Transcatheter heart valve with micro-anchors

• US 8,460,366 B2
• Filed: 07/18/2011
• Issued: 06/11/2013
• Est. Priority Date: 10/15/2007
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US13/185,254
• Publication Number:
  US 20120016470A1
• Time in Patent Office: 694 Days
• Field of Search: 623/1.36, 623 21- 219, 623 124- 127, 623 11- 123
• US Class Current: 623/1.36
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61F 2250/006 modular

Abstract

Various embodiments of methods and apparatus for treating defective heart valve are disclosed herein. In one exemplary embodiment, a transcatheter heart valve is disclosed that includes an expandable shape memory stent and a valve member supported by the stent. A plurality of micro-anchors can be disposed along an outer surface of the stent for engaging native tissue. The transcatheter heart valve can be configured to be advanced into a dilated valve annulus via a balloon catheter. The balloon can be inflated to expand the transcatheter heart valve from a collapsed diameter to an over-expanded diameter such that the micro-anchors engage tissue along the surrounding valve annulus. After engaging the tissue, the balloon can be deflated and the shape memory stent can retract or recoil toward its predetermined recoil diameter. As the stent recoils, the surrounding tissue is pulled inward by the stent such that the diameter of the valve annulus is reduced.

Claims

1. A system for treating aortic insufficiency, comprising:

a delivery catheter comprising an elongate body and a balloon disposed along a distal end portion of the elongate body;

a self-expandable support structure configured to be radially compressible into a compressed state for advancement through a patient'"'"'s body via the delivery catheter, the support structure having a preset diameter to which the support structure recoils following expansion to an over-expanded diameter larger than the preset diameter;

a flexible valve member secured within an interior of the support structure; and

a plurality of grabbing mechanisms disposed along an outer surface of the support structure, the grabbing mechanisms configured to penetrate native tissue of an aortic valve for reducing a diameter of the aortic valve by pulling the native tissue of the aortic valve inwards when the support structure recoils from the over-expanded diameter to the preset diameter without dislodging from their engaged positions.

2. The system of claim 1, wherein the grabbing mechanisms comprise a projection having a hook, a sharpened barb, tree-shaped barbs, or an anchor-shaped barb.

3. The system of claim 1, wherein the grabbing mechanisms are formed of a shape memory alloy.

4. The system of claim 1, wherein the flexible valve member is a valve assembly formed of pericardial tissue.

5. The system of claim 4, wherein the valve assembly comprises three leaflets configured to replace the function of the aortic valve.

6. The system of claim 1, wherein the grabbing mechanisms comprise a strip of projections disposed circumferentially around the support structure.

7. The prosthetic heart valve of claim 1, wherein the grabbing mechanisms comprise a strip of projections disposed along a vertical axis of the support structure.

8. The prosthetic heart valve of claim 1, wherein the grabbing mechanisms include a projection that changes shape after a period of time.

9. The prosthetic heart valve of claim 8, wherein the projection is initially held in an undeployed state by a resorbable material.

10. A system for treating aortic insufficiency, comprising:

a self-expandable outer support structure configured to be radially compressible for delivery via a catheterization technique, the support structure having a first diameter to which the support structure recoils following expansion to a second diameter greater than the first diameter;

a plurality of grabbing mechanisms disposed on an outer surface of the outer support structure, the grabbing mechanisms configured to penetrate native tissue of the aortic valve and to reduce a diameter of the aortic valve by pulling the native tissue of the aortic valve inwards when the support structure recoils from the second diameter to the first diameter without dislodging from their engaged positions;

an inner support structure configured to be radially compressible and expandable into an expanded state within the interior of the outer support structure; and

a flexible valve member secured within an interior of the inner support structure.

11. The system of claim 10, wherein the grabbing mechanisms comprise a projection having a hook, a sharpened barb, tree-shaped barbs, or an anchor-shaped barb.

12. The system of claim 10, wherein any one or more of the outer support structure, the inner support structure, or the grabbing mechanisms are formed of a shape memory alloy.

13. The system of claim 10, wherein the flexible membrane is formed of pericardial tissue.

14. The system of claim 10, wherein the inner support structure is configured to self-expand into engagement with the outer support structure.