WO2024029585A1 - Fil-guide - Google Patents

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Publication number
WO2024029585A1
WO2024029585A1 PCT/JP2023/028368 JP2023028368W WO2024029585A1 WO 2024029585 A1 WO2024029585 A1 WO 2024029585A1 JP 2023028368 W JP2023028368 W JP 2023028368W WO 2024029585 A1 WO2024029585 A1 WO 2024029585A1
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WO
WIPO (PCT)
Prior art keywords
core shaft
electrode
guide wire
electric element
ultrasonic sensor
Prior art date
Application number
PCT/JP2023/028368
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English (en)
Japanese (ja)
Inventor
健太 加藤
剛 中山
健太 中村
将弘 江崎
誠 西岸
尚史 安田
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 WO2024029585A1 publication Critical patent/WO2024029585A1/fr

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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 technology disclosed herein relates to a guidewire.
  • the doctor performing the procedure uses an X-ray fluoroscope to contrast the coronary arteries and uses images of the blood vessels to guide the guide wire to the stenotic or occluded area (hereinafter referred to as the "lesion area").
  • the guidewire serves as a kind of rail to carry the subsequent balloon catheter or stent to the lesion, and whether the guidewire passes through the lesion greatly contributes to the success rate of the procedure. .
  • Guide wires are known that have an ultrasonic sensor attached to their distal end in order to assist in diagnosing a lesion (see, for example, Patent Documents 1 and 2).
  • the user inserts the guide wire into the lesion while monitoring the hardness and blood flow inside the lesion and surrounding body detected by the ultrasonic sensor.
  • these guide wires include a core shaft, an exterior body that covers the outer periphery of the core shaft, an ultrasonic sensor element disposed between the core shaft and the exterior body, and a pair of ultrasonic sensor elements having a distal end.
  • the structure includes a pair of signal lines connected to the electrodes and arranged along the core shaft.
  • This specification discloses a technique that can solve the above-mentioned problems.
  • the guidewire disclosed in this specification is a guidewire that includes a conductive core shaft, an exterior body that covers the outer periphery of the core shaft, and a first an electrical element having an electrode and a second electrode; a signal line disposed along the core shaft and having a tip end electrically connected to the first electrode of the electrical element; a connecting portion that electrically connects the second electrode and the core shaft.
  • the first electrode of the electric element is electrically connected to the tip of the signal line disposed along the core shaft, and the second electrode of the electric element is electrically connected to the core shaft. It is connected to the. That is, the core shaft functions as a signal transmission section. Therefore, according to the present guidewire, the wiring structure of the guidewire can be simplified compared to, for example, a configuration in which a pair of electrodes of an electric element are each connected via a signal line.
  • the guidewire disclosed in this specification is a guidewire, and includes a conductive core shaft, an outer casing that covers the outer periphery of the core shaft, an outer periphery of the core shaft, and an outer periphery of the outer casing. an electric element located between a surface and having a first electrode and a second electrode; and an electric element disposed along the core shaft, the distal end portion of which is electrically connected to the first electrode of the electric element. and a connecting portion that electrically connects the second electrode of the electric element and the core shaft.
  • the wiring structure of the guidewire can be simplified compared to, for example, a configuration in which a pair of electrodes of an electric element are each connected via a signal line.
  • the signal line may be a lead wire.
  • the wiring structure of the guide wire can be simplified compared to a configuration in which a pair of electrodes of an electric element are each connected via a signal line due to the relatively simple configuration.
  • the second electrode of the electric element may be a ground electrode. According to the present guidewire, electrical fluctuations in the core shaft or a portion electrically connected to the core shaft can be suppressed.
  • the connecting portion may have a conductive distal tip joined to the distal end portion of the core shaft.
  • the second electrode of the electric element and the core shaft are electrically connected using the distal tip. Therefore, according to the present guidewire, the electrical connection structure between the second electrode and the core shaft is superior to that in which the second electrode and the core shaft are electrically connected without using the distal tip, for example. can be simplified.
  • the guide wire further includes a flexible substrate having a distal end electrically connected to the distal tip and a proximal end electrically connected to the second electrode of the electric element, and the flexible substrate
  • the structure may include a reinforcing member disposed along at least one side of the distal end portion and joined to the distal tip. According to the present guidewire, the reinforcing member can prevent the flexible substrate from detaching from the distal tip.
  • the portion of the flexible substrate that overlaps the proximal end of the reinforcing member in the radial direction of the core shaft has a tapered shape that becomes wider toward the proximal end.
  • a certain configuration may also be used.
  • the rigidity gap caused by the presence or absence of the reinforcing member at the proximal end of the reinforcing member can be reduced by the tapered shape of the flexible substrate.
  • the guide wire further includes a flexible substrate having a distal end electrically connected to the distal tip and a proximal end electrically connected to the second electrode of the electric element;
  • the electrical element may also be configured to include an insulating cover disposed on the electrical element and covering at least the distal end side of the electrical element. According to the present guidewire, the insulating cover can prevent, for example, a short circuit between the distal tip and the electric element.
  • connection portion may be a conductive joint portion that joins the second electrode of the electric element and the core shaft.
  • the wiring structure of the guide wire can be simplified compared to a configuration in which a pair of electrodes of an electric element are each connected via a signal line due to the relatively simple configuration.
  • a wiring passage is formed inside the core shaft, a communication hole communicating with the wiring passage is formed on the outer peripheral surface of the core shaft, and a part of the signal line is connected to the core shaft.
  • the wiring may be wired to the wiring passageway and the communication hole of the shaft.
  • the connecting portion may have a lead wire extending along the core shaft.
  • the electrical element and the core shaft can be electrically connected while suppressing the influence on the flexibility of the core shaft.
  • the technology disclosed in this specification can be realized in various forms, such as a guide wire, a system including a guide wire and a control device (guide wire system), and a method for manufacturing them. It can be realized with.
