Apparatus and methods for valve and tether fixation

Inventors

Huddleston, Preston James • Panus, David A. • Dale, Theodore Paul • Eidenschink, Tracee • Griffin, Kevin Patrick

Assignees

Tendyne Holdings Inc

Abstract

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.

Core Innovation

The invention relates to a minimally invasive prosthetic heart valve system that uses an epicardial tethered anchor and a tether-based fixation and tensioning mechanism. A prosthetic heart valve includes an expandable frame assembly with an inner frame and an outer frame, and a prosthetic valve assembly disposed within the inner frame to allow blood to flow from an inflow end toward an outflow end and to block reverse flow. The inner frame includes a tether connecting portion positioned at a radial center through coupling to a plurality of struts extending radially inwardly toward the radial center.

An anchor is adapted to be disposed on or adjacent an epicardial surface of a heart of a patient, and a tether has a distal end fixedly coupled to the anchor and extends proximally from the anchor. The tether defines a protrusion having a width greater than portions of the tether adjacent the protrusion. The tether extends through the tether connecting portion and is slidably coupled to the tether connecting portion so the prosthetic heart valve can translate along the tether toward the distal end while the distal end of the tether remains fixedly coupled to the anchor.

To prevent undesired proximal movement, the protrusion is configured to engage the tether connecting portion. The tether connecting portion includes a flap hingedly coupled to the tether connecting portion, with the flap moveable between an open position in which the prosthetic heart valve may translate distally over the protrusion and a closed position preventing proximal translation of the prosthetic heart valve over the protrusion relative to the tether. In the closed position, the flap abuts and contacts a rim of a stem body included in the tether connection portion, and the flap is spaced away from the rim in the open position.

Claims Coverage

The partial content includes two independent claims. Each independent claim centers on the same core arrangement of an expandable inner-frame prosthetic valve that translates along an anchored tether using a tether protrusion engaged by a hingedly mounted flap at a tether connection portion, with one independent claim directed to the system and one to an implanting method.

Across the independent claims, the inventive concept is a prosthetic mitral/heart valve with an inner frame positioned at a tether radial center that translates along an epicardial anchored tether, where a tether protrusion engages a hingedly mounted flap at the tether connection portion to allow distal translation in an open position and prevent proximal translation in a closed position. The method claim applies the same structure during implantation by positioning an epicardial anchor, advancing and deploying into a native valve annulus, tensioning the tether, translating the valve along the tether, and fixing the valve to the tether while tensioned.

Stated Advantages

Documented Applications