Medical devices

Abstract

In a catheter where the inner tube and outer tube are bonded together with adhesive, the displacement of the outer tube relative to the inner tube is suppressed. [Solution] The medical device comprises an inner tube, an outer tube covering the inner tube, and an adhesive for joining the inner tube and the outer tube. The base end of the outer tube is located closer to the tip than the base end of the inner tube, and the adhesive covers the base end of the outer tube and is present in the gap between the outer circumferential surface of the inner tube and the inner circumferential surface of the outer tube. The base end of the outer tube is provided with an engaging portion that catches with the adhesive in the longitudinal direction when the outer tube is moved in the longitudinal direction.

Description

Technical Field

[0001] The present disclosure relates to medical devices.

Background Art

[0002] A catheter having an inner tube and an outer tube covering the inner tube is known. For example, Patent Document 1 describes a catheter having a first outer tubular member as the inner tube and a second outer tubular member as the outer tube.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] In a catheter, the inner tube and the outer tube may be adhered by an adhesive. For example, when at least one of the inner tube and the outer tube is formed of a resin having excellent heat resistance such as PEEK, an operator may adopt adhesion with an adhesive because it is difficult to adhere the tubes by heat welding.

[0005]

Means for Solving the Problems

[0006] This disclosure is made to solve at least some of the problems described above and can be implemented in the following forms.

[0007] According to one embodiment of the present disclosure, a medical device is provided. The medical device comprises an inner tube, an outer tube covering the inner tube, and an adhesive joining the inner tube and the outer tube, wherein the base end of the outer tube is located on the tip side of the base end of the inner tube, the adhesive covers the base end of the outer tube and is present in the gap between the outer circumferential surface of the inner tube and the inner circumferential surface of the outer tube, and the base end of the outer tube is provided with an engaging portion that catches with the adhesive in the longitudinal direction when the outer tube is moved in the longitudinal direction. [Brief explanation of the drawing]

[0008] [Figure 1] This is an explanatory diagram showing an example of a catheter as a medical device. [Figure 2] This is an explanatory diagram showing an example of a catheter as a medical device. [Figure 3] This is a cross-sectional view of the catheter along line AA in Figure 1. [Figure 4] Figure 1 is a cross-sectional view of the catheter along line BB. [Figure 5] Figure 1 is a cross-sectional view of the catheter along the CC line. [Figure 6] Figure 1 is a cross-sectional view of the catheter along the DD line. [Figure 7] This is a diagram showing a cross-section of a catheter. [Figure 8] This is a diagram illustrating how to use a catheter. [Figure 9] This is a diagram illustrating how to use a catheter. [Figure 10] Figure 1 is a longitudinal end view of a portion of the catheter shown. [Figure 11] Figure 1 is a longitudinal end view of a portion of the catheter shown. [Figure 12] This is a longitudinal end view of a portion of the catheter according to the second embodiment. [Figure 13] This is a perspective view of the outer tube. [Figure 14] This diagram illustrates the deformation of the outer tube. [Figure 15] This is a perspective view of the outer tube of the third embodiment. [Figure 16] This is a perspective view of the outer tube of the fourth embodiment. [Figure 17] This is a longitudinal end view of a portion of the catheter according to the fifth embodiment. [Figure 18] This is a longitudinal end view of a portion of the catheter according to the sixth embodiment. [Figure 19] This is a longitudinal end view of a portion of the catheter according to the seventh embodiment. [Figure 20] This is an explanatory diagram showing an example of a catheter according to the eighth embodiment. [Modes for carrying out the invention]

[0009] <First Embodiment> FIG. 1 and FIG. 2 are explanatory diagrams showing an example of the medical device 1. The medical device 1 of the present embodiment is, for example, a catheter used to treat a lesion in a living body lumen, such as a CTO that has occurred in a blood vessel. Hereinafter, the medical device 1 will also be referred to as "catheter1". CTO is an abbreviation for Chronic Total Occlusion. As shown in FIGS. 1 and 2, the catheter 1 includes a sensor tube 10, an OTW tube 20, an RX tube 30, a first marker 41, a second marker 42, a first outer tube 50, a branch connector 60, first reinforcing members 61 to third reinforcing members 63, an outer cylindrical member 64, an inner cylindrical member 67, a connector 65, a connector 25, a sensor 70, a second outer tube 80, and a heat shrink tube 90. OTW is an abbreviation for Over The Wire. RX is an abbreviation for Rapid Exchange.

[0010] In FIG. 1, the illustration of the sensor 70 is omitted to explain the mode of the tube and the lumen in the tube. In FIG. 2, the sensor 70 built in the sensor lumen 10L in the sensor tube 10 is represented by a broken line and is hatched.

[0011] In FIGS. 1 and 2, for convenience of explanation, there are parts where the relative ratios of the sizes of each member are different from the actual ones. Some parts of each member include exaggerated parts. In FIGS. 1 and 2, XYZ axes orthogonal to each other 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, and the Z axis corresponds to the width direction of the catheter 1. The left side of FIGS. 1 and 2, that is, the -X axis direction is called the "tip side" of the catheter 1 and each member, and the right side of FIGS. 1 and 2, that is, the +X axis direction is called the "base end side" of the catheter 1 and each member. Of both ends in the longitudinal direction of the catheter 1 and each member, one end located on the tip side is called the "tip", and the other end located on the base end side is called the "base end". The tip and its vicinity are called the "tip part", and the base end and its vicinity are called the "base end part". The tip side is inserted into the living body, and the base end side is operated by an operator such as a doctor. These points are also common in FIGS. 3 and later. In the present embodiment, "the same" and "equal" do not mean only when they exactly match, but mean allowing differences due to manufacturing errors or the like. "Constant" is synonymous with "substantially constant", and means being substantially constant while allowing fluctuations due to manufacturing errors or the like.

[0012] FIGS. 3 to 7 are views showing cross-sections of the catheter 1. FIG. 3 is a cross-sectional view of the catheter 1 taken along line A-A in FIG. 1. FIG. 4 is a cross-sectional view of the catheter 1 taken along line B-B in FIG. 1. FIG. 5 is a cross-sectional view of the catheter 1 taken along line C-C in FIG. 1. FIG. 6 is a cross-sectional view of the catheter 1 taken along line D-D in FIG. 1. FIG. 7 is a cross-sectional view of the catheter 1 taken along line E-E in FIG. 1. Hereinafter, the aspect of the catheter 1 will be described using FIGS. 1 to 7.

[0013] The sensor tube 10 is a cylindrical member having an elongated outer shape. The sensor tube 10 is a tubular body. The sensor tube 10 extends linearly along the longitudinal direction of the catheter 1 in parallel with the OTW tube 20 and the RX tube 30. Inside the sensor tube 10, a sensor lumen 10L for accommodating the sensor 70 is formed. The sensor lumen 10L is illustrated by a broken line in FIG. 1. The sensor lumen 10L is a lumen for the sensor 70.

[0014] The tip of the sensor tube 10 is located at the same or slightly proximal end as the tip of the RX tube 30 in the longitudinal direction of the catheter 1. The tip of the sensor tube 10 has a tip opening 101 that connects 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 moist. The proximal end of the sensor tube 10 is located proximal to the proximal end of the OTW lumen 20L and the proximal end of the RX tube 30 in the longitudinal direction of the catheter 1. The proximal end of the sensor tube 10 is inserted into the lumen of the inner cylindrical member 67 and held in a state where it can move relative to the inner cylindrical member 67. In other words, the inner cylindrical member 67 is arranged along the outer circumferential surface of the proximal end of the sensor tube 10 and is movable in the longitudinal direction of the sensor tube 10. The lumen of the inner cylindrical member 67 is connected to the sensor lumen 10L. The base end of the inner cylindrical member 67 is fixed to the connector 65. A fluid supply unit 66 is attached to the connector 65, and the fluid supply unit 66 has a base end opening 102 that connects the base end of the inner cylindrical member 67 and the sensor lumen 10L to the outside. The base end opening 102 is a fluid supply port to the inner cylindrical member 67 and the sensor lumen 10L.

