Anti-paravalvular leakage component for a transcatheter valve prosthesis

• US 10,702,379 B2
• Filed: 04/24/2017
• Issued: 07/07/2020
• Est. Priority Date: 02/01/2013
• Status: Active Grant

• Current Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Inventors: Garde, Kshitija, Racchini, Joel, Rothstein, Paul, Sandstrom, Jeffrey
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US15/494,923
• Publication Number:
  US 20170224480A1
• Time in Patent Office: 1,170 Days
• 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 2220/005 using adhesives
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0017 Angular shapes
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A transcatheter valve prosthesis includes an expandable tubular stent, a prosthetic valve within the stent, and an anti-paravalvular leakage component coupled to and encircling the tubular stent. The anti-paravalvular leakage component includes a radially-compressible annular scaffold, which is a sinusoidal patterned ring of self-expanding material, and an impermeable membrane extending over the annular scaffold. The anti-paravalvular leakage component has an expanded configuration in which at least segments of the annular scaffold curve radially away from the tubular stent. Alternatively, the anti-paravalvular leakage component includes a plurality of self-expanding segments and an annular sealing element coupled to inner surfaces of the segments. The anti-paravalvular leakage component has an expanded configuration in which the segments curve radially away from the tubular stent and the annular sealing element is positioned between an outer surface of the tubular stent and inner surfaces of the segments. The segments may be orthogonal or oblique to the outer surface of the tubular stent.

Claims

1. A transcatheter valve prosthesis comprising:

a stent having a proximal end, a distal end and a plurality of diamond-shaped openings formed within the stent, each diamond-shaped opening being formed from struts of the stent, the stent having a compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve;

a prosthetic valve component disposed within and secured to the stent; and

an anti-paravalvular leakage component coupled to and encircling an outer surface of the stent, the anti-paravalvular leakage component including a plurality of self-expanding segments and an annular sealing element attached to the plurality of self-expanding segments,

wherein each self-expanding segment is U-shaped and has a first end and a second end that are attached directly to the outer surface of the stent on opposing struts of a respective diamond-shaped opening at first and second attachment points, respectively,

wherein the respective first and second attachment points are located on opposing sides of a respective diamond-shaped opening of the plurality of diamond-shaped openings of the stent, such that the respective first and second attachment points are circumferentially spaced apart on the stent,

wherein the anti-paravalvular leakage component has an expanded configuration in which each self-expanding segment extends radially away from, and is oblique to, the outer surface of the stent, such that a plane defined by each self-expanding segment is non-perpendicular with respect to a tangential plane taken through its respective first and second attachment points on the stent.

2. The transcatheter valve prosthesis of claim 1, wherein each self-expanding segment has a concave profile when the anti-paravalvular leakage component is in the expanded configuration.

3. The transcatheter valve prosthesis of claim 1, wherein each self-expanding segment has a convex profile when the anti-paravalvular leakage component is in the expanded configuration.

4. The transcatheter valve prosthesis of claim 1, wherein the annular sealing element is attached to inner surfaces of the plurality of self-expanding segments and is disposed between the outer surface of the stent and the inner surfaces of the plurality of self-expanding segments when the anti-paravalvular leakage component is in the expanded configuration.

5. The transcatheter valve prosthesis of claim 1, wherein the annular sealing element is attached to outer surfaces of the plurality of self-expanding segments.

6. The transcatheter valve prosthesis of claim 1, wherein the plane defined by each self-expanding segment forms an angle between 20 and 80 degrees with respect to its respective tangential plane.

7. A transcatheter valve prosthesis comprising:

a stent having a proximal end, a distal end and a plurality of diamond-shaped openings formed within the stent, each diamond-shaped opening being formed from struts of the stent, the stent having a compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve;

a prosthetic valve component disposed within and secured to the stent; and

an anti-paravalvular leakage component coupled to and encircling an outer surface of the stent, the anti-paravalvular leakage component including a plurality of self-expanding segments and an annular sealing element attached to the plurality of self-expanding segments,

wherein each self-expanding segment is U-shaped and has a first end and a second end that are attached directly to the outer surface of the stent on opposing struts of a respective diamond-shaped opening at first and second attachment points, respectively,

wherein the respective first and second attachment points are located on opposing sides of a respective diamond-shaped opening of the plurality of diamond-shaped openings of the stent, such that the respective first and second attachment points are circumferentially spaced apart on the stent but are not axially spaced apart on the stent in a longitudinal direction of the stent,

wherein the anti-paravalvular leakage component has an expanded configuration in which each self-expanding segment extends radially away from, and is oblique to, the outer surface of the stent, such that a plane defined by each self-expanding segment is non-perpendicular with respect to a tangential plane taken through its respective first and second attachment points on the stent.

8. The transcatheter valve prosthesis of claim 7, wherein each self-expanding segment has a concave profile when the anti-paravalvular leakage component is in the expanded configuration.

9. The transcatheter valve prosthesis of claim 7, wherein the annular sealing element is attached to inner surfaces of the plurality of self-expanding segments and is disposed between the outer surface of the stent and the inner surfaces of the plurality of self-expanding segments when the anti-paravalvular leakage component is in the expanded configuration.

10. The transcatheter valve prosthesis of claim 7, wherein the annular sealing element is attached to outer surfaces of the plurality of self-expanding segments.

11. The transcatheter valve prosthesis of claim 7, wherein the plane defined by each self-expanding segment forms an angle between 20 and 80 degrees with respect to its respective tangential plane.