Catheter-based system for delivery and retrieval of a leadless pacemaker
Catheter-based delivery systems for delivery and retrieval of a leadless pacemaker include features to facilitate improved manipulation of the catheter and improved capture and docking functionality of leadless pacemakers. Such functionality includes mechanisms directed to deflecting and locking a deflectable catheter, maintaining tension on a retrieval feature, protection from anti-rotation, and improved docking cap and drive gear assemblies.
1. A system, comprising:
a leadless pacemaker having a coupling feature at a proximal end; and
a retrieval catheter comprising
a catheter shaft,
a handle coupled to a proximal end of the catheter shaft, and
a docking cap having an internal surface defining a docking cap volume, wherein the docking cap is inflexible, the docking cap comprising
a cap portion coupled to a distal end of the catheter shaft,
a plurality of longitudinal members extending distally from the cap portion, wherein adjacent longitudinal members of the plurality of longitudinal members define an opening into the docking cap volume from an outer member surface of the docking cap to the internal surface, the opening sized to allow the coupling feature at the proximal end of the leadless pacemaker to extend at least partially through the opening during retrieval, and
an annulus coupled to the plurality of longitudinal members opposite to the cap portion, wherein the annulus includes a transition surface extending from the internal surface to an outer edge of a distal face radially outward from the outer member surface to guide the leadless pacemaker into the docking cap volume.
2. The system of claim 1 , further comprising a sheath disposed over at least a portion of the opening.
3. The system of claim 2 , wherein the sheath comprises a fluorinated ethylene propylene (FEP) sheet.
4. The system of claim 2 , wherein the sheath includes a heat-shrink sheet about the the plurality of longitudinal members.
5. The system of claim 1 , wherein the internal surface extends perpendicular to the distal face, and wherein the transition surface includes a curved transition between the distal face and the internal surface.
6. The system of claim 5 , wherein the curved transition has a radius of curvature from and including 0.017 inches to and including 0.150 inches and an arc length from and including 0.017 inches to and including 0.035 inches.
7. The system of claim 1 , further comprising a torque feature disposed on an interior surface of at least one of the plurality of longitudinal members, the torque feature shaped to engage a portion of the leadless pacemaker during retrieval.
8. The system of claim 7 , wherein the torque feature includes a protrusion extending into the docking cap volume, and wherein the torque feature includes a concave scallop extending from a proximal edge of the transition surface to a longitudinal face.
9. The system of claim 7 , wherein the torque feature is offset from the annulus.
10. The system of claim 1 , wherein the docking cap is formed from one or more of stainless steel, titanium, or a polymer loaded with a radiopaque additive.
11. The system of claim 1 , wherein the docking cap volume has a diameter from and including 0.10 inches to and including 0.25 inches.
12. A catheter for retrieval of a leadless pacemaker, comprising:
a catheter shaft having a distal shaft end; and
a docking cap having an internal surface defining a docking cap volume, wherein the docking cap is inflexible, the docking cap comprising:
a cap portion coupled to the distal shaft end,
a plurality of longitudinal members extending distally from the cap portion, wherein adjacent longitudinal members of the plurality of longitudinal members define an opening into the docking cap volume from an outer member surface of the docking cap to the internal surface, the opening sized to allow a coupling feature at a proximal end of the leadless pacemaker to extend at least partially through the opening during retrieval, and
an annulus coupled to the plurality of longitudinal members opposite to the cap portion, wherein the annulus includes a transition surface extending from the internal surface to an outer edge of a distal face radially outward from the outer member surface.
13. The catheter of claim 12 , further comprising a sheath disposed over at least a portion of the opening.
14. The catheter of claim 13 , wherein the sheath comprises a fluorinated ethylene propylene (FEP) heat-shrink sheet about the plurality of longitudinal members.
15. The catheter of claim 12 , wherein the internal surface extends perpendicular to the distal face, and wherein the transition surface includes a curved transition between the distal face and the internal surface.
16. The catheter of claim 15 , wherein the curved transition has a radius of curvature from and including 0.017 inches to and including 0.150 inches and an arc length from and including 0.017 inches to and including 0.035 inches.
17. The catheter of claim 12 , further comprising a torque feature disposed on an interior surface of at least one of the plurality of longitudinal members.
18. The catheter of claim 17 , wherein the torque feature includes a protrusion extending from the internal surface of one of the plurality of longitudinal members into the docking cap volume, and wherein the torque feature includes a concave scallop extending from a proximal edge of the transition surface to a longitudinal face.
19. The catheter of claim 17 , wherein the torque feature is offset from the annulus.
20. The catheter of claim 12 , wherein the docking cap volume has a diameter from and including 0.210 inches to and including 0.25 inches.