WO2021255879A1 - Catheter - Google Patents

Catheter Download PDF

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Publication number
WO2021255879A1
WO2021255879A1 PCT/JP2020/023861 JP2020023861W WO2021255879A1 WO 2021255879 A1 WO2021255879 A1 WO 2021255879A1 JP 2020023861 W JP2020023861 W JP 2020023861W WO 2021255879 A1 WO2021255879 A1 WO 2021255879A1
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WO
WIPO (PCT)
Prior art keywords
marker
tip
mesh member
core wire
attached
Prior art date
Application number
PCT/JP2020/023861
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/JP2020/023861 priority Critical patent/WO2021255879A1/en
Publication of WO2021255879A1 publication Critical patent/WO2021255879A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • 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
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • 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
    • A61M29/00Dilators with or without means for introducing media, e.g. remedies

Definitions

  • the present invention relates to a catheter.
  • Non-Patent Document 1 As a medical device for improving blood flow by removing obstructions that occlude blood vessels such as chronic total occlusion (CTO), for example, after performing pseudoluminal dilation using an anterograde guide wire, A technique for passing a retrograde guide wire through this false cavity is disclosed (see, for example, Non-Patent Document 1).
  • CTO chronic total occlusion
  • Such a technique is called the Reverse CART method.
  • a catheter having a tubular member formed of a mesh is placed in a blood vessel proximal to the occlusion, and a core wire connected to the member is pulled. Extend the mesh with and capture the retrograde guidewire through the opening of the mesh.
  • the tension of the core wire and the expansion diameter of the mesh member do not always correspond to each other. For this reason, it is not always possible to accurately grasp the expanded state of the mesh member when the core wire is pulled only by the operation at hand. For example, when the core wire is pulled excessively, the core wire comes off from the mesh member or the like. There is a risk.
  • the present invention has been made based on the above circumstances, and an object of the present invention is to provide a catheter capable of reliably grasping the expansion diameter of a mesh member accompanying the operation of a core wire.
  • Some aspects of this disclosure include (1) A tubular mesh member that can be expanded and contracted in the radial direction, A hollow shaft connected to the base end of the mesh member, A hollow tip connected to the tip of the mesh member, The tip portion is connected to the tip portion of the mesh member and / or the tip tip, and passes through the inside of the mesh member and the hollow shaft so that the proximal end is located closer to the proximal end side than the proximal end of the hollow shaft.
  • An induction film attached to the mesh member and having a tip located between the base end of the tip and the tip of the hollow shaft.
  • a radiation opaque first marker and a second marker attached to any of the mesh member, the hollow shaft, the tip tip, the core wire, and the induction membrane.
  • the first marker and the second marker are attached to different members whose distances between the first marker and the second marker change according to the degree of expansion of the mesh member by the core wire.
  • catheter (2) The catheter according to (1) above, wherein the first marker is attached to the induction membrane and the second marker is attached to the core wire.
  • the second marker is attached to a plurality of points of the core wire along the long axis direction.
  • the catheter according to (2) wherein each of the plurality of locations is arranged so as to correspond to the degree of expansion of the mesh member.
  • the second marker is attached to a plurality of points of the core wire along the long axis direction.
  • the first marker is attached to the hollow shaft, and the second marker is attached to any one of the mesh member, the tip tip, the core wire, and the induction film.
  • the catheter according to (1), (6) The second marker is attached to the core wire.
  • the outer shape of the marker is the catheter according to any one of (1) to (6) above, which has an ellipsoidal shape.
  • the "tip side” means the direction along the long axis direction of the catheter and the direction in which the mesh member is located with respect to the hollow shaft.
  • the “base end side” is a direction along the long axis direction of the hollow shaft, and means a direction opposite to the tip end side.
  • the “tip” refers to the end portion on the distal end side of any member or portion, and the “base end” refers to the end portion on the proximal end side of any member or portion.
  • the “major axis direction” means the longitudinal direction of the catheter and the “diametrical direction” means the direction orthogonal to the major axis direction.
  • the present invention can provide a catheter capable of reliably grasping the expansion diameter of the mesh member accompanying the operation of the core wire.
  • the catheter of the present disclosure is, for example, a tubular mesh member that can be expanded and contracted in the radial direction, a hollow shaft connected to the base end portion of the mesh member, and a hollow tip tip connected to the tip end portion of the mesh member. And / or the inside of the mesh member and the hollow shaft so that the tip portion is connected to the tip portion of the mesh member and / or the tip end and the proximal end is located closer to the proximal end side than the proximal end of the hollow shaft.
  • a core wire extending through the mesh member, an induction film attached to the mesh member and having a tip located between the base end of the tip tip and the tip of the hollow shaft, and the mesh member, the hollow shaft, the tip tip, and the tip.
  • the core wire and the first marker and the second marker of radiodensity attached to any of the induction membranes are provided, and the first marker and the second marker are the above-mentioned by the above-mentioned core wire. It is attached to different members whose distances between the first marker and the second marker change according to the degree of diameter expansion of the mesh member.
  • the "forward guide wire” means a guide wire used to guide the catheter in a body cavity such as a blood vessel
  • the “retrograde guide wire” means the inside of the body cavity. It means a guide wire facing the catheter.
  • the dimensions of the catheter shown in each drawing are the dimensions shown for facilitating the understanding of the contents of the implementation, and do not correspond to the actual dimensions.
  • the left side in the drawing is the distal end side (distal side) inserted into the body, and the right side is the proximal end side (proximal side, hand side) operated by a technician such as a doctor.
  • FIG. 1 is a schematic side view showing the first embodiment, and is a view in which the mesh member has a reduced diameter.
  • the catheter 1 generally includes a mesh member 11, a hollow shaft 21, a tip tip 31, a core wire 41, an induction film 51, a first marker 61, and a second marker. It is composed of a marker 71 and a connector 81.
  • the mesh member 11 is a tube-shaped member that is formed of a mesh-shaped member and can be expanded and contracted in the radial direction.
  • the mesh member 11 is composed of, for example, a wire 11w braided into a mesh shape, and can be easily expanded or contracted (deformed) by deforming the wire 11w.
  • the opening 11a of the mesh member 11 can accept, for example, a retrograde guide wire (not shown).
  • the tip of the mesh member 11 is joined to the core wire 41 (described later), and the base end is joined to the hollow shaft 21 (described later). Therefore, when the core wire 41 is pulled toward the base end side, the mesh member 11 bulges outward in the radial direction to expand the diameter, and a larger opening 11a is formed.
  • the diameter of the mesh member 11 is reduced and becomes smaller, which facilitates the movement of the catheter 1 in the body cavity.
  • Examples of the material of the wire 11w constituting the mesh member 11 include a metal material such as stainless steel such as SUS304, a nickel titanium alloy, and a cobalt-chromium alloy; and a resin material such as polyamide, polyester, polyacrylate, and polyether ether ketone. Can be mentioned. Among these, a metal material is preferable from the viewpoint of improving strength and flexibility.
  • the mesh member 11 is composed of a plurality of strands 11w, the materials of the strands 11w may be the same or different.
  • the hollow shaft 21 is a hollow shaft connected to the base end portion of the mesh member 11. Specifically, the hollow shaft 21 has a lumen 21h penetrating from the tip end to the base end, for example.
  • a core wire 41, a retrograde guide wire, or the like, which will be described later, is inserted into the lumen 21h.
  • the hollow shaft 21 has antithrombotic property, biocompatibility, and flexibility because the hollow shaft 21 is inserted into a body cavity such as a blood vessel.
  • the material include resin materials such as polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluororesin.
  • a method of joining the mesh member 11 and the hollow shaft 21 described above for example, a method of embedding the base end portion of the mesh member 11 in the tip end portion of the hollow shaft 21 by welding or the like can be adopted.
  • the tip tip 31 is a hollow member connected to the tip of the mesh member 11.
  • the tip 31 can, for example, reduce the resistance of the catheter 1 to move forward in the body cavity and allow the catheter 1 to advance smoothly.
  • the tip tip 31 has a lumen 31h for passing an antegrade guide wire (not shown) or the like.
  • the tip portion of the tip tip 31 can be formed into a rounded shape toward the tip side.
  • the tip end portion of the tip end 31 is joined to the tip end portion of the mesh member 11 or the like.
  • the material constituting the tip tip 31 has flexibility so as to alleviate the impact on the body cavity and the like.
  • a material include resin materials such as polyurethane and polyurethane elastomer.
  • a method of joining the tip tip 31 and the mesh member 11 for example, a method of burying the tip of each wire 11w constituting the mesh member 11 in the base end of the tip tip 31 by welding or the like can be adopted. can.
  • the core wire 41 extends through the inside of the mesh member and the hollow shaft so that the tip is connected to the tip and / or the tip of the mesh member and the proximal end is located closer to the proximal end than the proximal end of the hollow shaft. It is a member. Specifically, for example, the tip of the core wire 41 is joined to the tip tip 31 and penetrates the inside of the mesh member 11 (the space inside the mesh member 11) and the lumen 21h of the hollow shaft 21, and the base end thereof. It can be arranged so as to be exposed from the lumen 81h of the connector 81, which will be described later, to the proximal end side.
  • the mesh member 11 can be expanded or contracted by moving the core wire 41 forward and backward along the long axis direction.
  • the material constituting the core wire 41 preferably has sufficient rigidity and tensile strength from the viewpoint of reliably expanding and contracting the mesh member 11 and preventing the core wire 41 itself from being cut.
  • a material include stainless steel such as SUS304, metal materials such as nickel-titanium alloy and cobalt-chromium alloy, and the like.
  • a method of joining the core wire 41 and the tip tip 31 and / or the mesh member 11 for example, a method of embedding the tip of the core wire 41 in the base end of the tip tip 31 by welding or the like, and / or the tip of the core wire 41. A method of welding the portion and the tip portion of the mesh member 11 can be adopted.
  • the guide film 51 is a thin film-like member attached to a mesh member and whose tip is located between the base end of the tip tip and the tip of the hollow shaft.
  • the tip of the inductive film 51 is located at the maximum diameter expansion portion 11s of the mesh member 11 (the portion where the outer diameter becomes the largest when the mesh member 11 is expanded), and the base end is a hollow shaft. It can be arranged so as to be located at the tip of 21.
