WO2021079633A1 - Cathéter - Google Patents

Cathéter 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
Authority
WO
WIPO (PCT)
Prior art keywords
marker
tip
catheter
hollow shaft
inner shaft
Prior art date
Application number
PCT/JP2020/033808
Other languages
English (en)
Japanese (ja)
Inventor
太一 鷲尾
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 WO2021079633A1 publication Critical patent/WO2021079633A1/fr

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Classifications

    • 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)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un cathéter comprenant un marqueur, la profondeur d'insertion du cathéter étant visible non seulement in vivo mais aussi in vitro. En outre, le cathéter est conçu de manière à supprimer le pelage du marqueur et les effets du marqueur sur le diamètre externe du cathéter.　Une tige interne 1 a une lumière 11 dans la direction axiale X. Une tige externe 2 est disposée de façon à recouvrir la tige interne 1. Un fil central 3 s'étend dans la direction axiale X entre la tige interne 1 et la tige externe 2. Un marqueur 5 est disposé à un emplacement prédéfini entre la tige interne 1 et la tige externe 2. Le marqueur 5 retient intégralement la tige interne 1 et le fil central 3.
PCT/JP2020/033808 2019-10-24 2020-09-07 Cathéter WO2021079633A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2019193251A JP2021065439A (ja) 2019-10-24 2019-10-24 カテーテル
JP2019-193251 2019-10-24

Publications (1)

Publication Number Publication Date
WO2021079633A1 true WO2021079633A1 (fr) 2021-04-29

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ID=75619776

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2020/033808 WO2021079633A1 (fr) 2019-10-24 2020-09-07 Cathéter

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JP (1) JP2021065439A (fr)
WO (1) WO2021079633A1 (fr)

Citations (3)

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

Patent Citations (3)

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

Also Published As

Publication number Publication date
JP2021065439A (ja) 2021-04-30

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