Device for cardiac therapy

• US 7,027,863 B1
• Filed: 10/25/2000
• Issued: 04/11/2006
• Est. Priority Date: 10/25/1999
• Status: Expired due to Term

• Current Assignee: Impulse Dynamics NV
• Original Assignee: Impulse Dynamics NV
• Inventors: Darvish, Nissim, Haluska, Edward, Belsky, Ziv, Prutchi, David, Routh, Andre G.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US10/111,516
• Time in Patent Office: 1,994 Days
• Field of Search: 607 4- 14
• US Class Current: 607/5
• 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 1/39622 Pacing therapy

Abstract

A multi-modal cardiotherapy device (100) includes an anti-arrhythmic unit (118) for delivering multiple types of anti-arrhythmic therapy to a heart, a cardiac contractility modulating unit (108) for delivering cardiac contractility modulating signals to the heart, and for applying anti-arrhythmic cardiac contractility modulating signal therapy to the heart, one or more sensing units (112) for sensing electrical signals related to electrical activity of the heart to provide an output signal, one or more detecting units (116) operatively connected to the sensing unit(s) (112) for detecting in the output signal cardiac events of the heart, a controller unit (106) operatively connected to the anti-arrhythmic unit (118), the cardiac contractility modulating unit (108) and the detecting unit(s) (116). The controller unit (106) processes the output of the detecting unit(s) (116) to detect a cardiac arrhythmia or indications of a possible arrhythmia in the heart and controls the application of anti-arrhythmic therapy, anti-arrhythmic cardiac contractility modulating signal therapy, and cardiac contractility modulating therapy to the heart. The device may be an implantable device or a non-implantable device. The device (100) may also include a pacing unit (102). Methods are disclosed for using the device for delivering multi-modal cardiotherapy to the heart.

Claims

1. A method for operating a multi-modal cardiotherapy device to deliver multi-modal cardiotherapy to a heart, the method comprising the steps of:

providing a device configured for delivering cardiac contractility modulating signals and a plurality of anti-arrhythmic therapy modalities to said heart;

applying cardiac contractility modulating signals to said heart to modulate the contractility of at least a portion of said heart;

detecting an arrhythmia or indications of possible arrhythmia in said heart;

delivering to said heart an anti-arrhythmic therapy selected from said plurality of anti-arrhythmic therapy modalities based on the type of said arrhythmia or said indications detected in said step of detecting; and

coordinating the application of cardiac contractility modulating signals of said step of applying with the delivering of said anti-arrhythmic therapy of said step of delivering.

2. The method according to claim 1 wherein said plurality of anti-arrhythmic therapy modalities comprises cardiac contractility modulating signal anti-arrhythmic therapy and one or more anti-arrhythmic therapy modalities selected from defibrillating shock therapy, cardioverting shock therapy, anti-tachycardia pacing therapy, variable energy shock therapy, anti-bradycardia pacing therapy and any combination thereof.

3. The method according to claim 2 wherein said cardiac contractility modulating signal anti-arrhythmic therapy comprises delivering one or more of said cardiac contractility modulating signals to said heart for reducing the prevalence of arrhythmic episodes detected in said heart.

4. The method according to claim 1 wherein said step of applying cardiac contractility modulating signals to said heart is performed for modulating the cardiac output of said heart.

5. The method according to claim 1 wherein said step of coordinating comprises the step of terminating the applying of cardiac contractility modulating signals to said heart of said step of applying, prior to or upon said delivering to said heart of said anti-arrhythmic therapy.

6. The method according to claim 5 wherein said step of coordinating comprises the step of renewing the applying of cardiac contractility modulating signals to said heart after said delivering to said heart of said anti-arrhythmic therapy is terminated.

7. The method according to claim 1 wherein said indications of possible arrhythmia include the detection of T-wave alternans in said heart.

