METHODS AND SYSTEMS FOR HEART FAILURE PREVENTION AND TREATMENTS USING ULTRASOUND AND LEADLESS IMPLANTABLE DEVICES

• US 20070055184A1
• Filed: 08/29/2006
• Published: 03/08/2007
• Est. Priority Date: 08/31/2005
• Status: Active Grant

• Current Assignee: EBR Systems, Inc.
• Original Assignee: EBR Systems, Inc.
• Inventors: Cowan, Mark, Brisken, Axel, Echt, Debra, Riley, Richard
• Granted Patent: US 7,765,001 B2
• Time in Patent Office: Days
• US Class Current: 601/2
• 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 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: A61N 2007/0004 Applications of ultrasound therapy
• 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

The present invention relies on a controller-transmitter device to deliver ultrasound energy into cardiac tissue in order to directly improve cardiac function and/or to energize one or more implanted receiver-stimulator devices that transduce the ultrasound energy to electrical energy to perform excitatory and/or non-excitatory treatments for heart failure. The acoustic energy can be applied as a single burst or as multiple bursts.

Claims

1. A system for heart failure therapy comprising:

one or more acoustic receiver-stimulators having an electrode assembly adapted to be implanted in direct contact with cardiac tissue at one or more heart locations selected to provide a preferred pattern of activation and/or mechanical contraction; and

an acoustic controller-transmitter, wherein the controller-transmitter and receiver-stimulator are adapted to transmit and receive acoustic energy which provides both energy and signal information to the receiver-stimulator sufficient to stimulate the heart,

wherein the receiver-stimulator comprises an acoustic receiver which receives acoustic energy and generates alternating current, converter circuitry which produces a direct current or waveform from the alternating current to stimulate the cardiac tissue, and electrodes adapted to deliver the direct current or waveform to myocardial tissue.

2. A system as in claim 1, wherein the implantable receiver-stimulator is adapted to be placed and secured at a location in the right ventricle such as the ventricular septum.

3. A system as in claim 1, wherein the implantable receiver-stimulator is adapted to be placed and secured at a location in or on the left ventricle.

4. A system as in claim 1, wherein the controller-transmitter is external.

5. A system as in claim 1, wherein the controller-transmitter is implantable in a subcutaneous region and directs acoustic energy to the receiver-stimulator.

6. A system for the delivery of electrical current to a patient'"'"'s heart to improve and/or prevent deterioration of heart function, comprising:

one or more acoustic receiver-stimulators having an electrode assembly adapted to be implanted in direct contact with cardiac tissue; and

an acoustic controller-transmitter, wherein the controller-transmitter and receiver-stimulator are adapted to transmit and receive acoustic energy which provides both energy and signal information to the receiver-stimulator,

wherein the receiver-stimulator comprises an acoustic receiver which receives acoustic energy and generates alternating current, means for converting the alternating current to a direct current or waveform to provide a non-excitatory electrical current and electrodes adapted to deliver the direct current or waveform to myocardial tissue,

wherein the implantable receiver-stimulator is adapted to be placed and secured at a location sufficient to deliver energy to the heart tissue and wherein the transmitted acoustic energy is adapted to provide non-excitatory current which prolongs action potential duration.

7. A system as in claim 6, wherein the non-excitatory electrical current further improves tissue contractility.

8. A system as in claim 6, wherein the one or more implantable receiver-stimulators are adapted to be placed and secured at one or more ventricular locations.

9. A system as in claim 8, wherein the one or more implantable receiver-stimulators are adapted to be placed and secured in the right ventricle.

10. A system as in claim 8, wherein the one or more implantable receiver-stimulators are adapted to be placed and secured in the left ventricle.

11. A system as in claim 6, wherein the acoustic energy is delivered during an absolute refractory period.

12. A system as in claim 6, wherein the acoustic energy is delivered at the time of or delayed from a detected physiologic event.

