Leadless tissue stimulation systems and methods

• US 7,558,631 B2
• Filed: 09/27/2006
• Issued: 07/07/2009
• Est. Priority Date: 12/21/2004
• Status: Active Grant

• Current Assignee: EBR Systems, Inc.
• Original Assignee: EBR Systems, Inc.
• Inventors: Riley, Richard E., Cowan, Mark W., Brisken, Axel F., Echt, Debra S.
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Flory; Christopher A
• Application Number:
  US11/535,857
• Publication Number:
  US 20070078490A1
• Time in Patent Office: 1,014 Days
• Field of Search: 607/33, 607/57, 607/122, 607/123, 607/129, 128/898
• US Class Current: 607/122
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• 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 external controller-transmitter system are used for leadless acute stimulation of the heart, particularly after heart surgery. Cardiac pacing and arrhythmia control is accomplished with one or more implantable receiver-stimulators and an external system that alternatively includes the use of an external pacemaker. Receiver-stimulators are implanted in the heart during surgery or during an acute interventional procedure and then a triggered for stimulation by using the external system. In one embodiment of these systems, a controller-transmitter is activated by an external pacemaker to time the delivery of acoustic energy transmission 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 heart tissue.

Claims

1. A method for stimulating cardiac tissue, said method comprising:

placing a pacing lead to be in contact with a heart of a patient at a first cardiac stimulation site on a right side of the heart,

implanting a leadless receiver-stimulator at a second cardiac stimulation site in a left ventricle of the heart,

connecting the pacing lead to an external pacemaker,

generating an electrical pacing pulse from the external pacemaker and applying the electrical pacing pulse to the pacing lead, wherein said electrical pacing pulse delivers cardiac stimulation energy to the first cardiac stimulation site,

detecting the electrical pacing pulse using an externally located acoustic energy generator;

upon detecting the pacing pulse, generating acoustic energy using the externally located acoustic energy generator that is coupled to the patient; and

receiving said acoustic energy by the leadless receiver stimulator at the second cardiac stimulation site, wherein said acoustic energy is converted into cardiac stimulation energy based on both energy and signal information included in the generated acoustic energy.

2. The method of claim 1, wherein receiving comprises receiving the acoustic energy at least two different cardiac stimulation sites.

3. The method of claim 2, wherein the signal information sequentially activates two receiver-stimulators to stimulate two different cardiac sites sequentially.

4. The method of claim 2, wherein the signal information simultaneously activates two receiver-stimulators to stimulate two different cardiac sites simultaneously.

5. The method of claim 1, wherein the cardiac stimulation energy is delivered to treat a cardiac arrhythmia.

6. The method of claim 1, wherein the cardiac stimulation energy is delivered to terminate cardiac arrhythmia.

7. The method of claim 1, wherein the cardiac stimulation energy is delivered to improve cardiac hemodynamics.

8. A method as in claim 1, further comprising removing the pacing lead from the patient, while leaving the implanted leadless receiver-stimulator in place.

9. A system for stimulating cardiac tissue, said system comprising:

an external pacemaker and one or more temporary pacing leads having an electrode assembly adapted to be in direct contact with cardiac tissue on a right side of a heart wherein the external pacemaker is adapted to sense cardiac activity using the pacing leads and deliver electrical pacing pulse energy sufficient to stimulate the cardiac tissue using the pacing lead;

an external acoustic controller-transmitter adapted to be connected to one or more of the pacing leads and to detect pacing level electrical signals on the pacing leads; and

an implantable leadless acoustic receiver-stimulator having an electrode assembly adapted to be in direct contact with cardiac tissue in a left ventricle of the heart, wherein the controller-transmitter is adapted to transmit acoustic energy, wherein the acoustic energy is transmitted upon detecting the pacing level electrical signal by the external acoustic controller-transmitter and the receiver-stimulator is adapted to receive acoustic energy, wherein the transmission from the controller-transmitter contains energy and signal information sufficient to stimulate said cardiac tissue.

10. The system of claim 9, wherein the receiver-stimulator comprises an acoustic receiver which receives acoustic energy and generates electrical energy, means for converting the electrical energy to a direct current or waveform to stimulate the cardiac tissue, and electrodes adapted to deliver the direct current or waveform to myocardial tissue.

11. The system of claim 10, wherein the implantable receiver-stimulator and temporary pacing leads are adapted to be secured within a chamber, respectively the left ventricle and a right heart.

12. The system of claim 10, wherein the implantable receiver-stimulator and temporary pacing leads are adapted to be embedded and secured within the myocardial tissue.

13. The system of claim 10, wherein the implantable receiver-stimulator and temporary pacing leads are adapted to be secured within (1) a left ventricle and (2) the coronary veins or arteries of the heart, respectively.

14. The system of claim 9, wherein the externally applied acoustic controller-transmitter is adapted to trigger an acoustic transmission into a patient upon detecting the electrical pacing pulse signal to synchronize contraction between the left and right ventricles.

