COLLAPSIBLE PROSTHETIC VALVE HAVING AN INTERNAL COVER

• US 20140081392A1
• Filed: 11/25/2013
• Published: 03/20/2014
• Est. Priority Date: 12/31/1996
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Inventors: Letac, Brice, Cribier, Alain
• Granted Patent: US 9,095,432 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A prosthetic valve is provided for implantation in a stenosed aortic valve. The prosthetic valve includes a radially collapsible frame configured for advancement through a patient'"'"'s vasculature using a catheterization technique. A collapsible valvular structure is sewn to the frame for permitting blood to flow in only one direction. An internal cover extends along an internal surface of the frame. The internal cover forms a tubular sleeve positioned between a lower extremity of the frame and the valvular structure. The internal cover prevents the passage of blood through spaces between bars of the frame. An upper end of the internal cover is sutured to the valvular structure. The internal cover is preferably made of pericardium.

Claims

1. A prosthetic valve for implantation in a stenosed aortic valve, comprising:

a frame having an upper extremity, a lower extremity, an external surface and an internal surface, the frame being compressible to a compressed external diameter suitable for introduction into a femoral artery by a transcutaneous catheterization technique, the frame being expandable for implantation in the stenosed aortic valve, the external surface of the frame adapted to directly contact the stenosed aortic valve;

a collapsible valvular structure adapted for permitting blood to flow in one direction; and

an internal cover extending between a lower extremity of the frame and the valvular structure, the internal cover sewn to the frame and to the valvular structure, the internal cover contacting the internal surface of the frame and providing a tubular sleeve for preventing a passage of blood through a wall of the frame between the lower extremity of the frame and the valvular structure;

wherein the wall of the frame is uncovered along an upper portion of the frame for permitting passage of blood from the aorta to the coronary ostia.

2. The prosthetic valve of claim 1, wherein the lower extremity of the frame forms a zig-zag line.

3. The prosthetic valve of claim 2, wherein an inlet end of the internal cover is fastened to the lower extremity of the frame along the zig-zag line.

4. The prosthetic valve of claim 3, wherein an outlet end of the internal cover is sewn to the valvular structure.

5. The prosthetic valve of claim 4, wherein the internal cover is made with pericardium.

6. The prosthetic valve of claim 1, wherein the frame comprises a plurality of bars having diameters in the range of 0.1 to 0.6 mm.

7. The prosthetic valve of claim 6, wherein the valvular structure is sewn to the bars of the frame.

8. The prosthetic valve of claim 1, wherein the compressed external diameter of the frame is capable of introduction into the femoral artery through an 18 French arterial introducer.

9. The prosthetic valve of claim 1, wherein the frame is configured to be expanded by a balloon.

10. The prosthetic valve of claim 1, wherein the internal cover is extended at a lower end and applied to an external wall of the frame for providing an external cover.

11. The prosthetic valve of claim 1, wherein the frame is a metallic frame.

12. A prosthetic valve for implantation in a stenosed aortic valve by a transcutaneous catheterization technique, comprising:

a compressible and expandable frame having an external surface and an internal surface, the frame having a compressed external diameter capable of being introduced into a patient'"'"'s vasculature using a catheterization technique, the external surface of the frame adapted to directly contact the stenosed aortic valve;

a collapsible valvular structure having open and closed states, the valvular structure sewn directly to the frame between the upper and lower extremities of the frame; and

an internal cover sewn to the frame, the internal cover fixed to the internal surface of the frame, the internal cover forming a sleeve for preventing a passage of blood through a wall of the frame, the internal cover having an inlet end sewn to the lower extremity of the frame, the internal cover having an outlet end sewn to the valvular structure.

13. The prosthetic valve of claim 12, wherein the internal cover is made with pericardium.

14. The prosthetic valve of claim 13, wherein the frame comprises a concave profile.

15. A prosthetic valve for implantation in a stenosed aortic valve, the prosthetic valve comprising:

a frame having a plurality of bars, the frame being compressible to a compressed external diameter capable of being introduced into a patient'"'"'s vasculature using a catheterization technique, the frame being expandable for implantation in the stenosed aortic valve, the bars of the frame having a diameter in the range of 0.1 to 0.6 mm, the frame having an upper extremity formed with a zig-zag shape and a lower extremity formed with a zig-zag shape;

a flexible valvular structure having an open state and a closed state, the valvular structure positioned between the upper and lower extremities of the frame when in the closed state; and

an internal cover sewn to the frame for preventing a passage of blood through spaces between the bars of the frame, the internal cover contacting an internal surface of the frame, the internal cover having an inlet end sewn to the lower extremity of the frame, the internal cover having an outlet end sewn to the valvular structure;

wherein blood is permitted to pass through spaces in the frame between the valvular structure and the upper extremity of the frame.

16. The prosthetic valve of claim 15, wherein the internal cover is made with pericardium.

17. The prosthetic valve of claim 15, wherein the frame comprises a concave shape profile.

18. The prosthetic valve of claim 15, wherein the valvular structure comprises stiffened zones for inducing the valvular structure to follow a patterned movement.

19. The prosthetic valve of claim 15, wherein the frame is configured to be expanded by a balloon.

20. The prosthetic valve of claim 15, wherein the frame constitutes a grate type structure.