WO2020079825A1 - Catheter - Google Patents

Catheter Download PDF

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Publication number
WO2020079825A1
WO2020079825A1 PCT/JP2018/038972 JP2018038972W WO2020079825A1 WO 2020079825 A1 WO2020079825 A1 WO 2020079825A1 JP 2018038972 W JP2018038972 W JP 2018038972W WO 2020079825 A1 WO2020079825 A1 WO 2020079825A1
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WO
WIPO (PCT)
Prior art keywords
hollow shaft
core wire
tip
catheter
mesh member
Prior art date
Application number
PCT/JP2018/038972
Other languages
French (fr)
Japanese (ja)
Inventor
俊彦 塚本
知也 沢田
築 國安
高歓 山口
盛貴 荻堂
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/JP2018/038972 priority Critical patent/WO2020079825A1/en
Publication of WO2020079825A1 publication Critical patent/WO2020079825A1/en

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    • 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
    • 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

Definitions

  • the present invention relates to a catheter.
  • CTO chronic total occlusion
  • the ante guide wire is inserted by the antegrade approach (approach from the ante side) to form a gap in the CTO or a false cavity under the intima of the blood vessel.
  • a retro guide wire is inserted from the opposite side (peripheral side) of the CTO by the retrograde approach (retro approach), and is pushed into the formed gap of the CTO or into the pseudointimal cavity. This allows the ante-side guide wire and the retro-side guide wire to communicate with each other.
  • a medical device having a triangular pyramid-shaped funnel at the tip is known as a medical device that easily transports the ante-side guide wire and the retro-side guide wire.
  • this medical device is inserted from the ante side, the retro guide wire is easily received by this funnel (for example, see Patent Document 1).
  • the present invention has been made based on the above circumstances, and an object thereof is to provide a catheter in which a retro guide wire can be easily inserted into the first hollow shaft side.
  • a catheter is configured such that a first hollow shaft and a proximal end thereof are joined to a distal end of the first hollow shaft and expand or contract in a radial direction.
  • a core wire extending inside the mesh member and the first hollow shaft, a tip joined to the tip tip, extending in a space inside the mesh member toward a base end side, and a base end of the tip tip base.
  • a second hollow shaft located between an end and a tip of the first hollow shaft, and a restraint portion that restrains the second hollow shaft to the core wire.
  • the core wire extends along an inner peripheral surface or an outer peripheral surface of the second hollow shaft,
  • the restraint portion may be a joint portion that joins the second hollow shaft and the core wire.
  • the constraining portion may contact the proximal end surface of the second hollow shaft to constrain the proximal end of the second hollow shaft to the core wire.
  • the second hollow shaft has a cylindrical shape
  • the core wire is configured to pass through the inside of the second hollow shaft
  • the restraint portion has an outer diameter smaller than an outer diameter of the second hollow shaft.
  • a ring member having an annular shape and abutting on the base end surface of the second hollow shaft may be included, and a connecting member that connects the ring member and the core wire may be included.
  • the core wire extends along an inner peripheral surface or an outer peripheral surface of the second hollow shaft, and the restraint portion is a clip that sandwiches the core wire and the second hollow shaft and restrains the second hollow shaft to the core wire. It may be.
  • the present invention can provide a catheter in which the retro guide wire can be easily inserted into the first hollow shaft side.
  • FIG. 2 is a sectional view taken along line II-II of FIG. 1. It is sectional drawing of the catheter which concerns on 1st Embodiment, and is a figure which shows the state which the mesh member expanded.
  • A) is a cross-sectional view of the distal end portion of the catheter according to the second embodiment, and (b) is a cross-sectional view taken along line IVb-IVb of (a).
  • A) is sectional drawing of the front-end
  • (b) is sectional drawing which followed the Vb-Vb line of (a).
  • the term “antegrade guide wire” means, among the guide wires, a guide wire that is pushed forward to a surgical site such as an occlusion site in a blood vessel prior to a catheter, and a “retrograde guide wire”.
  • guide wire means, for example, a guide wire that comes inside the blood vessel from the distal end side of the catheter.
  • the “tip side” refers to the direction along the longitudinal direction of the catheter and the direction in which the tip is positioned with respect to the mesh member.
  • the “proximal end side” refers to a direction along the longitudinal direction, which is opposite to the distal end side.
  • the “tip” refers to the end on the tip side in each member that constitutes the catheter.
  • the “proximal end” refers to the end portion on the proximal end side of each member that constitutes the catheter.
  • FIG. 1 is a cross-sectional view of a catheter 1 according to a first embodiment of the present invention, showing a state in which a mesh member 20 is contracted.
  • the catheter 1 includes a first hollow shaft 10, a mesh member 20, a distal tip 30, a second hollow shaft 40, a core wire 50, a restraining portion 60, and a connector 70.
  • the first hollow shaft 10 has a distal shaft 11 and a proximal shaft 12.
  • the tip of the tip shaft 11 is connected to the base end of the mesh member 20.
  • the distal end of the proximal shaft 12 is connected to the proximal end of the distal shaft 11.
  • a connector 70 is connected to the proximal end of the proximal shaft 12.
  • the tip side shaft 11 has a lumen 13 for inserting the antegrade guide wire, the retrograde guide wire, and the core wire 50 therein.
  • the proximal shaft 12 has a lumen 14 into which the core wire 50 is inserted.
  • the distal shaft 11 and the proximal shaft 12 form a guide wire port 15 that opens toward the proximal side.
  • a retrograde guidewire is delivered to the exterior of the catheter 1 via the guidewire port 15.
  • the material forming the first hollow shaft 10 preferably has antithrombogenicity, flexibility, and biocompatibility because the first hollow shaft 10 is inserted into a blood vessel.
  • a metal material is mentioned.
  • a resin material is preferable.
  • polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, fluororesin, etc. can be adopted.
  • the proximal shaft 12 is preferably made of a metal material because pushability is required.
  • stainless steel such as SUS304, nickel titanium alloy, cobalt chromium alloy, etc. can be adopted.
  • the mesh member 20 is a tubular member that can be expanded or contracted in the radial direction.
  • the core wire 50 which will be described later, is pulled toward the proximal end side, the mesh member 20 is deformed out-of-plane and expanded outward in the radial direction as shown in FIG.
  • a retrograde guidewire is received in the catheter 1 through the apertures in the member 20. ..
  • the mesh member 20 is formed so that a plurality of element wires 21 are knitted in a lattice shape and become a tube shape as a whole. Further, the mesh member 20 has openings between the adjacent braided wires, and receives the retrograde guide wire through the expanded openings when the diameter is increased.
  • the tip 30 and the first hollow shaft 10 are joined to the tip and the base of each element wire 21 that constitutes the mesh member 20.
  • each of the strands 21 constituting the mesh member 20 may be a single strand or a plurality of strands. For example, from a twisted wire in which a plurality of metal wires having different diameters are twisted together. It may be formed.
  • a metal material or a resin material can be adopted as a material forming each strand 21 of the mesh member 20.
  • the resin material include polyamide, polyester, polyarylate, and polyether ether ketone. From the viewpoint of improving strength and flexibility, a metal material is preferable.
  • the metal material include stainless steel such as SUS304, nickel titanium alloy, and cobalt chromium alloy.
  • the strands of wire may be formed of the same material or different materials.
  • the material forming each strand 21 of the mesh member 20 may be a radiopaque material from the viewpoint of improving the visibility of the mesh member 20.
  • the radiopaque material include gold, platinum, tungsten, and alloys containing these elements (for example, platinum-nickel alloy and the like).
  • 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 guide member 22 is provided on the mesh member 20, and the tip of the guide film 22 is located between the base end of the tip 30 and the tip of the first hollow shaft 10.
  • the guide film 22 smoothly guides the retrograde guide wire received through the openings of the mesh member 20 toward the first hollow shaft 10.
  • the leading end of the guide film 22 is located substantially at the center of the mesh member 20 in the long axis direction, and the base end is located at the end of the first hollow shaft 10.
  • the guide film 22 is formed on the mesh member 20 so as to bridge adjacent strands.
  • the retrograde guide wire is guided into the first hollow shaft 10 through the mesh member 20 by expanding the guide film 22 into a funnel shape when the mesh member 20 expands in diameter.
  • At least a part of the guide film 22 (for example, the outer circumference of the tip of the guide film 22) may be bonded to the mesh member 20, and may be, for example, a film-like member (not shown).
  • Examples of the material forming the guide film 22 include polyethylene, polyurethane, polyamide, polyamide elastomer, polyolefin, polyester, polyester elastomer and the like. Among these, polyurethane is preferable as the above material from the viewpoint of improving the sliding property of the surface.
  • the method for forming the guide film 22 is not particularly limited. For example, a dip method may be used for the guide film to be arranged on the mesh member 20, a method of fusing the tip of the film to the mesh member 20 for a film-like guide film, and the like. Can be adopted.
  • the tip 30 is connected to the tip of the mesh member 20.
  • the distal tip 30 is formed in a sharpened shape toward the distal side so that the catheter 1 can easily advance in the blood vessel, and each strand of the mesh member 20 is formed at the proximal end of the distal tip 30.
  • Each tip, the tip of the second hollow shaft 40, and the tip of the core wire 50 are embedded.
  • the catheter 1 has flexibility because the catheter 1 advances in the blood vessel.
  • the material having flexibility include resin materials such as polyurethane and polyurethane elastomer.
  • the second hollow shaft 40 is connected to the tip 30 and projects toward the proximal end in the space inside the mesh member 20. As shown in FIG. 1, the proximal end of the second hollow shaft 40 is located between the distal end of the first hollow shaft 10 and the proximal end of the distal tip 30 in the space inside the mesh member 20. Further, as shown in FIG. 3, the second hollow shaft 40 has its proximal end in the space inside the mesh member 20 in the space inside the mesh member 20 in a state where the mesh member 20 is expanded radially outward. And the base end of the tip 30. This is to make it easier to receive the retrograde guide wire in the first hollow shaft 10.
  • the material forming the second hollow shaft 40 since the second hollow shaft 40 is also inserted into the blood vessel similarly to the first hollow shaft 10 described above, it has antithrombotic property, flexibility and biocompatibility. It is preferable to have.
  • the material include the same materials as those exemplified in the description of the first hollow shaft 10, but a resin material is preferable from the viewpoint of flexibility.
  • the core wire 50 has its tip connected to the tip 30, and its base extends to the outside of the connector 70 located on the base side of the first hollow shaft 20. Therefore, the core wire 50 penetrates the mesh member 20, the lumens 13 and 14 of the first hollow shaft 10 and the through hole 71 of the connector 70.
  • the core wire 50 advances and retracts in the major axis direction of the catheter 1, and the mesh member 20 expands and contracts in the radial direction.
