WO2024004479A1 - Guide wire - Google Patents

Guide wire Download PDF

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Publication number
WO2024004479A1
WO2024004479A1 PCT/JP2023/019857 JP2023019857W WO2024004479A1 WO 2024004479 A1 WO2024004479 A1 WO 2024004479A1 JP 2023019857 W JP2023019857 W JP 2023019857W WO 2024004479 A1 WO2024004479 A1 WO 2024004479A1
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WO
WIPO (PCT)
Prior art keywords
coil
guide wire
coil body
distal end
core shaft
Prior art date
Application number
PCT/JP2023/019857
Other languages
French (fr)
Japanese (ja)
Inventor
忠裕 小池
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 WO2024004479A1 publication Critical patent/WO2024004479A1/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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires

Definitions

  • the present invention relates to a guidewire.
  • a guide wire has been used when inserting medical devices such as catheters into tubular organs such as blood vessels and the gastrointestinal tract or body tissues for treatment or examination.
  • a guide wire has a structure in which a coil is attached to the tip of the core wire and the tip is flexible. It is also required to have enough torque transmittance to rotate the distal end as intended by the operator's operation.
  • some guidewires have a sensor attached to a cylindrical casing provided at the tip, and a sensor is used to determine the characteristics of a thrombus by introducing blood flow etc. into the sensor and measuring the impedance of the blood.
  • a guidewire with a In such a guide wire, a lead wire extending from the sensor is integrated along the core wire, but a guide wire including such a lead wire is also required to have both flexibility and torque transmittance.
  • Patent Document 1 discloses a guide wire in which the inside of a coil provided at the distal end is filled with resin.
  • the present invention has been made in view of these points, and an object of the present invention is to provide a guidewire that maintains the flexibility of the coil tip and has improved rotation followability.
  • the present invention includes a core shaft and at least one coil body disposed so as to surround the distal end side of the core shaft, and the at least one coil body is connected to a first coil section. and a second coil portion disposed on the proximal end side of the first coil portion in the axial direction, and the second coil portion has a coating layer made of a heat-shrinkable tube along its outer peripheral surface.
  • the present invention provides a guidewire in which the first coil portion is not provided with a covering layer made of a heat-shrinkable tube (invention 1).
  • the coating layer is formed only on the outer peripheral surface of the proximal end of the coil body disposed on the distal end side of the core shaft, and the coating layer is formed of a heat-shrinkable tube.
  • the first coil part and the second coil part in the present invention may each be separate coil bodies, or one coil body may have both of them.
  • the second coil portion has a hydrophilic coating layer formed on the outside of the coating layer (invention 2).
  • a sensor unit may be disposed between the first coil part and the second coil part (invention 3).
  • connection cable that electrically connects the sensor unit and an external device may be arranged inside the at least one coil body (invention 4).
  • FIG. 1 is an explanatory diagram showing the structure of a guide wire according to a first embodiment of the present invention. It is an explanatory view showing the structure of the guide wire concerning a 2nd embodiment of the present invention.
  • FIG. 1 is an explanatory diagram showing the structure of the guide wire 10 according to the first embodiment, and is a partial sectional view partially showing a cross section of the guide wire 10 along the axial direction.
  • distal side refers to the direction along the axial direction of the guide wire 10, and means the direction in which the guide wire 10 advances toward the treatment/examination site.
  • proximal side refers to a direction along the axial direction of the guide wire 10, and means a direction opposite to the distal end side.
  • distal end refers to the distal end of any member or site, and the term “base end” refers to the proximal end of any member or site.
  • distal end refers to a part of any member or part that includes the distal end and extends from the distal end towards the proximal end to the middle of the member, etc.; Refers to a part of a member or part that includes its base end and extends from the base end toward the distal end to the middle of the member.
  • the right side in the figure is the “distal side” that is inserted into the body, and the left side in the figure is the "proximal side” that is operated by a technician such as a doctor.
  • the guide wire 10 includes an elongated core shaft 1, a distal tip 2 attached to the distal end of the core shaft 1, and a proximal end side of the distal tip 2. a first coil body 3 and a second coil body 4 arranged to surround the sensor unit 5 and the sensor unit 5 arranged between the first coil body 3 and the second coil body 4; (not shown).
  • the second coil body 4 is arranged closer to the proximal end of the guide wire 10 than the first coil body 3 in the axial direction.
  • the first coil body 3 is an example of the "first coil section" of the present invention
  • the second coil body 4 is an example of the "second coil section" of the present invention.
  • "at least one coil body” of the present invention includes two coil bodies, the first coil body 3 and the second coil body 4, and the “first coil section” of the present invention includes two coil bodies, the first coil body 3 and the second coil body 4.
  • the "second coil part” is a first coil body 3, and the “second coil part” is a second coil body 4, which are separate coil bodies.
  • the guide wire 10 is inserted into a blood vessel for treatment or examination, and the sensor unit 5 incorporates a resistance sensor (not shown) for measuring the impedance of blood within the blood vessel.
  • a resistance sensor not shown
  • the guide wire to which the present invention is applied is not limited to this, and the present invention can also be applied to, for example, a guide wire inserted into a living body lumen other than a blood vessel such as a gastrointestinal tract.
  • the axis passing through the center of the guide wire 10 is represented by an axis C in FIG. 1, and the axis C coincides with the axis passing through the centers of the core shaft 1, the first coil body 3, and the second coil body 4. ing.
  • the core shaft 1 is an elongated member with a perfect circular cross section extending along the axis C, and has a tapered shape whose diameter gradually decreases from the base end toward the distal end.
  • the core shaft 1 has a first shaft part 11, a second shaft part 12, a third shaft part 13, and a fourth shaft part 14 in this order from the base end to the distal end, each of which is made of stainless steel or nickel titanium. It is made of metal materials such as alloys, nickel-chromium alloys, cobalt-chromium alloys, and tungsten.
  • the first shaft part 11, the second shaft part 12, the third shaft part 13, and the fourth shaft part 14 may be formed using different materials, or may be formed using the same material. .
  • each of the first shaft part 11, the second shaft part 12, the third shaft part 13, and the fourth shaft part 14 may be formed of a composite material that is a combination of a plurality of different materials.
  • the first shaft portion 11 is disposed at the most proximal end of the core shaft 1 and extends coaxially with the axis C of the guide wire 10, and its distal end is welded to the proximal end of the second shaft portion 12.
  • the first shaft portion 11 has a substantially cylindrical shape with a substantially constant outer diameter from the base end to the distal end. For example, the outer diameter of the first shaft portion 11 is 0 over the entire length of the first shaft portion 11. .25mm.
  • the second shaft part 12 is arranged on the distal end side of the first shaft part 11 and extends coaxially with the axis C of the guide wire 10, and its distal end is welded to the base end of the third shaft part 13.
  • the second shaft portion 12 has a tapered shape (approximately truncated conical shape) whose diameter gradually decreases from the base end toward the distal end.
  • the outer diameter of the second shaft portion 12 is 0.25 mm, and 0.16 mm at the tip.
  • the third shaft portion 13 is disposed on the distal end side of the second shaft 12 and extends coaxially with the axis C of the guide wire 10, and its distal end is welded to the base end of the fourth shaft portion 14.
  • the third shaft portion 13 has a tapered shape (approximately truncated conical shape) whose diameter gradually decreases from the base end toward the distal end.
  • the outer diameter of the third shaft portion 13 is 0.16 mm, and 0.11 mm at the tip.
  • the fourth shaft portion 14 is disposed at the most distal side of the core shaft 1, extends coaxially with the axis C of the guide wire 10, and has its distal end fixed to the distal tip 2.
  • the fourth shaft part 14 has a substantially cylindrical shape with a substantially constant outer diameter from the base end to the distal end. For example, the outer diameter of the fourth shaft part 11 is 0 over the entire length of the fourth shaft part 14. .11mm.
  • first shaft portion 11, second shaft portion 12, third shaft portion 13, and fourth shaft portion 14 can be arbitrarily determined.
  • the distal tip 2 integrally holds the distal end of the core shaft 10 and the distal end of the first coil body 3, and is disposed at the most distal end of the guide wire 10.
  • the tip 2 is formed of any bonding agent, for example, metal solder such as silver solder, gold solder, zinc, Sn--Ag alloy, Au--Sn alloy, or adhesive such as epoxy adhesive.
  • the first coil body 3 has a two-layer structure in which an outer coil 32 is arranged outside an inner coil 31, and is arranged outside the fourth shaft portion 14 of the core shaft 1.
  • the tip of the first coil body 3 is soldered to the tip tip 2, and the base end of the first coil body 3 is bonded to a sensor unit 5, which will be described later, with an adhesive.
  • a coating layer made of a heat-shrinkable tube is not formed on the outer peripheral surface of the first coil body 3.
  • the outer diameter of the first coil body 3 is approximately 0.35 mm, and the length in the direction of the axis C is approximately 30 mm.
