WO2024241377A1 - 医療デバイス - Google Patents

医療デバイス Download PDF

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Publication number
WO2024241377A1
WO2024241377A1 PCT/JP2023/018775 JP2023018775W WO2024241377A1 WO 2024241377 A1 WO2024241377 A1 WO 2024241377A1 JP 2023018775 W JP2023018775 W JP 2023018775W WO 2024241377 A1 WO2024241377 A1 WO 2024241377A1
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WO
WIPO (PCT)
Prior art keywords
tube
catheter
sensor
medical device
marker
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.)
Ceased
Application number
PCT/JP2023/018775
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English (en)
French (fr)
Japanese (ja)
Inventor
宏友 清水
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.)
Asahi Intecc Co Ltd
Original Assignee
Asahi Intecc Co Ltd
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 Asahi Intecc Co Ltd filed Critical Asahi Intecc Co Ltd
Priority to PCT/JP2023/018775 priority Critical patent/WO2024241377A1/ja
Priority to JP2025521598A priority patent/JPWO2024241377A1/ja
Publication of WO2024241377A1 publication Critical patent/WO2024241377A1/ja
Priority to US19/383,788 priority patent/US20260060652A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61B8/08—Clinical applications
    • A61B8/0891—Clinical applications for diagnosis of blood vessels
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445—Details of catheter construction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • 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
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B15/00—Details of spraying plant or spraying apparatus not otherwise provided for; Accessories
    • B05B15/50—Arrangements for cleaning; Arrangements for preventing deposits, drying-out or blockage; Arrangements for detecting improper discharge caused by the presence of foreign matter

Definitions

  • the present invention relates to a medical device.
  • Patent Document 1 describes a medical device that includes a transducer unit for transmitting and receiving ultrasound toward biological tissue, an image lumen for allowing the transducer unit and drive shaft to move, and a guidewire lumen for allowing a guidewire to be inserted.
  • the ultrasound image acquisition mechanism including the drive shaft and transducer unit will also be referred to as a "sensor.” Using such a medical device to perform a percutaneous procedure can improve the safety and efficiency of the procedure.
  • multiple lumens are provided by combining multiple tubes.
  • the first tube and the second tube are joined by thermal fusion or adhesion.
  • the first and second tubes made of a resin material are thermally fused, there is an issue that the first and second tubes are deformed by heat.
  • disadvantages arise due to the hardening of the adhesive (e.g., reduced flexibility and operability, reduced acoustic properties).
  • these issues are not limited to medical devices with built-in sensors, but are also common to medical devices that are configured to allow a sensor to be inserted and are used in combination with the sensor. Furthermore, these issues are not limited to the vascular system, but are common to medical devices inserted into various organs within the human body, such as the lymphatic system, biliary system, urinary system, respiratory tract system, digestive system, secretory glands, and reproductive organs.
  • the present invention has been made to solve at least some of the problems described above, and aims to avoid the disadvantages that may arise from using adhesives in medical devices having multiple tubes while suppressing deformation of the tubes.
  • the present invention has been made to solve at least some of the problems described above, and can be realized in the following form.
  • a medical device includes a first tube having a first lumen and a second tube having a second lumen, the second tube being bonded to the first tube by a coating agent along a portion of the longitudinal direction of the medical device.
  • the first tube and the second tube can be bonded with a coating agent without using heat fusion or adhesive. This makes it possible to suppress deformation of the first and second tubes that occurs when bonding is performed by heat fusion. It also makes it possible to avoid disadvantages that occur when bonding is performed using an adhesive, such as reduced flexibility and operability due to hardening of the bonded portion, and reduced acoustic properties at the bonded portion.
  • the first lumen may be for inserting a sensor that acquires image information.
  • the medical device can be configured as a device that can be used in conjunction with a sensor that acquires image information.
  • the second tube may have an acoustic window in which the flesh of the second tube is present over the entire circumferential direction, and the first tube and the second tube may be bonded by the coating agent over at least a portion of the longitudinal direction of the acoustic window.
  • bonding is performed by the coating agent rather than an adhesive over at least a portion of the acoustic window where sensing by the sensor (acquisition of image information) is performed, so that it is possible to avoid the adhesive interfering with sensing by the sensor.
  • a gap may be formed between a common circumscribing line of the first tube and the second tube and the outer periphery of the first and second tubes.
  • the coating agent may be a base agent for a hydrophilic coating.
  • the hydrophilic coating can serve to bond the first and second tubes.
  • the medical device of the above embodiment may include a first marker having radiopacity and a second marker having radiopacity, the second marker being provided on the proximal side of the first marker, and the joint between the first tube and the second tube formed by the coating agent may be provided over the entire area between the first marker and the second marker. With this configuration, the entire area between the first marker and the second marker can be bonded by the coating agent.
  • the joint between the first tube and the second tube formed by the coating agent may include a first joint and a second joint provided at a position away from the first joint toward the base end.
  • the joint between the first and second tubes can be provided at two locations away from each other.
  • the present invention can be realized in various forms, such as medical devices, medical tubes, catheters, and methods for manufacturing these.
  • FIG. 1 is an explanatory diagram illustrating a configuration of a medical device.
  • FIG. 1 is an explanatory diagram illustrating a configuration of a medical device.
  • FIG. 2 is a cross-sectional view of the catheter.
  • FIG. 1 is a diagram illustrating a method of using a catheter.
  • FIG. 1 is a diagram illustrating a method of using a catheter.
  • FIG. 2 is an enlarged view of a portion of the distal end of the catheter.
  • 7 is a cross-sectional view of the catheter taken along line FF in FIG. 6.
  • FIG. 11 is a cross-sectional view of a catheter according to a second embodiment.
  • FIG. 11 is a cross-sectional view of a catheter according to a third embodiment.
  • FIG. 13 is an enlarged view of a portion of the distal end side of the catheter of the fourth embodiment.
  • FIG. 13 is an enlarged view of a portion of the tip side of the catheter of the fifth embodiment.
  • FIG. 13 is an enlarged view of a portion of the tip side of the catheter of the sixth embodiment.
  • First Embodiment 1 and 2 are explanatory diagrams illustrating the configuration of a medical device 1.
  • the medical device 1 of this embodiment is a catheter used to treat a lesion in a living lumen, such as a CTO occurring in a blood vessel.
  • the medical device 1 is also called a "catheter 1". As shown in FIG. 1 and FIG.
  • the catheter 1 includes a sensor tube 10, an OTW (Over The Wire) tube 20, an RX (Rapid Exchange) tube 30, a distal tip 40, a first marker 41, a second marker 42, a first outer tube 50, a branch connector 60, a first reinforcing member 61 to a third reinforcing member 63, a cylindrical member 64, a connector 65, a connector 25, a sensor 70, a second outer tube 80, and a heat shrink tube 90.
