Flexible heart valve

• US 7,179,290 B2
• Filed: 10/28/2004
• Issued: 02/20/2007
• Est. Priority Date: 09/22/2000
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences (Edwards Lifesciences Corporation)
• Inventors: Cao, Dongbu
• Primary Examiner(s): BARRETT, THOMAS C
• Application Number:
  US10/977,409
• Publication Number:
  US 20050096739A1
• Time in Patent Office: 845 Days
• Field of Search: 623/2.17, 623/2.19
• US Class Current: 623/2.19
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A flexible prosthetic tissue-type heart valve having commissures that are substantially decoupled from a cusp support structure. The valve includes three leaflets having arcuate cusp edges and opposed concave shaped free edges, with outwardly-directed attachment tabs therebetween. A cusp support structure in either one or more pieces attaches to the leaflet cusp edges. Three commissures are each formed partly with an axially-extending insert member to which two adjacent leaflet tabs attach. An inverted V-shaped clip maintains close contact between the adjacent leaflet tabs and provides a stress-relieving clamping action in conjunction with the insert member. The insert member attaches about its lower end to base sections of the cusp support structure, or to an intermediate sewing ring, so that the commissures may pivot about the cusp support structure.

Claims

1. A heart valve for implantation in an annulus of a heart having commissures on an outflow end adapted to move in conformity with an anatomical wall structure adjacent the annulus, the heart valve comprising:

three leaflets made of a biocompatible and compliant material, each leaflet having a rounded cusp edge opposite a free edge, and a pair of generally oppositely-directed tabs separating the cusp edge and free edge;

a cusp support structure generally defining a ring and a valve axis and having three separate rounded pieces arranged generally evenly about the valve axis to define the ring each rounded piece adapted to conform to the cusp edge of one of the leaflets, the cusp edge of each leaflet being attached to a different rounded piece of the cusp support structure so that the three leaflets are arranged generally evenly about the valve axis, the attached leaflet cusp edges and rounded pieces together defining valve cusps curving toward an inflow end of the valve; and

three valve commissure posts disposed between the valve cusps and projecting generally axially toward an outflow end of the valve, the commissure posts being defined by a generally axially extending insert member, and an inverted V-shaped clip positioned radially inward from the insert member, tabs from each two adjacent leaflets being juxtaposed to extend radially outward with respect to the axis through the inverted V-shaped clip and being wrapped around and secured to the insert member, the valve commissure posts being attachable to the anatomical wall structure; and

six highly compliant connector sections attached between adjacent ends of the rounded pieces of the cusp support structure and the V-shaped clips to permit pivoting of the valve commissure posts.

2. The heart valve of claim 1, wherein the connector sections are made of fabric.

3. The heart valve of claim 1, wherein the connector sections are made of an elastomer.

4. The heart valve of claim 1, wherein each piece of the cusp support structure comprises a relatively rigid rod-like element having a fabric covering.

5. The heart valve of claim 1, further including a sewing band shaped to follow the valve cusps and being attached therealong, the sewing band providing a platform for implanting the heart valve such that the valve cusps are attachable adjacent the annulus.

6. The heart valve of claim 5, wherein the sewing band attaches to the valve cusps and wherein the inflow end of each commissure post is pivotally attached to a portion of the sewing band that bridges one of three gaps defined between the three separate pieces of the cusp support structure.

7. The heart valve of claim 6, wherein each piece of the cusp support structure is made of a pre-formed biocompatible fabric having a radially outward tab to which the cusp edge of a leaflet attaches.

8. The heart valve of claim 1, wherein each V-shaped clip is formed of a flexible material adapted to flex apart during an open cycle of the valve wherein fluid flow through the valve causes the free edges of adjacent leaflet tabs to separate.

9. The heart valve of claim 8, further including a fabric covering around each V-shaped clip that extends around the associated insert member and permits suture attachment of the clip to the insert.

10. The heart valve of claim 1, wherein the three leaflets each have a concave free edge.

11. A prosthetic aortic heart valve having pivoting commissures, comprising:

three flexible leaflets having cusp edges;

a one piece ring-shaped cusp support structure having three cusp supports that are curved toward the inflow end of the valve and are connected by three commissure base sections, each cusp support being attached to the cusp edge of one of the leaflets to define valve cusps, the valve cusps being disposed generally in a circle about a valve axis at an inflow end of the valve;

three generally axially extending commissure posts disposed in between the valve cusps around the circle and extending toward an outflow end of the valve, the commissure posts each being defined by an insert to which two adjacent leaflets attach, wherein the inserts are structurally separate from the three cusp supports but coupled thereto at an end closest to the cusp supports to enable radial in and out pivoting of the outflow end of the commissure posts relative to the cusp supports;

a sewing band shaped to follow the valve cusps and being attached therealong, the sewing band and inserts providing a platform for implanting the aortic heart valve such that the valve cusps are attachable adjacent the annulus, and the inserts are attachable to the ascending aorta, the commissure posts therefore being freely moveable with respect to the valve cusps so as to generally pivot radially in and out in conjunction with movement of the ascending aorta during the repetitive cycles of systole and diastole such that the heart valve is dynamically coupled to the damping characteristics of the ascending aorta.

12. The heart valve of claim 11, wherein the inflow end of the insert member of each commissure post is bifurcated and straddles the associated commissure base section.

13. The heart valve of claim 11, wherein the cusp support structure comprises a relatively rigid rod-like element having a fabric covering, the commissure posts being attached to the commissure base sections of the cusp support structure using sutures through the fabric covering.

14. The heart valve of claim 11, wherein each flexible leaflet further includes free edges on the outflow ends, and two side tabs, and wherein the side tabs of adjacent leaflets wrap around and are secured to the corresponding insert.

15. The heart valve of claim 14, wherein each of the commissure posts further includes an inverted V-shaped clip positioned radially inward from the insert, the adjacent leaflet tabs being juxtaposed to extend radially outward with respect to the axis through the inverted V-shaped clip and being wrapped around and secured to the insert.

16. The heart valve of claim 15, wherein each V-shaped clip is formed of a flexible material adapted to flex apart during an open cycle of the valve wherein fluid flow through the valve causes the free edges of adjacent leaflet tabs to separate.

17. The heart valve of claim 15, further including a fabric covering around each V-shaped clip that extends around the associated insert and permits suture attachment of the clip to the insert.

18. The heart valve of claim 14, wherein the three leaflets each have a concave free edge.