  • the material forming the core wire 50 preferably has sufficient tensile strength and rigidity from the viewpoint of preventing cutting of the core wire 50 itself and surely expanding and contracting the mesh member 20.
  • the material include stainless steel such as SUS304 and metallic materials such as nickel titanium alloy and cobalt chromium alloy.
  • FIG. 2 is a sectional view taken along the line II-II in FIG.
  • the mesh member 20 is not shown in FIG.
  • the restraint portion 60 is arranged on the proximal end side of the second hollow shaft 40, and has a ring member 61 and four connecting shafts 62.
  • the ring member 61 has an annular shape, the inner diameter of which is larger than the inner diameter of the second hollow shaft 40 and the outer diameter of which is smaller than the outer diameter of the second hollow shaft 40.
  • the ring member 61 is in contact with the base end surface 41 of the second hollow shaft 40 in a state where its long axis (the axis extending in the longitudinal direction of the catheter 1) is substantially coaxial with the long axis of the second hollow shaft 40.
  • the ring member 61 is located within the range of the base end surface 41 of the second hollow shaft 40 when viewed in the long axis direction. That is, the ring member 61 does not have a portion protruding inward and outward of the second hollow shaft 40 in the radial direction.
  • the core wire 50 penetrates the inside of the ring member 61.
  • each connection shaft 62 is joined (welded, welded, or adhered) to the outer peripheral surface of the core wire 50, and the other end of each connection shaft 62 is joined (welded, welded, or adhered) to the base end face 63 of the ring member 61. ) Has been.
  • the connecting shaft 62 is joined to the core wire 50, the ring member 61 is joined to the connecting shaft 62, and the distal end surface 64 of the ring member 61 is in contact with the proximal end surface 41 of the second hollow shaft 40.
  • the restraint portion 60 restrains the second hollow shaft 40 to the core wire 50.
  • the four connecting shafts 62 correspond to connecting members. Further, the surface roughness of the distal end surface 64 of the ring member 61 and / or the proximal end surface 41 of the second hollow shaft 40 may be increased to improve the binding force of the second hollow shaft 40 to the core wire 50. Further, the second hollow shaft 40 and the ring member 61 may be joined together. Further, the other end of each connection shaft 62 may be joined to the inner peripheral surface of the ring member 61.
  • a metal material or a resin material can be adopted as the material forming the ring member 61 and the four connecting shafts 62.
  • the resin material include polyamide, polyester, polyarylate, and polyether ether ketone.
  • the metal material include stainless steel such as SUS304, nickel titanium alloy, and cobalt chrome alloy.
  • the ring member 61 and the four connecting shafts 62 are preferably made of the same material, but may be made of different materials.
  • the material forming the ring member 61 and the four connecting shafts 62 may be a radiopaque material from the viewpoint of improving the visibility of the ring member 61 and the four connecting shafts 62.
  • the radiopaque material include gold, platinum, tungsten, and alloys containing these elements (for example, platinum-nickel alloy and the like).
  • 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 connector 70 is a member for an operator to hold the catheter 1. As shown in FIG. 1, the connector 70 is connected to the proximal end of the first hollow shaft 10 and is a through hole communicating with the lumens 13 and 14 of the first hollow shaft 1 so that the core wire 50 can be exposed to the outside. 71 and an opening 72 formed at the base end of the through hole 71.
  • the form of the connector 70 is not particularly limited, and may be any shape as long as it is easy for the operator to grip.
  • a balloon catheter (not shown) is inserted to the occluded region using the antegrade guide wire W1 as a guide, and the occluded region is expanded by expanding the diameter of the balloon. . After expanding the occluded part, the balloon is contracted to remove the balloon catheter from the blood vessel.
  • the proximal end of the antegrade guide wire W1 is passed through the through hole at the distal end of the distal tip 30 and passes through the inside of the distal tip 30 and the second hollow shaft 40 to come out of the catheter 1 from the guide wire port 15.
  • the catheter 1 is inserted into the catheter 1, and the distal end of the catheter 1 is pushed forward to the occlusion site in the blood vessel using the antegrade guide wire W1 as a guide.
  • the catheter 1 is inserted into a blood vessel in a state where the mesh member 20 has a reduced diameter, and is maintained in the reduced diameter state until the tip of the catheter 1 reaches the occlusion site.
  • the antegrade guidewire W1 is pulled out from the catheter 1 by pulling the antegrade guidewire W1 toward the proximal end side. Then, by pulling the core wire 50 exposed to the outside of the connector 70 toward the proximal end side, the distance between the tip of the mesh member 20 and the tip of the first hollow shaft 10 is narrowed, and as a result, the mesh member 20 is radially moved. It expands out-of-plane and expands in diameter.
  • the guide film 22 is expanded in diameter in accordance with the expansion of the mesh member 20.
  • the membrane 22 has a funnel shape as a whole. Since the mesh opening is expanded as the mesh member 20 is expanded, the retrograde guide wire W2 can be easily received. Further, since the proximal end of the second hollow shaft 40 is restrained by the core wire 50 by the restraint portion 60, the second hollow shaft 40 does not tilt and moves along the long axis direction (longitudinal direction) of the catheter 1. To do.
  • the mesh member 20 is expanded in diameter, and then the antegrade guide wire W1 is pulled toward the proximal end side to advance.
  • the sex guide wire W1 may be withdrawn from the catheter 1.
  • the retrograde guide wire W2 coming from the distal end side is received in the catheter 1.
  • a route through which the retrograde guide wire W2 goes for example, a false cavity in the blood vessel wall surrounding the occlusion site, a through hole penetrating the occlusion site, or the like is assumed. It may be the wire W2.
  • the retrograde guide wire W2 is received in the space inside the mesh member 20 through the openings of the expanded mesh member 20, and then inserted into the distal end side shaft 11 of the first hollow shaft 10 and through the guide wire port 15. Is delivered to the outside of the catheter 1.
  • the second hollow shaft 40 is constrained to the core wire 50 by the constraining portion 60.
  • the ring member 61 of the restraint portion 60 is in contact with the base end surface 41 of the second hollow shaft 40 to restrain the base end of the second hollow shaft 40 to the core wire 50. Therefore, when the core wire 50 is pulled to expand the mesh member 20, the second hollow shaft 40 can be prevented from being separated from the core wire 50, and the long axis of the second hollow shaft 40 can be prevented from being displaced. .
  • the second hollow shaft 40 does not hinder the insertion of the retrograde guide wire W2, and the retrograde guide wire W2 can be easily inserted into the first hollow shaft 10 side.
  • the retrograde guide wire W2 since the proximal end of the second hollow shaft 40 is restrained by the core wire 50, when the retrograde guide wire W2 comes into contact with the second hollow shaft 40, the retrograde guide wire W2 is fixed to the second hollow shaft 40. It can be guided along the first hollow shaft 10 side.
  • the core wire 50 is configured to pass through the inside of the second hollow shaft 40, and the restraint portion 60 has an annular shape having an outer diameter smaller than the outer diameter of the second hollow shaft 40.
  • a ring member 61 that abuts on the base end surface 41 of the above, and a connecting shaft 62 that connects the ring member 61 and the core wire 50.
  • FIG. 4A is a sectional view of the distal end portion of the catheter 101 according to the second embodiment of the present invention
  • FIG. 4B is a sectional view taken along the line IVb-IVb of FIG. 4A.
  • the mesh member 20 is not shown in FIG. 4B.
  • the catheter 101 has a first hollow shaft 10, a mesh member 20, a distal end tip 30, a second hollow shaft 40, a core wire 50, and a restraining portion 160. And a connector 70 (see FIG. 1).
  • the catheter 101 of the second embodiment is different from the catheter 1 of the first embodiment in the configuration of the restraint portion 160. Since the configurations of the first hollow shaft 10, the mesh member 20, the tip 30, the second hollow shaft 40, the core wire 50, and the connector 70 are the same as those of the first embodiment, the same parts are The same reference numerals are given and detailed description thereof is omitted.
  • the core wire 50 extends along the inner peripheral surface 42 of the second hollow shaft 40.
  • the base end of the second hollow shaft 40 is joined (welded, welded, or bonded) to the core wire 50 by the restraint portion 160. Whether the base end of the second hollow shaft 40 and the core wire 50 are joined by welding, welding, or adhesion may be appropriately selected according to the material forming the second hollow shaft 40 and the core wire 50.
  • the restraint portion 160 corresponds to a joint portion that joins the second hollow shaft 40 and the core wire 50.
  • the proximal end of the second hollow shaft 40 is restrained with respect to the core wire 50 by the restraint portion 160 which is a joint portion. Accordingly, when the core wire 50 is pulled to expand the mesh member 20, the second hollow shaft 40 can be prevented from being separated from the core wire 50, and the long axis of the second hollow shaft 40 can be prevented from being displaced. . Therefore, the second hollow shaft 40 does not hinder the insertion of the retrograde guide wire W2, and the retrograde guide wire W2 can be easily inserted into the first hollow shaft 10 side.
  • the retrograde guide wire W2 since the proximal end of the second hollow shaft 40 is constrained by the core wire 50, when the retrograde guide wire W2 contacts the second hollow shaft 40, the retrograde guide wire W2 is fixed to the second hollow shaft 40. It can be guided along the first hollow shaft 10 side.
  • FIG. 5A is a cross-sectional view of the distal end portion of the catheter 102 according to the modified example of the second embodiment
  • FIG. 5B is a cross-sectional view taken along the line Vb-Vb of FIG. 5A.
  • illustration of the mesh member 20 is abbreviate
  • the core wire 50 extends along the outer peripheral surface 43 of the second hollow shaft 40.
  • the base end of the second hollow shaft 40 is joined (welded, welded, or bonded) to the core wire 50 by the restraint portion 161.
  • which of the welding, welding, and adhesion methods is used to join the base end of the second hollow shaft 40 and the core wire 50 depends on the material forming the second hollow shaft 40 and the core wire 50. It may be selected appropriately.
  • the restraint portion 161 corresponds to a joint portion that joins the second hollow shaft 40 and the core wire 50.
  • the proximal end of the second hollow shaft 40 is restrained with respect to the core wire 50 by the restraint portion 161 which is a joint portion. Thereby, also in the said catheter 102, the same effect as the said catheter 101 is produced.
  • FIG. 6 is a cross-sectional view of the distal end portion of the catheter 201 according to the third embodiment of the present invention.
  • the catheter 201 has a first hollow shaft 10, a mesh member 20, a tip 30, a second hollow shaft 40, a core wire 50, a restraining portion 260, and a connector. 70 (see FIG. 1).
