Pacesetter, Inc.

St. Jude Medical, Cardiology Division, Inc.

Daniel Goodman

Daniel Coyle

Jennifer Heisel

Scott Kerns

David Rickheim

Adam Weber

Scott Smith

Craig E Mar

Bernhard Arnar

Mike Sacha

Benjamin F James, Iv

Thomas Blake Eby

Tyler J Strang

Kavous Sahabi

Arees Garabed

Sondra Orts

Scott Iverson

Travis Lieber

Tracee E Eidenschink

John Pocrnich

Benjamin F James Iv

Systems and methods for delivering and retrieving a leadless pacemaker are described. A leadless pacemaker retrieval system includes a catheter system having a snare assembly to capture the leadless pacemaker. The catheter system includes sheaths extending distally from a shaft, and the snare assembly includes several snare legs, such as segments of snare loops, that extend from one sheath to connect to another sheath. The snare loops can have bights that connect to opposing sheaths to form a docking space between the legs of the snare loops and radially between the sheaths. The snare assembly is movable between an engaged position and a disengaged position by translating the snare legs within lumens of the corresponding sheaths. In the engaged position, the snare assembly tightens around the leadless pacemaker to allow the leadless pacemaker to be retrieved. Other embodiments are also described and claimed.

Implant delivery and retrieval systems and methods

An introducer hub assembly, such as an introducer hub assembly of a leadless cardiac pacemaker, including a hemostatic seal having a cross-slit configuration, is described. The hemostatic seal can be retained between a hub cap and an introducer hub. The hemostatic seal includes a first section having first slits intersecting along a longitudinal axis of the introducer hub, and a second section having second slits intersecting along the longitudinal axis. The first slits are angularly offset relative to the second slits to reduce a likelihood that fluid will leak directly through the seal. Other embodiments are also described and claimed.

Introducer hub assembly having cross-slit seal

A transport system for delivery or retrieval of a biostimulator, such as a leadless cardiac pacemaker, is described. The biostimulator transport system includes a docking cap supported by a bearing within a bearing housing. The bearing allows relative rotation between a torque shaft connected to the docking cap and an outer catheter connected to the bearing housing. The bearing housing and the docking cap include respective bearing retainers that constrain the bearing within the bearing housing without a weld attachment. The weldless retainers of the biostimulator transport system provide a robust mechanical securement of the bearing that is not vulnerable to corrosion. Other embodiments are also described and claimed.

Biostimulator transport system having weldless bearing retainer

The present disclosure provides collapsible medical devices that may be introduced via a delivery device into a pre-existing patent foramen ovale or trans-septal puncture hole and left in place to provide both a sealing function on the atrial wall and a septal-access function for additional procedures. The disclosed medical devices include a penetrable and re-sealable gasket material disposed in an open lumen in the medical device. This penetrable and re-sealable material allows catheters or other medical devices to pass therethough for providing additional therapy to an individual. By allowing the access point or portal to be opened by a guidewire or another medical tool, the medical devices as disclosed herein may be particularly suitable for a variety of cardiac procedures including, for example, atrial fibrillation, mitral valve replacement or repair, left atrial appendage closures, and the like.

Collapsible medical device for atrial sealing and trans-septal access

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

Leadless biostimulator attachment feature

Growing community of inventors

Minnetonka, MN, United States of America

Daniel Goodman