Single suture biological tissue aortic stentless valve

• US 6,254,636 B1
• Filed: 06/26/1998
• Issued: 07/03/2001
• Est. Priority Date: 06/26/1998
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Peredo, Mario Osvaldo Vrandecic
• Primary Examiner(s): Willse, David H.
• Application Number:
  US09/105,703
• Time in Patent Office: 1,103 Days
• Field of Search: 623/2, 623/900, 623/2.12, 623/2.13, 623/2.14, 623/2.15, 623/2.16
• US Class Current: 623/2.15
• 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 semilunar stentless valve is constructed entirely of biocompatible material, and has a plurality of leaflets that are joined to form an annulus and coapt to form a one-way valve. The leaflets open fully to minimize obstruction. A narrow rim strip overlies commissures where the leaflets join and around a base of the valve. The valve is of a conical design, flexible, easy to fit and preserves the integrity of the coronary sinuses. The valves can be implanted with a single suture row, reducing implant time significantly.

Claims

1. A stentless valve prosthesis made entirely of biological tissue comprising a sheet form of biological tissue cut to provide a plurality of leaflets, each leaflet having edges joined to edges of other leaflets to encircle a flow opening and form a flow passage, the edges extending in a direction along the flow passage and outflow ends of the leaflets being of size to coapt to form a valve, and a narrow rim strip of biological material sutured to the leaflets around an inflow end, the narrow rim strip having post portions extending along commissures formed where the edges of adjacent leaflets join, and overlying and being sutured to the leaflets along the commissures.

2. The valve of claim 1, wherein the plurality of leaflets comprises three leaflets to form a valve, the rim strip comprising a narrow rim of tissue along the inflow end, the leaflets having base peripheries smoothly curved outwardly around a base at the inflow end.

3. The valve of claim 1, wherein an outflow end of the valve has a larger diameter than the inflow end to form a conical shape.

4. A stentless valve prosthesis made entirely of biological material comprising a plurality of leaflets having edges joined along commissures to encircle a flow opening and of size to coapt to form a valve, a separate commissure post supporting leaflets joined at each commissure, a rim strip sutured to the leaflets around an inflow end, the rim strip having a rim post portion extending along each commissure post and sutured to the leaflets and to the commissure posts where adjacent leaflets join.

5. The valve of claim 4, wherein each commissure post has a slot in which mating edges of two adjacent leaflets are positioned, the rim post portions being sutured to ends of the leaflets extending through the respective slot to an exterior of the commissure post.

6. The valve of claim 4, wherein said commissure posts and rim post portions extend in the direction of flow beyond edges of the leaflets at an outflow end.

7. The valve of claim 4, wherein said leaflets are individually formed, and have leaflet portions that extend to an exterior from the commissure posts, said leaflet portions being covered by the rim post portions when the rim post portions are sutured to the commissure posts.

8. A stentless tissue valve prosthesis, comprising a plurality of three substantially identically constructed leaflets of biological tissue, said leaflets having outflow edges at outflow ends that are substantially straight, and inflow edges that are curved, each leaflet being joined to two other leaflets along commissures extending from an inflow end to an outflow end, thereby forming an interior flow passage, the outflow ends of said leaflets coapting to prevent reverse flow, the curved inflow edges of the leaflets forming a rim for attachment to tissue, a reinforcing strip of biological tissue along the curved inflow edges of the leaflets on an exterior of the leaflets to form a suture reinforcement along the rim, and a separate strip of biological tissue at each commissure secured to hold adjacent leaflets forming the commissures together, a periphery of the valve being defined by the leaflets and the separate strips at each commissure.

9. A stentless tissue valve prosthesis, comprising a plurality of three substantially identically constructed leaflets of biological tissue, said leaflets having outflow edges at outflow ends that are substantially straight, and inflow edges that are curved, each leaflet being joined to two other leaflets along commissures extending from an inflow end to an outflow end, thereby forming an interior flow passage, the outflow ends of said leaflets coapting to prevent reverse flow, the curved inflow edges of the leaflets forming edge portions for attachment to tissue, a plurality of commissure posts, one for each commissure, each commissure post comprising a post of biological tissue having a longitudinal slit therein, said slit being of size to receive two thicknesses of leaflet tissue at a respective commissure, to form a commissure junction between the leaflets, a rim secured to the edge portions of the leaflet and having rim post portions sutured to the commissure posts, the commissure posts and rim post portions being spaced apart so the leaflets are free to move outwardly between the rim post portions.

10. A stentless valve prosthesis comprising a plurality of leaflets having edges joined to encircle a flow opening and of size to coapt to form a valve having commissures formed where adjacent leaflets join, a tissue post sutured at each commissure, the leaflets having base portions curving outwardly from a central axis between the commissures to form an inflow end, and the base portions forming at least a part of a sewing rim for the valve.

11. The stentless valve prosthesis of claim 10, wherein the tissue is bovine pericardial tissue.