Optimized geometry of a tissue pattern for semilunar heart valve reconstruction

• US 6,328,763 B1
• Filed: 06/11/1999
• Issued: 12/11/2001
• Est. Priority Date: 10/06/1995
• Status: Expired due to Term

• Current Assignee: Cardiomend LLC
• Original Assignee: Cardiomend LLC
• Inventors: Suggitt, Robert W., Hanlon, James G., Love, Jack W.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US09/330,689
• Time in Patent Office: 914 Days
• Field of Search: 623/2.12, 623/2.13, 623/2.15, 623/2.19, 623/2.42
• US Class Current: 623/2.15
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2472 Devices for testing

Abstract

A new and unique, optimized, two-dimensional heart valve tissue pattern, valve, and a method of reconstructing a three-dimensional semilunar heart valve, or portion thereof. In one preferred embodiment, the two-dimensional valve tissue pattern, and method of the present invention, comprises a two-dimensional configuration developed and optimized by employing, in part, the anatomy of a three-dimensional human heart valve, and said two-dimensional configuration delimits a two dimensional area that corresponds to the shape of tissue to be used in the repair of at least one leaflet of a circulatory system semilunar valve, wherein the configuration delimits at least one segment, and up to all three segments, of a three segment “trefoil” shape.

Claims

1. A two-dimensional valve tissue pattern comprising a configuration that corresponds to the shape of tissue to be used in a reconstruction of at least one leaflet of a circulatory system valve, wherein the pattern comprises a configuration having three lobes arranged about a central coaption point within a central aperture.

2. The valve tissue pattern of claim 1 wherein each lobe is comprised of an outer perimeter and an inner edge.

3. The valve tissue pattern of claim 2 wherein the outer perimeter of each lobe has a rounded surface.

4. The valve tissue pattern of claim 3 wherein the inner edge of each lobe is linear.

5. The valve tissue pattern of claim 1 wherein said aperture has three sides.

6. The valve tissue pattern of claim 5 wherein the three lobes are asymmetrically arranged about the central coaption point.

7. The valve tissue pattern of claim 5 wherein the central aperture is a triangle.

8. The valve tissue pattern of claim 5 wherein the central aperature corresponds to the shape of an equilateral triangle in which each of the edges of said equilateral triangle correspond to a line of coaption on each of the lobes.

9. The valve tissue pattern of claim 8 wherein each lobe comprises an outer perimeter and an inner edge.

10. The valve tissue pattern of claim 9 wherein the outer perimeter of each lobe has a rounded surface.

11. The valve tissue pattern of claim 10 wherein each lobe meets adjacent lobes at commisure areas located at the point where the outer perimeter of each lobe meets the inner edge of the same lobe.

12. The valve tissue pattern of claim 1 wherein when the two-dimensional valve tissue pattern is affixed to the annulus of a heart, said valve tissue pattern forms to provide a competent valve leaflet reconstruction.

13. The valve tissue pattern of claim 5 wherein the three lobes are arranged in substantial radial symmetry about the central coaption point.

14. The valve tissue pattern of claim 9 wherein when the valve tissue pattern is affixed to the annulus of a heart, and said valve pattern forms a three-dimensional valve, the line of coaption of each lobe meets with the lines of coaption of the other two lobes.

15. The valve tissue pattern of claim 9 wherein the three lobes meet at a central coaption point.

16. The valve tissue pattern of claim 1 wherein the pattern is comprised of autologous, homologous or heterologous tissue.

17. The valve tissue pattern of claim 16 wherein said tissue is pericardium.

18. The valve tissue pattern of claim 1 wherein the two-dimensional tissue pattern is derived from unwrapping the three-dimensional geometry of a native anatomical circulatory system valve.

19. A two-dimensional valve tissue pattern comprising a configuration that corresponds to the shape of tissue to be used in the reconstruction of at least one leaflet of a native circulatory system valve, wherein the two-dimensional tissue pattern is reduced to a size which is smaller than the expected size of valve leaflets of a normal valve having a valve annulus of the size of the native circulatory system valve, such that when the tissue pattern is exposed to loads and pressures of the circulatory system, the tissue stretches and substantially conforms to the expected size of a normal valve.

20. The valve tissue pattern of claim 19 wherein the two-dimensional tissue pattern is reduced to a size which is approximately ten percent smaller than would normally be prepared to reconstruct a valve having a native anatomical size.