catheter

Abstract

The present invention provides a catheter that can prevent entanglement between the catheter and the guidewire inserted into the catheter. [Solution] A catheter 1 having a longitudinal direction x and a radial direction y, comprising: a catheter body 2 having a first inner surface 12 defining a first lumen 11 and a second inner surface 22 defining a second lumen 21 whose proximal end 21A is located distal to the first lumen 11 and does not move in the longitudinal direction x relative to the first lumen 11; and a marker portion 60 disposed on the outer surface of the proximal part of the catheter body 2 and extending in the longitudinal direction x, the marker portion 60 indicating the alignment direction 2P of the first lumen 11 and the second lumen 21 in the radial direction y at the most proximal position 2M among the locations where the first inner surface 12 and the second inner surface 22 are present around the entire circumference.

Description

Technical Field

[0001] The present invention relates to a catheter.

Background Art

[0002] A catheter that can be inserted into blood vessels or the like to examine and treat a diseased part of the human body is used. Depending on the procedure, a so-called Rx type (rapid exchange type) catheter having a cross-section in which two lumens are arranged side by side may be used. In such a catheter, one lumen functions as a guide wire lumen, and the other lumen functions as a delivery lumen for other medical tools. Patent Document 1 discloses that in an Rx type catheter, except for the guide wire lumen, the guide wire is configured to be disposed outside the catheter.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] An Rx type catheter having a cross-section in which two lumens are arranged side by side is delivered to a diseased part by being inserted into a guiding catheter that has been previously inserted into the body. However, when inserting and removing the catheter from the guiding catheter, the catheter and the guide wire inserted into the lumen of the catheter may become entangled in the guiding catheter, resulting in deterioration of the delivery performance of the catheter or damage to the catheter. Therefore, an object of the present invention is to provide a catheter that can suppress entanglement between the catheter and the guide wire inserted into the catheter.

Means for Solving the Problems

[0005] The catheter according to an embodiment that has been able to solve the above problems is as follows. [1] A catheter having a longitudinal direction and a radial direction, A catheter body having a first inner surface defining a first lumen, and a second inner surface defining a second lumen whose proximal end is distal to the first lumen and which does not move in the longitudinal direction relative to the first lumen, A catheter comprising: a marker portion disposed on the outer surface of the proximal portion of the catheter body and extending in the longitudinal direction, the marker portion indicating the radial alignment direction of the first lumen and the second lumen at the most proximal position among the locations where the first inner surface is present around its entire circumference and the second inner surface is present around its entire circumference.

[0006] Furthermore, the catheter according to the embodiment is preferably one of the following [2] to

[17] . [2] In the longitudinal direction, the catheter body has a first portion which is inserted into the medical device and a second portion which is located proximal to the first portion and is not inserted into the medical device. The marker portion is the catheter described in [1], which is located in the second part. [3] The catheter body has a first cylindrical portion having the first lumen, The first cylindrical portion has a first section located proximal to the second lumen in the longitudinal direction, The marker portion is located in the first section of the first cylindrical portion of the catheter according to [1] or [2]. [4] The catheter according to [3], wherein the marker portion is arranged from the distal end to the proximal end of the first section of the first tube portion. [5] The catheter according to any one of the following [1] to [4], wherein the marker portion is located on the outer surface of the proximal portion of the first tube, on the side furthest from the second lumen. [6] The catheter according to any one of the items [1] to [4], wherein the marker portion is located on the outer surface of the proximal portion of the first tube, on the side closer to the second lumen. [7] The catheter according to any one of the items [1] to [6], wherein the marker portion is located only within a range of ±45° in the circumferential direction of the first cylindrical portion, centered on the alignment direction of the first lumen and the second lumen. [8] The catheter body has a second tube portion having the second lumen, The catheter according to any one of the items [1] to [7], wherein the marker portion is not provided in the second tube portion. [9] The catheter body comprises a first tube portion having the first lumen, and a third tube portion enclosing the first tube portion proximal to the second lumen, The marker portion is arranged on the outer surface of the third cylindrical portion, the catheter according to any one of [1] to [8].

[10] The first cylindrical portion has a first section located proximal to the second lumen in the longitudinal direction, The catheter as described in [9], wherein the marker portion is located in the portion of the third cylindrical portion that overlaps with the first section in the longitudinal direction.

[11] The catheter according to [9] or

[10] , wherein the marker portion is located in the third cylindrical portion, from the distal end to the proximal end of the portion that overlaps the first section with the longitudinal portion.

[12] The catheter according to any one of the following [9] to

[11] , wherein the marker portion is located on the outer surface of the proximal portion of the third tube, on the side furthest from the second lumen.

[13] The catheter according to any one of the following [9] to

[12] , wherein the marker portion is located on the outer surface of the proximal portion of the third tube, on the side closer to the second lumen.

[14] The catheter according to any one of the items [9] to

[13] , wherein the marker portion is located only within a range of ±45° in the circumferential direction of the third cylindrical portion, centered on the alignment direction of the first lumen and the second lumen.

[15] The catheter according to any one of the items [1] to

[14] , wherein the marker portion is a raised ridge arranged on the outer surface of the catheter body.

[16] The catheter according to any one of the items [1] to

[14] , wherein the marker portion is a groove located on the outer surface of the catheter body.

