Catheter and manufacturing method of catheter

Abstract

To provide a catheter whose outer diameter can be suppressed though a necessary structure is provided for its shaft, and a manufacturing method thereof.SOLUTION: A catheter 1 includes a long-sized tubular shaft 2. The shaft 2 includes a marker 40 wound with a metal wire 41 along a long axis direction inside a thick portion. The marker 40 includes a first shape part 43 in which the wire 41 has a certain shape, and a second shape part 44 adjacent to the first shape part 43 along the long axis direction, in which the wire 41 has a shape different from the shape of the first shape part 43.SELECTED DRAWING: Figure 5

Description

[Technical field]

[0001] The present invention relates to a catheter for use within a lumen such as a blood vessel, and a method for manufacturing the same. [Background technology]

[0002] One method for treating lesions such as stenosis and blockages in blood vessels is endovascular treatment, which uses a device inserted percutaneously into the blood vessel to perform treatment from within the blood vessel. In endovascular treatment, a catheter is used to deliver a diagnostic contrast agent or a guide wire to the lesion.

[0003] In order to visually confirm the catheter inserted into the blood vessel under X-ray imaging, the catheter is provided with a marker having X-ray contrast. The marker is provided inside the shaft constituting the catheter, and is known to be, for example, a coil made of a metal having X-ray contrast, such as gold, platinum, or tungsten. An example of a catheter having such a marker is that shown in Patent Document 1. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2005-278905 A Summary of the Invention [Problem to be solved by the invention]

[0005] The catheter shaft has multiple regions with different characteristics along its length, such as regions with high rigidity and regions with high flexibility. Therefore, the shaft has different structures along its length, such as the outer diameter and the presence or absence of a reinforcing body. The wire material constituting the marker needs to have a certain thickness to ensure visibility. When the marker is provided across different structures along the length of the shaft, the marker may be located on the outer periphery of those structures, which may increase the outer diameter of the shaft and hinder the improvement of the passability of the shaft.

[0006] The present invention has been made to solve the above-mentioned problems, and has an object to provide a catheter that can reduce the outer diameter while providing the necessary structure in the shaft, and a method for manufacturing the same. [Means for solving the problem]

[0007] To achieve the above objective, (1) a catheter is provided having a long tubular shaft, the shaft having a marker inside a thick wall of the shaft, the marker being made of a metal wire wound along a longitudinal direction, the marker having a first shaped portion in which the wire has a certain shape, and a second shaped portion adjacent to the first shaped portion along the longitudinal direction and in which the wire has a shape different from that of the first shaped portion.

[0008] (9) A method for manufacturing a catheter that achieves the above-mentioned object is a method for manufacturing a catheter having a marker inside the thickness of a long tubular shaft, comprising the steps of winding a wire material that serves as the marker on the outer surface of an inner layer shaft, processing a portion of the inner layer shaft in the longitudinal direction of the region in which the wire material is wound by radially crushing the wire material to form a marker on the outer surface of the inner layer shaft having a first shaped portion and a second shaped portion adjacent to the first shaped portion along the longitudinal direction, the second shaped portion being a portion of the wire material that has a different shape from the first shaped portion, and forming an outer layer on the outside of the inner layer shaft. Effect of the Invention

[0009] The catheter (1) configured as described above has the first and second shape portions of the marker positioned to match the structure of the shaft, thereby providing the necessary structure to the shaft and reducing the outer diameter of the shaft while ensuring its function as a marker.

[0010] (2) In the catheter of (1) above, the marker may have a cross-sectional shape of the wire rod in the first shaped portion that is different from that in the second shaped portion. This makes it possible to prevent the outer diameter from becoming large by disposing a thin portion of the marker in a portion where it is desired to reduce the outer diameter of the shaft, since the catheter has a different thickness in the first shaped portion and the second shaped portion.

[0011] (3) In the catheter of (1) or (2), the shaft may include a reinforcing body made of braided metal wires in at least a portion of the longitudinal direction, and the marker may be configured so that at least a portion of the longitudinal direction radially overlaps the reinforcing body. This allows the catheter to prevent the marker from falling off, since a portion of the marker overlaps the reinforcing body.

[0012] (4) In the catheter of any of (1) to (3) above, the first shape portion may have a different pitch of the wire rod from that of the second shape portion, thereby ensuring the flexibility of the shaft and the X-ray contrast of the marker.