  • the inner coil 31 is a substantially cylindrical coil formed by spirally winding a wire made of a metal material such as stainless steel alloy, nickel titanium alloy, nickel chromium alloy, cobalt chromium alloy, tungsten, or platinum. Yes, it may be a single coil formed by winding one strand into a single thread, or it may be a multi-thread coil formed by winding a plurality of strands into multiple threads.
  • a metal material such as stainless steel alloy, nickel titanium alloy, nickel chromium alloy, cobalt chromium alloy, tungsten, or platinum.
  • each stranded wire may be a multi-filament stranded wire coil formed by winding the wire into multiple threads.
  • the inner coil 31 is a multi-thread coil made of six stainless steel wires wound in multiple threads.
  • the outer coil 32 is a substantially cylindrical coil formed by spirally winding a wire made of a metal material such as stainless steel alloy, nickel titanium alloy, nickel chromium alloy, cobalt chromium alloy, tungsten, or platinum. Yes, it may be a single coil formed by winding one strand into a single thread, or it may be a multi-thread coil formed by winding a plurality of strands into multiple threads.
  • a metal material such as stainless steel alloy, nickel titanium alloy, nickel chromium alloy, cobalt chromium alloy, tungsten, or platinum.
  • each stranded wire may be a single stranded wire coil formed by winding a stranded wire made by twisting a plurality of strands together into a single thread, or by using a plurality of stranded wires made by twisting a plurality of strands, each stranded wire is It may be a multi-filament stranded wire coil formed by winding the wire into multiple threads. In this embodiment, it is a single coil made by winding a single platinum wire into a single coil.
  • the second coil body 4 has a structure in which a coating layer 42 is placed on the outside of the coil 41, and is placed outside the third shaft portion 13 of the core shaft 1.
  • the tip of the second coil body 4 is glued to a sensor unit 5, which will be described later, and the base end of the second coil body 4 is glued to the core shaft 1 and an outer tube 6, which will be described later.
  • the covering layer 42 is formed by covering the outer peripheral surface of the coil 41 with a heat-shrinkable tube and shrinking the heat-shrinkable tube by applying heat. That is, in the second coil body 4, a covering layer 42 made of a heat-shrinkable tube is formed along the outer peripheral surface of the coil 41.
  • the covering layer 42 is not bonded to the coil 41 except at both ends, and is in contact with the outer circumferential surface of the coil 41 so as to tighten the coil 41 from the outside.
  • the outer diameter of the second coil body 4 is approximately 0.34 mm, and the length in the direction of the axis C is approximately 270 mm.
  • the coil 41 is a substantially cylindrical coil formed by spirally winding a wire made of a metal material such as stainless steel alloy, nickel titanium alloy, nickel chromium alloy, cobalt chromium alloy, tungsten, or platinum. , it may be a single coil formed by winding one strand into a single thread, or it may be a multi-thread coil formed by winding a plurality of strands into multiple threads, It may be a single stranded wire coil formed by winding a stranded wire made by twisting together a single wire into a single thread, or it may be a single stranded wire coil formed by winding a stranded wire made by twisting a plurality of strands together. It may be a multi-filament stranded wire coil formed by winding multiple threads. In this embodiment, the coil 41 is a multi-thread coil made of 16 stainless steel wires wound in multiple threads.
  • the heat-shrinkable tube that forms the coating layer 42 is not particularly limited as long as it is a resin tube that has the property of shrinking when heated, but it is preferably a resin tube that is thin but has excellent strength, such as , a tube formed by making a PET (polyethylene terephthalate) film into a cylindrical shape can be used.
  • the heat-shrinkable tube forming the coating layer 42 it is preferable to use a thin tube with a film thickness of 10 ⁇ m or less, and more preferably a film thickness of 5 ⁇ m or less.
  • the film thickness exceeds 10 ⁇ m, the rigidity of the second coil body 4 on which the coating layer 42 is disposed becomes too high, which may impede blood vessel followability.
  • the coating layer 42 does not necessarily have to be formed over the entire length of the second coil body 4. For example, even if there is a portion where the coating layer 42 is not formed at the base end or the distal end of the second coil body 4. good.
  • the sensor unit 5 is configured by, for example, pasting a resistance sensor on the outer peripheral surface of a substantially cylindrical housing, and is arranged between the first coil body 3 and the second coil body 4.
  • the sensor unit 5 is fixed to the core shaft 1 so that the core shaft 1 passes through the housing along the central axis of the housing. Note that although the sensor unit 5 of this embodiment measures the impedance of blood within a blood vessel, it is not limited thereto, and a sensor unit that acquires other information may be used.
  • the distal end of the sensor unit 5 and the proximal end of the first coil body 3, and the proximal end of the sensor unit 5 and the distal end of the second coil body 4 are each bonded with an adhesive. Applying heat to the area around the sensor unit 5 may cause damage or malfunction of the resistance sensor, so the sensor unit 5, first coil body 3, and second coil body 4 are connected using adhesive rather than soldering. It is fixed by gluing it using.
  • the lead wire 51 is a connection cable that electrically connects the sensor unit 5 and an external device (not shown), and is introduced into the coil 41 of the second coil body 4 from the sensor unit 5 along the core shaft 1. , is arranged so as to be drawn out from the inside of the coil 41, through the inside of the first outer tube 6a and the second outer tube 6b, and from the proximal end of the guide wire 10 to the outside.
  • An outer tube 6 is arranged on the base end side of the second coil body 4 so as to cover the first shaft part 11 and the second shaft part 12 of the core shaft 1.
  • the proximal end of the second coil body 4 is bonded to the distal end of the first outer tube 6a using an adhesive, and the proximal end of the first outer tube 6a is inserted into the distal end of the second outer tube 6b. It is attached using adhesive.
  • a connector (not shown) operated by a technician such as a doctor is attached to the base end of the second outer tube 6b by known fixing means such as brazing or adhesive bonding.
  • the outer tube 6 (first outer tube 6a and second outer tube 6b) is preferably a resin tube with a low coefficient of friction and excellent sliding properties, and for example, a PI (polyimide) tube can be used.
  • the first outer tube 6a has an outer diameter of about 0.30 mm and a length in the axis C direction of about 20 mm
  • the second outer tube 6b has an outer diameter of about 0.35 mm and a length in the axis C direction.
  • the length is approximately 1600mm.
  • the outer tube 6 may be formed of a single resin material, or may be divided into a plurality of regions and formed using a plurality of resin materials each having different characteristics.
  • the guide wire 10 is coated with a hydrophilic coating agent to facilitate movement within the blood vessel.
  • hydrophilic coating agents include cellulose-based polymers, polyethylene oxide-based polymers, and maleic anhydride-based polymers (e.g., maleic anhydride copolymers such as methyl vinyl ether-maleic anhydride copolymers).
  • coating agents using hydrophilic materials such as acrylamide-based polymer substances (e.g., polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide block copolymers), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone, hyaluronate, etc. can do.
  • a first hydrophilic film layer 7 is formed on the outer tube 6, and a first hydrophilic film layer 7 is formed on the outer peripheral surface of the outer tube 6 on the proximal side of the part of the second coil body 4 where the first hydrophilic film layer 7 is formed.
  • Two hydrophilic film layers 8 are formed.
  • the first hydrophilic film layer 7 is formed directly on the outer circumferential surface of the outer coil 32, and in the second coil body 4, the first hydrophilic film layer 7 is formed along the outer circumferential surface of the coil 41.
  • the first hydrophilic film layer 7 or the second hydrophilic film layer 8 is formed on the outside of the covering layer 42.
  • the first hydrophilic film layer 7 is formed thinner than the second hydrophilic film layer 8, and in this embodiment, the second hydrophilic film layer 8 has a layer thickness of about 2-3 ⁇ m. , the layer thickness of the first hydrophilic film layer 7 is 1 ⁇ m or less. This ensures the flexibility of the distal end of the guide wire 10, that is, the portion from the distal tip 2 to the first coil body 3. In addition, in FIG. 1, it is shown that there is a gap between the first hydrophilic film layer 7 and the first coil body 3, and between the second hydrophilic film layer 8 and the first outer tube 6a.
  • first outer tube 6a is coated with a first hydrophilic film layer 7 or a second hydrophilic film layer 8 .
  • the second hydrophilic film layer 8 does not need to be formed over the entire length of the second outer tube 6b.
  • the guide wire 10 as described above has the coating layer 42 formed only on the outer circumferential surface of the coil 41 of the second coil body 4 among the coil bodies disposed on the distal end side of the core shaft 1, and
  • the flexibility of the coil tip provided at the tip of the guide wire 10 can be improved. It is possible to improve rotation followability while maintaining the following. This is because by covering the second coil body 4 with the coating layer 42 so as to tighten it, compressive pressure is applied in the radial direction and length direction of the coil 41, and the adhesion between the wires forming the coil 41 increases.
  • the first coil body 3 has no coating layer made of a heat-shrinkable tube formed along its outer peripheral surface, its movement is not restricted, and the flexibility of the coil tip is maintained.
  • this difference can be reduced by covering the second coil body 4 with the coating layer 42 made of a heat-shrinkable tube. becomes.