  • the catheter 101 of the second embodiment differs from the catheter 1 of the first embodiment in the configuration of the restraint portion 260. Since the configurations of the first hollow shaft 10, the mesh member 20, the tip 30, the second hollow shaft 40, the core wire 50, and the connector 70 are the same as those of the first embodiment, the same parts are The same reference numerals are given and detailed description thereof is omitted.
  • the core wire 50 extends along the inner peripheral surface 42 of the second hollow shaft 40.
  • a clip serving as a restraining portion 260 is provided at the base end of the second hollow shaft 40, and the core wire 50 and the second hollow shaft 40 are sandwiched between the clips, and the second hollow shaft 40 is restrained by the core wire 50.
  • the material forming the restraint portion 260 which is a clip, preferably has antithrombogenicity, flexibility, and biocompatibility, and examples thereof include a resin material and a metal material.
  • the resin material for example, polyamide, polyester, polyarylate, polyether ether ketone, or the like can be adopted.
  • the metal material for example, stainless steel such as SUS304, nickel titanium alloy, cobalt chrome alloy, or the like can be adopted.
  • the proximal end of the second hollow shaft 40 is constrained to the core wire 50 by the constraining portion 260 that is a clip. Accordingly, when the core wire 50 is pulled to expand the mesh member 20, the second hollow shaft 40 can be prevented from being separated from the core wire 50, and the long axis of the second hollow shaft 40 can be prevented from being displaced. . Therefore, the second hollow shaft 40 does not hinder the insertion of the retrograde guide wire W2, and the retrograde guide wire W2 can be easily inserted into the first hollow shaft 10 side.
  • the retrograde guide wire W2 since the proximal end of the second hollow shaft 40 is restrained by the core wire 50, when the retrograde guide wire W2 comes into contact with the second hollow shaft 40, the retrograde guide wire W2 is fixed to the second hollow shaft 40. It can be guided along the first hollow shaft 10 side.
  • FIG. 7 is a cross-sectional view of the distal end portion of the catheter 202 according to the modified example of the third embodiment.
  • the core wire 50 extends along the outer peripheral surface 43 of the second hollow shaft 40.
  • a clip that is a restraint portion 261 is provided at the base end of the second hollow shaft 40, and the core wire 50 and the second hollow shaft 40 are sandwiched between the clips, and the second hollow shaft 40 is restrained by the core wire 50.
  • the material forming the restraint portion 261 which is a clip is the same as the material forming the restraint portion 260 described above.
  • the proximal end of the second hollow shaft 40 is constrained to the core wire 50 by the constraining portion 261 which is a clip. Thereby, also in the said catheter 202, the same effect as the said catheter 201 is produced.
  • the present invention is not limited to the configurations of the above-described embodiments, and is shown by the scope of the claims, and is intended to include all modifications within the scope and meaning equivalent to the scope of the claims. To be done. For example, 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.
  • connecting shaft 62 of the restraint portion 60 of the catheter 1 of the first embodiment is four, the connecting shaft 62 may be two as in the restraint portion 360 shown in FIG. Even with this configuration, the second hollow shaft 40 can be restrained by the core wire 50.
  • the number of connecting shafts 62 may be other than two or four.
  • the core wire 50 may extend along the outer peripheral surface 43 of the second hollow shaft 40, and the second hollow shaft 40 may be bound to the core wire 50 by the restraining portion 460.
  • the restraint portion 460 includes a rectangular ring member 461 and four connecting shafts 462.
  • the core wire 50 penetrates the inside of the ring member 461, and a part of the ring member 461 is in contact with the base end surface 41 of the second hollow shaft 40.
  • the four connecting shafts 462 are arranged radially at substantially equal intervals around the core wire 50. One end of each connection shaft 462 is joined (welded, welded, or bonded) to the outer peripheral surface of the core wire 50, and the other end of each connection shaft 462 is joined (welded, welded, or bonded) to the base end face 463 of the ring member 461. ) Has been.
  • the material forming the ring member 461 and the four connecting shafts 462 is the same as the material forming the ring member 61 and the four connecting shafts 62 of the first embodiment, so that the material of the first embodiment is the same. The description is cited and the detailed description is omitted.
  • the restraint portion 460 also prevents the second hollow shaft 40 from separating from the core wire 50 when the core wire 50 is pulled to expand the mesh member 20, and prevents the major axis of the second hollow shaft 40 from shifting. can do. Therefore, the second hollow shaft 40 does not hinder the insertion of the retrograde guide wire W2, and the retrograde guide wire W2 can be easily inserted into the first hollow shaft 10 side. Further, since the proximal end of the second hollow shaft 40 is restrained by the core wire 50, when the retrograde guide wire W2 comes into contact with the second hollow shaft 40, the retrograde guide wire W2 is fixed to the second hollow shaft 40. It can be guided along the first hollow shaft 10 side.
  • the number of connecting shafts 62 may be other than four.

Abstract

Provided is a catheter in which a retro-side guide wire can be easily inserted into a first hollow shaft side. The catheter comprises: a first hollow shaft 10; a tubular mesh member 20 that is joined at the proximal end to the distal end of the first hollow shaft 10 and configured to expand or contract in the radial direction; a distal end tip 30 that is joined to the distal end of the mesh member 20; a core wire 50 that is joined at the distal end to the distal end tip 30 and extends inside the mesh member 20 and the first hollow shaft 10 such that the proximal end of the core wire is located closer to the proximal end side than the proximal end of the first hollow shaft 10; a second hollow shaft 40 that is joined at the distal end to the distal end tip 30, extends in the space inside the mesh member 20 toward the proximal end side, and has the proximal end located between the proximal end of the distal end tip 30 and the distal end of the first hollow shaft 10; and a restraining portion 60 that restrains the second hollow shaft 40 to the core wire 50.

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 procedure to improve blood flow by removing occluders that block blood vessels, such as chronic total occlusion (CTO: Chronic total occlusion). First, the ante guide wire is inserted by the antegrade approach (approach from the ante side) to form a gap in the CTO or a false cavity under the intima of the blood vessel. Next, a retro guide wire is inserted from the opposite side (peripheral side) of the CTO by the retrograde approach (retro approach), and is pushed into the formed gap of the CTO or into the pseudointimal cavity. This allows the ante-side guide wire and the retro-side guide wire to communicate with each other.
 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ている(例えば、特許文献1参照)。 On the other hand, a medical device having a triangular pyramid-shaped funnel at the tip is known as a medical device that easily transports the ante-side guide wire and the retro-side guide wire. When this medical device is inserted from the ante side, the retro guide wire is easily received by this funnel (for example, see 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
 ところで、レトロ側ガイドワイヤを受け入れる構成として、第1中空シャフトの先端側に先端チップ、メッシュ部材、および第2中空シャフトを設け、コアワイヤにより先端チップおよびメッシュ部材内の第2中空シャフトを引っ張ることにより、メッシュ部材を拡張させて、レトロ側ガイドワイヤを第1中空シャフトへ挿入させる構成が考えられる。しかし、当該構成では、第2中空シャフトが拡張したメッシュ部材内で傾斜することにより、レトロ側ガイドワイヤの第1中空シャフト側への挿入を阻害する可能がある。 By the way, as a structure for receiving the retro guide wire, by providing a tip chip, a mesh member, and a second hollow shaft on the tip side of the first hollow shaft, and pulling the tip chip and the second hollow shaft in the mesh member by the core wire, A configuration is conceivable in which the mesh member is expanded and the retro guide wire is inserted into the first hollow shaft. However, in the said structure, since the 2nd hollow shaft inclines in the expanded mesh member, insertion of the retro guide wire to the 1st hollow shaft side may be obstructed.
 本発明は、以上のような事情に基づいてなされたものであり、その目的は、レトロ側ガイドワイヤを第1中空シャフト側に容易に挿入可能なカテーテルを提供することにある。 The present invention has been made based on the above circumstances, and an object thereof is to provide a catheter in which a retro guide wire can be easily inserted into the first hollow shaft side.
 かかる目的を達成するために、本発明の一形態に係るカテーテルは、第1中空シャフトと、基端が前記第1中空シャフトの先端に接合され、径方向に拡張または収縮するように構成されたチューブ状のメッシュ部材と、前記メッシュ部材の先端に接合された先端チップと、先端が前記先端チップに接合され、基端が前記第1中空シャフトの基端よりも基端側に位置するように、前記メッシュ部材および前記第1中空シャフトの内側を延びるコアワイヤと、先端が前記先端チップに接合され、前記メッシュ部材の内側の空間を基端側に向かって延び、基端が前記先端チップの基端と前記第1中空シャフトの先端との間に位置する第2中空シャフトと、前記第2中空シャフトを前記コアワイヤに拘束する拘束部と、を備える。 In order to achieve such an object, a catheter according to an aspect of the present invention is configured such that a first hollow shaft and a proximal end thereof are joined to a distal end of the first hollow shaft and expand or contract in a radial direction. A tubular mesh member, a tip tip joined to the tip of the mesh member, a tip joined to the tip tip, and a base end located closer to the base end side than the base end of the first hollow shaft. A core wire extending inside the mesh member and the first hollow shaft, a tip joined to the tip tip, extending in a space inside the mesh member toward a base end side, and a base end of the tip tip base. A second hollow shaft located between an end and a tip of the first hollow shaft, and a restraint portion that restrains the second hollow shaft to the core wire.
 前記コアワイヤは、前記第2中空シャフトの内周面または外周面に沿って延び、
 前記拘束部は、前記第2中空シャフトと前記コアワイヤとを接合する接合部であっててもよい。
The core wire extends along an inner peripheral surface or an outer peripheral surface of the second hollow shaft,
The restraint portion may be a joint portion that joins the second hollow shaft and the core wire.
 前記拘束部は、前記第2中空シャフトの基端面に当接して、前記第2中空シャフトの基端を前記コアワイヤに拘束してもよい。 The constraining portion may contact the proximal end surface of the second hollow shaft to constrain the proximal end of the second hollow shaft to the core wire.
 前記第2中空シャフトは円筒形状であって、前記コアワイヤは、前記第2中空シャフトの内側を通るように構成され、前記拘束部は、前記第2中空シャフトの外径よりも小さい外径を有する円環形状をなし前記第2中空シャフトの前記基端面に当接するリング部材と、前記リング部材と前記コアワイヤとを接続する接続部材と、を有してもよい。 The second hollow shaft has a cylindrical shape, the core wire is configured to pass through the inside of the second hollow shaft, and the restraint portion has an outer diameter smaller than an outer diameter of the second hollow shaft. A ring member having an annular shape and abutting on the base end surface of the second hollow shaft may be included, and a connecting member that connects the ring member and the core wire may be included.
