WO2021079633A1 - Catheter - Google Patents

Catheter Download PDF

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Publication number
WO2021079633A1
WO2021079633A1 PCT/JP2020/033808 JP2020033808W WO2021079633A1 WO 2021079633 A1 WO2021079633 A1 WO 2021079633A1 JP 2020033808 W JP2020033808 W JP 2020033808W WO 2021079633 A1 WO2021079633 A1 WO 2021079633A1
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WO
WIPO (PCT)
Prior art keywords
marker
tip
catheter
hollow shaft
inner shaft
Prior art date
Application number
PCT/JP2020/033808
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French (fr)
Japanese (ja)
Inventor
太一 鷲尾
Original Assignee
朝日インテック株式会社
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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 WO2021079633A1 publication Critical patent/WO2021079633A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • This disclosure relates to catheters.
  • Patent Document 1 discloses a catheter having an outer shaft and an inner shaft inserted into the outer shaft, which is on the outer surface of the inner shaft and is provided with a marker coated on the outer shaft.
  • Patent Document 2 discloses a catheter having a plurality of markers at the tip end portion.
  • the marker is only used to grasp the position of the catheter in the living body, and the insertion depth of the catheter cannot be visually confirmed from outside the body.
  • the present disclosure provides a catheter having a marker that allows the insertion depth of the catheter to be visually recognized not only in vivo but also in vitro, and further suppresses the peeling of the marker and the influence of the marker on the outer diameter of the catheter.
  • the purpose is to do.
  • a catheter includes a first hollow shaft having a lumen along the axial direction, a second hollow shaft arranged to cover the first hollow shaft, and the first hollow shaft.
  • a core wire extending along the axial direction between the shaft and the second hollow shaft is provided at a predetermined portion between the first hollow shaft and the second hollow shaft.
  • a marker is provided, and the marker integrally holds the first hollow shaft, the second hollow shaft, and the core wire.
  • a catheter that includes a marker that allows the insertion depth of the catheter to be visually recognized not only in the living body but also in the outside of the living body, and further suppresses the peeling of the marker and the influence of the marker on the outer diameter of the catheter. Will be possible.
  • FIG. 3 is a cross-sectional view taken along the line IV-IV of FIG.
  • sectional drawing which shows an example of the cross section of the marker along the VV line of FIG.
  • sectional drawing which shows another example of the cross section of the marker along the VV line of FIG.
  • perspective view which shows another example of a marker 5.
  • a perspective view which shows another example of a marker 5.
  • It is a schematic longitudinal sectional view which shows another example of the catheter of one Embodiment of this disclosure.
  • FIG. 1 is a schematic side view showing the appearance of the catheter according to the embodiment of the present disclosure.
  • FIG. 2 is a schematic vertical cross-sectional view showing the catheter of the first embodiment of the present disclosure.
  • FIG. 3 is an enlarged view of the region A of FIG.
  • FIG. 4 is a cross-sectional view taken along the line IV-IV of FIG.
  • the catheter 100 shown in FIGS. 1 to 4 has an inner shaft 1, an outer shaft 2, a core wire 3, a handle 4, a marker 5, and a tip tip 6.
  • the core wire 3 is omitted.
  • the central axis of the inner shaft 1 is referred to as a long axis, and the direction along the long axis is referred to as an axial direction X.
  • the inner shaft 1 is a first hollow shaft having a hollow shape (cylindrical shape), and has a cavity 11 penetrating along the axial direction X.
  • the base end portion of the inner shaft 1 is connected to the handle 4 so that the lumen 11 communicates with the lumen of the handle 4.
  • Openings 12 communicating with the lumen 11 are formed at both ends of the inner shaft 1. However, the opening 12 on the base end side of the inner shaft 1 is not shown.
  • the outer shaft 2 is a second hollow shaft having a hollow shape, and has a cavity 21 penetrating along the axial direction X.
  • the outer shaft 2 is arranged so as to cover the inner shaft 1. Specifically, the inner shaft 1 is inserted into the cavity 21 of the outer shaft 2.
  • the base end portion of the outer shaft 2 is connected to the handle 4. Openings 22 communicating with the lumen 21 are formed at both ends of the outer shaft 2. However, the opening 22 on the base end side of the outer shaft 2 is not shown.
  • the inner shaft 1 and the outer shaft 2 may or may not be arranged coaxially.
  • the outer shaft 2 has a transmission region having transparency to a predetermined light (electromagnetic wave).
  • the outer shaft 2 has, as a transmission region, a visible light transmission region 23 that is transparent to visible light and a radiation transmission region 24 that is transparent to a predetermined radiation such as X-rays.
  • the visible light transmitting region 23 is provided on the base end side of the outer shaft 2
  • the radiation transmitting region 24 is provided on the tip end side of the outer shaft 2. Further, the tip of the visible light transmitting region 23 and the base end of the radiation transmitting region 24 are connected to each other.
  • the visible light transmission region 23 can be formed of, for example, a resin material such as nylon, polyethylene, or polyimide.
  • the radiation transmission region 24 can be formed of, for example, a resin material such as nylon, polyethylene and polyurethane. In the example of FIG. 1, the radiation transmitting region 24 may have opacity to visible light or may have transparency to visible light.
  • the core wire 3 is arranged between the inner shaft 1 and the outer shaft 2 and extends in the axial direction X of the inner shaft 1. Specifically, the core wire 3 is provided on the outside of the inner shaft 1 in the cavity 21 of the outer shaft 2.
  • the number of core wires 3 is not particularly limited. In the figure, two core wires 3 are shown, but one core wire 3 may be used, or three or more core wires 3 may be provided.
  • the cross-sectional shape of the core wire 3 is substantially circular in the figure, but may be another shape such as an ellipse.
  • the base end portion of the core wire 3 is connected to the handle 4.
  • the handle 4 is a member that the operator who uses the catheter 100 grips and operates the catheter 100.
  • the handle 4 is connected to the base end portions of the inner shaft 1, the outer shaft 2 and the core wire 3.
  • the configuration and shape of the handle 4 are not particularly limited.
  • the marker 5 is a member for grasping the position of the catheter in the living body.
  • the marker 5 is provided at a predetermined portion between the inner shaft 1 and the outer shaft 2. Specifically, the marker 5 is provided on the outside of the inner shaft 1 in the cavity 21 of the outer shaft 2. Further, the marker 5 is provided at a position facing the visible light transmitting region 23 and a position facing the radiation transmitting region 24 of the outer shaft 2, respectively. In the example of the figure, two markers 5 are provided at each of the position facing the visible light transmitting region 23 and the position facing the radiation transmitting region 24, but the number and arrangement of the markers are shown in this example. Not limited.
  • the marker 5 is opaque to light in which the outer shaft 2 at the opposite position is transparent.
  • the first marker 51 which is a marker 5 facing the visible light transmitting region 23
  • has a second marker 5 which is opaque to visible light and faces the radiation transmitting region 24.
  • the marker 52 is impermeable to radiation.
  • the first marker 51 may be, for example, a resin material colored with a predetermined color as long as it has transparency to visible light.
  • the second marker 52 may be formed of, for example, a metal having impermeable to radiation such as tungsten, platinum, silver, and gold, and may be used as a resin material for radiation such as barium sulfate or tungsten powder. On the other hand, it may be formed by containing a material having impermeable property.
  • the marker 5 integrally holds the inner shaft 1 and the core wire 3.
  • the marker 5 may integrally hold at least one core wire 3 and the inner shaft 1.
