WO2018008515A1 - Balloon catheter - Google Patents

Balloon catheter Download PDF

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Publication number
WO2018008515A1
WO2018008515A1 PCT/JP2017/023961 JP2017023961W WO2018008515A1 WO 2018008515 A1 WO2018008515 A1 WO 2018008515A1 JP 2017023961 W JP2017023961 W JP 2017023961W WO 2018008515 A1 WO2018008515 A1 WO 2018008515A1
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WO
WIPO (PCT)
Prior art keywords
balloon
reinforcing portion
reinforcing
balloon catheter
drug
Prior art date
Application number
PCT/JP2017/023961
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French (fr)
Japanese (ja)
Inventor
匡生 佐藤
荘一郎 北
仁 田原
良二 中野
渡邊　基一
西出　拓司
Original Assignee
株式会社カネカ
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.)
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Publication date
Application filed by 株式会社カネカ filed Critical 株式会社カネカ
Publication of WO2018008515A1 publication Critical patent/WO2018008515A1/en

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    • 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, and more particularly to a balloon catheter holding a drug.
  • stenosis occurs in a blood vessel that is a flow path for blood to circulate in the body, and various diseases occur when blood circulation is delayed.
  • a stenosis occurs in a coronary artery that supplies blood to the heart, there is a risk of causing serious diseases such as angina pectoris and myocardial infarction.
  • One method for treating such a stenosis of a blood vessel is an angioplasty (PTA, PTCA, etc.) that expands the stenosis using a balloon catheter.
  • Angioplasty is widely performed because it is a minimally invasive therapy that does not require thoracotomy such as bypass surgery.
  • restenosis may occur in an expanded stenosis, and drug elution with a drug layer on the surface is a treatment method that reduces the frequency of such restenosis (restenosis rate).
  • Treatment using a stent is performed.
  • drug-eluting balloon catheters in which a drug is held in the balloon portion of the balloon catheter have been proposed (for example, Patent Documents 1 to 4). If a drug-eluting balloon catheter is used, the drug can be transferred to the blood vessel wall by expanding the balloon at the stenosis or lesion, and the occurrence of restenosis can be expected to be suppressed.
  • Advantages of a treatment method using a drug-eluting balloon catheter include that no foreign matter is left in the body, and that small blood vessels into which a stent cannot be inserted can be treated.
  • an object of the present invention is to deliver a drug to a desired portion such as a stenosis or a lesion in an inner wall of a body cavity such as a blood vessel wall as far as possible in the stenosis or a lesion.
  • An object of the present invention is to provide a balloon catheter that can be used.
  • the balloon catheter of the present invention that has solved the above-mentioned problems is a balloon catheter having a shaft and a balloon provided on the outer side of the shaft, and the balloon is formed on the outer surface of the base balloon and the base balloon. It has a feature in that it has a reinforcing part arranged linearly or in a net shape, the reinforcing part is formed to protrude from the outer surface of the balloon, and the medicine is held in the reinforcing part.
  • the balloon is preferably provided with a reinforcing portion having a height of 0.2 mm or more and 0.5 mm or less. It is preferable that a portion other than the reinforcing portion is formed on the outer surface of the balloon in a size including a circle having a diameter of at least 0.5 mm.
  • the balloon may be provided with a main reinforcing portion having a height of 0.2 mm to 0.5 mm and an auxiliary reinforcing portion having a height of 0.01 mm to less than 0.2 mm as the reinforcing portion.
  • the drug is held at least on the main reinforcing portion.
  • a portion other than the main reinforcing portion is formed on the outer surface of the balloon in a size including a circle having a diameter of at least 0.5 mm.
  • the reinforcing portion protrudes outward in the balloon radial direction from a portion other than the reinforcing portion on the outer side surface of the balloon when the pressure is 2.03 MPa (20 atm).
  • the reinforcing portion is preferably formed by bonding a fiber material to the outer surface of the base balloon.
  • the reinforcing portion may be formed by joining a metal material to the outer surface of the base balloon.
  • At least a part of the reinforcing portion is provided so as to extend in the axial direction of the balloon. Further, a part of the reinforcing part may be provided so as to extend in the axial direction of the balloon, and the other part may be provided so as to extend spirally in the circumferential direction of the balloon.
  • the main reinforcing portion and the auxiliary reinforcing portion are provided as the reinforcing portion
  • the main reinforcing portion is provided extending in the axial direction of the balloon
  • the auxiliary reinforcing portion is provided extending in the circumferential direction of the balloon. It is preferable.
  • the main reinforcement portion is provided to extend in a spiral shape in the circumferential direction of the balloon
  • the auxiliary reinforcement portion is provided to extend in a spiral shape in the opposite direction to the main reinforcement portion in the circumferential direction of the balloon. It is also preferable.
  • the drug is preferably an antiproliferative agent or an immunosuppressive agent.
  • the balloon catheter of the present invention since the balloon is formed by providing the reinforcing portion on the outer surface of the base balloon in a linear or mesh shape, when the balloon is pressurized, the balloon is prevented from being overexpanded. It becomes easy to apply the medicine held in the reinforcing part to a desired location on the inner wall of the body cavity such as a stenosis part or a lesion part. In addition, coupled with the scoring function of the reinforcing part, the reinforcing part can be bitten into the stenosis part or the lesion part, and the medicine can be delivered to the back of the stenosis part or the lesion part.
  • FIG. 1 represents a plan view of a balloon catheter.
  • 2A is a cross-sectional view taken along the line AA of the balloon catheter shown in FIG. 1
  • FIG. 2B is a cross-sectional view taken along the line BB of the balloon catheter shown in FIG.
  • the top view of a balloon is represented as an example of the balloon with which the balloon catheter shown in FIG. 1 is equipped.
  • the top view of the other example of a balloon is represented.
  • the top view of the other example of a balloon is represented.
  • the top view of the other example of a balloon is represented.
  • the top view of the other example of a balloon is represented.
  • the top view of the other example of a balloon is represented.
  • the present invention relates to a balloon catheter in which a drug is held on the balloon surface.
  • a reinforcing portion is provided in a linear or net shape on the outer surface of the base balloon, and the reinforcing portion protrudes from the outer surface of the balloon.
  • the present invention relates to a balloon catheter having a provided balloon and having a medicine held in a reinforcing part of the balloon.
  • the reinforcing portion is provided in a linear shape or a net shape on the outer surface of the base balloon, and the medicine is held in the reinforcing portion, so that the stenosis portion is limited to a limited range such as a stenosis portion or a lesion portion. Or the drug can be easily delivered to the back of the lesion.
  • FIG. 1 shows a plan view of a balloon catheter
  • FIGS. 2 (a) and 2 (b) show an AA sectional view and a BB sectional view of the balloon catheter shown in FIG. 1, respectively.
  • FIG. 1 shows a configuration example of an over-the-wire type balloon catheter in which a wire is inserted from the distal side to the proximal side of the shaft.
  • the balloon catheter 1 has a shaft 2 and a balloon 10 provided outside the shaft 2.
  • the balloon catheter 1 has a proximal side and a distal side, a balloon 10 is provided on the distal side of the shaft 2, and a hub 5 is provided on the proximal side of the shaft 2.
  • the proximal side of the balloon catheter refers to the direction of the proximal side of the user (operator) with respect to the extending direction of the balloon catheter (particularly the shaft), and the distal side is opposite to the proximal side.
  • the direction that is, the direction on the treatment target side
  • a direction from the proximal side to the distal side of the balloon is referred to as an axial direction.
  • the balloon catheter 1 is configured such that a pressure fluid is supplied from the hub 5 to the inside of the balloon 10 through the shaft 2, and the expansion and contraction of the balloon 10 can be controlled using an indeflator.
  • the shaft 2 is usually provided with a flow path for pressure fluid and a wire insertion path for guiding the progress of the shaft 2 inside.
  • the shaft 2 includes an inner tube 3 and an outer tube 4, and the inner tube 3 functions as a wire insertion path, and a space between the inner tube 3 and the outer tube 4 functions as a flow path for pressure fluid.
  • the inner tube 3 extends from the distal end of the outer tube 4 and penetrates the balloon 10 in the axial direction, and the distal side of the balloon 10 is joined to the inner tube 3.
  • the proximal side is configured to be joined to the outer tube 4.
  • the hub 5 has a fluid injection part 6 that communicates with the flow path of the pressure fluid, and a treatment part 7 that communicates with the wire insertion path.
  • the treatment unit 7 can function as an injection port for a medicine or the like, or a suction port for a fluid or the like in a body cavity.
  • the bonding of the balloon 10, the shaft 2 (the inner tube 3, the outer tube 4) and the hub 5 can be performed using a conventionally known bonding means such as an adhesive or heat welding.
  • an X-ray opaque marker may be arranged at the portion of the shaft 2 where the balloon 10 is located in order to make it possible to confirm the position of the balloon 10 under X-ray fluoroscopy.
  • the present invention can also be applied to a rapid exchange type balloon catheter in which a wire is inserted halfway from the distal side to the proximal side of the shaft.
  • the wire insertion path may be provided in a part of the shaft including the distal side of the shaft, and the treatment portion may not be provided in the hub.
  • FIGS. 1 and 2 show a general balloon catheter in which blood does not pass through the shaft. However, the present invention does not expand the balloon for a long time so that the medicine held in the balloon is transferred to the inner wall of the blood vessel.
  • FIG. 3 shows an enlarged view of the balloon provided in the balloon catheter shown in FIG.
  • the balloon provided in the balloon catheter is not limited to the balloon shown in FIG.
  • the balloon 10 has a base balloon 11 and a reinforcing portion 12 arranged in a linear or net shape on the outer surface of the base balloon 11, and the reinforcing portion 12 is formed to protrude from the outer surface of the base balloon 11.
  • the base balloon 11 defines the basic shape of the balloon 10 and is formed in a bag shape having openings on the proximal side and the distal side.
  • the reinforcing portion 12 is provided on the outer surface of the base balloon 11 in a linear or net pattern, and the reinforcing portion 12 is fixed to the outer surface of the base balloon 11 in this pattern.
  • the balloon 10 is preferably a so-called non-compliant type in which the balloon diameter hardly increases even when the balloon is pressurized above a certain pressure.
  • the balloon 10 has a cylindrical straight tube portion 14, a proximal taper portion 15 connected to the proximal side thereof, and a distal taper portion 16 connected to the distal side.
  • the proximal taper portion 15 and the distal taper portion 16 are formed so as to be reduced in diameter as they move away from the straight tube portion 14.
  • a cylindrical proximal sleeve 17 is connected to the proximal side of the proximal tapered portion 15, and a cylindrical distal sleeve 18 is connected to the distal side of the distal tapered portion 16.
  • the proximal sleeve 17 is joined to the outer tube 4 of the shaft 2
  • the distal sleeve 18 is joined to the inner tube 3 of the shaft 2.
  • the balloon 10 can be formed in a substantially cylindrical shape by setting the taper angle of the tapered portions 15 and 16 to 90 ° with respect to the axial direction.
  • the balloon 10 is configured such that the distal tapered portion 16 swells from the proximal tapered portion 15 through the straight tube portion 14 when a pressure fluid is supplied, and in the present invention, the inflatable portion. Is considered a balloon.
  • the base balloon can be manufactured, for example, by molding a resin.
  • the base balloon can be manufactured by placing a resin tube extruded by extrusion molding in a mold and biaxially stretching blow molding.
  • the base balloon can be formed in an arbitrary shape depending on the shape of the mold.
  • the base balloon can be manufactured by a known molding method such as dip molding, injection molding, and compression molding.
  • the base balloon may be composed of a plurality of resin layers, or may have a layer other than the resin layer.
  • the resin constituting the base balloon examples include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, vinyl chloride resins, silicone resins, and natural rubber. These may use only 1 type and may use 2 or more types together.
  • polyamide resins, polyester resins, and polyurethane resins are preferably used.
  • an elastomer resin from the viewpoint of thinning the balloon and flexibility.
  • nylon 12 and nylon 11 and the like are suitable materials for the base balloon among polyamide resins, and nylon 12 is preferably used because it can be molded relatively easily when blow molding.
  • polyamide elastomers such as polyether ester amide elastomers and polyamide ether elastomers are preferably used from the viewpoint of thinning the balloon and flexibility.
  • polyether ester amide elastomers are preferably used because they have high yield strength and good dimensional stability of the balloon.
  • the dimensions of the base balloon may be appropriately set according to the size of the treatment site.
  • the axial length is preferably 5 mm to 300 mm and the outer diameter is preferably 1 mm to 12 mm.
  • the axial length is preferred. Is preferably 10 mm to 100 mm, and the outer diameter is preferably 3 mm to 30 mm.
  • the reinforcing portion 12 is provided on the outer surface of the base balloon 11 in a linear or net pattern.
  • the reinforcing portion 12 is formed so as to protrude on the outer surface of the balloon 10, that is, provided on the outer surface of the balloon 10 so as to protrude outward in the balloon radial direction.
  • the reinforcing portion 12 is provided as a layer partially disposed on the outer surface of the base balloon 11.
  • a non-reinforcing portion 13 is formed in a portion other than the reinforcing portion 12 on the outer surface of the balloon 10.
  • the reinforcing portion 12 is formed so as to protrude from the non-reinforcing portion 13 on the outer surface of the balloon 10, and the non-reinforcing portion 13 is formed to be recessed with respect to the reinforcing portion 12.
  • the reinforcing portion 12 is formed thicker than the non-reinforcing portion 13.
  • the linear reinforcing part 12 As the reinforcing part 12 provided in a linear pattern, a mode in which the linear reinforcing part 12 is arranged so as to extend in the axial direction of the balloon (see FIG. 4A), the linear reinforcing part 12 includes A mode (see FIG. 4B) extending in the circumferential direction of the balloon and arranged in a ring shape, and a mode in which a linear reinforcing portion is arranged in a spiral shape (coil shape) on the outer surface of the balloon (FIG. 4 ( see c)).
  • a mode see FIG. 4B
  • a linear reinforcing portion is arranged in a spiral shape (coil shape) on the outer surface of the balloon (FIG. 4 ( see c)
  • a plurality of linear reinforcing portions may be provided, but the reinforcing portions are arranged so as not to cross each other.
  • the reinforcing part provided in the net-like pattern is not particularly limited as long as the linear reinforcing parts are arranged so as to cross each other, for example, formed by combining each aspect of the linear pattern described above can do.
  • the linear reinforcing portions may simply intersect each other (overlapping structure) or may form a knitted structure (braided structure).
  • FIG. 3 shows a mode in which the reinforcing portions are arranged in a net pattern in which a pattern extending linearly in the axial direction and a right-handed and left-handed spiral pattern are combined.
  • FIG. 5A shows a mode in which the reinforcing portions are arranged in a net-like pattern in which right-handed and left-handed spiral patterns are combined.
  • FIG. 5B shows a mode in which the reinforcing portions are arranged in a hexagonal lattice pattern.
  • the height and line width of the reinforcing part may be appropriately set according to the desired performance of the balloon.
