Anti-arrhythmic device and a method of delivering anti-arrhythmic cardiac therapy

• US 7,953,481 B1
• Filed: 10/25/2000
• Issued: 05/31/2011
• Est. Priority Date: 10/25/1999
• Status: Expired due to Fees

• Current Assignee: Impulse Dynamics NV
• Original Assignee: Impulse Dynamics NV
• Inventors: Haluska, Edward, Policker, Shay, Belsky, Ziv, Shemer, Itzhak
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US10/111,512
• Time in Patent Office: 3,870 Days
• Field of Search: 607/7, 607/11, 607/14, 607/15, 607/4, 607/9
• US Class Current: 607/14
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

A cardiac contractility modulating (CCM) device (30) includes an anti-arrhythmic therapy unit (38) for detecting a cardiac arrhythmia in a heart (2) of a patient based on processing electrical signals related to cardiac activity sensed at the heart, and for delivering anti-arrhythmic therapy to the heart. The device includes a cardiac contractility modulating (CCM) unit (40) capable of delivering cardiac contractility modulating (CCM) signals to the heart for modulating the contractility of a portion of the heart. The device (30) includes a power source (165). The device may be an implantable device or a non-implantable device. A method for delivering anti-arrhythmic therapy to a heart. The method includes applying one or more non-excitatory cardiac contractility modulating electrical signals to said heart.

Claims

1. A method of applying a plurality of cardiac contractility modulating electrical signals to the heart, the method comprising:

calculating a level of arrhythmia prevalence by counting a plurality of arrhythmic episodes in said heart during a given period;

comparing between said level of arrhythmia prevalence and a value representing a level of arrhythmia prevalence of arrhythmia to be treated; and

applying, in response to an outcome of said comparing, one or more of said plurality of cardiac contractility modulating electrical signals to said heart for reducing said level of arrhythmia prevalence,

wherein said cardiac contractility modulating electrical signals are capable of increasing contractility of cardiac muscle cells of the heart.

2. The method according to claim 1 wherein said calculating comprises processing electrical signals sensed in or about said heart to obtain data representative of the heart rate of said heart, classifying the determined heart rate according to a classification method adapted to determine the suspected occurrence of different types of arrhythmia based on said determined heart rate, and wherein said applying comprises controlling a delivery of said cardiac contractility modulating electrical signals to said heart based on the type of suspected arrhythmia detected by said classifying.

3. The method according to claim 1 wherein said calculating comprises processing electrical signals sensed in or about said heart to determine a first value representative of said level of arrhythmia prevalence within a time period of said a plurality of arrhythmic episodes in said heart, comparing said first value to said initiation threshold, and wherein said applying comprises the delivering of said one or more cardiac contractility modulating electrical signals to said heart for a first therapy period if said first value is larger than said initiation threshold.

4. The method according to claim 3 wherein said calculating further comprises continuing said calculating within the duration of said first therapy period.

5. The method according to claim 4 further including the delivering a second type of anti-arrhythmic therapy to said heart if a tachy-arrhythmia is detected within the duration of said first therapy period, said second type of anti-arrhythmic therapy is different from said applying of said one or more cardiac contractility modulating signals of said first therapy period.

6. The method according to claim 5 wherein said second type of anti-arrhythmic therapy is selected from a defibrillating shock therapy, a cardioverting shock therapy, an anti-tachycardia pacing therapy, and a variable energy shock therapy.

7. The method according to claim 5 further including terminating the delivery of said cardiac contractility modulating electrical signals of said first therapy period prior to delivering said second type of anti arrhythmic therapy to said heart.

8. The method according to claim 4 further including changing at least one signal parameter of said cardiac contractility modulating electrical signals delivered to said heart if a tachy-arrhythmia is still detected within the duration of said first therapy period.

9. The method according to claim 8 wherein said at least one signal parameter is selected from the duration of said cardiac contractility modulating electrical signals, the amplitude of said cardiac contractility modulating electrical signals, the waveform of said cardiac contractility modulating electrical signals, the polarity of said cardiac contractility modulating electrical signals, and any combination thereof.

10. The method according to claim 1, wherein said contractility modulating electrical signals are applied to the cardiac muscle before the end of the effective refractory period of said cardiac muscle.

11. The method according to claim 1, wherein said method is used for anti-arrhythmic therapy to the heart.

12. The method according to claim 1, wherein said applying is performed as long as said level of arrhythmia prevalence exceeds said initiation threshold.

