Methods and systems for treating heart failure with vibrational energy

• US 20050070962A1
• Filed: 06/15/2004
• Published: 03/31/2005
• Est. Priority Date: 09/30/2003
• Status: Abandoned Application

• Current Assignee: EBR Systems, Inc.
• Original Assignee: EBR Systems, Inc.
• Inventors: Riley, Richard E., Cowan, Mark W., Brisken, Axel F., Echt, Debra S.
• Application Number:
  US10/869,631
• Publication Number:
  US 20050070962A1
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61H 2201/5007 computer controlled
• CPC Class Codes: A61H 2201/5043 Displays
• CPC Class Codes: A61H 2201/5097 wireless
• CPC Class Codes: A61H 2230/06 Heartbeat rate
• CPC Class Codes: A61H 23/0245 with ultrasonic transducers, e.g. piezoelectric
• CPC Class Codes: A61H 31/005 with feedback for the user
• CPC Class Codes: A61H 31/006 Power driven

Abstract

Methods and apparatus for treating heart failure rely on delivering ultrasonic or other vibrational energy to the heart. The energy may be delivered acutely or chronically, in response to detected cardiac events, in response to manual actuation and/or in response to operation of an implantable defibrillator. The vibrational transducer is implanted so that the vibrational energy can be directed toward at least a portion of the heart in order to increase contractility, vasodilation, tissue perfusion, and/or cardiac output.

Claims

1. A method for treating heart failure, said method comprising:

delivering vibrational energy from a vibrational transducer to a heart in a patient suffering from or at risk of heart failure.

2. A method as in claim 1, wherein delivery is performed by an implanted vibrational transducer.

3. A method as in claim 1, wherein delivery is performed with an external vibrational transducer.

4. A method as in any one of claims 1-3, wherein the vibrational energy is delivered under conditions which increase at least one of contractility, vasodilation, tissue perfusion or cardiac output.

5. A method as in any one of claims 1-3, wherein the vibrational energy is delivered substantially continually.

6. A method as in any one of claims 1-3, wherein the vibrational energy is delivered in response to a manually initiated external signal.

7. A method as in any one of claims 1-3, wherein the vibrational energy is selectively delivered following defibrillation.

8. A method as in any one of claims 1-3, wherein the vibrational energy is delivered in response to detection of a cardiac event.

9. A method as in claim 8, wherein the patient or another individual detects the cardiac event and initiates delivery of the vibrational energy.

10. A method as in claim 8, wherein detection is performed by an implanted sensor, which automatically initiates delivery of the vibrational energy.

11. A method as in any one of claims 1-3, further comprising diagnosing the patient to be suffering from or at risk of heart failure.

12. A method as in any one of claims 1-3, wherein the vibrational energy is delivered to substantially the entire heart.

13. A method as in any one of claims 1-3, wherein the energy is delivered preferentially to a ventricular region of the heart.

14. A method as in any one of claims 1-3, wherein the vibrational transducer is implanted at least partially under the patient'"'"'s ribs.

15. A method as in any one of claims 1-3, wherein the vibrational transducer is implanted at least partially in a gap between the patient'"'"'s ribs.

16. A method as in any one of claims 1-3, wherein the vibrational transducer is implanted at least partially over the patient'"'"'s ribs.

17. A method as in any one of claims 1-3, wherein the vibrational transducer is implanted in the abdominal region.

18. A method as in any one of claims 1-3, wherein the vibrational transducer is implanted in a subcutaneous space of the anterior chest over the sternum.

19. A method as in any one of claims 1-3, wherein the vibrational transducer is implanted in a subcutaneous space of the anterior chest over the ribs.

20. A method as in any one of claims 1-3, wherein the vibrational transducer consists essentially of a single piezo-electric ceramic in a housing with an air backing.

21. A method as in any one of claims 1-3, wherein the vibrational transducer comprises a piezo-composite material including piezo-electric ceramic posts in a polymer matrix.

22. A method as in any one of claims 1-3, wherein the vibrational transducer comprises single crystal piezo-electric, polymer piezo-electric, or magnetostrictive materials.

23. A method as in any one of claims 1-3, wherein delivering vibrational energy comprises energizing individual vibrational transducer segments either in series or parallel, wherein at least some of the segments direct vibrational energy to different regions of the heart.

24. A method as any one of claims 1-3, wherein delivering vibrational energy comprises sequentially energizing individual vibrational transducer segments, wherein at least some of the segments direct vibrational energy to the same region of the heart.

25. A method as in any one of claims 1-3, wherein the vibrational energy has a frequency in the range from 0.02 to 10 MHz, a burst length less than 5,000 cycles, a burst rate less than 100 kHz, a duty cycle less than 50%, a mechanical index less than 20, and a thermal index less than 4.

26. A method as in any one of claims 1-3, wherein the vibrational energy is delivered during a portion of the cardiac cycle.

27. A method as in claim 26, wherein the vibrational energy is delivered during the refractory period of the cardiac cycle.

