Flexible heart valve and associated connecting band

• US 7,481,838 B2
• Filed: 12/05/2003
• Issued: 01/27/2009
• Est. Priority Date: 01/26/1999
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Recktenwald, William, Schreck, Stefan G., Carpentier, Alain F., Nguyen-Thien-Nhon, Diana, Rhee, Richard S., Lam, Hung Ly
• Primary Examiner(s): Sweet; Thomas J
• Assistant Examiner(s): Stroud; Jonathan R
• Application Number:
  US10/729,035
• Publication Number:
  US 20040148018A1
• Time in Patent Office: 1,880 Days
• Field of Search: 623/2.14, 623/2.18, 623/1.26, 623/21, 623/2.12, 623/2.17, 623/2.19, 623/2.38, 623/2.4
• US Class Current: 623/2.18
• 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.

Claims

1. A prosthetic heart valve, comprising:

a flexible stent having alternating inflow cusps and outflow commissures;

a plurality of flexible leaflets attached to the stent so as to form a one-way valve within the stent; and

a suture-permeable connecting band attached to the stent providing 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 commissures opening in the inflow direction for enhancing freedom of movement of the stent cusps, and

wherein the stent has bioresorbable commissures and is designed to separate the valve into individual leaflets after implant, and the connecting band is discontinuous at the stent commissures.

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 connecting band includes three cusp portions separated by three upstanding commissure portions, and wherein the cusp portions each define an inner generally radially oriented ledge for receiving and supporting the stent cusps.

4. The prosthetic heart valve of claim 3, 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.

5. The connecting band of claim 1, wherein the stent comprises individual stent members joined with bioresorbable material at abutting commissure regions to form the bioresorbable commissures.

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

7. The prosthetic heart valve of claim 6, 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.

8. The prosthetic heart valve of claim 7, wherein the flap has a width that varies along the cusps and commissures of the stent, the flap being narrower in the cusps.

9. The prosthetic heart valve of claim 7, wherein the leaflets each have an arcuate cusp edge and a coapting edge, and wherein the connecting band attaches along the fabric covering flap and the cusp edges of the leaflets are attached between the band and the stent flap.

10. The prosthetic heart valve of claim 7, wherein the connecting band attaches along the fabric covering flap.

11. The prosthetic heart valve of claim 1, wherein the stent is highly flexible and permits relative radial cusp movement.

12. The prosthetic heart valve of claim 11, wherein the stent is made of Nitinol.

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

a flexible elongated stent formed generally in a tube with cusp regions 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 region wherein the commissure tips join adjacent commissure regions and the juxtaposed commissure regions define axial spaces therebetween;

a plurality of flexible leaflets attached to the stent so as to form a one-way valve within the stent; and

a suture-permeable band having a shape that mimics the alternating stent cusps and commissures and is attached along the undulating periphery of the stent so as to project outward from the stent along the stent cusps and commissures and provide an interface between the assembled valve and surrounding host tissue, and

wherein the stent has bioresorbable commissures and is designed to separate the valve into individual leaflets after implant, and the suture-permeable band is discontinuous at the stent commissures.

14. The prosthetic heart valve of claim 13, wherein the band includes arcuate cusp portions generally conforming to the stent cusp regions and commissure portions therebetween each having an inverted U-shape to define a downwardly opening gap that enhances flexibility of the valve.

15. The prosthetic heart valve of claim 14, 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 cusp regions.

16. The prosthetic heart valve of claim 15, wherein the inwardly angled ledges of the cusp portions of the band are sized to support the stent cusp regions.

17. The prosthetic heart valve of claim 15, wherein the suture-permeable band has a free margin along the undulating periphery for connecting the heart valve to an anatomical orifice.

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

19. The prosthetic heart valve of claim 13, wherein the stent comprises individual stent members joined with bioresorbable material at abutting commissure regions to form the bioresorbable commissures.

20. The prosthetic heart valve of claim 13, further comprising a fabric covering on the stent that exhibits a flap projecting outward therefrom substantially the entire length of the undulating periphery.

21. The prosthetic heart valve of claim 20, further comprising a plurality of flexible leaflets attached to the stent so as to form a one-way valve within the stent wherein the leaflets each have an arcuate cusp edge and a coapting edge, and wherein the suture-permeable band attaches along the fabric covering flap and the cusp edges of the leaflets are attached between the band and the stent flap.

22. The prosthetic heart valve of claim 13, wherein the stent is highly flexible and permits relative radial cusp movement.

23. The prosthetic heart valve of claim 22, wherein the stent is made of Nitinol.

24. A prosthetic heart valve, comprising:

a flexible stent having alternating inflow cusps and outflow commissures;

a plurality of flexible leaflets attached to the stent so as to form 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 connecting band conforms to the alternating stent cusps and commissures and defines an axial gap along the commissures opening in the inflow direction for enhancing freedom of movement of the stent cusps, and

wherein the stent has bioresorbable commissures and is designed to separate the valve into individual leaflets after implant, and the connecting band is discontinuous at the stent commissures.

25. The prosthetic heart valve of claim 24, wherein the connecting band includes cusp portions separated by upstanding commissure portions, and wherein the cusp portions each define an inner generally radially oriented ledge for receiving and supporting the stent cusps.

26. The prosthetic heart valve of claim 24, wherein the connecting band includes cusp portions separated by upstanding commissure portions and an outer free margin along a periphery thereof for connecting the heart valve to an anatomical orifice.

27. The prosthetic heart valve of claim 26, 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.

28. The prosthetic heart valve of claim 24, 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.

29. The prosthetic heart valve of claim 28, wherein the leaflets each have an arcuate cusp edge and a coapting edge, and wherein the connecting band attaches along the fabric covering flap and the cusp edges of the leaflets are attached between the connecting band and the stent flap.

30. 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, and has a width that varies along the cusps and commissures of the stent, the flap being narrower in the cusps;

a plurality of flexible leaflets attached to the stent so as to form 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 connecting band conforms to the alternating stent cusps and commissures and defines an axial gap along the commissures opening in the inflow direction for enhancing freedom of movement of the stent cusps.

31. The prosthetic heart valve of claim 30, wherein the connecting band includes cusp portions separated by upstanding commissure portions, and wherein the cusp portions each define an inner generally radially oriented ledge for receiving and supporting the stent cusps.

32. The prosthetic heart valve of claim 30, wherein the connecting band includes cusp portions separated by upstanding commissure portions and an outer free margin along a periphery thereof for connecting the heart valve to an anatomical orifice.

33. The prosthetic heart valve of claim 32, 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.

34. The prosthetic heart valve of claim 30, wherein the leaflets each have an arcuate cusp edge and a coapting edge, and wherein the connecting band attaches along the fabric covering flap and the cusp edges of the leaflets are attached between the connecting band and the stent flap.