8. The method according to claim 1 wherein said step of detecting further includes the step of determining the heart rate of said heart and disabling the applying of said cardiac contractility modulating signals to said heart within the duration of a cardiac contractility modulating signal free time period if said heart rate is larger than a first threshold value.

9. The method according to claim 1 wherein said step of detecting further includes the step of enabling the applying of said cardiac contractility modulating signals to said heart if no arrhythmia or indications of possible arrhythmia are detected within the duration of said cardiac contractility modulating signal free time period.

10. A method for operating a multi-modal cardiotherapy device to deliver multi-modal cardiotherapy to a heart, the device is configured for delivering cardiac contractility modulating signals and a plurality of anti-arrhythmic therapy modalities to said heart, the method comprising the steps of:

applying cardiac contractility modulating signals to said heart to modulate the cardiac output of said heart;

detecting an arrhythmia or indications of possible arrhythmia in said heart;

delivering to said heart an anti-arrhythmic therapy selected from said plurality of anti-arrhythmic therapy modalities based on the type of said arrhythmia or said indications detected in said step of detecting; and

coordinating the application of cardiac contractility modulating signals of said step of applying with the delivering of said anti-arrhythmic therapy of said step of delivering.

11. The method according to claim 10 wherein said plurality of anti-arrhythmic therapy modalities comprises cardiac contractility modulating signal anti-arrhythmic therapy and one or more anti-arrhythmic therapy modalities selected from defibrillating shock therapy, cardioverting shock therapy, anti-tachycardia pacing therapy, variable energy shock therapy, anti-bradycardia pacing therapy and any combination thereof.

12. The method according to claim 11 wherein said cardiac contractility modulating signal antiarrhythmic therapy comprises delivering one or more of said cardiac contractility modulating signals to said heart for reducing the prevalence of arrhythmic episodes detected in said heart.

13. The method according to claim 10 wherein said step of applying cardiac contractility modulating signals to said heart is performed for modulating the cardiac output of said heart.

14. The method according to claim 10 wherein said step of coordinating comprises the step of terminating the applying of cardiac contractility modulating signals to said heart of said step of applying, prior to or upon said delivering to said heart of said anti-arrhythmic therapy.

15. The method according to claim 14 wherein said step of coordinating comprises the step of renewing the applying of cardiac contractility modulating signals to said heart after said delivering to said heart of said anti-arrhythmic therapy is terminated.

16. The method according to claim 10 wherein said indications of possible arrhythmia include the detection of T-wave alternans in said heart, as an indication of a possible cardiac arrhythmia.

17. The method according to claim 10 wherein said step of detecting further includes the step of determining the heart rate of said heart and disabling the applying of said cardiac contractility modulating signals to said heart within the duration of a cardiac contractility modulating signal free time period if said heart rate is larger than a first threshold value.

18. The method according to claim 10 wherein said step of detecting further includes the step of enabling the applying of said cardiac contractility modulating signals to said heart if no arrhythmia or indications of possible arrhythmia are detected within the duration of said cardiac contractility modulating signal free time period.

19. A multi-modal cardiotherapy device comprising:

an anti-arrhythmic unit for delivering anti-arrhythmic therapy to said heart;

a cardiac contractility modulating unit configured for delivering cardiac contractility modulating signals to said heart for modulating the cardiac contractility of at least a portion of said heart, and for applying anti-arrhythmic cardiac contractility modulating signal therapy to said heart;

a sensing unit for sensing electrical signals related to electrical activity of said heart to provide an output signal;

a detecting unit operatively connected to said sensing unit for receiving said output signal of said sensing unit and for detecting in said output signal cardiac events of said heart;

a controller unit operatively connected to said anti-arrhythmic unit, said cardiac contractility modulating unit and said detecting unit;

for processing the output of said detecting unit to detect a cardiac arrhythmia or indications of possible arrhythmia, controlling the application of said anti-arrhythmic therapy by said anti-arrhythmic unit, and for controlling the application of said anti-arrhythmic cardiac contractility modulating signal therapy, and the modulating of said cardiac contractility of said portion of said heart by said cardiac contractility modulating unit; and

at least one power source for providing power to said anti-arrhythmic therapy unit, said cardiac contractility modulating unit, said sensing unit, said detecting unit, and said controller unit.