  • the sensor tube 10 is also called a “medical device” or a “medical tube”.
  • the OTW tube 20 is also called a "medical device” or a “medical tube”.
  • the sensor 70 is not shown in order to explain the configuration of the tube and the lumen within the tube.
  • the sensor 70 built into the sensor lumen 10L in the sensor tube 10 is shown by a dashed line and hatched with diagonal lines.
  • FIG. 1 and FIG. 2 for the sake of convenience, the relative size ratio of each component is different from the actual one. Also, some of the components are exaggerated. Also, in FIG. 1 and FIG. 2, mutually orthogonal XYZ axes are illustrated.
  • the X axis corresponds to the longitudinal direction of the catheter 1
  • the Y axis corresponds to the height direction of the catheter 1
  • the Z axis corresponds to the width direction of the catheter 1.
  • the left side (-X axis direction) of FIG. 1 and FIG. 2 is called the "tip side" of the catheter 1 and each component
  • the right side (+X axis direction) of FIG. 1 and FIG. 2 is called the "base end side" of the catheter 1 and each component.
  • the one end located on the tip side is called the "tip” and the other end located on the base side is called the “base end”.
  • the tip and its vicinity are called the “tip portion”, and the base end and its vicinity are called the “base end portion”.
  • the tip side is inserted into the living body, and the base side is operated by an operator such as a doctor.
  • Figure 3 is a cross-sectional view of the catheter 1.
  • Figure 3(A) shows a cross-section of the catheter 1 taken along line A-A in Figure 1.
  • Figure 3(B) shows a cross-section of the catheter 1 taken along line B-B in Figure 1.
  • Figure 3(C) shows a cross-section of the catheter 1 taken along line C-C in Figure 1.
  • Figure 3(D) shows a cross-section of the catheter 1 taken along line D-D in Figure 1.
  • Figure 3(E) shows a cross-section of the catheter 1 taken along line E-E in Figure 1.
  • the configuration of the catheter 1 will be explained below using Figures 1 to 3.
  • the sensor tube 10 is a cylindrical member (tubular body) with a long outer shape.
  • the sensor tube 10 extends linearly along the longitudinal direction (X-axis direction) of the catheter 1, parallel to the OTW tube 20 and the RX tube 30.
  • a sensor lumen 10L (dashed line) for accommodating the sensor 70 is formed inside the sensor tube 10.
  • the sensor lumen 10L is a lumen for the sensor 70.
  • the tip of the sensor tube 10 is located at the same position as or slightly closer to the base end than the tip of the RX tube 30 in the longitudinal direction of the catheter 1.
  • a tip opening 101 is formed at the tip of the sensor tube 10, connecting the tip of the sensor lumen 10L to the outside.
  • the tip opening 101 is a fluid outlet for keeping the inside of the sensor lumen 10L wet.
  • the base end of the sensor tube 10 is located closer to the base end than the base end of the OTW lumen 20L and the base end of the RX tube 30 in the longitudinal direction of the catheter 1.
  • a first reinforcing member 61, a branch connector 60, a cylindrical member 64, and a connector 65 are attached to the base end side of the sensor tube 10 from the tip side toward the base end side. Details will be described later.
  • a fluid supply unit 66 is attached to the connector 65, and a base end opening 102 is formed in the fluid supply unit 66, connecting the base end of the sensor lumen 10L to the outside.
  • the proximal opening 102 is a fluid supply port to the sensor lumen 10L.
  • the sensor tube 10 has a distal tube 11 arranged on the distal side, and a base tube 12 arranged on the proximal side of the distal tube 11.
  • the distal tube 11 and the base tube 12 are both cylindrical members (tubular bodies) having an elongated outer shape.
  • the distal tube 11 and the base tube 12 are connected inside the first outer tube 50 in the longitudinal direction.
  • the distal tube 11 and the base tube 12 each constitute a part of the sensor lumen 10L.
  • the OTW tube 20 is a cylindrical member (tubular body) with a long outer shape.
  • the OTW tube 20 extends linearly along the longitudinal direction of the catheter 1, parallel to the sensor tube 10 and the RX tube 30, on the distal side of the branch connector 60.
  • An OTW lumen 20L (dashed line) is formed inside the OTW tube 20 for accommodating a treatment device (e.g., a plasma guidewire or a penetration guidewire).
  • the OTW lumen 20L is a so-called over-the-wire (OTW) type lumen that does not have a base end opening in the portion that is placed in the biological lumen when the catheter 1 is in use.
  • the tip of the OTW tube 20 is located on the proximal side of the tip of the sensor tube 10 and the tip of the RX tube 30 in the longitudinal direction of the catheter 1.
  • a tip opening 201 is formed at the tip of the OTW tube 20, which connects the tip of the OTW lumen 20L to the outside.
  • the tip opening 201 is a device projection port for projecting a therapeutic device toward biological tissue.
  • the tip of the OTW tube 20 is cut at an angle, so that the tip opening 201 faces in a direction intersecting the longitudinal direction of the catheter 1. This makes it easier for the therapeutic device to reach the biological tissue present around the catheter 1 when the catheter 1 is in use.
  • the base end of the OTW tube 20 is located on the distal side of the base end of the sensor tube 10 and on the proximal side of the base end of the RX tube 30 in the longitudinal direction of the catheter 1.
  • a first reinforcing member 61, a branch connector 60, a second reinforcing member 62, a third reinforcing member 63, and a connector 25 are attached on the base end side of the OTW tube 20, from the tip side to the base end side.
  • the connector 25 has a base end opening 202 that connects the base end of the OTW lumen 20L to the outside.
  • the base end opening 202 is a device insertion port for inserting a therapeutic device into the OTW lumen 20L.
  • the OTW tube 20 has a distal tube 21 disposed on the distal side, and a proximal tube 22 disposed on the proximal side of the distal tube 21.
  • the distal tube 21 and the proximal tube 22 are both cylindrical members (tubular bodies) having an elongated outer shape.
  • the distal tube 21 and the proximal tube 22 are connected inside the first outer tube 50 in the longitudinal direction. That is, the distal tube 21 and the proximal tube 22 each constitute a part of the OTW lumen 20L.
  • the RX tube 30 is a cylindrical member (tubular body) with a long outer shape.
  • the RX tube 30 extends linearly along the longitudinal direction of the catheter 1, parallel to the sensor tube 10 and the OTW tube 20.
  • An RX lumen 30L (dashed line) for accommodating the work hose wire is formed inside the RX tube 30.
