Coated medical device
AssigneeICON Interventional Systems, Inc.
InventorsJoseph Furst, William Brodbeck
Life of this patent
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Abstract
A stent that is adapted for introduction into a body passageway and which releases at least one biological agent after being inserted in the body passageway. The release of the at least one biological agent can be a controlled release via molecular diffusion through a non-porous polymer layer.
Claims45
A stent adapted for introduction into a body passageway of a patient, said stent comprising a base structure, biological agent and polymer;
- said base structure including at least one of said biological agent coated on at least a portion of said base structure, at least one layer of polymer coated on at least a portion of said base structure or combinations thereof;
- said at least one biological agent at least partially mixed with said polymer, over-coated with a layer of said polymer or combinations thereof;
- said polymer including a non-porous polymer, said non-porous polymer having a molecular weight, molecular structure, layer thickness or combinations thereof to at least partially control a rate of release of said biological agent from said stent by a molecular diffusion process.
The stent as defined in claimi, wherein the outer surface of polymer layer includes at least one layer of biological agent.
A stent adapted for introduction into a vascular passageway of a patient, said stent comprising a base structure, a biological agent and a polymer;
- said base structure including at least one of said biological agent coated on at least a portion of said base structure and at least one polymer at least partially coated over said layer of biological agent;
- said polymer including a non-porous polymer that at least partially controls a rate of release of said biological agent from said stent by a molecular diffusion process;
- said polymer including parylene, parylene C, parylene N, parylene F, parylene derivatives, parylene C derivatives, parylene N derivatives, parylene F derivatives, or combinations thereof;
- said polymer layer having a thickness of about 0.1-30 microns;
- said biological agent including trapidil, trapidil derivatives, or combinations thereof;
- said biological agent present on said stent in an amount of about 0.001 ug-100 ug per mm2.
The stent as defined in claiml 7, wherein the outer surface of polymer layer includes at least one layer of biological agent.
A method of manufacturing a stent that controllably releases biological agent via molecular diffusion at least partially through polymer comprising:
- a) providing a base structure of a stent;
- b) coating said biological agent on at least a portion of said base structure;
- and,
- c) coating a polymer layer over at least a portion of said biological agent, said polymer layer including a non-porous polymer, said non-porous polymer having a coating thickness, molecular weight and molecular structure to allow said biological agent to molecularly diffuse through said non-porous layer.
A method of delivering at least one biological agent locally in a body passageway comprising:
- a. selecting a stent, said stent comprising a base structure, a biological agent and a polymer;
- said base structure including at least one of said biological agent coated on at least a portion of said base structure and at least one polymer at least partially coated over said layer of biological agent;
- said polymer including a non-porous polymer that at least partially controls a rate of release of said biological agent from said stent by a molecular diffusion process;
- said polymer including parylene, parylene C, parylene N, parylene F, parylene derivatives, parylene C derivatives, parylene N derivatives, parylene F derivatives, or combinations thereof, said polymer layer having a thickness of about 0.1-30 microns;
- said biological agent including trapidil, trapidil derivatives, or combinations thereof, said biological agent present on said stent in an amount of about 0.001 ug-1 00 ug per mm2;
- b. positioning said stent in a body passageway;
- c. expanding said stent in said body passageway;
- and,
- d. controllably releasing at least a portion of said biological agent from said stent by molecular diffusion through at least a portion of said polymer.
Dependencies are inferred from the claim text.