WO2018169054A1 - Cathéter à ballonnet, son procédé de production et procédé de traitement - Google Patents

Cathéter à ballonnet, son procédé de production et procédé de traitement Download PDF

Info

Publication number
WO2018169054A1
WO2018169054A1 PCT/JP2018/010473 JP2018010473W WO2018169054A1 WO 2018169054 A1 WO2018169054 A1 WO 2018169054A1 JP 2018010473 W JP2018010473 W JP 2018010473W WO 2018169054 A1 WO2018169054 A1 WO 2018169054A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
drug
metal layer
balloon catheter
crystal
Prior art date
Application number
PCT/JP2018/010473
Other languages
English (en)
Japanese (ja)
Inventor
村田悠
黒崎靖夫
後藤博
Original Assignee
テルモ株式会社
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 テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2019506300A priority Critical patent/JP7073339B2/ja
Publication of WO2018169054A1 publication Critical patent/WO2018169054A1/fr

Links

Images

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
    • A61L29/08—Materials for coatings
    • A61L29/10—Inorganic 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
    • A61L29/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • 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
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention relates to a balloon catheter in which a crystalline drug is provided on the outer surface of the balloon, a manufacturing method thereof, and a treatment method.
  • the balloon catheter has been used to improve a lesion (stenosis) occurring in a living body lumen.
  • the balloon catheter usually includes a long shaft portion and a balloon that is provided on the distal end side of the shaft portion and is expandable in the radial direction. By expanding the deflated balloon after reaching a target location in the body via a thin living body lumen, the lesioned part can be expanded.
  • a drug eluting balloon in which a drug for suppressing stenosis is coated on the outer surface of the balloon is used.
  • the drug coated on the outer surface is instantaneously released to the lesioned part, thereby preventing restenosis.
  • the morphological form of the drug coated on the outer surface of the balloon affects the drug release from the balloon surface and the tissue transferability at the lesion.
  • the form of the drug coated on the outer surface of the balloon can be adjusted by changing the conditions for volatilizing the solvent after applying a coating liquid containing the drug and the solvent to the outer surface of the balloon.
  • Patent Document 1 describes a balloon catheter in which an adhesive additive such as a polymer is included in a layer containing a therapeutic agent on the balloon to improve the adhesiveness of the drug.
  • the layer containing the drug and the adhesive additive is located in the outermost layer of the balloon. For this reason, even if it contains an adhesive additive, there is a limit to the effect of suppressing the dropout of the drug.
  • proteins and the like are likely to adhere to the outer surface of the balloon within the blood vessel. When protein or the like adheres to the outer surface of the balloon, the transfer of the drug to the living tissue at the target position may be inhibited.
  • the present invention has been made to solve the above-described problems, and can effectively prevent the drug from dropping from the outer surface of the balloon, can be easily transported in a living body lumen, and can be transferred to a living tissue. It is an object of the present invention to provide a balloon catheter with improved drug transferability, a method for producing the same, and a treatment method.
  • a balloon catheter that achieves the above-mentioned object is a balloon catheter that can be inserted into a living body lumen, and is a long catheter body, a balloon that is provided on the distal side of the catheter body and is expandable in the radial direction, A coating layer containing a drug disposed on the outer surface of the balloon; and a metal layer deposited on the outer surface of the coating layer without being deposited on the outer surface of the balloon.
  • the metal layer is deposited on the outer surface of the coating layer containing the drug. Therefore, when the balloon is delivered to the target position in the living body, the drug falls off the metal layer. Can be suppressed. Further, the surfaces of the balloon and the coat layer are easily slipped by the metal layer, and the conveyance within the blood vessel is facilitated. In addition, proteins or the like hardly adhere to the surface of the coat layer in the living body, and the drug transfer property to the living tissue at the target position is improved.
  • the material of the metal layer may contain at least one selected from the group consisting of gold, platinum, chromium, zinc, nickel, silver, and copper. Thereby, even if the metal layer falls off in the living body, safety to the living body can be maintained.
  • the metal layer may partially cover the outer surface of the coat layer.
  • the drug may be rapamycin, paclitaxel, docetaxel, or everolimus.
  • a method of manufacturing a balloon catheter that achieves the above object is a method of manufacturing a balloon catheter in which a coating layer containing a drug is formed on the outer surface of the balloon, wherein the coating layer including the drug is formed on the outer surface of the balloon. And depositing a metal on the outer surface of the coat layer to form a metal layer.
  • the metal is deposited on the outer surface of the coating layer containing the drug. Therefore, when the balloon is delivered to the target position in the living body, the drug is dropped. Can be suppressed. Moreover, the surface of the balloon is easily slipped by the metal layer, which facilitates transportation within the blood vessel. In addition, protein or the like hardly adheres to the surface of the balloon in the living body, and the transferability of the drug to the living tissue at the target position is improved.
  • the material of the metal layer may contain at least one selected from the group consisting of gold, platinum, chromium, zinc, nickel, silver, and copper. Thereby, even if the metal layer falls off in the living body, safety to the living body can be maintained.
  • the metal layer may be partially formed on the outer surface of the coat layer.
  • medical agent differs can be arbitrarily formed in the outer surface of a balloon.
  • a treatment method for achieving the above object is a treatment method for delivering a drug to a lesion in a living body lumen using the balloon catheter, wherein the balloon is inserted into the living body lumen to reach the lesion.
  • the treatment method configured as described above uses a balloon catheter in which a metal layer is deposited on the outer surface of a coating layer containing a drug, the drug drops off when the balloon is delivered to a target position in vivo. This can be suppressed by the metal layer. Moreover, the surface of the balloon is easily slipped by the metal layer, which facilitates transportation within the blood vessel. In addition, protein or the like hardly adheres to the surface of the balloon in the living body, and the transferability of the drug to the living tissue at the target position is improved.
