# US 9,872,999 B2 · Leadless cardiac pacemaker system for usage in combination with an implantable cardioverter-defibrillator

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- Number: US 9,872,999 B2
- Document ID: US9872999B2
- Status: Granted
- Kind: B2
- Application number: 15/596,290
- Filed: 2017-05-16
- Published: 2017-09-07
- Granted: 2018-01-23
- Earliest claimed: 2005-10-14
- Assignees: Pacesetter, Inc.
- Applicants: Pacesetter, Inc.
- Inventors: Peter M. Jacobson
- Web page: https://patentgrep.com/patent/US9872999B2

## CPC

- A61N 1/056: {Transvascular endocardial electrode systems}
- A61N 1/0573: {chacterised by means penetrating the heart tissue, e.g. helix needle or hook}
- A61N 1/0587: {Epicardial electrode systems; Endocardial electrodes piercing the pericardium}
- A61N 1/059: {Anchoring means}
- A61N 1/3621: {for treating or preventing abnormally high heart rate}
- A61N 1/3627: {for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy}
- 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)}
- A61N 1/368: comprising more than one electrode co-operating with different heart regions {(A61N1/3622, A61N1/3627 take precedence)}
- A61N 1/3684: {for stimulating the heart at multiple sites of the ventricle or the atrium}
- A61N 1/36842: {Multi-site stimulation in the same chamber}
- A61N 1/3704: {Circuits specially adapted therefor, e.g. for sensitivity control}
- A61N 1/3706: {Pacemaker parameters (stimulation threshold A61N1/371)}
- A61N 1/3708: {for power depletion}
- A61N 1/372: Arrangements in connection with the implantation of stimulators
- A61N 1/37205: {Microstimulators, e.g. implantable through a cannula}
- A61N 1/37217: {characterised by the communication link, e.g. acoustic or tactile}
- A61N 1/37252: {Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data}
- A61N 1/3727: {characterised by the modulation technique}
- A61N 1/37288: {Communication to several implantable medical devices within one patient}
- A61N 1/37512: {Pacemakers}
- A61N 1/3756: {Casings with electrodes thereon, e.g. leadless stimulators}
- A61N 1/3925: {Monitoring; Protecting}
- A61N 1/3956: {Implantable devices for applying electric shocks to the heart, e.g. for cardioversion}
- A61N 1/39622: {Pacing therapy}
- H04B 13/005: {Transmission systems in which the medium consists of the human body}
- A61M 25/0662: {Guide tubes}
- A61N 1/36542: {controlled by body motion, e.g. acceleration}
- A61N 1/37518: {Anchoring of the implants, e.g. fixation}
- A61N 2001/058: {Fixing tools}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- H04B: TRANSMISSION
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 2)

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.

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 1)

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.