VALVE PROSTHESIS AND KIT

• US 20140046434A1
• Filed: 08/08/2013
• Published: 02/13/2014
• Est. Priority Date: 08/10/2012
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Rolando, Giovanni, Gaschino, Paolo, Ghione, Laura, Achiluzzi, Monica, Marchisio, Andrea
• Granted Patent: US 9,186,249 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

Described is a valve prosthesis comprising: an annular structure, and a plurality of valve leaflets, and a plurality of anchoring members attached around the annular structure, the anchoring members including: a web portion coupled to the annular structure and extending axially thereto, and two end portions at axially opposed sides of the web portion, the end portions having: an insertion condition for insertion of the prosthesis, wherein the end portions are aligned to the web portion and extend axially with respect to the annular structure; and an anchoring condition for anchoring the prosthesis, wherein the end portions extend at an angle to the web portion radially outwardly of the annular structure to provide anchoring of the prosthesis proximally and distally, respectively, of the annulus, and wherein one end portion forms an obtuse angle with the web portion.

Claims

1. A valve prosthesis for location at a valve annulus, the prosthesis comprising:

an annular structure with an axial blood flow lumen and a plurality of valve leaflets movable under the action of blood between an open position and a closed position to permit and to impede, respectively, blood flow through said axial blood flow lumen, and

a plurality of anchoring members attached around the annular structure, the anchoring members including;

a web portion coupled to the annular structure and extending axially thereto, and

two end portions at axially opposed sides of the web portion, the end portions having;

an insertion condition for insertion of the prosthesis, wherein the end portions are aligned to the web portion and extend axially with respect to the annular structure; and

an anchoring condition for anchoring the prosthesis, wherein the end portions are shaped asymmetrically and extend at an angle to the web portion radially outwardly of the annular structure to provide anchoring of the prosthesis proximally and distally, respectively, of the annulus, and wherein one end portion forms an obtuse angle with the web portion.

2. The valve prosthesis of claim 1, including anchoring members having at least one end portion with an insertion condition wherein the at least one end portion is spread apart from the web portion and extends axially from the annular structure and an anchoring condition wherein the at least one end portion is folded towards the web portion at an angle thereto radially outwardly of the annular structure.

3. The valve prosthesis of claim 1, including anchoring members having at least one end portion with an insertion condition wherein the at least one end portion is folded against the web portion and extends axially with respect to the annular structure and an anchoring condition wherein the at least one end portion is deployed away from the web portion at an angle thereto radially outwardly of the annular structure.

4. The valve prosthesis of claim 1, including a sheet-like covering on the outer side of the annular structure and anchoring members having their web and end portions radially outwardly of the covering.

5. The valve prosthesis of claim 1, including anchoring members adjustably coupled to the annular structure.

6. The valve prosthesis of claim 1, including anchoring members coupled to the annular structure by flexible links.

7. The valve prosthesis of claim 4, wherein the flexible links include suture stitches through the sheet-like covering.

8. The valve prosthesis of claim 1, wherein the anchoring members include an elastic material.

9. The valve prosthesis of claim 1, including anchoring members having a body shape selected from a group consisting of:

an elongated ring-shaped body having loop portions and an intermediate portion between the loop portions forming the end portions and the web portion, respectively, of the anchoring member, and

a blade-like body.

10. The valve prosthesis of claim 1, including anchoring members distributed with uniform spacing around the annular structure.

11. The valve prosthesis of claim 1, including anchoring members distributed with non-uniform spacing around the annular structure.

12. The valve prosthesis of claim 1, including a set of identical anchoring members.

13. The valve prosthesis of claim 1, including anchoring members having different sizes and/or shapes at different places around the annular structure.

14. The valve prosthesis of claim 1, wherein the annular structure has a shape selected from a group consisting of circular, non-circular, and D-shaped.

15. The valve prosthesis of any of claim 1, including anchoring members with end portions which elastically assume the anchoring condition in the absence of applied deformation stress.

16. The valve prosthesis of claim 1, wherein the annular structure is contractible to a radially contracted insertion condition and expandable to a radially expanded implantation condition.

17. The valve prosthesis of claim 16, wherein the annular structure is self-expandable to the radially expanded implantation condition.

18. The valve prosthesis of claim 15, wherein the annular structure is expandable to a radially expanded implantation condition under the action of an expansion member.

19. A delivery kit for a valve prosthesis including:

an unexpanded expandable member carrying a valve radially contracted thereon, wherein the valve comprises;

an annular structure with an axial blood flow lumen and a plurality of valve leaflets movable under the action of blood between an open position and a closed position to permit and to impede, respectively, blood flow through said axial blood flow lumen, and

a plurality of anchoring members attached around the annular structure, the anchoring members including;

a web portion coupled to the annular structure and extending axially thereto, and

two end portions at axially opposed sides of the web portion, the end portions having;

an insertion condition for insertion of the prosthesis, wherein the end portions are aligned to the web portion and extend axially with respect to the annular structure; and

an anchoring condition for anchoring the prosthesis, wherein the end portions are shaped asymmetrically and extend at an angle to the web portion radially outwardly of the annular structure to provide anchoring of the prosthesis proximally and distally, respectively, of the annulus, and wherein one end portion forms an obtuse angle with the web portion; and

a sheath member arranged around the expandable member and radially constricting to the insertion condition, the end portions of the anchoring members of the valve prosthesis radially contracted on the expandable member, the sheath member slidable over the expandable member to sequentially disengage the end portions of the anchoring members to permit the end portions to assume the anchoring condition with the annular structure radially expanded due to expansion of the expandable member.

20. A method of implanting a valve prosthesis at a valve annulus, comprising the steps of:

providing a delivery sleeve;

providing a valve prosthesis within the delivery sleeve, wherein the valve prosthesis comprises;

an annular structure with an axial blood flow lumen and a plurality of valve leaflets movable under the action of blood between an open position and a closed position to permit and to impede, respectively, blood flow through said axial blood flow lumen, and

a plurality of anchoring members attached around the annular structure, the anchoring members including;

a web portion coupled to the annular structure and extending axially thereto, and

two end portions at axially opposed sides of the web portion, the end portions having;

an insertion condition for insertion of the prosthesis, wherein the end portions are aligned to the web portion and extend axially with respect to the annular structure;

delivering the delivery sleeve and valve prosthesis together to the valve annulus; and

retracting the delivery sleeve, wherein the end portions of the valve prosthesis have an anchoring condition for anchoring the prosthesis, in which the end portions are shaped asymmetrically and extend at an angle to the web portion radially outwardly of the annular structure to provide anchoring of the prosthesis proximally and distally, respectively, of the annulus, and wherein one end portion forms an obtuse angle with the web portion.