Medical device

Abstract

To provide a medical device with two or more lumens, allowing an operator to use many combined devices in a limited lumen of a guiding catheter.SOLUTION: A medical device includes a first tube with a first lumen, a second tube with a second lumen, and a third tube with a third lumen. An outer peripheral surface of the first tube and an outer peripheral surface of the second tube are joined together, and in a cross section at a prescribed position in a longitudinal direction of the medical device, a first area which is an area of a region surrounded by an outer circumference of the medical device, is equal to or smaller than a second area which is an area of a region surrounded by one common external tangent of the first tube and the second tube, and a contour line formed by outer circumferences of the first tube and the second tube.SELECTED DRAWING: Figure 7

Description

[Technical field]

[0001] The present invention relates to medical devices. [Background technology]

[0002] Since the procedure for opening a CTO is complicated, the procedure may be performed under the guidance of a sensor that obtains image information of biological tissues by ultrasound. In such a case, a catheter having two or more lumens is used, a sensor is inserted into one lumen, and a therapeutic device is inserted into the other lumen, and the procedure is performed while using both the sensor and the therapeutic device. In order to improve safety and operability, such catheters generally have a thin and flexible tip end and a thick and rigid base end. For example, Patent Documents 1 to 3 disclose devices that can be used in such procedures. Patent Document 4 discloses an aspiration catheter having a guidewire lumen and an aspiration lumen. Patent Document 5 discloses an irrigation catheter that realizes irrigation flow by using a multi-lumen irrigation tubing. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2018-033507 A [Patent Document 2] JP 2015-180275 A [Patent Document 3] JP 2013-34652 A [Patent Document 4] JP 2010-57831 A [Patent Document 5] JP 2016-5641 A Summary of the Invention [Problem to be solved by the invention]

[0004] Here, in the PCI procedure, in addition to the above-mentioned catheters, a guiding catheter may be used to guide multiple devices used in the procedure, such as a guidewire or a microcatheter, to the position of the CTO lesion. Hereinafter, the other devices inserted into the guiding catheter are also called "combined devices". Although the guiding catheter has a thick lumen capable of accommodating multiple devices, the lumen is limited in thickness due to the constraint of being inserted into a blood vessel. For this reason, it has been required for the medical device to be able to use as many combined devices as possible within the limited lumen of the guiding catheter. However, the devices described in Patent Documents 1 to 5 do not take this point into consideration at all.

[0005] These issues are not limited to PCI procedures such as CTO opening, but are common to all medical devices used in percutaneous procedures, and are also common to medical devices inserted into various organs in the human body, including the lymphatic system, biliary system, urinary system, respiratory system, digestive system, secretory glands, and reproductive organs, as well as the vascular system.

[0006] The present invention has been made to solve at least some of the above-mentioned problems, and aims to enable the use of many combination devices within the limited lumen of a guiding catheter in a medical device having two or more lumens. [Means for solving the problem]

[0007] The present invention has been made to solve at least part of the above-mentioned problems, and can be realized in the following forms.

[0008] (1) According to one embodiment of the present invention, there is provided a medical device comprising a first tube having a first lumen, a second tube having a second lumen, and a third tube having a third lumen, the outer circumferential surface of the first tube and the outer circumferential surface of the second tube being joined, and in a cross section of the medical device at a predetermined position in the longitudinal direction, a first area, which is an area of ​​a region surrounded by the outer periphery of the medical device, is equal to or smaller than a second area, which is an area of ​​a region surrounded by a common circumferential line of the first tube and the second tube and a contour line formed by the outer peripheries of the first tube and the second tube.

[0009] This configuration allows the cross-sectional area of ​​the medical device at a given position to be reduced, and therefore allows the use of many combined devices within the limited lumen of the guiding catheter in a medical device having two or more lumens.

[0010] (2) In the medical device of the above embodiment, a gap may be formed between the common circumscribing line and the outer periphery of the first and second tubes in the cross section. With this configuration, when the medical device is inserted into the guiding catheter, the combination device can be positioned in the gap.

[0011] (3) In the medical device of the above embodiment, the predetermined position is a first predetermined position, and in a cross section of the medical device at a second predetermined position in the longitudinal direction, where the third tube is present, a gap is formed between the common circumscribing line and the outer peripheries of the first and second tubes, and the gap may be an inner cavity of the medical device. According to this configuration, the gap formed between the common circumscribing line and the outer peripheries of the first and second tubes makes the medical device flexible even when the third tube is present.

[0012] (4) In the medical device of the above embodiment, when the common circumscribing line is a first common circumscribing line in the cross section, the first area may be equal to or smaller than a third area, which is an area of ​​a region surrounded by a second common circumscribing line between the first tube and the second tube, which is different from the first common circumscribing line, and a contour line formed by the outer circumferences of the first tube and the second tube. According to this configuration, the medical device can have a structure in which a constriction (recess) is provided on both sides of the adjacent portion between the first tube and the second tube in the cross section. As a result, according to this configuration, in a medical device having two or more lumens, it is possible to use even more combination devices within the limited lumen of the guiding catheter, and the limited width of the combination devices can be further expanded.

[0013] (5) In the medical device of the above aspect, the first lumen may be a lumen for a sensor that acquires image information. With this configuration, a procedure can be performed under the guidance of a sensor that acquires image information of biological tissue by ultrasound.

[0014] (6) In the medical device of the above aspect, the first tube, the second tube, and the third tube may be joined at their outer circumferential surfaces. With this configuration, the pushing force applied by the surgeon at hand can be more efficiently transmitted to the distal end side.