[0013] (5) In any of the catheters described above in (3), the first shaped section may have a cross-sectional shape that is elongated in one direction and the second shaped section may have a cross-sectional shape that is circular. This allows the catheter to ensure high X-ray contrast in the second shaped section while reducing the outer diameter in the first shaped section.

[0014] (6) In the catheter of (5) above, the marker may be disposed so that the first shape portion is located radially outward of the reinforcing body. This makes it possible to suppress the outer diameter of the catheter at the portion where the reinforcing body is disposed, thereby preventing the outer diameter of the shaft from becoming large.

[0015] (7) In the catheter of (5) above, the marker may be disposed such that the base end of the first shaped portion is located distal to the distal end of the reinforcing body, and the second shaped portion is located radially outward of the reinforcing body. This allows the catheter to have a smaller outer diameter at the distal end side of the reinforcing body and a tapered shape at the distal end, thereby improving the passage of the shaft through blood vessels.

[0016] (8) In the catheter of either (3) or (5) above, the reinforcing body may have a first region and a second region adjacent to the first region along the longitudinal direction and having a pitch of the wires larger than the pitch of the wires in the first region, the first shaped region may have a larger pitch of the wires than the second shaped region, and the marker may be disposed so that the first shaped region overlaps the second region of the reinforcing body in the radial direction. This makes it possible to suppress a decrease in flexibility of the shaft because the pitch between the marker and the reinforcing body is large in the overlapping portion between the marker and the reinforcing body.

[0017] The manufacturing method of the catheter configured as described above forms the first shaped portion by compressing a portion of the wound wire that forms the marker, thereby reliably reducing the outer diameter of the first shaped portion of the shaft. [Brief description of the drawings]

[0018] [Figure 1] FIG. 1 is a front view showing a catheter according to an embodiment. [Diagram 2] FIG. 2 is an enlarged cross-sectional view of a portion of the catheter shaft. [Diagram 3] FIG. [Figure 4] FIG. 2 is a partially enlarged front view of the reinforcing member and the marker at the tip of the shaft. [Diagram 5] FIG. 2 is an enlarged cross-sectional view of the tip portion of the shaft. [Figure 6] FIG. 11 is an enlarged cross-sectional view of a tip portion of a shaft according to a modified example. [Figure 7] FIG. 2 is a cross-sectional view showing the manufacturing process of the catheter, depicting the state in which the reinforcing body and marker wire are wound around the inner layer shaft. [Figure 8] FIG. 11 is a cross-sectional view showing the manufacturing process of the catheter, illustrating the state in which the wire is being deformed in the base end portion of the marker. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. Note that dimensions in the drawings may be exaggerated and may differ from actual dimensions for convenience of explanation. In addition, in this specification and the drawings, components having substantially the same functional configurations are given the same reference numerals to avoid duplicated explanation. In this specification, the side of the catheter that is inserted into a blood vessel is referred to as the "tip side" and the side that is operated is referred to as the "base side".

[0020] In the explanation of this specification, the direction in which the catheter extends in its natural state (straight state with no external force applied) is referred to as the "longitudinal direction". The direction of rotation about the longitudinal direction of the catheter as the reference axis is referred to as the "circumferential direction". Additionally, the side of the catheter that is inserted into the blood vessel is referred to as the distal end, and the end opposite the distal end is referred to as the proximal end. Additionally, the portion including a certain range in the longitudinal direction from the distal end (the most distal end) is referred to as the "tip portion", and the portion including a certain range in the longitudinal direction from the proximal end (the most proximal end) is referred to as the "proximal end".

[0021] The catheter 1 according to this embodiment is a device that is percutaneously inserted into a blood vessel and used for performing treatment or diagnosis within the blood vessel. As shown in Fig. 1, the catheter 1 has a long tubular shaft 2 having a distal end and a proximal end, a hub 3 connected to the proximal end of the shaft 2, and a kink-resistant protector 4 that surrounds the connection portion of the shaft 2 and the hub 3.

[0022] The shaft 2 is a flexible tubular member, and as shown in Fig. 2, a lumen 5 is formed inside from the base end to the tip end. A guide wire is inserted into the lumen 5 when the catheter 1 is inserted into a blood vessel. The lumen 5 can also be used as a passage for a contrast agent, a therapeutic agent, an embolic substance, or a medical instrument.

[0023] The effective length of the shaft 2 is not particularly limited, but is, for example, 600 mm to 1500 mm. The effective length of the shaft 2 is the length of a portion that can be inserted into a blood vessel or a sheath. In this embodiment, the effective length is the length from the tip of the anti-kink protector 4 to the tip of the shaft 2.