  • the retrograde guide wire received through the opening 11a of the mesh member 11 can be smoothly guided toward the opening 21a at the tip of the hollow shaft 21.
  • Examples of the material constituting the inductive film 51 include polyethylene, polyurethane, polyamide, polyamide elastomer, polyolefin, polyester, polyester elastomer and the like.
  • polyurethane is preferable as the material from the viewpoint of improving the sliding property of the surface.
  • the guide film 51 may be bonded to the mesh member over the entire surface, or only a part thereof (for example, the tip portion of the guide film) may be bonded to the mesh member.
  • a method of joining the guide film and the mesh member for example, a method of heating and melting the material forming the guide film and immersing the mesh member in the melted material to bridge the strands (close the opening).
  • a method of welding the outer periphery of the opening on the tip end side of the funnel-shaped film to the mesh member or the like can be adopted.
  • the tip of the guide film 51 of the present embodiment is located at the maximum diameter expansion portion 11s (substantially central portion in the major axis direction) of the mesh member 11, the base end is located at the tip of the hollow shaft 21, and the mesh member 11 It is formed so as to bridge (close the opening 11a) between the strands 11w.
  • the first marker 61 and the second marker 71 are radiation opaque markers.
  • the first marker 61 and the second marker 71 are the mesh member 11, the hollow shaft 21, the tip tip 31, the core wire 41, and the guide film 51, which correspond to the degree of expansion of the mesh member 11 by the core wire 41. It is attached to any member different from each other in which the distance between the marker 1 and the marker 2 changes.
  • the member to which the first marker 61 is attached examples include an induction film, a hollow shaft, and the like.
  • the first marker When the first marker is attached to the induction membrane, the first marker may be provided, for example, on a part of the induction membrane or may be provided over the entire induction membrane.
  • the first marker When the first marker is attached to the hollow shaft, the first marker may be provided at a specific portion of the hollow shaft, for example, or may be provided over the entire hollow shaft.
  • the member to which the second marker 71 is attached examples include a tip tip, a core wire, a mesh member, a hollow shaft, and the like.
  • the second marker 71 may be provided, for example, on the tip and / or core wire.
  • the second marker 71 may be provided, for example, on the tip tip and / or the core wire.
  • Each of the first marker 61 and the second marker 71 may be fixed (adhesive, welded, etc.) over a part or the whole on the member to be attached, and may be fixed (adhesion, welding, etc.) to a part or the whole of the member. It may be mixed over.
  • a brazing material containing a radiation-impermeable substance may be used as a marker and formed by brazing to a member to which the second marker 71 is attached.
  • fine particles containing a radiation-impermeable substance may be used as a marker, and the marker may be formed by dispersing the fine particles inside the member to be attached.
  • radiodensity permeable material used for the first marker 61 and the second marker 71 examples include gold, platinum, tungsten, or an alloy containing these elements (for example, platinum nickel alloy).
  • the radiodensity material is a combination of a non-radiodensity substance and a radiodensity substance, such as a substance coated with a radiodensity substance on the surface of the substance that is not radiodensity. You may.
  • the first marker 61 is attached to the induction film 51 and the second marker 71 is attached to the core wire 41.
  • a second marker 71 is provided at one location on the core wire 41, or as shown in FIG. 2B, a plurality of different locations on the core wire 41 along the long axis direction.
  • a second marker 71 can be provided on the surface.
  • the first and second markers 61, 71 are arranged so that the position where the specific second marker 71 crosses the first marker 61 corresponds to the optimum expansion state of the mesh member 11. You may.
  • the first marker 61 is attached to the guide film 51 and the second marker 71 is attached to the core wire 41, so that the expansion diameter of the mesh member 11 is ensured by the positional relationship between the guide film 51 and the core wire 41. Can be grasped.
  • the second marker 71 is attached to a plurality of positions of the core wire 41 along the major axis direction, and each of the second marker 71 expands the mesh member 11. It is preferable that they are arranged so as to correspond to the degree of diameter. Specifically, as shown in FIG. 2B, for example, the spacing in the major axis direction of the adjacent second markers 71 and 71 is determined so that the difference in the expansion diameter (outer diameter) of the mesh member 11 becomes equal. You may do so. As a result, the expanded diameter of the mesh member 11 can be reliably grasped from the positional relationship between the first marker 61 and the second marker 71 that are visually recognized.
  • the second marker 71 is attached to a plurality of points of the core wire 41 along the major axis direction, and the second marker 71, which is adjacent to each other, is attached to the plurality of points. It is also preferable that the intervals between 71 are equal. Specifically, as shown in FIG. 2C, for example, a plurality of second markers 71 may be arranged at equal intervals on the core wire 41 along the major axis direction. As a result, even if a part of the second marker 71 out of the plurality of second markers 71 cannot be visually recognized, the position of the second marker 71 that cannot be visually recognized by the visible second marker 71 can be inferred. The expanded diameter of the mesh member 11 can be accurately grasped from the positional relationship between the first marker 61 and the visible or estimated second marker 71.
  • the outer shape of the marker (first marker or second marker) attached to the core wire 41 is preferably an ellipsoidal shape.
  • a brazing material containing a radiation-impermeable substance is used, and the brazing material is brazed so as to surround the surface of the core wire 41 to form a second marker 71.
  • the outer shape can be formed into an ellipsoidal shape (see the second marker 711).
  • radiation-impermeable fine particles 61a are used as the first marker 61, and the fine particles 61a are dispersed throughout the induction film 51, and a brazing material is used as the second marker 71.
  • the catheter 1 is exemplified in which a plurality of second markers 711 (71) are waxed to a specific site on the core wire 41.
  • the connector 81 is a member for which the operator grips the catheter 1.
  • the connector 81 is connected to the base end portion of the hollow shaft 21 and has a lumen 81h communicating with the lumen 21h and an opening 81a located at the base end of the lumen 81h.
  • the form of the connector 81 is not particularly limited as long as the effect of the present invention is not impaired.
  • the usage mode of the catheter 1 will be described.
  • a procedure for passing a retrograde guide wire through a site where an obstruction is present in a blood vessel (hereinafter, also referred to as an “occluded site”) will be described.
  • an antegrade guide wire (not shown) is inserted into the blood vessel, and then the antegrade guide wire is pushed along the blood vessel to the obstruction site.
  • a balloon catheter (not shown) is inserted to the occlusion site using the antegrade guide wire as a guide, and the balloon is expanded in diameter to expand the occlusion site. After expanding the occluded area, the balloon is contracted and the balloon catheter is removed from the blood vessel.
  • the proximal end of the anterograde guide wire passes from the tip opening 31a of the tip tip 31 through the lumen 31h, the space inside the mesh member 11, the lumen 21h, and the lumen 81h, and passes through the opening 81a to the catheter 1.
  • An anterograde guide wire is inserted into the catheter 1 so as to come out of the catheter 1, and the tip of the catheter 1 is pushed to the occlusion site in the blood vessel by using the anterograde guide wire as a guide.
  • the catheter 1 is inserted into the blood vessel in a state where the mesh member 11 is reduced in diameter, and the diameter is maintained in the reduced state until the tip of the catheter 1 reaches the occlusion site.
  • the antegrade guide wire is pulled out from the catheter 1 by pulling the antegrade guide wire toward the proximal end side with respect to the catheter 1. ..
  • the tip of the mesh member 11 and the tip of the hollow shaft 21 are shown as shown in FIGS. 4A to 4D.
  • the distance from the mesh member 11 is narrowed in the order of FIGS. 4A, 4B, 4C, and 4D, and the mesh member 11 is deformed (bulged) outward in the radial direction to expand the diameter.
  • the mesh opening 11a is also expanded as the diameter of the mesh member 11 is expanded, it becomes easy to accept the retrograde guide wire.
  • the first marker 61 is attached to the induction film 51 and the second marker 71 is attached to the core wire 41, the first marker 61 and the second marker 71 are positioned at predetermined positions.
  • the expansion diameter of the mesh member 11 is adjusted. After the tip of the catheter 1 reaches the obstruction site along the antegrade guide wire, the mesh member 11 is expanded radially outward, and then the antegrade guide wire is pulled out from the catheter 1. May be good.
  • the retrograde guide wire catheter 1 comes from the distal end side.
  • the retrograde guide wire RGW is accepted into the space inside the mesh member 11 through the mesh opening 11a of the expanded mesh member 11, and then enters the lumen 21h of the hollow shaft 21 via the opening 21a at the tip of the hollow shaft 21. Accepted (see Figure 4).
  • one end of the retrograde guide wire is pulled out of the body via, for example, a port 21p (see FIG. 1) provided in the middle of the hollow shaft 21.
  • the catheter 1 since the catheter 1 has the above configuration, it is possible to reliably grasp the expansion diameter of the mesh member 11 accompanying the operation of the core wire 41. As a result, for example, it is possible to prevent the core wire 41 from being excessively pulled and broken from the tip portion and / or the tip tip 31 of the mesh member 11.
  • FIG. 4 is a schematic side view showing the first embodiment, and is a view in which the mesh member has a reduced diameter.
  • the catheter 2 generally includes a mesh member 11, a hollow shaft 21, a tip tip 31, a core wire 41, an induction film 52, a first marker 62, and a second marker. It is composed of a marker 71 and a connector 81.
  • Catheter 2 is different from the first embodiment in that the induction membrane 52 and the first marker 62 are different from the first embodiment.
  • the configurations of the mesh member 11, the hollow shaft 21, the tip tip 31, the core wire 41, the first marker 71, and the connector 81 are the same as those in the first embodiment, the same parts are designated by the same reference numerals. The detailed description thereof will be omitted. Further, since the configurations other than the configurations of the induction membrane 52 and the first marker 62 and the usage mode of the catheter 2 shown below are the same as those of the first embodiment, detailed description thereof will be omitted.
  • the guide film 52 is a member that is attached to a mesh member and whose tip is located between the base end of the tip tip and the tip of the hollow shaft.
  • the tip of the guide film 52 of the present embodiment is located at the maximum diameter expansion portion 11s (substantially central portion in the major axis direction) of the mesh member 11, the base end is located at the tip of the hollow shaft 21, and the mesh member 11 It is formed so as to bridge (close the opening 11a) between the strands 11w.