[0015] The present invention can be realized in various aspects, for example, in the form of a medical device, a catheter, and a manufacturing method thereof. [Brief description of the drawings]

[0016] [Figure 1] FIG. 1 is an explanatory diagram illustrating the configuration of a catheter as a medical device. [Diagram 2] FIG. 1 is an explanatory diagram illustrating the configuration of a catheter as a medical device. [Diagram 3] FIG. 2 is a cross-sectional view of the catheter. [Figure 4]FIG. 1 is a diagram illustrating a method of using a catheter. [Diagram 5] FIG. 1 is a diagram illustrating a method of using a catheter. [Figure 6] FIG. 13 is a diagram illustrating a common external tangent. [Figure 7] FIG. 4 is a diagram illustrating a first area and a second area. [Figure 8] FIG. 4 is a diagram illustrating a first area and a third area. [Figure 9] FIG. 13 is a diagram illustrating a state when a guiding catheter is inserted. [Figure 10] FIG. 4 is a cross-sectional view of a catheter according to a second embodiment. [Figure 11] FIG. 11 is a cross-sectional view of a catheter according to a third embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] First Embodiment 1 and 2 are explanatory diagrams illustrating the configuration of a medical device 1. The medical device 1 of this embodiment is a catheter used to treat a lesion in a biological lumen, such as a CTO occurring in a blood vessel. Hereinafter, the medical device 1 is also referred to as a "catheter 1." As shown in FIGS. 1 and 2, the catheter 1 includes a sensor tube 10, an OTW (Over The Wire) tube 20, an RX (Rapid Exchange) tube 30, a distal tip 40, a first marker 41, a second marker 42, a covering portion 50, a branch connector 60, a first reinforcing member 61 to a third reinforcing member 63, a cylindrical member 64, a connector 65, a connector 25, and a sensor 70.

[0018] In order to explain the configuration of the tube and the lumen inside the tube, the sensor 70 is omitted from the illustration in Fig. 1. In Fig. 2, the sensor 70 built into the sensor lumen 10L inside the sensor tube 10 is indicated by a dashed line and hatched with oblique lines.

[0019] For the sake of convenience, in Fig. 1 and Fig. 2, the relative ratio of the sizes of the components is different from the actual ratio. Also, some of the components are exaggerated. Also, in Fig. 1 and Fig. 2, mutually orthogonal XYZ axes are illustrated. The X axis corresponds to the longitudinal direction of the catheter 1, the Y axis corresponds to the height direction of the catheter 1, and the Z axis corresponds to the width direction of the catheter 1. The left side (-X axis direction) of Fig. 1 and Fig. 2 is called the "tip side" of the catheter 1 and each component, and the right side (+X axis direction) of Fig. 1 and Fig. 2 is called the "base end side" of the catheter 1 and each component. Also, of both ends in the longitudinal direction (X axis direction) of the catheter 1 and each component, one end located on the tip side is called the "tip" and the other end located on the base side is called the "base end". Also, the tip and its vicinity are called the "tip portion", and the base end and its vicinity are called the "base end portion". The tip side is inserted into the living body, and the base side is operated by an operator such as a doctor. These points also apply to Figures 3 and onwards.

[0020] FIG. 3 is a cross-sectional view of the catheter 1. FIG. 3(A) shows a cross-section of the catheter 1 taken along line AA in FIG. 1. FIG. 3(B) shows a cross-section of the catheter 1 taken along line BB in FIG. 1. FIG. 3(C) shows a cross-section of the catheter 1 taken along line CC in FIG. 1. FIG. 3(D) shows a cross-section of the catheter 1 taken along line DD in FIG. 1. FIG. 3(E) shows a cross-section of the catheter 1 taken along line EE in FIG. 1. FIG. 3(F) shows a cross-section of the catheter 1 taken along line FF in FIG. The configuration of the catheter 1 will be explained below with reference to FIGS. 1 to 3.

[0021] The sensor tube 10 is a cylindrical member (tubular body) having a long outer shape. The sensor tube 10 extends linearly along the longitudinal direction (X-axis direction) of the catheter 1 in parallel with the OTW tube 20 and the RX tube 30. A sensor lumen 10L (broken line) for accommodating the sensor 70 is formed inside the sensor tube 10. The sensor lumen 10L is a lumen for the sensor 70.

[0022] The tip of the sensor tube 10 is located at the same position as or slightly closer to the base end than the tip of the RX tube 30 in the longitudinal direction of the catheter 1. A tip opening 101 is formed at the tip of the sensor tube 10, which communicates the tip of the sensor lumen 10L with the outside. The tip opening 101 is a fluid outlet for making the inside of the sensor lumen 10L wet. The base end of the sensor tube 10 is located closer to the base end than the base end of the OTW lumen 20L and the base end of the RX tube 30 in the longitudinal direction of the catheter 1. A first reinforcing member 61, a branch connector 60, a cylindrical member 64, and a connector 65 are attached to the base end side of the sensor tube 10 from the tip side toward the base end side. Details will be described later. A fluid supply unit 66 is attached to the connector 65, and a base end opening 102 is formed at the fluid supply unit 66, which communicates the base end of the sensor lumen 10L with the outside. The proximal opening 102 is a fluid supply port to the sensor lumen 10L.

[0023] As shown in Fig. 1, the sensor tube 10 has a distal tube 11 disposed on the distal side, and a proximal tube 12 disposed on the proximal side of the distal tube 11. The distal tube 11 and the proximal tube 12 are both cylindrical members (tubular bodies) having an elongated outer shape. The distal tube 11 and the proximal tube 12 are connected at any point in the longitudinal direction where the covering portion 50 is provided. That is, the distal tube 11 and the proximal tube 12 each constitute a part of the sensor lumen 10L.

[0024] The OTW tube 20 is a cylindrical member (tubular body) having a long outer shape. The OTW tube 20 extends linearly along the longitudinal direction of the catheter 1 in parallel with the sensor tube 10 and the RX tube 30 on the distal side of the branch connector 60. An OTW lumen 20L (broken line) for accommodating a treatment device (e.g., a plasma guidewire or a penetration guidewire) is formed inside the OTW tube 20. The OTW lumen 20L is a so-called over-the-wire (OTW) type lumen that does not have a base end opening in a portion that is placed in a biological lumen when the catheter 1 is used.

