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WO2025158984A1 - Matériau médical, son procédé de production et outil médical - Google Patents

Matériau médical, son procédé de production et outil médical

Info

Publication number
WO2025158984A1
WO2025158984A1 PCT/JP2025/001096 JP2025001096W WO2025158984A1 WO 2025158984 A1 WO2025158984 A1 WO 2025158984A1 JP 2025001096 W JP2025001096 W JP 2025001096W WO 2025158984 A1 WO2025158984 A1 WO 2025158984A1
Authority
WO
WIPO (PCT)
Prior art keywords
block copolymer
medical material
medical
hydrophobic resin
coating
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/JP2025/001096
Other languages
English (en)
Japanese (ja)
Inventor
望 渡邉
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Publication of WO2025158984A1 publication Critical patent/WO2025158984A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings

Definitions

  • the present invention relates to medical materials, their manufacturing methods, and medical devices.
  • Medical devices inserted into the body such as plastic insertion needles, dilators, sheaths (introducers), catheters, and medical tubing, are required to exhibit excellent slip properties (sliding ability, lubricity) to reduce tissue damage to blood vessels and other tissues and improve operability for the surgeon.
  • PTFE Polytetrafluoroethylene
  • PFAS organic fluorine compounds
  • PTFE polytetrafluoroethylene
  • the present invention was made in consideration of the above circumstances, and aims to provide a medical material or medical device that has mechanical properties (particularly tensile strength and tensile elongation) comparable to those of polytetrafluoroethylene (PTFE) and superior slip properties (slidability) to PTFE.
  • mechanical properties particularly tensile strength and tensile elongation
  • PTFE polytetrafluoroethylene
  • sliding properties sliding
  • the inventors conducted extensive research to solve the above problems. As a result, they discovered that the above problems could be solved by combining a block copolymer having specific structural units with a specific hydrophobic resin, leading to the completion of the present invention.
  • a medical material comprising a block copolymer having a structural unit (A) derived from a reactive monomer having an epoxy group and a structural unit (B) derived from a hydrophilic monomer, and at least one hydrophobic resin selected from the group consisting of polyvinyl chloride resins and polyurethane elastomers, wherein the content of the hydrophobic resin in the medical material is greater than the content of the block copolymer, the medical material has a sliding resistance of 50 gf or less, and satisfies at least one of a tensile strength of 8.0 MPa or more and a tensile elongation of more than 80%. 2.
  • the hydrophobic resin is preferably contained in a proportion of 125 parts by mass or more and 300 parts by mass or less per 100 parts by mass of the block copolymer.
  • the reactive monomer having an epoxy group preferably includes at least one selected from the group consisting of glycidyl acrylate, glycidyl methacrylate, 3,4-epoxycyclohexylmethyl acrylate, 3,4-epoxycyclohexylmethyl methacrylate, ⁇ -methylglycidyl methacrylate, and allyl glycidyl ether.
  • the hydrophilic monomer contains at least one selected from the group consisting of N,N-dimethylacrylamide, acrylamide, 2-hydroxyethyl methacrylate, and N-vinylpyrrolidone.
  • a medical device comprising or consisting of the medical material described in any one of 1. to 4. above.
  • a medical device comprising a substrate layer and a coating layer containing or consisting of the medical material described in any one of 1. to 4. above.
  • the medical device described in 5. or 6. above is preferably a plastic insertion needle, a dilator, a sheath (introducer), a catheter, or a medical tube.
  • Yet another aspect of the present invention is 8.
  • One aspect of the present invention relates to a medical material comprising a block copolymer having a structural unit (A) derived from a reactive monomer having an epoxy group and a structural unit (B) derived from a hydrophilic monomer, and at least one hydrophobic resin selected from the group consisting of polyvinyl chloride resin and polyurethane elastomer, wherein the content of the hydrophobic resin in the medical material is greater than the content of the block copolymer, the medical material has a sliding resistance of 50 gf or less, and satisfies at least one of a tensile strength of 8.0 MPa or greater and a tensile elongation of more than 80%.
  • This configuration makes it possible to provide medical materials and medical devices that have mechanical properties (particularly tensile strength and tensile elongation) comparable to those of polytetrafluoroethylene (PTFE) and superior slipperiness (slidability) to PTFE.
  • mechanical properties particularly tensile strength and tensile elongation
  • PTFE polytetrafluoroethylene
  • the structural unit (A) derived from a reactive monomer having an epoxy group is also referred to simply as the "structural unit (A) of the present invention” or “structural unit (A).”
  • the structural unit (B) derived from a hydrophilic monomer is also referred to simply as the “structural unit (B) of the present invention” or “structural unit (B).”
  • a block copolymer having structural units (A) and (B) is also referred to simply as the "block copolymer of the present invention” or “block copolymer.”
  • hydrophobic resin selected from the group consisting of polyvinyl chloride resin and polyurethane elastomer
  • hydrophobic resin of the present invention or “hydrophobic resin.”
  • a structural unit when a structural unit is defined as being "derived from” a certain monomer, it means that the structural unit is generated by cleavage of one of the polymerizable unsaturated double bonds of the corresponding monomer.
  • the term “(meth)acrylic” includes both acrylic and methacrylic.
  • the term “(meth)acrylic acid” includes both acrylic acid and methacrylic acid.
  • the term “(meth)acryloyl” includes both acryloyl and methacryloyl.
  • the term “(meth)acryloyl group” includes both acryloyl and methacryloyl groups.
  • the term “(meth)acrylate” includes both acrylate and methacrylate.
  • alkoxyalkyl (meth)acrylate includes both alkoxyalkyl acrylate and alkoxyalkyl methacrylate.
  • X to Y indicating a range includes both X and Y and means “X or greater and Y or less.”
  • X and/or Y includes each of X and Y and all combinations of one or more of them, and specifically means at least one of X and Y, and includes X alone, Y alone, and a combination of X and Y.
  • a block copolymer is combined with a hydrophobic resin (at least one of polyvinyl chloride resin and polyurethane elastomer).
  • the block copolymer provides slipperiness (slidability, lubricity) to the material.
  • the block copolymer exhibits superior slipperiness (slidability, lubricity) to PTFE. Therefore, the medical material of the present invention and medical devices made using the medical material exhibit slipperiness (slidability) equal to or greater than PTFE.
