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WO2025100515A1 - Catheter for image acquisition - Google Patents

Catheter for image acquisition Download PDF

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Publication number
WO2025100515A1
WO2025100515A1 PCT/JP2024/039744 JP2024039744W WO2025100515A1 WO 2025100515 A1 WO2025100515 A1 WO 2025100515A1 JP 2024039744 W JP2024039744 W JP 2024039744W WO 2025100515 A1 WO2025100515 A1 WO 2025100515A1
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WO
WIPO (PCT)
Prior art keywords
inner tube
signal lines
imaging catheter
tube
circumferential surface
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/JP2024/039744
Other languages
French (fr)
Japanese (ja)
Inventor
泰徳 山下
隆史 伊藤
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
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 Terumo Corp filed Critical Terumo Corp
Publication of WO2025100515A1 publication Critical patent/WO2025100515A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters

Definitions

  • the present invention relates to a catheter for acquiring images.
  • the present invention was made based on the above problem, and specifically aims to provide an imaging catheter that improves pushability without increasing the number of parts.
  • the imaging catheter extends a signal line having a wire portion made of a metallic material in a direction intersecting the longitudinal direction of the inner tube so as to be arranged along the outer circumferential surface of the inner tube, thereby increasing the bending rigidity in the direction intersecting the longitudinal direction of the inner tube and improving pushability.
  • the imaging catheter uses an existing signal line without using a separate member such as a reinforcing member to improve pushability, so there is no problem of increased manufacturing costs due to an increased number of parts.
  • FIG. 1 is a schematic configuration diagram of a medical system including an image acquisition catheter according to an embodiment.
  • FIG. 2 is a diagram showing an image acquisition catheter according to an embodiment.
  • FIG. 2 is a cross-sectional view of an imaging catheter according to an embodiment.
  • FIG. 11 is a partial cross-sectional view showing a wiring shape of a second form of the signal line in the imaging catheter according to the embodiment.
  • FIG. 11 is a partial cross-sectional view showing a wiring shape of a third form of the signal line in the imaging catheter according to the embodiment.
  • FIG. 13 is a partial cross-sectional view showing a modified example of the fourth form of the signal line in the imaging catheter according to the embodiment.
  • the "longitudinal direction” is the direction along the central axis of the imaging catheter 100.
  • the "radial direction” is the direction moving away from or approaching the central axis in an orthogonal cross section (transverse cross section) with the central axis of the imaging catheter 100 as the reference axis.
  • the "circumferential direction” is the rotational direction with the central axis of the imaging catheter 100 as the reference axis.
  • the side of the imaging catheter 100 where the proximal hub portion 60 is located is referred to as the "base end side.”
  • the side of the imaging catheter 100 that is located opposite the base end side and that is introduced into the living body is referred to as the "tip side.”
  • the "tip portion” refers to a portion that includes a certain range from the tip (the most distal end) toward the base end side
  • the “base end portion” refers to a portion that includes a certain range from the base end (the most proximal end) toward the tip end side.
  • the image acquisition catheter 100 is configured as an IVUS catheter that utilizes intravascular ultrasound (IVUS).
  • IVUS intravascular ultrasound
  • blood vessels are exemplified as a biological lumen to which the image acquisition catheter 100 is applied.
  • the biological lumen to which the image acquisition catheter 100 is applied is not limited to blood vessels, and may be, for example, biological organs such as the bile duct, trachea, esophagus, other digestive tract, urethra, and ear and nose cavities.
  • the medical system 1 includes an image acquisition catheter 100 and an external device 300.
  • the medical system 1 inserts the image acquisition catheter 100 into a patient's blood vessel, delivers the sensor unit 30 to the lesion, and outputs images (such as cross-sectional images of the blood vessels) captured at and around the lesion to the external device 300 for use in diagnosing the characteristics of the lesion.
  • the imaging catheter 100 has an inner tube 10, an outer tube 20, a sensor unit 30, a joint unit 40, a signal line 50, a proximal hub unit 60, and an imaging unit 70.
  • the imaging catheter 100 is configured as a so-called "over-the-wire type catheter” in which a guidewire can be inserted and removed from the catheter base end through a first lumen 11 of the inner tube 10.
  • the imaging catheter 100 may also be configured as a so-called "rapid exchange type catheter.”
  • the inner tube 10 is a long tubular member having a first lumen 11 through which a guide wire can be inserted, the first lumen 11 extending from the distal end to the proximal end.
  • the inner tube 10 has a distal end located at the distal end of the imaging catheter 100 and a proximal end located at the proximal end of the first port 61 of the proximal hub portion 60, and is configured to allow the guide wire to be inserted and removed.
  • the material that makes up the inner tube 10 is a material that can be used in catheters, etc., and can be, for example, various thermoplastic elastomers such as styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polyimide-based, polybutadiene-based, trans-polyisoprene-based, fluororubber-based, and chlorinated polyethylene-based.
  • various thermoplastic elastomers such as styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polyimide-based, polybutadiene-based, trans-polyisoprene-based, fluororubber-based, and chlorinated polyethylene-based.
  • the outer tube 20 is disposed so as to cover the inner tube 10 at a position proximal to the sensor unit 30, so as to define a second lumen 21, through which a plurality of signal lines 50 can be inserted, between the outer tube 20 and the inner tube 10.
  • the proximal end of the outer tube 20 is located distal to the distal opening of the second port 62 inside the proximal hub portion 60. This allows the signal lines 50 to be inserted from the sensor unit 30 through the second lumen 21 and then led out of the second port 62.
  • the outer tube 20 is disposed coaxially with the inner tube 10.
  • the outer tube 20 can be made of, for example, the same material as the inner tube 10 exemplified above.
  • the sensor unit 30 is disposed at the distal end of the inner tube 10, which is closer to the distal end than the outer tube 20.
  • the sensor unit 30 is composed of a reinforcing body 31 and a film sensor 32.
  • the sensor unit 30 transmits and receives ultrasonic waves within a biological lumen, and enables transmission of electrical signals between the sensor unit 300 and an external device 300 via signal lines 50 connected to each of the transducers 32a.
  • the reinforcing body 31 has a cylindrical shaft portion 31a, a tip support portion 31b that is disposed at the tip of the shaft portion 31a and has a larger diameter than the outer diameter of the shaft portion 31a, and a base end support portion 31c that is disposed at the base end of the shaft portion 31a and has a larger diameter than the outer diameter of the shaft portion 31a.
  • the reinforcing body 31 can be formed of a metal material.
  • the reinforcing body 31 has a third lumen 31d formed therein through which the inner tube 10 can be inserted.
  • the film sensor 32 is made of a flexible board with electronic components mounted on a form board, and an electronic circuit including multiple transducers 32a is formed on the outer surface.
  • the film sensor 32 is wound around the tip support portion 31b and base support portion 31c of the reinforcement body 31.
  • Each transducer 32a has an oscillator made of a piezoelectric material with piezoelectric properties, such as ceramics or quartz, capable of converting an electrical signal into ultrasonic vibrations.
  • the transducers 32a form a phased array arranged in a ring shape along the circumferential direction of the reinforcing body 31 when the film sensor 32 is wrapped around the reinforcing body 31.
  • the sensor unit 30 can acquire tomographic images of blood vessels over a wide range in the circumferential direction at once without rotating the sensor unit 30.
  • the multiple transducers 32a have the function of transmitting ultrasonic waves based on an electric signal (pulse signal) into the body cavity and receiving ultrasonic waves reflected from the biological tissue in the body cavity.
  • Each of the transducers 32a is disposed on the outer surface of the film sensor 32 and is connected to a multiplexer 32b.
  • the multiplexer 32b is a combination circuit that selects one of the multiple input lines and connects it to a single output line.
  • Each of the transducers 32a is connected to each of the multiple signal lines 50 via the multiplexer 32b.
  • Each of the transducers 32a is configured so that the multiplexer 32b can sequentially switch between transmitting and receiving operations. In other words, the multiple transducers 32a sequentially receive each received signal and sequentially transmit the received signal via the multiplexer 32b.
  • the multiplexer 32b is driven and controlled by a control IC 32c formed on the film sensor 32.
  • the joint 40 joins the sensor unit 30 to the inner tube 10 and/or the outer tube 20.
  • the joint 40 has a distal joint 41, a proximal joint 42, and a filling joint 43.
  • the distal joint 41, the proximal joint 42, and the filling joint 43 are all formed of a resin bonding agent.
  • the tip joint 41 is disposed on the tip side of the sensor unit 30 so as to be adjacent to the tip support portion 31b of the sensor unit 30 and to be in contact with the outer circumferential surface of the inner tube 10. This allows the sensor unit 30 to be firmly joined to the inner tube 10.
  • the tip joint 41 has a tapered surface 41a whose outer diameter decreases from the tip support portion 31b of the sensor unit 30 toward the outer circumferential surface of the inner tube 10. Because the tip joint 41 has a tapered surface 41a, it is possible to improve the insertability of the imaging catheter 100.
  • the tip joint 41 can be formed using only a resin adhesive. This allows the tip joint 41 to be shorter in the longitudinal direction at the tip of the sensor unit 30 compared to the joint structure between the sensor unit 30 and the inner tube 10 using a fusion tube applied in conventional devices. As a result, the imaging catheter 100 has improved blood vessel passage and can suppress blood vessel damage caused by contact with the blood vessel inner wall during advancement and retraction operations.
  • the base end joint 42 is disposed adjacent to the base end support portion 31c of the sensor unit 30 and between the tip end of the outer tube 20. This allows the sensor unit 30 to be firmly joined to the outer tube 20.
  • the filling joint 43 is filled into the internal space 33 formed between the shaft portion 31a of the reinforcing body 31 and the wound film sensor 32. This allows the film sensor 32 to be firmly joined to the reinforcing body 31.
  • the filling joint 43 can also be filled into the third lumen 31d. This allows the sensor portion 30 to be firmly joined to the inner tube 10. By filling the filling joint 43 into the third lumen 31d so as to connect between the tip joint 41 and the base joint 42, the joint strength of the entire joint 40 can be increased.
  • the resin adhesive used as the joint 40 has a property of being fluid when applied and hardening due to a chemical change caused by a curing process after application.
  • a UV-curable adhesive or a thermosetting adhesive (such as an epoxy-based adhesive) can be suitably used as the resin adhesive.
  • the distal joint 41, proximal joint 42, and filling joint 43 constituting the joint 40 can be formed from the same resin adhesive.
  • the resin adhesive constituting the distal joint 41 partially penetrates into the interface between the reinforcing body 31 and the film sensor 32 on the distal side of the sensor section 30.
  • the resin adhesive constituting the proximal joint 42 partially penetrates into the interface between the reinforcing body 31 and the film sensor 32 on the proximal side of the sensor section 30. This allows the imaging catheter 100 to firmly bond the sensor section 30 to the inner tube 10 and the outer tube 20 using only the resin adhesive without using a fusion tube or the like, and simplifies the manufacturing process.
  • the signal lines 50 have wire portions 51 made of a metallic material having electrical conductivity and contrast properties, one end of which is connected to the sensor unit 30 and the other end of which is connected to the connector 110. Each of the signal lines 50 is connected to the multiplexer 32b or the control IC 32c by soldering or the like.