  • An explanatory diagram schematically showing the configuration of the guide wire 100 in the first embodiment Explanatory diagram showing the wiring structure of a part of the FPC 40 on which the ultrasonic sensor array 30 is mounted Explanatory diagram showing the electrical configuration of the guide wire 100 Explanatory diagram showing a part of the manufacturing process of the guide wire 100
  • An explanatory diagram schematically showing the configuration of a guide wire 100A in a first modification example An explanatory diagram schematically showing the configuration of a guide wire 100B in a second modification example
  • An explanatory diagram schematically showing the configuration of the distal end portion of the guide wire 100C in the second embodiment An explanatory diagram schematically showing the configuration of the proximal end portion of the guide wire 100C in the second embodiment
  • Explanatory diagram showing the configuration of a cross section at each position of the distal end portion of the guide wire 100C Explanatory diagram showing the configuration of the cross section at each position of the proximal end portion of the guide wire 100C
  • FIG. 1 is an explanatory diagram schematically showing the configuration of a guide wire 100 in the first embodiment.
  • FIG. 1 shows the configuration of a side cross section (YZ cross section) of the guide wire 100.
  • the Z-axis positive direction side is the distal end side (distal side) inserted into the body
  • the Z-axis negative direction side is the base end side (proximal side) operated by a technician such as a doctor.
  • FIG. 1 shows the guide wire 100 as a whole in a straight line substantially parallel to the Z-axis direction, the guide wire 100 has enough flexibility to be curved. Further, in FIG. 1, illustration of a portion of the guide wire 100 is omitted.
  • the guide wire 100 of this embodiment uses an ultrasonic sensor to transmit ultrasound waves into a blood vessel, and also receives ultrasound waves (echoes) reflected inside and outside the blood vessel and returned, and the elapsed time from transmission to reception.
  • This is an imaging guide wire used for diagnostic support that visualizes (images) the state of blood vessels based on the amplitude of the received signal, etc. Therefore, the guidewire 100 includes a guidewire main body 112 and an ultrasonic sensor array 30 disposed on the distal end side of the guidewire main body 112.
  • the guide wire main body 112 is a wire-shaped device having a small diameter as a whole (for example, a diameter of about 0.2 mm or more and 0.5 mm or less).
  • the guidewire body 112 includes a core shaft 10 and a coil body 22.
  • the coil body 22 is an example of an exterior body in the claims.
  • the core shaft 10 is a rod-shaped member having a small diameter at the distal end and a large diameter at the proximal end.
  • the core shaft 10 includes a narrow diameter portion 11 having a circular cross section, a large diameter portion 13 having a circular cross section that is located on the proximal side of the narrow diameter portion 11 and has a larger diameter than the narrow diameter portion 11, and a narrow diameter portion 13. 11 and the large diameter part 13, and has a tapered part 12 whose diameter gradually increases from the boundary position with the small diameter part 11 to the boundary position with the large diameter part 13.
  • the core shaft 10 is made of a conductive metal wire in order to carry a signal line as described later, and is made of, for example, a metal material, stainless steel (SUS302, SUS304, SUS316, etc.), a superelastic alloy such as a Ni-Ti alloy, etc. , piano wire, nickel-chromium alloy, cobalt alloy, tungsten, etc.
  • the coil body 22 is a coil-shaped member formed into a hollow cylindrical shape by spirally winding a wire.
  • the coil body 22 is arranged so as to surround the outer periphery of the distal end portion (in this embodiment, the narrow diameter portion 11 and the tapered portion 12) of the core shaft 10.
  • the coil body 22 is made of, for example, a metal material, stainless steel (SUS302, SUS304, SUS316, etc.), a superelastic alloy such as a Ni-Ti alloy, a piano wire, a radiolucent alloy such as a nickel-chromium alloy, or a cobalt alloy, It is composed of a radiopaque alloy such as gold, platinum, tungsten, or an alloy containing these elements (eg, platinum-nickel alloy).
  • a conductive distal tip 60 is provided at the distal end of the core shaft 10 of the guidewire main body 112.
  • the distal tip 60 is, for example, a cylindrical member having a hemispherical distal end.
  • the distal tip 60 is made of a conductive material (for example, metal; in this embodiment, silver solder).
  • the ultrasonic sensor array 30 is an ultrasonic probe (echo) that transmits ultrasonic waves based on transmitted electrical signals, receives reflected ultrasonic waves (echoes) inside and outside the blood vessel, and outputs received electrical signals. probe).
  • the ultrasonic sensor array 30 has a relatively small size (eg, width and height of 0.5 mm or less) in order to be mounted at the distal end of the guidewire body 112.
  • the ultrasonic sensor array 30 includes a plurality of (four in this embodiment) ultrasonic sensors 31 arranged two-dimensionally.
  • the ultrasonic transmitting/receiving surface of each ultrasonic sensor 31 is arranged so as to face the radially outer side of the guidewire body 112 (in the positive Y-axis direction in the state of FIG. 1). That is, the guide wire 100 of this embodiment can realize imaging in a side view.
  • the ultrasonic sensor 31 is an example of an electric element in the claims.
  • the guide wire 100 further includes an electrode terminal section 70 disposed at the proximal end of the guide wire main body 112 and an FPC (Flexible Printed Circuit) 40.
  • the FPC 40 transmits a signal between a first electrode 33 (described later) of each ultrasonic sensor 31 constituting the ultrasonic sensor array 30 and an electrode terminal section 70 .
  • the FPC 40 is provided between the core shaft 10 and the coil body 22 and arranged along the core shaft 10. The distal end of the FPC 40 is joined to the distal tip 60, and the base end of the FPC 40 reaches the electrode terminal section 70.
  • the FPC 40 is arranged so that one surface (hereinafter referred to as the "outer surface 40a") faces the radially outer side of the core shaft 10, and the other surface (hereinafter referred to as the “inner surface 40b") faces the radially inner side of the core shaft 10. has been done.
  • the ultrasonic sensor array 30 is mounted on the outer surface 40a of the FPC 40.
  • the FPC 40 is an example of a flexible substrate in the claims.
  • the guide wire 100 further includes a housing 50.
  • the housing 50 is a substantially cylindrical member that covers a portion of the ultrasonic sensor array 30 and the FPC 40 at the distal end of the guide wire 100, and is made of, for example, metal.
