JP2023137533A - Catheter and manufacturing method of tubular shaft - Google Patents

Abstract

To provide a catheter capable of shortening a manufacturing time and reducing costs, and to provide a manufacturing method of a tubular shaft.SOLUTION: A catheter 1 including a tubular shaft 2 having a lumen 5 penetrating from a tip to a base end is such that: the tubular shaft 2 includes a tubular body 100 having an inner layer 10 for forming the lumen 5, and a contract part 30 wound around the outer peripheral surface of the tubular body 100; and the contract part 30 includes a metal sheet 31 having X-ray impermeability and wound around the outer peripheral surface of the tubular body 100, and a contract adhesive agent 32 containing an X-ray impermeable material and a resin material, arranged at the one surface side of the metal sheet 31, and adhered to the outer peripheral surface of the tubular body 100.SELECTED DRAWING: Figure 3

Description

The present invention relates to a method for manufacturing a catheter and a tubular shaft used within a lumen of a blood vessel or the like.

In recent years, treatment within the lumen of a blood vessel or the like using a catheter has been actively performed because the surgical invasion is extremely low. For example, catheters are used to be selectively introduced into the complexly branched blood vessels in the body. Generally, catheters are selectively pushed along guide wires that are introduced into the blood vessels in advance to deliver therapeutic drugs or diagnostics. Contrast medium, etc. for use is distributed from the proximal end to the distal end.

In manufacturing contrast catheters, support catheters, and the like, a manufacturing method in which a long tube body is continuously formed and processed by extrusion coating molding is sometimes used. In this manufacturing method, in order to place an X-ray contrast marker at the tip of the catheter to provide contrast under X-ray fluoroscopy, a metal contrast marker is caulked to the tube body by swaging, A method is used in which a contrast marker is coated on a tube body and the outside thereof is covered with an outer layer (for example, see Patent Document 1). Patent Document 1 describes a spiral contrast marker.

Japanese Patent Application Publication No. 2016-154632

For example, when placing a contrast marker on a tubular body that has been continuously molded by extrusion coating molding or the like, off-line processing that is not incorporated into the tubular body molding process is required. For this reason, the manufacturing time of the tubular shaft on which the contrast marker (contrast region) is arranged increases, and the cost increases.

The present invention has been made to solve the above-mentioned problems, and an object of the present invention is to provide a method for manufacturing a catheter and a tubular shaft that can shorten manufacturing time and reduce costs.

A catheter that achieves the above object is a catheter equipped with a tubular shaft having a lumen penetrating from a distal end to a proximal end, the tubular shaft having a tubular body having an inner layer forming the lumen, and an outer periphery of the tubular body. a contrasting section wrapped around a surface, the contrasting section comprising: a metal sheet having X-ray opacity and wound around the outer circumferential surface of the tube; and an X-ray opaque material and a resin material. and a contrast adhesive disposed on one side of the metal sheet and bonded to the outer peripheral surface of the tube.

The catheter configured as described above is formed by adhering a radiopaque metal sheet to the tube body using a contrast adhesive containing an X-ray opaque material, so the contrast adhesion to the tube body is Since the arrangement of the agent and the metal sheet is very easy, manufacturing time can be shortened and costs can be reduced.

The thickness of the metal sheet may be greater than the thickness of the contrast adhesive. Thereby, the catheter can obtain high X-ray contrast properties due to the metal sheet.

The thickness of the metal sheet may be smaller than the thickness of the contrast adhesive. As a result, the catheter can be formed using a thin metal sheet to suppress an extreme increase in rigidity of the tubular shaft.

The thickness of the metal sheet may be equal to the thickness of the contrast adhesive. As a result, the catheter can provide a good balance between providing X-ray contrast properties and suppressing an extreme increase in the rigidity of the tubular shaft.

The tubular body may include a reinforcing body including a plurality of wire rods arranged to surround the inner layer and braided into a tubular shape, and a part of the contrast adhesive may be arranged in a gap between the plurality of wire rods. good. This allows the catheter to increase the adhesion strength of the contrast adhesive to the tube body. In addition, by placing a portion of the contrast adhesive in the gap between multiple wire rods, the layer containing only the contrast adhesive placed radially outward from the reinforcing body can be made thinner, thereby promoting reduction in the diameter of the tubular shaft. .