  • the signal lines 50 are capable of transmitting and receiving electrical signals between the sensor unit 30 and the external device 300 by connecting the connector 110 to the connector 330 of the external device 300.
  • the signal lines 50 are connected to the connector 110 in a state where the portions of the signal lines 50 exposed from the second port 62 of the proximal hub unit 60 on the base end side are bundled together to form a cable 120.
  • the signal line 50 can be made up of multiple pieces of each, including a coated wire in which the wire portion 51 is coated with a fluororesin or the like, and a coaxial cable in which the outer conductor and inner conductor formed by the wire portion 51 are arranged at regular concentric intervals.
  • the signal line 50 is a coaxial cable used as a dedicated receiving line, the transmission loss of the electrical signal (imaging data) acquired by the sensor unit 30 can be reduced.
  • the signal line 50 can also be made up of a flexible cable in which multiple wire portions 51 are sandwiched between resin films or the like, or a flat cable in which multiple wire portions 51 covered with an insulating coating are arranged in parallel in a band shape.
  • each of the signal lines 50 extends in a direction intersecting the longitudinal direction of the inner tube 10 so as to be arranged along the outer circumferential surface of the inner tube 10. At least a portion of each of the signal lines 50 can be in a wiring shape (first form to fourth form) as shown in Figures 3 to 5.
  • the imaging catheter 100 can improve pushability by arranging the signal lines 50 on the inner tube 10 or the outer tube 20 as in each of the forms shown below.
  • the number of signal lines 50 arranged on the outer circumferential surface of the inner tube 10 or the inner circumferential surface of the outer tube 20 can be set appropriately.
  • the imaging catheter 100 when the imaging catheter 100 extends the signal lines 50 along the outer circumferential surface of the inner tube 10 or the inner circumferential surface of the outer tube 20 in a direction intersecting the longitudinal direction, all of the signal lines 50 connected to the sensor unit 30 may be used, or a portion (several lines) of the multiple signal lines 50 connected to the sensor unit 30 may be used.
  • the signal line 50 is disposed on the outer peripheral surface of the inner tube 10, but it may also be disposed on the inner peripheral surface of the outer tube 20.
  • the wiring shape of the signal line 50 in the first embodiment is such that at least a portion of each of the signal lines 50 is wound around the outer circumferential surface of the inner tube 10, as shown in FIG. 3, to have a spiral portion 52 that is wound in a spiral shape around the outer circumferential surface of the inner tube 10.
  • the spiral portion 52 is formed in a predetermined region from the tip to the base of the inner tube 10.
  • the spiral portion 52 has a coarsely wound portion 52a in which the signal line 50 is coarsely wound around the outer circumferential surface of the inner tube 10, and a densely wound portion 52b adjacent to the coarsely wound portion 52a in which the signal line 50 is densely wound around the outer circumferential surface of the inner tube 10.
  • At least one of the coarsely wound portion 52a and the densely wound portion 52b is arranged in the longitudinal direction of the inner tube 10.
  • the densely wound portion 52b can be arranged in multiple alternating fashion in the longitudinal direction with the loosely wound portion 52a and the tightly wound portion 52b spaced apart at regular intervals on the outer peripheral surface of the inner tube 10. Since the signal line 50 has a wire portion 51 that is conductive and has contrast properties, the densely wound portion 52b can function as the contrast portion 70. Therefore, the imaging catheter 100 does not need to have a separate contrast portion 70 at the tip of the inner tube 10, and the configuration can be simplified.
  • the loosely wound portion 52a and the tightly wound portion 52b may be wound in a single layer around the outer circumferential surface of the inner tube 10, as shown in FIG. 3, or may be wound in a radially overlapping manner.
  • the wiring shape of the signal wire 50 according to the second embodiment is such that the signal wire 50 is wound around the outer circumferential surface of the inner tube 10 to have straight portions 53 in which at least a portion of the signal wire 50 extends along the longitudinal direction, and tightly wound portions 54 in which at least a portion of the signal wire 50 is tightly wound along the outer circumferential surface of the inner tube 10 in a direction perpendicular to the longitudinal direction of the inner tube 10.
  • the straight portions 53 and tightly wound portions 54 are alternately arranged in the longitudinal direction of the inner tube 10.
  • the straight portions 53 and tightly wound portions 54 are formed in a predetermined region from the tip end to the base end of the inner tube 10.
  • the densely wound portion 54 shown in FIG. 4 can be arranged at regular intervals on the outer circumferential surface of the inner tube 10, similar to the densely wound portion 52b of the first embodiment. If arranged in this manner, the densely wound portion 54 can function as the imaging portion 70 while improving the pushability of the imaging catheter 100, similar to the densely wound portion 52b shown in FIG. 3.
  • the imaging catheter 100 effectively has increased bending rigidity in a direction intersecting with the longitudinal axis direction.
  • the blade portion 55 can also achieve effects such as reducing the clearance between the inner tube 10 and the outer tube 20 and improving resistance to breakage.
  • the imaging catheter 100 shown in the fourth shape does not have a wiring shape (braided portion 55) at the tip of the inner tube 10 that also serves as reinforcement by the signal line 50, as in the third shape. Therefore, the contrast section 70 can be disposed at the tip of the inner tube 10.
  • the tip of the inner tube 10 may employ a first type of spiral portion 52 (a loosely wound portion 52a and a tightly wound portion 52b) that can function as a contrast section 70, and a second type of straight portion 53 and a tightly wound portion 54.
  • each of the signal wires 50 can be fixed to the outer circumferential surface of the inner tube 10 with adhesive or the like to prevent the winding position of the signal wires 50 from shifting during use of the device.
  • the proximal hub portion 60 has a first port 61 and a second port 62 , and is connected to the base ends of the inner tube 10 and the outer tube 20 .
  • the proximal opening of the first port 61 of the hand hub section 60 is connected in communication with the first lumen 11 of the inner tube 10. This allows the hand hub section 60 to insert and remove a guide wire into and from the inner tube 10.
  • the proximal opening of the second port 62 of the hand hub section 60 is connected in communication with the second lumen 21 of the outer tube 20. This allows the hand hub section 60 to lead out the proximal ends of multiple signal lines 50 from the second port 62.
  • the imaging section 70 is disposed near the tip of the inner tube 10.
  • the imaging section 70 can be made of, for example, a known metal material that has X-ray contrast properties (X-ray opacity).
  • the contrast imaging sections 70 can be placed at regular intervals along the longitudinal direction of the inner tube 10 so as to function as markers when measuring the distance of the sensor section 30 to the lesion in the blood vessel and the length of the lesion.
  • the placement interval of the contrast imaging sections 70 can be set, for example, between 10 mm and 40 mm.
  • the imaging section 70 can be a ring-shaped metal part with X-ray contrast that can be attached to the outer surface of the inner tube 10 by swaging or other processes.
  • the imaging section 70 is not limited to being attached to the outer surface of the inner tube 10, but may also be partially or completely embedded inside the tube wall of the inner tube 10.
  • the number, shape, spacing, etc. of the imaging sections 70 can be set appropriately according to the specifications of the imaging catheter 100.
  • the signal line 50 of the imaging catheter 100 when the wiring form of the signal line 50 of the imaging catheter 100 is the first form shown in FIG. 3 or the second form shown in FIG. 4, the signal line 50 can function as the imaging section 70, so there is no need to provide a separate imaging section 70.
  • the fourth form shown in FIG. 6 multiple signal lines 50 are braided into a braid at the base end of the inner tube 10, and although the signal lines 50 have imaging properties, they do not have the function of measuring the distance of the sensor unit 30 to the lesion, so it is preferable to place the imaging section 70 at the tip of the inner tube 10.
  • the blade portion 55 is formed in the range from the tip of the proximal hub portion 60 to the tip of the inner tube 10 on the proximal side of the sensor portion 30. Therefore, when the imaging catheter 100 is formed with the blade portion 55 shown in the third embodiment, it is preferable that the imaging portion 70 is arranged in a shape that can be distinguished from the shape of the blade portion 55 during imaging.
  • the external device 300 includes a control unit 310 , a display device 320 , and a connector 330 .
  • the external device 300 is electrically connected to the imaging catheter 100 by connecting the connector 110 of the imaging catheter 100 to the connector 330. This allows the external device 300 to transmit and receive electrical signals to and from the sensor unit 30 of the imaging catheter 100.
  • the control unit 310 is mainly composed of a CPU, memory, and input/output units, and is responsible for controlling the entire medical system 1.
  • the control unit 310 outputs a control signal to the sensor unit 30 of the image acquisition catheter 100 to emit ultrasound, inputs a detection signal from the sensor unit 30, and performs predetermined signal processing based on the detection signal to acquire image data (tomographic image).
  • the control unit 310 displays information (images) based on the acquired image data on the display device 320.
  • the imaging catheter 100 is a device for acquiring diagnostic ultrasound tomographic images in a living body lumen, and includes an inner tube 10 having a first lumen 11, a sensor unit 30 arranged at the tip of the inner tube 10 and including a ring-shaped arrangement of multiple transducers 32a for transmitting and receiving ultrasound in the living body lumen, multiple signal lines 50 connected to each of the transducers 32a and enabling transmission of electrical signals between the multiple transducers 32a and an external device 300, and an outer tube 20 arranged to cover the inner tube 10 at a position closer to the base end than the sensor unit 30 so as to define a second lumen 21 through which the multiple signal lines 50 can be inserted between the inner tube 10 and the outer tube 20, each of the multiple signal lines 50 having a wire portion 51 made of a metal material, and at least a portion of each of the multiple signal lines 50 extending in a direction intersecting the longitudinal direction of the inner tube 10 so as to be arranged along the outer circumferential surface of the inner tube 10 or the inner circum
  • the imaging catheter 100 extends in a direction intersecting the longitudinal direction of the inner tube 10 so that at least a portion of each of the signal lines 50, which have wire portions 51 made of a metallic material, is arranged along the outer circumferential surface of the inner tube 10, thereby increasing the bending rigidity in the direction intersecting the longitudinal direction of the inner tube 10 and improving pushability.
  • the imaging catheter 100 uses the signal line 50, which is an existing component, without using a separate member such as a reinforcing member to improve pushability, so there is no problem of increased manufacturing costs due to an increase in the number of parts.
  • Medical system 10 inner tube, 11 first lumen, 20 outer tube, 21 second lumen, 30 sensor unit, 31 Reinforcement body (31a shaft portion, 31b tip support portion, 31c base end support portion, 31d third lumen), 32 film sensor (32a transducer, 32b multiplexer, 32c control IC), 33 interior space, 40 joint, 41 Tip joint, 42 proximal junction, 43 Filling joint, 50 signal line, 51 wire portion, 52 spiral part (52a loosely wound part, 52b, 54 closely wound part), 53 Extension part, 55 Blade portion, 60 Hand hub part, 61 first port, 62 second port, 70 Contrast department, 100 Image acquisition catheter, 110 Connector of imaging catheter; 120 cable, 300 external device, 310 control unit, 320 display device, 330 External device connector.