[0024] The hub 3 is fixed liquid-tightly to the base end of the shaft 2 by adhesive, heat fusion, a fastener (not shown), or the like. The hub 3 functions as an insertion port for a guidewire or medical instrument into the lumen 5, an injection port for a contrast medium, a therapeutic agent, or an embolic substance into the lumen 5, etc. The hub 3 also functions as a gripping portion when the catheter 1 is operated.

[0025] The hub 3 is formed from a resin such as, but not limited to, polycarbonate, polyamide, polysulfone, polyarylate, or methacrylate-butylene-styrene copolymer.

[0026] The anti-kink protector 4 is provided to surround the connection portion between the shaft 2 and the hub 3, and suppresses kinking of the shaft 2 at the connection portion between the shaft 2 and the hub 3. The anti-kink protector 4 is made of an elastic material such as natural rubber, silicone resin, elastomer, or the like.

[0027] 2, the shaft 2 has an inner layer 10, a reinforcing body 20 disposed on the outside of the inner layer 10, and an outer layer 30 disposed on the outside of the inner layer 10 and the reinforcing body 20. The reinforcing body 20 is provided between the inner layer 10 and the outer layer 30, and is thus embedded within the wall thickness of the shaft 2.

[0028] The inner layer 10 has a lumen 5 formed therein. The inner layer 10 is made of a low-friction material such as a fluorine-based resin such as polytetrafluoroethylene (PTFE) or high-density polyethylene (HDPE).

[0029] As shown in FIG. 3, the reinforcing body 20 is formed by braiding a plurality of wires 21 into a tubular shape with gaps. The wires 21 used in the reinforcing body 20 are formed of metal wires such as stainless steel, platinum (Pt) and tungsten (W), resin fibers, carbon fibers, glass fibers, etc. The braid pitch of the reinforcing body 20 is 50 μm or more and 500 μm or less. The cross-sectional shape of the wires 21 can be circular, rectangular, etc., and a plurality of shapes may be used in combination. When the wires 21 have a circular cross section, the outer diameter is 10 μm or more and 100 μm or less, more preferably 20 μm or more and 60 μm or less. When the wires 21 have a rectangular cross section, the width is 30 μm or more and 200 μm or less, and the thickness is 10 μm or more and 50 μm or less.

[0030] The outer layer 30 is a tubular member that covers the outer periphery of the inner layer 10 and the reinforcing member 20. The hardness of the outer layer 30 increases stepwise or gradually from the tip to the base end. As an example, the hardness of the material forming the area of ​​the outer layer 30 that is more than 500 mm from the tip to the base end is about four times the hardness of the material forming the area of ​​the outer layer 30 that is 100 mm or less from the tip to the base end. Therefore, the bending rigidity of the shaft 2 is low at the tip end and high at the base end.

[0031] The outer layer 30 is formed of a polymer material such as polyolefin (polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these), polyvinyl chloride, polyamide, polyester elastomer, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture of these, a thermoplastic resin, or a thermosetting resin such as an epoxy resin.

[0032] The outer surface of the outer layer 30 may be coated with a low-friction material that reduces friction. The low-friction material is preferably a hydrophilic polymer that becomes gel-like when swollen. The hydrophilic polymer may be a cellulose-based polymer, a polyethylene oxide-based polymer, a maleic anhydride-based polymer (e.g., a maleic anhydride copolymer such as a methyl vinyl ether-maleic anhydride copolymer), an acrylamide-based polymer (e.g., polyacrylamide, a block copolymer of glycidyl methacrylate-dimethylacrylamide), a water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone, or a derivative thereof.

[0033] 4, the reinforcing body 20 has a first region 23 on the base end side in which the wires 21 are braided at pitch P1, and a second region 24 adjacent to the first region 23 along the longitudinal direction in which the wires 21 are braided at pitch P2 larger than pitch P1 of the first region 23. The second region 24 is disposed at the tip portion of the shaft 2, and the tip position of the second region 24 is located on the base end side relative to the tip of the shaft 2. In other words, the shaft 2 has a region in which the reinforcing body 20 is not provided at the most distal portion.

[0034] As shown in Figures 4 and 5, a marker 40 having X-ray contrast is provided at the tip of the shaft 2. The marker 40 is formed by winding a metal wire 41 into a coil shape and is embedded inside the wall thickness of the shaft 2. The wire 41 can be made of gold. The wire 41 may also be made of a metal other than gold having X-ray contrast, such as platinum, tantalum, tungsten, iridium, or an alloy of these metals.