The contrast portion may be wound around the outer peripheral surface of the tubular body in a range of less than 360 degrees around the axis of the tubular body. As a result, the contrast portions do not overlap in the circumferential direction, so it is possible to prevent the outer diameter of the tubular shaft from increasing. In addition, the operator can easily determine the direction of the catheter because it is easy for the operator to distinguish and understand the shading of the area where the contrast area formed in the circumferential direction is provided and the area where it is not provided from the image obtained by the X-ray contrast device. can.

The contrast portion may be in the shape of a belt that is elongated in one direction, and may be spirally wound so as to partially overlap the outer circumferential surface of the tubular body. This makes it easy for the operator to distinguish and understand the shading of the overlapping and non-overlapping areas of the contrast region from the image obtained by the X-ray contrast device, and thus the orientation of the catheter can be easily understood.

The overlapping region of the contrast region may be formed more on the distal side than on the proximal end side of the contrast region. As a result, many overlapping parts of the contrast region that are easy for the operator to identify from images obtained by the X-ray contrast device are placed on the distal end of the tubular shaft, where it is desirable to grasp the position preferentially. The operator can effectively grasp the position of the part.

A method for manufacturing a tubular shaft that achieves the above object is a method for manufacturing a tubular shaft having a lumen penetrating from a distal end to a proximal end, the method comprising: a metal sheet having radiopaque properties; a radiopaque material; A contrast adhesive containing a resin material and disposed on one side of the metal sheet is wrapped around the outer peripheral surface of a tube having an inner layer forming the lumen, and the metal sheet is It is characterized in that an X-ray opaque contrast area is formed by adhering to the tubular body with the contrast adhesive.

The manufacturing method for the tubular shaft configured as described above uses both a contrast adhesive and a metal sheet, so that the contrast adhesive maintains the shape of the metal sheet before pasting, which can be difficult to handle due to its thinness. This improves work efficiency. Furthermore, since the contrast region can be formed on the tubular shaft simply by pasting the contrast adhesive fixed on the metal sheet to the tubular body, manufacturing time can be shortened and costs can be reduced. In addition, since the manufactured catheter is provided with contrast properties by both the contrast adhesive and the metal sheet, sufficient contrast properties can be obtained.

The tubular body has a reinforcing body including a plurality of wire rods arranged so as to surround the inner layer and braided into a tubular shape, and when wrapping the contrast portion around the outer circumferential surface of the tubular body, the contrast adhesive is A portion may be arranged in gaps between the plurality of wire rods. Thereby, the present manufacturing method can increase the adhesive strength of the contrast adhesive to the tube body. In addition, by placing a portion of the contrast adhesive in the gap between multiple wire rods, the layer containing only the contrast adhesive placed radially outward from the reinforcing body can be made thinner, thereby promoting reduction in the diameter of the tubular shaft. .

FIG. 1 is a plan view showing a catheter according to an embodiment. FIG. 2 is a cross-sectional view showing a distal end portion of a catheter according to an embodiment. 3 is a sectional view taken along line A-A' in FIG. 2. FIG. FIG. 2 is a transparent plan view showing the outer layer of the catheter according to the embodiment. FIG. 3 is a cross-sectional view showing a state in which a contrast sheet is attached to a tube body. FIG. 7 is a plan view showing the outer layer of the catheter according to the first modification as seen through. FIG. 7 is a plan view showing the outer layer of a catheter according to a second modified example;

Embodiments of the present invention will be described below with reference to the drawings. Note that the dimensions in the drawings may be exaggerated and differ from the actual dimensions for convenience of explanation. Further, in this specification and the drawings, constituent elements having substantially the same functional configuration are designated by the same reference numerals and redundant explanation will be omitted. In this specification, the side of the catheter that is inserted into the living body lumen will be referred to as the "distal side," and the side that will be operated will be referred to as the "proximal side."