  • the reinforcing portions may all be provided at the same height, or may be provided so as to have different height portions.
  • all the reinforcement parts may be provided with the same line width, and may be provided so that it may have a part with a different line width.
  • the line width of the reinforcing portion extending in the axial direction is preferably larger than the line width of the reinforcing portion extending in the circumferential direction.
  • the height of the reinforcing portion is preferably 0.01 mm or more, more preferably 0.1 mm or more, and preferably 0.5 mm or less.
  • the height of the reinforcing part means a height protruding from the outer surface of the balloon, and can be obtained by measuring the height from the non-reinforcing part.
  • the thickness of the fiber material may be the height of the reinforcing portion.
  • the line width of the reinforcing portion is, for example, preferably 0.02 mm or more, more preferably 0.1 mm or more, and preferably 0.3 mm or less.
  • the line width of the reinforcing portion is obtained by measuring, for example, the half-value width of the height of the reinforcing portion (the width of the portion where the height of the reinforcing portion is half), or the reinforcing portion is formed from a fiber material as described later. When doing, it is good also considering the width
  • the height and line width of the reinforcing part can be obtained by measuring the cut section of the balloon.
  • the proportion of the reinforcing portion on the outer surface of the balloon may be appropriately set according to the desired performance of the balloon.
  • the area ratio of the reinforcing portion on the outer surface of the straight tube portion of the balloon is preferably 20% or more, more preferably 30% or more, and preferably 80% or less, more preferably 60% or less.
  • the area ratio of the reinforced part on the outer surface of the balloon is defined as the area where the height of the reinforced part is halved as the boundary between the reinforced part and the non-reinforced part, and the higher part is regarded as the reinforced part. Can be requested.
  • the height and line width of the reinforcing portion and the area ratio of the reinforcing portion described above can be obtained by cutting or expanding the balloon and measuring the balloon in a non-pressurized state.
  • Various values to be described later also mean values in a non-pressurized state of the balloon unless otherwise specified.
  • the reinforcing part may be made of the same material as the base balloon or may be made of a different material.
  • the reinforcing part is preferably made of a material that is stronger and harder to stretch than the base balloon. By configuring the reinforcing part in this way, the reinforcing part can have a scoring function, or the dimensional stability of the balloon. Can be increased.
  • the reinforcing portion can be formed, for example, by bonding a fiber material to the outer surface of the base balloon.
  • the fiber material may be monofilament or multifilament. From the viewpoint of increasing the strength of the balloon, the fiber material preferably has a higher strength and is less likely to stretch (has a higher elastic modulus) than the base balloon, and preferably has a higher tensile strength. Examples of such a fiber material include polyarylate fiber, aramid fiber, ultrahigh molecular weight polyethylene fiber, PBO fiber, and carbon fiber.
  • the reinforcing portion may be formed by joining a metal material to the outer surface of the base balloon.
  • the metal material is a material having higher elasticity than the base balloon and has a high scoring function.
  • the metal material include nitinol (Ni— Ti alloy), cobalt alloy, tantalum, and stainless steel (SUS304, etc.). Among these, nitinol is preferable because it has a wide elastic range and provides a high scoring function.
  • a plurality of fiber materials 21 parallel to the axial direction of the base balloon and arranged at intervals in the circumferential direction, and a plurality of spirally wound fiber materials 22, 23 are knitted.
  • the reinforcing portion can be formed by superimposing or knitting them as they are without knitting.
  • the fiber material 21, the fiber material 22 (23), and the fiber material 23 (22) may be overlapped sequentially from the surface over the entire length of the base balloon 11 in the axial direction.
  • the fiber material 22 (23), the fiber material 21, and the fiber material 23 (22) may be overlapped, or the fiber material 22 (23), the fiber material 23 (22), and the fiber material 21 may be overlapped.
  • the fiber materials 21, 22, and 23 may be structured so as to be knitted by regularly replacing the outer side and the inner side in the balloon radial direction.
  • the winding direction of the spirally wound fiber material 22 is opposite to that of the spirally wound fiber material 23.
  • the fiber materials 21, 22, and 23 may be wound uniformly or may be wound non-uniformly. For example, by forming a plurality of fibers together to form the fiber materials 21, 22, and 23, when a large number of fibers are arranged in the circumferential direction, they can be easily manufactured without using a complicated device. Is possible.
  • a method of joining the fiber material to the base balloon a method in which an adhesive is applied from the outside of the fiber material in a state where the fiber material is disposed on the outer surface of the base balloon, and an adhesive is applied to the base balloon and / or the fiber material. Thereafter, a method of arranging a fiber material on the outer surface of the base balloon, a method of joining the fiber material to the base balloon by heat welding, and the like can be mentioned.
  • a resin can also be used as the adhesive.
  • the number of fiber materials may be set as appropriate in consideration of the size of the base balloon, the thickness of the fiber material (height and line width of the reinforcing portion), the strength of the balloon, the amount of drug retained, and the like.
  • a plurality of fiber materials extending in the axial direction are preferably arranged at intervals in the circumferential direction, and the number of fibers arranged in the circumferential direction at this time is 3 to 30
  • the number of spirally wound fiber materials is preferably 3 to 30, and the winding angle at this time ranges from 50 ° to 80 ° with respect to the axial direction. It is preferable to set by.
  • Drugs are held in the reinforcing part of the balloon.
  • the drug By holding the drug in the reinforcing part of the balloon, it becomes possible to deliver the drug to the back of the stenosis part or the lesion part in combination with the scoring function of the reinforcing part.
  • the drug held in the balloon is not particularly limited as long as it is a pharmacologically active substance, and examples thereof include pharmaceutically acceptable drugs such as non-gene therapy drugs, gene therapy drugs, small molecules, and cells.
  • pharmaceutically acceptable drugs such as non-gene therapy drugs, gene therapy drugs, small molecules, and cells.
  • an anti-restenosis agent such as an antiproliferative agent or an immunosuppressive agent can be preferably used as the drug.
  • drugs such as paclitaxel, sirolimus (rapamycin), everolimus, and zotarolimus can be used. These drugs may be used alone or in combination of two or more.
  • the drug may be held in the reinforcing part as a drug layer, or may be held in the reinforcing part in the form of a microcapsule or the like. Moreover, the chemical
  • the drug may contain, together with the pharmacologically active substance, an auxiliary agent for improving the dispersibility, solubility, migration to the blood vessel wall, and storage stability of the drug. As auxiliary agents, stabilizers, binders, disintegrants, moisture-proofing agents, preservatives, dissolution aids and the like are used.
  • lactose sucrose, maltose, dextrin, xylitol, erythritol, mannitol, ethylenediamine
  • examples thereof include potassium iodide, urea, polysorbate, dibutylhydroxytoluene, sodium pyrosulfite, ascorbic acid, tocopherol, benzoic acid, and paraoxybenzoic acid esters.
  • the drug may be held in a balloon in a state protected with a coating layer in order to prevent the drug from eluting into the blood or falling off during delivery to the stenosis or lesion (during delivery).
  • the coating layer is preferably a water-soluble polymer from the viewpoint of preventing the initial burst of the drug, for example, carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, hydroxyethyl cellulose, polyvinyl alcohol, alginic acid, pectin, gum arabic, gellan gum, gua gum Xanthan gum, carrageenan, gelatin and the like.
  • the outer surface of the balloon may be subjected to a surface treatment.
  • the surface treatment include plasma treatment, laser treatment, ion treatment, ozone treatment, discharge treatment, and primer treatment.
  • the medicine may be held in the non-reinforcing part, which is a part other than the reinforcing part, but the reinforcing part protrudes from the non-reinforcing part while the medicine is held in the balloon. It is preferable that Thereby, it becomes easy to deliver the medicine held in the reinforcing part to the back of the stenosis part or the lesion part.
  • the state where the drug is held in the balloon includes a state where the drug is held in the balloon and a coating layer or the like is further provided.
  • the balloon should be provided with a reinforcing part with a height of 0.2 mm or more and 0.5 mm or less in order to enhance the scoring function of the reinforcing part and facilitate the delivery of the drug to the back of the stenosis or lesion. Is preferred. If a reinforcing portion having such a height is provided on the outer surface of the balloon, it becomes easier to deliver the drug deeper into the stenosis or lesion by causing the reinforcement to bite into the stenosis or lesion. . Moreover, since the overexpansion at the time of balloon pressurization can also be suppressed by the reinforcing portion, it is possible to deliver the drug to the back of the stenotic portion calcified in angioplasty.
  • the height of the reinforcing part means the maximum height of the reinforcing part, and the balloon may be provided with a reinforcing part having a lower height.
  • the reinforcing portion is preferably provided so that the protruding state on the outer surface of the balloon is conspicuous, and specifically, it is preferably provided with a certain distance from the adjacent reinforcing portion. From this point, on the outer surface of the balloon, a portion other than the reinforcing portion is formed in a size including a circle having a diameter of at least 0.5 mm (the diameter is more preferably 0.8 mm, and further preferably 1.0 mm). It is preferable that In addition, the circle described here is a figure temporarily drawn so that the diameter of the inscribed circle in contact with the reinforcing portion is maximized, and is for expressing the size of a portion other than the reinforcing portion.
  • the outer surface of the balloon has a portion other than the reinforcing portion having a diameter of 1.5 mm (the diameter is more preferably 1.3 mm, and 1.1 mm is More preferably, it is formed in a size not including a circle.
  • the diameter is more preferably 1.3 mm, and 1.1 mm is More preferably, it is formed in a size not including a circle.
  • the diameter of the inscribed circle 19 in contact with a plurality of adjacent reinforcing portions 12 is 0.5 mm or more. It is preferable that it is less than 1.5 mm.
  • the inscribed circle 19 is defined so as to have the largest diameter at a portion surrounded by the reinforcing portion 12 or a portion sandwiched therebetween.
  • the size of the portion other than the reinforcing portion on the outer surface of the balloon described above is preferably determined with respect to the reinforcing portion having a height of 0.2 mm or more and 0.5 mm or less. That is, it is preferable that a portion other than the reinforcing portion having a height of 0.2 mm or more and 0.5 mm or less is formed on the outer surface of the balloon in a size including a circle having a diameter of at least 0.5 mm. It is preferable that it is formed in a size that does not include a circle having a diameter of 1.5 mm.
  • the preferred range of the height of the reinforcing portion and the preferred range of the size of the portion other than the reinforcing portion are as described above. By providing the reinforcing portion in this manner, it becomes easy to enhance the scoring function of the balloon or to deliver more medicine to the back of the stenosis or lesion.
  • the balloon is provided with a main reinforcing portion having a height of 0.2 mm to 0.5 mm and an auxiliary reinforcing portion having a height of 0.01 mm to less than 0.2 mm as the reinforcing portion.
  • the medicine is held at least on the main reinforcing portion.
  • the main reinforcing part can enhance the scoring function or function to deliver the drug to the back of the stenosis part or the lesioned part, and the auxiliary reinforcing part can improve the pressure resistance and shape retention of the balloon. it can.
  • the height of an auxiliary reinforcement part 0.01 mm or more is more preferable, and 0.1 mm or less is more preferable.
  • FIG. 6 and 7 show examples of balloons provided with a main reinforcing portion and an auxiliary reinforcing portion as reinforcing portions.
  • the balloon shown in FIG. 6 is the same as the balloon shown in FIG. 3 except that the reinforcing portion 12 extending in the axial direction of the balloon is provided as the main reinforcing portion 12A, and the reinforcing portion 12 extending spirally in the circumferential direction of the balloon. Is provided as an auxiliary reinforcing portion 12B.
  • the balloon shown in FIG. 7 is provided with a reinforcing portion 12 extending in a spiral shape in one direction as a main reinforcing portion 12A among the reinforcing portions 12 extending spirally in one direction and the other direction in the balloon circumferential direction.
  • the reinforcing portion 12 extending in a spiral shape in the other direction is provided as the auxiliary reinforcing portion 12B.
  • the outer surface of the balloon has a portion other than the main reinforcing portion having a diameter of at least 0.5 mm (the diameter is more preferably 0.8 mm, more preferably 1.0 mm). Is more preferable). Further, the portion other than the main reinforcing portion is preferably formed in a size that does not include a circle having a diameter of 1.5 mm (the diameter is more preferably 1.3 mm, and further preferably 1.1 mm). In the balloon shown in FIGS. 6 and 7, in the straight tube portion of the balloon, the distance between the adjacent main reinforcing portions 12A is preferably 0.5 mm or more, and preferably less than 1.5 mm.
  • the portion other than the main reinforcing portion is formed in a size including at least a circle having a diameter of 0.5 mm and not including a circle having a diameter of 1.5 mm.
  • the installation mode of the auxiliary reinforcing portion is not particularly limited, and may be provided at a higher density than the main reinforcing portion, may be provided at a lower density, or may be provided at a similar density.
  • an auxiliary reinforcement part is provided in a larger area ratio than a main reinforcement part from the point which improves the shape retention property of a balloon, ensuring the scoring function and chemical
  • the main reinforcing portion and the auxiliary reinforcing portion are each composed of a fiber material
  • the fiber material forming the main reinforcing portion and the fiber material forming the auxiliary reinforcing portion may be overlapped without being knitted, or knitted together.
  • the reinforcing portion is preferably provided at an area ratio of 30% or more in the straight tube portion of the balloon, and at an area ratio of 40% or more. More preferably, it is provided.
  • the area ratio of the main reinforcing part and the auxiliary reinforcing part is preferably within such a range.
  • the reinforcing portion is provided so as to extend in the axial direction of the balloon.
  • the reinforcing portion is provided so as to extend in the axial direction of the balloon over the entire axial direction of the balloon.
  • FIGS. As the balloon provided with such a reinforcing portion, for example, FIGS. ), And the balloon shown in FIG.
  • the balloon is expanded, blood flow is hindered. The actual time is that the time to expand the is limited.
  • a gap extending in the axial direction of the balloon is easily formed between the balloon and the blood vessel wall when the balloon is expanded. That is, a gap is easily formed between the balloon and the blood vessel wall between the adjacent axially extending portions of the reinforcing portion. Therefore, even if the balloon is expanded, it is possible to prevent the blood flow from being completely stopped, and it is possible to take a long time in a state where the balloon is expanded.
  • the drug can be applied to a desired part of the blood vessel wall such as a stenosis or a lesion. It becomes easy to apply selectively.
  • the drug is preferably held at least in the axially extending portion of the reinforcing portion.
  • a part of the reinforcing part is provided extending in the axial direction of the balloon and the other part is provided extending spirally in the circumferential direction of the balloon.
  • the main reinforcing portion 12A extends in the axial direction of the balloon
  • the auxiliary reinforcing portion 12B extends in the circumferential direction of the balloon. It is preferably provided.
  • the portion extending in the circumferential direction may extend in a spiral shape in the circumferential direction, or may extend in a ring shape in the circumferential direction.
  • the main reinforcing portion extends in the axial direction. It is preferable to be provided only in the portion. A part of the axially extending portion may be composed of an auxiliary reinforcing portion. It is preferable that the circumferentially extending portion is composed only of the auxiliary reinforcing portion.
