Flexible heart valve having moveable commissures

• US 6,461,382 B1
• Filed: 09/22/2000
• Issued: 10/08/2002
• Est. Priority Date: 09/22/2000
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Cao, Dongbu
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): BARRETT, THOMAS C
• Application Number:
  US09/668,660
• Time in Patent Office: 746 Days
• Field of Search: 623/2.1, 623/2-2-, 623/2-7-
• 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 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. The sewing band is scalloped and enables attachment of the valve along the scalloped aortic root so as to couple the valve to the natural motion of the aorta. Increased vibrational damping results from this biomechanical coupling.

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 rounded sections each adapted to conform to the cusp edge of the leaflets, the cusp edge of each leaflet being attached to a different rounded section 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 sections together defining valve cusps curving toward an inflow end of the valve;

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 two adjacent leaflet tabs, a generally axially extending insert member, and an inverted V-shaped clip positioned radially inward from the insert member, 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 member, an inflow end of each commissure post being generally pivotally coupled with respect to the cusp support structure so as to permit both radially inward and outward movement thereof, the valve commissure posts being attachable to the anatomical wall structure; and

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.

2. The heart valve of claim 1, wherein the valve is sized for implantation in an aortic annulus, wherein the anatomical wall structure is the aorta.

3. The heart valve of claim 1, wherein the cusp support structure comprises a one-piece ring.

4. The heart valve of claim 3, wherein the cusp support structure comprises the rounded sections curved toward the inflow end of the valve and connected by commissure base sections about which the valve commissure posts pivot.

5. The heart valve of claim 4, wherein the cusp support structure comprises a relatively rigid rod-like element having a fabric covering, the valve commissure posts being attached to the cusp support structure using sutures through the fabric covering.

6. The heart valve of claim 4, wherein the inflow end of the insert member of each commissure post is bifurcated and straddles the associated commissure base section.

7. The heart valve of claim 6, wherein each commissure base section is circular in cross-section, and wherein the divergent legs of the bifurcated inflow end of the associated insert member are sutured together to capture the commissure base section therebetween.

8. The heart valve of claim 1, wherein the cusp support structure comprises three separate pieces arranged generally evenly about the valve axis to define the ring.

9. The heart valve of claim 8, wherein each piece of the cusp support structure comprises a relatively rigid rod-like element having a fabric covering, the sewing band attaching to the valve cusps using sutures through the fabric covering of each piece of the cusp support structure, 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.

10. The heart valve of claim 8, 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.

11. The heart valve of claim 8, wherein the three separate pieces of the cusp support structure are coupled by six highly compliant connector sections attached between adjacent ends of the rounded sections and V-shaped clips.

12. The heart valve of claim 11, wherein the connector sections are made of fabric.

13. The heart valve of claim 11, wherein the connector sections are made of an elastomer.

14. 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.

15. The heart valve of claim 14, 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.

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

17. An aortic heart valve adapted to have reduced vibration-related strain, comprising:

three leaflets each having arcuate cusp edges on their inflow ends, free edges on the outflow ends, and two side tabs;

three cusp supports each 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 and adjacent tabs of two leaflets attached thereto, 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 pivoting of the outflow end of the commissure posts relative to the cusp supports; and

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.

18. The heart valve of claim 17, wherein the three cusp supports together define a onepiece ring-shaped cusp support structure.

19. The heart valve of claim 18, wherein the cusp support structure comprises the three cusp supports that are curved toward the inflow end of the valve and are connected by three commissure base sections about which the commissure posts pivot.

20. The heart valve of claim 19, 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.

21. The heart valve of claim 19, wherein the inflow end of the insert member of each commissure post is bifurcated and straddles the associated commissure base section.

22. The heart valve of claim 17, wherein the three cusp supports are separate elements coupled together by mutual attachment to the sewing band.

23. The heart valve of claim 22, wherein each cusp support comprises a relatively rigid rod-like element having a fabric covering, the sewing band attaching to the cusp supports using sutures through the fabric covering of each cusp support, 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 cusp supports.

24. The heart valve of claim 22, wherein each cusp support is made of a pre-formed biocompatible fabric having a radially outward tab to which the cusp edge of a leaflet attaches.

25. The heart valve of claim 17, 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.

26. The heart valve of claim 25, 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.

27. The heart valve of claim 25, 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.

28. The heart valve of claim 25, wherein the three cusp supports are separate elements coupled together by six compliant connector sections attached between adjacent ends of the cusp supports and V-shaped clips.

29. The heart valve of claim 17, wherein the three leaflets each have a concave free edge.