  • the adhesion of the coating agent improves when coating the coating layer (heat-shrinkable tube) rather than directly coating the outer circumferential surface of the coil, so it is easier to coat the guidewire. Improvements in slip characteristics can be expected.
  • FIG. 2 is an explanatory view showing the structure of the guide wire 10A according to the second embodiment, and is a partial sectional view partially showing a cross section of the guide wire 10A along the axial direction.
  • differences from the first embodiment will be mainly described, and descriptions of structures similar to the first embodiment will be omitted.
  • the guide wire 10A includes an elongated core shaft 1, a distal tip 2 attached to the distal end of the core shaft 1, and a proximal end side of the distal tip 2.
  • a coil body 9 is arranged so as to surround the coil body 9.
  • the guide wire 10A includes only one coil body 9 at the distal end of the core shaft 1, has no sensor unit or lead wire, is not coated with a hydrophilic coating agent, and has the following features: This differs from the guide wire 10 of the first embodiment in that the core shaft 1 is not covered with an outer tube.
  • the coil body 9 has a first coil part 91 and a second coil part 92 arranged closer to the proximal end side than the first coil part 91 in the axial direction.
  • the first coil portion 91 corresponds to the first coil body 3 in the first embodiment, and is a portion where a coating layer made of a heat-shrinkable tube is not formed on the outer peripheral surface of the coil 90 of the coil body 9.
  • the second coil portion 92 corresponds to the second coil body 4 in the first embodiment, and a coating layer 921 made of a heat-shrinkable tube is formed on the outer peripheral surface of the coil 90 of the coil body 9. It is a part.
  • "at least one coil body” of the present invention is realized by a single coil body called the coil body 9, and the first coil part 91 and the second coil part 92 that the coil body 9 has These correspond to the "first coil section” and “second coil section” of the present invention, respectively.
  • the coil 90 is a substantially cylindrical coil formed by spirally winding a wire made of a metal material such as stainless steel alloy, nickel titanium alloy, nickel chromium alloy, cobalt chromium alloy, tungsten, or platinum. , it may be a single coil formed by winding one strand into a single thread, or it may be a multi-thread coil formed by winding a plurality of strands into multiple threads, It may be a single stranded wire coil formed by winding a stranded wire made by twisting together a single wire into a single thread, or it may be a single stranded wire coil formed by winding a stranded wire made by twisting a plurality of strands together.
  • a metal material such as stainless steel alloy, nickel titanium alloy, nickel chromium alloy, cobalt chromium alloy, tungsten, or platinum.
  • the coil 90 may be a multi-filament stranded wire coil formed by winding multiple threads.
  • the coil 90 is a multi-thread coil made of 16 stainless steel wires wound in multiple threads, but the tip side of the coil 90, that is, the portion corresponding to the first coil portion 91 is rough.
  • the proximal end of the coil 90, that is, the portion corresponding to the second coil portion 92 is tightly wound.
  • the outer surface of the core shaft 1 located on the proximal end side of the coil 90 is coated with a lubricious coating (not shown) such as a PTFE coating or a hydrophilic coating, similar to a general guide wire. .
  • the guide wire 10A of this embodiment does not have a sensor unit, it may have a sensor unit similar to the guide wire 10 according to the above embodiment, for example, on the proximal end side of the second coil portion 92.
  • the lead wire similarly to the guide wire 10, the lead wire may be arranged along the core shaft 1, or the proximal end side of the core shaft 1 may be covered by the outer tube together with the lead wire. .

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  • Engineering & Computer Science (AREA)
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Abstract

A guide wire 10 according to the present invention comprises a core shaft 1 and at least one coil body disposed so as to surround the distal end of the core shaft 1, wherein the at least one coil body includes a first coil section 3 and a second coil section 4 located further toward the base end in the axial direction than the first coil section 3. A coating layer 42 made of a heat-shrinkable tube is formed along the outer circumferential surface of the second coil section 4, whereas a coating layer made of a heat-shrinkable tube is not formed on the first coil section 3. This allows the guide wire to have enhanced rotational compliance while maintaining the flexibility of the distal end of the coil.

Description

ガイドワイヤguide wire
　本発明は、ガイドワイヤに関する。 The present invention relates to a guidewire.
　従来、血管や消化管等の管状器官や体内組織に、治療や検査のためにカテーテル等の医療デバイスを挿入する際、ガイドワイヤが用いられている。一般的に、ガイドワイヤはコア線の先端にコイルが装着され、先端に柔軟性を持たせた構造を有しているが、その一方で、ガイドワイヤには、手元部分（基端部分）を手技者が操作することによって先端部を意図したように回転させられるだけのトルク伝達性を備えることも求められる。 Conventionally, guide wires have been used when inserting medical devices such as catheters into tubular organs such as blood vessels and the gastrointestinal tract or body tissues for treatment or examination. Generally, a guide wire has a structure in which a coil is attached to the tip of the core wire and the tip is flexible. It is also required to have enough torque transmittance to rotate the distal end as intended by the operator's operation.
　ところで、ガイドワイヤの中には、先端部に設けられた円筒状のケーシングにセンサを取り付け、センサに血流等を導入して血液のインピーダンスを測定することで血栓の性状を判別するためのセンサ付きのガイドワイヤがある。このようなガイドワイヤにおいては、センサから伸びるリード線をコア線に沿わせて一体化させるが、このようなリード線を含むガイドワイヤにおいても柔軟性とトルク伝達性の両立が求められる。 By the way, some guidewires have a sensor attached to a cylindrical casing provided at the tip, and a sensor is used to determine the characteristics of a thrombus by introducing blood flow etc. into the sensor and measuring the impedance of the blood. There is a guidewire with a In such a guide wire, a lead wire extending from the sensor is integrated along the core wire, but a guide wire including such a lead wire is also required to have both flexibility and torque transmittance.
　トルク伝達性を高めるために、例えば特許文献１には、先端部に設けられたコイル内部に樹脂を充填したガイドワイヤが開示されている。 In order to improve torque transmittance, for example, Patent Document 1 discloses a guide wire in which the inside of a coil provided at the distal end is filled with resin.
特開２０１０－２１４０５４号公報Japanese Patent Application Publication No. 2010-214054
　特許文献１のようにコイル内に樹脂を充填すると、コイルそのものが担う伝達トルクはコイルが疎巻きになるが故に弱くなり、ガイドワイヤとしてのトルク伝達性は、樹脂のトルク伝達能に依存することになってしまう。ところが、金属に比して樹脂のトルク伝達能は低いので、コイル内に樹脂を充填したとしても、ガイドワイヤの操作性を改善するだけのトルク伝達性の向上にはならないという問題があった。また、コイル内に樹脂が充填されていることにより、ガイドワイヤ先端部の柔軟性が失われてしまうおそれがあった。 When the coil is filled with resin as in Patent Document 1, the transmission torque carried by the coil itself becomes weaker because the coil is loosely wound, and the torque transmission performance as a guide wire depends on the torque transmission ability of the resin. Become. However, since the torque transmission ability of resin is lower than that of metal, there is a problem in that even if the coil is filled with resin, the torque transmission ability will not be improved enough to improve the operability of the guide wire. Furthermore, since the coil is filled with resin, there is a risk that the tip end of the guidewire may lose its flexibility.
　本発明は、このような点に鑑みてなされたものであり、コイル先端の柔軟性を維持しつつ、回転追従性を高めたガイドワイヤを提供することを目的とする。 The present invention has been made in view of these points, and an object of the present invention is to provide a guidewire that maintains the flexibility of the coil tip and has improved rotation followability.
　上記目的を達成するため、本発明は、コアシャフトと、該コアシャフトの先端側を取り囲むように配置された少なくとも１つのコイル体と、を備え、前記少なくとも１つのコイル体が、第１コイル部と、該第１コイル部よりも軸線方向の基端側に配置された第２コイル部と、を含み、前記第２コイル部には、熱収縮性チューブからなる被覆層がその外周面に沿って形成されており、前記第１コイル部には、熱収縮性チューブからなる被覆層が形成されていない、ガイドワイヤを提供する（発明１）。 In order to achieve the above object, the present invention includes a core shaft and at least one coil body disposed so as to surround the distal end side of the core shaft, and the at least one coil body is connected to a first coil section. and a second coil portion disposed on the proximal end side of the first coil portion in the axial direction, and the second coil portion has a coating layer made of a heat-shrinkable tube along its outer peripheral surface. The present invention provides a guidewire in which the first coil portion is not provided with a covering layer made of a heat-shrinkable tube (invention 1).
　かかる発明（発明１）によれば、コアシャフトの先端側に配置されたコイル体の基端側の外周面にのみ被覆層を形成し、かつ被覆層を熱収縮性チューブで形成することによって、コイル体と被覆層とを接着せずに接触するだけの状態にすることで、ガイドワイヤの先端部に設けられたコイル先端の柔軟性を維持しつつ、回転追従性を高めることができる。なお、本発明における第１コイル部及び第２コイル部は、それぞれが別体のコイル体であってもよいし、１つのコイル体がその両方を有するものであってもよい。 According to this invention (invention 1), the coating layer is formed only on the outer peripheral surface of the proximal end of the coil body disposed on the distal end side of the core shaft, and the coating layer is formed of a heat-shrinkable tube. By simply contacting the coil body and the coating layer without adhering them, it is possible to maintain the flexibility of the coil distal end provided at the distal end of the guide wire and improve rotation followability. In addition, the first coil part and the second coil part in the present invention may each be separate coil bodies, or one coil body may have both of them.