13. The method according to claim 1, wherein said plurality of cardiac contractility modulating electrical signals comprise non-excitatory cardiac contractility modulating electrical signals.

14. The method according to claim 1, wherein said applying is performed repetitively.

15. The method according to claim 1, wherein said level of arrhythmia prevalence is selected from a group consisting of:

a level of prevalence of ventricular tachycardia (VT) and a level of prevalence of ventricular fibrillation (VF).

16. A method of applying anti-arrhythmic therapy to a heart, the method comprising:

sensing in or about a heart electrical signals related to cardiac activity of said heart;

calculating a level of arrhythmia prevalence by counting a plurality of arrhythmic episodes in said heart during a given period;

processing said electrical signals to obtain data representative of the heart rate of said heart;

processing said data to detect a cardiac tachy-arrhythmia or an indication of a possible tachy-arrhythmia in said heart; and

in response to said processing, reducing said level of arrhythmia prevalence by repetitively applying one or more non-excitatory cardiac contractility increasing electrical signals to said heart, said applying being performed in response to detecting said tachy-arrhythmia or said indication, wherein said non-excitatory cardiac contractility increasing electrical signals are capable of increasing contractility of cardiac muscle cells of the heart for said anti-arrhythmic therapy.

17. The method according to claim 16 wherein said second processing comprises classifying said data according to a classification method adapted to detect the suspected occurrence of different types of arrhythmia, and controlling a delivery in said applying of said one or more non-excitatory cardiac contractility increasing electrical signals to said heart based on the type of suspected arrhythmia detected by said classifying.

18. The method according to claim 16 wherein said second processing comprises processing said data to determine a first value representative of the level of arrhythmia prevalence of a plurality of arrhythmic episodes in said heart within a time period, comparing said first value to a threshold value, and wherein said applying comprises the delivering of said cardiac contractility increasing electrical signals to said heart for a first therapy period if said first value is larger than said threshold value.

19. The method according to claim 18 wherein said second processing comprises continuing said processing to determine a second value representative of the level of arrhythmia prevalence within at least a portion of the duration of said first therapy period.

20. The method according to claim 19 further including the delivering a second type of anti-arrhythmic therapy to said heart if a tachy-arrhythmia or said indication is detected within the duration of said first therapy period, said second type of anti-arrhythmic therapy is different from said applying of said cardiac contractility increasing signals of said first therapy period.

21. The method according to claim 20 wherein said second type of anti-arrhythmic therapy is selected from a defibrillating shock therapy, a cardioverting shock therapy, an anti-tachycardia pacing therapy, and a variable energy shock therapy.

22. The method according to claim 20 further including terminating the delivery of said cardiac contractility increasing electrical signals of said first therapy period prior to delivering said second type of anti arrhythmic therapy to said heart.

23. The method according to claim 19 further including changing at least one signal parameter of said one or more cardiac contractility increasing electrical signals delivered to said heart if a tachy-arrhythmia or said indication is still detected within the duration of said first therapy period.

24. The method according to claim 23 wherein said at least one signal parameter is selected from the duration of said cardiac contractility increasing electrical signals, the amplitude of said cardiac contractility increasing electrical signals, the waveform of said cardiac contractility increasing electrical signals, the polarity of said cardiac contractility increasing electrical signals, and any combination thereof.

25. The method according to claim 16, wherein said contractility increasing electrical signals are applied to the cardiac muscle before the end of the effective refractory period of said cardiac muscle.

26. A method for reducing the prevalence of arrhythmic episodes in a heart, the method comprising:

calculating a level of arrhythmia prevalence by counting a plurality of arrhythmic episodes in said heart during a given period;

comparing between said level of arrhythmia prevalence and a value representing a level of arrhythmia prevalence of arrhythmia to be treated; and

reducing said level of arrhythmia prevalence by applying one or more non-excitatory cardiac contractility, increasing electrical signals to at least a portion of said heart;

wherein said non-excitatory cardiac contractility increasing electrical signals are capable of increasing contractility of cardiac muscle cells of the heart.

27. The method according to claim 26 wherein said non-excitatory cardiac contractility increasing electrical signals comprise current pulses delivered to said at least a portion of said heart.

28. The method according to claim 27 wherein said current pulses are square current pulses delivered to the left ventricle of said heart, said current pulses have an amplitude in the range of 6-15 milliamperes, a pulse duration in the range of 20-40 milliseconds, and a delay of 20-90 milliseconds from a triggering event sensed in or about the right ventricle of said heart.