  • the balloon catheter 10 is a drug-eluting catheter in which drug crystals are provided on the outer surface of the balloon 30 as shown in FIGS.
  • the side of the balloon catheter 10 to be inserted into the living body lumen is referred to as “tip” or “tip side”
  • the proximal side for operation is referred to as “base end” or “base end side”.
  • the balloon catheter 10 includes a long catheter body 20, a balloon 30 provided at the distal end portion of the catheter body 20, a coat layer 40 containing a drug provided on the outer surface of the balloon 30, and an outer surface of the coat layer 40. And a hub 26 fixed to the proximal end of the catheter body 20.
  • the catheter body 20 includes an outer tube 21 that is a tube having an open front end and a proximal end, and an inner tube 22 that is a tube disposed inside the outer tube 21.
  • the inner tube 22 is housed in the hollow interior of the outer tube 21, and the catheter body 20 has a double tube structure at the distal end.
  • the hollow interior of the inner tube 22 is a guide wire lumen 24 through which the guide wire is inserted.
  • an expansion lumen 23 through which the expansion fluid of the balloon 30 flows is formed inside the hollow of the outer tube 21 and outside the inner tube 22.
  • the inner tube 22 opens to the outside at the opening 25.
  • the inner tube 22 protrudes further to the distal end side than the distal end of the outer tube 21.
  • the balloon 30 has a proximal end portion fixed to the distal end portion of the outer tube 21 and a distal end portion fixed to the distal end portion of the inner tube 22. Thereby, the inside of the balloon 30 communicates with the expansion lumen 23.
  • the balloon 30 can be expanded by injecting an expansion fluid into the balloon 30 through the expansion lumen 23.
  • the expansion fluid may be a gas or a liquid.
  • a gas such as helium gas, CO 2 gas, O 2 gas, N 2 gas, Ar gas, air, mixed gas, or a liquid such as physiological saline or contrast medium is used. Can do.
  • a cylindrical straight portion 31 (expanded portion) having the same outer diameter when expanded is formed in the central portion of the balloon 30 in the axial direction, and the outer diameter gradually increases on both sides of the straight portion 31 in the axial direction.
  • a taper portion 33 that changes to is formed.
  • medical agent is formed in the whole outer surface of the straight part 31.
  • FIG. The range in which the coating layer 40 is formed in the balloon 30 is not limited to the straight portion 31, and may include at least a part of the tapered portion 33 in addition to the straight portion 31, or one of the straight portions 31. It may be only part.
  • the hub 26 is formed with a base end opening portion 27 that functions as a port that communicates with the expansion lumen 23 of the outer tube 21 and allows the expansion fluid to flow in and out.
  • the length of the balloon 30 in the axial direction is not particularly limited, but is preferably 5 to 500 mm, more preferably 10 to 300 mm, and still more preferably 20 to 200 mm.
  • the outer diameter of the balloon 30 at the time of expansion is not particularly limited, but is preferably 1 to 10 mm, more preferably 2 to 8 mm.
  • the outer surface of the balloon 30 before the coating layer 40 is formed is smooth and non-porous.
  • the outer surface of the balloon 30 before the coat layer 40 is formed may have minute holes that do not penetrate the membrane.
  • the outer surface of the balloon 30 before the coating layer 40 is formed may have both a smooth and non-porous range and a range with minute holes that do not penetrate the membrane.
  • the size of the minute holes is, for example, 0.1 to 5 ⁇ m in diameter and 0.1 to 10 ⁇ m in depth, and may have one or a plurality of holes for one crystal.
  • the size of the minute holes is, for example, a diameter of 5 to 500 ⁇ m and a depth of 0.1 to 50 ⁇ m, and one hole or a plurality of crystals may be included for one hole.
  • the balloon 30 has a certain degree of flexibility so that it can be expanded when it reaches a blood vessel, tissue, etc., and has a certain degree of hardness so that the drug can be released from the coat layer 40 on its outer surface.
  • the balloon 30 is made of metal or resin, but at least the outer surface of the balloon 30 on which the coat layer 40 is provided is preferably made of resin.
  • the constituent material of at least the outer surface of the balloon 30 is, for example, a polyolefin such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these, soft poly
  • a thermoplastic resin such as vinyl chloride resin, polyamide, polyamide elastomer, nylon elastomer, polyester, polyester elastomer, polyurethane, fluororesin, silicone rubber, latex rubber, or the like can be used.
  • polyamides are preferable. That is, at least a part of the outer surface of the balloon 30 that coats the drug is a polyamide.
  • the polyamide is not particularly limited as long as it is a polymer having an amide bond.
  • polytetramethylene adipamide nylon 46
  • polycaprolactam nylon 6
  • polyhexamethylene adipamide nylon 66
  • Homopolymers such as polyhexamethylene sebacamide (nylon 610), polyhexamethylene dodecamide (nylon 612), polyundecanolactam (nylon 11), polydodecanolactam (nylon 12), caprolactam / lauryl lactam copolymer Polymer (nylon 6/12), caprolactam / aminoundecanoic acid copolymer (nylon 6/11), caprolactam / ⁇ -aminononanoic acid copolymer (nylon 6/9), caprolactam / hexamethylene diammonium adipate copolymer ( Nylon 6/66 Copolymers such as a copolymer of adipic acid and meta-x
  • a polyamide elastomer which is a block copolymer having nylon 6, nylon 66, nylon 11, nylon 12 or the like as a hard segment and polyalkylene glycol, polyether, aliphatic polyester or the like as a soft segment is also a material of the balloon 30.
  • the said polyamides may be used individually by 1 type, and may use 2 or more types together.
  • the balloon 30 preferably has a smooth surface of polyamide.
  • the balloon 30 has a coat layer 40 formed on the outer surface thereof, and a metal layer 37 is formed on the outer side by vapor deposition of a metal material.
  • the coat layer 40 includes an additive 41 (excipient) containing a water-soluble low-molecular compound disposed in a layered manner on the outer surface of the balloon 30, and a water-insoluble drug crystal 42 extending with an independent long axis. And have.
  • the end of drug crystal 42 may be in direct contact with the outer surface of balloon 30, but additive 41 is present between the end of drug crystal 42 and the outer surface of balloon 30 without direct contact. May be.
  • the end portion of the drug crystal 42 may be positioned on the surface of the layer of the additive 41, and the drug crystal 42 may protrude from the additive 41.
  • the plurality of drug crystals 42 may be regularly arranged on the outer surface of the balloon 30. Alternatively, the plurality of drug crystals 42 may be irregularly arranged on the outer surface of the balloon 30.
  • the amount of the drug contained in the coat layer 40 is not particularly limited, but is 0.1 ⁇ g / mm 2 to 10 ⁇ g / mm 2 , preferably 0.5 ⁇ g / mm 2 to 5 ⁇ g / mm 2 , more preferably 0.5 ⁇ g. / Mm 2 to 3.5 ⁇ g / mm 2 , more preferably 1.0 ⁇ g / mm 2 to 3 ⁇ g / mm 2 .
