Implanting grafts to valve leaflets for cardiac procedures

Patent metadata

Field	Value
Publication number	US-12458498-B2
Application number	US-202217650225-A
Country	US
Kind code	B2
Filing date	Feb 7, 2022
Priority date	Feb 10, 2021
Publication date	Nov 4, 2025
Grant date	Nov 4, 2025

Abstract

Described herein are methods and apparatus for implanting grafts to leaflets for cardiac procedures that are performed minimally-invasively while the heart is beating. The graft elongates, reinforces, and patches the leaflet. In certain disclosed examples, the graft is secured to the atrium or ventricle side of the leaflet with an artificial cord implanted on an edge of the graft to improve coaptation. In some disclosed examples, the graft is secured to both leaflets to enable an edge-to-edge procedure similar to the Alfieri technique. Some examples of the disclosed methods including introducing the graft into the ventricle and guiding it into place using artificial cords previously implanted in the leaflet.

First claim

What is claimed is:

1 . A method for implanting a graft on a ventricle-facing surface of a leaflet in a heart, the method comprising:
puncturing a wall of a ventricle near an apex of the heart to gain access to the ventricle; installing an artificial cord having a distal anchor and a suture extending proximally from the distal anchor, the distal anchor deployed on an atrium-facing surface of the leaflet, the suture extending proximally through the leaflet and through the puncture in the wall of the ventricle to a region outside the heart; implanting an edge cord at an edge of a graft, the edge cord including an edge anchor and an edge suture extending from the edge anchor, the graft configured to extend beyond an edge of the leaflet to effectively elongate the leaflet; directing the graft along the artificial cord from the region outside the heart to the ventricle-facing surface of the leaflet such that a proximal end of the edge cord extends through the puncture in the wall of the ventricle to the region outside the heart; and deploying a mechanical fastener to secure the graft to the ventricle-facing surface of the leaflet, the suture of the artificial cord being threaded through the mechanical fastener outside of the heart and then being directed along the artificial cord to secure the graft against the leaflet.

2 . The method of claim 1 , wherein the graft reduces mitral valve regurgitation.

3 . The method of claim 1 , wherein the method is performed while the heart is beating.

4 . The method of claim 1 , further comprising anchoring the suture and the edge suture to an external wall of the heart.

5 . The method of claim 1 , wherein the mechanical fastener comprises a locking knot, the locking knot including a locking suture extending proximally from the locking knot.

6 . The method of claim 5 further comprising advancing the locking knot distally along the artificial cord to secure the graft to the ventricle-facing surface of the leaflet.

7 . The method of claim 5 , wherein the suture, the edge suture, and the locking suture extend proximally through an opening in a wall of a ventricle.

8 . The method of claim 5 , wherein the suture of the artificial cord is threaded through the locking knot and the locking knot is directed along the artificial cord to push against the graft.

9 . The method of claim 8 further comprising deploying the locking knot by tensioning the locking suture in the region outside of the heart.

10 . The method of claim 1 , further comprising adjusting a tension on the edge suture to adjust coaptation of the leaflet.

11 . The method of claim 1 , wherein the graft is slidably coupled to the artificial cord outside of the heart prior to directing the graft along the artificial cord to the ventricle-facing surface of the leaflet.

12 . The method of claim 1 , wherein the edge cord is implanted prior to directing the graft along the artificial cord.

13 . The method of claim 1 , wherein the edge cord is implanted after directing the graft along the artificial cord.

14 . The method of claim 1 , wherein directing the graft to the leaflet includes using the artificial cord as a guide for the graft through the ventricle to the ventricle-facing surface of the leaflet.

15 . The method of claim 1 , wherein the edge cord is implanted at the edge of the graft prior to the graft entering the ventricle and prior to directing the graft to the ventricle-facing surface of the leaflet.

16 . The method of claim 1 , wherein the mechanical fastener is further used to position the graft against the leaflet.

17 . The method of claim 1 , wherein the mechanical fastener is deployed after the graft is positioned against the leaflet.

18 . The method of claim 1 further comprising deploying one or more additional edge cords to an edge of the graft after deployment of the mechanical fastener.

19 . The method of claim 18 further comprising adjusting the one or more additional edge cords to adjust the graft to improve coaptation.

20 . The method of claim 1 , wherein the mechanical fastener has a delivery configuration in which the mechanical fastener is slidable along the suture of the artificial cord and a deployed configuration in which the mechanical fastener is fixed to the suture of the artificial cord to inhibit relative movement between the mechanical fastener and the suture of the artificial cord.

Assignees

• Edwards Lifesciences Corp

Inventors

• Cournane Stephen
• Cortez Jr Felino V
• Epstein Stephen
• Zanetti Luke Anthony
• Etheridge Julie Marie

Classifications

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title

• A61F2250/0012

  for adjusting elasticity, flexibility, spring rate or mechanical tension · CPC title

• A61F2220/0008

  Fixation appliances for connecting prostheses to the body · CPC title

• A61F2/2457

  Chordae tendineae prostheses · CPC title

• A61F2/2463 Primary

  Implants forming part of the valve leaflets · CPC title