Anti-paravalvular leakage components for a transcatheter valve prosthesis

• US 9,132,007 B2
• Filed: 01/10/2013
• Issued: 09/15/2015
• 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
• Primary Examiner(s): Iwamaye, Andrew
• Assistant Examiner(s): LOPEZ, LESLIE ANN
• Application Number:
  US13/738,376
• Publication Number:
  US 20140194981A1
• Time in Patent Office: 978 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.1, 623 212- 219, 623 236- 238
• US Class Current: 1/1
• 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 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 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

an elongated strand having a first end, a second end, and a body extending between the first and second ends, the second end of the elongated strand being slidingly positioned over the body of the elongated strand such that the body of the elongated strand includes a radially expandable control ring that is coupled to the second edge of the skirt and a tether extending from the radially expandable control ring, wherein the first end of the elongated strand is configured to be pulled to move the second end of the elongated strand along the body of the elongated strand in order to selectively contract a diameter of the radially expandable control ring in situ and wherein the first end of the elongated strand is also configured to be pushed to move the second end of the elongated strand along the body of the elongated strand in order to selectively expand a diameter of the radially expandable control ring in situ.

2. The transcatheter valve prosthesis of claim 1, wherein the second end of the elongated strand is slidingly positioned over the body of the elongated strand via a series of interlocking teeth.

3. The transcatheter valve prosthesis of claim 1, wherein the body of the elongated strand includes at least one weakened area that breaks apart when force is applied thereto such that at least a portion of the tether is configured to be disconnected from the radially expandable control ring, the at least one weakened area being positioned along the tether.

4. The transcatheter valve prosthesis of claim 3, wherein the body of the elongated 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 in a series of interlocking teeth.

5. The transcatheter valve prosthesis of claim 3, wherein the at least one weakened area is a short segment of the elongated strand having a smaller diameter than the remaining length of the elongated strand.

6. The transcatheter valve prosthesis of claim 3, wherein the at least one weakened area includes a plurality of perforations.