Biostimulator having fixation element

Patent metadata

Field	Value
Publication number	US-11850435-B2
Application number	US-202117513794-A
Country	US
Kind code	B2
Filing date	Oct 28, 2021
Priority date	Nov 6, 2017
Publication date	Dec 26, 2023
Grant date	Dec 26, 2023

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 housing having a longitudinal axis and containing an electronics compartment; and
a fixation element mounted on the housing, wherein the fixation element includes a helix extending distally from the housing along a helical axis about the longitudinal axis to a distal edge, wherein the distal edge extends around the helical axis and defines a plurality of helix faces on the helical axis, wherein a transverse plane orthogonal to the longitudinal axis intersects a center of the plurality of helix faces, and wherein the helix includes a leading point at a convergence of the plurality of helix faces distal to the transverse plane.

2. The biostimulator according to claim 1 , wherein the helix includes an ellipsoidal outer surface extending around the helical axis.

3. The biostimulator according to claim 2 , wherein the distal edge is at an intersection between the ellipsoidal outer surface and the plurality of helix faces.

4. The biostimulator according to claim 1 , wherein the leading point is on the distal edge.

5. The biostimulator according to claim 1 , wherein a longitudinal plane intersects and is orthogonal to the transverse plane at the center of the plurality of helix faces.

6. The biostimulator according to claim 5 , wherein the leading point is at a twelve o'clock position on the longitudinal plane.

7. The biostimulator according to claim 6 , wherein the twelve o'clock position is on the distal edge.

8. The biostimulator according to claim 5 , wherein the plurality of helix faces includes a plurality of bevel faces converging at the leading point.

9. The biostimulator according to claim 8 , wherein the plurality of bevel faces intersect to form a double-bevel that extends from the leading point along the plurality of helix faces to a base on the distal edge.

10. The biostimulator according to claim 9 , wherein the double-bevel forms a leading edge extending along the longitudinal plane.

11. The biostimulator according to any one of claim 9 , wherein the base is on a same side of the transverse plane as the housing.

12. The biostimulator according to claim 11 , wherein a vector extends distally from the base parallel to the helical axis, and wherein an angle between the vector and the leading edge is in a range of 10 to 60 degrees.

13. The biostimulator according to claim 12 , wherein a tip length between the vector and the leading point is in a range of 0.002 to 0.02 inches.

14. The biostimulator of claim 1 further comprising a helix mount having a helix mount flange, wherein the helix mount flange includes one or more marks defining an alignment range.

15. The biostimulator according to claim 14 , wherein the leading point is aligned with the alignment range.

16. 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 a helix extending along a helical axis about the longitudinal axis to a distal edge, wherein the distal edge extends distally from the housing around the helical axis and defines a plurality of helix faces on the helical axis, wherein a transverse plane orthogonal to the longitudinal axis intersects a center of the plurality of helix faces, and wherein the helix includes a leading point at a convergence of the plurality of helix faces distal to the transverse plane.

17. The biostimulator system according to claim 16 , wherein a longitudinal plane intersects and is orthogonal to the transverse plane at the center of the plurality of helix faces.

18. The biostimulator system according to claim 17 , wherein the leading point is at a twelve o'clock position on the longitudinal plane.

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 a helix extending distally from the housing along a helical axis about the longitudinal axis to a distal edge, wherein the distal edge extends around the helical axis and defines a plurality of helix faces on the helical axis, wherein a transverse plane orthogonal to the longitudinal axis intersects a center of the plurality of helix faces, and wherein the helix includes a leading point at a convergence of the plurality of helix faces distal to the transverse plane; and
torqueing the catheter to rotate the housing and force the fixation element into the target anatomy.

20. The method of claim 19 , wherein a longitudinal plane intersects and is orthogonal to the transverse plane at the center of the plurality of helix faces, and wherein the leading point is at a twelve o'clock position on the longitudinal plane.

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

• A61N1/372

  Arrangements in connection with the implantation of stimulators · CPC title

• A61N1/37518 Primary

  Anchoring of the implants, e.g. fixation · CPC title

• A61N1/375 Primary

  Constructional arrangements, e.g. casings · CPC title

• A61N1/3756

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

• A61N1/37205

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