MINIMALLY-INVASIVE HEART VALVES

• US 20100211165A1
• Filed: 04/26/2010
• Published: 08/19/2010
• Est. Priority Date: 04/06/2000
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Schreck, Stefan
• Granted Patent: US 8,349,000 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 2/2427 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

Expandable prosthetic heart valves for minimally invasive valve replacement are disclosed. In one preferred embodiment, an expandable prosthetic heart valve includes a support stent comprising an expandable tubular base along an inflow end and three upstanding commissure posts along an outflow end. The three commissure posts are spaced at 120 degree intervals with gaps therebetween. The prosthetic heart valve further includes a tubular flexible member having a prosthetic section and a fabric section. The prosthetic section is connected to the three commissure posts and defines three leaflets, preferably formed of pericardial tissue. The fabric section is sutured to the expandable tubular base. The tubular base may be formed with a shape memory material and is sized for deployment with an annulus of a native aortic valve. After deployment, the three commissure posts support the leaflets above the tubular base for replacing the function of the native aortic valve. In one variation, flanges may be provided on the support stent for improving attachment of the support stent to the host tissue.

Claims

1. A prosthetic heart valve, comprising:

a collapsible and expandable support stent formed of a self-expanding metallic material, the support stent including a generally tubular base along an inflow end and three commissure posts provided along an outflow end and extending in an outflow direction, the three commissure posts being cantilevered from the base, each commissure post having a slot formed therein; and

a flexible tubular member configured for attachment to the support stent, the flexible tubular member comprising a fabric section connected to the base along the inflow end of the support stent and a leaflet section defining three leaflets connected to the commissure posts along the outflow end of the support stent, wherein portions of the leaflet section extend outward through the slots in the commissure posts for securing the leaflet section to the commissure posts;

wherein the base of the support stent is configured for contacting the annulus of a native aortic valve and wherein the commissure posts of the support stent support the three leaflets downstream of the base.

2. The prosthetic heart valve of claim 1, wherein the leaflet section forms loops that pass through each of the commissure posts slots and the prosthetic heart valve further includes inserts disposed within the loops on an outside region of each commissure post, the inserts each having a greater width than the circumferential width of the slots to prevent the loops from pulling inward through the slots.

3. The prosthetic heart valve of claim 2, further including stitches securing the leaflet section loops to the inserts.

4. The prosthetic heart valve of claim 3, further including stitching attaching each insert to a respective commissure post.

5. The prosthetic heart valve of claim 1, wherein the support stent further comprises flanges for improved attachment to host tissue.

6. The prosthetic heart valve of claim 1, wherein the leaflet section is made of bovine pericardial tissue.

7. The prosthetic heart valve of claim 1, wherein the self-expanding metallic material is Nitinol.

8. The prosthetic heart valve of claim 1, wherein the fabric section is attached to the base by sutures.

9. The prosthetic heart valve of claim 1, wherein the fabric section is attached to the leaflet section by sutures along a seam.

10. The prosthetic heart valve of claim 1, wherein the seam is located substantially along an outflow portion of the base.

11. The prosthetic heart valve of claim 1, wherein the fabric section surrounds the base.

12. The prosthetic heart valve of claim 1, wherein the fabric section is made from a polyester material.

13. The prosthetic heart valve of claim 1, wherein the fabric section is made with polytetrafluoroethylene.

14. A prosthetic heart valve, comprising:

a collapsible and expandable support stent made with a self-expanding metallic material, the support stent including a generally tubular base along an inflow end and three commissure posts provided along an outflow end and extending in an outflow direction, the commissure posts being spaced in 120 degree intervals with gaps therebetween, the support stent further comprising at least one attachment member for improved attachment to host tissue;

a fabric section connected to the base along the inflow end of the support stent, the fabric section made from a polyester material; and

a leaflet section defining three leaflets formed of bovine pericardium, the three leaflets attached to the commissure posts for opening and closing;

wherein the base of the support stent is configured for contacting the annulus of a native aortic valve and wherein the commissure posts of the support stent are configured to maintain the three leaflets at a location downstream of the annulus of the native aortic valve.

15. The prosthetic heart valve of claim 14, wherein each commissure post has a slot formed therein and wherein portions of the leaflet section pass through each of the commissure posts slots for securement to the outside thereof.

16. The prosthetic heart valve of claim 15, wherein the portions of the leaflet sections form loops and wherein inserts are disposed within the loops on the outside of each commissure post, the inserts each having a greater width than a circumferential width of the slots to prevent the loops from pulling inward through the slots.

17. The prosthetic heart valve of claim 14, wherein the attachment member is a flange.

18. The prosthetic heart valve of claim 14, wherein the fabric section is attached to the base by sutures.

19. The prosthetic heart valve of claim 14, wherein the fabric section is attached to the leaflet section by sutures along a seam.

20. The prosthetic heart valve of claim 19, wherein the seam is located substantially along an outflow portion of the base.

21. The prosthetic heart valve of claim 14, wherein the fabric section surrounds the base.

22. The prosthetic heart valve of claim 14, wherein the fabric section is made from a woven polyester material.

23. The prosthetic heart valve of claim 14, wherein the fabric section is made with polytetrafluoroethylene.

24. A prosthetic heart valve, comprising:

a collapsible and expandable support made with a metallic material, the support stent including a generally tubular base along an inflow end and three commissure posts provided along an outflow end and extending in an outflow direction, the commissure posts being spaced in 120 degree intervals with gaps therebetween;

a fabric section connected to the base along the inflow end of the support stent, the fabric section made from a polyester material; and

a leaflet section formed of bovine pericardium, the leaflet section attached to the fabric section by sutures along a seam, the leaflet section being attached to the commissure posts and defining three leaflets for opening and closing;

wherein the base of the support stent is configured for contacting the annulus of a native aortic valve and wherein the commissure posts of the support stent are configured to maintain the three leaflets at a location downstream of the annulus of the native aortic valve.

25. The prosthetic heart valve of claim 24, wherein each commissure post has a slot formed therein and wherein the leaflet section forms loops that pass through each of the commissure posts slots for securement to the outside thereof.

26. The prosthetic heart valve of claim 24, wherein the support stent further comprises at least one flange portion for improved attachment to host tissue.

27. The prosthetic heart valve of claim 24, wherein the fabric section is attached to the base by sutures.

28. The prosthetic heart valve of claim 24, wherein the fabric section surrounds the base.

29. The prosthetic heart valve of claim 24, wherein the fabric section is made from a woven polyester material.

30. The prosthetic heart valve of claim 24, wherein the fabric section is made with polytetrafluoroethylene.