  • the tip of the RX tube 30 is located at the same position as or slightly distal to the tip of the sensor tube 10 in the longitudinal direction of the catheter 1.
  • a hollow tip tip 40 is joined to the tip of the RX tube 30.
  • a tip opening 301 is formed at the tip of the tip tip 40, which connects the tip of the RX lumen 30L to the outside.
  • the tip opening 301 is a wire insertion port for inserting the work hose wire into the RX lumen 30L.
  • the base end of the RX tube 30 is located distal to the base end of the sensor tube 10 and the base end of the OTW tube 20 in the longitudinal direction of the catheter 1.
  • a base end opening 302 is formed at the base end of the RX tube 30, which connects the base end of the RX lumen 30L to the outside.
  • the base end opening 302 is a wire withdrawal port for drawing the work hose wire out to the outside.
  • the base end opening 302 faces in a direction that intersects with the longitudinal direction of the catheter 1. This makes it easier to pull out the work hose wire from the base end opening 302 when the catheter 1 is in use.
  • the distal tip 40 is a radiopaque cylindrical member whose outer diameter expands from the distal end to the proximal end.
  • the distal tip 40 is joined to the distal end of the RX tube 30, so that it is positioned at the distal end of the catheter 1 and advances through the biological lumen ahead of other members.
  • the lumen of the distal tip 40 is connected to the RX lumen 30L of the RX tube 30, and at the distal end of the distal tip 40, as described above, a distal opening 301 is formed that connects the distal end of the RX lumen 30L to the outside.
  • the first marker 41 and the second marker 42 are annular members having radiopaque properties.
  • the first marker 41 is arranged so that the base end of the first marker 41 and the base end of the distal tip 40 are in the same position in the longitudinal direction of the catheter 1.
  • the first marker 41 is embedded between the outer peripheral surface of the RX tube 30 and the inner peripheral surface of the distal tip 40.
  • the second marker 42 is arranged so that the base end of the second marker 42 and the distal tip of the distal opening 201 are in the same position in the longitudinal direction of the catheter 1.
  • the second marker 42 is bonded to the outer peripheral surface of the RX tube 30.
  • the first marker 41 and the second marker 42 can be bonded, for example, by bonding resins together by thermal melting or by bonding with an adhesive such as an epoxy adhesive.
  • the second marker 42 is visible to the naked eye. In this way, by placing the first marker 41 and the second marker 42 on the RX tube 30, it is possible to prevent the first marker 41 and the second marker 42 from interfering with sensing (acquisition of image information) by the sensor 70.
  • the sensor tube 10 in the cross section taken along line A-A, the sensor tube 10 (specifically, the distal tube 11) and the RX tube 30 are arranged, and their outer circumferential surfaces are joined together.
  • the sensor tube 10 in the cross section taken along line B-B, the sensor tube 10 (specifically, the distal tube 11), the OTW tube 20 (specifically, the distal tube 21), and the RX tube 30 are arranged, and their outer circumferential surfaces are joined together.
  • the sensor tube 10 in the cross section taken along line C-C, the sensor tube 10 (specifically, the distal tube 11), the OTW tube 20 (specifically, the distal tube 21), and the RX tube 30 are covered by the first outer tube 50.
  • the three tubes 10, 20, and 30 are fixed together by having the outer circumferential surfaces of each of the three tubes 10, 20, and 30 covered by the melt-formed first outer tube 50.
  • the sensor tube 10 in the cross section taken along line D-D, the sensor tube 10 (specifically, the distal tube 11), the OTW tube 20 (specifically, the proximal tube 22), and the RX tube 30 are covered by the first outer tube 50, as in FIG. 3(C).
  • FIG. 3(E) in the cross section taken along line E-E, the sensor tube 10 (specifically, the proximal tube 12) and the OTW tube 20 (specifically, the proximal tube 22) are covered by the second outer tube 80.
  • the two tubes 10, 20 are fixed together by having the outer circumferential surfaces of the two tubes 10, 20 covered by the melt-formed second outer tube 80.
  • the sensor tube 10, the OTW tube 20, and the RX tube 30 may be joined in the A-A cross section and the B-B cross section using any bonding agent such as an epoxy adhesive, or may be welded by heat.
  • the height LY of the catheter 1 is greater than the width LZ of the catheter 1.
  • the height LY of the catheter 1 is less than the width LZ of the catheter 1.
  • the relationship of the inner diameters (lumens) of the three tubes 10, 20, and 30 is the inner diameter of the sensor lumen 10L > the inner diameter of the OTW lumen 20L > the inner diameter of the RX lumen 30L.
  • these outer and inner diameters are merely examples and may be changed as desired.
  • the A-A and B-B cross sections in other words, the outer shape of the catheter 1 on the distal side of the first outer tube 50, is a shape that follows the contours of the two tubes 10, 30 (or the three tubes 10, 20, 30) arranged next to each other, and a constriction (concave) is formed in the adjacent portion of each tube.
  • the C-C and D-D cross sections in other words, the outer shape of the catheter 1 in the portion covered by the first outer tube 50, is a triangle with rounded corners (round-cornered triangle).
  • the E-E cross section in other words, the outer shape of the catheter 1 in the portion covered by the second outer tube 80, is an ellipse.
  • the three tubes 10, 20, and 30 (specifically, the sensor tube 10, the OTW tube 20, and the RX tube 30) are fixed by the three tubes 90, 50, and 80.
  • the heat shrink tube 90 is disposed between the first outer tube 50 and the second outer tube 80 in the longitudinal direction of the catheter 1.
  • the heat shrink tube 90 covers the sensor tube 10 (specifically, a portion of the distal end of the base end tube 12) and the OTW tube 20 (specifically, a portion of the distal end of the base end tube 22) to bundle the two tubes 10, 20.
  • the heat shrink tube 90 does not cover the RX tube 30, and the RX tube 30 is disposed along the outer circumferential surface of the heat shrink tube 90 with the outer circumferential surface of the heat shrink tube 90 in contact with the outer circumferential surface of the RX tube 30.
  • the tip of the heat shrink tube 90 is located on the proximal side of the tip of the first outer tube 50 and on the distal side of the base end opening 302. In other words, the tip of the heat shrink tube 90 is covered by the first outer tube 50.
  • the base end of the heat shrink tube 90 is located closer to the base end than the tip of the second outer tube 80 and closer to the tip end than the first reinforcing member 61. That is, the base end of the heat shrink tube 90 is covered by the second outer tube 80. In other words, the middle portion of the heat shrink tube 90 in the longitudinal direction of the catheter 1 is not covered by the first outer tube 50 or the second outer tube 80.
  • the first outer tube 50 is disposed on the distal side of the heat shrink tube 90 in the longitudinal direction of the catheter 1.
