Optimized dosing for drug coated stents

• US 20050202061A1
• Filed: 05/11/2005
• Published: 09/15/2005
• 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.
• Granted Patent: US 7,906,133 B2
• Time in Patent Office: Days
• US Class Current: 424/426
• 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 drug coated stent comprising:

a structural member insertable into a body lumen of a patient; and

a drug coated onto at least a portion of said structural member;

wherein said drug is released from said stent into the patient for a time period of at least eight days after insertion into the patient, wherein drug release rate is maximized between 24 hours and three days after insertion.

2. The drug coated stent of claim 1, wherein said drug is released from said stent into the patient for a time period of at least ten days after insertion into the patient.

3. The drug coated stent of claim 1, wherein said drug comprises paclitaxel.

4. The drug coated stent of claim 1, wherein said drug is incorporated into a polymer carrier coated onto at least a portion of said structural member.

5. The drug coated stent of claim 4, wherein said polymer comprises styrene.

6. A drug coated stent comprising:

a structural member insertable into a body lumen of a patient; and

a drug coated onto at least a portion of said structural member;

wherein said drug is released from said stent at a varying rate over time, said rate being maximized between 24 hours and three days after insertion into the patient, wherein less than about 60 micrograms of the drug is released within ten days after insertion.

7. The drug coated stent of claim 6, wherein said rate is maximized at approximately two days after insertion into the patient.

8. The drug coated stent of claim 6, wherein said drug comprises paclitaxel.

9. The drug coated stent of claim 6, wherein said drug is incorporated into a polymer carrier coated onto at least a portion of said structural member.

10. The drug coated stent of claim 9, wherein said polymer comprises styrene.

11. A paclitaxel coated stent comprising:

a structural member insertable into a body lumen of a patient; and

paclitaxel coated onto at least a portion of said structural member;

wherein less than about 60 micrograms of paclitaxel is released from said stent ten days after exposure to an aqueous environment.

12. The paclitaxel coated stent of claim 11, wherein less than about 20 micrograms of paclitaxel is released from said stent ten days after exposure to an aqueous environment.

13. The paclitaxel coated stent of claim 11, wherein less than about 15 micrograms of paclitaxel is released from said stent ten days after exposure to an aqueous environment.

14. The paclitaxel coated stent of claim 11, wherein less than about 10 micrograms of paclitaxel is released from said stent ten days after exposure to an aqueous environment.

15. The paclitaxel coated stent of claim 11, wherein less than about 8 micrograms of paclitaxel is released from said stent ten days after exposure to an aqueous environment.

16. The paclitaxel coated stent of claim 11, wherein less than about 6 micrograms of paclitaxel is released from said stent ten days after exposure to an aqueous environment.

17. The paclitaxel coated stent of claim 11, wherein less than about 4 micrograms of paclitaxel is released from said stent ten days after exposure to an aqueous environment.

18. The paclitaxel coated stent of claim 11, wherein said drug is incorporated into a polymer carrier coated onto at least a portion of said structural member.

19. The drug coated stent of claim 18, wherein said polymer comprises styrene.

20. A paclitaxel coated stent comprising:

a structural member insertable into a body lumen of a patient; and

paclitaxel coated onto at least a portion of said structural member;

wherein less than about 10 micrograms of paclitaxel is released from said stent two days after exposure to an aqueous environment.

21. The paclitaxel coated stent of claim 20, wherein less than about 5 micrograms of paclitaxel is released from said stent two days after exposure to an aqueous environment.

22. The paclitaxel coated stent of claim 20, wherein less than about 2 micrograms of paclitaxel is released from said stent two days after exposure to an aqueous environment.

23-29. -29. (canceled)