　上記発明（発明１）においては、前記第２コイル部が、前記被覆層の外側に形成された親水性被膜層を有することが好ましい（発明２）。 In the above invention (invention 1), it is preferable that the second coil portion has a hydrophilic coating layer formed on the outside of the coating layer (invention 2).
　上記発明（発明１，２）においては、前記第１コイル部と前記第２コイル部との間にセンサユニットが配置されていてもよい（発明３）。 In the above inventions (inventions 1 and 2), a sensor unit may be disposed between the first coil part and the second coil part (invention 3).
　上記発明（発明３）においては、前記センサユニットと外部機器とを電気的に接続する接続ケーブルが、前記少なくとも１つのコイル体の内部に配置されていてもよい（発明４）。 In the above invention (invention 3), a connection cable that electrically connects the sensor unit and an external device may be arranged inside the at least one coil body (invention 4).
　本発明によれば、コイル先端の柔軟性を維持しつつ、回転追従性を高めたガイドワイヤを提供することができる。 According to the present invention, it is possible to provide a guidewire that maintains the flexibility of the coil tip and has improved rotation followability.
本発明の第１実施形態に係るガイドワイヤの構造を示す説明図である。FIG. 1 is an explanatory diagram showing the structure of a guide wire according to a first embodiment of the present invention. 本発明の第２実施形態に係るガイドワイヤの構造を示す説明図である。It is an explanatory view showing the structure of the guide wire concerning a 2nd embodiment of the present invention.
　以下、本発明の実施形態を図面に基づいて説明する。なお、本発明は、以下に説明する実施形態にのみ限定されるものではなく、記載された実施形態はあくまでも本発明の技術的特徴を説明するための例示にすぎない。また、各図面に示す形状や寸法はあくまでも本発明の内容の理解を容易にするために示したものであり、実際の形状や寸法を正しく反映したものではない。 Hereinafter, embodiments of the present invention will be described based on the drawings. Note that the present invention is not limited only to the embodiments described below, and the described embodiments are merely examples for explaining the technical features of the present invention. In addition, the shapes and dimensions shown in each drawing are merely shown to facilitate understanding of the content of the present invention, and do not accurately reflect the actual shapes and dimensions.
＜第１実施形態＞
　図１は第１実施形態に係るガイドワイヤ１０の構造を示す説明図であり、ガイドワイヤ１０の軸方向に沿った横断面を部分的に示す部分断面図となっている。 <First embodiment>
FIG. 1 is an explanatory diagram showing the structure of the guide wire 10 according to the first embodiment, and is a partial sectional view partially showing a cross section of the guide wire 10 along the axial direction.
　本明細書において、「先端側」とは、ガイドワイヤ１０の軸方向に沿う方向であって、ガイドワイヤ１０が治療・検査部位に向かって進行する方向を意味する。「基端側」とは、ガイドワイヤ１０の軸方向に沿う方向であって、上記先端側と反対の方向を意味する。また、「先端」とは、任意の部材または部位における先端側の端部、「基端」とは、任意の部材または部位における基端側の端部をそれぞれ示す。さらに、「先端部」とは、任意の部材または部位において、その先端を含み上記先端から基端側に向かって上記部材等の中途まで延びる部位を指し、「基端部」とは、任意の部材または部位において、その基端を含みこの基端から先端側に向かって上記部材等の中途まで延びる部位を指す。なお、図１においては、図示右側が体内へと挿入される「先端側」であり、図示左側が医師等の手技者によって操作される「基端側」である。 In this specification, the term "distal side" refers to the direction along the axial direction of the guide wire 10, and means the direction in which the guide wire 10 advances toward the treatment/examination site. The term "proximal side" refers to a direction along the axial direction of the guide wire 10, and means a direction opposite to the distal end side. Furthermore, the term "distal end" refers to the distal end of any member or site, and the term "base end" refers to the proximal end of any member or site. Furthermore, the term "distal end" refers to a part of any member or part that includes the distal end and extends from the distal end towards the proximal end to the middle of the member, etc.; Refers to a part of a member or part that includes its base end and extends from the base end toward the distal end to the middle of the member. In FIG. 1, the right side in the figure is the "distal side" that is inserted into the body, and the left side in the figure is the "proximal side" that is operated by a technician such as a doctor.
　図１に示すように、ガイドワイヤ１０は、長尺状のコアシャフト１と、コアシャフト１の先端に取り付けられた先端チップ２と、先端チップ２の基端側において、コアシャフト１の先端側を取り囲むように配置された第１コイル体３及び第２コイル体４と、第１コイル体３と第２コイル体４との間に配置されたセンサユニット５と、センサユニット５と外部機器（不図示）とを電気的に接続するリード線（接続ケーブル）５１とを備えている。第２コイル体４は、第１コイル体３よりもガイドワイヤ１０の軸線方向の基端側に配置されている。第１コイル体３は本発明の「第１コイル部」の一例であり、第２コイル体４は本発明の「第２コイル部」の一例である。すなわち、本実施形態においては、本発明の「少なくとも１つのコイル体」が第１コイル体３及び第２コイル体４という２つのコイル体を含むものであり、本発明の「第１コイル部」が第１コイル体３、「第２コイル部」が第２コイル体４というそれぞれ別体のコイル体となっている。 As shown in FIG. 1, the guide wire 10 includes an elongated core shaft 1, a distal tip 2 attached to the distal end of the core shaft 1, and a proximal end side of the distal tip 2. a first coil body 3 and a second coil body 4 arranged to surround the sensor unit 5 and the sensor unit 5 arranged between the first coil body 3 and the second coil body 4; (not shown). The second coil body 4 is arranged closer to the proximal end of the guide wire 10 than the first coil body 3 in the axial direction. The first coil body 3 is an example of the "first coil section" of the present invention, and the second coil body 4 is an example of the "second coil section" of the present invention. That is, in the present embodiment, "at least one coil body" of the present invention includes two coil bodies, the first coil body 3 and the second coil body 4, and the "first coil section" of the present invention includes two coil bodies, the first coil body 3 and the second coil body 4. The "second coil part" is a first coil body 3, and the "second coil part" is a second coil body 4, which are separate coil bodies.
　ガイドワイヤ１０は、治療や検査のために血管に挿入されるものであり、センサユニット５には血管内の血液のインピーダンスを測定するための抵抗センサ（不図示）が組み込まれている。なお、本発明が適用されるガイドワイヤはこれに限られるものではなく、例えば消化管等の血管以外の生体管腔内に挿入されて用いられるガイドワイヤに本発明を適用することもできる。 The guide wire 10 is inserted into a blood vessel for treatment or examination, and the sensor unit 5 incorporates a resistance sensor (not shown) for measuring the impedance of blood within the blood vessel. Note that the guide wire to which the present invention is applied is not limited to this, and the present invention can also be applied to, for example, a guide wire inserted into a living body lumen other than a blood vessel such as a gastrointestinal tract.
　ガイドワイヤ１０の中心を通る軸は、図１において軸線Ｃで表されており、軸線Ｃは、コアシャフト１や第１コイル体３、第２コイル体４の各中心を通る軸とそれぞれ一致している。 The axis passing through the center of the guide wire 10 is represented by an axis C in FIG. 1, and the axis C coincides with the axis passing through the centers of the core shaft 1, the first coil body 3, and the second coil body 4. ing.
　コアシャフト１は、軸線Ｃに沿って延びる断面が正円形状の長尺状の部材であり、基端から先端に向かって徐々に縮径されていく先細り形状を有している。コアシャフト１は、基端から先端に向かって、第１シャフト部１１、第２シャフト部１２、第３シャフト部１３及び第４シャフト部１４をこの順に有しており、それぞれステンレス合金やニッケルチタン合金、ニッケルクロム合金、コバルトクロム合金、タングステン等の金属材料で形成されている。第１シャフト部１１、第２シャフト部１２、第３シャフト部１３及び第４シャフト部１４は、それぞれ異なる材料を用いて形成されていてもよいし、同じ材料を用いて形成されていてもよい。また、第１シャフト部１１、第２シャフト部１２、第３シャフト部１３及び第４シャフト部１４のそれぞれが、複数の異なる材料を組み合わせた複合材料で形成されていてもよい。 The core shaft 1 is an elongated member with a perfect circular cross section extending along the axis C, and has a tapered shape whose diameter gradually decreases from the base end toward the distal end. The core shaft 1 has a first shaft part 11, a second shaft part 12, a third shaft part 13, and a fourth shaft part 14 in this order from the base end to the distal end, each of which is made of stainless steel or nickel titanium. It is made of metal materials such as alloys, nickel-chromium alloys, cobalt-chromium alloys, and tungsten. The first shaft part 11, the second shaft part 12, the third shaft part 13, and the fourth shaft part 14 may be formed using different materials, or may be formed using the same material. . Moreover, each of the first shaft part 11, the second shaft part 12, the third shaft part 13, and the fourth shaft part 14 may be formed of a composite material that is a combination of a plurality of different materials.
