Method and systems for heart failure prevention and treatments using ultrasound and leadless implantable devices

• US 10,207,115 B2
• Filed: 04/26/2016
• Issued: 02/19/2019
• Est. Priority Date: 08/31/2005
• Status: Active Grant

• Current Assignee: EBR Systems, Inc.
• Original Assignee: EBR Systems, Inc.
• Inventors: Echt, Debra S., Riley, Richard E., Cowan, Mark W., Brisken, Axel F.
• Primary Examiner(s): Hulbert, Amanda
• Application Number:
  US15/138,582
• Publication Number:
  US 20160235976A1
• Time in Patent Office: 1,029 Days
• 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 comprising electrodes 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 comprising a housing and at least one physiological sensor disposed on an outer surface of the housing, 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 and converter circuitry which produces a direct current or waveform from the alternating current to stimulate the cardiac tissue; and

wherein at least one of the electrodes is adapted to deliver the direct current or waveform to myocardial tissue;

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

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

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

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

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.

3. A system as in claim 2, wherein the implantable receiver-stimulator is adapted to be placed and secured at the ventricular septum.

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

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

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

an acoustic controller-transmitter, wherein the controller-transmitter is adapted to transmit acoustic energy into the patient'"'"'s body to provide two or more of the following functions;

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

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

6. A system as in claim 5, wherein leadless pacing or leadless cardiac contractility modulation therapy is delivered by the one or more acoustic receiver-stimulators and activated by the said 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, and 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; and

wherein the controller-transmitter is external.