Intravascular delivery of methylprednisolone

• US 7,018,405 B2
• Filed: 02/13/2001
• Issued: 03/28/2006
• Est. Priority Date: 12/22/2000
• Status: Expired due to Fees

• Current Assignee: Avantec Vascular Corporation
• Original Assignee: Avantec Vascular Corporation
• Inventors: Yan, John, Sirhan, Motasim
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US09/782,804
• Publication Number:
  US 20020082677A1
• Time in Patent Office: 1,869 Days
• Field of Search: 623/1.42, 623/1.43, 623/1.44, 623/1.45, 623/1.46, 623/1.47, 623/1.48
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

The present invention provides improved devices and methods for minimizing and/or inhibiting restenosis and hyperplasia after intravascular intervention. In particular, the present invention provides luminal prostheses which allow for programmed and controlled methylprednisolone delivery with increased efficacy to selected locations within a patient'"'"'s vasculature to inhibit restenosis. An intraluminal delivery prosthesis may comprise an expansible structure and means on or within the structure for releasing methylprednisolone into the body lumen to inhibit smooth muscle cell proliferation.

Claims

1. A method for inhibiting restenosis in a blood vessel following recanalization of the blood vessel, said method comprising:

implanting a vascular prosthesis in the blood vessel; and

releasing methylprednisolone and mycophenolic acid from the prosthesis when implanted in the blood vessel.

2. A method as in claim 1, wherein methylprednisolone is released from the prosthesis at a rate between 5 μ

g/day to 200 μ

g/day.

3. A method as in claim 2, wherein methylprednisolone is released at a rate between 10 μ

g/day to 60 μ

g/day.

4. A method as in claim 1, wherein methylprednisolone is released from the prosthesis within a time period of 1 day to 45 days in a vascular environment.

5. A method as in claim 4, wherein methylprednisolone is released within a time period of 7 days to 21 days in a vascular environment.

6. A method as in claim 1, wherein the releasing comprises delaying substantial release of methylprednisolone for at least one hour following implantation of the prosthesis.

7. A method as in claim 6, wherein delaying release comprises slowing releasing methylprednisolone from a reservoir with a material that at least partially degrades in a vascular environment over said one hour.

8. A method as in claim 6, wherein delaying release comprises slowing releasing methylprednisolone with a matrix that at least partially degrades in a vascular environment over said one hour.

9. A method as in claim 6, wherein delaying release comprises slowing releasing methylprednisolone with a nondegradable matrix that allows diffusion of methylprednisolone through the nondegradable matrix after said one hour.

10. A method as in claim 6, wherein delaying release comprises slowing releasing methylprednisolone with a rate limiting barrier that allows diffusion of methylprednisolone through the barrier after said one hour.

11. A method as in any one of claims 8–

10, wherein the prosthesis is coated with the matrix or barrier by spraying, dipping, deposition, or painting.

12. A method as in claim 1, wherein methylprednisolone is substantially released within a time period of 2 days to 3 months.

13. A method as in claim 1, wherein methylprednisolone and mycophenolic acid are released simultaneously.

14. A method as in claim 1, wherein methylprednisolone and mycophenolic acid are released sequentially.

15. A method for inhibiting restenosis in a blood vessel following recanalization of the blood vessel, said method comprising:

implanting a vascular prosthesis in the blood vessel; and

releasing methylprednisolone and mizoribine from the prosthesis when implanted in the blood vessel.

16. A method as in claim 15, wherein methylprednisolone and mizoribine are released simultaneously.

17. A method as in claim 15, wherein methylprednisolone and mizoribine are released sequentially.

18. A method as in claim 15, wherein methylprednisolone is released from the prosthesis at a rate between 5 μ

g/day to 200 μ

g/day.

19. A method as in claim 18, wherein methylprednisolone is released at a rate between 10 μ

g/day to 60 μ

g/day.

20. A method as in claim 15, wherein methylprednisolone is released from the prosthesis within a time period of 1 day to 45 days in a vascular environment.

21. A method as in claim 20, wherein methylprednisolone is released within a time period of 7 days to 21 days in a vascular environment.

22. A method as in claim 15, wherein the releasing comprises delaying substantial release of methylprednisolone for at least one hour following implantation of the prosthesis.

23. A method as in claim 22, wherein delaying release comprises slowing releasing methylprednisolone from a reservoir with a material that at least partially degrades in a vascular environment over said one hour.

24. A method as in claim 22, wherein delaying release comprises slowing releasing methylprednisolone with a matrix that at least partially degrades in a vascular environment over said one hour.

25. A method as in claim 22, wherein delaying release comprises slowing releasing methylprednisolone with a nondegradable matrix that allows diffusion of methylprednisolone through the nondegradable matrix after said one hour.

26. A method as in claim 22, wherein delaying release comprises slowing releasing methylprednisolone with a rate limiting barrier that allows diffusion of methylprednisolone through the barrier after said one hour.

27. A method as in any one of claims 24–

26, wherein the prosthesis is coated with the matrix or barrier by spraying, dipping, deposition, or painting.

28. A method as in claim 15, wherein methylprednisolone is substantially released within a time period of 2 days to 3 months.