  • the amount of crystals of the coat layer 40 is not particularly limited, but is preferably 5 to 500,000 [crystal / (10 ⁇ m 2 )] (number of crystals per 10 ⁇ m 2 ), more preferably 50 to 50,000 [crystal / (10 ⁇ m 2 )], more preferably 500 to 5,000 [crystal / (10 ⁇ m 2 )].
  • the drug crystal 42 may have a form having independent long axes. Further, the drug crystal 42 may be other morphological types.
  • the plurality of drug crystals 42 may be present in a state where they are combined, or may be present in contact with each other with a plurality of adjacent drug crystals 42 forming different angles.
  • the plurality of drug crystals 42 may be positioned on the balloon surface with a space (a space not including a crystal). There may be both a plurality of drug crystals 42 in a combined state and a plurality of drug crystals 42 independent from each other on the surface of the balloon 30.
  • the plurality of drug crystals 42 may be arranged in a brush shape around the circumference having different major axis directions.
  • Each of the drug crystals 42 exists independently, has a certain length, and one end (base end) of the length portion is fixed to the additive 41 or the balloon 30.
  • the drug crystal 42 does not form a complex structure with the adjacent drug crystal 42 and is not connected.
  • the major axis of the crystal is almost linear.
  • the drug crystal 42 forms a predetermined angle with respect to the surface with which the base portion where the major axes intersect is in contact.
  • the drug crystals 42 stand independently without contacting each other.
  • the base of the drug crystal 42 may be in contact with another base on the balloon 30.
  • the base of the drug crystal 42 may be independent on the balloon 30 without contacting the other base.
  • the drug crystal 42 may be hollow or solid. Both a hollow drug crystal 42 and a solid drug crystal 42 may be present on the surface of the balloon 30. When the drug crystal 42 is hollow, at least the vicinity of its tip is hollow.
  • the cross section of the drug crystal 42 in a plane perpendicular to the major axis of the drug crystal 42 (perpendicular) has a hollow.
  • the drug crystal 42 having the hollow has a polygonal cross section of the drug crystal 42 in a plane perpendicular (perpendicular) to the long axis.
  • the polygon is, for example, a triangle, a tetragon, a pentagon, or a hexagon.
  • the drug crystal 42 has a distal end (or distal end surface) and a proximal end (or proximal end surface), and a side surface between the distal end (or distal end surface) and the proximal end (or proximal end surface) is a plurality of substantially flat surfaces. It is formed as a configured long polyhedron.
  • This crystal form type (hollow elongated body crystal form type) constitutes the whole or at least a part of a certain plane on the surface in contact with the base.
  • the length in the major axis direction of the drug crystal 42 having a major axis is preferably 5 ⁇ m to 20 ⁇ m, more preferably 9 ⁇ m to 11 ⁇ m, and even more preferably around 10 ⁇ m.
  • the diameter of the drug crystal 42 having a long axis is preferably 0.01 ⁇ m to 5 ⁇ m, more preferably 0.05 ⁇ m to 4 ⁇ m, and even more preferably 0.1 ⁇ m to 3 ⁇ m.
  • a combination having a diameter of 0.01 to 5 ⁇ m when the length is 5 ⁇ m to 20 ⁇ m, and a combination when the length is 5 to 20 ⁇ m examples include combinations having a diameter of 0.05 to 4 ⁇ m, and combinations having a diameter of 0.1 to 3 ⁇ m when the length is 5 to 20 ⁇ m.
  • the drug crystal 42 having the long axis is linear in the long axis direction, but may be curved. Both the linear drug crystal 42 and the curved drug crystal 42 may exist on the surface of the balloon 30.
  • the above-mentioned crystal form type having a crystal having a long axis is 50% by volume or more, more preferably 70% by volume or more with respect to the entire drug crystal on the outer surface of the balloon 30.
  • the drug crystal 42 which is a crystal particle having a long axis, is formed so as to stand on the outer surface of the balloon 30 or the additive 41.
  • the additive 41 is present in the region where the drug crystal 42 is present, and may not be present in the region where the drug crystal 42 is absent.
  • the additive 41 is distributed and present in the space between the plurality of drug crystals 42 in the forest.
  • the proportion of the substance constituting the coat layer 40 is preferably such that the water-insoluble drug crystal 42 occupies a larger volume than the additive 41.
  • the additive 41 does not form a matrix.
  • the matrix is a layer in which a relatively high-molecular substance (polymer or the like) is continuously formed, forms a network-like three-dimensional structure, and has a fine space therein. Therefore, the water-insoluble drug constituting the crystal is not attached to the matrix material.
  • the water-insoluble drug constituting the crystal is not embedded in the matrix material.
  • the additive 41 may form a matrix.
  • the additive 41 is coated on the outer surface of the balloon 30 while being dissolved in a solvent, and then dried to form a layer.
  • the additive 41 is amorphous.
  • the additive 41 may be crystal particles.
  • Additive 41 may be present as a mixture of amorphous and crystalline particles.
  • the additive 41 in FIG. 3 is in the state of crystal grains and / or particulate amorphous. Alternatively, the additive 41 may be in a film-like amorphous state.
  • the additive 41 is formed as a layer containing a water-insoluble drug. Alternatively, the additive 41 may be formed as an independent layer that does not contain a water-insoluble drug.
  • the thickness of the additive 41 is 0.1 to 5 ⁇ m, preferably 0.3 to 3 ⁇ m, more preferably 0.5 to 2 ⁇ m.
  • the layer containing the drug crystal 42 of a long crystal form type has low toxicity and high stenosis-inhibiting effect when delivered into the body.
  • a water-insoluble drug containing a hollow long crystalline form is effective because it has good permeability to the tissue and good solubility because one unit of the crystal becomes small when the drug moves into the tissue. It can act to suppress stenosis.
  • toxicity is low because the drug hardly remains in the tissue as a large mass.
  • the layer containing the drug crystal 42 having a long crystal form type has a small crystal size (length in the long axis direction) that moves to the tissue of about 10 ⁇ m. Therefore, it acts uniformly on the affected part of the lesion and increases tissue permeability. Furthermore, since the size of the transferred drug crystal 42 is small, an excessive amount of drug does not stay in the affected area for an excessive period of time, so that it is possible to exhibit a high stenosis suppressing effect without developing toxicity. Think.
  • the drug coated on the outer surface of the balloon 30 may include an amorphous type.
  • the drug crystal 42 and the amorphous may be arranged so as to have regularity in the coat layer 40. Alternatively, crystals and amorphous materials may be arranged irregularly.
