Acoustically-powered wireless defibrillator

• US 7,751,881 B2
• Filed: 06/18/2007
• Issued: 07/06/2010
• Est. Priority Date: 06/20/2006
• Status: Active Grant

• Current Assignee: EBR Systems, Inc.
• Original Assignee: EBR Systems, Inc.
• Inventors: Cowan, Mark W., Brisken, Axel F.
• Primary Examiner(s): Bockelman; Mark W
• Assistant Examiner(s): Dinga; Roland
• Application Number:
  US11/764,546
• Publication Number:
  US 20070293895A1
• Time in Patent Office: 1,114 Days
• Field of Search: 607/4, 607/5, 607/9, 607/10, 607/30, 607/32, 607/33, 607/35, 607/60, 607/61
• US Class Current: 607/5
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence
• CPC Class Codes: A61N 1/3975 Power supply A61N1/378 takes precedence

Abstract

An acoustic transmitter produces a pulsed ultrasound waveform which is transmitted through body tissues to an implanted receiver-stimulator device. The waveform has an acoustic amplitude, pulse width, and pulse repetition period, which corresponds to a pacing pulse electrical amplitude, pacing pulse width, and pacing cycle length, respectively. The receiver-stimulator device intercepts at least a portion of the transmitted acoustic energy and coverts that acoustic energy into electrical energy using piezoelectric or other devices. This electrical energy is applied to circuitry, which produces a desired stimulating pulse waveform, which is then applied to tissue-contacting electrodes.

Claims

1. A method for treating cardiac fibrillation or cardiac tachycardia, said method comprising:

implanting a controller-transmitter at a subcutaneous implantation site to generate acoustic energy, wherein the controller-transmitter comprises sensing electrodes that are configured to detect undesirable cardiac arrhythmias;

implanting a receiver-defibrillator at a cardiac implantation site, wherein the receiver-defibrillator comprises one or more electrode assemblies adapted to deliver defibrillation energy to cardiac tissue;

generating acoustic energy at the subcutaneous implantation site using the controller-transmitter;

receiving said acoustic energy at the cardiac implantation site using the receiver-defibrillator; and

using an external programmer to program one or more settings of the controller-transmitter;

wherein said acoustic energy is converted to electrical energy by the receiver-defibrillator at a rate of 1-10 J/sec, stored at a level to produce appropriate amplitude, and delivered with an appropriate waveform sufficient to treat the cardiac fibrillation or cardiac tachycardia.

2. A system for treating cardiac fibrillation or cardiac tachycardia, said system comprising:

an implantable acoustic controller-transmitter comprising sensing electrodes configured to detect undesirable cardiac arrhythmias; and

an implantable acoustic receiver-defibrillator having electrode assemblies adapted to deliver defibrillation energy to the cardiac muscle tissue; and

an external programmer configured to program one or more settings of the controller-transmitter;

wherein the controller-transmitter and receiver-defibrillator are adapted to transmit and receive acoustic energy, respectively, which provides both defibrillation energy and signal information to the receiver-defibrillator sufficient to provide cardiac defibrillation or termination of cardiac tachycardia, and wherein the receiver-defibrillator is configured to convert the received acoustic energy to electrical energy at a rate of 1-10 J/sec.

3. The system as in claim 2, wherein the receiver-defibrillator comprises an acoustic receiver which receives acoustic energy and converts the acoustic energy to electrical energy, means for accumulating and storing the electrical energy, means to generate an appropriate waveform from the stored electrical energy to defibrillate the cardiac tissue, and defibrillation electrodes adapted to deliver the defibrillation waveform to cardiac tissue.

4. The system of claim 3, wherein the receiver-defibrillator has distal and proximal ends, where the distal end of the receiver-defibrillator is adapted to be secured in the right ventricular apex of the heart, and the proximal end is adapted to be located above the heart.

5. The system of claim 4, wherein one defibrillation electrode is adapted to be located near the right ventricular apex of the heart, another defibrillation electrode is adapted to be located within brachiocephalic, subclavian, or a vein generally superior to the heart.

6. The system of claim 3, wherein the controller-transmitter comprises a power source, control and timing circuitry to detect undesirable cardiac arrhythmias and provide a defibrillation output signal, means for converting the defibrillation output signal to an acoustic energy signal, and means for transmitting the acoustic energy signal to the receiver-defibrillator.

7. The system of claim 6, wherein the control circuitry is configured to process an ECG signal from the sensing electrodes, and wherein the sensing electrodes are adapted to be located on the exterior surface of the controller-transmitter and in contact with body tissue.

8. A method for treating cardiac fibrillation or cardiac tachycardia and stimulating cardiac muscle, said method comprising:

implanting a controller-transmitter at a subcutaneous implantation site to generate acoustic energy, wherein the controller-transmitter comprises sensing electrodes that are configured to detect undesirable cardiac arrhythmias;

implanting a receiver-defibrillator-stimulator at a cardiac implantation site, wherein the receiver-defibrillator-stimulator comprises one or more electrode assemblies adapted to be in direct contact with cardiac tissue and deliver defibrillation or stimulation energy to cardiac muscle tissue;

generating acoustic energy at the subcutaneous implantation site using the controller-transmitter; and

receiving said acoustic energy at the cardiac implantation site using the receiver-defibrillator-stimulator; and

using an external programmer to program one or more settings of the controller-transmitter;

wherein said acoustic energy is converted by the receiver-defibrillator-stimulator to electrical energy at a rate of 1-10 J/sec, wherein the electrical energy is suitable for either cardiac defibrillation or for treating cardiac tachycardia or for cardiac muscle stimulation based on both energy and signal information encoded in the generated acoustic energy.

