LEADLESS CARDIAC STIMULATION SYSTEMS

• US 20130268042A1
• Filed: 12/17/2012
• Published: 10/10/2013
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Hastings, Roger, Sadasiva, Anupama, Pikus, Michael J., Kveen, Graig L.
• Granted Patent: US 10,076,658 B2
• Time in Patent Office: Days
• US Class Current: 607/127
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• 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 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37512 Pacemakers
• 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

Abstract

Various configurations of systems that employ leadless electrodes to provide pacing therapy are provided. In one example, a system that provides multiple sites for pacing of myocardium of a heart includes wireless pacing electrode assemblies that are implantable at sites proximate the myocardium using a percutaneous, transluminal, catheter delivery system. Also disclosed are various configurations of such systems, wireless electrode assemblies, and delivery catheters for delivering and implanting the electrode assemblies.

Claims

1. A system, comprising:

an intravascularly-deliverable elongate actuator; and

an intravascularly-deliverable leadless electrode assembly, comprising;

an attachment mechanism configured to secure at least a portion of the leadless electrode assembly to a myocardium of a heart, the attachment mechanism including a sharp tip configured to penetrate into the myocardium of the heart;

a detachment member configured to be mechanically engaged and mechanically disengaged from the elongate actuator in response to a user actuation of the elongate actuator;

an electrostimulation generator circuit; and

respective electrostimulation electrodes coupled to the electrostimulation generator circuit and configured to provide an electrostimulation to the myocardium of the heart;

wherein the detachment member is configured to be releasably mechanically coupled to the intravascularly-deliverable elongate actuator using a cavity and engaging feature configured to fit at least in part in the cavity.

2. The system of claim 1, wherein the elongate actuator comprises the cavity.

3. The system of claim 2, wherein the engaging feature comprises a spherically-shaped ball.

4. The system of claim 1, wherein the elongate actuator comprises one or more fingers extending inwardly towards a central axis of the elongate actuator;

and

wherein the leadless electrode assembly comprises one or more features configured to be engaged by the one or more respective inwardly-extending fingers.

5. The system of claim 1, wherein the elongate actuator is configured to mechanically engage the detachment member using a user-applied pushing or pulling motion of the elongate actuator in a distal direction with respect to a user manipulating the elongate actuator.

6. The system of claim 5, wherein the elongate actuator is configured to mechanically engage the detachment member using a combination of the user-applied pushing or pulling motion in the distal direction and a user-applied rotational motion of the elongate actuator.

7. The system of claim 1, wherein the detachment mechanism and engaging feature are configured to provide a mechanical coupling between the elongate actuator and the leadless electrode assembly sufficient to permit forcible removal of the attachment mechanism from the myocardium without disengaging the elongate actuator from the leadless electrode assembly.

8. The system of claim 1, wherein the leadless electrode assembly comprises a second attachment mechanism including one or more tines including a retracted configuration and user-extendable configuration, the one or more tines including respective sharp tips configured to penetrate into the myocardium, and configured to extend outward from the leadless electrode assembly, in the user-extendable configuration, in response to actuation of the elongate actuator by a user.

9. The system of claim 8, wherein the one or more tines are configured to transition from the retracted configuration to the user-extendable configuration in response to a user-applied linear motion of the elongate actuator in a distal direction with respect to a user manipulating the elongate actuator.

10. The system of claim 1, wherein the attachment mechanism comprises a helical tine.

11. The system of claim 10, wherein the detachment member and the elongate actuator are configured to permit rotation of the leadless electrode assembly to after engagement of the leadless electrode assembly by elongate actuator to unscrew the helical tine from the myocardium.

12. The system of claim 1, comprising:

an intravascularly-deliverable catheter defining a lumen;

wherein the leadless electrode assembly and the elongate actuator are sized and shaped to transit the lumen during delivery of the leadless electrode assembly to an implantation site or removal of the leadless electrode assembly from the implantation site.

13. The system of claim 1, wherein the leadless electrode assembly comprises a power source coupled to the electrostimulation generator circuit and configured to provide operating energy to the electrostimulation generator circuit.

14. The system of claim 13, wherein the power source includes a radioactive source.

15. An intravascularly-deliverable leadless electrostimulation electrode assembly, comprising:

an attachment mechanism comprising a helical tine configured to secure at least a portion of the leadless electrode assembly to a myocardium of a heart, the helical tine including a sharp tip configured to penetrate into the myocardium of the heart;

a detachment member configured to be mechanically engaged and mechanically disengaged from an intravascularly-deliverable elongate actuator in response to a user actuation of the elongate actuator;

an electrostimulation generator circuit; and

respective electrostimulation electrodes coupled to the electrostimulation generator circuit and configured to provide an electrostimulation to the myocardium of the heart;

wherein the detachment member is configured to be releasably mechanically coupled to the intravascularly-deliverable elongate actuator using a cavity and engaging feature configured to fit at least in part in the cavity.

16. The intravascularly-deliverable leadless electrode assembly of claim 15, wherein the engaging feature comprises a spherically-shaped ball.

17. The intravascularly-deliverable leadless electrode assembly of claim 15, wherein the leadless electrode assembly comprises one or more features configured to be engaged by one or more respective fingers.

18. The intravascularly-deliverable leadless electrode assembly of claim 15, comprising a second attachment mechanism including one or more tines including a retracted configuration and user-extendable configuration, the one or more tines including respective sharp tips configured to penetrate into the myocardium, and configured to extend outward from the leadless electrode assembly, in the user-extendable configuration, in response to actuation of the elongate actuator by a user.

19. The intravascularly-deliverable leadless electrode assembly of claim 15, comprising a power source coupled to the electrostimulation generator circuit and configured to provide operating energy to the electrostimulation generator circuit at least in part using a radioactive source.

20. A system, comprising:

an intravascularly-deliverable elongate actuator including a cavity;

an intravascularly-deliverable leadless electrode assembly, comprising;

an attachment mechanism comprising a helical tine configured to secure at least a portion of the leadless electrode assembly to a myocardium of a heart, the helical tine including a sharp tip configured to penetrate into the myocardium of the heart;

a detachment member configured to be mechanically engaged and mechanically disengaged from the elongate actuator in response to a user actuation of the elongate actuator;

an electrostimulation generator circuit;

respective electrostimulation electrodes coupled to the electrostimulation generator circuit and configured to provide an electrostimulation to the myocardium of the heart; and

a power source coupled to the electrostimulation generator circuit and configured to provide operating energy to the electrostimulation generator circuit at least in part using a radioactive source; and

an intravascularly-deliverable catheter defining a lumen;

wherein the leadless electrode assembly and the elongate actuator are sized and shaped to transit the lumen during delivery of the leadless electrode assembly to an implantation site or removal of the leadless electrode assembly from the implantation site; and

wherein the detachment member is configured to be releasably mechanically coupled to the intravascularly-deliverable elongate actuator using the cavity and engaging feature configured to fit at least in part in the cavity.