[0015] As shown in Figure 1, the sensor tube 10 has a tip-side tube 11 positioned at the tip end and a base-side tube 12 positioned closer to the base end than the tip-side tube 11. Both the tip-side tube 11 and the base-side tube 12 are cylindrical members having an elongated outer shape. Both the tip-side tube 11 and the base-side tube 12 are tubular bodies. The tip-side tube 11 and the base-side tube 12 are connected inside the first outer tube 50 in the longitudinal direction. That is, the sensor lumen 10L includes the lumen of the tip-side tube 11 and the lumen of the base-side tube 12.

[0016] The OTW tube 20 is a cylindrical component with an elongated outer shape. The OTW tube 20 is a tubular body. Towards the tip of the branch connector 60, 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. An OTW lumen 20L for housing a therapeutic device is formed inside the OTW tube 20. In Figure 1, the OTW lumen 20L is shown by a dashed line. The OTW lumen 20L is a so-called over-the-wire type lumen. Examples of therapeutic devices include plasma guidewires and through-guidewires.

[0017] The tip of the OTW tube 20 is located in the longitudinal direction of the catheter 1, proximal to the tip of the sensor tube 10 and proximal to the tip of the RX tube 30. The tip of the OTW tube 20 has a tip opening 201 that connects the tip of the OTW lumen 20L to the outside. The tip opening 201 is a device protrusion for extending the therapeutic device toward biological tissue. The tip opening 201 is an elliptical shape formed by the oblique cut of the tip of the OTW tube 20. "Oblique" means in a direction that intersects with the longitudinal direction of the catheter 1, and as you move from the proximal end to the tip, it moves toward the center of the catheter 1. The proximal end of the OTW tube 20 is located in the longitudinal direction of the catheter 1, proximal to the proximal end of the sensor tube 10 and proximal to the proximal end of the RX tube 30. The proximal end of the OTW tube 20 is fitted with a first reinforcing member 61, a branch connector 60, a second reinforcing member 62, a third reinforcing member 63, and a connector 25, arranged from the tip end towards the proximal end. Further details will be described later. The connector 25 has a proximal end opening 202 that connects the proximal end of the OTW lumen 20L to the outside. The proximal end opening 202 is a device insertion port for inserting a therapeutic device into the OTW lumen 20L.

[0018] As shown in Figure 1, the OTW tube 20 has a tip-side tube 21 positioned at the tip end and a base-side tube 22 positioned closer to the base end than the tip-side tube 21. Both the tip-side tube 21 and the base-side tube 22 are cylindrical members having an elongated outer shape. Both the tip-side tube 21 and the base-side tube 22 are tubular bodies. The tip-side tube 21 and the base-side tube 22 are connected inside the first outer tube 50 in the longitudinal direction. That is, the OTW lumen 20L includes the lumen of the tip-side tube 21 and the lumen of the base-side tube 22.

[0019] The RX tube 30 is a cylindrical component with an elongated outer shape. The RX tube 30 is a tubular body. 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. Inside the RX tube 30, an RX lumen 30L is formed to house the workhorse wire. In Figure 1, the RX lumen 30L is shown by a dashed line. A hollow tip 40 is attached to the tip of the RX tube 30. Details of the tip 40 will be described later. In other words, the RX tube 30 includes the tip 40. The RX lumen 30L includes the lumen of the RX tube 30 and the lumen of the tip 40. The tip of the RX lumen 30L is located further forward than the tip of the sensor lumen 10L.

[0020] The tip of the RX tube 30 is located at the same or slightly further forward position as the tip of the sensor tube 10 in the longitudinal direction of the catheter 1. The tip of the RX tube 30 has a tip opening 301 that connects the tip of the RX lumen 30L to the outside. Specifically, the tip opening 301 is formed at the tip of the tip 40. The tip opening 301 is a wire insertion port for inserting the workhorse wire into the RX lumen 30L. The base end of the RX tube 30 is located further forward than 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. The base end of the RX tube 30 has a base end opening 302 that connects the base end of the RX lumen 30L to the outside. The base end opening 302 is a wire outlet for pulling the workhorse wire to the outside. The proximal opening 302 is an elliptical shape formed by the oblique cut of the proximal end of the RX tube 30, and is oriented in a direction intersecting the longitudinal direction of the catheter 1. This makes it easier to pull out the workhose wire from the proximal opening 302 when using the catheter 1.

[0021] The tip 40 is a tubular member that is radiopaque and whose outer diameter increases from the tip to the proximal end. By being joined to the tip of the RX tube 30, the tip 40 is located at the tip of the catheter 1 and advances through the biological lumen ahead of other members. The lumen of the tip 40 is connected to the RX lumen 30L of the RX tube 30, and as described above, a tip opening 301 is formed at the tip of the tip 40 that connects the tip of the RX lumen 30L to the outside.

[0022] The first marker 41 and the second marker 42 are radiopaque annular members. The first marker 41 is positioned such that its base end and the base end of the tip 40 are at the same position in the longitudinal direction of the catheter 1. The first marker 41 is embedded between the outer circumferential surface of the RX tube 30 and the inner circumferential surface of the tip 40. The second marker 42 is positioned such that its tip and the tip of the tip opening 201 are at the same position in the longitudinal direction of the catheter 1. The second marker 42 is bonded to the outer circumferential surface of the RX tube 30. For joining the first marker 41 and the second marker 42, for example, bonding resins by thermal melting or bonding with an adhesive such as an epoxy adhesive can be employed. In this way, by placing the first marker 41 and the second marker 42 on the RX tube 30 instead of the sensor tube 10, it is possible to suppress interference between the first marker 41 and the second marker 42 and sensing by the sensor 70. Sensing refers to the acquisition of image information by the sensor 70.

[0023] As shown in Figure 3, in the cross-section along line AA, the tip tube 11 of the sensor tube 10 and the RX tube 30 are positioned. In the AA cross-section, the sensor tube 10 and the RX tube 30 are joined with a portion of the outer surface of the sensor tube 10 and a portion of the outer surface of the RX tube 30 in contact with each other. As shown in Figure 4, in the cross-section along line BB, the tip tube 11 of the sensor tube 10 and the tip tube 21 of the OTW tube 20 are positioned. In the BB cross-section, the sensor tube 10 and the OTW tube 20 are joined with a portion of the outer surface of the sensor tube 10 and a portion of the outer surface of the OTW tube 20 in contact with each other. The joining of the sensor tube 10 and the OTW tube 20 in this portion may be performed using any bonding agent such as an epoxy adhesive, or it may be welded by heat.

[0024] As shown in Figure 5, in the cross-section along the CC line, the tip tube 11 of the sensor tube 10, the tip tube 21 of the OTW tube 20, and the RX tube 30 are covered by the first outer tube 50. Specifically, the three tubes 10, 20, and 30 are integrally fixed by being covered by the first outer tube 50, which is formed by melt-molding the outer surfaces of each of the three tubes 10, 20, and 30. As shown in Figure 6, in the cross-section along the DD line, the tip tube 11 of the sensor tube 10, the base tube 22 of the OTW tube 20, and the RX tube 30 are covered by the first outer tube 50, similar to Figure 5. As shown in Figure 7, in the cross-section along the EE line, the base tube 12 of the sensor tube 10 and the base tube 22 of the OTW tube 20 are covered by the second outer tube 80. Specifically, the two tubes 10 and 20 are integrally fixed together by covering each outer surface of the two tubes 10 and 20 with a second outer tube 80 that is molten.

