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

• US 10,314,694 B2
• Filed: 03/24/2017
• Issued: 06/11/2019
• 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., Ashworth, Paul E., Schraut, Julia
• Primary Examiner(s): Prone, Christopher D.
• Assistant Examiner(s): Shipmon, Tiffany P
• Application Number:
  US15/468,466
• Publication Number:
  US 20170196687A1
• Time in Patent Office: 809 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 prosthetic heart valve, comprising:

(a) a stent that is radially collapsible to a collapsed condition and radially expandable from the collapsed condition to an expanded condition, the stent extending in a longitudinal direction from an inflow end to an outflow end;

(b) a valve element mounted within the stent, the valve element being collapsible and expandable along with the stent, the valve element being arranged to allow flow of blood from the inflow end toward the outflow end when the stent is in the expanded condition; and

(c) a cuff including a first wall and a second wall, the second wall being positioned radially outward of the first wall and radially outward of the stent, the second wall being spaced a first distance from the first wall at a plurality of first locations, the first locations being spaced apart from one another around a periphery of the stent, the second wall being spaced a second distance from the first wall at a plurality of second locations, each of the second locations being positioned between adjacent ones of the first locations when the stent is in the expanded condition so that the first and second walls cooperatively define a plurality of openings at the second locations, each said opening facing toward the outflow end and the second distance being greater than the first distance.

2. The prosthetic heart valve of claim 1, wherein the second wall is attached to the first wall at each of the first locations.

3. The prosthetic heart valve of claim 1, wherein a multiplicity of the second locations are disposed at a same distance from the inflow end in the longitudinal direction.

4. The prosthetic heart valve of claim 3, wherein the second locations are disposed at uniform intervals around the periphery of the stent.

5. The prosthetic heart valve of claim 1, wherein the stent is a unitary balloon-expandable metallic stent.

6. The prosthetic heart valve of claim 5, wherein the metallic stent is non-woven.

7. The prosthetic heart valve of claim 1, wherein the stent includes a plurality of struts forming rows of cells, a row of cells adjacent the outflow end forming apices at an outflow edge of the stent.

8. The prosthetic heart valve of claim 1, wherein an outflow edge of the stent is disposed closer to an edge of the first wall than to the plurality of first locations.

9. The prosthetic heart valve of claim 1, wherein the stent is cylindrical when in the collapsed condition.

10. A prosthetic heart valve, comprising:

(a) a stent that is radially collapsible to a collapsed condition and radially expandable from the collapsed condition to an expanded condition, the stent extending in a longitudinal direction from an inflow end to an outflow end;

(b) a valve element mounted within the stent, the valve element being collapsible and expandable along with the stent, the valve element being arranged to allow flow of blood from the inflow end toward the outflow end in the longitudinal direction when the stent is in the expanded condition; and

(c) a cuff including a first wall and a second wall radially outward of the first wall and radially outward of the stent, the second wall being attached to the first wall at a plurality of first locations spaced from the inflow end of the stent, the first locations being spaced apart from one another around a periphery of the stent, the second wall being detached from the first wall at a plurality of second locations, each of the second locations being disposed between adjacent ones of the first locations when the stent is in the expanded condition, the cuff defining openings at the second locations for entry of blood between the first and second walls.

11. The prosthetic heart valve of claim 10, wherein a multiplicity of the second locations are disposed at a same distance from the inflow end in the longitudinal direction.

12. The prosthetic heart valve of claim 10, wherein the second locations are disposed at uniform intervals around the periphery of the stent.

13. The prosthetic heart valve of claim 10, wherein the stent is a unitary balloon-expandable metallic stent.

14. The prosthetic heart valve of claim 13, wherein the metallic stent is non-woven.

15. The prosthetic heart valve of claim 10, wherein the stent includes a plurality of struts forming rows of cells, a row of cells adjacent the outflow end forming apices at an outflow edge of the stent.

16. The prosthetic heart valve of claim 10, wherein an outflow edge of the stent is disposed closer to an edge of the first wall than to the plurality of first locations.

17. The prosthetic heart valve of claim 10, wherein the stent is cylindrical when in the collapsed condition.