WO2020250934A1 - Cathéter - Google Patents

Cathéter Download PDF

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Publication number
WO2020250934A1
WO2020250934A1 PCT/JP2020/022857 JP2020022857W WO2020250934A1 WO 2020250934 A1 WO2020250934 A1 WO 2020250934A1 JP 2020022857 W JP2020022857 W JP 2020022857W WO 2020250934 A1 WO2020250934 A1 WO 2020250934A1
Authority
WO
WIPO (PCT)
Prior art keywords
tip
hollow shaft
mesh member
core wire
base end
Prior art date
Application number
PCT/JP2020/022857
Other languages
English (en)
Japanese (ja)
Inventor
雄太 中川
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
Publication of WO2020250934A1 publication Critical patent/WO2020250934A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes

Definitions

  • This disclosure relates to catheters.
  • CTO chronic complete occlusion
  • the obstruction is removed at a site where the obstruction in the blood vessel exists. Therefore, there is one that extends the mesh-like wire in the radial direction (see, for example, Patent Document 1).
  • a medical device that operates the tip portion according to the operator's will by using the operation wire at hand (see, for example, Patent Document 2).
  • the tip of the operation wire is joined to the rear end tip.
  • An object of the present disclosure is to provide a catheter capable of suppressing breakage of a joint portion between an operation wire (core wire in the present disclosure) and a member (tip tip in the present disclosure) to be joined to the operation wire.
  • the catheter according to one embodiment of the present disclosure is configured such that a first hollow shaft and a proximal end are joined to the tip of the first hollow shaft and expand or contract in the radial direction.
  • a second hollow shaft located between the tip and the base end of the mesh member and extending the inside of the mesh member toward the tip side, the tip of the mesh member, the tip of the core wire, and the second hollow shaft.
  • a tip tip having a joint portion for joining with and is provided.
  • the tip portion of the second hollow shaft, the tip portion of the core wire, and the tip portion of the mesh member may be arranged in this order from the inside to the outside in the radial direction.
  • the tip of the core wire may be formed with a recess or a through hole into which a part of the second hollow shaft enters.
  • the position of the tip of the mesh member and the position of the tip of the core wire may be deviated from each other.
  • the present disclosure can provide a catheter capable of suppressing breakage of a joint portion between a core wire and a tip.
  • FIG. 1 It is a schematic cross-sectional view of the catheter which concerns on embodiment of this disclosure, and is the figure which shows the state which the mesh member contracted. It is a schematic cross-sectional view of a catheter, and is the figure which shows the state which the mesh member expanded.
  • (A) is a schematic cross-sectional view showing a joined state of a mesh member, a tip tip, a second hollow shaft, and a core wire
  • (b) is a cross-sectional view taken along line bb of (a). It is a figure which shows the modification of the core wire.
  • the "forward guide wire” means the guide wire which is pushed to the operative part such as the occluded part in the blood vessel prior to the catheter, and is “retrograde guide wire”.
  • the "tip side” refers to a direction along the longitudinal direction of the catheter in which the tip tip is located with respect to the mesh member.
  • the “base end side” refers to a direction along the longitudinal direction and opposite to the tip end side.
  • the “tip” refers to the distal end of each member constituting the catheter.
  • the “base end” refers to the end portion of each member constituting the catheter on the base end side.
  • FIG. 1 is a schematic cross-sectional view of the catheter 1 according to the embodiment of the present disclosure, showing a state in which the mesh member 20 is contracted.
  • 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 (hand side, proximal side) operated by an operator such as a doctor.
  • FIG. 2 is a schematic cross-sectional view of the catheter 1 and shows a state in which the mesh member 20 is expanded.
  • the catheter 1 includes a first hollow shaft 10, a mesh member 20, a tip tip 30, a second hollow shaft 40, a core wire 50, a marker 60, and a connector 70. ..
  • the first hollow shaft 10 has a tip end side shaft 11 and a base end side shaft 12.
  • the tip of the tip-side shaft 11 is connected to the base end of the mesh member 20.
  • the tip of the base end side shaft 12 is connected to the base end of the tip end side shaft 11.
  • a connector 70 is connected to the base end of the base end side shaft 12.
  • the tip side shaft 11 has a lumen 13 for inserting an antegrade guide wire (not shown), a retrograde guide wire W2 (FIG. 2), and a core wire 50 inside.
  • the base end side shaft 12 has a lumen 14 for inserting the core wire 50 inside.
  • the distal end side shaft 11 and the proximal end side shaft 12 form a guide wire port 15 that opens toward the proximal end side.
  • the retrograde guide wire W2 is delivered to the outside of the catheter 1 via the guide wire port 15.