  • the hydrophobic resin promotes the ring-opening and crosslinking reaction of the epoxy groups present in the block copolymer, improving mechanical properties (e.g., tensile strength and tensile elongation).
  • the medical material of the present invention and medical devices made using the medical material have excellent slipperiness (slidability) and mechanical properties (e.g., tensile strength and tensile elongation), and these properties are well balanced.
  • the medical material of the present invention contains more hydrophobic resin than block copolymer. Therefore, when a medical device is made using the medical material of the present invention, the ring-opening (crosslinking reaction) of the epoxy groups proceeds at a high density. This increases the strength of the medical device (or the film strength in the case of a coating layer). Therefore, the present invention can provide a medical material that has mechanical properties (particularly tensile strength and tensile elongation) comparable to those of polytetrafluoroethylene (PTFE) and superior slip properties (slidability) to PTFE.
  • PTFE polytetrafluoroethylene
  • the block copolymer according to the present invention has a structural unit (A) derived from a reactive monomer having an epoxy group and a structural unit (B) derived from a hydrophilic monomer.
  • the reactive monomer having an epoxy group that constitutes the block copolymer has an epoxy group as its reactive group.
  • the epoxy group opens, causing crosslinking (bonding) between the block copolymers and increasing strength.
  • the ring-opened epoxy group can also cause crosslinking (bonding) between the block copolymer and the substrate layer.
  • the reactive monomers that make up the block copolymer are not particularly limited as long as they contain an epoxy group, and known compounds can be used. Among these, because it is easier to control the crosslinking or polymerization of the block copolymer, it is preferable for the reactive monomers containing an epoxy group to include at least one selected from the group consisting of glycidyl acrylate, glycidyl methacrylate (GMA), 3,4-epoxycyclohexylmethyl acrylate, 3,4-epoxycyclohexylmethyl methacrylate, ⁇ -methylglycidyl methacrylate, and allyl glycidyl ether. Among these, glycidyl (meth)acrylate is more preferred, with glycidyl methacrylate being particularly preferred, considering its ability to further promote the crosslinking reaction and ease of production.
  • the above reactive monomers may be used alone or in combination of two or more types.
  • the structural unit (A) (reactive site) derived from the reactive monomer may be a homopolymer type composed of a single type of reactive monomer, or a copolymer type composed of two or more types of the above reactive monomers.
  • the structural unit (A) may be in the form of a block copolymer or a random copolymer.
  • the reactive monomer having an epoxy group includes at least one selected from the group consisting of glycidyl acrylate, glycidyl methacrylate, 3,4-epoxycyclohexylmethyl acrylate, 3,4-epoxycyclohexylmethyl methacrylate, ⁇ -methylglycidyl methacrylate, and allyl glycidyl ether.
  • the reactive monomer having an epoxy group is at least one of glycidyl acrylate and glycidyl methacrylate.
  • the reactive monomer having an epoxy group is glycidyl methacrylate.
  • hydrophilic monomers that make up the block copolymer swell when in contact with body fluids (e.g., blood, urine) or aqueous solvents, imparting excellent slipperiness (lubricity). Therefore, by introducing structural units (B) derived from such hydrophilic monomers into the block copolymer, medical devices made from this medical material will have excellent slipperiness (lubricity), reducing friction when the medical device comes into contact with the wall of a lumen, such as a blood vessel wall.
  • the hydrophilic monomers that make up the block copolymer are not particularly limited as long as they have the above properties, and known compounds can be used. Examples include acrylamide and its derivatives, vinylpyrrolidone, acrylic acid, methacrylic acid and their derivatives, polyethylene glycol acrylate and its derivatives, monomers with sugars or phospholipids in the side chains, and water-soluble monomers such as maleic anhydride.
  • acrylic acid methacrylic acid, N-methylacrylamide, N,N-dimethylacrylamide (DMAA), acrylamide, acryloylmorpholine, N,N-dimethylaminoethyl acrylate, N-vinylpyrrolidone, 2-methacryloyloxyethyl phosphorylcholine, 2-methacryloyloxyethyl-D-glycoside, 2-methacryloyloxyethyl-D-mannoside, vinyl methyl ether, 2-hydroxyethyl (meth)acrylate, 4-hydroxybutyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, 2-hydroxybutyl (meth)acrylate, 6-hydroxyhexyl (meth)acrylate, 1,4-cyclohexanedimethanol mono(meth)acrylate, 1-chloro-2-hydroxypropyl (meth)acrylate, diethylene glycol mono(meth)acrylate, 1,6-hexaned
  • the hydrophilic monomer preferably includes at least one selected from the group consisting of N,N-dimethylacrylamide, acrylamide, 2-hydroxyethyl methacrylate, and N-vinylpyrrolidone, and more preferably at least one selected from the group consisting of N,N-dimethylacrylamide, acrylamide, and 2-hydroxyethyl methacrylate.
  • N,N-dimethylacrylamide is particularly preferred as the hydrophilic monomer.
  • the above hydrophilic monomers may be used alone or in combination of two or more types.
  • the structural unit (B) (hydrophilic moiety) derived from the hydrophilic monomer may be a homopolymer type composed of a single hydrophilic monomer, or a copolymer type composed of two or more of the above hydrophilic monomers.
  • the structural unit (B) may be in the form of a block copolymer or a random copolymer.
  • the hydrophilic monomer includes at least one selected from the group consisting of N,N-dimethylacrylamide, acrylamide, 2-hydroxyethyl methacrylate, and N-vinylpyrrolidone.
  • the hydrophilic monomer is at least one selected from the group consisting of N,N-dimethylacrylamide, acrylamide, and 2-hydroxyethyl methacrylate.
  • the hydrophilic monomer is N,N-dimethylacrylamide.
  • the block copolymer has the above-mentioned structural unit (A) and structural unit (B).
  • the ratio of the structural unit (A) to the structural unit (B) is not particularly limited as long as the above-mentioned effects are achieved. Considering further improvements in lubricity (slipperiness, slidability), the ratio of the structural unit (A) to the structural unit (B) (molar ratio of structural unit (A):structural unit (B)) is preferably 1:2 to 1:100, more preferably 1:2 to 1:50, even more preferably 1:5 to 1:50, and particularly preferably 1:10 to 1:30.