The catheter 1 according to this embodiment is percutaneously inserted into an artery in an arm or an artery in a lower limb, and is used for treatment, diagnosis, and the like. As shown in FIG. 1, the catheter 1 includes an elongated tubular shaft 2, a hub 3 connected to the proximal end of the tubular shaft 2, and an anti-kink protector 4 provided at a connection site between the tubular shaft 2 and the hub 3. have.

As shown in FIGS. 1 to 4, the tubular shaft 2 is a flexible tubular member that is elongated along the axial direction X of the tubular shaft 2, and has a lumen 5 inside from the base end to the tip end. is formed. A guide wire is inserted through the lumen 5 when the catheter 1 is inserted into a blood vessel. Furthermore, the lumen 5 can also be used as a passage for medical solutions, embolic substances, contrast agents, medical instruments, and the like.

The effective length of the tubular shaft 2 is not particularly limited, but is, for example, 100 mm to 3000 mm. Note that the effective length of the tubular shaft 2 is the length of a portion that can be inserted into a blood vessel, a sheath, or the like. In this embodiment, the effective length is the length from the leading edge of the anti-kink protector 4 to the leading edge of the tubular shaft 2.

The tubular shaft 2 is composed of a plurality of layers, including an inner layer 10 forming the inner surface 11 of the lumen 5, a reinforcing body 20 formed outside the inner layer 10, and a reinforcing body 20 disposed outside the inner layer 10 and the reinforcing body 20. and an outer layer 40 formed outside the inner layer 10 and the reinforcing body 20.

The inner layer 10 has a lumen 5 formed therein. The inner diameter of the inner layer 10 is not particularly limited, but is, for example, 0.3 mm to 2.8 mm. The constituent material of the inner layer 10 can be a thermoplastic resin, a thermosetting resin, or the like, and preferably is a fluororesin such as polytetrafluoroethylene (PTFE), a low-friction material such as high-density polyethylene (HDPE), or the like.

The reinforcing body 20 is formed by braiding a plurality of wire rods 21 into a tubular shape around the outer periphery of the inner layer 10 so as to have gaps. The reinforcing body 20 may be wound with the wire 21 while changing the winding direction, such as horizontally wound in the same direction, right-handed or left-handed, or the winding pitch, inter-lattice distance, inclination angle with respect to the circumferential direction, etc. may be changed depending on the position. It may be changed and the configuration is not particularly limited.

The wire diameter (diameter) of the wire 21 of the reinforcing body 20 is not particularly limited, but is, for example, 0.03 mm to 0.08 mm.

The wire rods 21 used in the reinforcing body 20 can be made of stainless steel, metal wires such as platinum (Pt) or tungsten (W), resin fibers, carbon fibers, glass fibers, etc., or a plurality of these wire rods 21 can be used in combination. It's okay.

The contrast unit 30 includes a metal sheet 31 that is radiopaque and a contrast adhesive 32 that is placed on the inner surface of the metal sheet 31. The contrast unit 30 is wound around the outer peripheral surface of the reinforcing body 20 at an angle of less than 360 degrees about the axis of the tubular shaft 2 . Therefore, the contrast portions 30 do not overlap in the radial direction, which is the radial direction centered on the axis of the tubular shaft 2 . That is, the contrast section 30 is formed in a C-shape in a cross section perpendicular to the axis of the tubular shaft 2. Therefore, the outer diameter of the tubular shaft 2 is prevented from increasing. Note that the contrast portion 30 may be wrapped around the outer peripheral surface of the inner layer 10 instead of the reinforcing body 20.

The metal sheet 31 is a thin and flexible sheet (foil). The constituent material of the metal sheet 31 is not particularly limited as long as it is an X-ray opaque metal, such as platinum, gold, silver, tungsten, iridium, or an alloy thereof.