[17] The catheter according to any one of [1] to

[14] , wherein the marker portion includes a plurality of markers arranged along the longitudinal direction. [Effects of the Invention]

[0007] With the above catheter, even if the entire portion of the catheter containing the second lumen is inserted into a medical device such as a guiding catheter, the operator can estimate the alignment direction of the first and second lumens from the marker portion. This prevents entanglement between the catheter and medical tools such as guidewires inserted into the second lumen. Furthermore, because entanglement is prevented, an improvement in the pushing force of other medical tools inserted into the first lumen can also be expected. [Brief explanation of the drawing]

[0008] [Figure 1] Figure 1 is a schematic diagram of a catheter according to an embodiment of the present invention, and the catheter is a schematic diagram showing an example of a dual-lumen catheter. [Figure 2] Figure 2 is a schematic diagram showing the catheter in use as shown in Figure 1, illustrating the state in which the guidewire, inserted through the guiding catheter, is inserted into the second lumen of the catheter. [Figure 3] Figure 3 is a schematic diagram showing the usage of the catheter in Figure 1, and depicts the catheter in Figure 2 inserted into the guiding catheter. [Figure 4] Figure 4 is a longitudinal cross-sectional view of the distal end of the catheter shown in Figure 1. [Figure 5] Figure 5 is a longitudinal cross-sectional view of the catheter shown in Figure 1, near the proximal end of the second lumen. [Figure 6]Figure 6 is a cross-sectional view taken along line VI-VI of the catheter shown in Figure 4. [Figure 7] Figure 7 is a cross-sectional view taken along line VII-VII of the catheter shown in Figure 5. [Figure 8] Figure 8 is a cross-sectional view of the catheter shown in Figure 7 with the arrangement direction of the first lumen and the second lumen added. [Figure 9] Figure 9 is a cross-sectional view showing a modified example of the catheter shown in Figure 7. [Figure 10] Figure 10 is a schematic diagram showing a modified example of the catheter shown in Figure 1, and is a schematic diagram showing an example of a dual-lumen catheter. [Figure 11] Figure 11 is a schematic diagram showing a modified example of the catheter shown in Figure 1, and is a schematic diagram showing an example of a balloon catheter. [Figure 12] Figure 12 is an end-face view of the cross-section taken along line XII-XII of the catheter shown in Figure 11. [Figure 13] Figure 13 is an end-face view of the cross-section taken along line XIII-XIII of the catheter shown in Figure 11. [Figure 14] Figure 14 is an end-face view of the cross-section of the catheter shown in Figure 13 with the arrangement direction of the first lumen and the second lumen added. [Figure 15] Figure 15 is an enlarged cross-sectional view of the proximal portion of the catheter body of the catheter shown in Figure 1. [Figure 16] Figure 16 is a cross-sectional view taken along line XVI-XVI of the catheter shown in Figure 15, and is a cross-sectional view showing the marker portion. [Figure 17] Figure 17 is a cross-sectional view showing a modified example of the marker portion of the catheter shown in Figure 15. [Figure 18] Figure 18 is a cross-sectional view showing another modified example of the marker portion of the catheter shown in Figure 15. [Figure 19] Figure 19 is a cross-sectional view taken along line XIX-XIX of the catheter shown in Figure 18, and is a cross-sectional view showing the marker portion. [Figure 20] Figure 20 is a cross-sectional view showing yet another modified example of the marker portion of the catheter shown in Figure 15. [Figure 21]Figure 21 is a side view showing yet another modification of the marker portion of the catheter shown in Figure 15. [Figure 22] Figure 22 is a side view (partially a cross-sectional view) showing yet another modified example of the catheter marker section shown in Figure 15. [Figure 23] Figure 23 is a cross-sectional view of the catheter shown in Figure 22, specifically the section between XXIII and XXIII, and shows the marker portion. [Figure 24] Figure 24 is a cross-sectional view showing yet another modification of the marker portion of the catheter shown in Figure 15. [Figure 25] Figure 25 is a cross-sectional view of the catheter shown in Figure 24, specifically the XXV-XXV section, and shows the marker portion. [Figure 26] Figure 26 is a schematic diagram showing the arrangement of the marker portion of the catheter in Figure 15. [Figure 27] Figure 27 is a schematic diagram showing a modified arrangement of the catheter marker portion shown in Figure 26. [Figure 28] Figure 28 is a schematic diagram showing the arrangement of the marker portion of the catheter in Figure 24. [Figure 29] Figure 29 is a schematic diagram showing a modified arrangement of the catheter marker portion shown in Figure 28. [Modes for carrying out the invention]

[0009] The present invention will be described in more detail below based on the embodiments described below. However, the present invention is not limited by the embodiments described below, and it is certainly possible to implement it with appropriate modifications within the scope that is consistent with the spirit of the preceding and following descriptions, and all such modifications are included within the technical scope of the present invention. In addition, hatching and component reference numerals may be omitted in the drawings for convenience, in which case please refer to the specification or other drawings. Furthermore, the dimensions of various components in the drawings may differ from the actual dimensions, as priority has been given to helping to understand the features of the present invention.