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Abstract

[Problem] To provide a catheter for image acquisition that makes it possible to improve pushability without increasing the number of components. [Solution] A catheter for image acquisition comprises: an inner tube 10; a sensor portion 30 disposed at a tip-end portion of the inner tube 10 and including a plurality of transducers 32a for transmitting and receiving ultrasonic waves in a biological lumen, the plurality of transducers 32a being circumferentially arranged in a ring shape; a plurality of signal lines 50 connected to the respective transducers 32a and enabling transmission of electric signals to and from an external device 300; an outer tube 20 disposed to cover the inner tube 10 at a position closer to the proximal side than the sensor portion 30 so as to define a second lumen 21 through which the plurality of signal lines 50 can be passed; and a hand-side hub portion 60 connected to the proximal part of the inner tube 10 and the proximal part of the outer tube 20, and including a first port 71 and a second port 62. Each of the plurality of signal lines 50 has an element wire part 51 formed of a metal material. At least a part of each of the plurality of signal lines 50 extends in a direction intersecting the longitudinal direction of the inner tube 10 or the outer tube 20 so as to be disposed along the outer circumferential surface of the inner tube 10 or the inner circumferential surface of the outer tube 20.

Description

画像取得用カテーテルImaging Catheter

　本発明は、画像取得用カテーテルに関する。 The present invention relates to a catheter for acquiring images.

　血管等の管腔器官内に生じた狭窄部や閉塞部等の病変部の治療では、これらの性状を観察又は治療後の状態を観察するため、診断画像を取得する医療装置として血管内超音波診断法（ＩＶＵＳ：Ｉｎｔｒａｖａｓｃｕｌａｒ　Ｕｌｔｒａｓｏｕｎｄ）を利用した画像取得用カテーテルが使用される（特許文献１を参照）。 When treating lesions such as stenoses and occlusions that occur in tubular organs such as blood vessels, an imaging catheter that utilizes intravascular ultrasound (IVUS) is used as a medical device to obtain diagnostic images in order to observe the characteristics of these lesions or their condition after treatment (see Patent Document 1).

特表２０２１－５３３９１２号公報Special Publication No. 2021-533912

　画像取得用カテーテルにおいて、プッシャビリティ（押し込み力）が高い程、生体管腔内に進出させる際に有用である。特に、画像取得用カテーテルを下肢の静脈に適用した場合、心臓血管等とは異なり直進的に押し込んで使用するため、プッシャビリティを高めたいという要請が大きい。 The higher the pushability (pushing force) of an imaging catheter, the more useful it is when advancing it into a biological lumen. In particular, when an imaging catheter is applied to the veins of the lower limbs, unlike in the cardiovascular system, it is pushed in a straight line, so there is a strong demand for improved pushability.

　画像取得用カテーテルのプッシャビリティは、カテーテルの長軸方向と交差する方向への曲げ剛性を高めることが効果的である。そのため、画像取得用カテーテルは、例えば、カテーテルに補強部材等を使用してカテーテルの曲げ剛性を高めることができる。しかし、画像取得用カテーテルは、補強部材等を使用してプッシャビリティを向上させると、部品点数の増加により製造コストが嵩むという問題がある。 Increasing the bending rigidity of an imaging catheter in a direction intersecting the long axis direction of the catheter is effective for improving the pushability. For this reason, the bending rigidity of the imaging catheter can be increased, for example, by using a reinforcing member or the like in the catheter. However, there is a problem with imaging catheters in that using a reinforcing member or the like to improve the pushability increases the number of parts, resulting in higher manufacturing costs.

　本発明は、上記課題に基づいてなされたものであり、具体的には、部品点数を増加させずにプッシャビリティの向上が図れる画像取得用カテーテルを提供することを目的とする。 The present invention was made based on the above problem, and specifically aims to provide an imaging catheter that improves pushability without increasing the number of parts.

　本発明は、下記（１）～（６）の何れか１つに記載の手段によって達成され得る。 The present invention can be achieved by any one of the means described below in (1) to (6).

　（１）生体管腔内において診断用の超音波断層画像を取得するための画像取得用カテーテルであって、第１ルーメンを備える内管と、前記内管の先端部に配置され、前記生体管腔内において超音波を送受信する複数のトランスデューサーが周方向にリング状に配置されたセンサ部と、前記トランスデューサーの各々と接続され、前記複数のトランスデューサーと外部装置との間での電気信号の伝送を可能にする複数の信号線と、前記内管との間に前記複数の信号線が挿通可能な第２ルーメンを区画するように、前記センサ部よりも基端側の位置で前記内管を覆うように配置された外管と、を有し、前記複数の信号線の各々は、金属材料で構成された素線部を有し、前記複数の信号線の各々の少なくとも一部は、前記内管の外周面、又は前記外管の内周面に沿って配置されるように前記内管の長軸方向と交差する方向に延在している、画像取得用カテーテル。 (1) An imaging catheter for acquiring diagnostic ultrasonic tomographic images in a living body lumen, the imaging catheter comprising: an inner tube with a first lumen; a sensor section disposed at the tip of the inner tube, in which a plurality of transducers for transmitting and receiving ultrasonic waves in the living body lumen are arranged in a circumferential ring shape; a plurality of signal lines connected to each of the transducers and enabling transmission of electrical signals between the plurality of transducers and an external device; and an outer tube disposed to cover the inner tube at a position on the base side of the sensor section so as to define a second lumen between the inner tube and the sensor section, through which the plurality of signal lines can be inserted; each of the plurality of signal lines has a wire portion made of a metal material, and at least a portion of each of the plurality of signal lines extends in a direction intersecting the longitudinal direction of the inner tube so as to be arranged along the outer circumferential surface of the inner tube or the inner circumferential surface of the outer tube.

　（２）前記複数の信号線の各々の少なくとも一部は、前記内管の外周面に螺旋状に巻回された螺旋状部を有する、上記（１）に記載の画像取得用カテーテル。 (2) An imaging catheter as described in (1) above, in which at least a portion of each of the plurality of signal lines has a spiral portion wound in a spiral shape around the outer circumferential surface of the inner tube.

　（３）前記螺旋状部は、前記内管の外周面に対し前記信号線が粗巻きされた粗巻部と、前記粗巻部に隣接して配置され前記内管の外周面に対し前記信号線が密巻きされた密巻部と、を有する、上記（２）に記載の画像取得用カテーテル。 (3) The imaging catheter described in (2) above, wherein the spiral portion has a coarsely wound portion in which the signal wire is coarsely wound around the outer circumferential surface of the inner tube, and a densely wound portion disposed adjacent to the coarsely wound portion in which the signal wire is densely wound around the outer circumferential surface of the inner tube.

　（４）前記螺旋状部は、前記粗巻部と前記密巻部が前記内管の長軸方向に交互に複数配置され、前記密巻部は、一定間隔を空けて複数配置される、上記（３）に記載の画像取得用カテーテル。 (4) The imaging catheter described in (3) above, in which the helical portion has multiple coarsely wound portions and densely wound portions arranged alternately in the longitudinal direction of the inner tube, and multiple densely wound portions are arranged at regular intervals.

　（５）前記複数の信号線の各々の少なくとも一部は、前記内管の外周面にブレード状に編組されたブレード部を有する、上記（１）に記載の画像取得用カテーテル。 (5) An imaging catheter as described in (1) above, in which at least a portion of each of the plurality of signal lines has a braided portion braided into a braid shape on the outer circumferential surface of the inner tube.

　（６）前記ブレード部は、手元ハブの先端から前記内管の先端に向かう前記内管の基端部に形成され、前記内管の先端部には、造影マーカーが配置される、上記（５）に記載の画像取得用カテーテル。 (6) An imaging catheter as described in (5) above, in which the blade portion is formed at the base end of the inner tube extending from the tip of the hand hub toward the tip of the inner tube, and a contrast marker is disposed at the tip of the inner tube.

　本発明に係る画像取得用カテーテルは、次のような作用効果を奏し得る。 The imaging catheter according to the present invention can achieve the following effects:

　画像取得用カテーテルは、金属材料で構成される素線部を有する信号線を内管の外周面に沿って配置されるように内管の長軸方向と交差する方向に延在させることで、内管の長軸方向と交差する方向への曲げ剛性が高まり、プッシャビリティが向上する。また、画像取得用カテーテルは、プッシャビリティを向上させる上で、補強部材等の別部材を使用せず既存の信号線を用いているため、部品点数の増加により製造コストが嵩むといった問題が生じない。 The imaging catheter extends a signal line having a wire portion made of a metallic material in a direction intersecting the longitudinal direction of the inner tube so as to be arranged along the outer circumferential surface of the inner tube, thereby increasing the bending rigidity in the direction intersecting the longitudinal direction of the inner tube and improving pushability. In addition, the imaging catheter uses an existing signal line without using a separate member such as a reinforcing member to improve pushability, so there is no problem of increased manufacturing costs due to an increased number of parts.

実施形態に係る画像取得用カテーテルを含む医療システムの概略構成図である。1 is a schematic configuration diagram of a medical system including an image acquisition catheter according to an embodiment. 実施形態に係る画像取得用カテーテルを示す図である。FIG. 2 is a diagram showing an image acquisition catheter according to an embodiment. 実施形態に係る画像取得用カテーテルの断面図である。FIG. 2 is a cross-sectional view of an imaging catheter according to an embodiment. 実施形態に係る画像取得用カテーテルにおける信号線の第２形態の配線形状を示す部分断面図である。FIG. 11 is a partial cross-sectional view showing a wiring shape of a second form of the signal line in the imaging catheter according to the embodiment. 実施形態に係る画像取得用カテーテルにおける信号線の第３形態の配線形状を示す部分断面図である。FIG. 11 is a partial cross-sectional view showing a wiring shape of a third form of the signal line in the imaging catheter according to the embodiment. 実施形態に係る画像取得用カテーテルにおける信号線の第４形態の変形例を示す部分断面図である。FIG. 13 is a partial cross-sectional view showing a modified example of the fourth form of the signal line in the imaging catheter according to the embodiment.