  • main reinforcing portion and the auxiliary reinforcing portion are provided in this way, a wider gap is easily formed between the adjacent main reinforcing portions extending in the axial direction of the balloon between the balloon and the blood vessel wall, and the balloon is expanded.
  • the blood flow at the time of letting it be maintained can be taken longer for the time of balloon expansion.
  • the main reinforcing portion 12A is provided so as to extend spirally in the circumferential direction of the balloon, and the auxiliary reinforcing portion 12B is provided around the balloon. It is also preferable to extend in a spiral direction opposite to the main reinforcing portion in the direction.
  • a portion extending in a spiral shape in one direction is a first spiral extending portion and a portion extending in a spiral shape in the other direction is a second spiral extending portion in the reinforcing portion
  • the reinforcing portion is preferably provided only in the first spiral extending portion, and a part of the first spiral extending portion may be constituted by an auxiliary reinforcing portion. It is preferable that the second spirally extending portion is composed only of the auxiliary reinforcing portion.
  • the balloon thus configured may further have an axially extending portion as a reinforcing portion, but in this case, the axially extending portion is preferably composed only of an auxiliary reinforcing portion. .
  • the main reinforcement part and the auxiliary reinforcement part are provided in this way, the main reinforcement part bites into the stenosis part and the lesion part so that it is oblique to the extending direction of the blood vessel, and the blood vessel is expanded in the entire circumferential direction. It becomes easy to let you. Therefore, it becomes easier to push the stenosis part or lesion part of the blood vessel more effectively and deliver the medicine to the back of the stenosis part or lesion part.
  • the balloon is preferably folded and folded at the fold extending in the axial direction of the balloon before expansion.
  • an axially extending portion of the reinforcing portion where the medicine is held is present.
  • the fold folds of the balloon are defined as viewed from the outside of the balloon, and are formed so that the folds of the mountain folds face outward in the radial direction of the balloon.
  • the elastic modulus of the fiber material 21 extending in the axial direction is higher than the elastic modulus of the fiber materials 22 and 23 extending in the circumferential direction.
  • Many drugs that are held in a drug-eluting balloon catheter that suppresses restenosis of blood vessels have adverse effects when applied to the inner wall of normal blood vessels that are not stenosis or lesions.
  • the expansion in the axial direction cannot be suppressed, and the drug can be applied to normal blood vessels to prevent restenosis of the lesion. New lesions could occur either proximally or distally.
  • the balloon is formed as described above, expansion of the balloon in the axial direction can be suppressed, and the vascular wall such as a stenosis or a lesion is limited while avoiding applying the drug to an unintended normal blood vessel. It becomes easy to apply to the range.
  • a straight tube length balloon that matches the length of the stenosis or lesion, it is possible to apply more of the drug held in the balloon to the target stenosis or lesion. It becomes possible.
  • the balloon preferably has an outer diameter at 2.03 MPa (20 atm) pressurization of 1.5 D or less, more preferably 1.4 D or less, where D is the outer diameter at 0.20 MPa (2 atm) pressurization. Preferably, 1.3D or less is more preferable. If a balloon is formed in this way, the balloon can be pressurized up to a pressure as high as 20 atm, and expansion of the balloon in the radial direction at the time of pressurization can be suppressed. It becomes possible to spread by applying a balloon treatment, and the drug can be delivered to the back of such a stenosis.
  • the length of the straight tube portion when the pressure is 0.20 MPa (2 atm) is L
  • the length of the straight tube portion when the pressure is 2.03 MPa (20 atm) may be 1.4 L or less.
  • 1.3 L or less is more preferable, and 1.2 L or less is more preferable.
  • the reinforcing portion protrudes outward in the radial direction of the balloon from the portion other than the reinforcing portion on the outer side surface of the balloon even at a pressure of 2.03 MPa (20 atm).
  • the reinforcing portion is formed to protrude to the outer surface side of the balloon when the balloon is not pressurized.
  • the balloon has a high pressure of 20 atm. Even when the pressure is increased, the reinforcing portion can be bitten into the calcified narrowed portion. Therefore, it becomes easy to deliver the medicine to the back of the calcified stenosis.
  • the pressure at the time of pressurization described above corresponds to the value of a pressure gauge provided in an indeflator that is a device used at the time of balloon expansion.
  • Balloon catheter 2 Shaft 3: Inner tube 4: Outer tube 5: Hub 10: Balloon 11: Base balloon 12, 12A, 12B: Reinforced portion 13: Non-reinforced portion 14: Straight tube portion 15: Proximal side taper portion 16: Distal taper

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Abstract

A balloon catheter 1 having a shaft 2 and a balloon 10 provided on the outside of the shaft 2. The balloon 10 has a base balloon and a reinforced section 12 arranged linearly or in a mesh-like shape on the outside surface of the base balloon. The reinforced section 12 is formed protruding to the outside surface of the balloon 10 and a drug is held in the reinforced section 12.

Description

バルーンカテーテルBalloon catheter
　本発明は、バルーンカテーテルに関するものであり、詳細には、薬剤が保持されたバルーンカテーテルに関するものである。 The present invention relates to a balloon catheter, and more particularly to a balloon catheter holding a drug.
　体内で血液が循環するための流路である血管に狭窄が生じ、血液の循環が滞ることにより、様々な疾患が発生することが知られている。特に心臓に血液を供給する冠状動脈に狭窄が生じると、狭心症、心筋梗塞等の重篤な疾病をもたらすおそれがある。このような血管の狭窄部を治療する方法の一つとして、バルーンカテーテルを用いて狭窄部を拡張させる血管形成術（ＰＴＡ、ＰＴＣＡ等）がある。血管形成術は、バイパス手術のような開胸術を必要としない低侵襲療法であることから広く行われている。 It is known that stenosis occurs in a blood vessel that is a flow path for blood to circulate in the body, and various diseases occur when blood circulation is delayed. In particular, when a stenosis occurs in a coronary artery that supplies blood to the heart, there is a risk of causing serious diseases such as angina pectoris and myocardial infarction. One method for treating such a stenosis of a blood vessel is an angioplasty (PTA, PTCA, etc.) that expands the stenosis using a balloon catheter. Angioplasty is widely performed because it is a minimally invasive therapy that does not require thoracotomy such as bypass surgery.
　ところで、血管形成術の場合、拡張した狭窄部に再狭窄が生じることがあり、そのような再狭窄が発生する頻度（再狭窄率）を低減する治療法として、薬剤層を表面に有する薬剤溶出ステントを用いた治療が行われている。また、バルーンカテーテルのバルーン部分に薬剤を保持させた薬剤溶出バルーンカテーテルも提案されている（例えば、特許文献１～４）。薬剤溶出バルーンカテーテルを用いれば、狭窄部や病変部でバルーンを拡張することにより薬剤を血管壁へ移行させることができ、再狭窄の発生抑制が期待できる。薬剤溶出バルーンカテーテルを用いた治療法の利点としては、体内に異物を残すことがないこと、ステントが挿入できない小血管も治療対象とできることなどが挙げられる。 By the way, in the case of angioplasty, restenosis may occur in an expanded stenosis, and drug elution with a drug layer on the surface is a treatment method that reduces the frequency of such restenosis (restenosis rate). Treatment using a stent is performed. In addition, drug-eluting balloon catheters in which a drug is held in the balloon portion of the balloon catheter have been proposed (for example, Patent Documents 1 to 4). If a drug-eluting balloon catheter is used, the drug can be transferred to the blood vessel wall by expanding the balloon at the stenosis or lesion, and the occurrence of restenosis can be expected to be suppressed. Advantages of a treatment method using a drug-eluting balloon catheter include that no foreign matter is left in the body, and that small blood vessels into which a stent cannot be inserted can be treated.
米国特許第５３０４１２１号明細書US Pat. No. 5,304,121 特表平５－５０５１３２号公報Japanese National Patent Publication No. 5-505132 特表２００８－５２９７４０号公報Special table 2008-529740 特開２０１５－２１７２６０号公報Japanese Patent Laid-Open No. 2015-217260
　薬剤溶出バルーンカテーテルを用いる場合、バルーンに保持させた薬剤を、狭窄部や病変部等の血管壁の所望の箇所のできるだけ限定した範囲に、しかも容易に流出しないように狭窄部や病変部のできるだけ奥の方に移行させることが望ましい。本発明は前記事情に鑑みてなされたものであり、その目的は、血管壁等の体腔内壁の狭窄部や病変部など所望の箇所に、狭窄部や病変部のできるだけ奥まで薬剤を届けることができるバルーンカテーテルを提供することにある。 When using a drug-eluting balloon catheter, the drug held in the balloon should be as much as possible in the stenosis or lesion so that it does not easily flow out to the desired area of the blood vessel wall such as the stenosis or lesion. It is desirable to move to the back. The present invention has been made in view of the above circumstances, and an object of the present invention is to deliver a drug to a desired portion such as a stenosis or a lesion in an inner wall of a body cavity such as a blood vessel wall as far as possible in the stenosis or a lesion. An object of the present invention is to provide a balloon catheter that can be used.
　前記課題を解決することができた本発明のバルーンカテーテルとは、シャフトと、シャフトの外側に設けられたバルーンとを有するバルーンカテーテルであって、バルーンは、ベースバルーンと、ベースバルーンの外側面に線状または網状に配置された補強部とを有し、補強部がバルーンの外側面に突出して形成され、補強部に薬剤が保持されているところに特徴を有する。 The balloon catheter of the present invention that has solved the above-mentioned problems is a balloon catheter having a shaft and a balloon provided on the outer side of the shaft, and the balloon is formed on the outer surface of the base balloon and the base balloon. It has a feature in that it has a reinforcing part arranged linearly or in a net shape, the reinforcing part is formed to protrude from the outer surface of the balloon, and the medicine is held in the reinforcing part.
　バルーンには、高さが０．２ｍｍ以上０．５ｍｍ以下の補強部が設けられていることが好ましい。バルーンの外側面には、補強部以外の部分が少なくとも直径０．５ｍｍの円形を包含する大きさで形成されていることが好ましい。 The balloon is preferably provided with a reinforcing portion having a height of 0.2 mm or more and 0.5 mm or less. It is preferable that a portion other than the reinforcing portion is formed on the outer surface of the balloon in a size including a circle having a diameter of at least 0.5 mm.
　バルーンには、補強部として、高さが０．２ｍｍ以上０．５ｍｍ以下の主補強部と、高さが０．０１ｍｍ以上０．２ｍｍ未満の補助補強部とが設けられていてもよく、この場合、少なくとも主補強部に薬剤が保持されていることが好ましい。この場合、バルーンの外側面には、主補強部以外の部分が少なくとも直径０．５ｍｍの円形を包含する大きさで形成されることが好ましい。 The balloon may be provided with a main reinforcing portion having a height of 0.2 mm to 0.5 mm and an auxiliary reinforcing portion having a height of 0.01 mm to less than 0.2 mm as the reinforcing portion. In this case, it is preferable that the drug is held at least on the main reinforcing portion. In this case, it is preferable that a portion other than the main reinforcing portion is formed on the outer surface of the balloon in a size including a circle having a diameter of at least 0.5 mm.
　補強部は、２．０３ＭＰａ（２０ａｔｍ）加圧時に、バルーンの外側面の補強部以外の部分よりもバルーン径方向の外方に突出していることが好ましい。補強部は、ベースバルーンの外側面に繊維材料が接合されて形成されていることが好ましい。補強部は、ベースバルーンの外側面に金属材料が接合されて形成されていてもよい。 It is preferable that the reinforcing portion protrudes outward in the balloon radial direction from a portion other than the reinforcing portion on the outer side surface of the balloon when the pressure is 2.03 MPa (20 atm). The reinforcing portion is preferably formed by bonding a fiber material to the outer surface of the base balloon. The reinforcing portion may be formed by joining a metal material to the outer surface of the base balloon.
　補強部の少なくとも一部は、バルーンの軸方向に延在して設けられていることが好ましい。また、補強部の一部はバルーンの軸方向に延在して設けられ、他部はバルーンの周方向にらせん状に延在して設けられていてもよい。 It is preferable that at least a part of the reinforcing portion is provided so as to extend in the axial direction of the balloon. Further, a part of the reinforcing part may be provided so as to extend in the axial direction of the balloon, and the other part may be provided so as to extend spirally in the circumferential direction of the balloon.
　補強部として主補強部と補助補強部とが設けられる場合は、主補強部がバルーンの軸方向に延在して設けられ、補助補強部がバルーンの周方向に延在して設けられていることが好ましい。また、主補強部は、バルーンの周方向にらせん状に延在して設けられ、補助補強部は、バルーンの周方向に主補強部とは反対向きのらせん状に延在して設けられていることも好ましい。 When the main reinforcing portion and the auxiliary reinforcing portion are provided as the reinforcing portion, the main reinforcing portion is provided extending in the axial direction of the balloon, and the auxiliary reinforcing portion is provided extending in the circumferential direction of the balloon. It is preferable. In addition, the main reinforcement portion is provided to extend in a spiral shape in the circumferential direction of the balloon, and the auxiliary reinforcement portion is provided to extend in a spiral shape in the opposite direction to the main reinforcement portion in the circumferential direction of the balloon. It is also preferable.
　薬剤は、抗増殖剤または免疫抑制剤であることが好ましい。 The drug is preferably an antiproliferative agent or an immunosuppressive agent.
　本発明のバルーンカテーテルは、ベースバルーンの外側面に補強部が線状または網状に設けられてバルーンが形成されているため、バルーンを加圧した際に、バルーンの過拡張が抑えられ、バルーンの補強部に保持した薬剤を、狭窄部や病変部等の体腔内壁の所望の箇所に塗布することが容易になる。その上で、補強部のスコアリング機能と相まって、補強部を狭窄部や病変部に食い込ませて、狭窄部や病変部の奥まで薬剤を届けることが可能となる。 In the balloon catheter of the present invention, since the balloon is formed by providing the reinforcing portion on the outer surface of the base balloon in a linear or mesh shape, when the balloon is pressurized, the balloon is prevented from being overexpanded. It becomes easy to apply the medicine held in the reinforcing part to a desired location on the inner wall of the body cavity such as a stenosis part or a lesion part. In addition, coupled with the scoring function of the reinforcing part, the reinforcing part can be bitten into the stenosis part or the lesion part, and the medicine can be delivered to the back of the stenosis part or the lesion part.
バルーンカテーテルの平面図を表す。1 represents a plan view of a balloon catheter. 図２（ａ）は図１に示したバルーンカテーテルのＡ－Ａ断面図を表し、図２（ｂ）は図１に示したバルーンカテーテルのＢ－Ｂ断面図を表す。2A is a cross-sectional view taken along the line AA of the balloon catheter shown in FIG. 1, and FIG. 2B is a cross-sectional view taken along the line BB of the balloon catheter shown in FIG. 図１に示したバルーンカテーテルに備えられるバルーンの一例として、バルーンの平面図を表す。The top view of a balloon is represented as an example of the balloon with which the balloon catheter shown in FIG. 1 is equipped. バルーンの他の例の平面図を表す。The top view of the other example of a balloon is represented. バルーンの他の例の平面図を表す。The top view of the other example of a balloon is represented. バルーンの他の例の平面図を表す。The top view of the other example of a balloon is represented. バルーンの他の例の平面図を表す。The top view of the other example of a balloon is represented.