  • the molar ratio of the structural unit (A):structural unit (B) can be controlled by adjusting the charge ratio (molar ratio) of each monomer during the production stage of the block copolymer. Therefore, the charging ratio (molar ratio) of the reactive monomer to the hydrophilic monomer in the production stage of the block copolymer is preferably 1:2 to 1:100, more preferably 1:2 to 1:50, even more preferably 1:5 to 1:50, and particularly preferably 1:10 to 1:30.
  • the composition (molar ratio) of the structural unit (A):structural unit (B) can be confirmed, for example, by subjecting the copolymer to NMR measurement ( 1 H-NMR measurement, 13 C-NMR measurement, etc.).
  • composition of each structural unit can be measured by known methods.
  • the composition (molar ratio) of each structural unit can be measured by measuring the integral ratio of the intensity of each signal in the 1H -NMR spectrum of the block copolymer solution.
  • the block copolymer of the present invention is essentially composed of, or consists of, structural unit (A) derived from at least one reactive monomer selected from the group consisting of glycidyl acrylate, glycidyl methacrylate, 3,4-epoxycyclohexylmethyl acrylate, 3,4-epoxycyclohexylmethyl methacrylate, ⁇ -methylglycidyl methacrylate, and allyl glycidyl ether, and structural unit (B) derived from at least one hydrophilic monomer selected from the group consisting of N,N-dimethylacrylamide, acrylamide, 2-hydroxyethyl methacrylate, and N-vinylpyrrolidone.
  • structural unit (A) derived from at least one reactive monomer selected from the group consisting of glycidyl acrylate, glycidyl methacrylate, 3,4-epoxycyclohexylmethyl acrylate, 3,4-epoxycycl
  • the block copolymer according to the present invention is essentially composed of, or consists of, a structural unit (A) derived from at least one reactive monomer of glycidyl acrylate and glycidyl methacrylate, and a structural unit (B) derived from at least one hydrophilic monomer selected from the group consisting of N,N-dimethylacrylamide, acrylamide, and 2-hydroxyethyl methacrylate.
  • the block copolymer according to the present invention is essentially composed of, or consists only of, a structural unit (A) derived from glycidyl methacrylate (a reactive monomer having an epoxy group) and a structural unit (B) derived from N,N-dimethylacrylamide (a hydrophilic monomer).
  • the weight-average molecular weight of the block copolymer is preferably 10,000 to 10,000,000 from the viewpoint of solubility.
  • the weight-average molecular weight of the block copolymer is more preferably 100,000 to 5,000,000 from the viewpoint of ease of preparation of the coating liquid.
  • “weight-average molecular weight” refers to a value measured by gel permeation chromatography (GPC) using polystyrene as the standard substance.
  • the hydrophobic resin of the present invention is at least one of polyvinyl chloride and polyurethane elastomer.
  • the hydrophobic resin induces ring-opening of epoxy groups present in the block copolymer. Ring-opening of the epoxy groups promotes crosslinking (bonding) between the block copolymers.
  • the ring-opened epoxy groups can also crosslink (bond) the block copolymer to the substrate layer. Therefore, in medical devices obtained using the medical material of the present invention, the coating layer is firmly bonded to the substrate layer.
  • the hydrophobic resin according to the present invention is at least one of polyvinyl chloride and polyurethane elastomer.
  • the hydrophobic resin contains at least polyvinyl chloride resin, and polyvinyl chloride resin is more preferable.
  • the hydrophobic resin contains at least polyurethane elastomer, and it is more preferable that it consists solely of polyurethane elastomer.
  • the weight-average molecular weight (Mw) of the hydrophobic resin is 1,000 or more. From the standpoint of solubility, the weight-average molecular weight of the hydrophobic resin is preferably 500,000 or less. Furthermore, from the standpoint of promoting crosslinking and stability, the weight-average molecular weight of the hydrophobic resin is preferably 10,000 or more. As an example, the weight-average molecular weight (Mw) of the hydrophobic resin is 1,000 to 10,000,000, and preferably 10,000 to 500,000.
  • the mixing ratio (mass ratio) of block copolymer to hydrophobic resin is such that the content of hydrophobic resin is greater than the content of block copolymer.
  • medical devices e.g., plastic insertion needles, dilators, sheaths (introducers), catheters, medical tubing
  • slipperiness sliding property, lubricity
  • medical devices which partially include a coating layer made of medical material
  • medical devices formed using the medical material of the present invention have slipperiness (sliding property, lubricity), so there is no need to apply a separate coating with lubricity.
  • the hydrophobic resin is preferably contained in a ratio of 125 to 300 parts by mass per 100 parts by mass of the block copolymer, more preferably 150 to 230 parts by mass per 100 parts by mass of the block copolymer, and particularly preferably 160 to 180 parts by mass per 100 parts by mass of the block copolymer.
  • the mixing ratio (mass ratio) of the block copolymer to the hydrophobic resin is within the above range, the medical device (or coating layer) formed using the medical material will have sufficient mechanical properties and lubricity (especially excellent lubricity) and an excellent balance between these.
  • the medical material according to the present invention (and therefore the medical device (or coating layer) formed using the medical material) has mechanical properties (particularly tensile strength and tensile elongation) comparable to those of polytetrafluoroethylene (PTFE), while also having excellent slip properties (slidability) comparable to or better than PTFE.
  • PTFE polytetrafluoroethylene
  • the medical material (and therefore the medical device (or coating layer) formed using the medical material) has a sliding resistance of 50 gf or less.
  • the sliding resistance is preferably less than 30 gf, and more preferably less than 20 gf. Since a lower sliding resistance is preferable, there is no particular lower limit and the lower limit is 0 gf, but a value of 3 gf or more is acceptable. Therefore, the sliding resistance of the medical material is, for example, 0 gf to 50 gf, preferably 0 gf to less than 30 gf, and more preferably 0 gf to less than 20 gf. The sliding resistance of the medical material may also be 3 gf to less than 30 gf, or 3 gf to less than 20 gf. In this specification, "sliding resistance" is a value measured according to the method described in the examples.
  • the medical material (and therefore the medical device (or coating layer) formed using said medical material) satisfies at least one of a tensile strength of 8.0 MPa or more and a tensile elongation of greater than 80%.
  • the medical material satisfies both a tensile strength of 8.0 MPa or more and a tensile elongation of greater than 80%.
  • the tensile strength of the medical material is preferably 8.4 MPa or more, more preferably 10 MPa or more, even more preferably 20 MPa or more, and particularly preferably 25 MPa or more. Since a higher tensile strength of the medical material is preferable, there is no particular upper limit, but it is usually 200 MPa or less.