　以下、本発明を実施するための形態について、図面を参照しながら詳細に説明する。ここで示す実施形態は、本発明の技術的思想を具体化するために例示するものであって、本発明を限定するものではない。また、本発明の要旨を逸脱しない範囲で当業者等により考え得る実施可能な他の形態、実施例及び運用技術等は全て本発明の範囲、要旨に含まれると共に、特許請求の範囲に記載された発明とその均等の範囲に含まれる。 Below, the form for carrying out the present invention will be described in detail with reference to the drawings. The embodiment shown here is an example to embody the technical idea of the present invention, and does not limit the present invention. Furthermore, all other possible forms, examples, and operational techniques that can be conceived by those skilled in the art without departing from the gist of the present invention are included in the scope and gist of the present invention, and are included in the scope of the inventions described in the claims and their equivalents.

　更に、本明細書に添付する図面は、図示と理解のし易さの便宜上、適宜縮尺、縦横の寸法比、形状等について、実物から変更し模式的に表現される場合があるが、あくまで一例であって、本発明の解釈を限定するものではない。 Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be depicted diagrammatically with appropriate changes in scale, aspect ratio, shape, etc. from the actual product, but these are merely examples and do not limit the interpretation of the present invention.

　本明細書において、説明の便宜上、以下の方向について定義する。図１において、「長軸方向」は、画像取得用カテーテル１００の中心軸に沿う方向とする。「径方向」は、画像取得用カテーテル１００の中心軸を基準軸とした軸直交断面（横断面）において中心軸に対して離隔又は接近する方向とする。「周方向」は、画像取得用カテーテル１００の中心軸を基準軸とした回転方向とする。 For ease of explanation, the following directions are defined in this specification. In FIG. 1, the "longitudinal direction" is the direction along the central axis of the imaging catheter 100. The "radial direction" is the direction moving away from or approaching the central axis in an orthogonal cross section (transverse cross section) with the central axis of the imaging catheter 100 as the reference axis. The "circumferential direction" is the rotational direction with the central axis of the imaging catheter 100 as the reference axis.

　画像取得用カテーテル１００において手元ハブ部６０が配置される側を「基端側」と称する。また、画像取得用カテーテル１００において基端側とは反対側に位置し、生体内に導入される側を「先端側」と称する。また、「先端部」とは、先端（最先端）から基端側に向かう一定の範囲を含む部分を意味し、「基端部」とは、基端（最基端）から先端側に向かう一定の範囲を含む部分を意味する。 The side of the imaging catheter 100 where the proximal hub portion 60 is located is referred to as the "base end side." The side of the imaging catheter 100 that is located opposite the base end side and that is introduced into the living body is referred to as the "tip side." The "tip portion" refers to a portion that includes a certain range from the tip (the most distal end) toward the base end side, and the "base end portion" refers to a portion that includes a certain range from the base end (the most proximal end) toward the tip end side.

　本実施形態において、画像取得用カテーテル１００は、血管内超音波診断法（ＩＶＵＳ：Ｉｎｔｒａｖａｓｃｕｌａｒ　Ｕｌｔｒａｓｏｕｎｄ）を利用したＩＶＵＳカテーテルとして構成する。 In this embodiment, the image acquisition catheter 100 is configured as an IVUS catheter that utilizes intravascular ultrasound (IVUS).

　本実施形態では、画像取得用カテーテル１００の適用対象となる生体管腔として血管を例示する。ただし、画像取得用カテーテル１００の適用対象となる生体管腔は血管のみに限定されることはなく、例えば、胆管、気管、食道、その他消化管、尿道、耳鼻内腔等の生体器官であってもよい。 In this embodiment, blood vessels are exemplified as a biological lumen to which the image acquisition catheter 100 is applied. However, the biological lumen to which the image acquisition catheter 100 is applied is not limited to blood vessels, and may be, for example, biological organs such as the bile duct, trachea, esophagus, other digestive tract, urethra, and ear and nose cavities.

　図１に示すように、医療システム１は、画像取得用カテーテル１００と、外部装置３００と、を有する。医療システム１は、患者の血管に画像取得用カテーテル１００を挿入してセンサ部３０を病変部まで送達し、病変部及び病変部周辺で撮像した画像（血管の断層画像等）を外部装置３００に出力して病変部の性状を診断する際に使用する。 As shown in FIG. 1, the medical system 1 includes an image acquisition catheter 100 and an external device 300. The medical system 1 inserts the image acquisition catheter 100 into a patient's blood vessel, delivers the sensor unit 30 to the lesion, and outputs images (such as cross-sectional images of the blood vessels) captured at and around the lesion to the external device 300 for use in diagnosing the characteristics of the lesion.

　＜画像取得用カテーテル＞
　画像取得用カテーテル１００は、内管１０と、外管２０と、センサ部３０と、接合部４０と、信号線５０と、手元ハブ部６０と、造影部７０と、を有する。画像取得用カテーテル１００は、内管１０の第１ルーメン１１を通じてカテーテル基端からガイドワイヤが出し入れ可能な、所謂「オーバーザワイヤ型のカテーテル」として構成される。ただし、画像取得用カテーテル１００は、所謂「ラピッドエクスチェンジ型のカテーテル」として構成してもよい。 <Image acquisition catheter>
The imaging catheter 100 has an inner tube 10, an outer tube 20, a sensor unit 30, a joint unit 40, a signal line 50, a proximal hub unit 60, and an imaging unit 70. The imaging catheter 100 is configured as a so-called "over-the-wire type catheter" in which a guidewire can be inserted and removed from the catheter base end through a first lumen 11 of the inner tube 10. However, the imaging catheter 100 may also be configured as a so-called "rapid exchange type catheter."

　〈内管〉
　内管１０は、先端から基端まで延在するガイドワイヤが挿通可能な第１ルーメン１１を有する長尺な管状部材である。内管１０は、先端が画像取得用カテーテル１００の先端に位置し、基端が手元ハブ部６０の第１ポート６１の基端に位置し、ガイドワイヤが出し入れ可能に構成される。 <Inner tube>
The inner tube 10 is a long tubular member having a first lumen 11 through which a guide wire can be inserted, the first lumen 11 extending from the distal end to the proximal end. The inner tube 10 has a distal end located at the distal end of the imaging catheter 100 and a proximal end located at the proximal end of the first port 61 of the proximal hub portion 60, and is configured to allow the guide wire to be inserted and removed.

　内管１０の構成材料は、カテーテル等で適用可能な材料であり、例えば、スチレン系、ポリオレフィン系、ポリウレタン系、ポリエステル系、ポリアミド系、ポリイミド系、ポリブタジエン系、トランスポリイソプレン系、フッ素ゴム系、塩素化ポリエチレン系等の各種熱可塑性エラストマー等を使用することができる。 The material that makes up the inner tube 10 is a material that can be used in catheters, etc., and can be, for example, various thermoplastic elastomers such as styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polyimide-based, polybutadiene-based, trans-polyisoprene-based, fluororubber-based, and chlorinated polyethylene-based.

　〈外管〉
　外管２０は、内管１０との間に複数の信号線５０が挿通可能な第２ルーメン２１を区画するように、センサ部３０よりも基端側の位置で内管１０を覆うように配置される。外管２０の基端は、手元ハブ部６０の内部で第２ポート６２の先端開口より先端側に位置する。これにより、信号線５０は、センサ部３０から第２ルーメン２１を挿通した後、第２ポート６２から導出できる。外管２０は、内管１０と同軸上に配置される。 <Outer tube>
The outer tube 20 is disposed so as to cover the inner tube 10 at a position proximal to the sensor unit 30, so as to define a second lumen 21, through which a plurality of signal lines 50 can be inserted, between the outer tube 20 and the inner tube 10. The proximal end of the outer tube 20 is located distal to the distal opening of the second port 62 inside the proximal hub portion 60. This allows the signal lines 50 to be inserted from the sensor unit 30 through the second lumen 21 and then led out of the second port 62. The outer tube 20 is disposed coaxially with the inner tube 10.

　外管２０は、例えば上記に例示した内管１０と同様の材料で構成することができる。 The outer tube 20 can be made of, for example, the same material as the inner tube 10 exemplified above.

　〈センサ部〉
　センサ部３０は、外管２０より先端側の内管１０の先端部に配置されている。センサ部３０は、補強体３１と、フィルムセンサ３２と、で構成される。センサ部３０は、生体管腔内において超音波を送受信し、トランスデューサー３２ａの各々と接続される信号線５０を介して外部装置３００との間で電気信号の伝送を可能とする。 <Sensor section>
The sensor unit 30 is disposed at the distal end of the inner tube 10, which is closer to the distal end than the outer tube 20. The sensor unit 30 is composed of a reinforcing body 31 and a film sensor 32. The sensor unit 30 transmits and receives ultrasonic waves within a biological lumen, and enables transmission of electrical signals between the sensor unit 300 and an external device 300 via signal lines 50 connected to each of the transducers 32a.

　補強体３１は、円柱状の軸部３１ａと、軸部３１ａの先端に配置され軸部３１ａの外径よりも大径な先端支持部３１ｂと、軸部３１ａの基端に配置され軸部３１ａの外径よりも大径な基端支持部３１ｃと、を有する。補強体３１は、金属材料で形成できる。補強体３１は、内管１０が挿通可能な第３ルーメン３１ｄが形成される。 The reinforcing body 31 has a cylindrical shaft portion 31a, a tip support portion 31b that is disposed at the tip of the shaft portion 31a and has a larger diameter than the outer diameter of the shaft portion 31a, and a base end support portion 31c that is disposed at the base end of the shaft portion 31a and has a larger diameter than the outer diameter of the shaft portion 31a. The reinforcing body 31 can be formed of a metal material. The reinforcing body 31 has a third lumen 31d formed therein through which the inner tube 10 can be inserted.

　フィルムセンサ３２は、フォルム基板上に電子部品を実装したフレキシブル基板で構成され、外表面に複数のトランスデューサー３２ａ等を含む電子回路が形成される。フィルムセンサ３２は、補強体３１の先端支持部３１ｂ及び基端支持部３１ｃに巻回される。 The film sensor 32 is made of a flexible board with electronic components mounted on a form board, and an electronic circuit including multiple transducers 32a is formed on the outer surface. The film sensor 32 is wound around the tip support portion 31b and base support portion 31c of the reinforcement body 31.

