Flexible heart valve and associated connecting band

• US 7,993,393 B2
• Filed: 09/10/2009
• Issued: 08/09/2011
• Est. Priority Date: 01/26/1999
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Frater, Robert, Recktenwald, William J., Rhee, Richard S., Lam, Hung Ly, Schreck, Stefan G., Carpentier, Alain F., Nguyen-Thien-Nhon, Diana
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): STROUD, JONATHAN R
• Application Number:
  US12/557,404
• Publication Number:
  US 20100057193A1
• Time in Patent Office: 698 Days
• Field of Search: 623/2.18
• US Class Current: 623/2.14
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A highly flexible tissue-type heart valve is disclosed having a structural stent in a generally cylindrical configuration with cusps and commissures that are permitted to move radially. The stent commissures are constructed so that the cusps are pivotably or flexibly coupled together at the commissures to permit relative movement therebetween. The stent may be cloth-covered and may be a single element or may be made in three separate elements for a three cusp valve, each element having a cusp portion and two commissure portions; adjacent commissure portions for each pair of adjacent stent element combining to form the stent commissures. If the stent has separate elements their commissure portions may be pivotably or flexible coupled, or may be designed to completely separate into independent leaflets at bioresorbable couples. The cloth covering may have an outwardly projecting flap that mates with valve leaflets (e.g., pericardial leaflets) along the cusps and commissures. A connecting band may be provided that follows the cusps and commissures and extends outwardly. The valve is connected to the natural tissue along the undulating connecting band using conventional techniques, such as sutures. The connecting band may be a cloth-covered silicon member and attaches to the underside of the valve at the cusps to provide support to the stent and to the outer side of the valve at the commissures. The connecting band includes commissure portions defining generally axial gaps that help permit flexing of the valve.

Claims

1. A suture-permeable connecting band formed of a silicone rubber inner member surrounded by a cloth cover, the connecting band having cusp portions separated by three upstanding commissure portions and attached to the stent/leaflet sub-assembly to provide outer free margins in the assembled heart valve and a flexible interface for suturing the valve to surrounding host tissue, wherein the connecting band closely conforms to the alternating stent cusps and commissures and defines an axial gap along the commissure portions opening to the inflow direction for enhancing freedom of movement of the stent cusps, the axial gap extending substantially the length of each commissure portion such that there is no structural connection between adjacent cusp portions except at an arcuate outflow tip of each commissure portion located approximately at the level of commissure tips of the flexible stent, wherein the outer free margins of the connecting band are angled upwardly and outwardly with respect to a central axis of the connecting band at each cusp portion and gradually re-align to be parallel to the central axis along the commissure portions.

2. The prosthetic heart valve of claim 1, wherein there are three stent cusps and three commissures.

3. The prosthetic heart valve of claim 1, wherein the cusp portions of the connecting band each define an inner generally radially oriented ledge for receiving and supporting the stent cusps.

4. The prosthetic heart valve of claim 1, wherein the stent comprises a fabric covered rod-like structure.

5. The prosthetic heart valve of claim 4, wherein the fabric covering closely surrounds the rod-like structure and exhibits a flap projecting outward therefrom substantially the entire length of the stent cusps and commissures to which leaflets attach.

6. The prosthetic heart valve of claim 5, wherein the flap has a width that varies along the cusps and commissures of the stent, the flap being narrower adjacent the stent cusps than adjacent the stent commissures.

7. The prosthetic heart valve of claim 5, wherein the leaflets each have an arcuate cusp edge and a coapting edge, and wherein the cusp edges of the leaflets attach between the connecting band and the fabric covering flap.

