WO2019220612A1 - Catheter - Google Patents

Catheter Download PDF

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Publication number
WO2019220612A1
WO2019220612A1 PCT/JP2018/019242 JP2018019242W WO2019220612A1 WO 2019220612 A1 WO2019220612 A1 WO 2019220612A1 JP 2018019242 W JP2018019242 W JP 2018019242W WO 2019220612 A1 WO2019220612 A1 WO 2019220612A1
Authority
WO
WIPO (PCT)
Prior art keywords
tube portion
tube
distal end
shaft
catheter
Prior art date
Application number
PCT/JP2018/019242
Other languages
French (fr)
Japanese (ja)
Inventor
武治 桂田
Original Assignee
朝日インテック株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 朝日インテック株式会社 filed Critical 朝日インテック株式会社
Priority to PCT/JP2018/019242 priority Critical patent/WO2019220612A1/en
Publication of WO2019220612A1 publication Critical patent/WO2019220612A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for

Definitions

  • the present invention relates to a catheter.
  • CTO chronic total occlusion
  • a medical device having a triangular pyramid funnel at the tip is known as a medical device for easily transporting the ante side guide wire and the retro side guide wire. If this medical device is inserted from the ante side, the retro-side guide wire can be easily received by this funnel. (For example, refer to Patent Document 1).
  • An object of the present invention is to provide a catheter that can shorten the procedure time.
  • the catheter of the present invention includes a first inner shaft, an outer shaft disposed on the outer periphery of the first inner shaft, and a cylindrical receiving member provided on the outer shaft.
  • the outer shaft includes a shaft portion, a first tube portion whose base end is connected to a tip end of the shaft portion, and is configured to expand and contract in a radial direction, and a base end at the tip end of the first tube portion.
  • a second tube portion connected and configured to contract in the axial direction; and a third tube portion configured to expand and contract in the radial direction with a proximal end connected to a distal end of the second tube portion.
  • the receiving member has a distal end portion, an intermediate portion, and a proximal end portion, the distal end portion is fixed to the distal end portion of the second tube portion, and the proximal end portion is a proximal end of the second tube portion.
  • the intermediate part is configured to expand in the radial direction.
  • An opening that communicates the inside and the outside of the second tube portion is formed in a portion of the second tube portion that faces the intermediate portion of the receiving member.
  • a tip end of the first inner shaft is connected to the opening.
  • the first tube portion, the second tube portion, and the third tube portion are configured such that when the first tube portion and the third tube portion expand in a radial direction, the first tube portion is at least an axial tip.
  • the third tube portion extends at least toward the proximal end side in the axial direction, whereby the second tube portion contracts in the axial direction, and the intermediate portion of the receiving member has a diameter. It is configured to expand in the direction.
  • the receiving member may be a mesh member or a coil body.
  • the catheter may further include a second inner shaft and a distal tip connected to a distal end of the third tube portion of the outer shaft.
  • the distal end of the second inner shaft may be connected to the proximal end of the distal tip or the distal end of the outer shaft.
  • the present invention can provide a catheter that can shorten the procedure time.
  • FIG. 4 shows a cross-sectional view of the catheter shown in FIG. 3 taken along line IV-IV.
  • the “ante-side guide wire” means a guide wire that is pushed forward to an operation site such as an occlusion site in a blood vessel prior to the catheter among the guide wires, and “retro-side guide wire”.
  • guide wire means, for example, a guide wire that comes in the blood vessel from the distal end side of the catheter.
  • the “tip side (distal side)” refers to the side where the tip 30 is located in the longitudinal direction of the catheter 1.
  • the “proximal side (proximal side)” refers to a side opposite to the tip side in the longitudinal direction.
  • the “distal end” refers to the end portion on the distal end side in each member constituting the catheter 1, and the “proximal end” refers to the end portion on the proximal end side in each member constituting the catheter 1.
  • FIG. 1 is an overall view of the catheter 1 according to the first embodiment, and shows a state in which the first tube portion 13 and the third tube portion 15 are contracted.
  • FIG. 2 is a cross-sectional view of the vicinity of the distal end portion of the catheter 1 and shows a state where the first tube portion 13 and the third tube portion 15 are expanded.
  • the catheter 1 includes an outer shaft 10, a hub 20, a distal tip 30, a first inner shaft 40, a second inner shaft 50, a reinforcing body 60, and a receiving member 70. Prepare.
  • the outer shaft 10 is a tubular member that defines an expansion lumen 10a through which a liquid such as a contrast medium or physiological saline flows.
  • the outer shaft 10 includes a first shaft portion 11, a second shaft portion 12, a first tube portion 13, a second tube portion 14, and a third tube portion 15 that are arranged in order from the proximal end side.
  • the first shaft portion 11 is a metal tubular member called a hypotube, and defines a part of the expansion lumen 10a.
  • a hub 20 is attached to the rear end of the first shaft portion 11.
  • the material which comprises the 1st shaft part 11 is not specifically limited, Superelastic alloys, such as stainless steel (SUS304) and a Ni-Ti alloy, can be used.
  • the hub 20 is attached with an indeflator (not shown).
  • a liquid such as a contrast medium and physiological saline is supplied from the indeflator (not shown) through the hub 20 to the expansion lumen 10a.
  • the second shaft portion 12 is a tubular member made of a resin material such as polyamide, polyamide elastomer, polyolefin, polyester, or polyester elastomer, and defines a part of the expansion lumen 10a.
  • the distal end portion of the first shaft portion 11 is inserted and fixed (welded) to the proximal end portion of the second shaft portion 12.
  • the base end portion of the second shaft portion 12 and the tip end portion of the first shaft portion 11 form a first opening portion 10b that opens toward the base end side.
  • a second opening 12a is formed at an intermediate portion of the second shaft portion 12 between the distal end portion and the proximal end portion.
  • the first tube portion 13, the second tube portion 14, and the third tube portion 15 are tubular members made of a stretchable flexible resin material such as polyurethane or polyurethane elastomer, and a part of the expansion lumen 10a is used. Define. In this embodiment, the 1st tube part 13, the 2nd tube part 14, and the 3rd tube part 15 are comprised integrally.
  • the proximal end of the first tube portion 13 is fixed (welded) to the distal end of the second shaft portion 12.
  • the first tube portion 13 is configured to expand and contract in the radial direction.
  • the 2nd tube part 14 is located in the front end side of the 1st tube part 13, and is comprised so that it may shrink
  • a third opening portion 14 a is formed at an intermediate portion between the distal end portion and the proximal end portion of the second tube portion 14.
  • the retro side guide wire W2 is inserted into the retro lumen 41 of the first inner shaft 40 from the third opening 14a via the expanded receiving member 70 (see FIG. 2). That is, the third opening portion 14 a functions as an entrance of the retro lumen 41. Therefore, the third opening 14a is configured as wide as possible so that the retro-side guide wire W2 can be easily inserted. Specifically, the third opening portion 14 a is configured to extend over about a half circumference along the circumferential direction of the second tube portion 14.
  • the expansion lumen 10 a is provided with a shaft for communicating a plurality of other openings with the retro lumen 41 of the first inner shaft 40.
  • the 3rd tube part 15 is located in the front end side of the 2nd tube part 14, and is comprised so that it may expand and contract in the radial direction.
  • the first tube portion 13 and the third tube portion 15 are configured to be thinner than the second tube portion 14 so as to easily expand and contract in the radial direction.
  • the 1st tube part 13 and the 3rd tube part 15 expand in radial direction so that it may mention later (refer FIG. 2).
  • the first tube portion 13 extends at least toward the distal end side (second tube portion 14 side) in the axial direction
  • the third tube portion 15 extends at least on the proximal end side (second tube portion 14 in the axial direction).
  • the second tube portion 14 contracts in the axial direction
  • the distal end portion 71 and the proximal end portion 73 of the receiving member 70 approach each other, whereby the intermediate portion 72 of the receiving member 70 expands in the radial direction.
  • the 2nd tube part 14 is constituted with the 1st tube part 13 and the 2nd tube.
  • the material may be different from that of the portion 14, for example, a material that is flexible enough to absorb the elongation by being compressed and deformed by the expansion of the first tube portion 13 and the second tube portion 14.
  • the distal tip 30 is a tubular member made of a flexible resin such as polyurethane or polyurethane elastomer, and is fixed (welded) to the distal end of the third tube portion 15.
  • the tip 30 is sharpened toward the tip side.
  • the distal end of the third tube portion 15 is fixed to the inner periphery of the proximal end of the distal tip 30.
  • the first inner shaft 40 is a tubular member made of a resin such as polyethylene, polyurethane, polyamide, polyamide elastomer, polyolefin, polyester, or polyester elastomer, and has a retro lumen 41 for inserting the retro-side guide wire W2 therein. Define.
  • the tip of the first inner shaft 40 is joined to the third opening 14 a of the second tube portion 14.
  • the tip of the first inner shaft 40 has a shape corresponding to the third opening 14 a of the second tube portion 14. If there are a plurality of third openings 14a, a plurality of first inner shafts 40 are provided corresponding to the plurality of third openings 14a.
  • the proximal end of the first inner shaft 40 is joined to the first opening 10 b formed by the proximal end portion of the second shaft portion 12 and the distal end portion of the first shaft portion 11.
  • the first inner shaft 40 extends from the second tube portion 14 to the proximal end portion of the second shaft portion 12 (the distal end portion of the first shaft portion 11) in the expansion lumen 10a.
  • the second inner shaft 50 is a tubular member made of a resin such as polyethylene, polyurethane, polyamide, polyamide elastomer, polyolefin, polyester, or polyester elastomer, and has an anthermen 51 for inserting the antenna guide wire W1 therein. Define.
  • the distal end of the second inner shaft 50 is joined to the proximal end of the distal tip 30.
  • a base end of the second inner shaft 50 is joined to a second opening 12 a formed in the second shaft portion 12.
  • the second inner shaft 50 extends from the proximal end of the distal tip 30 to the middle portion of the second shaft portion 12 in the expansion lumen 10a.
  • Markers 52, 53, and 54 are attached to the second inner shaft 50 near the distal end portion of the second shaft portion 12, and on the outer periphery at positions corresponding to the insides of the first tube portion 13 and the third tube portion 15. .
  • the markers 52, 53, 54 are made of a radiopaque material.
  • a resin material for example, a polyamide resin, a polyolefin resin, a polyester resin, a polyurethane resin, a silicone resin, a fluorine resin, etc.
  • a radiopaque material such as bismuth trioxide, tungsten, barium sulfate, etc.
  • a metal material for example, it may be formed of a radiopaque material such as gold, platinum, tungsten, or an alloy containing these elements (for example, a platinum nickel alloy). preferable.
  • the reinforcing body 60 is attached to the inner peripheral surface of the distal end portion of the first shaft portion 11 and extends toward the distal end.
  • the reinforcing body 60 is a tapered metallic wire rod having a circular cross section and having a diameter reduced toward the tip.
  • the material of the reinforcing body 60 is, for example, a superelastic alloy such as stainless steel (SUS304) or a Ni—Ti alloy.
  • the heel reinforcement 60 passes through the second shaft portion 12 and extends to the first tube portion 13.
  • the tip of the reinforcing body 60 is not fixed to the outer shaft 10, the first inner shaft 40, or the second inner shaft 50, but is not limited thereto.
  • the end of the reinforcing body 60 may be fixed so as to be sandwiched between the outer shaft 10 and the first inner shaft 40 or the second inner shaft 50 or between the first inner shaft 40 and the second inner shaft 50. .
  • the receiving member 70 is a coil body made of a metal material (for example, stainless steel) and is wound around the outer periphery of the second tube portion 14.
  • the receiving member 70 has a distal end portion 71, an intermediate portion 72, and a proximal end portion 73.
  • the distal end portion 71 is fixed (welded) to the distal end portion of the second tube portion 14.
  • the base end portion 73 is fixed (welded) to the base end portion of the second tube portion 14.
  • the intermediate portion 72 is not fixed to the outer periphery of the second tube portion 14 and is configured to be expandable in the radial direction.
  • the receiving member 70 may be made of a radiopaque material from the viewpoint of improving visibility.
  • radiopaque material examples include gold, platinum, tungsten, or an alloy containing these elements (for example, platinum nickel alloy).
  • the radiopaque material may be a combination of the radiopaque material and a material other than this material, such as a material coated on the surface of a material that is not radiopaque.
  • the ante-side guide wire W1 is inserted into a blood vessel, for example, and pushed along the blood vessel to a site where an obstruction exists (hereinafter also referred to as “occlusion site”).
  • occlusion site a site where an obstruction exists
  • the proximal end of the ante-side guide wire W1 is inserted through the second inner shaft 50 via the distal tip 30, and the catheter 1 with the ante-side guide wire W1 as a guide. Push the tip of the tube to the occlusion site in the blood vessel.
  • a liquid such as a contrast medium or physiological saline is supplied to the expansion lumen 10a from the indeflator (not shown) via the hub 20.
  • the first tube portion 13 and the third tube portion 15 expand in the radial direction, and the outer peripheral surfaces of the first tube portion 13 and the third tube portion 15 are in the vicinity of the occlusion site. Squeeze out radially.
  • the first tube portion 13 extends at least toward the distal end side (second tube portion 14 side) in the axial direction
  • the third tube portion 15 extends at least on the proximal end side (second tube portion 14 in the axial direction). Side).
  • the 2nd tube part 14 shrinks to an axial direction, and when the front-end
  • the retro-side guide wire W2 coming from the distal end side is received by the catheter 1.
  • a path to which the retro-side guide wire W2 is directed for example, a false cavity in a blood vessel wall surrounding the occlusion site, a through-hole penetrating the occlusion site, and the like are assumed. W2 may be sufficient.
  • the retro-side guide wire W2 is guided to the third opening 14a of the second tube portion 14 by the expanded intermediate portion 72, inserted through the first inner shaft 40, and delivered to the outside of the catheter 1 from the first opening 10b. Is done.