　本発明は、バルーン表面に薬剤が保持されたバルーンカテーテルに関するものであり、詳細には、ベースバルーンの外側面に補強部が線状または網状に設けられ、補強部がバルーンの外側面に突出して設けられたバルーンを有し、バルーンの補強部に薬剤が保持されたバルーンカテーテルに関するものである。本発明のバルーンカテーテルによれば、ベースバルーンの外側面に補強部を線状または網状に設け、補強部に薬剤を保持させることにより、狭窄部や病変部などの限られた範囲に、狭窄部や病変部の奥の方まで薬剤を届けることが容易に行える。 The present invention relates to a balloon catheter in which a drug is held on the balloon surface. Specifically, a reinforcing portion is provided in a linear or net shape on the outer surface of the base balloon, and the reinforcing portion protrudes from the outer surface of the balloon. The present invention relates to a balloon catheter having a provided balloon and having a medicine held in a reinforcing part of the balloon. According to the balloon catheter of the present invention, the reinforcing portion is provided in a linear shape or a net shape on the outer surface of the base balloon, and the medicine is held in the reinforcing portion, so that the stenosis portion is limited to a limited range such as a stenosis portion or a lesion portion. Or the drug can be easily delivered to the back of the lesion.
　以下、下記実施の形態に基づき本発明のバルーンカテーテルを具体的に説明するが、本発明はもとより下記実施の形態によって制限を受けるものではなく、前・後記の趣旨に適合し得る範囲で適当に変更を加えて実施することも勿論可能であり、それらはいずれも本発明の技術的範囲に包含される。なお、各図面において、便宜上、ハッチングや部材符号等を省略する場合もあるが、かかる場合、明細書や他の図面を参照するものとする。また、図面における種々部材の寸法は、本発明の特徴の理解に資することを優先しているため、実際の寸法とは異なる場合がある。 Hereinafter, the balloon catheter of the present invention will be described in detail based on the following embodiment, but the present invention is not limited by the following embodiment as a matter of course, and is appropriately within a range that can meet the purpose described above and below. Of course, it is possible to carry out with modifications, and these are all included in the technical scope of the present invention. In addition, in each drawing, although hatching, a member code | symbol, etc. may be abbreviate | omitted for convenience, in this case, a description and another drawing shall be referred. In addition, the dimensions of the various members in the drawings are given priority to contribute to the understanding of the characteristics of the present invention, and may be different from the actual dimensions.
　図１および図２を参照して、バルーンカテーテルの全体構成について説明する。図１には、バルーンカテーテルの平面図を示し、図２（ａ）と図２（ｂ）にはそれぞれ、図１に示したバルーンカテーテルのＡ－Ａ断面図とＢ－Ｂ断面図を示している。図１には、シャフトの遠位側から近位側にわたってワイヤを挿通するオーバーザワイヤ型のバルーンカテーテルの構成例を示している。 The overall configuration of the balloon catheter will be described with reference to FIG. 1 and FIG. FIG. 1 shows a plan view of a balloon catheter, and FIGS. 2 (a) and 2 (b) show an AA sectional view and a BB sectional view of the balloon catheter shown in FIG. 1, respectively. Yes. FIG. 1 shows a configuration example of an over-the-wire type balloon catheter in which a wire is inserted from the distal side to the proximal side of the shaft.
　バルーンカテーテル１は、シャフト２と、シャフト２の外側に設けられたバルーン１０とを有する。バルーンカテーテル１は近位側と遠位側を有し、シャフト２の遠位側にバルーン１０が設けられ、シャフト２の近位側にはハブ５が設けられる。本発明において、バルーンカテーテルの近位側とは、バルーンカテーテル（特にシャフト）の延在方向に対して使用者（術者）の手元側の方向を指し、遠位側とは近位側の反対方向（すなわち処置対象側の方向）を指す。また、バルーンの近位側から遠位側への方向を軸方向と称する。 The balloon catheter 1 has a shaft 2 and a balloon 10 provided outside the shaft 2. The balloon catheter 1 has a proximal side and a distal side, a balloon 10 is provided on the distal side of the shaft 2, and a hub 5 is provided on the proximal side of the shaft 2. In the present invention, the proximal side of the balloon catheter refers to the direction of the proximal side of the user (operator) with respect to the extending direction of the balloon catheter (particularly the shaft), and the distal side is opposite to the proximal side. The direction (that is, the direction on the treatment target side) is indicated. A direction from the proximal side to the distal side of the balloon is referred to as an axial direction.
　バルーンカテーテル１は、ハブ５からシャフト２を通じてバルーン１０の内部に圧力流体が供給されるように構成され、インデフレーターを用いてバルーン１０の拡張および収縮を制御できる。 The balloon catheter 1 is configured such that a pressure fluid is supplied from the hub 5 to the inside of the balloon 10 through the shaft 2, and the expansion and contraction of the balloon 10 can be controlled using an indeflator.
　シャフト２は通常内部に、圧力流体の流路と、シャフト２の進行をガイドするワイヤの挿通路が設けられる。例えば、シャフト２は内管３と外管４から構成され、内管３がワイヤの挿通路として機能し、内管３と外管４の間の空間が圧力流体の流路として機能する。この場合、シャフト２の遠位側では、内管３が外管４の遠位端から延出してバルーン１０を軸方向に貫通し、バルーン１０の遠位側が内管３と接合され、バルーン１０の近位側が外管４と接合されるように構成される。 The shaft 2 is usually provided with a flow path for pressure fluid and a wire insertion path for guiding the progress of the shaft 2 inside. For example, the shaft 2 includes an inner tube 3 and an outer tube 4, and the inner tube 3 functions as a wire insertion path, and a space between the inner tube 3 and the outer tube 4 functions as a flow path for pressure fluid. In this case, on the distal side of the shaft 2, the inner tube 3 extends from the distal end of the outer tube 4 and penetrates the balloon 10 in the axial direction, and the distal side of the balloon 10 is joined to the inner tube 3. The proximal side is configured to be joined to the outer tube 4.
　ハブ５は、圧力流体の流路と連通した流体注入部６と、ワイヤの挿通路と連通した処置部７を有する。処置部７は、ワイヤを挿通する以外に、薬剤等の注入口や、生体体腔内の流体等の吸引口として機能させることができる。 The hub 5 has a fluid injection part 6 that communicates with the flow path of the pressure fluid, and a treatment part 7 that communicates with the wire insertion path. In addition to inserting the wire, the treatment unit 7 can function as an injection port for a medicine or the like, or a suction port for a fluid or the like in a body cavity.
　バルーン１０、シャフト２（内管３、外管４）、ハブ５の接合は、接着剤や熱溶着など従来公知の接合手段を用いて行うことができる。また、シャフト２のバルーン１０が位置する部分には、バルーン１０の位置をＸ線透視下で確認することを可能にするため、Ｘ線不透過マーカーを配置してもよい。 The bonding of the balloon 10, the shaft 2 (the inner tube 3, the outer tube 4) and the hub 5 can be performed using a conventionally known bonding means such as an adhesive or heat welding. In addition, an X-ray opaque marker may be arranged at the portion of the shaft 2 where the balloon 10 is located in order to make it possible to confirm the position of the balloon 10 under X-ray fluoroscopy.
　本発明は、シャフトの遠位側から近位側に至る途中までワイヤを挿通するラピッドエクスチェンジ型のバルーンカテーテルにも適用できる。その場合は、ワイヤの挿通路をシャフトの遠位側を含むシャフトの一部に設け、ハブには処置部を設けないようにすることもできる。また図１および図２には、シャフトの内部に血液が通ったりしない一般的なバルーンカテーテルを示しているが、本発明は、バルーンを長い時間拡張することによってバルーンに保持された薬剤を血管内壁などへ移行しやすくするために、バルーンを通過し、該バルーンの近位側と遠位側を血液などが移動できる灌流用ルーメンを有する灌流型バルーンカテーテルに適用することもできる。 The present invention can also be applied to a rapid exchange type balloon catheter in which a wire is inserted halfway from the distal side to the proximal side of the shaft. In this case, the wire insertion path may be provided in a part of the shaft including the distal side of the shaft, and the treatment portion may not be provided in the hub. FIGS. 1 and 2 show a general balloon catheter in which blood does not pass through the shaft. However, the present invention does not expand the balloon for a long time so that the medicine held in the balloon is transferred to the inner wall of the blood vessel. Can be applied to a perfusion-type balloon catheter having a perfusion lumen that can pass through a balloon and move blood between a proximal side and a distal side of the balloon.
　図３には、図１に示したバルーンカテーテルに備えられたバルーンの拡大図を示した。なお、バルーンカテーテルに備えられるバルーンは、図３に示したバルーンに限定されない。 FIG. 3 shows an enlarged view of the balloon provided in the balloon catheter shown in FIG. The balloon provided in the balloon catheter is not limited to the balloon shown in FIG.
　バルーン１０は、ベースバルーン１１と、ベースバルーン１１の外側面に線状または網状に配置された補強部１２とを有し、補強部１２がベースバルーン１１の外側面に突出して形成されている。ベースバルーン１１はバルーン１０の基本形状を規定し、近位側と遠位側にそれぞれ開口を有する袋状に形成される。補強部１２はベースバルーン１１の外側面に線状または網状のパターンで設けられており、補強部１２が当該パターンでベースバルーン１１の外側面に固定されている。ベースバルーン１１の外側面に補強部１２を設けることにより、バルーン１０の耐圧性を高めたり加圧時の過拡張の抑制が可能となる。また、補強部１２にスコアリング機能を付与して、血管形成術において石灰化した狭窄部に亀裂を入れて拡張することも可能となる。従って、バルーン１０は、ある圧力以上ではバルーンを加圧してもバルーン径がほとんど増加しない、いわゆるノンコンプライアント型であることが好ましい。 The balloon 10 has a base balloon 11 and a reinforcing portion 12 arranged in a linear or net shape on the outer surface of the base balloon 11, and the reinforcing portion 12 is formed to protrude from the outer surface of the base balloon 11. The base balloon 11 defines the basic shape of the balloon 10 and is formed in a bag shape having openings on the proximal side and the distal side. The reinforcing portion 12 is provided on the outer surface of the base balloon 11 in a linear or net pattern, and the reinforcing portion 12 is fixed to the outer surface of the base balloon 11 in this pattern. By providing the reinforcing portion 12 on the outer surface of the base balloon 11, it is possible to increase the pressure resistance of the balloon 10 and to suppress overexpansion during pressurization. It is also possible to give the reinforcing part 12 a scoring function and to expand the stenosis part calcified in angioplasty by cracking. Therefore, the balloon 10 is preferably a so-called non-compliant type in which the balloon diameter hardly increases even when the balloon is pressurized above a certain pressure.
　バルーン１０は、図３に示すように、円筒形状の直管部１４と、その近位側に接続する近位側テーパー部１５と、遠位側に接続する遠位側テーパー部１６とを有することが好ましく、近位側テーパー部１５と遠位側テーパー部１６は直管部１４から離れるに従って縮径するように形成される。近位側テーパー部１５の近位側には円筒形状の近位側スリーブ１７が接続し、遠位側テーパー部１６の遠位側には円筒形状の遠位側スリーブ１８が接続しており、図１に示したカテーテルでは、近位側スリーブ１７がシャフト２の外管４に接合され、遠位側スリーブ１８がシャフト２の内管３に接合されている。直管部１４の外径や軸方向の長さ、テーパー部１５、１６のテーパー角度や軸方向の長さは、バルーン１０の所望の機能に応じて適宜設定すればよい。また、テーパー部１５、１６のテーパー角度を軸方向に対して９０°に設定して、バルーン１０を略円筒形状に形成することもできる。なお、バルーン１０は圧力流体が供給されることにより近位側テーパー部１５から直管部１４を経て遠位側テーパー部１６が膨らむように構成されており、本発明においては当該膨張可能な部分をバルーンと見なす。 As shown in FIG. 3, the balloon 10 has a cylindrical straight tube portion 14, a proximal taper portion 15 connected to the proximal side thereof, and a distal taper portion 16 connected to the distal side. Preferably, the proximal taper portion 15 and the distal taper portion 16 are formed so as to be reduced in diameter as they move away from the straight tube portion 14. A cylindrical proximal sleeve 17 is connected to the proximal side of the proximal tapered portion 15, and a cylindrical distal sleeve 18 is connected to the distal side of the distal tapered portion 16. In the catheter shown in FIG. 1, the proximal sleeve 17 is joined to the outer tube 4 of the shaft 2, and the distal sleeve 18 is joined to the inner tube 3 of the shaft 2. What is necessary is just to set suitably the outer diameter of the straight tube | pipe part 14, the length of an axial direction, the taper angle of the taper parts 15 and 16, and the length of an axial direction according to the desired function of the balloon 10. FIG. In addition, the balloon 10 can be formed in a substantially cylindrical shape by setting the taper angle of the tapered portions 15 and 16 to 90 ° with respect to the axial direction. The balloon 10 is configured such that the distal tapered portion 16 swells from the proximal tapered portion 15 through the straight tube portion 14 when a pressure fluid is supplied, and in the present invention, the inflatable portion. Is considered a balloon.
　ベースバルーンは、例えば、樹脂を成形することにより製造することができる。例えば、押出成形によって押し出された樹脂チューブを金型に配置し、二軸延伸ブロー成形することによりベースバルーンを製造することができる。ベースバルーンは、金型の形状によって任意の形状に形成することができる。また、ディップ成形、射出成形、圧縮成形などの公知の成形方法によりベースバルーンを製造することもできる。ベースバルーンは複数層の樹脂層から構成されていてもよく、あるいは樹脂層以外の層を有していてもよい。 The base balloon can be manufactured, for example, by molding a resin. For example, the base balloon can be manufactured by placing a resin tube extruded by extrusion molding in a mold and biaxially stretching blow molding. The base balloon can be formed in an arbitrary shape depending on the shape of the mold. In addition, the base balloon can be manufactured by a known molding method such as dip molding, injection molding, and compression molding. The base balloon may be composed of a plurality of resin layers, or may have a layer other than the resin layer.
