Cardiac valve prosthesis particularly for replacement of the aortic valve

• US 5,713,953 A
• Filed: 02/15/1996
• Issued: 02/03/1998
• Est. Priority Date: 05/24/1991
• Status: Expired due to Term

• Current Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Original Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Inventors: Vallana, Franco, Curcio, Maria, Rinaldi, Stefano, Stacchino, Carla
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/601,970
• Time in Patent Office: 719 Days
• Field of Search: 623/1, 623/2, 623/3, 623/11, 623/66, 623/900
• US Class Current: 623/2.15
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A stentless prosthesis is made completely from material, for example bovine pericardium, other than valve material. A projection of the valve sleeve allows reparatory operations on surrounding tissues.

Claims

1. A stentless cardiac valve prosthesis adapted for implantation in a human body part and for having blood flow in a path therethrough from upstream to downstream, comprising:

a) an outer tubular member of biological tissue other than valvular tissue having an edge, wherein said edge of said outer member is adapted for attachment to the human body part in the downstream portion of the blood path; and

b) an inner member connected to said outer member, wherein said inner member axially projects beyond said edge of said outer member, wherein said inner member has self supporting leaflets with arcuate edges and an extended portion, wherein said connection comprises at least one stitching line having a festoon course with loops following said arcuate edges of said leaflets and wherein said edge of said outer member is at least about 1 cm. from said festoon line, wherein said extended portion of said inner member is adapted for attachment to the human body part in the upstream portion of the blood path, wherein said leaflets are adapted to move between an open position and a closed position and form a conical shape when in the closed position and wherein said outer member and said inner member are stentless.

2. The prosthesis of claim 1, wherein said prosthesis comprises substantially non-valvular tissue.

3. The prosthesis of claim 1, wherein the prosthesis is selected from the group consisting of biological material and synthetic material.

4. The prosthesis of claim 1, wherein said extended portion of said outer member and said extended portion of said inner member extend a predetermined length for suturing the prosthesis to the body part during the implantation.

5. The prosthesis of claim 4, wherein said leaflets have arcuate edges, and wherein said outer member has homologous edges spaced a predetermined distance from said arcuate edges.

6. The prosthesis of claim 5, wherein said homologous edge has a generally festoon course following said arcuate edges of said leaflets.

7. The prosthesis of claim 5, wherein said homologous edge is generally straight.

9. The prosthesis of claim 4, wherein said inner member projects a predetermined distance upstream of said edge of said outer member.

10. The prosthesis of claim 4, wherein said inner and outer members are formed from a generally trapezoidal shape.

11. The prosthesis of claim 3, wherein said synthetic material is selected from the group of materials having continuous, micro-porous, and composite properties and combinations thereof.

12. The prosthesis of claim 3, wherein said synthetic material is polyurethane.

13. The prosthesis of claim 4, wherein the connection between said inner and outer members is selected from the group consisting of stitching, welding, and gluing and combinations thereof.

8. The prosthesis of claim 25, wherein said homologous edge is spaced at least about 1 cm from said arcuate edges of said leaflets.