  • the housing 50 is joined to the tip of the coil body 22 by, for example, welding.
  • a pair of openings 52 are formed through the housing 50 .
  • the housing 50 is arranged so that the ultrasonic transmitting and receiving surface of the ultrasonic sensor 31 is exposed through one opening 52.
  • the housing 50 protects the ultrasonic sensor array 30 and FPC 40.
  • the housing 50 may be a member integrated with the coil body 22, or may be made of a resin material.
  • the guide wire 100 further includes an outer shaft 80.
  • the outer shaft 80 is a substantially cylindrical member that covers the outer periphery of the core shaft 10 and the FPC 40 on the base end side of the coil body 22, and is made of, for example, metal.
  • the outer shaft 80 is joined to the base end of the coil body 22 by, for example, welding.
  • the outer shaft 80 protects the FPC 40.
  • the outer shaft 80 may be a member integrated with the coil body 22.
  • FIG. 2 is an explanatory diagram showing the wiring structure of a portion of the FPC 40 on which the ultrasonic sensor array 30 is mounted.
  • FIG. 2(A) shows the top configuration of a part of the FPC 40
  • FIG. 2(B) shows the configuration of the side cross section (YZ cross section) of the FPC 40 at the BB position in FIG. 2(A). It is shown.
  • each ultrasonic sensor 31 includes a piezoelectric element 32, which is an ultrasonic oscillation unit, and a first electrode 33 and a second electrode 34, which are arranged to sandwich the piezoelectric element 32 in the front-rear direction.
  • the piezoelectric element 32 is made of, for example, ceramics such as PZT (lead zirconate titanate) or polymers such as PVDF (polyvinylidene fluoride).
  • the first electrode 33 and the second electrode 34 are made of a conductive material such as copper.
  • a MEMS device such as a CMUT (Capacitive Micro-machined Ultrasound Transducer) may be used as the ultrasonic oscillator.
  • the first electrode 33 and the second electrode 34 are an example of a pair of electrodes in the claims.
  • the first electrode 33 is arranged on the proximal end side of the ultrasonic sensor 31.
  • the first electrode 33 is separated into each of the plurality of ultrasonic sensors 31. That is, one independent first electrode 33 is provided for each ultrasonic sensor 31.
  • the second electrode 34 is placed on the tip side of the ultrasonic sensor 31. Regarding the second electrode 34, the integral second electrode 34 is shared by each ultrasonic sensor 31. That is, one second electrode 34 functions as the second electrode 34 of all the ultrasonic sensors 31.
  • the potential of the second electrode 34 is set to a predetermined reference potential (ground level or common level). That is, the second electrode 34 is a ground electrode.
  • a wiring layer 42 made of a conductive material such as copper is disposed on a base layer 41 made of an insulating material such as polyimide.
  • This is a flexible circuit board on which a cover layer 43 made of a flexible material is disposed.
  • the wiring layer 42 has a plurality of (four in this embodiment) individual patterns 44 and a common pattern 45.
  • Each individual pattern 44 is individually provided for each of the plurality of ultrasonic sensors 31 constituting the ultrasonic sensor array 30 (that is, a dedicated signal line for each ultrasonic sensor 31), and is 31 and is electrically connected to the first electrode 33 .
  • the individual pattern 44 is an example of a signal line in the claims.
  • the common pattern 45 is arranged between the tip 60 and the ultrasonic sensor array 30.
  • the width of the common pattern 45 is wider than the width of each individual pattern 44.
  • the distal end of the common pattern 45 is joined to the distal tip 60 (see FIG. 1), and the proximal end of the common pattern 45 is joined to the second electrode 34 of the ultrasonic sensor 31.
  • the tip 60 and the common pattern 45 are examples of the connecting portion in the claims.
  • the guide wire 100 further includes a reinforcing member 46.
  • the reinforcing member 46 is arranged along at least one side of the tip of the FPC 40 .
  • the reinforcing member 46 is a flat metal pad, and is arranged so as to be in contact with the inner surface 40b of the portion of the FPC 40 where the common pattern 45 is arranged.
  • the tip of the reinforcing member 46 is brazed to the tip 60.
  • the shape of the portion of the FPC 40 that overlaps the base end portion 46A of the reinforcing member 46 in the radial direction (Y-axis direction) of the core shaft 10 is a tapered shape that becomes wider toward the base end side.
  • the base layer 41 has a tapered base portion 41A.
  • the tapered base portion 41A has a tapered shape in which the width continuously increases from the distal end side to the proximal end side of the base layer 41.
  • the tapered base portion 41A is arranged at a position overlapping the base end portion 46A of the reinforcing member 46 in the radial direction (Y-axis direction) of the core shaft 10.
  • the common pattern 45 has a tapered pattern portion 45A.
  • the tapered pattern portion 45A has a tapered shape in which the width continuously increases from the distal end side to the proximal end side of the common pattern 45.
  • the taper pattern portion 45A is arranged at a position overlapping the base end portion 46A of the reinforcing member 46 in the radial direction (Y-axis direction) of the core shaft 10.
  • the cover layer 43 includes a distal end cover layer 43A and a proximal end cover layer 43B.
  • the tip side cover layer 43A is located on the tip side with respect to the ultrasonic sensor 31, and covers a part of the common pattern 45. Further, the distal end cover layer 43A is disposed at a position overlapping the base end portion 46A of the reinforcing member 46 in the radial direction (Y-axis direction) of the core shaft 10.
  • the proximal cover layer 43B is located on the proximal side with respect to the ultrasonic sensor 31 and covers the individual patterns 44.
  • FIG. 3 is an explanatory diagram showing the electrical configuration of the guide wire 100.
  • the first electrode 33 of each ultrasonic sensor 31 of the ultrasonic sensor array 30 is electrically connected to each external electrode 72 of the electrode terminal section 70 via the individual pattern 44 of the FPC 40.
  • the second electrode 34 of each ultrasonic sensor 31 is electrically connected to an external ground electrode 74 of the electrode terminal section 70 via the core shaft 10.