  • the tensile strength of the medical material is, for example, 8.0 MPa to 200 MPa, preferably 8.4 MPa to 200 MPa, more preferably 10 MPa to 200 MPa, even more preferably 20 MPa to 200 MPa, and particularly preferably 25 MPa to 200 MPa.
  • "tensile strength" is a value measured according to the method described in the examples.
  • the tensile elongation of the medical material is preferably 100% or more, more preferably 120% or more, even more preferably 150% or more, and particularly preferably 400% or more. Since a higher tensile elongation of the medical material is preferable, there is no particular upper limit, but it is usually 500% or less.
  • the tensile elongation of the medical material is, for example, more than 80% and 500% or less, preferably 100% or more and 500% or less, more preferably 120% or more and 500% or less, even more preferably 150% or more and 500% or less, and particularly preferably 400% or more and 500% or less.
  • tensile elongation refers to a value measured according to the method described in the Examples.
  • the medical material according to the present invention has a sliding resistance of 50 gf or less and at least one of a tensile strength of 8.0 MPa or more and a tensile elongation of more than 80%.
  • a medical material satisfying these properties may be produced by any method, but can be produced particularly by appropriately controlling the heating conditions and the mixing ratio of the block copolymer and the hydrophobic resin.
  • the present invention provides a method for producing a medical material according to the present invention, which comprises: preparing a mixture by mixing the block copolymer, the hydrophobic resin, and the organic solvent so that the content of the hydrophobic resin is greater than the content of the block copolymer (mixture preparation step); and heat-treating the mixture at a temperature greater than 100°C and less than 150°C for 30 minutes to 3 hours (mixture heat-treatment step).
  • a mixture is prepared by mixing a block copolymer, a hydrophobic resin, and an organic solvent.
  • the mixing ratio of the block copolymer to the hydrophobic resin is such that the content of the hydrophobic resin is greater than the content of the block copolymer.
  • the hydrophobic resin is mixed with the block copolymer at a mixing ratio of 125 to 300 parts by mass per 100 parts by mass of the block copolymer. It is more preferable to mix the hydrophobic resin with the block copolymer at a mixing ratio of 150 to 230 parts by mass per 100 parts by mass of the block copolymer.
  • the hydrophobic resin with the block copolymer at a mixing ratio of 160 to 180 parts by mass per 100 parts by mass of the block copolymer.
  • the organic solvents that can be used to prepare the mixture are not particularly limited as long as they can dissolve the block copolymer and hydrophobic resin (and other components, if used). They are appropriately selected depending on the type of block copolymer and hydrophobic resin (and other components, if used). From the viewpoint of high solubility, alcoholic solvents such as methanol, ethanol, isopropyl alcohol, and butanol; and organic solvents such as dichloromethane, chloroform, carbon tetrachloride, tetrahydrofuran (THF), dimethyl sulfoxide, N,N-dimethylformamide (DMF), dioxane, and benzene are preferred.
  • alcoholic solvents such as methanol, ethanol, isopropyl alcohol, and butanol
  • organic solvents such as dichloromethane, chloroform, carbon tetrachloride, tetrahydrofuran (THF), dimethyl sulfoxide, N,N-
  • the concentration of the block copolymer in the mixture is 0.1 to 20% by mass, preferably 0.5 to 15% by mass, and more preferably 1 to 10% by mass.
  • the concentration of the hydrophobic resin in the mixture is preferably such that the mixing ratio with the block copolymer falls within the range described above. When the concentrations of the block copolymer and hydrophobic resin are within the above ranges, the sliding resistance, tensile strength, and tensile elongation of the medical material (and therefore the medical device (or coating layer) formed using the medical material) can be more appropriately controlled.
  • the order in which the block copolymer and hydrophobic resin are mixed is not particularly limited.
  • the block copolymer and hydrophobic resin can be charged all at once to the organic solvent, (2) the block copolymer can be added to the organic solvent and then the hydrophobic resin can be added, or (3) the hydrophobic resin can be added to the organic solvent and then the block copolymer can be added.
  • the above additions can be carried out with stirring.
  • the mixture can be stirred after the above additions.
  • Heat treatment step of the mixture In this step, the mixture obtained in the above (mixture preparation step) is heat-treated at a temperature above 100°C and below 150°C for 30 minutes to 3 hours.
  • This heat treatment allows for more appropriate control of the sliding resistance, tensile strength, and tensile elongation of the medical material, particularly the sliding resistance.
  • the heat treatment temperature is below 100°C or the heat treatment time is less than 30 minutes, the heat treatment is insufficient, and the desired durability in terms of slipperiness is not achieved.
  • the heat treatment temperature exceeds 150°C or the heat treatment time exceeds 3 hours the heat treatment proceeds excessively, and the desired durability in terms of slipperiness is also not achieved.
  • the heat treatment temperature is preferably 105°C to 140°C, more preferably above 105°C to 120°C.
  • the heat treatment time is preferably 40 minutes to 2 hours, more preferably 50 minutes to 1.5 hours.
  • the heat treatment step may be performed once or may be repeated two or more times. In the latter case, it is preferable that the heat treatment temperature in the entire heat treatment step (all repeated heat treatment steps) is higher than 100° C. and lower than 150° C., and that the heat treatment time in the entire heat treatment step is 30 minutes to 3 hours, both of which are within the above-mentioned ranges.
  • the medical material according to the present invention has mechanical properties (particularly tensile strength and tensile elongation) comparable to those of polytetrafluoroethylene (PTFE) and has slip properties (slidability) that are equal to or superior to those of PTFE.
  • PTFE polytetrafluoroethylene
  • the present invention therefore also provides a medical device comprising or consisting of the medical material of the present invention.
  • the sliding resistance of the medical device is 50 gf or less (preferably less than 30 gf, more preferably less than 20 gf), and the medical device satisfies at least one of the following, and preferably both: a tensile strength of 8.0 MPa or more (preferably 8.4 MPa or more, more preferably 10 MPa or more, even more preferably 20 MPa or more, and particularly preferably 25 MPa or more) and a tensile elongation of more than 80% (preferably 100% or more, more preferably 120% or more, even more preferably 150% or more, and particularly preferably 400% or more).