  • the induction membrane 52 does not include a marker formed of a radiation-impermeable material (for example, the first marker 61a (fine particles) exemplified in the catheter 1).
  • the first marker 62 is a radiation opaque marker.
  • the first marker 62 is attached to the hollow shaft 21.
  • the mounting position of the first marker 62 may be, for example, provided along the circumferential direction of the tip of the hollow shaft 21 so as to surround the opening 21a at the tip of the hollow shaft 21, and may be provided halfway in the long axis direction of the hollow shaft 21. It may be provided in.
  • the second marker is preferably attached to any of a mesh member, a tip tip, a core wire, and an inductive membrane. This makes it possible to reliably grasp the expanded diameter of the mesh member based on the positional relationship between the hollow shaft and other members.
  • the first marker 62 is brazed around the opening 21a at the tip of the hollow shaft 21.
  • a plurality of second markers 71 are attached to different portions on the core wire 41 along the major axis direction so that at least one of them can move from the distal end side to the proximal end side with respect to the first marker 62. ..
  • the identification of the plurality of second markers 71 when the marker (for example, the marker 71 located in the center of the second marker 71 in the long axis direction) crosses the first marker 62, the mesh member 11 is in the optimum expanded state (see FIG. 6B).
  • the second marker 71 may be arranged so as to be.
  • the catheter 2 since the catheter 2 has the above configuration, it is possible to reliably grasp the expansion diameter of the mesh member 11 accompanying the operation of the core wire 41.
  • the catheter 1 in which the first marker 61 is provided over the entire induction membrane 51 and the second marker 71 is provided in a plurality of different sites on the core wire 41 has been described.
  • the catheter 2 in which the first marker 62 is provided at the tip of the hollow shaft 21 and the second marker 71 is provided at a plurality of different parts on the core wire 41 has been described.
  • the first marker and the second marker may be attached to different members whose distances between the first marker and the second marker change according to the degree of expansion of the mesh member by the core wire. ..
  • the second marker is the first of the mesh members to which the first marker is not attached, the hollow shaft, the tip tip, and the inductive membrane. It may be any of the parts where the marker is not attached. Further, when the first marker is provided on the hollow shaft, the second marker may be any of a mesh member, a tip tip, a core wire, and an inductive membrane.
  • the catheter 1 in which the first marker 61 is provided over the entire induction membrane 51 has been described.
  • the marker provided on the induction membrane may be inside and / or part of the induction membrane.
  • the marker may be provided in one annular shape orthogonal to the major axis, or in two or more annular rings orthogonal to the major axis and arranged at predetermined intervals. Further, the marker may be provided in one area or two or more areas.
  • the catheter 1 in which the outer shape of the second marker 71 provided on the core wire 41 has an ellipsoidal shape has been described.
  • the shape of the marker provided on the core wire 41 may be, for example, the same shape as a part of the core wire 41 (a shape in which a part of the core wire 41 contains a radiation-impermeable material).
  • 7A may have a shape that tapers toward the tip side (see marker 732 in FIG. 7B), or may have a cylindrical shape that covers the outer periphery of the core wire 41 (see marker 733 in FIG. 7C). ..

Abstract

The purpose of the present invention is to provide a catheter whereby the diameter to which a mesh member expands in response to operation of a core wire can be reliably ascertained. This catheter 1 comprises: a tubular mesh member 11 capable of expanding and contracting; a hollow shaft 21; a distal-end tip 31; a core wire 41; a guide membrane 51 attached to the mesh member 11; and a radioopaque first marker 61 and second marker 71 attached to any of the mesh member 11, the hollow shaft 21, the distal-end tip 31, the core wire 41, and the guide membrane 51. The first marker 61 and the second marker 71 are attached to mutually different members such that the distance between the first marker 61 and the second marker 71 changes in accordance with the degree of diameter expansion of the mesh member 11 by the core wire 41.

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:Chronic 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医療器具として、例えば、順行性ガイドワイヤを用いて偽腔拡張を行った後、この偽腔に逆行性ガイドワイヤを通す技術が開示されている(例えば、非特許文献1参照)。 As a medical device for improving blood flow by removing obstructions that occlude blood vessels such as chronic total occlusion (CTO), for example, after performing pseudoluminal dilation using an anterograde guide wire, A technique for passing a retrograde guide wire through this false cavity is disclosed (see, for example, Non-Patent Document 1).
 このような技術はReverse CART法と呼ばれ、例えば、閉塞部よりも近位の血管内にメッシュで形成されたチューブ状の部材を有するカテーテルを配置し、上記部材に接続されたコアワイヤを引っ張ることでメッシュを拡張し、メッシュの開口を通して逆行性ガイドワイヤを捕獲する。 Such a technique is called the Reverse CART method. For example, a catheter having a tubular member formed of a mesh is placed in a blood vessel proximal to the occlusion, and a core wire connected to the member is pulled. Extend the mesh with and capture the retrograde guidewire through the opening of the mesh.
 しかしながら、上述したような従来のカテーテルでは、コアワイヤの引張度合いとメッシュ部材の拡張径とが必ずしも対応していない。このため、手元の操作だけではコアワイヤを引っ張ったときのメッシュ部材の拡張状態を必ずしも正確に把握することができず、例えば、コアワイヤが過度に引っ張られた場合、コアワイヤがメッシュ部材等から外れてしまう虞がある。 However, in the conventional catheter as described above, the tension of the core wire and the expansion diameter of the mesh member do not always correspond to each other. For this reason, it is not always possible to accurately grasp the expanded state of the mesh member when the core wire is pulled only by the operation at hand. For example, when the core wire is pulled excessively, the core wire comes off from the mesh member or the like. There is a risk.
 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、コアワイヤの操作に伴うメッシュ部材の拡張径を確実に把握することが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 of the present invention is to provide a catheter capable of reliably grasping the expansion diameter of a mesh member accompanying the operation of a core wire.
 本開示のいくつかの態様は、
(1)径方向に拡縮可能なチューブ状のメッシュ部材と、
 前記メッシュ部材の基端部に接続された中空シャフトと、
 前記メッシュ部材の先端部に接続された中空の先端チップと、
 先端部が前記メッシュ部材の先端部および/または前記先端チップに接続され、基端が前記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中空シャフトの内部を通って延びるコアワイヤと、
 前記メッシュ部材に取り付けられ、先端が前記先端チップの基端と前記中空シャフトの先端との間に位置する誘導膜と、
 前記メッシュ部材、前記中空シャフト、前記先端チップ、前記コアワイヤ、および前記誘導膜のうちのいずれかに取り付けられた放射線不透過性の第1のマーカおよび第2のマーカと、を備え、
 前記第1のマーカおよび第2のマーカは、前記コアワイヤによる前記メッシュ部材の拡径度合いに対応して前記第1のマーカと第2のマーカとの距離が変化する互いに異なる部材に取り付けられているカテーテル、
(2)前記第1のマーカは前記誘導膜に取り付けられ、かつ前記第2のマーカは前記コアワイヤに取り付けられている前記(1)に記載のカテーテル、
(3)前記第2のマーカは、長軸方向に沿った前記コアワイヤの複数箇所に取り付けられており、
 前記複数箇所のそれぞれは、前記メッシュ部材の拡径度合いに対応するように配置されている前記(2)に記載のカテーテル、
(4)前記第2のマーカは、長軸方向に沿った前記コアワイヤの複数箇所に取り付けられており、
 前記複数箇所のうちの隣り合う第2のマーカどうしの間隔がいずれも等しい前記(2)に記載のカテーテル、
(5)前記第1のマーカは前記中空シャフトに取り付けられ、かつ前記第2のマーカは、前記メッシュ部材、前記先端チップ、前記コアワイヤ、および前記誘導膜のうちのいずれかに取り付けられている前記(1)に記載のカテーテル、
(6)前記第2のマーカは前記コアワイヤに取り付けられており、
 前記第2のマーカが前記第1のマーカよりも先端側から基端側に移動可能である前記(5)に記載のカテーテル、並びに
(7)前記コアワイヤに取り付けられる第1のマーカまたは第2のマーカの外形は、楕円体形状である前記(1)から(6)のいずれか一項に記載のカテーテル、である。
Some aspects of this disclosure include
(1) A tubular mesh member that can be expanded and contracted in the radial direction,
A hollow shaft connected to the base end of the mesh member,
A hollow tip connected to the tip of the mesh member,
The tip portion is connected to the tip portion of the mesh member and / or the tip tip, and passes through the inside of the mesh member and the hollow shaft so that the proximal end is located closer to the proximal end side than the proximal end of the hollow shaft. With the extending core wire,
An induction film attached to the mesh member and having a tip located between the base end of the tip and the tip of the hollow shaft.
A radiation opaque first marker and a second marker attached to any of the mesh member, the hollow shaft, the tip tip, the core wire, and the induction membrane.
The first marker and the second marker are attached to different members whose distances between the first marker and the second marker change according to the degree of expansion of the mesh member by the core wire. catheter,
(2) The catheter according to (1) above, wherein the first marker is attached to the induction membrane and the second marker is attached to the core wire.
(3) The second marker is attached to a plurality of points of the core wire along the long axis direction.
The catheter according to (2), wherein each of the plurality of locations is arranged so as to correspond to the degree of expansion of the mesh member.
(4) The second marker is attached to a plurality of points of the core wire along the long axis direction.
The catheter according to (2) above, wherein the intervals between adjacent second markers among the plurality of locations are the same.
(5) The first marker is attached to the hollow shaft, and the second marker is attached to any one of the mesh member, the tip tip, the core wire, and the induction film. The catheter according to (1),
(6) The second marker is attached to the core wire.
The catheter according to (5) above, wherein the second marker can be moved from the distal end side to the proximal end side with respect to the first marker, and (7) the first marker or the second marker attached to the core wire. The outer shape of the marker is the catheter according to any one of (1) to (6) above, which has an ellipsoidal shape.
