Tendyne Holdings, Inc.

Preston James Huddleston

Tracee E Eidenschink

Theodore Paul Dale

David Panus

Zachary Vidlund

Mitchell F McBride

Kevin Patrick Griffin

Nathan T Smith

Aaron L Swandal

David A Panus

A prosthetic mitral valve with improved blood flow to the left ventricular outflow tract. The prosthetic mitral valve includes an expandable outer stent having an atrial end and a ventricular end, and an expandable inner stent attached to and at least partially positioned within the outer stent. The inner stent has an inflow end, an outflow end and a tether connector securing a tether. A valve assembly including a cuff and a plurality of leaflets may be disposed within the inner stent. The tether connector is positioned at the inflow end of the inner stent so as to shorten the overall length of the prosthetic valve.

Tether attachment for mitral valve

A valve and tether fixation mechanism includes an anchor, a tether, and a prosthetic heart valve. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The tether may have a distal end coupled to the anchor. The tether may extend proximally from the anchor and connect to a tensioning mechanism. The prosthetic valve may be configured to translate along the tether. The valve may have a tether connecting portion configured to allow for adjustment of the tension in the tether and affix the prosthetic valve to the tether at a desired tension.

Apparatus and methods for valve and tether fixation

A delivery catheter system includes an anchor catheter, a collapsible and expandable anchor, a balloon catheter, and a needle. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The anchor may be configured to be received within the anchor catheter. The balloon catheter may be positioned radially inward of the anchor catheter, and may include an inflatable balloon at a distal end thereof. The balloon may be in fluid communication with the balloon catheter. The needle may be positioned radially inward of the balloon catheter and may be translatable relative to the balloon, the needle having a sharp distal tip.

Apparatus and methods for minimally invasive transapical access

A delivery catheter system includes a guide catheter, an anchor catheter, a collapsible and expandable anchor, a balloon formed from a portion of the positioning catheter, and a needle. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The anchor may be configured to be received within the anchor catheter. The balloon may be inflated or deflated and provide mechanical support to enable the needle to pierce a ventricle wall. A metallic guide wire can simultaneously be inserted through the aorta to outline the heart when viewed through fluoroscopic imaging.

Apparatus and methods for minimally invasive transcatheter transapical puncture, imaging, and catheter alignment techniques

An apical pad for securing a prosthetic heart valve within a native valve annulus. The apical pad includes a first collar, a second collar and plurality of struts extending between the first collar and the second collar. The plurality of struts has a delivery condition in which the plurality of struts collectively form a first cross-section and a deployed condition in which the plurality of struts collectively form a second cross-section greater than the first cross-section. The apical pad may be coupled to a tether extending from a prosthetic heart valve and may transition from the delivery condition to the deployed condition by tensioning the tether.

Fully-transseptal apical pad with pulley for tensioning

A heart valve delivery system may include a handle, a shaft having a proximal end fixedly connected to the handle and extending distally along an axis away from the handle to a free end, and a tube surrounding the shaft. The tube may have a proximal end connected to the handle and extend distally along the axis away from the handle to a distal end. The tube may be axially movable relative to the shaft and the handle between a fully extended position at which the tube extends distally farther than the shaft, and a fully retracted position at which the shaft extends distally farther than the tube. The system may include an inserter for guiding insertion of the tube. In addition or in alternative to the inserter, the system may include a funnel for loading the prosthetic valve into the tube.

Distally loaded sheath and loading funnel

Apparatus and methods are described herein for use in the delivery of a prosthetic mitral valve. In some embodiments, an apparatus includes a tether fixer assembly configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart. The fixer assembly defines a lumen configured to receive therethrough a tether extending from the prosthetic valve and a movable portion. The fixer assembly is movable between a first configuration, in which the movable portion is disengaged with the tether, and a second configuration in which the movable portion is engaged with the tether. The fixer assembly can be disposed against an epicardial pad positioned on the outside surface of the heart when in the second configuration to secure the prosthetic valve, the epicardial pad and tether in a desired position within the heart.

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Maplewood, MN, United States of America

Preston James Huddleston