Patent ID: 8377462

Claim:
A coating for an implantable medical device, comprising: a first layer disposed over a surface of the implantable medical device, comprising poly{[N,N′-sebacoyl-bis-(L-leucine)-1,6-hexylene diester]-co-[N,N′-sebacoyl-L-lysine 4-amino-2,2,6,6-tetramethylpiperidine-N-oxide]}(PEA-TEMPO) and poly {[N,N′-sebacoyl-bis-(L-leucine)-1,6-hexylene diester]-co-[N,N′-sebacoyl-L-lysine benzyl ester]}(PEA-BZ) and a bioactive agent; wherein bioactive agent loading in the first layer is about 49 μg/cm 2 to about 250 μg/cm 2 , PEA-TEMPO/PEA-BZ loading in the first layer is about 150 μg/cm 2 to about 2200 μg/cm 2 , and the wt:wt ratio of PEA-TEMPO/PEA-BZ to bioactive agent is about 3:1 to about 20:1, a second release profile controlling layer disposed over the first layer comprising poly {[N,N′-sebacoyl-bis-(L-leucine)-1,6-hexylene diester]-co-[N,N′-sebacoyl-L-lysine 4-amino-2,2,6,6-tetramethylpiperidine-N-oxide]}(PEA-TEMPO) and poly {[N,N′-sebacoyl-bis-(L-leucine)-1,6-hexylene diester]-co-[N,N′-sebacoyl-L-lysine benzyl ester]}(PEA-BZ) and a bioactive agent; wherein: bioactive agent loading in the second layer is about 0 μg/cm 2 to about 50 μg/cm 2 ; and PEA-TEMPO/PEA-BZ loading in the second layer is about 100 μg/cm 2 to about 2500 μg/cm 2 , a topcoat layer disposed over the second layer, wherein the topcoat comprises an biobenefical material selected from the group consisting of poly(propylene oxide), poly (ethylene glycol) acrylate (PEGA), phosphoryl choline, choline, poly(aspirin), poly(styrene-isoprene-styrene)-PEG (SIS-PEG), polystyrene-PEG, polyisobutylene-PEG, polycaprolactone-PEG (PCL-PEG), PLA-PEG, poly(methyl methacrylate)-PEG (PMMA-PEG), polydimethylsiloxane-co-PEG (PDMS-PEG), poly(vinylidene fluoride)-PEG (PVDF-PEG), polypropylene oxide-co-polyethylene glycol, poly(tetramethylene glycol), hydroxy functional poly(vinyl pyrrolidone), fibrinogen, dextran, dextrin, heparin, fragments and derivatives of heparin, glycosamino glycan (GAG), GAG derivatives, elastin, chitosan, alginate, hydroxyethyl methacrylate (HEMA), hydroxypropyl methacrylate (HPMA), hydroxypropylmethacrylamide, methacrylic acid (MA) and acrylic acid (AA).