[0025] The tip of the OTW tube 20 is located on the proximal side of the tip of the sensor tube 10 and the tip of the RX tube 30 in the longitudinal direction of the catheter 1. A tip opening 201 that communicates the tip of the OTW lumen 20L with the outside is formed at the tip of the OTW tube 20. The tip opening 201 is a device projection port for projecting a therapeutic device toward biological tissue. The tip of the OTW tube 20 is cut obliquely, so that the tip opening 201 faces a direction intersecting the longitudinal direction of the catheter 1. This makes it easier for the therapeutic device to reach the biological tissue present around the catheter 1 when the catheter 1 is used. The base end of the OTW tube 20 is located on the distal side of the base end of the sensor tube 10 and on the proximal side of the base end of the RX tube 30 in the longitudinal direction of the catheter 1. A first reinforcing member 61, a branch connector 60, a second reinforcing member 62, a third reinforcing member 63, and a connector 25 are attached to the base end of the OTW tube 20 from the tip side toward the base end. Details will be described later. The connector 25 is formed with a base end opening 202 that communicates the base end of the OTW lumen 20L with the outside. The base end opening 202 is a device insertion port for inserting a treatment device into the OTW lumen 20L.

[0026] 1, the OTW tube 20 has a distal tube 21 disposed on the distal side and a proximal tube 22 disposed on the proximal side of the distal tube 21. The distal tube 21 and the proximal tube 22 are both cylindrical members (tubular bodies) having an elongated outer shape. The distal tube 21 and the proximal tube 22 are connected at any point in the longitudinal direction where the covering portion 50 is provided. That is, the distal tube 21 and the proximal tube 22 each constitute a part of the OTW lumen 20L.

[0027] The RX tube 30 is a cylindrical member (tubular body) having a long outer shape. The RX tube 30 extends linearly along the longitudinal direction of the catheter 1 in parallel with the sensor tube 10 and the OTW tube 20. An RX lumen 30L (broken line) for accommodating a work hose wire is formed inside the RX tube 30.

[0028] The tip of the RX tube 30 is located at the same position as or slightly closer to the tip of the sensor tube 10 in the longitudinal direction of the catheter 1. A hollow tip tip 40 is joined to the tip of the RX tube 30. A tip opening 301 is formed at the tip of the tip tip 40, which communicates the tip of the RX lumen 30L with the outside. The tip opening 301 is a wire insertion port for inserting the work hose wire into the RX lumen 30L. The base end of the RX tube 30 is located on the tip side of the base end of the sensor tube 10 and the base end of the OTW tube 20 in the longitudinal direction of the catheter 1. A base end opening 302 is formed at the base end of the RX tube 30, which communicates the base end of the RX lumen 30L with the outside. The base end opening 302 is a wire withdrawal port for withdrawing the work hose wire to the outside. By cutting the base end of the RX tube 30 obliquely, the base end opening 302 faces a direction intersecting the longitudinal direction of the catheter 1. This makes it easier to pull out the work hose wire from the base end opening 302 when the catheter 1 is in use.

[0029] The distal tip 40 is a cylindrical member having radiopaque properties and an outer diameter expanding from the distal end side to the proximal end side. The distal tip 40 is positioned at the distal end of the catheter 1 by being joined to the distal end of the RX tube 30, and advances through the body lumen ahead of other members. The lumen of the distal tip 40 communicates with the RX lumen 30L of the RX tube 30, and at the distal end of the distal tip 40, as described above, a distal opening 301 is formed that communicates the distal end of the RX lumen 30L with the outside.

[0030] The first marker 41 and the second marker 42 are annular members having radiopaque properties. The first marker 41 is disposed on the outer peripheral surface of the RX tube 30 at a position adjacent to the base end of the distal tip 40, and is bonded to the outer peripheral surface of the RX tube 30. The second marker 42 is disposed on the outer peripheral surface of the RX tube 30 at a position adjacent to the distal end of the distal opening 201 of the OTW tube 20, and is bonded to the outer peripheral surface of the RX tube 30. For example, bonding between resins by thermal melting or bonding with an adhesive such as an epoxy adhesive can be used to bond the first marker 41 and the second marker 42. The first marker 41 and the second marker 42 may be colored so that the surgeon can directly see them. In this way, by disposing the first marker 41 and the second marker 42 on the RX tube 30, it is possible to suppress the first marker 41 and the second marker 42 from interfering with sensing (acquisition of image information) by the sensor 70.

[0031] As shown in FIG. 3(A), in the cross section taken along line AA, only the distal tip 40 exists. As shown in FIG. 3(B), in the cross section taken along line BB, the outer circumferential surfaces of the sensor tube 10 (specifically, the distal tube 11) and the RX tube 30 are joined together. As shown in FIG. 3(C), in the cross section taken along line CC, the outer circumferential surfaces of the sensor tube 10 (specifically, the distal tube 11), the OTW tube 20 (specifically, the distal tube 21), and the RX tube 30 are joined together. As shown in FIG. 3(D), in the cross section taken along line DD, the outer circumferential surfaces of the sensor tube 10 (specifically, the distal tube 11), the OTW tube 20 (specifically, the distal tube 21), and the RX tube 30 are joined together. In addition, in the DD cross section, the covering portion 50 covers the outer portions of the three tubes 10, 20, 30 along the outer peripheries of the three tubes 10, 20, 30, thereby fixing the three tubes 10, 20, 30. As shown in Fig. 3(E) in the cross section along the EE line, the outer peripheries of the sensor tube 10 (specifically, the distal tube 11), the OTW tube 20 (specifically, the proximal tube 22), and the RX tube 30 are joined together. In the EE cross section as well, the covering portion 50 covers the outer portions of the three tubes 10, 20, 30 along the outer peripheries of the three tubes 10, 20, 30, thereby fixing the three tubes 10, 20, 30. As shown in FIG. 3(F), in the cross section taken along line FF, the outer circumferential surfaces of the sensor tube 10 (specifically, the base end tube 12) and the OTW tube 20 (specifically, the base end tube 22) are joined together.