[0010] The catheter according to this embodiment is a catheter having a longitudinal direction and a radial direction, and comprises a catheter body having a first inner surface defining a first lumen and a second inner surface defining a second lumen whose proximal end is located distal to the first lumen and does not move in the longitudinal direction relative to the first lumen, and a marker portion disposed on the outer surface of the proximal part of the catheter body and extending in the longitudinal direction, the marker portion indicating the alignment direction of the first lumen and the second lumen in the radial direction at the most proximal position among the locations where the first inner surface and the second inner surface are present around the entire circumference. With the above catheter, even if the entire portion of the catheter having the second lumen is inserted into a guiding catheter, the operator can estimate the alignment direction of the first lumen and the second lumen from the marker portion, thus preventing entanglement between the guidewire inserted into the second lumen and the catheter. Furthermore, because entanglement is prevented, an improvement in the pushing force of other medical tools inserted into the first lumen can be expected.

[0011] A catheter according to an embodiment will be described with reference to Figures 1 to 29. Figure 1 is a schematic diagram of a catheter according to an embodiment of the present invention, and is a schematic diagram showing an example of a dual-lumen catheter. Figure 2 is a schematic diagram showing the catheter of Figure 1 in use, and shows the state in which a guidewire inserted through a guiding catheter is inserted into the second lumen of the catheter. Figure 3 is a schematic diagram showing the catheter of Figure 1 in use, and shows the state in which the catheter of Figure 2 is inserted into a guiding catheter. Figure 4 is a longitudinal cross-sectional view of the distal end of the catheter of Figure 1. Figure 5 is a longitudinal cross-sectional view of the catheter of Figure 1 near the proximal end of the second lumen. Figure 6 is a cross-sectional view of the catheter of Figure 4 along line VI-VI. Figure 7 is a cross-sectional view of the catheter of Figure 5 along line VII-VII. Figure 8 is a cross-sectional view of the catheter of Figure 7 with the alignment of the first and second lumens added. Figure 9 is a cross-sectional view showing a modified example of the catheter of Figure 7. Figure 10 is a schematic diagram showing a modified version of the catheter in Figure 1, where the catheter is an example of a dual-lumen catheter. Figure 11 is a schematic diagram showing a modified version of the catheter in Figure 1, where the catheter is an example of a balloon catheter. Figure 12 is an end view of the XII-XII section of the catheter in Figure 11. Figure 13 is an end view of the XIII-XIII section of the catheter in Figure 11. Figure 14 is an end view of the catheter in Figure 13 with the alignment of the first and second lumens added. Figure 15 is an enlarged cross-sectional view of the proximal part of the catheter body of the catheter in Figure 1. Figure 16 is an XVI-XVI cross-sectional view of the catheter in Figure 15, showing the marker section. Figure 17 is a cross-sectional view showing a modified version of the marker section of the catheter in Figure 15. Figure 18 is a cross-sectional view showing another modified version of the marker section of the catheter in Figure 15. Figure 19 is an XIX-XIX cross-sectional view of the catheter in Figure 18, showing the marker section. Figure 20 is a cross-sectional view showing yet another modification of the marker portion of the catheter in Figure 15. Figure 21 is a side view showing yet another modification of the marker portion of the catheter in Figure 15. Figure 22 is a side view (partial cross-sectional view) showing yet another modification of the marker portion of the catheter in Figure 15.Figure 23 is a cross-sectional view of the catheter from Figure 22, between XXIII and XXIII, showing the marker portion. Figure 24 is a cross-sectional view showing yet another modified example of the marker portion of the catheter from Figure 15. Figure 25 is a cross-sectional view of the catheter from Figure 24, between XXV and XXV, showing the marker portion. Figure 26 is a schematic diagram showing the arrangement of the marker portion of the catheter from Figure 15. Figure 27 is a schematic diagram showing a modified example of the arrangement of the marker portion of the catheter shown in Figure 26. Figure 28 is a schematic diagram showing the arrangement of the marker portion of the catheter from Figure 24. Figure 29 is a schematic diagram showing a modified example of the arrangement of the marker portion of the catheter shown in Figure 28. Note that in Figures 15 and 16, as shown in Figures 1, 10, 11, etc., the catheter 1 comprises a catheter body 2 and a marker portion 60.

[0012] Catheter 1 is used for treatment and examination by inserting, for example, the catheter body 2 into a body cavity such as a patient's blood vessel or digestive tract. By inserting the catheter body 2 into the lumen of a medical device 70, such as a guiding catheter, which is inserted into the body beforehand, and moving the catheter body 2 distally, the catheter body 2 can be delivered to the lesion. Specifically, a guiding catheter as a medical device 70 as shown in Figure 2 is inserted into the body, a guidewire 75 is inserted from the proximal side of the guiding catheter (for example, a Y-connector as shown in Figure 2), and catheter 1 is inserted into the guiding catheter along the guidewire 75 as shown in Figure 3. Although not shown, by protruding catheter 1 from the distal end of the guiding catheter, treatment and other procedures can be performed on the lesion using catheter 1 or a medical tool inserted inside catheter 1. Catheter 1 is preferably a so-called rapid exchange type catheter.

[0013] As can be understood from Figure 1, etc., the catheter 1 has a longitudinal direction x and a radial direction y, and preferably also has a circumferential direction z, as shown in Figure 6, etc. The longitudinal direction x can also be called the longitudinal axis direction. The catheter 1 preferably has a distal end and a proximal end in the longitudinal direction x. The proximal side of the catheter 1 refers to the direction toward the user or operator's proximal side with respect to the longitudinal direction x of the catheter 1, and the distal side refers to the opposite direction from the proximal side, i.e., the direction toward the target of treatment. Note that in Figures 1, 4, 5, 10, 11, etc., the right side of the figure is the proximal side and the left side of the figure is the distal side. The radial direction y of the catheter 1 refers to the radial direction of the catheter 1, and in the radial direction y, inward refers to the direction toward the longitudinal axis center of the catheter 1, and outward refers to the direction extending radially from the longitudinal axis center on the opposite side from inward. The circumferential direction z of the catheter 1 refers to the direction around the longitudinal axis. In the following, when the length of each component of catheter 1 is divided into two equal parts along its longitudinal direction x, the proximal side may be referred to as the proximal portion, and the distal side as the distal portion.