[0035] In the marker 40, a first shaped portion 43 in which the wire 41 has a constant cross-sectional shape and a second shaped portion 44 in which the wire 41 has a cross-sectional shape different from that of the first shaped portion 43 are adjacent to each other along the longitudinal direction. The first shaped portion 43 is disposed on the base end side of the shaft 2, and the second shaped portion 44 is disposed on the tip end side of the shaft 2. In the first shaped portion 43, the wire 41 has a cross-sectional shape that is elongated in one direction and is flat. In the second shaped portion 44, the wire 41 has a cross-sectional shape that is circular. The wire 41 in the first shaped portion 43 is longer in the longitudinal direction than in the radial direction of the shaft 2, and is thinner in the radial direction than the wire 41 in the second shaped portion 44.

[0036] In the marker 40, the pitch P3 of the wires 41 in the first shaped portion 43 is larger than the pitch P4 of the wires 41 in the second shaped portion 44. The pitch P3 of the wires 41 in the first shaped portion 43 can be 10 μm to 1000 μm, and the pitch P4 of the wires 41 in the second shaped portion 44 can be 1 μm to 900 μm. In addition, the first shaped portion 43 on the base end side overlaps with the second region 24 of the reinforcing body 20 in the radial direction. Since the first shaped portion 43, which is a part of the marker 40, overlaps with the reinforcing body 20, falling off of the marker 40 can be suppressed.

[0037] In the second region 24 of the reinforcing body 20 overlapping the marker 40, the pitch P2 is larger than the pitch P1 of the first region 23, and the pitch P3 of the wire 41 in the first shaped portion 43 of the marker 40 overlapping the reinforcing body 20 is larger than the pitch P4 of the second shaped portion 44. Therefore, a decrease in flexibility of the shaft 2 in the region where the reinforcing body 20 and the marker 40 overlap can be suppressed.

[0038] The first shape portion 43 of the marker 40, which overlaps the reinforcing body 20 in the radial direction, has a flat cross-sectional shape in which the wire 41 is thin in the radial direction, so that the combined thickness of the reinforcing body 20 and the marker 40 is not increased, and the outer diameter of the shaft 2 is not increased. On the other hand, the second shape portion 44 of the marker 40 does not have the reinforcing body 20, so that the wire 41 can have a cross-sectional circular shape that is thicker than the first shape portion 43. In this way, the second shape portion 44 of the marker 40 has a large thickness and a small winding pitch, so that the contrast can be improved. That is, the catheter 1 has a different shape from the first shape portion 43, so that the catheter 1 can suppress the outer diameter from being increased by the marker 40 while providing the reinforcing body 20, which is a structure for performing the function of the shaft 2.

[0039] Next, a catheter 1 having a shaft 2 according to a modified example will be described. As shown in FIG. 6, the marker 50 may have a first shaped portion 53 disposed on the distal end side and a second shaped portion 54 disposed on the proximal end side. In the first shaped portion 53, the wire 51 has a cross-sectional shape that is elongated in one direction and is flat. In the second shaped portion 54, the wire 51 has a cross-sectional shape that is circular. The second shaped portion 54 overlaps with the reinforcing body 20 in the radial direction. The proximal end of the first shaped portion 53 is located on the distal side of the distal end of the reinforcing body 20, and does not overlap with the reinforcing body 20.

[0040] The shaft 2 has a tapered portion 2a at the tip where the first shaped portion 53 of the marker 50 is disposed, the outer diameter of which decreases toward the tip. Therefore, the outer diameter and thickness of the shaft 2 decrease toward the tip. Since the wire 51 of the first shaped portion 53 has a thin shape in the thickness direction as described above, the outer diameter of the shaft 2 can be reduced. By providing the tapered portion 2a at the tip of the shaft 2, the shaft 2 can be made to pass through the blood vessels well. In this way, the tapered portion 2a, which is a structure for performing the function of the shaft 2, is provided, while preventing the outer diameter from increasing due to the marker 50. In addition, since the second shaped portion 54 overlaps with the reinforcing body 20, the marker portion 50 can be prevented from falling off.

