Leadless cardiac pacemaker system for usage in combination with an implantable cardioverter-defibrillator

• US 10,238,883 B2
• Filed: 12/18/2017
• Issued: 03/26/2019
• 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.
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US15/845,043
• Publication Number:
  US 20180126180A1
• Time in Patent Office: 463 Days
• 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 cardiac pacing system comprising one or more leadless cardiac pacemakers configured for implantation in electrical contact with a cardiac chamber and configured to perform cardiac pacing functions in combination with a co-implanted implantable cardioverter-defibrillator (ICD). The leadless cardiac pacemaker comprises at least two leadless electrodes configured for delivering cardiac pacing pulses, sensing evoked and/or natural cardiac electrical signals, and bidirectionally communicating with the co-implanted ICD.

Claims

1. A method of operating a cardiac pacing system comprising:

using electrodes of a subcutaneous implantable cardioverter-defibrillator (SICD) to sense cardiac signals in one or more chambers of the patient'"'"'s heart;

using the electrodes of the SICD to send a triggering signal to a leadless pacemaker by conducted communication between the SICD and the leadless pacemaker;

using a pair of electrodes of the leadless pacemaker to receive the triggering signal from the SICD;

using the pair of electrodes of the leadless pacemaker, which were used to receive the triggering signal from the SICD, to perform pacing in a chamber of the patient'"'"'s heart; and

using the pair of electrodes of the leadless pacemaker, which were used to receive the triggering signal from the SICD and to perform the pacing, to convey information to the SICD via conducted communication by discharging a capacitor, coupled across the pair of electrodes of the leadless pacemaker, to form an electrical pulse during a refractory period of the heart and encoding the information to be conveyed on the electrical pulse.

2. The method of claim 1, further comprising:

controlling charging of the capacitor coupled across the pair of electrodes of the leadless pacemaker, to control recharging of the capacitor;

wherein the controlling charging includes discontinuing recharging when a power source terminal voltage falls below a predetermined value to ensure sufficient voltage for powering the leadless cardiac pacemaker.

3. The method of claim 1, further comprising ensuring that circuitry of the leadless pacemaker consumes no more than 64 microwatts.

4. The method of claim 1, further comprising ensuring that a primary power supply of the leadless pacemaker sources no more than 70 microwatts instantaneously.

5. The method of claim 1, further comprising:

using the pair of electrodes of the leadless pacemaker to receive a signal having a pulse duration from the SICD; and

the leadless pacemaker determining whether the signal is a triggering signal based on the pulse duration of the signal.

6. The method of claim 1, further comprising:

the leadless pacemaker determining whether a triggering signal has arrived within a predetermined limit; and

in response to the leadless pacemaker determining that the triggering signal has arrived within the predetermined limit, the leadless pacemaker activating delivery of a pacing pulse following a predetermined delay.

7. The method of claim 1, further comprising using the SICD to identify depolarization of the one or more chambers of the patient'"'"'s heart by using the information conveyed to the SICD from the leadless pacemaker.

8. The method of claim 1, wherein the triggering signal sent by the SICD to the leadless pacemaker configures the leadless pacemaker to deliver overdrive anti-tachycardia pacing.

9. The method of claim 1, further comprising:

using a low-gain setting of a receiving amplifier of the leadless pacemaker to detect an edge of a pacing pulse;

switching the setting of the receiving amplifier to a high-gain setting to decode the triggering signal of the SICD.

10. The method of claim 1, further comprising using the SICD to detect an arrhythmia by using the information conveyed to the SICD by the leadless pacemaker.

11. The method of claim 10, further comprising using the triggering signals from the SICD to configure the leadless pacemaker to deliver anti-arrhythmia pacing.

12. The method of claim 10, further comprising using the triggering signals from the SICD to configure the leadless pacemaker and at least a second leadless pacemaker for multi-site pacing.

13. A method of operating a cardiac pacing system comprising:

using electrodes of a subcutaneous implantable cardioverter-defibrillator (SICD) to sense signals from one or more chambers of the patient'"'"'s heart;

using the electrodes of the SICD to send a triggering signal to one or more leadless pacemakers by conducted communication between the SICD and the one or more leadless pacemakers;

using electrodes of the one or more leadless pacemakers to receive the triggering signal from the SICD;

using the electrodes of the one or more leadless pacemakers, which were used to receive the triggering signal from the SICD, to perform pacing in one or more chambers of the patient'"'"'s heart; and

using the electrodes of the one or more leadless pacemakers, which were used to receive the triggering signal from the SICD and to perform the pacing, to convey information to the SICD via conducted communication by discharging a capacitor, coupled across at least one pair of the electrodes of the one or more leadless pacemakers, to form an electrical pulse during a refractory period of the heart and encoding the information to be conveyed on the electrical pulse.

14. The method of claim 13, wherein:

using the electrodes of the one or more leadless pacemakers to receive the triggering signal from the SICD comprises using the electrodes of three or more leadless pacemakers to receive the triggering signal from the SICD; and

using the electrodes of the one or more leadless pacemakers, which were used to receive the triggering signal from the SICD, to perform pacing in one or more chambers of the patient'"'"'s heart comprises using the electrodes of at least three leadless pacemakers, which were used to receive the triggering signal from the SICD, to perform pacing in at least three chambers of the patient'"'"'s heart for cardiac resynchronization therapy.

15. The method of claim 13, further comprising using the information conveyed to the SICD from the one or more leadless pacemakers to identify depolarization of the one or more chambers of the patient'"'"'s heart.

16. The method of claim 13, wherein the triggering signal sent by the SICD to the one or more leadless pacemakers configures the one or more leadless pacemakers to deliver overdrive anti-tachycardia pacing.

17. The method of claim 13, further comprising:

using a low-gain setting of a receiving amplifier of the one or more leadless pacemakers to detect an edge of the triggering signal;

switching the setting of the receiving amplifier to a high-gain setting to decode the triggering signal.

18. The method of claim 13, further comprising using the SICD to detect an arrhythmia using the information conveyed to the SICD by the one or more leadless pacemakers.

19. The method of claim 18, further comprising using the triggering signals from the SICD to configure the one or more leadless pacemakers to deliver anti-arrhythmia pacing.

20. The method of claim 18, further comprising using the triggering signals from the SICD to configure at least two leadless pacemakers for multi-site pacing such as to provide synchronized depolarization for tachyarrhythmia prevention.