TISSUE-TYPE HEART VALVE WITH A GRAFT SUPPORT RING OR STENT

• US 3,714,671 A
• Filed: 11/30/1970
• Issued: 02/06/1973
• Est. Priority Date: 11/30/1970
• Status: Expired due to Term

• Current Assignee: Paul Kahn, Samuel H. Goodenough, William Sterling Edwards
• Original Assignee: Paul Kahn, Samuel H. Goodenough, William Sterling Edwards
• Inventors: Edwards, William Sterling, Kahn, Paul, Goodenough, Samuel H.
• Primary Examiner(s): Gaudet, Richard A.
• Assistant Examiner(s): Frinks, Ronald L.
• Application Number:
  US05/093,545
• Time in Patent Office: 799 Days
• Field of Search: 3/1,DIG.3 128/334R
• US Class Current: 623/2.19
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A tricuspid valve and a graft support ring or stent therefor. The frame of the stent comprises three wire arcs, each formed along a circular or elliptical cylindrical surface. Each arc has an upstanding end portion that blends into a line parallel to the axis of the cylinder. Preferably, each arc is a separate wire, and, an elastomeric coating or a cloth pledget may lie over the meeting ends, which may be welded together. A fabric covering completely surrounds and encloses the frame, the coating or pledget preventing later strike-through of the fabric by the metal during use. The fabric covering preferably provides a pair of radial wings at each post, one extending inwardly and the other one outwardly, and it also provides a continuous projection along the length of the wires for stitching. To this graft support ring is sutured living tissue, preferably autologous or homologous, by stitches to the wings and the continuous projection. A plurality of such tissue members, e.g., fascia lata, is used, one for each wire arc, shaped to provide a cusptype valve. The tissue covers essentially all the surfaces of the fabric on both the inner and outer. faces, so that essentially nothing but tissue is in contact with the blood and body tissues after the valve is installed.

Claims

1. A heart valve stent frame of metal wire formed along a closed-curve cylindrical surface and comprising a plurality of upstanding posts blending into a plurality of arcuately dipped portions, each said post comprising two wire portions, one radially within the other so that the circumferential thickness of each said post is only the width of one said wire portion.

2. The stent frame of claim 1 having a smooth shield covering each said post.

3. The stent frame of claim 2 wherein said shield comprises an elastomeric coating.

4. The stent frame of claim 2 wherein said shield comprises a fabRic pledget.

5. A tricuspid heart valve stent frame, comprising three metal wires, each formed generally along a segment of a closed-curve cylindrical surface, each wire having an upstanding portion at each end parallel to the axis of the cylinder and also having an arcuately dipped intermediate portion, each end of each wire being in-line radially with the end of another said wire and secured to it, whereby the meeting ends lie with one end radially within the other and without increasing the thickness along the cylindrical surface beyond the wire thickness.

6. A tricuspid heart valve stent frame, comprising three identical curved wires disposed in a circular closed figure around a circular cylindrical surface, each wire having an upstanding vertical portion at each end parallel to the axis of the cylinder and having an arcuately dipped intermediate portion, the wire ends of each adjacent pair of wires being welded together radially in line, whereby the meeting ends lie with one end radially within the other without increasing the thickness along the cylindrical surface beyond the wire thickness.

7. The stent frame of claim 6 wherein said welded ends are covered with a smooth shield.

8. The stent frame of claim 7 wherein said shield comprises a coating of silicone elastomer.

9. The stent frame of claim 7 wherein said shield comprises a fabric pledget.

10. A tricuspid graft support ring for valve fabrication and implantation, including in combination:

a frame of metal wire encircling a closed-curved cylindrical surface and having a plurality of upstanding posts blending into a plurality of arcuately dipped intermediate portions, each post comprising two substantially parallel wire portions in-line radially so that the thickness of each post along the circumferential distance is only that of one said wire portion, and a fabric covering completely surrounding said frame and enclosing the frame and providing extension portions for anchoring stitches.

11. The ring of claim 10 for a tricuspid valve having three posts and three arcuately dipped portions and being generally circular in shape.

12. The ring of claim 10 wherein said extension portions of said fabric covering comprise a pair of radial wings at each post, one extending inwardly and one outwardly and a continuous portion along each arcuately dipped portion.

13. The ring of claim 10 wherein said upstanding posts are smoothly covered by shield means to prevent the metal from striking through the fabric.

14. The ring of claim 13 wherein the smooth covering shield means is an elastomeric coating on the wire.

15. The ring of claim 13 wherein the smooth covering shield means is a cloth pledget.

16. The ring of claim 10 wherein said frame comprises three wires secured together, their ends meeting at the posts.

17. A graft support ring for valve transplantation, including in combination:

a frame made up of three metal wires, each formed generally along a segment of a circular cylindrical surface, each wire having an upstanding portion at each end parallel to the axis of the cylinder and having an arcuately dipped intermediate portion, each end of each wire being in line radially with the end of another said wire and secured to it, so that the meeting ends lie with one radially within the other and without adding to the thickness along the cylindrical surface, said meeting ends forming three posts, a shield over each said post, and a fabric covering completely surrounding said frame and enclosing the frame, said shield preventing later strikethrough of the cloth by the metal during use, said fabric covering providing a pair of radial wings at each post for receiving stitches, one extending inwardly and one outwardly, and providing a stitch-receiving projection along said arcuately dipped portions.

18. A tricuspid heart valve, comprising a metal frame formed along a closed-curve cylindrical surface and comprising three upstanding posts blenDing into three arcuately dipped intermediate portions, each said post comprising two wire portions disposed so that one lies radially within the other so that each post is only as wide in a circumferential direction as one said wire portion, a fabric covering completely surrounding said frame and enclosing the frame and providing extension portions for receiving stitches, and three tissue members, one for each said dipped portion shaped to meet in a cusp and provide a tricuspid valve and covering all surfaces of said fabric and frame both inside and out and sutured to said fabric.

19. The heart valve of claim 18 wherein said extensions comprise a substantially continuous extension along each said dipped portion and a pair of radially extending wings at each said post, one extending in radially and the other extending out radially.

20. A heart valve, comprising a frame made up of a plurality of wires, each formed along a circular cylindrical surface, each wire having an upstanding portion at each end blending into a line parallel to the axis of the cylinder and having an arcuately dipped intermediate portion, each end of each wire being in line radially with the end of an adjacent said wire, so that when the ends meet, they lie with one radially within the other and meet without forming a thickness greater than their wire thickness along the cylindrical surface, said meeting ends forming posts, a smooth covering over each said post, a fabric covering completely surrounding said frame and enclosing the frame, said smooth covering preventing later strike-through of the cloth by the metal during use, said fabric covering providing a pair of radial wings at each post, one extending inwardly and one outwardly, and providing a continuous projection along each said arcuately dipped portion, for sewing attachment, and a plurality of tissue members, one for each said wire, shaped to provide a cuspid valve and covering substantially all surfaces of said fabric and wires, both inside and out, and sutured to said fabric wings and said projection.