Methods of implanting minimally-invasive prosthetic heart valves

• US 10,022,220 B2
• Filed: 04/03/2014
• Issued: 07/17/2018
• Est. Priority Date: 04/06/2000
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Schreck, Stefan
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US14/244,712
• Publication Number:
  US 20140222140A1
• Time in Patent Office: 1,566 Days
• Field of Search: 623 21- 119
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

Methods of implanting prosthetic heart valves for minimally invasive valve replacement are disclosed. In one preferred embodiment, a compressible and expandable prosthetic heart valve includes a support stent comprising an expandable tubular base and three upstanding commissure posts. The three commissure posts are spaced at 120 degree intervals. The prosthetic heart valve further includes a tubular flexible member which is secured to the support stent. The tubular flexible member preferably includes a prosthetic section and a fabric section. The prosthetic section is connected to the three commissure posts and defines three leaflets and three commissure portions. The commissure portions are secured along the commissure posts. The tubular base of the support stent may be self-expandable or balloon-expandable. The fabric section of the tubular flexible member surrounds the tubular base of the support stent for contacting an annulus of the native heart valve.

Claims

1. A method of treating a diseased aortic valve, comprising:

compressing a valve prosthesis to a compressed state, percutaneously delivering the valve prosthesis via a catheter through a femoral artery, and expanding the valve prosthesis to an expanded state in the diseased aortic valve,

wherein the valve prosthesis comprises;

a support stent comprising a tubular base and a plurality of axially-extending commissure posts coupled to the tubular base, the commissure posts having slots formed therein, the tubular base being self-expandable and comprising a shape memory material;

a leaflet section comprising a plurality of leaflets made from pericardium, the leaflet section having an inlet end extending along a circumference of the tubular base and a plurality of commissures coupled to the commissure posts, wherein portions of the commissures extend outwardly through the slots in the commissure posts for securing the leaflet section to the commissure posts; and

a skirt surrounding the tubular base, the skirt made from a biocompatible material and adapted for placement between the tubular base and surrounding tissue of the diseased aortic valve.

2. The method of claim 1, wherein the biocompatible material is one of a biocompatible sheet material and a biocompatible fabric material.

3. The method of claim 1, wherein the catheter has a length of at least about 80 cm.

4. The method of claim 1, wherein the commissure posts have axial lengths that remain substantially constant while expanding the valve prosthesis from the compressed state to the expanded state.

5. The method of claim 1, further comprising capturing the skirt between the tubular base and the surrounding tissue, the skirt being in direct contact with the surrounding tissue.

6. A method of treating a diseased cardiac valve, comprising:

compressing a valve prosthesis to a compressed state for delivery to an implantation site and expanding the valve prosthesis to an expanded state for deployment at the implantation site,

wherein the valve prosthesis comprises;

a support stent comprising a tubular member defining an axis and a plurality of axially-extending commissure posts coupled to the tubular member;

a leaflet section comprising a plurality of leaflets made from pericardium, the leaflet section having an inlet end extending along a circumference of the tubular member and a plurality of commissures coupled to the commissure posts, wherein the commissure posts have axially-extending slots and wherein portions of the commissures extend outwardly through the slots in the commissure posts for securing the leaflet section to the commissure posts; and

a skirt surrounding the tubular member, the skirt comprising a biocompatible material adapted for placement between the tubular member and surrounding tissue of the diseased cardiac valve;

wherein the valve prosthesis is percutaneously delivered via a catheter through a femoral artery to the implantation site, the catheter having a length sufficient to reach the implantation site.

7. The method of claim 6, wherein the biocompatible material is a biocompatible sheet material.

8. The method of claim 6, wherein the biocompatible material is a biocompatible fabric material.

9. The method of claim 6, wherein the catheter has a length of at least about 80 cm.

10. The method of claim 6, wherein the tubular member is one of self-expandable comprising shape memory material and balloon-expandable.

11. The method of claim 6, wherein the skirt drapes outside of and surrounds the tubular member.

12. The method of claim 6, wherein the commissure posts have axial lengths that remain substantially constant while expanding the valve prosthesis from the compressed state to the expanded state.

13. The method of claim 6, the method further comprising the step of capturing the skirt between the tubular member and the surrounding tissue, the skirt being in direct contact with the surrounding tissue.