  • each individual pattern 44 and the core shaft 10 transmit electric signals inputted to the ultrasonic sensor 31 from the electrode terminal section 70 to the ultrasonic sensor 31 for transmitting ultrasonic waves, and A received electrical signal output from the ultrasonic sensor 31 in response to the received ultrasonic wave is transmitted from the ultrasonic sensor 31 to the electrode terminal section 70 .
  • FIG. 4 is an explanatory diagram showing a part of the manufacturing process of the guide wire 100.
  • FIG. 4 shows an example of a process for electrically connecting the second electrode 34 of the ultrasonic sensor array 30 and the core shaft 10.
  • the core shaft 10 and the FPC 40 on which the ultrasonic sensor array 30 is mounted are inserted into the housing 50.
  • the FPC 40 is arranged so that the ultrasonic transmitting and receiving surface of the ultrasonic sensor 31 is exposed from one opening 52 of the housing 50.
  • the core shaft 10 and the FPC 40 are separated from each other and are not electrically connected.
  • the respective distal ends of the core shaft 10 and the FPC 40 protrude from the housing 50 toward the distal end side. Then, as shown in FIG. 4C, the protruding portions of the core shaft 10 and the FPC 40 and the tip of the housing 50 are brazed together.
  • the brazing material is, for example, aluminum alloy solder, silver solder, gold solder, or the like. As a result, a mass R of wax that covers the tip of the housing 50 is formed. Next, as shown in FIG. 4(D), the solder mass R is polished to form a tip 60.
  • the first electrode 33 of the ultrasonic sensor 31 is electrically connected to the tip of the individual pattern 44 arranged along the core shaft 10.
  • the second electrode 34 of the ultrasonic sensor 31 is electrically connected to the tip of the core shaft 10. That is, the core shaft 10 functions as a signal transmission section. Therefore, according to the present embodiment, the wiring structure of the guide wire 100 can be simplified compared to, for example, a configuration in which each of the pair of electrodes of the ultrasonic sensor 31 is connected via a signal line.
  • the width of the FPC 40 can be made narrower as the number of signal lines arranged on the FPC 40 is smaller.
  • blood vessel selectivity can be improved by making the guide wire 100 thinner, for example. Further, it is possible to suppress a decrease in the rotation dependence of the guide wire 100 due to the core shaft 10 becoming thinner due to the restriction of the arrangement space due to the FPC 40.
  • the second electrode 34 is a ground electrode. According to this embodiment, electrical fluctuations in the core shaft 10 or the portion electrically connected to the core shaft 10 can be suppressed. For example, electrical fluctuations in the exposed portion of the base end of the core shaft 10 and the distal tip 60 can be suppressed.
  • the core shaft 10 and the second electrode 34 of the ultrasonic sensor 31 are electrically connected via a conductive tip 60 joined to the tip of the core shaft 10. Therefore, according to the present embodiment, the core shaft 10 and the second electrode 34 are The electrical connection structure can be simplified.
  • the guide wire 100 includes a reinforcing member 46.
  • the reinforcing member 46 is arranged along at least one side of the tip of the FPC 40 .
  • the reinforcing member 46 can prevent the FPC 40 from detaching from the distal tip 60.
  • the reinforcing member 46 improves the wettability of the brazing material, thereby preventing the FPC 40 from repelling the brazing material and causing bonding defects. I can do it.
  • the reinforcing member 46 is arranged so as to protrude outward from the FPC 40 in the width direction, it is possible to more effectively prevent the FPC 40 from repelling the brazing material and causing a bonding failure.
  • the shape of the portion of the FPC 40 that overlaps the base end 46A of the reinforcing member 46 in the radial direction (Y-axis direction) of the core shaft 10 is a tapered shape that becomes wider toward the base end. .
  • the rigidity gap due to the presence or absence of the reinforcing member 46 can be reduced by the tapered shape of the FPC 40.
  • the tip side cover layer 43A is located on the tip side with respect to the ultrasonic sensor 31, and covers a part of the common pattern 45. According to this embodiment, the insulating tip-side cover layer 43A can suppress, for example, a short circuit between the tip 60 and the ultrasonic sensor 31. Further, during the manufacturing stage of the guide wire 100, it is possible to suppress the brazing material from flowing into the ultrasonic sensor 31.
  • FIG. 5 is an explanatory diagram schematically showing the configuration of the guide wire 100A in the first modification.
  • the FPC 40 and the core shaft 10 are electrically connected by joining the distal end portion of the FPC 40 to the distal tip 60 (see FIG. 1).
  • the distal end portion of the FPC 40 is not joined to the distal tip 60 and is spaced apart from the distal tip 60.
  • the guide wire 100A includes a conductive (for example, metal) connecting member 90.
  • the connecting member 90 is located between the distal end of the FPC 40 and the core shaft 10 (thin diameter section 11) in the radial direction of the guide wire 100A, and one end of the connecting member 90 is joined to the distal end of the FPC 40 to connect. The other end of the member 90 is joined to the core shaft 10.
  • the FPC 40 and the core shaft 10 are electrically connected via the connecting member 90. Even with such a configuration, the wiring structure of the guide wire 100A can be simplified. Note that when the connecting member 90 and the distal tip 60 are close to each other, there is no problem even if the connecting member 90 and the distal tip 60 come into contact with each other.
  • FIG. 6 is an explanatory diagram schematically showing the configuration of a guide wire 100B in a second modification.
  • the FPC 40 is arranged on the outer peripheral side of the core shaft 10 (see FIG. 1).
  • a wiring passage 16a is formed inside the core shaft 10, and a pair of communication holes 18a, 18b are formed on the outer periphery of the core shaft 10.
  • the wiring passage 16a is a hole that extends linearly in the longitudinal direction (Z-axis direction) of the core shaft 10.
  • the wiring passage 16a is located closer to the proximal end than the coil body 22 in the longitudinal direction of the core shaft 10.
  • the wiring passage 16a is preferably located on the central axis of the core shaft 10.
  • the communication hole 18a is a hole that extends from the tip of the wiring passage 16a toward the outside in the radial direction of the core shaft 10 and is open to the outer circumferential surface of the core shaft 10.
