CARDIAC VALVE PROSTHESIS

• US 20120172982A1
• Filed: 12/30/2011
• Published: 07/05/2012
• Est. Priority Date: 02/10/2005
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Inventors: Stacchino, Carla, Bergamasco, Giovanni, Burriesci, Gaetano, Righini, Giovanni
• Granted Patent: US 8,540,768 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• 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 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: Y10T 29/49833 Punching, piercing or reaming part by surface of second part

Abstract

A cardiac valve prosthesis includes a frame and a set of prosthetic valve leaflets supported by the frame. The frame defines a principal axis of the cardiac valve prosthesis and includes first and second annular elements expandable from a radially contracted state to a radially expanded state, a plurality of valve supports supporting the leaflets, and a plurality of connecting members. The valve supports are angularly spaced from one another about the principal axis of the cardiac valve prosthesis, and the connecting members extend between and connect the first and second annular elements. When the annular elements are in the radially expanded state each of the connecting members arches radially outward with respect to the annular elements and is configured to project into one of the Valsalva sinuses when implanted. The connecting members are angularly spaced from the valve supports about the principal axis.

Claims

1. A cardiac valve prosthesis configured for implantation at an implantation site including a plurality of Valsalva sinuses, the cardiac valve prosthesis comprising:

a frame defining a principal axis of the cardiac valve prosthesis and a lumen for passage of blood flow through the cardiac valve prosthesis, the frame including;

first and second annular elements, the annular elements expandable from a radially contracted state to a radially expanded state;

a plurality of valve supports extending from at least one of the first or second annular elements and angularly spaced from one another about the principal axis of the cardiac valve prosthesis; and

a plurality of anchor members extending between and connecting the first and second annular elements, the anchor members configured to assist in anchoring the prosthesis at the implantation site, wherein when the first and second annular elements are in the radially expanded state the anchor members arch radially outward with respect to the annular elements, and wherein the anchor members are angularly spaced from the valve supports about the principal axis of the cardiac valve prosthesis; and

a set of prosthetic valve leaflets supported by the valve supports, the valve leaflets configured to assume an open configuration under the action of blood flowing in a direction from the first annular element toward the second annular element, and are further configured to assume a substantially closed configuration in which the valve leaflets cooperate with one another to inhibit blood flow in a direction from the second annular element toward the first annular element.

2. The cardiac valve prosthesis of claim 1, wherein each of the anchor members is configured to project into one of the Valsalva sinuses when the cardiac valve prosthesis is implanted.

3. The cardiac valve prosthesis of claim 2, wherein the anchor members are configured to engage a respective Valsalva sinus wall when the cardiac valve prosthesis is implanted.

4. The cardiac valve prosthesis of claim 1, wherein the first annular element is configured to be positioned proximal to the Valsalva sinuses when implanted, and wherein the second annular element is configured to be positioned distal to the Valsalva sinuses when the cardiac valve prosthesis is implanted.

5. The cardiac valve prosthesis of claim 1, wherein the plurality of anchor members includes three sets of anchor members each configured to project into one of the Valsalva sinuses when the cardiac valve prosthesis is implanted.

6. The cardiac valve prosthesis of claim 5, wherein each set of anchor members includes a pair of anchor members spaced from one another about the principal axis of the cardiac valve prosthesis, and wherein each anchor member within each pair is positioned so as to not interfere with a coronary ostia when the cardiac valve prosthesis is implanted.

7. The cardiac valve prosthesis of claim 1, wherein the valve supports extend only from the first annular element.

8. The cardiac valve prosthesis of claim 1, wherein the valve supports extend from and between both of the annular elements.

9. The cardiac valve prosthesis of claim 1, wherein the valve supports are substantially linear.

10. The cardiac valve prosthesis of claim 1, wherein the anchor members extend in a generally sinusoidal pattern between the first and second annular elements.

16. The cardiac valve prosthesis of claim 5, wherein each set of connecting members includes a pair of connecting members spaced from one another about the principal axis of the cardiac valve prosthesis, and wherein each connecting member within each pair is positioned so as to not interfere with a coronary ostia when the cardiac valve prosthesis is implanted.

17. The cardiac valve prosthesis of claim 1, wherein the valve supports extend only from the first annular element.

18. The cardiac valve prosthesis of claim 1, wherein the valve supports extend from and between both of the annular elements.

19. The cardiac valve prosthesis of claim 1, wherein the valve supports are substantially linear.

20. The cardiac valve prosthesis of claim 1, wherein the connecting members extend in a generally sinusoidal pattern between the first and second annular elements.

11. A cardiac valve prosthesis configured for implantation at an implantation site including a plurality of Valsalva sinuses, the cardiac valve prosthesis comprising:

a frame defining a principal axis of the cardiac valve prosthesis and a lumen for passage of blood flow through the cardiac valve prosthesis, the frame including;

first and second annular elements, the annular elements expandable from a radially contracted state to a radially expanded state;

a plurality of valve supports extending from at least one of the first or second annular elements and angularly spaced from one another about the principal axis of the cardiac valve prosthesis; and

a plurality of connecting members extending between and connecting the first and second annular elements, wherein when the first and second annular elements are in the radially expanded state each of the connecting members arches radially outward with respect to the annular elements and is configured to project into one of the Valsalva sinuses when implanted, and wherein the connecting members are angularly spaced from the valve supports about the principal axis of the cardiac valve prosthesis; and

a set of prosthetic valve leaflets supported by the valve supports, the valve leaflets configured to assume an open configuration under the action of blood flowing in a direction from the first annular element toward the second annular element, and are further configured to assume a substantially closed configuration in which the valve leaflets cooperate with one another to inhibit blood flow in a direction from the second annular element toward the first annular element.

12. The cardiac valve prosthesis of claim 11, wherein each connecting member is configured to assist in anchoring the cardiac valve prosthesis at the implantation site when the cardiac valve prosthesis is implanted.

13. The cardiac valve prosthesis of claim 12, wherein each of the connecting members is configured to engage a respective Valsalva sinus wall when the cardiac valve prosthesis is implanted.

14. The cardiac valve prosthesis of claim 11, wherein the first annular element is configured to be positioned proximal to the Valsalva sinuses when implanted, and wherein the second annular element is configured to be positioned distal to the Valsalva sinuses when the cardiac valve prosthesis is implanted.

15. The cardiac valve prosthesis of claim 11, wherein the plurality of connecting members includes three sets of connecting members each configured to project into one of the Valsalva sinuses when the cardiac valve prosthesis is implanted.