  • the size of the medical device can be appropriately selected depending on the desired application (e.g., a catheter).
  • the present invention also provides a medical device comprising a substrate layer and a coating layer containing or consisting of the medical material of the present invention.
  • the sliding resistance of the coating layer is 50 gf or less (preferably less than 30 gf, more preferably less than 20 gf), and the coating layer satisfies at least one of the following: a tensile strength of 8.0 MPa or more (preferably 8.4 MPa or more, more preferably 10 MPa or more, even more preferably 20 MPa or more, particularly preferably 25 MPa or more) and a tensile elongation of more than 80% (preferably 100% or more, more preferably 120% or more, even more preferably 150% or more, particularly preferably 400% or more), and preferably satisfies both.
  • the medical device may be in a form consisting of the medical material and the other components described above, a form consisting of the medical material and a coiled or braided metal (for example, a structure in which a metal coil or metal braid is embedded in a tubular medical device made using the medical material), or a form coated on a metal wire or metal surface.
  • the substrate layer may be made of any material, including, for example, metal materials, polymer materials (resin materials), and ceramics.
  • the metallic material constituting the substrate layer is not particularly limited, and metallic materials commonly used for medical devices such as catheters, guidewires, and indwelling needles can be used. Specific examples include various stainless steels such as SUS304, SUS314, SUS316, SUS316L, SUS420J2, and SUS630, as well as gold, platinum, silver, copper, nickel, cobalt, titanium, iron, aluminum, tin, and various alloys such as nickel-titanium alloys, nickel-cobalt alloys, cobalt-chromium alloys, and zinc-tungsten alloys. These may be used alone or in combination of two or more.
  • the metallic material best suited for the substrate layer of the intended use, such as a catheter, guidewire, or indwelling needle, can be appropriately selected.
  • the polymer material (resin material or elastomer material) is not particularly limited, and polymer materials commonly used in medical devices such as plastic insertion needles (indwelling needles), dilators, sheaths (introducers), catheters, or medical tubing can be used.
  • polyamide resins such as polyethylene resins and polypropylene resins, modified polyolefin resins, cyclic polyolefin resins, epoxy resins, polyurethane resins, diallyl phthalate resins (allyl resins), polycarbonate resins, fluororesins (e.g., polytetrafluoroethylene resins), amino resins (urea resins, melamine resins, benzoguanamine resins), polyester resins such as polyethylene terephthalate resins and polybutylene terephthalate resins, styrene resins, acrylic resins, polyacetal resins, vinyl acetate resins, phenolic resins, vinyl chloride resins, silicone resins (silicon resins), polyether resins, and polyimide resins.
  • polyamide resins such as polyethylene resins and polypropylene resins
  • modified polyolefin resins such as polyethylene resins and polypropylene resins
  • cyclic polyolefin resins
  • thermoplastic elastomers such as polyurethane elastomers, polyester elastomers, and polyamide elastomers (nylon elastomers) can also be used as materials for the base layer.
  • polymer materials may be used alone, as a mixture of two or more types, or as a copolymer of two or more monomers constituting any of the above resins or elastomers.
  • polyethylene resins, polyurethane resins, polyethylene terephthalate resins, polyamide resins, and polyamide elastomers are preferred, with polyamide resins and polyamide elastomers being more preferred.
  • the carboxyl and amino groups contained as terminal groups in polyamide resins and polyamide elastomers can undergo crosslinking reactions with epoxy groups in block copolymers.
  • these polymer materials are relatively soft and can be easily impregnated with block copolymers and hydrophobic resins.
  • the polymer material can be appropriately selected to be optimal for the substrate layer of the intended use, such as a plastic insertion needle (indwelling needle), dilator, sheath (introducer), catheter, or medical tubing.
  • the shape of the substrate layer is not particularly limited and can be selected appropriately depending on the intended use, such as sheet, wire, rod, or tube.
  • the entire substrate layer may be made of one of the materials listed above.
  • the substrate layer may be a multilayer structure formed by laminating different materials in multiple layers, or a structure in which components made of different materials are joined together for each portion of the medical device.
  • the substrate may have a structure in which the surface of a substrate layer core made of one of the materials listed above is coated with one of the other materials listed above by an appropriate method to form a substrate surface layer.
  • Examples of the latter include a substrate surface layer formed by coating the surface of a substrate layer core made of a resin material or the like with a metal material by an appropriate method (conventionally known methods such as plating, metal vapor deposition, sputtering, etc.); a substrate surface layer formed by coating the surface of a substrate layer core made of a hard reinforcing material such as a metal or ceramic material with a polymer material that is softer than the metal reinforcing material by an appropriate method (conventionally known methods such as dipping, spraying, coating, printing, etc.); or a substrate surface layer formed by combining the reinforcing material that forms the substrate layer core with a polymer material.
  • the core substrate layer may also be a multilayer structure formed by laminating different materials in multiple layers, or a structure in which components formed from different materials are joined together for each portion of the medical device.
  • a separate middle layer may also be formed between the core substrate layer and the substrate surface layer.
  • the substrate surface layer may also be a multilayer structure formed by laminating different materials in multiple layers, or a structure in which components formed from different materials are joined together for each portion of the medical device.
  • Another layer may be provided between the substrate layer and the coating layer.
  • the other layer may be made of a material similar to the polymer material (resin material or elastomer material) described above.
  • the coating layer may be made of a medical material and the other components mentioned above, or may be made of a medical material and a coiled or braided metal (for example, a structure in which a metal coil or metal braid is embedded in a coating layer made using a medical material).
  • a method for manufacturing the medical device includes molding a mixture containing a block copolymer and a hydrophobic resin, and, if necessary, the other components described above.
  • the mixture can be prepared by mixing the block copolymer and the hydrophobic resin, adding the block copolymer and the hydrophobic resin all at once to a solvent, adding the block copolymer and the hydrophobic resin to a solvent in that order, or adding the hydrophobic resin and the block copolymer to a solvent in that order.
  • the solvent can be appropriately selected depending on the type of block copolymer and hydrophobic resin used.
  • the concentration of the block copolymer in the mixture is 0.1 to 20% by mass, preferably 0.5 to 15% by mass, and more preferably 1 to 10% by mass.
  • the concentration of the hydrophobic resin in the mixture is preferably such that the mixing ratio with the block copolymer falls within the above-mentioned range.