[0025] In the AA, BB, CC, and DD cross-sections, the height LY of catheter 1 is greater than the width LZ of catheter 1. In the EE cross-section, the height LY of catheter 1 is smaller than the width LZ of catheter 1. As shown in Figures 3 to 7, the relative sizes of the outer diameters of the three tubes 10, 20, and 30 are: outer diameter of sensor tube 10 > outer diameter of OTW tube 20 > outer diameter of RX tube 30. The relative sizes of the inner diameters of the three tubes 10, 20, and 30 are: inner diameter of sensor lumen 10L > inner diameter of OTW lumen 20L > inner diameter of RX lumen 30L. These relative sizes of outer and inner diameters are merely examples and can be changed as needed.

[0026] In the AA and BB cross-sections, the external shape of catheter 1 follows the contour of the adjacent tubes, with constrictions formed at the adjacent portions of each tube. These constrictions are also called recesses. In the CC and DD cross-sections, in other words, the external shape of catheter 1 in the portion covered by the first outer tube 50 is a triangular shape with rounded corners. This triangular shape with rounded corners is also called a rounded-corner triangular shape. In the EE cross-section, in other words, the external shape of catheter 1 in the portion covered by the second outer tube 80 is elliptical.

[0027] Returning to Figure 1, let's continue the explanation. On the tip side of the first reinforcing member 61, the sensor tube 10, the OTW tube 20, and the RX tube 30 are fixed by three tubes 90, 50, and 80.

[0028] The heat shrink tubing 90 is positioned between the first outer tube 50 and the second outer tube 80 in the longitudinal direction of the catheter 1. The heat shrink tubing 90 covers a portion of the tip end of the proximal tube 12 of the sensor tube 10 and a portion of the tip end of the proximal tube 22 of the OTW tube 20, bundling them together. The heat shrink tubing 90 does not cover the RX tube 30. The RX tube 30 is positioned along the outer circumferential surface of the heat shrink tubing 90, with the outer circumferential surface of the heat shrink tubing 90 in contact with the outer circumferential surface of the RX tube 30. The tip of the heat shrink tubing 90 is located closer to the proximal end than the tip of the first outer tube 50, and closer to the tip than the proximal end opening 302. That is, the tip of the heat shrink tubing 90 is covered by the first outer tube 50. The proximal end of the heat shrink tubing 90 is located closer to the proximal end than the tip of the second outer tube 80, and closer to the tip than the first reinforcing member 61. In other words, the proximal end of the heat-shrinkable tube 90 is covered by the second outer tube 80. The middle portion of the heat-shrinkable 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.

[0029] The first outer tube 50 is positioned in the longitudinal direction of the catheter 1, towards the tip of the catheter compared to the heat-shrinkable tube 90. The first outer tube 50 is located towards the proximal end of the tip opening 201, in the section where the three tubes 10, 20, and 30 extend in parallel. In the example shown in Figure 1, the tip of the first outer tube 50 is located near the midpoint between the tip opening 201 and the proximal end opening 302. The proximal end of the first outer tube 50 is located near the proximal end of the proximal end opening 302. In this way, the first outer tube 50 is positioned away from the tip opening 201 towards the proximal end. This prevents the sensing by the sensor 70 inserted into the sensor lumen 10L from being obstructed by the first outer tube 50. The first outer tube 50 covers and fixes the tip of the heat shrink tube 90, a portion of the sensor tube 10 exposed from the tip of the heat shrink tube 90, a portion of the OTW tube 20 exposed from the tip of the heat shrink tube 90, and a portion of the base end of the RX tube 30. As shown in Figures 5 and 6, the first outer tube 50 has a rounded triangular outer shape and has thickened sections that are melt-molded along the outer surfaces of the three tubes 10, 20, and 30.

[0030] The second outer tube 80 is positioned on the proximal side of the catheter 1 in the longitudinal direction, relative to the heat-shrinkable tube 90. The second outer tube 80 is located on the proximal side of the proximal opening 302 and is provided in the section where the two tubes 10 and 20 extend side by side. In the example shown in Figure 1, the tip of the second outer tube 80 is located slightly away from the proximal opening 302 towards the proximal side. The proximal end of the second outer tube 80 is located inside the first reinforcing member 61. The second outer tube 80 covers and fixes the proximal end of the heat-shrinkable tube 90, a portion of the sensor tube 10 exposed from the proximal end of the heat-shrinkable tube 90, and a portion of the OTW tube 20 exposed from the proximal end of the heat-shrinkable tube 90. As shown in Figure 7, the second outer tube 80 has an elliptical outer shape and has a thickened section that is melt-molded along the outer circumferential surfaces of the two tubes 10 and 20.

[0031] At the proximal end of catheter 1, a first reinforcing member 61 and a branching connector 60 are provided, extending from the tip end towards the proximal end. The first reinforcing member 61 is a cylindrical member positioned towards the tip end of the branching connector 60. The first reinforcing member 61 reinforces the tip end of the branching connector 60 by covering the outer circumference of the second outer tube 80, which bundles the sensor tube 10 and the OTW tube 20. The branching connector 60 is attached to the proximal end of the first reinforcing member 61. The branching connector 60 is a member having a bifurcated lumen. The OTW tube 20 is inserted into one lumen of the branching connector 60. The sensor tube 10 is inserted into the other lumen of the branching connector 60.

[0032] On one side of the branch connector 60, a second reinforcing member 62, a third reinforcing member 63, and a connector 25 are provided, extending from the tip end to the base end. On the other side of the branch connector 60, an outer cylindrical member 64, an inner cylindrical member 67, and a connector 65 are provided, extending from the tip end to the base end. The outer cylindrical member 64 is a cylindrical member positioned closer to the base end than the branch connector 60. The inner cylindrical member 67 is passed through the lumen of the outer cylindrical member 64 and held in a state where it can move relative to the outer cylindrical member 64. Protrusions are provided on the inner circumferential surface of the base end of the outer cylindrical member 64 and on the outer circumferential surface of the tip end of the inner cylindrical member 67. The engagement of these protrusions prevents the inner cylindrical member 67 from detaching from the outer cylindrical member 64 during relative movement. The base end of the sensor tube 10 is inserted into the lumen of the outer cylindrical member 64. The sensor tube 10 is held in a state where it can move relative to the inner cylindrical member 67. In other words, the inner cylindrical member 67 is positioned so as to be movable in the longitudinal direction of the sensor tube 10 along the outer circumferential surface of the base end of the sensor tube 10. The connector 65 is a member joined to the base end of the inner cylindrical member 67. The base end side of the connector 65 is provided with a housing for accommodating the connection terminal 75 of the sensor 70. The outer circumferential surface of the connector 65 is provided with a fluid supply section 66 having a base end opening 102 formed therein that connects the base end of the sensor lumen 10L and the base end of the lumen of the inner cylindrical member 67 to the outside. The lumen of the inner cylindrical member 67 is part of the sensor lumen 10L.

[0033] The sensor 70 shown in Figure 2 is an imaging sensor for acquiring image information. As shown in Figure 2, the sensor 70 comprises a main body 71, a probe 72, and a connection terminal 75. The main body 71 is a long, elongated member that extends along the longitudinal direction of the catheter 1. Inside the main body 71 is a driving cable that electrically connects the probe 72 and the connection terminal 75. The driving cable is coaxial. The probe 72 is equipped with an ultrasonic transducer that emits ultrasound toward biological tissue and receives ultrasound that propagates through the biological tissue and is reflected. The ultrasonic transducer is also called an ultrasonic transducer, piezoelectric element, ultrasonic transmitting / receiving element, or ultrasonic element. 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 externally provided console terminal. The connection terminal 75 is provided at the base end of the main body 71 and is housed within the casing of the connector 65.