  • the material constituting the first hollow shaft 10 since the first hollow shaft 10 is inserted into the blood vessel, it is preferable to have antithrombotic property, flexibility and biocompatibility, and a resin material or a resin material or Metal materials can be mentioned. Since the tip end side 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 and the like can be adopted. Since the base end side shaft 12 is required to have pushability, a metal material is preferable. For example, stainless steel such as SUS304, nickel titanium alloy, cobalt chrome alloy and the like can be adopted.
  • the mesh member 20 is a tubular member that can expand or contract in the radial direction.
  • the core wire 50 which will be described later, is pulled toward the proximal end side, the mesh member 20 expands in diameter by being deformed out of the plane and bulging outward in the radial direction, as shown in FIG.
  • the retrograde guide wire W2 is received by the catheter 1 through the opening of the member 20.
  • the mesh member 20 is formed so that a plurality of strands 21 are woven in a grid pattern to form a tube as a whole. Further, the mesh member 20 has an opening between the knitted adjacent strands, and receives the retrograde guide wire W2 through the enlarged opening when the diameter is expanded.
  • the tip tip 30 and the first hollow shaft 10 are joined to the tip end and the base end of each of the strands 21 constituting the mesh member 20, respectively.
  • each wire 21 constituting the mesh member 20 can adopt either a single wire or a plurality of wires, for example, from a stranded wire in which a plurality of metal wires having different wire diameters are twisted together. It may be formed.
  • a metal material or a resin material can be adopted as the material constituting each wire 21 of the mesh member 20.
  • the resin material include polyamide, polyester, polyarylate, and polyetheretherketone. 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, cobalt chromium alloy and the like.
  • the strands 21 may be made of the same material or different materials.
  • each wire 21 of the mesh member 20 may be a radiation opaque material from the viewpoint of improving the visibility of the mesh member 20.
  • the radiation opaque material include gold, platinum, tungsten, and alloys containing these elements (for example, platinum-nickel alloy).
  • the radiation-impermeable material may be a combination of the radiation-impermeable material and a material other than this material, such as a material coated on the surface of a material that is not radiation-impermeable.
  • the mesh member 20 is provided with an induction film 22, and the tip of the induction film 22 is located between the base end of the tip tip 30 and the tip end of the first hollow shaft 10.
  • the guide film 22 smoothly guides the retrograde guide wire W2 (FIG. 2) received through the opening of the mesh member 20 toward the first hollow shaft 10.
  • the tip of the guide film 22 is located substantially at the center of the mesh member 20 in the major axis direction, and the base end is located at the tip of the first hollow shaft 10.
  • the induction film 22 is formed on the mesh member 20 so as to crosslink the adjacent strands.
  • the retrograde guide wire W2 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. Be taken.
  • the guide film 22 may be in the form of a film (not shown), for example, as long as at least a part (for example, the outer periphery of the tip of the guide film 22) is bonded to the mesh member 20.
  • Examples of the material constituting the induction film 22 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.
  • the method for forming the guide film 22 is not particularly limited, and for example, a dip method is used for the guide film arranged on the mesh member 20, and a method for fusing the tip of the film to the mesh member 20 is used for the film-like guide film. Can be adopted.
  • the tip tip 30 has a substantially cylindrical shape and is provided on the tip side of the mesh member 20. Specifically, the tip tip 30 is formed in a sharp shape toward the tip side so that the catheter 1 can easily proceed in the blood vessel.
  • the catheter 1 has flexibility because it travels in the blood vessel.
  • the material having such flexibility include resin materials such as nylon (polyamide), polyurethane, and polyurethane elastomer.
  • the base end of the second hollow shaft 40 is located between the tip end of the mesh member 20 and the base end, and the inside of the mesh member 20 extends toward the tip end side.
  • the outer diameter of the second hollow shaft 40 is slightly smaller than the inner diameter of the tip tip 30.
  • the tip 41 of the second hollow shaft 40 is inserted into the tip 30.
  • the second hollow shaft 40 has the tip and the tip of the first hollow shaft 10 in the space inside the mesh member 20 in a state where the mesh member 20 has a diameter expanded outward in the radial direction. It is configured to be located between the base end of the chip 30. This is to facilitate accepting the retrograde guide wire W2 in the first hollow shaft 10.