  • molding methods can be used in the same manner or with appropriate modifications. Specific examples include dipping, which involves applying a medical material to a substrate (e.g., a wire) by immersion and then removing the substrate; melt extrusion molding; paste extrusion molding; and spray coating. Molding conditions are also not particularly limited and can be appropriately selected depending on the type and amount of medical material used and the type and size of the medical device.
  • the molding temperature is, for example, greater than 100°C and less than 150°C, preferably greater than 105°C and less than 140°C, and more preferably greater than 105°C and less than 120°C.
  • the molding time is, for example, 30 minutes to 3 hours, preferably 40 minutes to 2 hours, and more preferably 50 minutes to 1.5 hours.
  • the molding operation may be performed once or repeatedly two or more times. In the latter case, it is preferable that the molding temperature during the entire molding operation (all repeated molding operations) is greater than 100°C and less than 150°C, and that the molding time during the entire molding operation is 30 minutes or more and 3 hours or less, each falling within the above range.
  • a manufacturing method for the medical device includes, for example, preparing a coating liquid containing a block copolymer, a hydrophobic resin, and a solvent (preparation step); applying the coating liquid to the substrate layer to form a coating film on the substrate layer (coating step); and heat-treating the coating film at a temperature above 100°C and below 150°C for 30 minutes to 3 hours (heat-treatment step).
  • a drying step drying step
  • a washing step may be performed after the heat-treatment step.
  • the hydrophobic resin is stably retained in the coating layer (covering layer). Furthermore, the epoxy groups of the block copolymer are ring-opened without the need for the addition of an acid or base. Therefore, with the medical material of the present invention, a separate washing step is not required, which is advantageous for mass production.
  • a coating liquid containing a block copolymer, a hydrophobic resin, and a solvent is prepared.
  • a coating liquid containing a block copolymer, a hydrophobic resin, and a solvent may be purchased and used.
  • the coating liquid may be prepared by mixing the block copolymer, the hydrophobic resin, and the solvent.
  • Hydrophobic resins are stable in the coating solution, making them preferable in terms of safety and ease of operation. Furthermore, if the coating solution is kept at room temperature, the ring-opening of the epoxy groups (crosslinking reaction) will not proceed. This makes them easy to work with.
  • the concentration of the block copolymer in the coating solution is 0.1 to 20% by mass, preferably 0.5 to 15% by mass, and more preferably 1 to 10% by mass.
  • the concentration of the hydrophobic resin in the mixture is preferably such that the mixing ratio with the block copolymer falls within the range shown below. If the concentrations of the block copolymer and hydrophobic resin are within the above ranges, the sliding resistance, tensile strength, and tensile elongation of the medical material can be more appropriately controlled.
  • the mixing ratio of the block copolymer and hydrophobic resin when preparing the coating solution is such that the content of the hydrophobic resin is greater than the content of the block copolymer.
  • the hydrophobic resin is mixed with the block copolymer at a ratio of 125 to 300 parts by weight per 100 parts by weight of the block copolymer. It is more preferable to mix the hydrophobic resin with the block copolymer at a ratio of 150 to 230 parts by weight per 100 parts by weight of the block copolymer. It is particularly preferable to mix the hydrophobic resin with the block copolymer at a ratio of 160 to 180 parts by weight per 100 parts by weight of the block copolymer.
  • the sliding resistance, tensile strength, and tensile elongation of the medical material can be more appropriately controlled. Furthermore, a uniform coating layer of the desired thickness can be easily obtained with a single coating, and the viscosity of the solution remains within an appropriate range, which is advantageous in terms of operability (e.g., ease of coating) and production efficiency.
  • the coating liquid is applied onto a substrate layer to form a coating film on the substrate layer.
  • the substrate layer is the same as that described above (medical device).
  • the method for applying (coating) the coating liquid to the surface of the substrate layer is not particularly limited, and conventional methods can be applied, such as application/printing, immersion (dipping, dip coating), spraying, spin coating, mixed solution-impregnated sponge coating, bar coating, die coating, reverse coating, comma coating, gravure coating, and doctor knife. Of these, immersion (dipping, dip coating) methods are preferred.
  • the coating film when forming a coating film (coating layer, covering layer) only on a portion of the substrate layer, the coating film (coating layer, covering layer) can be formed on the desired surface area of the substrate layer by immersing only a portion of the substrate layer in the coating liquid and coating the coating liquid onto that portion of the substrate layer.
  • the surface portions of the substrate layer that do not require the formation of a coating film (coating layer, covering layer) can be protected (coated, etc.) with a suitable removable member or material.
  • the substrate layer is then immersed in the coating liquid to coat the substrate with the coating liquid.
  • the protective member (material) covering the surface portions of the substrate layer that do not require the formation of a coating film (coating layer, covering layer) can be removed, and the coating can be reacted by heating or other means to form a coating film (coating layer, covering layer) on the desired surface portion of the substrate layer.
  • the present invention is not limited to these formation methods, and conventionally known methods can be used to form a coating film (coating layer, covering layer).
  • a coating film coating layer, covering layer
  • other coating methods e.g., applying the coating liquid to a desired surface portion of a medical device using an application device such as a sprayer, bar coater, die coater, reverse coater, comma coater, gravure coater, spray coater, or doctor knife
  • the immersion method is preferably used, as it allows both the outer and inner surfaces to be coated at the same time.
  • the amount of coating liquid to be applied is preferably such that the thickness (dry film thickness) of the resulting coating layer (coating layer) is 0.1 to 300 ⁇ m, more preferably 0.5 to 200 ⁇ m, and even more preferably 1 to 100 ⁇ m.
  • drying process In this step, if necessary, the coating film is dried to remove at least a portion of the solvent.
  • drying conditions there are no particular restrictions on the drying conditions as long as they allow the solvent to be removed, and they can be selected appropriately depending on the type of solvent.
  • the drying temperature is, for example, 10°C to 50°C, preferably 10°C to 30°C, and more preferably 20°C to 25°C.
  • the drying time is, for example, 10 minutes to 5 hours, preferably 20 minutes to 3 hours, and more preferably 30 minutes to 1.5 hours.
  • pressure conditions during drying and drying can be carried out under normal pressure (atmospheric pressure).
  • the coating film formed in the above (applying step) or the coating film dried in the above (drying step) is heat-treated at a temperature above 100°C but below 150°C for 30 minutes to 3 hours.
