Anti-paravalvular leakage component for a transcatheter valve prosthesis

• US 9,675,451 B2
• Filed: 04/01/2014
• Issued: 06/13/2017
• 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: Rothstein, Paul, Garde, Kshitija, Racchini, Joel, Sandstrom, Jeffrey
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US14/242,347
• Publication Number:
  US 20140243966A1
• Time in Patent Office: 1,169 Days
• Field of Search: 623 124, 623 218
• 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 tubular stent having a proximal end, a distal end and a longitudinal axis, the tubular 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 tubular stent; and

an anti-paravalvular leakage component coupled to and encircling an outer surface of the tubular 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, a first end and a second end of each self-expanding segment being attached directly to the outer surface of the tubular stent at first and second attachment points, respectively, the first and second attachment points being at axially spaced apart locations on the longitudinal axis of the tubular stent, wherein the anti-paravalvular leakage component has an expanded configuration in which the plurality of self-expanding segments curve radially away from the outer surface of the tubular stent and are oblique to the outer surface of the tubular stent such that a plane defined by each self-expanding segment is non-perpendicular with respect to a tangential plane of the tubular stent taken through the first and second attachments points.

2. 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 positioned between the outer surface of the tubular stent and the inner surfaces of the plurality of self-expanding segments when the anti-paravalvular leakage component is in the expanded configuration.

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

4. The transcatheter valve prosthesis of claim 1, wherein the first and second ends of each self-expanding segment are attached to opposing peaks of a diamond-shaped opening formed within the tubular stent.

5. The transcatheter valve prosthesis of claim 1, wherein the first and second ends of each self-expanding segment are attached to consecutive sides of a diamond-shaped opening formed within the tubular stent.

6. The transcatheter valve prosthesis of claim 1, wherein each self-expanding segment is U-shaped.

7. The transcatheter valve prosthesis of claim 6, wherein the first and second attachment points of each self-expanding segment are positioned on opposing sides of a diamond-shaped opening formed within the tubular stent.

8. The transcatheter valve prosthesis of claim 1, wherein the first and second attachment points of each self-expanding segment are positioned on adjacent peaks or sides of two adjacent diamond-shaped openings formed within the tubular stent.

9. The transcatheter valve prosthesis of claim 1, wherein at least one self-expanding segment of the plurality of self-expanding segments includes only a middle portion that curves radially away from the outer surface of the tubular stent when the anti-paravalvular leakage component is in the expanded configuration.

10. The transcatheter valve prosthesis of claim 1, wherein at least one self-expanding segment of the plurality of self-expanding segments is sinusoidal along the length thereof.

11. The transcatheter valve prosthesis of claim 1, wherein at least one self-expanding segment of the plurality of self-expanding segments includes a middle portion having additional bump along the length thereof.

12. The transcatheter valve prosthesis of claim 1, wherein the plurality of self-expanding segments are spaced apart in approximately equal intervals around the tubular stent.

13. The transcatheter valve prosthesis of claim 1, wherein the flexibility of the anti-paravalvular leakage component varies around the circumference of the tubular stent.

14. The transcatheter valve prosthesis of claim 1, wherein the tubular stent includes a plurality of diamond-shaped openings formed within the tubular stent and two self-expanding segments of the plurality of self-expanding segments of the anti-paravalvular leakage component are attached to the tubular stent such that the two self-expanding segments extend over one diamond-shaped opening formed within the tubular stent.

15. 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 the tangential plane of the outer surface of the tubular stent.

16. A transcatheter valve prosthesis comprising:

a tubular 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 tubular stent; and

an anti-paravalvular leakage component coupled to and encircling an outer surface of the tubular 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, a first end and a second end of each self-expanding segment being attached to the outer surface of the tubular stent at first and second attachment points, respectively, wherein the anti-paravalvular leakage component has an expanded configuration in which the plurality of self-expanding segments curve radially away from the outer surface of the tubular stent, and

wherein at least a first self-expanding segment of the plurality of self-expanding segments at a first location on the tubular stent has a first configuration when the anti-paravalvular leakage component is in the expanded configuration and at least a second self-expanding segment of the plurality of self-expanding segments at a second location on the tubular stent has a second configuration when the anti-paravalvular leakage component is in the expanded configuration, the first and second locations being circumferentially spaced apart and the first configuration and the second configuration having different flexibilities, such that the flexibility of the anti-paravalvular leakage component at the plurality of self-expanding segments varies around the circumference of the tubular stent when the anti-paravalvular leakage component is in the expanded configuration.

17. The transcatheter valve prosthesis of claim 16, wherein at least one self-expanding segment of the plurality of self-expanding segments are oblique to the outer surface of the tubular stent such that a plane defined by each self-expanding segment is non-perpendicular with respect to a tangential plane of the tubular stent taken through the first and second attachments points.

18. The transcatheter valve prosthesis of claim 17, wherein the plane defined by each self-expanding segment forms an angle between 20 and 80 degrees with respect to the tangential plane of the outer surface of the tubular stent.

19. The transcatheter valve prosthesis of claim 16, wherein the first self-expanding segment is more flexible than the second self-expanding segment and the first self-expanding segment is longitudinally aligned with native valve commissures in situ.

20. A transcatheter valve prosthesis comprising:

a tubular 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 tubular stent; and

an anti-paravalvular leakage component coupled to and encircling an outer surface of the tubular 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, a first end and a second end of each self-expanding segment being attached to the outer surface of the tubular stent at first and second attachment points, respectively, wherein the anti-paravalvular leakage component has an expanded configuration in which the plurality of self-expanding segments curve radially away from the outer surface of the tubular stent, and

wherein the plurality of self-expanding segments are spaced apart in non-equal intervals around the tubular stent such that the frequency of the self-expanding segments varies around the circumference of the tubular stent, the frequency of the self-expanding segments being the highest at portions of the tubular stent that are longitudinally aligned with native valve commissures in situ.