IP Library › Granted Patent US 50,564
Granted Patent E1
US 50,564 · App. 17/361,150 · Granted Sep 2, 2025

Leadless cardiac pacemaker with secondary fixation capability

Inventor: Alan Ostroff (Pleasanton, CA)
Assignee: PACESETTER, INC.
A61N1/3756A61N1/0573A61N1/37512A61N1/37518
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Quick Facts
Patent No.
US 50,564
App. No.
17/361,150
Granted
Sep 2, 2025
Kind
E1
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 (44)

1. A leadless biostimulator comprising:

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

a primary fixation element configured to actively 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, wherein the expanded configuration of the expandable structure has a cross-sectional dimension that is greater than a diameter of a vascular exit pathway from the heart chamber so that expansion of the expandable structure confines the leadless biostimulator and the expandable structure to the heart chamber, wherein the expandable structure further comprises a coupling mechanism that couples the expandable structure to the housing to allow for movement of the expandable structure with respect to the housing.

2. The leadless biostimulator of claim 1 wherein the 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 2 , wherein the plurality of struts has an asymmetrical bowed configuration such that a greater radial diameter is proximally-skewed.

5. The leadless biostimulator of claim 2 , wherein the plurality of struts is configured to compress when the heart chamber contracts during a heart-beat so that the plurality of struts do not interfere with movement of heart muscle of the heart chamber.

6. The leadless biostimulator of claim 1 wherein the heart chamber is a right ventricle of the heart and the vascular exit pathway from the heart chamber is a pulmonic value valve.

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

8. The leadless biostimulator of claim 1 , wherein the expandable structure 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.

9. The leadless biostimulator of claim 8 1 wherein the coupling mechanism comprises a swivel, wherein the swivel is configured to insulate the biostimulator from torque when the biostimulator is affixed to the heart wall with the heart chamber.

10. The leadless biostimulator of claim 8 1 wherein the coupling mechanism comprises a flexible tether.

11. 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, wherein the coupling mechanism isolates the housing from destabilizing force that could otherwise be conveyed to the housing by movement of the expandable structure.

12. The leadless biostimulator of claim 1 , further comprising a one or more soluble coverings configured to encapsulate at least one of the primary fixation element and the secondary fixation element.

13. The leadless biostimulator of claim 1 12 , wherein the one or more soluble coverings is configured to encapsulate encapsulates the secondary fixation element so that the secondary fixation element is secured in the collapsed linear configuration.

14. The leadless biostimulator of claim 1 , wherein the expandable structure has a stiffness configured to prevent the biostimulator from turning or reorienting within the heart chamber when the biostimulator is dislodged from the heart wall.

15. The leadless biostimulator of claim 1 , wherein the heart chamber is a right ventricle of the heart and the vascular exit pathway from the heart chamber is a pulmonic artery.

16. The leadless biostimulator of claim 1 , wherein the heart chamber is a right ventricle of the heart and the vascular exit pathway from the heart chamber is a semilunar valve, and wherein the expanded configuration of the expandable structure is configured not to pass through the semilunar valve so that the biostimulator does not enter the pulmonary artery.

17. A method of retaining a leadless biostimulator within a human heart of a patient an adult human, 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;

actively 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 have a cross-sectional linear dimension greater than a downstream vascular exit from the heart chamber such that the expandable member is confined to the heart chamber and the leadless biostimulator is confined to the heart chamber by the expandable member, wherein the expandable member further comprises a coupling mechanism that couples the expandable member to a housing of the biostimulator to allow for movement of the expandable member with respect to the housing.

18. The method of claim 17 wherein the heart chamber is a right ventricle of the heart and wherein the downstream vascular exit from the heart chamber is pulmonary artery.

19. The method of claim 17 , wherein expanding the expandable member within the heart comprises bowing struts of the expandable member from a linear configuration to a bowed configuration.

20. A leadless biostimulator comprising:

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

a plurality of fixation features including

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

a secondary fixation element including a plurality of struts that collectively form an expandable structure connected to a proximal portion of the housing, the plurality of struts of the expandable structure being adapted to assume a compressed linear configuration during delivery and an expanded bowed configuration after delivery, wherein the expanded bowed configuration of the expandable structure has a proximally-skewed cross-sectional dimension that is greater than a diameter of a vascular exit pathway from the heart chamber so that expansion of the expandable structure confines the leadless biostimulator and the expandable structure to the heart chamber, wherein the expandable structure further comprises a coupling mechanism that couples the expandable structure to the housing to allow for movement of the expandable structure with respect to the housing.

21. The leadless biostimulator of claim 20 , wherein the plurality of struts are configured to compress when the heart chamber contracts.

22. A leadless biostimulator comprising:

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

a plurality of fixation features including

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

a secondary fixation element having an expandable structure connected to a proximal portion of the housing, the expandable structure including a plurality of tines mounted on a collar encircling the housing and being adapted to assume a compressed linear configuration during delivery and an expanded configuration after delivery, wherein the expanded configuration of the expandable structure is a native outwardly bowed configuration having a cross-sectional dimension that is greater than a diameter of a vascular exit pathway from the heart chamber so that expansion of the expandable structure confines the leadless biostimulator and the expandable structure to the heart chamber.

23. The leadless biostimulator of claim 22 , wherein the heart chamber is a right ventricle of a heart and the vascular exit pathway from the heart chamber is a pulmonary valve.

24. A leadless biostimulator comprising:

a housing having a longitudinal axis and being sized and configured to be disposed within a heart chamber of an adult human; and

a plurality of fixation features including

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

a secondary fixation element having an expandable structure connected to a proximal portion of the housing, the expandable structure including a plurality of struts disposed parallel to the longitudinal axis and being adapted to assume a compressed linear configuration during delivery and an expanded configuration after delivery, wherein the expanded configuration of the expandable structure has a cross-sectional dimension that is greater than a diameter of a vascular exit pathway from the heart chamber so that expansion of the expandable structure confines the leadless biostimulator and the expandable structure to the heart chamber, wherein the expandable structure further comprises a coupling mechanism that couples the expandable structure to the housing to allow for movement of the expandable structure with respect to the housing.

25. The leadless biostimulator of claim 24 , wherein the expandable structure comprises nitinol.

Assignments (2)
MERGER Recorded Jan 31, 2023
From: NANOSTIM, INC.
To: PACESETTER, INC.
Reel/Frame 062553/0188 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 19, 2023
From: OSTROFF, ALAN
To: NANOSTIM, INC.
Reel/Frame 062420/0513 →
Continuity (4)
Continuation 12698969 · Feb 2, 2010
Provisional Application 61155038 · Feb 24, 2009
Provisional Application 61149176 · Feb 2, 2009
Reissue 13967180 · Aug 14, 2013
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