15. The system of claim 9, wherein the externally applied acoustic controller-transmitter is adapted to trigger an acoustic transmission into a patient based upon detecting the electrical pacing pulse signal to synchronize contraction within the left ventricle.

16. The system of claim 9, wherein the externally applied acoustic controller-transmitter is adapted to trigger an acoustic transmission into a patient based upon detecting the electrical pacing pulse signal to synchronize contraction between the left and right atria.

17. The system of claim 9, wherein the externally applied acoustic controller-transmitter is adapted to trigger an acoustic transmission into a patient based upon detecting the electrical pacing pulse signal to synchronize contraction between the atrium and the ventricle.

18. The system of claim 9, wherein the externally applied acoustic controller-transmitter is adapted to trigger an acoustic transmission into a patient based upon detecting the electrical pacing pulse signal to synchronize contraction between multiple sites within the heart.

19. The system of claim 9, wherein the external pacemaker and the externally applied acoustic controller-transmitter are adapted to be an integrated device.

20. The system of claim 9, wherein the externally applied acoustic controller-transmitter comprises a power source, control and timing circuitry to detect the electrical pacing signal and to trigger an acoustic transmission into a patient.

21. The system of claim 20, wherein control and timing circuitry includes one or more means for sensing physiologic variables or non-physiologic variables in order to adjust timing of the trigger.

22. The system of claim 21, wherein sensing non-physiologic variables includes detecting the electrical pacing signal and timing the trigger from that detection in order to synchronize the cardiac stimulation from the implantable receiver-stimulator with the external pacemaker.

23. The system of claim 21, wherein means for sensing physiologic variables includes a blood pressure sensor.

24. The system of claim 21, wherein means for sensing physiologic or non-physiologic variables includes an electrogram signal processor for processing signals from electrodes that are in contact with tissue.

25. The system of claim 24, wherein the electrogram signal processor is adapted to detect intrinsic cardiac beats.

26. The system of claim 25, wherein the control circuitry can selectively pace after detecting tachyarrhythmia.

27. The system of claim 24, wherein the electrogram signal processor is adapted to detect pacemaker pacing output.

28. The system of claim 24, wherein the electrogram signal processor is adapted to detect non-intrinsic cardiac beats initiated by pacemaker pacing outputs.

29. The system of claim 24, wherein the electrogram signal processor is adapted to detect tachyarrhythmia.

30. The system of claim 21, wherein means for sensing physiologic variables includes impedance sensor to detect changes in the body related to respiration cycles or lung edema.

31. The system of claim 21, wherein means for sensing physiologic variables includes a temperature sensor.

32. The system of claim 9, further comprising at least one additional receiver-stimulator device.

33. The system of claim 32, wherein the system is programmed to activate the receiver-stimulator devices sequentially.

34. The system of claim 32, wherein the system is programmed to activate the receiver-stimulator devices simultaneously.

35. The system of claim 34, wherein the external pacemaker and the external acoustic controller-transmitter are integrated into a single device.

36. The system of claim 35, wherein the external controller-transmitter/pacemaker combination comprises a power source, control and timing circuitry to deliver at least one conventional electrical pacing pulse energy signal to cardiac tissue through electrodes on the temporary pacing leads, and to trigger multiple acoustic transmissions to multiple receiver-stimulators.

37. The system of claim 9, wherein the transmitter and receiver-stimulator are adapted to transmit and receive acoustic energy wherein the frequency of the acoustic energy is between 20 kHz and 10 MHz.

38. The system of claim 37, wherein the frequency of the acoustic energy is most preferably between 800 kHz and 1.2 MHz.

39. A method for stimulating cardiac tissue, said method comprising:

generating acoustic energy at an external site on a patient synchronously with detecting a pacing pulse or electrical activity delivered to a right side of a patient'"'"'s heart;

receiving said acoustic energy at a cardiac stimulation site, wherein said acoustic energy is converted into cardiac stimulation energy based on both energy and signal information included in the generated acoustic energy; and

using the cardiac stimulation energy for stimulation or pacing at the cardiac stimulation site by a leadless receiver stimulator implanted in a left ventricle of the patient'"'"'s heart.

40. The method of claim 39, wherein stimulating cardiac tissue provides left ventricular stimulation synchronously with right ventricular stimulation.

41. The method of claim 39, wherein stimulating cardiac tissue provides right atrial stimulation synchronously with left ventricular stimulation.

42. The method of claim 39, wherein synchronizing the cardiac tissue stimulation is performed by processing electrogram signals.

43. The method of claim 42, wherein the processing of electrogram signals and synchronizing the stimulation is performed by sensing atrial and/or ventricular electrogram signals obtained from a surface ECG.

44. The method of claim 42, wherein the processing of electrogram signals and synchronizing the stimulation is performed through a direct connection to leads in contact with the heart.

45. The method of claim 39, wherein synchronizing the stimulation is performed by detecting intrinsic or non-intrinsic cardiac beats from an electrogram signal.

46. A method as in claim 39, further comprising removing the pacing lead from the patient, while leaving the implanted leadless receiver-stimulator in place.