　第１シャフト部１１はコアシャフト１の最も基端側に配置され、ガイドワイヤ１０の軸線Ｃと同軸に延びており、その先端は第２シャフト部１２の基端に溶接されている。第１シャフト部１１は、基端から先端にかけて略一定の外径を有する略円柱形状を有しており、例えば第１シャフト部１１の外径は、第１シャフト部１１の全長に亘って０．２５ｍｍである。 The first shaft portion 11 is disposed at the most proximal end of the core shaft 1 and extends coaxially with the axis C of the guide wire 10, and its distal end is welded to the proximal end of the second shaft portion 12. The first shaft portion 11 has a substantially cylindrical shape with a substantially constant outer diameter from the base end to the distal end. For example, the outer diameter of the first shaft portion 11 is 0 over the entire length of the first shaft portion 11. .25mm.
　第２シャフト部１２は第１シャフト部１１の先端側に配置され、ガイドワイヤ１０の軸線Ｃと同軸に延びており、その先端は第３シャフト部１３の基端に溶接されている。第２シャフト部１２は、基端から先端に向かって徐々に縮径していくテーパ形状（略円錐台形状）を有しており、例えば第２シャフト部１２の外径は、基端部において０．２５ｍｍ、先端部において０．１６ｍｍである。 The second shaft part 12 is arranged on the distal end side of the first shaft part 11 and extends coaxially with the axis C of the guide wire 10, and its distal end is welded to the base end of the third shaft part 13. The second shaft portion 12 has a tapered shape (approximately truncated conical shape) whose diameter gradually decreases from the base end toward the distal end. For example, the outer diameter of the second shaft portion 12 is 0.25 mm, and 0.16 mm at the tip.
　第３シャフト部１３は第２シャフト１２の先端側に配置され、ガイドワイヤ１０の軸線Ｃと同軸に延びており、その先端は第４シャフト部１４の基端に溶接されている。第３シャフト部１３は、基端から先端に向かって徐々に縮径していくテーパ形状（略円錐台形状）を有しており、例えば第３シャフト部１３の外径は、基端部において０．１６ｍｍ、先端部において０．１１ｍｍである。 The third shaft portion 13 is disposed on the distal end side of the second shaft 12 and extends coaxially with the axis C of the guide wire 10, and its distal end is welded to the base end of the fourth shaft portion 14. The third shaft portion 13 has a tapered shape (approximately truncated conical shape) whose diameter gradually decreases from the base end toward the distal end. For example, the outer diameter of the third shaft portion 13 is 0.16 mm, and 0.11 mm at the tip.
　第４シャフト部１４はコアシャフト１の最も先端側に配置され、ガイドワイヤ１０の軸線Ｃと同軸に延びており、その先端は先端チップ２に固着されている。第４シャフト部１４は、基端から先端にかけて略一定の外径を有する略円柱形状を有しており、例えば第４シャフト部１１の外径は、第４シャフト部１４の全長に亘って０．１１ｍｍである。 The fourth shaft portion 14 is disposed at the most distal side of the core shaft 1, extends coaxially with the axis C of the guide wire 10, and has its distal end fixed to the distal tip 2. The fourth shaft part 14 has a substantially cylindrical shape with a substantially constant outer diameter from the base end to the distal end. For example, the outer diameter of the fourth shaft part 11 is 0 over the entire length of the fourth shaft part 14. .11mm.
　なお、第１シャフト部１１、第２シャフト部１２、第３シャフト部１３、第４シャフト部１４の外径、軸線Ｃ方向の長さ及び横断面形状は任意に決定できる。 Note that the outer diameters, lengths in the axis C direction, and cross-sectional shapes of the first shaft portion 11, second shaft portion 12, third shaft portion 13, and fourth shaft portion 14 can be arbitrarily determined.
　先端チップ２は、コアシャフト１０の先端と第１コイル体３の先端とを一体的に保持しているものであり、ガイドワイヤ１０の最も先端に配置されている。先端チップ２は、任意の接合剤、例えば銀ロウ、金ロウ、亜鉛、Ｓｎ―Ａｇ合金、Ａｕ―Ｓｎ合金等の金属はんだや、エポキシ系接着剤等の接着剤によって形成される。 The distal tip 2 integrally holds the distal end of the core shaft 10 and the distal end of the first coil body 3, and is disposed at the most distal end of the guide wire 10. The tip 2 is formed of any bonding agent, for example, metal solder such as silver solder, gold solder, zinc, Sn--Ag alloy, Au--Sn alloy, or adhesive such as epoxy adhesive.
　第１コイル体３は、内側コイル３１の外側に外側コイル３２が配置された２層構造のコイル体となっており、コアシャフト１の第４シャフト部１４の外側に配置されている。第１コイル体３の先端は先端チップ２にはんだ付けされており、第１コイル体３の基端は、後述するセンサユニット５に接着剤で接着されている。第１コイル体３の外周面には熱収縮性チューブからなる被覆層が形成されていない。本実施形態においては、第１コイル体３の外径は約０．３５ｍｍ、軸線Ｃ方向の長さは約３０ｍｍである。 The first coil body 3 has a two-layer structure in which an outer coil 32 is arranged outside an inner coil 31, and is arranged outside the fourth shaft portion 14 of the core shaft 1. The tip of the first coil body 3 is soldered to the tip tip 2, and the base end of the first coil body 3 is bonded to a sensor unit 5, which will be described later, with an adhesive. A coating layer made of a heat-shrinkable tube is not formed on the outer peripheral surface of the first coil body 3. In this embodiment, the outer diameter of the first coil body 3 is approximately 0.35 mm, and the length in the direction of the axis C is approximately 30 mm.
　内側コイル３１は、例えばステンレス合金やニッケルチタン合金、ニッケルクロム合金、コバルトクロム合金、タングステン、プラチナ等の金属材料で形成された素線を螺旋状に巻回して形成される略円筒形状のコイルであり、１本の素線を単条に巻回して形成される単条コイルであってもよく、複数本の素線を多条に巻回して形成される多条コイルであってもよく、複数本の素線を撚り合せた撚線を単条に巻回して形成される単条撚線コイルであってもよく、複数本の素線を撚り合せた撚線を複数用い、各撚線を多条に巻回して形成される多条撚線コイルであってもよい。本実施形態においては、内側コイル３１は、６本のステンレス合金製の素線を多条巻きにした多条コイルである。 The inner coil 31 is a substantially cylindrical coil formed by spirally winding a wire made of a metal material such as stainless steel alloy, nickel titanium alloy, nickel chromium alloy, cobalt chromium alloy, tungsten, or platinum. Yes, it may be a single coil formed by winding one strand into a single thread, or it may be a multi-thread coil formed by winding a plurality of strands into multiple threads. It may be a single stranded wire coil formed by winding a stranded wire made by twisting a plurality of strands together into a single thread, or by using a plurality of stranded wires made by twisting a plurality of strands, each stranded wire is It may be a multi-filament stranded wire coil formed by winding the wire into multiple threads. In this embodiment, the inner coil 31 is a multi-thread coil made of six stainless steel wires wound in multiple threads.
　外側コイル３２は、例えばステンレス合金やニッケルチタン合金、ニッケルクロム合金、コバルトクロム合金、タングステン、プラチナ等の金属材料で形成された素線を螺旋状に巻回して形成される略円筒形状のコイルであり、１本の素線を単条に巻回して形成される単条コイルであってもよく、複数本の素線を多条に巻回して形成される多条コイルであってもよく、複数本の素線を撚り合せた撚線を単条に巻回して形成される単条撚線コイルであってもよく、複数本の素線を撚り合せた撚線を複数用い、各撚線を多条に巻回して形成される多条撚線コイルであってもよい。本実施形態においては、１本のプラチナ製の素線を単条巻きにした単条コイルである。 The outer coil 32 is a substantially cylindrical coil formed by spirally winding a wire made of a metal material such as stainless steel alloy, nickel titanium alloy, nickel chromium alloy, cobalt chromium alloy, tungsten, or platinum. Yes, it may be a single coil formed by winding one strand into a single thread, or it may be a multi-thread coil formed by winding a plurality of strands into multiple threads. It may be a single stranded wire coil formed by winding a stranded wire made by twisting a plurality of strands together into a single thread, or by using a plurality of stranded wires made by twisting a plurality of strands, each stranded wire is It may be a multi-filament stranded wire coil formed by winding the wire into multiple threads. In this embodiment, it is a single coil made by winding a single platinum wire into a single coil.
