Leadless cardiac pacemaker triggered by conductive communication

• US 8,352,025 B2
• Filed: 10/13/2006
• Issued: 01/08/2013
• Est. Priority Date: 10/14/2005
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Nanostim, Inc (Abbott Laboratories Incorporated)
• Inventors: Jacobson, Peter M.
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US11/549,596
• Publication Number:
  US 20070088398A1
• Time in Patent Office: 2,279 Days
• Field of Search: 600508-509, 607 2- 9, 607/33, 607 36- 37
• US Class Current: 607/2
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• 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 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• 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 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/3704 Circuits specially adapted therefor, e.g. for sensitivity control
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/3708 for power depletion
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• 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 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• 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 1/37512 : Pacemakers
• CPC Class Codes: A61N 1/37518 : Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 : Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3925 : Monitoring; Protecting
• CPC Class Codes: A61N 1/3956 : Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/39622 : Pacing therapy
• CPC Class Codes: A61N 2001/058 : Fixing tools
• CPC Class Codes: H04B 13/005 : Transmission systems in which the medium consists of the human body

Abstract

A leadless cardiac pacemaker configured for implantation in electrical contact with a left ventricular cardiac chamber and configured for leadless triggered left-ventricular pacing for cardiac resynchronization therapy (CRT) in response to conducted signals from a pulse generator.

Claims

1. A cardiac pacing system comprising:

a leadless cardiac pacemaker configured for implantation in electrical contact with a left ventricular cardiac chamber and performing leadless triggered left-ventricular pacing for cardiac resynchronization therapy (CRT) in response to conducted signals from a co-implanted pulse generator, the leadless cardiac pacemaker comprising a pacing pulse generator configured to generate pulses adapted to perform cardiac pacing and pulses encoding information for transmission as communication signals during a refractory period, the leadless cardiac pacemaker configured to receive communication directly from a non-implanted programmer.

2. The system according to claim 1 further comprising:

at least one implanted leadless or electrode-lead pulse generator comprising the co-implanted pulse generator, the co-implanted pulse generator being configured to generate pulses adapted to perform cardiac pacing and pulses adapted to encode information for transmission as communication signals to the leadless cardiac pacemaker.

3. The system according to claim 1 wherein the leadless cardiac pacemaker is configured for operation as a left-ventricular pacemaker for cardiac resynchronization therapy in response to wireless conducted signals from the co-implanted pulse generator, the wireless conducted signals being conducted pacing pulse, refractory and/or subliminal signals delivered in response to cardiac contractions, the leadless cardiac pacemaker programmable for operation as the left-ventricular pacemaker by bidirectional communication with a non-implanted programmer wherein information comprising programmable parameter settings is encoded in pulses generated by the pacing pulse generator.

4. The system according to claim 1 wherein the leadless cardiac pacemaker further comprises:

a hermetic housing configured for placement on or attachment to the inside or outside of a cardiac chamber; and

at least two electrodes abutting or adjacent to the housing and configured for delivering the pulses from the pacing pulse generator and for receiving triggering signals from the co-implanted pulse generator.

5. The system according to claim 4 wherein the at least two electrodes are configured for sensing electrical activity from cardiac chamber muscle.

6. The system according to claim 4 wherein the at least two electrodes are configured for bidirectional communication with at least one other device.

7. The system according to claim 1 further comprising:

the leadless cardiac pacemaker configured for leadless triggered left-ventricular pacing in response to conducted signals selected from a group consisting of a signal from a separate implanted pulse generator, a signal from at least one electrode-lead of a separate implanted pulse generator, a right-ventricular pacing pulse delivered by an implanted pulse generator, an atrial pacing pulse delivered by an implanted pulse generator, a signal delivered in combination with a cardioversion function, and a signal delivered in combination with a defibrillation function.

8. The system according to claim 1 further comprising:

the leadless cardiac pacemaker configured to operate as a “

slave”

left-ventricular leadless cardiac pacemaker wherein the leadless cardiac pacemaker is triggered by an atrial pacing stimulation pulse or right-ventricular pacing stimulation pulse of the co-implanted pulse generator operative for right-ventricular and/or atrial pacing.

9. The system according to claim 1 further comprising:

the leadless pacemaker configured for implantation adjacent to the inside or outside wall of a cardiac chamber and configured for leadless conductive communication with the co-implanted pulse generator.

10. The system according to claim 1 further comprising:

the leadless pacemaker configured for left-ventricular pacing triggered by conducted communication from the co-implanted pulse generator, the left-ventricular pacing triggered by a right-ventricular pacing pulse and/or an atrial pacing pulse delivered by the co-implanted pulse generator.

11. The system according to claim 1 further comprising:

at least two electrodes abutting or adjacent to the housing and configured for delivering pulses generated by the pacing pulse generator and configured for operation as an incoming communication channel for receiving triggering information from the co-implanted pulse generator, the triggering information comprising an electrical signal resulting from a right-ventricular pacing stimulation pulse or an atrial pacing stimulation pulse of an implanted pulse generator and electrode-lead system.

12. The system according to claim 11 further comprising:

a controller coupled to the at least two electrodes adapted to examine triggering information validity and, for a valid condition, activating delivery of a pacing stimulation pulse following a predetermined delay of zero or more milliseconds.