  • the retro-side guide wire W2 delivered from the first opening 10b passes through the blood vessel, and then the end is delivered out of the body. Thereby, it is possible to create a state in which the retro side guide wire W2 penetrates the occluded portion and both end portions of the retro side guide wire W2 are exposed to the outside of the body.
  • the second tube portion 14 contracts in the axial direction.
  • the intermediate portion 72 of the receiving member 70 can be expanded in the radial direction.
  • the retro-side guide wire W2 is guided from the third opening 14a to the first inner shaft 40 by receiving the retro-side guide wire W2 with the receiving member 70 in a state where the intermediate portion 72 of the receiving member 70 is radially expanded. be able to.
  • two steps consisting of a step of expanding the occlusion site with a balloon catheter or the like and a step of inserting the medical member for receiving the retro side guide wire W2 to the occlusion site after removing the balloon catheter or the like are combined into one step. Since it can be a process, the procedure time can be shortened.
  • the receiving member 70 is a coil body, it is possible to provide a member that receives the retro-side guide wire W2 with a simple configuration.
  • the distal end of the second inner shaft 50 is connected to the proximal end of the distal tip 30, the retro-side guide wire W2 received by the receiving member 70 in a state where the antenna-side guide wire W1 is passed through the second inner shaft 50. Can be passed through the first inner shaft 40. Therefore, it is possible to prevent the antenna side guide wire W1 and the retro side guide wire W2 from being entangled. Therefore, since the procedure can be performed efficiently, the procedure time can be shortened.
  • FIG. 3 is a partial cross-sectional view of the vicinity of the distal end portion of the catheter 101 according to the second embodiment, showing a state in which the first tube portion 113 and the third tube portion 115 are contracted.
  • 4 shows a cross-sectional view of the catheter 101 shown in FIG. 3 taken along the line IV-IV.
  • FIG. 5 is a cross-sectional view of the vicinity of the distal end portion of the catheter 101 and shows a state where the first tube portion 113 and the third tube portion 115 are expanded.
  • the catheter 101 includes an outer shaft 110, a hub 20 (not shown), a distal tip 30, a first inner shaft 40, a second inner shaft 50, a reinforcing body 60, and a receiving member 70.
  • the configuration of the outer shaft 110 is different from the configuration of the outer shaft 10 of the first embodiment.
  • the configuration of the hub 20 (not shown), the tip tip 30, the first inner shaft 40, the second inner shaft 50, the reinforcing body 60, and the receiving member 70 is the same as that of the first embodiment.
  • the same reference numerals are given and the description is omitted.
  • the outer shaft 110 is a tubular member that defines an expansion lumen 110a through which a liquid such as a contrast medium or physiological saline flows.
  • the outer shaft 110 has a first shaft portion 11 (not shown), a second shaft portion 12, a first tube portion 113, a second tube portion 114, and a third tube portion 115 arranged in order from the proximal end side.
  • first shaft portion 11 not shown
  • second shaft portion 12 a first tube portion 113
  • second tube portion 114 a second tube portion 114
  • a third tube portion 115 arranged in order from the proximal end side.
  • the first tube portion 113 and the second tube portion 114 are tubular members made of a flexible resin material having elasticity such as polyurethane and polyurethane elastomer, respectively, and define a part of the expansion lumen 110a.
  • the second tube portion 114 may be made of a resin material that is more flexible than the first tube portion 113.
  • the third tube portion 115 is a tubular member made of a resin material such as polyamide, polyamide elastomer, polyolefin, polyester, or polyester elastomer, and defines a part of the expansion lumen 110a.
  • the 1st tube part 113, the 2nd tube part 114, and the 3rd tube part 115 are comprised separately from each other.
  • the proximal end of the first tube portion 113 is fixed (welded) to the outer periphery of the distal end of the second shaft portion 12.
  • the first tube portion 113 is configured to expand and contract in the radial direction.
  • the 2nd tube part 114 is located in the front end side of the 1st tube part 113, and is comprised so that it may shrink
  • the proximal end of the second tube portion 114 is fixed (welded) to the outer periphery of the distal end of the first tube portion 113.
  • a third opening 114 a is formed at an intermediate portion between the distal end portion and the proximal end portion of the second tube portion 114.
  • the 3rd tube part 115 is located in the front end side of the 2nd tube part 114, and is comprised so that it may expand and contract in the radial direction.
  • the proximal end of the third tube portion 115 is fixed (welded) to the outer periphery of the distal end of the second tube portion 114. In FIG. 3, the external appearance of the third tube portion 115 is shown.
  • the third tube portion 115 is configured to be folded in a contracted state.
  • the third tube portion 115 includes a cylindrical tube main body portion 116 and two wing portions 117.
  • the two wing parts 117 are connected to the tube body part 116 at positions facing each other in the radial direction.
  • FIG. 4 when the third tube portion 115 is contracted, the two wing portions 117 are folded along the outer periphery of the tube main body portion 116.
  • the wing portion 117 expands, and the third tube portion 115 expands so that the cross-sectional shape becomes an annular shape as a whole.
  • the tube portion 113 and the third tube portion 115 expand in the radial direction, and the outer peripheral surfaces of the first tube portion 113 and the third tube portion 115 push the vicinity of the blocked site in the radial direction.
  • the first tube portion 113 extends at least toward the distal end side in the axial direction (second tube portion 114 side)
  • the third tube portion 115 extends at least in the proximal end side in the axial direction (second tube portion 114). Side).
  • the second tube portion 114 contracts in the axial direction, and the distal end portion 71 and the proximal end portion 73 of the receiving member 70 approach each other, whereby the intermediate portion 72 of the receiving member 70 expands in the radial direction.
  • the retro-side guide wire W2 is guided to the third opening 114a of the second tube portion 114 by the expanded intermediate portion 72, inserted through the first inner shaft 40, and delivered to the outside of the catheter 101 from the first opening 10b. Is done.
  • the step of expanding the occluded portion with a balloon catheter or the like and the removal of the balloon catheter or the like and then receiving the retro side guide wire W2 Since the two steps including the step of inserting the medical member up to the occlusion site can be made into one step, the procedure time can be shortened.
  • FIG. 6 is an external view of the vicinity of the distal end portion of the catheter 201 according to the third embodiment, and shows a state in which the first tube portion 213 and the third tube portion 215 are contracted.
  • FIG. 7 is an external view of the vicinity of the distal end portion of the catheter 201 according to the third embodiment, and shows a state where the first tube portion 213 and the third tube portion 215 are expanded.
  • the catheter 201 includes an outer shaft 210, a hub 20 (not shown), a tip 30, a first inner shaft 40, a second inner shaft 50, a reinforcing body 60 (not shown), a receiving member 270, Is provided.
  • the configurations of the outer shaft 210 and the receiving member 270 are different from the configurations of the outer shaft 10 and the receiving member 70 of the first embodiment.
  • the configuration of the hub 20 (not shown), the tip tip 30, the first inner shaft 40, the second inner shaft 50, and the reinforcing body 60 (not shown) is the same as that of the first embodiment. The same reference numerals are given and the description is omitted.
  • the outer shaft 210 is a tubular member that defines an expansion lumen 210a through which a liquid such as a contrast medium or physiological saline flows.
  • the outer shaft 210 has a first shaft portion 11 (not shown), a second shaft portion 12, a first tube portion 213, a second tube portion 214, and a third tube portion 215 arranged in order from the base end side.
  • first shaft portion 11 not shown
  • second shaft portion 12 a first tube portion 213, a second tube portion 214
  • a third tube portion 215 arranged in order from the base end side.
  • the first tube portion 213, the second tube portion 214, and the third tube portion 215 are tubular members made of a stretchable flexible resin material such as polyurethane and polyurethane elastomer, and a part of the expansion lumen 210a is formed. Define. In the present embodiment, the first tube portion 213, the second tube portion 214, and the third tube portion 215 are configured separately from each other.
  • the proximal end of the first tube portion 213 is fixed (welded) to the outer periphery of the distal end of the second shaft portion 12.
  • the first tube portion 213 is configured to expand and contract in the radial direction.
  • the 2nd tube part 214 is located in the front end side of the 1st tube part 213, and is comprised so that it may shrink
  • the proximal end of the second tube portion 214 is fixed (welded) to the outer periphery of the distal end of the first tube portion 213.
  • a third opening 214a is formed at an intermediate portion of the second tube portion 214 between the distal end portion and the proximal end portion.
  • the third tube portion 215 is located on the distal end side of the second tube portion 214 and is configured to expand and contract in the radial direction.
  • the proximal end of the third tube portion 215 is fixed (welded) to the outer periphery of the distal end of the second tube portion 214.
  • the distal end of the third tube portion 215 is fixed (welded) to the outer periphery of the proximal end of the distal tip 30.
  • the first tube portion 213 and the third tube portion 215 are configured to be thinner than the second tube portion 214 so as to easily expand and contract in the radial direction.
  • the second tube portion 214 may be made of a resin material that is more flexible than the first tube portion 213 and the third tube portion 215.
  • the receiving member 270 is a mesh member in which a plurality of strands are knitted into a lattice shape to form a tube shape as a whole, and is disposed on the outer periphery of the second shaft portion 214.
  • the receiving member 270 has a distal end portion 271, an intermediate portion 272, and a proximal end portion 273.
  • the distal end portion 271 is fixed (welded) to the distal end portion of the second tube portion 214.
  • the proximal end portion 273 is fixed (welded) to the proximal end portion of the second tube portion 214.
  • the distal end of the distal end portion 271 is covered with the proximal end of the third tube portion 215.
  • the proximal end of the proximal end portion 273 is covered with the distal end of the first tube portion 213.
  • the intermediate portion 272 is not fixed to the outer periphery of the second tube portion 214 and is configured to be expandable in the radial direction.
  • Each wire of the receiving member 270 may be a single wire or a stranded wire obtained by twisting a plurality of strands.
  • a metal material or a resin material can be employed as a material constituting each element wire of the receiving member 270.
  • the metal material include stainless steel such as SUS304, nickel titanium alloy, cobalt chrome alloy, and the like.
  • the resin material include polyamide, polyester, polyacrylate, polyether ether ketone, and the like.
  • the material constituting each strand of the receiving member 270 may be a radiopaque material.
  • the radiopaque material include gold, platinum, tungsten, or an alloy containing these elements (for example, platinum nickel alloy).
  • the radiopaque material may be a combination of the radiopaque material and a material other than this material, such as a material coated on the surface of a material that is not radiopaque.
  • the receiving member 270 is provided with a guide film 274.
  • the distal end of the guide film 274 is located at a position facing the third opening 214 a of the intermediate portion 272 of the receiving member 270 or on the base end portion 273 side from the position.
  • the guide film 274 smoothly guides the retro-side guide wire W2 received through the opening of the receiving member 270 toward the third opening 214a.
  • Examples of the material constituting the induction film 274 include polyethylene, polyurethane, polyamide, polyamide elastomer, polyolefin, polyester, polyester elastomer, and the like.
  • the method of forming the guide film 274 is not particularly limited. For example, a dipping method is used for the guide film disposed on the receiving member 270, and a method of fusing the leading end of the film to the receiving member 270 is used for the film-like guide film. be able to.
  • the catheter 201 of the present embodiment when the liquid is supplied to the expansion lumen 210a after the catheter 201 has traveled to the occlusion site via the ante side guide wire W1, as shown in FIG.
  • the tube portion 213 and the third tube portion 215 expand in the radial direction, and the outer peripheral surfaces of the first tube portion 213 and the third tube portion 215 push the vicinity of the closed site in the radial direction.
  • the first tube portion 213 extends at least toward the distal end side (second tube portion 214 side) in the axial direction
  • the third tube portion 215 extends at least on the proximal end side (second tube portion 214 in the axial direction). Side).
  • the second tube portion 214 contracts in the axial direction, and the distal end portion 271 and the proximal end portion 273 of the receiving member 270 approach each other, whereby the intermediate portion 272 of the receiving member 270 expands in the radial direction.
  • the induction film 274 expands into a funnel shape.
  • the retro-side guide wire W2 is guided to the third opening 214a of the second tube portion 214 by the expanded intermediate portion 272 and the guide membrane 274, inserted through the first inner shaft 40, and from the first opening 10b to the catheter 201. Sent to outside.
  • the step of expanding the occluded portion with a balloon catheter or the like and the removal of the balloon catheter or the like and then receiving the retro side guide wire W2 Since the two steps including the step of inserting the medical member up to the occlusion site can be made into one step, the procedure time can be shortened.
  • this invention is not limited to the structure of embodiment mentioned above, is shown by the claim, and intends that all the changes within the meaning and range equivalent to a claim are included. Is done. A part of the configuration of the above-described embodiment may be deleted or replaced with another configuration, or another configuration may be added to the configuration of the above-described embodiment.
  • the receiving member 70 that is the coil body of the first and second embodiments may be used in place of the receiving member 270 in the third embodiment.
  • the receiving member 270 that is the mesh member of the third embodiment may be used in place of the receiving member 70 in the first and second embodiments.
  • the third tube portion 115 of the second embodiment may be used in place of the third tube portion 215 in the third embodiment.
  • the guide film 274 is provided on the receiving member 270, but the guide film 274 may not be provided.
  • a guide film may be provided on the receiving member 70 in the first and second embodiments.