The contrast adhesive 32 is formed by kneading a resin material such that fine X-ray opaque material is dispersed therein. The contrast adhesive 32 is arranged so as to adhere to substantially the entire surface of the inner surface of the metal sheet 31 (the side facing the axis of the tubular shaft 2). The radiopaque material contained in the contrast adhesive 32 may include metal powders such as platinum, gold, silver, tungsten, iridium, or alloys thereof, barium sulfate, bismuth oxide, or coupling compounds thereof. X-ray contrast agents, etc. The resin material included in the contrast adhesive 32 is, for example, epoxy resin. The resin material included in the contrast adhesive 32 may be a thermoplastic resin or a thermosetting resin as long as it functions as an adhesive. The contrast fluid 120 may be conductive ink containing gold powder, conductive solder, or the like.

The thickness (radial thickness) T1 of the metal sheet 31 is preferably 0.01 μm to 100 μm, more preferably 5 μm to 50 μm, and even more preferably 10 μm to 30 μm. The thickness (radial thickness) T2 of the contrast adhesive 32 is preferably 0.01 μm to 100 μm, more preferably 5 μm to 50 μm, and even more preferably 10 μm to 30 μm. The thickness T1 of the metal sheet 31 may be greater than the thickness T2 of the contrast adhesive 32, may be smaller than the thickness T2 of the contrast adhesive 32, or may be equal to the thickness T2 of the contrast adhesive 32.

The outer layer 40 is a tubular member that covers the outer periphery of the inner layer 10, the reinforcing body 20, and the contrast section 30. The outer layer 40 forms an outer surface 41 that is the radially outer surface of the tubular shaft 2 .

The constituent material of the outer layer 40 is, for example, polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these), polyvinyl chloride, Polymer materials such as polyamide, polyester elastomer, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, and fluororesin, thermoplastic resins such as mixtures thereof, and thermosetting resins such as epoxy resins can be used.

The hub 3 has a proximal end portion of the tubular shaft 2 fixed in a fluid-tight manner by adhesive, heat fusion, a fastener (not shown), or the like. The hub 3 functions as an insertion port for guide wires and medical instruments into the lumen 5, an injection port for medical solutions, embolic substances, contrast agents, etc. into the lumen 5, and also serves as a gripping portion when operating the catheter 1. It also functions as The material constituting the hub 3 is not particularly limited, but thermoplastic resins such as polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer can be suitably used.

The anti-kink protector 4 is made of an elastic material and is provided so as to surround the tubular shaft 2, and suppresses kinking of the tubular shaft 2 at the connection portion between the tubular shaft 2 and the hub 3. As the constituent material of the kink-resistant protector 4, for example, natural rubber, silicone resin, etc. can be suitably used.

Next, a method for manufacturing the tubular shaft 2 according to this embodiment will be described.

First, the manufacturer prepares a long core wire with an outer diameter equal to the inner diameter of the inner layer 10. Next, an inner layer 10 is formed on the core wire. Inner layer 10 may be formed by extrusion molding or dip molding.

After this, the reinforcing body 20 is formed so as to cover at least a portion of the inner layer 10. The reinforcing body 20 is formed by continuously winding a plurality of wire rods 21 on the inner layer 10 using a braiding machine (brader). Next, the tubular component having the inner layer 10 and the reinforcing body 20 is cut to a predetermined length in the axial direction X to form a tubular body 100 as shown in FIG. In addition to a braid, the reinforcing body 20 may be a unidirectional coil, a wire rod parallel to the long axis, or a combination thereof, or may not have a reinforcing body.

Next, a band-shaped contrast sheet 101 having a contrast adhesive 32 attached to one side of the metal sheet 31 is prepared, and the contrast sheet 101 is attached to the tube body 100 so that the contrast adhesive 32 adheres to the outer peripheral surface of the tube body 100. Wrap it around the body 100 at a predetermined position. For example, if the contrast sheet 101 is provided in a roll having a constant width, it is easy to cut out a predetermined length and use it. If the contrast adhesive 32 is a mixture of a thermoplastic resin and a large number of minute particles made of an X-ray opaque material, the contrast adhesive 32 can be used after or before being adhered to the tube body 100. It becomes fluid due to heating during adhesion, and adheres to the inner layer 10 and the reinforcing body 20 while entering the gaps between the plurality of wire rods 21 of the reinforcing body 20 . After this, the contrast adhesive 32 is cooled or hardened, and is firmly adhered to the tube body 100. The metal sheet 31 suppresses outflow of the fluid contrast adhesive 32 and prevents the contrast adhesive 32 from mixing with the resin material of the outer layer 40 .