[0041] Next, a method for manufacturing the shaft 2 having the marker 40 will be described. As shown in FIG. 7, an inner layer shaft 12 that will become the inner layer 10 is prepared. A first core material 60 is disposed in the inner cavity of the inner layer shaft 12. Next, the reinforcing body 20 is braided on the outer surface of the inner layer shaft 12. After the reinforcing body 20 is braided, the wire 41 is wound so that a part of the reinforcing body 20 overlaps with a part of the reinforcing body 20 in the longitudinal direction. At this stage, the cross-sectional shape of the wire 41 is entirely circular. The wire 41 is wound so that the pitch is large in the region where the reinforcing body 20 is provided and is small in the region on the tip side of the tip of the reinforcing body 20. The reinforcing body 20 is present in the portion depicted by the dashed line in the figure, and in the region where the reinforcing body 20 is provided, the wire 41 is located outside this region.

[0042] 8, the first core material 60 in the lumen of the inner layer shaft 12 is replaced with a second core material 61 harder than the first core material 60, and the portion of the wire material 41 that overlaps with the reinforcing body 20 is placed in a mold 70 and swaged to reduce the outer diameter. By swaging, the wire material 41 is crushed in the radial direction of the inner layer shaft 12 and processed into a flat shape that is longer in the major axis direction than in the radial direction. This forms the marker 40 having a first shaped portion 43 and a second shaped portion 44.

[0043] Once the markers 40 are formed, an outer layer shaft (not shown) is provided on the outside of the inner layer shaft 12, and a heat shrink tube is placed over the outer layer shaft. By heating the outer layer shaft, the heat shrink tube is shrunk and the outer layer shaft is welded to the inner layer shaft 12, forming the shaft 2 having the reinforcing body 20 and the markers 40 inside the wall thickness.

[0044] As described above, the catheter 1 according to the present embodiment (1) is a catheter 1 having a long tubular shaft 2, the shaft 2 has a marker 40 formed by winding a metal wire 41 along the longitudinal direction inside the thick-walled portion, and the marker 40 has a first shaped portion 43 in which the wire 41 has a certain shape, and a second shaped portion 44 adjacent to the first shaped portion 43 along the longitudinal direction and in which the wire 41 has a shape different from that of the first shaped portion 43. The catheter 1 thus configured is able to provide the shaft 2 with a necessary structure by arranging the first shaped portion 43 and the second shaped portion 44 of the marker 40 in accordance with the structure of the shaft 2, thereby ensuring the function of the marker 40 and reducing the outer diameter of the shaft 2.

[0045] (2) In the catheter 1 of (1) above, the marker 40 may have a cross-sectional shape of the wire 41 in the first shaped portion 43 that is different from the cross-sectional shape of the wire 41 in the second shaped portion 44. As a result, the catheter 1 has different thicknesses in the first shaped portion 43 and the second shaped portion 44, so that the thin portion of the marker 40 can be disposed in a portion of the shaft 2 where it is desired to reduce the outer diameter, thereby preventing the outer diameter from becoming large.

[0046] (3) In the catheter 1 of (1) or (2) above, the shaft 2 may include a reinforcing body 20 made of braided metal wires 21 in at least a portion of the longitudinal direction inside the wall thickness, and the marker 40 may be configured so that at least a portion of the longitudinal direction radially overlaps with the reinforcing body 20. In this way, the catheter 1 has a portion of the marker 40 overlapping with the reinforcing body 20, thereby preventing the marker 40 from falling off.

[0047] (4) In the catheter 1 of any of (1) to (3) above, the first shaped portion 43 may have a different pitch of the wire 41 from that of the second shaped portion 44. This allows the catheter 1 to ensure both the flexibility of the shaft 2 and the X-ray contrast of the markers 40.

[0048] (5) In any of the catheters 1 described above in (3), the first shaped portion 43 may have a cross-sectional shape that is elongated in one direction and the second shaped portion 44 may have a cross-sectional shape that is circular. This allows the catheter 1 to ensure high X-ray contrast in the second shaped portion 44 while keeping the outer diameter of the first shaped portion 43 small.

[0049] (6) In the catheter 1 of (5) above, the marker 40 may be arranged so that the first shape portion 43 is located radially outside the reinforcing body 20. This makes it possible to suppress the outer diameter of the portion of the catheter 1 where the reinforcing body 20 is arranged, thereby preventing the outer diameter of the shaft 2 from becoming large.

[0050] (7) In the catheter 1 of (5) above, the marker 40 may be arranged such that the base end of the first shaped portion 43 is located distal to the tip of the reinforcing body 20, and the second shaped portion 44 is located radially outward of the reinforcing body 20. This allows the catheter 1 to have a smaller outer diameter at the distal end side of the reinforcing body 20 and to have a tapered tip, thereby improving the passability of the shaft 2 through blood vessels.