  • the communication hole 18a opens at a position facing the base end of the coil body 22.
  • the communication hole 18b is a hole that extends from the base end of the wiring passage 16a toward the outside in the radial direction of the core shaft 10 and is open to the outer circumferential surface of the core shaft 10.
  • the communication hole 18b opens at a position facing the electrode terminal portion 70.
  • the base end portion of the FPC 40 is inserted through the communication hole 18a, passes through the wiring path 16a, is pulled out again from the communication hole 18b to the outer peripheral surface side of the core shaft 10, and is electrically connected to the electrode terminal portion 70.
  • the guide wire is When the outer diameter of 100B is maintained, the outer diameter of the core shaft 10 can be increased, and the torque performance of the guide wire 100B can be improved.
  • the communication hole 18a opens on the outer peripheral surface of the tapered portion 12 of the core shaft 10. Therefore, it is possible to suppress the portion of the FPC 40 that is drawn out from the communication hole 18a from protruding beyond the maximum outer diameter of the core shaft 10. Further, the communication hole 18a is inclined toward the base end side of the core shaft 10 so as to approach the central axis of the core shaft 10 and communicates with the wiring passage 16a, so that the FPC 40 is connected from the communication hole 18a to the wiring passage 16a. Easy to insert.
  • the communication hole 18b is inclined from the wiring passage 16a toward the base end of the core shaft 10 so as to approach the outer circumferential surface of the core shaft 10, so that the FPC 40 is led out from the wiring passage 16a through the communication hole 18b. It's easy to do.
  • the core shaft 10 also includes a distal end portion having a narrow diameter portion 11 and a tapered portion 12, a pipe-shaped portion 14, and a base end portion 15.
  • the distal end portion, the pipe-shaped portion 14, and the base end portion 15 are each formed of different materials (for example, a metal material, a conductive coating, etc.), and are joined to each other.
  • the wiring passage 16a is formed in the pipe-shaped portion 14, the communication hole 18a is formed in the tapered portion 12 at the tip end, and the communication hole 18b is formed in the base end portion 15. Note that at least two of the distal end portion, the pipe-shaped portion 14, and the base end portion 15 may be integrally formed of the same material.
  • the communication hole 18a may be formed at a joint portion (not shown) between the tip portion and the pipe-shaped portion 14.
  • the communication hole 18b may be formed at a joint portion (not shown) between the pipe-shaped portion 14 and the base end portion 15.
  • FIG. 7 is an explanatory diagram schematically showing the configuration of the distal end portion of the guide wire 100C in the second embodiment
  • FIG. 8 is an explanatory diagram schematically showing the configuration of the proximal end portion of the guide wire 100C.
  • FIG. 7 shows the configuration of a side surface (YZ plane) of the distal end portion of the guide wire 100C, and the configuration of a longitudinal section (YZ cross section) of a portion of the distal end portion.
  • FIG. 7 shows an enlarged view of a peripheral portion X1 of an ultrasonic sensor 30C, which will be described later, of the guide wire 100C
  • FIG. 8 shows a longitudinal section of the proximal portion of the guidewire 100.
  • the guide wire 100C includes a guide wire main body 112C and an ultrasonic sensor 30C disposed on the distal end side of the guide wire main body 112C.
  • the guide wire main body 112C includes a core shaft 10C, a first coil body 21C, and a second coil body 22C.
  • the first coil body 21C and the second coil body 22C are an example of an exterior body in the claims.
  • the core shaft 10C is a rod-shaped member that extends over the entire length of the guidewire body 112C.
  • the core shaft 10C is made of a conductive metal wire in order to carry a signal line, and is made of, for example, a metal material, stainless steel (SUS302, SUS304, SUS316, etc.), a superelastic alloy such as a Ni-Ti alloy, a piano wire, It is made of nickel-chromium alloy, cobalt alloy, tungsten, etc.
  • the outer diameter of the portion of the core shaft 10C located at the distal end of the guide wire 100C is smaller than the outer diameter of the portion located at the proximal end of the guide wire 100C (see FIGS. 7 and 7). 8).
  • the first coil body 21C and the second coil body 22C are coil-shaped members formed into a hollow cylindrical shape by spirally winding a wire.
  • the first coil body 21C and the second coil body 22C are arranged so as to surround the outer periphery of the tip side portion of the core shaft 10C.
  • the first coil body 21C is arranged so as to be adjacent to the distal tip 60, and the second coil body 22C is located closer than the first coil body 21C. It is located on the proximal side.
  • the first coil body 21C and the second coil body 22C are arranged apart from each other in the stretching direction, and a space is secured between the first coil body 21C and the second coil body 22C. .
  • the first coil body 21C and the second coil body 22C are made of, for example, a metal material, stainless steel (SUS302, SUS304, SUS316, etc.), a superelastic alloy such as a Ni-Ti alloy, a piano wire, or a nickel-chromium alloy. or a radiopaque alloy such as a cobalt alloy, or a radiopaque alloy such as gold, platinum, tungsten, or an alloy containing these elements (for example, a platinum-nickel alloy).
  • a metal material stainless steel (SUS302, SUS304, SUS316, etc.)
  • a superelastic alloy such as a Ni-Ti alloy, a piano wire, or a nickel-chromium alloy.
  • a radiopaque alloy such as a cobalt alloy, or a radiopaque alloy such as gold, platinum, tungsten, or an alloy containing these elements (for example, a platinum-nickel alloy).
  • the ultrasonic sensor 30C is arranged between the first coil body 21C and the second coil body 22C along the core shaft 10C.
  • the ultrasonic sensor 30C is an ultrasonic probe (probe) that transmits ultrasonic waves based on transmitted electric signals, receives the ultrasonic waves (echoes) reflected inside and outside the blood vessel and returns, and outputs the received electric signals. ).
  • the ultrasonic transmitting/receiving surface of the ultrasonic sensor 30C is arranged so as to face the radially outer side of the guide wire main body 112C (in the positive Y-axis direction in the state of FIG. 7).
