Collapsible prosthetic valve having an internal cover

• US 9,095,432 B2
• Filed: 11/25/2013
• Issued: 08/04/2015
• Est. Priority Date: 12/31/1996
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Inventors: Cribier, Alain
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US14/089,332
• Publication Number:
  US 20140081392A1
• Time in Patent Office: 617 Days
• Field of Search: 623/900, 623/2.14, 623/2.17
• US Class Current: 1/1
• 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 metallic frame comprising a plurality of intersecting bars, 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 stenosed aortic valve, the external surface of the frame adapted to directly contact the stenosed aortic valve after implantation;

a collapsible valvular structure made with pericardium, the valvular structure having an open state and a closed state for permitting blood to flow in one direction, the valvular structure fastened to the frame along a fastening line; and

an internal cover made with pericardium, the internal cover having an inlet end sewn to the lower extremity of the frame and an outlet end sewn to the frame at a location between the fastening line of the valvular structure and the upper extremity of the frame for covering approximately 3 to 5 mm of the frame above the fastening line, the internal cover sewn to the frame along the internal surface for additional reinforcement, 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 inlet end of the internal cover and the outlet end of the internal cover;

wherein the wall of the frame is uncovered between the outlet end of the internal cover and the upper extremity 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 the inlet end of the internal cover is sewn to the lower extremity of the frame along the zig-zag line.

4. The prosthetic valve of claim 3, wherein the outlet end of the internal cover is sewn to the frame along a zig-zag line.

5. The prosthetic valve of claim 1, wherein the plurality of bars have diameters in the range of 0.1 to 0.6 mm

6. The prosthetic valve of claim 5, wherein the valvular structure is sewn to the internal cover.

7. 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.

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

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

a compressible and expandable metallic frame comprising a plurality of intersecting bars with spaces therebetween, the plurality of bars having diameters in the range of 0.1 to 0.6 mm, the frame providing a wall 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 after implantation;

a collapsible valvular structure made of pericardium, the valvular structure having open and closed states, the valvular structure positioned between the upper and lower extremities of the frame; and

an internal cover made with pericardium the internal cover having an inlet end sewn to a lower extremity of the frame and an outlet end sewn to the frame between a fastening line of the valvular structure and an upper extremity of the frame, the internal cover sewn to the internal surface of the frame between the inlet and outlet ends for additional reinforcement, the internal cover forming a sleeve for preventing a passage of blood through the wall of the frame between the inlet and outlet ends of the internal cover;

wherein a portion of the internal cover extends above the fastening line such that the wall of the frame is covered between the fastening line and the outlet of the internal cover for blocking the spaces between the bars and wherein the wall of the frame is uncovered between the outlet end of the internal cover and the upper extremity of the frame for permitting passage of blood through the spaces between the bars for allowing blood to pass from the aorta to the coronary ostia.

10. The prosthetic valve of claim 9, wherein the frame comprises a concave profile.

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

a metallic frame constituting a grate structure having a plurality of intersect bars with spaces therebetween, 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;

an internal cover made with pericardium, the internal cover sewn to the frame for preventing a passage of blood through the 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; and

a flexible valvular structure made with pericardium and sewn to the internal cover, the 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;

wherein the internal cover has an outlet end sewn to the frame at a location between a fastening line of the valvular structure and the upper extremity of the frame for covering a portion of the frame above the fastening line and thereby blocking the spaces in the frame between the fastening line and the outlet end of the internal cover and wherein blood is permitted to pass through the spaces in the frame between the outlet end of the internal cover and the upper extremity of the frame.

12. The prosthetic valve of claim 11, wherein the outlet end of the internal cover is sewn to intercrossing bars of the frame along a zig-zag line.

13. The prosthetic valve of claim 11, wherein the frame is configured to be expanded by a balloon.