Stented bioprosthetic heart valve

• US 6,350,282 B1
• Filed: 12/11/1995
• Issued: 02/26/2002
• Est. Priority Date: 04/22/1994
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Eberhardt, Carol E.
• Primary Examiner(s): Milano, Michael
• Application Number:
  US08/570,373
• Time in Patent Office: 2,269 Days
• Field of Search: 623/2, 623/900, 623/2.13, 623/2.14, 623/2.15, 623/2.16, 623/2.17, 623/2.18, 623/2.19
• US Class Current: 623/2.13
• 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 2/2415 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 supported bioprosthetic heart valve is provided. The valve includes a stent and a bilogical valve member. The stent has an annular frame defined by a support rail. The support rail is formed to define a triad of axially-projecting circumferentially-spaced commissure posts, each post having an inverted U-shaped configuration and a pair of legs. Each of the pair of legs has an upper end and a lower end. The lower end of each leg merges smoothly with the lower end of a leg of an adjacent commissure post. A sleeve having an inflow end and an outflow end is fitted around the annular frame. The biological valve member is defined by a tubular wall and three leaflets, the three leaflets being attached to the tubular wall and axially converging along three commissures. The biological valve member has a shape which fits the contour of the support rail and is disposed under the support rail. The biological valve member is sutured to the support rail and the outflow end of the sleeve. The bioprosthetic valve member also includes a suturing cuff which is not rigidly attached to the support rail allowing the valve to expand and contract in the lateral direction. The suturing cuff is formed by wrapping the inflow end of the sleeve around a ring-shaped cushion and suturing the sleeve to itself encapsulating thus the ring-shaped cushion. An inflow support ring may also be provided within the suturing cuff for added lateral support.

Claims

1. A supported bioprosthetic heart valve having an inflow and and outflow side, the heart valve comprising:

a) a stent having an annular frame defined by a support rail, the support rail having an inflow and an outflow side corresponding to the inflow and outflow sides of the heart valve, the annular frame defining relatively exterior and interior directions;

b) a biological valve member defined by a tubular wall and a plurality of leaflets, the plurality of leaflets being attached to the tubular wall and axially converging along commisures of the plurality of leaflets, the biological valve member extending

i) from the outflow side of the heart valve toward the outflow side of the heart valve and ending at the inflow side of the support rail; and

ii) not extending around the support rail; and

c) a sleeve fitted around and tangentially exterior to the annular frame, the sleeve having an inflow end and an outflow end, the outflow end being folded interiorly over the support rail and secured to the support rail along the entire annular perimeter of the support rail such that a recess is formed along the entire annular perimeter of the support rail directly underneath the support rail, the sleeve also secured to the biological valve member such that an outflow end of the tubular wall of the biological valve member is secured to the sleeve within the recess directly underneath the entire annular perimeter of the support rail and whereby the overall thickness of the valve wall at the tubular wall of the biological valve member includes the thickness of the biological valve member and the sleeve and does not include the thickness of the support rail.

2. The supported bioprosthetic heart valve of claim 1, in which the inflow end of the sleeve is folded upon itself and sutured in place to form a suturing cuff.

3. The supported bioprosthetic heart valve of claim 1, further comprising a ring shaped cushion disposed around the sleeve at the inflow end.

4. The supported bioprosthetic heart valve of claim 3, in which the inflow end of the sleeve is wrapped around the ring-shaped cushion and sutured to itself to encapsulate the ring-shaped cushion and form a suturing cuff.

5. The supported bioprosthetic heart valve of claim 3, further comprising an inflow support ring disposed around the sleeve at the inflow end adjacent to the ring-shaped cushion.

6. The supported bioprosthetic heart valve of claim 5, in which the inflow end of the sleeve is wrapped around the ring-shaped cushion and the inflow support ring and sutured to itself to encapsulate the ring-shaped cushion and inflow support ring to form a suturing cuff.

7. The supported bioprosthetic heart valve of claim 1, in which the support rail comprises a triad of axially-projecting circumferentially-spaced commissure posts, each commissure post having an inverted U-shaped configuration comprising a rounded upper end and a pair of legs, each of the pair of legs comprising an upper end and a lower end, the lower end of each leg curving outwardly and merging smoothly with the lower end of a leg of an adjacent commissure post.

8. The supported bioprosthetic heart valve of claim 1 wherein the folded sleeve is secured to the support rail along a perimeter of the support rail by suturing an outer portion of the sleeve to the folded portion of the sleeve.

9. The supported bioprosthetic heart valve of claim 1 wherein the tubular wall of the biological valve member is secured to the sleeve within the recess by a suture through the tubular wall of the biological valve member, around the support rail and back through the tubular wall.

10. A supported bioprosthetic heart valve having an inflow and an outflow side, the heart valve comprising:

a) a stent having an annular frame defining relatively exterior and interior directions, and including a support rail, the support rail having a contour defined by a triad of axially-projecting circumferentially-spaced commissure posts, the support rail having an inflow and an outflow side corresponding to the inflow and outflow sides of the heart valve;

b) a biological valve member having an inflow end and an outflow end, a tubular wall and three leaflets, the three leaflets being attached to the tubular wall and axially converging along three commissures, the tubular wall of the biological valve member extending from the inflow side of the heart valve toward the outflow side of the heart valve and ending at the inflow side of the support rail in a shape that conforms to the shape of the support rail, but not extending around, the support rail; and

c) a sleeve fitted around and tangentially exterior to the annular frame, the sleeve having an inflow end and an outflow end, the outflow end being folded interiorly over the support rail and secured to the support rail along the entire annular perimeter of the support rail such that a recess is formed along the entire annular perimeter of the support rail directly underneath the support rail, the sleeve also secured to the biological valve member such that an outflow end of the tubular wall of the biological valve member is secured to the sleeve within the recess directly underneath the entire annular perimeter of the support rail and whereby the overall thickness of the valve wall at the tubular wall of the biological valve member includes the thickness of the biological valve member and the sleeve and does not include the thickness of the support rail.

11. The supported bioprosthetic heart valve of claim 10, in which the inflow end of the sleeve is folded upon itself and stitched in place to form a cuff that is not rigidly attached to the support rail so that the valve may expand and contract in a lateral direction.

12. The support bioprosthetic heart valve of claim 10, further comprising a ring-shaped cushion disposed around the sleeve at the inflow end.

13. The supported bioprosthetic heart valve of claim 12, in which the inflow end of the sleeve is wrapped around the ring-shaped cushion and sutured to itself to encapsulate the ring-shaped cushion and form a suturing cuff that is not rigidly attached to the support rail so that the valve may expand and contract in a lateral direction.

14. The supported bioprosthetic heart valve of claim 12, further comprising an inflow support ring disposed around the sleeve at the inflow end adjacent to the ring-shaped cushion.

15. The supported bioprosthetic heart valve of claim 14, in which the inflow end of the sleeve is wrapped around the ring-shaped cushion and the inflow support ring and is sutured to itself to encapsulate the ring-shaped cushion and inflow support ring and form a supported suturing cuff that is not rigidly attached to the support rail so that the valve may expand and contract in a lateral direction.

16. The supported bioprosthetic heart valve of claim 10 wherein the folded sleeve is secured to the support rail along a perimeter of the support rail by suturing an outer portion of the sleeve to the folded portion of the sleeve.

17. The supported bioprosthetic heart valve of claim 10 wherein the tubular wall of the biological valve member is secured to the sleeve within the recess by a suture through the tubular wall of the biological valve member, around the support rail and back through the tubular wall.