  • the marker 5 is formed of, for example, an annular member, and is formed so as to cover predetermined portions of the inner shaft 1 and the core wire 3.
  • the marker 5 may be locally fixed to the outer shaft 2.
  • the method for fixing the marker 5 and the outer shaft 2 is not particularly limited, and is, for example, welding or adhesion with an adhesive.
  • FIG. 5 is a cross-sectional view showing an example of a cross section of the marker 5 along the VV line of FIG. 3, and FIG. 6 is another example of a cross section of the marker 5 along the VV line of FIG. It is sectional drawing which shows.
  • a slit 55 having an annular groove shape is formed on the outer peripheral surface of the marker 5.
  • the slit 55 may be provided so that the marker 5 becomes sparse (low volume) toward the tip end side of the inner shaft 1.
  • FIG. 5 is a cross-sectional view showing an example of a cross section of the marker 5 along the VV line of FIG. 3
  • FIG. 6 is another example of a cross section of the marker 5 along the VV line of FIG. It is sectional drawing which shows.
  • a slit 55 having an annular groove shape is formed on the outer peripheral surface of the marker 5.
  • the slit 55 may be provided so that the marker 5 becomes sparse (
  • the width of the slit 55 is widened toward the tip end side of the inner shaft 1, so that the marker 5 is sparse toward the tip end side. Further, in the example of FIG. 6, the density of forming the slit 55 is lowered toward the tip side in the axial direction, so that the marker 5 is sparse toward the tip side.
  • FIG. 7 and 8 are perspective views showing another example of the marker 5.
  • a slit 56 having a spiral groove shape is formed on the outer peripheral surface of the marker 5 instead of the annular slit 55.
  • the marker 5 is formed in a coil shape. In this case, for example, by lengthening the pitch P of the coil forming the marker 5 toward the tip side in the axial direction, the winding density of the coil forming the marker 5 is lowered toward the tip side in the axial direction.
  • the marker 5 may be sparse toward the tip side.
  • the tip tip 6 is provided at the tip of the catheter 100. Specifically, the base end of the tip tip 6 is connected to the tip end portion of the outer shaft 2, and the tip end of the tip tip 6 is connected to the tip end portion of the inner shaft 1.
  • the tip tip 6 has a lumen 61 penetrating along the axial direction, and is formed so that the tip portion has a substantially sharp shape toward the tip side.
  • the configuration of the tip of the catheter 100 is not limited to the above example.
  • the tip tip 6 may not be present.
  • a balloon may be connected to the tip end portion of the catheter 100. That is, the catheter 100 may be used as a balloon catheter.
  • FIG. 9 is a schematic vertical cross-sectional view showing the catheter 100 when the catheter 100 is a balloon catheter.
  • the catheter 100 shown in FIG. 9 has a configuration in which the tip 6 is removed and the inner shaft 7, the balloon 8 and the tip 9 are added to the configuration shown in FIG.
  • the inner shaft 7 is a third hollow shaft having a hollow shape, and has a lumen 71 penetrating along the axial direction X.
  • the inner shaft 7 is arranged between the inner shaft 1 and the outer shaft 2, and extends from the middle portion of the outer shaft 2 in the axial direction X to the tip portion of the outer shaft 2. Openings 72 that communicate with the lumen 71 are formed at both ends of the outer shaft 2.
  • the base end portion of the inner shaft 7 is connected to an intermediate portion of the outer shaft 2 in the axial direction X, and the opening 72 on the base end side of the lumen 71 is arranged so as to face the outside of the outer shaft 2.
  • the balloon 8 is arranged so that the tip end is joined to the tips of the inner shafts 1 and 7, the base end is joined to the outer shaft 2, and the balloon 8 covers at least a part of the inner shafts 1 and 7 exposed from the outer shaft 2. ..
  • the balloon 8 is a member that can be expanded and contracted, and is inflated by injecting an expansion medium (for example, expansion liquid or air) into the balloon 8.
  • the tip tip 9 is connected to the tips of the inner shafts 1 and 7.
  • the tip tip 9 has a lumen 91 penetrating along the axial direction, and is formed so that the tip portion has a substantially sharp shape toward the tip side.
  • the lumen 91 of the tip tip 9 communicates with the lumens 11 and 71 of the inner shafts 1 and 7.
  • the marker 5 is provided on the proximal end side of the opening 72 on the proximal end side of the inner shaft 7, but may be provided on the distal end side of the opening 72.
  • the marker 5 provided on the tip side of the opening 72 may integrally hold the inner shafts 1 and 7 and the core wire 3.
  • the catheter 100 may be configured to include an inner shaft 7 and not to include a balloon 8, or may be configured to include a balloon 8 and not to include an inner shaft 7.
  • FIG. 10 is a schematic vertical sectional view showing an example of a catheter 100 having an inner shaft 7 and not having a balloon 8.
  • the catheter 100 shown in FIG. 10 has a configuration in which the tip tip 6a is added to the configuration shown in FIG. 9, excluding the balloon 8 and the tip tip 9.
  • the tip tip 6a is provided at the tip of the catheter 100. Specifically, the base end of the tip tip 6 is connected to the tip end portion of the outer shaft 2, and the tip end of the tip tip 6a is connected to the tip end portions of the inner shafts 1 and 7. At least one tip of the inner shafts 1 and 7 may be exposed from the tip tip 6a.
  • the tip tip 6a has a lumen 61a penetrating along the axial direction, and is formed so that the tip portion has a substantially sharp shape toward the tip side.
  • FIG. 11 is a schematic vertical sectional view showing an example of a catheter 100 having a balloon 8 and not having an inner shaft 7.
  • the catheter 100 shown in FIG. 11 has a configuration in which the tip tip 9a is added to the configuration shown in FIG. 9, excluding the inner shaft 7 and the tip tip 9.
  • the balloon 8 is arranged so that the tip end is joined to the tip end of the inner shaft 1, the base end is joined to the outer shaft 2, and the balloon 8 covers at least a part of the inner shaft 1 exposed from the outer shaft 2. Will be done.
  • the tip tip 9a is connected to the tip of the inner shaft 1.
  • the tip tip 9 has a lumen 91a penetrating along the axial direction, and is formed so that the tip portion has a substantially sharp shape toward the tip side.
  • the lumen 91a of the tip tip 9a communicates with the lumen 11 of the inner shaft 1.
  • FIG. 12 is a diagram for explaining an example of a method of manufacturing the catheter 100, particularly a method of manufacturing the portion where the marker 5 is formed. Note that FIG. 12 shows a portion (right figure) corresponding to the region A in FIG. 2 and a cross-sectional view (left figure) along the IX-IX line in the right figure in each of the steps a to f.
  • a hollow tube made of resin is prepared as the inner shaft 1, and the core metal 101 is inserted into the inner shaft 1.
  • the inner shaft 1 into which the core metal 101 is inserted and the core wire 3 are inserted into the heat shrinkable tube 102 (step a).
  • the heat-shrinkable tube 102 is contracted by applying heat to the heat-shrinkable tube 102, and the inner shaft 1 and the core wire 3 are temporarily fixed by the heat-shrinkable tube 102 (step b).
  • step c the inner shaft 1 and the core wire 3 are inserted into the additional tube 103 having impermeable light to a predetermined light, and the additional tube 103 is covered with the heat shrinkable tube 102 (step c).
  • the additional tube 103 is fixed to the inner shaft 1 and the core wire 3 to form a marker 5 that integrally holds the inner shaft 1 and the core wire 3 (step d).
