Anti-paravalvular leakage component for a transcatheter valve prosthesis

• US 8,986,375 B2
• Filed: 03/12/2013
• Issued: 03/24/2015
• Est. Priority Date: 03/12/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Garde, Kshitija, Haarstad, Philip, Kovalsky, Igor, Nash, Stephen, Pellegrini, Gianfranco, Rinne, Finn, Rust, Matthew, Sandstrom, Jeffrey, Savage, Padraig, Steinberg, William
• Primary Examiner(s): Shay, Randy
• Application Number:
  US13/795,066
• Publication Number:
  US 20140277419A1
• Time in Patent Office: 742 Days
• Field of Search: 623/1.18, 623/1.31, 623/1.32, 623/2.17, 623/2.18, 623/2.38
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• 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 stent which includes a plurality of self-expanding struts and an annular sealing membrane. Each strut has a first end coupled to a distal end of the stent and a second end not coupled to the stent. Each anti-paravalvular leakage component is moveable between a compressed configuration and a deployed configuration. In the compressed configuration, each strut extends distally away from the distal end of the stent. In the deployed configuration, each strut extends proximally away from the distal end of the stent. In an embodiment hereof, the deployed strut has a C-shape and is twisted such that the C-shape lies in a plane substantially along or tangential with the outer surface of the stent. In another embodiment hereof, the deployed strut is rolled-up and extends radially away from the outer surface of the stent.

Claims

1. 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 stent; and

a plurality of self-expanding struts, each strut having a first end coupled to a distal end of the tubular stent and a free end not coupled to the tubular stent, wherein each strut is moveable between a compressed configuration in which the strut extends distally away from the distal end of the stent and a deployed configuration in which the strut has a C-shape that extends proximally away from the distal end of the stent and is twisted such that the C-shape is oriented substantially flush with an outer surface of the stent.

2. The transcatheter valve prosthesis of claim 1, wherein each strut has a partially deployed configuration when transforming between the compressed configuration and the deployed configuration in which the strut has a C-shape that extends radially away from the outer surface of the tubular stent.

3. The transcatheter valve prosthesis of claim 2, wherein the strut is oriented within a plane taken through a longitudinal axis of the tubular stent when in the partially deployed configuration.

4. The transcatheter valve prosthesis of claim 1, wherein each strut has a partially deployed configuration when transforming between the compressed configuration and the deployed configuration in which the strut has a C-shape that extends circumferentially around at least a portion of the tubular stent.

5. The transcatheter valve prosthesis of claim 1, wherein each strut extends generally parallel with a longitudinal axis of the tubular stent when in the compressed configuration.

6. The transcatheter valve prosthesis of claim 1, further comprising:

a sealing membrane coupled to the plurality of self-expanding struts such that the membrane encircles the outer surface of the tubular stent when in the deployed configuration.

7. The transcatheter valve prosthesis of claim 6, wherein a diameter of the sealing membrane is greater than an expanded outer diameter of the tubular stent such that sealing material of the membrane between the struts billows.

8. The transcatheter valve prosthesis of claim 6, wherein the sealing membrane includes a first layer coupled to an inner surface of the struts and a second layer coupled to an outer surface of the struts, thereby sandwiching the struts between the first and the second layer of sealing membrane.

9. The transcatheter valve prosthesis of claim 1, wherein the struts are spaced apart in approximately equal intervals around the tubular stent.

10. 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 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 struts and an annular sealing membrane coupled to the struts, each strut having a first end coupled to a distal end of the tubular stent and a free end not coupled to the tubular stent, wherein the anti-paravalvular leakage component is moveable between a compressed configuration in which each strut extends distally away from the distal end of the stent and a deployed configuration in which each strut has a C-shape that extends proximally away from the distal end of the stent and is twisted such that the C-shape lies in a plane tangential with an outer surface of the stent or a plane parallel to the plane tangential with the outer surface of the stent.

11. The transcatheter valve prosthesis of claim 10, wherein the anti-paravalvular leakage component has a partially deployed configuration when transforming between the compressed configuration and the deployed configuration in which each strut has a C-shape that extends radially away from the outer surface of the tubular stent and is oriented within a plane taken through a longitudinal axis of the tubular stent.

12. The transcatheter valve prosthesis of claim 10, wherein the anti-paravalvular leakage component has a partially deployed configuration when transforming between the compressed configuration and the deployed configuration in which the strut has a C-shape that extends circumferentially around at least a portion of the tubular stent.

13. The transcatheter valve prosthesis of claim 10, wherein each strut extends generally parallel with a longitudinal axis of the tubular stent when the anti-paravalvular leakage component is in the compressed configuration.

14. The transcatheter valve prosthesis of claim 10, wherein a diameter of the sealing membrane is greater than an expanded outer diameter of the tubular stent such that sealing material of the membrane between the struts billows.

15. The transcatheter valve prosthesis of claim 10, wherein the sealing membrane includes a first layer coupled to an inner surface of the struts and a second layer coupled to an outer surface of the struts, thereby sandwiching the struts between the first and the second layer of sealing membrane.