[0051] (8) In the catheter 1 of either (3) or (5) above, the reinforcing body 20 may have a first region 23 and a second region 24 adjacent to the first region 23 along the longitudinal direction and in which the pitch of the wires 21 is larger than the pitch of the wires 21 in the first region 23, the first shaped region 43 may have a larger pitch of the wires 41 than the second shaped region 44, and the marker 40 may be arranged so that the first shaped region 43 radially overlaps with the second region 24 of the reinforcing body 20. In this way, the catheter 1 can suppress a decrease in flexibility of the shaft 2 because the pitch of the marker 40 and the reinforcing body 20 is large in the portion where the marker 40 and the reinforcing body 20 overlap.

[0052] The method of manufacturing a catheter 1 according to the present embodiment (9) is a method of manufacturing a catheter 1 having a marker 40 inside the wall thickness of a long tubular shaft 2, and includes the steps of winding a wire 41 that will become the marker 40 on the outer surface of an inner layer shaft 12, performing a process of radially crushing the wire 41 in a part of the longitudinal direction of the region of the inner layer shaft 12 in which the wire 41 is wound, thereby forming a marker 40 having a first shaped portion 43 and a second shaped portion 44 adjacent to the first shaped portion 43 along the longitudinal direction and in which the wire 41 has a shape different from that of the first shaped portion 43, on the outer surface of the inner layer shaft 12, and forming an outer layer 30 on the outside of the inner layer shaft 12. The method of manufacturing a catheter 1 configured in this manner is such that the wire 41 that forms the marker 40 is partially crushed in a wound state to form the first shaped portion 43, and therefore the outer diameter of the part of the shaft 2 in which the first shaped portion 43 is located can be reliably reduced.

[0053] The present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical concept of the present invention. [Explanation of symbols]

[0054] 1 Catheter 2 Shaft 2a Tapered section 3. Hub 4 Anti-kink protector 5 Lumens 10 Inner layer 12 Inner shaft 20 Reinforcement 21 Wire 23 First area 24 Second area 30 outer layer 40 Markers 41 Wire rod 43 1st shape part 44 Second shape part

Claims

1. A catheter having a long tubular shaft, The shaft includes a marker formed by winding a metal wire along a longitudinal direction inside the shaft, The marker is a catheter having a first shaped portion in which the wire has a certain shape, and a second shaped portion adjacent to the first shaped portion along the longitudinal direction, in which the wire has a shape different from the first shaped portion.

2. The catheter according to claim 1 , wherein the marker has a cross-sectional shape of the wire at the first shaped portion different from a cross-sectional shape of the wire at the second shaped portion.

3. The shaft includes a reinforcing body formed by braiding metal wires in at least a partial region in the longitudinal direction, and The catheter according to claim 2 , wherein the marker overlaps radially with the reinforcing member at least in a portion of its longitudinal direction.

4. The catheter according to any one of claims 1 to 3, wherein the first shaped portion has a different pitch of the wire material from that of the second shaped portion.

5. The catheter according to claim 3 , wherein the first shaped section has a cross-sectional shape that is elongated in one direction and the second shaped section has a cross-sectional shape that is circular.

6. The catheter according to claim 5 , wherein the marker is arranged so that the first shape portion is located radially outside the reinforcement body.

7. The catheter according to claim 5 , wherein the marker is arranged so that the base end of the first shaped portion is located distal to the tip of the reinforcement body, and the second shaped portion is located radially outward of the reinforcement body.

8. The reinforcing body has a first region and a second region adjacent to the first region along the longitudinal direction, the second region having a pitch of the wires greater than the pitch of the wires in the first region, The first shaped portion has a larger pitch of the wire than the second shaped portion, The catheter of claim 3 , wherein the marker is positioned such that the first shape portion radially overlaps the second region of the reinforcement body.

9. A method for manufacturing a catheter having a marker inside a wall thickness of a long tubular shaft, comprising the steps of: a step of winding a wire rod serving as the marker on an outer surface of the inner layer shaft; forming a marker on an outer surface of the inner layer shaft, the marker having a first shaped portion and a second shaped portion adjacent to the first shaped portion along the longitudinal direction, the second shaped portion being a portion of the wire wound around the inner layer shaft, the second shaped portion having a different shape from the first shaped portion; forming an outer layer on the outside of the inner layer shaft; A method for manufacturing a catheter having the above structure.

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