Anti-thrombogenic and anti-restenotic vascular medical devices
View Patent ↗A medical device is provided which is adapted for implantation or insertion into the vasculature. The medical device has (a) a medical device substrate; (b) a lower polymeric layer, provided over the substrate made of a nitric oxide donor and a polymer; and (c) an upper polymeric layer, provided over the lower polymer layer, made of a polymer and an anti-restenotic agent.
1. An implantable or insertable medical device comprising: (a) a metallic substrate and (b) a coating comprising; (1) a lower polymeric layer provided over the substrate, said lower polymeric layer comprising a nitric oxide donor and a polymer; and (2) an upper polymeric layer provided over the lower polymer layer, said upper polymeric layer comprising a polymer and an anti-restenotic agent, wherein the medical device is adapted for implantation or insertion into the vasculature.
2. The implantable or insertable medical device of claim 1 , wherein the metallic substrate is a stainless steel or a nickel-titanium alloy substrate.
3. The implantable or insertable medical device of claim 1 , wherein the nitric oxide donor is selected from S-nitrosylated compounds and nonoate compounds.
4. The implantable or insertable medical device of claim 1 , wherein the lower polymeric layer comprises a plurality of nitric oxide donors.
5. The implantable or insertable medical device of claim 1 , wherein the lower polymeric layer completely covers the substrate.
6. The implantable or insertable medical device of claim 1 , wherein the lower polymeric layer covers only a portion of the substrate.
7. The implantable or insertable medical device of claim 1 , wherein the lower polymeric layer comprises a plurality of different polymers selected from homopolymers and copolymers.
8. The implantable or insertable medical device of claim 1 , wherein the lower polymeric layer comprises a copolymer.
9. The implantable or insertable medical device of claim 8 , wherein constitutional units forming the copolymer comprise olefin and vinyl aromatic monomers.
10. The implantable or insertable medical device of claim 1 , wherein the lower polymeric layer comprises a block copolymer.
11. The implantable or insertable medical device of claim 1 , wherein the anti-restenotic agent is selected from paclitaxel, rapamycin, and tacrolimus.
12. The implantable or insertable medical device of claim 1 , wherein the anti-restenotic agent is paclitaxel.
13. The implantable or insertable medical device of claim 1 , wherein the upper polymeric layer comprises a plurality of anti-restenotic agents.
14. The implantable or insertable medical device of claim 1 , wherein the upper polymeric layer completely covers the lower polymeric layer.
15. The implantable or insertable medical device of claim 1 , wherein the upper polymeric layer covers only a portion of the lower polymeric layer.
16. The implantable or insertable medical device of claim 1 , wherein the upper polymeric layer comprises a plurality of different polymers selected from homopolymers and copolymers.
17. The implantable or insertable medical device of claim 1 , wherein the upper polymeric layer comprises a copolymer.
18. The implantable or insertable medical device of claim 17 , wherein the upper and lower polymeric layers comprise different polymers.
19. The implantable or insertable medical device of claim 1 , wherein the upper polymeric layer comprises a block copolymer.
20. The implantable or insertable medical device of claim 1 , wherein the upper and lower polymeric layers comprise different polymers.
21. The implantable or insertable medical device of claim 1 , wherein the upper and lower polymeric layers comprise the same polymer.
22. The implantable or insertable medical device of claim 1 , wherein the upper and lower polymeric layers comprise the same block copolymer.
23. The implantable or insertable medical device of claim 22 , wherein said block copolymer comprises a polyolefin block.
24. The implantable or insertable medical device of claim 22 , wherein said block copolymer comprises a poly(vinyl aromatic) block.
25. The implantable or insertable medical device of claim 22 , wherein said block copolymer comprises a polyolefin block and a poly(vinyl aromatic) block.
26. The implantable or insertable medical device of claim 1 , wherein the medical device is a stent.
27. The implantable or insertable medical device of claim 1 , wherein the medical device is a stent, wherein the lower polymer layer comprises the nitric oxide donor and a block polymer comprising polyisobutylene and polystyrene blocks, and wherein the upper polymeric layer comprises paclitaxel and a block polymer comprising polyisobutylene and polystyrene blocks.