Method and system for closing left atrial appendage

• US 10,702,274 B2
• Filed: 05/26/2017
• Issued: 07/07/2020
• Est. Priority Date: 05/26/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Groothuis, Adam, Cahalane, Steven D.
• Primary Examiner(s): Severson, Ryan J.
• Application Number:
  US15/606,611
• Publication Number:
  US 20170340329A1
• Time in Patent Office: 1,138 Days
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot

Abstract

The present teachings provide methods for resizing, reducing, and closing left atrial appendage. Specifically, a percutaneous trans-septal access is first established from outside the body to a patient'"'"'s LAA. At least two tissue anchors are then implanted inside the LAA chamber and along the tissue wall. At least one anchor is implanted near the opening of the LAA camber. Both tissue anchors are pulled together so that the wall of the LAA chamber collapse. The LAA chamber is therefore resized, reduced, and/or closed off completely. This closure method and system could be used alone in closing LAA chamber. This closure method and system could also be used in addition to other treatment mechanisms, such as filling the LAA chamber with space-filling material, then closing off its opening.

Claims

1. A method for resizing a left atrium appendage comprising,

inserting a locating wire from a right atrium, across an atrial septum, across a left atrium, and into a left atrial appendage (LAA) chamber,

advancing the locating wire through a tissue wall at a first location inside the LAA chamber,

subsequently, implanting a first tissue anchor at the first location by advancing the first tissue anchor along the locating wire and into the tissue wall at the first location,

subsequently, and independently of advancing the locating wire through the tissue wall at the first location, advancing the locating wire through the tissue wall at a second location inside the LAA chamber,

subsequently, implanting a second tissue anchor at the second location by advancing the second tissue anchor along the locating wire and into the tissue wall at the second location, and

subsequently, pulling the first and second tissue anchors toward each other so that the first and second locations of the LAA chamber are pulled together.

2. The method of claim 1, further including the steps of:

advancing the locating wire through the tissue wall at a third location approximate to a bottom of the LAA chamber, and

subsequently, implanting a third tissue anchor at the third location by advancing the third tissue anchor along the locating wire and into the tissue wall at the second location, wherein pulling the first and second tissue anchors toward each other comprises pulling the first, second and third tissue anchors toward each other so that the bottom of the LAA chamber is everted and tissue wall at the first, second and third locations of the LAA chamber are pulled together.

3. The method of claim 1, wherein a distal end of the locating wire is configured to connect to an RF energy source, and wherein advancing the locating wire through the tissue wall at the first location comprises using the RF energy source to drive the distal end of the locating wire to apply RF energy to the tissue wall at the first location.

4. The method of claim 1, wherein advancing the first tissue anchor along the locating wire and into the tissue wall at the first location comprises advancing the first tissue anchor using a tissue anchor delivery catheter that tracks along the locating wire.

5. The method of claim 1, wherein:

the first tissue anchor has a unitary construction defined by a plurality of folded panels, the tissue anchor being coupled to a tensioning member that is threaded through the tissue anchor in a distal direction and is threaded through the tissue anchor in a proximal direction, and

the method further comprises, subsequently to advancing the first tissue anchor along the locating wire and into the tissue wall at the first location, pulling a proximal end portion of the tensioning member such that the first tissue anchor becomes compressed to form the plurality of panels along pre-defined fold lines.

6. The method of claim 5, wherein the proximal end portion of the tensioning member extends outside the body, the tensioning member and the locating wire being disposed within a lumen of a common catheter.

7. The method of claim 1, wherein each of the first and second tissue anchors comprises a foldable anchor that has a tensioning member extending along a length thereof and the step of pulling the first and second tissue anchors toward each other comprises the step of pulling the tensioning members of the first and second tissue anchors.

8. The method of claim 7, further including, subsequently to pulling the tensioning members of the first and second tissue anchors, locking a lock member to the tensioning members of the first and second tissue anchors.

9. The method of claim 1, wherein the first tissue anchor has a size different than a size of the second tissue anchor, and wherein implanting the first tissue anchor comprises implanting the first tissue anchor that has the size different to the size of the second tissue anchor.

10. The method of claim 1, wherein a proximal portion of the second tissue anchor is smaller than a distal portion thereof, and wherein implanting the second tissue anchor comprises implanting the second tissue anchor that has the proximal portion that is smaller than the distal portion.

11. The method of claim 1, further including the step of prior to pulling the first and second tissue anchors toward each other, injecting a space filling material into the LAA, wherein the space filling material is selected from a group consisting of:

a solid, a liquid, a gas, a foam, and a gel.

12. The method of claim 11, wherein the space filling material comprises a first reagent and a second reagent, the second reagent being functional to activate the first reagent.

13. The method of claim 1, wherein the second tissue anchor is delivered by a tissue anchor delivery catheter and has a collapsed delivery profile and a radially expanded deployed configuration, wherein in the collapsed delivery profile, the second tissue anchor is elongated and is housed inside a lumen of the tissue anchor delivery catheter and in the radially expanded deployed configuration, the second tissue anchor expands radially and assumes at least one of an open umbrella shape and a plate shape.

14. The method of claim 13, wherein the second tissue anchor, in the radially expanded deployed configuration, comprises a continuous wire with spiral turns.

15. The method of claim 13, wherein the second tissue anchor, in the radially expanded deployed configuration, comprises multiple struts extending from a common center.

16. The method of claim 1, wherein inserting the locating wire across the atrial septum comprises piercing the atrial septum at the fossa ovalis using the locating wire.

17. The method of claim 1, wherein the first location is near an opening of the LAA, and wherein implanting the first tissue anchor comprises implanting the first tissue anchor such that (i) a distal portion of the first tissue anchor is placed against an outside of the LAA chamber, (ii) a proximal portion of the first tissue anchor is placed against an inside of the LAA chamber, and (iii) a tensioning member that extends along and passes through the first tissue anchor also extends proximally from the first tissue anchor and through a lumen of a tissue anchor delivery catheter to an outside of a patient'"'"'s body.