Low profile transcatheter heart valve

• US 8,454,685 B2
• Filed: 06/23/2011
• Issued: 06/04/2013
• Est. Priority Date: 06/06/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Hariton, Ilia, Benichou, Netanel, Nitzan, Yaacov, Felsen, Bella, Nguyen-Thien-Nhon, Diana, Khanna, Rajesh, Nguyen, Son, Levi, Tamir, Pelled, Itai
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US13/167,549
• Publication Number:
  US 20110319991A1
• Time in Patent Office: 712 Days
• Field of Search: 623 21- 219
• US Class Current: 623/2.17
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/005 using adhesives
• 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: B05B 1/185 characterised by their outlet element; Mounting arrangements therefor
• CPC Class Codes: E03C 1/025 Water supply lines as such, e.g. shower hoses
• CPC Class Codes: E03C 1/066 allowing height adjustment of shower head
• CPC Class Codes: Y10T 29/49863 with prestressing of part

Abstract

An implantable prosthetic valve, according to one embodiment, comprises a frame, a leaflet structure, and a skirt member. The frame can have a plurality of axial struts interconnected by a plurality of circumferential struts. The leaflet structure comprises a plurality of leaflets (e.g., three leaflets arrange to form a tricuspid valve). The leaflet structure has a scalloped lower edge portion secured to the frame. The skirt member can be disposed between the leaflet structure and the frame.

Claims

1. An implantable prosthetic valve, comprising:

a radially collapsible and expandable annular frame, the frame having three commissure attachment posts and three rows of circumferential struts extending between the commissure attachment posts, a first row of circumferential struts defining an inflow end of the frame and second and third rows of circumferential struts spaced apart from the first row adjacent an outflow end of the frame, the first row connected to the second and third rows by a plurality of axial struts, each row of circumferential struts comprising angled struts arranged in a zig-zag pattern and interconnected by a generally U-shaped crown structure for improved collapsibility;

a leaflet structure comprising three leaflets formed of pericardial tissue, each leaflet having an upper edge, a curved lower edge and two side flaps, wherein each side flap is secured to an adjacent side flap of another leaflet to form commissures of the leaflet structure, each commissure being attached to one of the commissure attachment posts;

an annular skirt member positioned between the annular frame and the leaflet structure, the curved lower edge of each leaflet sutured to an inner surface of the skirt member along a scalloped line; and

a pair of reinforcing bars positioned adjacent each commissure attachment post, each reinforcing bar comprising a plurality of holes, wherein each side flap extends around a reinforcing bar and each reinforcing bar is sutured to a commissure attachment post for reinforcing the attachments between the leaflet structure and the commissure attachment posts.

2. The prosthetic valve of claim 1, wherein the commissures of the leaflet structure are attached to the commissure attachment posts with sutures extending through the side flaps, the reinforcing bars and the commissure attachment posts.

3. The prosthetic valve of claim 1, wherein each reinforcing bar is covered by a protective sleeve.

4. The prosthetic valve of claim 1, further comprising an annular elastomeric layer encapsulating at least a portion of the frame.

5. The prosthetic valve of claim 1, wherein the angled struts are connected at angles (A) between about 90 and 110 degrees when the annular frame is in an expanded state.

6. The prosthetic valve of claim 1, wherein the frame comprises a nickel cobalt chromium alloy.

7. The prosthetic valve of claim 6, wherein the nickel cobalt chromium alloy comprises MP35N.

8. The prosthetic valve of claim 1, further comprising reinforcing strips secured to an inner surface of the lower edge portion of a leaflet such that the leaflets are sandwiched between the annular skirt member and the reinforcing strips.

9. The prosthetic valve of claim 1, wherein the struts of the first row are thicker than the struts of the second and third rows.

10. The prosthetic valve of claim 1, wherein the annular frame is plastically-expandable.

11. The prosthetic valve of claim 1, wherein each of the reinforcing bars has four holes which correspond to four holes formed in each of the commissure attachment posts.

12. The prosthetic valve of claim 1, wherein the first and second rows of circumferential struts have parallel zig-zag patterns.

13. The prosthetic valve of claim 12, wherein the zig-zag pattern of the third row of circumferential struts is opposite from the first and second rows.

