Flexible stent having a pattern formed from a sheet of material

• US 5,632,771 A
• Filed: 01/25/1995
• Issued: 05/27/1997
• Est. Priority Date: 07/23/1993
• Status: Expired due to Term

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Boatman, Scott E., Brummett, Kimberly D.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US08/378,073
• Time in Patent Office: 853 Days
• Field of Search: 606/198, 606/191, 606/195, 623/1, 623/12
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/885 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A flexible stent having a waveform pattern formed from a sheet of biocompatible material and into a tubular shape for maintaining the patency of a lumen such as in a coronary vessel. The waveform pattern of the stent is formed from a flat sheet of malleable, biocompatible material by, for example, photochemically etching the sheet and leaving a framework or plurality of closed cells. The waveform pattern is formed into a tubular shape around a deflated, delivery catheter balloon with segments of the closed cells being interposed only overlapping a reinforcing member extending longitudinally along the stent. The stent material is treated to reduce the coefficient of friction of the material and to aid in the radial expansion of the stent with the balloon. Radiopaque markers are positioned at the ends of the stent to aid the physician in positioning the stent at an occlusion site.

Claims

1. A flexible stent comprising:

a seamless sheet of biocompatible material having a pattern in a surface of said seamless sheet, said pattern including in said seamless sheet a reinforcing member extending longitudinally therealong and a plurality of cells extending laterally from said reinforcing member, selected of said cells each being a closed cell, having a fixedly sized aperture extending through said surface of said seamless sheet and a segment extending laterally from said reinforcing member and disposed at least partially around the aperture of the cell, each segment of said selected cells being separated from any other cell in said stent.

2. The flexible stent of claim 1 wherein said pattern is formed into a tubular shape and wherein each segment of said selected cells does not overlap itself or a segment of any other cell in said stent when said pattern is in said tubular shape.

3. The flexible stent of claim 2 wherein said tubular shape is radially alterable and wherein said pattern when in said tubular shape includes first and second outermost edges aligned with a longitudinal axis of said tubular shape which move relative to each other when said tubular shape is being radially altered.

4. The flexible stent of claim 2 wherein said pattern when in said tubular shape includes an overlapping state in which at least one segment of said selected cells overlaps said reinforcing member and forms a combined thickness with and along said reinforcing member of no more than substantially twice a thickness of said sheet of material.

5. The flexible stent of claim 4 further comprising a catheter having a balloon positioned proximate a distal end of said catheter and wherein said pattern is positioned around said balloon and in said overlapping state.

6. The flexible stent of claim 5 wherein said balloon is inflatable to radially expand said pattern from said overlapping state to a nonoverlapping state.

7. The flexible stent of claim 2 wherein said cells of said pattern when in said tubular shape are interposed between each other.

8. The flexible stent of claim 1 wherein laterally extending segments of said selected cells each have a width substantially greater than a thickness of said sheet of material.

9. The flexible stent of claim 1 wherein said pattern includes a radiopaque marker at least at one end thereof.

10. The flexible stent of claim 1 wherein said pattern is etched in said sheet of material.

11. The flexible stent of claim 1 wherein said sheet of material has a surface with a coefficient of friction and wherein said surface has a treatment lowering said coefficient of friction.

12. The flexible stent of claim 11 wherein said treatment includes a coating on said surface of said sheet of material.

13. The flexible stent of claim 12 wherein said coating comprises at least one from a group consisting of parylene and polytetrafluoroethylene.

14. A flexible, tubular-shaped stent comprising:

a seamless sheet of biocompatible material having a tubular shape and a pattern in a surface of said seamless sheet, said pattern including in said surface of said seamless sheet a reinforcing member extending longitudinally therealong and a plurality of interposed closed cells extending laterally from said reinforcing member, said pattern having an overlapping state in which selected of said interposed closed cells only overlap said reinforcing member.

15. The flexible stent of claim 14 wherein said pattern when in said tubular shape also has an expanded state in which each of said selected cells does not overlap any adjacent one of said selected cells.

16. The flexible stent of claim 14 wherein each of said selected cells in said overlapping state only overlaps said reinforcing member and forms a combined thickness with and along said reinforcing member of no more than substantially twice a thickness of said sheet of material.

