Leadless cardiac stimulation device employing distributed logic

• US 9,889,312 B2
• Filed: 08/04/2014
• Issued: 02/13/2018
• Est. Priority Date: 12/16/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Bodner, Jeffrey P., Bierwerth, Randy
• Primary Examiner(s): Carey, Michael
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US14/450,914
• Publication Number:
  US 20140343620A1
• Time in Patent Office: 1,289 Days
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• 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 1/368 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 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• 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 1/3787 from an external energy source
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

Systems and methods involve an intrathoracic cardiac stimulation device operable to provide autonomous cardiac sensing and energy delivery. The cardiac stimulation device includes a housing configured for intrathoracic placement relative to a patient'"'"'s heart. A fixation arrangement of the housing is configured to affix the housing at an implant location within cardiac tissue or cardiac vasculature. An electrode arrangement supported by the housing is configured to sense cardiac activity and deliver stimulation energy to the cardiac tissue or cardiac vasculature. Energy delivery circuitry in the housing is coupled to the electrode arrangement. Detection circuitry is provided in the housing and coupled to the electrode arrangement. Communications circuitry may optionally be supported by the housing. A controller in the housing coordinates delivery of energy to the cardiac tissue or cardiac vasculature in accordance with an energy delivery protocol appropriate for the implant location.

Claims

1. A system comprising:

a co-implantable Implantable Cardiac Stimulation Device (ICSD) configured to be implanted in a patient and for delivering cardiac stimulation to the patient'"'"'s heart via two or more electrodes of the ICSD, the ICSD being free of any leads extending into the patient'"'"'s heart;

a co-implanted leadless cardiac stimulation device, comprising;

a housing configured for placement within the patient'"'"'s heart;

a fixation arrangement supported by the housing and configured to affix the housing at an implant location on an inner wall of the patient'"'"'s heart;

an electrode arrangement supported by the housing and configured to sense cardiac activity and deliver stimulation energy to the patient'"'"'s heart from within the patient'"'"'s heart;

energy delivery circuitry provided in the housing and operatively coupled to the electrode arrangement;

detection circuitry provided in the housing and operatively coupled to the electrode arrangement; and

circuitry provided in the housing and operatively coupled to the energy delivery circuitry and detection circuitry to coordinate cardiac sensing and/or energy delivery of the leadless cardiac stimulation device from within the patient'"'"'s heart, the circuitry further configured to communicate with the co-implantable ICSD and to work in conjunction with the co-implantable ICSD to delivery therapy to the patient'"'"'s heart, the circuitry is further configured to be able to deliver therapy to the patient'"'"'s heart even in the absence of pacing pulse trigger signals.

2. The system of claim 1, wherein the leadless cardiac stimulation device is free from any leads.

3. The system of claim 1, wherein the circuitry comprises communication circuitry in the housing, the communication circuitry facilitating communication with the co-implantable ICSD.

4. The system of claim 1, wherein the circuitry is configured to communicate with the co-implantable ICSD via uni-directional communication.

5. The system of claim 1, wherein the circuitry is configured to communicate with the co-implantable ICSD via bi-directional communication.

6. The system of claim 1, wherein the circuitry is configured to cooperatively deliver cardiac stimulation therapy with the co-implantable ICSD.

7. The system of claim 6, wherein the cardiac stimulation therapy comprises one or more of pacing therapy, resynchronization therapy, antitachycardia pacing therapy, rate smoothing therapy, regularization pacing therapy, and defibrillation/cardioversion therapy.

8. The system of claim 1, wherein the electrode arrangement includes one or more electrodes, and further comprising a coating or sleeve disposed on at least one of the one or more electrodes, wherein the coating includes a pharmacological agent.

9. The system of claim 8, wherein the pharmacological agent comprises a steroid.

10. The system of claim 1, wherein the co-implantable ICSD is implanted subcutaneously and outside of the rib cage of the patient.

11. A leadless cardiac stimulation device comprising:

a housing configured for placement inside a patient'"'"'s heart;

a fixation mechanism supported by the housing and configured to affix the housing at an implant location within the patient'"'"'s heart;

two or more electrodes supported by the housing and configured to sense cardiac activity and deliver stimulation energy to the patient'"'"'s heart;

energy delivery circuitry housed by the housing and operatively coupled to two or more of the electrodes;

detection circuitry housed by the housing and operatively coupled to two or more of the electrodes;

communication circuitry housed by the housing, the communication circuitry configured to at least one of transmit or receive communication messages between a co-implantable Implantable Cardio Stimulation Device (ICSD) that is configured to be implanted in the patient and is further configured to deliver cardiac stimulation to the patient'"'"'s heart via two or more electrodes of the ICSD; and

circuitry housed by the housing and operatively coupled to the energy delivery circuitry, the detection circuitry and the communication circuitry, the circuitry configured to coordinate cardiac sensing via the detection circuitry and/or coordinate cardiac stimulation therapy delivery via the energy delivery circuitry with the co-implantable ICSD, the circuitry further capable of delivering cardiac stimulation therapy to the patient'"'"'s heart even in the absence of pacing pulse trigger signals.

12. The leadless cardiac stimulation device of claim 11,

wherein the communication circuitry is configured to both transmit and receive communication messages between the leadless cardiac stimulation device and the co-implantable ICSD.

13. The leadless cardiac stimulation device of claim 11, wherein the circuitry is configured to cooperatively deliver cardiac stimulation therapy in concert with the co-implantable ICSD.

14. The leadless cardiac stimulation device of claim 11, wherein the cardiac stimulation therapy comprises one or more of pacing therapy, resynchronization therapy, antitachycardia pacing therapy, rate smoothing therapy, regularization pacing therapy, and defibrillation/cardioversion therapy.

15. The leadless cardiac stimulation device of claim 11 further comprising a coating or sleeve disposed on at least one of the two or more electrodes, wherein the coating includes a pharmacological agent.

16. The leadless cardiac stimulation device of claim 15, wherein the pharmacological agent comprises a steroid.

17. A leadless cardiac stimulation device comprising:

a housing configured for placement inside a chamber of a patient'"'"'s heart;

a fixation mechanism supported by the housing and configured to affix the housing at an implant location within the chamber of the patient'"'"'s heart;

two or more electrodes supported by the housing and configured to sense cardiac activity and deliver stimulation energy to the patient'"'"'s heart from within the chamber of the patient'"'"'s heart;

energy delivery circuitry housed by the housing and operatively coupled to two or more of the electrodes;

detection circuitry housed by the housing and operatively coupled to two or more of the electrodes;

communication circuitry housed by the housing, the communication circuitry configured to at least one of transmit or receive communication messages between a co-implantable Implantable Cardiac Stimulation Device (ICSD) that is configured to be implanted in the patient and is further configured to deliver cardiac stimulation to the patient'"'"'s heart via two or more electrodes of the ICSD; and

circuitry housed by the housing and operatively coupled to the energy delivery circuitry, the detection circuitry and the communication circuitry, the circuitry configured to coordinate antitachycardia pacing therapy and defibrillation/cardioversion therapy with the co-implantable ICSD, the circuitry is further configured to be able to deliver therapy to the patient'"'"'s heart even in the absence of pacing pulse trigger signals.

18. The leadless cardiac stimulation device of claim 17, wherein the communication circuitry is configured to transmit and receive communication messages between the leadless cardiac stimulation device and the co-implantable ICSD.