[0032] The sensor tube 10, the OTW tube 20, and the RX tube 30 may be joined using any bonding agent such as an epoxy adhesive, or may be welded by heat. In the BB, CC, DD, and EE cross sections, the height LY of the catheter 1 is greater than the width LZ of the catheter 1. On the other hand, in the FF cross section, the height LY of the catheter 1 is smaller than the width LZ of the catheter 1. As shown in Figs. 3(A) to (F), the relationship of the outer diameters of the three tubes 10, 20, and 30 is the outer diameter of the sensor tube 10>the outer diameter of the OTW tube 20>the outer diameter of the RX tube 30. In addition, the relationship of the inner diameters (lumens) of the three tubes 10, 20, and 30 is the inner diameter of the sensor lumen 10L>the inner diameter of the OTW lumen 20L>the inner diameter of the RX lumen 30L. However, these relationships of the outer diameters and inner diameters are merely examples, and may be changed arbitrarily.

[0033] Returning to FIG. 1, the explanation will be continued. The covering portion 50 is a resin layer for fixing the three tubes 10, 20, 30 (specifically, the sensor tube 10, the OTW tube 20, and the RX tube 30). The covering portion 50 is provided in a section in which the three tubes 10, 20, 30 extend side by side, in other words, in a section on the proximal side of the distal end opening 201 and on the distal side of the proximal end opening 302. As shown in FIG. 1, the covering portion 50 is preferably provided on the proximal side of the distal end opening 201, in other words, at a position away from the distal end opening 201 on the proximal side. In this way, it is possible to suppress the covering portion 50 from interfering with sensing (acquisition of image information) by the sensor 70 inserted into the sensor lumen 10L. As shown in FIG. 3(D) and FIG. 3(E), the covering portion 50 thinly covers the outer facing portions of the three tubes 10, 20, 30 along the outer periphery of the three tubes 10, 20, 30. This allows the covering portion 50 to fix the three tubes 10, 20, 30 while maintaining the constrictions (concave portions) formed in the adjacent portions of the tubes 10, 20, 30 in the cross section of the catheter 1.

[0034] The branch connector 60 is a member having a bifurcated lumen, and is disposed on the base end side of the catheter 1. The OTW tube 20 is inserted into one lumen of the branch connector 60. The sensor tube 10 is inserted into the other lumen of the branch connector 60. The first reinforcing member 61 is a cylindrical member disposed on the distal end side of the branch connector 60. The first reinforcing member 61 reinforces the distal end side of the branch connector 60 by covering the outer peripheries of the sensor tube 10 and the OTW tube 20 inserted into the branch connector 60.

[0035] The second reinforcing member 62 is a cylindrical member disposed on the base end side of one branch of the branch connector 60. The second reinforcing member 62 reinforces the base end side of the branch connector 60 by covering the outer periphery of the OTW tube 20 inserted into the branch connector 60. The third reinforcing member 63 is a cylindrical member disposed on the distal end side of the connector 25. The third reinforcing member 63 reinforces the distal end side of the connector 25 by covering the outer periphery of the OTW tube 20 inserted into the connector 25. The connector 25 is a member joined to the base end of the OTW tube 20. The connector 25 has a pair of wing portions for the surgeon to grasp. At the base end of the connector 25, a base end opening 202 (device insertion port) is formed that communicates between the base end of the OTW lumen 20L and the outside.

[0036] The tubular member 64 is a cylindrical member disposed on the base end side of the other branch of the branch connector 60. The tubular member 64 reinforces the base end side of the branch connector 60 by covering the outer periphery of the sensor tube 10 inserted into the branch connector 60. The connector 65 is a member joined to the base end of the sensor tube 10. A housing for accommodating the connection terminal 75 of the sensor 70 is provided on the base end side of the connector 65. A fluid supply section 66 is provided on the outer periphery of the connector 65, in which a base end opening 102 is formed to communicate between the base end of the sensor lumen 10L and the outside.

[0037] The sensor 70 (FIG. 2) is an imaging sensor for acquiring image information. As shown in FIG. 2, the sensor 70 includes a main body 71, a probe 72, and a connection terminal 75. The main body 71 is an elongated member extending along the longitudinal direction of the catheter 1. A driving cable (coaxial line) that electrically connects the probe 72 and the connection terminal 75 is built into the inside of the main body 71. The probe 72 includes an ultrasonic probe (also called an ultrasonic vibrator, a piezoelectric body, an ultrasonic transmission / reception element, or an ultrasonic element) that transmits ultrasonic waves toward biological tissue and receives ultrasonic waves reflected by the biological tissue. The probe 72 is also called an imaging core or a transducer. The connection terminal 75 is a terminal that electrically connects the sensor 70 to an external console terminal. The connection terminal 75 is provided at the base end of the main body 71 and is housed in the housing of the connector 65.

[0038] 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 FIG. 2, the sensor 70 is fixed to a connector 65. As shown by the white arrow in FIG. 2, the operator grasps the connector 65 and slides it in the forward and backward directions (the direction of the white arrow), thereby moving 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 covering portion 50, in other words, within a predetermined range MR including the tip opening 201.

[0039] The distal tube 11 of the sensor tube 10, the distal tube 21 of the OTW tube 20, the RX tube 30, and the covering portion 50 can be made of flexible materials such as thermoplastic resins such as polyethylene resin, polypropylene resin, and polyurethane, polyvinyl chloride, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer, polyamide elastomer, polyolefin elastomer, polyurethane elastomer, silicone rubber, latex rubber, etc. The distal tube 11 of the sensor tube 10, the distal tube 21 of the OTW tube 20, the RX tube 30, and the covering portion 50 may be made of the same material or different materials.