[0034] The sensor 70 is electrically connected to an external console terminal via a connection terminal 75, receiving power from the console terminal and outputting detection signals from the probe 72 to the console terminal. This allows the console terminal to display image information based on the detection signals from the probe 72. As shown in Figure 2, the sensor 70 is fixed to the connector 65. As indicated by the white arrows in Figure 2, the operator can move the position of the probe 72 of the sensor 70 within the 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, by grasping the connector 65 and sliding it in the forward and backward directions. Hereafter, the range MR will also be called the "movable range MR". The part of the catheter 1 that is particularly suitable for sensing by the sensor 70 will also be called the "acoustic window AW". As shown in Figure 2, the acoustic window AW is the section of the catheter 1 between the first marker 41 and the second marker 42.

[0035] The tip tube 11 of the sensor tube 10, the tip tube 21 of the OTW tube 20, and the RX tube 30 can be formed from a flexible material. Examples of flexible materials include 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 tip tube 11 of the sensor tube 10, the tip tube 21 of the OTW tube 20, and the RX tube 30 may be formed from the same material or from different materials.

[0036] 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 highly rigid resin. Examples of highly rigid resins include nylon resin, polyester resin, and PEEK resin. 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 tubes 11, 21, and 30 described above. 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 of different materials.

[0037] As shown in Figure 1, in the catheter 1 of this embodiment, a portion of the proximal end of the flexible RX tube 30 is overlapped with the highly rigid proximal tubes 12 and 22, thereby achieving a gradual change in the rigidity of the catheter 1. This gradual change in the rigidity of the catheter 1 can also be described as reducing the rigidity gap of the catheter 1. This suppresses kinking of the catheter 1. One or more of the tip tube 11 and proximal tube 12 of the sensor tube 10, the tip tube 21 and proximal tube 22 of the OTW tube 20, and the RX tube 30 may be configured as multiple layers with tubes made of different materials.

[0038] The tip 40, the first marker 41, and the second marker 42 can be formed from a radiopaque resin material or a metal material. Examples of radiopaque resin materials include polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, fluororesin, etc., mixed with radiopaque materials such as bismuth trioxide, tungsten, and barium sulfate. Examples of radiopaque metal materials include gold, platinum, tungsten, and alloys containing these elements. The tip 40, the first marker 41, and the second marker 42 may be formed from the same material or from different materials. If the tip 40, the first marker 41, and the second marker 42 are made of metal, images of the tip 40, the first marker 41, and the second marker 42 can be obtained not only from angiography images but also from images acquired by the sensor 70.

[0039] The branch connector 60, the first to third reinforcing members 61 to 63, the outer cylindrical member 64, the inner cylindrical member 67, the connector 65, and the connector 25 can be formed from well-known resin materials. The branch connector 60, the first to third reinforcing members 61 to 63, the outer cylindrical member 64, the inner cylindrical member 67, the connector 65, and the connector 25 may be formed from the same material or from different materials.

[0040] The heat-shrinkable tube 90 can be formed from a thermoplastic nylon-based elastomer resin. For example, polyamide elastomer can be used as a thermoplastic nylon-based elastomer resin. The heat-shrinkable tube 90 has the property of shrinking without melting when heated to a predetermined temperature range. The heat-shrinkable tube 90 exhibits improved adhesion when heated compared to when unheated. Adhesion refers to the property of easily sticking to other substances. The heat-shrinkable tube 90 may be formed from polyolefin, FEP, or silicone. FEP is an abbreviation for Fluorinated Ethylene Propylene.

[0041] The first outer tube 50 and the second outer tube 80 can be formed from a thermoplastic nylon-based elastomer resin. Unlike the heat-shrinkable 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 is made of a resin with a lower Shore hardness than the second outer tube 80. The first outer tube 50 and the second outer tube 80 may be made of the same material or of different materials.

[0042] Figures 8 and 9 illustrate the use of catheter 1. Procedures a1 to a6 described below illustrate the case of attempting to recanalize a CTO that has formed in a blood vessel using a forward approach. Catheter 1 may also be used with a reverse approach, or for procedures other than CTO recanalization.

[0043] (a1) The surgeon inserts the workhorse wire 200 into the blood vessel and delivers the tip of the workhorse wire 200 to the vicinity of the CTO. (a2) As shown in Figure 8, the operator inserts the proximal end of the workhorse wire 200 through the tip opening 301 of the catheter 1, passes it through the RX lumen 30L, and pulls it out through the proximal end opening 302 of the catheter 1. (a3) The operator advances the catheter 1 into the blood vessel along the workhorse wire 200, delivering the tip of the catheter 1 to near the CTO. In step a3, the catheter 1 may also be delivered to near the CTO by passing it through a guiding catheter that has been previously inserted into the blood vessel along the workhorse wire 200. (a4) As shown by the white arrow in Figure 9, the operator adjusts the position of the probe 72 of the sensor 70 within the movable range of MR by grasping the connector 65 and sliding it in the anterior-posterior direction. The operator aligns the positions of the CTO and the tip opening 201 while confirming the orientation of the CTO and the tip opening 201 by checking the image displayed on the console terminal. Position refers to the position in the direction of extension of the blood vessel. Orientation refers to the orientation in the circumferential direction of the inner wall of the blood vessel. (a5) As shown by the diagonal arrows in Figure 9, the operator inserts the tip of the therapeutic device 300 through the proximal opening 202 of the catheter 1, passes it through the OTW lumen 20L, and protrudes it through the tip opening 201 of the catheter 1. (a6) The operator treats the CTO using the therapeutic device 300 while checking the image displayed on the console terminal, adjusting the position of the probe 72 of the sensor 70 within the movable range of MR as needed. Any device such as a plasma guidewire or a penetration guidewire can be used as the therapeutic device 300.

[0044] The sensor tube 10, the OTW tube 20, and the RX tube 30 are collectively referred to as the "shaft." The base end tube 22 of the OTW tube 20 is also referred to as the "inner tube." The base end tube 12 of the sensor tube 10 is also referred to as the "other inner tube." The second outer tube 80, as explained in Figure 7, is also referred to as the "other outer tube."

[0045] Figures 10 and 11 are longitudinal end views of a portion PA of the catheter 1 shown in Figure 1. The portion PA of the catheter 1 is the proximal end of the OTW tube 20, as shown in Figure 1. At the proximal end of the OTW tube 20, the catheter 1 has an inner tube 22, an outer tube 600, a third reinforcing member 63, a connector 25, and adhesive 700. The inner tube 22 is the proximal end tube 22 of the OTW tube 20 described in Figures 1 to 9.

[0046] The outer tube 600 is a cylindrical member having an elongated outer shape. The outer tube 600 is a tubular body. In the section SE1 shown in Figure 1, the outer tube 600 covers a portion of the inner tube 22. In this embodiment, the outer tube 600 covers a portion of the inner tube 22 in the section from near the center of the second reinforcing member 62 to near the center of the connector 25. The base end of the outer tube 600 is located closer to the tip than the base end of the inner tube 22. The base end 6002 of the outer tube 600 is flared. The inner diameter Φ22 of the outer tube 600 at the base end 6002 gradually increases from the tip side towards the base end side. The outer diameter Φ23 of the outer tube 600 at the base end 6002 gradually increases from the tip side towards the base end side. In other words, a flared shape means a shape in which both the inner and outer diameters of the tube gradually increase toward the end face side. The flared shape can be described as a "tapered shape." Towards the tip of the base end 6002, the outer tube 600 has a constant inner diameter Φ21. The inner diameter Φ21 of the outer tube 600 is larger than the outer diameter Φ11 of the inner tube 22. In this embodiment, the outer tube 600 is made of PEEK resin.

