Stress absorbing flexible heart valve frame

• US 7,473,275 B2
• Filed: 01/11/2006
• Issued: 01/06/2009
• Est. Priority Date: 04/06/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Marquez, Salvador
• Primary Examiner(s): Matthews; William H.
• Application Number:
  US11/329,672
• Publication Number:
  US 20060229718A1
• Time in Patent Office: 1,091 Days
• Field of Search: 623 236- 241
• US Class Current: 623/2.38
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A flexible support frame for a prosthetic heart valve having commissure tips that are shaped to even out stresses imposed during use. The support frame is an elongated wire-like element formed by a plurality, typically three, of arcuate cusp regions on an inflow end alternating with the same number of commissures terminating in tips on an outflow end. The commissure tips are elongated relative to more simple shapes. The commissure tips may be shaped with a complex curve having two enlarged convex flexure portions separated by a concave bridge portion at the midpoint of the commissure tip. The support frame may be fabricated by separating a two-dimensional blank from a sheet and then converting the blank into a three-dimensional support frame shape. The cross-sectional thickness of the support frame may be variable, such as by adjusting the thickness of the pattern of the two-dimensional blank in the sheet. Desirably, the radial thickness remains constant while the circumferential dimension varies with a maximum located at the commissure tips.

Claims

1. A stress-absorbing flexible support frame for a prosthetic heart valve, comprising:

a support frame formed by an elongated wire-like element generally describing a tube around an axis and having a plurality of arcuate cusp regions on an inflow end alternating with the same number of commissures terminating in tips on an outflow end, the cusp and commissures being formed as a single element, the arcuate cusp regions being convex toward the inflow end and the commissure tips being generally convex toward the outflow end, wherein each cusp terminates on opposite ends at commissure regions extending from the cusp regions in the outflow direction and two adjacent commissure regions extending from adjacent cusp regions converge toward each of the commissure tips, and wherein each commissure tip comprises a continuous complex curve including a pair of arcuate outer flexure portions projecting in the outflow direction connected by an oppositely-curved inner bridge portion which spans between the flexure portions.

2. The support frame of claim 1, wherein the shape of each commissure tip resembles mouse ears.

3. The support frame of claim 1, wherein the flexure portions each possess a relatively large radius of curvature relative to a simple inverted U-shape between adjacent commissure regions.

4. The support frame of claim 1, wherein the adjacent commissure regions converge toward a smallest gap of dimension X, and wherein the length around each commissure tip is no less than 6X.

5. The support frame of claim 1, wherein the cross-section of the flexure portions is designed to absorb bending stresses at the commissure tips.

6. The support frame of claim 5, wherein the flexure portions have a larger cross-section than the bridge portion.

7. The support frame of claim 5, wherein the flexure portions have a larger cross-section than the commissure regions.

8. The support frame of claim 1, wherein the bridge portions are designed to break after certain number of movement cycles of the stent.

9. A stress-absorbing flexible support frame for a prosthetic heart valve, comprising:

a support frame formed by an elongated wire-like element generally describing a tube around an axis and having a plurality of arcuate cusp regions on an inflow end alternating with the same number of commissures terminating in tips on an outflow end, the cusp and commmissures being formed as a single element, the arcuate cusp regions being convex toward the inflow end and the commissure tips being generally convex toward the outflow end, wherein each cusp terminates on opposite ends at commissure regions extending from the cusp regions in the outflow direction and two adjacent commissure regions extending from adjacent cusp regions converge toward each of the commissure tips, and wherein the adjacent commissure regions converge toward a smallest gap of dimension X, and wherein the non-overlapping length around each commissure tip is no less than 6X, and wherein each commissure tip defines a continuous complex curve with at least two convex portions separated by a concave bridge portion at the midpoint of the commissure tip.

10. The support frame of claim 9, wherein the shape of each commissure tip resembles mouse ears.

11. The support frame of claim 9, wherein the flexure portions have a larger cross-section than the bridge portion.

12. The support frame of claim 9, wherein the flexure portions have a larger cross-section than the commissure regions.

13. A stress-absorbing flexible support frame for a prosthetic heart valve, comprising:

a support frame formed by an elongated wire-like element generally describing a tube around an axis and having a plurality of arcuate cusp regions on an inflow end alternating with the same number of commissures terminating in tips on an outflow end, the cusp and commissures being formed as a single element, the arcuate cusp regions being convex toward the inflow end and the commissure tips being generally convex toward the outflow end, wherein each cusp terminates on opposite ends at commissure regions extending from the cusp regions in the outflow direction and two adjacent commissure regions extending from adjacent cusp regions converge toward each of the commissure tips, and wherein the support frame has a varying cross-section with a maximum located at the commissure tips, and wherein each commissure tip defines a continuous complex curve with at least two convex portions separated by a concave bridge portion at the midpoint of the commissure tip.

14. The support frame of claim 13, wherein the flexure portions have a larger cross-section than the bridge portion.

15. The support frame of claim 13, wherein the flexure portions have a larger cross-section than the commissure regions.

16. The support frame of claim 13, wherein the support frame has a constant radial dimension and a varying circumferential dimension.

17. The support frame of claim 16, wherein the cross-section of the support frame is substantially rectangular throughout.

18. The support frame of claim 17, wherein the support frame is fabricated by separating a blank from a two-dimensional sheet and then converting the two-dimensional blank into a three-dimensional support frame shape.