 前記コアワイヤは、前記第2中空シャフトの内周面または外周面に沿って延び、前記拘束部は、前記コアワイヤおよび前記第2中空シャフトを挟み込み、前記第2中空シャフトを前記コアワイヤに拘束するクリップであってもよい。 The core wire extends along an inner peripheral surface or an outer peripheral surface of the second hollow shaft, and the restraint portion is a clip that sandwiches the core wire and the second hollow shaft and restrains the second hollow shaft to the core wire. It may be.
 本発明は、レトロ側ガイドワイヤを第1中空シャフト側に容易に挿入可能なカテーテルを提供することができる。 The present invention can provide a catheter in which the retro guide wire can be easily inserted into the first hollow shaft side.
第1の実施形態に係るカテーテルの断面図であり、メッシュ部材が収縮した状態を示す図である。It is a sectional view of the catheter concerning a 1st embodiment, and is a figure showing the state where the mesh member contracted. 図1のII-II線に沿った断面図である。FIG. 2 is a sectional view taken along line II-II of FIG. 1. 第1の実施形態に係るカテーテルの断面図であり、メッシュ部材が拡張した状態を示す図である。It is sectional drawing of the catheter which concerns on 1st Embodiment, and is a figure which shows the state which the mesh member expanded. (a)は、第2の実施形態に係るカテーテルの先端部分の断面図であり、(b)は、(a)のIVb-IVb線に沿った断面図ある。(A) is a cross-sectional view of the distal end portion of the catheter according to the second embodiment, and (b) is a cross-sectional view taken along line IVb-IVb of (a). (a)は、第2の実施形態の変形例に係るカテーテルの先端部分の断面図であり、(b)は、(a)のVb-Vb線に沿った断面図ある。(A) is sectional drawing of the front-end | tip part of the catheter which concerns on the modification of 2nd Embodiment, (b) is sectional drawing which followed the Vb-Vb line of (a). 第3の実施形態に係るカテーテルの先端部分の断面図である。It is sectional drawing of the front-end | tip part of the catheter which concerns on 3rd Embodiment. 第3の実施形態の変形例に係るカテーテルの先端部分の断面図である。It is sectional drawing of the front-end | tip part of the catheter which concerns on the modification of 3rd Embodiment. 拘束部の変形例を示す図である。It is a figure which shows the modification of a restraint part. 拘束部の他の変形例を示す図である。It is a figure which shows the other modification of a restraint part.
 本発明の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が、本発明は、当該図面に記載の実施形態にのみ限定されるものではない。 The catheter according to the embodiment of the present invention will be described with reference to the drawings, but the present invention is not limited to the embodiments described in the drawings.
 なお、本明細書において、「順行性ガイドワイヤ」とは、ガイドワイヤのうち、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、「逆行性ガイドワイヤ」とは、ガイドワイヤのうち、例えば血管内を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 term “antegrade guide wire” means, among the guide wires, a guide wire that is pushed forward to a surgical site such as an occlusion site in a blood vessel prior to a catheter, and a “retrograde guide wire”. The term “guide wire” means, for example, a guide wire that comes inside the blood vessel from the distal end side of the catheter.
 また、本明細書において、「先端側」とは、カテーテルの長手方向に沿った方向であってメッシュ部材に対する先端チップが位置する方向を指す。「基端側」とは、上記長手方向に沿った方向であって上記先端側とは反対の方向を指す。「先端」とは、カテーテルを構成する各部材における上記先端側の端部を指す。「基端」とは、カテーテルを構成する各部材における上記基端側の端部を指す。 In addition, in the present specification, the “tip side” refers to the direction along the longitudinal direction of the catheter and the direction in which the tip is positioned with respect to the mesh member. The “proximal end side” refers to a direction along the longitudinal direction, which is opposite to the distal end side. The “tip” refers to the end on the tip side in each member that constitutes the catheter. The “proximal end” refers to the end portion on the proximal end side of each member that constitutes the catheter.
[第1の実施形態]
 図1は、本発明の第1の実施形態に係るカテーテル1の断面図であり、メッシュ部材20が収縮した状態を示す図である。
 図1に示すように、カテーテル1は、第1中空シャフト10と、メッシュ部材20と、先端チップ30と、第2中空シャフト40と、コアワイヤ50と、拘束部60と、コネクタ70とを備える。
[First Embodiment]
FIG. 1 is a cross-sectional view of a catheter 1 according to a first embodiment of the present invention, showing a state in which a mesh member 20 is contracted.
As shown in FIG. 1, the catheter 1 includes a first hollow shaft 10, a mesh member 20, a distal tip 30, a second hollow shaft 40, a core wire 50, a restraining portion 60, and a connector 70.
 第1中空シャフト10は、先端側シャフト11と、基端側シャフト12とを有している。先端側シャフト11の先端は、メッシュ部材20の基端に接続されている。基端側シャフト12の先端は、先端側シャフト11の基端に接続されている。基端側シャフト12の基端には、コネクタ70が接続されている。 The first hollow shaft 10 has a distal shaft 11 and a proximal shaft 12. The tip of the tip shaft 11 is connected to the base end of the mesh member 20. The distal end of the proximal shaft 12 is connected to the proximal end of the distal shaft 11. A connector 70 is connected to the proximal end of the proximal shaft 12.
 先端側シャフト11は、内部に順行性ガイドワイヤ、逆行性ガイドワイヤ、及びコアワイヤ50を挿通させるためのルーメン13を有している。基端側シャフト12は、内部にコアワイヤ50を挿通させるためのルーメン14を有している。先端側シャフト11と基端側シャフト12との接続部において、先端側シャフト11と基端側シャフト12とにより、基端側に向かって開口するガイドワイヤポート15が形成されている。ガイドワイヤポート15を介して逆行性ガイドワイヤがカテーテル1の外部に送出される。 The tip side shaft 11 has a lumen 13 for inserting the antegrade guide wire, the retrograde guide wire, and the core wire 50 therein. The proximal shaft 12 has a lumen 14 into which the core wire 50 is inserted. At the connecting portion between the distal shaft 11 and the proximal shaft 12, the distal shaft 11 and the proximal shaft 12 form a guide wire port 15 that opens toward the proximal side. A retrograde guidewire is delivered to the exterior of the catheter 1 via the guidewire port 15.
 第1中空シャフト10を構成する材料としては、第1中空シャフト10が血管内に挿通されることから、抗血栓性、可撓性および生体適合性を有していることが好ましく、樹脂材料又は金属材料が挙げられる。先端側シャフト11は柔軟性が求められるため、樹脂材料が好ましい。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、フッ素樹脂等を採用することができる。基端側シャフト12は押し込み性が求められるため金属材料が好ましい。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を採用することができる。 The material forming the first hollow shaft 10 preferably has antithrombogenicity, flexibility, and biocompatibility because the first hollow shaft 10 is inserted into a blood vessel. A metal material is mentioned. Since the distal shaft 11 is required to have flexibility, a resin material is preferable. For example, polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, fluororesin, etc. can be adopted. The proximal shaft 12 is preferably made of a metal material because pushability is required. For example, stainless steel such as SUS304, nickel titanium alloy, cobalt chromium alloy, etc. can be adopted.
 メッシュ部材20は、径方向に拡張または収縮可能なチューブ状の部材である。このメッシュ部材20は、後述するコアワイヤ50を基端側に向かって引っ張る際、図2に示すように、面外変形して径方向外側へ膨出することで拡径し、この拡径したメッシュ部材20の目開きを介して逆行性ガイドワイヤをカテーテル1に受け入れる。  The mesh member 20 is a tubular member that can be expanded or contracted in the radial direction. When the core wire 50, which will be described later, is pulled toward the proximal end side, the mesh member 20 is deformed out-of-plane and expanded outward in the radial direction as shown in FIG. A retrograde guidewire is received in the catheter 1 through the apertures in the member 20. ‥
 本実施形態では、メッシュ部材20は、複数の素線21が格子状に編まれて全体としてチューブ状になるように形成されている。また、メッシュ部材20は、編まれた隣り合う素線間に目開きを有しており、拡径したときの拡大した目開きを通して逆行性ガイドワイヤを受け入れる。なお、メッシュ部材20を構成する各素線21の先端および基端には、それぞれ先端チップ30および第1中空シャフト10が接合されている。 In the present embodiment, the mesh member 20 is formed so that a plurality of element wires 21 are knitted in a lattice shape and become a tube shape as a whole. Further, the mesh member 20 has openings between the adjacent braided wires, and receives the retrograde guide wire through the expanded openings when the diameter is increased. The tip 30 and the first hollow shaft 10 are joined to the tip and the base of each element wire 21 that constitutes the mesh member 20.
 ここで、メッシュ部材20を構成する各素線21は、単一の線および複数の線のいずれをも採用することができ、例えば線径などが異なる複数の金属線が撚り合わされた撚線から形成されていてもよい。 Here, each of the strands 21 constituting the mesh member 20 may be a single strand or a plurality of strands. For example, from a twisted wire in which a plurality of metal wires having different diameters are twisted together. It may be formed.
 メッシュ部材20の各素線21を構成する材料としては金属材料又は樹脂材料を採用することができる。樹脂材料としては、ポリアミド、ポリエステル、ポリアリレート、及びポリエーテルエーテルケトン等があげられる。尚強度および可撓性を向上させる観点からは、金属材料であることが好ましい。当該金属材料としては、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。なお、各素線は、同一の材料で形成されていてもよく、異なる材料で形成されていてもよい。 A metal material or a resin material can be adopted as a material forming each strand 21 of the mesh member 20. Examples of the resin material include polyamide, polyester, polyarylate, and polyether ether ketone. From the viewpoint of improving strength and flexibility, a metal material is preferable. Examples of the metal material include stainless steel such as SUS304, nickel titanium alloy, and cobalt chromium alloy. The strands of wire may be formed of the same material or different materials.
 また、メッシュ部材20の各素線21を構成する材料としては、メッシュ部材20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。当該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。 Further, the material forming each strand 21 of the mesh member 20 may be a radiopaque material from the viewpoint of improving the visibility of the mesh member 20. Examples of the radiopaque material include gold, platinum, tungsten, and alloys containing these elements (for example, platinum-nickel alloy and the like). 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.
