WO2021064825A1 - カテーテル - Google Patents

カテーテル Download PDF

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Publication number
WO2021064825A1
WO2021064825A1 PCT/JP2019/038625 JP2019038625W WO2021064825A1 WO 2021064825 A1 WO2021064825 A1 WO 2021064825A1 JP 2019038625 W JP2019038625 W JP 2019038625W WO 2021064825 A1 WO2021064825 A1 WO 2021064825A1
Authority
WO
WIPO (PCT)
Prior art keywords
tip
mesh member
catheter
hollow shaft
wire
Prior art date
Application number
PCT/JP2019/038625
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
啓介 川口
Original Assignee
朝日インテック株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 朝日インテック株式会社 filed Critical 朝日インテック株式会社
Priority to JP2021550778A priority Critical patent/JPWO2021064825A1/ja
Priority to PCT/JP2019/038625 priority patent/WO2021064825A1/ja
Publication of WO2021064825A1 publication Critical patent/WO2021064825A1/ja

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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

Definitions

  • the present invention relates to a catheter.
  • CTO chronic complete occlusion
  • a catheter that captures a retrograde guide wire via a mesh member is known.
  • the catheter is transported to the occlusion site by, for example, inserting an anterograde guide wire previously inserted into a blood vessel through the guide tube of the catheter, and then retrograde after the anterograde guide wire is removed from the catheter. Accept sex guide wires.
  • the mesh member In order to accept the retrograde guide wire, it is necessary to expand the mesh member appropriately. However, for example, when the mesh member is located at the bent portion of the blood vessel, the mesh member may not be able to expand properly and the retrograde guide wire may not be properly received.
  • the present invention has been made based on the above circumstances, and an object of the present invention is to enable the mesh member to be appropriately expanded.
  • the catheter according to the first aspect includes a tubular mesh member that can be expanded and contracted in the radial direction, a hollow shaft connected to the base end portion of the mesh member, and a tip of the mesh member.
  • a hollow tip tip connected to the portion and a plurality of core wires having the tip portion connected to the tip portion of the mesh member and / or the tip end and extending through the inside of the mesh member and the hollow shaft.
  • the plurality of core wires are connected at positions where the tip portion is off-center in the tip portion of the mesh member and / or the tip end side view.
  • Each of the plurality of core wires may extend so that the proximal end is located closer to the proximal end side than the proximal end of the first hollow shaft.
  • the plurality of core wires may be connected to a common wire having the same proximal end, and the common wire may extend so as to be located closer to the proximal end side than the proximal end of the hollow shaft.
  • three or more core wires are provided, and the tip portions of the three or more core wires are on the circumference centered on the tip portion of the mesh member and / or the center in the tip side view of the tip tip. May be connected at positions where the distance between the tips thereof is even.
  • two core wires are provided, and the two core wires are positioned so that their respective tips are not on the same straight line passing through the tip of the mesh member and / or the center of the tip in the tip side view. It may be connected.
  • the mesh member can be appropriately expanded.
  • the catheter according to the embodiment will be described with reference to the drawings, but the present invention is not limited to the embodiments described in the drawings. Further, the dimensions of the catheter shown in each drawing are the dimensions shown for facilitating the understanding of the implementation contents, and do not correspond to the actual dimensions.
  • forward guide wire means a guide wire used to guide a catheter to a surgical part in a body cavity such as a blood vessel, and “retrograde guide”.
  • Wire means a guide wire that comes into the body cavity from the distal end side of the catheter.
  • the "tip side” means a direction along the longitudinal direction of the catheter (a direction along the axial direction of the hollow shaft) and a direction in which the mesh member is located with respect to the hollow shaft. ..
  • the “base end side” means a direction along the longitudinal direction of the catheter and a direction opposite to the distal end side.
  • the “tip” refers to the end portion on the distal end side of any member or portion, and the “base end” indicates the end portion on the proximal end side of any member or portion.
  • tip side view means viewing from the tip side of the catheter.
  • FIG. 1 is a schematic cross-sectional view of the catheter according to the first embodiment.
  • the catheter 1 roughly includes a hollow shaft 11, a mesh member 21, an induction membrane 31, a tip tip 41, a plurality of core wires 51, and a connector 61.
  • the hollow shaft 11 is a hollow shaft, and its tip is connected to the base end portion of the mesh member 21.
  • the hollow shaft 11 has, for example, a hollow tip side shaft 111 and a hollow base end side shaft 112.
  • the tip end side shaft 111 is connected to the base end portion of the mesh member 21.
  • the tip-side shaft 111 has a lumen 111a penetrating from the tip to the base end, and for example, an antegrade guide wire, a retrograde guide wire W (see FIG. 3), a core wire 51, and the like (not shown) are included. It is inserted.
  • the proximal end side shaft 112 is connected to the proximal end of the distal end side shaft 111 and has a lumen 112a penetrating from the distal end to the proximal end, and for example, a core wire 51 or the like is inserted therethrough.
  • a communication hole 113 that opens toward the proximal end side is formed at the connection portion between the distal end side shaft 111 and the hollow proximal end side shaft 112.