20. The multi-modal cardiotherapy device according to claim 19, wherein said anti-arrhythmic unit is configured for delivering to said heart multiple modes of ant-arrhythmic therapy selected from anti-bradycardia pacing therapy, defibrillating shock therapy, cardioverting shock therapy, anti-tachycardia pacing therapy, variable energy shock therapy, and any combination thereof.

21. The multi-modal cardiotherapy device according to claim 19, wherein said controller unit is configured for coordinating the application to said heart of anti-arrhythmic therapy by said anti-arrhythmic unit with the application to said heart of said anti-arrhythmic cardiac contractility modulating signal therapy by said cardiac contractility modulating unit.

22. The multi-modal cardiotherapy device according to claim 19, wherein said controller unit is configured for coordinating the application to said heart of anti-arrhythmic therapy by said anti-arrhythmic unit with said modulating of said cardiac contractility by said cardiac contractility modulating unit.

23. The multi-modal cardiotherapy device according to claim 19, wherein said anti-arrhythmic unit comprises a pacing unit configured for pacing at least one chamber of said heart.

24. The multi-modal cardiotherapy device according to claim 19 wherein said cardiac contractility modulating unit is configured for controllably delivering cardiac contractility modulating signal anti-arrhythmic therapy to said heart by controllably delivering one or more of said cardiac contractility modulating signals to said heart for reducing the prevalence of arrhythmic episodes detected in said heart.

25. The multi-modal cardiotherapy device according to claim 19 wherein said cardiac contractility modulating unit is configured for modulating the cardiac output of said heart by delivering said cardiac contractility modulating signals to said heart.

26. The multi-modal cardiotherapy device according to claim 19 wherein said controller unit is configured for terminating the applying of cardiac contractility modulating signals to said heart prior to or upon said delivering to said heart of said anti-arrhythmic therapy.

27. The multi-modal cardiotherapy device according to claim 19 wherein said controller unit is configured for renewing the applying of cardiac contractility modulating signals to said heart after said delivering to said heart of said anti-arrhythmic therapy is terminated.

28. The multi-modal cardiotherapy device according to claim 19 wherein said detecting unit is configured for detecting T-wave alternans in said heart, as an indication of a possible cardiac arrhythmia.

29. The multi-modal cardiotherapy device according to claim 19 further including electrodes operatively connected to said anti-arrhythmic unit, said cardiac contractility modulating unit, and said sensing unit, for delivering said anti-arrhythmic therapy to said heart, for applying said cardiac contractility modulating signals to said heart, and for sensing said electrical signals, respectively.

30. The multi-modal cardiotherapy device according to claim 19 wherein said controller unit is configured for determining the heart rate of said heart and for disabling said modulating of said cardiac contractility of said portion of said heart by said cardiac contractility modulating unit within the duration of a cardiac contractility modulating signal free time period if said heart rate is larger than a first threshold value.

31. The multi-modal cardiotherapy device according to claim 19 wherein said controller unit is configured for enabling said modulating of said cardiac contractility of said portion of said heart by said cardiac contractility modulating unit if no arrhythmia or indications of possible arrhythmia are detected within the duration of said cardiac contractility modulating signal free time period.