[0040] The distal tube 21 of the sensor tube 10 and the proximal tube 22 of the OTW tube 20 can be made of a resin having high rigidity, such as nylon resin, polyester resin, PEEK resin, etc. The distal tube 21 of the sensor tube 10 and the proximal tube 22 of the OTW tube 20 may be made of the same material or different materials. Any one or more of the distal tube 11 and proximal tube 12 of the sensor tube 10, the distal tube 21 and proximal tube 22 of the OTW tube 20, and the RX tube 30 may have a multi-layer structure in which tubes made of different materials are stacked on top of each other.

[0041] The tip 40, the first marker 41, and the second marker 42 can be made of a resin material or a metal material having radiopacity. For example, when a radiopaque resin material is used, it can be formed by mixing a radiopaque material such as bismuth trioxide, tungsten, barium sulfate, etc. with polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, fluororesin, etc. For example, when a radiopaque metal material is used, it can be formed of gold, platinum, tungsten, or an alloy containing these elements (for example, platinum-nickel alloy). The tip 40, the first marker 41, and the second marker 42 may be formed of the same material or different materials.

[0042] The branch connector 60, the first reinforcing member 61 to the third reinforcing member 63, the tubular member 64, the connector 65, and the connector 25 can be made of a known resin material. The branch connector 60, the first reinforcing member 61 to the third reinforcing member 63, the tubular member 64, the connector 65, and the connector 25 may be made of the same material or different materials.

[0043] 4 and 5 are diagrams for explaining a method of using the catheter 1. Steps a1 to a6 described below illustrate a case in which a CTO (lesion) occurring in a blood vessel is recanalized using an antegrade approach. However, the catheter 1 may also be used in a retrograde approach, or for a procedure other than CTO recanalization.

[0044] (a1) The surgeon inserts the work horse wire 200 into a blood vessel, and delivers the tip of the work horse wire 200 to the vicinity of the CTO. (a2) The surgeon inserts the base end of the work horse wire 200 from the tip opening 301 of the catheter 1, passes it through the RX lumen 30L, and pulls it out from the base end opening 302 of the catheter 1 (FIG. 4). (a3) ​​The surgeon pushes the catheter 1 along the work horse wire 200 into the blood vessel, and delivers the tip of the catheter 1 to the vicinity of the CTO. Note that in step a3, the catheter 1 may be delivered to the vicinity of the CTO by passing it through a guiding catheter that has been inserted into the blood vessel in advance along the work horse wire 200. (a4) The operator grasps the connector 65 and slides it in the front-rear direction (FIG. 5: the direction of the white arrow) to adjust the position of the probe 72 of the sensor 70 within the range MR, while checking the image displayed on the console terminal to align the position and orientation of the CTO and the distal end opening 201. The position means the position in the extension direction of the blood vessel, and the orientation means the orientation in the circumferential direction of the inner wall of the blood vessel. (a5) The operator inserts the distal end of the treatment device 300 from the base end opening 202 of the catheter 1, passes through the OTW lumen 20L, and protrudes from the distal end opening 201 of the catheter 1 (FIG. 5). (a6) The operator treats the CTO using the treatment device 300 while adjusting the position of the probe 72 of the sensor 70 within the range MR as necessary and checking the image displayed on the console terminal. As described above, any device such as a plasma guidewire or a penetration guidewire can be used as the treatment device 300.

[0045] The sensor tube 10, the OTW tube 20, and the RX tube 30 are collectively referred to as the "shaft." The sensor lumen 10L corresponds to the "first lumen," and the sensor tube 10 corresponds to the "first tube." The OTW lumen 20L corresponds to the "second lumen," and the OTW tube 20 corresponds to the "second tube." The RX lumen 30L corresponds to the "third lumen," and the RX tube 30 corresponds to the "third tube." In this embodiment, "same" and "equal" do not mean strictly the same, but mean that differences due to manufacturing errors and the like are allowed. Furthermore, "constant" is synonymous with "approximately constant," and means that the values ​​are approximately constant while allowing for deviations due to manufacturing errors and the like.

[0046] Fig. 6 is a diagram explaining the common circumstantial line. Fig. 6(A) shows a cross section of the catheter 1 taken along line DD in Fig. 1. Fig. 6(B) shows a cross section of the catheter 1 taken along line FF in Fig. 1. Figs. 6(A) and (B) show the common circumstantial lines EC1 and EC2 of the sensor tube 10 (first tube) and the OTW tube 20 (second tube) by dashed lines, respectively. The common circumstantial line EC1 is also referred to as the "first common circumstantial line EC1," and the common circumstantial line EC2 is also referred to as the "second common circumstantial line EC2."

[0047] As shown in Fig. 6(A), in the cross section of the catheter 1 taken along the DD line, a gap SP is formed between the first common circumscribing line EC1 and the outer periphery of the sensor tube 10 and the OTW tube 20. As shown in Fig. 6(A), in the cross section of the catheter 1 taken along the DD line, a gap SP is formed between the second common circumscribing line EC2 and the outer periphery of the catheter 1 (specifically, the outer periphery of the covering portion 50). In the cross section of the catheter 1 taken along the DD line, the first common circumscribing line EC1 intersects with the RX tube 30. The gap SP formed between the first common circumscribing line EC1 and the outer periphery of the sensor tube 10 and the OTW tube 20 is a lumen formed inside the catheter 1.

[0048] As shown in Fig. 6(B), in the cross section of the catheter 1 taken along the line FF, a gap SP is formed between the first common circumscribing line EC1 and the outer periphery of the catheter 1. As shown in Fig. 6(B), in the cross section of the catheter 1 taken along the line FF, a gap SP is formed between the first common circumscribing line EC1 and the outer periphery of the sensor tube 10 and the OTW tube 20. In addition, a gap SP is formed between the second common circumscribing line EC2 and the outer periphery of the catheter 1. A gap SP is formed between the second common circumscribing line EC2 and the outer periphery of the sensor tube 10 and the OTW tube 20. These gaps SP correspond to the above-mentioned "constrictions (recesses) formed in the adjacent portions of the tubes 10, 20."

