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US 11,951,002 B2Granted
Apparatus and methods for valve and tether fixation
AssigneeTendyne Holdings, Inc.
InventorsPreston James Huddleston, David A. Panus, Theodore Paul Dale, Tracee Eidenschink, Kevin Patrick Griffin
Life of this patent
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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.
Claims14
A prosthetic heart valve system comprising:
- a prosthetic heart valve having an expandable frame assembly including an inner frame and an outer frame, and a prosthetic valve assembly disposed within the inner frame, the prosthetic valve assembly configured to allow blood to flow in a direction from an inflow end of the inner frame toward an outflow end of the inner frame and to block blood from flowing from the outflow end of the inner frame toward the inflow end of the inner frame, the inner frame including a tether connecting portion, wherein the inner frame includes a plurality of struts that extend radially inwardly toward a radial center of the inner frame, the tether connecting portion being coupled to the plurality of struts so that the tether connecting portion is positioned at the radial center of the inner frame;
- an anchor adapted to be disposed on or adjacent an epicardial surface of a heart of a patient;
- and
- a tether having a distal end fixedly coupled to the anchor, the tether extending proximally from the anchor, the tether defining a protrusion having a width greater than portions of the tether adjacent the protrusion,
- wherein the tether extends through the tether connection portion and is slidably coupled to the tether connection portion so that the prosthetic heart valve can translate along the tether toward the distal end of the tether while the distal end of the tether is fixedly coupled to the anchor, the protrusion of the tether configured to engage the tether connecting portion to prevent proximal movement of the prosthetic heart valve relative to the tether,
- wherein the tether connecting portion includes a flap hingedly coupled to the tether connecting portion, 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, the tether connection portion including a stem body that includes a rim, the flap abutting and contacting the rim in the closed position, the flap spaced away from the rim in the open position.
3 more elements
A method of implanting a prosthetic heart valve system, the method comprising:
- positioning an anchor adjacent a ventricular wall while a distal end of a tether is fixedly coupled to and extends proximally from the anchor, the anchor being adapted to be disposed on or adjacent an epicardial surface of a heart of a patient, the tether defining a protrusion having a width greater than portions of the tether adjacent the protrusion;
- advancing the prosthetic heart valve distally along the tether while the anchor is positioned adjacent the ventricular wall, the prosthetic heart valve having an expandable frame assembly including an inner frame and an outer frame, and a prosthetic valve assembly disposed within the inner frame, the prosthetic valve assembly configured to allow blood to flow in a direction from an inflow end of the inner frame toward an outflow end of the inner frame and to block blood from flowing from the outflow end of the inner frame toward the inflow end of the inner frame, the prosthetic heart valve including a tether connecting portion, wherein the inner frame includes a plurality of struts that extend radially inwardly toward a radial center of the inner frame, the tether connecting portion being coupled to the plurality of struts so that the tether connecting portion is positioned at the radial center of the inner frame;
- deploying the prosthetic heart valve into a native valve annulus;
- pulling the tether in a proximal direction to tension the tether, the tether extending through the tether connection portion and being slidably coupled to the tether connection portion so that the prosthetic heart valve can translate along the tether toward the distal end of the tether while the distal end of the tether is fixedly coupled to the anchor, the protrusion of the tether configured to engage the tether connecting portion to prevent proximal movement of the prosthetic heart valve relative to the tether;
- and
- fixing the prosthetic heart valve to the tether while the tether is tensioned,
- wherein the tether connecting portion includes a flap hingedly coupled to the tether connecting portion, 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, the tether connection portion including a stem body that includes a rim, the flap abutting and contacting the rim in the closed position, the flap spaced away from the rim in the open position.
4 more elements
Dependencies are inferred from the claim text.