WO2024241379A1 - 医療デバイス、及び、医療デバイスの製造方法 - Google Patents

医療デバイス、及び、医療デバイスの製造方法 Download PDF

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Publication number
WO2024241379A1
WO2024241379A1 PCT/JP2023/018777 JP2023018777W WO2024241379A1 WO 2024241379 A1 WO2024241379 A1 WO 2024241379A1 JP 2023018777 W JP2023018777 W JP 2023018777W WO 2024241379 A1 WO2024241379 A1 WO 2024241379A1
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WO
WIPO (PCT)
Prior art keywords
tube
distal
medical device
tip
proximal
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/JP2023/018777
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English (en)
French (fr)
Japanese (ja)
Inventor
誠 西岸
良基 加藤
一輝 杉若
宏友 清水
悠介 城戸
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/JP2023/018777 priority Critical patent/WO2024241379A1/ja
Priority to JP2025521600A priority patent/JPWO2024241379A1/ja
Publication of WO2024241379A1 publication Critical patent/WO2024241379A1/ja
Priority to US19/382,333 priority patent/US20260061158A1/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
    • 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
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • 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
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side

Definitions

  • the present invention relates to a medical device and a method for manufacturing a medical device.
  • Catheters used in percutaneous procedures are known.
  • the procedures may be performed under the guidance of a sensor that acquires image information of biological tissues using ultrasound.
  • a catheter with two lumens is used, and the sensor is inserted into one lumen and a therapeutic device is inserted into the other lumen, so that the procedure is performed using both the sensor and the therapeutic device.
  • catheters generally have a structure in which the tip end is thin and flexible and the base end is thick and rigid.
  • Patent Document 1 discloses a device including a support tube having a tip portion made only of flexible resin and a base portion in which an inner resin layer and an outer resin layer are integrally laminated.
  • Patent Document 2 discloses a long medical member including a first member and a second member having an inner diameter larger than the first member and disposed on the base side of the first member, with the base end of the first member and the tip of the second member each being connected by a connecting member.
  • the device described in Patent Document 1 has an issue in that no consideration is given to the rigidity gap at the boundary between the flexible tip side section and the highly rigid base side section.
  • the long member described in Patent Document 2 has only a single lumen and is only used to perform treatment within the pulmonary airways, and no consideration is given to a multi-lumen configuration for performing procedures under sensor guidance. Note that 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 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 achieve gradual stiffness change in a medical device that has at least two lumens formed by different tubes arranged at the distal and proximal ends.
  • 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 proximal tube having a first bending stiffness and constituting a part of a first lumen, a first distal tube having a second bending stiffness lower than the first bending stiffness, disposed distally of the first proximal tube, joined to a proximal end of the first proximal tube, and constituting a part of the first lumen, a second proximal tube having a third bending stiffness and constituting a part of the second lumen, and a second distal tube having a fourth bending stiffness lower than the third bending stiffness, disposed distally of the second proximal tube, joined to a proximal end of the second proximal tube, and constituting a part of the second lumen, the distal position of the second proximal tube being located distally of the distal position of the first proximal tube in the longitudinal direction of the medical device.
  • the tip position of the second base-end tube is located more distal than the tip position of the first base-end tube. That is, the first joint where the first tip-end tube and the first base-end tube are joined, and the second joint where the second tip-end tube and the second base-end tube are joined are offset (located at different positions) in the longitudinal direction of the medical device. Therefore, compared to when the first joint and the second joint are in the same position, a gradual change in the rigidity of the medical device can be achieved, and the occurrence of kinking in the medical device can be suppressed. As a result, when a pushing force is applied to the medical device during use, the medical device can be suppressed from buckling.
  • the tip of the first base-side tube may be provided with a tapered section whose outer diameter narrows from the base end to the tip, and the outer circumferential surface of the tapered section may be in contact with the inner circumferential surface of the first tip-side tube.
  • the tapered section makes it easier to connect the first base-side tube to the first tip-side tube.
  • the medical device of the above embodiment may further include a third tube that defines a third lumen and has its base end located between the tip and base end of the tapered portion. With this configuration, the medical device can be configured to have a third lumen.
  • the first base-side tube and the second base-side tube may be bundled together by a heat-shrink tube, and the heat-shrink tube may be disposed between the tip and base of the tapered portion.
  • the first base-side tube and the second base-side tube can be bundled together without bonding by using a heat-shrink tube.
  • the heat-shrink tube is disposed between the tip and base of the tapered portion, the presence of the heat-shrink tube can be prevented from increasing the outer diameter of the medical device.
  • the tapered portion is a first tapered portion
  • the tip portion of the second base-end tube is provided with a second tapered portion having an outer diameter that narrows from the base end toward the tip, the outer circumferential surface of the second tapered portion is in contact with the inner circumferential surface of the second tip-end tube, and the length of the first tapered portion in the longitudinal direction of the medical device may be longer than the length of the second tapered portion.
  • the second tapered portion makes it easier to connect the second base-end tube to the second tip-end tube.