[0014] The catheter body 2 is preferably a tubular structure having at least two lumens. The catheter body 2 may be a part of the catheter 1 other than the handle 8. The catheter body 2 may be provided with strain relief to prevent kinking of the proximal part of the catheter body 2.

[0015] The catheter body 2 is preferably flexible. Examples of the catheter body 2 include a resin tube, a metal tube, a hollow body formed by arranging wires in a predetermined pattern, a hollow body with at least one of its inner or outer surfaces coated with resin, or a combination thereof, for example, a combination of these connected in the longitudinal direction x. The resin tube can be manufactured, for example, by extrusion molding. Examples of hollow bodies with wires arranged in a predetermined pattern include a cylindrical body having a mesh structure by simply crossing or weaving the wires, and a coil in which the wires are wound. The wires may be one or more single wires, or one or more stranded wires. The type of mesh structure is not particularly limited, nor are the number of turns or density of the coil particularly limited. The mesh structure or coil may be formed at a constant density over the entire longitudinal direction x of the first cylindrical portion 10 and / or the second cylindrical portion 20, or it may be formed so that the density differs depending on the position in the longitudinal direction x.

[0016] The material constituting the catheter body 2 is preferably resin, metal, or a combination of resin and metal. Using resin makes it easier to impart flexibility and elasticity to the shaft. Using metal improves the ease of insertion of the catheter 1 into the vascular lumen.

[0017] Examples of resins that make up the catheter body 2 include polyamide resins such as polyamide, polyamide elastomer, and polyether polyamide; polyester resins such as polyethylene terephthalate and polyester elastomer; polyurethane resins such as polyurethane and polyurethane elastomer; polyolefin resins such as polyethylene, polypropylene, and ethylene-propylene copolymer; fluorine resins such as PTFE, PFA, and ETFE; aromatic polyether ketone resins such as polyether ether ketone; polyphenylene sulfide resin; polystyrene resin; vinyl chloride resin; silicone resin; natural rubber; synthetic rubber; and polyimide resin. These may be used individually or in combination of two or more. Examples of polyamides include nylon 12 and nylon 11. Examples of polyamide elastomers include polyether ester amide elastomer and polyamide ether elastomer.

[0018] Examples of metals that make up the catheter body 2 include stainless steel such as SUS304 and SUS316, carbon steel, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, nickel-titanium alloy, cobalt-chromium alloy, or combinations thereof.

[0019] The length of the catheter body 2 in the longitudinal direction x is several to tens of times longer than the length of the handle 8 in the same direction, for example, about 500 mm to 2000 mm. The outer diameter of the catheter body 2 should be, for example, about 0.6 mm to 5 mm.

[0020] As shown in Figures 1, 10, and 11, the catheter body 2 has a first lumen 11 and a second lumen 21, with the proximal end 21A of the second lumen 21 being located distally to that of the first lumen 11. More specifically, it is preferable that the proximal end 21A of the second lumen 21 is located distally to that of the proximal end of the first lumen 11.

[0021] As shown in Figures 6, 7, 12, and 13, the catheter body 2 has a first inner surface 12 that defines the first lumen 11 and a second inner surface 22 that defines the second lumen 21.

[0022] The first lumen 11 is preferably extended in the longitudinal direction x. The second lumen 21 is preferably extended in the longitudinal direction x. The second lumen 21 is preferably shorter in the longitudinal direction x than the first lumen 11. As shown in Figures 2 to 3, it is preferable that a guide wire 75 is inserted through the second lumen 21. Although not shown, it is preferable that a medical tool is inserted through the first lumen 11. It is more preferable that a medical tool other than the guide wire 75 is inserted through the first lumen 11.

[0023] As can be seen from Figures 4, 5, and 11, it is preferable that the first lumen 11 and the second lumen 21 do not move relative to each other in the longitudinal direction x. In the radial direction y, the first lumen 11 and the second lumen 21 may or may not move relative to each other. As shown in Figure 11, the first lumen 11 and the second lumen 21 may be configured not to move in a portion of the longitudinal direction x, and to be movable in other portions of the longitudinal direction x.

[0024] As shown in Figures 7, 8, 13, and 14, in catheter 1, the first lumen 11 and the second lumen 21 are aligned radially y in at least a portion of the longitudinal x direction of the catheter body 2. More specifically, in the catheter body 2, the first lumen 11 and the second lumen 21 are aligned radially y at the most proximal position 2M (Figures 1, 5, and 10) where the first inner surface 12 and the second inner surface 22 are present around the entire circumference.

[0025] As shown in Figures 4, 5, and 11, the catheter body 2 may have a first cylindrical portion 10 having a first lumen 11. Alternatively, the catheter body 2 may have a second cylindrical portion 20 having a second lumen 21.

[0026] As shown in Figures 4 and 5, in catheter 1, the first cylindrical portion 10 and the second cylindrical portion 20 may be aligned in the radial direction y. In that case, the first cylindrical portion 10 and the second cylindrical portion 20 may or may not be fixed to each other.