Next, an outer layer 40 is formed on the outside of the inner layer 10, the reinforcing body 20, and the contrast section 30, as shown in FIGS. 2 to 4. Thereby, the tubular shaft 2 is completed. The method of forming the outer layer 40 is not particularly limited. For example, the outer layer 40 may be formed by extrusion molding or dip molding. Alternatively, the outer layer 40 may be formed by arranging a tubular member that is the raw material of the outer layer 40 outside the inner layer 10, the reinforcing body 20, and the contrast unit 30, and then covering the tubular member with a heat shrink tube and heating it. . The tubular member is softened or melted by heating and is tightly joined to the outside of the inner layer 10, the reinforcing body 20, and the contrast portion 30 by the contraction force of the heat-shrinkable tube. After this, the heat-shrinkable tube is removed.

After forming the outer layer 40, the core wire is pulled out from the lumen 5 of the inner layer 10. Thereafter, the hub 3 and the anti-kink protector 4 are attached to the tubular shaft 2, and other members (for example, a distal tip) are attached as necessary to complete the catheter 1.

As described above, the catheter 1 according to the present embodiment includes the tubular shaft 2 having the lumen 5 penetrating from the distal end to the proximal end. and a contrasting section 30 wrapped around the outer circumferential surface of the tube 100, the contrasting section 30 being made of a metal sheet that is X-ray opaque and wrapped around the outer circumferential surface of the tube 100. 31, and a contrast adhesive 32 containing an X-ray opaque material and a resin material, disposed on one side of the metal sheet 31, and bonded to the outer peripheral surface of the tube body 100.

The catheter 1 configured as described above is formed by adhering a metal sheet 31 with radiopaque to the tube body 100 with a contrast adhesive 32 containing an X-ray opaque material. Since it is very easy to arrange the contrast adhesive 32 and metal sheet 31 on 100, manufacturing time can be shortened and costs can be reduced. In addition, since the catheter 1 is provided with X-ray contrast properties by both the contrast adhesive 32 and the metal sheet 31, the metal sheet 31 is made thin to suppress an extreme increase in the rigidity of the tubular shaft 2, and the It is possible to obtain excellent X-ray contrast properties.

The thickness of the metal sheet 31 may be greater than the thickness of the contrast adhesive 32. Thereby, the catheter 1 can obtain high X-ray contrast properties due to the metal sheet 31.

The thickness of the metal sheet 31 may be smaller than the thickness of the contrast adhesive 32. Thereby, in the catheter 1, the metal sheet 31 can be made thin and an extreme increase in the rigidity of the tubular shaft 2 can be suppressed.

The thickness of the metal sheet 31 may be equal to the thickness of the contrast adhesive 32. Thereby, the catheter 1 can achieve both of providing X-ray contrast properties and suppressing an extreme increase in the rigidity of the tubular shaft 2 in a well-balanced manner.

The tube body 100 has a reinforcing body 20 including a plurality of wire rods 21 arranged to surround the inner layer 10 and braided into a tubular shape, and a part of the contrast adhesive 32 is arranged in the gaps between the plurality of wire rods 21. Ru. Thereby, in the catheter 1, the adhesive strength of the contrast adhesive 32 to the tube body 100 can be increased. Further, by disposing a part of the contrast adhesive 32 in the gaps between the plurality of wire rods 21, the layer of only the contrast adhesive 32 disposed radially outward from the reinforcing body 20 is thinned, and the thickness of the tubular shaft 2 is reduced. Can promote smaller diameter.