  • the ultrasonic sensor 30C has a first electrode 33C and a second electrode 34C.
  • the ultrasonic sensor 30C is an example of an electric element in the claims, and the first electrode 33C and the second electrode 34C are an example of a pair of electrodes in the claims. In this embodiment, the first electrode 33C is a ground electrode.
  • the distal end portion of the guide wire 100C further includes a first lead wire R1 and a portion of a second lead wire R2.
  • the first lead wire R1 and the second lead wire R2 are enameled wires, for example.
  • the first lead wire R1 is provided between the distal tip 60 and the ultrasonic sensor 30C, and is arranged along the core shaft 10C.
  • the distal end of the first lead wire R1 is joined to the distal tip 60, and the base end of the first lead wire R1 is connected to the ultrasonic sensor 30C via a conductive joint 35C (for example, solder). It is electrically connected to the first electrode 33C.
  • the first electrode 33C of the ultrasonic sensor 30C and the core shaft 10C are electrically connected via the first lead wire R1 and the tip 60.
  • the first lead wire R1 and the tip 60 are examples of the connecting portion in the claims.
  • the second lead wire R2 is provided closer to the proximal end than the ultrasonic sensor 30C, and is arranged along the core shaft 10C.
  • the tip of the second lead wire R2 is electrically connected to the second electrode 34C of the ultrasonic sensor 30C via a conductive joint 36C (for example, solder).
  • a base end portion of the second lead wire R2 is electrically connected to a second electrode terminal portion 74C, which will be described later.
  • FIG. 9 shows the configuration of a cross section (XY section) at each position of the distal end portion of the guide wire 100C.
  • the portion where the first coil body 21C is arranged surrounds the outer periphery of the first lead wire R1 and the core shaft 10C.
  • a first coil body 21C is arranged. Note that there is a cavity between the first lead wire R1, the core shaft 10C, and the first coil body 21C.
  • the portion where the ultrasonic sensor 30C is arranged has a first tube 25C.
  • the first tube 25C is a tubular member that does not surround the first lead wire R1 but surrounds the outer periphery of the core shaft 10C.
  • the first tube 25C is provided between the first coil body 21C and the second coil body 22C, and is arranged on the outer periphery of the core shaft 10C.
  • the distal end of the first tube 25C is joined to the first coil body 21C via an adhesive section 37C, and the base end of the first tube 25C is connected to the second coil body via an adhesive section 38C. It is joined to 22C.
  • the first tube 25C is preferably made of an insulating material such as polyimide. By interposing the first tube 25C between the ultrasonic sensor 30C and the core shaft 10C, short-circuiting between the ultrasonic sensor 30C and the core shaft 10C can be suppressed.
  • the portion (II) where the ultrasonic sensor 30C is arranged further includes a first adhesive layer 50C and a second adhesive layer 52C.
  • the first adhesive layer 50C joins the inner peripheral surface of the first tube 25C and the outer peripheral surface of the core shaft 10C.
  • the second adhesive layer 52C is placed in close contact with the outer peripheral surface of the first tube 25C, and is arranged to cover the respective outer peripheries of the first lead wire R1 and the ultrasonic sensor 30C.
  • the outer shape of the cross section of the second adhesive layer 52C is approximately the same shape (approximately circular) as the first coil body 21C and the second coil body 22C.
  • the second adhesive layer 52C is an example of an exterior body in the claims.
  • the second coil body 22C is arranged so as to surround the outer periphery of the second lead wire R2 and the core shaft 10C.
  • a second coil body 22C is arranged. Note that there is a cavity between the second lead wire R2, the core shaft 10C, and the second coil body 22C.
  • the proximal end portion of the guide wire 100C further includes a first electrode terminal portion 72C and a second electrode terminal portion 74C.
  • the first electrode terminal portion 72C is arranged at the base end portion of the core shaft 10C.
  • the first electrode terminal portion 72C is, for example, a cylindrical electrode surrounding the outer periphery of the base end portion of the core shaft 10C.
  • a conductive joint 76C (for example, solder) is provided at the end of the core shaft 10C, and the first electrode terminal 72C and the base end of the core shaft 10C are electrically connected via the conductive joint 76C. connected.
  • the second electrode terminal portion 74C is disposed closer to the tip than the first electrode terminal portion 72C.
  • the first electrode terminal portion 72C and the second electrode terminal portion 74C are arranged at separate positions in the extending direction (Z-axis direction) of the guide wire 100C.
  • the second electrode terminal portion 74C is, for example, a cylindrical electrode surrounding the outer periphery of the core shaft 10C and the second lead wire R2.
  • the base end portion of the second lead wire R2 is electrically connected to the second electrode terminal portion 74C via a conductive joint portion 73C (for example, solder).
  • FIG. 10 shows the cross-sectional configuration of each position of the proximal end portion of the guide wire 100C.
  • a portion of the proximal end portion of the guide wire 100C that is closer to the distal end than the second electrode terminal portion 74C has a third adhesive layer 54C.
  • the third adhesive layer 54C is placed in close contact with the outer circumferential surface of the core shaft 10C and is arranged to cover the outer circumference of the second lead wire R2.
  • the external shape of the cross section of the third adhesive layer 54C is approximately the same shape (approximately circular) as the second coil body 22C.
  • the outer diameter of the core shaft 10C is the largest at this (IV) portion.
  • the portion where the second electrode terminal portion 74C is arranged has a second tube 81C.
  • the second tube 81C is a tubular member that does not surround the second lead wire R2 but surrounds the outer periphery of the core shaft 10C.
  • the third adhesive layer 54C extends to this (V) portion, and the second tube 81C is arranged between the core shaft 10C and the third adhesive layer 54C in the radial direction of the core shaft 10C. ing.
  • the second electrode terminal portion 74C is arranged so as to surround the outer periphery of the third adhesive layer 54C.
  • the second tube 81C is preferably made of an insulating material such as polyimide.
  • the second tube 81C By interposing the second tube 81C between the second electrode terminal portion 74C and the core shaft 10C, it is possible to suppress a short circuit between the second electrode terminal portion 74C and the core shaft 10C.
