Methods and systems for vibrational treatment of cardiac arrhythmias

• US 7,006,864 B2
• Filed: 06/15/2004
• Issued: 02/28/2006
• Est. Priority Date: 06/17/2003
• 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): Jastrzab, Jeffrey R.
• Application Number:
  US10/869,776
• Publication Number:
  US 20040260214A1
• Time in Patent Office: 623 Days
• Field of Search: 607/2, 607/3, 607/4, 607/5, 607/9, 601/2
• US Class Current: 607/3
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 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 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

Methods and apparatus for cardiac pacing, cardioversion, and defibrillation rely on delivering ultrasonic and other vibrational energy to the heart, usually after the onset of an arrhythmia. A vibrational transducer assembly is implanted or applied externally so that vibrational energy can be directed toward at least a portion of the heart from an anterior or posterior aspect, typically being implanted over the ribs, over the sternum, between the ribs, beneath the ribs, or on the back.

Claims

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

detecting an onset of an arrhythmia in a patient'"'"'s heart;

delivering controlled vibrational energy from a vibrational transducer to the heart under conditions which terminate the arrhythmia, 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 50, and a thermal index less than 4.

2. A method as in claim 1, wherein the arrhythmia is ventricular and the energy is delivered preferentially to a ventricular region of the heart.

3. A method as in claim 1, wherein the arrhythmia is atrial and the energy is delivered preferentially to an atrial region of the heart.

4. A method as in any one of claims 1–

3, wherein delivery is performed by an implanted vibrational transducer.

5. A method as in claim 4, wherein the vibrational transducer is implanted at least partially under the patient'"'"'s ribs.

6. A method as in claim 4, wherein the vibrational transducer is implanted at least partially in a gap between the patient'"'"'s ribs.

7. A method as in claim 4, wherein the vibrational transducer is implanted at least partially over the patient'"'"'s ribs.

8. A method as in claim 4, wherein the vibrational transducer is implanted in the abdominal region.

9. A method as in claim 4, wherein the vibrational transducer is implanted in a subcutaneous space of the anterior chest over the sternum.

10. A method as in claim 4, wherein the vibrational transducer is implanted in a subcutaneous space of the anterior chest over the ribs.

11. A method as in claim 4, wherein the vibrational transducer is implanted in a subcutaneous space of the posterior chest.

12. A method as in any one of claims 1–

3, wherein delivery is performed with an external vibrational transducer.

13. A method as in claim 12, wherein the vibrational transducer is placed over the anterior chest.

14. A method as in claim 12, wherein the vibrational transducer is placed on the patient'"'"'s back.

15. 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 different regions of the heart.

16. 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.

17. A method as in any one of claims 1–

3, wherein the vibrational transducer consists essentially of a single piezo-electric disposed in a housing with an air backing.

18. A method as in claim 17, wherein the vibrational transducer comprises a piezo-composite material including piezo-electric ceramic posts in a polymer matrix.

19. A method as in any one of claims 1–

3, wherein the vibrational energy is delivered to at least 50% of the heart.

20. A method as in any one of claims 1–

3, wherein the vibrational energy is selectively delivered to less than 50% of the heart.

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

a vibrational transducer implantable in a patient; and

control circuitry for detecting an onset of an arrhythmia and activating the vibrational transducer to deliver controlled vibrational energy to the heart under conditions which terminate the arrhythmia, wherein the vibrational transducer comprises a piezo-composite material including piezo-electric ceramic posts in a polymer matrix.

22. A system as in claim 21, wherein the vibrational transducer and the control circuitry are packaged in a common housing.

23. A system as in claim 21, wherein the vibrational transducer and the control circuitry are packaged in separately implantable housings, further comprising a cable for connecting the housings.

24. A system as in any one of claims 21–

23, wherein the vibrational transducer is adapted to deliver vibrational energy to at least 50% of the heart when implanted.

25. A system as in any one of claims 21–

23, wherein the vibrational transducer is adapted to deliver energy to less than 50% of the heart when implanted.

26. A system as in any one of claims 21–

23, 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 50, and a thermal index less than 4.

27. A system as in any one of claims 21–

23, wherein the control circuitry comprises ECG elements for detecting the onset of an arrhythmia and for synchronizing the delivery of vibrational energy in response to such detection.

28. A system as in any one of claims 21–

23, wherein the control circuitry comprises a power amplifier, an impedance matching circuit, and a signal generator, for each segment of the vibrational transducer.

29. A system as in any one of claims 21–

23, wherein the control circuitry comprises a remotely rechargeable battery.

30. A system as in any one of claims 21–

23, wherein the control circuitry comprises a transmitter andlor receiver for communication with an external controller.

31. A system as in any one of claims 21–

23, wherein the control circuitry is adapted to detect ventricular fibrillation or ventricular tachycardia.

32. A system as in any one of claims 21–

23, wherein the control circuitry is adapted to detect atrial fibrillation.

33. A system as in any one of claims 21–

23, wherein the control circuitry is adapted to detect any rhythm having a rate below a programmed setting for the ventricles.

34. A system as in any one of claims 21–

23, wherein the control circuitry is adapted to detect any rhythm having a rate below a programmed setting for the atria.

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

a vibrational transducer implantable in a patient; and

control circuitry for detecting an onset of an arrhythmia and activating the vibrational transducer to deliver controlled vibrational energy to the heart under conditions which terminate the arrhythmia, wherein the vibrational transducer and the control circuitry are packaged in a common housing and the transducer consists essentially of a single piezo-electric disposed in the housing with an air backing.

36. A system as in claim 35, wherein the vibrational transducer is adapted to deliver vibrational energy to at least 50% of the heart when implanted.

37. A system as in claim 35, wherein the vibrational transducer is adapted to deliver energy to less than 50% of the heart when implanted.

38. A system as in claim 35, 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 50, and a thermal index less than 4.

39. A system as in claim 35, wherein the control circuitry comprises ECG elements for detecting the onset of an arrhythmia and for synchronizing the delivery of vibrational energy in response to such detection.

40. A system as in claim 35, wherein the control circuitry comprises a power amplifier, an impedance matching circuit, and a signal generator, for each segment of the vibrational transducer.

41. A system as in claim 35, wherein the control circuitry comprises a remotely rechargeable battery.

42. A system as in claim 35, wherein the control circuitry comprises a transmitter and/or receiver for communication with an external controller.

43. A system as in claim 35, wherein the control circuitry is adapted to detect ventricular fibrillation or ventricular tachycardia.

44. A system as in claim 35 wherein the control circuitry is adapted to detect atrial fibrillation.

45. A system as in claim 35, wherein the control circuitry is adapted to detect any rhythm having a rate below a programmed setting for the ventricles.

46. A system as in claim 35, wherein the control circuitry is adapted to detect any rhythm having a rate below a programmed setting for the atria.