　ベースバルーンを構成する樹脂としては、ポリアミド系樹脂、ポリエステル系樹脂、ポリウレタン系樹脂、ポリオレフィン系樹脂、塩化ビニル系樹脂、シリコーン系樹脂、天然ゴム等が挙げられる。これらは１種のみを用いてもよく、２種以上を併用してもよい。なかでも、ポリアミド系樹脂、ポリエステル系樹脂、ポリウレタン系樹脂が好適に用いられる。これらの樹脂は、バルーンの薄膜化や柔軟性の点からエラストマー樹脂を用いることが好ましい。例えばポリアミド系樹脂の中でベースバルーンに好適な材料として、ナイロン１２、ナイロン１１等が挙げられ、ブロー成形する際に比較的容易に成形可能である点から、ナイロン１２が好適に用いられる。また、バルーンの薄膜化や柔軟性の点から、ポリエーテルエステルアミドエラストマー、ポリアミドエーテルエラストマー等のポリアミドエラストマーが好ましく用いられる。なかでも、降伏強度が高く、バルーンの寸法安定性が良好な点から、ポリエーテルエステルアミドエラストマーが好ましく用いられる。 Examples of the resin constituting the base balloon include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, vinyl chloride resins, silicone resins, and natural rubber. These may use only 1 type and may use 2 or more types together. Among these, polyamide resins, polyester resins, and polyurethane resins are preferably used. For these resins, it is preferable to use an elastomer resin from the viewpoint of thinning the balloon and flexibility. For example, nylon 12 and nylon 11 and the like are suitable materials for the base balloon among polyamide resins, and nylon 12 is preferably used because it can be molded relatively easily when blow molding. Further, polyamide elastomers such as polyether ester amide elastomers and polyamide ether elastomers are preferably used from the viewpoint of thinning the balloon and flexibility. Of these, polyether ester amide elastomers are preferably used because they have high yield strength and good dimensional stability of the balloon.
　ベースバルーンの寸法は、治療部位の大きさ等に応じて適宜設定すればよい。例えば、治療部位が血管の場合は、軸方向の長さを５ｍｍ～３００ｍｍ、外径を１ｍｍ～１２ｍｍとすることが好ましく、治療部位が十二指腸乳頭等の消化管の場合は、軸方向の長さを１０ｍｍ～１００ｍｍ、外径を３ｍｍ～３０ｍｍとすることが好ましい。 The dimensions of the base balloon may be appropriately set according to the size of the treatment site. For example, when the treatment site is a blood vessel, the axial length is preferably 5 mm to 300 mm and the outer diameter is preferably 1 mm to 12 mm. When the treatment site is a digestive tract such as a duodenal papilla, the axial length is preferred. Is preferably 10 mm to 100 mm, and the outer diameter is preferably 3 mm to 30 mm.
　補強部１２は、ベースバルーン１１の外側面に線状または網状のパターンで設けられる。補強部１２はバルーン１０の外側面に突出して形成され、すなわちバルーン１０の外側面においてバルーン径方向の外方に突出するように設けられる。補強部１２は、ベースバルーン１１の外側面に部分的に配置された層として設けられる。バルーン１０の外側面の補強部１２以外の部分には、非補強部１３が形成される。従って、バルーン１０の外側面において、補強部１２は非補強部１３よりも突出して形成され、非補強部１３は補強部１２に対して凹んで形成される。また、バルーン１０において、補強部１２は非補強部１３よりも厚みが厚く形成される。 The reinforcing portion 12 is provided on the outer surface of the base balloon 11 in a linear or net pattern. The reinforcing portion 12 is formed so as to protrude on the outer surface of the balloon 10, that is, provided on the outer surface of the balloon 10 so as to protrude outward in the balloon radial direction. The reinforcing portion 12 is provided as a layer partially disposed on the outer surface of the base balloon 11. A non-reinforcing portion 13 is formed in a portion other than the reinforcing portion 12 on the outer surface of the balloon 10. Accordingly, the reinforcing portion 12 is formed so as to protrude from the non-reinforcing portion 13 on the outer surface of the balloon 10, and the non-reinforcing portion 13 is formed to be recessed with respect to the reinforcing portion 12. In the balloon 10, the reinforcing portion 12 is formed thicker than the non-reinforcing portion 13.
　線状のパターンで設けられた補強部１２としては、線状の補強部１２がバルーンの軸方向に延びるように配置された態様（図４（ａ）を参照）、線状の補強部１２がバルーンの周方向に延び、リング状に配置された態様（図４（ｂ）を参照）、線状の補強部がバルーンの外側面にらせん状（コイル状）に配置された態様（図４（ｃ）を参照）などが示される。この場合、線状の補強部は複数設けられてもよいが、それぞれの補強部は互いに交わらないように配置される。 As the reinforcing part 12 provided in a linear pattern, a mode in which the linear reinforcing part 12 is arranged so as to extend in the axial direction of the balloon (see FIG. 4A), the linear reinforcing part 12 includes A mode (see FIG. 4B) extending in the circumferential direction of the balloon and arranged in a ring shape, and a mode in which a linear reinforcing portion is arranged in a spiral shape (coil shape) on the outer surface of the balloon (FIG. 4 ( see c)). In this case, a plurality of linear reinforcing portions may be provided, but the reinforcing portions are arranged so as not to cross each other.
　網状のパターンで設けられた補強部は、線状の補強部が互いに交わるように配置されたものであれば特に限定されず、例えば、上記に説明した線状のパターンの各態様を組み合わせて形成することができる。線状の補強部が交わる部分では、線状の補強部どうしが単に交差するものであってもよく（重ね合わせ構造）、編み構造を形成するものであってもよい（編組構造）。図３には、補強部が、軸方向に線状に延びるパターンと右巻きおよび左巻きのらせん状パターンが組み合わさった網状のパターンで配置された態様が示されている。図５（ａ）には、補強部が、右巻きおよび左巻きのらせん状パターンが組み合わさった網状のパターンで配置された態様が示されている。また、網状のパターンとして、三角格子や六角格子等の格子状パターンで補強部を設けてもよい。図５（ｂ）には、補強部が六角格子状のパターンで配置された態様が示されている。 The reinforcing part provided in the net-like pattern is not particularly limited as long as the linear reinforcing parts are arranged so as to cross each other, for example, formed by combining each aspect of the linear pattern described above can do. In the portion where the linear reinforcing portions intersect, the linear reinforcing portions may simply intersect each other (overlapping structure) or may form a knitted structure (braided structure). FIG. 3 shows a mode in which the reinforcing portions are arranged in a net pattern in which a pattern extending linearly in the axial direction and a right-handed and left-handed spiral pattern are combined. FIG. 5A shows a mode in which the reinforcing portions are arranged in a net-like pattern in which right-handed and left-handed spiral patterns are combined. Moreover, you may provide a reinforcement part with lattice-like patterns, such as a triangular lattice and a hexagonal lattice, as a net-like pattern. FIG. 5B shows a mode in which the reinforcing portions are arranged in a hexagonal lattice pattern.
　補強部の高さや線幅は、バルーンの所望する性能に応じて適宜設定すればよい。補強部は、全て同じ高さで設けられてもよく、異なる高さの部分を有するように設けられてもよい。また補強部は、全て同じ線幅で設けられてもよく、異なる線幅の部分を有するように設けられてもよい。なお、バルーンの軸方向への拡張を抑制する観点から、軸方向に延びる補強部の線幅が周方向に延びる補強部の線幅より太い方が好ましい。補強部の高さは、例えば、０．０１ｍｍ以上が好ましく、０．１ｍｍ以上がより好ましく、また０．５ｍｍ以下が好ましい。補強部の高さは、バルーンの外側面から突出した高さを意味し、非補強部からの高さを測定することにより求めることができる。補強部を繊維材料から形成する場合は、繊維材料の太さを補強部の高さとしてもよい。補強部の線幅は、例えば、０．０２ｍｍ以上が好ましく、０．１ｍｍ以上がより好ましく、また０．３ｍｍ以下が好ましい。補強部の線幅は、例えば、補強部の高さの半値幅（補強部の高さが半分となる箇所の幅）を測定することにより求めたり、後述するように補強部を繊維材料から形成する場合は、繊維材料の幅（太さ）を補強部の線幅としてもよい。補強部の高さや線幅は、バルーンの切断断面を測定することにより求めることができる。 The height and line width of the reinforcing part may be appropriately set according to the desired performance of the balloon. The reinforcing portions may all be provided at the same height, or may be provided so as to have different height portions. Moreover, all the reinforcement parts may be provided with the same line width, and may be provided so that it may have a part with a different line width. From the viewpoint of suppressing expansion of the balloon in the axial direction, the line width of the reinforcing portion extending in the axial direction is preferably larger than the line width of the reinforcing portion extending in the circumferential direction. For example, the height of the reinforcing portion is preferably 0.01 mm or more, more preferably 0.1 mm or more, and preferably 0.5 mm or less. The height of the reinforcing part means a height protruding from the outer surface of the balloon, and can be obtained by measuring the height from the non-reinforcing part. When the reinforcing portion is formed from a fiber material, the thickness of the fiber material may be the height of the reinforcing portion. The line width of the reinforcing portion is, for example, preferably 0.02 mm or more, more preferably 0.1 mm or more, and preferably 0.3 mm or less. The line width of the reinforcing portion is obtained by measuring, for example, the half-value width of the height of the reinforcing portion (the width of the portion where the height of the reinforcing portion is half), or the reinforcing portion is formed from a fiber material as described later. When doing, it is good also considering the width | variety (thickness) of a fiber material as the line | wire width of a reinforcement part. The height and line width of the reinforcing part can be obtained by measuring the cut section of the balloon.
　バルーンの外側面における補強部の割合（バルーンの外側面において補強部が占める面積割合）は、バルーンの所望する性能に応じて適宜設定すればよい。例えば、バルーンの直管部の外側面における補強部の面積割合は２０％以上が好ましく、３０％以上がより好ましく、また８０％以下が好ましく、６０％以下がより好ましい。バルーンの外側面における補強部の面積割合は、補強部の高さが半分となる箇所を補強部と非補強部の境界として定めて、それより高い部分を補強部と見なして、補強部の面積を求めることができる。また、後述するように補強部を繊維材料から形成する場合は、繊維材料の設置面積（ベースバルーン表面への投影面積）を補強部の面積として求めてもよい。 The proportion of the reinforcing portion on the outer surface of the balloon (the proportion of the area occupied by the reinforcing portion on the outer surface of the balloon) may be appropriately set according to the desired performance of the balloon. For example, the area ratio of the reinforcing portion on the outer surface of the straight tube portion of the balloon is preferably 20% or more, more preferably 30% or more, and preferably 80% or less, more preferably 60% or less. The area ratio of the reinforced part on the outer surface of the balloon is defined as the area where the height of the reinforced part is halved as the boundary between the reinforced part and the non-reinforced part, and the higher part is regarded as the reinforced part. Can be requested. Moreover, when forming a reinforcement part from a fiber material so that it may mention later, you may obtain | require the installation area (projection area to the base balloon surface) of a fiber material as an area of a reinforcement part.
　上記に説明した補強部の高さや線幅、補強部の面積割合は、バルーンを切断したり展開して、バルーンを非加圧状態で測定することにより求められる。後述する様々な値についても、特に断りのない限り、バルーンの非加圧状態での値を意味する。 The height and line width of the reinforcing portion and the area ratio of the reinforcing portion described above can be obtained by cutting or expanding the balloon and measuring the balloon in a non-pressurized state. Various values to be described later also mean values in a non-pressurized state of the balloon unless otherwise specified.
　補強部は、ベースバルーンと同じ材料から構成されてもよく、異なる材料から構成されてもよい。なお、補強部はベースバルーンよりも高強度で伸びにくい材料から構成されることが好ましく、このように補強部を構成することにより、補強部にスコアリング機能を持たせたり、バルーンの寸法安定性を高めることができる。 補強 The reinforcing part may be made of the same material as the base balloon or may be made of a different material. The reinforcing part is preferably made of a material that is stronger and harder to stretch than the base balloon. By configuring the reinforcing part in this way, the reinforcing part can have a scoring function, or the dimensional stability of the balloon. Can be increased.
　補強部は、例えば、繊維材料をベースバルーンの外側面に接合することにより形成することができる。繊維材料は、モノフィラメントであっても、マルチフィラメントであってもよい。繊維材料は、バルーンの高強度化の点から、ベースバルーンよりも高強度で伸びにくい（弾性率が高い）ことが好ましく、さらに高い引張強度を有することが好ましい。そのような繊維材料として、例えば、ポリアリレート繊維、アラミド繊維、超高分子量ポリエチレン繊維、ＰＢＯ繊維、炭素繊維等が挙げられる。 The reinforcing portion can be formed, for example, by bonding a fiber material to the outer surface of the base balloon. The fiber material may be monofilament or multifilament. From the viewpoint of increasing the strength of the balloon, the fiber material preferably has a higher strength and is less likely to stretch (has a higher elastic modulus) than the base balloon, and preferably has a higher tensile strength. Examples of such a fiber material include polyarylate fiber, aramid fiber, ultrahigh molecular weight polyethylene fiber, PBO fiber, and carbon fiber.
　補強部は、金属材料をベースバルーンの外側面に接合することにより形成してもよい。金属材料はベースバルーンよりも高弾性の材料であり、高いスコアリング機能を有する。金属材料として、例えば、ニチノール（Ｎｉ- Ｔｉ合金）、コバルト合金、タンタル、ステンレス（ＳＵＳ３０４等）が挙げられる。これらの中では、弾性域が広く、高いスコアリング機能が得られる点から、ニチノールが好ましい。 The reinforcing portion may be formed by joining a metal material to the outer surface of the base balloon. The metal material is a material having higher elasticity than the base balloon and has a high scoring function. Examples of the metal material include nitinol (Ni— Ti alloy), cobalt alloy, tantalum, and stainless steel (SUS304, etc.). Among these, nitinol is preferable because it has a wide elastic range and provides a high scoring function.
　例えば図３に示したバルーンの場合、ベースバルーンの軸方向に平行で、周方向に間隔をおいて並べた複数の繊維材料２１と、複数のらせん状に巻いた繊維材料２２、２３を、編み込まずにそのまま重ね合わせるか、または、編み込むことにより、補強部を形成することができる。各繊維材料を編み込まずに重ね合わせる場合、ベースバルーン１１の軸方向の全長にわたり、その表面から順に、繊維材料２１、繊維材料２２（２３）、繊維材料２３（２２）と重ねてもよいし、繊維材料２２（２３）、繊維材料２１、繊維材料２３（２２）と重ねてもよいし、繊維材料２２（２３）、繊維材料２３（２２）、繊維材料２１と重ねてもよい。各繊維材料を編み込む場合は、各繊維材料２１、２２、２３を規則的にバルーン径方向の外側と内側を入れ替えて編み込んだ構造であればよい。なお、らせん状に巻いた繊維材料２２の巻き方向は、らせん状に巻いた繊維材料２３とは反対方向である。繊維材料２１、２２、２３は均一に巻かれていてもよいし、不均一に巻かれていてもよい。例えば、複数本の繊維をまとめて繊維材料２１、２２、２３を形成することで、周方向に多くの本数の繊維を配置する際に、複雑な装置を使用することなく、簡便に製造することが可能となる。 For example, in the case of the balloon shown in FIG. 3, a plurality of fiber materials 21 parallel to the axial direction of the base balloon and arranged at intervals in the circumferential direction, and a plurality of spirally wound fiber materials 22, 23 are knitted. The reinforcing portion can be formed by superimposing or knitting them as they are without knitting. When the fiber materials are overlapped without being knitted, the fiber material 21, the fiber material 22 (23), and the fiber material 23 (22) may be overlapped sequentially from the surface over the entire length of the base balloon 11 in the axial direction. The fiber material 22 (23), the fiber material 21, and the fiber material 23 (22) may be overlapped, or the fiber material 22 (23), the fiber material 23 (22), and the fiber material 21 may be overlapped. In the case of knitting each fiber material, the fiber materials 21, 22, and 23 may be structured so as to be knitted by regularly replacing the outer side and the inner side in the balloon radial direction. The winding direction of the spirally wound fiber material 22 is opposite to that of the spirally wound fiber material 23. The fiber materials 21, 22, and 23 may be wound uniformly or may be wound non-uniformly. For example, by forming a plurality of fibers together to form the fiber materials 21, 22, and 23, when a large number of fibers are arranged in the circumferential direction, they can be easily manufactured without using a complicated device. Is possible.