　トランスデューサー３２ａの各々は、電気信号を超音波振動に変換可能なセラミックス、水晶等の圧電特性を有する圧電材からなる振動子を備える。トランスデューサー３２ａは、フィルムセンサ３２を補強体３１に巻回した状態において、補強体３１の周方向に沿ってリング状に配置したフェーズドアレイを構成する。センサ部３０は、このようなフェーズドアレイ型のセンサを用いることによって、センサ部３０を回転させることなく、血管の断層画像を周方向の広範囲にわたって一度に取得できる。トランスデューサー３２ａの種類、配置、個数について特に制限は無い。 Each transducer 32a has an oscillator made of a piezoelectric material with piezoelectric properties, such as ceramics or quartz, capable of converting an electrical signal into ultrasonic vibrations. The transducers 32a form a phased array arranged in a ring shape along the circumferential direction of the reinforcing body 31 when the film sensor 32 is wrapped around the reinforcing body 31. By using such a phased array type sensor, the sensor unit 30 can acquire tomographic images of blood vessels over a wide range in the circumferential direction at once without rotating the sensor unit 30. There are no particular limitations on the type, arrangement, or number of transducers 32a.

　複数のトランスデューサー３２ａは、電気信号（パルス信号）に基づく超音波を体腔内に送信し、かつ体腔内の生体組織から反射してきた超音波を受信する機能を有している。トランスデューサー３２ａの各々は、フィルムセンサ３２の外表面に配置され、各々がマルチプレクサ３２ｂに接続されている。マルチプレクサ３２ｂは、複数の入力線の中から一つを選択して単一出力線に接続する組合回路である。トランスデューサー３２ａの各々は、マルチプレクサ３２ｂを介して複数の信号線５０の各々と接続される。トランスデューサー３２ａの各々は、送信及び受信の各送受信動作を、マルチプレクサ３２ｂで順次切り替えられるように構成されている。すなわち、複数のトランスデューサー３２ａは、各受信信号を順次受信し、マルチプレクサ３２ｂを介して受信した信号を順次送信する。マルチプレクサ３２ｂは、フィルムセンサ３２上に形成された制御ＩＣ３２ｃによって駆動制御される。 The multiple transducers 32a have the function of transmitting ultrasonic waves based on an electric signal (pulse signal) into the body cavity and receiving ultrasonic waves reflected from the biological tissue in the body cavity. Each of the transducers 32a is disposed on the outer surface of the film sensor 32 and is connected to a multiplexer 32b. The multiplexer 32b is a combination circuit that selects one of the multiple input lines and connects it to a single output line. Each of the transducers 32a is connected to each of the multiple signal lines 50 via the multiplexer 32b. Each of the transducers 32a is configured so that the multiplexer 32b can sequentially switch between transmitting and receiving operations. In other words, the multiple transducers 32a sequentially receive each received signal and sequentially transmit the received signal via the multiplexer 32b. The multiplexer 32b is driven and controlled by a control IC 32c formed on the film sensor 32.

　〈接合部〉
　接合部４０は、センサ部３０を内管１０及び又は外管２０に接合する。接合部４０は、先端接合部４１と、基端接合部４２と、充填接合部４３と、を有する。先端接合部４１，基端接合部４２、及び充填接合部４３は、何れも樹脂製接合剤で形成される。 <Joint part>
The joint 40 joins the sensor unit 30 to the inner tube 10 and/or the outer tube 20. The joint 40 has a distal joint 41, a proximal joint 42, and a filling joint 43. The distal joint 41, the proximal joint 42, and the filling joint 43 are all formed of a resin bonding agent.

　先端接合部４１は、センサ部３０の先端支持部３１ｂと隣接して内管１０の外周面と接触するようにセンサ部３０の先端側に配置される。これにより、センサ部３０は、内管１０と強固に接合できる。 The tip joint 41 is disposed on the tip side of the sensor unit 30 so as to be adjacent to the tip support portion 31b of the sensor unit 30 and to be in contact with the outer circumferential surface of the inner tube 10. This allows the sensor unit 30 to be firmly joined to the inner tube 10.

　先端接合部４１は、センサ部３０の先端支持部３１ｂから内管１０の外周面に向かって外径が縮径するテーパー面４１ａを有する。先端接合部４１は、テーパー面４１ａを有するため、画像取得用カテーテル１００の挿入性を向上させることができる。 The tip joint 41 has a tapered surface 41a whose outer diameter decreases from the tip support portion 31b of the sensor unit 30 toward the outer circumferential surface of the inner tube 10. Because the tip joint 41 has a tapered surface 41a, it is possible to improve the insertability of the imaging catheter 100.

　先端接合部４１は、樹脂製接合剤のみで形成することができる。これにより、先端接合部４１は、従来デバイスで適用される融着用チューブを用いたセンサ部３０と内管１０との接合構造と比べて、センサ部３０の先端における長軸方向の長さを短くできる。そのため、画像取得用カテーテル１００は、血管通過性が向上すると共に、進退操作時の血管内壁との接触による血管損傷を抑制できる。 The tip joint 41 can be formed using only a resin adhesive. This allows the tip joint 41 to be shorter in the longitudinal direction at the tip of the sensor unit 30 compared to the joint structure between the sensor unit 30 and the inner tube 10 using a fusion tube applied in conventional devices. As a result, the imaging catheter 100 has improved blood vessel passage and can suppress blood vessel damage caused by contact with the blood vessel inner wall during advancement and retraction operations.

　基端接合部４２は、センサ部３０の基端支持部３１ｃと隣接して外管２０の先端部との間に配置される。これにより、センサ部３０は、外管２０と強固に接合できる。 The base end joint 42 is disposed adjacent to the base end support portion 31c of the sensor unit 30 and between the tip end of the outer tube 20. This allows the sensor unit 30 to be firmly joined to the outer tube 20.

　充填接合部４３は、補強体３１の軸部３１ａと巻回されたフィルムセンサ３２との間に形成される内部空間３３に充填される。これにより、フィルムセンサ３２は、補強体３１と強固に接合できる。また、充填接合部４３は、第３ルーメン３１ｄ内にも充填することができる。これにより、センサ部３０は、内管１０と強固に接合できる。また、充填接合部４３は、先端接合部４１と基端接合部４２との間を接続するように第３ルーメン３１ｄ内に充填することで、接合部４０全体の接合強度を高めることができる。 The filling joint 43 is filled into the internal space 33 formed between the shaft portion 31a of the reinforcing body 31 and the wound film sensor 32. This allows the film sensor 32 to be firmly joined to the reinforcing body 31. The filling joint 43 can also be filled into the third lumen 31d. This allows the sensor portion 30 to be firmly joined to the inner tube 10. By filling the filling joint 43 into the third lumen 31d so as to connect between the tip joint 41 and the base joint 42, the joint strength of the entire joint 40 can be increased.

　接合部４０として使用される樹脂製接合剤は、塗布時には流動性を有し、塗布後の硬化処理に基づく化学変化により硬化する性質を有する。樹脂製接合剤は、例えば、ＵＶ硬化型接着剤や熱硬化性接着剤（エポキシ系接着剤等）を好適に用いることができる。 The resin adhesive used as the joint 40 has a property of being fluid when applied and hardening due to a chemical change caused by a curing process after application. For example, a UV-curable adhesive or a thermosetting adhesive (such as an epoxy-based adhesive) can be suitably used as the resin adhesive.

　接合部４０を構成する先端接合部４１、基端接合部４２、及び充填接合部４３は、同一の樹脂製接合剤で形成できる。先端接合部４１を構成する樹脂製接合剤は、センサ部３０の先端側で補強体３１とフィルムセンサ３２との界面に一部入り込む。基端接合部４２を構成する樹脂製接合剤は、センサ部３０の基端側で補強体３１とフィルムセンサ３２との界面に一部入り込む。これにより、画像取得用カテーテル１００は、センサ部３０と内管１０及び外管２０との接合に際し、融着用チューブ等を用いずとも樹脂製接合剤のみで強固に接合できると共に、製造工程の簡素化が図れる。 The distal joint 41, proximal joint 42, and filling joint 43 constituting the joint 40 can be formed from the same resin adhesive. The resin adhesive constituting the distal joint 41 partially penetrates into the interface between the reinforcing body 31 and the film sensor 32 on the distal side of the sensor section 30. The resin adhesive constituting the proximal joint 42 partially penetrates into the interface between the reinforcing body 31 and the film sensor 32 on the proximal side of the sensor section 30. This allows the imaging catheter 100 to firmly bond the sensor section 30 to the inner tube 10 and the outer tube 20 using only the resin adhesive without using a fusion tube or the like, and simplifies the manufacturing process.

　〈信号線〉
　信号線５０は、導電性及び造影性を有する金属材料で構成される素線部５１を有し、一端がセンサ部３０に接続され、他端がコネクタ１１０に接続される。信号線５０の各々は、マルチプレクサ３２ｂや制御ＩＣ３２ｃと半田付け等により接続される。信号線５０は、コネクタ１１０と外部装置３００のコネクタ３３０とが接続されることで、センサ部３０と外部装置３００との間で電気信号の送受信が可能となる。信号線５０は、基端側の手元ハブ部６０の第２ポート６２から露出される部分について、各々を一纏めにしてケーブル１２０とした状態でコネクタ１１０に接続される。 Signal Line
The signal lines 50 have wire portions 51 made of a metallic material having electrical conductivity and contrast properties, one end of which is connected to the sensor unit 30 and the other end of which is connected to the connector 110. Each of the signal lines 50 is connected to the multiplexer 32b or the control IC 32c by soldering or the like. The signal lines 50 are capable of transmitting and receiving electrical signals between the sensor unit 30 and the external device 300 by connecting the connector 110 to the connector 330 of the external device 300. The signal lines 50 are connected to the connector 110 in a state where the portions of the signal lines 50 exposed from the second port 62 of the proximal hub unit 60 on the base end side are bundled together to form a cable 120.

　信号線５０は、素線部５１をフッ素系樹脂等で被覆した被覆電線と、素線部５１で形成される外部導体や内部導体とが一定の同心円の間隔で配置された同軸ケーブルとを含み、それぞれ複数本ずつ有して構成できる。信号線５０は、例えば同軸ケーブルを受信専用線として利用すると、センサ部３０で取得した電気信号（撮像データ）の伝送損失を低減させることができる。信号線５０は、複数本の素線部５１を樹脂フィルム等で挟み込んだフレキシブルケーブル、絶縁性の被膜で覆われた複数の素線部５１を帯状に並列させたフラットケーブルで構成してもよい。 The signal line 50 can be made up of multiple pieces of each, including a coated wire in which the wire portion 51 is coated with a fluororesin or the like, and a coaxial cable in which the outer conductor and inner conductor formed by the wire portion 51 are arranged at regular concentric intervals. For example, if the signal line 50 is a coaxial cable used as a dedicated receiving line, the transmission loss of the electrical signal (imaging data) acquired by the sensor unit 30 can be reduced. The signal line 50 can also be made up of a flexible cable in which multiple wire portions 51 are sandwiched between resin films or the like, or a flat cable in which multiple wire portions 51 covered with an insulating coating are arranged in parallel in a band shape.

