DRUG-DELIVERY ENDOVASCULAR STENT AND METHOD OF FORMING THE SAME

摘要

An intravascular stent and method for inhibiting restenosis, following vascular injury, is disclosed. The stent has an expandable, linked-filament body and a drug-release coating formed on the stent-body filaments, for contacting the vessel injury site when the stent is placed in-situ in an expanded condition. The coating releases, for a period of at least 4 weeks, a restenosis-inhibiting amount of a monocyclic triene immunosuppressive compound having an alkyl group substituent at carbon position 40 in the compound. The stent, when used to treat a vascular injury, gives good protection against clinical restenosis, even when the extent of vascular injury involves vessel overstretching by more than 30% diameter. Also disclosed is a stent having a drug-release coating composed of (i) 10 and 60 weight percent poly-dl-lactide polymer substrate and (ii) 40-90 weight percent of an anti-restenosis compound, and a polymer undercoat having a thickness of between 1-5 microns.

主权项

1. An endovascular stent for placement at a vascular injury site, for inhibiting restenosis at the site, comprising a body having an open-lattice structure formed of linked filaments said filaments having outside, side and inside surfaces, and carried on the one or more filaments a drug-release coating of a poly-lactide polymer having a thickness of between 3-30 microns, and composed of (i) 25-55 weight percent polymer substrate and (ii) 45-75 weight percent macrocyclic triene compound having the form: where R is CH2—CH2—OH or OH, said stent being expandable from a contracted condition in which the stent can be delivered to a vascular injury site via catheter, and an expanded condition in which the stent coating can be placed in contact with the vessel at the injury site, said coating being effective to release an amount of the compound to inhibit restenosis at the site.