  • the length of the first tapered portion different from the length of the second tapered portion, the gradual change in stiffness can be further improved.
  • the outer diameter of the first base-end tube may be larger than the outer diameter of the second base-end tube, and the base end position of the second tapered portion may be located distal to the tip position of the first base-end tube in the longitudinal direction of the medical device.
  • the melting point of the first base end tube may be higher than the melting point of the first tip end tube.
  • the first base end tube and the first tip end tube may be in contact with each other in an incompatible state.
  • the tubes can be joined together without causing the tubes to become incompatible with each other.
  • the outer diameter of the first base-end tube may be greater than the outer diameter of the second base-end tube.
  • a method for manufacturing a medical device includes stretching a first base-side tube to form a constriction in the first base-side tube, cutting the first base-side tube at the constriction to form a tapered portion at the distal end of the first base-side tube, and inserting at least a portion of the tapered portion of the first base-side tube into a first distal-side tube.
  • the tapered portion formed at the distal end of the first base-side tube can be used to join the first base-side tube and the first distal-side tube.
  • the first base-side tube when the first base-side tube is stretched, the first base-side tube may be heated to a temperature that is 100°C or more higher than the melting point of the first tip-side tube. According to this manufacturing method, the first base-side tube and the first tip-side tube can be joined even if the melting points of the first base-side tube and the first tip-side tube differ by 100°C or more.
  • the outer diameter at the base end of the first distal tube may be substantially the same as the outer diameter at a predetermined position away from the base end of the first distal tube in the longitudinal direction, and before the insertion, the inner diameter at the base end of the first distal tube may be substantially the same as the inner diameter at the predetermined position.
  • the first proximal tube and the first distal tube can be joined without processing (e.g., flaring) the first distal tube.
  • 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 the catheter near a tube joint.
  • FIG. 2 is a cross-sectional view of the catheter.
  • 1A to 1C are diagrams illustrating a manufacturing method of a catheter.
  • 1A to 1C are diagrams illustrating a manufacturing method of a catheter.
  • 11A to 11C are diagrams illustrating a manufacturing method of the catheter of the second embodiment.
  • FIG. 1A to 1C are diagrams illustrating a manufacturing method of a catheter.
  • FIG. 11 is an enlarged view of the vicinity of a tube joint portion in a catheter of a third embodiment.
  • 13A to 13C are diagrams illustrating a manufacturing method of the catheter of the fourth embodiment.
  • FIG. 13 is an enlarged view of the vicinity of a tube joint portion in a catheter according to a fifth 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.
  • the medical device 1 is also referred to as a "catheter 1".
  • the catheter 1 is used to treat a lesion in a living lumen, such as a CTO occurring in a blood vessel. As shown in FIG. 1 and FIG.
  • the catheter 1 includes a sensor tube 10, an over-the-wire (OTW) tube 20, a rapid exchange (RX) 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 referred to as 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 first distal tube 11 disposed on the distal side, and a first base tube 12 disposed on the base side of the first distal tube 11.
  • the first distal tube 11 and the first base tube 12 are both cylindrical members (tubular bodies) having an elongated outer shape.
  • the first distal tube 11 and the first base tube 12 are connected inside the first outer tube 50 in the longitudinal direction.
  • the first distal tube 11 and the first base tube 12 each constitute a part of the sensor lumen 10L.
  • the OTW tube 20 is a cylindrical member (tubular body) having a long outer shape.
  • the OTW tube 20 extends linearly along the longitudinal direction of the catheter 1 in parallel with the sensor tube 10 and the RX tube 30 on the distal side of the branch connector 60.
  • An OTW lumen 20L (dashed line) for accommodating a treatment device (e.g., a plasma guidewire or a penetration guidewire) is formed inside the OTW tube 20.
  • the OTW lumen 20L does not have a proximal opening in the portion that is placed in the biological lumen when the catheter 1 is in use.
  • the OTW lumen 20L is an over-the-wire (OTW) type lumen.
  • 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 second distal tube 21 disposed on the distal side, and a second proximal tube 22 disposed on the proximal side of the second distal tube 21.
  • the second distal tube 21 and the second proximal tube 22 are both cylindrical members (tubular bodies) having an elongated outer shape.
  • the second distal tube 21 and the second proximal tube 22 are connected inside the first outer tube 50 in the longitudinal direction. That is, the second distal tube 21 and the second 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 at 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 tip of the distal opening 201 are at 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 may be colored so that it can be directly viewed by the surgeon. 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 (specifically, the first tip tube 11) and the RX tube 30 are arranged, with their outer circumferential surfaces joined together.
  • the sensor tube 10 in the cross section taken along line B-B, the sensor tube 10 (specifically, the first tip tube 11), the OTW tube 20 (specifically, the second tip tube 21), and the RX tube 30 are arranged, with their outer circumferential surfaces joined together.
  • the sensor tube 10 in the cross section taken along line C-C, the sensor tube 10 (specifically, the first tip tube 11), the OTW tube 20 (specifically, the second tip tube 21), and the RX tube 30 are covered by the first outer tube 50.
