Catheter

Abstract

Provided is a catheter in which an X-ray non-permeable marker is disposed on a shaft provided with a reinforcing body, while being able to suppress an increase in the thickness of the shaft. The catheter (1) has a shaft (2) having a lumen (5) communicating from the front end to the base end. The shaft (2) has: a reinforcing body (20) having a plurality of wire materials (21) disposed at least partially between the inner surface (11) and the outer surface (41) of the shaft (2) forming the lumen (5) and woven into a tubular shape; and at least one X-ray non-permeable marker (30) disposed between the reinforcing body (20) and the outer surface (41), and the difference in outer diameter, that is, the outer diameter difference, between the outer diameter (D1) of the portion of the shaft (20) where the marker (30) is disposed and the outer diameter (D2) of the portion of the shaft (20) adjacent to the marker (30) in the axial direction of the shaft (20) is less than twice the thickness (T) of the marker (30).

Description

Technical Field

[0001] The present invention relates to a catheter used in a lumen such as a blood vessel. Background Art

[0002] In recent years, due to the very low surgical invasiveness, treatment in a lumen such as a blood vessel using a catheter has become popular. For example, a catheter used for selectively introducing into a complexly branched blood vessel in the body is usually selectively pushed along a guide wire previously introduced into the blood vessel, and a therapeutic agent, a diagnostic contrast agent, etc. are caused to flow from the proximal end side to the distal end side.

[0003] An X-ray non-permeable marker is disposed on the axis of the catheter so that the position in the lumen can be grasped from outside the body. For example, Patent Document 1 describes a catheter in which a marker is fixed to the outer peripheral surface of the axis by impact. In addition, Patent Document 2 describes a catheter in which a marker is disposed on the inner peripheral surface of the axis and a portion of the outer surface of the axis that protrudes radially is removed to be flat.

[0004] Although the axis is formed thin so as to be insertable into a blood vessel or the like, in order to ensure pushability, torque transmission property, etc., a reinforcing body formed by braiding wire materials may be provided. However, for example, in the case of inserting the axis from the radial artery of the hand for treating the lower limb, a long axis is required. When the axis is long, it is difficult to transmit the pushing force and torque acting on the proximal end portion of the axis to the distal end portion of the axis. Therefore, in order to improve pushability and torque transmission property, for example, it is considered to increase the wire diameter of the wire material of the reinforcing body.

[0005] Prior Art Documents

[0006] Patent Documents

[0007] Patent Document 1: Japanese Patent Application Laid-Open No. 2000-237319

[0008] Patent Document 2: Japanese Patent Application Laid-Open No. 6-197974 Summary of the Invention

[0009] If the wire diameter of the braided wire material is increased, when a marker is disposed on the axis in which the reinforcing body is embedded, the thickness of the portion of the axis where the marker is provided also increases.

[0010] The present invention has been made to solve the above problems, and an object thereof is to provide a catheter in which an X-ray non-permeable marker is disposed on an axis provided with a reinforcing body, and at the same time, an increase in the thickness of the axis can be suppressed.

[0011] One way of the catheter for achieving the above object is a catheter having a shaft with a lumen communicating from the front end to the base end. The catheter is characterized in that the shaft has: a reinforcing body having a plurality of wire materials disposed at least partially between the inner surface and the outer surface of the shaft forming the lumen and woven into a tubular shape; and at least one X-ray non-permeable marker disposed between the reinforcing body and the outer surface. The difference between the outer diameter of the portion of the shaft where the marker is disposed and the outer diameter of the portion of the shaft adjacent to the marker along the axial direction of the shaft is defined as the outer diameter difference, and the difference between the inner diameter of the portion of the shaft adjacent to the marker along the axial direction of the shaft and the inner diameter of the portion of the shaft where the marker is disposed is defined as the inner diameter difference. At least one of the outer diameter difference and the inner diameter difference is less than twice the thickness of the marker.