 メッシュ部材20には、誘導膜22が設けられ、誘導膜22の先端は先端チップ30の基端と第1中空シャフト10の先端との間に位置している。誘導膜22は、メッシュ部材20の目開きを通して受け入れた逆行性ガイドワイヤを第1中空シャフト10に向かって円滑に導くものである。誘導膜22は、先端がメッシュ部材20の長軸方向略中央部に位置し、基端が第1中空シャフト10の先端に位置している。誘導膜22は、隣り合う素線どうしを架橋するようにメッシュ部材20上に形成されている。ここで、逆行性ガイドワイヤは、メッシュ部材20が拡径する際に誘導膜22が漏斗形状に展開することで、メッシュ部材20を通して第1中空シャフト10内に導かれる。なお、誘導膜22は、少なくとも一部(例えば、誘導膜22の先端外周など)がメッシュ部材20に接合されていればよく、例えば、フィルム状のもの(不図示)であってもよい。 The guide member 22 is provided on the mesh member 20, and the tip of the guide film 22 is located between the base end of the tip 30 and the tip of the first hollow shaft 10. The guide film 22 smoothly guides the retrograde guide wire received through the openings of the mesh member 20 toward the first hollow shaft 10. The leading end of the guide film 22 is located substantially at the center of the mesh member 20 in the long axis direction, and the base end is located at the end of the first hollow shaft 10. The guide film 22 is formed on the mesh member 20 so as to bridge adjacent strands. Here, the retrograde guide wire is guided into the first hollow shaft 10 through the mesh member 20 by expanding the guide film 22 into a funnel shape when the mesh member 20 expands in diameter. At least a part of the guide film 22 (for example, the outer circumference of the tip of the guide film 22) may be bonded to the mesh member 20, and may be, for example, a film-like member (not shown).
 誘導膜22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。これらの中では、上記材料としては、表面の滑動性を向上させる観点から、ポリウレタンであることが好ましい。また、誘導膜22を形成する方法としては特に限定されず、例えば、メッシュ部材20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メッシュ部材20に融着する方法等を採用することができる。 Examples of the material forming the guide film 22 include polyethylene, polyurethane, polyamide, polyamide elastomer, polyolefin, polyester, polyester elastomer and the like. Among these, polyurethane is preferable as the above material from the viewpoint of improving the sliding property of the surface. The method for forming the guide film 22 is not particularly limited. For example, a dip method may be used for the guide film to be arranged on the mesh member 20, a method of fusing the tip of the film to the mesh member 20 for a film-like guide film, and the like. Can be adopted.
 先端チップ30は、メッシュ部材20の先端に接続されている。先端チップ30は、具体的には、カテーテル1が血管中を進行し易いように、先端側に向かって尖鋭状に形成されており、先端チップ30の基端に、メッシュ部材20の各素線それぞれの先端部、第2中空シャフト40の先端部、およびコアワイヤ50の先端部が埋設されている。 The tip 30 is connected to the tip of the mesh member 20. Specifically, the distal tip 30 is formed in a sharpened shape toward the distal side so that the catheter 1 can easily advance in the blood vessel, and each strand of the mesh member 20 is formed at the proximal end of the distal tip 30. Each tip, the tip of the second hollow shaft 40, and the tip of the core wire 50 are embedded.
 先端チップ30を構成する材料としては、カテーテル1が血管中を進行することから、柔軟性を有していることが好ましい。当該柔軟性と有する材料としては、例えば、ポリウレタン、ポリウレタンエラストマーなどの樹脂材料等が挙げられる。 As the material forming the distal tip 30, it is preferable that the catheter 1 has flexibility because the catheter 1 advances in the blood vessel. Examples of the material having flexibility include resin materials such as polyurethane and polyurethane elastomer.
 第2中空シャフト40は、先端チップ30に接続され、メッシュ部材20の内側の空間にて基端側に突出している。第2中空シャフト40の基端は、図1に示すように、メッシュ部材20の内側の空間における第1中空シャフト10の先端と先端チップ30の基端との間に位置している。また、第2中空シャフト40は、その基端が、図3に示すように、メッシュ部材20が径方向外側に拡径した状態において、メッシュ部材20の内側の空間における第1中空シャフト10の先端と先端チップ30の基端との間に位置するように構成されている。これは、逆行性ガイドワイヤを第1中空シャフト10に受け入れ易くするためである。 The second hollow shaft 40 is connected to the tip 30 and projects toward the proximal end in the space inside the mesh member 20. As shown in FIG. 1, the proximal end of the second hollow shaft 40 is located between the distal end of the first hollow shaft 10 and the proximal end of the distal tip 30 in the space inside the mesh member 20. Further, as shown in FIG. 3, the second hollow shaft 40 has its proximal end in the space inside the mesh member 20 in the space inside the mesh member 20 in a state where the mesh member 20 is expanded radially outward. And the base end of the tip 30. This is to make it easier to receive the retrograde guide wire in the first hollow shaft 10.
 第2中空シャフト40を構成する材料としては、上述した第1中空シャフト10と同様にこの第2中空シャフト40も血管内に挿通されることから、抗血栓性、可撓性および生体適合性を有していることが好ましい。当該材料としては、例えば、第1中空シャフト10の説明中で例示した材料と同様のもの等が挙げられるが、柔軟性の観点から樹脂材料が好ましい。 As the material forming the second hollow shaft 40, since the second hollow shaft 40 is also inserted into the blood vessel similarly to the first hollow shaft 10 described above, it has antithrombotic property, flexibility and biocompatibility. It is preferable to have. Examples of the material include the same materials as those exemplified in the description of the first hollow shaft 10, but a resin material is preferable from the viewpoint of flexibility.
 コアワイヤ50は、先端が先端チップ30に接続され、基端が第1中空シャフト20の基端側に位置するコネクタ70の外部まで延びている。よって、コアワイヤ50は、メッシュ部材20および第1中空シャフト10のルーメン13、14およびコネクタ70の通孔71を貫通している。なお、術者がコアワイヤ50をコネクタ70の外部にて操作することで、当該コアワイヤ50がカテーテル1の長軸方向に進退し、メッシュ部材20が径方向に拡縮する。 The core wire 50 has its tip connected to the tip 30, and its base extends to the outside of the connector 70 located on the base side of the first hollow shaft 20. Therefore, the core wire 50 penetrates the mesh member 20, the lumens 13 and 14 of the first hollow shaft 10 and the through hole 71 of the connector 70. When the operator operates the core wire 50 outside the connector 70, the core wire 50 advances and retracts in the major axis direction of the catheter 1, and the mesh member 20 expands and contracts in the radial direction.
 コアワイヤ50を構成する材料としては、コアワイヤ50自身の切断を防止しかつメッシュ部材20を確実に拡縮する観点から、十分な引張強度および剛性を有していることが好ましい。当該材料としては、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などの金属材料等が挙げられる。 The material forming the core wire 50 preferably has sufficient tensile strength and rigidity from the viewpoint of preventing cutting of the core wire 50 itself and surely expanding and contracting the mesh member 20. Examples of the material include stainless steel such as SUS304 and metallic materials such as nickel titanium alloy and cobalt chromium alloy.
 図2は、図1のII-II線に沿った断面図である。なお、図2では、メッシュ部材20の図示を省略している。 2 is a sectional view taken along the line II-II in FIG. The mesh member 20 is not shown in FIG.
 図1、2に示すように拘束部60は、第2中空シャフト40の基端側に配置され、リング部材61と、4本の接続シャフト62とを有する。リング部材61は、円環形状をなし、その内径は第2中空シャフト40の内径より大きく、その外径は、第2中空シャフト40の外径より小さく構成されている。リング部材61は、その長軸(カテーテル1の長手方向に延びる軸)が第2中空シャフト40の長軸と略同軸の状態で、第2中空シャフト40の基端面41に当接している。よって、リング部材61は、その長軸方向から見た時に第2中空シャフト40の基端面41の範囲内に位置している。すわなち、リング部材61は、径方向において第2中空シャフト40の内側・外側に突出する部分を有さない。リング部材61の内側を、コアワイヤ50が貫通している。 As shown in FIGS. 1 and 2, the restraint portion 60 is arranged on the proximal end side of the second hollow shaft 40, and has a ring member 61 and four connecting shafts 62. The ring member 61 has an annular shape, the inner diameter of which is larger than the inner diameter of the second hollow shaft 40 and the outer diameter of which is smaller than the outer diameter of the second hollow shaft 40. The ring member 61 is in contact with the base end surface 41 of the second hollow shaft 40 in a state where its long axis (the axis extending in the longitudinal direction of the catheter 1) is substantially coaxial with the long axis of the second hollow shaft 40. Therefore, the ring member 61 is located within the range of the base end surface 41 of the second hollow shaft 40 when viewed in the long axis direction. That is, the ring member 61 does not have a portion protruding inward and outward of the second hollow shaft 40 in the radial direction. The core wire 50 penetrates the inside of the ring member 61.
 図2に示すように、4本の接続シャフト62は、コアワイヤ50を中心として略等間隔に放射状に設けられている。各接続シャフト62の一端は、コアワイヤ50の外周面に接合(溶接、溶着、または接着)され、各接続シャフト62の他端は、リング部材61の基端面63に接合(溶接、溶着、または接着)されている。このように、コアワイヤ50に接続シャフト62が接合され、接続シャフト62にリング部材61が接合され、リング部材61の先端面64は第2中空シャフト40の基端面41に当接している。この結果、拘束部60は、第2中空シャフト40をコアワイヤ50に拘束している。4本の接続シャフト62は、接続部材に相当する。また、リング部材61の先端面64および/または第2中空シャフト40の基端面41の表面粗さを大きくして、第2中空シャフト40のコアワイヤ50に対する拘束力を向上させてもよい。また、第2中空シャフト40とリング部材61とを接合させてもよい。また、各接続シャフト62の他端を、リング部材61の内周面に接合させてもよい。 As shown in FIG. 2, the four connecting shafts 62 are provided radially at substantially equal intervals around the core wire 50. One end of each connection shaft 62 is joined (welded, welded, or adhered) to the outer peripheral surface of the core wire 50, and the other end of each connection shaft 62 is joined (welded, welded, or adhered) to the base end face 63 of the ring member 61. ) Has been. In this way, the connecting shaft 62 is joined to the core wire 50, the ring member 61 is joined to the connecting shaft 62, and the distal end surface 64 of the ring member 61 is in contact with the proximal end surface 41 of the second hollow shaft 40. As a result, the restraint portion 60 restrains the second hollow shaft 40 to the core wire 50. The four connecting shafts 62 correspond to connecting members. Further, the surface roughness of the distal end surface 64 of the ring member 61 and / or the proximal end surface 41 of the second hollow shaft 40 may be increased to improve the binding force of the second hollow shaft 40 to the core wire 50. Further, the second hollow shaft 40 and the ring member 61 may be joined together. Further, the other end of each connection shaft 62 may be joined to the inner peripheral surface of the ring member 61.
 リング部材61および4本の接続シャフト62を構成する材料としては、金属材料又は樹脂材料を採用することができる。樹脂材料としては、ポリアミド、ポリエステル、ポリアリレート、及びポリエーテルエーテルケトン等があげられる。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。リング部材61および4本の接続シャフト62は、同一の材料で構成されていることが好ましいが、異なる材料で構成されていてもよい。 As the material forming the ring member 61 and the four connecting shafts 62, a metal material or a resin material can be adopted. Examples of the resin material include polyamide, polyester, polyarylate, and polyether ether ketone. Examples of the metal material include stainless steel such as SUS304, nickel titanium alloy, and cobalt chrome alloy. The ring member 61 and the four connecting shafts 62 are preferably made of the same material, but may be made of different materials.
