Optimized dosing for drug coated stents

• US 6,908,622 B2
• Filed: 09/24/2002
• Issued: 06/21/2005
• Est. Priority Date: 09/24/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Barry, James J., Kamath, Kalpana R.
• Primary Examiner(s): Dodson, Shelley A.
• Assistant Examiner(s): George, Konata M.
• Application Number:
  US10/252,848
• Publication Number:
  US 20030059454A1
• Time in Patent Office: 1,001 Days
• Field of Search: 427/2.3, 427/2.25, 427/2.28, 427/355, 427/235, 427/232, 424/423
• US Class Current: 424/423
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

The inventors have found that both the drug dose and drug release profiles are significant factors for the safety and efficacy of drug coated stents. The inventors have identified optimum dosing and release kinetics for drug coated stents. In particular, the inventors have determined dosing and release kinetics that permit the delivery of the lowest effective drug dosage, thus enhancing patient safety and minimizing any side effects from the drug.

Claims

1. A stent coated with paclitaxel, said paclitaxel having a dosage of up to about 2 micrograms per square millimeter of the stent surface area, corresponding to approximate total dosage of 175 micrograms per stent.

3. The stent of claim 1, wherein the paclitaxel is incorporated into a polymer carrier coated onto at least a portion of the stent.

4. The stent of claim 3, wherein the polymer comprises styrene.

5. The stent of claim 3, wherein the weight fraction of the paclitaxel in the polymer carrier is less than about 35 percent.

6. The stent of claim 3, wherein said dosage is up to about 1 microgram per square millimeter of the stent surface area, and the weight fraction of the paclitaxel in the polymer carrier is less than about 25 percent.

7. The stent of claim 3, wherein said dosage is up to about 1 microgram per square millimeter of the stent surface area, and the weight fraction of the paclitaxel in the polymer carrier is less than about 8.8 percent.

8. The stent of claim 1 wherein the dosage is 0.7 to 1.5 micrograms per square millimeter.

9. The stent of claim 8 wherein the dosage is 1.0 to 1.3 micrograms per square millimeter.

10. The stent of claim 1 wherein the dosage is 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2.0 micrograms per square millimeter.

2. A stent coated with paclitaxel, said paclitaxel having a dosage of up to about 1 microgram per square millimeter of the stent surface area, corresponding to an approximate total dosage of 85 micrograms per stent.

21. The stent of claim 2, wherein the paclitaxel is incorporated into a polymer carrier coated onto at least a portion of the stent.

22. The stent of claim 21, wherein the polymer comprises styrene.

23. The stent of claim 21, wherein the weight fraction of the paclitaxel in the polymer carrier is less than about 35 percent.

24. The stent of claim 21, wherein said dosage is up to about 1 microgram per square millimeter of the stent surface area, and the weight fraction of the paclitaxel in the polymer carrier is less than about 25 percent.

25. The stent of claim 21, wherein said dosage is up to about 1 microgram per square millimeter of the stent surface area, and the weight fraction of the paclitaxel in the polymer carrier is less than about 8.8 percent.

26. The stent of claim 2 wherein the dosage is 0.7 to 1.5 micrograms per square millimeter.

27. The stent of claim 26 wherein the dosage is 1.0 to 1.3 micrograms per square millimeter.

28. The stent of claim 2 wherein the dosage is 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2.0 micrograms per square millimeter.

11. A stent coated with paclitaxel, said paclitaxel having a dosage of up to about 2 micrograms per square millimeter of the stent surface area, corresponding to an approximate total dosage of not more than 175 micrograms per stent.

13. The stent of claim 11, wherein the paclitaxel is incorporated into a polymer carrier coated onto at least a portion of the stent.

14. The stent of claim 13, wherein the polymer comprises styrene.

15. The stent of claim 13, wherein the weight fraction of the paclitaxel in the polymer carrier is less than about 35 percent.

16. The stent of claim 13, wherein said dosage is up to about 1 microgram per square millimeter of the stent surface area, and the weight fraction of the paclitaxel in the polymer carrier is less than about 25 percent.

17. The stent of claim 13, wherein said dosage is up to about 1 microgram per square millimeter of the stent surface area, and the weight fraction of the paclitaxel in the polymer carrier is less than about 8.8 percent.

18. The stent of claim 11 wherein the dosage is 0.7 to 1.5 micrograms per square millimeter.

19. The stent of claim 18 wherein the dosage is 1.0 to 1.3 micrograms per square millimeter.

20. The stent of claim 11 wherein the dosage is 0.4, 0.5 , 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2.0 micrograms per square millimeter.

12. A stent coated with paclitaxel, said paclitaxel having a dosage of up to about 1 microgram per square millimeter of the stent surface area, corresponding to an approximate total dosage of not more than 85 micrograms per stent.

29. The stent of claim 12, wherein the paclitaxel is incorporated into a polymer carrier coated onto at least a portion of the stent.

30. The stent of claim 29, wherein the polymer comprises styrene.

31. The stent of claim 29, wherein the weight fraction of the paclitaxel in the polymer carrier is less than about 35 percent.

32. The stent of claim 29, wherein said dosage is up to about 1 microgram per square millimeter of the stent surface area, and the weight fraction of the paclitaxel in the polymer carrier is less than about 25 percent.

33. The stent of claim 29, wherein said dosage is up to about 1 microgram per square millimeter of the stent surface area, and the weight fraction of the paclitaxel in the polymer carrier is less than about 8.8 percent.

34. The stent of claim 12 wherein the dosage is 0.7 to 1.5 micrograms per square millimeter.

35. The stent of claim 34 wherein the dosage is 1.0 to 1.3 micrograms per square millimeter.

36. The stent of claim 12 wherein the dosage is 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2.0 microgram per square millimeter.