LOW PROFILE TRANSCATHETER HEART VALVE

• US 20100036484A1
• Filed: 06/08/2009
• Published: 02/11/2010
• Est. Priority Date: 06/06/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen-Thien-Nhoh, Diana, Benichou, Netanel, Nguyen, Son V., Khanna, Rajesh, Felsen, Bella, Nitzan, Yaacov, Levi, Tamir, Pelled, Itai, Hariton, Ilia
• Granted Patent: US 7,993,394 B2
• Time in Patent Office: Days
• US Class Current: 623/2.180
• 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 a plurality of angularly spaced commissure attachment posts;

an annular skirt member positioned inside of and secured to the frame; and

a leaflet structure comprising a plurality of leaflets, the leaflet structure having a scalloped lower edge portion secured to an inner surface of the skirt member, each leaflet having an upper edge, a curved lower edge and two side flaps extending between respective ends of the upper edge and the lower edge, 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; and

a reinforcing bar positioned against each side flap for reinforcing the attachments between the commissures and the commissure attachment posts.

2. The prosthetic valve of claim 1, wherein the commissures 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, further comprising an elastomeric sleeve disposed on the outside of the frame.

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

5. The valve of claim 1, wherein the frame comprises a plurality of axial struts and a plurality of rows of circumferential struts extending between and interconnecting the axial struts.

6. The valve of claim 5, wherein at least one row of circumferential struts includes pairs of circumferential struts extending between two axial struts, the struts of each pair having adjacent ends interconnected by a generally U-shaped crown portion defining a gap between the adjacent ends.

7. The valve of claim 6, wherein an angle between each pair of struts is between about 90 and 110 degrees.

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

9. The valve of claim 4, wherein the nickel cobalt chromium alloy comprises MP35N.

10. The valve of claim 1, wherein the leaflets are connected to each other at adjacent sides to form commissures of the leaflet structure, each leaflet having a curved lower edge portion comprising a scallop extending between two commissures, the curved lower edge portions of the leaflets collectively defining the scalloped lower edge portion of the leaflet structure.

11. The valve of claim 10, further comprising an annular skirt secured to the inside of the frame.

12. The valve of claim 11, wherein the lower edge portion of the leaflet structure is secured to the inside of the skirt and the commissures are secured to respective axial struts of the frame.

13. The valve of claim 12, further comprising a reinforcing strip, separate from the skirt, that is secured to an inner surface of the lower edge portion of the leaflet structure.

14. The valve of claim 5, wherein the rows of circumferential struts includes at least a first row of circumferential struts adjacent the inflow end of the valve and a second row of circumferential struts adjacent the outflow end of the valve, wherein the struts of the first row are thicker than the struts of the second row.

15. An implantable prosthetic valve comprising:

a radially collapsible and expandable annular frame, the frame comprising a plurality of interconnected struts defining a plurality of open cells in the frame;

a leaflet structure supported by the frame and comprising a plurality of leaflets; and

an annular cover member disposed on and covering the cells of at least a portion of the frame, the cover member being made of silicon.

16. The valve of claim 15, wherein the cover member comprises a sleeve.

17. The valve of claim 15, wherein the sleeve is disposed on the outside of the frame.

18. The valve of claim 15, wherein the cover member is an encapsulating layer encapsulating said at least a portion of the frame and filling the cells of said at least a portion of the frame.

19. The valve of claim 15, wherein the leaflets are connected to each other at adjacent sides to form commissures of the leaflet structure, each leaflet having a curved lower edge portion comprising a scallop extending between two commissures, the curved lower edge portions of the leaflets collectively defining a scalloped lower edge portion of the leaflet structure that is positioned inside and secured to the frame.

20. A method of crimping an implantable prosthetic valve having a frame and leaflets supported by the frame, the method comprising:

placing the valve in the crimping aperture of a crimping device such that a compressible material is disposed between the crimping jaws of the crimping device and the frame of the valve; and

applying pressure against the compressible material and the valve with the crimping jaws to radially crimp the valve to a smaller profile and compress the compressible material against the valve such that the compressible material extends into open cells of the frame and pushes the leaflets away from the inside of the frame.

21. The method of claim 20, wherein the compressible material comprises a compressible sleeve and the method further comprises placing the sleeve between the valve and the crimping jaws.

22. The method of claim 21, wherein the compressible material comprises a sponge.

23. The method of claim 21, wherein the compressible material comprises a foamed material.

24. The method of claim 20, wherein the compressible material comprises a layer of compressible material disposed on each crimping jaw.

25. The method of claim 20, further comprising removing the crimped valve from the crimping device and implanting the valve inside the body of a patient.