[0027] As shown in Figure 4, it is preferable that the first cylindrical portion 10 has a distal opening 10G that communicates with the first lumen 11. The distal opening 10G can be used as an entrance or exit for medical tools or guide wires.

[0028] As shown in Figure 4, it is preferable that the second cylindrical portion 20 has a distal opening 20G that communicates with the second lumen 21. The distal opening 20G can be used as the entrance or exit for the guide wire 75.

[0029] As shown in Figure 5, it is preferable that the second cylindrical portion 20 has a proximal opening 20F that communicates with the second lumen 21. The proximal opening 20F can be used as the entrance or exit for the guide wire 75.

[0030] The structure of the first tube portion 10 and / or the second tube portion 20 can be described by referring to the description of the structure of the catheter body 2, but it is preferable that both the first tube portion 10 and the second tube portion 20 are made of resin tubing. The constituent materials of the first tube portion 10 and / or the second tube portion 20 can be described by referring to the description of the constituent materials of the catheter body 2. The first tube portion 10 and the second tube portion 20 may be made of the same material or of different materials.

[0031] The first cylindrical portion 10 and the second cylindrical portion 20 each preferably have one or more layers extending in the longitudinal direction x, and more preferably have multiple layers. The multiple layers preferably have an inner layer and an outer layer that encloses at least a portion of the inner layer. The multiple layers may further have an intermediate layer located between the inner layer and the outer layer. The number of intermediate layers is not limited to one, but may be two or more. It is preferable that each of the multiple layers contains a different material from the adjacent layer.

[0032] The intermediate layer preferably contains a different material from the inner or outer layer, but it may also contain the same material as the inner or outer layer.

[0033] It is preferable that the inner layer, intermediate layer, and outer layer are fixed to the adjacent layer. This makes it less likely for each layer to twist or warp. Examples of fixing methods include welding and bonding. Although not shown in the figures, a reinforcing member may be placed as the intermediate layer.

[0034] As shown in Figure 1, the first lumen 11 and the second lumen 21 may be aligned radially y over the entire length x of the section where both the first lumen 11 and the second lumen 21 are present. When using such a catheter, the catheter 1 is advanced into the body by inserting a guidewire 75, which has been placed in the body beforehand, into the second lumen 21 and guiding the catheter body 2 along it. Next, a medical tool is inserted into the first lumen 11 of the catheter body 2 and advanced into the body, allowing a procedure using the medical tool to be performed. As shown in Figure 1, the catheter 1 may also be a dual-lumen catheter.

[0035] In the catheter 1 shown in Figure 1, it is preferable that the second lumen 21 is located outside the first lumen 11. More preferably, the second lumen 21 is located outside the first lumen 11 along its entire longitudinal direction x.

[0036] As shown in Figures 1 and 11, it is preferable that the distal end 21B of the second lumen 21 is located distal to the distal end 11B of the first lumen 11. Although not shown, the distal end 21B of the second lumen 21 may be located proximal to the distal end 11B of the first lumen 11.

[0037] As shown in Figures 1, 10, and 11, the first lumen 11 may extend to the proximal end of the catheter body 2.

[0038] As shown in Figures 1, 4, and 5, the catheter body 2 may have an outer member 30 that extends in the longitudinal direction x and has a portion that encloses at least a part of the first cylindrical portion 10 and at least a part of the second cylindrical portion 20. The outer member 30 can protect the first cylindrical portion 10 and the second cylindrical portion 20, and can also make it easier to prevent the guide wire 75 from piercing through from inside the catheter 1.

[0039] The outer member 30 preferably contains at least one selected from the group consisting of polyethylene, polyurethane, polyurethane-based thermoplastic elastomer, styrene-based thermoplastic elastomer, polyamide elastomer, and polyamide. Of these, at least one selected from the group consisting of polyurethane and polyamide elastomer is more preferred.

[0040] The outer member 30 may have a columnar shape or a cylindrical shape.

[0041] As shown in Figures 1, 4, and 5, the outer member 30 has a columnar shape extending in the longitudinal direction x and containing resin, and at least a portion of the first cylindrical portion 10 and at least a portion of the second cylindrical portion 20 may be arranged within the columnar body 35. This makes it easier to maintain the shape of the first lumen 11 and the second lumen 21 extending in the longitudinal direction x even if the catheter body 2 is curved. It is preferable that the columnar body 35 is arranged at least between the proximal end 20A and the distal end 20B of the second cylindrical portion 20. The resin of the columnar body 35 may be present between the first cylindrical portion 10 and the second cylindrical portion 20.

[0042] The shape of the column 35 is preferably cylindrical, elliptical, or rounded polygonal column, and more preferably cylindrical or elliptical. This makes it easier to insert the catheter 1 into the body.

[0043] The columnar body 35 may be formed by covering a resin tube with a first cylindrical portion 10 and a second cylindrical portion 20 that are superimposed in the radial direction y, heating and welding them together, or the columnar body may be formed by injection molding of the first cylindrical portion 10 and the second cylindrical portion 20 that are superimposed in the radial direction y.

[0044] As shown in Figure 4, it is preferable that the distal end 30B of the outer member 30 is located distal to the distal end 20B of the second cylindrical portion 20. By arranging the outer member 30, which is made of a flexible material, in this manner, the flexibility of the portion distal to the distal end 20B of the second cylindrical portion 20 can be improved.