  • steps a to c may be omitted, the inner shaft 1 and the core wire 3 may be directly inserted into the additional tube 103, and then the process may be performed to fix the additional tube 103 to the inner shaft 1 and the core wire 3.
  • the catheter 100 includes an inner shaft 1 having a lumen 11 along the axial direction X, an outer shaft 2 arranged so as to cover the inner shaft 1, and an inner shaft 1.
  • a core wire 3 extending along the axial direction X and a marker 5 provided at a predetermined portion between the inner shaft 1 and the outer shaft 2 are provided between the inner shaft 2 and the outer shaft 2, and the marker 5 is provided. Holds the inner shaft 1 and the core wire 3 integrally.
  • the marker 5 makes it possible to visually recognize the insertion depth of the catheter 100 not only in the living body but also outside the living body, and further suppresses the peeling of the marker 5 and the influence of the marker 5 on the outer diameter of the catheter 100. It becomes possible. Further, since the marker 5 can be used as a member for suppressing twisting of the inner shaft 1 and the core wire 3, the marker 5 can be effectively used.
  • the marker 5 is circular. Therefore, it becomes possible to easily create the marker 5 that integrally holds the inner shaft 1 and the core wire 3.
  • annular or spiral slit 55 is formed on the outer peripheral portion of the marker 5. Therefore, it is possible to secure the bendability of the portion where the marker 5 is formed.
  • the marker 5 is sparse toward the tip end side of the inner shaft 1. Therefore, it is possible to make the tip end side of the marker 5 more easily bent than the base end side, so that the operability of the catheter 100 can be improved.
  • the marker 5 is fixed to the outer shaft 2. Therefore, it is possible to increase the rigidity of the portion where the marker 5 is formed.
  • the outer shaft 2 is provided with a visible light transmitting region 23 having transparency to visible light at a predetermined portion, and the marker 5 is a first first having transparency to visible light. Includes marker 51. Therefore, since the marker 5 can be visually confirmed, it is possible to grasp the length of the catheter 100 inserted in the living body.
  • the outer shaft 2 includes a radiation-transmitting region 24 that is transparent to radiation at a predetermined portion, and the marker 5 includes a second marker 52 that is opaque to radiation. Including. Therefore, since the marker 5 can be confirmed by using radiation, the position of the catheter 100 in the living body can be grasped.
  • the marker can be effectively used even in the catheter 100 provided with a plurality of inner shafts.
  • the balloon 8 is joined to the tip of the outer shaft 2. Therefore, the marker can be effectively used even in the catheter 100 having the balloon 8.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

Provided is a catheter including a marker whereby insertion depth of the catheter is visible not only in vivo but also in vitro. Further, the catheter is configured so as to suppress peeling of the marker and effects of the marker on the outer diameter of the catheter.　An inner shaft 1 has a lumen 11 along an axial direction X. An outer shaft 2 is disposed so as to cover the inner shaft 1. A core wire 3 extends along the axial direction X between the inner shaft 1 and the outer shaft 2. A marker 5 is provided at a predetermined location between the inner shaft 1 and the outer shaft 2. The marker 5 integrally holds the inner shaft 1 and the core wire 3.

Description

カテーテルcatheter
　本開示は、カテーテルに関する。 This disclosure relates to catheters.
　カテーテルには、生体内におけるカテーテルの位置を把握するためのマーカが設けられているものがある。例えば、特許文献１には、アウターシャフトと、アウターシャフトに挿入されたインナーシャフトとを有し、インナーシャフトの外表面上にあり、アウターシャフトに被覆されたマーカを設けたカテーテルが開示されている。また、特許文献２には、先端部に複数のマーカを備えたカテーテルが開示されている。 Some catheters are provided with a marker for grasping the position of the catheter in the living body. For example, Patent Document 1 discloses a catheter having an outer shaft and an inner shaft inserted into the outer shaft, which is on the outer surface of the inner shaft and is provided with a marker coated on the outer shaft. .. Further, Patent Document 2 discloses a catheter having a plurality of markers at the tip end portion.
国際公開２００６／１２６６４２International release 2006/1266242 特開２０１２－５９１０号公報Japanese Unexamined Patent Publication No. 2012-5910
　特許文献１および２に記載の技術では、マーカは、生体内におけるカテーテルの位置を把握するために使用されているだけであり、カテーテルの挿入深度を体外から目視で確認することはできなかった。 In the techniques described in Patent Documents 1 and 2, the marker is only used to grasp the position of the catheter in the living body, and the insertion depth of the catheter cannot be visually confirmed from outside the body.
　本開示は、生体内のみならず、生体外においてもカテーテルの挿入深度が視認可能なマーカを備え、さらに、マーカの剥離およびカテーテルの外径へのマーカの影響を抑制する構成とするカテーテルを提供することを目的としている。 The present disclosure provides a catheter having a marker that allows the insertion depth of the catheter to be visually recognized not only in vivo but also in vitro, and further suppresses the peeling of the marker and the influence of the marker on the outer diameter of the catheter. The purpose is to do.
　本開示の一態様に従うカテーテルは、軸方向に沿った内腔を有する第１の中空シャフトと、前記第１の中空シャフトを覆うように配置された第２の中空シャフトと、前記第１の中空シャフトと前記第２の中空シャフトとの間に、前記軸方向に沿って延設されたコアワイヤと、前記第１の中空シャフトと前記第２の中空シャフトとの間の所定の部位に設けられたマーカと、を備え、前記マーカは、前記第１の中空シャフト、前記第２の中空シャフトおよび前記コアワイヤを一体的に保持する。 A catheter according to one aspect of the present disclosure includes a first hollow shaft having a lumen along the axial direction, a second hollow shaft arranged to cover the first hollow shaft, and the first hollow shaft. A core wire extending along the axial direction between the shaft and the second hollow shaft is provided at a predetermined portion between the first hollow shaft and the second hollow shaft. A marker is provided, and the marker integrally holds the first hollow shaft, the second hollow shaft, and the core wire.
　本発明によれば、生体内のみならず、生体外においてもカテーテルの挿入深度が視認可能なマーカを備え、さらに、マーカの剥離やカテーテルの外径へのマーカの影響を抑制したカテーテルを提供することが可能になる。 According to the present invention, there is provided a catheter that includes a marker that allows the insertion depth of the catheter to be visually recognized not only in the living body but also in the outside of the living body, and further suppresses the peeling of the marker and the influence of the marker on the outer diameter of the catheter. Will be possible.
本開示の一実施形態のカテーテルの外観を示す概略側面図である。It is a schematic side view which shows the appearance of the catheter of one Embodiment of this disclosure. 本開示の一実施形態のカテーテルを示す概略縦断面図である。It is a schematic vertical sectional view which shows the catheter of one Embodiment of this disclosure. 図２の領域Ａの拡大図である。It is an enlarged view of the area A of FIG. 図３のＩＶ－ＩＶ線に沿った断面図である。FIG. 3 is a cross-sectional view taken along the line IV-IV of FIG. 図３のＶ－Ｖ線に沿ったマーカの断面の一例を示す断面図である。It is sectional drawing which shows an example of the cross section of the marker along the VV line of FIG. 図３のＶ－Ｖ線に沿ったマーカの断面の別の例を示す断面図である。It is sectional drawing which shows another example of the cross section of the marker along the VV line of FIG. マーカ５の別の例を示す斜視図である。It is a perspective view which shows another example of a marker 5. マーカ５の別の例を示す斜視図である。It is a perspective view which shows another example of a marker 5. 本開示の一実施形態のカテーテルの別の例を示す概略縦断面図である。It is a schematic longitudinal sectional view which shows another example of the catheter of one Embodiment of this disclosure. 本開示の一実施形態のカテーテルの別の例を示す概略縦断面図である。It is a schematic longitudinal sectional view which shows another example of the catheter of one Embodiment of this disclosure. 本開示の一実施形態のカテーテルの別の例を示す概略縦断面図である。It is a schematic longitudinal sectional view which shows another example of the catheter of one Embodiment of this disclosure. カテーテルの製造方法を説明するための図である。It is a figure for demonstrating the manufacturing method of a catheter.
