Altering heart valve leaflet attachment geometry to influence the location and magnitude of maximum loaded stress on the leaflet

• US 6,613,086 B1
• Filed: 03/13/2000
• Issued: 09/02/2003
• Est. Priority Date: 06/24/1998
• Status: Expired due to Term

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Carbomedics Inc. (Snia SpA)
• Inventors: Ryder, John Kenneth, Moe, Riyad E.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): STEWART, ALVIN J
• Application Number:
  US09/523,804
• Time in Patent Office: 1,268 Days
• Field of Search: 623/2.1, 623/2.12, 623/2.14, 623/2.17, 623/2.18, 623/2.19, 623/2.28, 623/2.29, 623/2.33, 606/194
• US Class Current: 623/2.12
• 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

A tri-leaflet prosthetic cardiac valve with leaflets having an analytic shape in a selected position. The leaflets are connected to a valve body at attachment curves. The shape of the leaflet is selected from a set of geometries that can be represented mathematically. The attachment curve is selected to improve the durability of the tri-leaflet valve by moving the point of maximum loaded stress along the attachment curve away from the commissures. An inner wall of the valve body is given a non-circular shape near the attachment curve, the shape of the inner wall corresponding to the attachment curve. Also, a method of making a valve by selecting an analytic leaflet shape, selecting an attachment curve to improve durability of the valve by moving the point of maximum loaded stress along the attachment curve away from the commissures, and forming a valve body to support one or more leaflets, the valve body having a non-circular inner wall conforming to the attachment curve.

Claims

1. A valve comprising:

a valve body having an inflow end, an outflow end, and an inner wall extending between the inflow end and the outflow end forming an orifice having a longitudinal dimension along an axis extending between the inflow end and the outflow end;

at least one flexible leaflet having an analytic shape in a selected position coupled to the inner wall along an attachment curve; and

wherein a portion of the inner wall intersecting the attachment curve has a noncylindrical shape in a plane perpendicular to the longitudinal axis of the orifice.

2. A valve comprising

a valve body having an inner wall defining an orifice;

at least one flexible leaflet having an analytic shape in a selected position wherein the leaflet has a surface and a free edge, with the free edge having a center point; and

an attachment curve having a first end and a second end, the leaflet being coupled to the valve body along the attachment curve at the inner wall, the inner wall being non-cylindrical along said attachment curve and wherein the attachment curve is configured to have a shortest distance measured along the surface of the leaflet between the center point of the free edge and a point on the attachment curve, said point being removed from both the first end and the second end of the attachment curve, said shortest distance being smaller than both the distance measured along the surface of the leaflet between the center point of the free edge and the first end of the attachment curve and the distance measured along the surface of the leaflet between the center point of the free edge and the second end of the attachment curve.

3. The valve of claim 2 wherein a region along said attachment curve shares said shortest distance.

4. The valve of claim 2 wherein said analytic shape comprises a portion of a cylindrical surface.

5. The valve of claim 2 wherein said analytic shape comprises a portion of an ellipsoid.

6. The valve of claim 2 wherein said analytic shape comprises a portion of a paraboloid.

7. The valve of claim 2 comprising three leaflets, each leaflet having an analytic shape in a selected position.

8. The valve of claim 2 wherein the inner wall is concave along the attachment curve.

9. The valve of claim 2 wherein the inner wall is convex along the attachment curve.

10. A method for making a valve comprising:

selecting at least one flexible leaflet having an analytic shape in a selected position;

forming a valve body having an inflow end, an outflow end, and an inner wall extending between the inflow end and the outflow end which forms an orifice having a longitudinal dimension along an axis extending between the inflow end and the outflow end; and

coupling said leaflet to said inner wall along an attachment curve wherein a portion of the inner wall intersecting the attachment curve has a non-cylindrical shape in a plane perpendicular to the longitudinal axis of the orifice.

11. A method of making a valve comprising:

selecting a leaflet having an analytic shape in a selected position wherein said leaflet has a surface and a free edge, with the free edge having a center point;

connecting said leaflet to a valve body along an attachment curve having a first end and a second end;

configuring the valve body with an inner wall, said inner wall having a non-cylindrical surface defined by said attachment curve; and

configuring the attachment curve to have a shortest distance measured along the surface of the leaflet between the center point of the free edge and a point on the attachment curve, said point being removed from both the first end and the second end of the attachment curve, said shortest distance being smaller than both the distance measured along the surface of the leaflet between the center point of the free edge and the first end of the attachment curve and the distance measured along the surface of the leaflet between the center point of the free edge and the second end of the attachment curve.

12. The method of claim 11 wherein a region of said attachment curve shares said shortest distance.

13. The method of claim 11 wherein said analytic shape comprises a portion of a cylindrical surface.

14. The method of claim 11 wherein said analytic shape comprises an ellipsoid.

15. The method of claim 11 wherein said analytic shape comprises a paraboloid.

16. The method of claim 11 wherein configuring said attachment curve includes locating a point of maximum stress on the leaflet away from commissures.

17. The method of claim 11 further comprising selecting three leaflets, each leaflet having an analytic shape in selected position.

18. The method of claim 11 wherein said leaflet has a surface and a free edge, the free edge having a center point;

and said attachment curve has a first end, a second end and a point of maximum stress between said first and second ends, said method further comprising;

calculating a calculated point on a calculated attachment curve defined by the intersection of the leaflet and a hypothetical circular inner wall, which calculated point is calculated to experience maximum stress under load; and

configuring the attachment curve so that a linear distance between said center point and said point of maximum stress is greater than a linear distance between said center point and said calculated point, said point of maximum stress being co-linear with said center point and said calculated point.

19. The method of claim 18 increasing a linear distance between said center point and said attachment curve beyond said calculated attachment curve for a region around said point of maximum stress.