[0012] Another way of the catheter for achieving the above object is a catheter having a shaft with a lumen communicating from the front end to the base end. The catheter is characterized in that the shaft has: a reinforcing body having a plurality of wire materials disposed at least partially between the inner surface and the outer surface of the shaft forming the lumen and woven into a tubular shape; and at least one X-ray non-permeable marker disposed between the reinforcing body and the outer surface. The difference between the maximum outer diameter of the marker and the maximum outer diameter of the portion of the reinforcing body adjacent to the marker along the axial direction of the shaft is less than twice the thickness of the marker.

[0013] Advantages of the Invention

[0014] In the catheter configured as described above, the outer diameter of the shaft provided with the reinforcing body and the X-ray non-permeable marker is not too large, and / or the inner diameter of the shaft is not too small. Therefore, the marker can be disposed on the shaft provided with the reinforcing body while suppressing an increase in the thickness of the shaft.

[0015] It may also be that the thickness of the outer layer of the portion of the shaft where the marker is disposed is the same as the thickness of the outer layer of the portion of the shaft adjacent to the marker along the axial direction of the shaft. Thus, the thickness of the outer layer is made uniform regardless of the presence or absence of the marker, while suppressing an increase in the thickness of the shaft.

[0016] It may also be that the marker has at least one convex portion at least on the inner surface side. Thus, the marker can be firmly fixed to the shaft. Therefore, it is possible to suppress the marker from coming off the shaft.

[0017] It may also be that the effective length of the shaft is 2100 mm or more. Thus, the catheter can easily reach the artery in the lower limb from the artery in the arm. Brief Description of the Drawings

[0018] Figure 1 It is a top view showing the catheter of the embodiment.

[0019] Figure 2 It is a cross-sectional view of the distal end portion of the catheter showing an embodiment.

[0020] Figure 3 It is a cross-sectional view of the distal end portion of the catheter showing an embodiment. (A) is a cross-sectional view along line A-A of Figure 2 and (B) is a cross-sectional view along line B-B of Figure 2 .

[0021] Figure 4 It is a top view showing through the outer layer of the catheter of the embodiment.

[0022] Figure 5 It is a top view showing a modified example of the catheter.

[0023] Figure 6 It is a top view showing another modified example of the catheter. Detailed Embodiment

[0024] Hereinafter, embodiments of the present invention will be described with reference to the drawings. In addition, for ease of explanation, the dimensions of the drawings are sometimes exaggerated and different from the actual dimensions. Also, in this specification and the drawings, components having substantially the same functional configuration are denoted by the same reference numerals, and thus repeated description is omitted. In this specification, the side where the catheter is inserted into the body lumen is referred to as the "distal end side", and the side where the operation is performed is referred to as the "proximal end side".

[0025] The catheter 1 of the present embodiment is used for introducing into the blood vessel from the radial artery of the arm and inserting it into the artery of the lower limb for treatment, diagnosis, etc. The artery of the lower limb refers to the artery near the bifurcation of the large artery iliac artery and the artery on the distal side. As Figure 1 shown, the catheter 1 has a long-sized shaft 2, a hub 3 connected to the proximal end of the shaft 2, and an anti-bending protector 4 provided at the connecting portion of the shaft 2 and the hub 3.

[0026] As Figures 1 to 4 shown, the shaft 2 is a flexible tubular member, and a lumen 5 is formed inside in the range from the proximal end to the distal end. When the catheter 1 is inserted into the blood vessel, the guide wire is inserted through the lumen 5. In addition, the lumen 5 can also be used as a passage for a liquid medicine, an embolization substance, a contrast agent, a medical instrument, etc.

[0027] The effective length of the shaft 2 is not particularly limited, preferably 1500 mm to 2600 mm, more preferably 1800 mm to 2300 mm, still more preferably 2100 mm to 2300 mm, and 2100 mm in this embodiment. Thus, the catheter 1 can reach the artery of the lower limb from the artery of the arm. In addition, the effective length of the shaft 2 is the length of the part that can be inserted into blood vessels, sheaths, etc. In this embodiment, the effective length is the length from the forefront of the anti-bending protector 4 to the forefront of the shaft 2. Preferably, when introduced from the femoral artery, the effective length of the shaft 2 is 650 mm or more, and when introduced from the distal part of the dorsal artery of the foot and the posterior tibial artery, the effective length of the shaft 2 is 300 mm or more.