[0045] Preferably, at least a portion of the inner surface 30E of the outer member 30 is fixed to the outer surface 10D of the first cylindrical portion 10 and the outer surface 20D of the second cylindrical portion 20. This makes the outer member 30 less likely to twist or warp. Examples of fixing methods include welding and bonding.

[0046] As shown in Figure 5, the catheter 1 may further have a third cylindrical portion 40 extending in the longitudinal direction x. Preferably, the third cylindrical portion 40 encloses the first cylindrical portion 10 proximal to the second lumen 21. More preferably, the third cylindrical portion 40 encloses the first cylindrical portion 10 proximal to the proximal end 21A of the second lumen 21. In particular, it is preferable that the third cylindrical portion 40 has a third lumen 41 extending in the longitudinal direction x, and that a part of the first cylindrical portion 10 is located in the third lumen 41. The third cylindrical portion 40 can form a double-tube structure (coaxial structure), which can improve the transmission of pushing force while protecting the first cylindrical portion 10. Specifically, it is preferable that the third cylindrical portion 40 has a fixed portion fixed to the first cylindrical portion 10 at its distal end and an unfixed portion that is not fixed to the first cylindrical portion 10 proximal to the fixed portion. Furthermore, it is preferable that the third cylindrical portion 40 has a fixing portion at its proximal end that is fixed to the handle 8.

[0047] The third cylindrical portion 40 is preferably located proximal to the proximal end 20A of the second cylindrical portion 20. This allows for a reduction in the outer diameter of the third cylindrical portion 40.

[0048] The third cylindrical portion 40 preferably contains the same resin as the outer member 30 or a harder resin, and more preferably a harder resin. A harder resin can improve pushability. Furthermore, it is preferable that the distal end of the third cylindrical portion 40 and the proximal end of the outer member 30 are fixed to each other.

[0049] The structure of the third tube portion 40 can be described by referring to the description of the structure of the catheter body 2. The constituent materials of the third tube portion 40 can be described by referring to the description of the constituent materials of the catheter body 2.

[0050] As shown in Figure 9, in the catheter 1, the outer member 30 is tubular and has a lumen 31 extending in the longitudinal direction x, and it is preferable that at least a part of the first tubular portion 10 and at least a part of the second tubular portion 20 are arranged in the lumen 31. This protects the first tubular portion 10 and the second tubular portion 20, and the gaps between the outer member 30 and the first tubular portion 10, and the gaps between the outer member 30 and the second tubular portion 20 allow each tubular portion to move to some extent, thereby releasing the force of the guide wire 75 from inside the catheter 1, and as a result, it is easier to prevent the guide wire 75 from puncturing the catheter. It is preferable that the distal end of the first tubular portion 10 is fixed to the outer member 30. It is preferable that at least one of the distal end and proximal end of the second tubular portion 20 is fixed to the outer member 30. This makes the tubular outer member 30 less likely to twist or bend. Within the cylindrical outer member 30, the first cylindrical portion 10 and the second cylindrical portion 20 may or may not be fixed to each other.

[0051] Unlike the catheter body 2 in Figure 1, the catheter body 2 does not necessarily have a third tube portion 40, as shown in Figure 10. In the catheter body 2 of Figure 1, the third tube portion 40 is positioned at the outermost edge in the radial direction y proximal to the second lumen 21, so the third tube portion 40 is exposed and the first tube portion 10 is not exposed. On the other hand, in the catheter body 2 of Figure 10, the first tube portion 10 is positioned at the outermost edge in the radial direction y proximal to the second lumen 21, so the first tube portion 10 is exposed.

[0052] As shown in Figures 6 and 7, it is preferable that the first cylindrical portion 10 and the second cylindrical portion 20 of the catheter body 2 are fixed to each other. This makes it possible to configure the catheter so that the first lumen 11 and the second lumen 21 do not move relative to each other.

[0053] As shown in Figure 9, the first cylindrical portion 10 and the second cylindrical portion 20 do not need to be fixed to each other in the radial direction y. Since each cylindrical portion can move in the radial direction y, the force of the guide wire 75 from inside the catheter 1 can be released, and as a result, it is easier to prevent the guide wire 75 from puncturing the catheter.

[0054] As shown in Figures 4-7, 11, and 13, it is preferable that the outer surface 10D of the first cylindrical portion 10 and the outer surface 20D of the second cylindrical portion 20 are fixed directly or indirectly in the radial direction y. This makes the second cylindrical portion 20 less prone to twisting or bending. Examples of fixing methods include welding and bonding. In Figures 4-7, the outer surface 10D of the first cylindrical portion 10 is fixed to the outer surface 20D of the second cylindrical portion 20 via an outer member 30. In Figure 11, the outer surface 10D of the first cylindrical portion 10 is fixed to the outer surface 20D of the second cylindrical portion 20 via a connecting tube 57. The connecting tube 57 is preferably, for example, a resin tube, but the structure and constituent materials of the connecting tube 57 can be found in the description of the structure and constituent materials of the catheter body 2.

[0055] As shown in Figures 5 and 11, the catheter body 2 may be directly or indirectly fixed at the most proximal position 2M among the locations where the first inner surface 12 and the second inner surface 22 are present around its entire circumference, with the outer surface 10D of the first cylindrical portion 10 and the outer surface 20D of the second cylindrical portion 20 being fixed together.