[0049] 6(B), in the cross section of the catheter 1 at the line FF, the outer diameter Lmax (maximum outer diameter) in the long axis direction of the catheter 1 is the outer diameter of the sensor tube 10 and the OTW tube 20, in other words, the outer diameter of two tubes. Meanwhile, the outer diameter Lmin (minimum outer diameter) in the short axis direction of the catheter 1 can be the outer diameter of the sensor tube 10, in other words, the outer diameter of one tube. Here, the outer diameter Lmin (minimum outer diameter) is equal to the outer diameter of the one of the sensor tube 10 and the OTW tube 20, which has the larger outer diameter.

[0050] In addition, in the longitudinal direction of the catheter 1, any position in the portion where the RX tube 30 exists (in other words, the portion where the three tubes 10, 20, 30 are arranged side by side) is also called the "second predetermined position." Also, any position on the proximal side of the second predetermined position (in other words, the portion where the two tubes 10, 20 are arranged side by side) is also called the "first predetermined position" or simply the "predetermined position."

[0051] FIG. 7 is a diagram for explaining the first area S1 and the second area S2. FIG. 7 shows a cross section of the catheter 1 at the line FF in FIG. 1. Here, the area of ​​the region surrounded by the outer periphery of the catheter 1 is called the "first area S1." In FIG. 7, the first area S1 is shown surrounded by a thick frame and dot-hatched. As shown in FIG. 7, the first area S1 in the cross section of the catheter 1 at the line FF is the area of ​​the region surrounded by the outer periphery of the sensor tube 10 and the OTW tube 20.

[0052] Moreover, the area of ​​the region surrounded by the first common circumscribing line EC1 and the contour line formed by the outer peripheries of the sensor tube 10 and the OTW tube 20 is referred to as the "second area S2." In Fig. 7, the second area S2 is shown surrounded by a dashed frame and hatched with diagonal lines. As shown in Fig. 7, the second area S2 in the cross section of the catheter 1 at line FF is the area of ​​the region surrounded by the first common circumscribing line EC1 and the contour line (shown by a hollow dashed line) formed by the outer peripheries of the sensor tube 10 and the OTW tube 20 and extending outward from the first common circumscribing line EC1.

[0053] 7, the first area S1 (bold frame, dot hatching) is equal to or smaller than the second area S2 (dashed frame, diagonal hatching). The first area S1 is smaller than the second area S2.

[0054] Fig. 8 is a diagram for explaining the first area S1 and the third area S3. Fig. 8 shows a cross section of the catheter 1 taken along line FF in Fig. 1. Here, in Fig. 8, as in Fig. 7, the area of ​​the region surrounded by the outer periphery of the catheter 1 (first area S1) is shown surrounded by a thick frame and hatched with dots.

[0055] Moreover, the area of ​​the region surrounded by the second common circumscribing line EC2 and the contour line formed by the outer peripheries of the sensor tube 10 and the OTW tube 20 is referred to as the "third area S3." In Fig. 8, the third area S3 is shown surrounded by a dashed frame and hatched with diagonal lines. As shown in Fig. 8, the third area S3 in the cross section of the catheter 1 at line FF is the area of ​​the region surrounded by the second common circumscribing line EC2 and the contour line formed by the outer peripheries of the sensor tube 10 and the OTW tube 20 and extending outward from the second common circumscribing line EC2 (shown by an outline dashed line).

[0056] 8, the first area S1 (bold frame, dot hatching) is equal to or smaller than the third area S3 (dashed frame, diagonal hatching). The first area S1 is smaller than the third area S3.

[0057] Fig. 9 is a diagram for explaining the state when a guiding catheter is inserted. Fig. 9(A) shows the state when the catheter 1 of this embodiment is inserted into the guiding catheter 501. Fig. 9(B) shows the state when the catheter 1x of the comparative example is inserted into the guiding catheter 501. Fig. 9 shows a cross section of a portion (line FF) where only the sensor tube 10 and the OTW tube 20 run side by side, which is the longest portion of the total length of the catheter 1 and the catheter 1x.

[0058] As shown in FIG. 9(A), when the catheter 1 of this embodiment is inserted into the guiding catheter 501, a space for inserting a combined device (in the illustrated example, a microcatheter 502 and guidewires 503 and 504) can be secured in the lumen of the guiding catheter 501. In other words, the catheter 1 of this embodiment does not hinder the insertion of the combined device into the lumen of the guiding catheter 501. This is because the catheter 1 satisfies the relationship of the first area S1≦the second area S2. In other words, the catheter 1 of this embodiment has a space SP (constriction, recess) between the first common circumscribing line EC1 and the outer periphery of the catheter 1 and a space SP (constriction, recess) between the second common circumscribing line EC2 and the outer periphery of the catheter 1, so that the combined device (particularly a large-diameter device such as the microcatheter 502) can be positioned in the space SP of the catheter 1 as illustrated, and the space in the lumen of the guiding catheter 501 can be effectively utilized.

[0059] 9(B), when the catheter 1x of the comparative example is inserted into the guiding catheter 501, the covering portion 50x becomes an obstacle and the microcatheter 502 cannot be inserted into the lumen of the guiding catheter 501. That is, with the catheter 1x of the comparative example, there are significant restrictions on the size and number of combined devices that can be inserted into the lumen of the guiding catheter 501, and the space in the lumen of the guiding catheter 501 cannot be effectively utilized.

