Anti-paravalvular leakage component for a transcatheter valve prosthesis

Patent metadata

Field	Value
Publication number	US-12594158-B2
Application number	US-202117210636-A
Country	US
Kind code	B2
Filing date	Mar 24, 2021
Priority date	Feb 1, 2013
Publication date	Apr 7, 2026
Grant date	Apr 7, 2026

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.

First claim

What is claimed is:

1 . A transcatheter valve prosthesis comprising:
a stent having a radially compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve, the stent including a support frame of struts and openings defined between the struts; a prosthetic valve component disposed within and secured to the stent; and a continuous outer annular component circumferentially surrounding an outer surface of the stent, the outer annular component including a plurality of self-expanding segments and an annular sealing element, the self-expanding segments coupled to and extending from the stent, the annular sealing element coupled to and covering an outer surface or an inner surface of each of the self-expanding segments, the outer annular component having an expanded configuration in which the self-expanding segments curve and extend radially away from the outer surface of the stent, wherein each self-expanding segment extends in a longitudinal direction of the stent and has a first end and a second end which are longitudinally spaced apart relative to the outer surface of the stent when the outer annular component is in the expanded configuration.

2 . The transcatheter valve prosthesis of claim 1 , wherein the self-expanding segments bow and the first and second ends of each self-expanding segment curves radially inward toward to outer surface of the stent.

3 . The transcatheter valve prosthesis of claim 2 , wherein the outer annular component includes a sinusoidal patterned ring of self-expanding material that defines a plurality of peaks and a plurality of valleys, and wherein each self-expanding segment is formed to extend between a respective peak and valley of the pluralities of peaks and valleys.

4 . The transcatheter valve prosthesis of claim 3 , wherein the plurality of peaks is attached to the outer surface of the stent and the plurality of valleys is not attached to the outer surface of the stent.

5 . The transcatheter valve prosthesis of claim 4 , wherein the outer annular component has a delivery configuration and wherein the plurality of valleys are configured to slide along the outer surface of the stent when transitioning between the delivery and expanded configurations of the outer annular component.

6 . The transcatheter valve prosthesis of claim 1 , wherein the first end of each self-expanding segment is attached to the outer surface of the stent.

7 . The transcatheter valve prosthesis of claim 6 , wherein the second end of each self-expanding segment is attached to the outer surface of the stent.

8 . The transcatheter valve prosthesis of claim 7 , wherein the stent includes a plurality of diamond-shaped openings and each self-expanding segment extends over a diamond-shaped opening of the plurality of diamond-shaped openings.

9 . The transcatheter valve prosthesis of claim 1 , wherein the annular sealing element includes a knit or woven polyester.

10 . The transcatheter valve prosthesis of claim 1 , wherein the annular sealing element is formed from a swellable material that collapses easily and expands to a larger volume after implantation.

11 . The transcatheter valve prosthesis of claim 1 , wherein the annular sealing element is formed from a compressible foam.

12 . The transcatheter valve prosthesis of claim 1 , wherein each self-expanding segment has a different cross-section and/or size from the struts of the stent.

13 . The transcatheter valve prosthesis of claim 12 , wherein each self-expanding segment is thinner than the struts of the stent.

14 . The transcatheter valve prosthesis of claim 12 , wherein each self-expanding segment has a circular cross-section and the struts of the stent have a non-circular cross-section.

15 . The transcatheter valve prosthesis of claim 1 , wherein each self-expanding segment has a concave profile when the outer annular component is in the expanded configuration.

16 . The transcatheter valve prosthesis of claim 1 , wherein each self-expanding segment has a convex profile when the outer annular component is in the expanded configuration.

17 . 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 outer annular component is in the expanded configuration.

Assignees

• Medtronic Cv Luxembourg S A R L

Inventors

• Eberhardt Carol
• Soundararajan Gopikrishnan
• Dang Kenny
• Rangwala Hussain
• Torrianni Mark
• Richardson Eric
• Garde Kshitija

Classifications

• A61F2250/0069

  Sealing means · CPC title

• A61F2230/008

  paraboloidal · CPC title

• A61F2230/0013

  Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped · CPC title

• A61F2220/005

  using adhesives · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title