Four-leaflet stented mitral heart valve

• US 20070050021A1
• Filed: 08/25/2005
• Published: 03/01/2007
• Est. Priority Date: 08/25/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Johnson, Derrick
• Granted Patent: US 7,455,689 B2
• Time in Patent Office: Days
• US Class Current: 623/2.140
• 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

Abstract

A prosthetic mitral heart valve having four separate flexible leaflets. The heart valve includes a support frame that may be non-circular, for example elliptical or “D-shaped”. The support frame may have an undulating outflow edge defined by four inflow cusps and four outflow commissures to which each of the flexible leaflets attaches. The support frame may comprise an undulating wireform and a surrounding stent defining a structure having four cantilevered posts projecting in the outflow direction to support the four leaflets. The heart valve is designed to be secured in the annulus and function as a standalone unit without papillary muscle connections to the leaflets. The four leaflets may be arranged in two opposed pairs, one pair being smaller than the other pair. The larger pair of leaflets may be identical, or differently sized. Existing sizes of heart valve leaflets may be utilized with the smaller leaflets being at least two leaflet sizes smaller than the larger leaflets in odd millimeter increments.

Claims

1. A prosthetic heart valve for implant at a valve annulus, comprising:

a support frame defining a non-circular orifice about an axis along an inflow-outflow direction; and

four separate flexible leaflets each separately mounted for movement on the support frame to provide a one-way valve in the elliptical orifice.

2. The prosthetic heart valve of claim 1, wherein the support frame defines an elliptical orifice.

3. The prosthetic heart valve of claim 2, wherein the four separate flexible leaflets are arranged in two pairs of a metrically opposed, symmetric leaflets.

4. The prosthetic heart valve of claim 2, wherein the four separate flexible leaflets are arranged in a first pair and a second pair of leaflets, each pair being diametrically opposed across the orifice, and wherein each one of the first pair of leaflets is substantially smaller than either leaflet of the second pair.

5. The prosthetic heart valve of claim 1, wherein the support frame defines a D-shaped orifice.

6. The prosthetic heart valve of claim 5, wherein the four separate flexible leaflets are arranged in a first pair and a second pair of leaflets, each pair being diametrically opposed across the orifice, and wherein the leaflets of the second pair are differently sized.

7. The prosthetic heart valve of claim 1, wherein the support frame comprises an undulating outflow edge including four alternating inflow cusps and flexible outflow commissures that extend generally axially in the outflow direction in a cantilevered fashion, and wherein each of the separate flexible leaflets has a cusp edge mounted to an inflow cusp of the support frame and two commissure edges mounted to adjacent outflow commissures of the support frame.

8. A prosthetic heart valve for implant at a valve annulus, comprising:

a support frame defining an orifice about an axis along an inflow-outflow direction, the support frame having an undulating outflow edge including four alternating inflow cusps and flexible outflow commissures that extend generally axially in the outflow direction in a cantilevered fashion; and

four separate flexible leaflets each separately mounted for movement along the outflow edge of the support frame to provide a one-way valve in the orifice, each leaflet including a cusp edge mounted to an inflow cusp of the support frame and two commissure edges mounted to adjacent outflow commissures of the support frame.

9. The prosthetic heart valve of claim 8, wherein the support frame defines an elliptical orifice.

10. The prosthetic heart valve of claim 8, wherein the valve is symmetric about two axes.

11. The prosthetic heart valve of claim 8, wherein the support frame defines a D-shaped orifice.

12. The prosthetic heart valve of claim 8, wherein the support frame comprises an undulating wireform and a stent therearound, the wireform generally defining the outflow edge of the support frame and having inverted V-shaped commissures through which the commissure edges of two adjacent leaflets extend, the stent having commissure posts of approximately the same height as the wireform commissures and to which the extending commissure edges attach.

13. The prosthetic heart valve of claim 12, wherein the wireform and stent are made of synthetic materials and the leaflets are made of biological sheet material.

14. The prosthetic heart valve of claim 8, wherein the support frame commissures have an axial height of at least 6 mm.

15. A prosthetic heart valve for implant at a valve annulus, comprising:

a support frame defining an orifice about an axis along an inflow-outflow direction; and

four separate flexible leaflets each separately mounted for movement on the support frame to provide a one-way valve in the orifice, wherein at least one of the leaflets is substantially smaller than at least one of the other leaflets.

16. The prosthetic heart valve of claim 15, wherein the four separate leaflets comprise a first pair and a second pair of leaflets, each pair being diametrically opposed across the orifice, and wherein each leaflet of the first pair is substantially smaller than either leaflet of the second pair.

17. The prosthetic heart valve of claim 16, wherein the two leaflets of the first pair are identically sized.

18. The prosthetic heart valve of claim 16, wherein the two leaflets of the second pair are identically sized.

19. The prosthetic heart valve of claim 15, wherein the support frame defines a non-circular orifice selected from the group consisting of:

elliptical; and

D-shaped.

20. The prosthetic heart valve of claim 15, wherein the support frame has an undulating outflow edge including four alternating inflow cusps and flexible outflow commissures that extend generally axially in the outflow direction in a cantilevered fashion and having an axial height of at least 6 mm.