Highly flexible heart valve connecting band

• US 20060229719A1
• Filed: 04/06/2005
• Published: 10/12/2006
• Est. Priority Date: 04/06/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Marquez, Salvador, Nguyen, Derek, Nguyen-Thien-Nhon, Diana
• Granted Patent: US 8,062,359 B2
• Time in Patent Office: Days
• US Class Current: 623/2.410
• 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 2220/005 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 connecting band for a highly flexible tissue-type heart valve having a stent with cusps and commissures that are permitted to move radially. The connecting band 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 inner suture-permeable 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. The inner member may include one or more slits along the cusps to enhance flexibility. The inner member may further include a continuous outwardly projecting sewing ridge around its periphery which includes a series of ribs separated by grooves around the inflow edge of the cusps. The sewing ridge enables supra-annular implant of a valve constructed with the connecting band.

Claims

1. A suture-permeable connecting band for securing a prosthetic heart valve to an anatomical cavity, comprising:

a flexible, continuous connecting band having an undulating shape generally defining a tube with alternating inflow cusps and outflow commissures, the cusps having large radii of curvatures relative to the commissures, an inflow edge of the connecting band substantially conforming to an outflow edge thereof and following the undulating shape such that axial gaps are created between adjacent cusps at the commissures, the gaps having a height of at least about 50% of the overall axial height of the connecting band, wherein each cusp has a varying cross-section between adjacent commissures that includes at least one relief point at which the cross-section abruptly reduces such that bending of each connecting band cusp occurs first at the relief point.

2. The heart valve connecting band of claim 1, wherein the relief point in each connecting band cusp comprises a generally radial slit.

3. The heart valve connecting band of claim 2, wherein there are a plurality of the generally radial slits provided in each connecting band cusp.

4. The heart valve connecting band of claim 3, wherein there are between 5-7 of the generally radial slits provided in each connecting band cusp.

5. The heart valve connecting band of claim 1, wherein the relief point in each connecting band cusp comprises a generally radial groove.

6. The heart valve connecting band of claim 5, wherein an inflow edge of each connecting band cusp comprises at least two generally radially-directed ribs separated by the generally radial groove.

7. The heart valve connecting band of claim 6, wherein a plurality of generally radially-directed ribs and grooves are provided that are angled toward the inflow direction, wherein the size of the ribs and grooves diminishes from a maximum at an apex of the cusps until they disappear prior to the commissures.

8. The heart valve connecting band of claim 1, wherein the connecting band is molded of silicone rubber.

9. A suture-permeable connecting band for securing a prosthetic heart valve to an anatomical cavity, comprising:

a flexible, continuous connecting band having an inflow end and an outflow end, the connecting band having an undulating shape generally circumscribing a tube with alternating inflow cusps and outflow commissures, the cusps having large radii of curvatures relative to the commissures, an inflow edge of the connecting band substantially conforming to an outflow edge thereof and following the undulating shape such that axial gaps are created between adjacent cusps at the commissures, the gaps having a height of at least about 50% of the overall axial height of the connecting band, a continuous sewing ridge being provided around the periphery of the connecting band that facilitates supra-annular attachment of the prosthetic valve, the sewing ridge being radially-outwardly directed at the commissures and larger and angled radially outward and toward the inflow end at the cusps.

10. The heart valve connecting band of claim 9, wherein the connecting band defines a free margin comprising a relatively narrow flap that angles radially outward and toward the outflow end at the cusps, and is substantially axially-aligned at the commissures.

11. The heart valve connecting band of claim 10, wherein the free margin gradually diminishes in size from each commissure to an apex of each cusp.

12. The heart valve connecting band of claim 10, wherein the free margin at the commissures projects axially and circumferentially beyond the sewing ridge.

13. The heart valve connecting band of claim 9, wherein the sewing ridge at the cusps defines an inflow end of the connecting band and includes a plurality of alternating generally radial ribs and grooves.

14. The heart valve connecting band of claim 13, wherein the size of the generally radial ribs varies and is greatest at an apex of each cusp.

15. The heart valve connecting band of claim 14, wherein a plurality of the alternating generally radial ribs and grooves are provided, wherein the size of the ribs and grooves diminishes from a maximum at an apex of the cusps until they disappear prior to the commissures.

16. The heart valve connecting band of claim 9, wherein the sewing ridge is discontinuous at the cusps and continuous at the commissures.

17. A method of supra-annular implantation of a flexible aortic prosthetic heart valve, comprising:

providing a flexible aortic prosthetic heart valve having a supporting structure to which prosthetic leaflets attach and project radially inward and to which a connecting band attaches and projects generally radially outward, the supporting structure and connecting band each generally circumscribing a tube and having an undulating shape with alternating inflow cusps and outflow commissures, the cusps having large radii of curvatures relative to the commissures, an inflow edge of the valve substantially conforming to an outflow edge thereof and following the undulating shape such that axial gaps are created between adjacent cusps at the commissures, the gaps having a height of at least about 50% of the overall axial height of the supporting structure, and a continuous outwardly directed sewing ridge that facilitates supra-annular attachment of the prosthetic valve;

removing the native leaflets at their line of attachment;

delivering the prosthetic heart valve to an aortic annulus; and

implanting the prosthetic heart valve to the aortic annulus by securing the connecting band exclusively to fibrous tissue along the line of native leaflet attachment.

18. The method of claim 17, wherein each cusp of the connecting band has a varying cross-section between adjacent commissures that includes at least one relief point at which the cross-section abruptly reduces such that bending of each connecting band cusp occurs first at the relief point.

19. The method of claim 18, wherein the relief point in each connecting band cusp comprises a generally radial slit, and the method includes securing the commissures of the prosthetic valve to the fibrous native leaflet commissures such that the valve cusps are subjected to bending forces in use and the radial slit enhances flexibility of the cusps.

20. The method of claim 18, wherein the relief point in each connecting band cusp comprises a generally radial groove, and wherein an inflow edge of each connecting band cusp comprises at least two generally radially-directed ribs separated by the generally radial groove, and the method includes securing the commissures of the prosthetic valve to the fibrous native leaflet commissures such that the valve cusps are subjected to bending forces in use and the radial groove enhances flexibility of the cusps.