The contrast unit 30 is wound around the outer peripheral surface of the tubular body 100 in a range of less than 360 degrees around the axis of the tubular body 100 . Thereby, since the contrast portions 30 (metal sheets 31) do not overlap in the circumferential direction, it is possible to prevent the outer diameter of the tubular shaft 2 from increasing. In addition, since it is easy for the operator to distinguish and understand the shading of the area where the contrast area 30 formed in the circumferential direction is provided and the area where the contrast area 30 is not provided from the image obtained by the X-ray contrast device, it is easy for the operator to orient the catheter 1. can be grasped.

Further, the method for manufacturing the tubular shaft 2 of the catheter 1 according to the present embodiment is a method for manufacturing the tubular shaft 2 having the lumen 5 penetrating from the distal end to the proximal end. and a contrast adhesive 32 containing an X-ray opaque material and a resin material and disposed on one side of the metal sheet 31. It is characterized in that the metal sheet 31 is wrapped around the outer peripheral surface of the body 100 and adhered to the tube body 100 with a contrast adhesive 32 to form an X-ray opaque contrast region 30.

The manufacturing method of the tubular shaft 2 configured as described above uses both the contrast adhesive 32 and the metal sheet 31, so that the shape of the metal sheet 31 before pasting, which may be difficult to handle due to its thinness, can be adjusted using the contrast adhesive 32 and the metal sheet 31. Since it can be maintained by the adhesive 32, workability is improved. Furthermore, since the contrast region 30 can be formed on the tubular shaft 2 by simply pasting the contrast adhesive 32 fixed to the metal sheet 31 onto the tube body 100, offline processing that is not incorporated into the molding process of the tube body 100 is required. However, manufacturing time can be shortened and costs can be reduced. In addition, in this manufacturing method, since both the contrast adhesive 32 and the metal sheet 31 provide X-ray contrast properties, the metal sheet 31 is formed thin to suppress an extreme increase in the rigidity of the tubular shaft 2. Can provide sufficient contrast.

The tubular body 100 has a reinforcing body 20 that includes a plurality of wire rods 21 that are arranged to surround the inner layer 10 and are braided into a tubular shape. 32 is placed in the gap between the plurality of wire rods 21. Thereby, the present manufacturing method can increase the adhesive strength of the contrast adhesive 32 to the tube body 100. Further, by disposing a part of the contrast adhesive 32 in the gaps between the plurality of wire rods 21, the layer of only the contrast adhesive 32 disposed radially outward from the reinforcing body 20 is thinned, and the thickness of the tubular shaft 2 is reduced. Can promote smaller diameter.

Note that the present invention is not limited to the embodiments described above, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, as in a first modification shown in FIG. 6, the contrast imaging unit 30 may be wound around the outer circumferential surface of the tubular body 100 in a spiral shape around the axis of the tubular body 100. The spiral contrast section 30 may be wound around the axis of the tubular body 100 over a range of 360 degrees or more. Thereby, since the contrast portions 30 (metal sheets 31) do not overlap in the circumferential direction, it is possible to prevent the outer diameter of the tubular shaft 2 from increasing. In addition, the operator can easily grasp the orientation of the catheter 1 because it is easy for the operator to distinguish and understand the shading of the spiral region where the contrast section 30 is provided and the region where the contrast section 30 is not provided from the image obtained by the X-ray contrast device. .

In addition, as in the second modification shown in FIG. 7, the contrast section 30 has a belt shape that is elongated in one direction, and may be spirally wound so as to partially overlap the outer circumferential surface of the tube body 100. good. That is, the pitch of the spiral of the contrast portion 30 gradually increases toward the base end. In the overlapping region 33 of the contrast section 30, the metal sheets 31 and the contrast adhesive 32 are arranged alternately in the radial direction. The overlapping region 33 of the contrast imaging unit 30 has higher X-ray contrast properties than the single region 34 that does not overlap. As a result, the operator can identify the overlapping region 33 of the contrast region 30, the single region 34 that does not overlap, and the contrast region 30 located in the spiral gap from the image obtained by the X-ray contrast device. Since it is easy to distinguish and understand the shading of the portion 35, the direction of the catheter 1, which has an outer diameter of 7 Fr or more and a thick wall, can be easily understood.

