Drug-delivery endovascular stent and method for treating restenosis

摘要

A radially expandable, endovascular stent designed for placement at a site of vascular injury, for inhibiting restenosis at the site, a method of using, and a method of making the stent. The stent includes a radially expandable body formed of one or more metallic filaments and a liquid-infusible mechanical anchoring layer attached to or formed in outer surface of the filaments. A drug coating in the stent is composed of a substantially polymer-free composition of an anti-restenosis drug, and has a substratum infused in the anchoring layer and a substantially continuous surface stratum of drug that is brought into direct contact with the vessel walls at the vascular site. Thus, the rate of release of the anti-restenosis drug from the surface stratum into said vascular site is determined solely by the composition of said drug coating.

主权项

1. A method of producing a radially expandable, endovascular stent designed for placement at a site of vascular injury, for inhibiting restenosis at the site, comprising applying a substantially polymer-free, liquid composition of an anti-restenosis drug to a radially expandable stent body formed of one or more metallic filaments defining an outer surface, and having attached thereto, a liquid-infusible mechanical anchoring layer having an average thickness of at least 3 μm, in an amount sufficient to infuse the composition into said anchoring layer, to form a drug coating substratum within the layer, and to form over the substratum, a substantially continuous surface stratum of drug, wherein the drug coating substratum constitutes 10 to 50% of the total composition of anti-restenosis drug and wherein the rate of release of the anti-restenosis drug from the surface stratum into said site of vascular injury is determined solely by the composition of said drug coating.