 なお、本明細書において、「先端側」とは、カテーテルの長軸方向に沿う方向であって、中空シャフトに対してメッシュ部材が位置する方向を意味する。「基端側」とは、中空シャフトの長軸方向に沿う方向であって、先端側と反対側の方向を意味する。「先端」とは、任意の部材または部位における先端側の端部、「基端」とは、任意の部材または部位における基端側の端部をそれぞれ示す。指定がない限り、「長軸方向」とはカテーテルの長手方向を意味し、「径方向」とは上記長軸方向に直交する方向を意味する。 In the present specification, the "tip side" means the direction along the long axis direction of the catheter and the direction in which the mesh member is located with respect to the hollow shaft. The "base end side" is a direction along the long axis direction of the hollow shaft, and means a direction opposite to the tip end side. The "tip" refers to the end portion on the distal end side of any member or portion, and the "base end" refers to the end portion on the proximal end side of any member or portion. Unless otherwise specified, the "major axis direction" means the longitudinal direction of the catheter and the "diametrical direction" means the direction orthogonal to the major axis direction.
 本発明は、コアワイヤの操作に伴うメッシュ部材の拡張径を確実に把握することが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 capable of reliably grasping the expansion diameter of the mesh member accompanying the operation of the core wire.
第1の実施形態を示す概略的断面図であって、メッシュ部材が縮径状態の図である。It is a schematic cross-sectional view which shows the 1st Embodiment, and is the figure which the mesh member is in the reduced diameter state. 第2のマーカの配置の一例を示す概略的断面図である。It is a schematic sectional drawing which shows an example of the arrangement of the 2nd marker. 第2のマーカの配置の一例を示す概略的断面図である。It is a schematic sectional drawing which shows an example of the arrangement of the 2nd marker. 第2のマーカの配置の一例を示す概略的断面図である。It is a schematic sectional drawing which shows an example of the arrangement of the 2nd marker. 第2のマーカの取り付け部位を拡大して示す概略的断面図である。It is the schematic sectional drawing which shows the attachment | attachment part of the 2nd marker enlarged. 第1の実施形態の縮径状態を示す概略的断面図である。It is a schematic cross-sectional view which shows the reduced diameter state of 1st Embodiment. 第1の実施形態の拡径状態の一例を示す概略的断面図である。It is a schematic cross-sectional view which shows an example of the diameter expansion state of 1st Embodiment. 第1の実施形態の拡径状態の一例を示す概略的断面図である。It is a schematic cross-sectional view which shows an example of the diameter expansion state of 1st Embodiment. 第1の実施形態の拡径状態の一例を示す概略的断面図である。It is a schematic cross-sectional view which shows an example of the diameter expansion state of 1st Embodiment. 第2の実施形態を示す概略的断面図であって、メッシュ部材が縮径状態の図である。It is a schematic cross-sectional view which shows the 2nd Embodiment, and is the figure which the mesh member is in the reduced diameter state. 第2の実施形態の縮径状態を示す概略的断面図である。It is a schematic cross-sectional view which shows the reduced diameter state of 2nd Embodiment. 第2の実施形態の拡径状態の一例を示す概略的断面図である。It is the schematic sectional drawing which shows an example of the diameter expansion state of 2nd Embodiment. コアワイヤに取り付けられるマーカの変形例を示す概略的断面図である。It is a schematic cross-sectional view which shows the modification of the marker attached to a core wire. コアワイヤに取り付けられるマーカの変形例を示す概略的断面図である。It is a schematic cross-sectional view which shows the modification of the marker attached to a core wire. コアワイヤに取り付けられるマーカの変形例を示す概略的断面図である。It is a schematic cross-sectional view which shows the modification of the marker attached to a core wire.
 本開示のカテーテルは、例えば、径方向に拡縮可能なチューブ状のメッシュ部材と、上記メッシュ部材の基端部に接続された中空シャフトと、上記メッシュ部材の先端部に接続された中空の先端チップと、先端部が上記メッシュ部材の先端部および/または上記先端チップに接続され、基端が上記中空シャフトの基端よりも基端側に位置するように上記メッシュ部材および上記中空シャフトの内部を通って延びるコアワイヤと、上記メッシュ部材に取り付けられ、先端が上記先端チップの基端と上記中空シャフトの先端との間に位置する誘導膜と、上記メッシュ部材、上記中空シャフト、上記先端チップ、上記コアワイヤ、および上記誘導膜のうちのいずれかに取り付けられた放射線不透過性の第1のマーカおよび第2のマーカと、を備え、上記第1のマーカおよび第2のマーカは、上記コアワイヤによる上記メッシュ部材の拡径度合いに対応して上記第1のマーカと第2のマーカとの距離が変化する互いに異なる部材に取り付けられている。 The catheter of the present disclosure is, for example, a tubular mesh member that can be expanded and contracted in the radial direction, a hollow shaft connected to the base end portion of the mesh member, and a hollow tip tip connected to the tip end portion of the mesh member. And / or the inside of the mesh member and the hollow shaft so that the tip portion is connected to the tip portion of the mesh member and / or the tip end and the proximal end is located closer to the proximal end side than the proximal end of the hollow shaft. A core wire extending through the mesh member, an induction film attached to the mesh member and having a tip located between the base end of the tip tip and the tip of the hollow shaft, and the mesh member, the hollow shaft, the tip tip, and the tip. The core wire and the first marker and the second marker of radiodensity attached to any of the induction membranes are provided, and the first marker and the second marker are the above-mentioned by the above-mentioned core wire. It is attached to different members whose distances between the first marker and the second marker change according to the degree of diameter expansion of the mesh member.
 なお、本明細書において、「順行性ガイドワイヤ」とは、血管などの体腔内において当該カテーテルを導くために用いられるガイドワイヤを意味し、「逆行性ガイドワイヤ」とは、体腔内を当該カテーテルに向かって対向してくるガイドワイヤを意味する。 In the present specification, the "forward guide wire" means a guide wire used to guide the catheter in a body cavity such as a blood vessel, and the "retrograde guide wire" means the inside of the body cavity. It means a guide wire facing the catheter.
 以下、本発明の第1および第2の実施形態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。また、各図面に示したカテーテルの寸法は、実施内容の理解を容易にするために示した寸法であり、実際の寸法に対応するものではない。また、各図面において、図示左側が体内に挿入される先端側(遠位側)、右側が医師等の手技者によって操作される基端側(近位側、手元側)である。 Hereinafter, the first and second embodiments 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. Further, the dimensions of the catheter shown in each drawing are the dimensions shown for facilitating the understanding of the contents of the implementation, and do not correspond to the actual dimensions. Further, in each drawing, the left side in the drawing is the distal end side (distal side) inserted into the body, and the right side is the proximal end side (proximal side, hand side) operated by a technician such as a doctor.
[第1の実施形態]
 図1は、第1の実施形態を示す概略的側面図であって、メッシュ部材が縮径状態の図である。当該カテーテル1は、図1に示すように、概略的に、メッシュ部材11と、中空シャフト21と、先端チップ31と、コアワイヤ41と、誘導膜51と、第1のマーカ61と、第2のマーカ71と、コネクタ81とにより構成されている。
[First Embodiment]
FIG. 1 is a schematic side view showing the first embodiment, and is a view in which the mesh member has a reduced diameter. As shown in FIG. 1, the catheter 1 generally includes a mesh member 11, a hollow shaft 21, a tip tip 31, a core wire 41, an induction film 51, a first marker 61, and a second marker. It is composed of a marker 71 and a connector 81.
 メッシュ部材11は、メッシュ状の部材で形成され、径方向に拡縮可能なチューブ状の部材である。メッシュ部材11は、具体的には、例えば、メッシュ状に編組された素線11wで構成されており、素線11wが変形することで容易に拡縮(変形)することができる。メッシュ部材11の開口11aは、例えば、逆行性ガイドワイヤ(不図示)等を受け入れることができる。メッシュ部材11の先端部は、コアワイヤ41(後述)に、基端部は中空シャフト21(後述)にそれぞれ接合されている。このため、コアワイヤ41を基端側に向かって引っ張るとメッシュ部材11は径方向外側へ膨出することで拡径し、より大きな開口11aが形成される。他方、コアワイヤ41を先端側に向かって押し出すとメッシュ部材11は縮径し、より小さくなって体腔内におけるカテーテル1の移動が容易となる。 The mesh member 11 is a tube-shaped member that is formed of a mesh-shaped member and can be expanded and contracted in the radial direction. Specifically, the mesh member 11 is composed of, for example, a wire 11w braided into a mesh shape, and can be easily expanded or contracted (deformed) by deforming the wire 11w. The opening 11a of the mesh member 11 can accept, for example, a retrograde guide wire (not shown). The tip of the mesh member 11 is joined to the core wire 41 (described later), and the base end is joined to the hollow shaft 21 (described later). Therefore, when the core wire 41 is pulled toward the base end side, the mesh member 11 bulges outward in the radial direction to expand the diameter, and a larger opening 11a is formed. On the other hand, when the core wire 41 is pushed out toward the tip side, the diameter of the mesh member 11 is reduced and becomes smaller, which facilitates the movement of the catheter 1 in the body cavity.
 メッシュ部材11を構成する素線11wの材料としては、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の金属材料;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などの樹脂材料等が挙げられる。これらの中では、強度および可撓性を向上させる観点から、金属材料であることが好ましい。なお、メッシュ部材11が複数本の素線11wで構成される場合、各素線11wの材料は、同一であってもよく、異なっていてもよい。 Examples of the material of the wire 11w constituting the mesh member 11 include a metal material such as stainless steel such as SUS304, a nickel titanium alloy, and a cobalt-chromium alloy; and a resin material such as polyamide, polyester, polyacrylate, and polyether ether ketone. Can be mentioned. Among these, a metal material is preferable from the viewpoint of improving strength and flexibility. When the mesh member 11 is composed of a plurality of strands 11w, the materials of the strands 11w may be the same or different.
 中空シャフト21は、メッシュ部材11の基端部に接続された中空形状のシャフトである。中空シャフト21は、具体的には、例えば、先端から基端に亘って貫通する内腔21hを有している。内腔21hには、例えば、後述するコアワイヤ41や、逆行性ガイドワイヤ等が挿通される。 The hollow shaft 21 is a hollow shaft connected to the base end portion of the mesh member 11. Specifically, the hollow shaft 21 has a lumen 21h penetrating from the tip end to the base end, for example. For example, a core wire 41, a retrograde guide wire, or the like, which will be described later, is inserted into the lumen 21h.