9. The method of claim 8, wherein receiving stimulating energy comprises receiving the acoustic energy at least two different cardiac sites.

10. The method of claim 8, wherein a predetermined configuration causes stimulation of at least two different sites simultaneously.

11. A system for treating cardiac fibrillation or cardiac tachycardia and for stimulating cardiac muscle tissue, said system comprising:

an implantable acoustic controller-transmitter comprising sensing electrodes configured to detect cardiac arrhythmias; and

an implantable acoustic receiver-defibrillator-stimulator having electrode assemblies adapted to deliver defibrillation energy or stimulation energy to the cardiac muscle tissue; and

an external programmer configured to program one or more settings of the controller-transmitter;

wherein the controller-transmitter and receiver-defibrillator-stimulator are adapted to transmit and receive acoustic energy, respectively, which provides energy to the receiver-defibrillator-stimulator sufficient for accomplishing one of either stimulation or defibrillation, and which also provides signal information sufficient to perform cardiac defibrillation or termination or cardiac tachycardia, and wherein the receiver-defibrillator-stimulator is configured to convert the received acoustic energy to electrical energy at a rate of 1-10 J/sec.

12. The system of claim 11, wherein the receiver-defibrillator-stimulator has proximal and distal ends, and wherein the receiver-defibrillator-stimulator comprises an acoustic receiver which receives acoustic energy and generates an alternating current signal, means for converting the alternating current signal to a direct current signal and further converting the direct current signal into stimulation energy or defibrillation energy, means for detecting whether the acoustic energy is intended to stimulate or defibrillate, means for applying stimulation energy to stimulation electrodes adapted to deliver the stimulation energy to myocardial tissue, means for accumulating and storing defibrillation energy, means to generate an appropriate waveform to defibrillate the cardiac tissue utilizing the stored defibrillation energy, and defibrillation electrodes adapted to deliver the defibrillation waveform to myocardial tissue.

13. The system of claim 12, wherein the distal end of the receiver-defibrillator-stimulator is adapted to be secured in the right ventricular apex of the heart, and wherein the proximal end is adapted to be located above the heart in the superior vena cava.

14. The system of claim 12, wherein the distal end of the receiver-defibrillator-stimulator is adapted to be secured in the right ventricular apex of the heart, and wherein the proximal end is adapted to be located above the heart.

15. The system of claim 12, wherein one defibrillation electrode is adapted to be located near the right ventricular apex of the heart, a second defibrillation electrode is adapted to be located within the superior vena cava, brachiocephalic vein or left subclavian vein, and one stimulation electrode is adapted to be located near the right ventricular apex of the heart in contact with right ventricular tissue.

16. The system of claim 15, wherein a second stimulation electrode is adapted to be located within the right atrium of the heart and disposed on the surface of the receiver-defibrillator-stimulator in such a manner to be in contact with right atrial tissue.

17. The system of claim 15, wherein a second stimulation electrode is adapted to be located within the right atrium of the heart and connected to the receiver-defibrillator-stimulator in such a manner to be in contact with right atrial tissue.

18. The system of claim 15, wherein a second stimulation electrode is adapted to provide stimulation to the right atrium sequentially with respect to the stimulation of the right ventricle.

19. The system of any one of the claims 11 through 18, wherein at least one independent receiver-stimulator is adapted to be secured within the left ventricle and provide stimulation synchronous with the stimulation of the right ventricle.

20. The system of any one of the claims 11 through 18, wherein at least one independent receiver-stimulator is adapted to be secured within the left ventricle and provide stimulation sequentially with the stimulation of the right ventricle.

21. The system of claim 11, wherein the controller-transmitter comprises a power source, control circuitry and timing circuitry to provide a pacing signal and to detect undesirable cardiac arrhythmias and provide a pacing or defibrillating output signal, means for converting the output signal to an acoustic energy signal, and means for transmitting the acoustic energy signal to the receiver-defibrillator-stimulator.

22. The system of claim 21, wherein control circuitry includes the sensing electrodes in order to adjust timing of stimulation or to detect undesirable cardiac arrhythmias.

23. The system of claim 22, wherein one or more physiologic variables sensed by the sensing electrodes determine the appropriate pacing or defibrillation therapy.

24. The system of claim 22 or 23, wherein the control circuitry is configured to process an ECG signal from the sensing electrodes, and wherein the sensing electrodes are located on the exterior surface of the controller-transmitter and adapted to be in contact with body tissue.

25. The system of claim 11, wherein the controller-transmitter comprises a housing and the sensing electrodes are disposed on the housing.

26. The system of claim 25, wherein the sensors are directly connected to the signal processing circuitry of the controller-transmitter.

27. The system of claim 11, wherein the external programmer transmits a radiofrequency signal and the controller-transmitter comprises circuitry for receiving the radiofrequency signal.

28. The system of claim 11, wherein the receiver-defibrillator-stimulator comprises ultrasound transducers, which convert acoustic energy to electrical energy, and the receiver-defibrillator-stimulator stores the converted electrical energy in response to the acoustic energy transmitted by the controller-transmitter, circuitry which detects a stimulation signal from the controller-transmitter, and at least one electrode which delivers the electrical energy to the electrode assemblies.

29. The system of claim 11, wherein the electrode assemblies are spaced further apart than conventional pacing electrodes.