Abstract

The purpose of the present invention is to provide a catheter capable of reducing the time for manipulation. In this catheter, a first tube part 13, a second tube part 14, and a third tube part 15 are configured such that when the first tube part 13 and the third tube part 15 are expanded in the radial direction, the first tuber part 13 is extended to at least the distal side in the axial direction and the third tube part 15 is extended to at least the proximal side in the axial direction. Accordingly, the second tube part 14 is contracted in the axial direction to cause an intermediate part 72 of a receiving member 70 to expand in the radial direction.

Description

カテーテルcatheter
 本発明は、カテーテルに関する。 The present invention relates to a catheter.
 慢性完全閉塞(CTO:Choronic total occlusion)のような血管を閉塞する閉塞物を除去して血流を改善する手技として、次のような手順を取る手技が知られている。まず、順行性アプローチ(アンテ側からのアプローチ)でアンテ側ガイドワイヤを挿入して、CTOに隙間、又は血管の内膜下に偽腔を形成する。次に、逆行性アプローチ(レトロ側からのアプローチ)によりCTOの反対側(末梢側)から、レトロ側ガイドワイヤを挿入し、形成されたCTOの隙間内又は内膜下の偽腔内に押し進める。これにより、アンテ側ガイドワイヤとレトロ側ガイドワイヤとを交通させる。 The following procedure is known as a technique for improving blood flow by removing a blockage that blocks a blood vessel, such as chronic total occlusion (CTO). First, an ante-side guide wire is inserted by an antegrade approach (an approach from the ante side) to form a gap in the CTO or a false cavity below the intima of the blood vessel. Next, a retro-side guide wire is inserted from the opposite side (peripheral side) of the CTO by a retrograde approach (approach from the retro side) and pushed into the formed CTO gap or into the pseudointima below the intima. As a result, the ante-side guide wire and the retro-side guide wire are brought into traffic.
 他方、アンテ側ガイドワイヤとレトロ側ガイドワイヤとを容易に交通させる医療デバイスとして、先端に三角錐状のファネルを有する医療デバイスが知られている。アンテ側からこの医療デバイスを挿入しておくと、このファネルにより、レトロ側ガイドワイヤを容易に受け入れることができる。(例えば、特許文献1参照)。 On the other hand, a medical device having a triangular pyramid funnel at the tip is known as a medical device for easily transporting the ante side guide wire and the retro side guide wire. If this medical device is inserted from the ante side, the retro-side guide wire can be easily received by this funnel. (For example, refer to Patent Document 1).
米国特許出願公開第2014/0025086号明細書US Patent Application Publication No. 2014/0025086
 上記の医療デバイスを上記手技に用いる場合、バルーンカテーテル等により偽腔を押し広げる工程と、バルーンカテーテル等を抜去したのち、上記医療デバイスを押し広げられた偽腔まで挿入する工程とからなる2つの工程が必要であり、手技時間が長くなってしまう。 When using the above medical device for the above procedure, there are two steps consisting of a step of expanding the false lumen with a balloon catheter or the like, and a step of removing the balloon catheter or the like and then inserting the medical device into the expanded false lumen. A process is necessary, and the procedure time becomes long.
 本発明の目的は、手技時間を短縮することができるカテーテルを提供することにある。 An object of the present invention is to provide a catheter that can shorten the procedure time.
 本発明のカテーテルは、第1インナーシャフトと、前記第1インナーシャフトの外周に配置されるアウターシャフトと、前記アウターシャフトに設けられた円筒状の受け入れ部材と、を備える。前記アウターシャフトは、シャフト部と、基端が前記シャフト部の先端に接続され、径方向に拡張および収縮するように構成された第1チューブ部と、基端が前記第1チューブ部の先端に接続され、軸方向に収縮するように構成された第2チューブ部と、基端が前記第2チューブ部の先端に接続され、径方向に拡張および収縮するように構成された第3チューブ部と、を有する。前記受け入れ部材は、先端部、中間部、および基端部を有し、前記先端部は、前記第2チューブ部の先端部に固定され、前記基端部は、前記第2チューブ部の基端部に固定され、前記中間部は、径方向に拡張するように構成されている。前記第2チューブ部の、前記受け入れ部材の前記中間部に対向する部分に、前記第2チューブ部の内外を連通する開口部が形成されている。前記開口部に、前記第1インナーシャフトの先端が接続されている。前記第1チューブ部、前記第2チューブ部、および前記第3チューブ部は、前記第1チューブ部および前記第3チューブ部が径方向に拡張するとき、前記第1チューブ部は少なくとも軸方向の先端側に向かって伸張し、前記第3チューブ部は少なくとも軸方向の基端側に向かって伸張することにより、前記第2チューブ部は軸方向に収縮して、前記受け入れ部材の前記中間部を径方向に拡張するように構成されている。 The catheter of the present invention includes a first inner shaft, an outer shaft disposed on the outer periphery of the first inner shaft, and a cylindrical receiving member provided on the outer shaft. The outer shaft includes a shaft portion, a first tube portion whose base end is connected to a tip end of the shaft portion, and is configured to expand and contract in a radial direction, and a base end at the tip end of the first tube portion. A second tube portion connected and configured to contract in the axial direction; and a third tube portion configured to expand and contract in the radial direction with a proximal end connected to a distal end of the second tube portion. Have. The receiving member has a distal end portion, an intermediate portion, and a proximal end portion, the distal end portion is fixed to the distal end portion of the second tube portion, and the proximal end portion is a proximal end of the second tube portion. The intermediate part is configured to expand in the radial direction. An opening that communicates the inside and the outside of the second tube portion is formed in a portion of the second tube portion that faces the intermediate portion of the receiving member. A tip end of the first inner shaft is connected to the opening. The first tube portion, the second tube portion, and the third tube portion are configured such that when the first tube portion and the third tube portion expand in a radial direction, the first tube portion is at least an axial tip. The third tube portion extends at least toward the proximal end side in the axial direction, whereby the second tube portion contracts in the axial direction, and the intermediate portion of the receiving member has a diameter. It is configured to expand in the direction.
 前記受け入れ部材は、メッシュ部材またはコイル体であってもよい。 The receiving member may be a mesh member or a coil body.
 前記カテーテルは、第2インナーシャフトと、前記アウターシャフトの前記第3チューブ部の先端に接続された先端チップと、を更に備えてもよい。前記第2インナーシャフトの先端は、前記先端チップの基端または前記アウターシャフトの先端に接続されていてもよい。 The catheter may further include a second inner shaft and a distal tip connected to a distal end of the third tube portion of the outer shaft. The distal end of the second inner shaft may be connected to the proximal end of the distal tip or the distal end of the outer shaft.
 本発明は、手技時間を短縮することができるカテーテルを提供することができる。 The present invention can provide a catheter that can shorten the procedure time.
第1の実施形態に係るカテーテルの全体図であって、第1チューブ部および第3チューブ部が収縮した状態を示す。It is a general view of the catheter which concerns on 1st Embodiment, Comprising: The state which the 1st tube part and the 3rd tube part contracted is shown. 第1の実施形態に係るカテーテルの先端部付近の断面図であって、第1チューブ部および第3チューブ部が拡張した状態を示す。It is sectional drawing of the front-end | tip part vicinity of the catheter which concerns on 1st Embodiment, Comprising: The state which the 1st tube part and the 3rd tube part expanded is shown. 第2の実施形態に係るカテーテルの先端部付近の一部断面図であって、第1チューブ部および第3チューブ部が収縮した状態を示す。It is a partial cross section figure near the front-end | tip part of the catheter which concerns on 2nd Embodiment, Comprising: The 1st tube part and the 3rd tube part show the state which contracted. 図3に示したカテーテルのIV-IV線に沿った断面図を示す。FIG. 4 shows a cross-sectional view of the catheter shown in FIG. 3 taken along line IV-IV. 第2の実施形態に係るカテーテルの先端部付近の断面図であって、第1チューブ部よび第3チューブ部が拡張した状態を示すIt is sectional drawing of the front-end | tip part vicinity of the catheter which concerns on 2nd Embodiment, Comprising: The state which the 1st tube part and the 3rd tube part expanded is shown. 第3の実施形態に係るカテーテルの先端部付近の外観図であって、第1チューブ部および第3チューブ部が収縮した状態を示す。It is an external view near the front-end | tip part of the catheter which concerns on 3rd Embodiment, Comprising: The 1st tube part and the 3rd tube part show the state which contracted. 第3の実施形態に係るカテーテルの先端部付近の外観図であって、第1チューブ部および第3チューブ部が拡張した状態を示す。It is an external view near the front-end | tip part of the catheter which concerns on 3rd Embodiment, Comprising: The 1st tube part and the 3rd tube part show the state expanded.
 以下、本実施形態に係るカテーテルについて図面を参照して説明する。本実施形態は図面に示された形態にのみ限定されない。 Hereinafter, the catheter according to the present embodiment will be described with reference to the drawings. The present embodiment is not limited to the form shown in the drawings.
 なお、本明細書において、「アンテ側ガイドワイヤ」とは、ガイドワイヤのうち、当該カテーテルに先立って血管中の閉塞部位などの術部に押し進められるガイドワイヤを意味し、「レトロ側ガイドワイヤ」とは、ガイドワイヤのうち、例えば血管内を当該カテーテルの先端側から向かって来るガイドワイヤを意味する。 In the present specification, the “ante-side guide wire” means a guide wire that is pushed forward to an operation site such as an occlusion site in a blood vessel prior to the catheter among the guide wires, and “retro-side guide wire”. The term “guide wire” means, for example, a guide wire that comes in the blood vessel from the distal end side of the catheter.
 また、本明細書において、「先端側(遠位側)」とは、カテーテル1の長手方向において先端チップ30が位置する側を指す。「基端側(近位側)」とは、長手方向において先端側に対する反対側を指す。「先端」とは、カテーテル1を構成する各部材における先端側の端部を指し、「基端」とは、カテーテル1を構成する各部材における基端側の端部を指す。 Further, in this specification, the “tip side (distal side)” refers to the side where the tip 30 is located in the longitudinal direction of the catheter 1. The “proximal side (proximal side)” refers to a side opposite to the tip side in the longitudinal direction. The “distal end” refers to the end portion on the distal end side in each member constituting the catheter 1, and the “proximal end” refers to the end portion on the proximal end side in each member constituting the catheter 1.
[第1の実施形態]
 第1の実施形態に係るカテーテル1について図面を参照して説明する。
[First Embodiment]
A catheter 1 according to a first embodiment will be described with reference to the drawings.
 図1は、第1の実施形態に係るカテーテル1の全体図であって、第1チューブ部13および第3チューブ部15が収縮した状態を示す。図2は、カテーテル1の先端部付近の断面図であって、第1チューブ部13および第3チューブ部15が拡張した状態を示す。 FIG. 1 is an overall view of the catheter 1 according to the first embodiment, and shows a state in which the first tube portion 13 and the third tube portion 15 are contracted. FIG. 2 is a cross-sectional view of the vicinity of the distal end portion of the catheter 1 and shows a state where the first tube portion 13 and the third tube portion 15 are expanded.
 図1に示すように、カテーテル1は、アウターシャフト10と、ハブ20と、先端チップ30と、第1インナーシャフト40と、第2インナーシャフト50と、補強体60と、受け入れ部材70と、を備える。 As shown in FIG. 1, the catheter 1 includes an outer shaft 10, a hub 20, a distal tip 30, a first inner shaft 40, a second inner shaft 50, a reinforcing body 60, and a receiving member 70. Prepare.
 アウターシャフト10は、造影剤や生理食塩水等の液体が流れる拡張ルーメン10aを画定する管状の部材である。アウターシャフト10は、基端側から順に並ぶ、第1シャフト部11と、第2シャフト部12と、第1チューブ部13と、第2チューブ部14と、第3チューブ部15と、を有する。 The outer shaft 10 is a tubular member that defines an expansion lumen 10a through which a liquid such as a contrast medium or physiological saline flows. The outer shaft 10 includes a first shaft portion 11, a second shaft portion 12, a first tube portion 13, a second tube portion 14, and a third tube portion 15 that are arranged in order from the proximal end side.
