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

• US 9,687,666 B2
• Filed: 07/12/2016
• Issued: 06/27/2017
• 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:
  US15/208,194
• Publication Number:
  US 20160317825A1
• Time in Patent Office: 350 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 cardiac pacing system comprising:

a subcutaneous implantable cardioverter-defibrillator (SICD) configured for implantation within a torso of a patient, the SICD comprising;

a housing;

an electric circuit contained within the housing; and

a subcutaneous lead having one or more electrodes coupled to the electric circuit, the one or more electrodes being configured to sense cardiac signals; and

at least one leadless pacemaker configured for implantation in at least one cardiac chamber of the patient and configured for leadless cardiac pacing, the at least one leadless pacemaker comprising;

a housing;

at least a first electrode formed integrally to the housing or coupled to the housing of the at least one leadless pacemaker at a maximum distance of 2 centimeters;

at least a second electrode formed integrally to the housing or coupled to the housing of the at least one leadless pacemaker at a maximum distance of 2 centimeters;

a pulse generator hermetically contained within the housing of the at least one leadless pacemaker and electrically coupled to at least the first and second electrodes of the at least one leadless pacemaker, the pulse generator configured to generate and deliver electrical pulses via at least the first and second electrodes of the leadless cardiac pacemaker to cause cardiac contractions;

circuitry contained within the housing of the at least one leadless pacemaker, the circuitry comprising a processor hermetically contained within the housing of the at least one leadless pacemaker and communicatively coupled to the pulse generator and at least the first and second electrodes of the at least one leadless pacemaker, the processor configured to control electrical pulse delivery according to programmed instructions, wherein the SICD is configured to transmit programming instructions to the at least one leadless pacemaker; and

a power supply hermetically contained within the housing of the at least one leadless pacemaker and coupled to the pulse generator, wherein the at least one leadless pacemaker comprises a plurality of leadless cardiac pacemakers comprising an atrial leadless cardiac pacemaker configured to be implanted within an atrial cardiac chamber and configured for dual-chamber pacing in combination with the SICD, the atrial leadless cardiac pacemaker configured to;

wait for an earliest occurring event of a plurality of events comprising a sensed atrial heartbeat, a communication of an event sensed on the at least first and second electrodes of the atrial leadless cardiac pacemaker encoding a heartbeat at a ventricular leadless cardiac pacemaker, or timeout of an escape interval;

respond to the sensed atrial heartbeat by generating a communication pulse that signals to at least one pacemaker of the leadless cardiac pacemaker plurality and optionally to the SICD that an atrial heartbeat has occurred and that encodes the communication pulse with a code signifying an atrial location and a sensed event type;

time a predetermined atrial-to-atrial escape interval beginning at delivery of an atrial pacing pulse; and

respond to timeout of an escape interval by delivering an atrial pacing pulse, causing an atrial heartbeat.

2. The cardiac pacing system of claim 1, wherein the plurality of leadless cardiac pacemakers further comprises a ventricular leadless cardiac pacemaker configured to be implanted within a ventricle of the patient, and wherein the atrial leadless cardiac pacemaker is configured to:

detect a signal originating from the ventricular leadless cardiac pacemaker;

examine an elapsed amount of the atrial-to-atrial escape interval since a most recent atrial heartbeat;

determine whether the signal originating from the co-implanted ventricular leadless cardiac pacemaker is premature;

in absence of a premature signal, wait for an event with no effect on atrial pacing;

for a premature signal, restart a ventricle-to-atrium escape interval that is shorter than the atrial-to-atrial escape interval and representative of a typical time from a ventricular beat to a next atrial beat in sinus rhythm; and

respond to timeout of an escape interval by delivering an atrial pacing pulse, causing an atrial heartbeat.

3. A cardiac pacing system comprising:

a subcutaneous implantable cardioverter-defibrillator (SICD) configured for implantation within a torso of a patient, the SICD comprising;

a housing;

an electric circuit contained within the housing; and

a subcutaneous lead having one or more electrodes coupled to the electric circuit, the one or more electrodes being configured to sense cardiac signals; and

at least one leadless pacemaker configured for implantation in at least one cardiac chamber of the patient and configured for leadless cardiac pacing, the at least one leadless pacemaker comprising;

a housing;

at least a first electrode formed integrally to the housing or coupled to the housing of the at least one leadless pacemaker at a maximum distance of 2 centimeters;

at least a second electrode formed integrally to the housing or coupled to the housing of the at least one leadless pacemaker at a maximum distance of 2 centimeters;

a pulse generator hermetically contained within the housing of the at least one leadless pacemaker and electrically coupled to at least the first and second electrodes of the at least one leadless pacemaker, the pulse generator configured to generate and deliver electrical pulses via at least the first and second electrodes of the leadless cardiac pacemaker to cause cardiac contractions;

circuitry contained within the housing of the at least one leadless pacemaker, the circuitry comprising a processor hermetically contained within the housing of the at least one leadless pacemaker and communicatively coupled to the pulse generator and at least the first and second electrodes of the at least one leadless pacemaker, the processor configured to control electrical pulse delivery according to programmed instructions, wherein the SICD is configured to transmit programming instructions to the at least one leadless pacemaker; and

a power supply hermetically contained within the housing of the at least one leadless pacemaker and coupled to the pulse generator, wherein the at least one leadless pacemaker comprises a plurality of leadless cardiac pacemakers comprising a right-ventricular leadless cardiac pacemaker configured for implantation within a right-ventricular cardiac chamber and configured for dual-chamber pacing in combination with the SICD, the right-ventricular leadless cardiac pacemaker configured to;

wait for an earliest occurring event of a plurality of events comprising a sensed right-ventricular heartbeat, a sensed communication pulse marking a heartbeat at an atrial leadless cardiac pacemaker, and timeout of an escape interval;

respond to the sensed right-ventricular heartbeat by generating a communication pulse that signals to at least one pacemaker of the leadless cardiac pacemaker plurality and optionally to the SICD that a right-ventricular heartbeat has occurred;

time a predetermined right ventricular-to-right ventricular escape interval; and

respond to timeout of an escape interval by delivering a right ventricular pacing pulse, causing a right ventricular heartbeat.