Low profile transcatheter heart valve

• US 10,292,817 B2
• Filed: 11/28/2018
• Issued: 05/21/2019
• 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:
  US16/202,967
• Publication Number:
  US 20190099269A1
• Time in Patent Office: 174 Days
• Field of Search: 623 211- 219, 623 124
• 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 method of assembling an implantable prosthetic valve, comprising:

suturing a reinforcing member to an inner surface of a leaflet structure adjacent a lower edge of the leaflet structure;

suturing a skirt member to an outer surface of the leaflet structure along a scallop line that tracks the lower edge of the leaflet structure to form an assembly comprised of the skirt member, the leaflet structure, and the reinforcing member;

placing the assembly inside of a radially collapsible and expandable annular frame, wherein the frame comprises a plastically deformable material selected from the group comprising stainless steel and a nickel-cobalt based alloy; and

suturing the skirt member to struts of the frame;

wherein the leaflet structure comprises three leaflets, each having a curved lower edge and the act of suturing the reinforcing member comprises suturing the reinforcing member to inner surfaces of the leaflets adjacent their curved lower edges.

2. The method of claim 1, wherein the reinforcing member comprises three separate reinforcing members, each of which is sutured to an inner surface of a respective leaflet adjacent its curved lower edge.

3. The method of claim 1, further comprising securing commissures of the leaflet structure to respective commissure attachment portions of the frame.

4. The method of claim 1, wherein the leaflets comprises pericardium and each of the reinforcing member and the skirt member comprises a fabric.

5. The method of claim 1, wherein the reinforcing member and the skirt member are separate pieces of material and the reinforcing member is sutured to the leaflet structure prior to suturing the skirt member to the leaflet structure.

11. The method of claim 1, wherein the reinforcing member comprises three separate reinforcing members, each of which is sutured to an inner surface of a respective leaflet adjacent its curved lower edge.

6. A method of assembling an implantable prosthetic valve, comprising:

suturing a reinforcing member to an inner surface of a leaflet structure adjacent a lower edge of the leaflet structure;

suturing a skirt member to an outer surface of the leaflet structure along a scallop line that tracks the lower edge of the leaflet structure to form an assembly comprised of the skirt member, the leaflet structure, and the reinforcing member;

placing the assembly inside of a radially collapsible and expandable annular frame, wherein the frame comprises a plastically deformable material selected from the group comprising stainless steel and a nickel-cobalt based alloy; and

suturing the skirt member to struts of the frame;

wherein the lower edge of the leaflet structure is secured to the frame only indirectly by the skirt member.

7. A method of assembling an implantable prosthetic valve, comprising:

suturing a reinforcing member to an inner surface of a leaflet structure adjacent a lower edge of the leaflet structure;

suturing a skirt member to an outer surface of the leaflet structure along a scallop line that tracks the lower edge of the leaflet structure to form an assembly comprised of the skirt member, the leaflet structure, and the reinforcing member;

placing the assembly inside of a radially collapsible and expandable annular frame, wherein the frame comprises a plastically deformable material selected from the group comprising stainless steel and a nickel-cobalt based alloy; and

suturing the skirt member to struts of the frame;

wherein the lower edge of the leaflet structure is sutured only to the skirt member and the reinforcing member.

8. A method of assembling an implantable prosthetic valve, comprising:

suturing a reinforcing member to inner surfaces of three tissue leaflets adjacent curved lower edges of the leaflets;

suturing a skirt member to outer surfaces of the leaflets with a suture that extends through the skirt member, the leaflets, and the reinforcing member along a scallop line that tracks the curved lower edges of the leaflets to form an assembly comprised of the skirt member, the leaflets, and the reinforcing member;

placing the assembly inside of a radially collapsible and expandable annular frame, the annular frame comprising at least three rows of circumferentially extending rows of angled struts including a first row of angled struts defining an inflow end of the frame, a second row of angled struts defining an outflow end of the frame, and a third row of angled struts positioned axially between the first and second rows of angled struts along a length of the frame, wherein the frame comprises a plastically deformable material selected from the group comprising stainless steel and a nickel-cobalt based alloy; and

suturing the skirt member to struts of the first and third rows of angled struts.

9. The method of claim 8, wherein the act of suturing the skirt member to the outer surfaces of the leaflets comprises forming in-and-out stitches with an Ethibond suture that extends through the skirt member, the leaflets, and the reinforcing member along the scallop line.

10. The method of claim 8, wherein each leaflet has two side flaps, wherein each side flap is connected to an adjacent side flap of another leaflet to form commissures of the leaflet structure, and the method further comprises securing the commissures of the leaflets to commissure attachment portions of the frame.

12. The method of claim 8, wherein the act of the suturing the skirt member to struts of the first and third rows of angled struts comprises suturing a lower edge portion of the skirt member to struts of the first row of angled struts and suturing an upper edge portion of the skirt member to struts of the second row of angled struts.

13. The method of claim 12, wherein the second and third rows of angled struts define upper and lower boundaries of an upper row of closed cells of the frame defining openings in the frame, and wherein the skirt member covers the entire extent of an inner surface of the frame except for the openings in the upper row of cells.

14. The method of claim 12, wherein suturing the upper edge portion of the skirt member to struts of the second row of angled struts comprises partially wrapping the upper edge portion of the skirt member around the struts of the second row of angled struts.

15. The method of claim 12, wherein the struts of the third row of angled struts are arranged in a zig-zag pattern and the upper edge portion of the skirt member comprises a zig-zag pattern that generally conforms to the zig-zag pattern of the third row of angled struts.

16. The method of claim 12, wherein the lower edges of the leaflets are secured to the frame only indirectly by the skirt member.

17. A method of assembling an implantable prosthetic valve, comprising:

placing a reinforcing member along a first surface of a leaflet structure adjacent an undulating lower edge of the leaflet structure;

placing a skirt member along a second surface of the leaflet structure;

securing the skirt member to the leaflet structure by forming in-and-out stitches with a suture that extends through the skirt member, the leaflet structure, and the reinforcing member along a scallop line that tracks the lower edge of the leaflet structure to form an assembly comprised of the skirt member, the leaflet structure, and the reinforcing member;

subsequent to securing the skirt member to the leaflet structure to form the assembly, placing the assembly inside of a radially collapsible and expandable annular frame, wherein the frame comprises a plastically deformable material selected from the group comprising stainless steel and a nickel-cobalt based alloy; and

suturing the skirt member to struts of the frame;

wherein the reinforcing member and the skirt member are separate pieces of material and the reinforcing member is sutured to the leaflets prior to securing the skirt member to the leaflet structure with the in-and-out stitches.

18. The method of claim 17, wherein the plastically deformable material comprises a nickel-cobalt-chromium-molybdenum alloy.