 また、リング部材61および4本の接続シャフト62を構成する材料としては、リング部材61および4本の接続シャフト62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。当該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 material forming the ring member 61 and the four connecting shafts 62 may be a radiopaque material from the viewpoint of improving the visibility of the ring member 61 and the four connecting shafts 62. Examples of the radiopaque material include gold, platinum, tungsten, and alloys containing these elements (for example, platinum-nickel alloy and the like). 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.
 コネクタ70は、術者がカテーテル1を把持する部材である。コネクタ70は、図1に示すように、第1中空シャフト10の基端に接続されており、コアワイヤ50を外部に露出できるように、第1中空シャフト1のルーメン13、14と相通する通孔71と、この通孔71の基端に形成された開口部72とを有している。なお、コネクタ70の形態は特に限定されず、オペレータが把持し易ければいずれの形状であってもよい。 The connector 70 is a member for an operator to hold the catheter 1. As shown in FIG. 1, the connector 70 is connected to the proximal end of the first hollow shaft 10 and is a through hole communicating with the lumens 13 and 14 of the first hollow shaft 1 so that the core wire 50 can be exposed to the outside. 71 and an opening 72 formed at the base end of the through hole 71. The form of the connector 70 is not particularly limited, and may be any shape as long as it is easy for the operator to grip.
 次に、上述したカテーテル1の使用態様の一例について説明する。 Next, an example of a usage mode of the catheter 1 described above will be described.
 まず順行性ガイドワイヤW1(不図示)を例えば血管内に挿入した後、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。順行性ガイドワイヤW1の先端が閉塞部位に到達した後、順行性ガイドワイヤW1をガイドとしてバルーンカテーテル(不図示)を閉塞部まで挿入し、バルーンを拡径させることによって閉塞部を押し広げる。閉塞部を押し広げた後、バルーンを縮径させてバルーンカテーテルを血管内から抜去する。 First, after inserting the antegrade guide wire W1 (not shown) into a blood vessel, for example, push it along the blood vessel to a site where an occluder is present (hereinafter also referred to as “occlusion site”). After the distal end of the antegrade guide wire W1 reaches the occluded region, a balloon catheter (not shown) is inserted to the occluded region using the antegrade guide wire W1 as a guide, and the occluded region is expanded by expanding the diameter of the balloon. . After expanding the occluded part, the balloon is contracted to remove the balloon catheter from the blood vessel.
 次に、順行性ガイドワイヤW1の基端を、先端チップ30の先端の通孔から先端チップ30および第2中空シャフト40の内側を通ってガイドワイヤポート15からカテーテル1の外部に出るようにカテーテル1に挿通し、順行性ガイドワイヤW1をガイドとしてカテーテル1の先端を血管内の閉塞部位まで押し進める。この際、カテーテル1は、メッシュ部材20が縮径した状態で血管に挿入され、カテーテル1の先端が閉塞部位に到達するまで上記縮径した状態を維持する。 Next, the proximal end of the antegrade guide wire W1 is passed through the through hole at the distal end of the distal tip 30 and passes through the inside of the distal tip 30 and the second hollow shaft 40 to come out of the catheter 1 from the guide wire port 15. The catheter 1 is inserted into the catheter 1, and the distal end of the catheter 1 is pushed forward to the occlusion site in the blood vessel using the antegrade guide wire W1 as a guide. At this time, the catheter 1 is inserted into a blood vessel in a state where the mesh member 20 has a reduced diameter, and is maintained in the reduced diameter state until the tip of the catheter 1 reaches the occlusion site.
 カテーテル1の先端がバルーンカテーテルで押し広げられた閉塞部位に到達した後、順行性ガイドワイヤW1を基端側に引っ張ることで順行性ガイドワイヤW1をカテーテル1から引き抜く。次いで、コネクタ70の外部に露出しているコアワイヤ50を基端側に向かって引っ張ることでメッシュ部材20の先端と第1中空シャフト10の先端との間隔が狭まり、結果としてメッシュ部材20が径方向外側に面外変形して拡径する。この際、本実施形態では、誘導膜22の先端がメッシュ部材20の長軸方向略中央部に接合されているので、メッシュ部材20の拡径に追従して誘導膜22が拡径され、誘導膜22が全体として漏斗形状になる。なお、メッシュ部材20の拡径に伴って目開きも拡張されるので、逆行性ガイドワイヤW2を受け入れやすい状態となる。また、第2中空シャフト40は、その基端が拘束部60によりコアワイヤ50に拘束されているので、第2中空シャフト40が傾倒せず、カテーテル1の長軸方向(長手方向)に沿って移動する。尚、カテーテル1の先端が、順行性ガイドワイヤW1に沿って閉塞部位に到達した後、メッシュ部材20を拡径させ、その後に順行性ガイドワイヤW1を基端側に引っ張ることで順行性ガイドワイヤW1をカテーテル1から引き抜くこととしてもよい。 After the distal end of the catheter 1 reaches the occluded site where the balloon catheter is pushed open, the antegrade guidewire W1 is pulled out from the catheter 1 by pulling the antegrade guidewire W1 toward the proximal end side. Then, by pulling the core wire 50 exposed to the outside of the connector 70 toward the proximal end side, the distance between the tip of the mesh member 20 and the tip of the first hollow shaft 10 is narrowed, and as a result, the mesh member 20 is radially moved. It expands out-of-plane and expands in diameter. At this time, in the present embodiment, since the tip of the guide film 22 is joined to the substantially central portion of the mesh member 20 in the longitudinal direction, the guide film 22 is expanded in diameter in accordance with the expansion of the mesh member 20. The membrane 22 has a funnel shape as a whole. Since the mesh opening is expanded as the mesh member 20 is expanded, the retrograde guide wire W2 can be easily received. Further, since the proximal end of the second hollow shaft 40 is restrained by the core wire 50 by the restraint portion 60, the second hollow shaft 40 does not tilt and moves along the long axis direction (longitudinal direction) of the catheter 1. To do. In addition, after the distal end of the catheter 1 reaches the occluded site along the antegrade guide wire W1, the mesh member 20 is expanded in diameter, and then the antegrade guide wire W1 is pulled toward the proximal end side to advance. The sex guide wire W1 may be withdrawn from the catheter 1.
 次に、図3に示すように、先端側から向かって来る逆行性ガイドワイヤW2をカテーテル1に受け入れる。上記逆行性ガイドワイヤ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逆行性ガイドワイヤW2であってもよい。逆行性ガイドワイヤW2は、拡径したメッシュ部材20の目開きを通してメッシュ部材20の内側の空間に受け入れられた後、第1中空シャフト10の先端側シャフト11に挿通され、ガイドワイヤポート15を介してカテーテル1の外部に送出される。 Next, as shown in FIG. 3, the retrograde guide wire W2 coming from the distal end side is received in the catheter 1. As the route through which the retrograde guide wire W2 goes, for example, a false cavity in the blood vessel wall surrounding the occlusion site, a through hole penetrating the occlusion site, or the like is assumed. It may be the wire W2. The retrograde guide wire W2 is received in the space inside the mesh member 20 through the openings of the expanded mesh member 20, and then inserted into the distal end side shaft 11 of the first hollow shaft 10 and through the guide wire port 15. Is delivered to the outside of the catheter 1.
 以上のように、カテーテル1において、第2中空シャフト40は、拘束部60によりコアワイヤ50に拘束されている。本実施形態では、拘束部60のリング部材61が第2中空シャフト40の基端面41に当接して、第2中空シャフト40の基端をコアワイヤ50に拘束している。このため、メッシュ部材20を拡張するためにコアワイヤ50を引っ張った時に、第2中空シャフト40のコアワイヤ50からの離間を防止し、第2中空シャフト40の長軸がずれるのを抑制することができる。これにより、逆行性ガイドワイヤW2の挿入を第2中空シャフト40が阻害せず、逆行性ガイドワイヤW2を第1中空シャフト10側に容易に挿入することができる。また、第2中空シャフト40の基端がコアワイヤ50に拘束されているので、逆行性ガイドワイヤW2が第2中空シャフト40に接触した場合には、逆行性ガイドワイヤW2を第2中空シャフト40に沿って第1中空シャフト10側に誘導することができる。 As described above, in the catheter 1, the second hollow shaft 40 is constrained to the core wire 50 by the constraining portion 60. In the present embodiment, the ring member 61 of the restraint portion 60 is in contact with the base end surface 41 of the second hollow shaft 40 to restrain the base end of the second hollow shaft 40 to the core wire 50. Therefore, when the core wire 50 is pulled to expand the mesh member 20, the second hollow shaft 40 can be prevented from being separated from the core wire 50, and the long axis of the second hollow shaft 40 can be prevented from being displaced. . As a result, the second hollow shaft 40 does not hinder the insertion of the retrograde guide wire W2, and the retrograde guide wire W2 can be easily inserted into the first hollow shaft 10 side. Further, since the proximal end of the second hollow shaft 40 is restrained by the core wire 50, when the retrograde guide wire W2 comes into contact with the second hollow shaft 40, the retrograde guide wire W2 is fixed to the second hollow shaft 40. It can be guided along the first hollow shaft 10 side.
 また、コアワイヤ50は、第2中空シャフト40の内側を通るように構成され、拘束部60は、第2中空シャフト40の外径よりも小さい外径を有する円環形状をなし第2中空シャフト40の基端面41に当接するリング部材61と、リング部材61とコアワイヤ50とを接続する接続シャフト62とを有する。これにより、径方向において第2中空シャフト40の外側に突出する部分がないので、リング部材61を設けても、逆行性ガイドワイヤW2の挿入をリング部材61が阻害せず、逆行性ガイドワイヤW2を第1中空シャフト10側に容易に挿入することができる。 The core wire 50 is configured to pass through the inside of the second hollow shaft 40, and the restraint portion 60 has an annular shape having an outer diameter smaller than the outer diameter of the second hollow shaft 40. A ring member 61 that abuts on the base end surface 41 of the above, and a connecting shaft 62 that connects the ring member 61 and the core wire 50. With this, since there is no portion protruding outward of the second hollow shaft 40 in the radial direction, even if the ring member 61 is provided, the ring member 61 does not hinder the insertion of the retrograde guide wire W2 and the retrograde guide wire W2. Can be easily inserted into the first hollow shaft 10 side.