  • This heat treatment allows for more appropriate control of the sliding resistance, tensile strength, and tensile elongation of the medical device, particularly the sliding resistance.
  • the heat treatment temperature is preferably 105°C or higher and 140°C or lower, more preferably above 105°C but below 120°C.
  • the heat treatment time is preferably 40 minutes to 2 hours, more preferably 50 minutes to 1.5 hours. Under these heat treatment conditions, the medical device can exhibit better lubricity and mechanical properties, and these properties can be well balanced.
  • crosslinking or polymerization in the block copolymer is effectively promoted, forming a strong layer (coat layer, covering layer). Therefore, high lubricity (surface lubricity) can be maintained for a longer period of time. Furthermore, by setting the heat treatment temperature and time below the upper limit values, excessive crosslinking or polymerization can be suppressed. This prevents the layer (coating layer, covering layer) from becoming too hard, thereby maintaining good lubricity (surface lubricity). Another advantage is that even polymer materials that are easily deformed or plasticized by heat can be used as the substrate layer. Therefore, the present invention broadens the range of materials available, enabling the manufacture of medical devices for a variety of applications.
  • the heat treatment step may be performed once or repeatedly performed two or more times. In the latter case, it is preferable that the heat treatment temperature during the entire heat treatment step (all repeated heat treatment steps) is greater than 100°C and less than 150°C, and that the heat treatment time during the entire heat treatment step is 30 minutes or more and 3 hours or less, each within the above range.
  • the heat treatment may be carried out after the drying treatment.
  • the solvent is distilled away and further heat treatment is carried out in a state where the block copolymer and hydrophobic resin are easily brought into contact with each other, thereby further improving the effect of promoting the crosslinking or polymerization of the block copolymer by the hydrophobic resin.
  • the heat treatment can be shortened, even polymer materials that are easily deformed or plasticized by heat can be used as the base layer.
  • the conditions (temperature, time, etc.) for the drying and heating treatments when these are performed are not particularly limited, but from the perspective of efficiently manufacturing medical devices, it is preferable to perform a drying treatment at a temperature of 10°C to 50°C, maintaining it for 10 minutes to 5 hours, followed by a heating treatment at a temperature of 105°C to 140°C, maintaining it for 40 minutes to 2 hours. From the same perspective, it is even more preferable to perform a drying treatment at a temperature of 10°C to 30°C, maintaining it for 20 minutes to 3 hours, followed by a heating treatment at a temperature above 105°C to 120°C, maintaining it for 50 minutes to 1.5 hours. After the above heating treatments, a further drying treatment may be performed.
  • a strong coating layer (covering layer) can be formed on the surface of the substrate layer. Furthermore, depending on the type of substrate layer, a crosslinking reaction can occur via the epoxy groups in the block copolymer in the layer (coating layer, covering layer), forming a high-strength coating layer (covering layer) that does not easily peel off from the substrate layer. Therefore, the drying/heating process described above can effectively suppress or prevent peeling of the coating layer (covering layer) from the substrate layer. Furthermore, there are no particular restrictions on the pressure conditions during the heating process, and the process can be carried out under normal pressure (atmospheric pressure).
  • a heating means for example, an oven can be used.
  • Medical devices are preferably used in devices that come into contact with body fluids, blood, etc., and have a surface that is lubricious in body fluids, physiological saline, and other aqueous liquids, enabling improved operability and reduced damage to tissues and mucous membranes.
  • Specific examples include plastic insertion needles, dilators, sheaths (introducers), catheters, medical tubing, etc. used in blood vessels, but other examples include the following medical devices. That is, in one embodiment of the present invention, the medical device is a plastic insertion needle, dilator, sheath (introducer), catheter, or medical tubing.
  • Catheters that are inserted or left in the digestive tract via the mouth or nose such as gastric catheters, nutritional catheters, and enteral feeding tubes;
  • Catheters that are inserted or placed in the airway or trachea via the mouth or nose such as oxygen catheters, oxygen cannulas, endotracheal tubes and cuffs, tracheostomy tubes and cuffs, and endotracheal suction catheters;
  • Catheters that are inserted or placed in the urethra or ureter such as urethral catheters, urinary catheters, and urethral balloon catheters;
  • Catheters inserted or left in various body cavities, organs, or tissues such as suction catheters, drainage catheters, and rectal catheters;
  • Catheters that are inserted or placed in blood vessels such as indwelling needles (e.g., plastic indwelling needles), IVH catheters, thermodilution catheters, angiography catheter
  • Synthesis Example 1 The following reaction was carried out to produce a block copolymer (1).
  • the block copolymer (1) synthesized in Synthesis Example 1 above was added to and dissolved in the solution (1) so that the final concentration in the coating solution was 5.0 mass% to prepare coating solution (1).
  • the sliding resistance (gf), tensile strength (MPa), and tensile elongation (%) of the tube (1) obtained above were measured according to the methods below. As a result, the sliding resistance, tensile strength, and tensile elongation of the tube (1) were 11.6 gf, 26.5 MPa, and 120%, respectively.
  • test specimens inner diameter: 1.775 mm, outer diameter: 1.950 mm.
  • Each test specimen was immersed in tap water and set in a pinch tester (OAKRIVER TECHNOLOGY, DL1000), and slid 100 times at a grip force of 500 gf, a test speed of 8.3 mm/s, and a test stroke of 25 mm (grip pad material: silicone, grip pad height: 12.35 mm).
  • the sliding resistance (gf) after 100 slides was measured to evaluate the sliding properties. The lower the sliding resistance, the better the sliding properties were judged to be.
  • a tetrafluoroethylene-hexafluoropropylene copolymer (FEP) wire (diameter: 1.775 mm) was dip-coated with the coating liquid (2) prepared above at a speed of 10 mm/sec, and then heated at 110°C for 1 hour to carry out a crosslinking reaction. After heating, the temperature was returned to room temperature (25°C), and the FEP wire was removed to obtain a tube (2) (inner diameter: 1.775 mm, outer diameter: 1.950 mm, cross-sectional area: 0.512 mm2 ).
  • FEP tetrafluoroethylene-hexafluoropropylene copolymer
  • the sliding resistance (gf), tensile strength (MPa), and tensile elongation (%) of the tube (2) obtained above were measured using the same methods as in Example 1. As a result, the sliding resistance, tensile strength, and tensile elongation of the tube (2) were 18.3 gf, 8.4 MPa, and 430%, respectively.