[0028] The shaft 2 is composed of multiple layers, having an inner layer 10 forming the inner surface 11 of the lumen 5, a reinforcing body 20 formed on the outer side of the inner layer 10, a marker 30 disposed radially outside the reinforcing body 20, and an outer layer 40 formed on the outer sides of the inner layer 10 and the reinforcing body 20. The thickness of the shaft 2 is greater than the sum of the thicknesses of the reinforcing body 20 and the marker 30. Therefore, the reinforcing body 20 and the marker 30 can be completely buried inside the shaft 2.

[0029] The inner diameter of the inner layer 10 is not particularly limited, preferably 0.4 mm to 1.2 mm, more preferably 0.5 mm to 1.2 mm, still more preferably 0.95 mm to 1.2 mm, and 1.05 mm in this embodiment. The inner diameter of the inner layer 10 can be smaller at the position covered by the marker 30 than at the part adjacent in the axial direction X of the shaft 2.

[0030] The inner layer 10 forms a lumen 5 inside. The constituent material of the inner layer 10 can be a thermoplastic resin, a thermosetting resin, etc., preferably a fluororesin such as polytetrafluoroethylene (PTFE), a low-friction material such as high-density polyethylene (HDPE), etc.

[0031] The reinforcing body 20 is formed by braiding a plurality of wire rods 21 around the outer periphery of the inner layer 10 in a tubular shape with gaps. In order to dispose the marker 30, the reinforcing body 20 is formed with a small-diameter part 22 where the outer diameter is locally reduced. The length of the small-diameter part 22 in the axial direction X is preferably not less than the length of the marker 30 in the axial direction X so that the marker 30 can be accommodated. The reinforcing body 20 can be formed by winding the wire rods 21 while changing the winding directions such as cross winding, right winding, and left winding in the same direction. In addition, the winding pitch, the lattice distance, the inclination angle with respect to the circumferential direction, etc. can also be changed according to the position, and the constitution is not particularly limited. In addition, the small-diameter part 22 may not be formed.

[0032] Preferably, the difference (D5 - D6) between the maximum outer diameter D5 of the marker 30 and the maximum outer diameter D6 of the portion of the reinforcing body 20 adjacent to the marker 30 in the axial direction X of the shaft 2 is less than twice the thickness T of the marker 30.

[0033] The wire diameter (diameter) of the wire 21 of the reinforcing body 20 is not particularly limited, preferably 0.03 mm to 0.08 mm, more preferably 0.03 mm to 0.06 mm, still more preferably 0.04 mm to 0.06 mm, and is 0.05 mm in the present embodiment.

[0034] The wire 21 for the reinforcing body 20 can be a metal wire such as stainless steel, platinum (Pt), tungsten (W), a resin fiber, a carbon fiber, a glass fiber, etc., or a plurality of these wires 21 can be used in combination.

[0035] The marker 30 is an X-ray non-permeable (X-ray contrast) tubular body that merges into the small-diameter portion 22 from the radially outer side. When the marker 30 is arranged, after arranging the reinforcing body 20 around the outer periphery of the inner layer 10, a tubular body formed of a material containing an X-ray non-permeable substance is arranged so as to surround the inner layer 10 and the reinforcing body 20. Then, the tubular body is pressed from the radially outer side to form a plurality of concave portions 31 and a plurality of convex portions 32 on the inner peripheral surface of the tubular body, the diameter of the tubular body is reduced, and the marker 30 is arranged on the shaft 2. Therefore, the cross-sectional shape of the marker 30 in the cross-section orthogonal to the axial direction X of the shaft 2 is non-circular. In the present embodiment, the concave portion 31 extends in the axial direction X of the shaft 2 and is formed in a groove shape. The convex portion 32 extends in the axial direction X of the shaft 2 and is formed in a beam shape. The concave portions 31 and the convex portions 32 are arranged substantially evenly along the circumferential direction of the marker 30. The number of the concave portions 31 and the convex portions 32 is not particularly limited. The more the number, the closer the cross-sectional shape of the marker 30 is to a circular shape. In addition, the concave portion 31 may not be in a groove shape. Also, the convex portion 32 may not be in a beam shape. For example, as Figure 5 shown in the modified example, the concave portions 31 and the convex portions 32 may be randomly arranged.

