Apparatus and methods for anterior valve leaflet management

• US 10,470,877 B2
• Filed: 04/27/2017
• Issued: 11/12/2019
• Est. Priority Date: 05/03/2016
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Inventors: Tegels, Zachary J., Urick, Michael J.
• Primary Examiner(s): Anderson, Gregory A
• Application Number:
  US15/499,129
• Publication Number:
  US 20170319333A1
• Time in Patent Office: 929 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2018/00369 Heart valves
• CPC Class Codes: A61B 2018/00619 Welding
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2250/0006 for adjusting angular orientation
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

In some embodiments, a method includes delivering to a native valve annulus (e.g., a native mitral valve annulus) of a heart a prosthetic heart valve having a body expandable from a collapsed, delivery configuration to an expanded, deployed configuration. The method can further include, after the delivering, causing the prosthetic heart valve to move from the delivery configuration to the deployed configuration. With the prosthetic heart valve in its deployed configuration, an anchor can be delivered and secured to at least one of a fibrous trigone of the heart or an anterior native leaflet of the native valve. With the prosthetic heart valve disposed in the native valve annulus and in its deployed configuration, an anchoring tether can extending from the anchor can be secured to a wall of the heart to urge the anterior native leaflet towards the body of the prosthetic heart valve.

Claims

1. A method, comprising:

delivering to a mitral valve annulus of a heart a prosthetic heart valve having a body expandable from a collapsed, delivery configuration to an expanded, deployed configuration;

after the delivering, causing the prosthetic heart valve to move from the delivery configuration to the deployed configuration;

delivering and securing an anchor to at least one of a fibrous trigone of the heart or an anterior native leaflet of the mitral valve; and

with the prosthetic heart valve disposed in the mitral valve annulus and in its deployed configuration, securing an anchoring tether extending from the anchor to a wall of the heart to urge the anterior native leaflet towards the body of the prosthetic heart valve.

2. The method of claim 1,

wherein the securing the anchoring tether includes coupling an epicardial pad device to the anchoring tether and securing the epicardial pad device to an apex region of the heart.

3. The method of claim 1, wherein the securing the anchoring tether includes securing the anchoring tether extending from the anchor to the wall of the heart such that the anterior native leaflet is urged away from a left ventricular outflow tract (LVOT) of the heart.

4. The method of claim 1, wherein the securing the anchoring tether includes securing the anchoring tether extending from the anchor to the wall of the heart such that the anterior native leaflet is immobilized relative to the body of the prosthetic heart valve.

5. The method of claim 1, wherein the anchor is a first anchor and the anchoring tether is a first anchoring tether, the method further comprising:

delivering and securing a second anchor to at least one of the anterior native leaflet or the fibrous trigone of the heart; and

with the prosthetic heart valve disposed in the mitral valve annulus and in its deployed configuration, securing a second anchoring tether extending from the second anchor to the wall of the heart to urge the anterior native leaflet of the mitral valve towards the body of the prosthetic heart valve.

6. The method of claim 1, wherein:

the securing the anchoring tether includes applying tension on the anchoring tether to modify a geometry of the mitral valve annulus.

7. The method of claim 1, wherein:

the anchor includes at least one of a helix coil shape or an expandable barb.

8. The method of claim 1, wherein:

the securing the anchor includes securing the anchor to a free-end portion of the anterior native leaflet.

9. The method of claim 1, wherein:

the securing the anchor includes securing the anchor to a hinge-point portion of the anterior native leaflet.