  • the metal layer 37 is deposited on the outer surface of the coating layer 40 described above. Since the metal layer 37 is very thin with respect to the thickness of the balloon 30, the flexibility of the balloon 30 is not hindered. In addition, since the coat layer 40 has the drug crystal 42 having the long axis, a part of the drug crystal 42 may protrude through the metal layer 37. In addition, the metal layer 37 may cover the surface of the protruding drug crystal 42 itself. The metal layer 37 suppresses the drug from falling off when delivering the balloon 30 to a target position in the living body. In addition, the metal layer 37 facilitates the transportation of the balloon 30 in the blood vessel in order to smooth the surface of the balloon 30. Moreover, the metal layer 37 suppresses that protein etc. adhere to the surface of the coat layer 40 in the living body. For this reason, the metal layer 37 improves the drug transferability to the living tissue at the target position.
  • the constituent material of the metal layer 37 is a metal material that can be removed in vivo, for example, gold (Au), platinum (Pt), chromium (Cr), zinc (Zn), nickel (Ni), silver ( Ag), copper (Cu), and an alloy containing at least one of these.
  • the metal layer 37 may or may not have conductivity.
  • the thickness of the metal layer 37 is not particularly limited as long as it can be formed by vapor deposition and does not hinder the flexibility of the balloon 30, but is, for example, 0.1 to 500 nm, preferably 0.1 to 100 nm, more preferably 0.1 to 50 nm.
  • the protective sheath 15 is a member that suppresses the drug from falling off the balloon 30 and is removed before the balloon catheter 10 is used.
  • the protective sheath 15 is made of a flexible material, for example, a polyolefin such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these, soft A thermoplastic resin such as polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, fluororesin, silicone rubber, latex rubber, or the like can be used.
  • the manufacturing apparatus 50 of the balloon catheter 10 can form the coat layer 40 and the metal layer 37 on the balloon 30.
  • the manufacturing apparatus 50 includes a rotation mechanism 60 that rotates the balloon catheter 10 and a support base 70 that supports the balloon catheter 10.
  • the manufacturing apparatus 50 further includes a coating liquid supply unit 90 provided with a dispensing tube 94 that applies the coating liquid 45 to the outer surface of the balloon 30, a moving mechanism unit 80 that moves the dispensing tube 94 relative to the balloon 30, and Have
  • the manufacturing apparatus 50 further includes a vapor deposition apparatus 120 that deposits metal on the outer surface of the coat layer 40 to form the metal layer 37, and a control unit 100 that controls each part of the manufacturing apparatus 50.
  • the rotation mechanism unit 60 holds the hub 26 of the balloon catheter 10 and rotates the balloon catheter 10 about the axis of the balloon 30 by a built-in driving source such as a motor.
  • a built-in driving source such as a motor.
  • the core material 61 is inserted and held in the guide wire lumen 24, and the core material 61 prevents the coating liquid 45 from flowing into the guide wire lumen 24.
  • a three-way cock that can open and close the flow path is connected to the proximal end opening 27 of the hub 26 in order to control the flow of fluid to the expansion lumen 23.
  • the support base 70 includes a tubular proximal end support portion 71 that accommodates the catheter main body 20 in a rotatable manner, and a distal end side support portion 72 that rotatably supports the core member 61. Note that the distal end side support portion 72 may rotatably support the distal end portion of the catheter body 20 instead of the core member 61 if possible.
  • the moving mechanism unit 80 includes a moving table 81 that can move linearly in a direction parallel to the axis of the balloon 30 and a tube fixing unit 83 to which the dispensing tube 94 is fixed.
  • the moving table 81 can move linearly by a driving source such as a built-in motor. As the moving table 81 moves, the dispensing tube 94 linearly moves in a direction parallel to the axis of the balloon 30.
  • the moving table 81 has a coating liquid supply unit 90 mounted thereon, and linearly moves the coating liquid supply unit 90 in both directions along the axis.
  • the coating liquid supply unit 90 is a part that applies the coating liquid 45 to the outer surface of the balloon 30.
  • the coating liquid supply unit 90 includes a container 92 that stores the coating liquid 45, a liquid feeding pump 93 that feeds the coating liquid 45 in an arbitrary liquid feeding amount, and a dispensing tube 94 that applies the coating liquid 45 to the balloon 30. It has.
  • the liquid feed pump 93 is, for example, a syringe pump, and is controlled by the control unit 100 to suck the coating liquid 45 from the container 92 through the suction tube 91 and to the dispensing tube 94 through the supply tube 96. Can be supplied at an arbitrary liquid feeding amount.
  • the liquid feed pump 93 is installed on the moving table 81 and can move linearly by the movement of the moving table 81.
  • the liquid feed pump 93 is not limited to a syringe pump as long as the coating liquid 45 can be fed, and may be a tube pump, for example.
  • the dispensing tube 94 communicates with the supply tube 96 and discharges the coating liquid 45 supplied from the liquid feed pump 93 through the supply tube 96 to the outer surface of the balloon 30.
  • the dispensing tube 94 is a flexible tubular member.
  • the dispensing tube 94 has an upper end fixed to the tube fixing portion 83, extends vertically downward from the tube fixing portion 83, and has an opening 95 at the discharge end 97 that is the lower end.
  • the dispensing tube 94 can move linearly in both directions along the axial direction of the balloon catheter 10 together with the liquid feed pump 93 installed on the moving table 81 by moving the moving table 81.
  • the dispensing tube 94 can supply the coating liquid 45 to the balloon 30 in a state where the dispensing tube 94 is pressed against the balloon 30 and is bent.
  • the dispensing tube 94 may not be a circular tube as long as the coating liquid 45 can be supplied.
  • the dispensing tube 94 may not extend in the vertical direction as long as the coating liquid 45 can be discharged from the opening 95. Further, the dispensing tube 94 may supply the coating liquid 45 to the balloon 30 at a position away from the outer surface of the balloon 30.
  • the dispensing tube 94 is preferably made of a flexible material so as to reduce the contact load on the balloon 30 and absorb the change in the contact position accompanying the rotation of the balloon 30 by bending.
  • the constituent material of the dispensing tube 94 is, for example, polyolefin such as polyethylene and polypropylene, cyclic polyolefin, polyester, polyamide, polyurethane, PTFE (polytetrafluoroethylene), ETFE (tetrafluoroethylene / ethylene copolymer), PFA (tetra Fluororesin such as fluoroethylene / perfluoroalkyl vinyl ether copolymer) or FEP (tetrafluoroethylene / hexafluoropropylene copolymer) can be applied, but if it is flexible and deformable There is no particular limitation.
  • the outer diameter of the dispensing tube 94 is not particularly limited, but is, for example, 0.1 mm to 5.0 mm, preferably 0.15 mm to 3.0 mm, and more preferably 0.3 mm to 2.5 mm.
  • the inner diameter of the dispensing tube 94 is not particularly limited, but is, for example, 0.05 mm to 3.0 mm, preferably 0.1 mm to 2.0 mm, and more preferably 0.15 mm to 1.5 mm.