　第２コイル体４は、コイル４１の外側に被覆層４２が配置された構造となっており、コアシャフト１の第３シャフト部１３の外側に配置されている。第２コイル体４の先端は、後述するセンサユニット５に接着剤で接着されており、第２コイル体４の基端は、コアシャフト１及び後述するアウターチューブ６に接着剤で接着されている。被覆層４２は、熱収縮性チューブをコイル４１の外周面に被せ、熱を加えることによってその熱収縮性チューブを収縮させて形成されたものである。すなわち、第２コイル体４には、熱収縮性チューブからなる被覆層４２がコイル４１の外周面に沿って形成されている。被覆層４２は、両端部を除いてコイル４１に接着されてはおらず、コイル４１を外側から締め付けるようにその外周面に接触している。本実施形態においては、第２コイル体４の外径は約０．３４ｍｍ、軸線Ｃ方向の長さは約２７０ｍｍである。 The second coil body 4 has a structure in which a coating layer 42 is placed on the outside of the coil 41, and is placed outside the third shaft portion 13 of the core shaft 1. The tip of the second coil body 4 is glued to a sensor unit 5, which will be described later, and the base end of the second coil body 4 is glued to the core shaft 1 and an outer tube 6, which will be described later. . The covering layer 42 is formed by covering the outer peripheral surface of the coil 41 with a heat-shrinkable tube and shrinking the heat-shrinkable tube by applying heat. That is, in the second coil body 4, a covering layer 42 made of a heat-shrinkable tube is formed along the outer peripheral surface of the coil 41. The covering layer 42 is not bonded to the coil 41 except at both ends, and is in contact with the outer circumferential surface of the coil 41 so as to tighten the coil 41 from the outside. In this embodiment, the outer diameter of the second coil body 4 is approximately 0.34 mm, and the length in the direction of the axis C is approximately 270 mm.
　コイル４１は、例えばステンレス合金やニッケルチタン合金、ニッケルクロム合金、コバルトクロム合金、タングステン、プラチナ等の金属材料で形成された素線を螺旋状に巻回して形成される略円筒形状のコイルであり、１本の素線を単条に巻回して形成される単条コイルであってもよく、複数本の素線を多条に巻回して形成される多条コイルであってもよく、複数本の素線を撚り合せた撚線を単条に巻回して形成される単条撚線コイルであってもよく、複数本の素線を撚り合せた撚線を複数用い、各撚線を多条に巻回して形成される多条撚線コイルであってもよい。本実施形態においては、コイル４１は、１６本のステンレス合金製の素線を多条巻きにした多条コイルである。 The coil 41 is a substantially cylindrical coil formed by spirally winding a wire made of a metal material such as stainless steel alloy, nickel titanium alloy, nickel chromium alloy, cobalt chromium alloy, tungsten, or platinum. , it may be a single coil formed by winding one strand into a single thread, or it may be a multi-thread coil formed by winding a plurality of strands into multiple threads, It may be a single stranded wire coil formed by winding a stranded wire made by twisting together a single wire into a single thread, or it may be a single stranded wire coil formed by winding a stranded wire made by twisting a plurality of strands together. It may be a multi-filament stranded wire coil formed by winding multiple threads. In this embodiment, the coil 41 is a multi-thread coil made of 16 stainless steel wires wound in multiple threads.
　被覆層４２を形成する熱収縮性チューブは、熱を加えることによって収縮する性質を有する樹脂製チューブであれば特に限定されないが、薄くても強度に優れた樹脂製チューブであることが好ましく、例えば、ＰＥＴ（ポリエチレンテレフタラート）製フィルムを円筒状にして形成されたチューブを用いることができる。 The heat-shrinkable tube that forms the coating layer 42 is not particularly limited as long as it is a resin tube that has the property of shrinking when heated, but it is preferably a resin tube that is thin but has excellent strength, such as , a tube formed by making a PET (polyethylene terephthalate) film into a cylindrical shape can be used.
　被覆層４２を形成する熱収縮性チューブとしては、フィルム厚が１０μｍ以下の薄肉チューブを用いることが好ましく、フィルム厚が５μｍ以下であることがより好ましい。フィルム厚が１０μｍを超えると、被覆層４２が配置された第２コイル体４の剛性が高くなりすぎてしまい、血管追従性に支障をきたすおそれがある。 As the heat-shrinkable tube forming the coating layer 42, it is preferable to use a thin tube with a film thickness of 10 μm or less, and more preferably a film thickness of 5 μm or less. When the film thickness exceeds 10 μm, the rigidity of the second coil body 4 on which the coating layer 42 is disposed becomes too high, which may impede blood vessel followability.
　被覆層４２は、必ずしも第２コイル体４の全長に亘って形成されていなくともよく、例えば第２コイル体４の基端部や先端部において被覆層４２が形成されていない箇所があってもよい。 The coating layer 42 does not necessarily have to be formed over the entire length of the second coil body 4. For example, even if there is a portion where the coating layer 42 is not formed at the base end or the distal end of the second coil body 4. good.
　センサユニット５は、例えば略円柱状のハウジングの外周面に、抵抗センサを貼り付けて構成され、第１コイル体３と第２コイル体４との間に配置されている。センサユニット５は、ハウジングの中心軸線に沿ってコアシャフト１がハウジングを貫通するように、コアシャフト１に固定されている。なお、本実施形態のセンサユニット５は、血管内の血液のインピーダンスを測定するものであるが、これに限られず他の情報を取得するセンサユニットを用いてもよい。 The sensor unit 5 is configured by, for example, pasting a resistance sensor on the outer peripheral surface of a substantially cylindrical housing, and is arranged between the first coil body 3 and the second coil body 4. The sensor unit 5 is fixed to the core shaft 1 so that the core shaft 1 passes through the housing along the central axis of the housing. Note that although the sensor unit 5 of this embodiment measures the impedance of blood within a blood vessel, it is not limited thereto, and a sensor unit that acquires other information may be used.
　センサユニット５の先端と第１コイル体３の基端、センサユニット５の基端と第２コイル体４の先端は、それぞれ接着剤によって接着されている。センサユニット５の周辺に熱をかけてしまうと抵抗センサの破損や故障を引き起こすおそれがあるため、センサユニット５と第１コイル体３及び第２コイル体４とは、はんだ付けではなく、接着剤を用いて接着することで固着させている。 The distal end of the sensor unit 5 and the proximal end of the first coil body 3, and the proximal end of the sensor unit 5 and the distal end of the second coil body 4 are each bonded with an adhesive. Applying heat to the area around the sensor unit 5 may cause damage or malfunction of the resistance sensor, so the sensor unit 5, first coil body 3, and second coil body 4 are connected using adhesive rather than soldering. It is fixed by gluing it using.
　リード線５１は、センサユニット５と外部機器（不図示）とを電気的に接続する接続ケーブルであり、センサユニット５からコアシャフト１に沿って第２コイル体４のコイル４１の内部に導入され、コイル４１の内部から第１アウターチューブ６ａ及び第２アウターチューブ６ｂの内部を経て、ガイドワイヤ１０の基端から外部へと引き出されるように配置されている。 The lead wire 51 is a connection cable that electrically connects the sensor unit 5 and an external device (not shown), and is introduced into the coil 41 of the second coil body 4 from the sensor unit 5 along the core shaft 1. , is arranged so as to be drawn out from the inside of the coil 41, through the inside of the first outer tube 6a and the second outer tube 6b, and from the proximal end of the guide wire 10 to the outside.
　第２コイル体４の基端側には、コアシャフト１の第１シャフト部１１及び第２シャフト部１２を覆うように、アウターチューブ６が配置されている。第２コイル体４の基端は第１アウターチューブ６ａの先端に接着剤を用いて接着されており、第１アウターチューブ６ａの基端は第２アウターチューブ６ｂの先端に挿し込まれた状態で接着剤を用いて接着されている。第２アウターチューブ６ｂの基端には、医師等の手技者によって操作されるコネクタ（不図示）が、ロウ付けや接着剤による接着等の公知の固着手段で取り付けられる。 An outer tube 6 is arranged on the base end side of the second coil body 4 so as to cover the first shaft part 11 and the second shaft part 12 of the core shaft 1. The proximal end of the second coil body 4 is bonded to the distal end of the first outer tube 6a using an adhesive, and the proximal end of the first outer tube 6a is inserted into the distal end of the second outer tube 6b. It is attached using adhesive. A connector (not shown) operated by a technician such as a doctor is attached to the base end of the second outer tube 6b by known fixing means such as brazing or adhesive bonding.
　アウターチューブ６（第１アウターチューブ６ａ及び第２アウターチューブ６ｂ）は、摩擦係数の低い摺動性に優れた樹脂製チューブであることが好ましく、例えば、ＰＩ（ポリイミド）チューブを用いることができる。本実施形態においては、第１アウターチューブ６ａの外径は約０．３０ｍｍ、軸線Ｃ方向の長さは約２０ｍｍであり、第２アウターチューブ６ｂの外径は約０．３５ｍｍ、軸線Ｃ方向の長さは約１６００ｍｍである。なお、アウターチューブ６は、単一の樹脂材料で形成されていてもよいし、複数の領域に分けてそれぞれ特性の異なる複数の樹脂材料を用いて形成されていてもよい。 The outer tube 6 (first outer tube 6a and second outer tube 6b) is preferably a resin tube with a low coefficient of friction and excellent sliding properties, and for example, a PI (polyimide) tube can be used. In this embodiment, the first outer tube 6a has an outer diameter of about 0.30 mm and a length in the axis C direction of about 20 mm, and the second outer tube 6b has an outer diameter of about 0.35 mm and a length in the axis C direction. The length is approximately 1600mm. Note that the outer tube 6 may be formed of a single resin material, or may be divided into a plurality of regions and formed using a plurality of resin materials each having different characteristics.