  • the three tubes 10, 20, 30 are fixed together by covering the outer circumferential surfaces of each of the three tubes 10, 20, 30 with the first outer tube 50 formed by melt molding.
  • the sensor tube 10 in the cross section taken along line D-D, the sensor tube 10 (specifically the first distal tube 11), the OTW tube 20 (specifically the second proximal tube 22), and the RX tube 30 are covered by the first outer tube 50, as in FIG. 3(C).
  • the sensor tube 10 specifically the first proximal tube 12
  • the OTW tube 20 specifically the second proximal tube 22
  • the two tubes 10, 20 are fixed together by covering the outer circumferential surfaces of each of the two tubes 10, 20 with the second outer tube 80 formed by melt molding.
  • 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 side of the first base end tube 12) and the OTW tube 20 (specifically, a portion of the distal end side of the second 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 proximal 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 first tip side 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 second tip side tube 21 and a portion of the tip side of the second base side 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 a 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 first 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 second 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 first tip tube 11 of the sensor tube 10, the second tip 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 first tip tube 11 of the sensor tube 10, the second tip tube 21 of the OTW tube 20, and the RX tube 30 may be made of the same material or different materials.
  • the first base-end side tube 12 of the sensor tube 10 and the second base-end side 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 first base-end side tube 12 of the sensor tube 10 and the second base-end side tube 22 of the OTW tube 20 are higher than the melting points of the above-mentioned tubes 11, 21, and 30.
  • the first base-end side tube 12 of the sensor tube 10 and the second base-end side 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 first base end tube 12 and the second base end tube 22, which are highly rigid (FIG. 1), thereby realizing a gradual change in the rigidity of the catheter 1 (reducing the rigidity gap of the catheter 1).
  • one or more of the first tip end tube 11 and the first base end tube 12 of the sensor tube 10, the second tip end tube 21 and the second base end 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) that has thermoplastic properties.
  • the heat shrink tube 90 has the property of shrinking without melting when heated. 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 corresponds to the "first tube,” and the sensor lumen 10L corresponds to the "first lumen.”
  • the OTW tube 20 corresponds to the “second tube,” and the OTW lumen 20L corresponds to the “second lumen.”
  • the RX tube 30 corresponds to the "third tube,” and the RX lumen 30L corresponds to the "third lumen.”
  • the heat shrink tube 90 corresponds to the "heat shrink tube.”
  • “same” and “equal” do not mean strictly the same, but rather mean that differences due to manufacturing errors and the like are allowed.
  • Constant is synonymous with “approximately constant,” and means that the values are approximately constant while allowing for variations due to manufacturing errors and the like.
  • FIG. 6 is an enlarged view of the vicinity of the tube joint of the catheter 1.
  • the first base-end tube 12 and the second base-end tube 22 are shown with diagonal hatching in FIG. 6.
  • FIG. 7 is a cross-sectional view of the catheter 1.
  • FIG. 7(A) shows a cross-section taken along line F-F in FIG. 6.
  • FIG. 7(B) shows a cross-section taken along line G-G in FIG. 6.
  • the joint between the first and second tip-end tubes 11, 21 and the first and second base-end tubes 12, 22 will be further explained using FIG. 6 and FIG. 7.
  • the bending rigidity of the first base end tube 12 is the "first bending rigidity”
  • the bending rigidity of the first tip end tube 11 is the “second bending rigidity”.
  • the second bending rigidity is lower than the first bending rigidity. Therefore, the melting point of the first base end tube 12 is higher than the melting point of the first tip end tube 11.
  • the bending rigidity of the second base end tube 22 is the "third bending rigidity”
  • the bending rigidity of the second tip end tube 21 is the "fourth bending rigidity”.
  • the fourth bending rigidity is lower than the third bending rigidity. Therefore, the melting point of the second base end tube 22 is higher than the melting point of the second tip end tube 21.
  • the first to fourth bending rigidities can be determined arbitrarily as long as they satisfy the above-mentioned magnitude relationship.
  • the first bending rigidity and the third bending rigidity are the same, but they may be different.
  • the second bending stiffness and the fourth bending stiffness are the same, but they may be different.
  • the first distal tube 11 of the sensor tube 10 is disposed distally of the first proximal tube 12, and the distal end of the first proximal tube 12 is joined to the proximal end of the first distal tube 11. This forms the sensor tube 10 having the sensor lumen 10L.
  • the distal end of the first proximal tube 12 is provided with a first tapered section 121 in which the outer diameter of the first proximal tube 12 narrows from the proximal end toward the distal end. In the first tapered section 121, the wall thickness of the first proximal tube 12 gradually becomes thinner toward the distal end.
  • the first tapered section 121 is covered by the proximal end of the first distal tube 11. In other words, in the range where the first tapered section 121 is provided, the first distal tube 11 and the first proximal tube 12 are arranged to overlap.
  • the first tapered section 121 is also simply called the "tapered section”.
