Leadless cardiac stimulation systems

• US 10,029,092 B2
• Filed: 12/15/2016
• Issued: 07/24/2018
• 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 N., Sadasiva, Anupama, Pikus, Michael J., Kveen, Graig L.
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US15/380,160
• Publication Number:
  US 20170136233A1
• Time in Patent Office: 586 Days
• 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 method of implanting a leadless pacing device, comprising:

advancing a leadless pacing device into a chamber of a heart within a delivery catheter, the leadless pacing device including;

a main body; and

a plurality of tines coupled to the main body, wherein each of the plurality of tines is configured to self-bias from a first configuration to a second configuration,

wherein the main body includes a battery, a first electrode positioned at a distal end of the main body, and a second electrode positioned proximal of the first electrode, the first and second electrodes configured to cooperate to deliver electrical stimulation to the heart; and

anchoring the leadless pacing device to a wall of the heart with the plurality of tines as the plurality of tines move to the second configuration, wherein each of the plurality of tines includes a portion extending distal of the first electrode in the second configuration and a distal tip that extends proximal of the first electrode in the second configuration.

2. The method of claim 1, further comprising:

positioning the first electrode against the wall of the heart.

3. The method of claim 2, wherein the step of positioning the first electrode against the wall of the heart is performed prior to engaging the wall of the heart with the plurality of tines.

4. The method 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 delivery of electrical stimulation to the wall of the heart while the second electrode is exposed to blood in the heart chamber.

5. The method of claim 1, wherein the portion extending distal of the first electrode in the second configuration extends along an arcuate pathway within the wall of the heart.

6. The method of claim 5, wherein the second configuration is a curled or hook configuration.

7. The method of claim 1, wherein the second electrode is located near a proximal end of the main body.

8. The method of claim 1, wherein the plurality of tines extend from the distal end of the main body in the second configuration.

9. The method of claim 8, wherein the plurality of tines extend from a location at a periphery of the distal end of the main body in the second configuration.

10. The method of claim 1, wherein the plurality of tines extend in a longitudinal direction about a periphery of the main body in the first configuration while advancing the leadless pacing device into the chamber of the heart within the delivery catheter.

11. A method of implanting a leadless pacing device, comprising:

advancing a leadless pacing device into a chamber of a heart within a delivery catheter with a plurality of tines of the leadless pacing device in a first configuration, the leadless pacing device including;

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

the plurality of tines coupled to the main body, wherein each of the plurality of tines is configured to self-bias from the first configuration to a second configuration;

deploying the leadless pacing device from the delivery catheter with the first electrode positioned against a wall of the heart; and

anchoring the leadless pacing device to the wall of the heart with the plurality of tines by moving the plurality of tines from the first configuration to the second configuration, wherein in the second configuration each of the plurality of tines includes a curled portion extending distal of the first electrode and a distal tip that extends proximal of the first electrode.

12. The method of claim 11, wherein the curled portion extends along an arcuate pathway within the wall of the heart.

13. The method of claim 11, wherein the plurality of tines extend in a longitudinal direction about a periphery of the main body in the first configuration.

14. The method of claim 11, wherein the plurality of tines extend from the distal end of the main body in the second configuration.

15. The method of claim 14, wherein the plurality of tines extend from a location at a periphery of the distal end of the main body in the second configuration.

16. A method of implanting a leadless pacing device, comprising:

advancing a leadless pacing device into a chamber of a heart within a delivery catheter with a plurality of tines of the leadless pacing device in a first configuration, the leadless pacing device including;

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

the plurality of tines coupled to the main body, wherein each of the plurality of tines is configured to self-bias from the first configuration to a second configuration;

positioning the first electrode against a wall of the heart; and

passing the plurality of tines through tissue of the wall of the heart as the plurality of tines transition from the first configuration to the second configuration, wherein in the second configuration each of the plurality of tines includes a portion extending distal of the first electrode and a distal tip that extends proximal of the first electrode.

17. The method of claim 16, wherein the portion extends along an arcuate pathway within the wall of the heart.

18. The method of claim 16, wherein the plurality of tines extend in a longitudinal direction about a periphery of the main body in the first configuration.

19. The method of claim 16, wherein the plurality of tines extend from the distal end of the main body in the second configuration.

20. The method of claim 19, wherein the plurality of tines extend from a location at a periphery of the distal end of the main body in the second configuration.