14. A method of treating a diseased cardiac valve, comprising:

implanting a valve prosthesis at an implantation site in the diseased cardiac valve,

wherein implanting the valve prosthesis comprises compressing the valve prosthesis to a compressed state for delivery to the implantation site, delivering the valve prosthesis via a catheter through a femoral artery, and expanding the valve prosthesis to an expanded state for deployment at the implantation site,

wherein the valve prosthesis comprises;

a support stent having an outflow end, the support stent comprising a metallic tubular member and a plurality of axially-extending commissure posts coupled to the metallic tubular member, the commissure posts having slots formed therein; and

a flexible member comprising a plurality of leaflets made from pericardium, the flexible member having an inlet end extending along a circumference of the metallic tubular member and a plurality of commissures coupled to the commissure posts, wherein portions of the flexible member extend outwardly through the slots in the commissure posts for securing a leaflet section of the flexible member to the commissure posts.

15. The method of claim 14, wherein the catheter has a length of at least about 80 cm.

16. The method of claim 14, wherein the metallic tubular member is self-expandable and comprises shape memory material.

17. The method of claim 14, wherein the metallic tubular member is balloon-expandable.

18. The method of claim 14, wherein the flexible member further comprises a biocompatible skirt extending around the metallic tubular member.

19. The method of claim 18, the method further comprising the step of capturing the skirt between the metallic tubular member and surrounding tissue, the skirt being in direct contact with the tissue.

20. The method of claim 18, wherein the leaflet section extends an entire axial height of the flexible member.

21. The method of claim 18, wherein the skirt comprises one of a biocompatible sheet material and a biocompatible fabric material.

22. The method of claim 14, wherein the plurality of commissure posts comprises three posts, wherein the three posts are circumferentially spaced apart by about 120 degrees.

23. The method of claim 14, wherein the commissure posts have axial lengths that remain substantially constant when expanding the valve prosthesis from the compressed state to the expanded state.

24. A method of treating a diseased cardiac valve, comprising:

implanting a valve prosthesis at an implantation site in the diseased cardiac valve,

wherein the valve prosthesis has a collapsed delivery configuration and an expanded deployment configuration, the step of implanting the valve prosthesis comprising percutaneously delivering the valve prosthesis in the collapsed delivery configuration via a catheter through a femoral artery to the implantation site,

wherein the valve prosthesis comprises;

a support stent having a plurality of axially-extending commissure posts, the commissure posts having slots formed therein in an outflow portion of the support stent, the support stent being self-expandable and comprising a shape memory material;

a leaflet section comprising a plurality of leaflets, the leaflet section having an inlet end extending along a circumference of the stent and a plurality of commissures coupled to the commissure posts, wherein portions of the commissures extend outwardly through the slots in the commissure posts for securing the leaflet section to the commissure posts; and

a skirt made from a biocompatible material that surrounds at least a portion of the support stent, the skirt adapted for placement between the support stent and surrounding tissue of the diseased cardiac valve.

25. A method of claim 24, wherein the support stent comprises a tubular member and wherein the plurality of axially-extending commissure posts extend from the tubular member.

26. A method of claim 25, wherein the leaflet section is made from bovine pericardium.

27. The method of claim 24, wherein the biocompatible material is one of a biocompatible sheet material and a biocompatible fabric material.

28. The method of claim 24, wherein the catheter has a length of at least about 80 cm.

29. The method of claim 24, wherein the plurality of commissure posts comprises three posts, wherein the three posts are circumferentially spaced apart by about 120 degrees.

30. The method of claim 24, wherein the commissure posts have axial lengths that remain substantially constant while expanding the valve prosthesis from the collapsed delivery configuration to the expanded deployment configuration.

31. The method of claim 24, the method further comprising capturing the skirt between the support stent and the surrounding tissue, the skirt being in direct contact with the surrounding tissue.

32. The method of claim 25, wherein the skirt drapes outside of and surrounds the tubular member.

33. A method of treating a diseased cardiac valve, comprising:

providing a valve prosthesis comprising a support stent and a leaflet section, the support stent having a plurality of axially-extending commissure posts formed with slots along an outflow portion of the support stent, the leaflet section having an inlet end extending along a circumference of the stent and a plurality of commissures coupled to the commissure posts, wherein portions of the commissures extend outwardly through the slots in the commissure posts for securing the leaflet section to the commissure posts;

compressing the valve prosthesis to a collapsed delivery configuration;

advancing the valve prosthesis via a catheter through a femoral artery; and

expanding the valve prosthesis to an expanded deployment configuration in a diseased cardiac valve, thereby replacing the function of the diseased cardiac valve.

34. The method of claim 33, wherein the valve prosthesis further comprises a skirt made from a biocompatible material, the skirt surrounding at least a portion of the support stent and adapted for placement between the support stent and surrounding tissue of the diseased cardiac valve.