[0056] As shown in Figures 11 and 12, at the most distal position 2N among the locations where the first inner surface 12 and the second inner surface 22 are present around their entire circumference, the first lumen 11 may be enclosed within the second lumen 21. As shown in Figure 11, the catheter body 2 has a distal shaft 45 and a proximal shaft 46, with a balloon 50 positioned at the distal end of the distal shaft 45, and the distal shaft 45 may be composed of a first cylindrical portion 10 and a second cylindrical portion 20. Thus, the catheter body 2 may be a balloon catheter. The balloon catheter may be a balloon catheter for stent delivery. In that case, a stent may be mounted on the deflated balloon of the balloon catheter. As shown in Figure 11, at the most distal position 2N among the locations where the first inner surface 12 and the second inner surface 22 are present around their entire circumference, the second cylindrical portion 20 is positioned in the first lumen 11 of the first cylindrical portion 10. The second lumen 21 of the second tube portion 20 can function as an insertion passage for a guidewire 75 that guides the advancement of the catheter body 2. The space between the first tube portion 10 and the second tube portion 20 can function as a flow path for the balloon inflation fluid. When the catheter body 2 has a first tube portion 10 and a second tube portion 20, the second tube portion 20 can extend from the distal end of the first tube portion 10 and penetrate distal to the balloon 50, with the distal end of the balloon 50 joined to the second tube portion 20 and the proximal end of the balloon 50 joined to the first tube portion 10.

[0057] The first cylindrical portion 10 may constitute the proximal shaft 46. That is, the distal shaft 45 and the proximal shaft 46 may be made of the same material. On the other hand, the distal shaft 45 and the proximal shaft 46 may be made of different materials. If the distal shaft 45 and the proximal shaft 46 are made of different materials, the proximal shaft 46 may be made of resin or metal.

[0058] The balloon 50 is formed in a cylindrical shape having a longitudinal direction and a radial direction. The radial direction of the balloon 50 is the direction perpendicular to the longitudinal direction and means the direction extending radially from the center of the balloon 50. The balloon 50 also has a circumferential direction, which is the direction along the outer circumference of the expanded balloon 50 in a cross section perpendicular to the longitudinal direction of the balloon 50. In this document, the longitudinal, radial, and circumferential directions of the balloon 50 are described as coinciding with the longitudinal direction x, radial direction y, and circumferential direction z of the catheter body 2, but these directions may be different from each other.

[0059] As shown in Figure 11, it is preferable that the balloon 50 has a straight tube section 51, a distal tapered section 52 located distal to the straight tube section 51, and a proximal tapered section 53 located proximal to the straight tube section 51, with respect to the longitudinal direction x. The straight tube section 51 is formed in a substantially cylindrical shape extending in the longitudinal direction x, and is formed to have the largest radial length (outer diameter) in the balloon 50. The distal tapered section 52 is connected to the distal end of the straight tube section 51. The distal tapered section 52 is formed such that its outer diameter decreases as it moves distally away from the straight tube section 51. The proximal tapered section 53 is connected to the proximal end of the straight tube section 51. The proximal tapered section 53 is formed such that its outer diameter decreases as it moves proximal away from the straight tube section 51. Preferably, the balloon 50 further includes a distal sleeve portion 54 located distal to the distal tapered portion 52, and a proximal sleeve portion 55 located proximal to the proximal tapered portion 53. The distal sleeve portion 54 is connected to the distal end of the distal tapered portion 52. The distal sleeve portion 54 is formed in a substantially cylindrical shape. The proximal sleeve portion 55 is connected to the proximal end of the proximal tapered portion 53. The proximal sleeve portion 55 is formed in a substantially cylindrical shape.

[0060] Preferably, the second cylindrical portion 20 extends distally from the distal end of the first cylindrical portion 10, and the second cylindrical portion 20 extends through the internal space of the balloon 50 from the proximal sleeve portion 55 to the distal sleeve portion 54. Furthermore, it is preferable that the outer surface of the second cylindrical portion 20 is joined to the inner surface of the distal sleeve portion 54 of the balloon 50, and the outer surface of the first cylindrical portion 10 is joined to the inner surface of the proximal sleeve portion 55 of the balloon 50. With the distal portion of the second shaft 20 configured in this way, the balloon expansion fluid can be supplied to the internal space of the balloon 50 through the space between the first cylindrical portion 10 and the second cylindrical portion 20.

[0061] The balloon 50 is preferably made of a resin, and more preferably a thermoplastic resin. This makes it easy to manufacture the balloon 50 by molding. Examples of resins that make up the balloon 50 include polyolefin resins such as polyethylene, polypropylene, and ethylene-propylene copolymer; polyester resins such as polyethylene terephthalate and polyester elastomer; polyurethane resins such as polyurethane and polyurethane elastomer; polyamide resins such as polyphenylene sulfide resin, polyamide, and polyamide elastomer; fluororesin, silicone resin, and natural rubber such as latex rubber. These may be used alone or in combination of two or more. Among these, polyamide resins, polyester resins, and polyurethane resins are preferably used. In particular, it is preferable to use elastomer resins from the viewpoint of thinning the balloon 50 and its flexibility. For example, among polyamide resins, nylon 12 and nylon 11 are suitable materials for the balloon 50, and nylon 12 is preferably used because it can be molded relatively easily when blow molding. Furthermore, from the viewpoint of thinning the balloon 50 and improving its flexibility, polyamide elastomers such as polyether ester amide elastomers and polyamide ether elastomers are preferably used. Among these, polyether ester amide elastomers are preferably used because they have high yield strength and good dimensional stability of the balloon 50.

