Stent and method of manufacturing same

• US 20060122686A1
• Filed: 10/17/2005
• Published: 06/08/2006
• Est. Priority Date: 05/10/2004
• Status: Abandoned Application

• Current Assignee: Baylis Medical Company Inc. (Boston Scientific Corporation)
• Original Assignee: Baylis Medical Company Inc. (Boston Scientific Corporation)
• Inventors: Gilad, Ran, Baylis, Frank, Biadillah, Youssef
• Application Number:
  US11/250,447
• Publication Number:
  US 20060122686A1
• Time in Patent Office: Days
• US Class Current: 623/1.130
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

A stent including a substantially radially expandable scaffold including interlinked struts, the scaffold being configurable into both a retracted and an expanded configuration. In the retracted configuration, the diameter of the scaffold along at least a portion thereof is smaller than the diameter of the scaffold the expanded configuration. The stent further includes a sheath mounted to the scaffold so that at least some of the struts are embedded into the sheath. The sheath allows a substantially radial movement of the struts between the expanded and the retracted configurations with the at least some of the struts remaining embedded in the sheath during the substantially radial movement.

Claims

1. A stent, said stent comprising:

a substantially radially expandable scaffold including interlinked struts, said scaffold being configurable into both a retracted and an expanded configuration, wherein in said retracted configuration, the diameter of said scaffold along at least a portion thereof is smaller than the diameter of said scaffold in said expanded configuration; and

a sheath mounted to said scaffold so that at least some of said struts are embedded into said sheath, said sheath allowing a substantially radial movement of said struts between said expanded and said retracted configurations with said at least some of said struts remaining embedded in said sheath during said substantially radial movement.

2. A stent as defined in claim 1, wherein said stent defines a stent longitudinal axis and wherein said at least some of said struts include a longitudinal strut extending in a direction substantially parallel to said stent longitudinal axis.

3. A stent as defined in claim 2, wherein said at least some of said struts include a pair of longitudinal struts extending in a substantially parallel relationship relative to each other, said longitudinal struts being interlinked so as to remain in a substantially parallel relationship relative to each other as said stent moves between said expanded and retracted configurations.

4. A stent as defined in claim 3, wherein each longitudinal strut defines corresponding longitudinal strut first and second ends, said first and second longitudinal struts being interconnected substantially adjacent their corresponding first and second ends by corresponding interconnecting strut arrangements, said interconnecting strut arrangements having a substantially V-shaped configuration.

5. A stent as defined in claim 4, wherein each of said interconnecting strut arrangements defines a pair of arrangement members pivotally attached together about an apex, said arrangement members being disposed such that said apexes of said first and second interconnecting strut arrangements move in the same longitudinal direction as said stent moves between said expanded and retracted configurations.

6. A stent as defined in claim 5, wherein said apexes of said first and second interconnecting strut arrangements move over the same longitudinal distance direction as said stent moves between said expanded and retracted configurations.

7. A stent as defined in claim 4, wherein each of said interconnecting strut arrangements defines a pair of arrangement members pivotally attached together about an apex, said arrangement members being disposed such that said apex of said first and second interconnecting strut arrangements move in opposite longitudinal directions as said stent moves between said expanded and retracted configurations.

8. A stent as defined in claim 1, wherein said struts form a cell perimeter of a plurality of adjacent cells, each of said cells having a sheath cell portion extending thereacross, at least one of said cells being configured such that there is substantially no longitudinal strain imparted on the corresponding sheath cell portion as said stent is moved between said stent retracted and expanded configurations.

9. A stent as defined in claim 8, wherein said stent defines a stent first longitudinal end and an opposed stent second longitudinal end, said stent having a stent passageway extending longitudinally thereacross, said stent further comprising at least one valve leaflet extending at least partially across said stent passageway.

10. A stent as defined in claim 1, wherein said stent defines a stent first longitudinal end and an opposed stent second longitudinal end, said stent having a stent passageway extending longitudinally thereacross, said stent further comprising at least one valve leaflet extending at least partially across said stent passageway.

11. A stent as defined in claim 10, wherein said at least one valve leaflet extends at least in part integrally from at least one of said at least some of said struts.

12. A stent as defined in claim 10, wherein said valve leaflet extends at least in part integrally from said sheath.

13. A stent as defined in claim 10, wherein said at least one valve leaflet extends integrally from at least one of said at least some of said struts and from said sheath

14. A stent as defined in claim 1, wherein said sheath includes a sheath material and said scaffold includes a scaffold material, said stent further comprising a binding layer of a binding substance positioned between at least a subset of said at least some of said struts and said sheath, said binding layer adhering to said scaffold material and to said sheath material with a binding force that is stronger than a binding force between said scaffold material and said sheath material.

15. A stent as defined in claim 14, wherein said sheath material includes a first polymer.

16. A stent as defined in claim 15, wherein said binding substance includes a second polymer.

17. A stent as defined in claim 16, wherein said first polymer includes a first polyurethane.

18. A stent as defined in claim 17, wherein said second polymer includes a second polyurethane different from said first polyurethane.

19. A stent as defined in claim 18, wherein the tensile modulus of elasticity of said second polyurethane is substantially larger than the tensile modulus of elasticity of said first polyurethane.

20. A stent as defined in claim 19, wherein the tensile modulus of elasticity of said second polyurethane is from about 1.5 to about 10 times larger than the tensile modulus of elasticity of said first polyurethane.