　以下、本開示の実施形態について図面を参照して説明する。 Hereinafter, embodiments of the present disclosure will be described with reference to the drawings.
　図１は、本開示の一実施形態のカテーテルの外観を示す概略側面図である。図２は、本開示の第１の実施形態のカテーテルを示す概略縦断面図である。図３は、図２の領域Ａの拡大図である。図４は、図３のＩＶ－ＩＶ線に沿った断面図である。 FIG. 1 is a schematic side view showing the appearance of the catheter according to the embodiment of the present disclosure. FIG. 2 is a schematic vertical cross-sectional view showing the catheter of the first embodiment of the present disclosure. FIG. 3 is an enlarged view of the region A of FIG. FIG. 4 is a cross-sectional view taken along the line IV-IV of FIG.
　図１～図４に示すカテーテル１００は、インナーシャフト１と、アウターシャフト２と、コアワイヤ３と、ハンドル４と、マーカ５と、先端チップ６とを有する。なお、図１では、コアワイヤ３を省略している。また、以下では、インナーシャフト１の中心軸を長軸、長軸に沿った方向を軸方向Ｘと呼ぶ。 The catheter 100 shown in FIGS. 1 to 4 has an inner shaft 1, an outer shaft 2, a core wire 3, a handle 4, a marker 5, and a tip tip 6. In FIG. 1, the core wire 3 is omitted. Further, in the following, the central axis of the inner shaft 1 is referred to as a long axis, and the direction along the long axis is referred to as an axial direction X.
　インナーシャフト１は、中空形状（円筒形状）を有する第１の中空シャフトであり、軸方向Ｘに沿って貫通する内腔１１を有する。インナーシャフト１の基端部は、内腔１１がハンドル４の内腔と連通するようにハンドル４と接続される。インナーシャフト１の両端には、内腔１１と連通する開口１２が形成される。ただし、インナーシャフト１の基端側の開口１２は図示していない。 The inner shaft 1 is a first hollow shaft having a hollow shape (cylindrical shape), and has a cavity 11 penetrating along the axial direction X. The base end portion of the inner shaft 1 is connected to the handle 4 so that the lumen 11 communicates with the lumen of the handle 4. Openings 12 communicating with the lumen 11 are formed at both ends of the inner shaft 1. However, the opening 12 on the base end side of the inner shaft 1 is not shown.
　アウターシャフト２は、中空形状を有する第２の中空シャフトであり、軸方向Ｘに沿って貫通する内腔２１を有する。アウターシャフト２は、インナーシャフト１を覆うように配置される。具体的には、アウターシャフト２の内腔２１にインナーシャフト１が挿入されている。アウターシャフト２の基端部は、ハンドル４と接続される。アウターシャフト２の両端には、内腔２１と連通する開口２２が形成される。ただし、アウターシャフト２の基端側の開口２２は図示していない。インナーシャフト１およびアウターシャフト２は、同軸上に配置されてもよいし、同軸上に配置されていなくてもよい。 The outer shaft 2 is a second hollow shaft having a hollow shape, and has a cavity 21 penetrating along the axial direction X. The outer shaft 2 is arranged so as to cover the inner shaft 1. Specifically, the inner shaft 1 is inserted into the cavity 21 of the outer shaft 2. The base end portion of the outer shaft 2 is connected to the handle 4. Openings 22 communicating with the lumen 21 are formed at both ends of the outer shaft 2. However, the opening 22 on the base end side of the outer shaft 2 is not shown. The inner shaft 1 and the outer shaft 2 may or may not be arranged coaxially.
　また、アウターシャフト２は、所定の光（電磁波）に対して透過性を有する透過領域を備える。具体的には、アウターシャフト２は、透過領域として、可視光に対して透過性を有する可視光透過領域２３と、Ｘ線などの所定の放射線に対して透過性を有する放射線透過領域２４とを有する。図の例では、可視光透過領域２３は、アウターシャフト２の基端部側に設けられ、放射線透過領域２４は、アウターシャフト２の先端部側に設けられる。また、可視光透過領域２３の先端と放射線透過領域２４の基端とが互いに接続されている。 Further, the outer shaft 2 has a transmission region having transparency to a predetermined light (electromagnetic wave). Specifically, the outer shaft 2 has, as a transmission region, a visible light transmission region 23 that is transparent to visible light and a radiation transmission region 24 that is transparent to a predetermined radiation such as X-rays. Have. In the example of the figure, the visible light transmitting region 23 is provided on the base end side of the outer shaft 2, and the radiation transmitting region 24 is provided on the tip end side of the outer shaft 2. Further, the tip of the visible light transmitting region 23 and the base end of the radiation transmitting region 24 are connected to each other.
　可視光透過領域２３は、例えば、ナイロン、ポリエチレンおよびポリイミドなどの樹脂材料で形成することができる。放射線透過領域２４は、例えば、ナイロン、ポリエチレンおよびポリウレタンなどの樹脂材料で形成することができる。なお、図１の例では、放射線透過領域２４は、可視光に対して不透過性を有していてもよく、可視光に対して透過性を有していても良い。 The visible light transmission region 23 can be formed of, for example, a resin material such as nylon, polyethylene, or polyimide. The radiation transmission region 24 can be formed of, for example, a resin material such as nylon, polyethylene and polyurethane. In the example of FIG. 1, the radiation transmitting region 24 may have opacity to visible light or may have transparency to visible light.
　コアワイヤ３は、インナーシャフト１とアウターシャフト２との間に配置され、インナーシャフト１の軸方向Ｘに延設されている。具体的には、コアワイヤ３は、アウターシャフト２の内腔２１内における、インナーシャフト１の外側に設けられる。コアワイヤ３の数は、特に限定されない。図では、コアワイヤ３は、２本示されているが、１本でもよいし、３本以上あってもよい。コアワイヤ３の横断面形状は、図では、略円形であるが、楕円形などの他の形状でもよい。コアワイヤ３の基端部はハンドル４と接続される。 The core wire 3 is arranged between the inner shaft 1 and the outer shaft 2 and extends in the axial direction X of the inner shaft 1. Specifically, the core wire 3 is provided on the outside of the inner shaft 1 in the cavity 21 of the outer shaft 2. The number of core wires 3 is not particularly limited. In the figure, two core wires 3 are shown, but one core wire 3 may be used, or three or more core wires 3 may be provided. The cross-sectional shape of the core wire 3 is substantially circular in the figure, but may be another shape such as an ellipse. The base end portion of the core wire 3 is connected to the handle 4.
　ハンドル４は、カテーテル１００を使用する術者がカテーテル１００を把持して操作する部材である。ハンドル４は、インナーシャフト１、アウターシャフト２およびコアワイヤ３の基端部と接続される。ハンドル４の構成および形状は、特に限定されない。 The handle 4 is a member that the operator who uses the catheter 100 grips and operates the catheter 100. The handle 4 is connected to the base end portions of the inner shaft 1, the outer shaft 2 and the core wire 3. The configuration and shape of the handle 4 are not particularly limited.