　繊維材料のベースバルーンへの接合方法としては、ベースバルーンの外側面に繊維材料を配置した状態で接着剤を繊維材料の外側から塗布する方法、ベースバルーンおよび／または繊維材料に接着剤を塗布した後、ベースバルーンの外側面に繊維材料を配置する方法、繊維材料を熱溶着によりベースバルーンに接合する方法等が挙げられる。接着剤としては、樹脂を用いることもできる。 As a method of joining the fiber material to the base balloon, a method in which an adhesive is applied from the outside of the fiber material in a state where the fiber material is disposed on the outer surface of the base balloon, and an adhesive is applied to the base balloon and / or the fiber material. Thereafter, a method of arranging a fiber material on the outer surface of the base balloon, a method of joining the fiber material to the base balloon by heat welding, and the like can be mentioned. A resin can also be used as the adhesive.
　繊維材料の本数は、ベースバルーンの大きさ、繊維材料の太さ（補強部の高さや線幅）、バルーンの強度、薬剤の保持量等を勘案して、適宜設定すればよい。例えば、軸方向に延びる繊維材料（軸方向に線状に延びる補強部）は周方向に間隔をおいて複数配されることが好ましく、このときの周方向に配置する本数は３本～３０本とすることが好ましい。また、らせん状に巻いた繊維材料は（らせん状に延びる補強部）の本数は３本～３０本とすることが好ましく、このときの巻き角度は軸方向に対して５０°～８０°の範囲で設定することが好ましい。 The number of fiber materials may be set as appropriate in consideration of the size of the base balloon, the thickness of the fiber material (height and line width of the reinforcing portion), the strength of the balloon, the amount of drug retained, and the like. For example, a plurality of fiber materials extending in the axial direction (reinforcing portions extending linearly in the axial direction) are preferably arranged at intervals in the circumferential direction, and the number of fibers arranged in the circumferential direction at this time is 3 to 30 It is preferable that In addition, the number of spirally wound fiber materials (reinforcing portions extending in a spiral shape) is preferably 3 to 30, and the winding angle at this time ranges from 50 ° to 80 ° with respect to the axial direction. It is preferable to set by.
　バルーンには、補強部に薬剤が保持されている。バルーンの補強部に薬剤を保持させることにより、補強部のスコアリング機能と相まって、狭窄部や病変部の奥まで薬剤を届けることが可能となる。 バ ル ー ン Drugs are held in the reinforcing part of the balloon. By holding the drug in the reinforcing part of the balloon, it becomes possible to deliver the drug to the back of the stenosis part or the lesion part in combination with the scoring function of the reinforcing part.
　バルーンに保持される薬剤は、薬理活性物質であれば特に限定されず、例えば、非遺伝子治療薬、遺伝子治療薬、小分子、細胞等の医薬として許容される薬剤が挙げられる。特に、バルーンカテーテルを血管形成術における治療後の血管の再狭窄を抑制する目的で使用する場合は、薬剤として抗増殖剤や免疫抑制剤などの抗再狭窄剤を好ましく用いることができ、具体的には、パクリタキセル、シロリムス（ラパマイシン）、エベロリムス、ゾタロリムス等の薬剤を用いることができる。これらの薬剤は、１種のみを用いてもよく、２種以上を用いてもよい。 The drug held in the balloon is not particularly limited as long as it is a pharmacologically active substance, and examples thereof include pharmaceutically acceptable drugs such as non-gene therapy drugs, gene therapy drugs, small molecules, and cells. In particular, when a balloon catheter is used for the purpose of suppressing vascular restenosis after treatment in angioplasty, an anti-restenosis agent such as an antiproliferative agent or an immunosuppressive agent can be preferably used as the drug. For example, drugs such as paclitaxel, sirolimus (rapamycin), everolimus, and zotarolimus can be used. These drugs may be used alone or in combination of two or more.
　薬剤は、薬剤層として補強部に保持されていてもよく、マイクロカプセル等の形態で補強部に保持されていてもよい。また、補強部に薬剤が染み込む形で保持されていてもよい。薬剤には、薬理活性物質とともに、薬剤の分散性、溶解性、血管壁への移行性、保存安定性を向上させるための助剤が含まれていてもよい。助剤としては、安定化剤、結合剤、崩壊剤、防湿剤、防腐剤、溶解助剤などが用いられ、具体的には、乳糖、白糖、麦芽糖、デキストリン、キシリトール、エリスリトール、マンニトール、エチレンジアミン、ヨウ化カリウム、尿素、ポリソルベート、ジブチルヒドロキシトルエン、ピロ亜硫酸ナトリウム、アスコルビン酸、トコフェロール、安息香酸、パラオキシ安息香酸エステル類等が挙げられる。 The drug may be held in the reinforcing part as a drug layer, or may be held in the reinforcing part in the form of a microcapsule or the like. Moreover, the chemical | medical agent may be hold | maintained at the reinforcement part. The drug may contain, together with the pharmacologically active substance, an auxiliary agent for improving the dispersibility, solubility, migration to the blood vessel wall, and storage stability of the drug. As auxiliary agents, stabilizers, binders, disintegrants, moisture-proofing agents, preservatives, dissolution aids and the like are used. Specifically, lactose, sucrose, maltose, dextrin, xylitol, erythritol, mannitol, ethylenediamine, Examples thereof include potassium iodide, urea, polysorbate, dibutylhydroxytoluene, sodium pyrosulfite, ascorbic acid, tocopherol, benzoic acid, and paraoxybenzoic acid esters.
　薬剤は、狭窄部や病変部への送達中（デリバリー中）に薬剤が血液中に溶出したり脱落することを抑制するために、被覆層で保護された状態でバルーンに保持されていてもよい。被覆層は、薬剤の初期バーストを防止する観点から水溶性高分子であることが望ましく、例えば、カルボキシルメチルセルロース、ヒドロキシプロピルセルロース、メチルセルロース、ヒドロキシエチルセルロース、ポリビニルアルコール、アルギン酸、ペクチン、アラビアガム、ジェランガム、グアガム、キサンタンガム、カラギーナン、ゼラチンなどから形成することができる。 The drug may be held in a balloon in a state protected with a coating layer in order to prevent the drug from eluting into the blood or falling off during delivery to the stenosis or lesion (during delivery). . The coating layer is preferably a water-soluble polymer from the viewpoint of preventing the initial burst of the drug, for example, carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, hydroxyethyl cellulose, polyvinyl alcohol, alginic acid, pectin, gum arabic, gellan gum, gua gum Xanthan gum, carrageenan, gelatin and the like.
　薬剤または被覆層のバルーン表面との密着性を高めるために、バルーンの外側面には表面処理が施されてもよい。表面処理としては、プラズマ処理、レーザー処理、イオン処理、オゾン処理、放電処理、プライマー処理等が例示できる。 In order to enhance the adhesion of the drug or coating layer to the balloon surface, the outer surface of the balloon may be subjected to a surface treatment. Examples of the surface treatment include plasma treatment, laser treatment, ion treatment, ozone treatment, discharge treatment, and primer treatment.
　バルーンの外側面には、補強部以外の部分である非補強部にも薬剤が保持されていてもよいが、バルーンに薬剤が保持された状態で、補強部が非補強部よりも突出して形成されていることが好ましい。これにより、補強部に保持させた薬剤を狭窄部や病変部の奥まで届けやすくなる。なお、バルーンに薬剤が保持された状態には、バルーンに薬剤が保持された上で、さらに被覆層等が設けられた状態が含まれる。 On the outer surface of the balloon, the medicine may be held in the non-reinforcing part, which is a part other than the reinforcing part, but the reinforcing part protrudes from the non-reinforcing part while the medicine is held in the balloon. It is preferable that Thereby, it becomes easy to deliver the medicine held in the reinforcing part to the back of the stenosis part or the lesion part. The state where the drug is held in the balloon includes a state where the drug is held in the balloon and a coating layer or the like is further provided.
　補強部のスコアリング機能を高め、薬剤を狭窄部や病変部の奥まで届けることを容易にする点から、バルーンには、高さが０．２ｍｍ以上０．５ｍｍ以下の補強部が設けられることが好ましい。バルーンの外側面にこのような高さの補強部が設けられれば、補強部を狭窄部や病変部に食い込ませるようにして、薬剤を狭窄部や病変部のより奥まで届けることが容易になる。また、補強部によってバルーン加圧時の過拡張を抑制することもできるため、血管形成術において石灰化した狭窄部の奥まで薬剤を届けることも可能となる。なお、補強部の高さとは補強部の最高高さを意味し、バルーンにはこれよりも高さの低い補強部が設けられていてもよい。 The balloon should be provided with a reinforcing part with a height of 0.2 mm or more and 0.5 mm or less in order to enhance the scoring function of the reinforcing part and facilitate the delivery of the drug to the back of the stenosis or lesion. Is preferred. If a reinforcing portion having such a height is provided on the outer surface of the balloon, it becomes easier to deliver the drug deeper into the stenosis or lesion by causing the reinforcement to bite into the stenosis or lesion. . Moreover, since the overexpansion at the time of balloon pressurization can also be suppressed by the reinforcing portion, it is possible to deliver the drug to the back of the stenotic portion calcified in angioplasty. The height of the reinforcing part means the maximum height of the reinforcing part, and the balloon may be provided with a reinforcing part having a lower height.
　補強部は、バルーンの外側面での突出状態が際立つように設けられることが好ましく、具体的には、隣接する補強部とある程度の間隔を空けて設けられることが好ましい。この点から、バルーンの外側面には、補強部以外の部分が、少なくとも直径０．５ｍｍ（当該直径は０．８ｍｍがより好ましく、１．０ｍｍがさらに好ましい）の円形を包含する大きさで形成されていることが好ましい。なお、ここで説明した円形とは、補強部に接する内接円の直径が最大となるように仮に描いた図形であり、補強部以外の部分の大きさを表現するためのものである。このように補強部を設けることにより、補強部のスコアリング機能を高めたり、薬剤を狭窄部や病変部の奥まで届けることが容易になる。一方、狭窄部や病変部に届ける薬剤量を確保する点から、バルーンの外側面には、補強部以外の部分が、直径１．５ｍｍ（当該直径は１．３ｍｍがより好ましく、１．１ｍｍがさらに好ましい）の円形を包含しない大きさで形成されていることが好ましい。例えば、図４（ａ）～（ｃ）と図５（ａ）～（ｂ）に示したバルーンでは、隣接する複数の補強部１２に接する内接円１９の直径が０．５ｍｍ以上となることが好ましく、また１．５ｍｍ未満となることが好ましい。なお、内接円１９は、補強部１２で囲まれた部分または挟まれた部分で最も大きな径を有するように規定される。 The reinforcing portion is preferably provided so that the protruding state on the outer surface of the balloon is conspicuous, and specifically, it is preferably provided with a certain distance from the adjacent reinforcing portion. From this point, on the outer surface of the balloon, a portion other than the reinforcing portion is formed in a size including a circle having a diameter of at least 0.5 mm (the diameter is more preferably 0.8 mm, and further preferably 1.0 mm). It is preferable that In addition, the circle described here is a figure temporarily drawn so that the diameter of the inscribed circle in contact with the reinforcing portion is maximized, and is for expressing the size of a portion other than the reinforcing portion. By providing the reinforcing portion in this manner, it becomes easy to enhance the scoring function of the reinforcing portion or to deliver the medicine to the back of the stenosis portion or the lesioned portion. On the other hand, from the viewpoint of securing the amount of drug delivered to the stenosis or lesion, the outer surface of the balloon has a portion other than the reinforcing portion having a diameter of 1.5 mm (the diameter is more preferably 1.3 mm, and 1.1 mm is More preferably, it is formed in a size not including a circle. For example, in the balloons shown in FIGS. 4 (a) to 4 (c) and FIGS. 5 (a) to 5 (b), the diameter of the inscribed circle 19 in contact with a plurality of adjacent reinforcing portions 12 is 0.5 mm or more. It is preferable that it is less than 1.5 mm. The inscribed circle 19 is defined so as to have the largest diameter at a portion surrounded by the reinforcing portion 12 or a portion sandwiched therebetween.
　上記に説明したバルーン外側面の補強部以外の部分の大きさは、高さが０．２ｍｍ以上０．５ｍｍ以下の補強部に対して定められることが好ましい。すなわち、バルーンの外側面には、高さが０．２ｍｍ以上０．５ｍｍ以下の補強部以外の部分が、少なくとも直径０．５ｍｍの円形を包含する大きさで形成されていることが好ましく、また直径１．５ｍｍの円形を包含しない大きさで形成されていることが好ましい。補強部の高さの好適範囲や補強部以外の部分の大きさの好適範囲は上記に説明した通りである。このように補強部を設けることにより、バルーンのスコアリング機能を高めたり、より多くの薬剤を狭窄部や病変部の奥まで届けることが容易になる。 The size of the portion other than the reinforcing portion on the outer surface of the balloon described above is preferably determined with respect to the reinforcing portion having a height of 0.2 mm or more and 0.5 mm or less. That is, it is preferable that a portion other than the reinforcing portion having a height of 0.2 mm or more and 0.5 mm or less is formed on the outer surface of the balloon in a size including a circle having a diameter of at least 0.5 mm. It is preferable that it is formed in a size that does not include a circle having a diameter of 1.5 mm. The preferred range of the height of the reinforcing portion and the preferred range of the size of the portion other than the reinforcing portion are as described above. By providing the reinforcing portion in this manner, it becomes easy to enhance the scoring function of the balloon or to deliver more medicine to the back of the stenosis or lesion.
　バルーンには、補強部として、高さが０．２ｍｍ以上０．５ｍｍ以下の主補強部と、高さが０．０１ｍｍ以上０．２ｍｍ未満の補助補強部とが設けられることも好ましい。この場合、少なくとも主補強部に薬剤が保持されていることが好ましい。この場合、主補強部によって、スコアリング機能を高めたり、薬剤を狭窄部や病変部の奥まで届けるように機能させることができ、補助補強部によってバルーンの耐圧性や形状保持性を高めることができる。補助補強部の高さは、０．０１ｍｍ以上がより好ましく、また０．１ｍｍ以下がより好ましい。 It is also preferable that the balloon is provided with a main reinforcing portion having a height of 0.2 mm to 0.5 mm and an auxiliary reinforcing portion having a height of 0.01 mm to less than 0.2 mm as the reinforcing portion. In this case, it is preferable that the medicine is held at least on the main reinforcing portion. In this case, the main reinforcing part can enhance the scoring function or function to deliver the drug to the back of the stenosis part or the lesioned part, and the auxiliary reinforcing part can improve the pressure resistance and shape retention of the balloon. it can. As for the height of an auxiliary reinforcement part, 0.01 mm or more is more preferable, and 0.1 mm or less is more preferable.
