Tissue heart valve and stent

• US 4,441,216 A
• Filed: 12/03/1981
• Issued: 04/10/1984
• Est. Priority Date: 11/03/1980
• Status: Expired due to Fees

• Current Assignee: Sorin Biomedical, Inc. (Snia SpA)
• Original Assignee: Shiley Incorporated
• Inventors: Lenker, Jay A., Rosenbluth, Robert F., Ionescu, Marian I.
• Primary Examiner(s): FRINKS, RONALD
• Application Number:
  US06/327,081
• Time in Patent Office: 859 Days
• Field of Search: 3/1.5, 3/1
• US Class Current: 623/2.19
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

An improved stent for prosthetic tissue heart valves having upright legs which have radiused upper tips which are approximately one-half the width of prior art stent legs is disclosed. These narrow tipped stent legs reduce stress induced in the leaflets by curvature of the leaflets around the tips of the stent legs in the closed position, extending the service life of the valve. Tabs are added to the tips of the stent legs to add structural strength. These tabs can be tapered or straight but their bottom portions must be narrower than the stent leg. The tabs have a plurality of holes in them through which coaptation stitches are passed. The coaptation stitch can be two separate stitches, one in a first plane and one in a second plane at 90° to the first plane, or, in the preferred embodiment, a single figure eight stitch passing through the holes in the tab in a plane coincident with the long axis of the stent leg.

Claims

1. A stent for a tissue heart valve having tissue cusps and coaptation stitches, said stent for reducing stress in the tissue of the cusps comprising:

a ring with scallops formed therein defining an aperture with inflow and outflow ends; and

a plurality of legs coupled to said ring and extending upwardly toward said outflow end each said leg dimensioned such that the radius of curvature of mobile tissue around and near the stent measured at the point of greatest curvature divided by the thickness of the tissue is greater than or equal to five at all points of contact between said tissue and said stent.

2. The stent of claim 1 further including inwardly projecting tab means at outflow end of each stent leg for adding structural strength to said legs.

3. The stent of claim 2 further including means on said tabs means coupled to said coaptation stitches for fixing the location of said stitches.

4. The stent of claim 3 wherein said means for coupling to said coaptation stitches is a plurality of holes through said tab means.

5. A tissue prosthetic heart valve comprising:

(a) a stent comprising;

(1) a ring with scallops formed therein defining an aperture with inflow and outflow ends; and

(2) a plurality of legs coupled to said ring extending upwardly toward said outflow end, each said leg dimensioned such that the quotient of the radius of curvature of mobile tissue inside and around said stent measured at the point of greatest curvature divided by the thickness of said tissue is greater than or equal to five at all points of contact between said tissue and said stent;

(b) a plurality of tissue leaflets attached to said stent and to each other to form a valving element; and

(c) a plurality of coaptation means for causing joining of the edges of said tissue leaflets in the vicinity of the tips of said stent legs.

6. The prosthetic heart valve of claim 5 further including inwardly projecting tab means at the outflow end of each stent leg for adding structural strength to said legs.

7. The prosthetic heart valve of claim 5 further including means on said tab means coupled to said coaptation means for fixing the location of said stitches.

8. The valve of claim 7 wherein said means for fixing the position of said coaptation means comprises a plurality of holes through said tab means.

9. The valve of claim 8 wherein said coaptation means comprises a plurality of stitches a first group of which lies in a plane generally parallel to the long axis of said stent legs and which are tied off above the tips of said stent legs, and a second group of which lies in a plane generally perpendicular to the plane of said first group and which are tied off at the outside edge of said stent legs.

10. The valve of claim 8 wherein said coaptation means is a plurality of stitches lying generally in a plane parallel to the long axis of the stent leg and passing through said plurality of holes and said tissue leaflets and which are tied off above the tips of said stent legs.

11. The valve of claim 10 wherein each said tab has two holes therein and wherein said coaptation stitches define figure eight patterns through said holes.

12. The valve of claim 6 wherein the distance that said tab means projects inwardly toward the center of said aperture is restricted to a distance which substantially eliminates touching between the tissue leaflets and the bottom surfaces of said tab means.

13. The valve of claim 8 wherein the distance that said tab means project inwardly toward the center of said aperture from the edge of said holes closest to the center of said aperture is restricted to a distance which substantially eliminates touching between the tissue leaflets and the bottom of said tabs means.

14. The valve of claim 8 wherein the distance that said tab means projects inwardly toward the center of said aperture from the edge of said holes closest to the center of said aperture is a maximum of forty thousandths of an inch for the uncovered stent.

15. The valve of claim 6 wherein the widths of said tab means remains constant throughout its height irrespective of the width of said stent legs.

16. The valve of claim 6 wherein the width of said tab means remains constant throughout its length while the width of said stent legs increases at points farther from the tips of said stent legs.

17. The valve of claim 8 wherein the width of said tab means decreases at points farther from the tips of said stent legs irrespective of the width of said stent legs.