  • the first distal tube 11 and the first proximal tube 12 are joined in an incompatible state at the overlapping portion of the first distal tube 11 and the first proximal tube 12.
  • this portion is also referred to as the "first joint.”
  • the outer peripheral surface 121o of the first tapered portion 121 contacts the inner peripheral surface 11i of the first distal tube 11.
  • the outer peripheral surface 121o and the inner peripheral surface 11i contact each other over the entire circumferential direction, but the outer peripheral surface 121o and the inner peripheral surface 11i contact each other only partially in the circumferential direction, and there may be portions where they do not contact each other.
  • the second distal tube 21 is disposed distally of the second proximal tube 22, and the distal end of the second proximal tube 22 is joined to the proximal end of the second distal tube 21.
  • the distal end of the second proximal tube 22 is provided with a second tapered section 221 in which the outer diameter of the second proximal tube 22 narrows from the proximal end toward the distal end.
  • the wall thickness of the second proximal tube 22 gradually becomes thinner toward the distal end.
  • the second tapered section 221 is covered by the proximal end of the second distal tube 21. In other words, in the range in which the second tapered section 221 is provided, the second distal tube 21 and the second proximal tube 22 are arranged to overlap.
  • the second distal tube 21 and the second proximal tube 22 are joined in an incompatible state at the portion where the second distal tube 21 and the second proximal tube 22 overlap.
  • this portion is also referred to as the "second joint.”
  • the outer peripheral surface of the second tapered portion 221 contacts the inner peripheral surface of the second distal tube 21.
  • the tip position P2 of the second base-end tube 22 is located on the tip side of the tip position P1 of the first base-end tube 12. That is, the first joint and the second joint are shifted in the longitudinal direction of the catheter 1. In other words, the first joint and the second joint are at different positions in the longitudinal direction of the catheter 1.
  • the base position of the second tapered portion 221 is located on the tip side of the tip position P1 of the first base-end tube 12. That is, the first joint and the second joint are at different positions in the longitudinal direction of the catheter 1 and are at positions that do not overlap each other.
  • the length L1 of the first tapered portion 121 is longer than the length L2 of the second tapered portion 221.
  • the lengths L1 and L2 can be determined arbitrarily as long as they satisfy the above-mentioned magnitude relationship.
  • the outer diameter ⁇ 12 of the first base-side tube 12 is larger than the outer diameter ⁇ 22 of the second base-side tube 22.
  • the outer diameter ⁇ 12 refers to the outer diameter of the first base-side tube 12 on the base side of the first tapered portion 121.
  • the outer diameter ⁇ 22 refers to the outer diameter of the second base-side tube 22 on the base side of the second tapered portion 221.
  • the base end of the RX tube 30 (third tube) is located between the tip and base ends of the first tapered portion 121.
  • the base end of the RX tube 30 is located within the range in which the first tapered portion 121 is provided.
  • the heat shrink tube 90 bundles together a portion of the tip side of the first base end tube 12 of the sensor tube 10 and a portion of the tip side of the second base end tube 22 of the OTW tube 20.
  • the heat shrink tube 90 is disposed between the tip and base end of the first tapered section 121. In other words, the heat shrink tube 90 is disposed within the range in which the first tapered section 121 is provided.
  • the first tapered portion 121 of the first base end tube 12 and the second base end tube 22 are covered by the heat shrink tube 90 with a portion of their outer circumferential surfaces 121o, 22o in contact with each other.
  • a gap SP is formed in the area surrounded by each outer circumferential surface 121o, 22o and the inner circumferential surface 90i of the heat shrink tube 90.
  • the gap SP exists on both sides of the contact portion between the tubes 12, 22.
  • the heat shrink tube 90 has a protrusion 91 that protrudes from one of the gaps SP (specifically, the gap SP on the side closer to the RX tube 30).
  • a recess 92 is formed in which the heat shrink tube 90 is recessed toward the contact portion side of the tubes 12, 22.
  • the RX tube 30 (third tube) is arranged in contact with the recess 92 on the outer surface of the heat shrink tube 90. This configuration allows the outer diameter of the catheter 1 to be reduced in cross section G-G shown in FIG. 7(B).
  • the first outer tube 50 covers the heat shrink tube 90 and the RX tube 30 that is arranged in contact with the outer circumferential surface of the heat shrink tube 90 (FIG. 7(B)).
  • the outer circumferential surface of the heat shrink tube 90 and the outer circumferential surface of the RX tube 30 are integrally fixed by the melt-formed first outer tube 50.
  • sections S1 to S4 along the longitudinal direction of the catheter 1 are defined.
  • section S1 is the section from the tip of the second tip-side tube 21 to the tip P2 of the second base-side tube 22.
  • Section S2 is the section from the tip P2 of the second base-side tube 22 to the tip P1 of the first base-side tube 12.
  • Section S3 is the section from the tip to the base end of the first taper section 121, in other words, the section in which the first taper section 121 is provided.
  • Section S4 is the section from the base end of the first taper section 121 to the base end of the first base-side tube 12.