The overlapping region 33 of the contrast imaging section 30 is formed more on the distal end side than on the proximal end side of the contrast imaging section 30. As a result, the overlapping region 33 of the contrast region 30, which is easy for the operator to identify from the image obtained by the X-ray contrast device, is located more on the distal end side of the tubular shaft whose position is desired to be grasped preferentially. The operator can effectively grasp the position of the tip of No. 2. Note that the overlapping portions 33 of the contrast imaging unit 30 may be formed uniformly along the axis, or may be formed more on the proximal side than on the distal side.

Further, the contrast imaging unit 30 may have an overlapping portion that is wound three times or more.

Furthermore, the contrast unit 30 disposed on the tubular shaft 2 is disposed at one location in the axial direction X, but may be disposed at two or more locations in the axial direction X.

Further, the contrast unit 30 does not need to contact the reinforcing body 20. Further, the contrast section 30 may be formed to cover the outer peripheral surface of the outer layer 40 instead of the inner side of the outer layer 40.

In addition, the catheter 1 can be inserted into blood vessels such as coronary arteries, abdominal arteries, lower limb peripheral arteries, blood vessels leading to cerebral blood vessels, cerebral blood vessels, and veins, as well as bile ducts, tracheas, esophagus, urethra, or other body lumens or body cavities. It may be inserted and used for treatment, diagnosis, etc.

1 Catheter 2 Tubular shaft 3 Hub 4 Anti-kink protector 5 Lumen 10 Inner layer 11 Inner surface 20 Reinforcement body 21 Wire 30 Contrast section 31 Metal sheet 32 Contrast adhesive 40 Outer layer 41 Outer surface 100 Tube 101 Contrast sheet X Axial direction

Claims (10)

A catheter comprising a tubular shaft having a lumen extending therethrough from a distal end to a proximal end, the catheter comprising:
The tubular shaft is
comprising a tube body having an inner layer forming the lumen, and a contrast portion wrapped around the outer peripheral surface of the tube body,
The contrast area is
a metal sheet having X-ray opacity and wrapped around the outer peripheral surface of the tube body;
A catheter comprising: a contrast adhesive containing an X-ray opaque material and a resin material, disposed on one side of the metal sheet, and bonded to the outer peripheral surface of the tube body. The catheter according to claim 1, wherein the thickness of the metal sheet is greater than the thickness of the contrast adhesive. The catheter according to claim 1, wherein the thickness of the metal sheet is smaller than the thickness of the contrast adhesive. The catheter of claim 1, wherein the thickness of the metal sheet is equal to the thickness of the contrast adhesive. The tubular body has a reinforcing body including a plurality of wire rods arranged to surround the inner layer and braided into a tubular shape,
The catheter according to any one of claims 1 to 4, wherein a portion of the contrast adhesive is placed in a gap between the plurality of wire rods. The catheter according to any one of claims 1 to 5, wherein the contrast portion is wound around the outer peripheral surface of the tubular body in a range of less than 360 degrees around the axis of the tubular body. 6. The contrast portion is in the form of a belt elongated in one direction, and is spirally wound so as to partially overlap the outer peripheral surface of the tube body. Catheter described in. 8. The catheter according to claim 7, wherein the contrast region overlaps more on the distal end side than on the proximal end side of the contrast region. A method for manufacturing a tubular shaft having a lumen penetrating from a distal end to a proximal end, the method comprising:
A contrast sheet having a metal sheet having X-ray opacity and a contrast adhesive containing an X-ray opaque material and a resin material and disposed on one side of the metal sheet is placed in the lumen. The metal sheet is wrapped around the outer circumferential surface of a tube having an inner layer forming an X-ray opaque contrast area by adhering the metal sheet to the tube with the contrast adhesive. Production method. The tubular body has a reinforcing body including a plurality of wire rods arranged to surround the inner layer and braided into a tubular shape,
10. The method for manufacturing a tubular shaft according to claim 9, wherein a part of the contrast adhesive is placed in a gap between the plurality of wire rods when the contrast portion is wound around the outer peripheral surface of the tubular body.

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