Leadless cardiac pacemaker with conducted communication

• US 9,168,383 B2
• Filed: 10/19/2011
• Issued: 10/27/2015
• Est. Priority Date: 10/14/2005
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Jacobson, Peter M., Ostroff, Alan, Ciciarelli, Timothy E.
• Primary Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US13/277,151
• Publication Number:
  US 20120109236A1
• Time in Patent Office: 1,469 Days
• Field of Search: 607 32- 33, 607/60
• US Class Current: 1/1
• 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 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• 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 1/3727 characterised by the modulation technique
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A leadless pacemaker for pacing a heart of a human includes a hermetic housing and at least two electrodes on or near the hermetic housing. The at least two electrodes are configured to deliver energy to stimulate the heart and to transfer information to or from at least one external device.

Claims

1. A leadless pacemaker for pacing a heart of a human comprising:

a hermetic housing;

at least two electrodes on or near the hermetic housing, the at least two electrodes configured to deliver energy to stimulate the heart and to transfer communication information to or from at least one external device; and

a pulse generator in the housing, the pulse generator configured to provide energy to the at least two electrodes and to transfer the communication information through the at least two electrodes to the external device.

2. The leadless pacemaker of claim 1, wherein the external device is a second leadless pacemaker, a defibrillator, a conventional pacemaker, an implanted programmer, or a programmer external to the body of the human.

3. The leadless pacemaker of claim 1, wherein the information is encoded in sub-threshold pulses.

4. The leadless pacemaker of claim 1, wherein the pulse generator further comprises a stimulation pulse generator in the housing, wherein the stimulation pulse generator is configured to provide energy to the at least two electrodes to stimulate the heart.

5. The leadless pacemaker of claim 1, further comprising a controller in the hermetic housing, the controller configured to communicate with the external device by transferring the information through the at least two electrodes.

6. The leadless pacemaker of claim 5, wherein the controller is configured to communicate with the external device by transferring the information through the at least two electrodes during a pacing pulse.

7. The leadless pacemaker of claim 5, wherein controller is configured to communicate with the external device by transferring the information through the at least two electrodes outside of a refractory period or pacing pulse.

8. The leadless pacemaker of claim 5, wherein the controller is configured to communicate with the external device by transferring the information through the at least two electrodes only during an absolute refractory period.

9. The leadless pacemaker of claim 5, wherein the controller is configured to provide charge balancing of the information before the end of a refractory period.

10. The leadless pacemaker of claim 5, wherein the controller is configured to transfer information to or from the external device by sending a bell-ringer signal to the external device and listening for a response from the external device only during a set time period after the bell-ringer signal.

11. The leadless pacemaker of claim 5, wherein the controller is configured to send a synchronization signal through the at least two electrodes to the external device to start transfer of a part of the information.

12. The leadless pacemaker of claim 5, wherein the controller is configured to measure a length of time between encoded information signals received by the at least two electrodes.

13. The leadless pacemaker of claim 12, wherein the controller is configured to use the measured length of time to estimate a clock frequency of the external device and optimize the timing of the transfer of information.

14. The leadless pacemaker of claim 1, further comprising a sensing amplifier to receive and amplify signals received by the, at least two electrodes, wherein the pacemaker is configured to discriminate signals received by the at least two electrodes for noise rejection.

15. A system for pacing a heart of a human comprising:

an external device; and

a leadless pacemaker comprising a hermetic housing, a pulse generator in the hermetic housing and at least two electrodes on the hermetic housing, the pulse generator configured to provide pacing pulses to the at least two electrodes to stimulate the heart and to transfer communication pulses through the at least two electrodes to provide communication information to the external device,

wherein the eternal device is not attached to the leadless pacemaker, and

wherein the at least two electrodes are configured to deliver the pacing pulses to stimulate the heart and to transfer the communication pulses to the external device.

16. The system of claim 15, wherein the communication pulses include sub-threshold pulses.

17. The system of claim 15, wherein the external device is a second leadless pacemaker, a defibrillator, a conventional pacemaker, an implanted programmer, or a programmer external to the body of the human.

18. The system of claim 17, wherein the external device is a programmer external to the body of the human, and wherein the programmer comprises at least two skin electrodes configured to attach to skin of the human, the at least two skin electrodes further configured to transfer the communication pulses to or from the leadless pacemaker.

19. The system of claim 18, wherein the external device further comprises a controller, the controller configured to communicate with the leadless pacemaker by transferring the communication pulses through the at least two skin electrodes.

20. The system of claim 19, wherein the controller is configured to transmit the communication pulses through the at least two skin electrodes using a biphasic square wave.

21. The system of claim 20, wherein the biphasic square wave has approximately a 25V peak amplitude.

22. The system of claim 15, wherein the external device further comprises a controller, the controller configured to communicate with the leadless pacemaker by transferring the communication pulses to or from the leadless pacemaker.

23. The system of claim 22, wherein the controller is configured to transfer the communication pulses during a pacing pulse.

24. The system of claim 22, wherein the controller is configured to transfer the communication pulses outside of a refractory period or pacing pulse.

25. The system of claim 22, wherein the controller is configured to transfer the communication pulses only during an absolute refractory period.

26. The system of claim 20, wherein the controller is configured to measure a length of time between the communication pulses transferred from the leadless pacemaker.

27. The system of claim 26, wherein the controller is configured to use the measured length of time to estimate a clock frequency of the leadless pacemaker and optimize the timing of the transfer of the communication pulses.

28. The system of claim 15, wherein the external device further comprising a sensing amplifier to receive and amplify the, communication pulses, and wherein the external device is configured to discriminate the communication pulses transferred from the leadless pacemaker for noise rejection.

29. A method of pacing a heart of a human, comprising:

providing a leadless pacemaker comprising a hermetic housing, a pulse generator in the hermetic housing and at least two electrodes on the hermetic housing;

configuring the pulse generator to provide pacing pulses and communication pulses to the at least two electrodes;

delivering the pacing pulses through the at least two electrodes of the leadless pacemaker to stimulate the heart; and

communicating the communication pulses between the at least two electrodes and an external device not attached to the leadless pacemaker.

30. The method of claim 29, wherein communicating occurs only during a refractory period.

31. The method of claim 29, wherein communicating occurs outside of a refractory period the pacing pulses.

32. The method of claim 29, further comprising charge balancing the communication pulses before the end of a refractory period.

33. The method of claim 29, wherein communicating occurs only during predetermined times in one or more pacing cycles.

34. The method of claim 29, further comprising sending a synchronization signal through the at least two electrodes to the external device to start transfer of a part of the communication pulses.