IP Library Granted Patent US 12708358
Granted Patent B2
US 12708358 · App. 18/301,044 · Granted Aug 18, 2026

Minimally-invasive defect closure

Inventors: Felino V. Cortez, Jr. (Bowie, MD); Stephen Cournane (Severn, MD); Nancy Ling Chung (Edgewater, MD); Luke Anthony Zanetti (Parkton, MD); Ashley Nicolette Hinga (Eldersburg, MD); Stephen Epstein (Millersville, MD)
Assignee: Edwards Lifesciences Corporation
A61B17/0401A61B2017/0409A61B2017/0414A61B2017/0464
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Quick Facts
Patent No.
US 12708358
App. No.
18/301,044
Filed
Apr 14, 2023
Granted
Aug 18, 2026
Kind
B2
Art Unit
3771
USPC
606/232
Abstract

Septal defect repair involves advancing an elongate shaft into an atrium of a heart of a patient through an outer atrial wall of the heart, contacting an atrial septum of the heart with a distal end of the elongate shaft, deploying a plurality of tissue anchors from the elongate shaft in tissue of the atrial septum, and cinching suture tails associated with the plurality of tissue anchors to at least partially close a defect in the atrial septum.

Claims (47)

1 . A method of repairing a septal defect, the method comprising:

inserting a rigid lumen of a hemostatic introducer through a chest wall portion that is over a left atrium of a heart of a patient;

advancing a rigid elongate shaft through the rigid lumen of the hemostatic introducer, through an outer atrial wall of the left atrium, and into the left atrium;

contacting an atrial septum of the heart with a distal end of the rigid elongate shaft, thereby forming a straight working lumen from outside the chest wall portion and spanning laterally across the left atrium directly to the atrial septum;

deploying a plurality of tissue anchors from the rigid elongate shaft in tissue of the atrial septum; and

cinching suture tails associated with the plurality of tissue anchors to at least partially close a defect in the atrial septum.

2 . The method of claim 1 , further comprising locking the suture tails in a cinched configuration.

3 . The method of claim 2 , further comprising advancing a suture fastener distally over the suture tails, wherein said locking the suture tails involves locking the suture fastener.

4 . The method of claim 1 , further comprising cutting-off proximal portions of the suture tails.

5 . The method of claim 1 , wherein the plurality of tissue anchors comprises three or more tissue anchors.

6 . The method of claim 1 , wherein the plurality of tissue anchors comprise suture-form knot anchors.

7 . The method of claim 6 , wherein each of the suture tails is integrated with a respective one of the suture-form knot anchors.

8 . The method of claim 1 , wherein said advancing the rigid elongate shaft into the left atrium is via a minimally-invasive access, between adjacent ribs.

9 . The method of claim 1 wherein;

a pledget is disposed about the suture tails and advanced distally along the suture tails toward the septal defect using a pusher disposed within the elongate shaft; and

the pledget is disposed within the elongate shaft and is advanced distally along the suture tails toward the septal defect after deployment of the plurality of tissue anchors.

10 . The method of claim 1 , wherein the introducer comprises one or more hemostasis valves.

11 . The method of claim 1 , wherein said deploying the plurality of tissue anchors involves:

puncturing the atrial septum with one or more needles deployed from the elongate shaft; and

pushing the plurality of tissue anchors off the one or more needles.

12 . The method of claim 11 , wherein:

the one or more needles comprises a first needle and a second needle;

each of the first and second needles, prior to said pushing, has winds of suture of one of the plurality of tissue anchors disposed about a distal portion thereof; and

said puncturing the atrial septum involves simultaneously deploying the first and second needles from the elongate shaft.

13 . The method of claim 1 , wherein said deploying the plurality of tissue anchors involves deploying a tissue anchor within a thickness of the atrial septum.

14 . The method of claim 13 , further comprising performing a short-throw needle puncture into the atrial septum prior to deploying the tissue anchor.

15 . The method of claim 1 , further comprising withdrawing the rigid elongate shaft away from the atrial septum, thereby exposing the suture tails in the left atrium.

16 . A method of repairing a septal defect, the method comprising:

advancing a rigid elongate shaft through a chest wall and through an outer atrial wall into a left atrium of a heart, the rigid elongate shaft housing a plurality of needles arranged in a parallel relationship;

positioning a distal end of the rigid elongate shaft at a target position at least partially over a septal defect in an atrial septum such that the distal end overlies at least a portion of a periphery of the septal defect;

deploying, from the distal end of the rigid elongate shaft while maintaining the distal end at the target position, the plurality of needles through septal tissue at a plurality of spaced locations around the periphery of the septal defect, the plurality of needles being arranged in a parallel relationship within the elongate shaft;

sliding a plurality of suture-form tissue anchors off respective ones of the plurality of needles while the distal end of the elongate shaft remains at the target position;

withdrawing the plurality of needles while leaving the plurality of tissue anchors implanted in the septal tissue; and

cinching suture tails associated with the plurality of tissue anchors to approximate edges of the septal defect.

17 . The method of claim 16 , wherein said deploying the plurality of needles in performed simultaneously.

18 . The method of claim 16 , wherein said deploying the plurality of needles in performed sequentially.

19 . A method of repairing a septal defect, the method comprising:

advancing a rigid elongate shaft through a chest wall, through an outer atrial wall into a left atrium of a heart of a patient's body, and into contact with an atrial septum;

deploying first and second tissue anchors in septal tissue of the atrial septum adjacent a septal defect, the first tissue anchor having a first suture tail and the second tissue anchor having a second suture tail, the first and second suture tails passing through the atrial septum;

threading the first and second suture tails through one or more coils of a knot portion of a locking suture, the one or more coils defining a passage through the knot through which the suture tails pass;

advancing the knot portion of the locking suture distally along the first and second suture tails using a knot holder shaft disposed within the rigid elongate shaft while the knot portion is in a delivery configuration in which the knot portion is slidable relative to the first and second suture tails;

approximating the tissue anchors toward one another by distal advancement of the knot portion; and

after achieving a desired approximation of the septal defect, transitioning the knot portion from the delivery configuration to a deployed configuration by proximally pulling a tether line running proximally from the knot portion to constrict the coils around the first and second suture tails to inhibit relative motion between the knot portion and the first and second suture tails.

20 . The method of claim 19 , wherein:

the knot holder shaft includes a side aperture;

the tether line runs proximally through a distal axial opening of the knot holder shaft and out of the side aperture; and

proximally pulling the tether line is performed from outside of the patient's body.