[0036] As Figures 2 to 3 shown, the thickness T of the marker 30 can be set as the average value of the thickness T of the marker 30 in the cross-section orthogonal to the axis of the shaft 2 at a specified position (for example, the center and the end in the axial direction X). The average value of the thickness T of the marker 30 in the cross-section orthogonal to the axis of the shaft 2 can be set, for example, as the value obtained by dividing the cross-sectional area of the marker 30 in this cross-section by the length in the circumferential direction of the marker 30 (for example, the average value of the circumferences of the inner peripheral surface and the outer peripheral surface of the marker 30).

[0037] The thickness T of the marker 30 is not particularly limited, preferably 0.02 mm to 0.1 mm, more preferably 0.

[0038] The constituent material of the marker 30 can suitably use platinum, gold, silver, tungsten, iridium, or a metal powder composed of these alloys, barium sulfate, bismuth oxide, or a material obtained by kneading an X-ray contrast agent such as their coupling compound.

[0039] As Figures 2 to 4 shown, the outer layer 40 is a tubular member that covers the outer peripheries of the inner layer 10, the reinforcing body 20, and the marker 30. The outer layer 40 forms an outer surface 41 that is the radially outer surface of the shaft 2. The outer surface 41 is formed with an outer layer convex portion 42 at a position covering the marker 30. The outer diameter D1 of the outer layer convex portion 42 is larger than the outer diameter D2 of the portion adjacent to the outer layer convex portion 42 along the axial direction X of the shaft 2. The difference between the outer diameter D1 of the outer layer convex portion 42 and the outer diameter D2 of the portion adjacent to the outer layer convex portion 42 along the axial direction X (adjacent portion 43), that is, the outer diameter difference (D1 - D2) is less than twice the thickness T of the marker 30.

[0040] The outer diameter D1 of the outer layer convex portion 42 is not particularly limited, preferably 0.7 mm to 1.6 mm, more preferably 1.3 mm to 1.5 mm, still more preferably 1.36 mm to 1.46 mm, and is 1.41 mm in this embodiment.

[0041] The outer diameter D2 of the portion adjacent to the outer layer convex portion 42 is not particularly limited, preferably 0.7 mm to 1.6 mm, more preferably 1.3 mm to 1.5 mm, still more preferably 1.35 mm to 1.45 mm, and is 1.40 mm in this embodiment. The outer diameter difference (D1 - D2) as the difference between the outer diameter D1 and the outer diameter D2 is preferably 0 mm to 0.06 mm, more preferably 0 mm to 0.03 mm, still more preferably 0 mm to 0.01 mm, and is 0.01 mm in this embodiment.

[0042] The constituent material of the outer layer 40 can, for example, be applied to thermoplastic resins such as polyolefins (such as 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, or thermosetting resins such as epoxy resin. An X-ray non-permeable substance can also be mixed in the outer layer 40.

[0043] The socket 3 is liquid-tightly fixed to the base end portion of the shaft 2 by means of an adhesive, heat fusion bonding, or a fastener (not shown). The socket 3 functions as an insertion port for a guide wire and a medical instrument into the lumen 5, an injection port for a liquid medicine, an embolizing substance, a contrast agent, etc. into the lumen 5, etc. In addition, it also functions as a gripping portion when operating the catheter 1. The constituent material of the socket 3 is not particularly limited, and for example, thermoplastic resins such as polycarbonate, polyamide, polysulfone, polyarylate, and isobutylene-butene-styrene copolymer can be appropriately used.

[0044] The anti-bending protector 4 is made of an elastic material provided so as to surround the periphery of the shaft 2, and suppresses the bending of the shaft 2 at the connecting portion between the shaft 2 and the socket 3. As the constituent material of the anti-bending protector 4, for example, natural rubber, silicone resin, etc. can be appropriately used.

