Stent having variable properties and method of its use

• US 20040102838A1
• Filed: 11/07/2003
• Published: 05/27/2004
• Est. Priority Date: 03/04/1998
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Killion, Douglas P., Lininger, James R.
• Granted Patent: US 7,060,091 B2
• Time in Patent Office: Days
• US Class Current: 623/1.16
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability

Abstract

A stent and method of its use, the stent in its expanded configuration, exhibiting varying outward radial force along its length. In use, the expanded stent is of a tapered configuration which provides greater force in vessel regions requiring greater force and less force in regions requiring less. In particular the stent is useful in the ostium regions and at areas of bifurcation in vessels. Varying force over the length of the stent is achieved by varying the number of elements, the density of elements, the thickness of the elements making up the stent body, and maintaining a substantially metal to artery ratio in the expanded stent over its length.

Claims

1. A stent having an unexpanded configuration and an expanded configuration, the latter having a length and a varying diameter along said length, comprising in the expanded configuration:

a tapered tubular shaped structure, said structure having a radially outward biased force and compression resistance, said force varying along said length in a predetermined manner, said tapered tubular structure having a first end region of largest diameter, a middle region of smaller diameter, and a second end region of smallest diameter, wherein said force is weaker in said first end region, stronger in said middle region than in said first region, and weaker in said second end region than in said middle region.

2. The stent of claim 1 including flexibility which varies along its length, the stent being stiffest in the region of stenosis contact and more flexible at the end regions.

3. The stent of claim 1 wherein the stent includes a relatively closed cell structure in the middle region compared to a more open cell structure at the end regions.

4. The stent of claim 1 wherein the strongest region of the stent is at the first end of larger diameter.

5. The stent of claim 4 including flexibility which varies along its length, the stent being stiffest in the region of stenosis contact and more flexible at the end of small diameter.

6. The stent of claim 4 wherein the stent includes a relatively closed cell structure at the first end region of largest diameter as compared to a more open cell structure at the other end region and the metal to artery ratio is substantially constant over the length of the stent in the expanded configuration.

7. The stent of claim 1 constructed and arranged as a self-expanding stent.

8. The stent of claim 1 constructed and arranged as a balloon expandable stent.

9. The stent of claim 1 wherein the stent structure is formed of a shape memory material so as to be self-expanding, the stent structure having an unexpanded configuration and an expanded memorized configuration, the unexpanded configuration having an average diameter less than that of the expanded configuration, the expanded configuration having a diameter which varies along the length of the stent from a first end region, to a middle region, and to a second end region, wherein the second configuration diameter is smaller in said first end region, larger in said middle region than in said first region, and largest in said second end region than in said middle region or said first end region.

10. The stent of claim 9 comprised of nitinol.

11. The stent of claim 9 wherein the stent includes relatively closed cell structure in the middle region compared to a more open cell structure at the end regions and the metal to artery ratio is substantially constant over the length of the stent in the expanded configuration.

12. The stent of claim 9 wherein the stent includes a relatively closed cell structure at the first end region of largest diameter as compared to a more open cell structure at the middle and other end region and the metal to artery ratio is substantially constant over the length of the stent in the expanded configuration.

13. A method of stenting a bifurcation region or ostial region in a blood vessel, comprising the steps of:

providing an unexpanded stent having predetermined properties over its length in an expanded configuration including outward radial force and compression resistance;

introducing the stent onto a catheter;

inserting the catheter and stent into an implantation region at bifurcation or ostium of a vessel;

expanding the stent to an enlarged diameter of a tapered configuration in support of the vessel wherein the aforementioned properties are exhibited, and

removing the catheter leaving the stent implanted in the vessel.

14. The method of claim 13 wherein the stent has a tapered tubular shaped structure, said structure having a radially outward biased force and compression resistance, said force varying along said length in a predetermined manner, said tapered tubular structure having a first end region of largest diameter, a middle region of smaller diameter, and a second end region of smallest diameter, wherein said force is weaker in said first end region, stronger in said middle region than in said first region, and weaker in said second end region than in said middle region.

15. The method of claim 14 wherein the stent is implanted in the bifurcation region of the common carotid artery, extending across the opening into the external carotid artery and into the internal carotid artery, the end of largest diameter being in the common carotid artery and the end of smallest diameter being in the internal carotid artery.

16. The method of claim 14 wherein the stent is formed of a shape memory material so as to be self-expanding, the stent structure having an unexpanded configuration and an expanded memorized configuration, the unexpanded configuration having an average diameter less than that of the expanded configuration, the expanded configuration having a diameter which varies along the length of the stent from a first end region, to a middle region, and to a second end region, wherein the second configuration diameter is smaller in said first end region, larger in said middle region than in said first region, and largest in said second end region than in said middle region or said first end region.

17. The method of claim 16 wherein the stent is implanted in the internal carotid with the end of largest diameter at the ostium thereof and the end of smallest diameter in healthy tissue downstream of the ostium.