# US 2025/0375556 A1 · Medical device and method for manufacturing the same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2025/0375556 A1 - Document ID: US20250375556A1 - Status: Published application - Kind: A1 - Application number: 19/307,609 - Filed: 2025-08-22 - Published: 2025-12-11 - Earliest claimed: 2023-03-10 - Assignees: Terumo Kabushiki Kaisha - Applicants: Terumo Kabushiki Kaisha - Inventors: Takeshi MATSUHASHI - Web page: https://patentgrep.com/patent/US20250375556A1 ## CPC - A61L 31/10: Macromolecular materials - A61L 29/04: Macromolecular materials - A61L 29/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds - A61L 29/085: {Macromolecular materials} - A61L 29/12: Composite materials, i.e. containing one material dispersed in a matrix of the same or different material - A61L 29/14: Materials characterised by their function or physical properties {, e.g. lubricating compositions} - A61L 31/04: Macromolecular materials - A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)} - A61L 31/12: Composite materials, i.e. containing one material dispersed in a matrix of the same or different material - A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials} - A61L 33/06: Use of macromolecular materials (grafting of a monomer onto the substrate A61L33/0088) - A61L 2400/10: Materials for lubricating medical devices - A61L 2420/08: Coatings comprising two or more layers - 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) ## Abstract A medical device with improved lubrication retaining property includes a base layer, and a lubricating layer having a first layer formed on at least a part of the base layer, and a second layer formed on at least a part of the first layer, in which the first layer includes a first copolymer having a structural unit derived from a hydrophilic monomer and a structural unit having an epoxy group, and has a swelling ratio of more than 70% and less than 1000%, and the second layer includes a second copolymer having a structural unit having an alkyl vinyl ether group and a structural unit having a carboxyl group or a salt or ester thereof. ## Claims ### Claim 1 A medical device comprising: a base layer; two additional layers that together constitute a lubricating layer and that are successively applied to the base layer so that the two additional layers overlie the base layer, the two additional layers that are successively applied to the base layer comprising a first layer and a second layer, at least a part of the first layer being in contact with the base layer and being between the base layer and the second layer, and at least a part of the second layer being in contact with the first layer; the first layer comprising a first copolymer, the first copolymer comprising a structural unit derived from a hydrophilic monomer and a structural unit having an epoxy group, the first layer having a swelling ratio of at least 190% and less than 1000%; and the second layer comprising a second copolymer, the second copolymer comprising a structural unit having an alkyl vinyl ether group and a structural unit having a carboxyl group or a salt or ester thereof. ### Claim 2 (depends on 1) The medical device according to claim 1, wherein the base layer comprises a metal material, a polymer material or a ceramic material. ### Claim 3 (depends on 1) The medical device according to claim 1, wherein the first copolymer comprises the structural unit derived from the hydrophilic monomer and the structural unit having the epoxy group in a molar ratio of 3:1 to 70:1. ### Claim 4 (depends on 1) The medical device according to claim 1, wherein the hydrophilic monomer comprises an amino group (—N(R1)(R2), wherein R1 and R2 each independently denote a hydrogen atom or an unsubstituted or substituted alkyl group having 1 to 4 carbon atoms), or an alkylene glycol chain. ### Claim 5 A medical device comprising: a base layer; a lubricating layer having a first layer formed on at least a part of the base layer and a second layer formed on at least part of the first layer; the first layer comprising a first copolymer, the first copolymer comprising a structural unit derived from a hydrophilic monomer and a structural unit having an epoxy group, the first layer having a swelling ratio of more than 70% and less than 1000%; and the second layer comprising a second copolymer, the second copolymer comprising a structural unit having an alkyl vinyl ether group and a structural unit having a carboxyl group or a salt or ester thereof. ### Claim 6 (depends on 5) The medical device according to claim 5, wherein the first copolymer comprises the structural unit derived from the hydrophilic monomer and the structural unit having the epoxy group in a molar ratio of 3:1 to 70:1. ### Claim 7 (depends on 5) The medical device according to claim 5, wherein the hydrophilic monomer comprises an amino group —N(R1)(R2), wherein R1 and R2 each independently denote a hydrogen atom or an unsubstituted or substituted alkyl group having 1 to 4 carbon atoms), or an alkylene glycol chain. ### Claim 8 (depends on 5) The medical device according to claim 5, wherein the hydrophilic monomer comprises at least one monomer selected from the group consisting of acrylamide, N-methyl acrylamide, N,N-dimethylacrylamide (DMAA), N-ethylacrylamide, N,N-diethylacrylamide (DEAA), N,N-dimethylaminopropylacrylamide, N,N-dimethylaminopropylmethacrylamide, 