  • Section S1 is a section in which the first distal tube 11 and the second distal tube 21, which have relatively low second and fourth bending stiffnesses, are present, and therefore the stiffness of the catheter 1 is relatively low.
  • Section S4 is a section in which the first proximal tube 12 and the second proximal tube 22, which have relatively high first and third bending stiffnesses, are present, and neither the first proximal tube 12 nor the second proximal tube 22 has a tapered portion, and therefore the stiffness of the catheter 1 is relatively high.
  • Section S2 is a section in which the first distal tube 11, which has a relatively low second bending stiffness, and the second proximal tube 22, which has a relatively high third bending stiffness, are present, and therefore the stiffness of the catheter 1 is higher than section S1 and lower than section S4.
  • section S3 includes the first base-end tube 12 and the second base-end tube 22, which have relatively high first and third bending stiffnesses
  • the first base-end tube 12 is formed with a first tapered portion 121, so the stiffness of the catheter 1 is higher than sections S1 and S2 and lower than section S4. That is, in sections S1 to S4 along the longitudinal direction of the catheter 1, the stiffness of the catheter 1 is S1 ⁇ S2 ⁇ S3 ⁇ S4. In this way, the catheter 1 of this embodiment can achieve a gradual change in stiffness from the tip side to the base side of the catheter 1.
  • FIGS. 8 and 9 are diagrams explaining a method for manufacturing the catheter 1.
  • a first distal tube 11 and a first proximal tube 12 are joined to form a sensor tube 10.
  • a method similar to that shown in FIG. 8 and FIG. 9 can also be used in the case of joining a second distal tube 21 and a second proximal tube 22 to form an OTW tube 20.
  • the tube that is the material for the first proximal tube 12 has an "a" added to the end of its reference number.
  • Figure 8 (A) shows the process of positioning the tube 12a during the constriction forming process.
  • the worker prepares the tube 12a, which is a long tubular body, and inserts a core bar C1 into the inside of the tube 12a.
  • the tip position of the core bar C1 is set to be closer to the base end than the tip position of the tube 12a.
  • a PEEK tube is used as the tube 12a.
  • FIG. 8(B) shows the step of forming the constriction 129 in the constriction forming step.
  • the worker holds the portion of the tube 12a away from the core C1 toward the base end with the first chuck HG1, and holds the tip of the tube 12a with the second chuck HG2.
  • the worker stretches the tube 12a by heating a portion of the tube 12a on the tip side of the first chuck HG1 (indicated by a dashed circle) at a predetermined heating temperature, while pulling the second chuck HG2 in the direction of the white arrow.
  • the heating temperature is the temperature at which the tube 12a melts and deforms. In this embodiment, the heating temperature is 100° C. or more higher than the melting point of the first tip-side tube 11.
  • the first chuck HG1 can be, for example, a vice
  • the second chuck HG2 can be, for example, a pair of needle-nose pliers.
  • Figure 8 (C) shows the tapered portion forming process.
  • a constriction 129 is formed at the tip of the core bar C1 of the tube 12a, surrounded by a dotted line circle.
  • the constriction 129 is the part where the outer diameter of the tube 12a is the thinnest.
  • the worker cuts the tube 12a at the constriction 129 using a feather cutter C2. This allows the first base end tube 12 to be formed with the first tapered portion 121 at its tip ( Figure 9 (A)).
  • FIG. 9(A) shows the state before insertion in the insertion process.
  • the operator prepares the first distal tube 11.
  • the outer diameter of the first distal tube 11 at the base end is the outer diameter ⁇ 11po
  • the inner diameter at the base end is the inner diameter ⁇ 11pi.
  • the outer diameter of the first distal tube 11 at a position PA (hereinafter also referred to as the "predetermined position PA") that is an arbitrary distance away from the base end of the first distal tube 11 in the longitudinal direction (the longitudinal direction of the first distal tube 11) is the outer diameter ⁇ 11ao
  • the inner diameter at the predetermined position PA is the inner diameter ⁇ 11ai.
  • the outer diameter ⁇ 11po at the base end of the first distal tube 11 is substantially the same as the outer diameter ⁇ 11ao at the predetermined position PA.
  • the inner diameter ⁇ 11pi at the base end of the first distal tube 11 is substantially the same as the inner diameter ⁇ 11ai at the predetermined position PA.
  • the outer diameter and inner diameter of the first distal tube 11 are constant up to the base end.
  • the operator inserts the first tapered portion 121 of the first proximal tube 12 into the first distal tube 11. In the illustrated example, a portion of the distal end side of the first tapered portion 121 is inserted into the first distal tube 11.
  • Figure 9 (B) shows the state after insertion during the insertion process.
  • the first tip-side tube 11 and the first base-side tube 12 are positioned with the outer circumferential surface 121o of the first tapered portion 121 of the first base-side tube 12 in contact with the inner circumferential surface 11i of the first tip-side tube 11, as shown in Figure 9 (B).
  • FIG. 9(C) shows the joining process.