[0045] Next, the manufacturing method of the catheter 1 of the present embodiment will be described.

[0046] First, a long-sized core wire having an outer diameter equal to the inner diameter of the inner layer 10 is prepared. Next, the inner layer 10 is formed on the core wire. The inner layer 10 can be formed by extrusion molding or by dip molding. Or the core wire can also be inserted into the inner layer 10 serving as a tube body.

[0047] Then, a reinforcing body 20 is formed so as to cover at least a part of the inner layer 10. The reinforcing body 20 is formed by continuously winding a plurality of wire materials 21 on the inner layer 10 using a braider.

[0048] Next, the marker 30 is disposed outside the inner layer 10 and the reinforcing body 20, and the marker 30 is pressed by a pressing machine so that it bites into the reinforcing body 20. Thus, the reinforcing body 20 is forced from the radially outer side and its diameter is reduced to form a small-diameter portion 22. In addition, the small-diameter portion 22 may not be formed on the marker 30. Then, an outer layer 40 having an outer layer convex portion 42 is formed outside the inner layer 10, the reinforcing body 20, and the marker 30. Thus, the difference between the outer diameter D1 of the portion of the shaft 2 where the marker 30 is disposed and the outer diameter D2 of the portion of the shaft 2 adjacent to the marker 30 along the axial direction X of the shaft 2, that is, the outer diameter difference (D1 - D2), is less than twice the thickness T of the marker 30. In addition, in the present embodiment, the portion adjacent to the marker 30 along the axial direction X refers to the front end side and / or the base end side portion of the marker 30. Further, the difference between the inner diameter D3 of the portion of the shaft 2 adjacent to the marker 30 along the axial direction X of the shaft 2 and the inner diameter D4 of the portion of the shaft 2 where the marker 30 is disposed, that is, the inner diameter difference (D3 - D4), is less than twice the thickness T of the marker 30. The inner diameters D3 and D4 may be equal or may not be equal. 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 may be formed by dip molding. Alternatively, after disposing a tube body that becomes the raw material of the outer layer 40 outside the inner layer 10, the reinforcing body 20, and the marker 30, a heat shrinkable tube is covered on the tube body and heated, thereby forming the outer layer 40. The tube body is softened or melted by heating, and at the same time, it is tightly contacted and joined to the outside of the inner layer 10, the reinforcing body 20, and the marker 30 by the shrinking force of the heat shrinkable tube. Then, the heat shrinkable tube after shrinking is removed.

[0049] After forming the outer layer 40, the core wire is pulled out from the lumen 5 of the inner layer 10. Then, a tube seat 3 and an anti-bending protector 4 are installed on the shaft 2, and other components (such as a front end piece) are installed as needed to complete the catheter 1.

[0050] As described above, the catheter 1 of the present embodiment has a shaft 2, and the shaft 2 has a lumen 5 that communicates from the front end to the base end. The shaft 2 has: a reinforcing body 20 that has a plurality of wire materials 21 that are disposed at least partially between the inner surface 11 of the shaft 2 forming the lumen 5 and the outer surface 41 of the shaft 2 and are woven into a tubular shape; and at least one X-ray non-permeable marker 30 that is disposed between the reinforcing body 20 and the outer surface 41. The difference between the outer diameter D1 of the portion of the shaft 2 where the marker 30 is disposed and the outer diameter D2 of the portion of the shaft 2 adjacent to the marker 30 along the axial direction X of the shaft 2, that is, the outer diameter difference (D1 - D2), is less than twice the thickness of the marker 30. Thus, the outer diameter of the shaft 2 provided with the reinforcing body 20 and the X-ray non-permeable marker 30 is not excessive. Therefore, the marker 30 can be disposed on the shaft 2 provided with the reinforcing body 20, and at the same time, an increase in the thickness of the shaft 2 can be suppressed. By suppressing an increase in the thickness of the shaft 2, the outer diameter of the shaft 2 can be minimized as much as possible, and the inner diameter of the shaft 2 can be maximized as much as possible. Such a catheter 1 is particularly effective when the introduced blood vessel (e.g., the radial artery) is thin and the blood vessel for treatment and diagnosis (e.g., the artery in the lower limb) is thick.