[0047] A portion of the inner tube 22 at its base end is not covered by the outer tube 600 and is located closer to the base end than the base end of the outer tube 600. The base end portion 222 of the inner tube 22 is flared. The inner diameter of the inner tube 22 at the base end portion 222 gradually increases from the tip end towards the base end. The outer diameter of the inner tube 22 at the base end portion 222 gradually increases from the tip end towards the base end. The flared portion of the inner tube 22 is not covered by the outer tube 600. Further towards the tip than the base end portion 222, the inner tube 22 has a constant outer diameter Φ11. A gap SP exists between the outer circumferential surface 22o of the inner tube 22 and the inner circumferential surface 600i of the outer tube 600. The gap SP is the space formed between the inner tube 22, which is the inner tube, and the outer tube 600, which is the outer tube. In this embodiment, the inner tube 22 is made of PEEK resin. In other words, in this embodiment, both the inner tube 22 and the outer tube 600 are primarily composed of PEEK.

[0048] The connector 25 has a tip portion 251, a base portion 252, a wing portion 253, and a stepped portion 254. The tip portion 251 is the part of the connector 25 that has a tapered outer shape. The base portion 252 is the part on which screw threads are formed on the outer surface. The wing portion 253 is the part of the connector 25 that has a pair of wings that protrude in the ±Y axis direction. The wing portion 253 is provided between the tip portion 251 and the base portion 252. An internal lumen is provided inside the connector 25. The internal lumen of the connector 25 has a constant inner diameter Φ31 on the tip side of the base portion 252. At the base portion 252, the internal lumen of the connector 25 has an inner diameter Φ32 that gradually widens from the tip side to the base side. The inner diameter Φ32 may be constant. The inner diameter Φ31 of the connector 25 is larger than the inner diameter Φ32 at the tip of the base portion 252. Therefore, a stepped portion 254 is formed inside the connector 25, corresponding to the transition between inner diameters Φ31 and Φ32. The base end of the inner tube 22 is fixed to the stepped portion 254 of the connector 25. In the illustrated example, the inner diameter Φ12 at the base end of the inner tube 22 is greater than or equal to the inner diameter Φ32 at the tip of the base end portion 252. This prevents the tip of the therapeutic device 300 inserted through the base end opening 202 from getting caught on the base end of the inner tube 22.

[0049] The connector 25 covers the base end 222 of the inner tube 22 and the base end 6002 of the outer tube 600. In other words, the base end 222 of the inner tube 22 and the base end 6002 of the outer tube 600 are located within the lumen of the connector 25. In the illustrated example, the tip of the connector 25 is located slightly towards the tip of the base end 6002 of the outer tube 600. The base end of the connector 25 is located towards the base end of the base end 222 of the inner tube 22.

[0050] The third reinforcing member 63 is a tapered tubular body. The inner and outer diameters of the third reinforcing member 63 gradually increase from the tip end to the base end. The third reinforcing member 63 covers the tip portion 251 of the connector 25 and a portion of the base end of the outer tube 600.

[0051] The adhesive 700 joins the inner tube 22, the outer tube 600, the connector 25, and the third reinforcing member 63. As shown in Figure 10, the adhesive 700 covers the outer peripheral surface 600o of the outer tube 600 on the base end side, including the base end 6002 of the outer tube 600. The adhesive 700 is present in the gap between the outer peripheral surface 600o of the outer tube 600 and the inner peripheral surface 25i of the connector 25. The adhesive 700 is present in the gap SP between the outer peripheral surface 22o of the inner tube 22 and the inner peripheral surface 600i of the outer tube 600. In the illustrated example, the tip position of the adhesive 700 present in the gap SP is slightly towards the tip of the base end 6002 of the outer tube 600. The tip of the adhesive 700 present in the gap SP may be further towards the tip than in the example shown in Figure 10. The tip of the adhesive 700 present in the gap SP may be further towards the base end than in the example shown in Figure 10. The adhesive 700 is located on the tip side of the connector 25. By providing the adhesive 700 on the tip side of the connector 25, the rigidity gap between the connector 25 and the outer tube 600 can be mitigated. The adhesive 700 is located in the lumen of the connector 25, on the base side of the base end of the outer tube 600. In the illustrated example, there is a portion of the lumen of the connector 25 that is not filled with adhesive 700. The lumen of the connector 25 may be completely filled with adhesive 700. Any adhesive, such as an epoxy adhesive, can be used as the adhesive 700.

[0052] The flared portion of the outer tube 600 is also called the "engaging portion 610". In the example in Figure 10, the engaging portion 610 is the base end portion 6002 of the outer tube 600. The engaging portion 610 is covered by the connector 25. The engaging portion 610 is the part that, for example, when the operator moves the outer tube 600 in the longitudinal direction during the use of the catheter 1, catches with the adhesive 700 in the longitudinal direction. The longitudinal movement of the outer tube 600 occurs when the operator grasps the outer tube 600 and pushes or pulls the catheter 1 during the procedure. As shown in Figure 11, when the outer tube 600 moves toward the tip in response to the pushing operation of the catheter 1, the outer circumferential surface 600o of the engaging portion 610 catches with the adhesive 700, thereby restricting the movement of the outer tube 600 toward the tip. When the outer tube 600 moves towards the proximal end in response to the pulling operation of catheter 1, the inner circumferential surface 600i of the engaging portion 610 catches on the adhesive 700, thereby restricting the movement of the outer tube 600 towards the proximal end. In other words, the engaging portion 610 of the outer tube 600 functions as an anchor by catching on the adhesive 700 in the longitudinal direction when the outer tube 600 is moved in the longitudinal direction.

[0053] As described above, in the catheter 1 of the first embodiment, in a catheter 1 in which the inner tube 22 and the outer tube 600 are bonded together with adhesive 700, the adhesive 700 covers the proximal end portion 6002 of the outer tube 600 and is present in the gap SP between the outer peripheral surface 22o of the inner tube 22 and the inner peripheral surface 600i of the outer tube 600. Therefore, the bonding strength by the adhesive 700 can be improved compared to the case in which the adhesive 700 is not present in the gap SP. In the catheter 1 of the first embodiment, the proximal end portion 6002 of the outer tube 600 is provided with an engaging portion 610 that catches with the adhesive 700 in the longitudinal direction. Therefore, even when a force is applied to move the outer tube 600 in the longitudinal direction during use of the catheter 1, the engaging portion 610 can suppress the displacement of the outer tube 600 relative to the inner tube 22. Displacement refers to displacement in the longitudinal direction.

[0054] Furthermore, the catheter 1 of the first embodiment includes a connector 25 that covers the proximal end 6002 of the outer tube 600, and the adhesive 700 is present in the gap between the outer peripheral surface 600o of the outer tube 600 and the inner peripheral surface 25i of the connector 25. Therefore, compared to a case where the proximal end 6002 of the outer tube 600 is not covered by the connector 25, the displacement of the outer tube 600 relative to the inner tube 22 can be further suppressed.

[0055] Furthermore, according to the catheter 1 of the first embodiment, the engagement portion 610 can be easily formed by making the base end portion 6002 of the outer tube 600 flared. Moreover, by making the base end portion 6002 of the outer tube 600 flared, the adhesive on the outside of the outer tube 600 can be guided from the flared portion of the outer tube 600 into the gap SP between the inner tube 22 and the outer tube 600. As a result, the amount of adhesive 700 in the gap SP can be increased, and the bonding strength by the adhesive 700 can be further improved.