  • the communication hole 113 is used, for example, as a guide wire port for sending the retrograde guide wire W received in the cavity 111a of the distal shaft 111 of the hollow shaft 11 to the outside of the catheter 1.
  • the distal end side shaft 111 and the proximal end side shaft 112 are integrally formed.
  • the hollow shaft 11 since the hollow shaft 11 is inserted into a body cavity such as a blood vessel, it is preferable that the hollow shaft 11 has antithrombotic property, flexibility and biocompatibility, and is preferably a resin material or a metal.
  • the material can be adopted. From the viewpoint of improving flexibility and the like, it is preferable to use a resin material such as a polyamide resin, a polyolefin resin, a polyester resin, a polyurethane resin, a silicone resin, or a fluororesin as the tip side shaft 111. From the viewpoint of improving pushability and the like, it is preferable to use a metal material such as stainless steel (SUS304 or the like) for the base end side shaft 112. As the proximal end side shaft 112, a hypotube (metal tube) can be preferably used.
  • the mesh member 21 is a tubular member that can be expanded and contracted in the radial direction.
  • the mesh member 21 is joined (fixed) to, for example, the tip of the hollow shaft 11.
  • a method of joining the mesh member 21 and the hollow shaft 11 for example, a method of embedding the base end portion of the mesh member 21 in the tip end portion of the hollow shaft 11 by welding or the like can be adopted.
  • the mesh member 21 is made of, for example, a wire rod 21a braided into a mesh shape, and is easily deformed (expanded / contracted).
  • the mesh member 21 is made of, for example, a wire rod 21a braided in a mesh shape, is easily deformed (expanded / contracted), and can receive the retrograde guide wire W through the opening 21b.
  • the base end of the mesh member 21 is joined (fixed) to the tip of the hollow shaft 11. Therefore, when the core wire 51 described later is pulled toward the base end side, the mesh member 21 bulges (diameters) outward in diameter, and the retrograde guide wire W is taken into the mesh member 21 through the widened opening 21b. be able to.
  • the base end portion of the core wire 51 is pushed into the hollow shaft 11 toward the tip end side, the diameter of the mesh member 21 is reduced, the mesh member 21 becomes compact, and the catheter 1 can be easily moved in the body cavity. it can.
  • the material of the wire rod 21a constituting the mesh member 21 examples include metal materials such as stainless steel (for example, SUS304), nickel-titanium alloys, and cobalt-chromium alloys; resins such as polyamide, polyester, polyacrylate, and polyetheretherketone. Materials and the like can be mentioned. Among these, from the viewpoint of improving the strength and flexibility and improving the visibility of the confirmation image used during the procedure, the material of the wire rod 21a is preferably a metal material. .. When the mesh member 21 is composed of a plurality of wire rods, these wire rods may be formed of the same material or may be formed of different materials.
  • the induction film 31 is a film-like member whose base end is located at the base end of the mesh member 21 and covers a part of the mesh member 21. According to the guide film 31, for example, the retrograde guide wire W received through the opening 21b of the mesh member 21 can be smoothly guided toward the opening 11b of the hollow shaft 11. Specifically, for example, the tip of the inductive film 31 is located between the base end of the tip tip 41 and the tip end of the hollow shaft 11, and the base end is located at the tip end of the hollow shaft 11.
  • Examples of the material constituting the induction film 31 include polyethylene, polyurethane, polyamide, polyamide elastomer, polyolefin, polyester, polyester elastomer and the like.
  • polyurethane is preferable as the material from the viewpoint of improving the sliding property of the surface.
  • a part of the inductive membrane 31 may be joined to the mesh member 21, for example, the tip end portion (for example, the outer periphery of the tip end end of the inductive membrane 31), the proximal end portion and / or the central portion of the inductive membrane 31 are joined. can do.
  • the material forming the induction film 31 is heated and melted, the mesh member 21 is immersed in the melted material, and the wire rods 21a are crosslinked (opening 21b).
  • a method of welding the open end of the funnel-shaped film to the mesh member 21, and the like can be adopted.
  • the tip is located at a substantially central portion in the axial direction of the mesh member 21, the base end is located at the tip of the hollow shaft 11, and the wire rods 21a of the mesh member 21 are crosslinked (the opening 21b is closed).
  • the induction film 31 and the mesh member 21 are joined so as to be used.
  • the tip tip 41 is a hollow member connected to the tip of the mesh member 21.
  • the tip tip 41 can, for example, reduce the resistance of the catheter 1 to move forward in the body cavity and allow the catheter 1 to advance smoothly.
  • the tip tip 41 is provided with a cavity 41a for inserting a guide wire (for example, an antegrade guide wire (not shown)), and the tip portion is rounded toward the tip side. It can be formed so as to have a substantially sharp shape.
  • the base end portion of the tip tip 41 is joined (fixed) to the tip end portion of the mesh member 21 or the like.
  • the material constituting the tip tip 41 is preferably flexible so as to reduce the impact on the body cavity and the like.
  • Examples of such a material include resin materials such as polyurethane and polyurethane elastomer.
  • a method of joining the tip tip 41 and the mesh member 21 for example, a method of burying the tip of each wire rod 21a constituting the mesh member 21 in the base end of the tip tip 41 by welding or the like can be adopted. it can.