[第2の実施形態]
 図4の(a)は、本発明の第2の実施形態に係るカテーテル101の先端部分の断面図であり、(b)は、図4(a)のIVb-IVb線に沿った断面図ある。なお、図4(b)では、メッシュ部材20の図示を省略している。
[Second Embodiment]
4A is a sectional view of the distal end portion of the catheter 101 according to the second embodiment of the present invention, and FIG. 4B is a sectional view taken along the line IVb-IVb of FIG. 4A. . The mesh member 20 is not shown in FIG. 4B.
 本実施形態に係るカテーテル101は、図4(a)に示すように、第1中空シャフト10と、メッシュ部材20と、先端チップ30と、第2中空シャフト40と、コアワイヤ50と、拘束部160と、コネクタ70(図1参照)とを備える。第2の実施形態のカテーテル101では、第1の実施形態のカテーテル1と比較して、拘束部160の構成が異なる。なお、第1中空シャフト10、メッシュ部材20、先端チップ30、第2中空シャフト40、コアワイヤ50、およびコネクタ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、同一部分には同一符号を付してその詳細な説明は省略する。 As shown in FIG. 4A, the catheter 101 according to the present embodiment has a first hollow shaft 10, a mesh member 20, a distal end tip 30, a second hollow shaft 40, a core wire 50, and a restraining portion 160. And a connector 70 (see FIG. 1). The catheter 101 of the second embodiment is different from the catheter 1 of the first embodiment in the configuration of the restraint portion 160. Since the configurations of the first hollow shaft 10, the mesh member 20, the tip 30, the second hollow shaft 40, the core wire 50, and the connector 70 are the same as those of the first embodiment, the same parts are The same reference numerals are given and detailed description thereof is omitted.
 本実施形態では、コアワイヤ50は、第2中空シャフト40の内周面42に沿って延びている。第2中空シャフト40の基端が、コアワイヤ50に対して拘束部160により接合(溶接、溶着、または接着)されている。第2中空シャフト40の基端とコアワイヤ50とを、溶接、溶着、または接着のいずれの方法で接合するかは、第2中空シャフト40およびコアワイヤ50を構成する材料に応じて適宜選択すればよい。拘束部160は、第2中空シャフト40とコアワイヤ50とを接合する接合部に相当する。 In the present embodiment, the core wire 50 extends along the inner peripheral surface 42 of the second hollow shaft 40. The base end of the second hollow shaft 40 is joined (welded, welded, or bonded) to the core wire 50 by the restraint portion 160. Whether the base end of the second hollow shaft 40 and the core wire 50 are joined by welding, welding, or adhesion may be appropriately selected according to the material forming the second hollow shaft 40 and the core wire 50. . The restraint portion 160 corresponds to a joint portion that joins the second hollow shaft 40 and the core wire 50.
 本実施形態のカテーテル101では、接合部である拘束部160により、第2中空シャフト40の基端が、コアワイヤ50に対して拘束されている。これにより、メッシュ部材20を拡張するためにコアワイヤ50を引っ張った時に、第2中空シャフト40のコアワイヤ50からの離間を防止し、第2中空シャフト40の長軸がずれるのを抑制することができる。よって、逆行性ガイドワイヤW2の挿入を第2中空シャフト40が阻害せず、逆行性ガイドワイヤW2を第1中空シャフト10側に容易に挿入することができる。また、第2中空シャフト40の基端がコアワイヤ50に拘束されているので、逆行性ガイドワイヤW2が第2中空シャフト40に接触した場合には、逆行性ガイドワイヤW2を第2中空シャフト40に沿って第1中空シャフト10側に誘導することができる。 In the catheter 101 of the present embodiment, the proximal end of the second hollow shaft 40 is restrained with respect to the core wire 50 by the restraint portion 160 which is a joint portion. Accordingly, when the core wire 50 is pulled to expand the mesh member 20, the second hollow shaft 40 can be prevented from being separated from the core wire 50, and the long axis of the second hollow shaft 40 can be prevented from being displaced. . Therefore, the second hollow shaft 40 does not hinder the insertion of the retrograde guide wire W2, and the retrograde guide wire W2 can be easily inserted into the first hollow shaft 10 side. Further, since the proximal end of the second hollow shaft 40 is constrained by the core wire 50, when the retrograde guide wire W2 contacts the second hollow shaft 40, the retrograde guide wire W2 is fixed to the second hollow shaft 40. It can be guided along the first hollow shaft 10 side.
 図5の(a)は、第2の実施形態の変形例に係るカテーテル102の先端部分の断面図であり、(b)は、図5(a)のVb-Vb線に沿った断面図ある。なお、図5(b)では、メッシュ部材20の図示を省略している。 5A is a cross-sectional view of the distal end portion of the catheter 102 according to the modified example of the second embodiment, and FIG. 5B is a cross-sectional view taken along the line Vb-Vb of FIG. 5A. . In addition, illustration of the mesh member 20 is abbreviate | omitted in FIG.5 (b).
 当該変形例に係るカテーテル102では、図5(a)、(b)に示すように、コアワイヤ50は、第2中空シャフト40の外周面43に沿って延びている。第2中空シャフト40の基端が、コアワイヤ50に対して拘束部161により接合(溶接、溶着、または接着)されている。上記と同様に、第2中空シャフト40の基端とコアワイヤ50とを、溶接、溶着、または接着のいずれの方法で接合するかは、第2中空シャフト40およびコアワイヤ50を構成する材料に応じて適宜選択すればよい。拘束部161は、第2中空シャフト40とコアワイヤ50とを接合する接合部に相当する。 In the catheter 102 according to the modified example, as shown in FIGS. 5A and 5B, the core wire 50 extends along the outer peripheral surface 43 of the second hollow shaft 40. The base end of the second hollow shaft 40 is joined (welded, welded, or bonded) to the core wire 50 by the restraint portion 161. Similarly to the above, which of the welding, welding, and adhesion methods is used to join the base end of the second hollow shaft 40 and the core wire 50 depends on the material forming the second hollow shaft 40 and the core wire 50. It may be selected appropriately. The restraint portion 161 corresponds to a joint portion that joins the second hollow shaft 40 and the core wire 50.
 本変形例のカテーテル102では、接合部である拘束部161により、第2中空シャフト40の基端が、コアワイヤ50に対して拘束されている。これにより、当該カテーテル102においても、上記のカテーテル101と同様の効果を奏する。 In the catheter 102 of this modified example, the proximal end of the second hollow shaft 40 is restrained with respect to the core wire 50 by the restraint portion 161 which is a joint portion. Thereby, also in the said catheter 102, the same effect as the said catheter 101 is produced.
[第3の実施形態]
 図6は、本発明の第3の実施形態に係るカテーテル201の先端部分の断面図である。
[Third Embodiment]
FIG. 6 is a cross-sectional view of the distal end portion of the catheter 201 according to the third embodiment of the present invention.
 本実施形態に係るカテーテル201は、図6に示すように、第1中空シャフト10と、メッシュ部材20と、先端チップ30と、第2中空シャフト40と、コアワイヤ50と、拘束部260と、コネクタ70(図1参照)とを備える。第2の実施形態のカテーテル101では、第1の実施形態のカテーテル1と比較して、拘束部260の構成が異なっている。なお、第1中空シャフト10、メッシュ部材20、先端チップ30、第2中空シャフト40、コアワイヤ50、およびコネクタ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、同一部分には同一符号を付してその詳細な説明は省略する。 As shown in FIG. 6, the catheter 201 according to the present embodiment has a first hollow shaft 10, a mesh member 20, a tip 30, a second hollow shaft 40, a core wire 50, a restraining portion 260, and a connector. 70 (see FIG. 1). The catheter 101 of the second embodiment differs from the catheter 1 of the first embodiment in the configuration of the restraint portion 260. Since the configurations of the first hollow shaft 10, the mesh member 20, the tip 30, the second hollow shaft 40, the core wire 50, and the connector 70 are the same as those of the first embodiment, the same parts are The same reference numerals are given and detailed description thereof is omitted.
 本実施形態では、コアワイヤ50は、第2中空シャフト40の内周面42に沿って延びている。第2中空シャフト40の基端には、拘束部260であるクリップが設けられ、コアワイヤ50と第2中空シャフト40とを挟み込み、第2中空シャフト40をコアワイヤ50に拘束している。クリップである拘束部260を構成する材料としては、抗血栓性、可撓性および生体適合性を有していることが好ましく、樹脂材料又は金属材料が挙げられる。樹脂材料としては、例えば、ポリアミド、ポリエステル、ポリアリレート、及びポリエーテルエーテルケトン等を採用することができる。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を採用することができる。 In the present embodiment, the core wire 50 extends along the inner peripheral surface 42 of the second hollow shaft 40. A clip serving as a restraining portion 260 is provided at the base end of the second hollow shaft 40, and the core wire 50 and the second hollow shaft 40 are sandwiched between the clips, and the second hollow shaft 40 is restrained by the core wire 50. The material forming the restraint portion 260, which is a clip, preferably has antithrombogenicity, flexibility, and biocompatibility, and examples thereof include a resin material and a metal material. As the resin material, for example, polyamide, polyester, polyarylate, polyether ether ketone, or the like can be adopted. As the metal material, for example, stainless steel such as SUS304, nickel titanium alloy, cobalt chrome alloy, or the like can be adopted.
 このように、本実施形態のカテーテル201では、クリップである拘束部260により、第2中空シャフト40の基端が、コアワイヤ50に対して拘束されている。これにより、メッシュ部材20を拡張するためにコアワイヤ50を引っ張った時に、第2中空シャフト40のコアワイヤ50からの離間を防止し、第2中空シャフト40の長軸がずれるのを抑制することができる。よって、逆行性ガイドワイヤW2の挿入を第2中空シャフト40が阻害せず、逆行性ガイドワイヤW2を第1中空シャフト10側に容易に挿入することができる。また、第2中空シャフト40の基端がコアワイヤ50に拘束されているので、逆行性ガイドワイヤW2が第2中空シャフト40に接触した場合には、逆行性ガイドワイヤW2を第2中空シャフト40に沿って第1中空シャフト10側に誘導することができる。 As described above, in the catheter 201 of the present embodiment, the proximal end of the second hollow shaft 40 is constrained to the core wire 50 by the constraining portion 260 that is a clip. Accordingly, when the core wire 50 is pulled to expand the mesh member 20, the second hollow shaft 40 can be prevented from being separated from the core wire 50, and the long axis of the second hollow shaft 40 can be prevented from being displaced. . Therefore, the second hollow shaft 40 does not hinder the insertion of the retrograde guide wire W2, and the retrograde guide wire W2 can be easily inserted into the first hollow shaft 10 side. Further, since the proximal end of the second hollow shaft 40 is restrained by the core wire 50, when the retrograde guide wire W2 comes into contact with the second hollow shaft 40, the retrograde guide wire W2 is fixed to the second hollow shaft 40. It can be guided along the first hollow shaft 10 side.