21. The prosthetic valve of claim 1, wherein the U-shaped crown structure between adjacent ends of two struts comprises a first portion connected to and extending at a non-zero angle from the end of one of the struts, a second portion connected to and extending at a non-zero angle from the adjacent end of the other strut, and a third, intermediate portion extending between and connecting the first and second portions such that a gap is defined between the first and second portions and the adjacent ends of the struts.

14. An implantable prosthetic valve, comprising:

a radially collapsible and expandable annular frame, the frame having three commissure attachment posts and at least three rows of circumferential struts extending between the commissure attachment posts, a first row of circumferential struts defining an inflow end of the frame and second and third rows of circumferential struts spaced apart from the first row adjacent an outflow end of the frame, the first row connected to the second and third rows by a plurality of axial struts;

a leaflet structure comprising three leaflets formed of pericardial tissue, each leaflet having an upper edge, a curved lower edge and two side flaps, wherein each side flap is secured to an adjacent side flap of another leaflet to form commissures of the leaflet structure, each commissure being attached to one of the commissure attachment posts;

an annular skirt member positioned between the annular frame and the leaflet structure, the curved lower edge of each leaflet sutured to an inner surface of the skirt member along a scalloped line; and

a reinforcing strip secured to an inner surface of the leaflet structure adjacent its curved lower edge such that the leaflets are sandwiched between the annular skirt member and the reinforcing strip.

15. The prosthetic valve of claim 14, wherein the reinforcing strip comprises a plurality of reinforcing strips, each of which is secured to an inner surface of a respective leaflet adjacent its lower edge.

16. The prosthetic valve of claim 14, wherein the reinforcing strip and the skirt member are separate pieces of material.

17. The prosthetic valve of claim 16, wherein each of the reinforcing strip and the skirt member is made of synthetic material.

22. The prosthetic valve of claim 14, wherein the skirt member has an upper edge and a lower edge, the upper edge being sutured to each strut of the second row of struts, and the lower edge being sutured to each strut of the first row of struts.

23. The prosthetic valve of claim 22, wherein the first and second row of struts are arranged in a zig-zag pattern and the upper edge of the skirt is shaped to correspond to the zig-zag pattern of the second row of struts.

24. The prosthetic valve of claim 22, wherein each strut of the second row of struts is sutured to the upper edge of the skirt with a suture comprising a plurality of suture loops extending around the strut and through the upper edge of the skirt.

18. An implantable prosthetic valve, comprising:

a radially collapsible and expandable annular frame, the frame having three commissure attachment posts and at least three rows of circumferential struts extending between the commissure attachment posts, a first row of circumferential struts defining an inflow end of the frame and second and third rows of circumferential struts spaced apart from the first row adjacent an outflow end of the frame, the first row connected to the second and third rows by a plurality of axial struts, each row of circumferential struts comprising angled struts arranged in a zig-zag pattern defining a plurality of apexes;

a leaflet structure comprising three leaflets formed of pericardial tissue, each leaflet having an upper edge, a curved lower edge and two side flaps, wherein each side flap is secured to an adjacent side flap of another leaflet to form commissures of the leaflet structure, each commissure being sutured to one of the commissure attachment posts via sutures extending through apertures in the commissure attachment posts, wherein all of the apertures are located along the length of the frame between a first plane that is perpendicular to the length and defined by the apexes of the second row of circumferential struts and a second plane that is perpendicular to the length and defined by the apexes of the third row of circumferential struts; and

an annular skirt member positioned between the annular frame and the leaflet structure, the curved lower edge of each leaflet sutured to an inner surface of the skirt member along a scalloped line.

19. The prosthetic valve of claim 18, further comprising a pair of reinforcing bars positioned adjacent each commissure attachment post, each reinforcing bar comprising a plurality of holes, wherein each side flap extends around a reinforcing bar and each reinforcing bar is sutured to a commissure attachment post for reinforcing the attachments between the leaflet structure and the commissure attachment posts, wherein all of the holes in each reinforcing bar are located between the first and second planes.

20. The prosthetic valve of claim 18, further comprising a reinforcing strip, separate from the annular skirt member, secured to an inner surface of the leaflet structure adjacent its curved lower edge such that the leaflets are sandwiched between the annular skirt member and the reinforcing strip.