  • the length of the dispensing tube 94 is not particularly limited, but is preferably within 5 times the balloon diameter, for example, 1.0 mm to 50 mm, preferably 3 mm to 40 mm, more preferably 5 mm to 35 mm. .
  • the vapor deposition apparatus 120 is an apparatus that forms a metal layer 37 by vapor-depositing metal on the outer surface of the coat layer 40.
  • the vapor deposition apparatus 120 can use a well-known thing.
  • the vapor deposition apparatus 120 is a vacuum vapor deposition apparatus, for example.
  • the control unit 100 is configured by a computer, for example, and comprehensively controls the rotation mechanism unit 60, the movement mechanism unit 80, and the coating liquid supply unit 90. Therefore, the control unit 100 can comprehensively control the rotation speed of the balloon 30, the moving speed of the dispensing tube 94 in the axial direction relative to the balloon 30, the medicine discharge speed from the dispensing tube 94, and the like.
  • the coating liquid 45 supplied to the balloon 30 by the dispensing tube 94 is a solution or suspension containing the constituent material of the coat layer 40, and contains a water-insoluble drug, an additive, and a solvent. After the coating liquid 45 is supplied to the outer surface of the balloon 30, the solvent is volatilized, so that the coating layer having the water-insoluble drug crystals 42 extending on the outer surface of the balloon 30 with independent long axes. 40 is formed.
  • the viscosity of the coating liquid 45 is 0.2 to 500 cP, preferably 0.2 to 50 cP, more preferably 0.2 to 10 cP.
  • Water-insoluble drug means a drug that is insoluble or sparingly soluble in water. Specifically, the solubility in water is less than 5 mg / mL at pH 5-8. Its solubility may be less than 1 mg / mL and even less than 0.1 mg / mL. Water-insoluble drugs include fat-soluble drugs.
  • examples of some preferred water-insoluble drugs include immunosuppressants, such as cyclosporines including cyclosporine, immunoactive agents such as rapamycin, anticancer agents such as paclitaxel, antiviral or antibacterial agents, anti-neoplastic agents, Analgesics and anti-inflammatory agents, antibiotics, antiepileptics, anxiolytics, antiparalytic agents, antagonists, neuron blocking agents, anticholinergics and cholinergic agents, antimuscarinic and muscarinic agents, antiadrenergic agents, Contains antiarrhythmic, antihypertensive, hormonal and nutritional agents.
  • immunosuppressants such as cyclosporines including cyclosporine, immunoactive agents such as rapamycin, anticancer agents such as paclitaxel, antiviral or antibacterial agents, anti-neoplastic agents, Analgesics and anti-inflammatory agents, antibiotics, antiepileptics, anxiolytics, antiparalytic agents, antagonist
  • Water-insoluble drugs are preferably paclitaxel and paclitaxel derivatives, taxanes, docetaxel and rapamycin and rapamycin derivatives, such as biolimus A9, pimecrolimus, everolimus, zotarolimus, tacrolimus, fasudil and epothilone, paclitaxel and rapamycin, especially docetaxel, and evelimel.
  • rapamycin, paclitaxel, docetaxel, and everolimus include analogs and / or derivatives thereof as long as they have similar medicinal effects.
  • paclitaxel and docetaxel are in an analog relationship.
  • Rapamycin and everolimus are in a derivative relationship. Of these, paclitaxel is more preferred.
  • Additive 41 includes a water-soluble low molecular weight compound.
  • the molecular weight of the water-soluble low molecular weight compound is 50 to 2000, preferably 50 to 1000, more preferably 50 to 500, and further preferably 50 to 200.
  • the water-soluble low molecular weight compound is preferably 5 to 10,000 parts by weight, more preferably 5 to 200 parts by weight, and still more preferably 8 to 150 parts by weight with respect to 100 parts by weight of the water-insoluble drug.
  • the constituent materials of water-soluble low molecular weight compounds are serine ethyl ester, citrate ester, polysorbate, water-soluble polymer, sugar, contrast agent, amino acid ester, glycerol ester of short-chain monocarboxylic acid, pharmaceutically acceptable salt and interface An activator or the like, or a mixture of two or more of these can be used.
  • the water-soluble low molecular weight compound has a hydrophilic group and a hydrophobic group and is characterized by being dissolved in water.
  • the water-soluble low molecular weight compound is preferably non-swellable or hardly swellable.
  • the additive 41 is preferably amorphous (amorphous) on the balloon 30.
  • the additive 41 containing a water-soluble low-molecular compound has an effect of uniformly dispersing the water-insoluble drug on the outer surface of the balloon 30. Furthermore, since the additive 41 is easily dissolved when the balloon 30 is expanded in the blood vessel, the particles of the water-insoluble drug drug crystal 42 on the outer surface of the balloon 30 can be easily released, and the drug crystal 42 into the blood vessel. This has the effect of increasing the amount of particles attached.
  • the additive 41 is preferably not a hydrogel. Since the additive 41 is a low molecular weight compound, it dissolves rapidly without swelling when in contact with an aqueous solution.
  • the additive 41 is easily dissolved when the balloon 30 is expanded in the blood vessel, the particles of the water-insoluble drug crystal 42 on the outer surface of the balloon 30 are easily released. It has the effect of increasing the amount of adhesion.
  • the additive 41 is a matrix made of a contrast agent such as Ultravist (registered trademark)
  • crystal particles are embedded in the matrix, and crystals are not generated from the balloon 30 toward the outside of the matrix.
  • the drug crystal 42 of the present embodiment can extend from the surface of the balloon 30 to the outside of the additive 41.
  • the solvent contained in the coating liquid 45 contains at least one of an organic solvent and water.
  • the organic solvent is not particularly limited, and tetrahydrofuran, acetone, glycerin, acetic acid, t-butyl alcohol, benzene, chlorohexane, o-dichlorobenzene, o-xylene, p-xylene, cyclohexanol, styrene, cyclohexane, ethanol, methanol Dichloromethane, hexane, ethyl acetate, i-butyl alcohol, s-butyl alcohol, propanol, butanol, toluene, ethylene glycol and the like.
  • some of these mixed solvents are preferable among tetrahydrofuran, ethanol, and acetone.
  • organic solvent and water mixture examples include, for example, tetrahydrofuran and water, tetrahydrofuran and ethanol and water, tetrahydrofuran and acetone and water, acetone and ethanol and water, and tetrahydrofuran, acetone, ethanol, and water.
  • an expansion fluid is supplied into the balloon 30 through a three-way cock connected to the proximal end opening 27 of the balloon catheter 10.
  • the three-way cock is operated in a state where the balloon 30 is expanded to seal the expansion lumen 23, and the state where the balloon 30 is expanded is maintained.
  • the balloon 30 is expanded at a pressure (for example, 4 atmospheres) lower than a pressure (for example, 8 atmospheres) at the time of use in the blood vessel.
  • the coating layer 40 can also be formed on the outer surface of the balloon 30 without expanding the balloon 30, and in this case, it is not necessary to supply the expansion fluid into the balloon 30.
