Endoluminal stent cross section for optimum biocompatibility

• US 6,685,737 B1
• Filed: 10/31/2000
• Issued: 02/03/2004
• Est. Priority Date: 10/31/2000
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Pacetti, Stephen D.
• Primary Examiner(s): Calvert, John J.
• Assistant Examiner(s): Smith, James G
• Application Number:
  US09/703,664
• Time in Patent Office: 1,190 Days
• Field of Search: 623/1.15, 623/1.21, 623/1.1, 623/1.3, 623/1.32
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/3011 Cross-sections or two-dimensional shapes
• CPC Class Codes: A61F 2002/30327 differing in diameter
• CPC Class Codes: A61F 2230/0002 Two-dimensional shapes, e.g. cross-sections
• CPC Class Codes: A61F 2230/0017 Angular shapes
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A stent design minimizing the disturbance of blood flow and minimizing the trauma caused by the stent to the vessel in which it is implanted. The geometry of the stent struts reduces the neointima hyperplasia caused by trauma to the vessel wall and caused by disturbance to the endothelium created by changes in fluid shear stress. A stent is disclosed that includes struts having an outer surface configured to reduce the injury and inflammation to the vessel wall. The shape of the outer surface of the stent strut that distributes the stress imposed on the vessel wall surface evenly over the stent outer surface is a singular arc whose radii of curvature is such that the vessel wall meets this circular arc at its edge, and at this edge the strut surface slope matches that of the vessel wall. The stent is further configured with struts that have an inner surface with a geometry that reduces the turbulence of the blood flow as it passes over the struts. The inner surface provides a smooth transition at the interface between the strut leading edge and the vessel wall, and provides a smooth transition at the interface between the strut trailing edge and the vessel wall, yielding a wing-like shape to the inner surface of the strut. The overall optimal geometry of the stent strut combines an outer surface that minimizes vessel injury with an inner surface having hydrodynamics that minimizes the disturbance to the blood flow in the vessel.

Claims

1. An endoprosthesis for implanting in a body lumen defined by a wall, comprising;

at least one strut forming a structural member, the strut having an outer surface, an inner surface and a width, wherein the shape of the outer surface is different from the shape of the inner surface and the outer surface is curved substantially an entire width of the strut, the outer surface being configured to engage and reduced damage to a lumen wall.

2. The endoprosthesis of claim 1, wherein the outer surface is symmetric relative to a radial vector.

3. The endoprosthesis of claim 1, wherein the outer surface is configured with a cross-section formed as a circular arc having a single radius of curvature.

4. The endoprosthesis of claim 3, wherein the radius of curvature of the outer surface is defined by the expression:

r=W÷

(2sin θ

), where r is the radius of curvature of the outer surface, W is a strut width and θ

is an angle in which the lumen wall intercepts the strut.

5. The endoprosthesis of claim 1, wherein the strut further includes a leading edge and a trailing edge, such that there is a first transition zone proximate the leading edge and the outer surface, and there is a second transition zone proximate the trailing edge and the outer surface, wherein the outer surface is configured with a cross-section having a single radius of curvature except at the first and second transition zones.

6. The endoprosthesis of claim 1, wherein the inner surface is non-symmetric relative to a radial vector.

7. The endoprosthesis of claim 2, wherein the inner surface is non-symmetric relative to a radial vector.

8. The endoprosthesis of claim 1, wherein the inner surface is hydrodynamically designed to minimize disturbance of fluid flow over the endoprosthesis.

9. The endoprosthesis of claim 3, wherein the inner surface is hydrodynamically configured to reduce disturbance of fluid flow over the endoprosthesis.

10. The endoprosthesis of claim 1, wherein the inner surface has a preferred fluid flow direction.

11. The endoprosthesis of claim 9, wherein the inner surface has a preferred fluid flow direction.

12. The endoprosthesis of claim 1, wherein the inner surface includes a first slope towards incoming fluid flow and a second slope facing away from incoming fluid flow, and wherein the first slope is steeper than the second slope.

13. The endoprosthesis of claim 12, wherein the inner surface along the second slope is tapered.

14. The endoprosthesis of claim 3, wherein the inner surface is foil shaped.

15. The endoprosthesis of claim 1, the outer surface having more curved surfaces than the inner surface.

16. The endoprosthesis of claim 1, the outer surface having a curve that evenly distributes stresses placed on a body lumen by the endoprosthesis.

20. The stent of claim 15, wherein the outer surface is configured with a cross-section having a radius of curvature defined by the expression:

r=W÷

(2sin θ

)), where r is the radius of curvature, W is a strut width and θ

is an angle in which the vessel wall intercepts the strut.

21. The stent of claim 20, wherein the inner surface is foil shaped.

17. A stent for implanting in a blood vessel, comprising:

a plurality of struts forming a structural member, each strut having an outer surface, an inner surface and a width, wherein the outer surface is curved substantially an entire width of the strut and is configured to engage and reduce damage to a wall of the blood vessel, and the inner surface is configured to reduce disturbance of blood flow over the stent and has a different shape from the outer surface.

18. The stent of claim 17, wherein the outer surface is configured with a cross-section formed as a circular arc having a single radius of curvature.

19. The stent of claim 18, wherein the inner surface includes a first slope towards incoming blood flow and a second slope facing away from incoming blood flow, such that the first slope is steeper than the second slope.

22. The stent of claim 17, the outer surface having more curved surfaces than the inner surface.

23. The stent of claim 17, the outer surface having a curve that evenly distributes stresses placed on a body lumen by the stent.