  • the material constituting the second hollow shaft 40 since the second hollow shaft 40 is also inserted into the blood vessel in the same manner as the first hollow shaft 10 described above, antithrombotic property, flexibility and biocompatibility are improved. 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 tip of the core wire 50 is connected to the tip tip 30, and the base end extends to the outside of the connector 70 located on the base end side of the first hollow shaft 10. Therefore, the core wire 50 penetrates the lumens 13 and 14 of the mesh member 20 and the first hollow shaft 10 and the through hole 71 of the connector 70.
  • the core wire 50 moves forward and backward in the major axis direction, and the mesh member 20 expands and contracts in the radial direction.
  • the marker 60 has a substantially annular shape or a substantially C shape in cross-sectional view, and covers the second hollow shaft 40 and the core wire 50.
  • the marker 60 allows the base end of the second hollow shaft 40 to move together without being separated from the core wire 50.
  • the marker 60 is formed of a resin material such as polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, or fluororesin, or a metal material such as stainless steel such as SUS304, nickel titanium alloy, or cobalt-chromium alloy.
  • a resin material such as polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, or fluororesin
  • a metal material such as stainless steel such as SUS304, nickel titanium alloy, or cobalt-chromium alloy.
  • a radiation-impermeable material such as bismuth trioxide, tungsten, or barium sulfate
  • a radiation-impermeable material such as platinum or tungsten. Is preferable.
  • the marker 60 is preferably located near the tip of the induction film 22 when the mesh member 20 is expanded.
  • the connector 70 is a member for which the operator grips the catheter 1. As shown in FIG. 1, the connector 70 is connected to the base end of the first hollow shaft 10, and is a through hole that communicates with the lumens 13 and 14 of the first hollow shaft 1 so that the core wire 50 can be exposed to the outside. It has a 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 any shape may be used as long as it is easy for the operator to grasp.
  • FIG. 3A is a schematic cross-sectional view showing a joined state of the mesh member 20, the tip tip 30, the second hollow shaft 40, and the core wire 50
  • FIG. 3B is a schematic cross-sectional view taken along line bb of FIG. It is a cross-sectional view.
  • the tip tip 30 has a base portion 31, a first joint portion 32, and a second joint portion 33.
  • the base portion 31, the first joint portion 32, and the second joint portion 33 may all be made of the same resin material, or may be made of different resin materials.
  • the base portion 31, the first joint portion 32, and the second joint portion 33 may be made of urethane
  • the base portion 31 may be made of urethane
  • the first joint portion 32 and the second joint portion 33 may be made of nylon. May be good.
  • the portions in contact with each other are welded. Therefore, the base portion 31, the first joint portion 32, and the second joint portion 33 are integrated.
  • the base portion 31 has a base end portion 31A and a tip portion 31B, and constitutes a tip portion and an intermediate portion of the tip tip 30.
  • the first joint portion 32 has a base end portion 32A and a tip end portion 32B.
  • the tip portion 32B of the first joint portion 32 covers the outer circumference of the base end portion 31A of the base portion 31, and the base end portion 32A of the first joint portion 32 is closer to the base end portion 31A than the base end portion 31A of the base portion 31.
  • the second joint portion 33 is located on the base end side of the base portion 31 and inside the base end portion 32A of the first joint portion 32.
  • the base end portion 31A, the first joint portion 32, and the second joint portion 33 of the base portion 31 correspond to the joint portion of the tip tip 30.
  • the tip portion 41 of the second hollow shaft 40, the tip portion 51 of the core wire 50, and the tip portion 23 of the mesh member 20 are arranged in contact with each other and overlapped from the inside to the outside in the radial direction. .. Then, the tip portion 23 of the mesh member 20, the tip portion 51 of the core wire 50, and the second hollow shaft 40 are joined to each other by the joint portion of the tip tip 30. A part of the inner circumference of the base end portion 31A of the base portion 31 and the inner circumference of the second joint portion 33 are welded to a part of the second hollow shaft 40. In this way, the tip portion 23 of the mesh member 20, the tip portion 51 of the core wire 50, and the second hollow shaft 40 are integrated by the joint portion of the tip tip 30.
  • a plurality of recesses 52 are formed in the tip portion 51 of the core wire 50.
  • a part of the second hollow shaft 40 is inserted into each recess 52. That is, the second hollow shaft 40 has a convex portion that enters each concave portion 52.
  • the position of the tip of the mesh member 20 and the position of the tip of the core wire 50 are deviated from each other.
  • the tip of the core wire 50 is located closer to the tip than the tip of the mesh member 20.
  • an antegrade guide wire W1 (not shown) is inserted into a blood vessel, for example, and then pushed along the blood vessel to a site where an obstruction exists (hereinafter, also referred to as an “occluded site”).