  • the balloon catheter 10 is rotatably installed on the support base 70, and the hub 26 is connected to the rotation mechanism 60.
  • the position of the moving table 81 is adjusted, and the dispensing tube 94 is positioned with respect to the balloon 30.
  • the dispensing tube 94 is positioned at the most distal end position where the coating layer 40 is formed in the balloon 30.
  • the extending direction (discharge direction) of the dispensing tube 94 is opposite to the rotation direction of the balloon 30 as shown in FIG. Accordingly, the balloon 30 rotates in the direction opposite to the direction in which the coating liquid 45 is discharged from the dispensing tube 94 at the position where the dispensing tube 94 is brought into contact. Thereby, physical stimulation can be given to the coating liquid 45 and formation of the crystal nucleus of a drug crystal can be promoted.
  • the extending direction (discharge direction) toward the opening 95 of the dispensing tube 94 is the direction opposite to the rotation direction of the balloon 30, the crystal of the water-insoluble drug formed on the outer surface of the balloon 30 is A crystal is easily formed including a morphological type including a plurality of drug crystals 42 each having an independent major axis.
  • the extending direction of the dispensing tube 94 does not have to be the reverse direction of the rotation direction of the balloon 30, and can therefore be the same direction or can be perpendicular.
  • the balloon catheter 10 is rotated by the rotation mechanism 60. Subsequently, while the amount of liquid fed is adjusted by the liquid feed pump 93 and the coating liquid 45 is supplied to the dispensing tube 94, the moving table 81 is moved to move the dispensing tube 94 along the axial direction of the balloon 30. Gradually move toward the proximal direction.
  • the coating liquid 45 discharged from the opening 95 of the dispensing tube 94 is applied while drawing a spiral on the outer peripheral surface of the balloon 30 as the dispensing tube 94 moves relative to the balloon 30. Since the balloon 30 is rotating, the coating liquid 45 applied to the outer peripheral surface of the balloon 30 tends to be uniform in the circumferential direction.
  • the moving speed of the dispensing tube 94 is not particularly limited, but is, for example, 0.01 to 2 mm / sec, preferably 0.03 to 1.5 mm / sec, and more preferably 0.05 to 1.0 mm / sec.
  • the discharge speed of the coating liquid 45 from the dispensing tube 94 is not particularly limited, but is, for example, 0.01 to 1.5 ⁇ L / sec, preferably 0.01 to 1.0 ⁇ L / sec, more preferably 0.03 to 0. .8 ⁇ L / sec.
  • the rotation speed of the balloon 30 is not particularly limited, but is, for example, 10 to 300 rpm, preferably 30 to 250 rpm, and more preferably 50 to 200 rpm.
  • the diameter of the balloon 30 when applying the coating liquid 45 is not particularly limited, but is, for example, 1 to 10 mm, preferably 2 to 7 mm.
  • the dispensing tube 94 is gradually moved in the axial direction of the balloon 30 while rotating the balloon 30. Thereby, the layer of the coating liquid 45 is gradually formed on the outer surface of the balloon 30 in the axial direction. After the layer of the coating liquid 45 is formed over the entire area to be coated by the balloon 30, the rotation mechanism section 60, the movement mechanism section 80, and the coating liquid supply section 90 are stopped.
  • the organic solvent contained in the coating solution applied to the outer surface of the balloon 30 volatilizes before water. Therefore, the organic solvent is volatilized in a state where the water-insoluble drug, the water-soluble low-molecular compound and water are left on the outer surface of the balloon 30. As described above, when the organic solvent is volatilized with water remaining, the water-insoluble drug is precipitated inside the water-soluble low-molecular compound containing water, and the crystal gradually grows from the crystal nucleus. As shown in FIG. 3, a morphological form of drug crystal 42 including a plurality of crystals each having a long axis independent from each other is formed on the outer surface of the balloon 30.
  • the base of the drug crystal 42 is located on the outer surface of the balloon 30, the surface of the additive 41, or inside the additive 41. After the organic solvent is volatilized and the drug crystals 42 are deposited, water is evaporated more slowly than the organic solvent, and an additive 41 containing a water-soluble low-molecular compound is formed.
  • the time for which water evaporates is appropriately set according to the type of drug, the type of water-soluble low molecular weight compound, the type of organic solvent, the ratio of materials, the amount of coating solution applied, etc. It is.
  • a metal layer 37 is formed on the outer surfaces of the balloon 30 and the coat layer 40 by a known vapor deposition apparatus 120.
  • the metal layer 37 can be formed only in a required part by performing masking etc. on the part of the balloon catheter 10 where the metal layer 37 is not formed.
  • the metal layer 37 is not formed on a portion of the outer surface of the balloon 30 where the coat layer 40 is not provided, and therefore, masking is preferably performed.
  • masking is a known technique. For example, masking can be performed by covering a portion of the outer surface of the balloon 30 where the metal layer 37 is not formed with a known masking tape that can be removed after the metal layer 37 is formed.
  • the expansion fluid is discharged from the balloon 30, and the balloon 30 is contracted and folded. Thereby, manufacture of the balloon catheter 10 is completed.
  • the balloon 30 has a substantially circular cross section in a state where the expansion fluid is injected therein. From this state, the balloon 30 is formed with the protruding blade portion 32, so that the blade outer portion 34a constituting the outer surface of the blade portion 32 and the inner portion of the blade portion 32 are formed as shown in FIG. A blade inner portion 34b constituting the side surface and an intermediate portion 34c located between the blade outer portion 34a and the blade inner portion 34b are formed. From this state, as shown in FIG. 7C, the blade portion 32 protruding outward in the radial direction is folded in the circumferential direction.
  • a root-side space portion 36 is formed between the root portion of the blade portion 32 and the intermediate portion 34c.
  • a minute gap is formed between the blade part 32 and the intermediate part 34c.
  • the region on the tip side of the base side space portion 36 of the blade portion 32 is in close contact with the intermediate portion 34c.
  • the ratio of the circumferential length of the base side space portion 36 to the circumferential length of the blade portion 32 is in the range of 1 to 95%.
  • the blade outer portion 34a of the balloon 30 receives a pressing force that rubs in the circumferential direction from a blade for folding the balloon 30, and is further heated. As a result, the long drug crystal 42 provided on the blade outer portion 34 a falls down on the surface of the balloon 30 and is easy to sleep. It is not necessary for all of the drug crystal 42 to sleep.
  • the drug crystal 42 is difficult to sleep.
