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

• US 9,872,999 B2
• Filed: 05/16/2017
• Issued: 01/23/2018
• 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:
  US15/596,290
• Publication Number:
  US 20170252573A1
• Time in Patent Office: 252 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 in one or more chambers of the patient'"'"'s heart; 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, wherein the circuitry consumes no more than 64 microwatts, 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 primary power supply hermetically contained within the housing of the at least one leadless pacemaker and coupled to the pulse generator, the primary power supply configured to supply energy for operations and electrical pulse generation as a source internal to the housing of the at least one leadless pacemaker.

2. The cardiac pacing system of claim 1, wherein:

the at least one leadless pacemaker further comprises a capacitor coupled across a pair of the at least first and second electrodes of the leadless pacemaker and adapted for charging and discharging wherein an electrical pulse is generated;

the pulse generator is further configured to convey information to the SICD by conducted communication via the at least first and second electrodes of the leadless pacemaker used for delivering the electrical pulses to cause cardiac contractions by discharging the capacitor to form an electrical pulse during a refractory period of the heart and encoding the information to be conveyed on the electrical pulse; and

the power supply is further configured to supply power for said conducted communication.

3. The cardiac pacing system of claim 2, wherein the circuitry of the at least one leadless pacemaker further comprises:

a charge pump circuit coupled to the capacitor and adapted for controlling charging of the capacitor, wherein the processor is further configured to control recharging of the capacitor, wherein recharging is discontinued when a power source terminal voltage falls below a predetermined value to ensure sufficient voltage for powering the at least one leadless cardiac pacemaker.

4. The cardiac pacing system of claim 1, wherein the primary power supply is configured to source no more than 70 microwatts instantaneously.

5. The cardiac pacing system of claim 1, wherein the electric circuit contained within the housing of the SICD is configured to at least one transmit and receive conducted communication using the one or more electrodes of the subcutaneous lead.

6. The cardiac pacing system of claim 1, wherein the at least first and second electrodes of the at least one leadless pacemaker are configured for receiving a signal having a pulse duration;

and wherein the processor of the at least one leadless pacemaker comprises a controller configured to determine whether the signal is a triggering signal based on the pulse duration of the signal.

7. The cardiac pacing system of claim 1, wherein the circuitry of the at least one leadless pacemaker comprises a controller configured to:

determine whether a triggering signal has arrived within a predetermined limit and,

when the triggering signal has arrived within a predetermined limit, activate delivery of a pacing pulse following a predetermined delay.