[0056] Furthermore, according to the catheter 1 of the first embodiment, since both the inner tube 22 and the outer tube 600 are mainly composed of PEEK, the rigidity of the proximal end of the catheter 1 can be improved without using metal, which may cause a decrease in acoustic properties. In other words, according to the catheter 1 of the first embodiment, a catheter 1 suitable for insertion of the sensor 70 can be provided. PEEK is a material that has excellent strength, sliding properties, wear resistance, heat resistance, etc. PEEK is difficult to bond. Conventionally, when bonding difficult-to-bond tubes such as PEEK, workers would perform surface modification treatment on the tubes before fixing them with adhesive in order to suppress the slippage of the outer tube relative to the inner tube. Surface modification treatment means processing the surface of the tube by priming or plasma treatment, etc. Surface modification treatment had problems such as being time-consuming, having a limited time frame for the effects to appear, and there being almost no change in appearance after treatment, making it difficult to judge performance by appearance. In this regard, according to the catheter 1 of the first embodiment, since the base end portion 6002 of the outer tube 600 has an engaging portion 610, even if the inner tube 22 and the outer tube 600 are mainly composed of PEEK and the operator does not perform surface modification treatment, the engaging portion 610 can suppress the displacement of the outer tube 600 relative to the inner tube 22.

[0057] Furthermore, according to the catheter 1 of the first embodiment, since the outer tube 600 has a proximal tube 12, which is another inner tube, and a second outer tube 80, which is another outer tube, on the tip side of the outer tube 600, it is possible to provide a catheter 1 that has a multi-lumen structure on the tip side and a single-lumen structure on the proximal side, and the quality of the catheter 1 can be improved.

[0058] <Second Embodiment> Figure 12 is a longitudinal end view of a portion PA in the catheter 1A of the second embodiment. Figure 13 is a perspective view of the outer tube 600A. The catheter 1A of the second embodiment is equipped with an outer tube 600A in place of the outer tube 600, as described in the embodiment of the first embodiment.

[0059] The base end 6002 of the outer tube 600A does not have a flared portion. The base end 6002 of the outer tube 600A has a through hole that penetrates the inner circumferential surface 600i side and the outer circumferential surface 600o side of the outer tube 600A. The through hole of the outer tube 600A is also called the "engaging portion 610A". As shown in Figure 13, the through hole of the outer tube 600A is circular in shape. The outer diameter Φ610A of the through hole is smaller than the inner diameter Φ21 of the outer tube 600A. In the example in Figure 12, two through holes are formed at opposing positions in the circumferential direction of the outer tube 600A. The number of through holes may be one or any number. The through holes may be provided at any position in the longitudinal and circumferential directions of the outer tube 600A.

[0060] Adhesive 700 is present inside the through-hole of the outer tube 600A. The engaging portion 610A is covered by the connector 25. As shown in Figure 13, when the outer tube 600A moves toward the tip in response to the pushing operation of the catheter 1A, the proximal side wall 610A1 of the engaging portion 610A catches on the adhesive 700, thereby restricting the outer tube 600A's movement toward the tip. When the outer tube 600A moves toward the proximal side in response to the pulling operation of the catheter 1A, the proximal side wall of the engaging portion 610A catches on the adhesive 700, thereby restricting the outer tube 600A's movement toward the proximal side.

[0061] Figure 14 illustrates the deformation of the outer tube 600A. In Figure 14, only the outer tube 600A is shown. As described above, the configuration of the engaging portion 610A can be changed in various ways, and the engaging portion 610A may be realized by a through hole. Figures 12 and 13 illustrate the case in which the engaging portion 610A is realized by a through hole with a flat edge. As shown in Figure 14, the edge of the through hole may be provided with an outer projection 611 that protrudes toward the outer circumferential surface 600o side of the outer tube 600A. Similarly, the edge of the through hole may be provided with an inner projection 612 that protrudes toward the inner circumferential surface 600i side of the outer tube 600A. Either the outer projection 611 or the inner projection 612 may be provided, or both may be provided. If at least one of the outer projection 611 or the inner projection 612 is provided, the anchoring effect of the engaging portion 610A can be increased.

[0062] The catheter 1A of the second embodiment described above can achieve the same effects as the first embodiment described above. Furthermore, according to the catheter 1A of the second embodiment, the engaging portion 610A can be easily formed by providing a through hole in the base end portion 6002 of the outer tube 600A. In addition, the adhesive 700 on the outside of the outer tube 600A can be guided through the through hole into the gap SP between the inner tube 22 and the outer tube 600A. As a result, the amount of adhesive 700 in the gap SP can be increased, and the bonding strength by the adhesive 700 can be further improved.

[0063] <Third Embodiment> Figure 15 is a perspective view of the outer tube 600B of the third embodiment. The catheter 1B of the third embodiment is equipped with an outer tube 600B in place of the outer tube 600A in the embodiment described in the second embodiment. The base end 6002 of the outer tube 600B is provided with a through hole that penetrates the inner circumferential surface 600i side and the outer circumferential surface 600o side of the outer tube 600B. The through hole of the outer tube 600B is also called the "engaging portion 610B". As shown in Figure 15, the through hole of the outer tube 600B is rectangular in shape. The through hole of the outer tube 600B is arranged so that the longitudinal direction of the rectangle is along the circumferential direction of the outer tube 600B. In the illustrated example, the number of through holes in the outer tube 600B is one. The number of through holes may be one or any number.

[0064] As described above, the shape of the through-hole of the engaging portion 610B can be arbitrarily changed. Figure 15 shows a rectangular shape as an example. The shape of the through-hole can be arbitrarily changed to an elliptical shape, a polygonal shape, etc. In the catheter 1B of the third embodiment, as in the second embodiment, the movement of the outer tube 600B toward the tip and the movement of the outer tube 600B toward the proximal end can be restricted by the adhesive 700 that has entered the inside of the through-hole of the outer tube 600B. The catheter 1B of the third embodiment described above can also achieve the same effects as the first and second embodiments described above.

[0065] <Fourth Embodiment> Figure 16 is a perspective view of the outer tube 600C of the fourth embodiment. The catheter 1C of the fourth embodiment is equipped with an outer tube 600C in place of the outer tube 600A, as described in the second embodiment. The base end 6002 of the outer tube 600C is provided with a through hole that penetrates the inner circumferential surface 600i side and the outer circumferential surface 600o side of the outer tube 600C. The through hole of the outer tube 600C is also called the "engaging portion 610C". As shown in Figure 16, the through hole of the outer tube 600C is a rectangular slit. The through hole of the outer tube 600C is provided continuously to the base end of the outer tube 600C, with the longitudinal direction of the rectangle aligned with the longitudinal direction of the outer tube 600C. In the illustrated example, the number of through holes in the outer tube 600C is one. The number of through holes may be one or more arbitrary numbers.

[0066] Thus, the shape of the through-hole of the engaging portion 610C can be arbitrarily changed. In the catheter 1C of the fourth embodiment, as in the second embodiment, the adhesive 700 that has entered the inside of the through-hole of the outer tube 600C can restrict the movement of the outer tube 600C toward the tip and the movement of the outer tube 600C toward the proximal end. The catheter 1C of the fourth embodiment described above can also achieve the same effects as the first and second embodiments described above.

[0067] <Fifth Embodiment> Figure 17 is a longitudinal end view of a portion PA of the catheter 1D of the fifth embodiment. The catheter 1D of the fifth embodiment is equipped with an outer tube 600D instead of the outer tube 600 as described in the first embodiment. The proximal end portion 6002 of the outer tube 600D is provided with a folded portion of the outer tube 600D. The folded portion is a portion of the outer tube 600D on the proximal end side that is folded back so that the inner circumferential surface 600i faces outward. The folded portion of the outer tube 600D is also called the "engaging portion 610D". In the example of Figure 17, the folded portion is provided over the entire circumferential direction of the outer tube 600D. The folded portion may be provided only on a portion of the circumferential direction of the outer tube 600D.

