Medical device

Abstract

This medical device comprises: a first tube that forms a sensor lumen; a second tube that forms a lumen for inserting a therapeutic device; and a branch connector that holds a portion of each of the first tube and the second tube. The branch connector has: a distal end-side opening that opens toward the distal end side; a first proximal end-side opening that opens toward the proximal end side; a second proximal end-side opening that is on the proximal end side and opens toward a direction different from the first proximal end-side opening; a first passage which connects the distal end-side opening and the first proximal end-side opening, through which the first tube is passed, and which has a linear shape over the entire length of the branch connector; and a second passage which connects the distal end-side opening and the second proximal end-side opening, through which the second tube is passed, and which has a shape bent with respect to the first passage.

Description

Medical device

[0001] The present disclosure relates to a medical device.

[0002] Medical devices that enable the combined use of two or more devices are known. For example, Patent Document 1 describes a catheter having a sheath main body portion formed with a first lumen for passing a first guide wire and a second lumen for passing a second guide wire. In the catheter of Patent Document 1, a bifurcated hub is attached to the proximal end side of the sheath main body portion.

[0003] Japanese Patent Application Laid-Open No. 2004-130110

[0004] By the way, there is a desire to improve the accuracy of procedures by using a therapeutic device in combination with a sensor that acquires information inside the body. In a medical device that enables the combined use of a sensor and a therapeutic device, interference between the proximal end portion of the sensor and the proximal end portion of the therapeutic device at the operator's hand may impede the procedure. Therefore, in a medical device that enables the combined use of a sensor and a therapeutic device, it has been required to make it difficult for the sensor and the therapeutic device to interfere on the operator's hand side. The catheter described in Patent Document 1 does not consider the above problems at all. Furthermore, in such a medical device, it has been required not to interfere with the operation of the sensor. Furthermore, in such a medical device, it has been required to maintain the slidability of the therapeutic device.

[0005] The present disclosure has been made to solve at least a part of the above problems and can be realized in the following forms.

[0006] According to one embodiment of the present disclosure, a medical device is provided. The medical device comprises a first tube forming a sensor lumen for inserting a sensor for acquiring information inside the body, a second tube forming a lumen for inserting a therapeutic device different from the sensor, and a branch connector holding a portion of the first tube and a portion of the second tube, wherein the branch connector has a tip-side opening that opens toward the tip side, a first base-side opening that opens toward the base-side, a second base-side opening on the base-side that opens in a direction different from the first base-side opening, a first passage connecting the tip-side opening and the first base-side opening and through which the first tube passes, having a straight shape over the entire length of the branch connector, and a second passage connecting the tip-side opening and the second base-side opening and through which the second tube passes, having a curved shape relative to the first passage.

[0007] This is an explanatory diagram showing an example of a medical device. This is an explanatory diagram showing an example of a medical device. This is a cross-sectional view of the catheter along line A-A in Figure 1. This is a cross-sectional view of the catheter along line B-B in Figure 1. This is a cross-sectional view of the catheter along line C-C in Figure 1. This is a cross-sectional view of the catheter along line D-D in Figure 1. This is a diagram showing a cross-section of the catheter. This is a diagram explaining how to use the catheter. This is a diagram explaining how to use the catheter. This is an external view of the branch connector. This is a longitudinal cross-sectional view of the branch connector. This is a longitudinal cross-sectional view of the branch connector with the first tube and the second tube passed through it. This is a longitudinal cross-sectional view of the branch connector of the second embodiment. This is a longitudinal cross-sectional view of the branch connector of the third embodiment. This is a longitudinal cross-sectional view of the branch connector of the fourth embodiment. This is a longitudinal cross-sectional view of the branch connector of the fifth embodiment. This is a longitudinal cross-sectional view of the branch connector of the sixth embodiment.

[0008] <First Embodiment> Figures 1 and 2 are explanatory diagrams showing an example of a medical device 1. The medical device 1 of this embodiment is a catheter used to treat lesions in the lumen of a living body, such as CTOs occurring in blood vessels. Hereafter, the medical device 1 will also be referred to as "catheter 1". CTO is an abbreviation for Chronic Total Occlusion. As shown in Figures 1 and 2, the catheter 1 comprises 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.

[0009] In Figure 1, the sensor 70 is omitted from the illustration in order to explain the configuration of the tube and the lumen inside the tube. In Figure 2, the sensor 70 built into the sensor lumen 10L inside the sensor tube 10 is represented by a dashed line and hatched with diagonal lines.

[0010] Figures 1 and 2 include some inaccuracies in the relative sizes of the components for illustrative purposes. Some parts of the components are exaggerated. Figures 1 and 2 illustrate mutually orthogonal X, Y, and Z axes. The X-axis corresponds to the longitudinal direction of catheter 1, the Y-axis corresponds to the height direction of catheter 1, and the Z-axis corresponds to the width direction of catheter 1. The left side of Figures 1 and 2, i.e., the -X-axis direction, is called the "tip side" of catheter 1 and each component, and the right side of Figures 1 and 2, i.e., the +X-axis direction, is called the "proximal end side" of catheter 1 and each component. Of the two ends of catheter 1 and each component in the longitudinal direction, the end located on the tip side is called the "tip," and the other end located on the proximal end side is called the "proximal end." The tip and its vicinity are called the "tip portion," and the proximal end and its vicinity are called the "proximal end portion." The tip side is inserted into the body, and the proximal end side is manipulated by a surgeon such as a physician. These points are also common in Figures 3 and beyond. In this embodiment, "same" and "equal" do not mean exactly the same, but rather allow for differences due to manufacturing errors, etc. "Constant" is synonymous with "approximately constant," meaning that it is approximately constant while allowing for variations due to manufacturing errors, etc.

