Stent coating

• US 20030040790A1
• Filed: 07/31/2002
• Published: 02/27/2003
• Est. Priority Date: 04/15/1998
• Status: Abandoned Application

• Current Assignee: ICON Interventional Systems, Inc.
• Original Assignee: ICON Interventional Systems, Inc.
• Inventors: Furst, Joseph G.
• Application Number:
  US10/209,591
• Publication Number:
  US 20030040790A1
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/426 Immunomodulating agents, i.e. cytokines, interleukins, interferons
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

An expandable stent for use within a body passageway having a body member with two ends and a wall surface disposed between the ends. The body member has a first diameter to permit delivery of the body member into a body passageway and a second expanded diameter. The surface of the stent is coated with a biological agent and a polymer which controls the release of the biological agent.

Claims

1. An expandable stent for use within in a body passageway including a body member, a intermediate compound, and a biological agent, said body member having first and second ends and a wall surface disposed between said first and second ends defining a longitudinal axis of said body member, said body member having a first cross-sectional shape having a first cross-sectional area which permits intraluminal delivery of said body member into the body cavity, and a second expanded cross-sectional shape having a second cross-sectional area which is greater than said first cross-sectional area, said biological agent at least partially coated on the surface of said body member, said intermediate compound at least partially securing said biological agent to said body member, said intermediate compound including at least one radiation induced cross-linking that at least partially encapsulates at least a portion of said biological agent in said intermediate compound.

2. The stent as defined in claim 1, wherein said biological agent is releasably coated on said stent.

3. The stent as defined in claim 1, wherein said cross-linking in said intermediate compound at least partially delays delivery of said biological agent into said body passageway.

4. The stent as defined in claim 2, wherein said cross-linking in said intermediate compound at least partially delays delivery of said biological agent into said body passageway.

5. The stent as defined in claim 1, wherein at least a portion of said biological agent forms a polymer salt complex with said intermediate compound.

6. The stent as defined in claim 4, wherein at least a portion of said biological agent forms a polymer salt complex with said intermediate compound.

7. The stent as defined in claim 1, wherein said intermediate compound includes a polymer, a copolymer or mixtures thereof.

8. The stent as defined in claim 6, wherein said intermediate compound includes a polymer, a copolymer or mixtures thereof.

9. The stent as defined in claim 1, wherein said intermediate compound includes hydrophobic and hydrophilic compounds.

10. The stent as defined in claim 8, wherein said intermediate compound includes hydrophobic and hydrophilic compounds.

11. The stent as defined in claim 1, wherein said intermediate compound includes an ethylene-acrylic acid copolymer, parylene, parylene derivatives, and mixtures thereof.

12. The stent as defined in claim 11, wherein said intermediate compound includes an ethylene-acrylic acid copolymer, parylene, parylene derivatives, and mixtures thereof.

13. The stent as defined in claim 8, wherein said intermediate compound includes an ethylene-acrylic acid copolymer, parylene, parylene derivatives, and mixtures thereof.

14. The stent as defined in claim 1, wherein said biological agent includes Trapidil, GM-CSF, and mixtures thereof.

15. The stent as defined in claim 13, wherein said biological agent includes Trapidil, GM-CSF, and mixtures thereof.

16. The stent as defined in claim 1, wherein said wall surface being at least partially formed by a plurality of intersecting elongated members, at least some of said elongated members intersecting with one another intermediate said first and second ends of said body member, said plurality of intersecting elongated members forming a plurality of openings in said wall surface, at least one of said openings in said wall surface is formed of at least four intersecting elongated members which define the top, bottom and two sides of said opening, said top and said bottom sides are substantially parallel to one another in said first and said second cross-sectional shapes of said body member.

17. The stent as defined in claim 15, wherein said wall surface being at least partially formed by a plurality of intersecting elongated members, at least some of said elongated members intersecting with one another intermediate said first and second ends of said body member, said plurality of intersecting elongated members forming a plurality of openings in said wall surface, at least one of said openings in said wall surface is formed of at least four intersecting elongated members which define the top, bottom and two sides of said opening, said top and said bottom sides are substantially parallel to one another in said first and said second cross-sectional shapes of said body member.

18. The expandable intraluminal graft as defined in claim 16, wherein said top and bottom sides of said opening are substantially parallel along said longitudinal axis of said body member.

19. The expandable intraluminal graft as defined in claim 17, wherein said top and bottom sides of said opening are substantially parallel along said longitudinal axis of said body member.

20. The expandable intraluminal graft as defined in claim 16, wherein said two sides of said opening are substantially parallel to one another in said first and said second cross-sectional shapes of said body member.

21. The expandable intraluminal graft as defined in claim 18, wherein said two sides of said opening are substantially parallel to one another in said first and said second cross-sectional shapes of said body member.