  • the second lead wire R2 is arranged along the outer peripheral surface of the second tube 81C.
  • a portion of the proximal end portion of the guide wire 100C between the second electrode terminal portion 74C and the first electrode terminal portion 72C includes a third tube 82C. are doing.
  • the second tube 81C and the third adhesive layer 54C extend to this (VI) portion.
  • the third tube 82C is a tubular member surrounding the outer periphery of the third adhesive layer 54C.
  • the third tube 82C is preferably made of an insulating material such as polyimide.
  • the third tube 82C is interposed between the first electrode terminal part 72C and the second electrode terminal part 74C in the extending direction of the core shaft 10C, so that the first electrode terminal part 72C and the second electrode terminal part It is possible to suppress a short circuit between the portion 74C and the portion 74C.
  • the second tube 81C and the third adhesive layer 54C extend to a portion of the proximal end portion of the guide wire 100C where the first electrode terminal portion 72C is arranged. ing.
  • the first electrode terminal portion 72C is arranged so as to surround the outer periphery of the third adhesive layer 54C.
  • the first electrode 33C of the ultrasonic sensor 30C is connected to the first electrode 33C via the first lead wire R1, the distal tip 60, and the core shaft 10C. It is electrically connected to the terminal portion 72C.
  • the first electrode terminal portion 72C functions as a ground electrode.
  • the second electrode 34C of the ultrasonic sensor 30C is electrically connected to the second electrode terminal portion 74C via the second lead wire R2. That is, the core shaft 10C functions as a signal transmission section. Therefore, according to the present embodiment, for example, the pair of electrodes 33C and 34C of the ultrasonic sensor 30C are connected to two electrodes extending from the ultrasonic sensor 30C toward the proximal end without using the core shaft 10C.
  • the wiring structure at the proximal end portion of the guide wire 100C can be simplified.
  • the ultrasonic sensor 30C and the core shaft 10C are electrically connected via a flexible first lead wire R1. Therefore, it is possible to prevent the electrical connection structure between the ultrasonic sensor 30C and the core shaft 10C from adversely affecting the flexibility of the core shaft 10C.
  • FIG. 11 is an explanatory diagram schematically showing the configuration of a guide wire 100D in the third embodiment.
  • FIG. 11 shows an enlarged view of the peripheral portion X2 of the ultrasonic sensor 30C of the guide wire 100D.
  • the same components as those of the guide wire 100C of the second embodiment described above among the configurations of the guide wire 100D of the third embodiment will be given the same reference numerals, and the description thereof will be omitted as appropriate.
  • the guide wire 100D of the third embodiment differs from the guide wire 100C of the second embodiment in that it does not include the first lead wire R1.
  • the guide wire 100D includes a core shaft (not shown), a first coil body 21C, and a core reinforcement body 26D.
  • the core shaft is a rod-shaped member that extends along the extending direction of the guide wire 100D and has a small diameter at the distal end and a large diameter at the proximal end.
  • the core shaft D has the same shape as the core shaft 10 of the first embodiment, and has a narrow diameter portion with a circular cross section, and is located on the proximal side with respect to the narrow diameter portion. It is located between the large diameter part with a circular cross section and the small diameter part and the large diameter part, and the diameter gradually increases from the boundary position with the small diameter part to the boundary position with the large diameter part. It has a tapered portion (not shown). have.
  • the first coil body 21C is arranged so as to surround the outer periphery of the narrow diameter portion 11D.
  • the core reinforcing body 26D has a cylindrical shape, the tip of the core reinforcing body 26D is located at the narrow diameter part of the core shaft, and the base end of the core reinforcing body 26D is connected to the third adhesive layer from the base end of the insulating member 25D. 54C, and is arranged so as to surround the outer periphery of the core shaft.
  • the core reinforcing body 26D is made of a conductive material (metal, etc.), and is composed of, for example, a metal coil.
  • the ultrasonic sensor 30D is arranged between the second adhesive layer 52C and the core reinforcement 26D.
  • the ultrasonic sensor 30D has a first electrode 33D and a second electrode 34D.
  • the ultrasonic sensor 30D is an example of an electric element in the claims, and the first electrode 33D and the second electrode 34D are an example of a pair of electrodes in the claims.
  • the first electrode 33D is a ground electrode.
  • the ultrasonic sensor 30D is disposed so as to be located between the outer circumferential surface of the core shaft and the outer circumferential surface of the second adhesive layer 52C (exterior body) in the direction along the core shaft 10D.
  • the first electrode 33D is provided on the inner peripheral surface of the ultrasonic sensor 30D facing the core reinforcing body 26D.
  • a brazing layer 13D is formed on the outer peripheral surface of the core reinforcing body 26D.
  • the first electrode 33D is joined and electrically connected to the core reinforcing body 26D via a conductive joint 35D (for example, solder) and a brazing layer 13D.
  • the second electrode 34D is provided on the outer peripheral surface of the ultrasonic sensor 30D on the opposite side to the core reinforcing body 26D. Further, the second electrode 34D extends to the proximal side surface of the ultrasonic sensor 30D.
  • the tip of the second lead wire R2 is joined to the portion of the second electrode 34D that extends to the proximal side surface of the ultrasonic sensor 30D via a conductive joint 36D (for example, solder). electrically connected to the
  • An insulating member 25D having an arc-shaped cross section is disposed in a portion of the brazing layer 13D of the core reinforcing body 26D that is closer to the proximal end than the conductive joint 35D.
  • the insulating member 25D is made of, for example, insulating resin.
  • the insulating member 25D extends further toward the proximal end than the second electrode 34D and the conductive joint 36D.
  • the insulating member 25D suppresses a short circuit between the second electrode 34D and the conductive joint 36D and the core shaft (core reinforcement 26D).
  • the insulating member 25D may have a circular cross section and surround the entire circumference of the brazing layer 13D, for example.
  • the insulating member 25D is joined to the inner circumferential surface of the ultrasonic sensor 30D via an insulating joint 39D (for example, resin). Thereby, it is possible to suppress the insulating member 25D from moving in the direction along the core shaft or in the circumferential direction.
