Claims for Patent: 8,021,678

Summary for Patent: 8,021,678

Title:	Implantable medical device with polymer coating in a surface area to volume ratio providing surface erosion characteristics
Abstract:	The present invention relates to an implantable medical device comprising therapeutic agents coated on the device using polyesters for the drug reservoir layer that exhibit surface-eroding characteristics.
Inventor(s):	Hossainy; Syed Faiyaz Ahmed (Fremont, CA), Pacetti; Stephen D. (San Jose, CA), Simhambhatla; Murthy V. (San Jose, CA)
Assignee:	Advanced Cardiovascular Systems, Inc. (Santa Clara, CA)
Application Number:	11/351,598
Patent Claims:	1. An implantable medical device, comprising: a polymer layer comprising a biocompatible biodegradable polymer wherein the polymer layer is disposed over a surface of the medical device at a surface area to volume ratio of from about 100 mm.sup.-1 to about 1000 mm.sup.-1; and, a therapeutic agent dispersed in the polymer layer at a drug/polymer wt/wt ratio of from about 1:5 to about 5:1. 2. The device of claim 1, wherein the surface is an outer surface and optionally all or part of an edge surface. 3. The device of claim 1, wherein the surface is a luminal surface and optionally all or part of an edge surface. 4. The implantable medical device of claim 1, wherein the polymer layer has a surface area to volume ratio of from about 100 mm.sup.-1 to about 500 mm.sup.-1. 5. The implantable medical device of claim 1, wherein the polymer layer has a surface area to volume ratio of from about 100 mm.sup.-1 to about 250 mm.sup.-1. 6. The implantable medical device of claim 1, wherein the drug/polymer wt/wt ratio is from about 1:2 to 2:1. 7. The implantable medical device of claim 1, wherein the drug/polymer wt/wt ratio is about 1:1. 8. The implantable medical device of claim 1, wherein the biocompatible biodegradable polymer is selected from the group consisting of poly(L-lactide), poly(D-lactide), poly(D,L-lactide), poly(meso-lactide), polyglycolide, poly(L-lactide-co-D, L-lactide), poly(L-lactide-co-glycolide), poly(D-lactide-co-glycolide), poly(D,L-lactide-co-glycolide), poly(meso-lactide-co-glycolide), poly(caprolactone), poly(hydroxyvalerate), poly(hydroxybutyrate), poly (ester amide), and poly(ethylene glycol-co-butylene terephthalate) (POLYACTIVE.RTM.). 9. The implantable medical device of claim 1, wherein the biocompatible biodegradable polymer has a molecular weight of from about 20 to about 600 kDaltons. 10. The implantable medical device of claim 1, wherein the biocompatible biodegradable polymer has as molecular weight of from about 40 to about 200 kDaltons. 11. The implantable medical device of claim 1, wherein the biocompatible biodegradable polymer has as molecular weight of from about 50 to about 100 kDaltons. 12. The implantable medical device of claim 8, wherein the biocompatible biodegradable polymer has a molecular weight of from about 20 to about 600 kDaltons. 13. The implantable medical device of claim 8, wherein the biocompatible biodegradable polymer has a molecular weight of from about 40 to about 200 kDaltons. 14. The implantable medical device of claim 8, wherein the biocompatible biodegradable polymer has as molecular weight of from about 50 to about 100 kDaltons 15. The implantable medical device of claim 1, wherein the biocompatible biodegradable polymer is substantially amorphous. 16. The implantable medical device of claim 15, wherein the biocompatible biodegradable polymer is selected from the group consisting of poly(D,L-lactide), poly(meso-lactide), poly(L-lactide-co-D,L-lactide), poly(L-lactide-co-glycolide), poly(D,L-lactide-co-glycoide), poly(D-lactide-co-glycolide) and poly(meso-lactide-co-glycolide). 17. The implantable medical device of claim 1, wherein the therapeutic agent is selected from the group consisting of actinomycin D, paclitaxel, docetaxel, methotrexate, azathioprine, vincristine, vinblastine, fluorouracil, doxorubicin hydrochloride, mitomycin, sodium heparin, low molecular weight heparins, heparinoids, heparin derivatives having hydrophobic counter ions, hirudin, argatroban, forskolin, vapiprost, prostacyclin, dextran, D-phe-pro-arg-chloromethylketone, dipyridamole, glycoprotein IIb/IIIa platelet membrane receptor antagonist antibody, recombinant hirudin, and thrombin, angiopeptin, captopril, cilazapril, lisinopril, nifedipine, colchicine, fibroblast growth factor (FGF) antagonists, fish oil ( -3- fatty acid), histamine antagonists, lovastatin, monoclonal antibodies, nitroprusside, phosphodiesterase inhibitors, prostaglandin inhibitors, suramin, serotonin blockers, steroids, thioprotease inhibitors, triazolopyrimidine, nitric oxide, permirolast potassium, alpha-interferon, genetically engineered epithelial cells, rapamycin, everolimus, dexamethasone and 17-allylamino-17-demethoxygeldanamycin. 