[0051] In addition, the difference (D5 - D6) between the maximum outer diameter D5 of the marker 30 and the maximum outer diameter D6 of the portion of the reinforcing body 20 adjacent to the marker 30 along the axial direction of the shaft 2 is less than twice the thickness T of the marker 30. Thus, the outer diameter of the shaft 2 provided with the reinforcing body 20 and the X-ray non-permeable marker 30 is not excessive, and the inner diameter of the shaft 2 is not too small. Therefore, the marker 30 can be disposed on the shaft 2 provided with the reinforcing body 20, and at the same time, an increase in the thickness of the shaft 2 can be suppressed.

[0052] In addition, it may be that the thickness W1 of the outer layer 40 of the portion of the shaft 2 where the marker 30 is disposed is the same as the thickness W2 of the outer layer 40 of the portion of the shaft 2 adjacent to the marker 30 along the axial direction of the shaft 2. Thus, the thicknesses W1 and W2 of the outer layer 40 are made uniform regardless of the presence or absence of the marker 30, and at the same time, an increase in the thickness of the shaft 2 can be suppressed. Assuming that the thicknesses W1 and W2 of the outer layer 40 are sufficient, the outer layer convex portion 42 based on the presence or absence of the marker 30 may not be formed. Therefore, even if the thicknesses W1 and W2 of the outer layer 40 are thin and uniform, the outer diameter difference (D1 - D2) can be made less than the thickness of the marker 30.

[0053] In addition, the marker 30 has at least one convex portion 32 on at least the inner surface side. Thus, the marker 30 can be firmly fixed to the shaft 2. Therefore, the marker 30 can be prevented from coming off the shaft 2.

[0054] In addition, the effective length of the shaft 2 is 2100 mm or more. Thus, the catheter 1 can easily reach the artery in the lower limb from the artery in the arm.

[0055] In addition, the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, in the above-described embodiment, the number of the markers 30 disposed on the shaft 2 is one, but it may be two or more. In addition, the catheter 1 may also be inserted from a blood vessel other than the artery of the arm. In addition, the catheter 1 may also be used for the treatment and diagnosis of blood vessels other than the arteries of the lower extremities. In addition, the catheter 1 may also be used to insert into the bile duct, trachea, esophagus, urethra, or other biological lumens and body cavities for treatment and diagnosis, etc.

[0056] In addition, as Figure 6 in another modified example shown, the inner diameter D4 of the portion of the shaft 2 where the marker 30 is disposed may be smaller than the inner diameter D3 of the adjacent portion 43 adjacent to the marker 30 in the axial direction X along the shaft 2. Preferably, the inner diameter difference (D3 - D4) between the inner diameter D3 and the inner diameter D4 is less than twice the thickness T of the marker 30. Thus, the inner diameter of the shaft 2 provided with the reinforcing body 20 and the X-ray non-permeable marker 30 will not be too small. Therefore, the marker 30 can be disposed on the shaft 2 provided with the reinforcing body 20 while suppressing an increase in the thickness of the shaft 2. By suppressing an increase in the thickness of the shaft 2, the outer diameter of the shaft 2 can be minimized as much as possible, and the inner diameter of the shaft 2 can be maximized as much as possible. Such a catheter 1 is particularly effective when the blood vessel into which it is introduced (e.g., the radial artery) is thin and the blood vessel for treatment and diagnosis (e.g., the artery of the lower extremity) is thick.

[0057] In addition, it may be that only one of the outer diameter difference (D1 - D2) and the inner diameter difference (D3 - D4) is less than twice the thickness T of the marker 30. Or it may be that both the outer diameter difference (D1 - D2) and the inner diameter difference (D3 - D4) are less than twice the thickness T of the marker 30.

