Low profile prosthetic xenograft heart valve

• US 4,388,735 A
• Filed: 11/03/1980
• Issued: 06/21/1983
• Est. Priority Date: 11/03/1980
• Status: Expired due to Term

• Current Assignee: Sorin Biomedical, Inc. (Snia SpA)
• Original Assignee: Shiley Incorporated
• Inventors: Lenker, Jay A., Rosenbluth, Robert F., Seiler, Louis Jr., Ionescu, Marian I.
• Primary Examiner(s): FRINKS, RONALD
• Application Number:
  US06/203,804
• Time in Patent Office: 960 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

Prosthetic heart valves comprising an annular, right cylindrical, metal stent covered with fabric to which a glutaraldehyde-stabilized pericardial valving element formed of three leaflets, each having a plateau on a truncated triangle extending higher at the center than at the edges, and formed as a cylinder having a diameter substantially equal to the diameter of the stent, and having a low profile is disclosed.

Claims

1. A prosthetic heart valve comprising:

a stent comprising an annular base integrally formed with three legs extending upwardly a distance H from the lowermost portion of the base, the space between the legs configured to form generally elliptically shaped scallops having a depth U measured from the top of the posts to the bottom of the scallop, the stent circumferentially forming a substantially right cylinder having an interior diameter D with the legs extending parallel to the axis of the cylinder, to the lower edge of the stent forming scallops corresponding generally to the arc of the scallops between the legs, the scallops of the lower edge of the base and the scallops between the legs vertically defining three generally elliptically shaped one-third portions of the base between the respective upright legs;

fabric covering totally encompassing and following the configuration of the stent;

an annular sewing ring attached to the fabric covering, extending outwardly from the base;

a tissue valve element formed of three tissue leaflets joined to form a generally cylindrical three-cusp valving element, each leaflet having a top edge forming a raised truncated triangular form with a central plateau, the sides diverging from each side of the plateau to corners adjacent sides of the leaflet;

means attaching the tissue valve element around the fabric covered stent; and

a coaptation stitch through the tissue leaflets adjacent the upper edge thereof disposed directly above the top of the fabric covered stent legs fixing the leaflets to form three cusps with said plateau extended upwardly midway between the legs, the upper edges of the cusps meeting in the closed position of the valve with the plateaus adjacent each other, and in the open position of the valve the tissue valve element forming a cylinder having an inside diameter at the top of the valve substantially equal to the inside diameter of the fabric covered stent.

2. The prosthetic heart valve of claim 1 wherein the ratio U/D is from 0.5 to 0.65.

3. The prosthetic heart valve of claim 2 wherein the ratio U/D is from about 0.55 to about 0.62.

4. The prosthetic heart valve of claim 3 wherein the width of the area of coaptation of the cusps in the closed position is about 0 to 1 mm in the center and about 3 to 7 mm halfway between the center of the valve and the coaptation stitch.

5. The prosthetic heart valve of claim 1 wherein the sewing ring extends outwardly circumferentially forming an annulus vertically following the scalloped curvature of the base of the stent.

6. The prosthetic heart valve of claim 5 wherein the ratio U/D is from about 0.50 to about 0.65.

7. The prosthetic heart valve of claim 6 wherein the ratio U/D is from about 0.55 to about 0.62.

8. In a xenograft heart valve prosthesis which comprises a circumferentially annular stent having an annular base and legs extending vertically from the base toward the outflow end of the valve, a sewing ring circumferentially attached annularly to the outside of the stent, and a three-cusp tissue valve element attached to the stent, the improvement wherein the valve element comprises three tissue leaflets joined to form a generally cylindrical valve element having three truncated triangular portions extending centrally of each of the cusps respectively toward the outflow end of the valve each having a plateau centrally between the legs extending in the outflow direction of the valve beyond the ends of the legs, the valve element forming in the open position a cylinder having three truncated triangles on the outflow end thereof and in the closed position three cusps arcing inwardly between the legs, the outflow end of the leaflets touching with the three plateaus adjacent each other in the center of the outflow end of the valve.

9. The prosthesis of claim 8 wherein the cusps of the valve lay in face-to-face contact along a radial line from the legs to the center, the width of the contact being from 0 to 2 mm in the center of the valve and from about 3 to about 7 mm about halfway between the center and the leg of the stent.

10. The prosthesis of claim 8 wherein the stent circumferentially is in the form of a right cylinder of constant diameter.

11. The prosthesis of claim 8 wherein the distance U from the inflow end of the stent to the bottom of the scallop on the outflow end of the stent is from about 0.50 to about 0.62 of the inside diameter of the stent.

12. In a xenograft heart valve prosthesis which comprises a circumferentially annular stent having an inflow end and an outflow end, the stent including an annular base and legs extending in the outflow direction therefrom, three outflow end scallops, an annular sewing ring attached to and surrounding the stent, and a tissue valving member around and attached to the stent to form a three-cusp valve, the cusps being located, respectively, in the scallops between the respective three legs, the improvement wherein the depth U of the scallops, as measured from the bottom of scallops on the outflow edge of the stent to the outflow end of the legs, is from 0.50 to about 0.65 of the internal diameter D of the stent and wherein said valving member is formed to have three truncated triangular portions converging to three plateaus.