　マーカ５は、生体内におけるカテーテルの位置を把握するための部材である。マーカ５は、インナーシャフト１とアウターシャフト２との間の所定の部位に設けられる。具体的には、マーカ５は、アウターシャフト２の内腔２１内における、インナーシャフト１の外側に設けられる。また、マーカ５は、アウターシャフト２の可視光透過領域２３と対向する位置および放射線透過領域２４と対向する位置のそれぞれに設けられる。図の例では、マーカ５は、可視光透過領域２３と対向する位置および放射線透過領域２４と対向する位置のそれぞれに、２つずつ設けられているが、マーカの数および配置は、この例に限定されない。 The marker 5 is a member for grasping the position of the catheter in the living body. The marker 5 is provided at a predetermined portion between the inner shaft 1 and the outer shaft 2. Specifically, the marker 5 is provided on the outside of the inner shaft 1 in the cavity 21 of the outer shaft 2. Further, the marker 5 is provided at a position facing the visible light transmitting region 23 and a position facing the radiation transmitting region 24 of the outer shaft 2, respectively. In the example of the figure, two markers 5 are provided at each of the position facing the visible light transmitting region 23 and the position facing the radiation transmitting region 24, but the number and arrangement of the markers are shown in this example. Not limited.
　マーカ５は、対向する位置のアウターシャフト２が透過性を有する光に対して不透過性を有する。具体的には、可視光透過領域２３と対向するマーカ５である第１のマーカ５１は、可視光に対して不透過性を有し、放射線透過領域２４と対向するマーカ５である第２のマーカ５２は、放射線に対して不透過性を有する。第１のマーカ５１は、例えば、可視光に対して透過性を有していれば樹脂材料を所定の色で着色したものでもよい。第２のマーカ５２は、例えば、タングステンや白金、銀、金などの放射線に対して不透過性を有する金属で形成されていてもよく、樹脂材料に硫酸バリウムやタングステン粉末などのような放射線に対して不透過性を有する材料を含有させて形成されていてもよい。 The marker 5 is opaque to light in which the outer shaft 2 at the opposite position is transparent. Specifically, the first marker 51, which is a marker 5 facing the visible light transmitting region 23, has a second marker 5 which is opaque to visible light and faces the radiation transmitting region 24. The marker 52 is impermeable to radiation. The first marker 51 may be, for example, a resin material colored with a predetermined color as long as it has transparency to visible light. The second marker 52 may be formed of, for example, a metal having impermeable to radiation such as tungsten, platinum, silver, and gold, and may be used as a resin material for radiation such as barium sulfate or tungsten powder. On the other hand, it may be formed by containing a material having impermeable property.
　また、マーカ５は、インナーシャフト１とコアワイヤ３とを一体的に保持する。コアワイヤ３が複数ある場合、マーカ５は、少なくとも１つのコアワイヤ３とインナーシャフト１とを一体的に保持すればよい。また、マーカ５は、例えば、環状の部材で形成され、インナーシャフト１とコアワイヤ３の所定の部位を覆うように形成される。また、マーカ５は、アウターシャフト２と局所的に固着されてもよい。マーカ５とアウターシャフト２とを固着させる方法は、特に限定されないが、例えば、溶着または接着剤による接着などである。 Further, the marker 5 integrally holds the inner shaft 1 and the core wire 3. When there are a plurality of core wires 3, the marker 5 may integrally hold at least one core wire 3 and the inner shaft 1. Further, the marker 5 is formed of, for example, an annular member, and is formed so as to cover predetermined portions of the inner shaft 1 and the core wire 3. Further, the marker 5 may be locally fixed to the outer shaft 2. The method for fixing the marker 5 and the outer shaft 2 is not particularly limited, and is, for example, welding or adhesion with an adhesive.
　図５は、図３のＶ－Ｖ線に沿ったマーカ５の断面の一例を示す断面図であり、図６は、図３のＶ－Ｖ線に沿ったマーカ５の断面の別の例を示す断面図である。図５および図６の例では、マーカ５の外周面には、環状の溝形状からなるスリット５５が形成されている。スリット５５は、図に示したように複数あってもよい。また、スリット５５は、マーカ５がインナーシャフト１の先端側に向かって疎（低体積）となるように設けられてもよい。図５の例では、インナーシャフト１の先端側に向かってスリット５５の幅を広くすることで、マーカ５を先端側に向かって疎としている。また、図６の例では、スリット５５を形成する密度を軸方向の先端側に向かって低くすることで、マーカ５を先端側に向かって疎としている。 FIG. 5 is a cross-sectional view showing an example of a cross section of the marker 5 along the VV line of FIG. 3, and FIG. 6 is another example of a cross section of the marker 5 along the VV line of FIG. It is sectional drawing which shows. In the examples of FIGS. 5 and 6, a slit 55 having an annular groove shape is formed on the outer peripheral surface of the marker 5. There may be a plurality of slits 55 as shown in the figure. Further, the slit 55 may be provided so that the marker 5 becomes sparse (low volume) toward the tip end side of the inner shaft 1. In the example of FIG. 5, the width of the slit 55 is widened toward the tip end side of the inner shaft 1, so that the marker 5 is sparse toward the tip end side. Further, in the example of FIG. 6, the density of forming the slit 55 is lowered toward the tip side in the axial direction, so that the marker 5 is sparse toward the tip side.
　図７および図８は、マーカ５の別の例を示す斜視図である。図７の例では、マーカ５の外周面に、環状のスリット５５の代わりに、螺旋状の溝形状からなるスリット５６が形成されている。また、図８の例では、マーカ５は、コイル状に形成されている。この場合、例えば、マーカ５を形成するコイルのピッチＰを軸方向の先端側に向かって長くすることで、マーカ５を形成するコイルの巻密度を軸方向の先端側に向かって低くして、マーカ５を先端側に向かって疎としてもよい。 7 and 8 are perspective views showing another example of the marker 5. In the example of FIG. 7, a slit 56 having a spiral groove shape is formed on the outer peripheral surface of the marker 5 instead of the annular slit 55. Further, in the example of FIG. 8, the marker 5 is formed in a coil shape. In this case, for example, by lengthening the pitch P of the coil forming the marker 5 toward the tip side in the axial direction, the winding density of the coil forming the marker 5 is lowered toward the tip side in the axial direction. The marker 5 may be sparse toward the tip side.
　先端チップ６は、カテーテル１００の先端部に設けられる。具体的には、先端チップ６の基端は、アウターシャフト２の先端部と接続され、先端チップ６の先端はインナーシャフト１の先端部と接続される。先端チップ６は、軸方向に沿って貫通する内腔６１を有し、かつ、先端部が先端側に向かって略尖鋭形状となるように形成される。 The tip tip 6 is provided at the tip of the catheter 100. Specifically, the base end of the tip tip 6 is connected to the tip end portion of the outer shaft 2, and the tip end of the tip tip 6 is connected to the tip end portion of the inner shaft 1. The tip tip 6 has a lumen 61 penetrating along the axial direction, and is formed so that the tip portion has a substantially sharp shape toward the tip side.