  • the worker inserts the first base-end tube 12 into the first tip-end tube 11, and then applies any adhesive, such as an epoxy adhesive, to the outer circumferential surface of the step LP between the first tip-end tube 11 and the first base-end tube 12.
  • the step LP is a portion closer to the base end than the base end of the first tip-end tube 11, and where the outer diameter of the first base-end tube 12 is reduced by the first tapered portion 121. Note that application of adhesive to the step LP may be omitted.
  • the worker prepares the OTW tube 20 in the same manner as described above, and then bundles the sensor tube 10 and the OTW tube 20 with the heat shrink tube 90.
  • the worker then places the RX tube 30 on the tubes 10, 20 bundled with the heat shrink tube 90, and integrates them using the first outer tube 50.
  • the sensor tube 10 (first distal tube 11 and first proximal tube 12) and the OTW tube 20 (second distal tube 21 and second proximal tube 22) are fixed by the first outer tube 50. Note that the step portion LP in FIG. 9(C) is not visible on the outside because it is covered by the thick portion of the first outer tube 50 as shown in FIG. 7(A).
  • the tip position P2 of the second base-end tube 22 is located on the tip side of the tip position P1 of the first base-end tube 12. That is, the first joint where the first tip-end tube 11 and the first base-end tube 12 are joined and the second joint where the second tip-end tube 21 and the second base-end tube 22 are joined are shifted (located at different positions) in the longitudinal direction of the catheter 1 (medical device). Therefore, compared to the case where the first joint and the second joint are located at the same position, it is possible to realize a gradual change in the stiffness of the catheter 1 (FIG.
  • the tip of the first base-side tube 12 is provided with a first tapered portion 121, which makes it easier to connect the first base-side tube 12 to the first tip-side tube 11.
  • the tip of the second base-side tube 22 is provided with a second tapered portion 221, which makes it easier to connect the second base-side tube 22 to the second tip-side tube 21.
  • the catheter 1 since it is equipped with an RX tube 30, the catheter 1 (medical device) can be configured to have an RX lumen 30L (third lumen).
  • the base end position of the second taper section 221 is located on the tip side of the tip position P1 of the first base end tube 12.
  • the first taper section 121 and the second taper section 221 do not overlap in the longitudinal direction of the catheter 1, but are located at different positions. Therefore, as described in FIG. 6, the variation in the outer diameter of the first base end tube 12 and the second base end tube 22 in the longitudinal section of the catheter 1 where three tubes (specifically, the first base end tube 12, the second base end tube 22, and the RX tube 30 as the third tube) exist can be reduced. As a result, as shown in FIG.
  • the bias in the position of the RX tube 30 (the RX tube 30 being biased relative to either the first base end tube 12 or the second base end tube 22) can be reduced.
  • the RX tube 30 may be biased toward one of the first and second base-end tubes due to the difference in outer diameter between the relatively large-diameter first base-end tube and the relatively small-diameter second base-end tube.
  • the first base-end tube 12 has the first tapered portion 121, so such bias can be suppressed as shown in FIG. 7(B).
  • the first base-end tube 12 and the second base-end tube 22 can be bundled together without gluing by using a heat shrink tube 90.
  • the heat shrink tube 90 is disposed between the tip and base of the first tapered portion 121, so that the presence of the heat shrink tube 90 can prevent the outer diameter of the catheter 1 (medical device) from becoming larger.
  • the melting point of the first base-end tube 12 is higher than the melting point of the first tip-end tube 11, so that it is possible to join tubes having different melting points. Furthermore, according to the catheter 1 of the first embodiment, the first base-end tube 12 and the first tip-end tube 11 are in contact with each other in an incompatible state, so that it is possible to join the tubes without causing them to become compatible with each other.
  • the first base-end tube 12 and the first tip-end tube 11 can be joined by using the first tapered portion 121 (tapered portion) formed at the tip of the first base-end tube 12.
  • the first base-end tube 12 and the first tip-end tube 11 can be joined even if the melting points of the first base-end tube 12 and the first tip-end tube 11 differ by 100°C or more.
  • the manufacturing method of the catheter 1 of the first embodiment as explained in Figs. 9(A) and (B), by using the first tapered portion 121, the first base-end tube 12 and the first tip-end tube 11 can be joined without processing the first base-end tube 12 (e.g., flaring).
  • Second Embodiment Fig. 10 is a diagram illustrating a method for manufacturing a catheter 1A of the second embodiment.
  • the catheter 1A of the second embodiment differs from the first embodiment described in Fig. 9 in the contents of the insertion step and the joining step.
  • the constriction forming step and the tapered portion forming step are the same as those in the first embodiment.
  • FIG. 10(A) shows the state before insertion in the insertion process.
  • the operator prepares the first tip tube 11A.
  • the first tip tube 11A is different from the first tip tube 11 of the first embodiment in that the base end is flared.
  • the outer diameter ⁇ 11poA at the base end of the first tip tube 11A is larger than the outer diameter ⁇ 11aoA at the predetermined position PA.
