Adhesion promoting primer for coated surfaces
View Patent ↗An expandable medical device includes a plurality of elongated struts, forming a substantially cylindrical device which is expandable from a first diameter to a second diameter. A plurality of different beneficial agents may be loaded into different openings within the struts for delivery to the tissue. For treatment of conditions such as restenosis, different agents are loaded into different openings in the device to address different biological processes involved in restenosis and are delivered at different release kinetics matched to the biological process treated. The different agents may also be used to address different diseases from the same drug delivery device. In addition, anti-thrombotic agents may be affixed to at least a portion of the surfaces of the medical device for the prevention of sub-acute thrombosis. To ensure that the different agents remain affixed to the device as well as to each other, primer layers may be utilized.
1. An implantable medical device comprising:
a substantially cylindrical intraluminal scaffold which is expandable from a first diameter for delivery into a vessel, to a second diameter for expanding the vessel, the intraluminal scaffold having a luminal surface and an abluminal surface, the distance between the luminal surface and the abluminal surface defining the wall thickness of the intraluminal scaffold, the intraluminal scaffold also including a plurality of openings extending from the luminal to abluminal surface;
a primer layer including multiple layers, the primer layer covering the luminal surface, the abluminal surface and the surfaces of the plurality of the openings;
a first coating comprising a material having a first electric charge affixed to the primer layer;
a second coating comprising a material having a second electric charge affixed to the first coating only in the plurality of openings, the second electric charge being opposite of the first electric charge; and
at least one therapeutic agent deposited in at least one of the plurality of openings, wherein the second coating is configured as an intermediate layer between the first coating and the at least one therapeutic agent.
2. The implantable medical device according to claim 1 , wherein the first coating comprises an anti-thrombotic agent.
3. The implantable medical device according to claim 2 , wherein the anti-thrombotic agent comprises a polysaccharide.
4. The implantable medical device according to claim 3 , wherein the polysaccharide comprises sulfated polysaccharides.
5. The implantable medical device according to claim 3 , wherein the polysaccharide comprises heparin.
6. The implantable medical device according to claim 1 , wherein the second coating comprises a polymeric cation.
7. The implantable medical device according to claim 6 , wherein the polymeric cation is selected from the group consisting of an oligomeric arginine peptide, polylysine, poly(arginine), protamine, poly(dimethylaminoethyl)methacrylate, poly(dimethylaminoethyl acrylate) and poly(ethyleneimine).
8. The implantable medical device according to claim 1 , wherein the second coating comprises a polymeric conjugate.
9. The implantable medical device according to claim 8 , wherein the polymeric conjugate comprises a first component comprising a bioabsorbable polymer and a second component is selected from the group consisting of an oligomeric arginine peptide, polylysine, poly(arginine), protamine, poly(dimethylaminoethyl)methacrylate, poly(dimethylaminoethyl acrylate) and poly(ethyleneimine).
10. The implantable medical device according to claim 9 , wherein the bioabsorbable polymer comprises poly(lactic-co-glycolic acid).
11. The implantable medical device according to claim 10 , wherein the at least one therapeutic agent is selected from the group consisting of an anti-restenotic, an anti-inflamatory, an anti-thrombotic, an anti-proliferative and a cardioprotectant for minimizing damage to infarcted tissue.