[0011] Figures 3 to 7 show cross-sectional views of the catheter 1. Figure 3 is a cross-sectional view of the catheter 1 along the line A-A in Figure 1. Figure 4 is a cross-sectional view of the catheter 1 along the line B-B in Figure 1. Figure 5 is a cross-sectional view of the catheter 1 along the line C-C in Figure 1. Figure 6 is a cross-sectional view of the catheter 1 along the line D-D in Figure 1. Figure 7 is a cross-sectional view of the catheter 1 along the line E-E in Figure 1. Hereafter, the configuration of the catheter 1 will be described using Figures 1 to 7.

[0012] The sensor tube 10 is a cylindrical member with 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, parallel to the OTW tube 20 and the RX tube 30. Inside the sensor tube 10, a sensor lumen 10L is formed to house the sensor 70. In Figure 1, the sensor lumen 10L is shown with a dashed line. The sensor lumen 10L is the lumen for the sensor 70.

[0013] 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 in a state where it can move 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 lumen of the inner cylindrical member 67 and the base end of the sensor lumen 10L to the outside. The base end opening 102 is a fluid supply port to the lumen of the inner cylindrical member 67 and the sensor lumen 10L.

[0014] 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.

[0015] The OTW tube 20 is a cylindrical member 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. Inside the OTW tube 20, an OTW lumen 20L is formed to house a therapeutic device. 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. The therapeutic device is a different device from the sensor 70.

[0016] 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 obliquely cutting the tip of the OTW tube 20. The opening surface of the tip opening 201 is inclined with respect to a plane perpendicular to the longitudinal direction 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.

[0017] 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.

[0018] The RX tube 30 is a cylindrical member 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.

[0019] 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. The opening surface of the proximal opening 302 is inclined with respect to a plane perpendicular to 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.

[0020] 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.

[0021] 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 joined to the outer circumferential surface of the RX tube 30. For joining the first marker 41 and the second marker 42, for example, resin-to-resin joining by thermal melting or joining with an adhesive such as an epoxy adhesive can be employed. In this way, by arranging 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.

[0022] As shown in Figure 3, in the cross section along line A-A, the tip tube 11 of the sensor tube 10 and the RX tube 30 are positioned. In the A-A 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 B-B, the tip tube 11 of the sensor tube 10 and the tip tube 21 of the OTW tube 20 are positioned. In the B-B 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 section may be performed using any bonding agent such as an epoxy adhesive, or it may be welded by heat.

[0023] As shown in Figure 5, in the cross-section along the line C-C, 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 line D-D, 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 line E-E, 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 formed by melt molding.

[0024] In the A-A, B-B, C-C, and D-D cross-sections, the height LY of catheter 1 is greater than the width LZ of catheter 1. In the E-E 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.

[0025] The outer shape of catheter 1 in the A-A and B-B cross-sections 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 C-C and D-D cross-sections, in other words, the outer shape of catheter 1 in the portion covered by the first outer tube 50 is a triangular shape with rounded corners. A triangular shape with rounded corners is also called a rounded-corner triangular shape. In the E-E cross-section, in other words, the outer shape of catheter 1 in the portion covered by the second outer tube 80 is elliptical.

[0026] 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.

[0027] 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 base end of the heat shrink tubing 90 is located closer to the base end than the tip of the second outer tube 80, and closer to the tip than the first reinforcing member 61. That is, the base end of the heat shrink tubing 90 is covered by the second outer tube 80. The middle portion of the heat shrink tubing 90 in the longitudinal direction of the catheter 1 is not covered by the first outer tube 50 or the second outer tube 80.

[0028] The first outer tube 50 is positioned in the longitudinal direction of the catheter 1, closer to the tip than the heat-shrinkable tube 90. The first outer tube 50 is located closer to the proximal end than the tip opening 201, and is provided 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 center of the section 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.

[0029] 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.

[0030] At the proximal end of the 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 closer to the tip than the branching connector 60. The first reinforcing member 61 reinforces the tip side 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 closer to the proximal end than 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.

[0031] 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 that allows it to move relative to the inner cylindrical member 67. In other words, the inner cylindrical member 67 is positioned to move along the outer circumferential surface of the base end of the sensor tube 10 in the longitudinal direction 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 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 forms a part of the sensor lumen 10L.

[0032] 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.

[0033] 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. 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 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, 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.

[0034] 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 made of 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 made of the same material or of different materials.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] The branch connector 60 can be formed from a well-known resin material. Examples of well-known resin materials for forming the branch connector 60 include polycarbonate, polysulfone, polypropylene, and polymethyl methacrylate. 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 can be formed from a well-known resin material. 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 may be formed from the same material or from different materials.

[0039] 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 not heated. 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.

[0040] 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.

[0041] Figures 8 and 9 illustrate the method of using catheter 1. Procedures a1 to a6 described below illustrate the case of attempting to recanalize a CTO that has occurred 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.

[0042] (a1) The operator inserts the workhorse wire 200 into the blood vessel and delivers the tip of the workhorse wire 200 to near 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 opening 302 of the catheter 1. (a3) ​​The operator pushes the catheter 1 into the blood vessel along the workhorse wire 200 and delivers 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 MR by grasping the connector 65 and sliding it in the front-back direction. The operator aligns the CTO with 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 direction of the inner wall of the blood vessel. (a5) As shown by the diagonal arrow in Figure 9, the operator inserts the tip of the treatment device 300 from the proximal opening 202 of the catheter 1, passes it through the OTW lumen 20L, and protrudes it from the tip opening 201 of the catheter 1. (a6) The operator treats the CTO using the treatment 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 MR as needed. Any device such as a plasma guidewire or a penetration guidewire can be used as the treatment device 300.

[0043] Of the sensor tube 10, the proximal end tube 12 is also called the "first tube". Of the OTW tube 20, the proximal end tube 22 is also called the "second tube". The OTW lumen 20L is also called the "lumen for inserting the therapeutic device". The cylindrical member 64, connector 65, and inner cylindrical member 67 are collectively called the "first unit". The outer tube 29, second reinforcing member 62, third reinforcing member 63, and connector 25, which will be described later, are collectively called the "second unit".