[0060] As described above, the catheter 1 (medical device) of the first embodiment includes the sensor tube 10 (first tube) constituting the sensor lumen 10L (first lumen) and the OTW tube 20 (second tube) constituting the OTW lumen 20L (second lumen), and since the outer circumferential surface of the sensor tube 10 and the outer circumferential surface of the OTW tube 20 are joined, the pushing force applied by the surgeon at hand can be efficiently transmitted to the tip side. Also, in a cross section at a predetermined position in the longitudinal direction of the catheter 1, a first area S1, which is the area of ​​the region surrounded by the outer periphery of the catheter 1, is equal to or smaller than a second area S2, which is the area of ​​the region surrounded by a common circumferential line EC1 of the sensor tube 10 and the OTW tube 20 and a contour line formed by the outer peripheries of the sensor tube 10 and the OTW tube 20. Therefore, in the cross section of the catheter 1, the outer diameter Lmax (maximum outer diameter) in the long axis direction is the outer diameter of two tubes, while the outer diameter Lmin (minimum outer diameter) in the short axis direction is the outer diameter of one tube. In addition, the catheter 1 can have a structure in which a constriction (concave) is provided in the portion adjacent to the sensor tube 10 and the OTW tube 20 in the cross section. As a result, according to the catheter 1 of the first embodiment, as described in FIG. 9(A), the insertion of the combination devices 502, 503, and 504 in the lumen of the guiding catheter 501 is less likely to be hindered, as compared with the conventional configuration (for example, the configuration of FIG. 9) in which the cross section of the catheter 1 is a circle or ellipse that includes the sensor tube 10 and the OTW tube 20. Therefore, according to the catheter 1 of the first embodiment, in a medical device having two or more lumens, many combination devices 502, 503, and 504 can be used in the limited lumen of the guiding catheter 501, and the limited width of the combination devices can be expanded.

[0061] Moreover, according to the catheter 1 (medical device) of the first embodiment, in the cross section of the catheter 1, a gap SP is formed between the common circumscribing lines EC1, EC2 and the outer periphery of the catheter 1, so that when the catheter 1 is inserted into the guiding catheter 501, the combination devices 502, 503, 504 can be positioned in the gap SP portion. Furthermore, according to the catheter 1 (medical device) of the first embodiment, as shown in Fig. 6(A), the gap SP formed between one common circumscribing line EC1 and the outer periphery of the sensor tube 10 and the OTW tube 20 (first and second tubes) makes the catheter 1 flexible even when the RX tube 30 (third tube) is present.

[0062] Furthermore, in the cross section of the catheter 1 (medical device) of the first embodiment at a predetermined position in the longitudinal direction, the first area S1 is equal to or smaller than the third area S3, which is the area of ​​a region surrounded by a second common circumscribing line EC2 between the sensor tube 10 and the OTW tube 20, which is different from the first common circumscribing line EC1, and a contour line formed by the outer circumferences of the sensor tube 10 and the OTW tube 20. Therefore, the catheter 1 can be structured such that, in the cross section, there are constrictions (recesses) on both sides of the adjacent portion between the sensor tube 10 and the OTW tube 20. As a result, according to the catheter 1 of the first embodiment, in a medical device having two or more lumens, it is possible to use even more combination devices 502, 503, 504 within the limited lumen of the guiding catheter 501, and the limited width of the combination devices can be further expanded.

[0063] Furthermore, according to the catheter 1 (medical device) of the first embodiment, the sensor lumen 10L is a sensor lumen 10L that acquires image information, and therefore the catheter 1 can be used to perform procedures under the guidance of a sensor 70 that acquires image information of biological tissue by ultrasound.

[0064] Furthermore, the catheter 1 (medical device) of the first embodiment further includes an RX tube 30 (third tube) that constitutes an RX lumen 30L (third lumen), so that the pushing force applied by the surgeon at hand can be transmitted to the tip side more efficiently. In addition, the RX lumen 30L can be used in combination with a device such as a work hose wire 200.

[0065] <Second embodiment> Fig. 10 is a cross-sectional view of a catheter 1A of a second embodiment. Fig. 10 shows a cross-section of the catheter 1A taken along line FF in Fig. 1. The catheter 1A of the second embodiment has a covering portion 50A instead of the covering portion 50 in the configuration described in the first embodiment.

[0066] The covering portion 50A is provided not only in the section described in the first embodiment (the section where the three tubes 10, 20, 30 extend side by side), but also in the section where only the sensor tube 10 and the OTW tube 20 run side by side. In other words, the covering portion 50A is also provided in the section between the base end opening 302 of the catheter 1 and the first reinforcing member 61. In the catheter 1A of the second embodiment, as in the first embodiment, the relationship of the first area S1≦the second area S2 and the relationship of the first area S1≦the third area S3 are established. In the catheter 1A of the second embodiment, as in the first embodiment, a gap SP is formed between the first common circumscribing line EC1 and the outer periphery of the catheter 1A, and a gap SP is formed between the second common circumscribing line EC2 and the outer periphery of the catheter 1A.

[0067] In this way, the configuration of the catheter 1A can be modified in various ways, and the covering portion 50A may be provided in any section of the catheter 1A. The catheter 1A of the second embodiment as described above can also achieve the same effects as the first embodiment described above.

[0068] <Third embodiment> Fig. 11 is a cross-sectional view of a catheter 1B of a third embodiment. Fig. 11(A) shows a cross-section of the catheter 1B taken along line DD in Fig. 1. Fig. 11(B) shows a cross-section of the catheter 1B taken along line FF in Fig. 1. The catheter 1B of the third embodiment has a bonding agent 51 instead of the covering portion 50 in the configuration described in the first embodiment.

[0069] The bonding agent 51 is disposed in adjacent portions of the sensor tube 10, the OTW tube 20, and the RX tube 30 to bond the three tubes 10, 20, and 30 to each other. As the bonding agent 51, any bonding agent such as an epoxy adhesive can be used. In the catheter 1B of the third embodiment, as in the first embodiment, the relationship of the first area S1≦the second area S2 and the relationship of the first area S1≦the third area S3 are established. In the catheter 1B of the third embodiment, as in the first embodiment, a gap SP is formed between the first common circumscribing line EC1 and the outer periphery of the catheter 1B, and a gap SP is formed between the second common circumscribing line EC2 and the outer periphery of the catheter 1B.