　ガイドワイヤ１０は、血管内での動きを円滑にするために、親水性コーティング剤によってコーティングされている。親水性コーティング剤としては、例えば、セルロース系高分子物質、ポリエチレンオキサイド系高分子物質、無水マレイン酸系高分子物質（例えば、メチルビニルエーテル―無水マレイン酸共重合体等の無水マレイン酸共重合体）、アクリルアミド系高分子物質（例えば、ポリアクリルアミド、ポリグリシジルメタクリレート―ジメチルアクリルアミドのブロック共重合体）、水溶性ナイロン、ポリビニルアルコール、ポリビニルピロリドン、ヒアルロン酸塩等の親水性材料を用いたコーティング剤を使用することができる。 The guide wire 10 is coated with a hydrophilic coating agent to facilitate movement within the blood vessel. Examples of hydrophilic coating agents include cellulose-based polymers, polyethylene oxide-based polymers, and maleic anhydride-based polymers (e.g., maleic anhydride copolymers such as methyl vinyl ether-maleic anhydride copolymers). , coating agents using hydrophilic materials such as acrylamide-based polymer substances (e.g., polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide block copolymers), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone, hyaluronate, etc. can do.
　本実施形態においては、ガイドワイヤ１０の先端チップ２から第１コイル体３、センサユニット５を経て第２コイル体４の先端部（センサユニット５の基端から約５ｍｍの位置）までの外周面に第１親水性皮膜層７が形成されており、第２コイル体４の第１親水性皮膜層７が形成されている部分よりも基端側で、アウターチューブ６にかけての外周面には第２親水性皮膜層８が形成されている。つまり、第１コイル体３には、外側コイル３２の外周面に第１親水性皮膜層７が直接形成されており、第２コイル体４には、コイル４１の外周面に沿って形成されている被覆層４２の外側に、第１親水性皮膜層７又は第２親水性皮膜層８が形成されていることになる。 In this embodiment, the outer peripheral surface from the distal tip 2 of the guide wire 10 to the distal end of the second coil body 4 (approximately 5 mm from the proximal end of the sensor unit 5) via the first coil body 3 and the sensor unit 5. A first hydrophilic film layer 7 is formed on the outer tube 6, and a first hydrophilic film layer 7 is formed on the outer peripheral surface of the outer tube 6 on the proximal side of the part of the second coil body 4 where the first hydrophilic film layer 7 is formed. Two hydrophilic film layers 8 are formed. That is, in the first coil body 3, the first hydrophilic film layer 7 is formed directly on the outer circumferential surface of the outer coil 32, and in the second coil body 4, the first hydrophilic film layer 7 is formed along the outer circumferential surface of the coil 41. The first hydrophilic film layer 7 or the second hydrophilic film layer 8 is formed on the outside of the covering layer 42.
　第１親水性皮膜層７は第２親水性皮膜層８よりも層厚が薄く形成されており、本実施形態においては、第２親水性皮膜層８は層厚が約２－３μであるが、第１親水性皮膜層７の層厚は１μ以下である。これによってガイドワイヤ１０の先端部、つまり先端チップ２から第１コイル体３にかけての部分の柔軟性が確保されている。なお、図１においては、第１親水性皮膜層７と第１コイル体３との間や、第２親水性皮膜層８と第１アウターチューブ６ａとの間に隙間があるように表されているが、実際にはこのような隙間が形成されることはなく、第１コイル体３、センサユニット５、第２コイル体４、第１アウターチューブ６ａ及び第２アウターチューブ６ｂの外周面が第１親水性皮膜層７又は第２親水性皮膜層８によってコーティングされる。また、第２親水性皮膜層８は第２アウターチューブ６ｂの全長に亘って形成されていなくともよい。 The first hydrophilic film layer 7 is formed thinner than the second hydrophilic film layer 8, and in this embodiment, the second hydrophilic film layer 8 has a layer thickness of about 2-3 μm. , the layer thickness of the first hydrophilic film layer 7 is 1 μm or less. This ensures the flexibility of the distal end of the guide wire 10, that is, the portion from the distal tip 2 to the first coil body 3. In addition, in FIG. 1, it is shown that there is a gap between the first hydrophilic film layer 7 and the first coil body 3, and between the second hydrophilic film layer 8 and the first outer tube 6a. However, in reality, such a gap is not formed, and the outer peripheral surfaces of the first coil body 3, sensor unit 5, second coil body 4, first outer tube 6a, and second outer tube 6b are It is coated with a first hydrophilic film layer 7 or a second hydrophilic film layer 8 . Further, the second hydrophilic film layer 8 does not need to be formed over the entire length of the second outer tube 6b.
　以上説明したようなガイドワイヤ１０は、コアシャフト１の先端側に配置されたコイル体のうち、第２コイル体４のコイル４１の外周面にのみ被覆層４２を形成し、かつ被覆層４２を熱収縮性チューブで形成することによって、第２コイル体４と被覆層４２とを接着せずに接触するだけの状態にすることで、ガイドワイヤ１０の先端部に設けられたコイル先端の柔軟性を維持しつつ、回転追従性を高めることができる。これは、第２コイル体４を被覆層４２が締め付けるように被覆することで、コイル４１の径方向及び長さ方向に圧縮圧力がかかり、コイル４１を構成する素線間の密着性が増すことに起因しており、素線間の密着性が増せば、それだけトルク伝達性が高くなり、回転追従性を改善することにつながる。一方、第１コイル体３は、熱収縮性チューブからなる被覆層がその外周面に沿って形成されていないため、その動きが規制されないこととなり、コイル先端の柔軟性は維持される。また一般的に、コイル体のトルク伝達性には回転方向によって差が生じるが、熱収縮性チューブからなる被覆層４２で第２コイル体４を被覆することで、その差を軽減させることが可能となる。 The guide wire 10 as described above has the coating layer 42 formed only on the outer circumferential surface of the coil 41 of the second coil body 4 among the coil bodies disposed on the distal end side of the core shaft 1, and By forming the second coil body 4 with a heat-shrinkable tube so that the second coil body 4 and the coating layer 42 are in contact with each other without adhesion, the flexibility of the coil tip provided at the tip of the guide wire 10 can be improved. It is possible to improve rotation followability while maintaining the following. This is because by covering the second coil body 4 with the coating layer 42 so as to tighten it, compressive pressure is applied in the radial direction and length direction of the coil 41, and the adhesion between the wires forming the coil 41 increases. This is due to the fact that the greater the adhesion between the wires, the higher the torque transmission, which leads to improved rotation followability. On the other hand, since the first coil body 3 has no coating layer made of a heat-shrinkable tube formed along its outer peripheral surface, its movement is not restricted, and the flexibility of the coil tip is maintained. Generally, there are differences in the torque transmittance of the coil body depending on the rotation direction, but this difference can be reduced by covering the second coil body 4 with the coating layer 42 made of a heat-shrinkable tube. becomes.
　さらに、親水性コーティング剤によるコーティングは、コイルの外周面にそのままコーティングするよりも、被覆層（熱収縮性チューブ）上にコーティングした方が、コーティング剤の密着性が向上するため、よりガイドワイヤの滑り特性の改善が期待できる。 Furthermore, when coating with a hydrophilic coating agent, the adhesion of the coating agent improves when coating the coating layer (heat-shrinkable tube) rather than directly coating the outer circumferential surface of the coil, so it is easier to coat the guidewire. Improvements in slip characteristics can be expected.
＜第２実施形態＞
　図２は第２実施形態に係るガイドワイヤ１０Ａの構造を示す説明図であり、ガイドワイヤ１０Ａの軸方向に沿った横断面を部分的に示す部分断面図となっている。以下においては、第１実施形態との相違点を中心に説明し、第１実施形態と同様の構造については説明を省略する。 <Second embodiment>
FIG. 2 is an explanatory view showing the structure of the guide wire 10A according to the second embodiment, and is a partial sectional view partially showing a cross section of the guide wire 10A along the axial direction. In the following, differences from the first embodiment will be mainly described, and descriptions of structures similar to the first embodiment will be omitted.
　図２に示すように、ガイドワイヤ１０Ａは、長尺状のコアシャフト１と、コアシャフト１の先端に取り付けられた先端チップ２と、先端チップ２の基端側において、コアシャフト１の先端側を取り囲むように配置されたコイル体９とを備えている。ガイドワイヤ１０Ａは、コアシャフト１の先端部にコイル体９を１つだけ備えている点、センサユニットやリード線は備えていない点、親水性コーティング剤によってコーティングされていない点、基端側のコアシャフト１がアウターチューブで被覆されていない点で第１実施形態のガイドワイヤ１０とは異なる。 As shown in FIG. 2, the guide wire 10A includes an elongated core shaft 1, a distal tip 2 attached to the distal end of the core shaft 1, and a proximal end side of the distal tip 2. A coil body 9 is arranged so as to surround the coil body 9. The guide wire 10A includes only one coil body 9 at the distal end of the core shaft 1, has no sensor unit or lead wire, is not coated with a hydrophilic coating agent, and has the following features: This differs from the guide wire 10 of the first embodiment in that the core shaft 1 is not covered with an outer tube.