　カテーテル１００の先端部の構成は、上記の例に限らない。例えば、先端チップ６はなくてもよい。また、カテーテル１００の先端部には、バルーンが接続されてもよい。つまり、カテーテル１００をバルーンカテーテルとしてもよい。 The configuration of the tip of the catheter 100 is not limited to the above example. For example, the tip tip 6 may not be present. Further, a balloon may be connected to the tip end portion of the catheter 100. That is, the catheter 100 may be used as a balloon catheter.
　図９は、カテーテル１００をバルーンカテーテルとした場合における、カテーテル１００を示す概略縦断面図である。図９に示すカテーテル１００は、図１に示した構成に対して、先端チップ６を除き、かつ、インナーシャフト７、バルーン８および先端チップ９を加えた構成を有する。 FIG. 9 is a schematic vertical cross-sectional view showing the catheter 100 when the catheter 100 is a balloon catheter. The catheter 100 shown in FIG. 9 has a configuration in which the tip 6 is removed and the inner shaft 7, the balloon 8 and the tip 9 are added to the configuration shown in FIG.
　インナーシャフト７は、中空形状を有する第３の中空シャフトであり、軸方向Ｘに沿って貫通する内腔７１を有する。インナーシャフト７は、インナーシャフト１とアウターシャフト２との間に配置され、アウターシャフト２の軸方向Ｘにおける中途部からアウターシャフト２の先端部まで延設される。アウターシャフト２の両端には、内腔７１と連通する開口７２が形成される。インナーシャフト７の基端部は、アウターシャフト２の軸方向Ｘにおける中途部と接続され、内腔７１の基端側の開口７２がアウターシャフト２の外部に面するように配置される。なお、インナーシャフト７は、複数あってもよい。 The inner shaft 7 is a third hollow shaft having a hollow shape, and has a lumen 71 penetrating along the axial direction X. The inner shaft 7 is arranged between the inner shaft 1 and the outer shaft 2, and extends from the middle portion of the outer shaft 2 in the axial direction X to the tip portion of the outer shaft 2. Openings 72 that communicate with the lumen 71 are formed at both ends of the outer shaft 2. The base end portion of the inner shaft 7 is connected to an intermediate portion of the outer shaft 2 in the axial direction X, and the opening 72 on the base end side of the lumen 71 is arranged so as to face the outside of the outer shaft 2. There may be a plurality of inner shafts 7.
　バルーン８は、先端がインナーシャフト１および７の先端に接合され、基端がアウターシャフト２と接合され、アウターシャフト２から露出されたインナーシャフト１および７の少なくとも一部を覆うように配置される。バルーン８は、拡縮可能な部材であり、内部に拡張媒体（例えば、拡張液または空気）が注入されることで膨らむ。 The balloon 8 is arranged so that the tip end is joined to the tips of the inner shafts 1 and 7, the base end is joined to the outer shaft 2, and the balloon 8 covers at least a part of the inner shafts 1 and 7 exposed from the outer shaft 2. .. The balloon 8 is a member that can be expanded and contracted, and is inflated by injecting an expansion medium (for example, expansion liquid or air) into the balloon 8.
　先端チップ９は、インナーシャフト１および７の先端部と接続される。先端チップ９は、軸方向に沿って貫通する内腔９１を有し、かつ、先端部が先端側に向かって略尖鋭形状となるように形成される。先端チップ９の内腔９１は、インナーシャフト１および７の内腔１１および７１と連通される。 The tip tip 9 is connected to the tips of the inner shafts 1 and 7. The tip tip 9 has a lumen 91 penetrating along the axial direction, and is formed so that the tip portion has a substantially sharp shape toward the tip side. The lumen 91 of the tip tip 9 communicates with the lumens 11 and 71 of the inner shafts 1 and 7.
　なお、図では、マーカ５は、インナーシャフト７の基端部側の開口７２よりも基端側に設けられているが、開口７２よりも先端側に設けられてもよい。この場合、開口７２よりも先端側に設けられたマーカ５は、インナーシャフト１および７とコアワイヤ３とを一体的に保持してもよい。 In the figure, the marker 5 is provided on the proximal end side of the opening 72 on the proximal end side of the inner shaft 7, but may be provided on the distal end side of the opening 72. In this case, the marker 5 provided on the tip side of the opening 72 may integrally hold the inner shafts 1 and 7 and the core wire 3.
　また、カテーテル１００は、インナーシャフト７を備え、かつ、バルーン８を備えない構成でもよいし、バルーン８を備え、かつ、インナーシャフト７を備えない構成でもよい。 Further, the catheter 100 may be configured to include an inner shaft 7 and not to include a balloon 8, or may be configured to include a balloon 8 and not to include an inner shaft 7.
　図１０は、インナーシャフト７を備え、かつ、バルーン８を備えていないカテーテル１００の一例を示す概略縦断面図である。図１０に示すカテーテル１００は、図９に示した構成に対して、バルーン８および先端チップ９を除き、先端チップ６ａを加えた構成を有する。 FIG. 10 is a schematic vertical sectional view showing an example of a catheter 100 having an inner shaft 7 and not having a balloon 8. The catheter 100 shown in FIG. 10 has a configuration in which the tip tip 6a is added to the configuration shown in FIG. 9, excluding the balloon 8 and the tip tip 9.
　先端チップ６ａは、カテーテル１００の先端部に設けられる。具体的には、先端チップ６の基端は、アウターシャフト２の先端部と接続され、先端チップ６ａの先端はインナーシャフト１および７の先端部と接続される。インナーシャフト１および７の少なくとも一方の先端は、先端チップ６ａから露出してもよい。先端チップ６ａは、軸方向に沿って貫通する内腔６１ａを有し、かつ、先端部が先端側に向かって略尖鋭形状となるように形成される。 The tip tip 6a is provided at the tip of the catheter 100. Specifically, the base end of the tip tip 6 is connected to the tip end portion of the outer shaft 2, and the tip end of the tip tip 6a is connected to the tip end portions of the inner shafts 1 and 7. At least one tip of the inner shafts 1 and 7 may be exposed from the tip tip 6a. The tip tip 6a has a lumen 61a penetrating along the axial direction, and is formed so that the tip portion has a substantially sharp shape toward the tip side.
　図１１は、バルーン８を備え、かつ、インナーシャフト７を備えていないカテーテル１００の一例を示す概略縦断面図である。図１１に示すカテーテル１００は、図９に示した構成に対して、インナーシャフト７および先端チップ９を除き、先端チップ９ａを加えた構成を有する。 FIG. 11 is a schematic vertical sectional view showing an example of a catheter 100 having a balloon 8 and not having an inner shaft 7. The catheter 100 shown in FIG. 11 has a configuration in which the tip tip 9a is added to the configuration shown in FIG. 9, excluding the inner shaft 7 and the tip tip 9.
　バルーン８は、図１１の例では、先端がインナーシャフト１の先端に接合され、基端がアウターシャフト２と接合され、アウターシャフト２から露出されたインナーシャフト１の少なくとも一部を覆うように配置される。 In the example of FIG. 11, the balloon 8 is arranged so that the tip end is joined to the tip end of the inner shaft 1, the base end is joined to the outer shaft 2, and the balloon 8 covers at least a part of the inner shaft 1 exposed from the outer shaft 2. Will be done.
　先端チップ９ａは、インナーシャフト１の先端部と接続される。先端チップ９は、軸方向に沿って貫通する内腔９１ａを有し、かつ、先端部が先端側に向かって略尖鋭形状となるように形成される。先端チップ９ａの内腔９１ａは、インナーシャフト１の内腔１１と連通される。 The tip tip 9a is connected to the tip of the inner shaft 1. The tip tip 9 has a lumen 91a penetrating along the axial direction, and is formed so that the tip portion has a substantially sharp shape toward the tip side. The lumen 91a of the tip tip 9a communicates with the lumen 11 of the inner shaft 1.
