Self-expandable heart valve with stabilizers

• US 9,724,193 B2
• Filed: 04/25/2016
• Issued: 08/08/2017
• 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 B
• Application Number:
  US15/138,115
• Publication Number:
  US 20160338827A1
• Time in Patent Office: 470 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 includes three bioprosthetic leaflets, each having an arcuate outer edge opposite a coapting edge and two tabs located on opposite sides of the coapting edge. The prosthetic heart valve also includes a self-expandable support frame defining three commissures spaced 120 degrees apart. Each commissure preferably includes two axially-extending attachment flanges with an axial slot therebetween. Each attachment flange includes a plurality of assembly holes through which sutures are passed to secure the leaflet tabs to the attachment flanges. The prosthetic heart valve also includes three outwardly flared U-shaped stabilizing members integrally formed with the leaflet support frame. The three stabilizing members having outer apices spaced 120 degrees apart and offset by 60 degrees from the three commissures. The stabilizing members are shaped to contact the surrounding aorta for stabilizing and anchoring the prosthetic heart valve in the implant position.

Claims

1. A prosthetic aortic heart valve, comprising:

three bioprosthetic leaflets made from pericardium, each leaflet having an arcuate outer edge opposite a coapting edge and two tabs on opposite sides of the coapting edge that project laterally beyond the outer edge;

a self-expandable tubular leaflet support frame arranged around a flow axis, the leaflet support frame defining three commissures distributed 120°

apart around the flow axis, wherein each commissure comprises two axially-extending attachment flanges, each including a plurality of assembly holes through which sutures are passed to secure the leaflet tabs to the attachment flanges; and

three outwardly flared U-shaped stabilizing members integrally formed with the leaflet support frame having outer apices distributed 120°

apart around the flow axis offset 60°

from the three commissures that contact the surrounding aorta and help stabilize and anchor the heart valve in its implant position.

2. The heart valve of claim 1, wherein the leaflet support frame and stabilizing members are formed from nitinol.

3. The heart valve of claim 1, wherein the outer apices of each stabilizing member point toward an outflow end of the support frame.

4. The heart valve of claim 1, wherein one tab each of two adjacent leaflets are secured to each commissure by passing through an axial slot in the respective commissure.

5. The heart valve of claim 4, further including a panel of fabric secured outside of each commissure, wherein the sutures are passed through the panel of fabric, the leaflets, and the assembly holes in the attachment flanges.

6. The heart valve of claim 4, further including a panel of fabric secured outside of each commissure, wherein the sutures pass through the panel of fabric.

18. The heart valve of claim 1, wherein each of the attachment flanges includes three assembly holes.

19. The heart valve of claim 1, wherein the commissures of the leaflet support frame are positioned adjacent the coapting edge of the leaflets.

20. The heart valve of claim 4, wherein the axial slot is disposed between the attachment flanges of the respective commissure, and wherein one tab each of two adjacent leaflets pass through the axial slot, diverge from each other, and extend partially around respective attachment flanges.

7. A prosthetic aortic heart valve, comprising:

three bioprosthetic leaflets made from pericardium, each leaflet having an arcuate outer edge opposite a coapting edge and two tabs on opposite sides of the coapting edge that project laterally beyond the outer edge;

a self-expandable tubular leaflet support frame arranged around a flow axis, the leaflet support frame defining three commissures distributed 120°

apart around the flow axis, wherein one tab each of two adjacent leaflets are secured to each commissure by passing through an axial slot in the commissure, the commissure having a plurality of assembly holes therein;

a fabric covering on the leaflet support frame to which the arcuate outer edge of each leaflet secures;

a panel of fabric separate from the fabric covering secured outside of each commissure, wherein the leaflet tabs are secured to the commissures via sutures passed through the panel, the leaflets and the assembly holes in the commissures; and

three outwardly angled stabilizing members integrally formed with the leaflet support frame having outer ends distributed 120°

apart around the flow axis offset 60°

from the three commissures that contact the surrounding aorta and help stabilize and anchor the heart valve in its implant position.

8. The heart valve of claim 7, wherein the leaflet support frame and stabilizing members are formed from nitinol.

9. The heart valve of claim 7, wherein the stabilizing members flare outwardly.

10. The heart valve of claim 7, wherein the stabilizing members are U-shaped and an outer apex of each stabilizing member points toward an outflow end of the support frame.

11. A prosthetic aortic heart valve, comprising:

a valve member defined by three bioprosthetic leaflets;

a self-expandable nitinol leaflet support frame arranged around a flow axis, the leaflet support frame defining three commissures distributed 120°

apart around the flow axis, wherein each commissure comprises two spaced attachment flanges that each have a plurality of assembly holes formed therein, wherein the leaflets are secured inside the support frame by sutures extending through the assembly holes of the attachment flanges to define a one-way valve that permits flow through the support frame in an outflow direction; and

three outwardly angled nitinol stabilizing members integrally formed with the leaflet support frame defined by thin struts connected at two points to the support frame extending in the outflow direction to outer apices distributed 120°

apart around the flow axis offset 60°

from the three commissures that contact the surrounding aorta and help stabilize and anchor the heart valve in its implant position.

12. The heart valve of claim 11, wherein the stabilizing members flare outwardly.

13. The heart valve of claim 11, wherein each leaflet has a pair of tabs extending from opposite sides of a free edge of the leaflet, and wherein each commissure includes a slot disposed between the attachment flanges through which the leaflet tabs can extend.

14. The heart valve of claim 13, wherein two tabs of adjacent leaflets meet and pass together through the slot to the outside of one of the commissures of the support frame and are attached thereto using the sutures which extend through the tabs and the assembly holes.

15. The heart valve of claim 14, wherein the attachment flanges and the slot extend axially along a length of the support frame.

16. The heart valve of claim 11, wherein the stabilizing members are U-shaped.

17. The heart valve of claim 11, further including a fabric covering on both sides of the leaflet support frame to which each leaflet secures and a panel of fabric separate from the fabric covering, wherein the panel of fabric is secured outside of each commissure by the sutures.