　コイル体９は、第１コイル部９１と、第１コイル部９１よりも軸線方向の基端側に配置された第２コイル部９２とを有する。第１コイル部９１は、第１実施形態における第１コイル体３に対応するものであり、コイル体９のコイル９０の外周面に熱収縮性チューブからなる被覆層が形成されていない部分である。また、第２コイル部９２は、第１実施形態における第２コイル体４に対応するものであり、コイル体９のコイル９０の外周面に熱収縮性チューブからなる被覆層９２１が形成されている部分である。すなわち、本実施形態においては、本発明の「少なくとも１つのコイル体」がコイル体９という単一のコイル体によって実現されており、コイル体９が有する第１コイル部９１及び第２コイル部９２が、それぞれ本発明の「第１コイル部」及び「第２コイル部」に相当するものである。 The coil body 9 has a first coil part 91 and a second coil part 92 arranged closer to the proximal end side than the first coil part 91 in the axial direction. The first coil portion 91 corresponds to the first coil body 3 in the first embodiment, and is a portion where a coating layer made of a heat-shrinkable tube is not formed on the outer peripheral surface of the coil 90 of the coil body 9. . Further, the second coil portion 92 corresponds to the second coil body 4 in the first embodiment, and a coating layer 921 made of a heat-shrinkable tube is formed on the outer peripheral surface of the coil 90 of the coil body 9. It is a part. That is, in this embodiment, "at least one coil body" of the present invention is realized by a single coil body called the coil body 9, and the first coil part 91 and the second coil part 92 that the coil body 9 has These correspond to the "first coil section" and "second coil section" of the present invention, respectively.
　コイル９０は、例えばステンレス合金やニッケルチタン合金、ニッケルクロム合金、コバルトクロム合金、タングステン、プラチナ等の金属材料で形成された素線を螺旋状に巻回して形成される略円筒形状のコイルであり、１本の素線を単条に巻回して形成される単条コイルであってもよく、複数本の素線を多条に巻回して形成される多条コイルであってもよく、複数本の素線を撚り合せた撚線を単条に巻回して形成される単条撚線コイルであってもよく、複数本の素線を撚り合せた撚線を複数用い、各撚線を多条に巻回して形成される多条撚線コイルであってもよい。本実施形態においては、コイル９０は、１６本のステンレス合金製の素線を多条巻きにした多条コイルであるが、コイル９０の先端側、つまり第１コイル部９１に相当する部分は粗巻きになっており、コイル９０の基端側、つまり第２コイル部９２に相当する部分は密巻きになっている。なお、コイル９０よりも基端側に位置するコアシャフト１の外表面には、一般的なガイドワイヤと同様に、ＰＴＦＥコーティングや親水性コーティング等の潤滑性コーティング（不図示）が施されている。 The coil 90 is a substantially cylindrical coil formed by spirally winding a wire made of a metal material such as stainless steel alloy, nickel titanium alloy, nickel chromium alloy, cobalt chromium alloy, tungsten, or platinum. , it may be a single coil formed by winding one strand into a single thread, or it may be a multi-thread coil formed by winding a plurality of strands into multiple threads, It may be a single stranded wire coil formed by winding a stranded wire made by twisting together a single wire into a single thread, or it may be a single stranded wire coil formed by winding a stranded wire made by twisting a plurality of strands together. It may be a multi-filament stranded wire coil formed by winding multiple threads. In this embodiment, the coil 90 is a multi-thread coil made of 16 stainless steel wires wound in multiple threads, but the tip side of the coil 90, that is, the portion corresponding to the first coil portion 91 is rough. The proximal end of the coil 90, that is, the portion corresponding to the second coil portion 92 is tightly wound. Note that the outer surface of the core shaft 1 located on the proximal end side of the coil 90 is coated with a lubricious coating (not shown) such as a PTFE coating or a hydrophilic coating, similar to a general guide wire. .
　本実施形態のガイドワイヤ１０Ａはセンサユニットを有していないが、上記実施形態に係るガイドワイヤ１０と同様のセンサユニットを、例えば第２コイル部９２の基端側に有していてもよく、その場合には、ガイドワイヤ１０と同様に、リード線がコアシャフト１に沿うように配置されていてもよいし、コアシャフト１の基端側をリード線とともにアウターチューブが被覆していてもよい。 Although the guide wire 10A of this embodiment does not have a sensor unit, it may have a sensor unit similar to the guide wire 10 according to the above embodiment, for example, on the proximal end side of the second coil portion 92. In that case, similarly to the guide wire 10, the lead wire may be arranged along the core shaft 1, or the proximal end side of the core shaft 1 may be covered by the outer tube together with the lead wire. .
　以上、本発明に係るガイドワイヤについて図面に基づいて説明してきたが、本発明は上記実施形態に限定されることはなく、種々の変更実施が可能である。 Although the guide wire according to the present invention has been described above based on the drawings, the present invention is not limited to the above embodiments, and various modifications can be made.
１０　ガイドワイヤ
　１　コアシャフト
　２　先端チップ
　３　第１コイル体
　　３１　内側コイル
　　３２　外側コイル
　４　第２コイル体
　　４１　コイル
　　４２　被覆層
　５　センサユニット
　５１　リード線
　６　アウターチューブ
　７　第１親水性皮膜層
　８　第２親水性皮膜層
１０Ａ　ガイドワイヤ
　９　コイル体
　　９１　第１コイル部
　　９２　第２コイル部 10 Guide wire 1 Core shaft 2 Tip tip 3 First coil body 31 Inner coil 32 Outer coil 4 Second coil body 41 Coil 42 Covering layer 5 Sensor unit 51 Lead wire 6 Outer tube 7 First hydrophilic film layer 8 Second hydrophilic sexual coating layer 10A guide wire 9 coil body 91 first coil part 92 second coil part

Claims (4)

  1. 　コアシャフトと、該コアシャフトの先端側を取り囲むように配置された少なくとも１つのコイル体と、を備え、
    　前記少なくとも１つのコイル体が、第１コイル部と、該第１コイル部よりも軸線方向の基端側に配置された第２コイル部と、を有し、
    　前記第２コイル部には、熱収縮性チューブからなる被覆層がその外周面に沿って形成されており、
    　前記第１コイル部には、熱収縮性チューブからなる被覆層が形成されていない、ガイドワイヤ。     comprising a core shaft and at least one coil body disposed so as to surround the distal end side of the core shaft,
    The at least one coil body has a first coil part and a second coil part disposed on the proximal end side of the first coil part in the axial direction,
    A covering layer made of a heat-shrinkable tube is formed along the outer peripheral surface of the second coil portion,
    A guide wire in which a covering layer made of a heat-shrinkable tube is not formed on the first coil portion.
  2. 　前記第２コイル部が、前記被覆層の外側に形成された親水性被膜層を有する、請求項１に記載のガイドワイヤ。 The guidewire according to claim 1, wherein the second coil portion has a hydrophilic coating layer formed outside the coating layer.
  3. 　前記第１コイル部と前記第２コイル部との間にセンサユニットが配置されている、請求項１及び２に記載のガイドワイヤ。 The guide wire according to Claims 1 and 2, wherein a sensor unit is disposed between the first coil part and the second coil part.
  4. 　前記センサユニットと外部機器とを電気的に接続する接続ケーブルが、前記少なくとも１つのコイル体の内部に配置されている、請求項３に記載のガイドワイヤ。 The guide wire according to claim 3, wherein a connection cable that electrically connects the sensor unit and an external device is arranged inside the at least one coil body.
PCT/JP2023/019857 2022-06-27 2023-05-29 Guide wire WO2024004479A1 (en)

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JP2022102706A JP2024003512A (en) 2022-06-27 2022-06-27 guide wire
JP2022-102706 2022-06-27

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004514508A (en) * 2000-12-01 2004-05-20 マイクラス　コーポレイション Multilayer guidewire
US20070293791A1 (en) * 2006-06-16 2007-12-20 Jeong Lee Guidewire With Lubricious Proximal Portion
JP2016518870A (en) * 2013-03-12 2016-06-30 ガイデッド インターヴェンションズ， インコーポレイテッド System including a guide wire for detecting fluid pressure

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004514508A (en) * 2000-12-01 2004-05-20 マイクラス　コーポレイション Multilayer guidewire
US20070293791A1 (en) * 2006-06-16 2007-12-20 Jeong Lee Guidewire With Lubricious Proximal Portion
JP2016518870A (en) * 2013-03-12 2016-06-30 ガイデッド インターヴェンションズ， インコーポレイテッド System including a guide wire for detecting fluid pressure

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