Anti-Paravalvular Leakage Components for a Transcatheter Valve Prosthesis

• US 20140194981A1
• Filed: 01/10/2013
• Published: 07/10/2014
• Est. Priority Date: 01/10/2013
• Status: Active Grant

• Current Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Inventors: Menk, Ana, Mosher, Scott
• Granted Patent: US 9,132,007 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

A valve prosthesis includes one or more anti-paravalvular leakage components coupled to a stent. The anti-paravalvular leakage component may encircle the stent and include a radially expandable control ring coupled to an unattached edge of a flexible skirt which extends the unattached skirt edge outwardly away from the stent and against the native heart valve to form an open-ended annular pocket around the stent. The anti-paravalvular leakage component may encircle the perimeter of the stent and include a flexible skirt having opposing edges coupled to the stent to form one or more enclosed compartments around the stent. Each compartment includes a one-way valve which allows for blood flow into the compartment but prevents blood flow out of the compartment. The anti-paravalvular leakage component may be at least one flap that is coupled to an inner surface of the stent and formed of a flexible material moveable by blood flow.

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

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

a skirt formed of a flexible material and having a first edge coupled to the tubular stent and an opposing second edge not coupled to the tubular stent, and

a radially expandable control ring coupled to the second edge of the skirt, wherein the control ring in an expanded diameter extends the second edge of the skirt outwardly away from the outer surface of the tubular stent and against the native heart valve to form an open-ended annular pocket between the skirt and the outer surface of the tubular stent.

2. The transcatheter valve prosthesis of claim 1, wherein the skirt is formed from a woven fabric or pericardial tissue.

3. The transcatheter valve prosthesis of claim 1, wherein the skirt includes an integral folded portion that forms two layers which extend over at least a portion of the outer surface of the stent.

4. The transcatheter valve prosthesis of claim 1, wherein the control ring is formed from a self-expanding material and has a first diameter for delivery within a vasculature and a second expanded diameter greater than then first diameter for deployment within the native heart valve.

5. The transcatheter valve prosthesis of claim 1, wherein an elongated strand forms the control ring and a tether extending from the control ring to a position outside of the body, the strand having an end slidingly positioned over a body thereof via a series of interlocking teeth to form the control ring with an adjustable diameter.

6. The transcatheter valve prosthesis of claim 5, wherein the body of the strand includes a weakened area that breaks apart when force is applied thereto.

7. The transcatheter valve prosthesis of claim 5, wherein the body of the strand includes a plurality of weakened areas that break apart when force is applied thereto, the weakened areas being positioned between adjacent pairs of interlocking teeth.

8. The transcatheter valve prosthesis of claim 1, further comprising a second anti-paravalvular leakage component coupled to an inner surface of the tubular stent, the second anti-paravalvular leakage component including at least one flap formed of a flexible material such that it is moveable by blood flow and having a first end coupled to the tubular stent adjacent to prosthetic valve component and an opposing second end not coupled to the tubular stent.

9. The transcatheter valve prosthesis of claim 8, wherein the at least one flap is annular and includes a plurality of radially-extending slits extending from the second end thereof.

10. The transcatheter valve prosthesis of claim 8, wherein the second anti-paravalvular leakage component includes a plurality of adjacent flaps positioned around the inner surface of the tubular stent.

12. The transcatheter valve prosthesis of claim 1, wherein an elongated strand forms the control ring and a tether extending from the control ring to a position outside of the body, the strand having an end slidingly positioned over a body thereof via a series of interlocking teeth to form the control ring with an adjustable diameter.

13. The transcatheter valve prosthesis of claim 12, wherein the body of the strand includes a weakened area that breaks apart when force is applied thereto.

14. The transcatheter valve prosthesis of claim 12, wherein the body of the strand includes a plurality of weakened areas that break apart when force is applied thereto, the weakened areas being positioned between adjacent pairs of interlocking teeth.

11. 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 skirt formed of a flexible material and having a first edge coupled to the tubular stent and an opposing second edge not coupled to the tubular stent, and

a control ring having an adjustable diameter coupled to the second edge of the skirt, wherein the diameter of the control ring may be varied in situ to selectively extend the second edge of the skirt outwardly away from the outer surface of the tubular stent and against the native heart valve.

15-20. -20. (canceled)