[0044] FIG. 10 is an external view of the branch connector 60. In FIG. 10, the inner cavity of the branch connector 60 is illustrated by a dashed line. The branch connector 60 has a tip-side coupling portion 661, a tip-side main body portion 662, a first base-side main body portion 663, a first base-side coupling portion 664, a second base-side main body portion 665, and a second base-side coupling portion 666.

[0045] The tip-side coupling portion 661 is a substantially cylindrical portion provided at the most tip side of the branch connector 60. A thread is formed on the outer peripheral surface of the tip-side coupling portion 661. The tip-side main body portion 662 is a cylindrical portion provided between the tip-side coupling portion 661 and the first base-side main body portion 663 of the branch connector 60. The first base-side main body portion 663 is a substantially cylindrical portion provided between the tip-side main body portion 662 and the first base-side coupling portion 664 of the branch connector 60. The length of the first base-side main body portion 663 in the X-axis direction is longer than the length of the tip-side main body portion 662. The first base-side coupling portion 664 is a substantially cylindrical portion provided at the most base side of the branch connector 60. A thread is formed on the outer peripheral surface of the first base-side coupling portion 664. The second base-side main body portion 665 is a cylindrical portion provided between the tip-side main body portion 662 and the second base-side coupling portion 666 of the branch connector 60. The length of the second base-side main body portion 665 in the X-axis direction is longer than the length of the tip-side main body portion 662. The second base-side coupling portion 666 is a substantially cylindrical portion provided at the most base side of the branch connector 60. A thread is formed on the outer peripheral surface of the second base-side coupling portion 666.

[0046] The tip-side coupling portion 661, the tip-side main body portion 662, the first base-side main body portion 663, and the first base-side coupling portion 664 are arranged along the X-axis direction with their respective lumens facing the X-axis direction. The X-axis direction is the longitudinal direction of the branch connector 60. The second base-side main body portion 665 and the second base-side coupling portion 666 are arranged along a direction intersecting the X-axis direction with their respective lumens facing a direction intersecting the X-axis direction. Figure 10 shows an axis O1 passing through the centers of the first base-side main body portion 663 and the first base-side coupling portion 664, and an axis O2 passing through the centers of the second base-side main body portion 665 and the second base-side coupling portion 666. Axis O1 and axis O2 intersect. As shown in Figure 10, the tip portion of the first base-side main body portion 663 and the tip portion of the second base-side main body portion 665 are integrated. In other words, the first base end body portion 663 and the second base end body portion 665 have an appearance like a straight pipe that has branched into two. The threads formed on the outer circumferential surfaces of the tip end joint portion 661, the first base end joint portion 664, and the second base end joint portion 666 have the same pattern. The threads formed on the outer circumferential surfaces of the tip end joint portion 661, the first base end joint portion 664, and the second base end joint portion 666 may have different patterns.

[0047] Figure 11 is a longitudinal cross-sectional view of the branch connector 60. Figure 11 is a longitudinal cross-sectional view of the branch connector 60 passing through the first passage 610 and the second passage 620, which will be described later. The portion of the branch connector 60 that opens toward the tip side is called the tip-side opening 600. The tip-side opening 600 is an opening provided at the tip of the tip-side coupling portion 661. The portion of the branch connector 60 that opens toward the base end side is called the first base-side opening 601. The first base-side opening 601 is an opening provided at the base end of the first base-side coupling portion 664. The first base-side opening 601 is on the base end side of the branch connector 60 and opens in the direction of the +X axis. The portion of the branch connector 60 that is on the base end side and opens in a direction different from the first base-side opening 601 is called the second base-side opening 602. The second base-side opening 602 is an opening provided at the base end of the second base-side coupling portion 666. The second base end opening 602 is located on the base end side of the branch connector 60 and opens in the direction of the +XY axis.

[0048] Of the branch connector 60, the inner cavity connecting the tip-side opening 600 and the first base-end side opening 601 is referred to as the first passage 610. The first passage 610 is formed by the inner cavities of the tip-side connecting portion 661, the tip-side main body portion 662, the first base-end side main body portion 663, and the first base-end side connecting portion 664. As shown in FIG. 11, the first passage 610 is linear over the entire length of the branch connector 60. In the branch connector 60 of the present embodiment, the length L610 of the first passage 610 in the X-axis direction is 10 mm or more and 50 mm or less. Of the branch connector 60, the inner cavity connecting the tip-side opening 600 and the second base-end side opening 602 is referred to as the second passage 620. The second passage 620 is formed by the inner cavities of the tip-side connecting portion 661, the tip-side main body portion 662, the second base-end side main body portion 665, and the second base-end side connecting portion 666. As shown in FIG. 11, the second passage 620 has a bent shape with respect to the first passage 610. The "bent shape" refers to at least either one of curvature and flexion. In the example of FIG. 11, the second passage 620 has a bent shape with respect to the first passage 610. In other words, the second passage 620 has a bent portion BP. The second passage 620 has a linear shape extending along the X-axis direction on the tip-side of the bent portion BP. The second passage 620 has a linear shape extending along the XY-axis direction on the base-end side of the bent portion BP.

[0049] In FIG. 11, a first virtual straight line VL1 connecting the center 600c of the tip-side opening 600 and the center 601c of the first base-end side opening 601 is shown by a two-dot chain line. A second virtual straight line VL2 connecting the center 600c of the tip-side opening 600 and the center 602c of the second base-end side opening 602 is shown by a two-dot chain line. In the branch connector 60 of the present embodiment, among the angles formed by the first virtual straight line VL1 and the second virtual straight line VL2, the acute angle θ is 5 degrees or more and 45 degrees or less. In the example of the present embodiment, as shown in FIG. 11, the first virtual straight line VL1 extends in a direction slightly inclined with respect to the X-axis. Even in this case, there is no change in that the first passage 610 extends linearly.