  • the first outer tube 50 is disposed on the proximal side of the distal opening 201, in a section where the three tubes 10, 20, 30 extend side by side.
  • the distal end of the first outer tube 50 is located near the center between the distal opening 201 and the proximal opening 302.
  • the proximal end of the first outer tube 50 is located near the proximal end of the proximal opening 302. In this way, it is preferable that the first outer tube 50 is disposed at a position away from the distal opening 201 on the proximal side.
  • the first outer tube 50 covers and fixes the tip of the heat shrink tube 90, the sensor tube 10 exposed from the tip of the heat shrink tube 90 (specifically, a portion of the base end side of the tip tube 11), the OTW tube 20 exposed from the tip of the heat shrink tube 90 (specifically, a portion of the base end side of the tip tube 21 and a portion of the tip end side of the base end tube 22), and the RX tube 30.
  • the first outer tube 50 has an outer shape of a rounded triangle and has a thick wall portion melt-molded along the outer circumferential surfaces of the three tubes 10, 20, and 30.
  • the second outer tube 80 is disposed on the base end side of the heat shrink tube 90 in the longitudinal direction of the catheter 1.
  • the second outer tube 80 is disposed on the base end side of the base end opening 302, in the section where the two tubes 10, 20 extend side by side.
  • the tip of the second outer tube 80 is located slightly away from the base end opening 302 toward the base end.
  • the base end of the second outer tube 80 is located inside the first reinforcing member 61.
  • the second outer tube 80 covers and fixes the base end of the heat shrink tube 90, the sensor tube 10 exposed from the base end of the heat shrink tube 90 (specifically, a portion of the base end side of the base end tube 12), and the OTW tube 20 exposed from the base end of the heat shrink tube 90 (specifically, a portion of the base end tube 22).
  • the second outer tube 80 has an elliptical outer shape and has a thick portion that is melt-molded along the outer circumferential surfaces of the two tubes 10 and 20.
  • the branch connector 60 is a member having a bifurcated lumen, and is disposed on the base end side of the catheter 1.
  • the OTW tube 20 is inserted into one lumen of the branch connector 60.
  • the sensor tube 10 is inserted into the other lumen of the branch connector 60.
  • the first reinforcing member 61 is a cylindrical member disposed on the distal side of the branch connector 60. The first reinforcing member 61 reinforces the distal side of the branch connector 60 by covering the outer periphery of the second outer tube 80 that bundles the sensor tube 10 and the OTW tube 20 together.
  • the second reinforcing member 62 is a cylindrical member disposed on the base end side of one branch of the branch connector 60.
  • the second reinforcing member 62 reinforces the base end side of the branch connector 60 by covering the outer periphery of the OTW tube 20 inserted into the branch connector 60.
  • the third reinforcing member 63 is a cylindrical member disposed on the distal end side of the connector 25.
  • the third reinforcing member 63 reinforces the distal end side of the connector 25 by covering the outer periphery of the OTW tube 20 inserted into the connector 25.
  • the connector 25 is a member joined to the base end of the OTW tube 20.
  • the connector 25 has a pair of wings for the surgeon to grasp.
  • the base end of the connector 25 is formed with a base end opening 202 (device insertion port) that connects the base end of the OTW lumen 20L to the outside.
  • the tubular member 64 is a cylindrical member located closer to the base end than the other branch of the branch connector 60.
  • the tubular member 64 reinforces the base end of the branch connector 60 by covering the outer periphery of the sensor tube 10 inserted into the branch connector 60.
  • the connector 65 is a member joined to the base end of the sensor tube 10.
  • a housing for accommodating the connection terminal 75 of the sensor 70 is provided on the base end side of the connector 65.
  • a fluid supply section 66 is provided on the outer periphery of the connector 65, with a base end opening 102 formed therein that communicates between the base end of the sensor lumen 10L and the outside.
  • the sensor 70 (FIG. 2) is an imaging sensor for acquiring image information. As shown in FIG. 2, the sensor 70 includes a main body 71, a probe 72, and a connection terminal 75.
  • the main body 71 is an elongated member extending along the longitudinal direction of the catheter 1.
  • a driving cable (coaxial line) that electrically connects the probe 72 and the connection terminal 75 is built into the inside of the main body 71.
  • the probe 72 includes an ultrasonic probe (also called an ultrasonic vibrator, piezoelectric body, ultrasonic transmission/reception element, or ultrasonic element) that transmits ultrasonic waves toward biological tissue and receives ultrasonic waves reflected by the biological tissue.
  • the probe 72 is also called an imaging core or transducer.
  • the connection terminal 75 is a terminal that electrically connects the sensor 70 to an external console terminal.
  • the connection terminal 75 is provided at the base end of the main body 71 and is housed in the housing of the connector 65.
  • the sensor 70 is electrically connected to an external console terminal via a connection terminal 75, receives power from the console terminal, and outputs a detection signal from the probe 72 to the console terminal. This allows the console terminal to display image information based on the detection signal from the probe 72.
  • the sensor 70 is fixed to a connector 65. As shown by the white arrow in FIG. 2, the operator can grasp the connector 65 and slide it in the forward and backward directions (in the direction of the white arrow) to move the position of the probe 72 of the sensor 70 within a range MR from the tip of the sensor lumen 10L to the tip of the first outer tube 50, in other words, within a predetermined range MR including the tip opening 201.
  • the range MR is also referred to as the "movable range MR”.
  • the part of the catheter 1 that is particularly suitable for sensing (obtaining image information) by the sensor 70 is also referred to as the "acoustic window AW".
  • the acoustic window AW is the section of the catheter 1 between the first marker 41 and the second marker 42.
  • the distal tube 11 of the sensor tube 10, the distal tube 21 of the OTW tube 20, and the RX tube 30 can be made of flexible materials such as thermoplastic resins such as polyethylene resin, polypropylene resin, and polyurethane, polyvinyl chloride, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer, polyamide elastomer, polyolefin elastomer, polyurethane elastomer, silicone rubber, and latex rubber.
  • the distal tube 11 of the sensor tube 10, the distal tube 21 of the OTW tube 20, and the RX tube 30 may be made of the same material or different materials.
  • the base end tube 12 of the sensor tube 10 and the base end tube 22 of the OTW tube 20 can be made of a resin having high rigidity, such as nylon resin, polyester resin, PEEK resin, etc.
  • the melting points of the base end tube 12 of the sensor tube 10 and the base end tube 22 of the OTW tube 20 are higher than the melting points of the above-mentioned tubes 11, 21, and 30.
  • the base end tube 12 of the sensor tube 10 and the base end tube 22 of the OTW tube 20 may be made of the same material or different materials.