 図7は、第3の実施形態の変形例に係るカテーテル202の先端部分の断面図である。 FIG. 7 is a cross-sectional view of the distal end portion of the catheter 202 according to the modified example of the third embodiment.
 当該変形例に係るカテーテル202では、図7に示すように、コアワイヤ50は、第2中空シャフト40の外周面43に沿って延びている。第2中空シャフト40の基端には、拘束部261であるクリップが設けられ、コアワイヤ50と第2中空シャフト40とを挟み込み、第2中空シャフト40をコアワイヤ50に拘束している。クリップである拘束部261を構成する材料としては、上記の拘束部260を構成する材料と同じである。 In the catheter 202 according to the modified example, as shown in FIG. 7, the core wire 50 extends along the outer peripheral surface 43 of the second hollow shaft 40. A clip that is a restraint portion 261 is provided at the base end of the second hollow shaft 40, and the core wire 50 and the second hollow shaft 40 are sandwiched between the clips, and the second hollow shaft 40 is restrained by the core wire 50. The material forming the restraint portion 261 which is a clip is the same as the material forming the restraint portion 260 described above.
 本変形例のカテーテル202では、クリップである拘束部261により、第2中空シャフト40の基端が、コアワイヤ50に対して拘束されている。これにより、当該カテーテル202においても、上記のカテーテル201と同様の効果を奏する。 In the catheter 202 of this modified example, the proximal end of the second hollow shaft 40 is constrained to the core wire 50 by the constraining portion 261 which is a clip. Thereby, also in the said catheter 202, the same effect as the said catheter 201 is produced.
 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。例えば、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。 It should be noted that the present invention is not limited to the configurations of the above-described embodiments, and is shown by the scope of the claims, and is intended to include all modifications within the scope and meaning equivalent to the scope of the claims. To be done. For example, 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の実施形態のカテーテル1の拘束部60の接続シャフト62は、4本であったが、図8に示す拘束部360ように、接続シャフト62は2本であってもよい。当該構成でも、第2中空シャフト40をコアワイヤ50に拘束することができる。なお、接続シャフト62の数は、2本または4本以外の本数であってもよい。 For example, although the connecting shaft 62 of the restraint portion 60 of the catheter 1 of the first embodiment is four, the connecting shaft 62 may be two as in the restraint portion 360 shown in FIG. Even with this configuration, the second hollow shaft 40 can be restrained by the core wire 50. The number of connecting shafts 62 may be other than two or four.
 また、図9に示すように、コアワイヤ50は、第2中空シャフト40の外周面43に沿って延びるようにし、拘束部460により第2中空シャフト40をコアワイヤ50に拘束してもよい。拘束部460は、矩形環状のリング部材461と、4本の接続シャフト462とを有する。リング部材461の内側をコアワイヤ50が貫通し、リング部材461の一部が、第2中空シャフト40の基端面41に当接している。 Further, as shown in FIG. 9, the core wire 50 may extend along the outer peripheral surface 43 of the second hollow shaft 40, and the second hollow shaft 40 may be bound to the core wire 50 by the restraining portion 460. The restraint portion 460 includes a rectangular ring member 461 and four connecting shafts 462. The core wire 50 penetrates the inside of the ring member 461, and a part of the ring member 461 is in contact with the base end surface 41 of the second hollow shaft 40.
 4本の接続シャフト462は、コアワイヤ50を中心として略等間隔に放射状に設けられている。各接続シャフト462の一端は、コアワイヤ50の外周面に接合(溶接、溶着、または接着)され、各接続シャフト462の他端は、リング部材461の基端面463に接合(溶接、溶着、または接着)されている。リング部材461および4本の接続シャフト462を構成する材料としては、第1の実施形態のリング部材61および4本の接続シャフト62を構成する材料と同じであるので、第1の実施形態での説明を援用してその詳細な説明は省略する。当該拘束部460によっても、メッシュ部材20を拡張するためにコアワイヤ50を引っ張った時に、第2中空シャフト40のコアワイヤ50からの離間を防止し、第2中空シャフト40の長軸がずれるのを抑制することができる。よって、逆行性ガイドワイヤW2の挿入を第2中空シャフト40が阻害せず、逆行性ガイドワイヤW2を第1中空シャフト10側に容易に挿入することができる。また、第2中空シャフト40の基端がコアワイヤ50に拘束されているので、逆行性ガイドワイヤW2が第2中空シャフト40に接触した場合には、逆行性ガイドワイヤW2を第2中空シャフト40に沿って第1中空シャフト10側に誘導することができる。なお、接続シャフト62の数は、4本以外の本数であってもよい。 The four connecting shafts 462 are arranged radially at substantially equal intervals around the core wire 50. One end of each connection shaft 462 is joined (welded, welded, or bonded) to the outer peripheral surface of the core wire 50, and the other end of each connection shaft 462 is joined (welded, welded, or bonded) to the base end face 463 of the ring member 461. ) Has been. The material forming the ring member 461 and the four connecting shafts 462 is the same as the material forming the ring member 61 and the four connecting shafts 62 of the first embodiment, so that the material of the first embodiment is the same. The description is cited and the detailed description is omitted. The restraint portion 460 also prevents the second hollow shaft 40 from separating from the core wire 50 when the core wire 50 is pulled to expand the mesh member 20, and prevents the major axis of the second hollow shaft 40 from shifting. can do. Therefore, the second hollow shaft 40 does not hinder the insertion of the retrograde guide wire W2, and the retrograde guide wire W2 can be easily inserted into the first hollow shaft 10 side. Further, since the proximal end of the second hollow shaft 40 is restrained by the core wire 50, when the retrograde guide wire W2 comes into contact with the second hollow shaft 40, the retrograde guide wire W2 is fixed to the second hollow shaft 40. It can be guided along the first hollow shaft 10 side. The number of connecting shafts 62 may be other than four.
 1、101、102、201、202 カテーテル
 10 第1中空シャフト
 20 メッシュ部材
 30 先端チップ
 40 第2中空シャフト
 41 基端面
 42 内周面
 43 外周面
 50 コアワイヤ
 60、160、161、260、261、360、460 拘束部
 61、461 リング部材
 62 接続シャフト
1, 101, 102, 201, 202 Catheter 10 First hollow shaft 20 Mesh member 30 Tip tip 40 Second hollow shaft 41 Base end face 42 Inner peripheral face 43 Outer peripheral face 50 Core wire 60, 160, 161, 260, 261, 360, 460 Restraint portions 61, 461 Ring member 62 Connection shaft

Claims (5)

  1.  第1中空シャフトと、
     基端が前記第1中空シャフトの先端に接合され、径方向に拡張または収縮するように構成されたチューブ状のメッシュ部材と、
     前記メッシュ部材の先端に接合された先端チップと、
     先端が前記先端チップに接合され、基端が前記第1中空シャフトの基端よりも基端側に位置するように、前記メッシュ部材および前記第1中空シャフトの内側を延びるコアワイヤと、
     先端が前記先端チップに接合され、前記メッシュ部材の内側の空間を基端側に向かって延び、基端が前記先端チップの基端と前記第1中空シャフトの先端との間に位置する第2中空シャフトと、
     前記第2中空シャフトを前記コアワイヤに拘束する拘束部と、を備えたカテーテル。
    A first hollow shaft,
    A tubular mesh member having a proximal end joined to the distal end of the first hollow shaft and configured to expand or contract in the radial direction;
    A tip chip joined to the tip of the mesh member,
    A core wire that extends inside the mesh member and the first hollow shaft so that the tip is joined to the tip and the base end is located closer to the base end side than the base end of the first hollow shaft;
    A second end having a distal end joined to the distal end tip, extending toward the proximal end side in a space inside the mesh member, and having a proximal end located between the proximal end of the distal end tip and the distal end of the first hollow shaft; A hollow shaft,
    A restraint portion that restrains the second hollow shaft to the core wire.
  2.  前記コアワイヤは、前記第2中空シャフトの内周面または外周面に沿って延び、
     前記拘束部は、前記第2中空シャフトと前記コアワイヤとを接合する接合部である、請求項1に記載のカテーテル。
    The core wire extends along an inner peripheral surface or an outer peripheral surface of the second hollow shaft,
    The catheter according to claim 1, wherein the restraint portion is a joint portion that joins the second hollow shaft and the core wire.
  3.  前記拘束部は、前記第2中空シャフトの基端面に当接して、前記第2中空シャフトの基端を前記コアワイヤに拘束する、請求項1に記載のカテーテル。 The catheter according to claim 1, wherein the restraint portion is in contact with a base end surface of the second hollow shaft to restrain the base end of the second hollow shaft to the core wire.
  4.  前記第2中空シャフトは円筒形状であって、
     前記コアワイヤは、前記第2中空シャフトの内側を通るように構成され、
     前記拘束部は、前記第2中空シャフトの外径よりも小さい外径を有する円環形状をなし前記第2中空シャフトの前記基端面に当接するリング部材と、前記リング部材と前記コアワイヤとを接続する接続部材と、を有する、請求項3に記載のカテーテル。
    The second hollow shaft has a cylindrical shape,
    The core wire is configured to pass inside the second hollow shaft,
    The restraint portion has an annular shape having an outer diameter smaller than the outer diameter of the second hollow shaft, and connects the ring member that comes into contact with the base end surface of the second hollow shaft, the ring member and the core wire. And a connecting member for connecting the catheter to the catheter.
  5.  前記コアワイヤは、前記第2中空シャフトの内周面または外周面に沿って延び、
     前記拘束部は、前記コアワイヤおよび前記第2中空シャフトを挟み込み、前記第2中空シャフトを前記コアワイヤに拘束するクリップである、請求項1に記載のカテーテル。
    The core wire extends along an inner peripheral surface or an outer peripheral surface of the second hollow shaft,
    The catheter according to claim 1, wherein the restraint portion is a clip that sandwiches the core wire and the second hollow shaft and restrains the second hollow shaft with the core wire.
PCT/JP2018/038972 2018-10-19 2018-10-19 Catheter WO2020079825A1 (en)

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JPH10118087A (en) * 1996-10-23 1998-05-12 Asahi Optical Co Ltd Tool for recovering foreign substance for endoscope
JP2014500745A (en) * 2010-11-15 2014-01-16 エンドバスキュラー ディベロップメント アクティエボラーグ Assembly with guide wire and fixator for attachment to a blood vessel
JP2017077323A (en) * 2015-10-20 2017-04-27 朝日インテック株式会社 catheter
WO2018193601A1 (en) * 2017-04-20 2018-10-25 朝日インテック株式会社 Catheter

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