  • a balloon catheter (not shown) is inserted to the occluded site using the antegrade guide wire W1 as a guide, and the balloon is expanded to expand the occluded site. .. After expanding the occluded area, the balloon is contracted and the balloon catheter is removed from the blood vessel.
  • the base end of the antegrade guide wire W1 is from the opening of the tip tip 30, the through hole of the tip tip 30 and the second hollow shaft 40, the space inside the mesh member 20, and the lumen 13 of the tip side shaft 11.
  • the antegrade guide wire W1 is inserted into the catheter 1 so as to pass through the guide wire port 15 and exit the catheter 1.
  • the tip of the catheter 1 is pushed into the blood vessel to the occluded site expanded by the balloon catheter.
  • the catheter 1 is inserted into the blood vessel with the mesh member 20 reduced in diameter, and maintains the reduced diameter until the tip of the catheter 1 reaches the occlusion site.
  • the antegrade guide wire W1 is pulled out from the catheter 1 by pulling the antegrade guide wire W1 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 It deforms out of the plane and expands its diameter.
  • the tip of the guiding film 22 is joined to the substantially central portion in the major axis direction of the mesh member 20, the guiding film 22 is expanded in diameter following the expansion of the mesh member 20 to guide the mesh member 20.
  • the film 22 has a funnel shape as a whole. Since the opening is also expanded as the diameter of the mesh member 20 is increased, the retrograde guide wire W2 is easily accepted. Further, since the base end of the second hollow shaft 40 is restrained by the core wire 50 by the marker 60, the second hollow shaft 40 does not tilt and moves along the long axis direction (longitudinal direction) of the catheter 1. .. After the tip of the catheter 1 reaches the occlusion site along the antegrade guide wire W1, the diameter of the mesh member 20 is expanded, and then the antegrade guide wire W1 is pulled toward the proximal end side to antegrade. The sex guide wire W1 may be pulled out from the catheter 1.
  • the retrograde guide wire W2 coming from the distal end side is received in the catheter 1.
  • a false cavity in the blood vessel wall surrounding the occlusion site, a through hole penetrating the occlusion site, or the like is assumed, and the retrograde guide from any of the routes is assumed. It may be wire W2.
  • the retrograde guide wire W2 is accepted into the space inside the mesh member 20 through the opening of the expanded mesh member 20, and then is inserted into the tip end side shaft 11 of the first hollow shaft 10 and is inserted through the guide wire port 15. It is delivered to the outside of the catheter 1.
  • the tip portion 23 of the mesh member 20, the tip portion 51 of the core wire 50, and the second hollow shaft 40 are joined to each other by the joint portion of the tip tip 30.
  • the operator pulls and operates the core wire 50.
  • the tensile force is received by the three members of the mesh member 20, the core wire 50, and the second hollow shaft. Therefore, it is possible to suppress damage to the joint portion of the mesh member 20, the core wire 50, and the second hollow shaft 40 due to the joint portion.
  • the tip portion 41 of the second hollow shaft 40, the tip portion 51 of the core wire 50, and the tip portion 23 of the mesh member 20 are arranged in this order from the inside to the outside in the radial direction.
  • the core wire 50 is located between the second hollow shaft 40 and the mesh member 20
  • the tensile force on the core wire 50 can be equally distributed between the second hollow shaft 40 and the mesh member 20. ..
  • damage to the joint portion of the mesh member 20, the core wire 50, and the second hollow shaft 40 due to the joint portion can be further suppressed.
  • the tip 51 of the core wire 50 is formed with a recess 52 into which a part of the second hollow shaft 40 enters. Due to the anchor effect, the joint strength between the core wire 50 and the second hollow shaft 40 can be improved. Therefore, it is possible to prevent the joint portion of the mesh member 20, the core wire 50, and the second hollow shaft 40 from being damaged by the tensile force on the core wire 50.
  • the position of the tip of the mesh member 20 and the position of the tip of the core wire 50 are deviated from each other.
  • the tip of the core wire 50 is located closer to the tip than the tip of the mesh member 20. With this configuration, the manufacture of the catheter 1 becomes easy.
  • a plurality of recesses 52 are formed in the tip portion 51 of the core wire 50, at least one recess 52 may be formed, and as shown in FIG. 4, a through hole 53 is used instead of the recess 52. There may be.
  • the tip of the core wire 50 was located closer to the tip than the tip of the mesh member 20, but the tip of the core wire 50 and the tip of the mesh member 20 may be substantially the same position in the long axis direction, or the core wire.
  • the tip of the 50 may be located closer to the base end than the tip of the mesh member 20.
  • Catheter 10 First hollow shaft 20: Mesh member 23: Tip portion 30: Tip tip 31: Base portion 31A: Base end portion 32: First joint portion 33: Second joint portion 40: Second hollow shaft 41: Tip Part 50: Core wire 51: Tip part 52: Recessed part 53: Through hole