 第1シャフト部11は、ハイポチューブと呼ばれる金属製の管状部材であり、拡張ルーメン10aの一部を画定する。第1シャフト部11の後端には、ハブ20が取り付けられている。第1シャフト部11を構成する材料は、特に限定されないが、ステンレス鋼(SUS304)、Ni-Ti合金などの超弾性合金を用いることができる。 The first shaft portion 11 is a metal tubular member called a hypotube, and defines a part of the expansion lumen 10a. A hub 20 is attached to the rear end of the first shaft portion 11. Although the material which comprises the 1st shaft part 11 is not specifically limited, Superelastic alloys, such as stainless steel (SUS304) and a Ni-Ti alloy, can be used.
 ハブ20には、図示せぬインデフレータが取り付けられる。図示せぬインデフレータからハブ20を介して、造影剤や生理食塩水等の液体が拡張ルーメン10aに供給される。 The hub 20 is attached with an indeflator (not shown). A liquid such as a contrast medium and physiological saline is supplied from the indeflator (not shown) through the hub 20 to the expansion lumen 10a.
 第2シャフト部12は、ポリアミド、ポリアミドエラストマー、ポリオレフィン、ポリエステル、ポリエステルエラストマーなどの樹脂材料からなる管状の部材であり、拡張ルーメン10aの一部を画定する。第2シャフト部12の基端部には、第1シャフト部11の先端部が挿入され固着(溶着)されている。第2シャフト部12の基端部と第1シャフト部11の先端部とにより、基端側に向かって開口する第1開口部10bが形成される。第2シャフト部12の、先端部と基端部との間の中間部には、第2開口部12aが形成されている。 The second shaft portion 12 is a tubular member made of a resin material such as polyamide, polyamide elastomer, polyolefin, polyester, or polyester elastomer, and defines a part of the expansion lumen 10a. The distal end portion of the first shaft portion 11 is inserted and fixed (welded) to the proximal end portion of the second shaft portion 12. The base end portion of the second shaft portion 12 and the tip end portion of the first shaft portion 11 form a first opening portion 10b that opens toward the base end side. A second opening 12a is formed at an intermediate portion of the second shaft portion 12 between the distal end portion and the proximal end portion.
 第1チューブ部13、第2チューブ部14、および第3チューブ部15は、ポリウレタン、ポリウレタンエラストマーなどの伸縮性のある柔軟な樹脂材料からからなる管状の部材であり、拡張ルーメン10aの一部を画定する。本実施形態では、第1チューブ部13、第2チューブ部14、および第3チューブ部15は、一体に構成されている。 The first tube portion 13, the second tube portion 14, and the third tube portion 15 are tubular members made of a stretchable flexible resin material such as polyurethane or polyurethane elastomer, and a part of the expansion lumen 10a is used. Define. In this embodiment, the 1st tube part 13, the 2nd tube part 14, and the 3rd tube part 15 are comprised integrally.
 第1チューブ部13は、その基端が第2シャフト部12の先端に固着(溶着)されている。第1チューブ部13は、その径方向に拡張および収縮するように構成されている。 The proximal end of the first tube portion 13 is fixed (welded) to the distal end of the second shaft portion 12. The first tube portion 13 is configured to expand and contract in the radial direction.
 第2チューブ部14は、第1チューブ部13の先端側に位置しており、その軸方向に収縮するように構成されている。第2チューブ部14の、先端部と基端部との間の中間部には、第3開口部14aが形成されている。 The 2nd tube part 14 is located in the front end side of the 1st tube part 13, and is comprised so that it may shrink | contract in the axial direction. A third opening portion 14 a is formed at an intermediate portion between the distal end portion and the proximal end portion of the second tube portion 14.
 尚、後述するように、レトロ側ガイドワイヤW2が、拡張した受け入れ部材70を経由して第3開口部14aから第1インナーシャフト40のレトロルーメン41に挿入される(図2参照)。即ち、第3開口部14aはレトロルーメン41の入口として機能する。従って、第3開口部14aは、レトロ側ガイドワイヤW2の挿入が容易となるように、できるだけ広く構成されている。具体的には、第3開口部14aは、第2チューブ部14の周方向に沿って、約半周分に亘って延びるように構成されている。 As will be described later, the retro side guide wire W2 is inserted into the retro lumen 41 of the first inner shaft 40 from the third opening 14a via the expanded receiving member 70 (see FIG. 2). That is, the third opening portion 14 a functions as an entrance of the retro lumen 41. Therefore, the third opening 14a is configured as wide as possible so that the retro-side guide wire W2 can be easily inserted. Specifically, the third opening portion 14 a is configured to extend over about a half circumference along the circumferential direction of the second tube portion 14.
 また、本実施形態では、第3開口部14aが1つのみ設けられているが、第2チューブ部14の先端部と基端部との間の中間部に、第3開口部14aに加えて、他の開口部が複数設けられた構成としてもよい。この場合、複数の他の開口部のうちの少なくとも一つは第3開口部14aと対向する位置(反対側の位置)に配置されることが好ましい。また、拡張ルーメン10aには、複数の他の開口部を第1インナーシャフト40のレトロルーメン41に連通させるためのシャフトが設けられる。 In the present embodiment, only one third opening 14a is provided, but in addition to the third opening 14a, an intermediate portion between the distal end portion and the proximal end portion of the second tube portion 14 is provided. A configuration in which a plurality of other openings are provided may be employed. In this case, it is preferable that at least one of the plurality of other openings is arranged at a position facing the third opening 14a (an opposite position). Further, the expansion lumen 10 a is provided with a shaft for communicating a plurality of other openings with the retro lumen 41 of the first inner shaft 40.
 第3チューブ部15は、第2チューブ部14の先端側に位置しており、その径方向に拡張および収縮するように構成されている。第1チューブ部13および第3チューブ部15は、径方向に拡張および収縮しやすいように、それらの厚さが第2チューブ部14よりも薄く構成されている。 The 3rd tube part 15 is located in the front end side of the 2nd tube part 14, and is comprised so that it may expand and contract in the radial direction. The first tube portion 13 and the third tube portion 15 are configured to be thinner than the second tube portion 14 so as to easily expand and contract in the radial direction.
 尚、後述するように第1チューブ部13および第3チューブ部15が径方向に拡張する(図2参照)。この時、第1チューブ部13は、少なくとも軸方向の先端側(第2チューブ部14側)に向かって伸張し、第3チューブ部15は、少なくとも軸方向の基端側(第2チューブ部14側)に向かって伸張する。この結果、第2チューブ部14が軸方向に収縮して、受け入れ部材70の先端部71と基端部73とが互いに近づくことにより、受け入れ部材70の中間部72が径方向に拡張する。従って、本実施形態では、第1チューブ部13、第2チューブ部14、及び第3チューブ部15を一体的に構成しているが、第2チューブ部14を第1チューブ部13及び第2チューブ部14と異なる材料、例えば、第1チューブ部13及び第2チューブ部14の拡張により圧縮変形して伸びを吸収できるだけの柔軟性のある材料で構成することとしてもよい。 In addition, the 1st tube part 13 and the 3rd tube part 15 expand in radial direction so that it may mention later (refer FIG. 2). At this time, the first tube portion 13 extends at least toward the distal end side (second tube portion 14 side) in the axial direction, and the third tube portion 15 extends at least on the proximal end side (second tube portion 14 in the axial direction). Side). As a result, the second tube portion 14 contracts in the axial direction, and the distal end portion 71 and the proximal end portion 73 of the receiving member 70 approach each other, whereby the intermediate portion 72 of the receiving member 70 expands in the radial direction. Therefore, in this embodiment, although the 1st tube part 13, the 2nd tube part 14, and the 3rd tube part 15 are comprised integrally, the 2nd tube part 14 is constituted with the 1st tube part 13 and the 2nd tube. The material may be different from that of the portion 14, for example, a material that is flexible enough to absorb the elongation by being compressed and deformed by the expansion of the first tube portion 13 and the second tube portion 14.
 先端チップ30は、ポリウレタン、ポリウレタンエラストマーなどの柔軟な樹脂からからなる管状の部材であり、第3チューブ部15の先端に固着(溶着)されている。先端チップ30は、先端側に向かって尖鋭状に構成されている。先端チップ30の基端の内周に、第3チューブ部15の先端が固着されている。 The distal tip 30 is a tubular member made of a flexible resin such as polyurethane or polyurethane elastomer, and is fixed (welded) to the distal end of the third tube portion 15. The tip 30 is sharpened toward the tip side. The distal end of the third tube portion 15 is fixed to the inner periphery of the proximal end of the distal tip 30.
 第1インナーシャフト40は、ポリエチレン、ポリウレタン、ポリアミド、ポリアミドエラストマー、ポリオレフィン、ポリエステル、またはポリエステルエラストマー等の樹脂からなる管状の部材であり、内部にレトロ側ガイドワイヤW2を挿入するためのレトロルーメン41を画定する。第1インナーシャフト40の先端は、第2チューブ部14の第3開口部14aに接合されている。第1インナーシャフト40の先端は、第2チューブ部14の第3開口部14aに対応する形状をなしている。なお、第3開口部14aが複数ある場合には、当該複数の第3開口部14aに対応して複数の第1インナーシャフト40が設けられる。第1インナーシャフト40の基端は、第2シャフト部12の基端部と第1シャフト部11の先端部とにより形成された第1開口部10bに接合されている。第1インナーシャフト40は、拡張ルーメン10a内において、第2チューブ部14から第2シャフト部12の基端部(第1シャフト部11の先端部)まで延びている。 The first inner shaft 40 is a tubular member made of a resin such as polyethylene, polyurethane, polyamide, polyamide elastomer, polyolefin, polyester, or polyester elastomer, and has a retro lumen 41 for inserting the retro-side guide wire W2 therein. Define. The tip of the first inner shaft 40 is joined to the third opening 14 a of the second tube portion 14. The tip of the first inner shaft 40 has a shape corresponding to the third opening 14 a of the second tube portion 14. If there are a plurality of third openings 14a, a plurality of first inner shafts 40 are provided corresponding to the plurality of third openings 14a. The proximal end of the first inner shaft 40 is joined to the first opening 10 b formed by the proximal end portion of the second shaft portion 12 and the distal end portion of the first shaft portion 11. The first inner shaft 40 extends from the second tube portion 14 to the proximal end portion of the second shaft portion 12 (the distal end portion of the first shaft portion 11) in the expansion lumen 10a.
 第2インナーシャフト50は、ポリエチレン、ポリウレタン、ポリアミド、ポリアミドエラストマー、ポリオレフィン、ポリエステル、またはポリエステルエラストマー等の樹脂からなる管状の部材であり、内部にアンテ側ガイドワイヤW1を挿入するためのアンテルーメン51を画定する。第2インナーシャフト50の先端は、先端チップ30の基端に接合されている。第2インナーシャフト50の基端は、第2シャフト部12に形成された第2開口部12aに接合されている。第2インナーシャフト50は、拡張ルーメン10a内において、先端チップ30の基端から第2シャフト部12の中間部まで延びている。 The second inner shaft 50 is a tubular member made of a resin such as polyethylene, polyurethane, polyamide, polyamide elastomer, polyolefin, polyester, or polyester elastomer, and has an anthermen 51 for inserting the antenna guide wire W1 therein. Define. The distal end of the second inner shaft 50 is joined to the proximal end of the distal tip 30. A base end of the second inner shaft 50 is joined to a second opening 12 a formed in the second shaft portion 12. The second inner shaft 50 extends from the proximal end of the distal tip 30 to the middle portion of the second shaft portion 12 in the expansion lumen 10a.
