Pacesetter, Inc.

David Rickheim

Daniel Coyle

Jennifer Heisel

Daniel Goodman

Adam Weber

Scott Smith

Dale Price

Scott Kerns

Craig E Mar

Bernhard Arnar

Mike Sacha

Benjamin F James, Iv

Byron Liehwah Chun

Thomas Blake Eby

Tyler J Strang

Kavous Sahabi

Arees Garabed

Sondra Orts

Travis Lieber

Benjamin F James Iv

A retrieval system for a biostimulator, such as a leadless cardiac pacemaker, is described. The biostimulator retrieval system includes a docking cap rotatably coupled to an outer catheter by a bearing. A torque shaft extends through the outer catheter and attaches to the docking cap to transmit torque to the docking cap to cause rotation of the docking cap relative to the outer catheter. The rotating docking cap can transmit torque to an attachment feature of a biostimulator received within the docking cap. The attachment feature can be captured by a snare that extends through the torque shaft. A cincher tube extends through the torque shaft around the snare, and advances over the snare independently from the torque shaft that is attached to the docking cap, to cinch the snare onto the attachment feature. Other embodiments are also described and claimed.

Biostimulator retrieval system having cincher tube

A valve bypass tool, and a biostimulator transport system having such a valve bypass tool, is described. The valve bypass tool includes an annular seal to seal against a protective sheath of the biostimulator transport system. The valve bypass tool is slidably mounted on the protective sheath and includes a bypass sheath to insert into an access introducer. The valve bypass tool can lock onto the access introducer by mating a locking tab of the valve bypass tool with a locking groove of the access introducer. The locking tab can have a detent that securely fastens the components to resist decoupling when the biostimulator transport system is advanced through the access introducer into a patient anatomy. Other embodiments are also described and claimed.

Biostimulator transport system having valve bypass tool

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.

Catheter-based system for delivery and retrieval of a leadless pacemaker

A leadless biostimulator including an attachment feature to facilitate precise manipulation during delivery or retrieval is described. The attachment feature can be monolithically formed from a rigid material, and includes a base, a button, and a stem interconnecting the base to the button. The stem is a single post having a transverse profile extending around a central axis. The transverse profile can be annular and can surround the central axis. The leadless biostimulator includes a battery assembly having a cell can that includes an end boss. A tether recess in the end boss is axially aligned with a face port in the button to receive tethers of a delivery or retrieval system through an inner lumen of the stem. The attachment feature can be mounted on and welded to the cell can at a thickened transition region around the end boss. Other embodiments are also described and claimed.

Leadless pacemaker having attachment feature

A biostimulator transport system, such as a biostimulator retrieval system, having a torque limiter to allow a torque shaft to slip rotationally relative to a handle, is described. The torque limiter can connect the torque shaft to the handle, and can include a slip mechanism, such as a flat spring or apposed clutch faces, that allow the torque shaft to slip relative to the handle when a resistance torque at a distal end of the torque shaft exceeds a torque threshold. Accordingly, torque can be applied to a biostimulator by the torque shaft with a reduced likelihood of over-torqueing the biostimulator within the target tissue. Other embodiments are also described and claimed.

Biostimulator transport system having torque limiter

A valve bypass tool, and a biostimulator transport system having such a valve bypass tool, is described. The valve bypass tool includes an annular seal to seal against a protective sheath of the biostimulator transport system. The valve bypass tool is slidably mounted on the protective sheath and includes a bypass sheath to insert into an access introducer. The valve bypass tool can lock onto the access introducer by mating a locking tab of the valve bypass tool with a locking groove of the access introducer. The locking tab can have a decent that securely fastens the components to resist decoupling when the biostimulator transport system is advanced through the access introducer into a patient anatomy. Other embodiments are also described and claimed.

Leadless biostimulator attachment feature

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Bloomington, MN, United States of America

David Rickheim