13. The prosthesis of claim 12 wherein the stent is circumferentially a right cylinder of constant diameter measured at both the inflow and outflow ends thereof.

16. The prosthesis of claim 12, 13, 14 or 15 wherein U is from about 0.55 to about 0.62 of D.

17. The prosthesis of claim 12, 13, 14 or 15 wherein the cusps of the valve lay in face-to-face contact along a radial line from the legs to the center, the width of the contact being from 0 to 2 mm in the center of the valve and from about 3 to about 7 mm about halfway between the center and the leg of the stent.

14. In a xenograft heart valve prosthesis which comprises a circumferentially annular stent having an inflow end and an outflow end, the stent including an annular base and legs extending in the outflow direction therefrom, three outflow end scallops, an annular sewing ring attached to and surrounding the stent, and a tissue valving member around and attached to the stent to form a three-cusp valve, the cusps being located, respectively, in the scallops between the respective three legs, the improvement wherein the depth U of the scallops as measured from the bottom of scallops on the outflow edge of the stent to the outflow end of the legs, is from 0.50 to about 0.65 of the internal diameter D of the stent and wherein said stent is circumferentially a right cylinder of constant diameter measured at both the inflow and outflow ends thereof and wherein the tissue valving member is generally cylindrical in form and is formed to have three truncated triangular portions extending from the outflow end thereof intermediate between the legs forming three plateaus which lie adjacent each other when the valve is closed.

15. The prosthesis of claim 14 further comprising fabric enclosing and conforming to the stent, the sewing ring and the valving member being attached to the fabric.

18. In a xenograft heart valve prosthesis which comprises a circumferentially annular stent having an annular base and legs extending vertically from the base toward the outflow end of the valve, a sewing ring circumferentially attached annularly to the outside of the stent, and a three-cusp tissue valve element attached to the stent, the improvement wherein the valve element comprises a generally cylindrical tissue valve element having an inflow end and an outflow end, the outflow end of the valve element comprising three substantially equal portions, each of said portions having a truncated triangular edge forming a central plateau edge which extends centrally of such portion toward the outflow end of the valve, being positioned intermediate the legs of the stent, the valve element forming in the open position a cylinder with three plateaus on the outflow end thereof and in the closed position three cusps arcing inwardly between the legs, the outflow ends of the leaflets touching each other, the three plateaus adjacent each other in the center of the outflow end of the valve.

19. The prosthesis of claim 18 wherein the cusps of the valve lay in face-to-face contact along a radial line from the legs to the center, the width of the contact being from 0 to 2 mm in the center of the valve and from about 3 to about 7 mm about halfway between the center and the leg of the stent.

20. The prosthesis of claim 18 further comprising a coaptation stitch adjacent the top of each leg and wherein the width of the area of coaptation of the cusps in the closed position is about 0 to 1 mm in the center and about 3 to 7 mm halfway between the center of the valve and the coaptation stitch.

21. In a xenograft heart valve prosthesis which comprises a circumferentially annular stent having an inflow end and an outlfow end, the stent including an annular base and legs extending in the outflow direction therefrom, three outflow and scallops, an annular sewing ring attached to and surrounding the stent, and a tissue valving member around and attached to the stent to form a three-cusp valve, the cusps being located, respectively, in the scallops between the respective three legs, the improvement wherein the depth U of the scallops, as measured from the bottom of scallops on the outflow edge of the stent to the outflow end of the legs, is from 0.50 to about 0.65 of the inside diameter D_in of the stent;

the stent is circumferentially measured at both the inflow and outflow ends thereof, the cusps of the valve being in face-to-face contact along a radial line from the legs to the center, the width of the contact being from 0 to 2 mm in the center of the valve and from about 3 to about 7 mm about halfway between the center and the leg of the stent.

22. In a xenograft heart valve prosthesis which comprises a circumferentially annular stent having an inflow end and an outflow end, the stent including an annular base and legs extending in the outflow direction therefrom, outflow end scallops, an annular sewing ring attached to and surrounding the stent, and a tissue valving member attached to the stent to form valve cusps, the cusps being located, respectively, in the scallops between the respective legs of the stent, the improvement wherein tissue cusps are formed of tissue fixed in the unstressed state, and wherein:

said stent comprises an annular base integrally formed with three legs extending upwardly a distance H from the lowermost portion of the base, the space between the legs configured to form generally elliptically shaped scallops having a depth U measured from the top of the posts to the bottom of the scallop, the stent circumferentially forming a substantially right cylinder having an interior diameter D with the legs extending parallel to the axis of the cylinder, to the lower edge of the stent forming scallops corresponding generally to the arc of the scallops between the legs, the scallops of the lower edge of the base and the scallops between the legs vertically defining three generally elliptically shaped one-third portions of the base between the respective upright legs;

including fabric covering totally encompassing and following the configuration of the stent;

the annular sewing ring being attached to the fabric covering, extending outwardly from the base;

the tissue valving member being formed of three tissue leaflets joined to form a generally cylindrical three-cusp valving element, each leaflet having a top edge forming a raised truncated triangular form with a central plateu, the sides diverging from each side of the plateau to corners adjacent to sides of the leaflet;

including means attaching the tissue valve element around the fabric covered stent; and

also including a coaptation stitch through the tissue leaflets adjacent the upper edge thereof disposed directly above the top of the fabric covered stent legs fixing the leaflets to form three cusps with said plateau extended upwardly midway between the legs, the upper edges of the cusps meeting in the closed position of the valve with the plateaus adjacent each other, and in the open position of the valve the tissue valve element forming a cylinder having an inside diameter at the top of the valve substantially equal to the inside diameter of the fabric covered stent.