[0050] Figure 12 is a longitudinal cross-sectional view of the branch connector 60 with the first tube 12 and the second tube 22 passed through it. As described above, the first tube 12 is the base end tube 12 of the sensor tube 10, and the second tube 22 is the base end tube 22 of the OTW tube 20. As shown in Figure 12, the first tube 12 is passed through the first passage 610. The second tube 22 is passed through the second passage 620. The portion of the lumen of the branch connector 60 through which both the first tube 12 and the second tube 22 are passed is called the tube bundle 630. The tube bundle 630 is formed by the lumen of the tip-side coupling portion 661 and the lumen of the tip-side main body portion 662. The tip of the tube bundle 630 is connected to the tip-side opening 600. The base end of the tube bundle 630 is connected to the first branch portion 611 and the second branch portion 621. As shown in Figure 11, the tube bundle 630 has a constant inner diameter Φ600 throughout its entire length, from the tip to the base. The inner diameter Φ600 of the tube bundle 630 can also be said to be the inner diameter of the tip-side opening 600.

[0051] The portion of the lumen of the branch connector 60 through which the first tube 12 passes but the second tube 22 does not is called the first branch section 611. In other words, only the first tube 12 passes through the first branch section 611. The first branch section 611 is formed by the lumen of the first base-side main body section 663 and the lumen of the first base-side connecting section 664. The first branch section 611 is located on the base side of the tube bundle section 630. The tip of the first branch section 611 is connected to the tube bundle section 630. The base end of the first branch section 611 is connected to the first base-side opening 601.

[0052] As shown in Figure 11, the first branch portion 611 includes a first small-diameter portion 6111 and a first large-diameter portion 6112. The first small-diameter portion 6111 is the part of the first branch portion 611 with a relatively small inner diameter. The first small-diameter portion 6111 has a constant inner diameter Φ6111 throughout its entire length, from tip to base. The first large-diameter portion 6112 is the part of the first branch portion 611 with a relatively large inner diameter. The first large-diameter portion 6112 has a constant inner diameter Φ601 throughout its entire length, from tip to base. The inner diameter Φ601 of the first large-diameter portion 6112 can also be said to be the inner diameter of the first base-side opening 601. The tip of the first large-diameter portion 6112 is connected to the base end of the first small-diameter portion 6111. The base end of the first large-diameter portion 6112 is connected to the first base-side opening 601. The inner diameter Φ601 of the second large-diameter portion 6212 is larger than the inner diameter Φ6111 of the first small-diameter portion 6111. A step 6113 is formed at the boundary between the first small-diameter portion 6111 and the first large-diameter portion 6112.

[0053] The portion of the lumen of the branch connector 60 through which the second tube 22 passes and through which the first tube 12 does not is called the second branch section 621. In other words, only the second tube 22 passes through the second branch section 621. The second branch section 621 is formed by the lumen of the second base-side main body section 665 and the lumen of the second base-side connecting section 666. The second branch section 621 is located on the base side of the tube bundle section 630. The tip of the second branch section 621 is connected to the tube bundle section 630. The base end of the second branch section 621 is connected to the second base-side opening 602.

[0054] As shown in Figure 11, the second branch portion 621 includes a second small-diameter portion 6211 and a second large-diameter portion 6212. The second small-diameter portion 6211 is the part of the second branch portion 621 where the inner diameter is relatively small. The second small-diameter portion 6211 has a constant inner diameter Φ6211 throughout its entire length, from the tip to the base. The second large-diameter portion 6212 is the part of the second branch portion 621 where the inner diameter is relatively large. The second large-diameter portion 6212 has a constant inner diameter Φ602 throughout its entire length, from the tip to the base. The inner diameter Φ602 of the second large-diameter portion 6212 can also be said to be the inner diameter of the second base-side opening 602. The tip of the second large-diameter portion 6212 is connected to the base end of the second small-diameter portion 6211. The base end of the second large-diameter portion 6212 is connected to the second base-side opening 602. The inner diameter Φ602 of the second large-diameter portion 6212 is larger than the inner diameter Φ6211 of the second small-diameter portion 6211. A step 6213 is formed between the second small-diameter portion 6211 and the second large-diameter portion 6212. The second small-diameter portion 6211 corresponds to the "small-diameter portion," and the second large-diameter portion 6212 corresponds to the "large-diameter portion."

[0055] As shown in Figure 11, in the longitudinal direction of the branch connector 60, the step 6213 of the second branch portion 621 is located closer to the tip than the step 6113 of the first branch portion 611. In the example in Figure 11, the inner diameter Φ6211 of the second small diameter portion 6211 is smaller than the inner diameter Φ6111 of the first small diameter portion 6111. The inner diameter Φ600 of the pipe bundle portion 630 is the same as the inner diameter Φ601 of the first large diameter portion 6112. In other words, the inner diameter Φ600 of the tip-side opening 600 is the same as the inner diameter Φ601 of the first base-side opening 601. The inner diameter Φ600 of the pipe bundle portion 630 is larger than the inner diameter Φ602 of the second large diameter portion 6212. In other words, the inner diameter Φ600 of the tip-side opening 600 is larger than the inner diameter Φ602 of the second base-side opening 602. The inner diameter Φ601 of the first large-diameter section 6112 is larger than the inner diameter Φ602 of the second large-diameter section 6212. In other words, the inner diameter Φ601 of the first base-side opening 601 is larger than the inner diameter Φ602 of the second base-side opening 602. As shown in Figure 12, the first passage 610 includes a pipe bundle section 630 and a first branch section 611. In other words, the first passage 610 includes a pipe bundle section 630, a first small-diameter section 6111, and a first large-diameter section 6112. A step 6113 is formed inside the first passage 610. The second passage 620 includes a pipe bundle section 630 and a second branch section 621. In other words, the second passage 620 includes a pipe bundle 630, a second small-diameter section 6211, and a second large-diameter section 6212. A step 6213 is formed on the inside of the second passage 620.