18. The implantable medical device of claim 1, wherein the therapeutic agent is an antiproliferative agent. 19. The implantable medical device of claim 18, wherein the therapeutic agent is everolimus. 20. The implantable medical device of claim 1, further comprising a primer layer applied onto the surface of the device between the surface and the polymer layer. 21. The implantable medical device of claim 20, wherein the primer layer comprises a polymer selected from the group consisting of poly(monochloro-paraxylylene) (PARYLENE C.RTM.), polyacrylate, polymethacrylate, poly(D,L-lactide), poly(L-lactide), poly (L-lactide-co-glycolide), poly(meso-lactide), poly(meso-lactide-co-glycolide), poly(D,L-lactide-co-glycolide), poly(caprolactone), poly(hydroxyvalerate) poly(hydroxybutyrate) and poly(ethylene glycol-co-butylene terephthalate) (POLYACTIVE.RTM.). 22. The implantable medical device of claim 21, wherein the primer layer comprises a polymer selected from the group consisting of poly(n-butyl methacrylate) and PARYLENE C.RTM.. 23. A method of treating a vascular disease comprising: deploying to a site in the vasculature of a patient in need thereof an implantable medical device comprising a biocompatible biodegradable polymer layer disposed over a surface thereof such that the surface area to volume ratio is from about 100 mm.sup.-1 to about 1000 mm.sup.-1, the polymer layer further comprising a therapeutic agent in a drug/polymer wt/wt ratio of from about 1:5 to about 5:1; and, releasing the implantable medical device at the site. 24. The method of claim 23, wherein deploying comprises using a catheter. 25. The method of claim 23, wherein the drug/polymer wt/wt ratio is from about 1:2 to about 2:1. 26. The method of claim 23, wherein the drug/polymer wt/wt ratio is about 1:1. 27. The method of claim 23, wherein the biocompatible biodegradable polymer has a number average molecular weight of from about 20 kDa to about 600 kDa. 28. The method of claim 23, wherein the biocompatible biodegradable polymer has a number average molecular weight of from about 40 kDa to about 200 kDa. 29. The method of claim 23, wherein the number average molecular weight is from about 50 kDa to about 100 kDa. 30. The method of claim 23, wherein the biocompatible biodegradable polymer is selected from the group consisting of poly(L-lactide), poly(D-lactide), poly(D,L-lactide), poly(L-lactide-co-D,L-lactide), poly(meso-lactide), polyglycolide, poly(L-lactide-co-glycolide), poly(D-lactide-co-glycolide), poly(D,L-lactide-co-glycolide), poly(meso-lactide-co-glycolide), poly(caprolactone), poly(hydroxyvalerate), poly(hydroxybutyrate), poly(ethylene glycol-co-butylene terephthalate) (POLYACTIVE.RTM.), and poly(ester amide). 31. The method of claim 23, wherein the biocompatible biodegradable polymer is substantially amorphous. 32. The method of claim 31, wherein the biocompatible biodegradable polymer is selected from the group consisting of poly(D,L-lactide), poly(meso-lactide), poly(L-lactide-co-glycolide), poly(D,Llactide-co-glycolide), poly (D-lactide-co-glycolide) and poly(meso-lactide-co-glycolide). 33. The method of claim 23, wherein the vascular disease is restenosis. 34. The method of claim 23, wherein the vascular disease is vulnerable plaque. 35. The method of claim 33, wherein the therapeutic agent is selected from the group consisting of everolimus and 17-allylamino-17-demethoxy-geldanamycin. 36. The method of claim 34, wherein the therapeutic agent is selected from the group consisting of everolimus and 17-allylamino-17-demethoxy-geldanamycin.

Details for Patent 8,021,678

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Jubilant Hollisterstier Llc	N/A	positive skin test control-histamine	Injection	103891	03/13/1924		2040-01-28