device of claim 43, wherein the means for determining comprises at least one of means for determining whether the ventricular rhythm is a suspected supraventricular tachycardia and means for determining whether the ventricular rhythm is a monomorphic ventricular tachycardia.

45. The device of claim 43, wherein the means for determining comprises means for comparing a ventricular cycle length to an atrial cycle length, wherein the ventricular cycle length is one of a median ventricular cycle length and a mean ventricular cycle length and the atrial cycle length is one of a median atrial cycle length and a mean atrial cycle length.

46. The device of claim 43, wherein the means for determining is further based on means for determining the ventricular rhythm is the non-lethal arrhythmia based on analyzing at least one of regularity of a plurality of ventricular cycle lengths, regularity of a morphological feature of the ventricular rhythm, A-V association, and rate of onset of at least one of atrial cycle lengths, ventricular cycle lengths, and A-V interval lengths.

47. The device of claim 43, further comprising means for detecting an intracardiac pressure, wherein the means for determining is further based on means for determining if the ventricular rhythm is a non-lethal arrhythmia based on an analysis of the intracardiac pressure.

48. The device of claim 43, further comprising means for measuring an intrathoracic impedance of a patient, wherein means for determining comprises means for determining whether the ventricular rhythm is a non-lethal arrhythmia based on an analysis of the intrathoracic impedance.

49. The device of claim 43, further comprising means for detecting activity of a patient, and further comprising means for determining whether the ventricular rhythm is a non-lethal arrhythmia based on an analysis of the activity of the patient.

50. The device of claim 43, wherein the means for determining comprises means for identifying at least one of cardiac and non-cardiac oversensing.

51. The device of claim 50, wherein means for identifying at least one of cardiac and non-cardiac oversensing comprises means for determining whether one of a median ventricular cycle length and a mean ventricular cycle length is less than or equal to an oversensing threshold value.