Low profile transcatheter heart valve

• US 10,492,905 B2
• Filed: 05/21/2018
• Issued: 12/03/2019
• 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 A., Nguyen, Son V., Levi, Tamir S., Pelled, Itai
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/984,716
• Publication Number:
  US 20180263769A1
• Time in Patent Office: 561 Days
• Field of Search: 623 21- 219
• 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

A method of crimping an implantable prosthetic valve can include placing protective material over at least a portion of the implantable prosthetic valve. The protective material can be configured to occupy space between open cells of a frame of the implantable prosthetic valve to prevent damage to a leaflet structure of the implantable prosthetic valve. The method can also include crimping the implantable prosthetic valve with the protective material on the implantable prosthetic valve, and removing the protective material from between the frame and the leaflet structure of the implantable prosthetic valve.

Claims

1. A prosthetic valve, comprising:

a radially compressible and expandable annular frame;

a leaflet structure comprising a plurality of leaflets supported within the frame and configured to regulate the flow of blood through the prosthetic valve in one direction; and

a skirt disposed around an outer surface of the frame and configured to seal against surrounding tissue when the prosthetic valve is implanted in a patient'"'"'s body, wherein the skirt comprises an elastomer;

wherein the skirt comprises a first layer comprised of the elastomer and a second layer comprised of a fabric.

2. The prosthetic valve of claim 1, wherein the elastomer comprises silicone.

3. The prosthetic valve of claim 1, wherein the skirt is stretchable.

4. The prosthetic valve of claim 1, wherein the frame comprises a plurality of struts defining a plurality of openings in the frame, wherein the skirt encapsulates at least a portion of the plurality of struts of the frame and extends across frame openings defined by the encapsulated struts.

5. The prosthetic valve of claim 4, wherein the skirt encapsulates the entirety of the plurality of struts of the frame.

6. The prosthetic valve of claim 4, wherein the skirt is formed by a process comprising dipping the frame in the elastomer when the elastomer is liquefied.

7. The prosthetic valve of claim 1, wherein the first layer is on the outside of the second layer.

8. A prosthetic valve, comprising:

a radially compressible and expandable annular frame;

a leaflet structure comprising a plurality of leaflets supported within the frame and configured to regulate the flow of blood through the prosthetic valve in one direction; and

a skirt disposed around an outer surface of the frame and configured to seal against surrounding tissue when the prosthetic valve is implanted in a patient'"'"'s body, wherein the skirt comprises an elastomer;

wherein portions of the skirt extend inwardly through openings in the frame and push the leaflets inwardly and away from an inner surface of the frame when the prosthetic valve is crimped from a radially expanded state to a radially compressed state.

9. A prosthetic valve, comprising:

a radially compressible and expandable annular frame;

a leaflet structure comprising a plurality of leaflets supported within the frame and configured to regulate the flow of blood through the prosthetic valve in one direction; and

a skirt disposed around an outer surface of the frame and configured to seal against surrounding tissue when the prosthetic valve is implanted in a patient'"'"'s body, wherein the skirt comprises an elastomer;

wherein the elastomer is compressible when the prosthetic valve is crimped from a radially expanded state to a radially compressed state.

10. A prosthetic valve, comprising:

a radially compressible and expandable annular frame;

a leaflet structure comprising a plurality of leaflets supported within the frame and configured to regulate the flow of blood through the prosthetic valve in one direction; and

an outer skirt extending around an outer surface of the frame, the outer skirt having a first layer formed from a fabric material and a second layer formed from a non-fabric material.

11. The prosthetic valve of claim 10, wherein the non-fabric material comprises an elastomer.

12. The prosthetic valve of claim 11, wherein the elastomer comprises silicone.

13. The prosthetic valve of claim 10, wherein the fabric material comprises PET.

14. The prosthetic valve of claim 10, wherein the second layer is outside of the first layer.

15. The prosthetic valve of claim 10, wherein the fabric material is substantially non-elastic and the non-fabric material is elastic.

16. A prosthetic valve, comprising:

a radially compressible and expandable annular frame comprising a plurality of struts defining a plurality of openings in the frame;

a leaflet structure comprising a plurality of leaflets supported within the frame and configured to regulate the flow of blood through the prosthetic valve in one direction; and

a skirt encapsulating at least a portion of the plurality of struts of the frame and extending across frame openings defined by the encapsulated struts.

17. The prosthetic valve of claim 16, wherein the skirt encapsulates the entire frame.

18. The prosthetic valve of claim 16, wherein the skirt is formed by a process comprising dipping the frame in a liquefied material that forms the skirt.

19. The prosthetic valve of claim 16, wherein the skirt comprises an elastomer.