  • a portion of the base end side of the flexible RX tube 30 is overlapped with the high rigidity base end tube 12 and base end tube 22 (FIG. 1), thereby realizing a gradual change in the stiffness of the catheter 1.
  • the gradual change in stiffness of the catheter 1 can be said to reduce the stiffness gap of the catheter 1. This makes it possible to suppress kinking of the catheter 1.
  • one or more of the distal tube 11 and proximal tube 12 of the sensor tube 10, the distal tube 21 and proximal tube 22 of the OTW tube 20, and the RX tube 30 may have a multi-layer structure in which tubes made of different materials are overlapped.
  • the tip 40, the first marker 41, and the second marker 42 can be made of a radiopaque resin material or a metal material.
  • a radiopaque resin material when using a radiopaque resin material, they can be formed by mixing a radiopaque material such as bismuth trioxide, tungsten, or barium sulfate with polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, or fluororesin.
  • a radiopaque metal material they can be formed of gold, platinum, tungsten, or an alloy containing these elements (e.g., platinum-nickel alloy).
  • the tip 40, the first marker 41, and the second marker 42 may be formed of the same material or different materials.
  • the branch connector 60, the first reinforcing member 61 to the third reinforcing member 63, the tubular member 64, the connector 65, and the connector 25 can be made of a known resin material.
  • the branch connector 60, the first reinforcing member 61 to the third reinforcing member 63, the tubular member 64, the connector 65, and the connector 25 may be made of the same material or different materials.
  • the heat shrink tube 90 is made of a nylon-based elastomer resin (e.g., polyamide elastomer) having thermoplastic properties.
  • the heat shrink tube 90 has the property of shrinking without melting when heated to a specific temperature range. Furthermore, the heat shrink tube 90 has improved adhesiveness (the property of easily adhering to other substances) when heated compared to when not heated.
  • the heat shrink tube 90 may also be made of polyolefin, FEP (Fluorinated Ethylene Propylene), or silicone.
  • the first outer tube 50 and the second outer tube 80 are formed from a nylon-based elastomer resin having thermoplastic properties. Unlike the heat shrink tube 90, the first outer tube 50 and the second outer tube 80 have the property of melting when heated. In this embodiment, the first outer tube 50 uses a resin with a lower Shore hardness than the second outer tube 80. However, the first outer tube 50 and the second outer tube 80 may be formed from the same material or different materials.
  • FIGS. 4 and 5 are diagrams explaining how to use the catheter 1. Steps a1 to a6 shown below illustrate an example of attempting to recanalize a CTO (lesion) that has occurred in a blood vessel using a antegrade approach. However, the catheter 1 may also be used in a retrograde approach, or for procedures other than recanalization of a CTO.
  • step a3 The surgeon inserts the work horse wire 200 into the blood vessel and delivers the tip of the work horse wire 200 close to the CTO.
  • step a3 The surgeon inserts the base end of the work horse wire 200 from the tip opening 301 of the catheter 1, passes it through the RX lumen 30L, and pulls it out from the base opening 302 of the catheter 1 (FIG. 4).
  • step a3 The surgeon pushes the catheter 1 along the work horse wire 200 into the blood vessel and delivers the tip of the catheter 1 close to the CTO.
  • the catheter 1 may be delivered close to the CTO by passing it through a guiding catheter that has been inserted into the blood vessel in advance along the work horse wire 200.
  • the operator grasps the connector 65 and slides it in the forward and backward directions (in the direction of the white arrow in FIG. 5 ) to adjust the position of the probe 72 of the sensor 70 within the movable range MR, while checking the image displayed on the console terminal to align the position and orientation of the CTO and the distal opening 201.
  • the position means the position in the extension direction of the blood vessel
  • the orientation means the orientation in the circumferential direction of the inner wall of the blood vessel.
  • the operator inserts the distal end of the treatment device 300 from the proximal opening 202 of the catheter 1, passes through the OTW lumen 20L, and protrudes from the distal opening 201 of the catheter 1 ( FIG. 5 ).
  • the operator uses the treatment device 300 to treat the CTO while checking the image displayed on the console terminal, while adjusting the position of the probe 72 of the sensor 70 within the movable range MR as necessary.
  • any device such as a plasma guidewire or a penetration guidewire can be used as the treatment device 300.
  • the sensor tube 10, the OTW tube 20, and the RX tube 30 are collectively referred to as the "shaft.”
  • the sensor tube 10 (the distal tube 11 and the proximal tube 12) corresponds to the “first tube,” and the sensor lumen 10L corresponds to the “first lumen.”
  • the RX tube 30 corresponds to the "second tube,” and the RX lumen 30L corresponds to the "second lumen.”
  • “same” and “equal” do not mean strictly the same, but rather allow for differences due to manufacturing errors, etc.
  • Constant is synonymous with “approximately constant,” and means that it is approximately constant while allowing for deviations due to manufacturing errors, etc.
  • Figure 6 is an enlarged view of a portion of the tip side of the catheter 1.
  • Figure 7 is a cross-sectional view of the catheter 1 taken along line F-F in Figure 6.
  • Figure 7 (F-F cross-section) is a cross-section of the catheter 1 including the acoustic window AW.
  • a portion of the cross-sectional view is shown enlarged in the dashed line in Figure 7.
  • the connection between the sensor tube 10 and the OTW tube 20 at the tip side of the catheter 1 will be further explained using Figures 6 and 7.
  • the section between the first marker 41 and the second marker 42 of the RX tube 30 (second tube) in the longitudinal direction of the catheter 1 is an acoustic window AW that is particularly suitable for sensing (acquisition of image information) by the sensor 70.
  • the flesh wall of the RX tube 30 is present over the entire circumferential direction of the acoustic window AW.
  • the RX tube 30 does not have any holes or notches that communicate between the inside and outside of the RX lumen 30L.
  • the catheter 1 of this embodiment has a joint 95 provided over the entire area between the first marker 41 and the second marker 42 (in other words, the entire longitudinal length of the acoustic window AW).
  • the joint 95 is a portion where the tip tube 11 (first tube) of the sensor tube 10 and the RX tube 30 (second tube) are joined by a coating agent.
  • the tip tube 11 of the sensor tube 10 and the RX tube 30 are also simply referred to as “tubes 10, 30" or "first and second tubes 10, 30.”
  • the coating agent includes a base agent and a top agent.
  • the base agent is an agent for improving the adhesion of the top agent to the resin tube (specifically, the distal tube 11 and the RX tube 30).
  • the base agent for example, acrylic resin, acrylamide, carboxylic acid, etc. can be used.
  • the top agent is an agent for imparting hydrophilicity.
  • a well-known hydrophilic resin such as hyaluronic acid can be used.