  • the core wire 51 has a tip end portion bonded (fixed) to the tip tip 41, and has a space inside the mesh member 21, a cavity 111a of the tip side shaft 111 of the hollow shaft 11, and a connector 61 described later. It can be arranged so that the proximal end is exposed to the outside through the lumen 61a.
  • the material constituting the core wire 51 preferably has sufficient rigidity and tensile strength from the viewpoint of reliably expanding and contracting the mesh member 21 and preventing the core wire 51 itself from being cut.
  • Examples of such a material include metal materials such as stainless steel (SUS304 and the like), nickel titanium alloys, and cobalt-chromium alloys.
  • a method of joining the core wire 51 and the tip tip 41 and / or the mesh member 21 for example, a method of burying the tip of the core wire 51 in the base end of the tip tip 41 by welding or the like, and / or the tip of the core wire 51.
  • a method of welding the portion and the tip portion of the mesh member 21 or the like can be adopted.
  • the connector 61 is a member for which the operator grips the catheter 1.
  • the connector 61 is connected to the base end portion of the hollow shaft 11.
  • the connector 61 is formed with a cavity 61a communicating with the cavity 111a of the hollow shaft 11 and an opening 61b formed at the base end of the cavity 61a so that the core wire 51 is exposed to the outside.
  • the form of the connector 61 is not particularly limited as long as the effect of the present invention is not impaired.
  • FIG. 2 is a diagram showing a connection state of the core wire according to the first embodiment.
  • FIG. 2 shows a connection state between the tip tip 41 and the plurality of core wires 51 when viewed from the tip side.
  • the tip tip 41 is a cylindrical hollow member.
  • a plurality of (two in the example of FIG. 2) core wires 51 are connected to the base end side of the tip tip 41 at a position deviated from the center O in the tip side view of the tip tip 41.
  • the core wires 51A and 51B are connected to positions on the circumference centered on the center O.
  • the core wire 51A and the core wire 51B are connected at positions where they are not on the same straight line passing through the center O. That is, the core wire 51B is connected at a position deviated from the straight line connecting the core wire 51A and the center O.
  • the force at the time of pulling can be dispersed, so that the diameter of the core wires can be reduced as compared with the case where a single core wire is provided.
  • the mounting portion of the tip tip 41 can be made smaller.
  • the diameter of the core wire can be reduced, it is possible to reduce the occurrence of obstacles due to the core wire (for example, obstacles that cannot avoid the core wire) when guiding the retrograde guide wire W to the hollow shaft 11. it can.
  • the usage mode of the catheter 1 will be described.
  • a procedure for passing the retrograde guide wire W through a site where an obstruction exists in a blood vessel (hereinafter, also referred to as an “occlusal site”) will be described.
  • an antegrade guide wire (not shown) is inserted into the blood vessel, and then the antegrade guide wire is pushed along the blood vessel to the occluded site.
  • the balloon catheter is pushed to the occluded site using the antegrade guide wire as a guide.
  • the balloon provided in the balloon catheter is expanded and contracted to form a cavity in the obstructed site, and then the balloon catheter is pulled out of the body.
  • an antegrade guide wire is inserted into the lumen 41a of the tip tip 41 from its base end, and the tip of the catheter 1 is pushed into the blood vessel to the cavity formed at the occlusion site using the antegrade guide wire as a guide.
  • the catheter 1 is inserted into the blood vessel with the mesh member 21 reduced in diameter, and the tip of the catheter 1 reaches the cavity of the occlusion site while the mesh member 21 is maintained in the reduced diameter state. Be done.
  • the antegrade guide wire is pulled from the catheter 1 by pulling the antegrade guide wire toward the proximal end side with respect to the catheter 1.
  • the end portion of the core wire 51 exposed to the outside from the opening 61b of the connector 61 is pulled toward the base end side.
  • the ends of the plurality of core wires 51 may be pulled at the same time, or the ends of any part of the core wires 51 may be pulled.
  • the mesh member 21 bulges (expands) toward the outside of the diameter.
  • the opening 21b of the mesh member 21 is also expanded as the diameter of the mesh member 21 is expanded, it becomes easy to accept the retrograde guide wire W coming from the tip side.
  • the tip of the guide film 31 since the tip of the guide film 31 is joined to the substantially central portion in the axial direction of the mesh member 21, the tip of the guide film 31 is also expanded in diameter following the expansion of the mesh member 21.
  • the induction film 31 develops in a funnel shape as a whole.
  • the retrograde guide wire W coming from the distal end side is received in the catheter 1.
  • a false cavity in the blood vessel wall surrounding the obstruction site, a through hole penetrating the obstruction site, or the like is assumed, and the retrograde guide wire from any of the routes is assumed. It may be W.
  • the retrograde guide wire W is received in the space inside the mesh member 21 through the opening 21b of the enlarged mesh member 21, and then is received in the cavity 111a of the tip side shaft 111 through the opening 11b at the tip of the hollow shaft 11. It is delivered to the outside of the catheter 1 through the communication hole 113.
  • the retrograde guide wire W can be received by the mesh member 21 and appropriately guided to the cavity 111a of the hollow shaft 11.
  • FIG. 4 is a diagram showing an example of the state of the catheter according to the first embodiment at the bent portion of the blood vessel.
  • the tip tip 41 and the mesh member 21 are in contact with the bent outer side (upper side in the figure) of the bent portion of the blood vessel 200. It will be in a bent state.
