Irradiated stent coating

• US 8,603,158 B2
• Filed: 03/26/2004
• Issued: 12/10/2013
• Est. Priority Date: 04/15/1998
• Status: Expired due to Fees

• Current Assignee: Mirus LLC
• Original Assignee: ICON Interventional Systems, Inc.
• Inventors: Furst, Joseph G.
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US10/810,356
• Publication Number:
  US 20040181277A1
• Time in Patent Office: 3,546 Days
• Field of Search: 623/1.11, 623/1.15, 623/1.16, 623/1.42, 623/1.46, 427/261, 424/423, 514/44, 604/509
• US Class Current: 623/1.42
• 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 2300/602 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

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 intraluminal graft for use within a body passageway including a body member, a intermediate compound, and biological agent, said intermediate compound, said at least one biological agent, and mixtures thereof coated on at least a portion of the body member, 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 or secured to the surface of said body member, said biological agent including two or more compounds selected from the group consisting of Trapidil, GM-CSF, Taxol, rapamycin, and mixtures thereof, said biological agent including Trapidil, said intermediate compound at least partially securing said biological agent to said body member, said intermediate compound at least partially encapsulating said biological agent in said intermediate compound, and combinations thereof.

2. The expandable intraluminal graft as defined in claim 1, wherein said intermediate compound is at least partially formed of 1) a biodegradable material and forms a polymer salt complex with said biological agent 2) a plurality of radiation induced cross-links that at least partially encapsulate said biological agent in said intermediate compound, or mixture thereof.

3. The expandable intraluminal graft as defined in claim 2, wherein said biological agent includes Trapidil and GM-CSF.

4. The expandable intraluminal graft as defined in claim 3, wherein said biological agent includes Taxol, rapamycin, and mixtures thereof.

5. The expandable intraluminal graft as defined in claim 4, wherein said biological agent is releasably coated on said body member.

6. The expandable intraluminal graft as defined in claim 5, wherein said intermediate compound at least partially delays delivery of said biological agent into said body passageway.

7. The expandable intraluminal graft as defined in claim 6, wherein said intermediate compound includes a polymer, a copolymer or mixtures thereof.

8. The expandable intraluminal graft as defined in claim 7, wherein said intermediate compound includes hydrophobic and hydrophilic compounds.

9. The expandable intraluminal graft as defined in claim 8, wherein said intermediate compound includes an ethylene-acrylic acid copolymer.

10. The expandable intraluminal graft as defined in claim 9, wherein said body member maintains a substantially constant longitudinal length when expanded from said first cross-sectional shape to said second cross-sectional shape.

11. The expandable intraluminal graft as defined in claim 10, wherein said first and second ends having a substantially smooth surface.

12. The expandable intraluminal graft as defined in claim 11, 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.

13. The expandable intraluminal graft as defined in claim 12, 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.

14. The expandable intraluminal graft as defined in claim 13, 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 at least one of said biological agents.

15. The expandable intraluminal graft as defined in claim 13, wherein at least a portion of said body member is formed of a biodegradable material.

16. The expandable intraluminal graft as defined in claim 5, wherein said intermediate compound includes a polymer, a copolymer or mixtures thereof.

17. The expandable intraluminal graft as defined in claim 16, wherein said intermediate compound includes hydrophobic and hydrophilic compounds.

18. The expandable intraluminal graft as defined in claim 17, wherein said intermediate compound includes an ethylene-acrylic acid copolymer.

19. The expandable intraluminal graft as defined in claim 2, wherein said intermediate compound includes a polymer, a copolymer or mixtures thereof.

20. The expandable intraluminal graft as defined in claim 19, wherein said intermediate compound includes hydrophobic and hydrophilic compounds.

21. The expandable intraluminal graft as defined in claim 20, wherein said intermediate compound includes an ethylene-acrylic acid copolymer.

22. The expandable intraluminal graft as defined in claim 1, wherein said intermediate compound includes a plurality of radiation induced cross-links that at least partially encapsulate said biological agent in said intermediate compound.

23. The expandable intraluminal graft as defined in claim 22, wherein said biological agent includes Trapidil and GM-CSF.

24. The expandable intraluminal graft as defined in claim 23, wherein said biological agent includes Taxol, rapamycin, and mixtures thereof.

25. The expandable intraluminal graft as defined in claim 24, wherein said biological agent is releasably coated on said body member.

26. The expandable intraluminal graft as defined in claim 25, wherein said intermediate compound at least partially delays delivery of said biological agent into said body passageway.

27. The expandable intraluminal graft as defined in claim 26, wherein said body member maintains a substantially constant longitudinal length when expanded from said first cross-sectional shape to said second cross-sectional shape.

28. The expandable intraluminal graft as defined in claim 27, wherein said first and second ends having a substantially smooth surface.

29. The expandable intraluminal graft as defined in claim 28, 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.

30. The expandable intraluminal graft as defined in claim 29, 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.

31. The expandable intraluminal graft as defined in claim 30, 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 at least one of said biological agents.

32. The expandable intraluminal graft as defined in claim 30, wherein at least a portion of said body member is formed of a biodegradable material.

33. The expandable intraluminal graft as defined in claim 1, wherein said biological agent includes Trapidil and GM-CSF.

34. The expandable intraluminal graft as defined in claim 33, wherein said biological agent includes Taxol, rapamycin, and mixtures thereof.

35. The expandable intraluminal graft as defined in claim 33, wherein said biological agent is releasably coated on said body member.

36. The expandable intraluminal graft as defined in claim 1, wherein said biological agent is releasably coated on said body member.

37. The expandable intraluminal graft as defined in claim 34, wherein said biological agent is releasably coated on said body member.

38. The expandable intraluminal graft as defined in claim 1, wherein said intermediate compound at least partially delays delivery of said biological agent into said body passageway.

39. 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.

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

41. 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.

42. 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.

43. 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 at least one of said biological agents.

44. The expandable intraluminal graft as defined in claim 1, wherein at least a portion of said body member is formed of a biodegradable material.