Prosthetic tissue heart valve

• US 4,084,268 A
• Filed: 04/22/1976
• Issued: 04/18/1978
• Est. Priority Date: 04/22/1976
• Status: Expired due to Term

• Current Assignee: Sorin Biomedical, Inc. (Snia SpA)
• Original Assignee: Shiley Laboratories Incorporated
• Inventors: Ionescu, Marian I., Fettel, Bruce E.
• Primary Examiner(s): Frinks, Ronald L.
• Application Number:
  US05/679,406
• Time in Patent Office: 726 Days
• Field of Search: 3/1.5, 3/1
• US Class Current: 623/2.15
• 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 2/2418 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

A tissue heart valve has a cloth-covered stent which provides several layers of padding over the stent edges and an integral sewing ring while maximizing the internal valve diameter for a given size heart annulus. No edges of the cloth are exposed. A continuation of the pledget covers all knots of the stitches connecting the tissue to the stent.

Claims

1. A prosthetic heart valve comprising:

a stent having an annular base and upright posts;

tissue valve means circumscribing said stent posts;

thread extending through said tissue stitching said tissue to said posts, said thread being twisted into knots outside the tissue;

a first layer of fabric extending along each said post outside said tissue;

said thread also stitching said first layer to said posts;

a second layer of fabric covering said knots which are located between said first and second layers; and

said first and second layers of fabric being a narrow pledget strip which is integral and continuous and folded back on itself over the knots.

2. A prosthetic heart valve in accordance with claim 1 and further comprising:

cloth fabric covering said post between said post and said tissue.

3. A prosthetic heart valve in accordance with claim 1 wherein:

said tissue is formed generally in a cylindrical shape circumscribing the posts of said stent as a group and is tacked around each individual post to form cusps for closing the valve passage.

4. A cloth covered stent for a prosthetic heart valve comprising:

a stent having an annular base and plural upright posts;

cloth fabric covering the interior surface of said stent;

cloth fabric covering the exterior surface of said stent;

a cylindrical tissue valve circumscribing said stent posts and said exterior cloth fabric;

said interior fabric being tightly wrapped around the bottom edge of said stent covering the bottom edge of said exterior fabric, and preventing loose cloth at the bottom edge.

5. A cloth covered stent in accordance with claim 4 and further comprising:

said interior fabric where wrapped around the bottom edge of said stent extending over the bottom edge of said tissue valve to cover said edge, and forming an integral annular sewing ring for grafting the stent onto a heart annulus.

6. A stent in accordance with claim 5 and said sewing ring further comprising:

an annular fabric pad circumscribing the stent base;

said interior fabric extending from its wrap around the bottom edge of the stent to wrap around the fabric pad and terminating in an edge adjacent said pad entirely covered by a layer of its own fabric.

7. A stent in accordance with claim 4 wherein:

said bottom edge of the exterior fabric is doubled over the bottom edge of the stent to form two layers of cloth cover tight against said bottom edge in addition to the layer of the covering interior fabric.

8. A stent in accordance with claim 4 wherein:

said interior and exterior fabrics are folded tightly over the top edge of said stent to form three layers of cloth covering over said edge.

9. A stent in accordance with claim 8 wherein:

said fabric is folded over the outer surface of the stent adjacent its top edge to form three layers of cloth on said outer surface adjacent the top edge.

10. A stent in accordance with claim 4 wherein:

at least partway around the stent the interior and exterior fabric are integral.

11. A stent in accordance with claim 4 wherein:

said fabric is folded around the posts of said stent to form three layers of fabric on the outside of each post.

12. A stent in accordance with claim 4 and further comprising:

a second layer of fabric on the interior of said posts.

13. A cloth covered stent for a prosthetic heart valve comprising:

a thin-walled stent having an annular base and plural upright posts, said stent having upper and lower edges;

a layer of cloth fabric covering the exterior surface of said stent;

a cylindrical tissue valve circumscribing said stent and said exterior fabric;

a layer of cloth fabric covering the interior surface of said stent;

three layers of cloth fabric tightly wrapped over and covering the upper edge of said stent;

three layers of cloth fabric tightly wrapped over and covering the lower edge of said stent;

the bottom portion of the stent base which fits in the heart annulus having only one layer of cloth covering the interior and only two layers covering the exterior; and

said fabric having no edges exposed.

14. A prosthetic heart valve comprising:

a thin-walled, rigid stent having an annular base and three equally spaced upright posts extending axially from said base;

the upper edge of said stent being scalloped in a smooth curve between said posts;

the bottom edge of said stent being scalloped with the high points on the scallops beneath the respective posts;

said stent base having a plurality of holes therethrough spaced around its circumference;

each said stent post having a plurality of holes therethrough spaced along its length;

three pieces of exterior Dacron velour fabric each covering the exterior of a post and of the base adjacent the post;

each of said three pieces of exterior fabric being wrapped over the upper edge of the stent in a single layer and being folded over the bottom edge of the stent in a double layer;

an interior Dacron velour fabric covering the interior surface of the stent;

said interior fabric being folded over the top edge of the stent in a double layer where covered by the interior fabric;

said interior fabric being folded over the top edge of the stent in a triple layer and also extending down to cover the exterior surface of the stent base where not covered by the exterior fabric and terminating in a double fold over the bottom edge of the stent base;

the portion of the interior fabric folded over the upper edge of the stent also providing second and third layers of fabric on the exterior of the stent posts over the holes through the posts and along the outer surface of the stent adjacent its upper edge;

a fabric sewing pad between the interior surface of each post at the holes through the post and interior fabric;

a generally cylindrical valve element of bovine pericardium tissue circumscribing the stent and fabric cover;

stitches tacking the tissue around each post causing the tissue normally to close in three cusps;

a Teflon fabric pledget strip outside the tissue at each post, each said pledget strip including a first layer adjacent said tissue and a second layer outside first layer, said layers being integrally formed by a fold at the upper end and being stitched together along their long edges;

thread stitches attaching said tissue to said stent through the holes therethrough, all of said thread stitches being knotted between the two layers of said pledget;

the bottom of said interior fabric being wrapped over said double layer of fabric on the bottom edge of the stent and extending outward and upward to form an integral sewing ring;

the sewing ring having an annular three layered pad of Teflon fabric covered by two layers of the interior fabric on the underside and a single layer on the upper side, the edge of said inner fabric being on the inner layer of the two underside layers and covered by the outer layer of said two layers; and

said sewing ring being sewn to said tissue and covering the bottom edges of the pledget.