[0056] As shown in Figure 12, the catheter 1 further includes an outer tube 29. The outer tube 29 is a cylindrical member having an elongated outer shape. The outer tube 29 is a tubular body. In the section SE1 shown in Figure 1, the outer tube 29 covers the outside of the second tube 22, thereby improving the rigidity of the second tube 22 at its base end. The outer tube 29 is located inside the branch connector 60 at the second large diameter portion 6212 of the second branch portion 621. The outer tube 29 is not located at the second small diameter portion 6211. In the example in Figure 12, the tip of the outer tube 29 is at the position of the step 6213 of the branch connector 60. The tip of the outer tube 29 and the step 6213 of the branch connector 60 are not in contact, and there may be a gap between them. The base end of the outer tube 29 is located towards the tip of the second tube 22. A connector 25 is joined to the base end of the outer tube 29. The outer tube 29 can be formed from, for example, PEEK resin. The outer tube 29 may also be formed from any metal.

[0057] As shown in Figure 9, when the sensor 70 is inserted into the catheter 1, the proximal end of the sensor 70 is covered by the first unit 701. The first unit 701 is a collective term for the cylindrical member 64, the connector 65, and the inner cylindrical member 67. The first unit 701 is connected to the branch connector 60 from the first proximal end opening 601. Specifically, as shown in Figure 12, the cylindrical member 64 of the first unit 701 is fitted into the first proximal end coupling portion 664 of the branch connector 60. As shown in Figure 9, when the therapeutic device 300 is inserted into the catheter 1, the proximal end of the therapeutic device 300 is covered by the second unit 702. The second unit 702 is a collective term for the outer tube 29, the second reinforcing member 62, the third reinforcing member 63, and the connector 25. The second unit 702 is connected to the branch connector 60 from the second proximal end opening 602. Specifically, as shown in Figure 12, the outer tube 29 of the second unit 702 is inserted into the second large-diameter portion 6212 of the branch connector 60. Furthermore, the second reinforcing member 62 of the second unit 702 is fitted into the second base end coupling portion 666 of the branch connector 60.

[0058] As described above, according to the catheter 1 of the first embodiment, the catheter 1 comprises a first tube 12 that forms a sensor lumen 10L, a second tube 22 that forms an OTW lumen 20L for inserting a therapeutic device 300, and a branching connector 60 that holds a portion of these. Therefore, a catheter 1 that can be used in combination with a sensor 70 and a therapeutic device 300 can be provided. Furthermore, since the second passage 620 of the catheter 1 has a curved shape relative to the first passage 610, as shown in Figure 9, an appropriate distance can be secured between the sensor 70 positioned on the side of the first passage 610 and the therapeutic device 300 positioned on the side of the second passage 620. Therefore, physical interference between the proximal end of the sensor 70 and the proximal end of the therapeutic device 300 can be suppressed at the operator's hand, and the operability of the catheter 1 can be improved. Furthermore, since the first passage 610 has a straight shape along the entire length of the branching connector 60, excessive bending of the sensor 70 inserted inside the first passage 610 can be suppressed. Therefore, it is possible to suppress interference with the operation of the sensor 70 due to excessive bending of the sensor 70. The operation of the sensor 70 refers to, for example, the rotation of the ultrasonic transducer built into the probe 72 of the sensor 70, and the sliding of the sensor 70 within the sensor tube 10. Inhibition of the rotation of the ultrasonic transducer means that sensing by the sensor 70 is hindered. As a result, the catheter 1 of the first embodiment provides a medical device that is easy for the operator to operate and can perform without impairing the function of the sensor 70.

[0059] The acute angle between the first virtual line VL1 and the second virtual line VL2 is called angle θ. If angle θ is too small, physical interference between the proximal end of the sensor 70 and the proximal end of the therapeutic device 300 cannot be adequately avoided. If angle θ is too large, the therapeutic device 300 will bend excessively, reducing its sliding properties. In the catheter 1 of the first embodiment, angle θ is 5 degrees or more and 45 degrees or less. Therefore, it is possible to avoid physical interference between the proximal end of the sensor 70 and the proximal end of the therapeutic device 300 while maintaining the sliding properties of the therapeutic device 300.

[0060] If the length L610 of the first passage 610 in the longitudinal direction of the branch connector 60 is too small, the effect of the branch connector 60 covering the sensor 70 and protecting the sensor 70 cannot be sufficiently obtained. If the length L610 of the first passage 610 is too large, it will cause the catheter 1 to become larger and reduce the design freedom of the catheter 1. According to the catheter 1 of the first embodiment, the length L610 of the first passage 610 is 10 mm or more and 50 mm or less. Therefore, the protective effect of the branch connector 60 on the sensor 70 can be obtained while maintaining the design freedom of the catheter 1.

[0061] Furthermore, according to the catheter 1 of the first embodiment, the branching connector 60 has a tube bundle portion 630, a first branch portion 611, and a second branch portion 621, the first passage 610 includes the tube bundle portion 630 and the first branch portion 611, and the second passage 620 includes the tube bundle portion 630 and the second branch portion 621. Therefore, as shown in Figure 12, the first tube 12 and the second tube 22 can be branched inside the branching connector 60.

[0062] Furthermore, according to the catheter 1 of the first embodiment, the second branch portion 621 has a second small-diameter portion 6211 and a second large-diameter portion 6212 having an inner diameter Φ602 that is larger than the second small-diameter portion 6211. Therefore, as shown in Figure 12, an outer tube 29 that is thicker than the second tube 22 can be inserted into the second large-diameter portion 6212. The catheter 1 of the first embodiment further includes an outer tube 29 that covers the outside of the second tube 22 and is positioned in the second large-diameter portion 6212, so the rigidity of the proximal end of the catheter 1 can be improved by the outer tube 29.

