Leadless tissue stimulation systems and methods

• US 8,315,701 B2
• Filed: 09/04/2009
• Issued: 11/20/2012
• Est. Priority Date: 12/21/2004
• Status: Active Grant

• Current Assignee: EBR Systems, Inc.
• Original Assignee: EBR Systems, Inc.
• Inventors: Cowan, Mark W., Echt, Debra S., Riley, Richard E., Brisken, Axel F.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US12/554,257
• Publication Number:
  US 20100228308A1
• Time in Patent Office: 1,173 Days
• Field of Search: 607/9, 607/30, 607/33, 607/60
• US Class Current: 607/33
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Systems including an implantable receiver-stimulator and an implantable controller-transmitter are used for leadless electrical stimulation of body tissues. Cardiac pacing and arrhythmia control is accomplished with one or more implantable receiver-stimulators and an external or implantable controller-transmitter. Systems are implanted by testing external or implantable devices at different tissue sites, observing physiologic and device responses, and selecting sites with preferred performance for implanting the systems. In these systems, a controller-transmitter is activated at a remote tissue location to transmit/deliver acoustic energy through the body to a receiver-stimulator at a target tissue location. The receiver-stimulator converts the acoustic energy to electrical energy for electrical stimulation of the body tissue. The tissue locations(s) can be optimized by moving either or both of the controller-transmitter and the receiver-stimulator to determine the best patient and device responses.

Claims

1. A system for stimulating cardiac muscle, said system comprising:

a subcutaneously implantable controller-transmitter, wherein the controller-transmitter is present in a sealed case; and

an implantable receiver-stimulator adapted to contact a cardiac stimulation site, wherein the receiver-stimulator is present in a sealed case;

wherein the controller-transmitter is configured to detect a pacing signal from a separate cardiac pacemaker, wherein the controller-transmitter is adapted to transmit acoustic energy upon detecting the pacing signal; and

the receiver-stimulator is adapted to receive the acoustic energy and convert the received acoustic energy into cardiac stimulation energy based on both energy and signal information included in the acoustic energy.

2. A system as in claim 1, wherein the receiver-stimulator comprises one or more stimulation electrodes adapted to deliver the cardiac stimulation energy such that the stimulation electrodes lie in electrical communication with the cardiac stimulation site.

3. A system as in claim 2, wherein the implantable receiver-stimulator is adapted to be placed and secured at any location within a cardiac chamber.

4. A system as in claim 2, wherein the implantable receiver-stimulator is adapted to be embedded and secured at any location within myocardial tissue.

5. A system as in claim 2, wherein the implantable receiver-stimulator is adapted to be placed and secured at any location on the epicardial aspect of the heart.

6. A system as in claim 2, wherein the implantable receiver-stimulator is adapted to be placed and secured at any location within the coronary veins or arteries of the heart.

7. A system as in claim 6, wherein the implantable receiver-stimulator is placed on a stent.

8. A system as in claim 6, wherein the implantable receiver-stimulator is adapted to be secured between the outside of a stent wall and the inside of a vessel wall.

9. A system as in claim 1, wherein the implantable receiver-stimulator is adapted to be placed and secured to synchronize contraction between the left and right ventricles.

10. A system as in claim 1, wherein the implantable receiver-stimulator is adapted to be placed and secured to synchronize contraction within the left ventricle.

11. A system as in claim 1, wherein the implantable receiver-stimulator is adapted to be placed and secured to synchronize contraction between the left and right atria.

12. A system as in claim 1, wherein the implantable receiver-stimulator is adapted to be placed and secured to synchronize contraction between the atria and the ventricles.

13. A system as in claim 1, wherein the implantable receiver-stimulator is adapted to be placed and secured to synchronize contraction between multiple sites within the heart.

14. A system as in claim 1, wherein the controller-transmitter is adapted to be placed externally on the patient to transmit acoustic energy to the implantable receiver-stimulator.

15. A system as in claim 1, wherein the controller-transmitter comprises a power source, control circuitry, means for generating the acoustic energy, and means for triggering transmission of the acoustic energy to the receiver-stimulator.

16. A system as in claim 15, wherein the control circuitry includes one or more means for sensing physiologic variables or non-physiologic variables in order to adjust timing of triggering transmission of acoustic energy.

17. A system as in claim 16, wherein sensing non-physiologic variables includes detecting the pacing signal and timing the transmission to synchronize the cardiac stimulation from the implantable receiver-stimulator with the separate cardiac pacemaker.

18. A system as in claim 16, wherein means for sensing physiologic variables includes a blood pressure sensor.

19. A system as in claim 16 or 17, wherein means for sensing physiologic or non-physiologic variables includes an electrogram signal processor for processing electrogram signals from electrodes that are located on the exterior surface of the controller-transmitter and are in contact with tissue.

20. A system as in claim 19, wherein the electrogram signal processor is adapted to detect intrinsic cardiac beats.

21. A system as in claim 20, wherein the control circuitry can selectively pace after detecting tachyarrhythmia.

22. A system as in claim 19, wherein the electrogram signal processor is adapted to detect the pacing signal from the separate cardiac pacemaker.

23. A system as in claim 19, wherein the electrogram signal processor is adapted to detect non-intrinsic cardiac beats initiated by pacing from the separate cardiac pacemaker.

24. A system as in claim 19, wherein the electrogram signal processor is adapted to detect tachyarrhythmia.

25. A system as in claim 16, wherein means for sensing physiologic variables includes an accelerometer for sensing body movement activity.

26. A system as in claim 16, wherein means for sensing physiologic variables includes processing heart sounds.

27. A system as in claim 16, wherein means for sensing physiologic variables includes processing impedance changes in the body related to respiration cycles or lung edema.

28. A system as in claim 16, wherein means for sensing physiologic variables includes processing body temperature.

29. A system as in claim 1, wherein detecting the pacing signal includes connecting a cable from the controller-transmitter to a pacing output channel of the separate cardiac pacemaker and detecting the occurrence of the pacing signal using the cable.

30. A system as in claim 1, further comprising at least one additional receiver-stimulator device.

31. A system as in claim 30, wherein the system is programmed to activate the receiver-stimulator devices sequentially.

32. A system as in claim 30, wherein the system is programmed to activate the receiver-stimulator devices simultaneously.

33. A system as in claim 1, wherein the implantable controller-transmitter includes control circuitry for a conventional pacemaker and is adapted to utilize electrode-tipped transvenous leads placed into the right atrium and/or right ventricle for conventional electrical pacing.

34. A system as in claim 1, wherein the controller-transmitter and receiver-stimulator are adapted to transmit and receive acoustic energy, and the frequency of the acoustic energy transmission is between 20 kHz and 10 MHz.

35. A system as in claim 34, wherein the frequency of the acoustic energy transmission is preferably between 800 kHz and 1.2 MHz.

36. A system as in claim 1, wherein the receiver-stimulator is configured to be mechanically deployed from a delivery system in order to be implanted at the cardiac stimulation site.

37. A system as in claim 36, wherein the delivery system comprises the receiver-stimulator temporarily affixed to a catheter.

38. A system as in claim 36, wherein the receiver-stimulator is permanently affixed to a catheter.

39. A system as in claim 36, wherein the controller-transmitter is an externally applied and operated device.

40. A system as in claim 36, wherein the controller-transmitter is an implanted device.

41. A system as in claim 40, wherein the implanted controller-transmitter is controlled by an external programmer.