 中空シャフト21を構成する材料としては、この中空シャフト21が血管などの体腔内に挿通されることから、抗血栓性、生体適合性、および可撓性を有していることが好ましい。上記材料としては、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、フッ素樹脂などの樹脂材料等が挙げられる。 As the material constituting the hollow shaft 21, it is preferable that the hollow shaft 21 has antithrombotic property, biocompatibility, and flexibility because the hollow shaft 21 is inserted into a body cavity such as a blood vessel. Examples of the material include resin materials such as polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluororesin.
 上述したメッシュ部材11と中空シャフト21との接合方法としては、例えば、メッシュ部材11の基端部を中空シャフト21の先端部に溶着等で埋設する方法等を採用することができる。 As a method of joining the mesh member 11 and the hollow shaft 21 described above, for example, a method of embedding the base end portion of the mesh member 11 in the tip end portion of the hollow shaft 21 by welding or the like can be adopted.
  先端チップ31は、メッシュ部材11の先端部に接続された中空の部材である。先端チップ31は、例えば、カテーテル1が体腔内を前進する際の抵抗を減らし、カテーテル1を円滑に進行させることができる。先端チップ31は、具体的には、例えば、順行性ガイドワイヤ(不図示)などを相通するための内腔31hを有している。先端チップ31の先端部は、先端側に向かって丸みを帯びた形状に形成することができる。先端チップ31は、基端部がメッシュ部材11等の先端部に接合されている。 The tip tip 31 is a hollow member connected to the tip of the mesh member 11. The tip 31 can, for example, reduce the resistance of the catheter 1 to move forward in the body cavity and allow the catheter 1 to advance smoothly. Specifically, the tip tip 31 has a lumen 31h for passing an antegrade guide wire (not shown) or the like. The tip portion of the tip tip 31 can be formed into a rounded shape toward the tip side. The tip end portion of the tip end 31 is joined to the tip end portion of the mesh member 11 or the like.
 先端チップ31を構成する材料としては、体腔等への衝撃を緩和できるように、柔軟性を有することが好ましい。このような材料としては、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。 It is preferable that the material constituting the tip tip 31 has flexibility so as to alleviate the impact on the body cavity and the like. Examples of such a material include resin materials such as polyurethane and polyurethane elastomer.
 先端チップ31とメッシュ部材11との接合方法としては、例えば、メッシュ部材11を構成する各素線11wの先端部を先端チップ31の基端部に溶着等で埋設する方法等を採用することができる。 As a method of joining the tip tip 31 and the mesh member 11, for example, a method of burying the tip of each wire 11w constituting the mesh member 11 in the base end of the tip tip 31 by welding or the like can be adopted. can.
 コアワイヤ41は、先端部がメッシュ部材の先端部および/または先端チップに接続され、基端が中空シャフトの基端よりも基端側に位置するようにメッシュ部材および中空シャフトの内部を通って延びる部材である。コアワイヤ41は、具体的には、例えば、先端部が先端チップ31に接合され、メッシュ部材11の内部(メッシュ部材11の内側の空間)および中空シャフト21の内腔21hを貫通し、基端が後述するコネクタ81の内腔81hから基端側に露出するように配置することができる。コアワイヤ41を長軸方向に沿って進退することで、メッシュ部材11を拡縮することができる。 The core wire 41 extends through the inside of the mesh member and the hollow shaft so that the tip is connected to the tip and / or the tip of the mesh member and the proximal end is located closer to the proximal end than the proximal end of the hollow shaft. It is a member. Specifically, for example, the tip of the core wire 41 is joined to the tip tip 31 and penetrates the inside of the mesh member 11 (the space inside the mesh member 11) and the lumen 21h of the hollow shaft 21, and the base end thereof. It can be arranged so as to be exposed from the lumen 81h of the connector 81, which will be described later, to the proximal end side. The mesh member 11 can be expanded or contracted by moving the core wire 41 forward and backward along the long axis direction.
 コアワイヤ41を構成する材料としては、メッシュ部材11を確実に拡縮しかつコアワイヤ41自身の切断を防止する観点から、十分な剛性および引張強度を有していることが好ましい。このような材料としては、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 constituting the core wire 41 preferably has sufficient rigidity and tensile strength from the viewpoint of reliably expanding and contracting the mesh member 11 and preventing the core wire 41 itself from being cut. Examples of such a material include stainless steel such as SUS304, metal materials such as nickel-titanium alloy and cobalt-chromium alloy, and the like.
 コアワイヤ41と、先端チップ31および/またはメッシュ部材11との接合方法としては、例えば、コアワイヤ41の先端部を先端チップ31の基端部に溶着等で埋設する方法、および/またはコアワイヤ41の先端部とメッシュ部材11の先端部とを溶接する方法等を採用することができる。 As a method of joining the core wire 41 and the tip tip 31 and / or the mesh member 11, for example, a method of embedding the tip of the core wire 41 in the base end of the tip tip 31 by welding or the like, and / or the tip of the core wire 41. A method of welding the portion and the tip portion of the mesh member 11 can be adopted.
 誘導膜51は、メッシュ部材に取り付けられ、先端が先端チップの基端と中空シャフトの先端との間に位置する薄膜状の部材である。誘導膜51は、具体的には、例えば、先端がメッシュ部材11の最大拡径部11s(メッシュ部材11が拡径したときに外径が最も大きくなる部位)に位置し、基端が中空シャフト21の先端に位置するように配置することができる。誘導膜51によれば、例えば、メッシュ部材11の開口11aを通して受け入れた逆行性ガイドワイヤを中空シャフト21の先端の開口21aに向かって円滑に導くことができる。 The guide film 51 is a thin film-like member attached to a mesh member and whose tip is located between the base end of the tip tip and the tip of the hollow shaft. Specifically, for example, the tip of the inductive film 51 is located at the maximum diameter expansion portion 11s of the mesh member 11 (the portion where the outer diameter becomes the largest when the mesh member 11 is expanded), and the base end is a hollow shaft. It can be arranged so as to be located at the tip of 21. According to the guide film 51, for example, the retrograde guide wire received through the opening 11a of the mesh member 11 can be smoothly guided toward the opening 21a at the tip of the hollow shaft 21.
 誘導膜51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。 Examples of the material constituting the inductive film 51 include polyethylene, polyurethane, polyamide, polyamide elastomer, polyolefin, polyester, polyester elastomer and the like. Among these, polyurethane is preferable as the material from the viewpoint of improving the sliding property of the surface.
 誘導膜51は、その全体に亘ってメッシュ部材に接合されていてもよく、その一部(例えば、誘導膜の先端部)のみメッシュ部材に接合されていてもよい。誘導膜とメッシュ部材とを接合する方法としては、例えば、誘導膜を形成する材料を加熱溶融し、この溶融した材料中にメッシュ部材を浸漬して素線どうしを架橋(開口を閉塞)する方法、漏斗状のフィルムの先端側の開口部外周をメッシュ部材に溶着する方法等を採用することができる。 The guide film 51 may be bonded to the mesh member over the entire surface, or only a part thereof (for example, the tip portion of the guide film) may be bonded to the mesh member. As a method of joining the guide film and the mesh member, for example, a method of heating and melting the material forming the guide film and immersing the mesh member in the melted material to bridge the strands (close the opening). , A method of welding the outer periphery of the opening on the tip end side of the funnel-shaped film to the mesh member or the like can be adopted.
 本実施形態の誘導膜51は、先端がメッシュ部材11の最大拡径部11s(長軸方向の略中央部)に位置し、基端が中空シャフト21の先端に位置すると共に、メッシュ部材11の素線11w間を架橋(開口11aを閉塞)するように形成されている。 The tip of the guide film 51 of the present embodiment is located at the maximum diameter expansion portion 11s (substantially central portion in the major axis direction) of the mesh member 11, the base end is located at the tip of the hollow shaft 21, and the mesh member 11 It is formed so as to bridge (close the opening 11a) between the strands 11w.
 第1のマーカ61および第2のマーカ71は、放射線不透過性のマーカである。第1のマーカ61および第2のマーカ71は、メッシュ部材11、中空シャフト21、先端チップ31、コアワイヤ41、および誘導膜51のうち、コアワイヤ41によるメッシュ部材11の拡径度合いに対応して第1のマーカと第2のマーカとの距離が変化する、互いに異なるいずれかの部材に取り付けられている。 The first marker 61 and the second marker 71 are radiation opaque markers. The first marker 61 and the second marker 71 are the mesh member 11, the hollow shaft 21, the tip tip 31, the core wire 41, and the guide film 51, which correspond to the degree of expansion of the mesh member 11 by the core wire 41. It is attached to any member different from each other in which the distance between the marker 1 and the marker 2 changes.
 第1のマーカ61を取り付ける部材としては、例えば、誘導膜、中空シャフト等が挙げられる。第1のマーカを誘導膜に取り付ける場合、第1のマーカは、例えば、誘導膜の一部に設けてもよく、誘導膜の全体に亘ってに設けてもよい。第1のマーカを中空シャフトに取り付ける場合、第1のマーカは、例えば、中空シャフトの特定の部位に設けてもよく、中空シャフトの全体に亘って設けてもよい。 Examples of the member to which the first marker 61 is attached include an induction film, a hollow shaft, and the like. When the first marker is attached to the induction membrane, the first marker may be provided, for example, on a part of the induction membrane or may be provided over the entire induction membrane. When the first marker is attached to the hollow shaft, the first marker may be provided at a specific portion of the hollow shaft, for example, or may be provided over the entire hollow shaft.
 第2のマーカ71を取り付ける部材としては、例えば、先端チップ、コアワイヤ、メッシュ部材、中空シャフト等が挙げられる。第1のマーカ61を誘導膜に取り付ける場合、第2のマーカ71は、例えば、先端チップおよび/またはコアワイヤに設けてもよい。第1のマーカ61を中空シャフトに取り付ける場合、第2のマーカ71は、例えば、先端チップおよび/またはコアワイヤに設けてもよい。 Examples of the member to which the second marker 71 is attached include a tip tip, a core wire, a mesh member, a hollow shaft, and the like. When the first marker 61 is attached to the inductive membrane, the second marker 71 may be provided, for example, on the tip and / or core wire. When the first marker 61 is attached to the hollow shaft, the second marker 71 may be provided, for example, on the tip tip and / or the core wire.