17. The flexible stent of claim 14 wherein each of said selected cells each has a fixedly sized aperture therein and wherein at least a segment of said selected cells overlaps said reinforcing member and is positioned in the fixedly sized aperture of the cell when said pattern is in said overlapping state.

18. A flexible, tubular-shaped stent comprising:

a seamless sheet of material having a tubular shape and a pattern in a surface of said seamless sheet, said pattern including in said seamless sheet a reinforcing member extending longitudinally therealong and a plurality of interposed cells extending laterally from and including said reinforcing member, selected of said interposed cells each being a closed cell and having a fixedly sized aperture extending through said seamless sheet and defined by a first and a second segment extending laterally from said reinforcing member at a first and a second angle, respectively, and a curved segment interconnecting the first and the second segment.

19. The flexible stent of claim 18 wherein said tubular shape is radially alterable and wherein said pattern when in said tubular shape includes first and second outermost edges aligned with a longitudinal axis of said tubular shape which move relative to each other when said tubular shape is being radially altered.

20. The flexible stent of claim 18 wherein said pattern when in said tubular shape includes an overlapping state in which at least one of the first and second substantially straight segments and the curved segment of said selected cells overlaps said reinforcing member and forms a combined thickness with and along said reinforcing member of no more than substantially twice a thickness of said sheet of material.

21. The flexible stent of claim 20 further comprising a catheter having a balloon positioned proximate a distal end of said catheter and wherein said pattern when in said tubular shape is positioned around said balloon and into said overlapping state.

22. The flexible stent of claim 20 wherein said pattern when in said tubular shape also has an expanded state in which each of said selected cells does not overlap any adjacent one of said selected cells.

23. The flexible stent of claim 20 wherein each of said selected interposed cells in said overlapping state only overlaps said reinforcing member and forms a combined thickness with and anywhere along said reinforcing member of no more than substantially twice a thickness of said sheet of material.

24. The flexible stent of claim 18 wherein said pattern includes a radiopaque marker at least at one end thereof.

25. A flexible, tubular-shaped stent comprising:

a seamless sheet of biocompatible material having a specified thickness and including in said seamless sheet of material a reinforcing member extending longitudinally therealong and a plurality of cells extending laterally from said reinforcing member in a surface of said seamless sheet of material, selected of said cells being a closed cell and including a fixedly sized aperture extending through said surface of said seamless sheet of material, said seamless sheet of material having a tubular shape including an overlapping state in which certain of said cells overlap said reinforcing member while none of cells overlap each other and form a combined thickness anywhere along said reinforcing member of no more than substantially twice said specified thickness of said seamless sheet of material.

26. The flexible stent of claim 25 wherein said tubular shape is radially alterable and wherein said reinforcing member and said cells when in said tubular shape includes first and second outermost edges aligned with said longitudinal axis which move relative to each other when said tubular shape is being radially altered.

27. A flexible stent comprising:

a seamless sheet of biocompatible material having a pattern in a surface of said seamless sheet, said pattern including in said seamless sheet a reinforcing member extending longitudinally therealong and a plurality of cells extending laterally from said reinforcing member, selected of said cells each being a closed cell, having a fixedly sized aperture extending through said surface of said seamless sheet and a segment extending laterally from said reinforcing member and disposed at least partially around the aperture of the cell, each segment of said selected cells being separated from any other segment disposed at least partially around the aperture of any other cell in said stent.

28. A flexible stent comprising:

a sheet of biocompatible material having a pattern in a surface of said sheet, said pattern including a reinforcing member extending longitudinally therealong and a plurality of closed cells each extending laterally from said reinforcing member and having a fixedly sized aperture extending through said surface of said sheet, each of said closed cells having segments extending laterally from said reinforcing member and in combination with said reinforcing member longitudinally reinforcing the cell, each of said closed cells being separated from any other of said closed cells.

29. The flexible stent of claim 28 wherein selected of said closed cells each has a generally triangular shape.

30. The flexible stent of claim 28 wherein said reinforcing member is laterally flexible when said sheet assumes a tubular shape.