Synthetic leaflets for heart valve repair or replacement

• US 20040088046A1
• Filed: 09/16/2003
• Published: 05/06/2004
• Est. Priority Date: 03/16/2001
• Status: Active Grant

• Current Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Original Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Inventors: Speziali, Giovanni
• Granted Patent: US 6,916,338 B2
• Time in Patent Office: Days
• US Class Current: 623/2.19
• 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 2/2415 Manufacturing methods

Abstract

Heart valve leaflets (10) arm described that include a plurality of supports (350) within a coapting portion (20) and a substantially arcuate portion (30). The plurality of supports (350) provide the leaflet (10) with anisotropic elasticity.

Claims

1. ) A synthetic heart valve leaflet comprising:

a) a coapting portion having a free edge;

b) a substantially arcuate portion adjacent said coapting portion, said arcuate portion having a peripheral edge; and

c) a plurality of supports within said coapting portion and said substantially arcuate portion, wherein said plurality of supports provide said leaflet with anisotropic elasticity, and wherein a region about the mid-line of said coapting portion has a thickness greater than the thickness of at least one other region of said leaflet.

4. ) The leaflet of claim 1, wherein the elasticity of said leaflet in a circumferential direction is greater than the elasticity in a radial direction, wherein said circumferential direction is from said coapting edge to said peripheral edge, and wherein said radial direction is perpendicular to said circumferential direction.

5. ) The leaflet of claim 1, wherein said leaflet is composed of a material selected from the group consisting of a biocompatible fabric and a biocompatible polymer.

6. ) The leaflet of claim 5, wherein said biocompatible polymer is a polyurethane.

7. ) The leaflet of claim 1, wherein said plurality of supports is composed of polytetrafluoroethylene.

2. ) The leaflet of claim 2, wherein said coapting portion extends between a pair of opposing tabs.

3. ) The leaflet of claim 2, wherein said substantially arcuate portion extends between said pair of opposing tabs.

8. ) A synthetic heart valve leaflet comprising:

a) a pair of opposing tabs;

b) a coapting portion extending between said pair of opposing tabs and having a free edge;

c) a substantially arcuate portion adjacent said coapting portion and having a peripheral edge; and

d) a plurality of supports extending between said pair of opposing tabs, wherein said plurality of supports provide said leaflet with anisotropic elasticity, and wherein a region about the mid-line of said coapting portion has a thickness greater than the thickness of at least one other region of said leaflet.

9. ) The leaflet of claim 8, wherein each support of said plurality of supports is increasingly arcuate from said coapting edge to said peripheral edge.

10. ) The leaflet of claim 9, wherein at least two supports of said plurality extend from one tab of said pair of opposing tabs to said region of greater thickness.

11. ) The leaflet of claim 8, wherein said plurality of supports are fibers.

12. ) The leaflet of claim 8, wherein each support of said plurality of supports comprises a region of said leaflet having a thickness greater than the thickness of adjacent regions of said leaflet.

13. ) The leaflet of claim 8, wherein said region of a greater thickness contains a movement-tracking component.

14. ) The leaflet of claim 13, wherein said movement-tracking component is a magnetic particle.

15. ) The leaflet of claim 8, wherein the thickness of said peripheral edge is greater than the thickness of said substantially arcuate portion.

16. ) The leaflet of claim 8, wherein said leaflet is composed of a material selected from the group consisting of a biocompatible fabric and a biocompatible polymer.

17. ) A prosthetic heart valve comprising a plurality of leaflets, wherein each leaflet comprises:

a) a coapting portion having a free edge;

b) a substantially arcuate portion adjacent said coapting portion, said arcuate portion having a peripheral edge; and

c) a plurality of supports within said coapting portion and said substantially arcuate portion, wherein said plurality of supports provide said leaflet with anisotropic elasticity, and wherein each said leaflet is attached to each other leaflet of said plurality.

18. ) The heart valve of claim 17, wherein said heart valve further comprises a stent, wherein each said leaflet is attached to said stent.

19. ) A heart valve comprising three leaflets, wherein each leaflet comprises:

a) a pair of opposing tabs;

b) a coapting portion extending between said pair of opposing tabs and having a coapting edge;

c) a substantially arcuate portion adjacent said coapting portion and having a peripheral edge; and

d) a plurality of supports extending between said pair of opposing tabs, wherein said plurality of supports provide said leaflet with anisotropic elasticity, and wherein each leaflet is attached to one tab of each of the other two leaflets.