Sustained release of superoxide dismutase mimics from implantable or insertable medical devices

• US 6,835,387 B2
• Filed: 06/11/2002
• Issued: 12/28/2004
• Est. Priority Date: 06/11/2002
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Herrmann, Robert A.
• Primary Examiner(s): Kishore, Gollamudi S.
• Assistant Examiner(s): Oh, Simon J.
• Application Number:
  US10/170,268
• Publication Number:
  US 20030228346A1
• Time in Patent Office: 931 Days
• Field of Search: 424/400, 424/422, 424/423, 424/424, 424/425
• US Class Current: 424/425
• CPC Class Codes: A61L 2300/114 Nitric oxide, i.e. NO
• 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 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

An implantable or insertable medical device is provided which comprises (a) a superoxide dismutase mimic and (b) a polymeric release region. Upon administration to a patient, the polymeric release region controls the release of the superoxide dismutase mimic, which is beneficially selected from a metal-chelate superoxide dismutase mimic and a nitroxide superoxide dismutase mimic. Also provided is a method of making an implantable or insertable medical device.

Claims

1. An implantable or insertable medical device comprising:

a superoxide dismutase mimic selected from 2,2,6,6-tetramethylpiperidine-1-yloxy, 4-hydroxytetramethyl-piperidine-1-oxyl, 4-hydroxy-2,2,6,6,-tetramethylpiperidine-1-N-oxyl, metal-pentaazacyclcopentadecane compounds, metal-porphyrin compounds, metal-porphine compounds, metal-desferioxamine compounds, metal-bis(cyclohexylpyridine) compounds and salen-metal compounds; and

a polymeric release region comprising a copolymer of an isobutylene monomer and a styrene monomer that controls the release of said superoxide dismutase mimic upon administration to a patient.

2. The implantable or insertable medical device of claim 1, wherein said superoxide dismutase mimic is disposed within a polymeric matrix.

3. The implantable or insertable medical device of claim 1, wherein said superoxide dismutase mimic is disposed beneath a polymeric barrier layer.

4. The implantable or insertable medical device of claim 1, wherein said medical device is a vascular stent.

5. The implantable or insertable medical device of claim 1, wherein said medical device is selected from a stent, a catheter, a balloon, a cerebral aneurysm filler coil and an arterio-venous shunt.

6. The implantable or insertable medical device of claim 1, wherein said medical device is a vascular medical device.

7. A method for treating a disease or condition comprising implanting or inserting the medical device of claim 1 into the body of a patient.

8. A method for treating a disease or condition comprising implanting or inserting the medical device of claim 1 into the vasculature of a patient.

9. The method of claim 7, wherein 50% of the total amount superoxide dismutase mimic that is released into the body from said medical device is released beyond 24 hours after administration.

10. The method of claim 8, wherein said disease or condition is restenosis.

11. A method of forming an implantable or insertable medical device comprising:

providing a solution or dispersion comprising a superoxide dismutase mimic selected from 2,2,6,6-tetramethylpiperidine-1-yloxy, 4-hydroxytetramethyl-piperidine-1-oxyl, 4-hydroxy-2,2,6,6,-tetramethylpiperidine-1-N-oxyl, metal-pentaazacyclopentadecane compounds, metal-porphyrin compounds, metal-porphine compounds, metal-desferioxamine compounds, metal-bis(cyclohexylpyridine) compounds and salen-metal compounds, copolymer of an isobutylene monomer and a styrene monomer, and a solvent;

contacting said solution or dispersion with a medical device; and

removing said solvent to form a superoxide dismutase mimic-containing polymeric matrix on said medical device,

wherein said polymeric matrix controls the release of said superoxide dismutase mimic upon administration to a patient.

12. The method of claim 11, wherein said medical device is selected from a stent, a catheter, a balloon, a cerebral aneurysm filler coil and an arterio-venous shunt.

13. The method of claim 11, wherein said solution or dispersion is contacted with said medical device by spraying said medical device with said solution or dispersion.

14. The method of claim 11, wherein said solution or dispersion is contacted with said medical device by dipping said medical device in said solution or dispersion.