[0068] Adhesive 700 is present inside the folded portion of the outer tube 600D. The engaging portion 610D is covered by the connector 25. As shown in Figure 17, when the outer tube 600D moves toward the tip in response to the pushing operation of the catheter 1D, the first surface 610D1 and the second surface 610D2 of the folded portion of the engaging portion 610D catch on the adhesive 700, thereby restricting the outer tube 600D's movement toward the tip. When the outer tube 600D moves toward the proximal end in response to the pulling operation of the catheter 1A, the surface of the folded portion of the engaging portion 610D opposite to the second surface 610D2 catches on the adhesive 700, thereby restricting the outer tube 600D's movement toward the proximal end.

[0069] Thus, the configuration of the engaging portion 610D can be modified in various ways, and the engaging portion 610D may be formed by providing a folded portion at the base end of the outer tube 600D. The catheter 1D of the fifth embodiment described above can also achieve the same effects as the first embodiment described above.

[0070] <Sixth Embodiment> Figure 18 is a longitudinal end view of a portion PA in the catheter 1E of the sixth embodiment. The catheter 1E of the sixth embodiment is equipped with an outer tube 600E instead of the outer tube 600 as described in the first embodiment. The base end portion 6002 of the outer tube 600E does not have a flared portion. The base end portion 6002 of the outer tube 600E has a hole on the outer peripheral surface 600o side. The hole is not a through hole, but a hole with a bottom. The hole in the outer tube 600E is also called the "engaging portion 610E". The hole in the outer tube 600E can be any shape, such as circular, rectangular, elliptical, or polygonal. In the example in Figure 18, two holes are formed at opposing positions in the circumferential direction of the outer tube 600E. The number of holes may be one or any number.

[0071] Adhesive 700 is present inside the hole of the outer tube 600E. The engaging portion 610E is covered by the connector 25. As shown in Figure 18, when the outer tube 600E moves toward the tip in response to the pushing operation of the catheter 1E, the proximal side wall 610E1 of the engaging portion 610E catches on the adhesive 700, thereby restricting the outer tube 600E's movement toward the tip. When the outer tube 600E moves toward the proximal side in response to the pulling operation of the catheter 1E, the proximal side wall of the engaging portion 610E catches on the adhesive 700, thereby restricting the outer tube 600E's movement toward the proximal side.

[0072] Thus, the configuration of the engaging portion 610E can be modified in various ways, and the engaging portion 610E may be formed by providing a hole at the base end of the outer tube 600E. The catheter 1E of the sixth embodiment described above can also achieve the same effects as the first embodiment described above.

[0073] <Seventh Embodiment> Figure 19 is a longitudinal end view of a portion PA in the catheter 1F of the seventh embodiment. The catheter 1F of the seventh embodiment is equipped with an outer tube 600F instead of the outer tube 600 and adhesive 700F instead of adhesive 700, as described in the embodiment of the first embodiment.

[0074] The outer tube 600F differs from the first embodiment in the position of its base end 6002. The base end 6002 of the outer tube 600F is located on the tip side of the connector 25 and inside the third reinforcing member 63. Therefore, the engaging portion 610 of the outer tube 600F is not covered by the connector 25 and is located on the tip side of the connector 25. Consequently, the adhesive 700F is not present in the gap between the outer circumferential surface 600o of the outer tube 600F and the inner circumferential surface 25i of the connector 25. The adhesive 700F is present in the gap between the outer circumferential surface 600o of the outer tube 600F and the inner circumferential surface of the third reinforcing member 63. Other aspects of the adhesive 700F are the same as in the first embodiment.

[0075] Thus, the configuration of the outer tube 600F can be modified in various ways. The base end portion 6002 of the outer tube 600F does not need to be covered by the connector 25. In other words, the engaging portion 610 of the outer tube 600F does not need to be covered by the connector 25. The catheter 1F of the seventh embodiment described above can also achieve the same effects as the first embodiment described above.

[0076] <Eighth Embodiment> Figure 20 is an explanatory diagram showing an example of a catheter 1G of the eighth embodiment. The catheter 1G of the eighth embodiment comprises a tip 800, an inner tube 22, an outer tube 600, a third reinforcing member 63, and a connector 25.

[0077] The tip 800 has a tapered cylindrical shape. The tip 800 has an outer shape that gradually widens from the tip side to the base side. The tip 800 is joined to the tip of the inner tube 22. The outer tube 600 covers a portion of the base side of the inner tube 22. The tip of the outer tube 600 is fixed to the outer circumferential surface of the inner tube 22. The tip of the outer tube 600 does not have to be fixed to the outer circumferential surface of the inner tube 22. The inner tube 22 is exposed to the outside between the base end of the tip 800 and the tip of the outer tube 600, and is not covered by the tip 800 and the outer tube 600. The configuration of the third reinforcing member 63 and the connector 25 is as described in the first embodiment. The configuration of the inner tube 22 and the outer tube 600 inside the third reinforcing member 63 and the connector 25 is as described in the first embodiment.

[0078] Thus, the configuration of catheter 1G can be modified in various ways, and as shown in Figure 20, it may be a single-lumen catheter equipped with one set of inner tubes 22 and outer tubes 600. Catheter 1G may also be a multi-lumen catheter equipped with two sets of inner tubes and outer tubes. When catheter 1G is a multi-lumen catheter, for example, in addition to the inner tubes 22 and outer tubes 600 shown in Figure 20, other inner tubes and other outer tubes may be provided. The other inner tubes are tubular bodies arranged alongside inner tube 22. The other outer tubes are tubular bodies that fix inner tube 22 and other inner tubes. When catheter 1G is a multi-lumen catheter, for example, in the configuration described in the first embodiment, the RX tube 30 and tip 40 may be omitted. The catheter 1G of the eighth embodiment described above can also achieve the same effects as the first embodiment described above.

[0079] <Modified form of this embodiment> This disclosure is not limited to the embodiments described above, and can be implemented in various forms without departing from its essence, including, for example, the following modifications.

[0080] [Example 1] The first to eighth embodiments described above show examples of catheters 1,1A to 1G. The configuration of catheters 1,1A to 1G can be modified in various ways. The embodiments described above illustrate the treatment of CTOs occurring in blood vessels. Catheters 1,1A to 1G can be inserted into various organs in the human body, not limited to the vascular system, but also the lymphatic system, biliary system, urinary tract, airway system, digestive system, secretory glands, and reproductive organs, and used for treatment or examination.

[0081] In the above embodiment, an example was given in which engaging portions 610, 610A to 610E are provided at the base end 6002 of the outer tube 600. The engaging portions 610, 610A to 610E may also be provided at the tip of the outer tube 600. In other words, the engaging portions 610, 610A to 610E may be provided inside the second reinforcing member 62. The engaging portion 610 may be provided at both the tip and base end of the outer tube 600.

[0082] In the above embodiment, an example of the arrangement of the adhesive 700 was described. The adhesive 700 may be present only in the lumen of the connector 25. In other words, the adhesive 700 may not be present on the tip side of the connector 25. In the vertical end face of Figure 10, the arrangement of the adhesive 700 inside the third reinforcing member 63 and the connector 25 is substantially symmetrical with respect to the axis O. In the vertical end face of Figure 10, the arrangement of the adhesive 700 inside the third reinforcing member 63 and the connector 25 may be asymmetrical with respect to the axis O.

