Collapsible prosthetic valve

• US 9,629,714 B2
• Filed: 07/21/2015
• Issued: 04/25/2017
• Est. Priority Date: 12/31/1996
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Inventors: Letac, Brice, Cribier, Alain
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US14/805,179
• Publication Number:
  US 20150320552A1
• Time in Patent Office: 644 Days
• 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 native aortic valve, comprising:

a frame comprising a plurality of intersecting wires, the 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 native aortic valve;

a collapsible valvular structure supported inside the frame, the valvular structure having an open state and a closed state for permitting blood to flow in one direction, wherein the valvular structure has an inlet end fastened to the frame along a fastening line that extends along a circumference of the inlet end, the inlet end defines an annular shape in a plane that is perpendicular to a central axis of the frame, wherein the valvular structure comprises a truncated hyperboloidal shape having a concave outer surface toward the aortic wall when the valvular structure is in the open state and the prosthetic valve is implanted in the native aortic valve, wherein the valvular structure has an outlet opening in the open state having a diameter that is smaller than a diameter of an inlet opening of the valvular structure; and

a plurality of elongated struts connected to the valvular structure inside of the frame to induce a patterned movement of the valvular structure between the open state and the closed state, the elongated struts extending lengthwise of the frame in a direction from the lower extremity to the upper extremity.

2. The prosthetic valve of claim 1, wherein the elongated struts extend from the fastening line toward the upper extremity of the frame.

3. The prosthetic valve of claim 1, wherein the elongated struts are rectilinear.

4. The prosthetic valve of claim 1, further comprising an external cover extending over and covering the external surface of the frame, the external cover having a lower extremity at the lower extremity of the frame and extending toward the upper extremity of the frame.

5. The prosthetic valve of claim 4, wherein the external cover comprises a synthetic biocompatible material.

6. The prosthetic valve of claim 5, wherein the external cover comprises polyethylene.

7. The prosthetic valve of claim 4, wherein the valvular structure has an upper extremity that extends above an upper extremity of the external cover when the frame is in an expanded state.

8. The prosthetic valve of claim 1, wherein the elongated struts comprise a stiffening material.

9. The prosthetic valve of claim 1, further comprising an internal cover extending between a lower extremity of the frame and the valvular structure, the internal cover having an inlet end sewn to the lower extremity of the frame, 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.

10. The prosthetic valve of claim 1, wherein the wires of the frame have diameters in the range of 0.1 to 0.6 mm.

11. The prosthetic valve of claim 1, wherein the frame has a diameter of about 20 to 25 mm when expanded.

12. The prosthetic valve of claim 1, wherein the frame has a height of 20 mm.

13. The prosthetic valve of claim 1, wherein the fastening line comprises a suture line securing the inlet end of the valvular to the wires of the frame.

14. A prosthetic valve for implantation in a native aortic valve, comprising:

a frame comprising a plurality of intersecting wires, the 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 native aortic valve;

a collapsible valvular structure supported inside the frame, the valvular structure having an open state and a closed state for permitting blood to flow in one direction, the valvular structure having an inlet end fastened to the frame along a fastening line that extends along a circumference of the inlet end, the inlet end defines an annular shape in a plane that is perpendicular to a central axis of the frame, wherein the valvular structure comprises a truncated hyperboloidal shape having a concave outer surface toward the aortic wall when the valvular structure is in the open state and the prosthetic valve is implanted in the native aortic valve;

wherein the valvular structure has an outlet opening in the open state having a diameter that is smaller than a diameter of an inlet opening of the valvular structure;

a plurality of elongated struts connected to the valvular structure inside of the frame to induce a patterned movement of the valvular structure between the open state and the closed state, the elongated struts extending lengthwise of the frame from the fastening line toward the upper extremity of the frame; and

an external cover extending over and covering the external surface of the frame, the external cover having a lower extremity at the lower extremity of the frame and extending toward the upper extremity of the frame.