 第1のマーカ61および第2のマーカ71それぞれは、例えば、取り付けられる部材上の一部または全体に亘って固着(接着、溶着など)されていてもよく、上記部材中の一部または全体に亘って混入されていてもよい。固着する場合、例えば、放射線不透過性の物質を含有するロウ材をマーカとして用い、第2のマーカ71が取り付けられる部材に蝋付けすることで形成してもよい。混入する場合、例えば、放射線不透過性の物質を含有する微粒子をマーカとして用い、取り付けられる部材の内部に微粒子を分散することでマーカを形成してもよい。 Each of the first marker 61 and the second marker 71 may be fixed (adhesive, welded, etc.) over a part or the whole on the member to be attached, and may be fixed (adhesion, welding, etc.) to a part or the whole of the member. It may be mixed over. In the case of fixing, for example, a brazing material containing a radiation-impermeable substance may be used as a marker and formed by brazing to a member to which the second marker 71 is attached. In the case of mixing, for example, fine particles containing a radiation-impermeable substance may be used as a marker, and the marker may be formed by dispersing the fine particles inside the member to be attached.
 第1のマーカ61および第2のマーカ71に用いられる放射線不透過性材料としては、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。放射線不透過性材料は、放射線不透過性ではない物質の表面に放射線不透過性の物質をコートしたものなど、放射線不透過性ではない物質と放射線不透過性の物質とを組み合わせたものであってもよい。 Examples of the radiodensity permeable material used for the first marker 61 and the second marker 71 include gold, platinum, tungsten, or an alloy containing these elements (for example, platinum nickel alloy). The radiodensity material is a combination of a non-radiodensity substance and a radiodensity substance, such as a substance coated with a radiodensity substance on the surface of the substance that is not radiodensity. You may.
 第1のマーカ61は誘導膜51に取り付けられ、かつ第2のマーカ71はコアワイヤ41に取り付けられていることが好ましい。具体的には、例えば、図2Aに示すように、第2のマーカ71をコアワイヤ41上の一箇所に設けたり、図2Bに示すように、長軸方向に沿ってコアワイヤ41上の異なる複数箇所に第2のマーカ71を設けることができる。かかる場合、特定の第2のマーカ71が第1のマーカ61を横切る位置が、メッシュ部材11の最適な拡張状態に対応するように、第1および第2のマーカ61,71を配置するようにしてもよい。このように、第1のマーカ61が誘導膜51に、第2のマーカ71がコアワイヤ41にそれぞれ取り付けられることで、誘導膜51とコアワイヤ41との位置関係により、メッシュ部材11の拡張径を確実に把握することができる。 It is preferable that the first marker 61 is attached to the induction film 51 and the second marker 71 is attached to the core wire 41. Specifically, for example, as shown in FIG. 2A, a second marker 71 is provided at one location on the core wire 41, or as shown in FIG. 2B, a plurality of different locations on the core wire 41 along the long axis direction. A second marker 71 can be provided on the surface. In such a case, the first and second markers 61, 71 are arranged so that the position where the specific second marker 71 crosses the first marker 61 corresponds to the optimum expansion state of the mesh member 11. You may. In this way, the first marker 61 is attached to the guide film 51 and the second marker 71 is attached to the core wire 41, so that the expansion diameter of the mesh member 11 is ensured by the positional relationship between the guide film 51 and the core wire 41. Can be grasped.
 第1のマーカ61が誘導膜51に取り付けられる場合、第2のマーカ71は、長軸方向に沿ったコアワイヤ41の複数箇所に取り付けられ、第2のマーカ71のそれぞれは、メッシュ部材11の拡径度合いに対応するように配置されていることが好ましい。具体的には、図2Bに示すように、例えば、メッシュ部材11の拡張径(外径)の差分が等しくなるように、隣り合う第2のマーカ71、71の長軸方向における間隔を決定するようにしてもよい。これにより、視認される第1のマーカ61と第2のマーカ71との位置関係から、メッシュ部材11の拡張径を確実に把握することができる。 When the first marker 61 is attached to the guide film 51, the second marker 71 is attached to a plurality of positions of the core wire 41 along the major axis direction, and each of the second marker 71 expands the mesh member 11. It is preferable that they are arranged so as to correspond to the degree of diameter. Specifically, as shown in FIG. 2B, for example, the spacing in the major axis direction of the adjacent second markers 71 and 71 is determined so that the difference in the expansion diameter (outer diameter) of the mesh member 11 becomes equal. You may do so. As a result, the expanded diameter of the mesh member 11 can be reliably grasped from the positional relationship between the first marker 61 and the second marker 71 that are visually recognized.
 第1のマーカ61が誘導膜51に取り付けられる場合、第2のマーカ71は、長軸方向に沿ったコアワイヤ41の複数箇所に取り付けられ、これら複数箇所のうちの隣り合う第2のマーカ71、71どうしの間隔がいずれも等しいことも好ましい。具体的には、図2Cに示すように、例えば、長軸方向に沿ってコアワイヤ41上に等間隔で複数の第2のマーカ71それぞれを配置してもよい。これにより、たとえ複数の第2のマーカ71のうちの一部の第2のマーカ71が視認できないとしても、視認可能な第2のマーカ71により視認できない第2のマーカ71の位置を推測することができ、第1のマーカ61と、視認可能な若しくは推測された第2のマーカ71との位置関係から、メッシュ部材11の拡張径を正確に把握することができる。 When the first marker 61 is attached to the induction film 51, the second marker 71 is attached to a plurality of points of the core wire 41 along the major axis direction, and the second marker 71, which is adjacent to each other, is attached to the plurality of points. It is also preferable that the intervals between 71 are equal. Specifically, as shown in FIG. 2C, for example, a plurality of second markers 71 may be arranged at equal intervals on the core wire 41 along the major axis direction. As a result, even if a part of the second marker 71 out of the plurality of second markers 71 cannot be visually recognized, the position of the second marker 71 that cannot be visually recognized by the visible second marker 71 can be inferred. The expanded diameter of the mesh member 11 can be accurately grasped from the positional relationship between the first marker 61 and the visible or estimated second marker 71.
 コアワイヤ41に取り付けられるマーカ(第1のマーカまたは第2のマーカ)の外形は、楕円体形状であることが好ましい。具体的には、図3に示すように、例えば、放射線不透過性の物質を含有するロウ材を用い、コアワイヤ41表面を取り囲むように上記ロウ材を蝋付けすることで第2のマーカ71の外形を楕円体形状に形成(第2のマーカ711参照)することができる。これにより、例えば、逆行性ガイドワイヤを中空シャフト21内に受け入れる際、逆行性ガイドワイヤの端部がマーカに引っ掛かるのを防止することができ、逆行性ガイドワイヤを円滑に捕獲することができる。 The outer shape of the marker (first marker or second marker) attached to the core wire 41 is preferably an ellipsoidal shape. Specifically, as shown in FIG. 3, for example, a brazing material containing a radiation-impermeable substance is used, and the brazing material is brazed so as to surround the surface of the core wire 41 to form a second marker 71. The outer shape can be formed into an ellipsoidal shape (see the second marker 711). Thereby, for example, when the retrograde guide wire is received in the hollow shaft 21, the end portion of the retrograde guide wire can be prevented from being caught by the marker, and the retrograde guide wire can be smoothly captured.
 本実施形態では、第1のマーカ61として放射線不透過性の微粒子61aが用いられ、この微粒子61aが誘導膜51の全体に亘って分散されていると共に、第2のマーカ71としてロウ材が用いられ、複数の第2のマーカ711(71)がコアワイヤ41上の特定の部位に蝋付けされたカテーテル1が例示されている。 In the present embodiment, radiation-impermeable fine particles 61a are used as the first marker 61, and the fine particles 61a are dispersed throughout the induction film 51, and a brazing material is used as the second marker 71. The catheter 1 is exemplified in which a plurality of second markers 711 (71) are waxed to a specific site on the core wire 41.
 コネクタ81は、オペレータがカテーテル1を把持する部材である。このコネクタ81は、中空シャフト21の基端部に接続されており、内腔21hに連通する内腔81hと、内腔81hの基端に位置する開口81aとを有している。なお、コネクタ81の形態は、本発明の効果を損なわない限り特に限定されない。 The connector 81 is a member for which the operator grips the catheter 1. The connector 81 is connected to the base end portion of the hollow shaft 21 and has a lumen 81h communicating with the lumen 21h and an opening 81a located at the base end of the lumen 81h. The form of the connector 81 is not particularly limited as long as the effect of the present invention is not impaired.
 次に、カテーテル1の使用態様について説明する。なお、ここでは、血管内の閉塞物が存在する部位(以下、「閉塞部位」ともいう)に逆行性ガイドワイヤを通過させる手技について説明する。 Next, the usage mode of the catheter 1 will be described. Here, a procedure for passing a retrograde guide wire through a site where an obstruction is present in a blood vessel (hereinafter, also referred to as an “occluded site”) will be described.
 まず、順行性ガイドワイヤ(不図示)を血管内に挿入した後、血管に沿って閉塞部位まで順行性ガイドワイヤを押し進める。順行性ガイドワイヤの先端が閉塞部位に到達した後、順行性ガイドワイヤをガイドとしてバルーンカテーテル(不図示)を閉塞部位まで挿入し、バルーンを拡径させることによって閉塞部位を押し広げる。閉塞部位を押し広げた後、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, an antegrade guide wire (not shown) is inserted into the blood vessel, and then the antegrade guide wire is pushed along the blood vessel to the obstruction site. After the tip of the antegrade guide wire reaches the occlusion site, a balloon catheter (not shown) is inserted to the occlusion site using the antegrade guide wire as a guide, and the balloon is expanded in diameter to expand the occlusion site. After expanding the occluded area, the balloon is contracted and the balloon catheter is removed from the blood vessel.