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un cathéter (1) comprenant : un premier arbre creux (10) ; un élément de maillage tubulaire (20) qui a une extrémité proximale reliée à la partie d'extrémité distale du premier arbre creux (10) et qui est conçu pour se dilater ou se contracter dans une direction radiale ; un fil d'âme (50) qui a une extrémité proximale qui est positionnée davantage vers le côté d'extrémité proximale que l'extrémité proximale du premier arbre creux (10) et qui s'étend à l'intérieur du premier arbre creux (10) et de l'élément de maillage (20) vers le côté d'extrémité distale ; un second arbre creux (40) qui a une extrémité proximale qui est positionnée entre l'extrémité distale et l'extrémité proximale de l'élément de maillage (20) et qui s'étend à l'intérieur de l'élément de maillage (20) vers le côté d'extrémité distale ; et une pointe distale (30) qui a une partie de liaison qui relie une partie d'extrémité distale (23) de l'élément de maillage (20), une partie d'extrémité distale (51) du fil d'âme (50), et le second arbre creux (40).
PCT/JP2020/022857 2019-06-11 2020-06-10 Cathéter WO2020250934A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2019-108781 2019-06-11
JP2019108781A JP2020199115A (ja) 2019-06-11 2019-06-11 カテーテル

Publications (1)

Publication Number Publication Date
WO2020250934A1 true WO2020250934A1 (fr) 2020-12-17

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PCT/JP2020/022857 WO2020250934A1 (fr) 2019-06-11 2020-06-10 Cathéter

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WO (1) WO2020250934A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023171200A1 (fr) * 2022-03-07 2023-09-14 朝日インテック株式会社 Cathéter

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004249093A (ja) * 2003-01-31 2004-09-09 Olympus Corp バスケット鉗子
JP2014030672A (ja) * 2012-08-06 2014-02-20 Asahi Intecc Co Ltd カテーテル
WO2018193604A1 (fr) * 2017-04-20 2018-10-25 朝日インテック株式会社 Cathéter
JP2019080939A (ja) * 2018-12-27 2019-05-30 朝日インテック株式会社 バルーンカテーテル

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004249093A (ja) * 2003-01-31 2004-09-09 Olympus Corp バスケット鉗子
JP2014030672A (ja) * 2012-08-06 2014-02-20 Asahi Intecc Co Ltd カテーテル
WO2018193604A1 (fr) * 2017-04-20 2018-10-25 朝日インテック株式会社 Cathéter
JP2019080939A (ja) * 2018-12-27 2019-05-30 朝日インテック株式会社 バルーンカテーテル

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023171200A1 (fr) * 2022-03-07 2023-09-14 朝日インテック株式会社 Cathéter

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