Expandable prosthetic valve having anchoring appendages

• US 10,098,733 B2
• Filed: 08/06/2014
• Issued: 10/16/2018
• 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): LOPEZ, LESLIE ANN
• Application Number:
  US14/452,849
• Publication Number:
  US 20140350666A1
• Time in Patent Office: 1,532 Days
• Field of Search: None
• 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 one or more valve sinuses, the prosthesis having a principal axis extending longitudinally therethrough and comprising:

an anchoring structure comprising an annular outflow member, an annular inflow member, three straight support members connected to and extending between the annular outflow member and the annular inflow member, and three arms with each of the three arms having a first end coupled to the annular outflow member and a second end configured to contact a base of the valve sinus, wherein the three arms are angularly spaced apart from one another about the principal axis of the prosthesis and are immediately adjacent one another, such that each of the three arms is non-overlapping with each immediately adjacent arm and a different one of the three straight support members is positioned between a pair of the immediately adjacent arms; and

three leaflets directly attached to the three straight support members of 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 a mesh structure having an expanded position such that in the expanded position the mesh structure is configured to engage a vessel wall at a location distal to the valve sinus, the annular outflow member being distal to the entirety of the three leaflets and wherein at least one of the three arms is shaped to engage at least a portion of a longitudinally extending surface of the valve sinus.

2. The valve prosthesis of claim 1 wherein each of the arms includes a first leg and a second leg and a U-shaped portion extending between the first and second legs.

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

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

5. The valve prosthesis of claim 1 wherein the three 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 three arms and said anchoring structure are dimensioned so that a native 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. A valve prosthesis comprising three valve leaflets coupled to an anchoring structure and having a distal end, the anchoring structure including an annular inflow member, an annular outflow member, three straight support members directly connected to and extending between the annular outflow member and the annular inflow member, and three anchoring arms, wherein each of the three anchoring arms is adapted to engage a valve sinus and has an outflow end attached to the annular outflow member, the outflow ends of the three anchoring arms are angularly spaced apart from each other around a principal axis of the prosthesis that extends longitudinally therethrough, each of the three anchoring arms is adjacent two other anchoring arms of the three anchoring arms and non-overlapping with each of the two immediately adjacent other anchoring arms, and each of the three anchoring arms is directly connected to only the annular outflow member and includes a free end adapted to contact a base of the valve sinus adjacent one or more native valve leaflets, wherein the annular outflow member is distal to the distal end of the three valve leaflets.

10. The valve prosthesis of claim 9 further comprising a seal disposed between a proximal end of the anchoring structure and the one or more native valve leaflets.

11. A valve prosthesis for implantation in or near a human heart at a valve site, the valve site including one or more valve sinuses, the prosthesis having a principal axis extending longitudinally therethrough and comprising:

an anchoring structure comprising an annular outflow member, an annular inflow member, three straight support members connected to and extending between the annular outflow member and the annular inflow member, and three arms with each arm of the three arms having outflow ends attached to the annular outflow member at distinct, spaced-apart locations on the annular outflow member and each arm of the three arms configured to contact a base of the one or more valve sinuses, wherein the outflow ends of the three arms are angularly spaced apart from one another about the principal axis of the prosthesis and the three arms are adjacent one another, such that each of the three arms is non-overlapping with an immediately adjacent arm of the three arms and a different one of the three straight support members is positioned between each pair of the immediately adjacent arms; and

three leaflets directly attached to the three straight support members of the anchoring structure, the three leaflets having a distal end 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 configured to engage a vessel wall at a location distal to the valve sinus, the annular outflow member distal to the distal end of the three leaflets and wherein at least one of the three arms is shaped to engage at least a portion of a longitudinally extending surface of the one or more valve sinuses.

12. The valve prosthesis of claim 11 wherein each of the arms includes a first leg coupled to the annular outflow member and a second leg coupled to the annular outflow member and a U-shaped portion extending between the first leg and the second leg.

13. The valve prosthesis of claim 11 wherein the three arms are configured to secure and stabilize the valve prosthesis at an implantation site relative to native heart valve leaflets.

14. The valve prosthesis of claim 11 wherein the three arms are configured to project into a space defined between an open valve leaflet and the sinus wall.

15. The valve prosthesis of claim 11 wherein the three arms comprise a shape memory material.

16. The valve prosthesis of claim 11 wherein the anchoring structure comprises a shape memory material.

17. The valve prosthesis of claim 11 wherein the three arms and said anchoring structure are dimensioned so that a native heart valve leaflet can fit therebetween.

18. The valve prosthesis of claim 11 wherein the annular inflow member is dimensioned to secure the valve prosthesis against a proximal surface of the valve annulus.