  • FIG. 5 is a diagram showing an example of expansion of a mesh member at a bending portion of a blood vessel of a catheter according to a comparative example.
  • the same portion as the catheter 1 according to the present embodiment will be described with reference to the same reference numerals.
  • the catheter 100 is provided with one core wire 51, and the core wire 51 is connected to the proximal end side of the distal end tip 41 at a position off-center in the distal end side view. In the state shown in FIG. 5, the core wire 51 is connected to the tip tip 41 at a position close to the bent outer side of the bent portion of the blood vessel 200.
  • FIG. 6 is a diagram showing an example of expansion of a mesh member at a bent portion of a blood vessel of the catheter according to the first embodiment.
  • one core wire 51 is connected to a position close to the outside of the bend of the bent portion of the blood vessel of the tip tip 41, while the other core wire 51 is connected to the bent portion of the blood vessel 200 of the tip tip 41. It is connected to a position far from the outside of the bend (inside the bend).
  • the orientation of the mesh member 21 and the like can be adjusted, and the mesh member 21 can be expanded. It can be done more effectively.
  • the mesh member 21 can accept the retrograde guide wire W and appropriately guide it to the cavity 111a of the hollow shaft 11.
  • the two core wires are connected at positions where they are not on the same straight line passing through the center O of the tip side view of the tip tip 41.
  • the two core wires have the same positional relationship with respect to the bending direction, specifically, for example, the core wire 51 is equidistant from the outside of the bending. Can be prevented.
  • the mesh member 21 can be adjusted to a state in which it is easier to expand.
  • FIG. 7 is a schematic cross-sectional view of the catheter according to the second embodiment.
  • the same parts as those of the catheter according to the first embodiment are designated by the same reference numerals.
  • the catheter 1A includes a plurality of core wires 52 instead of the plurality of core wires 51.
  • the method of connecting the core wire 52 and the tip tip 41 may be the same as the method of connecting the core wire 51 and the tip tip 41.
  • the material constituting the core wire 52 may be the same as the material constituting the core wire 51.
  • the core wire 52 has a length up to the middle portion of the tip side shaft 111 of the hollow shaft 11.
  • the plurality of core wires 52 are connected via a connecting member 53.
  • the connecting member 53 is connected to one common wire 54.
  • the common wire 54 is configured to have a length such that the base end is exposed to the outside through the cavity 111a of the tip end side shaft 111 of the hollow shaft 11 and the cavity 61a of the connector 61.
  • the same effect as that of the first embodiment can be obtained. Further, according to the catheter according to the present embodiment, the operator only needs to operate the common wire 54, so that the complexity of the procedure can be reduced.
  • FIG. 8 is a schematic cross-sectional view of the catheter according to the third embodiment.
  • the same parts as those of the catheter according to the first embodiment are designated by the same reference numerals.
  • Catheter 1B includes a plurality of core wires 55 instead of the plurality of core wires 51.
  • the method of connecting the core wire 55 and the tip tip 41 may be the same as the method of connecting the core wire 51 and the tip tip 41.
  • the material constituting the core wire 55 may be the same as the material constituting the core wire 51.
  • the core wire 55 has a length up to the middle portion of the tip side shaft 111 of the hollow shaft 11.
  • the plurality of core wires 55 are connected to one common wire 56.
  • the common wire 56 is configured to have a length such that the base end is exposed to the outside through the cavity 111a of the tip end side shaft 111 of the hollow shaft 11 and the cavity 61a of the connector 61.
  • the core wire 55 may be configured by branching the common wire 56.
  • the same effect as that of the first embodiment can be obtained. Further, according to the catheter according to the present embodiment, the operator only needs to operate the common wire 56, so that the complexity of the procedure can be reduced.
  • FIG. 9 is a diagram showing a connection state of the core wire according to the modified example.
  • catheters 1, 1A and 1B provided with two core wires 51 (52, 55) have been described as specific examples, but the present invention is not limited to this, and three or more core wires are provided. May be good.
  • each core wire 51 (52, 55) is located on the circumference centered on the center O of the tip tip 41 as shown in FIG. It suffices to connect three core wires 51 to.
  • the positions where the core wires 51 (52, 55) are connected are evenly spaced, in other words, the positions where the core wires 51 are connected are the positions of the vertices of an equilateral triangle whose center of gravity is the center O. You may.
  • the position where each core wire 51 (52, 55) is connected corresponds to the number of core wires 51 (52, 55) with the center O as the center of gravity. It may be the position of the apex of the regular polygon.
  • the position where the tip tip 41 is pulled, the pulling force, and the pulling length can be adjusted by the core wire 51 (52, 55), and the tip tip 41 is pulled by applying an even force. It is also possible to appropriately expand the mesh member 21.
  • the catheter 1 in which the hollow shaft 11 includes the distal end side shaft 111, the proximal end side shaft 112, and the communication hole 113 has been described, but the catheter does not have a communication hole and is from the distal end. It may be a catheter (over-the-wire type (OTW) catheter) with a hollow shaft having a single lumen extending over the proximal end.
  • OGW over-the-wire type