　画像取得用カテーテル１００において、信号線５０の各々の少なくとも一部は、内管１０の外周面に沿って配置されるように内管１０の長軸方向と交差する方向に延在している。信号線５０の各々の少なくとも一部は、図３～図５に示すような配線形状（第１形態～第４形態）とすることができる。画像取得用カテーテル１００は、以下に示す各形態のように内管１０又は外管２０に配置することで、プッシャビリティを向上できる。なお、図３～図５に示した各形態において、内管１０の外周面、又は外管２０の内周面に配置される信号線５０の本数は、適宜設定できる。すなわち、画像取得用カテーテル１００は、信号線５０を内管１０の外周面、又は外管２０の内周面に沿って長軸方向と交差する方向に延在させる際、センサ部３０に接続される全ての信号線５０を用いてもよいし、センサ部３０に接続される複数の信号線５０のうちの一部（数本）を用いてもよい。なお、以下に示す第１形態～第４形態は、信号線５０を内管１０の外周面に配置した形態であるが、外管２０の内周面に配置してもよい。 In the imaging catheter 100, at least a portion of each of the signal lines 50 extends in a direction intersecting the longitudinal direction of the inner tube 10 so as to be arranged along the outer circumferential surface of the inner tube 10. At least a portion of each of the signal lines 50 can be in a wiring shape (first form to fourth form) as shown in Figures 3 to 5. The imaging catheter 100 can improve pushability by arranging the signal lines 50 on the inner tube 10 or the outer tube 20 as in each of the forms shown below. In addition, in each of the forms shown in Figures 3 to 5, the number of signal lines 50 arranged on the outer circumferential surface of the inner tube 10 or the inner circumferential surface of the outer tube 20 can be set appropriately. In other words, when the imaging catheter 100 extends the signal lines 50 along the outer circumferential surface of the inner tube 10 or the inner circumferential surface of the outer tube 20 in a direction intersecting the longitudinal direction, all of the signal lines 50 connected to the sensor unit 30 may be used, or a portion (several lines) of the multiple signal lines 50 connected to the sensor unit 30 may be used. In the first to fourth forms described below, the signal line 50 is disposed on the outer peripheral surface of the inner tube 10, but it may also be disposed on the inner peripheral surface of the outer tube 20.

　（第１形態）
　第１形態に係る信号線５０の配線形状は、図３に示すように、信号線５０の各々の少なくとも一部を内管１０の外周面に螺旋状に巻回された螺旋状部５２を有するように、内管１０の外周面に巻回された形状を有する。 (First form)
The wiring shape of the signal line 50 in the first embodiment is such that at least a portion of each of the signal lines 50 is wound around the outer circumferential surface of the inner tube 10, as shown in FIG. 3, to have a spiral portion 52 that is wound in a spiral shape around the outer circumferential surface of the inner tube 10.

　螺旋状部５２は、内管１０の先端部から基端部までの所定領域に形成される。螺旋状部５２は、内管１０の外周面に対し信号線５０が粗巻きされた粗巻部５２ａと、粗巻部５２ａに隣接して配置され内管１０の外周面に対し信号線５０が密巻きされた密巻部５２ｂと、を有する。粗巻部５２ａ、密巻部５２ｂは、内管１０の長軸方向に少なくとも１つずつ配置される。螺旋状部５２は、内管１０の外周面に沿って粗巻部５２ａと密巻部５２ｂが内管１０の長軸方向に交互に配置されるため、密巻部５２ｂの領域で内管１０の長軸方向と交差する方向への曲げ剛性が高まり、血管への押し込み時の座屈等が抑制できる。なお、「密巻き」とは、内管１０の長軸方向で隣り合う信号線５０同士が接触した状態若しくは信号線５０の間隔が極めて少ない状態で密に巻回されることを意味する。「粗巻き」とは、内管１０の長軸方向で隣り合う信号線５０の間隔を密巻きよりも大きく粗に巻回されることを意味する。 The spiral portion 52 is formed in a predetermined region from the tip to the base of the inner tube 10. The spiral portion 52 has a coarsely wound portion 52a in which the signal line 50 is coarsely wound around the outer circumferential surface of the inner tube 10, and a densely wound portion 52b adjacent to the coarsely wound portion 52a in which the signal line 50 is densely wound around the outer circumferential surface of the inner tube 10. At least one of the coarsely wound portion 52a and the densely wound portion 52b is arranged in the longitudinal direction of the inner tube 10. Since the coarsely wound portion 52a and the densely wound portion 52b of the spiral portion 52 are arranged alternately along the outer circumferential surface of the inner tube 10 in the longitudinal direction of the inner tube 10, the bending rigidity in the direction intersecting the longitudinal direction of the inner tube 10 is increased in the region of the densely wound portion 52b, and buckling when pushed into a blood vessel can be suppressed. Note that "dense winding" means that the signal lines 50 are wound tightly in a state where adjacent signal lines 50 are in contact with each other in the longitudinal direction of the inner tube 10, or the signal lines 50 are wound with very little space between them. "Coarse winding" means that the signal lines 50 are wound loosely with a larger space between adjacent signal lines 50 in the longitudinal direction of the inner tube 10 than in dense winding.

　また、密巻部５２ｂは、図３に示すように、内管１０の外周面に対し一定間隔を空けて粗巻部５２ａと密巻部５２ｂを長軸方向に交互に複数配置することができる。信号線５０は、導電性及び造影性を有する素線部５１を有するため、密巻部５２ｂを造影部７０として機能させることができる。そのため、画像取得用カテーテル１００は、内管１０の先端部に造影部７０を別途配置する必要がなく構成を簡素化できる。 Furthermore, as shown in FIG. 3, the densely wound portion 52b can be arranged in multiple alternating fashion in the longitudinal direction with the loosely wound portion 52a and the tightly wound portion 52b spaced apart at regular intervals on the outer peripheral surface of the inner tube 10. Since the signal line 50 has a wire portion 51 that is conductive and has contrast properties, the densely wound portion 52b can function as the contrast portion 70. Therefore, the imaging catheter 100 does not need to have a separate contrast portion 70 at the tip of the inner tube 10, and the configuration can be simplified.

　なお、第１形態において、粗巻部５２ａ及び密巻部５２ｂは、図３に示すように、内管１０の外周面に対して１重巻きでもよいし、径方向に巻き重ねた重ね巻きとしてもよい。 In the first embodiment, the loosely wound portion 52a and the tightly wound portion 52b may be wound in a single layer around the outer circumferential surface of the inner tube 10, as shown in FIG. 3, or may be wound in a radially overlapping manner.

　（第２形態）
　第２形態に係る信号線５０の配線形状は、図４に示すように、信号線５０の各々の少なくとも一部を長軸方向に沿って延在させた直線部５３と、信号線５０の各々の少なくとも一部を内管１０の外周面に沿って内管１０の長軸方向と直交する方向に密巻きに巻回させた密巻部５４と、を有するように内管１０の外周面に巻回された形状を有する。直線部５３、密巻部５４は、内管１０の長軸方向に交互に複数配置される。直線部５３及び密巻部５４は、内管１０の先端部から基端部までの所定領域に形成される。 (Second form)
4 , the wiring shape of the signal wire 50 according to the second embodiment is such that the signal wire 50 is wound around the outer circumferential surface of the inner tube 10 to have straight portions 53 in which at least a portion of the signal wire 50 extends along the longitudinal direction, and tightly wound portions 54 in which at least a portion of the signal wire 50 is tightly wound along the outer circumferential surface of the inner tube 10 in a direction perpendicular to the longitudinal direction of the inner tube 10. The straight portions 53 and tightly wound portions 54 are alternately arranged in the longitudinal direction of the inner tube 10. The straight portions 53 and tightly wound portions 54 are formed in a predetermined region from the tip end to the base end of the inner tube 10.

　図４に示す密巻部５４は、第１形態の密巻部５２ｂと同様、内管１０の外周面に対し一定間隔を空けて複数配置することができる。密巻部５４は、このように配置すれば、図３に示す密巻部５２ｂと同様、画像取得用カテーテル１００のプッシャビリティ向上を図りつつ造影部７０として機能させることができる。 The densely wound portion 54 shown in FIG. 4 can be arranged at regular intervals on the outer circumferential surface of the inner tube 10, similar to the densely wound portion 52b of the first embodiment. If arranged in this manner, the densely wound portion 54 can function as the imaging portion 70 while improving the pushability of the imaging catheter 100, similar to the densely wound portion 52b shown in FIG. 3.

　なお、第２形態において、密巻部５４は、図４に示すように内管１０の外周面に対して１重巻きでもよいし、径方向に巻き重ねた重ね巻きとしてもよい。 In the second embodiment, the densely wound portion 54 may be wound in a single layer around the outer circumferential surface of the inner tube 10 as shown in FIG. 4, or may be wound in a radially overlapping manner.

　（第３形態）
　第３形態に係る信号線５０の配線形状は、図５に示すように、信号線５０の各々の少なくとも一部を内管１０の外周面にブレード状に編組されたブレード部５５を有するように、内管１０の外周面に巻回された形状を有する。ブレード部５５は、複数の信号線５０により内管１０の長軸方向と交差する方向に交差させながら網状に編み込まれた形状をなす。 (Third form)
5, the signal wires 50 according to the third embodiment have a wiring shape in which at least a portion of each signal wire 50 is wound around the outer circumferential surface of the inner tube 10 to have a braided braid portion 55 on the outer circumferential surface of the inner tube 10. The braid portion 55 has a shape in which the multiple signal wires 50 are woven into a net shape while crossing in a direction intersecting with the longitudinal direction of the inner tube 10.

　図５に示すように、ブレード部５５は、手元ハブ部６０の先端からセンサ部３０より基端側の内管１０の先端部までの範囲に形成すると、画像取得用カテーテル１００の全長の大部分がブレード部５５により補強される。したがって、画像取得用カテーテル１００は、長軸方向と交差する方向への曲げ剛性が効果的に高められる。また、ブレード部５５は、内管１０と外管２０との間のクリアランス低減や耐断線性の向上といった効果を奏することもできる。 As shown in FIG. 5, when the blade portion 55 is formed in the range from the tip of the proximal hub portion 60 to the tip of the inner tube 10 on the base end side of the sensor portion 30, most of the overall length of the imaging catheter 100 is reinforced by the blade portion 55. Therefore, the imaging catheter 100 effectively has increased bending rigidity in a direction intersecting with the longitudinal axis direction. The blade portion 55 can also achieve effects such as reducing the clearance between the inner tube 10 and the outer tube 20 and improving resistance to breakage.

