Methods and systems for treating arrhythmias using a combination of vibrational and electrical energy

• US 7,809,438 B2
• Filed: 01/25/2007
• Issued: 10/05/2010
• Est. Priority Date: 08/18/2003
• Status: Active Grant

• Current Assignee: EBR Systems, Inc.
• Original Assignee: EBR Systems, Inc.
• Inventors: Riley, Richard E., Brisken, Axel F., Echt, Debra S.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Malamud; Deborah
• Application Number:
  US11/627,284
• Publication Number:
  US 20070123939A1
• Time in Patent Office: 1,349 Days
• Field of Search: 607 2- 5, 607/119, 607/122, 607/129, 601/41
• US Class Current: 607/3
• CPC Class Codes: A61H 2201/5007 computer controlled
• CPC Class Codes: A61H 2201/501 connected to external computer devices or networks
• CPC Class Codes: A61H 2201/5043 Displays
• CPC Class Codes: A61H 2201/5058 Sensors or detectors
• CPC Class Codes: A61H 2201/5097 wireless
• 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
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy

Abstract

Methods and apparatus for cardiac pacing, cardioversion and defibrillation rely on delivering ultrasonic or other vibrational energy in combination with electrical energy to the heart, usually after the onset of an arrhythmia. A vibrational transducer and suitable electrical contacts may be combined in a single housing or distributed among various housings, and will usually be implantable so that the vibrational transducer can be directed at a target portion of the heart. Alternatively, external systems comprising the vibrational transducer and electrical contacts are also described.

Claims

1. A method for stabilizing cardiac arrhythmias, said method comprising:

delivering controlled vibrational energy to the heart from a vibrational transducer disposed in a housing, wherein the vibrational energy is delivered from the vibrational transducer through intervening non-cardiac tissue; and

delivering electrical energy to the heart, wherein the vibrational energy and electrical energy are delivered under conditions which terminate the arrhythmia, the housing is not in contact with the heart, and the vibrational transducer operates above 100 kHz, wherein the vibrational energy and the electrical energy are delivered at least partly simultaneously.

2. A method as in claim 1, wherein delivering at least one of the controlled vibrational energy and the electrical energy is performed by an implanted device.

3. A method as in claim 2, wherein both the controlled vibrational energy and the electrical energy are delivered by an implanted device.

4. A method as in claim 1, wherein delivering at least one of the controlled vibrational energy and the electrical energy is performed by an external device.

5. A method as in claim 4, wherein both the controlled vibrational energy and the electrical energy are delivered by an external device.

6. A method as in any one of claims 2-3, wherein the device is implanted at least partially under the patient'"'"'s ribs.

7. A method as in any one of claims 2-3, wherein the device is implanted at least partially in a gap between the patient'"'"'s ribs.

8. A method as in any one of claims 2-3, wherein the device is implanted at least partially over the patient'"'"'s ribs.

9. A method as in any one of claims 2-3, wherein the device is implanted in the abdominal region.

10. A method as in any one of claims 2-3, wherein the device is implanted in the subcutaneous space of the anterior chest over the sternum.

11. A method as in any one of claims 2-3, wherein the device is implanted in a subcutaneous space of the anterior chest over the ribs.

12. A method as in any one of claims 2-3, wherein the device is implanted in a subcutaneous space of the posterior chest.

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

14. A method as in 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.

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

16. 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.

17. A method as in any one of claims 1-3, wherein the vibrational energy has a frequency in the range from 0.1 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 50, and a thermal index less than 4.

18. A method as in any one of claims 1-3, wherein the vibrational energy is delivered to at least 50% of the heart.

19. A method as in any one of claims 1-3, wherein the vibrational energy is delivered to less than 50% of the heart.

20. A method as in claim 1, wherein the electrical energy is delivered externally at 360 Joules and below.

21. A method as in claim 1, wherein the electrical energy is delivered externally at 0.1 Joule and above.

22. A method as in claim 1, wherein the electrical energy is delivered through electrodes implanted in the heart, wherein the electrical energy is at 75 Joules and below.

23. A method as in claim 1, wherein the electrical energy is delivered through electrodes implanted in the heart, wherein the electrical energy is at 100 μ

Joules and above.

24. A method as in claim 1, wherein the electrical energy is delivered through electrodes implanted subcutaneously;

wherein the electrical energy is at 75 Joules and below.

25. A method as in claim 1, wherein the electrical energy is delivered through electrodes implanted subcutaneously, wherein the electrical energy is at 100 μ

Joules and above.

26. A method as in any one of claims 1-3, further comprising detecting an onset of an arrhythmia in a patient and initiating at least one of delivering the controlled vibrational energy and the electrical energy automatically in response to such detection.