　図１２は、カテーテル１００の製造方法、特に、マーカ５が形成された箇所の製造方法の一例を説明するための図である。なお、図１２は、各工程ａ～ｆにおける、図２の領域Ａに対応する部分（右図）と、右図のＩＸ－ＩＸ線に沿った断面図（左図）とを示している。 FIG. 12 is a diagram for explaining an example of a method of manufacturing the catheter 100, particularly a method of manufacturing the portion where the marker 5 is formed. Note that FIG. 12 shows a portion (right figure) corresponding to the region A in FIG. 2 and a cross-sectional view (left figure) along the IX-IX line in the right figure in each of the steps a to f.
　先ず、樹脂で形成された中空形状のチューブをインナーシャフト１として用意し、インナーシャフト１に芯金１０１を挿入する。芯金１０１を挿入したインナーシャフト１とコアワイヤ３とを熱収縮チューブ１０２に挿通させる（工程ａ） First, a hollow tube made of resin is prepared as the inner shaft 1, and the core metal 101 is inserted into the inner shaft 1. The inner shaft 1 into which the core metal 101 is inserted and the core wire 3 are inserted into the heat shrinkable tube 102 (step a).
　続いて、熱収縮チューブ１０２に熱を加えることで熱収縮チューブ１０２を収縮させ、熱収縮チューブ１０２によってインナーシャフト１とコアワイヤ３とを仮止めする（工程ｂ）。 Subsequently, the heat-shrinkable tube 102 is contracted by applying heat to the heat-shrinkable tube 102, and the inner shaft 1 and the core wire 3 are temporarily fixed by the heat-shrinkable tube 102 (step b).
　その後、所定の光に対する不透過性を有する追加チューブ１０３にインナーシャフト１およびコアワイヤ３と挿通させ、追加チューブ１０３を熱収縮チューブ１０２に被せる（工程ｃ） After that, the inner shaft 1 and the core wire 3 are inserted into the additional tube 103 having impermeable light to a predetermined light, and the additional tube 103 is covered with the heat shrinkable tube 102 (step c).
　そして、金型を用いて、追加チューブ１０３をインナーシャフト１およびコアワイヤ３に固着させて、インナーシャフト１およびコアワイヤ３を一体的に保持するマーカ５として形成する（工程ｄ）。 Then, using a mold, the additional tube 103 is fixed to the inner shaft 1 and the core wire 3 to form a marker 5 that integrally holds the inner shaft 1 and the core wire 3 (step d).
　さらに、マーカ５で保持されたインナーシャフト１およびコアワイヤ３をアウターシャフト２に挿入する（工程ｅ）。 Further, the inner shaft 1 and the core wire 3 held by the marker 5 are inserted into the outer shaft 2 (step e).
　最後に、インナーシャフト１から芯金１０１を引き抜く（工程ｆ）。 Finally, the core metal 101 is pulled out from the inner shaft 1 (process f).
　上記の製造方法は単なる一例であって、この例に限定されるものではない。例えば、工程ａ～ｃを省き、インナーシャフト１およびコアワイヤ３を追加チューブ１０３に直接挿通させ、その後、工程ｄに移行して、追加チューブ１０３をインナーシャフト１およびコアワイヤ３に固着させてもよい。 The above manufacturing method is merely an example, and is not limited to this example. For example, steps a to c may be omitted, the inner shaft 1 and the core wire 3 may be directly inserted into the additional tube 103, and then the process may be performed to fix the additional tube 103 to the inner shaft 1 and the core wire 3.
　以上説明したように本実施形態によれば、カテーテル１００は、軸方向Ｘに沿った内腔１１を有するインナーシャフト１と、インナーシャフト１を覆うように配置されたアウターシャフト２と、インナーシャフト１とアウターシャフト２との間に、軸方向Ｘに沿って延設されたコアワイヤ３と、インナーシャフト１とアウターシャフト２との間の所定の部位に設けられたマーカ５と、を備え、マーカ５は、インナーシャフト１およびコアワイヤ３を一体的に保持する。 As described above, according to the present embodiment, the catheter 100 includes an inner shaft 1 having a lumen 11 along the axial direction X, an outer shaft 2 arranged so as to cover the inner shaft 1, and an inner shaft 1. A core wire 3 extending along the axial direction X and a marker 5 provided at a predetermined portion between the inner shaft 1 and the outer shaft 2 are provided between the inner shaft 2 and the outer shaft 2, and the marker 5 is provided. Holds the inner shaft 1 and the core wire 3 integrally.
　したがって、マーカ５により、生体内のみならず、生体外においてもカテーテル１００の挿入深度が視認可能となり、さらに、マーカ５の剥離およびカテーテル１００の外径へのマーカ５の影響を抑制する構成とすることが可能となる。また、マーカ５をインナーシャフト１とコアワイヤ３との捻じれを抑制する部材として利用することが可能になるため、マーカ５を有効利用することが可能になる。 Therefore, the marker 5 makes it possible to visually recognize the insertion depth of the catheter 100 not only in the living body but also outside the living body, and further suppresses the peeling of the marker 5 and the influence of the marker 5 on the outer diameter of the catheter 100. It becomes possible. Further, since the marker 5 can be used as a member for suppressing twisting of the inner shaft 1 and the core wire 3, the marker 5 can be effectively used.
　また、本実施形態では、マーカ５は、環状である。このため、インナーシャフト１およびコアワイヤ３を一体的に保持するマーカ５を容易に作成することが可能になる。 Further, in the present embodiment, the marker 5 is circular. Therefore, it becomes possible to easily create the marker 5 that integrally holds the inner shaft 1 and the core wire 3.
　また、本実施形態では、マーカ５の外周部には、環状または螺旋状のスリット５５が形成されている。このため、マーカ５が形成された箇所の曲がりやすさを確保することが可能になる。 Further, in the present embodiment, an annular or spiral slit 55 is formed on the outer peripheral portion of the marker 5. Therefore, it is possible to secure the bendability of the portion where the marker 5 is formed.
　また、本実施形態では、マーカ５は、インナーシャフト１の先端側に向かって疎である。このため、マーカ５の基端部側よりも先端部側を曲がりやすくすることが可能になるため、カテーテル１００の操作性を高くすることが可能になる。 Further, in the present embodiment, the marker 5 is sparse toward the tip end side of the inner shaft 1. Therefore, it is possible to make the tip end side of the marker 5 more easily bent than the base end side, so that the operability of the catheter 100 can be improved.
　また、本実施形態では、マーカ５は、アウターシャフト２と固着されている。このため、マーカ５が形成された箇所の剛性を高くすることが可能になる。 Further, in the present embodiment, the marker 5 is fixed to the outer shaft 2. Therefore, it is possible to increase the rigidity of the portion where the marker 5 is formed.
　また、本実施形態では、アウターシャフト２は、可視光に対して透過性を有する可視光透過領域２３を所定の部位に備え、マーカ５は、可視光に対して不透過性を有する第１のマーカ５１を含む。このため、目視によりマーカ５を確認することができるため、生体内に挿入したカテーテル１００の長さを把握することが可能になる。 Further, in the present embodiment, the outer shaft 2 is provided with a visible light transmitting region 23 having transparency to visible light at a predetermined portion, and the marker 5 is a first first having transparency to visible light. Includes marker 51. Therefore, since the marker 5 can be visually confirmed, it is possible to grasp the length of the catheter 100 inserted in the living body.
