Leadless cardiac stimulation systems

• US 9,545,513 B2
• Filed: 03/24/2014
• Issued: 01/17/2017
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Hastings, Roger, Sadasiva, Anupama, Pikus, Michael J., Kveen, Graig L.
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US14/223,506
• Publication Number:
  US 20140207149A1
• Time in Patent Office: 1,030 Days
• US Class Current: 1/1
• 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 leadless pacing device comprising:

a main body including a battery and first and second electrodes configured to deliver electrical stimulation to a heart, the first electrode positioned at a distal tip of the main body; and

a plurality of tines coupled to the main body that are configured to engage the heart, the plurality of tines configured to self-bias from a first configuration for delivery to a heart chamber into a second configuration for engaging into a wall of the heart chamber, wherein the tines extend distal of the first electrode when moving between the first configuration and the second configuration, and wherein each of the plurality of tines includes a portion extending distal of the first electrode when in the second configuration and a distal tip that extends proximal of the first electrode when in the second configuration.

2. The leadless pacing device of claim 1, wherein the second electrode is located near a proximal end of the main body.

3. The leadless pacing device of claim 2, wherein the second electrode is a ring electrode.

4. The leadless pacing device of claim 2, wherein the first electrode is configured as a cathode and the second electrode is configured as an anode, wherein the first electrode is configured for engagement with the heart wall for delivery of the electrical stimulation when the second electrode is exposed to blood in the heart chamber.

5. The leadless pacing device of claim 1, wherein the plurality of tines extend from a distal end of the main body in the second configuration.

6. The leadless pacing device of claim 5, wherein the plurality of tines extend from a location at a periphery of the distal end of the main body in the second configuration.

7. The leadless pacing device of claim 1, wherein the plurality of tines are configured to extend in a longitudinal direction near the periphery of the main body in the first configuration during delivery to the heart chamber.

8. The leadless pacing device of claim 1, wherein the main body is cylindrically shaped.

9. The leadless pacing device of claim 1, wherein the second configuration is a curled configuration.

10. The leadless pacing device of claim 1, wherein the second configuration is a hook configuration.

11. A system, comprising:

a leadless pacing seed including a main body including a battery and two electrodes configured to deliver electrical stimulation to the heart, the leadless pacing seed including a plurality of tines coupled to the main body that are configured to engage the heart; and

a delivery catheter,

wherein the leadless pacing seed is configured to be positioned within the delivery catheter during delivery to the heart,

wherein the plurality of tines include a longitudinal configuration during delivery and a hooked or curled configuration when implanted,

wherein a distal tip of each of the plurality of tines points in a distal direction when in the longitudinal configuration within the delivery catheter, and wherein the distal tip of each of the plurality of tines points in a proximal direction when in the hooked or curled configuration when deployed from the delivery catheter, and

wherein the distal tip of each of the plurality of tines extends proximal of at least one of the two electrodes when in the hooked or curled configuration.

12. The system of claim 11, wherein, during delivery, the distal tip of each of the plurality of tines is constrained into the longitudinal configuration and is bent towards the longitudinal axis of the delivery catheter.

13. The system of claim 12, wherein the plurality of tines are configured to spring outwardly into the hooked or curled configuration when the leadless pacing seed is pushed out of the distal end of the delivery catheter.

14. The system of claim 11, further comprising a tether configured to couple the leadless pacing seed to the delivery catheter during delivery.

15. The system of claim 11, further comprising an extraction pull wire configured to pull the leadless pacing seed proximally within the delivery catheter.

16. A leadless pacing device comprising:

a main body, the main body including a battery and first and second electrodes configured to deliver an electrical pulse to a heart wall, the first electrode positioned at a distal end of the main body and the second electrode spaced proximally away from the first electrode; and

a plurality of tines configured to secure the main body to the heart wall, the plurality of tines biased to extend from a distal end of the main body in a curled or hooked configuration, wherein the leadless pacing device is configured to attach to the heart so that a threshold pull force of greater than 0.3 pounds is required to remove the leadless pacing device from the heart wall,

wherein each of the plurality of tines includes a distal tip that extends proximal of the first electrode when in the curled or hooked configuration; and

wherein each of the plurality of tines includes a curved portion that extends distal of the first electrode when in the curled or hooked configuration.

17. The leadless pacing device of claim 16, wherein the threshold pull force is greater than 0.5 pounds.

18. The leadless pacing device of claim 16, wherein the threshold pull force is greater than 1.0 pounds.

19. The leadless pacing device of claim 16, wherein the main body is cylindrical, sized and shaped for intravascular delivery to a location within the heart, and sized and shaped to fit entirely within the heart.