29. The method according to claim 26, wherein said contractility increasing electrical signals are applied to the cardiac muscle before the end of the effective refractory period of said cardiac muscle.

30. A method of applying non-excitatory cardiac contractility increasing signals to the heart as an anti-arrhythmic therapy, the method comprising:

calculating a level of arrhythmia prevalence by counting a plurality of arrhythmic episodes in said heart during a given period;

comparing between said level of arrhythmia prevalence and a value representing a level of arrhythmia prevalence of arrhythmia to be treated;

detecting a cardiac tachy-arrhythmia or an indication of a possible tachy-arrhythmia in said heart according to said comparison; and

reducing, in response to said detection, said level of arrhythmia prevalence by applying one or more of said non-excitatory cardiac contractility increasing signals to said heart in response to detecting said tachy-arrhythmia or said indication in said detecting,

wherein said non-excitatory cardiac contractility increasing electrical signals are capable of increasing contractility of cardiac muscle cells of the heart for said anti-arrhythmic therapy.

31. An anti-arrhythmic device for delivering anti-arrhythmic non-excitatory cardiac contractility increasing signal therapy to a heart, the device comprising:

a tachy-arrhythmia detecting unit configured for receiving and processing electrical cardiac signals related to cardiac activity sensed at said heart, calculating a level of arrhythmia prevalence by counting a plurality of arrhythmic episodes in said heart during a given period based on said processing electrical cardiac signals, and comparing between said level of arrhythmia prevalence and an initiation threshold;

a cardiac contractility modulating unit configured for delivering non-excitatory cardiac contractility increasing electrical signals to said heart in response to said comparing; and

a controller unit operatively connected to said tachy-arrhythmia detecting unit and to said cardiac contractility modulating unit, said controller unit being configured for controlling said cardiac contractility modulating unit to deliver one or more of said non-excitatory cardiac contractility increasing electrical signals to said heart in response to said level of arrhythmia prevalence, wherein said non-excitatory cardiac contractility increasing electrical signals are capable of increasing contractility of cardiac muscle cells of the heart for an anti-arrhythmic therapy.

32. The anti-arrhythmic device according to claim 31 wherein said controller unit is configured for obtaining data representative of the heart rate of said heart from said electrical cardiac signals, classifying the determined heart rate according to a classification method adapted to determine the suspected occurrence of different types of arrhythmia based on said determined heart rate, and controlling the delivery of said non-excitatory cardiac contractility increasing electrical signals to said heart by said cardiac contractility modulating unit based on the type of suspected arrhythmia detected by said classifying.

33. The anti-arrhythmic device according to claim 31 wherein said controller unit is configured for determining a first value representative of the level of arrhythmia prevalence within a time period of said a plurality of arrhythmic episodes in said heart, according to said electrical cardiac signals, and for initiating the delivering of said cardiac contractility increasing electrical signals to said heart by said cardiac contractility modulating unit for a first therapy period if according to said first value.

34. The anti-arrhythmic device according to claim 33 wherein said controller unit is configured for continuing said processing to determine a second value representative of the level of arrhythmia prevalence within at least a portion of the duration of said first therapy period.

35. The anti-arrhythmic device according to claim 34 wherein said controller unit is configured for delivering a second type of anti-arrhythmic therapy to said heart if a tachy-arrhythmia is detected within the duration of said first therapy period, said second type of anti-arrhythmic therapy is different from said delivering of said cardiac contractility increasing signals.

36. The anti-arrhythmic device according to claim 35 wherein said second type of anti-arrhythmic therapy is selected from a defibrillating shock therapy, a cardioverting shock therapy, an anti-tachycardia pacing therapy, and a variable energy shock therapy.

37. The anti-arrhythmic device according to claim 35 wherein said controller unit is configured for terminating the delivery of said cardiac contractility increasing electrical signals of said first therapy period prior to delivering said second type of anti arrhythmic therapy to said heart.

38. The anti-arrhythmic device according to claim 34 wherein said controller unit is configured for changing at least one signal parameter of said cardiac contractility increasing electrical signals delivered to said heart if a tachy-arrhythmia is still detected within the duration of said first therapy period.

39. The anti-arrhythmic device according to claim 38 wherein said at least one signal parameter is selected from the duration of said cardiac contractility increasing electrical signals, the amplitude of said cardiac contractility increasing electrical signals, the waveform of said cardiac contractility increasing electrical signals, the polarity of said cardiac contractility increasing electrical signals, and any combination thereof.