21. A stent as defined in claim 20, wherein the tensile modulus of elasticity of said second polyurethane is from about 2 to about 3 times larger than the tensile modulus of elasticity of said first polyurethane.

22. A stent as defined in claim 16, wherein said second polymer includes substantially more polar groups than said first polymer.

23. A stent as defined in claim 15, wherein said first polymer in selected from polystyrene-b-polyisobutylene-b-polystyrene (SIBS), polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), and Polynivyl alcohol cryogel (PVAC),

24. A stent as defined in claim 1, wherein said sheath includes a sheath material, said sheath material including a biological tissue.

25. A stent as defined in claim 1, wherein said valve has a substantially non-uniform thickness.

26. A stent as defined in claim 1, wherein said sheath includes a sheath material and said valve includes a valve material different from said sheath material.

27. A stent as defined in claim 1, wherein at least one of said struts is a substantially elongated strut defining a strut longitudinal axis and substantially longitudinally opposed strut first and second ends.

28. A stent as defined in claim 27, wherein said at least one of said strut has a cross-section in a plane oriented substantially perpendicularly to said strut longitudinal axis that changes in dimensions between said strut first and second ends.

29. A stent as defined in claim 28, wherein said at least one of said struts defines a substantially circumferentially extending strut flange.

30. A stent as defined in claim 27, wherein said at least one of said struts includes a strut aperture extending substantially radially from outside said scaffold to inside said scaffold.

31. A stent as defined in claim 30, wherein said strut aperture defines an aperture first end and a substantially longitudinally opposed aperture second end, said strut aperture having a cross-section in a plane oriented substantially perpendicularly to said strut longitudinal axis that changes in dimensions between said aperture first and second ends.

32. A method for manufacturing a stent, the stent having a stent passageway extending longitudinally therethrough, said method comprising:

providing a substantially radially expandable scaffold including interlinked struts, the scaffold being configurable into both a retracted and an expanded configuration, wherein in the retracted configuration, the diameter of the scaffold along at least a portion thereof is smaller than the diameter of the scaffold in said expanded configuration along the at least a portion thereof; and

mounting a sheath to the scaffold so that at least some of said struts are embedded into said sheath, said sheath allowing a substantially radial movement of said struts between said expanded and said retracted configurations with said at least some of said struts remaining embedded in said sheath during said substantially radial movement.

33. A method as defined in claim 32, wherein said mounting of the sheath to the scaffold is performed by depositing a polymer film onto at least a portion of the scaffold.

34. A method as defined in claim 33, wherein said depositing of the polymer film onto at least a portion of the scaffold includes dip-coating the scaffold with the polymer.

35. A method as defined in claim 33, wherein said depositing of the polymer film onto at least a portion of the scaffold includes spraying the scaffold with the polymer.

36. A method as defined in claim 33, wherein said depositing of the polymer film onto at least a portion of the scaffold includes molding the polymer around the scaffold.

37. A method as defined in claim 33, wherein said depositing of the polymer film on the scaffold includes positioning a first sheet of the polymer so that at least part of the first sheet is in proximity to the scaffold and applying heat to fuse the first sheet to the scaffold.

38. A method as defined in claim 37, wherein said positioning of the first sheet of the polymer includes surrounding at least a section of the scaffold with the first sheet prior to said application of heat.

39. A method as defined in claim 38, further comprising inserting a second sheet of the polymer within the scaffold so that the at least a portion of the scaffold is in proximity to the second sheet prior to said application of heat.

40. A method as defined in claim 33, wherein the scaffold is mounted onto a mandrel prior to said mounting of the sheath, the mandrel including a valve forming surface for forming a valve extending at least partially across the stent passageway.

41. A method as defined in claim 40, wherein the polymer film is deposited simultaneously on the scaffold and on the mandrel to form the valve.

42. A method as defined in claim 41, further comprising

covering the valve forming surface with a stripping substance prior to said mounting of the valve, the stripping substance being a substance that is soluble in a stripping solvent, the stripping solvent being a fluid into which the polymer is substantially non-soluble.

dipping the mandrel and the stent in the stripping solvent after said deposition of the polymer film;

and

removing the mandrel from the stent after the stripping solvent has dissolved at least in part the stripping substance.

43. A method as defined in claim 42, wherein the stripping substance is an aqueous solution.

44. A method as defined in claim 43, wherein the stripping solvent includes PVOH.

45. A method as defined in claim 44, wherein the stripping substance consists essentially of water.

46. A method as defined in claim 40, further comprising coating at least some of the struts with a binding substance prior to said forming of the sheath, the binding substance being a substance that adheres to said struts and to said sheath with a binding force that is stronger than a binding force between the scaffold and the sheath.

47. A method as defined in claim 32, further comprising forming the scaffold by removing material from a substantially cylindrical shell.

48. A method as defined in claim 32, further comprising expanding the stent prior to said mounting of the sheath.

49. A stent, said stent comprising:

a substantially radially expandable scaffold means including interlinked strut means, said scaffold means being configurable into both a retracted and an expanded configuration, wherein in said retracted configuration, the diameter of said scaffold means along at least a portion thereof is smaller than the diameter of said scaffold means in said expanded configuration; and

a sheath means mounted to said scaffold means so that at least some of said strut means are embedded into said sheath means, said sheath means allowing a substantially radial movement of said strut means between said expanded and said retracted configurations with said at least some of said strut means remaining embedded in said sheath means during said substantially radial movement.