 次に、順行性ガイドワイヤの基端が、先端チップ31の先端開口31aから内腔31h、メッシュ部材11の内側の空間、内腔21h、および内腔81hを通って開口81aを経てカテーテル1の外部に出るように、順行性ガイドワイヤをカテーテル1に挿通し、順行性ガイドワイヤ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11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 anterograde guide wire passes from the tip opening 31a of the tip tip 31 through the lumen 31h, the space inside the mesh member 11, the lumen 21h, and the lumen 81h, and passes through the opening 81a to the catheter 1. An anterograde guide wire is inserted into the catheter 1 so as to come out of the catheter 1, and the tip of the catheter 1 is pushed to the occlusion site in the blood vessel by using the anterograde guide wire as a guide. At this time, the catheter 1 is inserted into the blood vessel in a state where the mesh member 11 is reduced in diameter, and the diameter is maintained in the reduced state until the tip of the catheter 1 reaches the occlusion site.
 次に、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、カテーテル1に対して順行性ガイドワイヤを基端側に引っ張ることで順行性ガイドワイヤをカテーテル1から引き抜く。次いで、コネクタ81の開口81aから外部に露出しているコアワイヤ41の端部を基端側に向かって引っ張ると、図4A~図4Dに示すように、メッシュ部材11の先端と中空シャフト21の先端との間隔が図4A,図4B,図4C,図4Dの順で狭まり、メッシュ部材11が径方向外側に変形(膨出)して拡径する。この際、メッシュ部材11の拡径に伴ってメッシュ開口11aも拡張されるので、逆行性ガイドワイヤを受け入れやすい状態となる。本実施形態では、第1のマーカ61が誘導膜51に取り付けられ、かつ第2のマーカ71がコアワイヤ41に取り付けられているので、第1のマーカ61と第2のマーカ71とが所定の位置関係となるようにコアワイヤ41を引っ張ることで、メッシュ部材11の拡張径が調整される。なお、カテーテル1の先端が、順行性ガイドワイヤに沿って閉塞部位に到達した後、メッシュ部材11を径方向外側に拡径してから、順行性ガイドワイヤをカテーテル1から引き抜くようにしてもよい。 Next, after the tip of the catheter 1 reaches the occlusion site expanded by the balloon catheter, the antegrade guide wire is pulled out from the catheter 1 by pulling the antegrade guide wire toward the proximal end side with respect to the catheter 1. .. Next, when the end of the core wire 41 exposed to the outside is pulled from the opening 81a of the connector 81 toward the base end side, the tip of the mesh member 11 and the tip of the hollow shaft 21 are shown as shown in FIGS. 4A to 4D. The distance from the mesh member 11 is narrowed in the order of FIGS. 4A, 4B, 4C, and 4D, and the mesh member 11 is deformed (bulged) outward in the radial direction to expand the diameter. At this time, since the mesh opening 11a is also expanded as the diameter of the mesh member 11 is expanded, it becomes easy to accept the retrograde guide wire. In the present embodiment, since the first marker 61 is attached to the induction film 51 and the second marker 71 is attached to the core wire 41, the first marker 61 and the second marker 71 are positioned at predetermined positions. By pulling the core wire 41 so as to be related, the expansion diameter of the mesh member 11 is adjusted. After the tip of the catheter 1 reaches the obstruction site along the antegrade guide wire, the mesh member 11 is expanded radially outward, and then the antegrade guide wire is pulled out from the catheter 1. May be good.
 次に、先端側から向かって来る逆行性ガイドワイヤカテーテル1に受け入れる。逆行性ガイドワイヤ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であってもよい。逆行性ガイドワイヤRGWは、拡径したメッシュ部材11のメッシュ開口11aを通してメッシュ部材11の内側の空間に受け入れられた後、中空シャフト21先端の開口21aを介してこの中空シャフト21の内腔21hに受け入れられる(図4参照)。次いで、逆行性ガイドワイヤは、例えば、中空シャフト21の中途に設けられたポート21p(図1参照)を介し、その一端が体外に引き出される。 Next, accept it in the retrograde guide wire catheter 1 coming from the distal end side. As the path to which the retrograde guide wire is directed, for example, a false cavity in the blood vessel wall surrounding the obstruction site, a through hole penetrating the obstruction site, etc. are assumed, but the retrograde guide wire from any of the routes can be used. There may be. The retrograde guide wire RGW is accepted into the space inside the mesh member 11 through the mesh opening 11a of the expanded mesh member 11, and then enters the lumen 21h of the hollow shaft 21 via the opening 21a at the tip of the hollow shaft 21. Accepted (see Figure 4). Next, one end of the retrograde guide wire is pulled out of the body via, for example, a port 21p (see FIG. 1) provided in the middle of the hollow shaft 21.
 以上のように、カテーテル1は、上記構成であるので、コアワイヤ41の操作に伴うメッシュ部材11の拡張径を確実に把握することができる。その結果、例えば、コアワイヤ41が過度に引っ張られてメッシュ部材11の先端部および/または先端チップ31から破断するのを防止することができる。 As described above, since the catheter 1 has the above configuration, it is possible to reliably grasp the expansion diameter of the mesh member 11 accompanying the operation of the core wire 41. As a result, for example, it is possible to prevent the core wire 41 from being excessively pulled and broken from the tip portion and / or the tip tip 31 of the mesh member 11.
[第2の実施形態]
 図4は、第1の実施形態を示す概略的側面図であって、メッシュ部材が縮径状態の図である。当該カテーテル2は、図5に示すように、概略的に、メッシュ部材11と、中空シャフト21と、先端チップ31と、コアワイヤ41と、誘導膜52と、第1のマーカ62と、第2のマーカ71と、コネクタ81とにより構成されている。カテーテル2は、誘導膜52および第1のマーカ62が第1の実施形態と異なっている。なお、メッシュ部材11、中空シャフト21、先端チップ31、コアワイヤ41、第1のマーカ71およびコネクタ81の構成は、第1の実施形態のものと同様であるので、同一部位には同一符号を付してその詳細な説明は省略する。また、以下に示す誘導膜52および第1のマーカ62の構成以外の構成、およびカテーテル2の使用態様は、それぞれ第1の実施形態と同様であるので、その詳細な説明は省略する。
[Second Embodiment]
FIG. 4 is a schematic side view showing the first embodiment, and is a view in which the mesh member has a reduced diameter. As shown in FIG. 5, the catheter 2 generally includes a mesh member 11, a hollow shaft 21, a tip tip 31, a core wire 41, an induction film 52, a first marker 62, and a second marker. It is composed of a marker 71 and a connector 81. Catheter 2 is different from the first embodiment in that the induction membrane 52 and the first marker 62 are different from the first embodiment. Since the configurations of the mesh member 11, the hollow shaft 21, the tip tip 31, the core wire 41, the first marker 71, and the connector 81 are the same as those in the first embodiment, the same parts are designated by the same reference numerals. The detailed description thereof will be omitted. Further, since the configurations other than the configurations of the induction membrane 52 and the first marker 62 and the usage mode of the catheter 2 shown below are the same as those of the first embodiment, detailed description thereof will be omitted.
 誘導膜52は、メッシュ部材に取り付けられ、先端が先端チップの基端と中空シャフトの先端との間に位置する部材である。本実施形態の誘導膜52は、先端がメッシュ部材11の最大拡径部11s(長軸方向の略中央部)に位置し、基端が中空シャフト21の先端に位置すると共に、メッシュ部材11の素線11w間を架橋(開口11aを閉塞)するように形成されている。なお、誘導膜52には、放射線不透過性の材料で形成されたマーカ(例えば、カテーテル1にて例示した第1のマーカ61a(微粒子)など)が含まれていない。 The guide film 52 is a member that is attached to a mesh member and whose tip is located between the base end of the tip tip and the tip of the hollow shaft. The tip of the guide film 52 of the present embodiment is located at the maximum diameter expansion portion 11s (substantially central portion in the major axis direction) of the mesh member 11, the base end is located at the tip of the hollow shaft 21, and the mesh member 11 It is formed so as to bridge (close the opening 11a) between the strands 11w. The induction membrane 52 does not include a marker formed of a radiation-impermeable material (for example, the first marker 61a (fine particles) exemplified in the catheter 1).
 第1のマーカ62は、放射線不透過性のマーカである。カテーテル2では、第1のマーカ62が中空シャフト21に取り付けられている。第1のマーカ62の取り付け位置としては、例えば、中空シャフト21先端の開口21aを取り巻くように中空シャフト21の先端部の周方向に沿って設けてもよく、中空シャフト21の長軸方向における中途に設けてもよい。 The first marker 62 is a radiation opaque marker. In the catheter 2, the first marker 62 is attached to the hollow shaft 21. The mounting position of the first marker 62 may be, for example, provided along the circumferential direction of the tip of the hollow shaft 21 so as to surround the opening 21a at the tip of the hollow shaft 21, and may be provided halfway in the long axis direction of the hollow shaft 21. It may be provided in.
 第1のマーカ62が中空シャフト21に取り付けられる場合、第2のマーカは、メッシュ部材、先端チップ、コアワイヤ、および誘導膜のうちのいずれかに取り付けられることが好ましい。これにより、中空シャフトと他の部材との位置関係に基づいてメッシュ部材の拡張径を確実に把握することができる。 When the first marker 62 is attached to the hollow shaft 21, the second marker is preferably attached to any of a mesh member, a tip tip, a core wire, and an inductive membrane. This makes it possible to reliably grasp the expanded diameter of the mesh member based on the positional relationship between the hollow shaft and other members.
 本実施形態では、第1のマーカ62は、中空シャフト21の先端部における開口21a周囲に蝋付けされている。第2のマーカ71は、そのうちの少なくとも1つが第1のマーカ62よりも先端側から基端側に移動できるように、長軸方向に沿ってコアワイヤ41上の異なる部位に複数個取り付けられている。 In the present embodiment, the first marker 62 is brazed around the opening 21a at the tip of the hollow shaft 21. A plurality of second markers 71 are attached to different portions on the core wire 41 along the major axis direction so that at least one of them can move from the distal end side to the proximal end side with respect to the first marker 62. ..