[0058] In addition, it may be that the difference (D5 - D6) between the maximum outer diameter D5 of the marker 30 and the maximum outer diameter D6 of the portion of the reinforcing body 20 adjacent to the marker 30 in the axial direction of the shaft 2, the outer diameter difference (D1 - D2), and the inner diameter difference (D3 - D4) are all less than twice the thickness T of the marker 30.

[0059] In addition, this application claims priority based on Japanese Patent Application No. 2020-102078 filed on June 12, 2020, the disclosure of which is incorporated herein by reference in its entirety.

[0060] Explanation of Reference Numerals

[0061] 1 Catheter

[0062] 2 Shaft

[0063] 3 Hub

[0064] 4 Anti-bending Protector

[0065] 5 lumens

[0066] 10 inner layer

[0067] 11 inner surface

[0068] 20 reinforcing body

[0069] 21 wire material

[0070] 22 small diameter part

[0071] 30 mark

[0072] 31 recess

[0073] 32 protrusion

[0074] 40 outer layer

[0075] 41 outer surface

[0076] 42 outer layer protrusion

[0077] 43 adjacent part

[0078] D1 Outer diameter of the outer layer protrusion

[0079] D2 Outer diameter of the part adjacent to the outer layer protrusion

[0080] D3 Inner diameter of the part of the axis adjacent to the mark

[0081] D4 Inner diameter of the part of the axis where the mark is arranged

[0082] D5 Maximum outer diameter of the mark

[0083] D6 Outer diameter of the part adjacent to the mark

[0084] T Thickness of the mark

[0085] X Axis direction.

Claims

1. A catheter having a shaft with a lumen communicating from a distal end to a proximal end, wherein the catheter is characterized in that the shaft has: a reinforcing body having a plurality of wire materials disposed at least partially between an inner surface and an outer surface of the shaft forming the lumen and woven into a tubular shape; and at least one X-ray non-permeable marker disposed between the reinforcing body and the outer surface, at least one of an outer surface or an inner surface of a portion of the shaft where the marker is disposed protrudes radially, an outer diameter difference is defined as a difference between an outer diameter of a portion of the shaft where the marker is disposed and an outer diameter of a portion of the shaft adjacent to the marker along the axial direction of the shaft, and an inner diameter difference is defined as a difference between an inner diameter of a portion of the shaft adjacent to the marker along the axial direction of the shaft and an inner diameter of a portion of the shaft where the marker is disposed, the larger one of the outer diameter difference and the inner diameter difference is less than twice the thickness of the marker, the marker has a plurality of randomly arranged convex portions at least on the inner surface side.

2. The catheter according to claim 1, wherein a thickness of an outer layer of a portion of the shaft where the marker is disposed is the same as a thickness of an outer layer of a portion of the shaft adjacent to the marker along the axial direction of the shaft.

3. The catheter according to claim 1 or 2, wherein an effective length of the shaft is 2100 mm or more.

4. The catheter according to claim 1 or 2, wherein a thickness of the marker is 0.02 mm to 0.1 mm.

5. A catheter having a shaft with a lumen communicating from a distal end to a proximal end, wherein the catheter is characterized in that the shaft has: a reinforcing body having a plurality of wire materials disposed at least partially between an inner surface and an outer surface of the shaft forming the lumen and woven into a tubular shape; and at least one X-ray non-permeable marker disposed between the reinforcing body and the outer surface, at least one of an outer surface or an inner surface of a portion of the shaft where the marker is disposed protrudes radially, a difference between a maximum outer diameter of the marker and a maximum outer diameter of a portion of the reinforcing body adjacent to the marker along the axial direction of the shaft is less than twice the thickness of the marker, the marker has a plurality of randomly arranged convex portions at least on the inner surface side.

6. The catheter according to claim 5, wherein a thickness of an outer layer of a portion of the shaft where the marker is disposed is the same as a thickness of an outer layer of a portion of the shaft adjacent to the marker along the axial direction of the shaft.

7. The catheter according to claim 5 or 6, wherein an effective length of the shaft is 2100 mm or more.

8. The catheter according to claim 5 or 6, wherein a thickness of the marker is 0.02 mm to 0.1 mm.

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