40. An anti-arrhythmic device for delivering anti-arrhythmic non-excitatory cardiac contractility increasing signal therapy to a heart, the device comprising:

a tachy-arrhythmia detecting unit configured for receiving and processing electrical cardiac signals related to cardiac activity sensed at said heart during a given period;

calculating a level of arrhythmia prevalence by counting a plurality of arrhythmic episodes in said heart based on processing said electrical cardiac signals and comparing between said level of arrhythmia prevalence and an initiation threshold to detect one or more events selected from a cardiac tachy-arrhythmia and an indication of a possible tachy-arrhythmia;

a cardiac contractility modulating unit configured for delivering non-excitatory cardiac contractility increasing electrical signals to said heart and an anti-arrhythmic therapy in response to said determination; and

a controller unit operatively connected to said tachy-arrhythmia detecting unit and to said cardiac contractility modulating unit, said controller unit is configured for receiving from said tachy-arrhythmia detecting unit signals representing said one or more events, and for controlling said cardiac contractility modulating unit to deliver a plurality of said non-excitatory cardiac contractility increasing electrical signals to said heart in response to receiving said signals representing said one or more events from said tachy-arrhythmia detecting unit to reduce said level of arrhythmia prevalence, wherein said non-excitatory cardiac contractility increasing electrical signals are capable of increasing contractility of cardiac muscle cells of the heart for said anti-arrhythmic therapy.

41. The anti-arrhythmic device according to claim 40 wherein said controller unit is configured to obtain data representative of the heart rate of said heart according to said electrical cardiac signals, classifying the determined heart rate according to a classification method adapted to determine the suspected occurrence of different types of arrhythmia based on said determined heart rate, and controlling the delivery of said plurality of non-excitatory cardiac contractility increasing electrical signals to said heart by said cardiac contractility modulating unit based on the type of suspected arrhythmia detected by said classifying.

42. The anti-arrhythmic device according to claim 40 wherein said controller unit is configured for determining a first value representative of the level of arrhythmia prevalence within a time period of arrhythmic episodes in said heart according to said electrical cardiac signals, comparing said first value to a threshold value, and for initiating the delivering of said plurality of cardiac contractility increasing electrical signals to said heart by said cardiac contractility modulating unit for a first therapy period if said first value is larger than said threshold value.

43. The anti-arrhythmic device according to claim 42 wherein said controller unit is configured for continuing said processing to determine a second value representative of the level of arrhythmia prevalence of arrhythmic episodes in said heart within at least a portion of the duration of said first therapy period.

44. The anti-arrhythmic device according to claim 42 wherein said controller unit is configured for delivering a second type of anti-arrhythmic therapy to said heart if an event of said one or more events is detected within the duration of said first therapy period, said second type of anti-arrhythmic therapy is different from said delivering of said cardiac contractility increasing signals.

45. The anti-arrhythmic device according to claim 44 wherein said second type of anti-arrhythmic therapy is selected from a defibrillating shock therapy, a cardioverting shock therapy, an anti-tachycardia pacing therapy, and a variable energy shock therapy.

46. The anti-arrhythmic device according to claim 44 wherein said controller unit is configured for terminating the delivery of said cardiac contractility increasing electrical signals of said first therapy period prior to delivering said second type of anti arrhythmic therapy to said heart.

47. The anti-arrhythmic device according to claim 42 wherein said controller unit is configured for changing at least one signal parameter of said cardiac contractility increasing electrical signals delivered to said heart if a tachy-arrhythmia or an indication of a possible tachy-arrhythmia is still detected within the duration of said first therapy period.

48. The anti-arrhythmic device according to claim 47 wherein said at least one signal parameter is selected from the duration of said cardiac contractility increasing electrical signals, the amplitude of said cardiac contractility increasing electrical signals, the waveform of said cardiac contractility increasing electrical signals, the polarity of said cardiac contractility increasing electrical signals, and any combination thereof.

49. The anti-arrhythmic device according to claim 40 wherein said cardiac contractility modulating unit is also configured for delivering cardiac contractility reducing signals to said heart.

50. The anti-arrhythmic device according to claim 49 wherein said device also comprises a pacing unit for delivering pacing signals said heart.