  • a tetrafluoroethylene-hexafluoropropylene copolymer (FEP) wire (diameter: 1.775 mm) was dip-coated with the coating solution (3) prepared above at a speed of 10 mm/sec, and then heated at 110°C for 1 hour to carry out a crosslinking reaction. After heating, the temperature was returned to room temperature (25°C), and the FEP wire was removed to obtain a tube (3) (inner diameter: 1.775 mm, outer diameter: 1.950 mm, cross-sectional area: 0.512 mm2 ).
  • FEP tetrafluoroethylene-hexafluoropropylene copolymer
  • the sliding resistance (gf), tensile strength (MPa), and tensile elongation (%) of the tube (3) obtained above were measured using the same methods as in Example 1. As a result, the sliding resistance, tensile strength, and tensile elongation of the tube (3) were 26.1 gf, 8.0 MPa or more, and 80% or more, respectively.
  • the sliding resistance (gf), tensile strength (MPa), and tensile elongation (%) of the tube (4) obtained above were measured using the same methods as in Example 1. As a result, the sliding resistance, tensile strength, and tensile elongation of the tube (4) were 657.4 gf, 46.5 MPa, and 60%, respectively.
  • Comparative Example 2 A polytetrafluoroethylene (PTFE) tube (manufactured by Chukoh Chemical Industry Co., Ltd., model number: TUF-100, outer diameter: 3 mm, inner diameter: 2 mm, cross-sectional area: 3.93 mm 2 ) (5) (inner diameter: 1.775 mm, outer diameter: 1.950 mm, cross-sectional area: 0.512 mm 2 ) was prepared.
  • PTFE polytetrafluoroethylene
  • the sliding resistance (gf), tensile strength (MPa), and tensile elongation (%) of the tube (5) obtained above were measured using the same methods as in Example 1. As a result, the sliding resistance, tensile strength, and tensile elongation of the tube (5) were 353.7 gf, 27.5 MPa, and 300%, respectively.
  • Comparative Example 3 A polyurethane elastomer (trade name: Pellethane 2363-80AE, manufactured by Lubrizol) (TPU) was dissolved in N,N-dimethylformamide (DMF) so that the final concentration in the coating solution was 8.0% by mass (solution (4)).
  • TPU polyurethane elastomer
  • DMF N,N-dimethylformamide
  • a tetrafluoroethylene-hexafluoropropylene copolymer (FEP) wire (diameter: 1.775 mm) was dip-coated with the coating liquid (4) prepared above at a speed of 10 mm/sec, and then heated at 110°C for 1 hour. After heating, the temperature was returned to room temperature (25°C), and the FEP wire was removed to obtain a polyurethane elastomer (TPU) tube (6) (inner diameter: 1.775 mm, outer diameter: 1.950 mm, cross-sectional area: 0.512 mm2 ).
  • TPU polyurethane elastomer
  • the sliding resistance (gf), tensile strength (MPa), and tensile elongation (%) of the tube (6) obtained above were measured using the same methods as in Example 1. As a result, the sliding resistance, tensile strength, and tensile elongation of the tube (6) were 750.0 gf, 12.5 MPa, and 470%, respectively.
  • tube (1) in Example 1 has a tensile strength similar to that of the PTFE tube (tube (5)).
  • tube (2) in Example 2 has a higher tensile elongation than the PTFE tube (tube (5)).

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Abstract

L'invention concerne un matériau médical ayant des propriétés mécaniques comparables à celles du polytétrafluoroéthylène (PTFE) et ayant une glissance (capacité de glissement) supérieure à celle du PTFE.　Un matériau médical selon la présente invention comprend : un copolymère séquencé ayant un motif structural (A) dérivé d'un monomère réactif ayant un groupe époxy et un motif structural (B) dérivé d'un monomère hydrophile ; et au moins une résine hydrophobe choisie dans le groupe constitué par les résines de polychlorure de vinyle et les élastomères de polyuréthane. Le matériau médical contient la résine hydrophobe en une quantité supérieure à la quantité du copolymère séquencé, présente une résistance au glissement inférieure ou égale à 50 gf, et a une résistance à la traction de 8,0 MPa ou plus et/ou un allongement à la traction supérieur à 80 %.
PCT/JP2025/001096 2024-01-23 2025-01-16 Matériau médical, son procédé de production et outil médical Pending WO2025158984A1 (fr)

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006067943A1 (fr) * 2004-12-02 2006-06-29 Kaneka Corporation Composition de résine pour tubes et tubes
WO2014162872A1 (fr) * 2013-04-01 2014-10-09 テルモ株式会社 Dispositif médical et procédé de fabrication d'un dispositif médical
JP2015057081A (ja) * 2012-01-13 2015-03-26 テルモ株式会社 潤滑コート剤および当該潤滑コート剤で被覆されてなる医療デバイス
JP2016150163A (ja) * 2015-02-18 2016-08-22 テルモ株式会社 医療用具の製造方法
JP2020028640A (ja) * 2018-08-24 2020-02-27 テルモ株式会社 医療用具の製造方法および医療用具
JP2020028639A (ja) * 2018-08-24 2020-02-27 テルモ株式会社 医療用具の製造方法および医療用具
WO2024190656A1 (fr) * 2023-03-10 2024-09-19 テルモ株式会社 Outil médical et procédé de fabrication d'outil médical

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006067943A1 (fr) * 2004-12-02 2006-06-29 Kaneka Corporation Composition de résine pour tubes et tubes
JP2015057081A (ja) * 2012-01-13 2015-03-26 テルモ株式会社 潤滑コート剤および当該潤滑コート剤で被覆されてなる医療デバイス
WO2014162872A1 (fr) * 2013-04-01 2014-10-09 テルモ株式会社 Dispositif médical et procédé de fabrication d'un dispositif médical
JP2016150163A (ja) * 2015-02-18 2016-08-22 テルモ株式会社 医療用具の製造方法
JP2020028640A (ja) * 2018-08-24 2020-02-27 テルモ株式会社 医療用具の製造方法および医療用具
JP2020028639A (ja) * 2018-08-24 2020-02-27 テルモ株式会社 医療用具の製造方法および医療用具
WO2024190656A1 (fr) * 2023-03-10 2024-09-19 テルモ株式会社 Outil médical et procédé de fabrication d'outil médical

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