[0083] In the above embodiment, the base end 222 of the inner tube 22 is flared. The base end 222 of the inner tube 22 may not be flared, and the inner tube 22 may have a constant outer diameter Φ11 throughout its entire length from tip to base. In the above embodiment, the inner diameter Φ12 at the base end of the inner tube 22 is assumed to be greater than or equal to the inner diameter Φ32 at the tip of the base end 252. The inner diameter Φ12 at the base end of the inner tube 22 may be smaller than the inner diameter Φ32 at the tip of the base end 252.

[0084] In the above embodiment, both the inner tube 22 and the outer tube 600 are primarily composed of PEEK. At least one of the inner tube 22 and the outer tube 600 may be primarily composed of PEEK. In this case, for the other tube that is not primarily composed of PEEK, various materials as exemplified for the tip tube 11 of the sensor tube 10, or well-known resin materials can be used. Both the inner tube 22 and the outer tube 600 do not have to be primarily composed of PEEK.

[0085] In the above embodiment, an example of the sensor tube 10 and the OTW tube 20 was described. For example, the sensor tube 10 may be a single tube without a tip tube 11 and a base tube 12. Similarly, the OTW tube 20 may be a single tube without a tip tube 21 and a base tube 22. In this case, the single OTW tube 20 corresponds to the "inner tube". For example, the sensor tube 10, the OTW tube 20, and the RX tube 30 may be integrally molded on the tip side of the first reinforcing member 61. For example, the tip opening 201 of the OTW tube 20 may be a circular shape with the tip of the OTW tube 20 cut vertically. Similarly, the base opening 302 of the RX tube 30 may be a circular shape with the end of the RX tube 30 cut vertically.

[0086] In the above embodiment, the sensor 70 is built into the sensor lumen 10L of the sensor tube 10 and is not removable from the catheter 1. The sensor 70 may be removable from the catheter 1. That is, the catheter 1 does not have to include the sensor 70. For example, the outer surfaces of the first outer tube 50, the heat shrink tube 90, and the second outer tube 80, or the outer surfaces of the catheter 1 including these, may be coated with a hydrophilic resin or a hydrophobic resin.

[0087] In the above embodiment, an example of the tip 40 and markers 41 and 42 was described. For example, at least one of the tip 40, the first marker 41, and the second marker 42 may be omitted. Their arrangement and shape can be arbitrarily changed. For example, the first marker 41 may not overlap with the tip 40 and may be positioned adjacent to the base end of the tip 40 or at a position away from the base end of the tip 40. For example, at least one of the tip 40, the first marker 41, and the second marker 42 may be positioned on a tube different from the RX tube 30. For example, the tip 40 may have a constant outer diameter from the tip to the base end, and its cross-sectional shape may be asymmetrical. For example, at least one of the first marker 41 and the second marker 42 may have a shape other than an annular shape.

[0088] In the above embodiment, examples of tubes 50, 80, and 90 have been described. For example, at least one of the first outer tube 50, the second outer tube 80, and the heat shrink tube 90 may be omitted. For example, the shapes of the branch connector 60, the first reinforcing members 61 to the third reinforcing members 63, the outer cylindrical member 64, the inner cylindrical member 67, the connector 65, and the connector 25 described above are merely examples and may be changed as desired. For example, at least a portion of the branch connector 60, the first reinforcing member 61, the second reinforcing member 62, and the outer cylindrical member 64 and the inner cylindrical member 67 may be a single member or may be omitted. For example, the third reinforcing member 63 and the connector 25 may be a single member. For example, the outer cylindrical member 64 may be formed of a transparent material, and the inner cylindrical member 67 may be provided with a mechanism to assist in adjusting at least one of the front-to-back position of the sensor 70 and the circumferential orientation of the sensor 70. The auxiliary mechanism could be, for example, a scale provided at predetermined intervals along the longitudinal direction, or a scale provided at predetermined angles along the circumferential direction. A stopper may be used instead of a scale.

[0089] [Differentiation 2] The configurations of catheters 1, 1A to 1G in the first to eighth embodiments described above, and the configurations of catheters 1, 1A to 1G in the modified example 1 described above, may be combined as appropriate. For example, catheter 1 may be provided with an engagement portion that combines one or more of the engagement portions 610, 610A to 610E described in any of the first to sixth embodiments. For example, when the first and second embodiments are combined, the engagement portion 610 takes the form of a through hole provided in a flared portion. For example, in the configuration in the seventh embodiment where the engagement portion 610F described is not covered by the connector 25, the engagement portion 610F may be the configuration described in any of the second to sixth embodiments. For example, in catheter 1G described in the eighth embodiment, the engagement portion 610 may be the configuration described in any of the second to sixth embodiments. For example, in catheter 1G described in the eighth embodiment, a configuration in which the engagement portion 610F described in the seventh embodiment is not covered by the connector 25 may be adopted.

[0090] This embodiment has been described above based on embodiments and modifications. The embodiments described above are for the purpose of facilitating understanding of this embodiment and do not limit it. This embodiment can be modified and improved without departing from its spirit and the scope of the claims, and equivalents thereof are included in this embodiment. Technical features that are not described as essential in this specification may be deleted as appropriate.

Claims

1. Medical devices (1, 1A to 1G), Inner tube (22) and An outer tube (600, 600A to 600F) covers the inner tube (22), An adhesive (700, 700F) for joining the inner tube (22) and the outer tube (600, 600A to 600F), Equipped with, The base end of the outer tube (600, 600A to 600F) is located closer to the tip than the base end of the inner tube (22). The adhesive (700, 700F) covers the base end of the outer tube (600, 600A to 600F) and is present in the gap between the outer circumferential surface of the inner tube (22) and the inner circumferential surface of the outer tube (600, 600A to 600F). A medical device (1, 1A to 1G) is provided, wherein the base end of the outer tube (600, 600A to 600F) is provided with an engaging portion (610, 610A to 610E) that catches with the adhesive (700, 700F) in the longitudinal direction when the outer tube (600, 600A to 600F) is moved in the longitudinal direction.

2. A medical device (1, 1A to 1E, 1G) according to claim 1, further, The outer tube (600, 600A to 600E) is provided with a connector (25) that covers the base end, The adhesive (700) is present in the gap between the outer surface of the outer tube (600, 600A to 600E) and the inner surface of the connector (25). The aforementioned engaging portions (610, 610A to 610E) are covered by the connector (25) in a medical device (1, 1A to 1E, 1G).

3. A medical device (1,1F) according to claim 1 or claim 2, The engagement portion (610) is a portion of the outer tube (600, 600F) where the outer diameter gradually increases from the tip to the base end, in a medical device (1, 1F).

4. A medical device (1A to 1C) according to claim 1 or claim 2, The aforementioned engaging portion (610A to 610C) is a through hole that penetrates the inner and outer circumferential surfaces of the outer tube (600A to 600C), and is a medical device (1A to 1C).

5. A medical device (1D) according to claim 1 or claim 2, The engaging portion (610D) is a folded portion of the outer tube (600D) provided at the base end of the outer tube (600D), in a medical device (1D).

6. A medical device (1E) according to claim 1 or claim 2, The engaging portion (610E) is a hole provided on the outer circumferential surface side of the outer tube (600E), and is a hole that does not penetrate the inner circumferential surface side and the outer circumferential surface side of the outer tube (600E), in the medical device (1E).

7. A medical device (1,1A to 1G) according to any one of claims 1 to 6, At least one of the inner tube (22) and the outer tube (600, 600A to 600F) is a medical device (1, 1A to 1G) whose main component is PEEK.

8. A medical device (1,1A to 1F) according to any one of claims 1 to 7, further, Further towards the tip of the outer tube (600, 600A to 600F), another inner tube (12) is arranged alongside the inner tube (22), An outer tube (80) covers the inner tube (22) and the other inner tube (12) and fixes the inner tube (22) and the other inner tube (12), A medical device (1, 1A to 1F) equipped with the above.

Images