Coated medical device
First Claim
Patent Images
1. 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, said base structure including a surface structure, a micro-structure, an internal structure, or combinations thereof that are formed on or secured to said base structure, a plurality of said micro-structures extend upwardly from and above an outer surface of said base structure, said plurality of microstructures having a shape and size designed to penetrate into said body passageway at a treatment site when said base structure is expanded to an expanded cross-sectional area and to deliver said biological agent in said penetrated region of said body passageway, said plurality of microstructures having a height of less than 400 microns, said micro-structures at least partially coated with biological agent, at least partially made of biological agent, includes biological agent in an internal passage of said micro-structure, or combinations thereof;
wherein said biological agent is present on said stent in an amount of about 20 microgram-100 microgram per mm2; and
wherein a polymer layer that at least partially control a release of at least one of said biological agents from said stent, said polymer layer having a thickness of about 0.1-30 microns.
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Accused Products
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.
289 Citations
33 Claims
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1. 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, said base structure including a surface structure, a micro-structure, an internal structure, or combinations thereof that are formed on or secured to said base structure, a plurality of said micro-structures extend upwardly from and above an outer surface of said base structure, said plurality of microstructures having a shape and size designed to penetrate into said body passageway at a treatment site when said base structure is expanded to an expanded cross-sectional area and to deliver said biological agent in said penetrated region of said body passageway, said plurality of microstructures having a height of less than 400 microns, said micro-structures at least partially coated with biological agent, at least partially made of biological agent, includes biological agent in an internal passage of said micro-structure, or combinations thereof; wherein said biological agent is present on said stent in an amount of about 20 microgram-100 microgram per mm2; and wherein a polymer layer that at least partially control a release of at least one of said biological agents from said stent, said polymer layer having a thickness of about 0.1-30 microns. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- 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;
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12. A stent adapted for introduction into a body passageway of a patient, said stent comprising a base structure, a first biological agent and a first polymer;
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said base structure including a) said first biological agent coated on at least a portion of said base structure, b) said first polymer coated on at least a portion of said base structure, and combinations; said first biological agent at least partially a) mixed with said first polymer, b) over-coated with a layer of said first polymer, and combinations thereof; at least a portion of said base structure including said first biological agent coated on at least a portion of said base structure and said layer of said first polymer is at least partially over-coated on said first biological agent; said first polymer including a non- porous polymer, said non-porous first polymer having a) a molecular weight, b) molecular structure, c) layer thickness, and combinations thereof to at least partially control a rate of release of said first biological agent from said stent by a molecular diffusion process, said base structure including a plurality of micro-structures that are formed on or secured to said base structure and which extend upwardly from and above an outer surface of said base structure, said plurality of microstructures having a shape and size designed to penetrate into said body passageway at a treatment site when said base structure is expanded to an expanded cross-sectional area and to deliver said biological agent in said penetrated region of said body passageway, said plurality of microstructures having a height of less than 300 microns, a plurality of said micro-structures include biological agent in an internal passage of said micro-structure; wherein said biological agent is present on said stent in an amount of about 20 microgram-100 microgram per mm2; and wherein said layer of said first polymer has a thickness of about 0.1-30 microns. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33)
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Specification