22. The expandable intraluminal graft as defined in claim 19, wherein said two sides of said opening are substantially parallel to one another in said first and said second cross-sectional shapes of said body member.

23. The expandable intraluminal graft as defined in claim 16, wherein at least one of said openings in said wall surface having a substantially parallelogram shape when said body member is in said first cross-sectional shape.

24. The expandable intraluminal graft as defined in claim 21, wherein at least one of said openings in said wall surface having a substantially parallelogram shape when said body member is in said first cross-sectional shape.

25. The expandable intraluminal graft as defined in claim 22, wherein at least one of said openings in said wall surface having a substantially parallelogram shape when said body member is in said first cross-sectional shape.

26. The stent as defined in claim 1, wherein said wall surface including a first and second set of slots about a circumference of said body member, each set of slots including at least two slots positioned substantially parallel to one another along said longitudinal axis of said body member, said first and said second set of slots forming an angle between said sets of slots between 0-90°

when said body member is in said first cross-sectional shape.

27. The stent as defined in claim 15, wherein said wall surface including a first and second set of slots about a circumference of said body member, each set of slots including at least two slots positioned substantially parallel to one another along said longitudinal axis of said body member, said first and said second set of slots forming an angle between said sets of slots between 0-90°

when said body member is in said first cross-sectional shape.

28. The expandable intraluminal graft as defined in claim 26, wherein a plurality of said slots of said one set of slots include first and second ends, at least two adjacently positioned slots having said first and said second ends, said first ends of said slots lying in a first plane substantially parallel to a longitudinal axis of said body member when said body member is in said first cross-sectional shape, said second ends of said slots lying in a second plane substantially parallel to a longitudinal axis of said body member when said body member is in said first cross-sectional shape, said first and second set of slots are not parallel to said longitudinal axis of said body member when said body member is in said first cross-sectional shape.

29. The expandable intraluminal graft as defined in claim 27, wherein a plurality of said slots of said one set of slots include first and second ends, at least two adjacently positioned slots having said first and said second ends, said first ends of said slots lying in a first plane substantially parallel to a longitudinal axis of said body member when said body member is in said first cross-sectional shape, said second ends of said slots lying in a second plane substantially parallel to a longitudinal axis of said body member when said body member is in said first cross-sectional shape, said first and second set of slots are not parallel to said longitudinal axis of said body member when said body member is in said first cross-sectional shape.

30. The expandable intraluminal graft as defined in claim 26, wherein a plurality of said slots of said one set of slots include first and second ends, at least two adjacently positioned slots having said first and said second ends, said first ends of said slots lying in a first plane substantially parallel to a longitudinal axis of said body member when said body member is in said second cross-sectional shape, said second ends of said slots lying in a second plane substantially parallel to a longitudinal axis of said body member when said body member is in said second cross-sectional shape.

31. The expandable intraluminal graft as defined in claim 29, wherein a plurality of said slots of said one set of slots include first and second ends, at least two adjacently positioned slots having said first and said second ends, said first ends of said slots lying in a first plane substantially parallel to a longitudinal axis of said body member when said body member is in said second cross-sectional shape, said second ends of said slots lying in a second plane substantially parallel to a longitudinal axis of said body member when said body member is in said second cross-sectional shape.

32. The expandable intraluminal graft as defined in claim 26, wherein said first and second set of slots are not parallel to said longitudinal length of said body member when said body member is in said second cross-sectional shape.

33. The expandable intraluminal graft as defined in claim 31, wherein said first and second set of slots are not parallel to said longitudinal length of said body member when said body member is in said second cross-sectional shape.

34. The expandable intraluminal graft as defined in claim 26, wherein said body member is formed from a single piece of material.

35. The expandable intraluminal graft as defined in claim 33, wherein said body member is formed from a single piece of material.

36. The expandable intraluminal graft as defined in claim 1, wherein said body member maintains a substantially constant longitudinal length when expanded from said first cross-sectional shape to said second cross-sectional shape.

37. The expandable intraluminal graft as defined in claim 25, wherein said body member maintains a substantially constant longitudinal length when expanded from said first cross-sectional shape to said second cross-sectional shape.

38. The expandable intraluminal graft as defined in claim 35, wherein said body member maintains a substantially constant longitudinal length when expanded from said first cross-sectional shape to said second cross-sectional shape.

39. The expandable intraluminal graft as defined in claim 1, wherein said graft includes two body members and at least one connector connected between said two body members, said connector allowing transverse bending flexibility invariant to the plane of bending of said graft.

40. The expandable intraluminal graft as defined in claim 37, wherein said graft includes two body members and at least one connector connected between said two body members, said connector allowing transverse bending flexibility invariant to the plane of bending of said graft.