　図６および図７には、補強部として、主補強部と補助補強部が設けられたバルーンの例を示した。図６に示したバルーンは、図３に示したバルーンにおいて、バルーンの軸方向に延在する補強部１２が主補強部１２Ａとして設けられ、バルーンの周方向にらせん状に延在する補強部１２が補助補強部１２Ｂとして設けられている。図７に示したバルーンは、バルーン周方向の一方向と他方向にらせん状に延在する補強部１２のうち、一方向のらせん状に延在する補強部１２が主補強部１２Ａとして設けられ、他方向のらせん状に延在する補強部１２が補助補強部１２Ｂとして設けられている。 6 and 7 show examples of balloons provided with a main reinforcing portion and an auxiliary reinforcing portion as reinforcing portions. The balloon shown in FIG. 6 is the same as the balloon shown in FIG. 3 except that the reinforcing portion 12 extending in the axial direction of the balloon is provided as the main reinforcing portion 12A, and the reinforcing portion 12 extending spirally in the circumferential direction of the balloon. Is provided as an auxiliary reinforcing portion 12B. The balloon shown in FIG. 7 is provided with a reinforcing portion 12 extending in a spiral shape in one direction as a main reinforcing portion 12A among the reinforcing portions 12 extending spirally in one direction and the other direction in the balloon circumferential direction. The reinforcing portion 12 extending in a spiral shape in the other direction is provided as the auxiliary reinforcing portion 12B.
　バルーンの外側面に主補強部と補助補強部が設けられる場合、バルーンの外側面には、主補強部以外の部分が少なくとも直径０．５ｍｍ（当該直径は０．８ｍｍがより好ましく、１．０ｍｍがさらに好ましい）の円形を包含する大きさで形成されていることが好ましい。また主補強部以外の部分は、直径１．５ｍｍ（当該直径は１．３ｍｍがより好ましく、１．１ｍｍがさらに好ましい）の円形を包含しない大きさで形成されていることが好ましい。図６と図７に示したバルーンでは、バルーンの直管部において、隣接する主補強部１２Ａの離間距離が０．５ｍｍ以上となることが好ましく、また１．５ｍｍ未満となることが好ましく、このように主補強部１２Ａを設けることにより、主補強部以外の部分が少なくとも直径０．５ｍｍの円形を包含かつ直径１．５ｍｍの円形を包含しない大きさで形成されることとなる。一方、補助補強部の設置態様は特に限定されず、主補強部よりも高密度に設けられてもよく、低密度に設けられてもよく、同程度の密度で設けられてもよい。なお、主補強部によるスコアリング機能や薬剤供給性能を確保しつつ、バルーンの形状保持性を高める点からは、補助補強部は、主補強部よりも広い面積割合で設けられることが好ましい。 When the main reinforcing portion and the auxiliary reinforcing portion are provided on the outer surface of the balloon, the outer surface of the balloon has a portion other than the main reinforcing portion having a diameter of at least 0.5 mm (the diameter is more preferably 0.8 mm, more preferably 1.0 mm). Is more preferable). Further, the portion other than the main reinforcing portion is preferably formed in a size that does not include a circle having a diameter of 1.5 mm (the diameter is more preferably 1.3 mm, and further preferably 1.1 mm). In the balloon shown in FIGS. 6 and 7, in the straight tube portion of the balloon, the distance between the adjacent main reinforcing portions 12A is preferably 0.5 mm or more, and preferably less than 1.5 mm. By providing the main reinforcing portion 12A as described above, the portion other than the main reinforcing portion is formed in a size including at least a circle having a diameter of 0.5 mm and not including a circle having a diameter of 1.5 mm. On the other hand, the installation mode of the auxiliary reinforcing portion is not particularly limited, and may be provided at a higher density than the main reinforcing portion, may be provided at a lower density, or may be provided at a similar density. In addition, it is preferable that an auxiliary reinforcement part is provided in a larger area ratio than a main reinforcement part from the point which improves the shape retention property of a balloon, ensuring the scoring function and chemical | medical agent supply performance by a main reinforcement part.
　主補強部と補助補強部がそれぞれ繊維材料から構成される場合、主補強部を形成する繊維材料と補助補強部を形成する繊維材料はそれぞれ編み込まずに重ねあわせてもよいし、お互いに編み込まれてもよいが、主補強部と補助補強部がお互いに編み込まれて構成されることが好ましく、このような構成とすることで、製造時に主補強部と補助補強部を同時に形成でき、製造上容易にバルーンを作製することが可能となる。 When the main reinforcing portion and the auxiliary reinforcing portion are each composed of a fiber material, the fiber material forming the main reinforcing portion and the fiber material forming the auxiliary reinforcing portion may be overlapped without being knitted, or knitted together. However, it is preferable that the main reinforcing portion and the auxiliary reinforcing portion are knitted to each other. By adopting such a configuration, the main reinforcing portion and the auxiliary reinforcing portion can be formed at the same time during manufacturing. A balloon can be easily produced.
　バルーン加圧時の過拡張を抑制し、形状保持性を高める点からは、補強部は、バルーンの直管部において３０％以上の面積割合で設けられることが好ましく、４０％以上の面積割合で設けられることがより好ましい。補強部が主補強部と補助補強部から構成される場合は、主補強部と補助補強部とを合わせた面積割合がこのような範囲となることが好ましい。 From the viewpoint of suppressing overexpansion during balloon pressurization and enhancing shape retention, the reinforcing portion is preferably provided at an area ratio of 30% or more in the straight tube portion of the balloon, and at an area ratio of 40% or more. More preferably, it is provided. When the reinforcing part is composed of the main reinforcing part and the auxiliary reinforcing part, the area ratio of the main reinforcing part and the auxiliary reinforcing part is preferably within such a range.
　補強部の少なくとも一部は、バルーンの軸方向に延在して設けられていることが好ましい。この場合、バルーンの軸方向の全体にわたって、補強部がバルーンの軸方向に延在して設けられることが好ましく、そのように補強部が設けられたバルーンとしては、例えば図３、図４（ａ）、図６に示されたバルーンが挙げられる。補強部に保持された薬剤を血管壁等に確実に移行させるためには、バルーンを血管内である程度の時間拡張させておくことが望ましいが、バルーンを拡張させると血流が妨げられるため、バルーンを拡張させる時間は制限されるのが実態である。しかし、補強部の少なくとも一部がバルーンの軸方向に延在して設けられれば、バルーンを拡張させた際に、バルーンと血管壁の間にバルーンの軸方向に延びる隙間が形成されやすくなる。すなわち、補強部の隣接する軸方向延在部分の間で、バルーンと血管壁の間に隙間が形成されやすくなる。そのため、バルーンを拡張させても完全に血流が止められるのを防ぐことができ、バルーンを拡張させた状態での時間を長くとることができるようになる。また、補強部をバルーンの軸方向に延在して設けることにより、バルーンを加圧した際の軸方向への拡張が抑えられ、薬剤を狭窄部や病変部等の血管壁の所望の箇所に選択的に塗布することが容易になる。この場合、薬剤は、少なくとも補強部の軸方向延在部分に保持されることが好ましい。 It is preferable that at least a part of the reinforcing portion is provided so as to extend in the axial direction of the balloon. In this case, it is preferable that the reinforcing portion is provided so as to extend in the axial direction of the balloon over the entire axial direction of the balloon. As the balloon provided with such a reinforcing portion, for example, FIGS. ), And the balloon shown in FIG. In order to reliably transfer the drug held in the reinforcing part to the blood vessel wall or the like, it is desirable to expand the balloon for a certain amount of time in the blood vessel. However, if the balloon is expanded, blood flow is hindered. The actual time is that the time to expand the is limited. However, if at least a part of the reinforcing portion extends in the axial direction of the balloon, a gap extending in the axial direction of the balloon is easily formed between the balloon and the blood vessel wall when the balloon is expanded. That is, a gap is easily formed between the balloon and the blood vessel wall between the adjacent axially extending portions of the reinforcing portion. Therefore, even if the balloon is expanded, it is possible to prevent the blood flow from being completely stopped, and it is possible to take a long time in a state where the balloon is expanded. In addition, by providing a reinforcing part extending in the axial direction of the balloon, expansion in the axial direction when the balloon is pressurized can be suppressed, and the drug can be applied to a desired part of the blood vessel wall such as a stenosis or a lesion. It becomes easy to apply selectively. In this case, the drug is preferably held at least in the axially extending portion of the reinforcing portion.
　補強部の一部はバルーンの軸方向に延在して設けられ、他部はバルーンの周方向にらせん状に延在して設けられることも好ましい。この場合、上記の効果に加え、加圧時のバルーンの径方向への拡張を抑えることができる。そのため、石灰化などにより硬化した狭窄部に対してもバルーンを拡張させて押し広げることが可能となり、硬化した狭窄部の奥まで薬剤を届けることが可能となる。 It is also preferable that a part of the reinforcing part is provided extending in the axial direction of the balloon and the other part is provided extending spirally in the circumferential direction of the balloon. In this case, in addition to the above effect, expansion of the balloon in the radial direction during pressurization can be suppressed. Therefore, it is possible to expand and push the balloon to the stenosis part hardened by calcification or the like, and it is possible to deliver the medicine to the back of the hardened stenosis part.
　バルーンに主補強部と補助補強部が設けられる場合は、図６に示すように、主補強部１２Ａがバルーンの軸方向に延在して設けられ、補助補強部１２Ｂがバルーンの周方向に延在して設けられることが好ましい。周方向に延在する部分は、周方向にらせん状に延在してもよく、周方向にリング状に延在してもよい。この場合、補強部のバルーン軸方向に延在する部分を軸方向延在部分とし、補強部のバルーン周方向に延在する部分を周方向延在部分とすると、主補強部は軸方向延在部分のみに設けられることが好ましい。軸方向延在部分の一部は、補助補強部から構成されていてもよい。周方向延在部分は補助補強部のみから構成されることが好ましい。このように主補強部と補助補強部が設けられれば、バルーンの軸方向に延在する隣接する主補強部の間で、バルーンと血管壁の間により広い隙間が形成されやすくなり、バルーンを拡張させた際の血流を維持して、バルーン拡張時の時間をより長くとることができる。 When the main reinforcing portion and the auxiliary reinforcing portion are provided on the balloon, as shown in FIG. 6, the main reinforcing portion 12A extends in the axial direction of the balloon, and the auxiliary reinforcing portion 12B extends in the circumferential direction of the balloon. It is preferably provided. The portion extending in the circumferential direction may extend in a spiral shape in the circumferential direction, or may extend in a ring shape in the circumferential direction. In this case, assuming that the portion extending in the balloon axial direction of the reinforcing portion is an axially extending portion and the portion extending in the balloon circumferential direction of the reinforcing portion is the circumferentially extending portion, the main reinforcing portion extends in the axial direction. It is preferable to be provided only in the portion. A part of the axially extending portion may be composed of an auxiliary reinforcing portion. It is preferable that the circumferentially extending portion is composed only of the auxiliary reinforcing portion. If the main reinforcing portion and the auxiliary reinforcing portion are provided in this way, a wider gap is easily formed between the adjacent main reinforcing portions extending in the axial direction of the balloon between the balloon and the blood vessel wall, and the balloon is expanded. The blood flow at the time of letting it be maintained can be taken longer for the time of balloon expansion.
　バルーンに主補強部と補助補強部が設けられる場合は、図７に示すように、主補強部１２Ａがバルーンの周方向にらせん状に延在して設けられ、補助補強部１２Ｂがバルーンの周方向に主補強部とは反対向きのらせん状に延在して設けられることも好ましい。この場合、補強部のうち、一方向のらせん状に延在する部分を第１らせん状延在部分とし、他方向のらせん状に延在する部分を第２らせん状延在部分とすると、主補強部は第１らせん状延在部分のみに設けられることが好ましく、第１らせん状延在部分の一部は補助補強部から構成されてもよい。第２らせん状延在部分は補助補強部のみから構成されることが好ましい。なお、このように構成されたバルーンには、補強部としてさらに軸方向延在部分が形成されていてもよいが、この場合、軸方向延在部分は補助補強部のみから構成されることが好ましい。このように主補強部と補助補強部を設ければ、主補強部が血管の延在方向に対して斜め方向となるように狭窄部や病変部に食い込んで、血管を周方向の全体に拡張させやすくなる。そのため、より効果的に血管の狭窄部や病変部を押し広げて、狭窄部や病変部の奥まで薬剤を届けやすくなる。 When the main reinforcing portion and the auxiliary reinforcing portion are provided on the balloon, as shown in FIG. 7, the main reinforcing portion 12A is provided so as to extend spirally in the circumferential direction of the balloon, and the auxiliary reinforcing portion 12B is provided around the balloon. It is also preferable to extend in a spiral direction opposite to the main reinforcing portion in the direction. In this case, if a portion extending in a spiral shape in one direction is a first spiral extending portion and a portion extending in a spiral shape in the other direction is a second spiral extending portion in the reinforcing portion, The reinforcing portion is preferably provided only in the first spiral extending portion, and a part of the first spiral extending portion may be constituted by an auxiliary reinforcing portion. It is preferable that the second spirally extending portion is composed only of the auxiliary reinforcing portion. The balloon thus configured may further have an axially extending portion as a reinforcing portion, but in this case, the axially extending portion is preferably composed only of an auxiliary reinforcing portion. . If the main reinforcement part and the auxiliary reinforcement part are provided in this way, the main reinforcement part bites into the stenosis part and the lesion part so that it is oblique to the extending direction of the blood vessel, and the blood vessel is expanded in the entire circumferential direction. It becomes easy to let you. Therefore, it becomes easier to push the stenosis part or lesion part of the blood vessel more effectively and deliver the medicine to the back of the stenosis part or lesion part.
　薬剤が補強部の軸方向延在部分に保持される場合、バルーンは、拡張前、バルーンの軸方向に延びる折り目で折られて、畳まれていることが好ましく、この際、当該折り目のうち山折りの折り目以外に薬剤が保持された補強部の軸方向延在部分が存在していることが好ましい。なお、バルーンの山折りの折り目はバルーンの外側から見て規定され、バルーンの径方向の外方に山折りの折り目が向くように形成される。このようにバルーンを折り畳み形成することにより、バルーン表面に薬剤が安定して保持されやすくなり、バルーンのデリバリー中に薬剤が血液中に溶出したり脱落するのを抑えることができる。 When the medicine is held in the axially extending portion of the reinforcing portion, the balloon is preferably folded and folded at the fold extending in the axial direction of the balloon before expansion. In addition to the fold fold, it is preferable that an axially extending portion of the reinforcing portion where the medicine is held is present. The fold folds of the balloon are defined as viewed from the outside of the balloon, and are formed so that the folds of the mountain folds face outward in the radial direction of the balloon. By folding and forming the balloon in this way, the drug can be easily held stably on the surface of the balloon, and the drug can be prevented from eluting into the blood or falling off during the delivery of the balloon.
