Four-leaflet stented mitral heart valve

• US 9,339,381 B2
• Filed: 10/31/2008
• Issued: 05/17/2016
• Est. Priority Date: 08/25/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Johnson, Derrick
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US12/263,379
• Publication Number:
  US 20090054973A1
• Time in Patent Office: 2,755 Days
• Field of Search: 623 212- 219
• US Class Current: 1/1
• 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 mitral heart valve for implant at a mitral valve annulus, comprising:

a synthetic support frame having a rod-like wireform circumscribing a central orifice about an axis along an inflow-outflow direction, wherein the orifice as viewed along the axis is substantially elliptical, with a longer major dimension and a shorter minor dimension perpendicular thereto, the support frame having an outflow edge that undulates in the inflow-outflow direction with four (4) arcuate cusps extending toward the inflow direction, wherein the ends of adjacent cusps converge to form four (4) upstanding commissures each extending generally in the outflow direction in a cantilevered fashion to an axial height from the cusps of at least 6 mm;

wherein the support frame comprises a cloth covering on the wireform and a dual-band stent surrounding the wireform; and

four (4) separate leaflets each mounted in cooperation with the four (4) arcuate cusps of support frame to provide a one-way valve in the orifice.

2. The prosthetic heart valve of claim 1, wherein the axial height of the support frame commissures is between about 8 and 20 mm.

3. The prosthetic heart valve of claim 1, wherein the ratio of the minor dimension to the major dimension is approximately 3:

4.

4. The prosthetic heart valve of claim 1, wherein the ratio of the minor dimension to the major dimension is approximately 4:

5.

5. The prosthetic heart valve of claim 1, wherein ends of adjacent cusps converge asymptotically to form the upstanding commissures that terminate in inverted V-shaped tips.

6. The prosthetic heart valve of claim 1, wherein the commissures tilt slightly radially inwardly such that the support frame generally defines a conical surface of revolution.

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

8. The prosthetic heart valve of claim 1, wherein at least a part of the support frame material is selected from the group consisting of:

biocompatible metals, and

an alloy primarily including Ni, Co, and Cr.

9. The prosthetic heart valve of claim 1, wherein at least a part of the support frame material is selected from the group consisting of:

biocompatible polymers, and

an acetyl homopolymer.

10. The prosthetic heart valve of claim 8, wherein the leaflets are made of biological sheet material.

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

a support frame circumscribing a central orifice about an axis along an inflow-outflow direction, wherein the orifice as viewed along the axis has no straight lines and is substantially elliptical, the support frame having an undulating shape in the inflow-outflow direction with four (4) arcuate cusps extending toward the inflow direction, wherein the ends of adjacent cusps converge to form four (4) upstanding commissures each extending generally in the outflow direction in a cantilevered fashion; and

four (4) flexible leaflets each having a cusp region mounted around an arcuate support frame cusp and at least partway along adjacent commissures, and free edges that extend inward and provide a one-way valve in the orifice, wherein the four (4) flexible leaflets are arranged around the orifice in a diametrically opposed first pair and a diametrically opposed second pair of leaflets, and wherein the leaflets of the second pair are both larger than either of the leaflets of the first pair and the leaflets of the first pair are symmetric.

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

13. The prosthetic heart valve of claim 11, wherein the leaflets of the second pair are similarly sized.

14. The prosthetic heart valve of claim 11, wherein the support frame comprises a rod-like wireform having upstanding commissures each of which defines an inverted V-shaped tip through which commissure edges of two adjacent leaflets extend, the support frame further comprising a dual-band stent surrounding the wireform and having commissure posts of approximately the same height as the wireform commissures and to which the leaflet commissure edges attach.

15. The prosthetic heart valve of claim 14, wherein the wireform and stent are made of synthetic materials and the leaflets are made of biological sheet material.

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

a support frame circumscribing an orifice about an axis along an inflow-outflow direction, wherein the orifice as viewed along the axis is substantially elliptical, wherein the orifice as viewed along the axis has a longer major dimension and a shorter minor dimension perpendicular thereto, the orifice on an anterior side configured to attach to an anterior aspect of the mitral annulus while the remainder of the orifice defines a posterior side configured to attach to a posterior aspect of the mitral annulus, and wherein the support frame is non-planar so as to have an axial height of at least 6 mm and is made of synthetic materials capable of maintaining its non-planar shape after implant, wherein the support frame comprises a cloth covering on the wireform and a dual-band stent surrounding the wireform; and

four (4) separate flexible leaflets mounted around the support frame and having free edges that extend inward and provide a one-way valve in the orifice, wherein the four (4) flexible leaflets are arranged around the orifice with an anterior leaflet mounted along the anterior side of the support frame and three posterior leaflets mounted around the posterior side of the support frame, and wherein the posterior leaflet diametrically opposite the anterior leaflet is as large or larger than the anterior leaflet.

17. The prosthetic heart valve of claim 16, wherein the support frame has an outflow edge that undulates in the inflow-outflow direction with four (4) arcuate cusps extending toward the inflow direction, and wherein the ends of adjacent cusps converge to form four (4) upstanding commissures each extending generally in the outflow direction in a cantilevered fashion to an axial height from the cusps of at least 6 mm, the leaflets each having a cusp region mounted around a support frame cusp and at least partway along adjacent commissures.

18. The prosthetic heart valve of claim 16, wherein the support frame comprises a rod-like wireform having upstanding commissures each of which defines an inverted V-shaped tip through which commissure edges of two adjacent leaflets extend, the wherein the dual-band stent has commissure posts of approximately the same height as the wireform commissure and to which the leaflet commissure edges attach.

19. The prosthetic heart valve of claim 18, wherein the wireform and stent are made of synthetic materials and the leaflets are made of biological sheet material.

20. The prosthetic heart valve of claim 16, wherein the posterior leaflet is larger than the anterior leaflet and spans an angle of approximately 120°

.

21. The prosthetic heart valve of claim 20, wherein the anterior leaflet spans an angle of approximately 80°

.

22. The prosthetic heart valve of claim 20, wherein the two (2) leaflets other than the anterior and posterior leaflets are symmetric.

23. The prosthetic heart valve of claim 16, wherein the support frame comprises a rod-like wireform.

24. The prosthetic heart valve of claim 16, wherein at least a part of the synthetic material of the support frame is selected from the group consisting of:

biocompatible metals, and

an alloy primarily including Ni, Co, and Cr.

25. The prosthetic heart valve of claim 16, wherein at least a part of the synthetic material of the support frame is selected from the group consisting of:

biocompatible polymers, and

an acetyl homopolymer.

26. The prosthetic heart valve of claim 16, wherein the orifice is straighter on the anterior side while the remainder of the orifice defines a more rounded posterior side.