　（第４形態）
　図６には、信号線５０の第４形態の配線形状が示されている。第４形態は、図５に示した第３形態の変形例であり、信号線５０の各々の少なくとも一部を編組して形成したブレード部５５は、内管１０の基端部にのみ配置されている。画像取得用カテーテル１００は、血管内に押し込む際、手元ハブ部６０側を操作するため、プッシャビリティの観点から少なくとも手元ハブ部６０の先端から内管１０の先端に向かう内管１０の基端部に形成するのが好ましい。第４形態では、内管１０の基端部に形成されたブレード部５５の作用により、画像取得用カテーテル１００の基端部周辺の曲げ剛性が高まりプッシャビリティが向上する。なお、第４形態に示す画像取得用カテーテル１００では、第３形態のように内管１０の先端部に信号線５０による補強を兼ねた配線形状（ブレード部５５）を有さない。そのため、内管１０の先端部に、造影部７０を配置することができる。また、内管１０の先端部に、造影部７０として機能し得る第１形態の螺旋状部５２（粗巻部５２ａ及び密巻部５２ｂ）、第２形態の直線部５３及び密巻部５４を採用することもできる。 (4th form)
FIG. 6 shows a fourth wiring shape of the signal line 50. The fourth shape is a modification of the third shape shown in FIG. 5, and the braided portion 55 formed by braiding at least a part of each of the signal lines 50 is disposed only at the base end of the inner tube 10. When the imaging catheter 100 is pushed into a blood vessel, the proximal hub portion 60 side is operated, so from the viewpoint of pushability, it is preferable to form the braided portion at least at the base end of the inner tube 10 from the tip of the proximal hub portion 60 toward the tip of the inner tube 10. In the fourth shape, the action of the braided portion 55 formed at the base end of the inner tube 10 increases the bending rigidity around the base end of the imaging catheter 100, improving the pushability. Note that the imaging catheter 100 shown in the fourth shape does not have a wiring shape (braided portion 55) at the tip of the inner tube 10 that also serves as reinforcement by the signal line 50, as in the third shape. Therefore, the contrast section 70 can be disposed at the tip of the inner tube 10. In addition, the tip of the inner tube 10 may employ a first type of spiral portion 52 (a loosely wound portion 52a and a tightly wound portion 52b) that can function as a contrast section 70, and a second type of straight portion 53 and a tightly wound portion 54.

　このように、画像取得用カテーテル１００は、既存の構成要素である信号線５０を利用し、信号線５０の各々の少なくとも一部を、内管１０の外周面、又は外管２０の内周面に沿って配置されるように内管１０の長軸方向と交差する方向に延在させている。信号線５０は、金属材料で形成される素線部５１を有するため、内管１０の外周面、又は外管２０の内周面に沿って長軸方向と交差して配線すると、内管１０の長軸方向と交差する方向、又は外管２０の長軸方向と交差する方向への曲げ剛性が高まる。したがって、画像取得用カテーテル１００は、補強部材のような別部材を用いずとも、信号線５０を図３～図６に示した第１形態～第４形態の配線形状に配線するだけで長軸方向と交差する方向への曲げ剛性を高めることができる。 In this way, the imaging catheter 100 utilizes the signal lines 50, which are existing components, and extends at least a portion of each of the signal lines 50 in a direction intersecting the longitudinal direction of the inner tube 10 so as to be disposed along the outer peripheral surface of the inner tube 10 or the inner peripheral surface of the outer tube 20. Since the signal lines 50 have wire portions 51 formed of a metallic material, when the signal lines 50 are wired along the outer peripheral surface of the inner tube 10 or the inner peripheral surface of the outer tube 20 intersecting the longitudinal direction, the bending rigidity in the direction intersecting the longitudinal direction of the inner tube 10 or the direction intersecting the longitudinal direction of the outer tube 20 is increased. Therefore, the imaging catheter 100 can increase the bending rigidity in the direction intersecting the longitudinal direction by simply wiring the signal lines 50 in the wiring shapes of the first to fourth forms shown in Figures 3 to 6 without using a separate member such as a reinforcing member.

　なお、信号線５０を内管１０の外周面に配置する際、信号線５０の巻回位置等がデバイス使用中にずれてしまうことを防止するため、信号線５０の各々の少なくとも一部を内管１０の外周面に接着剤等で固定することができる。 When the signal wires 50 are arranged on the outer circumferential surface of the inner tube 10, at least a portion of each of the signal wires 50 can be fixed to the outer circumferential surface of the inner tube 10 with adhesive or the like to prevent the winding position of the signal wires 50 from shifting during use of the device.

　〈手元ハブ部〉
　手元ハブ部６０は、第１ポート６１と、第２ポート６２と、を有し、内管１０及び外管２０の基端部に接続される。 <Hand hub section>
The proximal hub portion 60 has a first port 61 and a second port 62 , and is connected to the base ends of the inner tube 10 and the outer tube 20 .

　手元ハブ部６０は、第１ポート６１の基端開口と、内管１０の第１ルーメン１１とが連通して接続される。これにより、手元ハブ部６０は、内管１０に対するガイドワイヤの出し入れが可能となる。手元ハブ部６０は、第２ポート６２の基端開口と外管２０の第２ルーメン２１とが連通して接続される。これにより、手元ハブ部６０は、複数の信号線５０の基端部を第２ポート６２から導出できる。 The proximal opening of the first port 61 of the hand hub section 60 is connected in communication with the first lumen 11 of the inner tube 10. This allows the hand hub section 60 to insert and remove a guide wire into and from the inner tube 10. The proximal opening of the second port 62 of the hand hub section 60 is connected in communication with the second lumen 21 of the outer tube 20. This allows the hand hub section 60 to lead out the proximal ends of multiple signal lines 50 from the second port 62.

　手元ハブ部６０は、例えば医療分野で適用可能な硬質樹脂や金属材料等によって構成することができる。 The hand hub portion 60 can be made of, for example, hard resin or metal materials that can be used in the medical field.

　〈造影部〉
　造影部７０は、内管１０の先端部付近に配置される。造影部７０は、例えばＸ線造影性（Ｘ線不透過性）を備える公知の金属材料等で構成することができる。 <Contrast department>
The imaging section 70 is disposed near the tip of the inner tube 10. The imaging section 70 can be made of, for example, a known metal material that has X-ray contrast properties (X-ray opacity).

　造影部７０は、血管内におけるセンサ部３０の病変部に対する距離や病変部の長さ等を測距する際のマーカーとして機能するように、内管１０の長軸方向に沿って一定間隔を空けて配置できる。造影部７０の配置間隔は、例えば、１０ｍｍ～４０ｍｍの間で設定できる。 The contrast imaging sections 70 can be placed at regular intervals along the longitudinal direction of the inner tube 10 so as to function as markers when measuring the distance of the sensor section 30 to the lesion in the blood vessel and the length of the lesion. The placement interval of the contrast imaging sections 70 can be set, for example, between 10 mm and 40 mm.

　造影部７０は、リング形状に成形したＸ線造影性の金属部品をスエージ加工等により内管１０の外周面に取り付けることができる。造影部７０は、内管１０の外周面に限らず、内管１０の管壁内部に一部若しくは全部が埋め込んだ状態で配置してもよい。なお、造影部７０の配置数、形状、配置間隔等は、画像取得用カテーテル１００の仕様に応じて適宜設定可能である。 The imaging section 70 can be a ring-shaped metal part with X-ray contrast that can be attached to the outer surface of the inner tube 10 by swaging or other processes. The imaging section 70 is not limited to being attached to the outer surface of the inner tube 10, but may also be partially or completely embedded inside the tube wall of the inner tube 10. The number, shape, spacing, etc. of the imaging sections 70 can be set appropriately according to the specifications of the imaging catheter 100.

　また、画像取得用カテーテル１００は、信号線５０の配線形態を図３に示す第１形態や図４に示す第２形態とすると、信号線５０を造影部７０として機能させることが可能であるため、造影部７０を別途設ける必要が無い。一方、図６に示す第４形態では、内管１０の基端部に複数の信号線５０がブレード状に編組されており、信号線５０が造影性を有するもののセンサ部３０の病変部に対する距離等を測距する機能を有さないため、造影部７０を内管１０の先端部に配置するのが好ましい。 In addition, when the wiring form of the signal line 50 of the imaging catheter 100 is the first form shown in FIG. 3 or the second form shown in FIG. 4, the signal line 50 can function as the imaging section 70, so there is no need to provide a separate imaging section 70. On the other hand, in the fourth form shown in FIG. 6, multiple signal lines 50 are braided into a braid at the base end of the inner tube 10, and although the signal lines 50 have imaging properties, they do not have the function of measuring the distance of the sensor unit 30 to the lesion, so it is preferable to place the imaging section 70 at the tip of the inner tube 10.

　なお、図５に示した第３形態において、ブレード部５５は、手元ハブ部６０の先端からセンサ部３０より基端側の内管１０の先端部までの範囲に形成される。そのため、画像取得用カテーテル１００は、第３形態に示すブレード部５５を形成した場合、造影部７０を配置する際、造影時にブレード部５５の形状と区別可能な形状とするのが好ましい。 In the third embodiment shown in FIG. 5, the blade portion 55 is formed in the range from the tip of the proximal hub portion 60 to the tip of the inner tube 10 on the proximal side of the sensor portion 30. Therefore, when the imaging catheter 100 is formed with the blade portion 55 shown in the third embodiment, it is preferable that the imaging portion 70 is arranged in a shape that can be distinguished from the shape of the blade portion 55 during imaging.

　＜外部装置＞
　外部装置３００は、制御ユニット３１０と、表示装置３２０と、コネクタ３３０と、を有する。 <External device>
The external device 300 includes a control unit 310 , a display device 320 , and a connector 330 .

　外部装置３００は、画像取得用カテーテル１００のコネクタ１１０をコネクタ３３０に接続することで、画像取得用カテーテル１００と電気的に接続される。これにより、外部装置３００は、画像取得用カテーテル１００のセンサ部３０との間で電気信号を送受信することが可能になる。 The external device 300 is electrically connected to the imaging catheter 100 by connecting the connector 110 of the imaging catheter 100 to the connector 330. This allows the external device 300 to transmit and receive electrical signals to and from the sensor unit 30 of the imaging catheter 100.

　制御ユニット３１０は、ＣＰＵ、メモリ、入出力部を主体に構成され、医療システム１全体の制御を司る。制御ユニット３１０は、画像取得用カテーテル１００のセンサ部３０に超音波を出射させる制御信号を出力し、センサ部３０からの検出信号を入力し、検出信号に基づき所定の信号処理をして画像データ（断層画像）を取得する。 The control unit 310 is mainly composed of a CPU, memory, and input/output units, and is responsible for controlling the entire medical system 1. The control unit 310 outputs a control signal to the sensor unit 30 of the image acquisition catheter 100 to emit ultrasound, inputs a detection signal from the sensor unit 30, and performs predetermined signal processing based on the detection signal to acquire image data (tomographic image).