13. The system according to claim 11 further comprising:

the incoming communication channel that communicates information selected from a group consisting of pacing rate, pulse duration, sensing threshold, delay intervals, refractory time intervals, stimulation pulse amplitudes, and parameters commonly programmed from an external programmer in a pacemaker; and

the at least two electrodes configured for operation as an outgoing communication channel adapted to communicate information encoded in at least one pulse generated by the pacing pulse generator and selected from a group consisting of programmable parameter settings, pacing and sensing event counts, battery voltage, battery current, information commonly displayed by external programmers used with pacemakers, and echoed information from the incoming channel to confirm correct programming.

14. The system according to claim 11 further comprising:

a controller coupled to the at least two electrodes adapted to examine signals received on the at least two electrodes, decode information encoded in the signals, and evaluate the decoded information for pacing pulse signature validation.

15. The system according to claim 11 further comprising:

a controller coupled to the at least two electrodes adapted to examine output pulse duration from the co-implanted pulse generator for usage as a signature for determining triggering information validity and, for a signature arriving within predetermined limits, activating delivery of a pacing pulse following a predetermined delay of zero or more milliseconds, the predetermined delay being determined from a method in a group consisting of preset at manufacture, programmed via an external programmer, and adaptively monitoring and conforming to duration of a triggering signal.

16. The system according to claim 11 further comprising:

a controller coupled to the at least two electrodes adapted to examine output pulse amplitude, duration, and rate from the co-implanted pulse generator for usage as a signature for determining triggering information validity and, for a signature arriving within predetermined limits, activating delivery of a pacing pulse following a predetermined delay of zero or more milliseconds.

17. The system according to claim 11 further comprising:

a controller coupled to the at least two electrodes adapted to trigger delivery of a left-ventricular pacing pulse from an atrial pacing pulse of the co-implanted pulse generator for cardiac resynchronization therapy (CRT) after a selected atrio-ventricular delay of 50 to 300 milliseconds, the controller further adapted to vary the atrio-ventricular delay according to time since a last delivered left-ventricular pacing pulse wherein a shorter atrio-ventricular delay is selected for a higher atrial rate.

28. The system according to claim 1 wherein the pacing pulse generator is further configured to generate stimulation pulses encoding information for transmission as communication signals.

29. The system according to claim 1 wherein the pacing pulse generator is configured to encode programmable parameter setting information on the pulses.

18. A cardiac pacing system comprising:

a leadless cardiac pacemaker configured for implantation in electrical contact with a cardiac chamber and configured for receiving and evaluating triggering information from a co-implanted pulse generator via an electrical signal conducted from an atrial or ventricular pacing pulse delivered by the co-implanted implanted pulse generator, the leadless cardiac pacemaker comprising a pacing pulse generator configured to generate pulses adapted to perform cardiac pacing and pulses encoding information for transmission as communication signals during a refractory period, the leadless cardiac pacemaker configured to receive communication directly from a non-implanted programmer.

19. The system according to claim 18 further comprising:

at least one implanted leadless or electrode-lead pulse generator comprising the co-implanted pulse generator and configured to conduct signals that trigger left-ventricular pacing to the leadless cardiac pacemaker by direct conduction using modulated signals.

20. The system according to claim 18 wherein the leadless cardiac pacemaker further comprises:

a hermetic housing configured for placement on or attachment to the inside or outside of a cardiac chamber; and

at least two electrodes abutting or adjacent to the housing and configured for delivering the pulses from the pacing pulse generator and for receiving triggering signals from the co-implanted pulse generator.

21. The system according to claim 20 wherein the at least two electrodes are configured for operation as an incoming communication channel for receiving triggering signals from the co-implanted pulse generator, the triggering information comprising a signal resulting from a pulse generated by the co-implanted pulse generator.

22. The system according to claim 21 further comprising:

a controller coupled to the at least two electrodes adapted to examine triggering information validity and, for a valid condition, activating delivery of a pacing stimulation pulse following a predetermined delay of zero or more milliseconds.

23. The system according to claim 21 further comprising:

a controller coupled to the at least two electrodes adapted to examine output pulse duration from the co-implanted pulse generator for usage as a signature for determining triggering information validity and, for a signature arriving within predetermined limits, activating delivery of a pacing pulse following a predetermined delay of zero or more milliseconds, the predetermined delay being determined from a method in a group consisting of preset at manufacture, programmed via an external programmer, and adaptively monitoring and conforming to duration of a triggering signal.

24. The system according to claim 21 further comprising:

a controller coupled to the at least two electrodes adapted to examine output pulse duration, amplitude, and rate from the co-implanted pulse generator for usage as a signature for determining triggering information validity and, for a signature arriving within predetermined limits, activating delivery of a pacing pulse following a predetermined delay of zero or more milliseconds.

25. The system according to claim 21 further comprising:

a controller coupled to the at least two electrodes adapted to trigger delivery of an atrial pacing pulse in response to sensing of an atrial heartbeat in sinus rhythm and in response to detection of sinus rhythm below a selected rate for atrial triggered pacing.

26. The system according to claim 21 further comprising:

a controller coupled to the at least two electrodes adapted to limit synchronous pacing pulse delivery rate to a selected maximum rate.

27. The system according to claim 18 further comprising:

a plurality of leadless cardiac pacemakers configured for implantation in electrical contact with at least one cardiac chamber and distributed epicardially, the leadless cardiac pacemaker plurality adapted to be timed from an initial triggering pulse for generating simultaneous pulses for defibrillation or cardioversion therapy.