  • the inner diameter ⁇ 11piA at the base end of the first tip tube 11A is larger than the inner diameter ⁇ 11aiA at the predetermined position PA.
  • the outer diameter and inner diameter of the first tip tube 11A gradually increase in a portion on the base end side.
  • the portion of the first tip tube 11A where the outer diameter ⁇ 11poA and inner diameter ⁇ 11piA are enlarged is also called the "flared portion 111". As shown by the white arrow in FIG. 10(A), the operator inserts the first tapered portion 121 of the first base end tube 12 into the flared portion 111 of the first tip end tube 11A.
  • Figure 10(B) shows the state after insertion during the insertion process.
  • the first distal tube 11A and the first proximal tube 12 are arranged with the outer circumferential surface 121o of the first tapered portion 121 of the first proximal tube 12 in contact with the inner circumferential surface 111i of the flared portion 111 of the first distal tube 11A.
  • the step LP described in the first embodiment is not formed (or the step LP is smaller).
  • FIG. 10(C) shows the joining process. As shown in FIG. 10(C), after inserting the first base-end tube 12 into the first tip-end tube 11A, the worker applies any adhesive, such as an epoxy adhesive, to the outer peripheral surface of the first base-end tube 12 located on the base-end side of the first tip-end tube 11A. The subsequent steps are as described in the first embodiment.
  • any adhesive such as an epoxy adhesive
  • the method for manufacturing the catheter 1A can be modified in various ways, and the occurrence of the step LP can be suppressed by forming a flared portion 111 at the base end of the first tip-side tube 11A.
  • the above-mentioned modifications are merely examples, and the method for manufacturing the catheter 1A can be modified in various ways.
  • the adhesive may be applied to the outer peripheral surface of the first tapered portion 121 of the first base-end tube 12 in the joining process.
  • the catheter 1A of the second embodiment and the method for manufacturing the catheter 1A as described above can also achieve the same effects as the first embodiment described above.
  • Third Embodiment 11 is an enlarged view of the vicinity of the tube joint in a catheter 1B of the third embodiment.
  • the catheter 1B of the third embodiment includes a sensor tube 10B instead of the sensor tube 10 in the configuration described in the first embodiment.
  • the sensor tube 10B includes a first base-end tube 12B having a first tapered portion 121B instead of the first base-end tube 12 described in the first embodiment.
  • the first tapered portion 121B has a length L1B in the longitudinal direction of the catheter 1B that is shorter than the length L1 described in the first embodiment.
  • the length L1B of the first tapered portion 121B is the same as the length L2 of the second tapered portion 221.
  • the base end of the RX tube 30 is located closer to the base end than the first tapered portion 121B.
  • the configuration of the catheter 1B can be modified in various ways, and the length L1B of the first tapered portion 121B and the length L2 of the second tapered portion 221 can be changed arbitrarily.
  • the length L1B of the first tapered portion 121B may be shorter than the length L2 of the second tapered portion 221.
  • Either the length L1B or the length L2 may be zero.
  • either the first base-end tube 12B or the second base-end tube 22 does not have a tapered portion.
  • the catheter 1B of the third embodiment as described above can also achieve the same effects as the first embodiment described above.
  • Fourth Embodiment Fig. 12 is a diagram illustrating a method for manufacturing a catheter 1C of the fourth embodiment.
  • the catheter 1C of the fourth embodiment differs from the first embodiment described in Fig. 9 in the content of the insertion step.
  • the constriction forming step, the tapered portion forming step, and the joining step are the same as those in the first embodiment.
  • FIG. 12(A) shows the state before insertion in the insertion process.
  • the operator prepares the first distal tube 11 and the connecting member 15.
  • the connecting member 15 is a member that is placed between the first distal tube 11 and the first proximal tube 12 to connect them.
  • the connecting member 15 is a tapered tubular body whose outer diameter and inner diameter each decrease from the proximal end to the distal end.
  • a PTFE tube can be used as the connecting member 15.
  • the operator inserts the connecting member 15 into the first distal tube 11 and inserts the first proximal tube 12 into the connecting member 15.
  • Figure 12 (B) shows the state after insertion during the insertion process.
  • the first base end tube 12 and the first tip end tube 11 are joined in an incompatible state without contacting each other via the connecting member 15.
  • the outer peripheral surface 121o of the first tapered portion 121 of the first base end tube 12 is in contact with the inner peripheral surface of the connecting member 15.
  • the inner peripheral surface 11i of the first tip end tube 11A is in contact with the outer peripheral surface of the connecting member 15.
  • the manufacturing method of catheter 1C can be modified in various ways, and by using connecting member 15, first base end tube 12 and first tip end tube 11 can be joined in an incompatible state without contacting each other.
  • the above-mentioned modifications are merely examples, and various modifications can be made to the manufacturing method of catheter 1C.
  • adhesive may be applied to at least one of the outer circumferential surface of connecting member 15 and the outer circumferential surface of first tapered portion 121 in the joining process.