 第2インナーシャフト50には、第2シャフト部12の先端部付近、第1チューブ部13、第3チューブ部15の内部に相当する位置の外周に、マーカ52、53、54が取り付けられている。マーカ52、53、54は、放射線不透過材料で構成されている。マーカ52、53、54は、樹脂材料を用いる場合、例えば、ポリアミド樹脂、ポリオレフィン樹脂、ポリエステル樹脂、ポリウレタン樹脂、シリコーン樹脂、フッ素樹脂などに、三酸化ビスマス、タングステン、硫酸バリウム等の放射線不透過材料を混ぜて形成することが好ましく、金属材料を用いる場合、例えば、放射線不透過材料である金、白金、タングステン、またはこれらの元素を含む合金(例えば、白金ニッケル合金等)等で形成することが好ましい。 Markers 52, 53, and 54 are attached to the second inner shaft 50 near the distal end portion of the second shaft portion 12, and on the outer periphery at positions corresponding to the insides of the first tube portion 13 and the third tube portion 15. . The markers 52, 53, 54 are made of a radiopaque material. For the markers 52, 53, 54, when using a resin material, for example, a polyamide resin, a polyolefin resin, a polyester resin, a polyurethane resin, a silicone resin, a fluorine resin, etc., a radiopaque material such as bismuth trioxide, tungsten, barium sulfate, etc. In the case of using a metal material, for example, it may be formed of a radiopaque material such as gold, platinum, tungsten, or an alloy containing these elements (for example, a platinum nickel alloy). preferable.
 補強体60は、第1シャフト部11の先端部の内周面に取り付けられ、先端に向かって延びている。補強体60は、断面が円形であり、先端に向かって細径化されたテーパ状の金属製の線材である。補強体60の材料は、例えば、ステンレス鋼(SUS304)やNi-Ti合金などの超弾性合金である。 The reinforcing body 60 is attached to the inner peripheral surface of the distal end portion of the first shaft portion 11 and extends toward the distal end. The reinforcing body 60 is a tapered metallic wire rod having a circular cross section and having a diameter reduced toward the tip. The material of the reinforcing body 60 is, for example, a superelastic alloy such as stainless steel (SUS304) or a Ni—Ti alloy.
  補強体60は、第2シャフト部12を通過して、第1チューブ部13まで延びている。図1では、補強体60の先端は、アウターシャフト10、第1インナーシャフト40、または第2インナーシャフト50に固定されていないが、これに限定されない。例えば、補強体60の先端をアウターシャフト10と、第1インナーシャフト40または第2インナーシャフト50と、もしくは、第1インナーシャフト40と第2インナーシャフト50とで挟み込むようにして固定してもよい。 The heel reinforcement 60 passes through the second shaft portion 12 and extends to the first tube portion 13. In FIG. 1, the tip of the reinforcing body 60 is not fixed to the outer shaft 10, the first inner shaft 40, or the second inner shaft 50, but is not limited thereto. For example, the end of the reinforcing body 60 may be fixed so as to be sandwiched between the outer shaft 10 and the first inner shaft 40 or the second inner shaft 50 or between the first inner shaft 40 and the second inner shaft 50. .
 受け入れ部材70は、金属材料(例えばステンレス鋼)などにより構成されたコイル体であり、第2チューブ部14の外周に巻回されている。受け入れ部材70は、先端部71、中間部72、および基端部73を有する。先端部71は、第2チューブ部14の先端部に固定(溶着)されている。基端部73は、第2チューブ部14の基端部に固定(溶着)されている。中間部72は、第2チューブ部14の外周には固定されておらず、径方向に拡張可能に構成されている。受け入れ部材70は、視認性を向上させる観点から、放射線不透過材料により構成されていてもよい。放射線不透過材料としては、例えば、金、白金、タングステン、またはこれらの元素を含む合金(例えば、白金ニッケル合金など)等が挙げられる。なお、放射線不透過性材料は、放射線不透過性ではない材料の表面にコートされるものなど、当該放射線不透過性材料とこの材料以外の材料とを組み合わせたものであってもよい。 The receiving member 70 is a coil body made of a metal material (for example, stainless steel) and is wound around the outer periphery of the second tube portion 14. The receiving member 70 has a distal end portion 71, an intermediate portion 72, and a proximal end portion 73. The distal end portion 71 is fixed (welded) to the distal end portion of the second tube portion 14. The base end portion 73 is fixed (welded) to the base end portion of the second tube portion 14. The intermediate portion 72 is not fixed to the outer periphery of the second tube portion 14 and is configured to be expandable in the radial direction. The receiving member 70 may be made of a radiopaque material from the viewpoint of improving visibility. Examples of the radiopaque material include gold, platinum, tungsten, or an alloy containing these elements (for example, platinum nickel alloy). The radiopaque material may be a combination of the radiopaque material and a material other than this material, such as a material coated on the surface of a material that is not radiopaque.
 次に、カテーテル1の使用態様について説明する。 Next, how the catheter 1 is used will be described.
 まず、アンテ側ガイドワイヤW1を例えば血管内に挿入し、血管に沿って閉塞物が存在する部位(以下「閉塞部位」ともいう)まで押し進める。アンテ側ガイドワイヤW1の先端が閉塞部位に到達した後、アンテ側ガイドワイヤW1の基端を先端チップ30を介して第2インナーシャフト50に挿通させ、アンテ側ガイドワイヤW1をガイドとして当該カテーテル1の先端を血管内にて閉塞部位まで押し進める。 First, the ante-side guide wire W1 is inserted into a blood vessel, for example, and pushed along the blood vessel to a site where an obstruction exists (hereinafter also referred to as “occlusion site”). After the distal end of the ante-side guide wire W1 reaches the occluded site, the proximal end of the ante-side guide wire W1 is inserted through the second inner shaft 50 via the distal tip 30, and the catheter 1 with the ante-side guide wire W1 as a guide. Push the tip of the tube to the occlusion site in the blood vessel.
 カテーテル1の先端が閉塞部位に到達した後、図示せぬインデフレータからハブ20を介して、造影剤や生理食塩水等の液体を拡張ルーメン10aに供給する。液体が供給されると、図2に示すように、第1チューブ部13および第3チューブ部15が径方向に拡張し、第1チューブ部13および第3チューブ部15の外周面が閉塞部位近傍を径方向に押し広げる。この時、第1チューブ部13は、少なくとも軸方向の先端側(第2チューブ部14側)に向かって伸張し、第3チューブ部15は、少なくとも軸方向の基端側(第2チューブ部14側)に向かって伸張する。これにより、第2チューブ部14が軸方向に収縮して、受け入れ部材70の先端部71と基端部73とが互いに近づくことにより、受け入れ部材70の中間部72が径方向に拡張する。 After the distal end of the catheter 1 reaches the occluded site, a liquid such as a contrast medium or physiological saline is supplied to the expansion lumen 10a from the indeflator (not shown) via the hub 20. When the liquid is supplied, as shown in FIG. 2, the first tube portion 13 and the third tube portion 15 expand in the radial direction, and the outer peripheral surfaces of the first tube portion 13 and the third tube portion 15 are in the vicinity of the occlusion site. Squeeze out radially. At this time, the first tube portion 13 extends at least toward the distal end side (second tube portion 14 side) in the axial direction, and the third tube portion 15 extends at least on the proximal end side (second tube portion 14 in the axial direction). Side). Thereby, the 2nd tube part 14 shrinks to an axial direction, and when the front-end | tip part 71 and the base end part 73 of the receiving member 70 mutually approach, the intermediate part 72 of the receiving member 70 expands to radial direction.
 次に、先端側から向かって来るレトロ側ガイドワイヤW2をカテーテル1に受け入れる。レトロ側ガイドワイヤW2が向かってくる経路としては、例えば、閉塞部位を囲繞する血管壁内の偽腔、閉塞部位を貫通する貫通孔等が想定されるが、いずれの経路からのレトロ側ガイドワイヤW2であってもよい。レトロ側ガイドワイヤW2は、拡張した中間部72により、第2チューブ部14の第3開口部14aへ導かれ、第1インナーシャフト40に挿通され、第1開口部10bからカテーテル1の外部に送出される。次いで、第1開口部10bから送出されたレトロ側ガイドワイヤW2は、血管内を通過した後、端部が体外に送出される。これにより、レトロ側ガイドワイヤW2が閉塞部位を貫通しかつ当該レトロ側ガイドワイヤW2の両端部が体外に露出した状態を作り出すことができる。 Next, the retro-side guide wire W2 coming from the distal end side is received by the catheter 1. As a path to which the retro-side guide wire W2 is directed, for example, a false cavity in a blood vessel wall surrounding the occlusion site, a through-hole penetrating the occlusion site, and the like are assumed. W2 may be sufficient. The retro-side guide wire W2 is guided to the third opening 14a of the second tube portion 14 by the expanded intermediate portion 72, inserted through the first inner shaft 40, and delivered to the outside of the catheter 1 from the first opening 10b. Is done. Next, the retro-side guide wire W2 delivered from the first opening 10b passes through the blood vessel, and then the end is delivered out of the body. Thereby, it is possible to create a state in which the retro side guide wire W2 penetrates the occluded portion and both end portions of the retro side guide wire W2 are exposed to the outside of the body.
 以上のように、上記のカテーテル1によれば、第1チューブ部13および第3チューブ部15を径方向に拡張させて閉塞部位を押し広げるとき、第2チューブ部14が軸方向に収縮するので、受け入れ部材70の中間部72を径方向に拡張させることができる。受け入れ部材70の中間部72を径方向に拡張させた状態で、レトロ側ガイドワイヤW2を受け入れ部材70で受け入れることにより、第3開口部14aから第1インナーシャフト40にレトロ側ガイドワイヤW2を導くことができる。したがって、バルーンカテーテル等により閉塞部位を押し広げる工程と、バルーンカテーテル等を抜去したのち、レトロ側ガイドワイヤW2を受け入れるための医療部材を閉塞部位まで挿入する工程とからなる2つの工程を、1つの工程とすることができるので、手技時間を短縮することができる。 As described above, according to the catheter 1 described above, when the first tube portion 13 and the third tube portion 15 are expanded in the radial direction to spread the obstruction site, the second tube portion 14 contracts in the axial direction. The intermediate portion 72 of the receiving member 70 can be expanded in the radial direction. The retro-side guide wire W2 is guided from the third opening 14a to the first inner shaft 40 by receiving the retro-side guide wire W2 with the receiving member 70 in a state where the intermediate portion 72 of the receiving member 70 is radially expanded. be able to. Therefore, two steps consisting of a step of expanding the occlusion site with a balloon catheter or the like and a step of inserting the medical member for receiving the retro side guide wire W2 to the occlusion site after removing the balloon catheter or the like are combined into one step. Since it can be a process, the procedure time can be shortened.
 受け入れ部材70は、コイル体であるので、簡易な構成でレトロ側ガイドワイヤW2を受け入れる部材を提供することができる。 Since the receiving member 70 is a coil body, it is possible to provide a member that receives the retro-side guide wire W2 with a simple configuration.
 第2インナーシャフト50の先端は、先端チップ30の基端に接続されているので、アンテ側ガイドワイヤW1を第2インナーシャフト50に通した状態で、受け入れ部材70で受け入れたレトロ側ガイドワイヤW2を、第1インナーシャフト40に通すことができる。よって、アンテ側ガイドワイヤW1とレトロ側ガイドワイヤW2とが絡まることを防止することができる。したがって、効率よく手技を行うことができるので手技時間を短縮することができる。 Since the distal end of the second inner shaft 50 is connected to the proximal end of the distal tip 30, the retro-side guide wire W2 received by the receiving member 70 in a state where the antenna-side guide wire W1 is passed through the second inner shaft 50. Can be passed through the first inner shaft 40. Therefore, it is possible to prevent the antenna side guide wire W1 and the retro side guide wire W2 from being entangled. Therefore, since the procedure can be performed efficiently, the procedure time can be shortened.
[第2の実施形態]
 第2の実施形態に係るカテーテル101について図面を参照して説明する。
[Second Embodiment]
A catheter 101 according to a second embodiment will be described with reference to the drawings.
 図3は、第2の実施形態に係るカテーテル101の先端部付近の一部断面図であって、第1チューブ部113および第3チューブ部115が収縮した状態を示す。図4は、図3に示したカテーテル101のIV-IV線に沿った断面図を示す。図5は、カテーテル101の先端部付近の断面図であって、第1チューブ部113および第3チューブ部115が拡張した状態を示す。 FIG. 3 is a partial cross-sectional view of the vicinity of the distal end portion of the catheter 101 according to the second embodiment, showing a state in which the first tube portion 113 and the third tube portion 115 are contracted. 4 shows a cross-sectional view of the catheter 101 shown in FIG. 3 taken along the line IV-IV. FIG. 5 is a cross-sectional view of the vicinity of the distal end portion of the catheter 101 and shows a state where the first tube portion 113 and the third tube portion 115 are expanded.