  • the region that does not face the root side space portion 36 that is, the region where the blade inner portion 34b and the intermediate portion 34c are in close contact with each other, Easy to receive pressure. Therefore, in this region, the drug crystal 42 falls down and tends to sleep.
  • the metal layer 37 may be deposited on the outer surface of the coat layer 40 after the balloon 30 is folded instead of folding the balloon 30 after the metal layer 37 is deposited on the outer surface of the coat layer 40.
  • the surgeon punctures a blood vessel from the skin by a known method such as the Seldinger method, and places an introducer (not shown).
  • the guide wire 200 (see FIG. 8) is inserted into the guide wire lumen 24.
  • the guide wire 200 and the balloon catheter 10 are inserted into the blood vessel from the inside of the introducer.
  • the balloon catheter 10 is advanced while the guide wire 200 is advanced, and the balloon 30 reaches the stenosis.
  • the balloon catheter 10 can suppress the drug crystal 40 from falling off.
  • a guiding catheter may be used to reach the balloon catheter 10 to the stenosis 300.
  • a predetermined amount of expansion fluid is injected from the proximal end opening 27 of the hub 26 using an inflator or a syringe, and the expansion fluid is sent into the balloon 30 through the expansion lumen 23.
  • the folded balloon 30 is expanded, and the narrowed portion 300 is pushed and expanded by the balloon 30.
  • the coat layer 40 provided on the reinforcing layer 35 on the outer surface of the balloon 30 contacts the narrowed portion 300.
  • the drug crystal 42 is delivered to the living body while the additive 41, which is a water-soluble low-molecular compound contained in the coat layer 40, gradually or rapidly dissolves.
  • the coat layer 40 including the drug crystal 42 is suppressed from being dropped by the metal layer 37 during transportation.
  • the coat layer 40 is inhibited from attaching proteins or the like in the living body by the metal layer 37. For this reason, the balloon catheter 10 can satisfactorily deliver the drug crystal 42 to the living tissue. Since the metal layer 37 is very thin and is destroyed when the balloon 30 is expanded, it does not hinder the transfer of the drug crystal 42 to the living tissue.
  • the expansion fluid is sucked and discharged from the proximal end opening 27 of the hub 26, and the balloon 30 is deflated and folded.
  • the guide wire 200 and the balloon catheter 10 are removed from the blood vessel via the introducer, and the procedure is completed.
  • the balloon catheter 10 is a balloon catheter 10 that can be inserted into a living body lumen, and is provided on the distal side of the long catheter body 20 and the catheter body 20 and has a diameter.
  • a balloon 30 that is expandable in the direction, a coat layer 40 containing a drug disposed on the outer surface of the balloon 30, and a metal layer 37 deposited on the outer surface of the coat layer 40.
  • the metal layer 37 is deposited on the outer surface of the coat layer 40 containing the drug, the drug drops off when the balloon 30 is delivered to the target position in the living body. This can be suppressed by the metal layer 37.
  • the surface of the balloon 30 is easily slipped by the metal layer 37, which facilitates conveyance within the blood vessel.
  • proteins and the like are less likely to adhere to the surfaces of the balloon 30 and the coat layer 40 in the living body, and the drug transfer property to the living tissue at the target position is improved.
  • the drug is water-soluble, the deposited metal layer 37 can suppress unintentional elution of the drug until the balloon 30 is expanded and the metal layer 37 is destroyed. For this reason, the drug may be water-soluble rather than water-insoluble. Examples of the water-soluble drug include pravastatin, rosuvastatin, fluvastatin and the like.
  • the material of the metal layer 37 is gold (Au), platinum (Pt), chromium (Cr), zinc (Zn), nickel (Ni), silver (Ag), copper (Cu) and at least one of these. Containing at least one selected from the group consisting of alloys and the like. Thereby, even if the metal layer 37 falls off in the living body, safety to the living body can be maintained.
  • the drug contains at least one selected from the group consisting of rapamycin, paclitaxel, docetaxel and everolimus.
  • the method for manufacturing the balloon catheter 10 according to the present embodiment is a method for manufacturing the balloon catheter 10 in which the coat layer 40 including the drug is formed on the outer surface of the balloon 30, and includes the drug on the outer surface of the balloon 30. Forming a coat layer 40; and depositing a metal on the outer surface of the coat layer 40 to form a metal layer 37.
  • the metal is deposited on the outer surface of the coat layer 40 containing the drug, so that the drug is dropped when the balloon 30 is delivered to the target position in the living body. Can be suppressed by the metal layer 37.
  • the surface of the balloon 30 is easily slipped by the metal layer 37, which facilitates conveyance within the blood vessel.
  • the metal layer 37 makes it difficult for proteins or the like to adhere to the surfaces of the balloon 30 and the coat layer 40 in the living body, and improves the drug transfer to the living tissue at the target position.
  • the present invention also includes a treatment method (therapeutic method) for delivering a drug to a lesion in a living body lumen using the balloon catheter 10.
  • a treatment method for delivering a drug to a lesion in a living body lumen using the balloon catheter 10.
  • the step of inserting the balloon 30 into the living body lumen to reach the lesioned part the step of expanding the balloon 30 and pressing it against the living tissue, and bringing the drug into contact with the living tissue while destroying the metal layer 37 And deflating the balloon 30 and removing it from the living body lumen.
  • the treatment method configured as described above uses the balloon catheter 10 in which the metal layer 37 is deposited on the outer surface of the coat layer 40 containing the drug, when the balloon 30 is delivered to a target position in vivo,
  • the metal layer 37 can suppress the drug from falling off.
  • the surface of the balloon 30 is easily slipped by the metal layer 37, which facilitates conveyance within the blood vessel.
  • proteins and the like are less likely to adhere to the surfaces of the balloon 30 and the coat layer 40 in the living body, and the drug transfer property to the living tissue at the target position is improved. Since the metal layer 37 is very thin and is destroyed when the balloon 30 is expanded, it does not hinder the transfer of the drug to the living tissue.
  • the balloon catheter 10 according to the above-described embodiment is a rapid exchange type, but may be an over-the-wire type.
  • the balloon catheter 10 may move along the axis without moving the dispensing tube 94.
  • the metal layer 37 may be partially provided on the outer surface of the coat layer 40.
  • a part of the coat layer 40 has an exposed portion 46 where the metal layer 37 is not provided.
  • medical agent differs on the balloon 30 can be formed arbitrarily.
  • the shape of the exposed portion 46 is not particularly limited.
  • the drug crystal 42 of the coat layer 40 may not penetrate the metal layer 37.

