Anatomically Approximate Prosthetic Mitral Valve

• US 20110015731A1
• Filed: 09/23/2010
• Published: 01/20/2011
• Est. Priority Date: 01/23/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Lam, Hung L., Carpentier, Alain F.
• Granted Patent: US 8,034,104 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2448 D-shaped rings
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

An anatomically approximate prosthetic heart valve includes dissimilar flexible leaflets, dissimilar commissures and/or a non-circular flow orifice. The heart valve may be implanted in the mitral position and have one larger leaflet oriented along the anterior aspect so as to mimic the natural anterior leaflet. Two other smaller leaflets extend around the posterior aspect of the valve. A basic structure providing peripheral support for the leaflets includes two taller commissures on both sides of the larger leaflet, with a third, smaller commissure between the other two leaflets. The larger leaflet may be thicker and/or stronger than the other two leaflets. The base structure defines a flow orifice intended to simulate the shape of the mitral annulus during the systolic phase. For example, the flow orifice may be elliptical. A relatively wide sewing ring has a contoured inflow end and is attached to the base structure in such a way that the valve can be implanted in an intra-atrial position and the taller commissures do not extend too far into the left ventricle, therefore avoiding injury to the ventricle.

Claims

1. A prosthetic heart valve having a low outflow profile, comprising:

a base structure having a central flow orifice oriented around a flow axis;

a plurality of flexible leaflets mounted on the base structure and projecting into the flow orifice, the flexible leaflets being mounted in the base structure so as to define a leaflet axial dimension from the inflow end to the outflow end thereof; and

a sewing ring having a scalloped inflow profile, mounted around the base structure at an attachment elevation at the outflow edge of the sewing ring, wherein the distance between the attachment elevation and the outflow end of the leaflets relative to the leaflet axial dimension is less than about 75%, and wherein the sewing ring includes an inner wall defining at least one ledge on which is supported the base structure having the flexible leaflets such that an inflow end of the heart valve is defined by the sewing ring.

2. The heart valve of claim 1, wherein the base structure includes a stent having three arcuate cusps on an inflow end and three upstanding commissures on an outflow end, and there are three arcuate ledges provided on the inner wall of the sewing ring each shaped to receive and support one of the arcuate cusps of the stent.

3. The heart valve of claim 2, wherein the sewing ring has an overall axial dimension and the three ledges provided on the inner wall are downward from an outflow rim to a depth that is greater than about 80% of the overall axial dimension of the sewing ring.

4. The heart valve of claim 1, wherein the central flow orifice is non-circular.

5. The heart valve of claim 4, wherein the non-circular central flow orifice is elliptical.

6. The heart valve of claim 4, wherein the valve is configured for placement in a mitral annulus, and the non-circular central flow orifice is substantially in the shape of a mitral annulus in its systolic phase.

7. The heart valve of claim 6, wherein the sewing ring is configured to attach to tissue of a left atrium adjacent to the mitral annulus.

8. The heart valve of claim 7, wherein the scalloped inflow profile of the sewing ring provides a contour that matches a contour of the tissue of the left atrium adjacent to the mitral annulus.

9. The heart valve of claim 1, wherein at least one of the plurality of flexible leaflets is configured differently from the others.

10. The heart valve of claim 9, wherein the at least one of the plurality of flexible leaflets is larger than the others.