Collapsible and re-expandable prosthetic heart valve cuff designs and complementary technological applications

• US 9,675,449 B2
• Filed: 08/06/2014
• Issued: 06/13/2017
• Est. Priority Date: 07/15/2008
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., Schraut, Julia Ann, Ashworth, Paul Edward
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US14/452,904
• Publication Number:
  US 20140350663A1
• Time in Patent Office: 1,042 Days
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.

Claims

1. A cuff adapted for use in a prosthetic heart valve having a stent body, the cuff comprising an inner wall and an outer wall extending in a distal direction, the outer wall being disposed outward of the inner wall so that the inner and outer walls cooperatively define at least one pocket, the outer wall having an edge facing in the distal direction, the edge of the outer wall being attached to the inner wall at a plurality of first locations but detached from the inner wall at at least one second location disposed between the first locations so that the inner wall and the edge of the outer wall are adapted to cooperatively define at least one opening facing distally for entry of blood into the pocket at the at least one second location, the cuff being sized, shaped and adapted for positioning on the stent body for placement within the native valve annulus to impede perivalvular leakage.

2. The cuff according to claim 1, wherein the at least one pocket is constructed and arranged so that flow of blood into at least one pocket will bias the outer wall outwardly into engagement within the native valve annulus.

3. The cuff according to claim 1, wherein the cuff includes a plurality of pockets.

4. The cuff according to claim 3, wherein the plurality of pockets are sized and shaped to minimize perivalvular leakage.

5. The cuff according to claim 1 wherein the edge of the outer wall is detached from the inner wall at a plurality of second locations so that the inner wall and the edge of the outer wall are adapted to cooperatively define a plurality of openings.

6. The cuff according to claim 5 wherein all of the second locations are arranged at the same position in the distal direction.

7. A cuff adapted for use in a prosthetic heart valve having a stent body, the cuff comprising an inner wall and an outer wall extending in an distal direction from a proximal end of the cuff, the outer wall being disposed outward of the inner wall so that the inner and outer walls cooperatively define at least one pocket and are adapted to define at least one opening, the inner wall extending distally beyond the outer wall, the cuff being sized, shaped and adapted for positioning on the stent body for placement within the native valve annulus to impede perivalvular leakage, the cuff being constructed and arranged so that flow of blood into pocket through the opening will bias the outer wall outwardly into engagement within the native valve annulus.

8. The cuff according to claim 7 wherein the at least one opening includes a plurality of openings facing in the distal direction.

9. The cuff according to claim 8 wherein the outer wall has a distal edge and wherein the inner wall and the distal edge of the outer wall are adapted to cooperatively define the openings.