[0063] Furthermore, according to the catheter 1 of the first embodiment, the inner diameter Φ601 of the first proximal end opening 601 connected to the first passage 610 is larger than the inner diameter Φ602 of the second proximal end opening 602 connected to the second passage 620. For this reason, a separate member for protecting the proximal end of the sensor 70 can be provided inside the first proximal end opening 601. As a result, the design freedom of the catheter 1 can be further improved.

[0064] Furthermore, the catheter 1 of the first embodiment further includes a first unit 701 that covers the proximal end of the sensor 70 inserted into the sensor lumen 10L of the catheter 1. Thus, the sensor 70 can be protected by the first unit 701. The catheter 1 further includes a second unit 702 that covers the proximal end of the therapeutic device 300 inserted into the OTW lumen 20L of the catheter 1. Thus, the therapeutic device 300 can be protected by the second unit 702.

[0065] <Second Embodiment> Figure 13 is a longitudinal cross-sectional view of the branch connector 60A of the second embodiment. The catheter 1A of the second embodiment is equipped with a branch connector 60A in place of the branch connector 60, as described in the first embodiment. The branch connector 60A has a second base-side body portion 665A in place of the second base-side body portion 665, and a second base-side coupling portion 666A in place of the second base-side coupling portion 666.

[0066] The second base-side main body portion 665A and the second base-side coupling portion 666A have a larger inclination angle with respect to the first base-side main body portion 663 and the first base-side coupling portion 664 compared to the first embodiment. In the example of Figure 13, the second base-side opening 602A provided at the base end of the second base-side coupling portion 666A opens toward the base end side of the branch connector 60A and toward the +XY axis direction. The second base-side opening 602A is more oriented toward the Y axis direction than in the example of the first embodiment. Even in this case, the fact that the second base-side opening 602A opens toward the base end remains unchanged. In Figure 13, the second virtual straight line VL2A connecting the center 600c of the tip-side opening 600 and the center 602c of the second base-side opening 602A is shown by a dashed line. In branch connector 60A, the acute angle θA between the first virtual line VL1 and the second virtual line VL2A is greater than 45 degrees.

[0067] Thus, the configuration of the branch connector 60A can be modified in various ways, and the acute angle θA formed by the first virtual line VL1 and the second virtual line VL2A may be greater than 45 degrees. Figure 13 illustrates the case where angle θA is greater than 45 degrees. Angle θA may also be less than 5 degrees. The catheter 1A of this second embodiment can also achieve the same effects as the first embodiment described above.

[0068] <Third Embodiment> Figure 14 is a longitudinal cross-sectional view of the branch connector 60B of the third embodiment. The catheter 1B of the third embodiment is equipped with a branch connector 60B instead of the branch connector 60 as described in the first embodiment. The branch connector 60B has a tip-side body portion 662B instead of the tip-side body portion 662. The length of the tip-side body portion 662B in the X-axis direction is longer than that of the tip-side body portion 662 described in the first embodiment. As a result, in the branch connector 60B shown in Figure 14, the length L610B of the first passage 610B in the X-axis direction is longer than 50 mm.

[0069] As described above, the configuration of the branch connector 60B can be modified in various ways, and the length L610B of the first passage 610B may be longer than 50 mm. Figure 14 illustrates the case where the length L610B is longer than 50 mm. The length L610B may also be shorter than 10 mm. Figure 14 illustrates the case in which the tip-side main body portion 662B has a different length from that of the first embodiment. In the branch connector 60B, the length L610B of the first passage 610B may be changed by making the length of at least one of the tip-side coupling portion 661, the tip-side main body portion 662, the first base-side main body portion 663, and the first base-side coupling portion 664 different. The catheter 1B of this third embodiment can also achieve the same effects as the first embodiment described above.

[0070] <Fourth Embodiment> Figure 15 is a longitudinal cross-sectional view of the branch connector 60C of the fourth embodiment. The catheter 1C of the fourth embodiment is equipped with a branch connector 60C in place of the branch connector 60, as described in the first embodiment. The branch connector 60C has a first base-side body portion 663C in place of the first base-side body portion 663, a first base-side coupling portion 664C in place of the first base-side coupling portion 664, a second base-side body portion 665C in place of the second base-side body portion 665, and a second base-side coupling portion 666C in place of the second base-side coupling portion 666.

[0071] A lumen with a constant inner diameter of Φ601C is formed inside the first base end body portion 663C. A lumen with a constant inner diameter of Φ601C is formed inside the first base end coupling portion 664C. For this reason, the first branch portion 611C of the branch connector 60C does not include the first small diameter portion and the first large diameter portion described in the first embodiment. No steps are formed inside the first passage 610C of the branch connector 60C. A lumen with a constant inner diameter of Φ602C is formed inside the second base end body portion 665C. A lumen with a constant inner diameter of Φ602C is formed inside the second base end coupling portion 666C. For this reason, the second branch portion 621C of the branch connector 60C does not include the second small diameter portion and the second large diameter portion described in the first embodiment. No steps are formed inside the second passage 620C of the branch connector 60C.

[0072] Thus, the configuration of the branch connector 60C can be modified in various ways, and at least one of the first branch portion 611C and the second branch portion 621C may have a constant inner diameter. In other words, at least one of the first passage 610C and the second passage 620C may not have a step on the inside. The catheter 1C of the fourth embodiment may or may not have the outer tube 29 described in the first embodiment. The catheter 1C of this fourth embodiment can also achieve the same effects as the first embodiment described above. According to the fourth embodiment, the structure of the branch connector 60C can be simplified.