  • an insulating joint 39D for example, resin
  • the first electrode 33D of the ultrasonic sensor 30D is connected via the core shaft (core reinforcing body 26D) without requiring the first lead wire R1. , are electrically connected to the first electrode terminal portion 72C.
  • the second electrode 34D of the ultrasonic sensor 30D is electrically connected to the second electrode terminal portion 74C via the second lead wire R2. That is, the core shaft (core reinforcement body 26D) functions as a signal transmission section. Therefore, according to the present embodiment, for example, the pair of electrodes of the ultrasonic sensor 30D can be connected via two signal lines extending from the ultrasonic sensor 30D to the base end side, without using the core shaft.
  • the wiring structure at the proximal end portion of the guide wire 100D can be simplified compared to a configuration in which the guide wire 100D is directly connected to each of the first electrode terminal portions 72C and 74C.
  • the core shaft 10 of the guide wire 100 has the narrow diameter portion 11, the tapered portion 12, and the large diameter portion 13. It may not have at least one of these parts, or it may have other parts in addition to the three parts.
  • the core shafts 10, 10C, and 10D are not limited to metal materials, but may be made of any conductive material; for example, they may be made of a resin material. The constituent materials of one part and the other part of the core shafts 10, 10C, and 10D may be different from each other.
  • the coil bodies 20D, 21C, 22, and 22C are exemplified as the exterior body, but for example, a resin coating or a tube material such as a hypotube may be used.
  • the outer layer of the coil bodies 20D, 21C, 22, and 22C is provided with a resin coating layer (polymer jacket) made of a thermoplastic resin selected from the group of urethane resins such as polyurethane, and amide resins such as polyamide. ), and may also include a radiopaque member within the resin coating layer.
  • a part of the configuration of the guide wires 100 to 100D may be omitted.
  • the guide wire 100 does not need to include the outer shaft 80.
  • the number and arrangement of the ultrasonic sensors 31 and 30C constituting the ultrasonic sensor array 30 are merely examples, and can be modified in various ways.
  • the plurality of ultrasonic sensors 31 constituting the ultrasonic sensor array 30 are arranged two-dimensionally, but the plurality of ultrasonic sensors 31 are arranged one-dimensionally (in one row). may be placed.
  • the guide wire 100 may be configured to include only one ultrasonic sensor 31.
  • the ultrasonic sensors 31 and 30C are exemplified as electric elements, but sensor elements having other detection principles, light emitting elements, imaging elements, etc. may also be used, for example.
  • the positional relationship between the first electrodes 33, 33C and the second electrodes 34, 34C in the ultrasonic sensors 31, 30C is not limited to the front-rear direction.
  • the first electrode 33 and the second electrode 34 may be arranged to sandwich the piezoelectric element 32 in the left-right direction, or in the same direction with respect to the piezoelectric element 32 (on the tip side or It may be placed on the proximal end side, etc.).
  • the FPC 40 is used as an example of the signal transmission section (signal line) that transmits signals between the first electrode 33 of the ultrasonic sensor 31 and the electrode terminal section 70, but the present invention is not limited to this. It may also be a conducting wire or the like. Further, in the first embodiment, the ultrasonic sensor array 30 may be mounted on the inner surface 40b of the FPC 40. Further, in the first embodiment described above, the first electrode 33 may be a ground electrode. In the second and third embodiments described above, the second electrode 34C may be a ground electrode.
  • the core shaft 10 and the second electrode 34 of the ultrasonic sensor 31 are electrically connected via the tip 60 and the common pattern 45. 10 and the second electrode 34 of the ultrasonic sensor 31 may be electrically connected via a conductive portion such as a via formed in the FPC 40. Further, in the above embodiment, the reinforcing member 46 may be arranged on the outer surface 40a side of the FPC 40.
  • the method for manufacturing the guide wire 100 in the first embodiment is merely an example, and can be modified in various ways.
  • the core shaft 10 and the FPC 40 may be joined using metal solder (Ag-Sn alloy, Au-Sn alloy, etc.).

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Abstract

La présente invention concerne un fil-guide comprenant : un arbre central électroconducteur ; un corps extérieur qui recouvre la périphérie externe de l'arbre central ; un élément électrique qui est disposé entre l'arbre central et le corps extérieur, et a une première électrode et une seconde électrode ; une ligne de signal qui est disposée le long de l'arbre central et a une partie d'extrémité de pointe connectée électriquement à la première électrode de l'élément électrique ; et une partie de connexion qui connecte électriquement la seconde électrode de l'élément électrique et l'arbre central. La seconde électrode de l'élément électrique est électriquement connectée à l'arbre central, et l'arbre central fonctionne comme une ligne de signal.
PCT/JP2023/028368 2022-08-03 2023-08-03 Fil-guide WO2024029585A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2022-123833 2022-08-03
JP2022123833 2022-08-03

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030220588A1 (en) * 2001-06-15 2003-11-27 Radi Medical Systems Ab Electrically conductive guide wire
JP2018122025A (ja) * 2017-02-03 2018-08-09 ニプロ株式会社 ガイドワイヤ及びガイドワイヤの製造方法
WO2020255566A1 (fr) * 2019-06-21 2020-12-24 朝日インテック株式会社 Réseau de capteurs ultrasonores, fil-guide, système de fil-guide, et cathéter
US20220111182A1 (en) * 2020-10-12 2022-04-14 Asahi Intecc Co., Ltd. Guide wire with conductive element

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030220588A1 (en) * 2001-06-15 2003-11-27 Radi Medical Systems Ab Electrically conductive guide wire
JP2018122025A (ja) * 2017-02-03 2018-08-09 ニプロ株式会社 ガイドワイヤ及びガイドワイヤの製造方法
WO2020255566A1 (fr) * 2019-06-21 2020-12-24 朝日インテック株式会社 Réseau de capteurs ultrasonores, fil-guide, système de fil-guide, et cathéter
US20220111182A1 (en) * 2020-10-12 2022-04-14 Asahi Intecc Co., Ltd. Guide wire with conductive element

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