  • the catheter 1C of the fourth embodiment and the manufacturing method of catheter 1C as described above can also achieve the same effects as the first embodiment described above.
  • Fifth Embodiment 13 is an enlarged view of the vicinity of the tube joint in a catheter 1D of the fifth embodiment.
  • the catheter 1D of the fifth embodiment does not include the second outer tube 80 and the heat shrink tube 90 in the configuration described in the first embodiment.
  • the first proximal tube 12 and the second proximal tube 22 are joined to each other on the proximal side of the first outer tube 50 by thermal welding or any bonding agent (for example, metal solder such as silver solder, gold solder, zinc, Sn-Ag alloy, Au-Sn alloy, or adhesive such as epoxy adhesive).
  • the configuration of the catheter 1D can be modified in various ways, and at least one of the second outer tube 80 and the heat shrink tube 90 may be omitted.
  • the catheter 1D of the fifth embodiment as described above can also achieve the same effects as the first embodiment described above.
  • the tip positions P1 and P2 in the longitudinal direction of the catheter 1 may be reversed. That is, the tip position P2 of the second base end tube 22 may be located closer to the base end than the tip position P1 of the first base end tube 12.
  • the RX tube 30 may be omitted to configure a catheter 1 consisting of two lumens.
  • the outer diameter of the first base end tube 12 and the outer diameter of the second base end tube 22 may be equal, or the relationship in magnitude between the outer diameters may be reversed from that in the first embodiment.
  • the melting point of the first base end tube 12 may be equal to the melting point of the first tip end tube 11, or the relationship in magnitude between the melting points may be reversed from that in the first embodiment.
  • the first base end tube 12 and the first tip end tube 11 may be joined in a compatible state. The same applies to these points (outer diameter, melting point, compatibility) for the second tip end tube 21 and the second base end tube 22.
  • 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.
  • 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 also 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 manufacturing method of catheters 1, 1A-1D described in Figures 8, 9, 10, and 12 is merely an example, and various modifications are possible.
  • the heating temperature in the constriction forming process can be changed as desired as long as it is a temperature at which tube 12a melts and deforms, and does not have to be a temperature 100°C higher than the melting point of first distal tube 11.
  • additional steps may be included between each of the above-mentioned steps, such as pre-treatment for processing or for arranging other components not described.
  • catheters 1, 1A-1D of the first to fifth embodiments and the configuration of the catheters 1, 1A-1D of the first modified example may be combined as appropriate.
  • the catheters 1A, 1C configured by the method described in either the second or fourth embodiment may be combined with the omission of the second outer tube 80 or the heat shrink tube 90 described in the fifth embodiment.
  • the catheter 1B described in the third embodiment may be combined with the omission of the second outer tube 80 or the heat shrink tube 90 described in the fifth embodiment.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
PCT/JP2023/018777 2023-05-19 2023-05-19 医療デバイス、及び、医療デバイスの製造方法 Ceased WO2024241379A1 (ja)

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JP2025521600A JPWO2024241379A1 (https=) 2023-05-19 2023-05-19
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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0373167A (ja) * 1988-10-20 1991-03-28 Terumo Corp 拡張体付カテーテル
JP2002355313A (ja) * 2001-03-29 2002-12-10 Nippon Zeon Co Ltd カテーテルチューブおよびバルーンカテーテル
JP2005334542A (ja) * 2004-05-31 2005-12-08 Piolax Medical Device:Kk 医療用チューブ及びその接合方法
JP2008188304A (ja) * 2007-02-06 2008-08-21 Terumo Corp 医療用カテーテル
JP2013005976A (ja) * 2011-06-27 2013-01-10 Goodman Co Ltd カテーテルチューブの製造方法
WO2022168386A1 (ja) * 2021-02-02 2022-08-11 朝日インテック株式会社 カテーテル
WO2022239763A1 (ja) * 2021-05-12 2022-11-17 朝日インテック株式会社 カテーテル
JP2023004052A (ja) * 2021-06-25 2023-01-17 朝日インテック株式会社 カテーテル

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0373167A (ja) * 1988-10-20 1991-03-28 Terumo Corp 拡張体付カテーテル
JP2002355313A (ja) * 2001-03-29 2002-12-10 Nippon Zeon Co Ltd カテーテルチューブおよびバルーンカテーテル
JP2005334542A (ja) * 2004-05-31 2005-12-08 Piolax Medical Device:Kk 医療用チューブ及びその接合方法
JP2008188304A (ja) * 2007-02-06 2008-08-21 Terumo Corp 医療用カテーテル
JP2013005976A (ja) * 2011-06-27 2013-01-10 Goodman Co Ltd カテーテルチューブの製造方法
WO2022168386A1 (ja) * 2021-02-02 2022-08-11 朝日インテック株式会社 カテーテル
WO2022239763A1 (ja) * 2021-05-12 2022-11-17 朝日インテック株式会社 カテーテル
JP2023004052A (ja) * 2021-06-25 2023-01-17 朝日インテック株式会社 カテーテル

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