Expandable prosthetic valve having anchoring appendages

• US 8,834,563 B2
• Filed: 12/16/2009
• Issued: 09/16/2014
• Est. Priority Date: 12/23/2008
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Righini, Giovanni
• Primary Examiner(s): Iwamaye, Andrew
• Assistant Examiner(s): COBURN, LESLIE ANN
• Application Number:
  US12/639,552
• Publication Number:
  US 20100161045A1
• Time in Patent Office: 1,735 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.1, 623 212- 219, 623/2.38
• US Class Current: 623/2.18
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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

Abstract

A heart valve prosthesis includes an expandable prosthetic valve including three valve leaflets coupled to an anchoring structure. The anchoring structure includes an annular member and a plurality of arms movably coupled to the annular member at one end. The free ends of the arms extend radially away from the prosthesis toward a valve annulus. The arms are configured to fit in a space defined between an open native valve leaflet and a wall of a valve sinus. The arms are sufficiently resilient such that they resist downward movement in response to pressure exerted on the prosthesis, facilitating anchorage and stabilization of the prosthesis at the implantation site.

Claims

1. A valve prosthesis for implantation in or near a human heart at a valve site, the valve site including an annulus, three valve sinuses, and vessel walls distal and proximal to the three valve sinuses, the prosthesis having a principal axis extending longitudinally therethrough and comprising:

an anchoring structure comprising an annular outflow member positioned about the principal axis and sized and shaped to engage the vessel wall distal to the three valve sinuses, an annular inflow member positioned about the principal axis and within the ventricle and sized and shaped to secure the valve prosthesis against a proximal surface of the valve annulus, and three straight support members connected to and extending between the annular outflow member and the annular inflow member, the support members angularly spaced from one another around the principal axis and oriented parallel to the principal axis of the prosthesis in an expanded configuration;

three, and only three, arms each coupled at one end to the annular outflow member, the three arms being non-overlapping with the immediately adjacent arm and angularly spaced from one another around the principal axis of the prosthesis, the arms having a first end coupled to the annular outflow member and a second end sized and shaped to contact a base of one of the three valve sinuses, and the arms each including a first leg and a second leg and a bridge portion attached to and extending between the first and second legs, wherein the legs have a length such that the bridge portion is positioned longitudinally between the annular outflow member and the annular inflow member such that when implanted at the valve site the bridge portion contacts the base of one of the three valve sinuses, and wherein at least one of the legs has a sinusoidal shape; and

three leaflets coupled to the anchoring structure and adapted to allow blood flow in a first direction and to prevent blood flow in a second direction;

wherein the annular outflow member has an expanded position sized and shaped to engage the vessel wall distal to the valve sinuses, and

wherein the three arms are shaped to engage an entire longitudinally extending surface of each of the valve sinuses, and to distribute an outwardly directed radial force along the longitudinally extending surface of each valve sinus.

2. The valve prosthesis of claim 1 wherein the bridge portion is U-shaped.

3. The valve prosthesis of claim 1 wherein the arms are configured to secure and stabilize the prosthetic heart valve at an implantation site relative to native heart valve leaflets.

4. The valve prosthesis of claim 1 wherein the arms are configured to contact a space defined between an open valve leaflet and the sinus wall.

5. The valve prosthesis of claim 1 wherein the arms comprise a shape memory material.

6. The valve prosthesis of claim 1 wherein the anchoring structure comprises a shape memory material.

7. The valve prosthesis of claim 1 wherein the arms and said expandable stent structure are dimensioned so that a native, stenotic heart valve leaflet can fit therebetween.

8. The valve prosthesis of claim 1 wherein the annular inflow member is dimensioned to secure the valve prosthesis against a proximal surface of the valve annulus.

9. The valve prosthesis of claim 1 wherein the first leg and second leg of each arm are spaced apart and configured to be positioned on opposite sides of a coronary ostium extending through each valve sinus such that blood can flow through the coronary ostium.

10. A valve prosthesis for implantation in or near a human heart at a valve site, the valve site including an annulus, three valve sinuses, and vessel walls distal and proximal to the three valve sinuses, the prosthesis having a principal axis extending longitudinally therethrough and comprising:

an anchoring structure comprising an annular outflow member positioned about the principal axis and sized and shaped to engage the vessel wall distal to the three valve sinuses, an annular inflow member positioned about the principal axis and within the ventricle and sized and shaped to secure the valve prosthesis against a proximal surface of the valve annulus, and three straight support members connected to and extending between the annular outflow member and the annular inflow member, the support members angularly spaced from one another around the principal axis and oriented parallel to the principal axis of the prosthesis in an expanded configuration;

three, and only three, arms coupled at one end to the annular outflow member, and angularly spaced from one another around the principal axis of the prosthesis, the arms having a first end coupled to the annular outflow member and a second end sized and shaped to contact a base of one of the three valve sinuses, and the arms each including a first leg and a second leg and a bridge portion attached to and extending between the first and second legs, wherein the legs are both attached to the annular outflow member at first ends and the bridge portion at second ends and have a length such that the bridge portion is positioned longitudinally between the annular outflow member and the annular inflow member such that when implanted at the valve site the bridge portion contacts the base of one of the three valve sinuses, and wherein at least one of the legs has a sinusoidal shape; and

three leaflets coupled to the anchoring structure and adapted to allow blood flow in a first direction and to prevent blood flow in a second direction;

wherein the annular outflow member has an expanded position sized and shaped to engage the vessel wall distal to the valve sinuses, and

wherein each of the three arms is angularly spaced 120 degrees apart from the immediately adjacent arm and each arm is shaped to distribute an outwardly directed radial force along the longitudinally extending surface of each valve sinus.

11. The valve prosthesis of claim 10 wherein the bridge portion is U-shaped.

12. The valve prosthesis of claim 10 wherein the arms are configured to secure and stabilize the prosthetic heart valve at an implantation site relative to native heart valve leaflets.

13. The valve prosthesis of claim 10 wherein the arms are configured to contact a space defined between an open valve leaflet and the sinus wall.

14. The valve prosthesis of claim 10 wherein the arms comprise a shape memory material.

15. The valve prosthesis of claim 10 wherein the anchoring structure comprises a shape memory material.

16. The valve prosthesis of claim 10 wherein the arms and said expandable stent structure are dimensioned so that a native, stenotic heart valve leaflet can fit therebetween.

17. The valve prosthesis of claim 10 wherein the annular inflow member is dimensioned to secure the valve prosthesis against a proximal surface of the valve annulus.

18. The valve prosthesis of claim 10 wherein the first leg and second leg of each arm are spaced apart and configured to be positioned on opposite sides of a coronary ostium extending through each valve sinus such that blood can flow through the coronary ostium.