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
PCT/JP2019/038625 2019-09-30 2019-09-30 カテーテル WO2021064825A1 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2021550778A JPWO2021064825A1 (enrdf_load_stackoverflow) 2019-09-30 2019-09-30
PCT/JP2019/038625 WO2021064825A1 (ja) 2019-09-30 2019-09-30 カテーテル

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2019/038625 WO2021064825A1 (ja) 2019-09-30 2019-09-30 カテーテル

Publications (1)

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WO2021064825A1 true WO2021064825A1 (ja) 2021-04-08

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090163891A1 (en) * 2007-12-20 2009-06-25 Bayer Schering Pharma Ag Catheter having a core wire and a low profile bond
JP2013509946A (ja) * 2009-11-09 2013-03-21 セント・ジュード・メディカル・エイトリアル・フィブリレーション・ディヴィジョン・インコーポレーテッド 繰り返し屈曲させることに起因してカテーテル又はシースが軸方向に縮むことを低減する装置
WO2018193599A1 (ja) * 2017-04-20 2018-10-25 朝日インテック株式会社 カテーテル

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090163891A1 (en) * 2007-12-20 2009-06-25 Bayer Schering Pharma Ag Catheter having a core wire and a low profile bond
JP2013509946A (ja) * 2009-11-09 2013-03-21 セント・ジュード・メディカル・エイトリアル・フィブリレーション・ディヴィジョン・インコーポレーテッド 繰り返し屈曲させることに起因してカテーテル又はシースが軸方向に縮むことを低減する装置
WO2018193599A1 (ja) * 2017-04-20 2018-10-25 朝日インテック株式会社 カテーテル

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