Biostimulator having fixation element

Patent metadata

Field	Value
Publication number	US-12427326-B2
Application number	US-202318393654-A
Country	US
Kind code	B2
Filing date	Dec 21, 2023
Priority date	Nov 6, 2017
Publication date	Sep 30, 2025
Grant date	Sep 30, 2025

Abstract

A biostimulator, such as a leadless cardiac pacemaker, including a fixation element to engage tissue and one or more backstop elements to resist back-out from the tissue, is described. The fixation element can be mounted on a housing of the biostimulator such that a helix of the fixation element extends distally to a leading point. The leading point can be located on a distal face of the helix at a position that is proximal from a center of the distal face. The backstop elements can include non-metallic filaments, such as sutures, or can include a pinch point of the biostimulator. The backstop features can grip the tissue to prevent unscrewing of the fixation element. Other embodiments are also described and claimed.

First claim

What is claimed is:

1. A biostimulator, comprising:
a fixation element including an outer surface extending along a helical axis about a longitudinal axis to a distal edge, wherein the outer surface peripherally surrounds the helical axis and the distal edge extends peripherally about the helical axis, wherein a wire face having three or more helix faces tapers distally and radially inward from the distal edge to converge at a leading point within a projected volume of the outer surface and radially between the helical axis and the distal edge.

2. The biostimulator of claim 1 , wherein the three or more helix faces includes a plurality of bevel faces converging at the leading point.

3. The biostimulator of claim 1 , wherein the outer surface includes an ellipsoidal outer surface, and wherein the distal edge is defined by an intersection between the ellipsoidal outer surface extending around the helical axis and the plurality of helix faces.

4. The biostimulator of claim 1 , wherein the leading point is radially inward from the distal edge.

5. The biostimulator of claim 4 , wherein a transverse plane extends orthogonal to the longitudinal axis and intersects the helical axis, and wherein the leading point is distal to the transverse plane.

6. The biostimulator of claim 5 , wherein a longitudinal plane extends orthogonal to the transverse plane and parallel to the longitudinal axis such that the longitudinal plane and the transverse plane intersect at a center of the wire face, and wherein the leading point is along the longitudinal plane distal to the transverse plane.

7. The biostimulator of claim 4 , wherein a transverse plane extends orthogonal to the longitudinal axis and intersects the helical axis, and wherein the leading point is proximal to the transverse plane.

8. The biostimulator of claim 7 , wherein a longitudinal plane extends orthogonal to the transverse plane and parallel to the longitudinal axis such that the longitudinal plane and the transverse plane intersect at a center of the wire face, and wherein the leading point is along the longitudinal plane proximal to the transverse plane.

9. The biostimulator of claim 1 , wherein the wire face has a plurality of quadrants, and wherein the leading point is within a quadrant of the plurality of quadrants.

10. The biostimulator of claim 9 , wherein the quadrant is a left quadrant.

11. The biostimulator of claim 9 , wherein the quadrant is a right quadrant.

12. A biostimulator system, comprising:
a torqueable catheter; and
a biostimulator coupled to the torqueable catheter, wherein the biostimulator includes
a housing having a longitudinal axis and containing an electronics compartment, and
a fixation element mounted on the housing, wherein the fixation element includes an outer surface extending along a helical axis about a longitudinal axis to a distal edge, wherein the outer surface peripherally surrounds the helical axis and the distal edge extends peripherally about the helical axis, wherein a wire face having three or more helix faces tapers distally and radially inward from the distal edge to converge at a leading point within a projected volume of the outer surface and radially between the helical axis and the distal edge.

13. The biostimulator system of claim 12 , wherein the three or more helix faces includes a plurality of bevel faces converging at the leading point.

14. The biostimulator system of claim 12 , wherein the outer surface includes an ellipsoidal outer surface, and wherein the distal edge is defined by an intersection between the ellipsoidal outer surface extending around the helical axis and the plurality of helix faces.

15. The biostimulator system of claim 12 , wherein the leading point is radially inward from the distal edge.

16. The biostimulator system of claim 12 , wherein the wire face has a plurality of quadrants, and wherein the leading point is within a quadrant of the plurality of quadrants.

17. The biostimulator system of claim 16 , wherein the quadrant is a left quadrant.

18. The biostimulator system of claim 16 , wherein the quadrant is a right quadrant.

19. A method, comprising:
advancing a catheter to a target anatomy, wherein a biostimulator is coupled to the catheter, wherein the biostimulator includes a housing having a longitudinal axis and containing an electronics compartment, and a fixation element mounted on the housing, wherein the fixation element includes an outer surface extending along a helical axis about a longitudinal axis to a distal edge, wherein the outer surface peripherally surrounds the helical axis and the distal edge extends peripherally about the helical axis, wherein a wire face having three or more helix faces tapers distally and radially inward from the distal edge to converge at a leading point within a projected volume of the outer surface and radially between the helical axis and the distal edge; and
torqueing the catheter to rotate the housing and force the fixation element into the target anatomy.

Assignees

• Pacesetter Inc

Inventors

• Mar Craig E
• Eby Thomas B
• Paspa Paul
• Orts Sondra
• Fishler Matthew G
• Lee Stephen
• Boling Carl Lance
• Luhrs Thomas Robert

Classifications

• A61N1/3756

  Casings with electrodes thereon, e.g. leadless stimulators · CPC title

• A61N1/37512

  Pacemakers · CPC title

• A61N1/057

  Anchoring means; Means for fixing the head inside the heart · CPC title

• A61N1/37205

  Microstimulators, e.g. implantable through a cannula · CPC title

• A61N1/375 Primary

  Constructional arrangements, e.g. casings · CPC title