EXPANDABLE PROSTHETIC VALVE HAVING ANCHORING APPENDAGES

• US 20140350666A1
• Filed: 08/06/2014
• Published: 11/27/2014
• 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
• Granted Patent: US 10,098,733 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 comprising:

an anchoring structure comprising an annular outflow member, an annular inflow member, and a plurality of arms each coupled at one end to the annular outflow member, the arms having a first end coupled to the annular outflow member and a second end configured to contact a base of the valve sinus; and

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

wherein the annular outflow member has an expanded position generally configured to engage a vessel wall at a location distal to the valve sinus, and wherein at least one of the plurality of arms is shaped to engage substantially an entire longitudinally extending surface of the valve sinus.

2. The valve prosthesis of claim 1 wherein each of the plurality of 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 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. A method of implanting an expandable valve prosthesis at a target implantation site in or near a patient'"'"'s heart, the implantation site including at least one valve sinus, the method comprising:

providing a heart valve prosthesis including a prosthetic valve having three leaflets coupled to an anchoring structure, the anchoring structure including an annular member coupled to a plurality of arms having first and second ends, such that the second ends are not directly coupled to the anchoring structure;

transitioning the prosthesis from an expanded position to a collapsed position;

delivering the prosthesis to a target implantation site within a patient'"'"'s heart in a minimally invasive manner;

facilitating expansion of the prosthesis including the arms; and

positioning the second ends of the arms in a space defined between a native valve leaflet and a sinus wall.

10. The method of claim 9 wherein the step of facilitating expansion of the prosthesis further includes inflating a balloon within the prosthesis such that the prosthesis including the arms is transitioned from the collapsed position to the expanded position.

11. The method of claim 9 wherein the prosthesis is delivered using an off pump procedure.

12. The method of claim 9 further comprising positioning an annular outflow member of the anchoring structure at a location distal to the valve sinus.

13. The method of claim 9 further comprising expanding the arms such that the arms contact the wall of the valve sinus along substantially the entirety of a length of the arms.

14. A valve prosthesis comprising an plurality of valve leaflets coupled to an anchoring structure, the anchoring structure including one or more anchoring arms adapted to substantially engage a valve sinus, the anchoring arms including a free end adapted to contact a base of the valve sinus adjacent one or more native valve leaflets.

15. The valve prosthesis of claim 14 further comprising a seal disposed between a proximal end of the anchoring structure and a native valve leaflet.

16. A kit for implanting a heart valve prosthesis at an implantation site within a patient'"'"'s heart, the kit comprising:

an expandable heart valve prosthesis including an expandable prosthetic heart valve having three leaflets coupled to an anchoring structure, the anchoring structure including an annular outflow member and a plurality of arms movably coupled to the annular member, wherein the arms are configured to contact a base of a valve sinus adjacent an open native heart valve leaflet;

a crimping tool adapted to transition the prosthesis from an expanded position to a collapsed position; and

a delivery catheter adapted to deliver the prosthesis to the implantation site.

17. The kit of claim 16 further comprising an inflatable balloon adapted to transition the prosthesis from the collapsed position to the expanded position at the implantation site.

18. The kit of claim 16 in which fingers and said expandable stent structure are dimensioned so that a native, stenotic heart valve leaflet can fit therebetween.