Leadless Cardiac Pacemaker with Secondary Fixation Capability

• US 20150297899A1
• Filed: 08/14/2013
• Published: 10/22/2015
• Est. Priority Date: 02/02/2009
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Nanostim, Inc (Abbott Laboratories Incorporated)
• Inventors: Ostroff, Alan
• Granted Patent: US 9,272,155 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• 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

Abstract

The invention relates to leadless cardiac pacemakers (LBS), and elements and methods by which they affix to the heart. The invention relates particularly to a secondary fixation of leadless pacemakers which also include a primary fixation. Secondary fixation elements for LBS'"'"'s may passively engage structures within the heart. Some passive secondary fixation elements entangle or engage within intraventricular structure such as trabeculae carneae. Other passive secondary fixation elements may engage or snag heart structures at sites upstream from the chamber where the LBS is primarily affixed. Still other embodiments of passive secondary fixation elements may include expandable structures.

Claims

1. A leadless biostimulator comprising:

a housing sized and configured to be disposed within a heart chamber of a human;

a primary fixation element configured to affix the biostimulator to a heart wall within the heart chamber; and

an expandable structure connected to a proximal portion of the housing, the expandable structure being adapted to assume a compressed linear configuration during delivery and an expanded configuration after delivery to confine the leadless biostimulator to the heart chamber.

2. The leadless biostimulator of claim 1 wherein expandable structure comprises a plurality of struts.

3. The leadless biostimulator of claim 2 wherein the plurality of struts comprise a looped shape.

4. The leadless biostimulator of claim 1 wherein the heart chamber is a right ventricle of the heart.

5. The leadless biostimulator of claim 1 wherein the expandable structure comprises nitinol.

6. The leadless biostimulator of claim 1 further comprising a coupling mechanism that couples the housing to the expandable structure to allow for movement of the expandable structure with respect to the housing.

7. The leadless biostimulator of claim 6 wherein the coupling mechanism isolates the housing from destabilizing force that could otherwise be conveyed to the housing by movement of the expandable structure.

8. The leadless biostimulator of claim 6 wherein the coupling mechanism comprises a swivel.

9. The leadless biostimulator of claim 6 wherein the coupling mechanism comprises a flexible tether.

10. A method of retaining a leadless biostimulator within a human heart of a patient, comprising:

confining an expandable member of the leadless biostimulator within a delivery device;

delivering the leadless biostimulator to a heart chamber with the delivery device;

affixing a primary fixation element of the leadless biostimulator to a heart wall of the heart chamber; and

expanding the expandable member within the heart chamber to confine the leadless biostimulator to the heart chamber.

11. The method of claim 10 wherein the heart chamber is a right ventricle of the heart.