# US 7,744,645 B2 · Laminated drug-polymer coated stent with dipped and cured layers > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 7,744,645 B2 - Document ID: US7744645B2 - Status: Granted - Kind: B2 - Application number: 10/674,296 - Filed: 2003-09-29 - Published: 2005-03-31 - Granted: 2010-06-29 - Earliest claimed: 2003-09-29 - Assignees: Medtronic Vascular, Inc. - Inventors: Ronan Thornton; Finbar Dolan - Web page: https://patentgrep.com/patent/US7744645B2 ## CPC - A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} - A61L 31/10: Macromolecular materials - A61L 2300/608: having two or more layers - A61L 2420/02: Methods for coating medical devices - A61L 2420/08: Coatings comprising two or more layers - Y10T 428/31663: As siloxane, silicone or silane - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract The present invention provides a method of applying a drug-polymer coating on a stent. A stent framework is dipped into a first polymeric solution including a first polymer, a first therapeutic agent, and a first solvent. The polymeric solution is dried and the first polymer is cured to form a thin drug-polymer layer on the stent framework. The steps of dipping the stent framework into the first polymeric solution, drying the first polymeric solution, and curing the first polymer are repeated until a target drug-polymer coating thickness is disposed on the stent framework. A drug-polymer coated stent including a stent framework and a laminated drug-polymer coated stent, a system for treating a vascular condition, and a method of treating a vascular condition are also disclosed. ## Claims ### Claim 1 A drug-polymer coated stent, comprising: a stent framework; a laminated drug-polymer coating disposed on the stent framework, the laminated drug-polymer coating including a plurality of thin drug-polymer layers, wherein the thin drug-polymer layers include a first therapeutic agent and a cured first polymer, and at least one thin barrier layer positioned between a first thin drug-polymer layer and a second thin drug-polymer layer, wherein the at least one thin barrier layer includes a cured second polymer, wherein the cured second polymer excludes drug interaction between the first thin drug-polymer layer and the second thin drug-polymer layer adjacent the at least one barrier layer. ### Claim 2 (depends on 1) The stent of claim 1 wherein the stent framework comprises one of a metallic base or a polymeric base. ### Claim 3 (depends on 1) The stent of claim 1 wherein the stent framework comprises a material selected from the group consisting of stainless steel, nitinol, tantalum, MP35N alloy, platinum, titanium, a chromium-based alloy, a suitable biocompatible alloy, a suitable biocompatible material, a biocompatible polymer, and a combination thereof. ### Claim 4 (depends on 1) The stent of claim 1 wherein the first therapeutic agent is selected from the group consisting of rapamycin, a rapamycin derivative, a rapamycin analogue, camptothecin, dexamethasone, 5-fluorouracil, a bioactive agent, a pharmaceutical drug, a therapeutic substance, and a combination thereof. ### Claim 5 (depends on 1) The stent of claim 1, wherein a concentration of the first therapeutic agent is modulated to provide a predetermined drug-release profile. ### Claim 6 (depends on 1) The stent of claim 1 wherein the at least one thin barrier layer comprises a diffusion barrier. ### Claim 7 (depends on 1) The stent of claim 1 wherein the cured second polymer comprises a silicone polymer. ### Claim 8 (depends on 1) The stent of claim 1 wherein the cured second polymer comprises an amphiphilic copolymer from acrylic acid and vinyl pyrollidone. ### Claim 9 (depends on 1) The stent of claim 1 further comprising a primer coat disposed directly on an outer surface of the stent framework. ### Claim 10 A system for treating a vascular condition, comprising: a catheter; and a coated stent coupled to the catheter, the coated stent including a stent framework and a laminated drug-polymer coating disposed on the stent framework, the laminated drug-polymer coating including a plurality of thin drug-polymer layers and at least one thin barrier layer positioned between a first thin drug-polymer layer and a second thin drug-polymer layer , wherein the thin drug-polymer layers include a first therapeutic agent and a cured first polymer and wherein the at least one thin barrier layer includes a cured second polymer, wherein the cured second polymer excludes drug interaction between the first thin drug-polymer layer and the second thin drug-polymer layer adjacent the at least one barrier layer. ### Claim 11 (depends on 10) The system of claim 10 wherein the catheter includes a balloon to expand the stent. ### Claim 12 (depends on 10) The system of claim 10, wherein the catheter includes a sheath that retracts to allow expansion of the stent. ### Claim 13 (depends on 10) The system of claim 10 wherein the stent framework comprises one of a metallic base or a polymeric base. ### Claim 14 (depends on 10) The system of claim 10 wherein the stent framework comprises a material selected from the group consisting of stainless steel, nitinol, tantalum, MP35N alloy, platinum, titanium, a chromium-based alloy, a suitable biocompatible alloy, a suitable biocompatible material, a biocompatible polymer, and a combination thereof. ### Claim 15 (depends on 10) The system of claim 10 wherein the first therapeutic agent is selected from the group consisting of rapamycin, a rapamycin derivative, a rapamycin analogue, camptothecin, dexamethasone, 5-fluorouracil, a bioactive agent, a pharmaceutical drug, a therapeutic substance, and a combination thereof. ### Claim 16 (depends on 10) The system of claim 10 wherein a concentration of the first therapeutic agent is modulated to provide a predetermined drug-release profile. ### Claim 17 (depends on 10) The system of claim 10 wherein the at least one thin barrier layer comprises a diffusion barrier. ### Claim 18 (depends on 10) The system of claim 10 wherein the cured second polymer comprises a silicone polymer. ### Claim 19 (depends on 10) The system of claim 10 wherein the cured second polymer comprises an amphiphilic copolymer from acrylic acid and vinyl pyrollidone. ### Claim 20 A method of treating a vascular condition, comprising: inserting a drug-polymer coated stent within a vessel of a body, the drug-polymer coated stent including a laminated drug-polymer coating having a plurality of thin drug-polymer layers and at least one thin barrier layer positioned between a first thin drug-polymer layer and a second thin drug-polymer layer one, wherein the thin drug-polymer layers include a first therapeutic agent and a cured first polymer and wherein the at least one thin barrier layer includes a cured second polymer, wherein the cured second polymer excludes drug interaction between the first thin drug-polymer layer and the second thin drug-polymer layer adjacent the at least one barrier layer; and eluting at least one therapeutic agent from the laminated drug-polymer coating into the body, wherein the first polymer is cured with one of thermal activation, electrical activation, or ionizing irradiation. ### Claim 21 (depends on 20) The method of claim 20 wherein the thin barrier layers control an elution rate of at least one therapeutic agent. ### Claim 22 (depends on 20) The method of claim 20 further comprising: selecting the cured first polymer and the cured second polymer based on a predetermined elution rate of at least one therapeutic agent. ### Claim 23 (depends on 20) The method of claim 20 wherein the at least one thin barrier layer comprises a diffusion barrier.