32. A multi-modal cardiotherapy device comprising:

anti-arrhythmic means for delivering multiple modes of anti-arrhythmic therapy to said heart;

cardiac contractility modulating means configured for delivering cardiac contractility modulating signals to said heart, for modulating the cardiac contractility of at least a portion of said heart, and for applying anti-arrhythmic cardiac contractility modulating signal therapy to said heart;

sensing means for sensing electrical signals related to cardiac activity sensed at said heart;

detecting means operatively connected to said sensing means for receiving the output signal of said sensing means and for detecting cardiac depolarization events of said heart;

controller means operatively connected to said anti-arrhythmic means, said cardiac contractility modulating means and said detecting means, for processing the output of said detecting means to detect a cardiac arrhythmia or indications of possible arrhythmia, controlling the application of said anti-arrhythmic therapy modes by said anti-arrhythmic means, and for controlling the application of said anti-arrhythmic cardiac contractility modulating signal therapy, and the modulating of said cardiac contractility by said cardiac contractility modulating means; and

means for providing power to said anti-arrhythmic means, said cardiac contractility modulating means, said sensing means, said detecting means and said controller means.

33. The multi-modal cardiotherapy device according to claim 32, wherein said anti-arrhythmic means is configured for delivering to said heart multiple modes of anti-arrhythmic therapy selected from anti-bradycardia pacing therapy, defibrillating shock therapy, cardioverting shock therapy, anti-tachycardia pacing therapy, variable energy shock therapy, and any combination thereof.

34. The multi-modal cardiotherapy device according to claim 32, wherein said controller means is configured for coordinating the application to said heart of anti-arrhythmic therapy by said anti-arrhythmic means with the application to said heart of said anti-arrhythmic cardiac contractility modulating signal therapy by said cardiac contractility modulating means.

35. The multi-modal cardiotherapy device according to claim 32, wherein said controller means is configured for coordinating the application to said heart of anti-arrhythmic therapy by said anti-arrhythmic means with said modulating of said cardiac contractility by said cardiac contractility modulating means.

36. The multi-modal cardiotherapy device according to claim 32, wherein said anti-arrhythmic means comprises pacing means configured for pacing at least one chamber of said heart.

37. The multi-modal cardiotherapy device according to claim 32 wherein said cardiac contractility modulating means is configured for controllably delivering cardiac contractility modulating signal anti-arrhythmic therapy to said heart by controllably delivering one or more of said cardiac contractility modulating signals to said heart for reducing the prevalence of arrhythmic episodes detected in said heart.

38. The multi-modal cardiotherapy device according to claim 32 wherein said cardiac contractility modulating means is configured for modulating the cardiac output of said heart by delivering said cardiac contractility modulating signals to said heart.

39. The multi-modal cardiotherapy device according to claim 32 wherein said controller means is configured for terminating the applying of cardiac contractility modulating signals to said heart prior to or upon said delivering to said heart of said anti-arrhythmic therapy.

40. The multi-modal cardiotherapy device according to claim 32 wherein said controller means is configured for renewing the applying of cardiac contractility modulating signals to said heart after said delivering to said heart of said anti-arrhythmic therapy is terminated.

41. The multi-modal cardiotherapy device according to claim 32 wherein said detecting means is configured for detecting T-wave alternans in said heart, as an indication of a possible cardiac arrhythmia.

42. The multi-modal cardiotherapy device according to claim 32 further including electrode means operatively connected to said anti-arrhythmic means, said cardiac contractility modulating means and said sensing means, for delivering said anti-arrhythmic therapy to said heart, for applying said cardiac contractility modulating signals to said heart, and for sensing said electrical signals, respectively.

43. The multi-modal cardiotherapy device according to claim 32 wherein said controller means is configured for determining the heart rate of said heart and for disabling said modulating of said cardiac contractility of said portion of said heart by said cardiac contractility modulating means within the duration of a cardiac contractility modulating signal free time period if said heart rate is larger than a first threshold value.

44. The multi-modal cardiotherapy device according to claim 32 wherein said controller means is configured for enabling said modulating of said cardiac contractility of said portion of said heart by said cardiac contractility modulating means if no arrhythmia or indications of possible arrhythmia are detected within the duration of said cardiac contractility modulating signal free time period.