27. A method as in claim 26, wherein the deliveries of both the controlled vibrational energy and the electrical energy are initiated in response to detection of the arrhythmia.

28. A method as in any one of claims 1-3, wherein the delivery of at least one of the controlled vibrational energy and electrical energy is initiated manually.

29. A method as in claim 28, wherein the deliveries of both the controlled vibrational energy and the electrical energy are initiated manually.

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

31. A method as in claim 29, wherein the electrical energy is preferentially delivered to a ventricular region of the heart.

32. A method as in any one of claims 1-3, wherein the vibrational energy is preferentially delivered to an atrial region of the heart.

33. A method as in claim 29, wherein the electrical energy is preferentially delivered to an atrial region of the heart.

34. A system for stabilizing cardiac arrhythmias, said system comprising:

a vibrational transducer disposed in a housing and adapted to deliver vibrational energy to the heart, wherein the vibrational transducer is adapted to deliver the vibrational energy to the heart through intervening non-cardiac tissue;

electrical contacts adapted to deliver electrical energy to the heart; and

control circuitry for delivering at least one of the vibrational energy and the electrical energy, wherein the housing is not in contact with the heart and the vibrational transducer operates above 100 kHz, wherein the vibrational energy and the electrical energy are delivered at least partly simultaneously.

35. A system as in claim 34, wherein the system is implantable and the electrical contacts are adapted to directly engage the heart.

36. A system as in claim 34, wherein the system is implantable and the electrical contacts are adapted to indirectly engage the heart.

37. A system as in claim 34 or 35, wherein the vibrational transducer operates at a frequency in the range from 0.1 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 50, and a thermal index less than 4.

38. A system as in claim 34 or 35, wherein the control circuitry delivers electrical energy at 75 Joules and below.

39. A system as in claim 34 or 35, wherein the control circuitry delivers electrical energy at 100 μ

Joules and above.

40. A system as in claim 34, wherein the vibrational transducer and the electrical contacts are adapted to externally engage a surface of the patient'"'"'s skin.

41. A system as in claim 34 or 40, wherein the vibrational transducer operates at a frequency in the range from 0.1 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 50, and a thermal index less than 4.

42. A system as in claim 41, wherein the control circuitry delivers electrical energy at 360 Joules and below.

43. A system as in claim 42, wherein the control circuitry delivers electrical energy at 0.10 Joule and above.

44. A system as in claim 34, wherein the control circuitry detects an onset of an arrhythmia and activates the vibrational transducer and delivers electrical energy in response to such detection.

45. A system as in claim 34, wherein the control circuitry is manually triggered to activate the vibrational transducer and deliver the electrical energy.

46. A system as in claim 34, wherein the delivery of vibrational energy is commenced prior to commencing the delivery of electrical energy.

47. A system as in claim 34, wherein the delivery of electrical energy is commenced prior to commencing the delivery of vibrational energy.

48. A system as in claim 34, wherein the vibrational transducer and the control circuitry are packaged in a common implantable housing.

49. A system as in claim 34, wherein the electrical contacts are adapted to form a part of the exterior of the common housing.

50. A system as in claim 34, wherein the electrical contacts comprise subcutaneously implantable leads.

51. A system as in claim 34, wherein the electrical contacts comprise transvenously implantable leads.

52. A system as in claim 34, wherein the vibrational transducer, the electrical contacts, and/or the control circuitry are packaged in separately implantable housings, further comprising cables for connecting the housings.

53. A system as in claim 34, wherein the vibrational transducer consists essentially of a single piezo-electric disposed in the housing with an air backing.

54. A system as in claim 34, wherein the vibrational transducer comprises a piezo-composite material including piezo-electric ceramic posts in a polymer matrix.

55. A system as in claim 34, wherein the vibrational transducer comprises a plurality of separately driven segments, wherein the segments are arranged to sequentially direct vibrational energy to different regions of the heart when the system is implanted.

56. A system as in claim 34, 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.

57. A system as in claim 34, wherein the vibrational transducer is adapted to preferentially deliver vibrational energy to a ventricular heart region when implanted.

58. A system as in claim 34, wherein the vibrational transducer is adapted to preferentially deliver vibrational energy, to an atrial region of the heart when implanted.

59. A system as in claim 34, wherein the control circuitry comprises sensor elements for detecting onset of an arrhythmia and for synchronizing the delivery of vibrational and electrical energy in response to such detection.

60. A system as in claim 59, wherein the control circuitry further comprises a power amplifier, an impedance matching circuit, and a signal generator, for each segment of the vibrational transducer.

61. A system as in claim 60, wherein the control circuitry further comprises a battery or a remotely rechargeable battery.

62. A system as in claim 61, wherein the control circuitry further comprises a transmitter and/or receiver for communication with an external controller.