[0070] In this way, the configuration of the catheter 1B can be modified in various ways, and the sensor tube 10, the OTW tube 20, and the RX tube 30 may be fixed by a bonding agent 51 instead of the covering portion 50. The catheter 1B of the third embodiment as described above can also achieve the same effects as the first embodiment described above.

[0071] <Modifications of this embodiment> The present invention is not limited to the above-described embodiment, and can be embodied in various forms without departing from the spirit and scope of the invention. For example, the following modifications are also possible.

[0072] [Variation 1] In the above first to third embodiments, one example of the configuration of the catheters 1, 1A to 1B has been shown. However, the configuration of the catheters 1, 1A to 1B can be modified in various ways.

[0073] For example, the outer peripheral surface of the covering portion 50, or the outer peripheral surface of the catheter 1 including the covering portion 50, may be coated with a hydrophilic resin or a hydrophobic resin. For example, the sensor 70 is built into the sensor lumen 10L of the sensor tube 10 and is configured so as not to be removable from the catheter 1. However, the sensor 70 may be configured so as to be removable from the catheter 1. In other words, the catheter 1 does not have to include the sensor 70 as a component.

[0074] For example, at least one of the distal tip 40, the first marker 41, and the second marker 42 may be omitted. For example, the shapes of the distal tip 40, the first marker 41, and the second marker 42 can be changed arbitrarily. The distal tip 40 may have a constant outer diameter from the distal end to the proximal end, and the cross-sectional shape may be asymmetric. The first marker 41 and the second marker 42 may have a shape other than a circular ring (for example, a shape obtained by cutting a circular ring at an arbitrary angle, a linear shape, or a coil shape obtained by winding a wire in a spiral shape).

[0075] For example, the arrangement of the distal tip 40, the first marker 41, and the second marker 42 can be changed arbitrarily. The first marker 41 may be arranged at a position different from the position adjacent to the base end of the distal tip 40 (for example, at a position distant from the distal tip 40). The second marker 42 may be arranged at a position different from the position adjacent to the distal end of the distal opening 201 of the OTW tube 20 (for example, at a position distant from the distal opening 201). The first marker 41 and the second marker 42 may be arranged on a tube (the sensor tube 10 or the OTW tube 20) different from the RX tube 30. The first marker 41 and the second marker 42 may be arranged on the same tube as described above, or may be arranged on different tubes.

[0076] For example, the sensor tube 10 may be composed of one tube or may be composed of three or more tubes. Similarly, the OTW tube 20 may be composed of one tube or may be composed of three or more tubes. Similarly, the RX tube 30 may be composed of two or more tubes.

[0077] For example, the shapes of the branch connector 60, the first reinforcing member 61 to the third reinforcing member 63, the cylindrical member 64, the connector 65, and the connector 25 described above are merely examples and may be changed as desired. For example, at least a part of the branch connector 60, the first reinforcing member 61, the second reinforcing member 62, and the cylindrical member 64 may be configured as one member or may be omitted. For example, the third reinforcing member 63 and the connector 25 may be configured as one member. For example, the cylindrical member 64 may be provided with a mechanism (for example, a scale or stopper provided at a predetermined length in the longitudinal direction, or a scale or stopper provided at a predetermined angle in the circumferential direction) that assists in adjusting at least one of the front-rear position of the sensor 70 and the orientation of the sensor 70 in the circumferential direction.

[0078] [Variation 2] The configurations of the catheters 1, 1A to 1B of the first to third embodiments and the configuration of the catheters 1, 1A to 1B of the first modification may be combined as appropriate.

[0079] Although the present aspect has been described above based on the embodiment and modified examples, the above-mentioned embodiment of the aspect is intended to facilitate understanding of the present aspect and does not limit the present aspect. The present aspect may be modified or improved without departing from the spirit and scope of the claims, and equivalents are included in the present aspect. Furthermore, if a technical feature is not described as essential in this specification, it may be deleted as appropriate.

Claims

1. A medical device comprising: a first tube having a first lumen; a second tube having a second lumen; a third tube having a third lumen; Equipped with an outer circumferential surface of the first tube and an outer circumferential surface of the second tube are joined together; A medical device, wherein in a cross section of the medical device at a predetermined position in the longitudinal direction, a first area, which is the area of ​​the region surrounded by the outer periphery of the medical device, is less than or equal to a second area, which is the area of ​​the region surrounded by a common circumferential line of the first tube and the second tube and a contour line formed by the outer peripheries of the first tube and the second tube.

2. 10. The medical device of claim 1, A medical device, wherein in the cross section, a gap is formed between the common circumtangent and the outer circumferences of the first and second tubes.

3. 3. The medical device of claim 1 or claim 2, the predetermined position is a first predetermined position, A medical device, wherein in a cross section at a second predetermined position in the longitudinal direction of the medical device, where the third tube is present, a gap is formed between the single common circumferential tangent and the outer periphery of the first and second tubes, and the gap is an inner cavity of the medical device.

4. 3. The medical device of claim 1 or claim 2, A medical device in which, in the cross section, when the common circumferential tangent is a first common circumferential tangent, the first area is less than or equal to a third area, which is the area of ​​the region surrounded by a second common circumferential tangent between the first tube and the second tube, which is different from the first common circumferential tangent, and a contour line formed by the outer circumferences of the first tube and the second tube.

5. 3. The medical device of claim 1 or claim 2, A medical device, wherein the first lumen is a lumen for a sensor that acquires image information.

6. 3. The medical device of claim 1 or claim 2, A medical device, wherein the first tube, the second tube, and the third tube are joined at their outer circumferential surfaces.

Images