 カテーテル101は、アウターシャフト110と、ハブ20(不図示)と、先端チップ30と、第1インナーシャフト40と、第2インナーシャフト50と、補強体60と、受け入れ部材70と、を備える。本実施形態では、アウターシャフト110の構成が第1の実施形態のアウターシャフト10の構成と異なる。なお、ハブ20(不図示)、先端チップ30、第1インナーシャフト40、第2インナーシャフト50、補強体60、および受け入れ部材70の構成は、第1の実施形態のものと同じ構成であるので、同一の符号を付して説明を省略する。 The catheter 101 includes an outer shaft 110, a hub 20 (not shown), a distal tip 30, a first inner shaft 40, a second inner shaft 50, a reinforcing body 60, and a receiving member 70. In the present embodiment, the configuration of the outer shaft 110 is different from the configuration of the outer shaft 10 of the first embodiment. The configuration of the hub 20 (not shown), the tip tip 30, the first inner shaft 40, the second inner shaft 50, the reinforcing body 60, and the receiving member 70 is the same as that of the first embodiment. The same reference numerals are given and the description is omitted.
 アウターシャフト110は、造影剤や生理食塩水等の液体が流れる拡張ルーメン110aを画定する管状の部材である。アウターシャフト110は、基端側から順に並ぶ、第1シャフト部11(不図示)と、第2シャフト部12と、第1チューブ部113と、第2チューブ部114と、第3チューブ部115と、を有する。第1シャフト部11(不図示)および第2シャフト部12は、第1の実施形態のものと同じ構成であるので、同一の符号を付して説明を省略する。 The outer shaft 110 is a tubular member that defines an expansion lumen 110a through which a liquid such as a contrast medium or physiological saline flows. The outer shaft 110 has a first shaft portion 11 (not shown), a second shaft portion 12, a first tube portion 113, a second tube portion 114, and a third tube portion 115 arranged in order from the proximal end side. Have. Since the 1st shaft part 11 (not shown) and the 2nd shaft part 12 are the same structures as the thing of a 1st embodiment, the same numerals are attached and explanation is omitted.
 第1チューブ部113および第2チューブ部114は、それぞれポリウレタン、ポリウレタンエラストマーなどの伸縮性のある柔軟な樹脂材料からからなる管状の部材であり、拡張ルーメン110aの一部を画定する。なお、第2チューブ部114は、第1チューブ部113よりも柔軟な樹脂材料により構成されていてもよい。第3チューブ部115は、ポリアミド、ポリアミドエラストマー、ポリオレフィン、ポリエステル、ポリエステルエラストマーなどの樹脂材料からなる管状の部材であり、拡張ルーメン110aの一部を画定する。本実施形態では、第1チューブ部113、第2チューブ部114、および第3チューブ部115は、互いに別体に構成されている。 The first tube portion 113 and the second tube portion 114 are tubular members made of a flexible resin material having elasticity such as polyurethane and polyurethane elastomer, respectively, and define a part of the expansion lumen 110a. Note that the second tube portion 114 may be made of a resin material that is more flexible than the first tube portion 113. The third tube portion 115 is a tubular member made of a resin material such as polyamide, polyamide elastomer, polyolefin, polyester, or polyester elastomer, and defines a part of the expansion lumen 110a. In this embodiment, the 1st tube part 113, the 2nd tube part 114, and the 3rd tube part 115 are comprised separately from each other.
 第1チューブ部113は、その基端が第2シャフト部12の先端の外周に固着(溶着)されている。第1チューブ部113は、その径方向に拡張および収縮するように構成されている。 The proximal end of the first tube portion 113 is fixed (welded) to the outer periphery of the distal end of the second shaft portion 12. The first tube portion 113 is configured to expand and contract in the radial direction.
 第2チューブ部114は、第1チューブ部113の先端側に位置しており、その軸方向に収縮するように構成されている。第2チューブ部114の基端は、第1チューブ部113の先端の外周に固着(溶着)されている。第2チューブ部114の、先端部と基端部との間の中間部には、第3開口部114aが形成されている。 The 2nd tube part 114 is located in the front end side of the 1st tube part 113, and is comprised so that it may shrink | contract in the axial direction. The proximal end of the second tube portion 114 is fixed (welded) to the outer periphery of the distal end of the first tube portion 113. A third opening 114 a is formed at an intermediate portion between the distal end portion and the proximal end portion of the second tube portion 114.
 第3チューブ部115は、第2チューブ部114の先端側に位置しており、その径方向に拡張および収縮するように構成されている。第3チューブ部115の基端は、第2チューブ部114の先端の外周に固着(溶着)されている。図3では、第3チューブ部115はその外観が示されている。 The 3rd tube part 115 is located in the front end side of the 2nd tube part 114, and is comprised so that it may expand and contract in the radial direction. The proximal end of the third tube portion 115 is fixed (welded) to the outer periphery of the distal end of the second tube portion 114. In FIG. 3, the external appearance of the third tube portion 115 is shown.
 図3、図4に示すように、第3チューブ部115は、収縮した状態では、折り畳まれるように構成されている。第3チューブ部115は、円筒状のチューブ本体部116と、2つの翼部117とを有する。2つの翼部117は、チューブ本体部116に対し、径方向で対向する位置にそれぞれ接続されている。図4に示すように、第3チューブ部115の収縮時は、2つの翼部117が、チューブ本体部116の外周に沿って折り畳まれた状態である。拡張ルーメン110aに液体が供給されると、翼部117が広がり、第3チューブ部115は全体として断面形状が円環状になるように拡張する。 As shown in FIGS. 3 and 4, the third tube portion 115 is configured to be folded in a contracted state. The third tube portion 115 includes a cylindrical tube main body portion 116 and two wing portions 117. The two wing parts 117 are connected to the tube body part 116 at positions facing each other in the radial direction. As shown in FIG. 4, when the third tube portion 115 is contracted, the two wing portions 117 are folded along the outer periphery of the tube main body portion 116. When the liquid is supplied to the expansion lumen 110a, the wing portion 117 expands, and the third tube portion 115 expands so that the cross-sectional shape becomes an annular shape as a whole.
 本実施形態のカテーテル101の使用態様では、カテーテル101がアンテ側ガイドワイヤW1を介して閉塞部位まで進んだ後、上記液体が拡張ルーメン110aに供給されると、図5に示すように、第1チューブ部113および第3チューブ部115が径方向に拡張し、第1チューブ部113および第3チューブ部115の外周面が閉塞部位近傍を径方向に押し広げる。この時、第1チューブ部113は、少なくとも軸方向の先端側(第2チューブ部114側)に向かって伸張し、第3チューブ部115は、少なくとも軸方向の基端側(第2チューブ部114側)に向かって伸張する。これにより、第2チューブ部114が軸方向に収縮して、受け入れ部材70の先端部71と基端部73とが互いに近づくことにより、受け入れ部材70の中間部72が径方向に拡張する。 In the usage mode of the catheter 101 of the present embodiment, when the liquid is supplied to the expansion lumen 110a after the catheter 101 has advanced to the occlusion site via the ante side guide wire W1, as shown in FIG. The tube portion 113 and the third tube portion 115 expand in the radial direction, and the outer peripheral surfaces of the first tube portion 113 and the third tube portion 115 push the vicinity of the blocked site in the radial direction. At this time, the first tube portion 113 extends at least toward the distal end side in the axial direction (second tube portion 114 side), and the third tube portion 115 extends at least in the proximal end side in the axial direction (second tube portion 114). Side). As a result, the second tube portion 114 contracts in the axial direction, and the distal end portion 71 and the proximal end portion 73 of the receiving member 70 approach each other, whereby the intermediate portion 72 of the receiving member 70 expands in the radial direction.
 レトロ側ガイドワイヤW2は、拡張した中間部72により、第2チューブ部114の第3開口部114aへ導かれ、第1インナーシャフト40に挿通され、第1開口部10bからカテーテル101の外部に送出される。 The retro-side guide wire W2 is guided to the third opening 114a of the second tube portion 114 by the expanded intermediate portion 72, inserted through the first inner shaft 40, and delivered to the outside of the catheter 101 from the first opening 10b. Is done.
 このように、本実施形態においても、第1の実施形態のカテーテル1と同様に、バルーンカテーテル等により閉塞部位を押し広げる工程と、バルーンカテーテル等を抜去したのち、レトロ側ガイドワイヤW2を受け入れるための医療部材を閉塞部位まで挿入する工程とからなる2つの工程を、1つの工程とすることができるので、手技時間を短縮することができる。 As described above, in this embodiment as well, in the same manner as the catheter 1 of the first embodiment, the step of expanding the occluded portion with a balloon catheter or the like and the removal of the balloon catheter or the like and then receiving the retro side guide wire W2 Since the two steps including the step of inserting the medical member up to the occlusion site can be made into one step, the procedure time can be shortened.
[第3の実施形態]
 次に、第3の実施形態に係るカテーテル201について図面を参照して説明する。
[Third Embodiment]
Next, a catheter 201 according to a third embodiment will be described with reference to the drawings.
 図6は、第3の実施形態に係るカテーテル201の先端部付近の外観図であって、第1チューブ部213および第3チューブ部215が収縮した状態を示す。図7は、第3の実施形態に係るカテーテル201の先端部付近の外観図であって、第1チューブ部213および第3チューブ部215が拡張した状態を示す。 FIG. 6 is an external view of the vicinity of the distal end portion of the catheter 201 according to the third embodiment, and shows a state in which the first tube portion 213 and the third tube portion 215 are contracted. FIG. 7 is an external view of the vicinity of the distal end portion of the catheter 201 according to the third embodiment, and shows a state where the first tube portion 213 and the third tube portion 215 are expanded.
 カテーテル201は、アウターシャフト210と、ハブ20(不図示)と、先端チップ30と、第1インナーシャフト40と、第2インナーシャフト50と、補強体60(不図示)と、受け入れ部材270と、を備える。本実施形態では、アウターシャフト210および受け入れ部材270の構成が第1の実施形態のアウターシャフト10および受け入れ部材70の構成と異なる。なお、ハブ20(不図示)、先端チップ30、第1インナーシャフト40、第2インナーシャフト50、および補強体60(不図示)の構成は、第1の実施形態のものと同じ構成であるので、同一の符号を付して説明を省略する。 The catheter 201 includes an outer shaft 210, a hub 20 (not shown), a tip 30, a first inner shaft 40, a second inner shaft 50, a reinforcing body 60 (not shown), a receiving member 270, Is provided. In the present embodiment, the configurations of the outer shaft 210 and the receiving member 270 are different from the configurations of the outer shaft 10 and the receiving member 70 of the first embodiment. The configuration of the hub 20 (not shown), the tip tip 30, the first inner shaft 40, the second inner shaft 50, and the reinforcing body 60 (not shown) is the same as that of the first embodiment. The same reference numerals are given and the description is omitted.
 アウターシャフト210は、造影剤や生理食塩水等の液体が流れる拡張ルーメン210aを画定する管状の部材である。アウターシャフト210は、基端側から順に並ぶ、第1シャフト部11(不図示)と、第2シャフト部12と、第1チューブ部213と、第2チューブ部214と、第3チューブ部215と、を有する。第1シャフト部11(不図示)および第2シャフト部12は、第1の実施形態のものと同じ構成であるので、同一の符号を付して説明を省略する。 The outer shaft 210 is a tubular member that defines an expansion lumen 210a through which a liquid such as a contrast medium or physiological saline flows. The outer shaft 210 has a first shaft portion 11 (not shown), a second shaft portion 12, a first tube portion 213, a second tube portion 214, and a third tube portion 215 arranged in order from the base end side. Have. Since the 1st shaft part 11 (not shown) and the 2nd shaft part 12 are the same structures as the thing of a 1st embodiment, the same numerals are attached and explanation is omitted.
 第1チューブ部213、第2チューブ部214、および第3チューブ部215は、ポリウレタン、ポリウレタンエラストマーなどの伸縮性のある柔軟な樹脂材料からからなる管状の部材であり、拡張ルーメン210aの一部を画定する。本実施形態では、第1チューブ部213、第2チューブ部214、および第3チューブ部215は、互いに別体に構成されている。 The first tube portion 213, the second tube portion 214, and the third tube portion 215 are tubular members made of a stretchable flexible resin material such as polyurethane and polyurethane elastomer, and a part of the expansion lumen 210a is formed. Define. In the present embodiment, the first tube portion 213, the second tube portion 214, and the third tube portion 215 are configured separately from each other.