13. A system as in claim 6, wherein the acoustic energy is delivered on command from an external communication source.

14. A system as in claim 6, wherein the controller-transmitter is external.

15. A system as in claim 6, wherein the controller-transmitter is implantable in a subcutaneous region and directs acoustic energy to the receiver-stimulator.

16. A system for the delivery of therapy to a patient'"'"'s heart, comprising:

an acoustic controller-transmitter, wherein the controller-transmitter is adapted to transmit acoustic energy to provide two or more of the following functions,

(a) ultrasound sonication of heart tissue to improve cardiac function, (b) ultrasound sonication of heart tissue to prevent deterioration of cardiac function, (c) leadless pacing to improve cardiac function, (d) leadless pacing to prevent deterioration of cardiac function, (c) leadless cardiac contractility modulation to improve cardiac function, and (f) leadless cardiac contractility modulation to prevent deterioration of cardiac function;

wherein cardiac function is one or more of contractility, vasodilation, tissue perfusion, or aortic pressure.

17. A system as in claim 16, wherein leadless pacing or leadless cardiac contractility modulation therapy is delivered by one or more acoustic receiver-stimulators having an electrode assembly adapted to be implanted in direct contact with the heart and activated by the said acoustic controller-transmitter,

wherein the control-transmitter and receiver-stimulator are adapted to transmit and receive acoustic energy which provides both energy and signal information to the receiver-stimulator,

wherein the receiver-stimulator comprises an acoustic receiver which receives acoustic energy and generates alternating current means for converting the alternating current to a direct current or waveform to electrodes adapted to deliver the direct current or waveform to myocardial tissue,

wherein the controller-transmitter directs acoustic energy to the receiver-stimulator

wherein the implantable receiver-stimulator is adapted to be placed and secured at a location sufficient to prevent and/or treat heart failure.

18. A system as in claim 16, wherein the controller-transmitter is external.

19. A system as in claim 16, wherein the controller-transmitter is implantable in a subcutaneous region and directs acoustic energy to the heart.

20. A method for treating a patient suffering from heart failure (HF), said method comprising:

transmitting from a controller-transmitter a signal to an implanted receiver-stimulator, wherein the acoustic signal provides both energy and signal information to stimulate the patient'"'"'s heart.

21. A method as in claim 20, wherein the receiver-stimulator generates an alternating current in response to the acoustic signal and converts the alternating current to a direct current and/or waveform to stimulate cardiac tissue.

22. A method as in claim 21, wherein the direct current is delivered to the cardiac tissue by electrodes.

23. A method as in claim 22, wherein the electrodes are implanted in the left and/or right ventricles.

24. A method as in any one of claims 21-23, wherein the direct current is converted to non-excitatory current which improves tissue contractility.

25. A method as in claim 24, wherein the non-excitatory current is delivered during ca absolute refractory period.

26. A method as in claim 24, wherein the non-excitatory current is delivered at a time of or delayed from a detected physiologic event.

27. A method as in claim 24, wherein the non-excitatory current is delivered on command from an external communication source.

28. A method as in claim 20, wherein the controller-transmitter is external.

29. A method as in claim 20, wherein the controller-transmitter is implantable in a subcutaneous region that directs acoustic energy to the heart.

30. A method as in claim 20, wherein the patient has been diagnosed as suffering from heart failure (HF).

31. A method of delivering therapy to a patient'"'"'s heart comprising:

transmitting acoustic energy to an implanted receiver stimulator to provide two or more of the following functions;

(a) ultrasound sonication of heart tissue to improve cardiac function, (b) ultrasound sonication of heart tissue to prevent deterioration of cardiac function, (c) leadless pacing to improve cardiac function, (d) leadless pacing to prevent deterioration of cardiac function, (e) leadless cardiac contractility modulation to improve cardiac function, and (f) leadless cardiac contractility modulation to prevent deterioration of cardiac function;

wherein cardiac function is one or more of contractility, vasodilation, tissue perfusion, or aortic pressure.