28. A method as in claim 26, wherein vibrational energy delivery is timed from the onset of a cardiac cycle.

29. A system for stabilizing cardiac function, said system comprising:

a vibrational transducer implantable in a patient; and

control circuitry for detecting an onset of a cardiac event associated with heart failure and activating the vibrational transducer to deliver controlled vibrational energy to the heart under conditions which treat the heart failure.

30. A system as in claim 29, wherein the vibrational transducer is adapted to delivering vibrational energy which can increase contractility.

31. A system as in any one of claims 29 and 30, wherein the vibrational transducer is adapted to delivering vibrational energy which can increase vasodilation.

32. A system as in any one of claims 29 and 30, wherein the vibrational transducer is adapted to delivering vibrational energy which can increase tissue perfusion.

33. A system as in any one of claims 29 and 30, wherein the vibrational transducer is adapted to delivering vibrational energy which can increase cardiac output.

34. A system as in any one of claims 29 and 30, wherein the vibrational transducer and the control circuitry are packaged in a common housing.

35. A system as in any one of claims 29 and 30, wherein the vibrational transducer and the control circuitry are packaged in separately implantable housings, further comprising a cable for connecting the housings.

36. A system as in any one of claims 29 and 30, wherein the vibrational transducer consists essentially of a single piezo-electric ceramic disposed in a housing with an air backing.

37. A system as in any one of claims 29 and 30, wherein the vibrational transducer comprises a piezo-composite material including piezo-electric ceramic posts in a polymer matrix.

38. A system as in any one of claims 29 and 30, wherein the vibrational transducer comprises single crystal piezo-electric, polymer piezo-electric, or magnetostrictive materials.

39. A system as in any one of claims 29 and 30, wherein delivering comprises energizing individual vibrational segments, wherein at least some of the segments direct vibrational energy to different regions of the heart.

40. A system as in any one of claims 29 and 30, wherein the vibrational transducer comprises a plurality of separately driven segments, wherein the segments are arranged to sequentially direct vibrational energy to the same region of the heart when the system is implanted.

41. A system as in any one of claims 29 and 30, wherein the vibrational transducer is adapted to deliver vibrational energy to at least 50% of the heart when implanted.

42. A system as in any one of claims 29 and 30, wherein the vibrational transducer is adapted to deliver energy to less than 50% of the heart when implanted.

43. A system as in any one of claims 29 and 30, wherein the control circuitry drives the vibrational transducer at a frequency in the range from 0.02 to 10 MHz, a burst length less than 5,000 cycles, a burst rate less than 100 kHz, a duty cycle less than 50%, a mechanical index less than 20, and a thermal index less than 4.

44. A system as in any one of claims 29 and 30, wherein the control circuitry comprises ECG elements for detecting onset of a cardiac cycle and for timing the delivery of vibrational therapy in response to such detection.

45. A system as in claim 44, wherein the timing for the delivery of the vibrational energy is adapted to be delivered during a portion of the cardiac cycle.

46. A system as in claim 45, wherein the portion of the cardiac cycle is the refractory period of the cardiac cycle.

47. A system as in any one of claims 29 and 30, wherein the control circuitry comprises a power amplifier, an impedance matching circuit, and a signal generator, for each segment of the vibrational transducer.

48. A system as in any one of claims 29 and 30, wherein the control circuitry comprises a remotely rechargeable battery.

49. A system as in any one of claims 29 and 30, wherein the control circuitry comprises a transmitter and/or receiver for communication with an external controller.

50. A system as in any one of claims 29 and 30, wherein the control circuitry is adapted to detect cardiac events.

51. A system as in any one of claims 29 and 30, wherein the control circuitry is adapted to detect delivery of defibrillation energy.

52. A system as in any one of claims 29 and 30, wherein the system further comprises a cardiovertor defibrillator.

53. A system for stabilizing cardiac function, said system comprising:

a vibrational transducer; and

control circuitry for activating the vibrational transducer to deliver controlled vibrational energy to the heart under conditions which treat the heart failure.

54. A system as in claim 53, wherein the vibrational transducer is adapted to contact an exterior surface of the patient'"'"'s skin and deliver the vibrational energy through the tissue overlying the heart.

55. A system as in claim 54, wherein the vibrational transducer is adapted to delivering vibrational energy which can increase contractility.

56. A system as in claim 55, wherein the vibrational transducer is adapted to delivering vibrational energy which can increase cardiac output.

57. A system as in any one of claims 53-56, wherein the control circuitry comprises a power amplifier, and impedance matching circuit, and a single generator, for activating the transducer.

58. A system as in any one of claims 53-56, wherein the control circuitry comprises ECG elements for detecting onset of a cardiac cycle and for timing the delivery of vibrational therapy in response to such detection.

59. A system as in any one of claims 53-56, wherein the timing for the delivery of the vibrational energy is adapted to be delivered during a portion of the cardiac cycle.

60. A system as in any one of claims 53-56, wherein the portion of the cardiac cycle is the refractory period of the cardiac cycle.

61. A system as in claim 60, wherein the control circuitry is adapted for manual delivery.

62. A system as in claim 60, wherein the control circuitry is adapted for automatic delivery in response to such detection.