Collapsible prosthetic heart valves

• US 9,345,571 B1
• Filed: 11/30/2015
• Issued: 05/24/2016
• Est. Priority Date: 09/26/2007
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., McCarthy, Andrea L., Figueiredo, Rubem L., Schraut, Julia A.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US14/954,367
• Publication Number:
  US 20160135950A1
• Time in Patent Office: 176 Days
• Field of Search: 623 21- 219
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

Prosthetic heart valves, which are collapsible to a relatively small circumferential size for less invasive delivery into a patient and which then re-expand to operating size at an implant site in the patient, include a collapsible/expandable stent-like supporting structure and various components of flexible, sheet-like material that are attached to the supporting structure. For example, these sheet-like other components may include prosthetic valve leaflets, layers of buffering material, cuff material, etc. Improved structures and techniques are provided for securing such other components to the stent-like supporting structure of the valve.

Claims

1. A prosthetic heart valve, comprising:

a stent having an inside, an outside, an inflow end with an inflow edge, an outflow end, a collapsed condition and an expanded condition, the stent extending in a longitudinal direction between the inflow end and the outflow end;

a valve element mounted within the stent; and

a structure having an inside wall on the inside of the stent and an outside wall on the outside of the stent, the structure including a single layer of material extending around the inflow edge from the inside wall to the outside wall, the inside wall having a first length in the longitudinal direction and the outside wall having a second length in the longitudinal direction less than the first length.

2. The prosthetic heart valve as claimed in claim 1, wherein the valve element includes a plurality of leaflets.

3. The prosthetic heart valve as claimed in claim 2, wherein each of the leaflets is attached to the inside wall of the structure.

4. The prosthetic heart valve as claimed in claim 3, wherein the outside wall of the structure is integral with the inside wall of the structure.

5. The prosthetic heart valve as claimed in claim 2, wherein each of the leaflets is integral with a portion of the structure.

6. The prosthetic heart valve as claimed in claim 1, wherein the structure extends around a periphery of the stent and includes an opening at the periphery of the stent facing toward the outflow end of the stent.

7. The prosthetic heart valve as claimed in claim 1, wherein the outside wall of the structure is directly connected to the stent.

8. The prosthetic heart valve as claimed in claim 1, wherein the inside wall of the structure is directly connected to the stent.

9. The prosthetic heart valve as claimed in claim 1, wherein the stent includes a plurality of closed cells formed by a plurality of struts, a group of the struts forming a zig-zag pattern of struts around a periphery of the stent, and the inside wall of the structure having a distal edge that coincides with the zig-zag pattern of struts.

10. The prosthetic heart valve as claimed in claim 1, further comprising a plurality of commissure features, the inside wall of the structure being attached to each of the commissure features.

11. The prosthetic heart valve as claimed in claim 1, further comprising a plurality of commissure features, the inside wall of the structure overlying each of the commissure features.

12. The prosthetic heart valve as claimed in claim 1, wherein the inside wall of the structure and the outside wall of the structure are collectively formed as a single piece of material.

13. The prosthetic heart valve as claimed in claim 1, wherein

the inflow end of the stent is at a proximal end of the prosthetic heart valve and the outflow end of the stent is at a distal end of the prosthetic heart valve,

the stent has an annulus portion with an inlet end and an outlet end, and

the structure has a proximal end and a distal end, the distal end being positioned proximally of the outlet end of the annulus portion.

14. The prosthetic heart valve as claimed in claim 1, wherein

the inflow end of the stent is at a proximal end of the prosthetic heart valve and the outflow end of the stent is at a distal end of the prosthetic heart valve,

the stent includes a first plurality of closed cells at the inflow end of the stent and a second plurality of closed cells at the outflow end of the stent,

the valve element in the expanded condition of the stent extends in the longitudinal direction distally of the first plurality of closed cells,

the second plurality of closed cells in the expanded condition of the stent is positioned at least partially distal to the valve element,

and the structure covers at least a portion of all of the cells in the first plurality of closed cells.

15. The prosthetic heart valve as claimed in claim 1, wherein the structure is formed from material having a first edge and a second edge, the second edge including curved sections alternating with recessed sections.

16. The prosthetic heart valve as claimed in claim 15, wherein the structure is connected to the stent so that the second edge forms a free edge of the outside wall of the structure.

17. A prosthetic heart valve, comprising:

a stent having an inside, an outside, a proximal end at an inflow end with an inflow edge, a distal end at an outflow end, a collapsed condition and an expanded condition, the stent having a length from the inflow end to the outflow end;

a valve element mounted within the stent so as to define a plurality of pockets on the inside of the stent, each of the pockets having an inner pocket wall and an outer pocket wall, the plurality of pockets residing at a predetermined position along the length of the stent; and

a structure extending around a periphery of the stent and having an inside wall on the inside of the stent and an outside wall on the outside of the stent, the inside wall being connected to the stent, the structure extending around the inflow edge from the inside wall to the outside wall and including at least one opening at the periphery of the stent, the opening being located at the predetermined position along the length of the stent and radially outward of at least one of the outer pocket walls, a distal end of the structure being positioned proximally of the distal end of the stent.

18. The prosthetic heart valve as claimed in claim 17, wherein the opening is at least partially on the outside of the stent.

19. The prosthetic heart valve as claimed in claim 17, wherein the inside wall of the structure defines a portion of the pockets.

20. The prosthetic heart valve as claimed in claim 17, wherein the opening faces toward the outflow end of the stent.

21. The prosthetic heart valve as claimed in claim 20, wherein the stent includes a plurality of closed cells formed by a plurality of struts, at least one of the struts passing through the opening.

22. The prosthetic heart valve as claimed in claim 17, wherein the inside wall of the structure defines a portion of the opening.

23. A prosthetic heart valve, comprising:

a stent having an inside, an outside, an inflow end with an inflow edge, an outflow end, a collapsed condition and an expanded condition, the stent having a length from the inflow end to the outflow end;

a valve element mounted within the stent, the valve element including a plurality of pockets disposed on the inside of the stent, each of the pockets having an inner pocket wall and an outer pocket wall; and

a structure extending around a periphery of the stent and having an inside wall on the inside of the stent and an outside wall on the outside of the stent, the inside wall being connected to the stent, the structure extending around the inflow edge from the inside wall to the outside wall and including at least one opening at the periphery of the stent, the opening being located radially outward of at least one of the pockets, the pockets and the opening each having a portion positioned an equal longitudinal distance from the inflow edge of the stent.

24. The prosthetic heart valve as claimed in claim 23, wherein the opening faces toward the outflow end of the stent.

25. The prosthetic heart valve as claimed in claim 24, wherein each of the pockets has an open side facing toward the outflow end of the stent.

26. The prosthetic heart valve as claimed in claim 23, wherein the stent includes a plurality of closed cells formed by a plurality of struts, at least one of the struts passing through the opening.

27. The prosthetic heart valve as claimed in claim 23, wherein the inside wall of the structure defines the outer pocket walls of the pockets.