  • the layer formed by applying the coating agent is also referred to as the "coating layer.”
  • the coating layer of this embodiment includes an undercoat layer 96 formed by applying a base agent, and a topcoat layer 97 formed by applying a topcoat agent.
  • the undercoat layer 96 is in contact with the outer peripheral surface 11o of the tip tube 11 and the outer peripheral surface 30o of the RX tube 30, thinly covering each of the outer peripheral surfaces 11o, 30o (FIG. 7). As shown in the dashed line in FIG. 7, the undercoat layer 96 penetrates between the outer peripheral surface 11o of the tip tube 11 and the outer peripheral surface 30o of the RX tube 30 in the portion where the tip tube 11 and the RX tube 30 are adjacent to each other.
  • the topcoat layer 97 thinly covers the outer peripheral surface 96o of the undercoat layer 96 while contacting the outer peripheral surface 96o ( Figure 7). As shown in the dashed line in Figure 7, the topcoat layer 97 does not penetrate between the outer peripheral surface 11o of the tip tube 11 and the outer peripheral surface 30o of the RX tube 30. In other words, in the example of Figure 7, it can be said that the base agent of the hydrophilic coating bonds the tip tube 11 of the sensor tube 10 and the RX tube 30.
  • the common circumscribing lines EC1 and EC2 of the distal tube 11 (first tube) of the sensor tube 10 and the RX tube 30 (second tube) are shown by dashed lines.
  • the common circumscribing line EC1 is also called the “first common circumscribing line EC1," and the common circumscribing line EC2 is also called the “second common circumscribing line EC2.”
  • a gap SP1 is formed between the outer periphery of the distal tube 11 and the RX tube 30 and the first common circumscribing line EC1.
  • a gap SP2 is formed between the outer periphery of the distal tube 11 and the RX tube 30 and the second common circumscribing line EC2.
  • the presence of the gaps SP1 and SP2 means that in the cross section of the catheter 1 including the acoustic window AW, the contour of the catheter 1 has a constriction (concave) in the adjacent portion of the two adjacently arranged tubes 11 and 30.
  • the method of forming the joint 95 may be, for example, the following methods b1 to b8.
  • (b1) Prepare a base liquid and a top liquid.
  • (b2) With the tip tube 11 (first tube) of the sensor tube 10 and the RX tube 30 (second tube) lined up, at least the entire portion intended to form the joint 95 is immersed in the base liquid.
  • the entire catheter 1 from the tip side of the second marker 42 may be immersed in the base, or the entire catheter 1 from the tip to the base may be immersed in the base.
  • the tip tip 40, the first marker 41, and the second marker 42 may already be formed on the tip of the RX tube 30, or the tubes 10, 20, and 30 may be fixed by the first outer tube 50 or the like.
  • the liquid base agent enters the gap between the adjacent parts of the tube 10 and the tube 30 (between the outer peripheral surface 11o and the outer peripheral surface 30o in FIG. 7) due to surface tension.
  • excess liquid base agent on the outer peripheral surfaces of the tube 10 and the tube 30 is sucked up, thereby controlling the film thickness of the undercoat layer 96.
  • the liquid base agent dries, thereby forming the undercoat layer 96.
  • step b2 At least the entire part intended to form the bond 95 is immersed in the liquid top agent.
  • step b7 Using a cleaning tissue or the like, excess liquid top agent on the outer peripheral surface of the undercoat layer 96 is sucked up, thereby controlling the film thickness of the overcoat layer 97.
  • step b8) The liquid top agent dries, thereby forming the overcoat layer 97.
  • the undercoat layer 96 formed from the base agent is thin, but has high adhesion to the tubes 10, 30, is resistant to mechanical loads, and does not impair the flexibility of the tubes 10, 30 even after the undercoat layer 96 (film) is formed, due to the nature of the base agent "improving the adhesion of the top agent to the tubes 10, 30."
  • the tip tube 11 of the sensor tube 10 and the RX tube 30 are bonded together by the undercoat layer 96 formed from the base agent, so that disadvantages that arise when bonding is performed using an adhesive, such as reduced flexibility and operability due to hardening of the joint 95, and reduced acoustic properties at the joint 95 (i.e., the acoustic window AW), can be avoided.
  • catheters when bonding is performed using an adhesive, the adhesive itself hardens, reducing the flexibility and acoustic properties of the catheter at the location where the adhesive is applied.
  • catheters are generally provided with a coating layer (undercoat layer 96, topcoat layer 97, etc.) to impart hydrophilicity or hydrophobicity in order to improve torque transmission and blood vessel tracking.
  • a coating layer is formed on the adhesive layer, further reducing the flexibility and acoustic properties of the catheter.
  • the thick adhesive layer further reduces the flexibility and acoustic properties of the catheter, and the outer diameter of the catheter at that location increases. Such a reduction in acoustic properties can cause problems such as darkening of the image obtained by the sensor and the occurrence of defects.
  • the catheter 1 of this embodiment does not use such a demeritful adhesive, and instead uses an undercoat layer 96 formed from a base agent to bond the distal tube 11 of the sensor tube 10 to the RX tube 30, thereby avoiding the deterioration of flexibility and operability due to hardening of the joint 95, and the deterioration of the acoustic characteristics of the joint 95 (i.e., the acoustic window AW).
  • heat is not applied when forming the joint 95 (undercoat layer 96 and topcoat layer 97), so deformation of the tubes 10 and 30 caused by heat can be suppressed.
  • the section on the base side of the joint 95 and on the distal side of the first outer tube 50 does not function as an acoustic window AW, so in this section, the three tubes 10, 20, and 30 may be bonded by heat welding.
  • the distal tube 11 (first tube) of the sensor tube 10 and the RX tube 30 (second tube) can be bonded by a coating agent without using heat fusion or adhesive.
  • This makes it possible to suppress deformation of the first and second tubes 10, 30 that occurs when bonding is performed by heat fusion.
  • the outer diameter of the catheter 1 can be reduced at the distal end of the catheter 1 where the bonding part 95 is provided, it is possible to improve passability to the lesion and reduce sliding with the combined device inside the guiding catheter.
  • the sensor lumen 10L (first lumen) is for inserting the sensor 70 that acquires image information
  • the catheter 1 (medical device) can be configured as a device that can be used in conjunction with the sensor 70 that acquires image information.
  • the catheter 1 of the first embodiment at least a portion of the acoustic window AW where sensing (acquisition of image information) by the sensor 70 is performed is bonded with a coating agent rather than with an adhesive, so that sensing by the sensor 70 is prevented from being hindered by the adhesive.
  • the entire acoustic window AW is bonded with a coating agent rather than with an adhesive, so that sensing by the sensor 70 is further prevented from being hindered by the adhesive.