　制御ユニット３１０は、取得した画像データに基づく情報（映像）を表示装置３２０に表示する。 The control unit 310 displays information (images) based on the acquired image data on the display device 320.

　以上説明したように、本実施形態に係る画像取得用カテーテル１００は、生体管腔内において診断用の超音波断層画像を取得するためのデバイスであって、第１ルーメン１１を備える内管１０と、内管１０の先端部に配置され、生体管腔内において超音波を送受信する複数のトランスデューサー３２ａが周方向にリング状に配置されたセンサ部３０と、トランスデューサー３２ａの各々と接続され、複数のトランスデューサー３２ａと外部装置３００との間での電気信号の伝送を可能にする複数の信号線５０と、内管１０との間に複数の信号線５０が挿通可能な第２ルーメン２１を区画するように、センサ部３０よりも基端側の位置で内管１０を覆うように配置された外管２０と、を有し、複数の信号線５０の各々は、金属材料で構成された素線部５１を有し、複数の信号線５０の各々の少なくとも一部は、内管１０の外周面、又は外管２０の内周面に沿って配置されるように内管１０の長軸方向と交差する方向に延在している。 As described above, the imaging catheter 100 according to this embodiment is a device for acquiring diagnostic ultrasound tomographic images in a living body lumen, and includes an inner tube 10 having a first lumen 11, a sensor unit 30 arranged at the tip of the inner tube 10 and including a ring-shaped arrangement of multiple transducers 32a for transmitting and receiving ultrasound in the living body lumen, multiple signal lines 50 connected to each of the transducers 32a and enabling transmission of electrical signals between the multiple transducers 32a and an external device 300, and an outer tube 20 arranged to cover the inner tube 10 at a position closer to the base end than the sensor unit 30 so as to define a second lumen 21 through which the multiple signal lines 50 can be inserted between the inner tube 10 and the outer tube 20, each of the multiple signal lines 50 having a wire portion 51 made of a metal material, and at least a portion of each of the multiple signal lines 50 extending in a direction intersecting the longitudinal direction of the inner tube 10 so as to be arranged along the outer circumferential surface of the inner tube 10 or the inner circumferential surface of the outer tube 20.

　画像取得用カテーテル１００は、金属材料で構成される素線部５１を有する信号線５０の各々の少なくとも一部を内管１０の外周面に沿って配置されるように内管１０の長軸方向と交差する方向に延在させることで、内管１０の長軸方向と交差する方向への曲げ剛性が高まり、プッシャビリティが向上する。また、画像取得用カテーテル１００は、プッシャビリティを向上させる上で、補強部材等の別部材を使用せず既存の構成要素である信号線５０を用いているため、部品点数の増加により製造コストが嵩むといった問題が生じない。 The imaging catheter 100 extends in a direction intersecting the longitudinal direction of the inner tube 10 so that at least a portion of each of the signal lines 50, which have wire portions 51 made of a metallic material, is arranged along the outer circumferential surface of the inner tube 10, thereby increasing the bending rigidity in the direction intersecting the longitudinal direction of the inner tube 10 and improving pushability. In addition, the imaging catheter 100 uses the signal line 50, which is an existing component, without using a separate member such as a reinforcing member to improve pushability, so there is no problem of increased manufacturing costs due to an increase in the number of parts.

　本出願は、２０２３年１１月１０日に出願された日本国特許出願第２０２３－１９２０５８号に基づいており、その開示内容は、参照により全体として引用されている。 This application is based on Japanese Patent Application No. 2023-192058, filed on November 10, 2023, the disclosure of which is incorporated by reference in its entirety.

　１　医療システム、
　１０　内管、
　１１　第１ルーメン、
　２０　外管、
　２１　第２ルーメン、
　３０　センサ部、
　３１　補強体（３１ａ　軸部、３１ｂ　先端支持部、３１ｃ　基端支持部、３１ｄ　第３ルーメン）、
　３２　フィルムセンサ（３２ａ　トランスデューサー、３２ｂ　マルチプレクサ、３２ｃ　制御ＩＣ）、
　３３　内部空間、
　４０　接合部、
　４１　先端接合部、
　４２　基端接合部、
　４３　充填接合部、
　５０　信号線、
　５１　素線部、
　５２　螺旋状部（５２ａ　粗巻部、５２ｂ、５４　密巻部）、
　５３　延在部、
　５５　ブレード部、
　６０　手元ハブ部、
　６１　第１ポート、
　６２　第２ポート、
　７０　造影部、
　１００　画像取得用カテーテル、
　１１０　画像取得用カテーテルのコネクタ、
　１２０　ケーブル、
　３００　外部装置、
　３１０　制御ユニット、
　３２０　表示装置、
　３３０　外部装置のコネクタ。
  1. Medical system,
10 inner tube,
11 first lumen,
20 outer tube,
21 second lumen,
30 sensor unit,
31 Reinforcement body (31a shaft portion, 31b tip support portion, 31c base end support portion, 31d third lumen),
32 film sensor (32a transducer, 32b multiplexer, 32c control IC),
33 interior space,
40 joint,
41 Tip joint,
42 proximal junction,
43 Filling joint,
50 signal line,
51 wire portion,
52 spiral part (52a loosely wound part, 52b, 54 closely wound part),
53 Extension part,
55 Blade portion,
60 Hand hub part,
61 first port,
62 second port,
70 Contrast department,
100 Image acquisition catheter,
110 Connector of imaging catheter;
120 cable,
300 external device,
310 control unit,
320 display device,
330 External device connector.

Claims (6)

　生体管腔内において診断用の超音波断層画像を取得するための画像取得用カテーテルであって、
　第１ルーメンを備える内管と、
　前記内管の先端部に配置され、前記生体管腔内において超音波を送受信する複数のトランスデューサーが周方向にリング状に配置されたセンサ部と、
　前記トランスデューサーの各々と接続され、前記複数のトランスデューサーと外部装置との間での電気信号の伝送を可能にする複数の信号線と、
　前記内管との間に前記複数の信号線が挿通可能な第２ルーメンを区画するように、前記センサ部よりも基端側の位置で前記内管を覆うように配置された外管と、を有し、
　前記複数の信号線の各々は、金属材料で構成された素線部を有し、
　前記複数の信号線の各々の少なくとも一部は、前記内管の外周面、又は前記外管の内周面に沿って配置されるように前記内管又は前記外管の長軸方向と交差する方向に延在している、画像取得用カテーテル。 1. An imaging catheter for acquiring diagnostic ultrasound tomographic images in a living body lumen, comprising:
an inner tube having a first lumen;
a sensor unit disposed at a distal end of the inner tube, the sensor unit including a plurality of transducers arranged in a circumferential ring shape for transmitting and receiving ultrasonic waves within the body lumen;
a plurality of signal lines connected to each of the transducers and enabling transmission of electrical signals between the plurality of transducers and an external device;
an outer tube disposed to cover the inner tube at a position on the proximal end side of the sensor unit so as to define a second lumen through which the plurality of signal lines can be inserted between the outer tube and the inner tube;
Each of the plurality of signal lines has a wire portion made of a metal material,
An imaging catheter, wherein at least a portion of each of the plurality of signal lines extends in a direction intersecting the longitudinal direction of the inner tube or the outer tube so as to be arranged along the outer peripheral surface of the inner tube or the inner peripheral surface of the outer tube. 　前記複数の信号線の各々の少なくとも一部は、前記内管の外周面に螺旋状に巻回された螺旋状部を有する、請求項１に記載の画像取得用カテーテル。 The imaging catheter according to claim 1, wherein at least a portion of each of the plurality of signal lines has a spiral portion wound in a spiral shape around the outer circumferential surface of the inner tube. 　前記螺旋状部は、前記内管の外周面に対し前記信号線が粗巻きされた粗巻部と、前記粗巻部に隣接して配置され前記内管の外周面に対し前記信号線が密巻きされた密巻部と、を有する、請求項２に記載の画像取得用カテーテル。 The imaging catheter according to claim 2, wherein the spiral portion has a coarsely wound portion in which the signal line is coarsely wound around the outer circumferential surface of the inner tube, and a densely wound portion disposed adjacent to the coarsely wound portion in which the signal line is densely wound around the outer circumferential surface of the inner tube. 　前記螺旋状部は、前記粗巻部と前記密巻部が前記内管の長軸方向に交互に複数配置され、前記密巻部は、一定間隔を空けて複数配置される、請求項３に記載の画像取得用カテーテル。 The imaging catheter according to claim 3, wherein the helical portion is arranged such that the loosely wound portion and the tightly wound portion are alternately arranged in the longitudinal direction of the inner tube, and the tightly wound portion is arranged at regular intervals. 　前記複数の信号線の各々の少なくとも一部は、前記内管の外周面にブレード状に編組されたブレード部を有する、請求項１に記載の画像取得用カテーテル。 The imaging catheter according to claim 1, wherein at least a portion of each of the plurality of signal lines has a braided portion braided into a braid on the outer circumferential surface of the inner tube. 　前記ブレード部は、手元ハブ部の先端から前記内管の先端に向かう前記内管の基端部に形成され、
　前記内管の先端部には、造影マーカーが配置される、請求項５に記載の画像取得用カテーテル。 The blade portion is formed at a base end portion of the inner tube extending from a tip end of the proximal hub portion to a tip end of the inner tube,
The imaging catheter according to claim 5 , wherein a contrast marker is disposed at a tip portion of the inner tube.
PCT/JP2024/039744 2023-11-10 2024-11-08 Catheter for image acquisition Pending WO2025100515A1 (en)

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US20100331763A1 (en) * 2002-02-28 2010-12-30 Ekos Corporation Ultrasound catheter with embedded conductors
WO2016111296A1 (en) * 2015-01-08 2016-07-14 テルモ株式会社 Medical device
JP2020508758A (en) * 2017-02-24 2020-03-26 テレフレックス メディカル インコーポレイテッド Intravascular detection device with flexible tip structure
WO2021149205A1 (en) * 2020-01-22 2021-07-29 オリンパス株式会社 Ultrasonic vibrator unit and ultrasonic endoscope

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100331763A1 (en) * 2002-02-28 2010-12-30 Ekos Corporation Ultrasound catheter with embedded conductors
JP2004016725A (en) * 2002-06-20 2004-01-22 Pentax Corp Ultrasound endoscope
WO2016111296A1 (en) * 2015-01-08 2016-07-14 テルモ株式会社 Medical device
JP2020508758A (en) * 2017-02-24 2020-03-26 テレフレックス メディカル インコーポレイテッド Intravascular detection device with flexible tip structure
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