Transcatheter heart valve with micro-anchors

• US 7,981,151 B2
• Filed: 10/15/2008
• Issued: 07/19/2011
• 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): Isabella; David
• Assistant Examiner(s): Stewart; Jason-Dennis
• Application Number:
  US12/252,161
• Publication Number:
  US 20090259306A1
• Time in Patent Office: 1,007 Days
• Field of Search: 623/1.11, 623/1.26, 623/2.11, 623/1.18, 623/1.36, 623/1.24, 604/509
• US Class Current: 623/2.1
• 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 method of treating aortic insufficiency in a human heart, comprising:

compressing a prosthetic heart valve for advancement through a patient'"'"'s vasculature, the prosthetic heart valve having a self-expandable support structure and a flexible valve member, the support structure comprising a shape memory material and having an outer surface with one or more projections extending radially outward therefrom, wherein the support structure is formed to have a recoil diameter when the support structure is not acted on by any external force;

positioning the prosthetic heart valve within the patient'"'"'s native aortic valve, the native aortic valve having an original diameter before treatment;

expanding the prosthetic heart valve to an over-expanded diameter that is larger than the recoil diameter, thereby causing the one or more projections on the outer surface of the support structure to engage native tissue of the patient'"'"'s native aortic valve, wherein expanding the prosthetic heart valve comprises inflating a balloon of a balloon catheter around which the prosthetic heart valve is disposed; and

allowing the prosthetic heart valve to retract from the over-expanded diameter toward the recoil diameter while the one or more projections are engaged with the native tissue of the patient'"'"'s native aortic valve and wherein the prosthetic heart valve pulls inward on the native aortic valve such that a final diameter of the native aortic valve is smaller than the original diameter of the native aortic valve after the prosthetic heart valve has retracted to the recoil diameter.

2. The method of claim 1, wherein the act of allowing the prosthetic heart valve to retract comprises deflating the balloon of the balloon catheter.

3. The method of claim 1, wherein the shape memory material is a shape memory alloy.

4. The method of claim 1, wherein the one or more projections include hooks, barbs, or anchors.

5. The method of claim 1, wherein at least one of the one or more projections changes its shape after penetrating the native tissue of the patient'"'"'s aortic valve.

6. A method of treating aortic insufficiency in a patient, comprising:

positioning a self-expandable outer stent within a patient'"'"'s native aortic valve, the native aortic valve having an untreated diameter, the outer stent comprising a shape memory alloy and having a preset recoil diameter;

expanding the outer stent to an over-expanded diameter by inflating a balloon on a balloon catheter around which the outer stent is disposed, thereby causing projections on the outer surface of the outer stent to engage tissue of the patient'"'"'s native aortic valve;

allowing the outer stent to retract from the over-expanded diameter toward the smaller recoil diameter while the projections are engaged with the tissue of the patient'"'"'s native aortic valve, thereby pulling inward on the native valve and causing the patient'"'"'s native aortic valve to be reduced from the untreated diameter to a treated diameter, the treated diameter being less than the untreated diameter;

positioning a prosthetic heart valve within the outer stent; and

expanding the prosthetic heart valve while the prosthetic heart valve is positioned within the outer stent.

7. The method of claim 6, wherein the act of expanding the prosthetic heart valve comprises frictionally securing the prosthetic heart valve within the outer stent.

8. The method of claim 6, wherein the act of expanding the prosthetic heart valve comprises engaging grooves provided within the outer stent with complementary members of the prosthetic heart valve.

9. The method of claim 6, wherein the act of expanding the prosthetic heart valve comprises engaging a snap mechanism that causes the prosthetic heart valve to be secured within the outer stent.

10. The method of claim 6, wherein the act of allowing the outer stent to retract comprises deflating the balloon of the balloon catheter.

11. The method of claim 6, wherein the prosthetic heart valve comprises a compressible and expandable inner support structure and a valve membrane secured in an interior of the inner support structure.