DRUG DELIVERY DEVICE COMPRISING A BILAYERED POLYMERIC COATING HAVING A CELL CYCLE INHIBITOR THAT ACTS SELECTIVELY AT THE G1 PHASE OF THE CELL CYCLE INCORPORATED INTO THE FIRST POLYMER COATING LAYER

摘要

There is provided herein a drug delivery device comprising an intraluminalmedicaldevice, the intraluminal medical device including a stent having a fenestratedstructure, the stent comprising a plurality of bands and links defining asubstantiallytubular device with openings. The device further comprises a polymeric coatingaffixed to the bands and links of the fenestrated structure, the polymericcoatinghaving first and second layers; and a therapeutic dosage of rapamycinincorporatedinto the polymeric coating for treatment of intimil hyperplasia, constrictivevascularremodeling, and inflammation caused by injury. The rapamycin is incorporatedintothe first layer of the polymeric coating, the first layer comprising asolution ofethylene-co-vinylacetate and polybutylmethacrylate. The second layer,comprisingpolybutylmethacrylate, acts as a diffusion layer. The first layer has athickness in therange from about eight microns to about twelve microns and the second layerhas athickness in the range from about one micron to about two microns, therapamycinbeing configured for release over a period of about seven to thirty days andhaving adosage in the range from about 35 to 430 micrograms per 15 to 18 mm lengthstentsthereby producing a peak 50 to 55 percent reduction in neointimal hyperplasiaofabout 175 micrograms for a 3.5 mm by 18 mm stent.