[0073] <Fifth Embodiment> Figure 16 is a longitudinal cross-sectional view of the branch connector 60D of the fifth embodiment. The catheter 1D of the fifth embodiment is equipped with a branch connector 60D instead of a branch connector 60, as described in the first embodiment. The branch connector 60D does not have the tip-side coupling portion 661 and the tip-side main body portion 662 described in the first embodiment. Therefore, the branch connector 60D does not have the tube bundle portion 630 described in the first embodiment. The first passage 610D of the branch connector 60D does not include the tube bundle portion 630 and includes only the first branch portion 611. The second passage 620D of the branch connector 60D does not include the tube bundle portion 630 and includes only the second branch portion 621. As shown in Figure 16, in the branch connector 60D, the openings provided at the tips of the first base-side main body portion 663 and the second base-side main body portion 665 are called the tip-side openings 600D.

[0074] As described above, the configuration of the branch connector 60D can be modified in various ways, and at least some of the parts described in the first embodiment may be omitted. In the example of Figure 16, the tip-side coupling portion 661 and the tip-side main body portion 662 are omitted. In the branch connector 60D, at least one of the tip-side coupling portion 661, the tip-side main body portion 662, the first base-side main body portion 663, the first base-side coupling portion 664, the second base-side main body portion 665, and the second base-side coupling portion 666 described in the first embodiment may be omitted. The catheter 1D of this fifth embodiment can also achieve the same effects as the first embodiment described above.

[0075] <Sixth Embodiment> Figure 17 is a longitudinal cross-sectional view of the branch connector 60E of the sixth embodiment. The catheter 1E of the sixth embodiment is equipped with a branch connector 60E in place of the branch connector 60, as described in the first embodiment. The branch connector 60E has a tip-side body portion 662E in place of the tip-side body portion 662, and a second base-side body portion 665E in place of the second base-side body portion 665.

[0076] As shown in Figure 17, a curved lumen is formed inside the tip-side main body portion 662E at the base end. A curved lumen is formed inside the second base-side main body portion 665E at the tip end. Therefore, the second passage 620E of the branch connector 60E has a curved shape relative to the first passage 610. In other words, the second passage 620E has a curved portion CP. The second passage 620E has a straight shape extending along the X-axis direction towards the tip side of the curved portion CP. The second passage 620E has a straight shape extending along the XY-axis direction towards the base end side of the curved portion CP.

[0077] Thus, the configuration of the branch connector 60E can be modified in various ways, and the second passage 620E may have a curved shape relative to the first passage 610. In the example of Figure 17, the second passage 620E includes a straight portion and a curved portion CP. The second passage 620E may have a curved shape throughout, from the tip to the base. The second passage 620E may have a combination of at least two of the curved portion, the bent portion and the straight portion. The catheter 1E of this sixth embodiment can also achieve the same effects as the first embodiment described above.

[0078] <Modifications of this Embodiment> This disclosure is not limited to the embodiments described above, and can be implemented in various forms without departing from the spirit thereof. For example, the following modifications are also possible.

[0079] [Modification 1] The first to sixth embodiments described above show examples of catheters 1, 1A to 1E. Various modifications are possible to the configuration of catheters 1, 1A to 1E. The above embodiments illustrate the treatment of CTO occurring in blood vessels. Catheters 1, 1A to 1E can be inserted into various organs in the human body, not limited to the vascular system, but also including the lymphatic system, biliary system, urinary tract system, airway system, digestive system, secretory glands, and reproductive organs, and used for treatment or examination.

[0080] In the above embodiment, an example of branch connectors 60, 60A to 60E is shown. Various modifications are possible to the configuration of branch connectors 60, 60A to 60E.

[0081] For example, the branch connector 60 may have a lumen that branches into three or any number of parts. If the branch connector 60 is trifurcated, the branch connector 60 may further be provided with a third base-side main body and a third base-side coupling. In this case, the branch connector 60 further has a third passage formed by the lumen of the tip-side coupling 661, the lumen of the tip-side main body 662, the lumen of the third base-side main body, and the lumen of the third base-side coupling. The third passage has a curved shape relative to the first passage 610, similar to the second passage 620. The third passage is curved in a different direction from the second passage 620. By using the trifurcated branch connector 60, the catheter 1 can be provided with additional lumens different from the sensor lumen 10L, OTW lumen 20L, and RX lumen 30L described in the first embodiment.

[0082] For example, the shapes of the tip-side coupling portion 661, tip-side main body portion 662, first base-side main body portion 663, first base-side coupling portion 664, second base-side main body portion 665, and second base-side coupling portion 666 are merely examples, and various modifications are possible. For example, at least one of the outer circumferential surfaces of the tip-side coupling portion 661, the first base-side coupling portion 664, and the second base-side coupling portion 666 may not have threads. For example, the outer shape of the tip-side main body portion 662 may differ from a cylindrical shape. For example, at least one of the outer surfaces of the tip-side main body portion 662, the first base-side main body portion 663, and the second base-side main body portion 665 may have irregularities formed on them.

[0083] For example, the branch connector 60 is exemplified as consisting of a housing in which the tip-side coupling portion 661, tip-side main body portion 662, first base-side main body portion 663, first base-side coupling portion 664, second base-side main body portion 665, and second base-side coupling portion 666 are integrally molded. At least a portion of the tip-side coupling portion 661, tip-side main body portion 662, first base-side main body portion 663, first base-side coupling portion 664, second base-side main body portion 665, and second base-side coupling portion 666 may be manufactured as individual components and combined to form the branch connector 60.

[0084] For example, the inner diameters Φ600, Φ601, Φ602, Φ6111, and Φ6211 of the branch connector 60 do not have to be constant. The relative sizes of the inner diameters Φ600, Φ601, Φ602, Φ6111, and Φ6211 of the branch connector 60 described in the first embodiment are merely examples and can be changed as desired.

