Prosthetic heart valve with cusp positioners

• US 10,159,567 B2
• Filed: 08/07/2017
• Issued: 12/25/2018
• Est. Priority Date: 03/18/2003
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Iobbi, Mario M Gabriel
• Primary Examiner(s): Prebilic, Paul
• Application Number:
  US15/670,778
• Publication Number:
  US 20170333182A1
• Time in Patent Office: 505 Days
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A prosthetic heart valve has three cusp regions positioned at an inflow end intermediate three commissure regions positioned at an outflow end thereof. A support frame including three cusp positioners is fixed with respect to a leaflet frame and located intermediate each pair of adjacent commissure regions. The valve is desirably compressible. In the aortic valve position, the cusp positioners angle outward into contact with the sinus cavities, and compress the native leaflets if they are not excised, or the aortic wall if they are.

Claims

1. A prosthetic aortic valve implantable without a need for anchoring sutures, the prosthetic aortic valve comprising:

a collapsible and expandable nitinol leaflet frame comprising an inflow end, an outflow end, and a flow axis, three U-shaped cusp regions located towards the inflow end and disposed circumferentially around the flow axis, and three axially-oriented commissure regions extending towards the outflow end and disposed around the flow axis, the commissure regions alternating between the three cusp regions, the leaflet frame describing a tubular surface of revolution around the flow axis;

three cusp positioners rigidly fixed with respect to the leaflet frame between the inflow end and the outflow end thereof, and around the flow axis, each cusp positioner intermediate two of the commissure regions, each cusp positioner including two legs and an apex therebetween, a portion of each cusp positioner being sinusoidal, the cusp positioners extending radially farther outward than the commissure regions, the inflow end, and the outflow end for contacting walls of sinus cavities of a native aortic valve; and

three flexible, bovine pericardium leaflets attached to the leaflet frame in a trifoil configuration with free edges thereof arranged to coapt to provide one-way occlusion, each leaflet having an arcuate cusp edge opposite the free edge.

2. The prosthetic aortic valve of claim 1, further comprising a covering extending around the leaflet frame.

3. The prosthetic aortic valve of claim 2, wherein the covering is polyethylene terephthalate cloth.

4. The prosthetic aortic valve of claim 1, wherein the three leaflets are three separate leaflets.

5. The prosthetic aortic valve of claim 4, wherein the leaflets are attached around the leaflet frame with the cusp edge of each leaflet extending along one of the cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the commissure regions.

6. The prosthetic aortic valve of claim 5, wherein each commissure edge of each leaflet includes a tab.

7. A prosthetic aortic valve implantable without a need for anchoring sutures comprising:

a collapsible and expandable nitinol leaflet frame comprising an inflow end, an outflow end, and a flow axis, three cusp regions located towards the inflow end and disposed circumferentially around the flow axis, and three axially-oriented commissure regions extending towards the outflow end and disposed around the flow axis, the commissure regions alternating between the three cusp regions;

three cusp positioners rigidly fixed with respect to the leaflet frame between the inflow end and the outflow end thereof, and around the flow axis, each cusp positioner intermediate two of the commissure regions, each cusp positioner including two legs and an apex therebetween, the cusp positioners extending radially farther outward than the commissure regions, the inflow end, and the outflow end; and

three flexible leaflets attached to the leaflet frame in a trifoil configuration with free edges thereof arranged to coapt to provide one-way occlusion, each leaflet having an arcuate cusp edge opposite the free edge.

8. The prosthetic aortic valve of claim 7, wherein the cusp regions are U-shaped.

9. The prosthetic aortic valve of claim 7, wherein at least a portion of each the cusp positioner is sinusoidal.

10. The prosthetic aortic valve of claim 7, wherein each cusp positioner is U-shaped.

11. The prosthetic aortic valve of claim 7, wherein the cusp positioners are configured for contacting walls of sinus cavities of a native aortic valve.

12. The prosthetic aortic valve of claim 7, further comprising a covering extending around the leaflet frame.

13. The prosthetic aortic valve of claim 12, wherein the covering is a cloth covering.

14. The prosthetic aortic valve of claim 7, wherein the leaflets are bovine pericardium leaflets.

15. The prosthetic aortic valve of claim 7, wherein the three leaflets are three separate leaflets.

16. The prosthetic aortic valve of claim 15, wherein the leaflets are attached around the leaflet frame with the cusp edge of each leaflet extending along one of the cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the commissure regions.

17. The prosthetic aortic valve of claim 16, wherein each commissure edge of each leaflet includes a tab.