 第1チューブ部213は、その基端が第2シャフト部12の先端の外周に固着(溶着)されている。第1チューブ部213は、その径方向に拡張および収縮するように構成されている。 The proximal end of the first tube portion 213 is fixed (welded) to the outer periphery of the distal end of the second shaft portion 12. The first tube portion 213 is configured to expand and contract in the radial direction.
 第2チューブ部214は、第1チューブ部213の先端側に位置しており、その軸方向に収縮するように構成されている。第2チューブ部214の基端は、第1チューブ部213の先端の外周に固着(溶着)されている。第2チューブ部214の、先端部と基端部との間の中間部には、第3開口部214aが形成されている。 The 2nd tube part 214 is located in the front end side of the 1st tube part 213, and is comprised so that it may shrink | contract in the axial direction. The proximal end of the second tube portion 214 is fixed (welded) to the outer periphery of the distal end of the first tube portion 213. A third opening 214a is formed at an intermediate portion of the second tube portion 214 between the distal end portion and the proximal end portion.
 第3チューブ部215は、第2チューブ部214の先端側に位置しており、その径方向に拡張および収縮するように構成されている。第3チューブ部215の基端は、第2チューブ部214の先端の外周に固着(溶着)されている。第3チューブ部215の先端は、先端チップ30の基端の外周に固着(溶着)されている。第1チューブ部213および第3チューブ部215は、径方向に拡張および収縮しやすいように、それらの厚さが第2チューブ部214よりも薄く構成されている。第2チューブ部214は、第1チューブ部213および第3チューブ部215よりも柔軟な樹脂材料により構成されていてもよい。 The third tube portion 215 is located on the distal end side of the second tube portion 214 and is configured to expand and contract in the radial direction. The proximal end of the third tube portion 215 is fixed (welded) to the outer periphery of the distal end of the second tube portion 214. The distal end of the third tube portion 215 is fixed (welded) to the outer periphery of the proximal end of the distal tip 30. The first tube portion 213 and the third tube portion 215 are configured to be thinner than the second tube portion 214 so as to easily expand and contract in the radial direction. The second tube portion 214 may be made of a resin material that is more flexible than the first tube portion 213 and the third tube portion 215.
 受け入れ部材270は、複数の素線を格子状に編み込んで全体としてチューブ状にしたメッシュ部材であり、第2シャフト部214の外周に配置されている。受け入れ部材270は、先端部271、中間部272、および基端部273を有する。先端部271は、第2チューブ部214の先端部に固定(溶着)されている。基端部273は、第2チューブ部214の基端部に固定(溶着)されている。先端部271の先端は、第3チューブ部215の基端に覆われている。基端部273の基端は、第1チューブ部213の先端に覆われている。中間部272は、第2チューブ部214の外周には固定されておらず、径方向に拡張可能に構成されている。 The receiving member 270 is a mesh member in which a plurality of strands are knitted into a lattice shape to form a tube shape as a whole, and is disposed on the outer periphery of the second shaft portion 214. The receiving member 270 has a distal end portion 271, an intermediate portion 272, and a proximal end portion 273. The distal end portion 271 is fixed (welded) to the distal end portion of the second tube portion 214. The proximal end portion 273 is fixed (welded) to the proximal end portion of the second tube portion 214. The distal end of the distal end portion 271 is covered with the proximal end of the third tube portion 215. The proximal end of the proximal end portion 273 is covered with the distal end of the first tube portion 213. The intermediate portion 272 is not fixed to the outer periphery of the second tube portion 214 and is configured to be expandable in the radial direction.
 受け入れ部材270の各素線は、単線であってもよいし、複数の素線を撚り合わせた撚線であってもよい。受け入れ部材270の各素線を構成する材料としては、金属材料または樹脂材料を採用することができる。上記金属材料としては、例えば、SUS304などのステンレス鋼、ニッケルチタン合金、コバルトクロム合金等が挙げられる。上記樹脂材料としては、例えば、ポリアミド、ポリエステル、ポリアクリレート、ポリエーテルエーテルケトン等が挙げられる。 Each wire of the receiving member 270 may be a single wire or a stranded wire obtained by twisting a plurality of strands. As a material constituting each element wire of the receiving member 270, a metal material or a resin material can be employed. Examples of the metal material include stainless steel such as SUS304, nickel titanium alloy, cobalt chrome alloy, and the like. Examples of the resin material include polyamide, polyester, polyacrylate, polyether ether ketone, and the like.
 受け入れ部材270の各素線を構成する材料としては、受け入れ部材270の視認性を向上させる観点から、放射線不透過性材料であってもよい。放射線不透過材料としては、例えば、金、白金、タングステン、またはこれらの元素を含む合金(例えば、白金ニッケル合金など)等が挙げられる。なお、放射線不透過性材料は、放射線不透過性ではない材料の表面にコートされるものなど、当該放射線不透過性材料とこの材料以外の材料とを組み合わせたものであってもよい。 From the viewpoint of improving the visibility of the receiving member 270, the material constituting each strand of the receiving member 270 may be a radiopaque material. Examples of the radiopaque material include gold, platinum, tungsten, or an alloy containing these elements (for example, platinum nickel alloy). The radiopaque material may be a combination of the radiopaque material and a material other than this material, such as a material coated on the surface of a material that is not radiopaque.
 受け入れ部材270には、誘導膜274が設けられている。誘導膜274の先端は、受け入れ部材270の中間部272の第3開口部214aに対向する位置もしくはその位置よりも基端部273側に位置している。誘導膜274は、受け入れ部材270の目開きを通して受け入れたレトロ側ガイドワイヤW2を第3開口部214aに向かって円滑に導くものである。 The receiving member 270 is provided with a guide film 274. The distal end of the guide film 274 is located at a position facing the third opening 214 a of the intermediate portion 272 of the receiving member 270 or on the base end portion 273 side from the position. The guide film 274 smoothly guides the retro-side guide wire W2 received through the opening of the receiving member 270 toward the third opening 214a.
 誘導膜274を構成する材料としては、例えば、ポリエチレン、ポリウレタン、ポリアミド、ポリアミドエラストマー、ポリオレフィン、ポリエステル、ポリエステルエラストマー等が挙げられる。誘導膜274を形成する方法としては特に限定されず、例えば、受け入れ部材270に配置する誘導膜ではディップ法、フィルム状の誘導膜ではフィルムの先端を受け入れ部材270に融着する方法等を採用することができる。 Examples of the material constituting the induction film 274 include polyethylene, polyurethane, polyamide, polyamide elastomer, polyolefin, polyester, polyester elastomer, and the like. The method of forming the guide film 274 is not particularly limited. For example, a dipping method is used for the guide film disposed on the receiving member 270, and a method of fusing the leading end of the film to the receiving member 270 is used for the film-like guide film. be able to.
 本実施形態のカテーテル201の使用態様では、カテーテル201がアンテ側ガイドワイヤW1を介して閉塞部位まで進んだ後、上記液体が拡張ルーメン210aに供給されると、図7に示すように、第1チューブ部213および第3チューブ部215が径方向に拡張し、第1チューブ部213および第3チューブ部215の外周面が閉塞部位近傍を径方向に押し広げる。この時、第1チューブ部213は、少なくとも軸方向の先端側(第2チューブ部214側)に向かって伸張し、第3チューブ部215は、少なくとも軸方向の基端側(第2チューブ部214側)に向かって伸張する。これにより、第2チューブ部214が軸方向に収縮して、受け入れ部材270の先端部271と基端部273とが互いに近づくことにより、受け入れ部材270の中間部272が径方向に拡張する。これにより、誘導膜274は、漏斗形状に拡張する。 In the usage mode of the catheter 201 of the present embodiment, when the liquid is supplied to the expansion lumen 210a after the catheter 201 has traveled to the occlusion site via the ante side guide wire W1, as shown in FIG. The tube portion 213 and the third tube portion 215 expand in the radial direction, and the outer peripheral surfaces of the first tube portion 213 and the third tube portion 215 push the vicinity of the closed site in the radial direction. At this time, the first tube portion 213 extends at least toward the distal end side (second tube portion 214 side) in the axial direction, and the third tube portion 215 extends at least on the proximal end side (second tube portion 214 in the axial direction). Side). Accordingly, the second tube portion 214 contracts in the axial direction, and the distal end portion 271 and the proximal end portion 273 of the receiving member 270 approach each other, whereby the intermediate portion 272 of the receiving member 270 expands in the radial direction. Thereby, the induction film 274 expands into a funnel shape.
 レトロ側ガイドワイヤW2は、拡張した中間部272および誘導膜274により、第2チューブ部214の第3開口部214aへ導かれ、第1インナーシャフト40に挿通され、第1開口部10bからカテーテル201の外部に送出される。 The retro-side guide wire W2 is guided to the third opening 214a of the second tube portion 214 by the expanded intermediate portion 272 and the guide membrane 274, inserted through the first inner shaft 40, and from the first opening 10b to the catheter 201. Sent to outside.
 このように、本実施形態においても、第1の実施形態のカテーテル1と同様に、バルーンカテーテル等により閉塞部位を押し広げる工程と、バルーンカテーテル等を抜去したのち、レトロ側ガイドワイヤW2を受け入れるための医療部材を閉塞部位まで挿入する工程とからなる2つの工程を、1つの工程とすることができるので、手技時間を短縮することができる。 As described above, in this embodiment as well, in the same manner as the catheter 1 of the first embodiment, the step of expanding the occluded portion with a balloon catheter or the like and the removal of the balloon catheter or the like and then receiving the retro side guide wire W2 Since the two steps including the step of inserting the medical member up to the occlusion site can be made into one step, the procedure time can be shortened.
 なお、本発明は、上述した実施形態の構成に限定されるものではなく、特許請求の範囲によって示され、特許請求の範囲と均等の意味および範囲内での全ての変更が含まれることが意図される。上述した実施形態の構成のうちの一部を削除したり、他の構成に置換してもよく、上述した実施形態の構成に他の構成を追加等してもよい。 In addition, this invention is not limited to the structure of embodiment mentioned above, is shown by the claim, and intends that all the changes within the meaning and range equivalent to a claim are included. Is done. A part of the configuration of the above-described embodiment may be deleted or replaced with another configuration, or another configuration may be added to the configuration of the above-described embodiment.
 例えば、第1、2の実施形態のコイル体である受け入れ部材70を、第3の実施形態において受け入れ部材270に代えて用いてもよい。第3の実施形態のメッシュ部材である受け入れ部材270を第1、2の実施形態において受け入れ部材70に代えて用いてもよい。第2の実施形態の第3チューブ部115を、第3の実施形態において第3チューブ部215に代えて用いてもよい。 For example, the receiving member 70 that is the coil body of the first and second embodiments may be used in place of the receiving member 270 in the third embodiment. The receiving member 270 that is the mesh member of the third embodiment may be used in place of the receiving member 70 in the first and second embodiments. The third tube portion 115 of the second embodiment may be used in place of the third tube portion 215 in the third embodiment.
 第3の実施形態において、受け入れ部材270に誘導膜274を設けたが、誘導膜274を設けなくてもよい。第1、2の実施形態における受け入れ部材70に誘導膜を設けてもよい。 In the third embodiment, the guide film 274 is provided on the receiving member 270, but the guide film 274 may not be provided. A guide film may be provided on the receiving member 70 in the first and second embodiments.
1、101、201 カテーテル
10、110、210 アウターシャフト
11 第1シャフト部 
12 第2シャフト部
13、113、213 第1チューブ部
14、114、214 第2チューブ部
14a、214a 開口部
15、115、215 第3チューブ部
40 第1インナーシャフト
50 第2インナーシャフト
70、270 受け入れ部材
71、271 先端部
72、272 中間部
73、273 基端部
 