8. A highly flexible prosthetic heart valve, consisting essentially of:

a flexible elongated stent formed generally in a tube with cusps on an inflow end alternating with commissure tips on an outflow end to form an undulating periphery, the stent having commissure regions on either side of each cusp wherein the commissure tips join adjacent commissure regions and the juxtaposed commissure regions define axial spaces therebetween that extend substantially the length of the adjacent commissure regions such that there is no structural connection between the adjacent commissure regions except at the respective commissure tip;

a plurality of flexible leaflets attached to the stent so as to form a one-way valve within the stent, each leaflet defining a cusp margin; and

a suture-permeable band attached and conforming to the undulating periphery of the stent and defining an axial gap opening to the inflow direction for enhancing freedom of movement of the stent cusps, the band supporting the stent on an inflow side of each cusp thereof and attaching to the outside of the stent at each commissure tip and providing suture-permeable interface between the assembled valve and surrounding host tissue, wherein the band includes arcuate cusp portions generally conforming to the stent cusps and commissure portions therebetween providing a suturing platform for connecting the heart valve to an anatomical orifice at each commissure tip, wherein the cusp margins of each leaflet are sandwiched between the stent cusps and the suture-permeable band.

9. The prosthetic heart valve of claim 8, wherein the commissure portions of the band each have an inverted U-shape.

10. The prosthetic heart valve of claim 8, wherein the commissure portions of the band are generally planar and axially aligned, and the cusp portions of the band each include an outwardly angled portion and an inwardly angled ledge sized to support the stent cusps.

11. The prosthetic heart valve of claim 10, wherein the inwardly angled ledges of the cusp portions of the band are sized to extend underneath the stent cusps.

12. The prosthetic heart valve of claim 10, wherein the suture-permeable band has a free margin for connecting the heart valve to an anatomical orifice including the outwardly angled portions at the cusp portions and generally axially-oriented margins at the commissure portions.

13. The prosthetic heart valve of claim 8, wherein the axial spaces of the stent are generally triangular and gradually increase in size from the attached commissure tips to the diverging cusps.

14. The prosthetic heart valve of claim 8, further comprising a fabric covering on the stent that exhibits a flap projecting outward therefrom substantially the entire length of the undulating periphery.

15. The prosthetic heart valve of claim 14, wherein the leaflets each have an arcuate cusp edge including the cusp margins and a coapting edge, and wherein the cusp edges of the leaflets attach between the suture-permeable band and the fabric covering flap.

16. A prosthetic heart valve, comprising:

A flexible stent having alternating inflow cusps and outflow commissures, wherein the stent comprises a fabric covered rod-like structure, wherein the fabric covering closely surrounds the rod-like structure and exhibits a flap projecting outward therefrom substantially the entire length of the stent cusps and commissures;

a plurality of flexible leaflets having cusp margins attached to the flap of the fabric covering the stent so as to form a stent/leaflet sub-assembly and a one-way valve within the stent; and

a suture-permeable connecting band attached to the stent providing an interface between the valve and surrounding host tissue, wherein the leaflet cusp margins attach between the suture-permeable connecting band and the fabric flap of the stent, and wherein the connecting band conforms to the alternating stent cusps and commissures and has arcuate cusp portions alternating with U-shaped commissure portions, the connecting band defining an axial gap below the U-shaped commissure portions for enhancing freedom of movement of the stent cusps.

17. The prosthetic heart valve of claim 16, wherein the cusp portions each define an inner generally radially oriented ledge for receiving and supporting the stent cusps.

18. The prosthetic heart valve of claim 16, wherein the connecting band includes an outer free margin along a periphery thereof for connecting the heart valve to an anatomical orifice.

19. The prosthetic heart valve of claim 18, wherein the connecting band outer free margin angles upwardly and outwardly with respect to a central axis of the connecting band at each cusp portion and gradually re-aligns to be parallel to the central axis along the commissure portions.

20. The prosthetic heart valve of claim 16, wherein the leaflets each have an arcuate cusp edge and a coapting edge, and wherein the cusp edges of the leaflets attach between the connecting band and the fabric covering flap.

21. The connecting band of claim 16, wherein the fabric covering flap has a width that varies along the cusps and commissures of the stent, the flap being narrower adjacent the stent cusps than adjacent the stent commissures.