Anti-Paravalvular Leakage Component for a Transcatheter Valve Prosthesis

• US 20140222144A1
• Filed: 02/01/2013
• Published: 08/07/2014
• 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: Soundararajan, Gopikrishnan, Dang, Kenny, Rangwala, Hussain, Torrianni, Mark, Richardson, Eric, Garde, Kshitija, Eberhardt, Carol
• Granted Patent: US 10,413,401 B2
• Time in Patent Office: Days
• US Class Current: 623/2.38
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• 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.

Claims

1. A transcatheter valve prosthesis comprising:

a tubular stent having a radially compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve, the tubular 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

an anti-paravalvular leakage component coupled to and circumferentially surrounding an outer surface of the tubular stent, the anti-paravalvular leakage component including

a radially-compressible annular scaffold and

a membrane of impermeable material extending over an outer surface of the annular scaffold,

wherein the annular scaffold is a sinusoidal patterned ring of self-expanding material that defines a plurality of peaks, a plurality of valleys, and a plurality of segments with each segment of the plurality of segments being formed to extend between a respective peak and valley of the pluralities of peaks and valleys, the anti-paravalvular leakage component having an expanded configuration in which the segments of the annular scaffold bow and curve radially away from the outer surface of the tubular stent.

2. The transcatheter valve prosthesis of claim 1, wherein the impermeable material is a knit or woven polyester and is coupled to the annular scaffold.

3. The transcatheter valve prosthesis of claim 1, wherein one of the peaks and valleys of the annular scaffold is coupled to the outer surface of the tubular stent and the other of the peaks and valleys of the annular scaffold is not coupled to the outer surface of the tubular stent.

4. The transcatheter valve prosthesis of claim 1, wherein the annular scaffold is formed from a single, continuous wire that has a different cross-section and/or size from the struts of the tubular stent.

5. The transcatheter valve prosthesis of claim 4, wherein the wire that forms the annular scaffold is thinner than the struts of the tubular stent.

6. The transcatheter valve prosthesis of claim 5, wherein the wire that forms the annular scaffold has a circular cross-section and the struts of the tubular stent are non-circular.

7. The transcatheter valve prosthesis of claim 1, wherein the peaks and valleys of the annular scaffold curve radially inward when the anti-paravalvular leakage component is in the expanded configuration.

8. The transcatheter valve prosthesis of claim 1, wherein the valleys of the annular scaffold curve radially inward and the peaks of the annular scaffold curve radially outward when the anti-paravalvular leakage component is in the expanded configuration.

9. The transcatheter valve prosthesis of claim 8, further comprising:

a second anti-paravalvular leakage component coupled to and encircling an outer surface of the tubular stent, the second anti-paravalvular leakage component including a second radially-compressible annular scaffold and a second membrane of impermeable material extending over an outer surface of the second annular scaffold, wherein the second annular scaffold is a sinusoidal patterned ring of self-expanding material that defines a plurality of peaks, a plurality of valleys, and a plurality of segments with each segment of the plurality of segments being formed to extend between a respective peak and valley of the pluralities of peaks and valleys, the second anti-paravalvular leakage component having an expanded configuration in which the segments of the second annular scaffold bow and curve radially away from the outer surface of the tubular stent and the peaks and valleys of the second annular scaffold curve radially inward.

10. The transcatheter valve prosthesis of claim 1, wherein graft material is coupled to at least a portion of the tubular stent.

11. A transcatheter valve prosthesis comprising:

a tubular stent having a radially compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve, the tubular stent including a support frame of struts and openings defined between the struts;

graft material coupled to at least a portion of the tubular stent;

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

an anti-paravalvular leakage component coupled to and circumferentially surrounding an outer surface of the tubular stent, the anti-paravalvular leakage component including

a radially-compressible annular scaffold and

a membrane of impermeable material extending over an outer surface of the annular scaffold,

wherein the annular scaffold is a sinusoidal patterned ring of self-expanding material that defines a plurality of peaks, a plurality of valleys, and a plurality of segments with each segment of the plurality of segments being formed to extend between a respective peak and valley of the pluralities of peaks and valleys, the anti-paravalvular leakage component having an expanded configuration in which the segments of the annular scaffold bow and curve radially away from the outer surface of the tubular stent, the valleys of the annular scaffold curve radially inward and are coupled to the outer surface of the tubular stent, and the peaks of the annular scaffold are not coupled to the outer surface of the tubular stent and curve radially inward towards or radially outward away from the outer surface of the tubular stent.

12-20. -20. (canceled)

21. A transcatheter valve prosthesis comprising:

a tubular stent having a radially compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve, the tubular 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

an anti-paravalvular leakage component coupled to and circumferentially surrounding an outer surface of the tubular stent, the anti-paravalvular leakage component including a radially-compressible annular scaffold and a membrane of impermeable material extending over an outer surface of the annular scaffold, the annular scaffold being a sinusoidal patterned ring of self-expanding material that defines a plurality of peaks, a plurality of valleys, and a plurality of segments with each segment of the plurality of segments being formed to extend between a respective peak and valley of the pluralities of peaks and valleys, wherein one of the peaks and valleys of the annular scaffold is coupled to the outer surface of the tubular stent and the other of the peaks and valleys of the annular scaffold is not coupled to the outer surface of the tubular stent such that one end of the annular scaffold is constrained and the opposing end of the annular scaffold is unconstrained, and

wherein the anti-paravalvular leakage component has an expanded configuration in which the segments of the annular scaffold bow and curve radially away from the outer surface of the tubular stent and a radially compressed delivery configuration in which the unconstrained end of the annular scaffold slides along the outer surface of the tubular stent to radially compress the segments of the annular scaffold.

22. The transcatheter valve prosthesis of claim 21, wherein the impermeable material is a knit or woven polyester and is coupled to the annular scaffold.

23. The transcatheter valve prosthesis of claim 21, wherein the annular scaffold is formed from a single, continuous wire that has a different cross-section and/or size from the struts of the tubular stent.

24. The transcatheter valve prosthesis of claim 23, wherein the wire that forms the annular scaffold is thinner than the struts of the tubular stent.

25. The transcatheter valve prosthesis of claim 24, wherein the wire that forms the annular scaffold has a circular cross-section and the struts of the tubular stent are non-circular.

26. The transcatheter valve prosthesis of claim 21, wherein the peaks and valleys of the annular scaffold curve radially inward when the anti-paravalvular leakage component is in the expanded configuration.

27. The transcatheter valve prosthesis of claim 21, wherein the valleys of the annular scaffold curve radially inward and the peaks of the annular scaffold curve radially outward when the anti-paravalvular leakage component is in the expanded configuration.

28. The transcatheter valve prosthesis of claim 27, further comprising:

a second anti-paravalvular leakage component coupled to and encircling an outer surface of the tubular stent, the second anti-paravalvular leakage component including a second radially-compressible annular scaffold and a second membrane of impermeable material extending over an outer surface of the second annular scaffold, wherein the second annular scaffold is a sinusoidal patterned ring of self-expanding material that defines a plurality of peaks, a plurality of valleys, and a plurality of segments with each segment of the plurality of segments being formed to extend between a respective peak and valley of the pluralities of peaks and valleys, the second anti-paravalvular leakage component having an expanded configuration in which the segments of the second annular scaffold bow and curve radially away from the outer surface of the tubular stent and the peaks and valleys of the second annular scaffold curve radially inward.

29. The transcatheter valve prosthesis of claim 21, wherein graft material is coupled to at least a portion of the tubular stent.