1, 101, 201 Catheter 10, 110, 210 Outer shaft 11 First shaft portion
12 2nd shaft part 13,113,213 1st tube part 14,114,214 2nd tube part 14a, 214a Opening part 15,115,215 3rd tube part 40 1st inner shaft 50 2nd inner shaft 70,270 Receiving members 71, 271 distal end 72, 272 intermediate 73, 273 proximal end

Claims (3)

  1.  第1インナーシャフトと、
     前記第1インナーシャフトの外周に配置されるアウターシャフトと、
     前記アウターシャフトに設けられた円筒状の受け入れ部材と、を備え、
     前記アウターシャフトは、
      シャフト部と、
      基端が前記シャフト部の先端に接続され、径方向に拡張および収縮するように構成された第1チューブ部と、
      基端が前記第1チューブ部の先端に接続され、軸方向に収縮するように構成された第2チューブ部と、
      基端が前記第2チューブ部の先端に接続され、径方向に拡張および収縮するように構成された第3チューブ部と、を有し、
     前記受け入れ部材は、先端部、中間部、および基端部を有し、前記先端部は、前記第2チューブ部の先端部に固定され、前記基端部は、前記第2チューブ部の基端部に固定され、前記中間部は、径方向に拡張するように構成され、
     前記第2チューブ部の、前記受け入れ部材の前記中間部に対向する部分に、前記第2チューブ部の内外を連通する開口部が形成され、
     前記開口部に、前記第1インナーシャフトの先端が接続され、
     前記第1チューブ部、前記第2チューブ部、および前記第3チューブ部は、前記第1チューブ部および前記第3チューブ部が径方向に拡張するとき、前記第1チューブ部は少なくとも軸方向の先端側に向かって伸張し、前記第3チューブ部は少なくとも軸方向の基端側に向かって伸張することにより、前記第2チューブ部は軸方向に収縮して、前記受け入れ部材の前記中間部を径方向に拡張するように構成されている、カテーテル。
    A first inner shaft;
    An outer shaft disposed on an outer periphery of the first inner shaft;
    A cylindrical receiving member provided on the outer shaft,
    The outer shaft is
    A shaft portion;
    A first tube portion having a proximal end connected to a distal end of the shaft portion and configured to expand and contract in a radial direction;
    A second tube portion configured to be proximally connected to a distal end of the first tube portion and contract in the axial direction;
    A proximal end connected to the distal end of the second tube portion, and a third tube portion configured to expand and contract in the radial direction, and
    The receiving member has a distal end portion, an intermediate portion, and a proximal end portion, the distal end portion is fixed to the distal end portion of the second tube portion, and the proximal end portion is a proximal end of the second tube portion. The intermediate portion is configured to expand in a radial direction,
    An opening that communicates the inside and the outside of the second tube portion is formed in a portion of the second tube portion that faces the intermediate portion of the receiving member,
    A tip of the first inner shaft is connected to the opening,
    The first tube portion, the second tube portion, and the third tube portion are configured such that when the first tube portion and the third tube portion expand in a radial direction, the first tube portion is at least an axial tip. The third tube portion extends at least toward the proximal end side in the axial direction, whereby the second tube portion contracts in the axial direction, and the intermediate portion of the receiving member has a diameter. A catheter configured to expand in a direction.
  2.  前記受け入れ部材は、メッシュ部材またはコイル体である、請求項1に記載のカテーテル。 The catheter according to claim 1, wherein the receiving member is a mesh member or a coil body.
  3.  第2インナーシャフトと、前記アウターシャフトの前記第3チューブ部の先端に接続された先端チップと、を更に備え、
     前記第2インナーシャフトの先端は、前記先端チップの基端または前記アウターシャフトの先端に接続されている、請求項1または請求項2に記載のカテーテル。
     
     
    A second inner shaft, and a tip connected to the tip of the third tube portion of the outer shaft;
    The catheter according to claim 1 or 2, wherein a distal end of the second inner shaft is connected to a proximal end of the distal tip or a distal end of the outer shaft.

PCT/JP2018/019242 2018-05-18 2018-05-18 Catheter WO2019220612A1 (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009517124A (en) * 2005-11-26 2009-04-30 コンテゴ メディカル エルエルシー Percutaneous transluminal angioplasty device with integrated embolic filter
JP2011517424A (en) * 2008-04-08 2011-06-09 リバース メディカル コーポレイション Occlusion device and method of use
JP2014503232A (en) * 2010-11-04 2014-02-13 ザ・チルドレンズ・ホスピタル・オブ・フィラデルフィア Magnetic target device, system, and method
US20160279393A1 (en) * 2015-03-25 2016-09-29 Covidien Lp Guidewire retrieval catheter
JP2017077323A (en) * 2015-10-20 2017-04-27 朝日インテック株式会社 catheter

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009517124A (en) * 2005-11-26 2009-04-30 コンテゴ メディカル エルエルシー Percutaneous transluminal angioplasty device with integrated embolic filter
JP2011517424A (en) * 2008-04-08 2011-06-09 リバース メディカル コーポレイション Occlusion device and method of use
JP2014503232A (en) * 2010-11-04 2014-02-13 ザ・チルドレンズ・ホスピタル・オブ・フィラデルフィア Magnetic target device, system, and method
US20160279393A1 (en) * 2015-03-25 2016-09-29 Covidien Lp Guidewire retrieval catheter
JP2017077323A (en) * 2015-10-20 2017-04-27 朝日インテック株式会社 catheter

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