  • gaps SP1, SP2 are formed between the common external tangents EC1, EC2 of the distal tube 11 (first tube) of the sensor tube 10 and the RX tube 30 (second tube) and the outer periphery of the first and second tubes 10, 30.
  • the gaps SP1, SP2 that do not impede sensing by the sensor 70 allow the sensor 70 to perform sensing better.
  • the coating agent is a base agent for the hydrophilic coating, so the hydrophilic coating can serve to bond the first and second tubes 10, 30.
  • the bonding portion 95 is provided over the entire area between the first marker 41 and the second marker 42 (the entire acoustic window AW), so the entire area between the first marker 41 and the second marker 42 can be bonded by the coating agent.
  • FIG. 8 is a cross-sectional view of a catheter 1A according to a second embodiment.
  • Fig. 8 shows a cross-section of the catheter 1A including an acoustic window AW taken along line F-F in Fig. 6.
  • the catheter 1A according to the second embodiment has a coupling portion 95A instead of the coupling portion 95 in the configuration described in the first embodiment.
  • the joint 95A is a portion where the tip tube 11 (first tube) of the sensor tube 10 and the RX tube 30 (second tube) are joined by a coating agent consisting of only one agent.
  • the coating agent of the second embodiment consists of only one agent having the functions of both a base agent and a top agent.
  • polyvinylpyrrolidone (PVP) can be used as such a coating agent.
  • the coating layer of the second embodiment has a layer 97A formed by applying a coating agent.
  • the layer 97A thinly covers each outer peripheral surface 11o, 30o of the tubes 10, 30 while contacting each outer peripheral surface 11o, 30o along the outer peripheral surfaces 11o, 30o of the tubes 10, 30 and penetrating into the gap between the adjacent portions of the tubes 10, 30 ( Figure 8: between the outer peripheral surface 11o and the outer peripheral surface 30o). That is, in the second embodiment, a coating agent consisting of only one agent bonds the distal tube 11 of the sensor tube 10 and the RX tube 30.
  • the configuration of the joint 95A can be modified in various ways, and the first and second tubes 10, 30 may be joined using a coating agent consisting of only one agent. Since the layer 97A has the functions of both a base agent and a top agent, like the undercoat layer 96 described in the first embodiment, it has the properties of being thin but having high adhesion to the tubes 10, 30, being resistant to mechanical loads, and not impairing the flexibility of the tubes 10, 30 even after the layer 97A (film) is formed. Therefore, the catheter 1A of the second embodiment as described above can also achieve the same effects as the first embodiment described above.
  • Fig. 9 is a cross-sectional view of a catheter 1B according to a third embodiment.
  • Fig. 9 shows a cross-section of the catheter 1B including the acoustic window AW taken along line F-F in Fig. 6.
  • the catheter 1B according to the third embodiment includes a coupling portion 95B instead of the coupling portion 95 in the configuration described in the first embodiment.
  • the joint portion 95B is a portion where the tip tube 11 (first tube) of the sensor tube 10 and the RX tube 30 (second tube) are joined by a coating agent containing three agents.
  • the coating agent of the third embodiment contains, in addition to the base agent and top agent described in the first embodiment, a second base agent disposed between the base agent and the top agent.
  • a second base agent disposed between the base agent and the top agent.
  • acrylic resin, acrylamide, carboxylic acid, etc. can be used as the second base agent.
  • the base agent for the undercoat layer 96 will also be referred to as the "first base agent" for distinction.
  • the coating layer of the third embodiment includes an undercoat layer 96 formed by applying a first base agent, an intermediate layer 98 formed by applying a second base agent, and an overcoat layer 97B formed by applying a top agent.
  • the undercoat layer 96 is as described in the first embodiment.
  • the intermediate layer 98 thinly covers the outer peripheral surface 96o of the undercoat layer 96 while contacting the outer peripheral surface 96o along the outer peripheral surface 96o of the undercoat layer 96.
  • the overcoat layer 97B thinly covers the outer peripheral surface 98o of the intermediate layer 98 while contacting the outer peripheral surface 98o along the outer peripheral surface 98o of the intermediate layer 98. That is, in the example of FIG. 9, it can be said that the base agent of the hydrophilic coating bonds the distal tube 11 of the sensor tube 10 and the RX tube 30.
  • the configuration of the joint portion 95B can be modified in various ways, and the first and second tubes 10, 30 may be joined using a coating agent containing three agents. Although three agents are exemplified in this embodiment, a coating agent containing four or more agents may be used.
  • the catheter 1B of the third embodiment as described above can also achieve the same effects as the first embodiment described above.
  • the first and second tubes 10, 30 can be joined using any coating agent having an agent composition according to the material of the tip tube 11 and the RX tube 30.
  • Fourth Embodiment 10 is an enlarged view of a portion of the distal end side of the catheter 1C of the fourth embodiment.
  • the catheter 1C of the fourth embodiment has a coupling part 95C instead of the coupling part 95 in the configuration described in the first embodiment.
  • the section between the first marker 41 and the second marker 42 corresponds to the acoustic window AW, and therefore, hereinafter, the section between the first marker 41 and the second marker 42 is also referred to as the "acoustic window section.”
  • the joint 95C includes a first joint 95C1 and a second joint 95C2.
  • the first joint 95C1 is provided at the tip of the acoustic window section.
  • the second joint 95C2 is provided in the acoustic window section, at a position away from the first joint 95C1 toward the base end.
  • the second joint 95C2 is provided at the base end of the acoustic window section.
  • the first joint 95C1 and the second joint 95C2 are respectively portions where the tip tube 11 (first tube) of the sensor tube 10 and the RX tube 30 (second tube) are joined by a coating agent. Therefore, at the first joint 95C1 and the second joint 95C2, the tubes 10 and 30 are joined to each other by a coating agent.
  • the configuration of the joint 95C can be modified in various ways, and it is sufficient that the first and second tubes 10, 30 are joined at least in a part of the acoustic window AW in the longitudinal direction of the catheter 1, and may have a non-joined portion.
  • first joint 95C1, second joint 95C2 are illustrated, but the joint 95C may include three or more joints provided at positions separated from each other.
  • the RX tube 30 may have a hole or a notch that communicates the inside and outside of the RX lumen 30L.
  • the catheter 1C of the fourth embodiment as described above can also achieve the same effect as the first embodiment described above.
  • the joints 95C1, C2 of the first and second tubes 10, 30 can be provided at two positions separated from each other. Therefore, the flexibility and acoustic characteristics of the catheter 1C in the non-joined portion can be further improved.