Abstract

La présente invention concerne : un cathéter à ballonnet qui est susceptible de supprimer efficacement un retrait accidentel d'un médicament depuis la surface externe d'un ballonnet, est facilement transporté à l'intérieur d'une lumière biologique et améliore la capacité de transfert du médicament à un tissu biologique ; son procédé de production ; et un procédé de traitement. Le cathéter à ballonnet (10) selon l'invention peut être inséré dans une lumière biologique et comprend : un corps principal de cathéter long (20) ; un ballonnet (30) disposé sur le côté distal du corps principal de cathéter (20) et apte à se dilater radialement ; une couche de revêtement (40) comprenant un médicament disposé sur la surface externe du ballonnet (30) ; et une couche métallique (37) déposée sur la surface externe de la couche de revêtement (40) sans être déposée sur la surface externe du ballonnet (30).
PCT/JP2018/010473 2017-03-16 2018-03-16 Cathéter à ballonnet, son procédé de production et procédé de traitement WO2018169054A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2019506300A JP7073339B2 (ja) 2017-03-16 2018-03-16 バルーンカテーテルおよびその製造方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2017050841 2017-03-16
JP2017-050841 2017-03-16

Publications (1)

Publication Number Publication Date
WO2018169054A1 true WO2018169054A1 (fr) 2018-09-20

Family

ID=63523131

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2018/010473 WO2018169054A1 (fr) 2017-03-16 2018-03-16 Cathéter à ballonnet, son procédé de production et procédé de traitement

Country Status (2)

Country Link
JP (1) JP7073339B2 (fr)
WO (1) WO2018169054A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102022203586A1 (de) 2021-11-04 2023-05-04 B. Braun Melsungen Aktiengesellschaft Medizinprodukt und Verfahren zur Herstellung eines Produkts, insbesondere Medizinprodukts

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002113092A (ja) * 2000-08-04 2002-04-16 Japan Lifeline Co Ltd 医療用具の製造方法および医療用具
JP2007144170A (ja) * 2005-11-23 2007-06-14 Cordis Corp 脈管の傷害後の再狭窄を防ぐための、ｐｉ３キナーゼ抑制因子の、単独の、あるいは、シロリムスとの組み合わせにおける、局所脈管送達
JP2009531157A (ja) * 2006-03-24 2009-09-03 ボストン サイエンティフィック リミテッド 電気的に作動可能な表面を有する方法および機器
JP2011517589A (ja) * 2008-03-28 2011-06-16 サーモディクス，インコーポレイティド 微粒子が配置された弾性基質を有する挿入可能な医療機器、および薬物送達方法
JP2012501219A (ja) * 2008-08-27 2012-01-19 ボストン サイエンティフィック サイムド，インコーポレイテッド 治療薬送達のための無機コーティングを有する医療用デバイス
JP2015516237A (ja) * 2012-05-09 2015-06-11 クック・メディカル・テクノロジーズ・リミテッド・ライアビリティ・カンパニーＣｏｏｋ Ｍｅｄｉｃａｌ Ｔｅｃｈｎｏｌｏｇｉｅｓ Ｌｌｃ 水不溶性治療剤と添加剤とを含むコーティングがなされた医療装置
WO2015151877A1 (fr) * 2014-04-01 2015-10-08 テルモ株式会社 Procédé de revêtement de ballonnet, procédé de commande de couche de revêtement et dispositif de revêtement de ballonnet
JP2016202916A (ja) * 2015-04-23 2016-12-08 テルモ株式会社 バルーンコーティング方法、バルーン回転方法およびバルーンコーティング装置

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002113092A (ja) * 2000-08-04 2002-04-16 Japan Lifeline Co Ltd 医療用具の製造方法および医療用具
JP2007144170A (ja) * 2005-11-23 2007-06-14 Cordis Corp 脈管の傷害後の再狭窄を防ぐための、ｐｉ３キナーゼ抑制因子の、単独の、あるいは、シロリムスとの組み合わせにおける、局所脈管送達
JP2009531157A (ja) * 2006-03-24 2009-09-03 ボストン サイエンティフィック リミテッド 電気的に作動可能な表面を有する方法および機器
JP2011517589A (ja) * 2008-03-28 2011-06-16 サーモディクス，インコーポレイティド 微粒子が配置された弾性基質を有する挿入可能な医療機器、および薬物送達方法
JP2012501219A (ja) * 2008-08-27 2012-01-19 ボストン サイエンティフィック サイムド，インコーポレイテッド 治療薬送達のための無機コーティングを有する医療用デバイス
JP2015516237A (ja) * 2012-05-09 2015-06-11 クック・メディカル・テクノロジーズ・リミテッド・ライアビリティ・カンパニーＣｏｏｋ Ｍｅｄｉｃａｌ Ｔｅｃｈｎｏｌｏｇｉｅｓ Ｌｌｃ 水不溶性治療剤と添加剤とを含むコーティングがなされた医療装置
WO2015151877A1 (fr) * 2014-04-01 2015-10-08 テルモ株式会社 Procédé de revêtement de ballonnet, procédé de commande de couche de revêtement et dispositif de revêtement de ballonnet
JP2016202916A (ja) * 2015-04-23 2016-12-08 テルモ株式会社 バルーンコーティング方法、バルーン回転方法およびバルーンコーティング装置

Also Published As

Publication number Publication date
JP7073339B2 (ja) 2022-05-23
JPWO2018169054A1 (ja) 2020-01-23

Similar Documents

Publication Publication Date Title
JP6472572B2 (ja) バルーンカテーテルおよびその製造方法並びに処置方法
WO2017164280A1 (fr) Cathéter à ballonnet, procédé de production de cathéter à ballonnet, et procédé de traitement
JP2017169740A (ja) バルーンカテーテルおよびその製造方法並びに処置方法
WO2017164281A1 (fr) Cathéter à ballonnet et son procédé de production, et procédé de traitement
US11369777B2 (en) Balloon catheter and manufacturing method thereof, and treatment method
WO2018169052A1 (fr) Méthode de production de cathéter à ballonnet
JP2018153283A (ja) バルーンコーティング方法
WO2018169054A1 (fr) Cathéter à ballonnet, son procédé de production et procédé de traitement
JP2018153290A (ja) バルーンカテーテルの製造方法および製造装置
US11369776B2 (en) Balloon catheter and manufacturing method thereof, and treatment method
JP2018153291A (ja) バルーンカテーテルの製造方法および製造装置
JP2018153288A (ja) バルーンカテーテルの製造方法および製造装置
JP2018153289A (ja) バルーンカテーテルの製造方法および製造装置
WO2018169053A1 (fr) Cathéter à ballonnet, son procédé de production, dispositif de production, et procédé de traitement
JP2017169734A (ja) バルーンカテーテル及びその製造方法並びに処置方法
JP2017169737A (ja) バルーンカテーテル及びその製造方法並びに処置方法
JP2017169741A (ja) バルーンカテーテルおよび処置方法
WO2017164279A1 (fr) Cathéter à ballonnet, procédé de production pour cathéter à ballonnet, et procédé de traitement
WO2018169051A1 (fr) Procédé de revêtement de ballonnet
JP2017169742A (ja) バルーンカテーテルおよびその製造方法並びに処置方法
WO2017164282A1 (fr) Cathéter à ballonnet, son procédé de production, et procédé de traitement
JP2018153287A (ja) バルーンカテーテルの製造方法および製造装置
JP2018153284A (ja) バルーンコーティング方法及びバルーンコーティング装置
JP2018153282A (ja) バルーンコーティング方法
JP2017169733A (ja) バルーンカテーテルおよびその製造方法並びに処置方法

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 18768588

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2019506300

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 18768588

Country of ref document: EP

Kind code of ref document: A1