IP Library Granted Patent US 11,759,234
Granted Patent B2
US 11,759,234 · App. 17/334,561 · Granted Sep 19, 2023

Pacemaker retrieval systems and methods

Inventors: Alexander Khairkhahan (Palo Alto, CA); Alan Klenk (San Jose, CA); Thomas Blake Eby (Mountain View, CA)
Assignee: PACESETTER, INC.
A61B17/3468A61N1/059A61N1/3756A61N1/37205A61B17/221A61B17/32056A61B2017/00358A61B2017/22035A61M25/0082A61N1/0573A61N1/362A61N2001/0578
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Quick Facts
Patent No.
US 11,759,234
App. No.
17/334,561
Granted
Sep 19, 2023
Kind
B2
Abstract

A catheter system for retrieving a leadless cardiac pacemaker from a patient is provided. The cardiac pacemaker can include a docking or retrieval feature configured to be grasped by the catheter system. In some embodiments, the retrieval catheter can include a snare configured to engage the retrieval feature of the pacemaker. The retrieval catheter can include a torque shaft selectively connectable to a docking cap and be configured to apply rotational torque to a pacemaker to be retrieved. Methods of delivering the leadless cardiac pacemaker with the delivery system are also provided.

Claims (26)

1. A delivery system for delivering a leadless pacemaker, comprising:

a first shaft having a shaft lumen extending along a longitudinal axis to a distal portion;

a docking cap disposed on the distal portion of the first shaft, wherein the docking cap includes a distal tip sloping inwards toward an interior wall defining an interior configured to receive a button of the leadless pacemaker, and wherein the interior wall is shaped to cup and contact the button of the leadless pacemaker when the leadless pacemaker is docked within the docking cap;

a sheath including a proximal end coupled to a catheter shaft and a distal end, wherein the sheath tapers radially outward from the proximal end to a radiopaque feature at the distal end having an outer dimension greater than the proximal end, and wherein the radiopaque feature is movable along the longitudinal axis relative to the first shaft to indicate whether the sheath is covering the leadless pacemaker;

a snare extending through the shaft lumen; and

a handle coupled to the first shaft, wherein the handle includes a deflection knob slidable to steer the first shaft, and a snare knob slidable to cause the snare to extend distally beyond the distal tip of the docking cap.

2. The delivery system of claim 1 , wherein the radiopaque feature includes a metal feature.

3. The delivery system of claim 1 further comprising a snare locking sleeve in the shaft lumen, wherein the snare extends through a sleeve lumen of the snare locking sleeve.

4. A leadless pacemaker system, comprising:

a leadless pacemaker having a retrieval feature including a button; and

a delivery system including

a first shaft having a shaft lumen extending along a longitudinal axis to a distal portion,

a docking cap disposed on the distal portion of the first shaft, wherein the docking cap includes a distal tip sloping inwards toward an interior wall defining an interior configured to receive the button of the leadless pacemaker, and wherein the interior wall is shaped to cup and contact the button of the leadless pacemaker when the leadless pacemaker is docked within the docking cap,

a sheath including a proximal end coupled to a catheter shaft and a distal end, wherein the sheath tapers radially outward from the proximal end to a radiopaque feature at the distal end having an outer dimension greater than the proximal end, and wherein the radiopaque feature is movable along the longitudinal axis relative to the first shaft to indicate whether the sheath is covering the leadless pacemaker,

a snare extending through the shaft lumen to grasp the button of the retrieval feature of the leadless pacemaker, and

a handle coupled to the first shaft, wherein the handle includes a deflection knob slidable to steer the first shaft, and a snare knob slidable to cause the snare to extend distally beyond the distal tip of the docking cap.

5. The leadless pacemaker system of claim 4 , wherein the radiopaque feature includes a metal feature.

6. The leadless pacemaker system of claim 4 further comprising a snare locking sleeve in the shaft lumen, wherein the snare extends through a sleeve lumen of the snare locking sleeve.

7. A method, comprising:

sliding a deflection knob on a handle to steer a first shaft of a delivery system, wherein the first shaft has a shaft lumen extending along a longitudinal axis to a distal portion, wherein the delivery system includes a docking cap disposed on the distal portion of the first shaft, wherein the docking cap includes a distal tip sloping inwards toward an interior wall defining an interior configured to receive a button of a leadless pacemaker, and wherein the interior wall is shaped to cup and contact the button of the leadless pacemaker when the leadless pacemaker is docked within the docking cap;

sliding a snare knob to cause a snare to extend distally beyond the distal tip of the docking cap, wherein the snare extends through the shaft lumen to grasp the button of a retrieval feature of the leadless pacemaker;

advancing a sheath of the delivery system along the longitudinal axis relative to the first shaft, wherein the sheath includes a proximal end coupled to a catheter shaft and a distal end, the sheath tapers radially outward from the proximal end to a radiopaque feature at the distal end having an outer dimension greater than the proximal end, and wherein the radiopaque feature is movable along the longitudinal axis relative to the first shaft to indicate whether the sheath is covering the leadless pacemaker; and

determining, under visualization, whether the sheath is fully covering the leadless pacemaker.

8. The method of claim 7 further comprising removing, in response to determining that the sheath is fully covering the leadless pacemaker, the leadless pacemaker from a patient.

9. The method of claim 7 , wherein the radiopaque feature includes a metal feature.

10. The method of claim 7 further comprising advancing a snare locking sleeve over the snare to grasp the retrieval feature.

Assignments (3)
MERGER Recorded Jan 20, 2023
From: NANOSTIM, INC.
To: PACESETTER, INC.
Reel/Frame 062439/0279 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 6, 2023
From: KHAIRKHAHAN, ALEXANDER; KLENK, ALAN; EBY, THOMAS BLAKE
To: NANOSTIM, INC.
Reel/Frame 062294/0811 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 3, 2022
From: EBY, THOMAS B.; KLENK, ALAN
To: PACESETTER, INC.
Reel/Frame 061647/0688 →
Continuity (5)
Continuation 16214709 · Dec 10, 2018
Continuation 14816302 · Aug 3, 2015
Continuation 13324802 · Dec 13, 2011
Provisional Application 61422622 · Dec 13, 2010
Related Publication 20210282811A1 · Sep 16, 2021