　バルーンは軸方向への拡張が抑えられることが好ましい。例えば図３に示したバルーンにおいて、軸方向に延在する繊維材料２１の弾性率が周方向に延在する繊維材料２２、２３の弾性率より高く形成されることが好ましい。血管の再狭窄を抑制する薬剤溶出バルーンカテーテルに保持される薬剤は、狭窄部や病変部ではない正常血管内壁に塗布すると悪影響を及ぼす薬剤も多い。これまでの薬剤溶出バルーンカテーテルでは、軸方向への拡張を抑制することができず、正常血管にも薬剤を塗布してしまうことにより、病変部の再狭窄を予防することはできても病変部近位側または遠位側に新たな病変を生じることがあった。しかし、上記のようにバルーンが形成されていれば、バルーンの軸方向への拡張が抑えられ、薬剤を意図しない正常血管に塗布すること避けつつ、狭窄部や病変部等の血管壁の限定した範囲に塗布することが容易になる。また、狭窄部や病変部等の長さに合わせた直管長のバルーンを適切に選択することで、バルーンに保持された薬剤のより多くを目的とする狭窄部や病変部等に塗布することが可能となる。 It is preferable that expansion of the balloon in the axial direction is suppressed. For example, in the balloon shown in FIG. 3, it is preferable that the elastic modulus of the fiber material 21 extending in the axial direction is higher than the elastic modulus of the fiber materials 22 and 23 extending in the circumferential direction. Many drugs that are held in a drug-eluting balloon catheter that suppresses restenosis of blood vessels have adverse effects when applied to the inner wall of normal blood vessels that are not stenosis or lesions. With conventional drug-eluting balloon catheters, the expansion in the axial direction cannot be suppressed, and the drug can be applied to normal blood vessels to prevent restenosis of the lesion. New lesions could occur either proximally or distally. However, if the balloon is formed as described above, expansion of the balloon in the axial direction can be suppressed, and the vascular wall such as a stenosis or a lesion is limited while avoiding applying the drug to an unintended normal blood vessel. It becomes easy to apply to the range. In addition, by appropriately selecting a straight tube length balloon that matches the length of the stenosis or lesion, it is possible to apply more of the drug held in the balloon to the target stenosis or lesion. It becomes possible.
　バルーンは、０．２０ＭＰａ（２ａｔｍ）加圧時の外径をＤとしたとき、２．０３ＭＰａ（２０ａｔｍ）加圧時の外径が１．５Ｄ以下となることが好ましく、１．４Ｄ以下がより好ましく、１．３Ｄ以下がさらに好ましい。このようにバルーンが形成されていれば、２０ａｔｍと高い圧力までバルーンを加圧することができ、しかも加圧時のバルーンの径方向への拡張が抑えられるため、石灰化した狭窄部に対してもバルーン施術を適用して押し広げることが可能となり、そのような狭窄部の奥まで薬剤を届けることができる。 The balloon preferably has an outer diameter at 2.03 MPa (20 atm) pressurization of 1.5 D or less, more preferably 1.4 D or less, where D is the outer diameter at 0.20 MPa (2 atm) pressurization. Preferably, 1.3D or less is more preferable. If a balloon is formed in this way, the balloon can be pressurized up to a pressure as high as 20 atm, and expansion of the balloon in the radial direction at the time of pressurization can be suppressed. It becomes possible to spread by applying a balloon treatment, and the drug can be delivered to the back of such a stenosis.
　バルーンは、０．２０ＭＰａ（２ａｔｍ）加圧時の直管部の長さをＬとしたとき、２．０３ＭＰａ（２０ａｔｍ）加圧時の直管部の長さが１．４Ｌ以下となることが好ましく、１．３Ｌ以下がより好ましく、１．２Ｌ以下がさらに好ましい。このようにバルーンが形成されていれば、加圧時のバルーンの軸方向への拡張が抑えられ、狭窄部や病変部等の血管壁の限定した範囲に薬剤を塗布することが容易になる。 When the length of the straight tube portion when the pressure is 0.20 MPa (2 atm) is L, the length of the straight tube portion when the pressure is 2.03 MPa (20 atm) may be 1.4 L or less. Preferably, 1.3 L or less is more preferable, and 1.2 L or less is more preferable. If the balloon is formed in this way, expansion of the balloon in the axial direction at the time of pressurization is suppressed, and it becomes easy to apply the drug to a limited range of the blood vessel wall such as a stenosis or a lesion.
　補強部は、２．０３ＭＰａ（２０ａｔｍ）加圧時にも、バルーンの外側面の補強部以外の部分よりもバルーン径方向の外方に突出していることが好ましい。補強部は、バルーンの非加圧時にバルーンの外面側に突出して形成されているが、２０ａｔｍ加圧時にも補強部がバルーンの外面側に突出して形成されていれば、バルーンを２０ａｔｍと高い圧力まで加圧した際にも、補強部を石灰化した狭窄部に対して食い込ませるようにすることができる。そのため、石灰化した狭窄部の奥まで薬剤を届けることが容易になる。 It is preferable that the reinforcing portion protrudes outward in the radial direction of the balloon from the portion other than the reinforcing portion on the outer side surface of the balloon even at a pressure of 2.03 MPa (20 atm). The reinforcing portion is formed to protrude to the outer surface side of the balloon when the balloon is not pressurized. However, if the reinforcing portion is formed to protrude to the outer surface side of the balloon even at 20 atm pressurization, the balloon has a high pressure of 20 atm. Even when the pressure is increased, the reinforcing portion can be bitten into the calcified narrowed portion. Therefore, it becomes easy to deliver the medicine to the back of the calcified stenosis.
　上記に説明した加圧時の圧力は、バルーン拡張時に使用するデバイスであるインデフレーターに備えられている圧力ゲージの値に相当する。 The pressure at the time of pressurization described above corresponds to the value of a pressure gauge provided in an indeflator that is a device used at the time of balloon expansion.
　本願は、２０１６年７月４日に出願された日本国特許出願第２０１６－１３２８４５号に基づく優先権の利益を主張するものである。２０１６年７月４日に出願された日本国特許出願第２０１６－１３２８４５の明細書の全内容が、本願に参考のために援用される。 This application claims the benefit of priority based on Japanese Patent Application No. 2016-132845 filed on July 4, 2016. The entire contents of Japanese Patent Application No. 2016-132845 filed on July 4, 2016 are hereby incorporated by reference.
　１：バルーンカテーテル
　２：シャフト
　３：内管
　４：外管
　５：ハブ
　１０：バルーン
　１１：ベースバルーン
　１２、１２Ａ、１２Ｂ：補強部
　１３：非補強部
　１４：直管部
　１５：近位側テーパー部
　１６：遠位側テーパー部 1: Balloon catheter 2: Shaft 3: Inner tube 4: Outer tube 5: Hub 10: Balloon 11: Base balloon 12, 12A, 12B: Reinforced portion 13: Non-reinforced portion 14: Straight tube portion 15: Proximal side taper portion 16: Distal taper

Claims (13)

  1. 　シャフトと、前記シャフトの外側に設けられたバルーンとを有するバルーンカテーテルであって、
    　前記バルーンは、ベースバルーンと、前記ベースバルーンの外側面に線状または網状に配置された補強部とを有し、前記補強部が前記バルーンの外側面に突出して形成され、
    　前記補強部に薬剤が保持されていることを特徴とするバルーンカテーテル。     A balloon catheter having a shaft and a balloon provided outside the shaft,
    The balloon has a base balloon and a reinforcing portion arranged in a linear or net shape on the outer surface of the base balloon, and the reinforcing portion is formed to protrude from the outer surface of the balloon,
    A balloon catheter characterized in that a drug is held in the reinforcing portion.
  2. 　前記バルーンには、高さが０．２ｍｍ以上０．５ｍｍ以下の前記補強部が設けられている請求項１に記載のバルーンカテーテル。 The balloon catheter according to claim 1, wherein the balloon is provided with the reinforcing portion having a height of 0.2 mm to 0.5 mm.
  3. 　前記バルーンの外側面には、前記補強部以外の部分が少なくとも直径０．５ｍｍの円形を包含する大きさで形成されている請求項１または２に記載のバルーンカテーテル。 The balloon catheter according to claim 1 or 2, wherein a portion other than the reinforcing portion is formed on the outer surface of the balloon in a size including a circle having a diameter of at least 0.5 mm.
  4. 　前記バルーンには、前記補強部として、高さが０．２ｍｍ以上０．５ｍｍ以下の主補強部と、高さが０．０１ｍｍ以上０．２ｍｍ未満の補助補強部とが設けられ、少なくとも前記主補強部に薬剤が保持されている請求項１に記載のバルーンカテーテル。 The balloon is provided with a main reinforcing portion having a height of 0.2 mm or more and 0.5 mm or less and an auxiliary reinforcing portion having a height of 0.01 mm or more and less than 0.2 mm as the reinforcing portion, and at least the main reinforcing portion. The balloon catheter according to claim 1, wherein a drug is held in the reinforcing portion.
  5. 　前記バルーンの外側面には、前記主補強部以外の部分が少なくとも直径０．５ｍｍの円形を包含する大きさで形成されている請求項４に記載のバルーンカテーテル。 The balloon catheter according to claim 4, wherein a portion other than the main reinforcing portion is formed on the outer surface of the balloon in a size including a circle having a diameter of at least 0.5 mm.
  6. 　前記補強部は、２．０３ＭＰａ（２０ａｔｍ）加圧時に、前記バルーンの外側面の前記補強部以外の部分よりもバルーン径方向の外方に突出している請求項１～５のいずれか一項に記載のバルーンカテーテル。 The reinforcing portion protrudes outward in the radial direction of the balloon from a portion other than the reinforcing portion on the outer side surface of the balloon when the pressure is 2.03 MPa (20 atm). The balloon catheter described.
  7. 　前記補強部は、前記ベースバルーンの外側面に繊維材料が接合されて形成されている請求項１～６のいずれか一項に記載のバルーンカテーテル。 The balloon catheter according to any one of claims 1 to 6, wherein the reinforcing portion is formed by bonding a fiber material to an outer surface of the base balloon.
  8. 　前記補強部は、前記ベースバルーンの外側面に金属材料が接合されて形成されている請求項１～７のいずれか一項に記載のバルーンカテーテル。 The balloon catheter according to any one of claims 1 to 7, wherein the reinforcing portion is formed by joining a metal material to an outer surface of the base balloon.
  9. 　前記補強部の少なくとも一部は、バルーンの軸方向に延在して設けられている請求項１～８のいずれか一項に記載のバルーンカテーテル。 The balloon catheter according to any one of claims 1 to 8, wherein at least a part of the reinforcing portion extends in the axial direction of the balloon.
  10. 　前記補強部の一部はバルーンの軸方向に延在して設けられ、他部はバルーンの周方向にらせん状に延在して設けられている請求項１～９のいずれか一項に記載のバルーンカテーテル。 The part of the reinforcing part is provided to extend in the axial direction of the balloon, and the other part is provided to extend spirally in the circumferential direction of the balloon. Balloon catheter.
  11. 　前記主補強部は、バルーンの軸方向に延在して設けられ、前記補助補強部は、バルーンの周方向に延在して設けられている請求項４または５に記載のバルーンカテーテル。 The balloon catheter according to claim 4 or 5, wherein the main reinforcing portion is provided to extend in an axial direction of the balloon, and the auxiliary reinforcing portion is provided to extend in a circumferential direction of the balloon.
  12. 　前記主補強部は、バルーンの周方向にらせん状に延在して設けられ、前記補助補強部は、バルーンの周方向に前記主補強部とは反対向きのらせん状に延在して設けられている請求項４または５に記載のバルーンカテーテル。 The main reinforcing portion is provided to extend in a spiral shape in the circumferential direction of the balloon, and the auxiliary reinforcing portion is provided to extend in a spiral shape opposite to the main reinforcing portion in the circumferential direction of the balloon. The balloon catheter according to claim 4 or 5.
  13. 　前記薬剤は、抗増殖剤または免疫抑制剤である請求項１～１２のいずれか一項に記載のバルーンカテーテル。 The balloon catheter according to any one of claims 1 to 12, wherein the drug is an antiproliferative agent or an immunosuppressive agent.
PCT/JP2017/023961 2016-07-04 2017-06-29 Balloon catheter WO2018008515A1 (en)

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JP2016-132845 2016-07-04

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* Cited by examiner, † Cited by third party
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JP2018000633A (en) * 2016-07-04 2018-01-11 株式会社カネカ Balloon catheter

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JP2008529740A (en) * 2005-02-17 2008-08-07 ボストン サイエンティフィック リミテッド Medical instruments
JP2008534032A (en) * 2005-02-09 2008-08-28 アンジオダイナミックス，インク． Reinforcing balloon for catheter
JP2009207533A (en) * 2008-02-29 2009-09-17 Kaneka Corp Medical tube
JP2009254626A (en) * 2008-04-17 2009-11-05 Kaneka Corp Composite balloon for catheter and manufacturing method for the same
JP2010500104A (en) * 2006-08-07 2010-01-07 ゴア エンタープライズ ホールディングス，インコーポレイティド Medical balloon and manufacturing method thereof
US20100076401A1 (en) * 2008-09-25 2010-03-25 Randolf Von Oepen Expandable Member Having A Covering Formed Of A Fibrous Matrix For Intraluminal Drug Delivery
JP2013523209A (en) * 2010-03-25 2013-06-17 ルトニックス，インコーポレーテッド Drug release coating for medical devices
JP2013524900A (en) * 2010-04-19 2013-06-20 イノラ ゲーエムベーハ Improved coating formulation for scoring or cutting balloon catheters
JP2014198134A (en) * 2013-03-29 2014-10-23 株式会社カネカ Balloon, balloon catheter, and method of manufacturing balloon

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JP2008534032A (en) * 2005-02-09 2008-08-28 アンジオダイナミックス，インク． Reinforcing balloon for catheter
JP2008529740A (en) * 2005-02-17 2008-08-07 ボストン サイエンティフィック リミテッド Medical instruments
JP2010500104A (en) * 2006-08-07 2010-01-07 ゴア エンタープライズ ホールディングス，インコーポレイティド Medical balloon and manufacturing method thereof
JP2009207533A (en) * 2008-02-29 2009-09-17 Kaneka Corp Medical tube
JP2009254626A (en) * 2008-04-17 2009-11-05 Kaneka Corp Composite balloon for catheter and manufacturing method for the same
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JP2013524900A (en) * 2010-04-19 2013-06-20 イノラ ゲーエムベーハ Improved coating formulation for scoring or cutting balloon catheters
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