2-acrylamide-2-methylpropanesulfonic acid, N-(2-hydroxyethyl) acrylamide, N-(2-hydroxypropyl) acrylamide, N-(2-hydroxybutyl) acrylamide, polyethylene glycol monoacrylate, polyethylene glycol monomethacrylate, alkoxypolyethylene glycol monoacrylate, and alkoxypolyethylene glycol monomethacrylate. ### Claim 9 (depends on 5) The medical device according to claim 5, wherein the structural unit having the epoxy group is a structural unit derived from at least one monomer selected from the group consisting of glycidyl acrylate, glycidyl methacrylate (GMA), 3,4-epoxycyclohexyl methyl acrylate, 3,4-epoxycyclohexyl methyl methacrylate, β-methyl glycidyl acrylate, and β-methyl glycidyl methacrylate. ### Claim 10 (depends on 5) The medical device according to claim 5, wherein the structural unit having the carboxyl group or the salt or ester thereof comprises at least one of: a structural unit represented by formula (1): wherein X1 denotes a hydrogen atom, an alkali metal, or an alkaline earth metal, and X2 denotes a hydrogen atom, an alkali metal, an alkaline earth metal, a straight chain alkyl group having 1 to 24 carbon atoms, or a branched chain alkyl group having 3 to 24 carbon atoms; and a structural unit represented by formula (2): wherein X3 denotes a hydrogen atom, an alkali metal, or an alkaline earth metal, and X4 denotes a hydrogen atom, an alkali metal, or an alkaline earth metal. ### Claim 11 (depends on 5) The medical device according to claim 5, wherein the structural unit having the alkyl vinyl ether group is represented by formula (3): wherein X5 denotes a straight chain alkyl group having 1 to 24 carbon atoms or a branched chain alkyl group having 3 to 24 carbon atoms. ### Claim 12 (depends on 5) The medical device according to claim 5, wherein the lubricating layer comprises a region in which the first copolymer and the second copolymer are bonded to each other. ### Claim 13 (depends on 5) The medical device according to claim 5, wherein the medical device is a catheter, a stent, or a guide wire. ### Claim 14 A method for manufacturing a medical device, the method comprising: applying a first coating liquid comprising a first copolymer, the first polymer comprising a structural unit derived from a hydrophilic monomer and a structural unit having an epoxy group, and a solvent to at least a part of a base layer to form a first precursor layer on at least part of the base layer; applying a second coating liquid comprising a second copolymer, the second copolymer comprising a structural unit having an alkyl vinyl ether group and a structural unit having a carboxyl group or a salt or ester thereof, and a solvent to at least part of the first precursor layer to obtain an intermediate laminated body, in which a second precursor layer is formed on at least part of the first precursor layer; and irradiating the intermediate laminated body with an electron beam. ### Claim 15 (depends on 14) The method according to claim 14, wherein irradiating the intermediate laminated body with an electron beam comprises irradiating the intermediate laminated body at an irradiation dose of 30 to 500 kGy. ### Claim 16 (depends on 14) The method according to claim 14, wherein the first copolymer comprises the structural unit derived from the hydrophilic monomer and the structural unit having the epoxy group in a molar ratio of 3:1 to 70:1. ### Claim 17 (depends on 14) The method according to claim 14, wherein the hydrophilic monomer comprises an amino group (—N(R1)(R2), wherein R1 and R2 each independently denote a hydrogen atom or an unsubstituted or substituted alkyl group having 1 to 4 carbon atoms), or an alkylene glycol chain. ### Claim 18 (depends on 14) The method according to claim 14, wherein the hydrophilic monomer comprises at least one monomer selected from the group consisting of acrylamide, N-methyl acrylamide, N,N-dimethylacrylamide (DMAA), N-ethylacrylamide, N,N-diethylacrylamide (DEAA), N,N-dimethylaminopropylacrylamide, N,N-dimethylaminopropylmethacrylamide, 2-acrylamide-2-methylpropanesulfonic acid, N-(2-hydroxyethyl) acrylamide, N-(2-hydroxypropyl) acrylamide, N-(2-hydroxybutyl) acrylamide, polyethylene glycol monoacrylate, polyethylene glycol monomethacrylate, alkoxypolyethylene glycol monoacrylate, and alkoxypolyethylene glycol monomethacrylate. ### Claim 19 (depends on 14) The method according to claim 14, wherein the structural unit having the epoxy group is a structural unit derived from at least one monomer selected from the group consisting of glycidyl acrylate, glycidyl methacrylate (GMA), 3,4-epoxycyclohexyl methyl acrylate, 3,4-epoxycyclohexyl methyl methacrylate, β-methyl glycidyl acrylate, and β-methyl glycidyl methacrylate. ### Claim 20 (depends on 14) The method according to claim 14, wherein the structural unit having the carboxyl group or the salt or ester thereof comprises at least one of: a structural unit represented by formula (1): wherein X1 denotes a hydrogen atom, an alkali metal, or an alkaline earth metal, and X2 denotes a hydrogen atom, an alkali metal, an alkaline earth metal, a straight chain alkyl group having 1 to 24 carbon atoms, or a branched chain alkyl group having 3 to 24 carbon atoms; and a structural unit represented by formula (2): wherein X3 denotes a hydrogen atom, an alkali metal, or an alkaline earth metal, and X4 denotes a hydrogen atom, an alkali metal, or an alkaline earth metal.