　また、本実施形態では、アウターシャフト２は、放射線に対して透過性を有する放射線透過領域２４を所定の部位に備え、マーカ５は、放射線に対して不透過性を有する第２のマーカ５２を含む。このため、放射線を用いてマーカ５を確認することができるため、生体内のカテーテル１００の位置を把握することが可能になる。 Further, in the present embodiment, the outer shaft 2 includes a radiation-transmitting region 24 that is transparent to radiation at a predetermined portion, and the marker 5 includes a second marker 52 that is opaque to radiation. Including. Therefore, since the marker 5 can be confirmed by using radiation, the position of the catheter 100 in the living body can be grasped.
　また、本実施形態では、インナーシャフト１とアウターシャフト２との間に、軸方向Ｘに沿った内腔を有し、軸方向Ｘに沿って延設されたインナーシャフト７を有する。このため、インナーシャフトを複数備えたカテーテル１００においても、マーカを有効利用することが可能になる。 Further, in the present embodiment, between the inner shaft 1 and the outer shaft 2, there is a lumen along the axial direction X, and an inner shaft 7 extending along the axial direction X is provided. Therefore, the marker can be effectively used even in the catheter 100 provided with a plurality of inner shafts.
　また、本実施形態では、アウターシャフト２の先端に接合されたバルーン８を有する。このため、バルーン８を有するカテーテル１００においても、マーカを有効利用することが可能になる。 Further, in the present embodiment, the balloon 8 is joined to the tip of the outer shaft 2. Therefore, the marker can be effectively used even in the catheter 100 having the balloon 8.
　上述した本開示の実施形態は、本開示の説明のための例示であり、本開示の範囲をそれらの実施形態にのみ限定する趣旨ではない。当業者は、本発明の範囲を逸脱することなしに、他の様々な態様で本発明を実施することができる。 The above-described embodiments of the present disclosure are examples for the purpose of explaining the present disclosure, and the scope of the present disclosure is not intended to be limited only to those embodiments. One of ordinary skill in the art can practice the present invention in various other aspects without departing from the scope of the present invention.
　１：インナーシャフト、２：アウターシャフト、３：コアワイヤ、４ハンドル、５：マーカ、６～６ａ：先端チップ、７：インナーシャフト、８：バルーン、９～９ａ：先端チップ、１１：内腔、１２：開口、２１：内腔、２２：開口、２３：可視光透過領域、２４：放射線透過領域、５１：第１のマーカ、５２：第２のマーカ、５５～５６：スリット、６１～６１ａ：内腔、７１：内腔、７２：開口、９１～９１ａ：内腔、１００：カテーテル 1: Inner shaft, 2: Outer shaft, 3: Core wire, 4 handle, 5: Marker, 6-6a: Tip tip, 7: Inner shaft, 8: Balloon, 9-9a: Tip tip, 11: Cavity, 12 : Aperture, 21: Cavity, 22: Aperture, 23: Visible light transmission region, 24: Radiation transmission region, 51: First marker, 52: Second marker, 55 to 56: Slit, 61 to 61a: Inner Cavity, 71: Cavity, 72: Aperture, 91-91a: Cavity, 100: Catheter

Claims (9)

  1. 　軸方向に沿った内腔を有する第１の中空シャフトと、
    　前記第１の中空シャフトを覆うように配置された第２の中空シャフトと、
    　前記第１の中空シャフトと前記第２の中空シャフトとの間に、前記軸方向に沿って延設されたコアワイヤと、
    　前記第１の中空シャフトと前記第２の中空シャフトとの間の所定の部位に設けられたマーカと、を備え、
    　前記マーカは、前記第１の中空シャフトおよび前記コアワイヤを一体的に保持する、カテーテル。     A first hollow shaft with an axial lumen and
    A second hollow shaft arranged so as to cover the first hollow shaft,
    A core wire extending along the axial direction between the first hollow shaft and the second hollow shaft,
    A marker provided at a predetermined portion between the first hollow shaft and the second hollow shaft is provided.
    The marker is a catheter that integrally holds the first hollow shaft and the core wire.
  2. 　前記マーカは、環状である、請求項１に記載のカテーテル。 The catheter according to claim 1, wherein the marker is annular.
  3. 　前記マーカの外周部には、環状または螺旋状のスリットが形成されている、請求項２に記載のカテーテル。 The catheter according to claim 2, wherein an annular or spiral slit is formed on the outer peripheral portion of the marker.
  4. 　前記マーカは、前記第１の中空シャフトの先端側に向かって疎である、請求項１ないし３のいずれか１項に記載のカテーテル。 The catheter according to any one of claims 1 to 3, wherein the marker is sparse toward the tip end side of the first hollow shaft.
  5. 　前記マーカは、前記第２の中空シャフトと固着されている、請求項１ないし４のいずれか１項に記載のカテーテル。 The catheter according to any one of claims 1 to 4, wherein the marker is fixed to the second hollow shaft.
  6. 　前記第２の中空シャフトは、可視光に対して透過性を有する可視光透過領域を前記所定の部位に備え、
    　前記マーカは、可視光に対して不透過性を有する第１のマーカを含む、請求項１ないし５のいずれか１項に記載のカテーテル。     The second hollow shaft is provided with a visible light transmitting region having transparency to visible light at the predetermined portion.
    The catheter according to any one of claims 1 to 5, wherein the marker includes a first marker that is opaque to visible light.
  7. 　前記第２の中空シャフトは、放射線に対して透過性を有する放射線透過領域を前記所定の部位に備え、
    　前記マーカは、放射線に対して不透過性を有する第２のマーカを含む、請求項１ないし６のいずれか１項に記載のカテーテル。     The second hollow shaft is provided with a radiation-transmitting region that is transparent to radiation at the predetermined portion.
    The catheter according to any one of claims 1 to 6, wherein the marker includes a second marker that is impermeable to radiation.
  8. 　前記第１の中空シャフトと前記第２の中空シャフトとの間に、前記軸方向に沿った内腔を有し、前記軸方向に沿って延設された第３の中空シャフトを有する、請求項１ないし７のいずれか１項に記載のカテーテル。 A claim that has a cavity along the axial direction between the first hollow shaft and the second hollow shaft, and a third hollow shaft extending along the axial direction. The catheter according to any one of 1 to 7.
  9. 　前記第２の中空シャフトの先端に接合されたバルーンを有する、請求項１ないし８のいずれか１項に記載のカテーテル。

          The catheter according to any one of claims 1 to 8, which has a balloon joined to the tip of the second hollow shaft.
PCT/JP2020/033808 2019-10-24 2020-09-07 Catheter WO2021079633A1 (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006016491A1 (en) * 2004-08-11 2006-02-16 Kaneka Corporation Catheter
US20120296366A1 (en) * 2011-05-20 2012-11-22 Boston Scientific Scimed, Inc. Balloon catheter with improved pushability
JP2015083028A (en) * 2013-10-25 2015-04-30 ニプロ株式会社 Balloon catheter

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006016491A1 (en) * 2004-08-11 2006-02-16 Kaneka Corporation Catheter
US20120296366A1 (en) * 2011-05-20 2012-11-22 Boston Scientific Scimed, Inc. Balloon catheter with improved pushability
JP2015083028A (en) * 2013-10-25 2015-04-30 ニプロ株式会社 Balloon catheter

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