  • the catheter 1D of the fifth embodiment includes a coupling portion 95D instead of the coupling portion 95 in the configuration described in the first embodiment.
  • the coupling portion 95D extends not only to the section between the first marker 41 and the second marker 42 (the acoustic window section) but also to a section on the proximal side of the second marker 42 (the proximal side of the acoustic window AW).
  • the coupling portion 95D is provided over the entire movable range MR of the sensor 70 from the distal end of the sensor lumen 10L to the distal end of the first outer tube 50.
  • the configuration of the coupling portion 95D can be modified in various ways, and may be provided in any range along the longitudinal direction of the catheter 1D.
  • the catheter 1D of the fifth embodiment as described above can also achieve the same effects as the first embodiment described above.
  • Sixth Embodiment 12 is an enlarged view of a portion of the distal end side of a catheter 1E of the sixth embodiment.
  • the catheter 1E of the sixth embodiment does not have the OTW tube 20 and the OTW lumen 20L formed by the OTW tube 20 in the configuration described in the first embodiment.
  • the configuration of the catheter 1E can be modified in various ways, and any part of the configuration described in the first embodiment may be omitted.
  • the sensor tube 10 may not include a distal tube 11 and a proximal tube 12, but may be configured from a single tube from the distal end to the proximal end.
  • the sensor tube 10 may also be configured by combining three or more tubes.
  • the catheter 1E of the sixth embodiment as described above can also achieve the same effects as the first embodiment described above.
  • the joint 95 may be provided only in a portion of the section between the first marker 41 and the second marker 42 (in other words, only in a portion of the section in the longitudinal direction of the acoustic window AW).
  • the gap SP1 may not be provided between the outer periphery of the distal tube 11 and the RX tube 30 and the first common circumscribing line EC1.
  • the portion described in FIG. 7 as corresponding to the gap SP1 may be provided with, for example, an undercoat layer 96 or an overcoat layer 97, or may be filled with a resin material or the like.
  • the gap SP2 between the outer periphery of the distal tube 11 and the RX tube 30 and the second common circumscribing line EC2 may be omitted.
  • the outer surfaces of the first outer tube 50, the heat shrink tube 90, and the second outer tube 80, or the outer surface of the catheter 1 including these, may be coated with a hydrophilic resin or a hydrophobic resin.
  • This coating may be a coating layer (undercoat layer 96, topcoat layers 97, 97B, layer 97A, intermediate layer 98) formed with the above-mentioned coating agent, or may be a coating layer separate from the coating layer formed with the above-mentioned coating agent.
  • the sensor 70 is built into the sensor lumen 10L of the sensor tube 10 and is configured so as not to be removable from the catheter 1. However, the sensor 70 may be configured so as to be removable from the catheter 1. In other words, the catheter 1 does not have to include the sensor 70 as a component.
  • the distal tip 40, the first marker 41, and the second marker 42 may be omitted.
  • the shapes of the distal tip 40, the first marker 41, and the second marker 42 can be changed arbitrarily.
  • the distal tip 40 may have a constant outer diameter from the distal end to the proximal end, and the cross-sectional shape may be asymmetric.
  • the first marker 41 and the second marker 42 may have a shape other than a circular ring (for example, a shape obtained by cutting a circular ring at an arbitrary angle, or a linear shape or a coil shape obtained by winding a wire in a spiral shape).
  • the arrangement of the distal tip 40, the first marker 41, and the second marker 42 can be changed as desired.
  • the first marker 41 may not overlap the distal tip 40, and may be arranged adjacent to the base end of the distal tip 40 or away from the base end of the distal tip 40.
  • the second marker 42 may be arranged at a position other than adjacent to the tip of the distal opening 201 of the OTW tube 20 (for example, away from the distal opening 201).
  • the first marker 41 and the second marker 42 may be arranged on a tube other than the RX tube 30 (the sensor tube 10 or the OTW tube 20).
  • the first marker 41 and the second marker 42 may be arranged on the same tube as described above, or on different tubes.
  • the first outer tube 50 and the second outer tube 80 may be omitted.
  • the first outer tube 50 and the second outer tube 80 are each composed of one layer, but at least one of the first outer tube 50 and the second outer tube 80 may be composed of two or more layers.
  • the cross-sectional shape of the catheter 1 in the part covered by the first outer tube 50 is a rounded triangle shape, but it may be any shape such as a circle or an ellipse.
  • the cross-sectional shape of the catheter 1 in the part covered by the second outer tube 80 is an ellipse shape, but it may be any shape such as a circle or a rounded triangle.
  • at least one of the first outer tube 50 and the second outer tube 80 may have an outer shape that follows the contour of the outer circumferential surface of the tube 10, 20 (or tube 10, 20, 30).
  • the shapes of the branch connector 60, the first reinforcing member 61 to the third reinforcing member 63, the cylindrical member 64, the connector 65, and the connector 25 described above are merely examples and may be changed as desired.
  • at least a portion of the branch connector 60, the first reinforcing member 61, the second reinforcing member 62, and the cylindrical member 64 may be configured as a single member or may be omitted.
  • the third reinforcing member 63 and the connector 25 may be configured as a single member.
  • the cylindrical member 64 may be provided with a mechanism (for example, a scale or stopper provided at a predetermined length in the longitudinal direction, or a scale or stopper provided at a predetermined angle in the circumferential direction) that assists in adjusting at least one of the front-to-rear position of the sensor 70 and the orientation of the sensor 70 in the circumferential direction.
  • a mechanism for example, a scale or stopper provided at a predetermined length in the longitudinal direction, or a scale or stopper provided at a predetermined angle in the circumferential direction
  • the method of forming the joint 95 described in steps b1 to b8 is merely an example, and various modifications are possible.
  • a liquid of the base agent or top agent may be applied to the surface by spraying it onto the tubes 10 and 30.
  • the control of the film thickness by absorbing the liquid may be omitted.
  • the configurations of the catheters 1, 1A to 1E of the first to sixth embodiments and the configuration of the catheters 1, 1A to 1E of the first modified example may be combined as appropriate.
  • the coupling parts 95C, 95D described in the fourth and fifth embodiments may be formed using the coating agent (one agent, three agents or more) described in the second and third embodiments.
  • the OTW tube 20 may be omitted in line with the sixth embodiment.

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006020944A (ja) * 2004-07-09 2006-01-26 Terumo Corp カテーテル
JP2012223206A (ja) * 2011-04-14 2012-11-15 Terumo Corp カテーテルおよびカテーテル組立体

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006020944A (ja) * 2004-07-09 2006-01-26 Terumo Corp カテーテル
JP2012223206A (ja) * 2011-04-14 2012-11-15 Terumo Corp カテーテルおよびカテーテル組立体

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