BIOSOLUBLE COATING COMPRISING ANTI-PROLIFERATIVE AND ANTI-INFLAMMATORY AGENT COMBINATION FOR TREATMENT OF VASCULAR DISORDERS

• US 20090297578A1
• Filed: 06/03/2008
• Published: 12/03/2009
• Est. Priority Date: 06/03/2008
• Status: Abandoned Application

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hossainy, Syed F.A., Lim, Florencia, Maslanka, Bozena Zofia, Ngo, Michael H., TROLLSAS, MIKAEL O.
• Application Number:
  US12/132,535
• Publication Number:
  US 20090297578A1
• Time in Patent Office: Days
• US Class Current: 424/423
• 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 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/604 Biodegradation
• 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

Drug-delivery systems such as drug-delivery stents having an anti-proliferative agent such as everolimus and an anti-flammatory agent such as clobetasol are provided. Also disclosed are methods of treating a vascular impairment such as restenosis or vulnerable plaque.

Claims

1. An implantable device, comprising a biosoluble coating deposited upon a body structure, the coating comprising:

a combination of an anti-inflammatory drug and an anti-proliferate drug, and

a biosoluble polymer for control the release of the anti-inflammatory drug and the anti-proliferate drug from the coating such that about 80% of the anti-inflammatory drug and/or about 80% of the anti-proliferate drug releases from the coating within about 1 to 3 days after deployment of the implantable device,

wherein the biosoluble coating solvates completely within about 30 days after deployment of the implantable device.

2. The implantable device of claim 1, wherein about 80% of the anti-inflammatory drug and about 80% of the anti-proliferate drug release from the coating within about 1 to 3 days after deployment of the implantable device.

3. The implantable device of claim 1, wherein about 80% of the anti-inflammatory drug and about 80% of the anti-proliferate drug release from the coating within about 1 to 21 days after deployment of the implantable device.

4. The implantable device of claim 1, wherein the biosoluble coating solvates completely within about 21 days after deployment of the implantable device.

5. The implantable device of claim 1, wherein the biosoluble coating solvates completely within about 14 days after deployment of the implantable device.

6. The implantable device of claim 1, wherein the biosoluble coating solvates completely within about 7 days after deployment of the implantable device.

7. The implantable device of claim 1, wherein the biosoluble coating solvates completely within about 1 to 3 days after deployment of the implantable device.

8. The implantable device of claim 1, wherein the biosoluble polymer is selected from poly(ethylene glycol) (PEG), poly(lactide-co-glycolide)-co-poly(ethylene glycol) (PLGA-PEG) block copolymer, other PEG copolymers, poly(vinyl alcohol) (PVA), hyaluronic acid, hydroxyl cellulose, Carboxymethylcellulose (CMC), polysaccharides, phosphoryl choline containing polymers, chitosan, collagen, and combinations thereof.

9. The implantable device of claim 1, wherein the anti-proliferative agent is selected from the group consisting of taxoids, everolimus, rapamycin, derivatives of everolimus, derivatives of rapamycin, derivatives of taxoids, and combinations thereof.

10. The implantable device of claim 1, wherein the anti-inflammatory agent is clobetasol.

11. The implantable device of claim 1, wherein the body structure is a bare metal stent.

23. A method of a medical condition in a blood vessel comprising implanting in the blood vessel an implantable device according to claim 1.

24. A method of a medical condition in a blood vessel comprising implanting in the blood vessel an implantable device according to claim 11.

12. A method of fabricating an implantable device, comprising

depositing on the implantable device a biosoluble coating onto a body structure, the biosoluble coating comprising

(a) a combination of an anti-inflammatory drug and an anti-proliferate drug, and

(b) a biosoluble polymer for control the release of the anti-inflammatory drug and the anti-proliferate drug from the coating such that about 80% of the anti-inflammatory drug and/or about 80% of the anti-proliferate drug releases from the coating within about 1 to 3 days after deployment of the implantable device,

wherein the biosoluble coating solvates completely within about 30 days after deployment of the implantable device.

13. The method of claim 12, wherein about 80% of the anti-inflammatory drug and about 80% of the anti-proliferate drug release from the coating within about 1 to 3 days after deployment of the implantable device.

14. The method of claim 12, wherein about 80% of the anti-inflammatory drug and about 80% of the anti-proliferate drug release from the coating within about 1 to 21 days after deployment of the implantable device.

15. The method of claim 12, wherein the biosoluble coating solvates completely within about 21 days after deployment of the implantable device.

16. The method of claim 12, wherein the biosoluble coating solvates completely within about 14 days after deployment of the implantable device.

17. The method of claim 12, wherein the biosoluble coating solvates completely within about 7 days after deployment of the implantable device.

18. The method of claim 12, wherein the biosoluble coating solvates completely within about 1 to 3 days after deployment of the implantable device.

19. The method of claim 12, wherein the biosoluble polymer is selected from poly(ethylene glycol) (PEG), poly(lactide-co-glycolide)-co-poly(ethylene glycol) (PLGA-PEG) block copolymer, other PEG copolymers, poly(vinyl alcohol) (PVA), hyaluronic acid, hydroxyl cellulose, Carboxymethylcellulose (CMC), polysaccharides, phosphoryl choline containing polymers, chitosan, collagen, and combinations thereof.

20. The method of claim 12, wherein the anti-proliferative agent is selected from the group consisting of taxoids, everolimus, rapamycin, derivatives of everolimus, derivatives of rapamycin, derivatives of taxoids, and combinations thereof.

21. The method of claim 12, wherein the anti-inflammatory agent is clobetasol.

22. The method of claim 12, wherein the body structure is a bare metal stent.