GROOVED DRUG-ELUTING MEDICAL DEVICES AND METHOD OF MAKING SAME
The invention relates to methods and apparatus for manufacturing implantable medical devices, such as intravascular stents, wherein the medical device has a surface treated to promote the migration of endothelial cells onto the surface of the medical device. In particular, the surface of the medical device has at least one groove formed therein, the at least one groove may have a drug-eluting polymer disposed therein or a drug-eluting polymer coating may be provided on the surface of the medical device and grooves formed in the drug eluting polymer coating.
1 . An implantable medical device, comprising an implantable biomaterial having a first surface and a second surface, at least one groove in at least one of the first surface and the second surface and a polymer capable of eluting a bioactive agent from the polymer disposed only at one of within the groove or on a landing area between adjacent grooves.
2 . The implantable medical device according to claim 1 , wherein the implantable biomaterial further comprises a stent and the at least one groove is inner surface of the stent.
3 . The implantable medical device according to claim 1 , wherein the bioactive agent comprises a compound selected from the group of compounds consisting of: antibiotic drugs, antiviral drugs, neoplastic agents, steroids, fibronectin, anti-clotting drugs, anti-platelet function drugs, drugs which prevent smooth muscle cell growth on inner surface wall of vessel, heparin, heparin fragments, aspirin, coumadin, tissue plasminogen activator, urokinase, hirudin, streptokinase, antiproliferatives, antioxidants, antimetabolites, thromboxane inhibitors, non-steroidal and steroidal anti-inflammatory drugs, immunosuppresents, such as rapomycin, beta and calcium channel blockers, genetic materials including DNA and RNA fragments, complete expression genes, antibodies, lymphokines, growth factors, vascular endothelial growth factor, fibroblast growth factor, prostaglandins, leukotrienes, laminin, elastin, collagen, nitric oxide and integrins.
4 . The implantable medical device according to claim 1 , wherein the implantable biomaterial is a metal.
5 . The implantable medical device according to claim 1 , wherein the implantable biomaterial is a polymer.
6 . The implantable medical device according to claim 5 , wherein the at least one groove is formed in the polymer.
7 . The implantable medical device according to claim 1 , wherein the at least one groove has a depth between about 0.5 microns and 10 microns.
8 . The implantable medical device according to claim 1 , wherein the at least one groove has a width between about 2 microns to 40 microns.
9 . The implantable medical device according to claim 1 , comprising a plurality of grooves separated by land areas, wherein the width of each of the plurality of grooves and the width of each of the land areas are substantially equal.
10 . A method of manufacturing an implantable medical device, comprising the steps of: providing an implantable medical device having a first surface and a second surface, and forming a plurality of grooves separated by land areas in at least one of the first surface or the second surface, and either i) at least partially filling at least one groove with a polymer or ii) disposing polymer on land areas the implantable medical device.
11 . The method of claim 10 , further comprising the step of exposing the land areas of the implantable medical device while leaving the at least one groove at least partially filed with the polymer.
12 . The method of claim 10 , further comprising the step of passivating exposed metal of the implantable medical device.
13 . The method of claim 10 , further comprising the step of disposing polymer on the implantable medical device and forming the plurality of grooves through the polymer and into at least one of the first surface or second surface of the implantable medical device.
14 . The method of claim 10 , further comprising the steps of disposing polymer on at least one of the first surface or the second surface of the implantable medical device and into the plurality of grooves therein, removing a portion of the polymer such that the land areas are exposed and the polymer resides only in the plurality of grooves.