[0085] For example, at least a portion of the first tube 12, which is routed inside the branch connector 60, may be covered by a separate outer tube. For example, the portion of the second tube 22, which is routed inside the branch connector 60, that is closer to the tip of the outer tube 29 may be covered by a separate outer tube. For example, at least a portion of the first tube 12, at least a portion of the second tube 22, and at least a portion of the outer tube 29 may be joined to the inner circumferential surface of the branch connector 60 inside the branch connector 60. Any adhesive, such as an epoxy adhesive, can be used as the bonding agent.

[0086] For example, at least one of the first tube 12 and the second tube 22, which are passed inside the branch connector 60, may be a double-lumen tube or a multi-lumen tube, rather than a single-lumen tube.

[0087] In the above embodiment, an example of the sensor tube 10 and the OTW tube 20 has been described. For example, the sensor tube 10 may be a single tube without a tip tube 11 and a base tube 12. In this case, the sensor tube 10 corresponds to the "first tube". The OTW tube 20 may be a single tube without a tip tube 21 and a base tube 22. In this case, the OTW tube 20 corresponds to the "second 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.

[0088] In the above embodiment, the sensor 70 is built into the sensor lumen 10L of the sensor tube 10 and cannot be removed 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.

[0089] 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.

[0090] In the above embodiment, an example of the tubes 50, 80, and 90 was 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 first reinforcing members 61 to 3rd 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 first reinforcing member 61, the second reinforcing member 62, 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-rear 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.

[0091] [Modification 2] The configurations of catheters 1, 1A to 1E in the first to sixth embodiments and the configurations of catheters 1, 1A to 1E in Modification 1 may be combined as appropriate. For example, a branch connector 60 may be formed having any two or more of the following features: the angle θA described in the second embodiment, the length L610B described in the third embodiment, the configuration in which the large-diameter and small-diameter portions are omitted as described in the fourth embodiment, the configuration in which the tube bundle portion is omitted as described in the fifth embodiment, and the configuration in which the second passage 620E has a curved portion CP as described in the sixth embodiment.

[0092] 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. A medical device (1, 1A to 1E) comprising: a first tube (12) forming a sensor lumen for inserting a sensor (70) for acquiring information inside the body; a second tube (22) forming a lumen for inserting a therapeutic device (300) different from the sensor (70); and a branch connector (60, 60A to 60E) holding a portion of the first tube (12) and a portion of the second tube (22), wherein the branch connector (60, 60A to 60E) has a tip-side opening (600, 600D) opening toward the tip side; a first proximal-side opening (601) opening toward the proximal-side; and a second proximal-side opening (602, 602A) on the proximal side that opens in a direction different from the first proximal-side opening (601), A medical device (1, 1A to 1E) comprising: a first passage (610, 610B to 610D) connecting the tip-side opening (600, 600D) and the first base-side opening (601), through which the first tube (12) passes, the first passage (610, 610B to 610D) having a straight shape over the entire length of the branch connector (60, 60A to 60E); and a second passage (620, 620C to 620E) connecting the tip-side opening (600, 600D) and the second base-side opening (602, 602A), through which the second tube (22) passes, the second passage (620, 620C to 620E) having a curved shape relative to the first passage (610, 610B to 610D).

2. A medical device (1, 1B to 1E) according to claim 1, wherein in the longitudinal cross-section of the branch connector (60, 60B to 60E) passing through the first passage (610, 610B to 610D) and the second passage (620, 620C to 620E), the acute angle of the angle formed by a first virtual line connecting the center of the tip-side opening (600, 600D) and the center of the first base-side opening (601), and a second virtual line connecting the center of the tip-side opening (600, 600D) and the center of the second base-side opening (602), is 5 degrees or more and 45 degrees or less.

3. A medical device (1, 1A, 1C to 1E) according to claim 1 or claim 2, wherein the length of the first passage (610, 610C, 610D) in the longitudinal direction of the branch connector (60, 60A, 60C to 60E) is 10 mm or more and 50 mm or less.

4. A medical device (1, 1A to 1C, 1E) according to any one of claims 1 to 3, wherein the branch connector (60, 60A to 60C, 60E) has: a tube bundle portion (630) connected to the tip-side opening (600) and through which the first tube (12) and the second tube (22) pass; a first branch portion (611, 611C) located on the proximal end side of the tube bundle portion (630) and connected to the first proximal end opening (601) and through which the first tube (12) passes; and a second branch portion (621, 621C) located on the proximal end side of the tube bundle portion (630) and connected to the second proximal end opening and through which the second tube (22) passes. A medical device (1, 1A to 1C, 1E) wherein the first passage (610, 610B, 610C) includes the tubular bundle (630) and the first branch (611, 611C), and the second passage (620, 620C, 620E) includes the tubular bundle (630) and the second branch (621, 621C).

5. A medical device (1, 1A, 1B, 1E) according to claim 4, wherein the second branch portion (621) has a small diameter portion (6211) and a large diameter portion (6212) having a larger inner diameter than the small diameter portion (6211), the tip of the large diameter portion (6212) is connected to the base end of the small diameter portion (6211), and the base end of the large diameter portion (6212) is connected to the second base end side opening (602, 602A).

6. A medical device (1, 1A, 1B, 1E) according to claim 5, further comprising an outer tube (29) covering the outside of the second tube (22), wherein the outer tube (29) is positioned in the large diameter portion (6212) and not in the small diameter portion (6211).

7. A medical device (1, 1A to 1E) according to any one of claims 1 to 6, wherein the inner diameter of the first proximal end opening (601) is larger than the inner diameter of the second proximal end opening (602, 602A).

8. A medical device (1, 1A to 1E) according to any one of claims 1 to 7, further comprising: a first unit (701) covering the proximal end of the sensor (70) inserted into the sensor lumen of the first tube (12), the first unit (701) connected to the first proximal end opening (601) of the branch connector (60, 60A to 60E); and a second unit (702) covering the proximal end of the therapeutic device (300) inserted into the lumen of the second tube (22), the second unit (702) connected to the second proximal end opening (602, 602A) of the branch connector (60, 60A to 60E).

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