23. The prosthetic heart valve of claim 22 wherein the ratio U/D is from 0.5 to 0.65.

24. The prosthetic heart valve of claim 22 wherein the ratio U/D is from about 0.55 to about 0.62.

25. The prosthetic heart valve of claim 22 wherein the width of the area of coaptation of the cusps in the closed position is about 0 to 1 mm in the center and about 3 to 7 mm halfway between the center of the valve and the coaptation stitch.

26. In a xenograft heart valve prosthesis which comprises a circumferentially annular stent having an inflow end and an outflow end, the stent including an annular base and legs extending in the outflow direction therefrom, outflow end scallops, an annular sewing ring attached to and surrounding the stent, and a tissue valving member attached to the stent to form valve cusps, the cusps being located, respectively, in the scallops between the respective legs of the stent, the valving member comprising three tissue lejaflets joined to form a generally cylindrical valve element having three truncated triangular portions extending centrally of each of the cusps respectively toward the outflow end of the valve each having a plateau centrally between the legs extending in the outflow direction of the valve beyond the ends of the legs, the valve element forming in the open position a cylinder having three truncated triangles on the outflow end thereof and in the closed position three cusps arcing inwardly between the legs, the outflow end of the leaflets touching with the three plateaus adjacent each other in the center of the outflow end of the valve.

27. The prosthesis of claim 26 wherein the cusps of the valve lay in face-to-face contact along a radial lines from the legs to the center, the width of the contact being from 0 to 2 mm in the center of the valve and from about 3 to about 7 mm about halfway between the center and the leg of the stent.

28. The prosthesis of claim 26 wherein the stent circumferentially is in the form of a right cylinder of constant diameter.

29. The prosthesis of claim 26 wherein the distance U from the inflow end of the stent to the bottom of the scallop on the outflow end of the stent is from about 0.50 to about 0.62 of the inside diameter of the stent.

30. The xenograft heart valve prosthesis of claim 26 wherein the depth of the scallops, as measured from the bottom of scallops on the outflow edge of the stent to the outflow end of the legs, is from 0.50 to about 0.65 of the internal diameter of the stent.

31. The prosthesis of claim 30 wherein the stent is circumferentially a right cylinder of constant diameter measured at both the inflow and outflow ends thereof.

32. In a xenograft heart valve prosthesis which comprises a circumferentially annular stent having an inflow end and an outflow end, the stent including an annular base and legs extending in the outflow direction therefrom, outflow end scallops, an annular sewing ring attached to and surrounding the stent, and a tissue valving member attached to the stent to form valve cusps, the cusps being located, respectively, in the scallops between the respective legs of the stent, the improvement wherein tissue cusps are formed of tissue fixed in the unstressed state and wherein the depth of the scallops, as measured from the bottom of scallops on the outflow edge of the stent to the outflow end of the legs, is from 0.50 to about 0.65 of the internal diameter of the stent, and wherein the tissue valving member is generally cylindrical in form and is formed to have three truncated triangular portions extending from the outflow end thereof intermediate between the legs forming three plateaus which lie adjacent each other when the valve is closed.

33. In a xenograft heart valve prosthesis which comprises a circumferentially annular stent having an inflow end and an outflow end, the stent including an annular base and legs extending in the outflow direction therefrom, outflow end scallops, an annular sewing ring attached to and surrounding the stent, and a tissue valving member attached to the stent to form valve cusps, the cusps being located, respectively, in the scallops between the respective legs of the stent, the improvement wherein tissue cusps are formed of tissue fixed in the unstressed state and wherein the valving member comprises a generally cylindrical tissue valve element having an inflow end and an outflow end, the outflow end of the valve element comprising three substantially equal portions, each of said portions having a truncated triangular edge forming a central plateau edge which extends centrally of such portion toward the outflow end of the valve, being positioned intermediate the legs of the stent, the valve element forming in the open position a cylinder with three plateaus on the outflow end thereof and in the closed position three cusps arcing inwardly between the legs, the outflow ends of the leaflets touching each other, the three plateaus adjacent each other in the center of the outflow end of the valve.

34. The prosthesis of claim 33 wherein the cusps of the valve lay in face-to-face contact along a radial line from the legs to the center, the width of the contact being from 0 to 2 mm in the center of the valve and from about 3 to about 7 mm about halfway between the center and the leg of the stent.