41. The expandable intraluminal graft as defined in claim 39, wherein said graft includes two body members and at least one connector connected between said two body members, said connector allowing transverse bending flexibility invariant to the plane of bending of said graft.

42. The expandable intraluminal graft as defined in claim 39, wherein said connector is substantially “

U”

shaped or “

V”

shaped.

43. The expandable intraluminal graft as defined in claim 1, wherein said body member is substantially tubular.

44. The expandable intraluminal graft as defined in claim 1, wherein said second cross-sectional area of said body member is variable.

45. The expandable intraluminal graft as defined in claim 1, wherein said first and second ends having a substantially smooth surface.

46. The expandable intraluminal graft as defined in claim 40, wherein said first and second ends having a substantially smooth surface.

47. The expandable intraluminal graft as defined in claim 41, wherein said first and second ends having a substantially smooth surface.

48. The expandable intraluminal graft as defined in claim 1, wherein a plurality of said intersecting elongated members are at least partially formed by a process including etching, laser cutting, and combinations thereof.

49. The expandable intraluminal graft as defined in claim 1, wherein said body member is at least partially coated with a material that is visible under fluoroscopy, said material being coated on an outer surface of said body member and at least one end of said body member.

50. The expandable intraluminal graft as defined in claim 1, wherein said body member is treated with Gamma or Beta radiation to reduce the vascular narrowing of at least a portion of said body cavity.

51. The expandable intraluminal graft as defined in claim 1, including a balloon, said balloon including at least one opening to allow delivery of said biological substance from an interior of said balloon to said body cavity, said biological substance includes said biological agent.

52. A biological matrix comprising a base compound and biological agent, said base compound including a polymer, copolymer or mixtures thereof, said base compound at least partially encapsulating at least a portion of said biological agent, said base compound including at least one radiation induced cross-linking, said at least one radiation induced cross-linking at least partially entrapping said biological agent in said base compound.

53. The biological matrix as defined in claim 52, wherein at least a portion of said biological agent forms a polymer salt complex with said base compound.

54. The biological matrix as defined in claim 52, wherein said base compound includes hydrophobic and hydrophilic compounds.

55. The biological matrix as defined in claim 53, wherein said base compound includes hydrophobic and hydrophilic compounds.

56. The biological matrix as defined in claim 52, wherein said base compound includes ethylene-acrylic acid copolymer, parylene, parylene derivatives, and mixtures thereof.

57. The biological matrix as defined in claim 54, wherein said base compound includes ethylene-acrylic acid copolymer, parylene, parylene derivatives, and mixtures thereof.

58. The biological matrix as defined in claim 55, wherein base compound includes ethylene-acrylic acid copolymer, parylene, parylene derivatives, and mixtures thereof.

59. The biological matrix as defined in claim 52, wherein said biological agent includes Trapidil and GM-CSF.

60. A method for producing an expandable stent coated with a biological agent comprising:

a) selecting a stent having a body member, said body member having a first cross-sectional shape having a first cross-sectional area which permits intraluminal delivery of said body member into the body cavity, and a second expanded cross-sectional shape having a second cross-sectional area which is greater than said first cross-sectional area;

b) coating at least a portion of said body member with a mixture of an intermediate compound and a biological agent, said intermediate compound including polymer, copolymer and combinations thereof; and

,

c) applying radiation to said coating to cause at least one cross-link to form in said intermediate compound that at least partially encapsulates at least a portion of said biological agent in said intermediate compound.

61. The method as defined in claim 60, wherein said intermediate compound includes ethylene-acrylic acid copolymer, parylene, parylene derivatives, and mixtures thereof.

62. The method as defined in claim 60, wherein said biological agent includes Trapidil, GM-CSF, and mixtures thereof.

63. The method as defined in claim 61, wherein said biological agent includes Trapidil, GM-CSF, and mixtures thereof.

64. A method for producing an expandable stent coated with a biological agent comprising:

a) selecting a stent having a body member, said body member having a first cross-sectional shape having a first cross-sectional area which permits intraluminal delivery of said body member into the body cavity, and a second expanded cross-sectional shape having a second cross-sectional area which is greater than said first cross-sectional area;

b) coating at least a portion of said body member with a mixture of an intermediate compound and a biological agent, said intermediate compound including polymer, copolymer and combinations thereof; and

,

c) applying radiation to said coating to cause at least one salt complex to form between intermediate compound and said biological agent.

65. The method as defined in claim 64, wherein said intermediate compound includes ethylene-acrylic acid copolymer, parylene, parylene derivatives, and mixtures thereof.

66. The method as defined in claim 64, wherein said biological agent includes Trapidil, GM-CSF, and mixtures thereof.

67. The method as defined in claim 65, wherein said biological agent includes Trapidil, GM-CSF, and mixtures thereof.