 このようなカテーテル2においては、例えば、メッシュ部材11が縮径している状態(図6A参照)から、コアワイヤ41を基端側に向かって引っ張る際、複数の第2のマーカ71のうちの特定のマーカ(例えば、第2のマーカ71のうちの長軸方向の中央に位置するマーカ71など)が第1のマーカ62を横切ったときにメッシュ部材11が最適な拡張状態(図6B参照)になるように、第2のマーカ71を配置してもよい。これにより、特定の第2のマーカ71が第1のマーカ62よりも基端側に移動することで、メッシュ部材11が特定の拡張径(例えば、拡張可能な最大径)に達したことを容易かつ確実に把握することができる。 In such a catheter 2, for example, when the core wire 41 is pulled toward the proximal end side from the state where the mesh member 11 is reduced in diameter (see FIG. 6A), the identification of the plurality of second markers 71. When the marker (for example, the marker 71 located in the center of the second marker 71 in the long axis direction) crosses the first marker 62, the mesh member 11 is in the optimum expanded state (see FIG. 6B). The second marker 71 may be arranged so as to be. As a result, it is easy for the mesh member 11 to reach a specific expansion diameter (for example, the maximum expandable diameter) by moving the specific second marker 71 closer to the proximal end side than the first marker 62. And it can be surely grasped.
 以上のように、カテーテル2は、上記構成であるので、コアワイヤ41の操作に伴うメッシュ部材11の拡張径を確実に把握することができる。 As described above, since the catheter 2 has the above configuration, it is possible to reliably grasp the expansion diameter of the mesh member 11 accompanying the operation of the core wire 41.
 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。 It should be noted that the present invention is not limited to the configuration of the above-described embodiment, but is indicated by the scope of claims, and is intended to include all modifications within the meaning and scope equivalent to the scope of claims. Will be done.
 例えば、第1の実施形態では、第1のマーカ61が誘導膜51の全体に亘って設けられ、かつ第2のマーカ71がコアワイヤ41上の異なる部位に複数設けられたカテーテル1について説明した。また、第2の実施形態では、第1のマーカ62が中空シャフト21の先端部に設けられ、かつ第2のマーカ71がコアワイヤ41上の異なる部位に複数設けられたカテーテル2について説明した。しかしながら、第1のマーカおよび第2のマーカは、コアワイヤによるメッシュ部材の拡径度合いに対応して第1のマーカと第2のマーカとの距離が変化する互いに異なる部材に取り付けられていればよい。例えば、第1のマーカが誘導膜に設けられる場合、第2のマーカは、メッシュ部材のうちの第1のマーカが取り付けられていない部位、中空シャフト、先端チップ、および誘導膜のうちの第1のマーカが取り付けられていない部位、のいずれであってもよい。また、第1のマーカが中空シャフトに設けられる場合、第2のマーカは、メッシュ部材、先端チップ、コアワイヤ、および誘導膜のいずれであってもよい。 For example, in the first embodiment, the catheter 1 in which the first marker 61 is provided over the entire induction membrane 51 and the second marker 71 is provided in a plurality of different sites on the core wire 41 has been described. Further, in the second embodiment, the catheter 2 in which the first marker 62 is provided at the tip of the hollow shaft 21 and the second marker 71 is provided at a plurality of different parts on the core wire 41 has been described. However, the first marker and the second marker may be attached to different members whose distances between the first marker and the second marker change according to the degree of expansion of the mesh member by the core wire. .. For example, when the first marker is provided on the inductive membrane, the second marker is the first of the mesh members to which the first marker is not attached, the hollow shaft, the tip tip, and the inductive membrane. It may be any of the parts where the marker is not attached. Further, when the first marker is provided on the hollow shaft, the second marker may be any of a mesh member, a tip tip, a core wire, and an inductive membrane.
 また、第1の実施形態では、第1のマーカ61が誘導膜51の全体に亘って設けられているカテーテル1について説明した。しかしながら、誘導膜に設けられるマーカは、誘導膜の内部および/または誘導膜上の一部であってもよい。この場合、マーカは、長軸に直交する一つの円環状、または長軸に直交しかつ所定の間隔で配置された二以上の円環状に設けてもよい。また、マーカは、一つの領域、または二以上の領域に設けてもよい。 Further, in the first embodiment, the catheter 1 in which the first marker 61 is provided over the entire induction membrane 51 has been described. However, the marker provided on the induction membrane may be inside and / or part of the induction membrane. In this case, the marker may be provided in one annular shape orthogonal to the major axis, or in two or more annular rings orthogonal to the major axis and arranged at predetermined intervals. Further, the marker may be provided in one area or two or more areas.
 また、上述した第1の実施形態では、コアワイヤ41に設けられた第2のマーカ71の外形が楕円体形状(第2のマーカ711)であるカテーテル1について説明した。しかしながら、コアワイヤ41に設けられるマーカの形状は、例えば、コアワイヤ41の一部と同一の形状(コアワイヤ41の一部に放射線不透過性の材料が含まれている形状)であってもよく(図7Aのマーカ731参照)、先端側に向かって先細る形状であってもよく(図7Bのマーカ732参照)、コアワイヤ41の外周を覆う円筒形状であってもよい(図7Cのマーカ733参照)。 Further, in the above-mentioned first embodiment, the catheter 1 in which the outer shape of the second marker 71 provided on the core wire 41 has an ellipsoidal shape (second marker 711) has been described. However, the shape of the marker provided on the core wire 41 may be, for example, the same shape as a part of the core wire 41 (a shape in which a part of the core wire 41 contains a radiation-impermeable material). 7A may have a shape that tapers toward the tip side (see marker 732 in FIG. 7B), or may have a cylindrical shape that covers the outer periphery of the core wire 41 (see marker 733 in FIG. 7C). ..
 1,2 カテーテル
 11 メッシュ部材
 21 中空シャフト
 31 先端チップ
 41 コアワイヤ
 51,52 誘導膜
 61,62 第1のマーカ
 71 第2のマーカ
1,2 Catheter 11 Mesh member 21 Hollow shaft 31 Tip tip 41 Core wire 51,52 Induction membrane 61,62 First marker 71 Second marker

Claims (7)

  1.  径方向に拡縮可能なチューブ状のメッシュ部材と、
     前記メッシュ部材の基端部に接続された中空シャフトと、
     前記メッシュ部材の先端部に接続された中空の先端チップと、
     先端部が前記メッシュ部材の先端部および/または前記先端チップに接続され、基端が前記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中空シャフトの内部を通って延びるコアワイヤと、
     前記メッシュ部材に取り付けられ、先端が前記先端チップの基端と前記中空シャフトの先端との間に位置する誘導膜と、
     前記メッシュ部材、前記中空シャフト、前記先端チップ、前記コアワイヤ、および前記誘導膜のうちのいずれかに取り付けられた放射線不透過性の第1のマーカおよび第2のマーカと、を備え、
     前記第1のマーカおよび第2のマーカは、前記コアワイヤによる前記メッシュ部材の拡径度合いに対応して前記第1のマーカと第2のマーカとの距離が変化する互いに異なる部材に取り付けられているカテーテル。
    A tubular mesh member that can be expanded and contracted in the radial direction,
    A hollow shaft connected to the base end of the mesh member,
    A hollow tip connected to the tip of the mesh member,
    The tip portion is connected to the tip portion of the mesh member and / or the tip tip, and passes through the inside of the mesh member and the hollow shaft so that the proximal end is located closer to the proximal end side than the proximal end of the hollow shaft. With the extending core wire,
    An induction film attached to the mesh member and having a tip located between the base end of the tip and the tip of the hollow shaft.
    A radiation opaque first marker and a second marker attached to any of the mesh member, the hollow shaft, the tip tip, the core wire, and the induction membrane.
    The first marker and the second marker are attached to different members whose distances between the first marker and the second marker change according to the degree of expansion of the mesh member by the core wire. catheter.
  2.  前記第1のマーカは前記誘導膜に取り付けられ、かつ前記第2のマーカは前記コアワイヤに取り付けられている請求項1に記載のカテーテル。 The catheter according to claim 1, wherein the first marker is attached to the induction membrane, and the second marker is attached to the core wire.
  3.  前記第2のマーカは、長軸方向に沿った前記コアワイヤの複数箇所に取り付けられており、
     前記複数箇所のそれぞれは、前記メッシュ部材の拡径度合いに対応するように配置されている請求項2に記載のカテーテル。
    The second marker is attached to a plurality of points of the core wire along the long axis direction.
    The catheter according to claim 2, wherein each of the plurality of locations is arranged so as to correspond to the degree of expansion of the mesh member.
  4.  前記第2のマーカは、長軸方向に沿った前記コアワイヤの複数箇所に取り付けられており、
     前記複数箇所のうちの隣り合う第2のマーカどうしの間隔がいずれも等しい請求項2に記載のカテーテル。
    The second marker is attached to a plurality of points of the core wire along the long axis direction.
    The catheter according to claim 2, wherein the intervals between the second markers adjacent to each other at the plurality of locations are the same.
  5.  前記第1のマーカは前記中空シャフトに取り付けられ、かつ前記第2のマーカは、前記メッシュ部材、前記先端チップ、前記コアワイヤ、および前記誘導膜のうちのいずれかに取り付けられている請求項1に記載のカテーテル。 15. The first marker is attached to the hollow shaft, and the second marker is attached to any one of the mesh member, the tip tip, the core wire, and the induction film. The catheter described.
  6.  前記第2のマーカは前記コアワイヤに取り付けられており、
     前記第2のマーカが前記第1のマーカよりも先端側から基端側に移動可能である請求項5に記載のカテーテル。
    The second marker is attached to the core wire and
    The catheter according to claim 5, wherein the second marker is movable from the distal end side to the proximal end side with respect to the first marker.
  7.  前記コアワイヤに取り付けられる第1のマーカまたは第2のマーカの外形は、楕円体形状である請求項1から請求項6のいずれか一項に記載のカテーテル。 The catheter according to any one of claims 1 to 6, wherein the outer shape of the first marker or the second marker attached to the core wire is an ellipsoidal shape.
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JP2009082566A (en) * 2007-10-01 2009-04-23 Kaneka Corp Catheter
WO2018193601A1 (en) * 2017-04-20 2018-10-25 朝日インテック株式会社 Catheter
WO2019234797A1 (en) * 2018-06-04 2019-12-12 朝日インテック株式会社 Catheter
JP2020062319A (en) * 2018-10-19 2020-04-23 朝日インテック株式会社 catheter

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