Leadless cardiac pacemaker with anti-unscrewing feature
A leadless cardiac pacemaker comprises a housing, a plurality of electrodes coupled to an outer surface of the housing, and a pulse delivery system hermetically contained within the housing and electrically coupled to the electrode plurality, the pulse delivery system configured for sourcing energy internal to the housing, generating and delivering electrical pulses to the electrode plurality. The pacemaker further comprises an anti-unscrewing feature disposed on either a fixation device of the pacemaker or on the housing itself. The anti-unscrewing feature can be configured to prevent the fixation device from disengaging the wall of the heart.
1. A leadless biostimulator, comprising:
a housing sized and configured to be implanted within a heart of a patient;
a primary fixation helix attached to the housing and configured to affix the housing to a wall of the heart by rotating in a screwing direction; and
an anti-unscrewing feature disposed on the primary fixation helix or the housing, the anti-unscrewing feature angled in a direction opposite the screwing direction of the primary fixation device so that rotation of the primary fixation helix only in an unscrewing direction causes the anti-unscrewing feature to engage the wall of the heart so as to prevent the primary fixation device from disengaging the wall of the heart.
2. The leadless biostimulator of claim 1 wherein the anti-unscrewing feature comprises at least one barb.
3. The leadless biostimulator of claim 2 wherein the at least one barb is pointed generally proximally away from a distal end of the fixation device.
4. The leadless biostimulator of claim 1 wherein the anti-unscrewing feature is at least one rounded feature.
5. The leadless biostimulator of claim 1 wherein the anti-unscrewing feature is a suture.
6. The leadless biostimulator of claim 5 wherein the suture is bio-absorbable.
7. The leadless biostimulator of claim 1 wherein the anti-unscrewing feature is arranged to provide resistance only in an unscrewing direction of the primary fixation device.
8. The leadless biostimulator of claim 2 wherein:
the barb comprises a triangular structure,
the triangular structure has a first and a second outward side with respect to the primary fixation device,
the first outward side forms an angle α with respect to the primary fixation device,
α is from 130 to 180 degrees,
the second outward side forms an angle β with respect to the primary fixation device, and
β is from 30 to 135 degrees.
9. The leadless biostimulator of claim 2 wherein the at least one barb extends less than 5 mm outward from the primary fixation device.
10. The leadless biostimulator of claim 2 wherein the at least one barb extends less than 1 mm outward from the primary fixation device.
11. The leadless biostimulator of claim 2 wherein the anti-unscrewing feature further comprises cutout features configured to promote tissue ingrowth and provide friction.
12. The leadless biostimulator of claim 2 wherein the anti-unscrewing feature further comprises scallops.
13. A leadless biostimulator, comprising:
a housing sized and configured to be implanted within a heart of a patient;
a primary fixation device attached to the housing and configured to affix the housing to a wall of the heart; and
an anti-unscrewing feature disposed on the primary fixation device, the anti-unscrewing feature angled to provide asymmetric torque providing the primary fixation device with more rotational friction in an unscrewing direction than in a screwing direction, so as to prevent the primary fixation device from disengaging the wall of the heart.
14. The leadless biostimulator of claim 13 further comprising at least one through-hole disposed in the housing, the at least one through-hole configured to promote tissue in-growth into the through-hole to prevent the primary fixation device from disengaging the wall of the heart.
15. The leadless biostimulator of claim 13 wherein the anti-unscrewing feature comprises at least one barb.
16. The leadless biostimulator of claim 15 wherein the at least one barb is pointed generally proximally away from a distal end of the fixation device.
17. The leadless biostimulator of claim 13 wherein the anti-unscrewing feature is a suture.
18. The leadless biostimulator of claim 17 wherein the suture is bio-absorbable.
19. The leadless biostimulator of claim 13 wherein the anti-unscrewing feature is angled to provide resistance only in an unscrewing direction of the primary fixation device.
20. A leadless biostimulator, comprising:
a housing sized and configured to be implanted within a heart of a patient;
a primary fixation helix attached to the housing and configured to affix the housing to a wall of the heart in a screwing direction; and
sutures disposed on the primary fixation helix or the housing, the sutures configured to point in a direction opposite the primary fixation helix such that rotation of the housing in an unscrewing direction causes the sutures to engage the wall of the heart so as to prevent the primary fixation helix from disengaging the wall of the heart.