51. The anti-arrhythmic device according to claim 50 wherein said pacing signals are selected from anti-tachi-arrhythmic pacing signals and anti-bradi-arrhythmic pacing signals.

52. An anti-arrhythmic device for delivering anti-arrhythmic non-excitatory cardiac contractility increasing signal therapy to a heart, the device comprising:

tachy-arrhythmia detecting means configured for receiving and processing electrical cardiac signals related to cardiac activity sensed at said heart during a given period, calculating a level of arrhythmia prevalence by counting a plurality of arrhythmic episodes in said heart based on processing said electrical cardiac, and comparing between said level of arrhythmia prevalence and an initiation threshold to detect one or more events selected from a cardiac tachy-arrhythmia and an indication of a possible tachy-arrhythmia;

cardiac contractility modulating means configured for delivering, in response to said determination, non-excitatory cardiac contractility increasing electrical signals to said heart as an anti-arrhythmic therapy; and

controller means operatively connected to said tachy-arrhythmia detecting means and to said cardiac contractility modulating means, said controller means is configured for receiving signals representing the detection of said one or more events from said tachy-arrhythmia detecting means, and for controlling said cardiac contractility modulating means to deliver a plurality of said non-excitatory cardiac contractility increasing electrical signals to said heart in response to the detecting of said one or more events to reduce said level of arrhythmia prevalence, wherein said non-excitatory cardiac contractility increasing electrical signals are capable of increasing contractility of cardiac muscle cells of the heart for said anti-arrhythmic therapy.

53. The anti-arrhythmic device according to claim 52 wherein said controller means is configured to obtain data representative of the heart rate of said heart according to said electrical cardiac signals, classifying the determined heart rate according to a classification method adapted to determine the suspected occurrence of different types of arrhythmia based on said determined heart rate, and controlling the delivery of said non-excitatory cardiac contractility increasing electrical signals to said heart by said cardiac contractility modulating means based on the type of suspected arrhythmia detected by said classifying.

54. The anti-arrhythmic device according to claim 52 wherein said controller means is configured to determine a first value representative of the level of arrhythmia prevalence within a time period of arrhythmic episodes in said heart according to said electrical cardiac signals, comparing said first value to a threshold value, and for initiating the delivering of said cardiac contractility increasing electrical signals to said heart by said cardiac contractility modulating means for a first therapy period if said first value is larger than said threshold value.

55. The anti-arrhythmic device according to claim 54 wherein said controller means is configured for continuing said processing to determine a second value representative of the level of arrhythmia within at least a portion of the duration of said first therapy period.

56. The anti-arrhythmic device according to claim 55 wherein said controller means is configured for delivering a second type of anti-arrhythmic therapy to said heart if an event of said one or more events is detected within the duration of said first therapy period, said second type of anti-arrhythmic therapy is different from said delivering of said cardiac contractility increasing signals.

57. The anti-arrhythmic device according to claim 56 wherein said second type of anti-arrhythmic therapy is selected from a defibrillating shock therapy, a cardioverting shock therapy, an anti-tachycardia pacing therapy, and a variable energy shock therapy.

58. The anti-arrhythmic device according to claim 56 wherein said controller means is configured for terminating the delivery of said cardiac contractility increasing electrical signals of said first therapy period prior to delivering said second type of anti arrhythmic therapy to said heart.

59. The anti-arrhythmic device according to claim 55 wherein said controller means is configured for changing at least one signal parameter of said cardiac contractility increasing electrical signals delivered to said heart if a tachy-arrhythmia or said indication is still detected within the duration of said first therapy period.

60. The anti-arrhythmic device according to claim 59 wherein said at least one signal parameter is selected from the duration of said cardiac contractility increasing electrical signals, the amplitude of said cardiac contractility increasing electrical signals, the waveform of said cardiac contractility increasing electrical signals, the polarity of said cardiac contractility increasing electrical signals, and any combination thereof.

61. An apparatus of applying a plurality cardiac contractility modulating electrical signals to the heart, the apparatus comprising:

a detection unit configured for calculating a level of arrhythmia prevalence by counting arrhythmic episodes in said heart and comparing between said level of arrhythmia prevalence and a cardiac contractility modulating therapy initiation threshold; and

a cardiac contractility modulating unit configured for applying one or more of said plurality of cardiac contractility modulating electrical signals to said heart in response to said comparison for reducing said level of arrhythmia prevalence,

wherein said cardiac contractility modulating electrical signals are capable of increasing contractility of cardiac muscle cells of the heart.