[0062] A tip 56 may be provided at the distal end of the distal shaft 45. The tip 56 may be provided as a separate component from the first cylindrical portion 10 distal to the distal end of the first cylindrical portion 10, or the distal end of the first cylindrical portion 10 may function as the tip 56 by extending the first cylindrical portion 10 distal to the distal end of the balloon 50. The tip 56 may have a through hole extending in the longitudinal direction x.

[0063] Figures 8 and 14 show the alignment direction 2P of the first lumen 11 and the second lumen 21 in the radial direction y at the most proximal position 2M where the first inner surface 12 and the second inner surface 22 are present around their entire circumference. Hereafter, the "most proximal position 2M where the first inner surface 12 and the second inner surface 22 are present around their entire circumference" may be simply referred to as position 2M.

[0064] The alignment direction 2P of the first lumen 11 and the second lumen 21 refers to the direction in which the first lumen 11 and the second lumen 21 are positioned within a range in which the user of the catheter 1 can visually perceive continuity. Preferably, the alignment direction 2P of the first lumen 11 and the second lumen 21 is the direction of extension of a straight line passing through the centroid 11C of the first lumen 11 and the centroid 21C of the second lumen 21 in a cross section perpendicular to the longitudinal direction x of the catheter body 2 at position 2M.

[0065] The catheter body 2 may have at least one radiopaque marker. Preferably, the radiopaque marker is located on the first tube portion 10 and / or the second tube portion 20. As shown in Figure 4, the first tube portion 10 may have a radiopaque marker 6A located proximal to the proximal end of the distal opening 10G and distal to a point 1 cm proximal to the proximal end of the distal opening 10G. This makes it easier to determine the position of the distal opening 10G.

[0066] The second tube portion 20 may have an X-ray opaque marker 6B distal to the distal end 10B of the first tube portion 10. This makes it easier to grasp the position of the curved portion of the catheter 1 when inserting it into a curved portion of the body, thereby facilitating insertion of the catheter 1 into the body.

[0067] The X-ray opaque marker is preferably ring-shaped. The X-ray opaque marker preferably contains an X-ray opaque material, and more preferably consists of an X-ray opaque material. The X-ray opaque material is preferably at least one selected from the group consisting of lead, barium, iodine, tungsten, gold, platinum, iridium, platinum-iridium alloy, stainless steel, titanium, cobalt-chromium alloy, palladium, bismuth, and tantalum.

[0068] As shown in Figures 1, 10, and 11, the handle 8 is located at the proximal end of the catheter body 2. The handle 8 is the part that the user grasps with their hand when manipulating the catheter 1, and by grasping and pressing the handle 8, the catheter 1 can be inserted into the body. The handle 8 can function as a hub or a manifold. The hub is used to connect the catheter body 2 to external devices. The manifold is used for the distribution and control of fluid pathways.

[0069] The handle 8 may be located at the proximal end of the catheter body 2, at the proximal end of the first tube portion 10, or at the proximal end of the third tube portion 40.

[0070] The handle 8 should have a shape and size that is easy for the user to grasp. The handle 8 may, for example, have a cylindrical shape. Preferably, the handle 8 has a hollow portion extending in the longitudinal direction x. Preferably, the hollow portion is in communication with the first lumen 11. Preferably, the handle 8 has a fluid injection portion (not shown) in communication with the hollow portion. A syringe or the like may be connected to the fluid injection portion of the handle 8 for injecting fluids such as fluid for expanding the balloon into the first lumen 11, contrast agent, or drug solution.

[0071] The handle 8 may have a bifurcated structure. In that case, it is preferable that a fluid injection section is provided on one of the bifurcated ends.

[0072] The handle 8 is preferably a resin molded product obtained by injection molding or the like. The resin can be, for example, a polyolefin resin such as polyethylene or polypropylene, a polyamide resin such as nylon, a polyester resin such as PET, an aromatic polyether ketone resin such as PEEK, a polyether polyamide resin, a polyurethane resin, a polyimide resin, a fluororesin such as PTFE, PFA, or ETFE, a polyvinyl chloride resin, a carbonate resin, a styrene resin such as styrene-butadiene copolymer, or a synthetic resin such as (meth)acrylic resin. Among these resins, transparent resins such as polycarbonate and polymethyl methacrylate are preferred.

[0073] The proximal end of the catheter body 2 is preferably located within the handle 8. This improves pushability.

[0074] As shown in Figures 1, 15, and 16, the catheter 1 has a marker portion 60 located on the outer surface of the proximal part of the catheter body 2, extending in the longitudinal direction x. The marker portion 60 indicates the alignment direction 2P of the first lumen 11 and the second lumen 21 in the radial direction y at the most proximal position of the location where the first inner circumferential surface 12 and the second inner circumferential surface 22 are present around their entire circumference. The marker portion 60 is a mark attached to the catheter body 2 so that the user of the catheter 1 can estimate the alignment direction 2P. In detail, by looking at the marker portion 60, the user can estimate the position of the second lumen 21 in the circumferential direction z relative to the first lumen 11. Various embodiments of the marker portion 60 will be described below, but one of these embodiments may be used alone, or a combination of two or more embodiments may be used.

[0075] The marker portion 60 only needs to be positioned on the outer surface of the proximal portion when the catheter body 2 is divided into two equal parts in the longitudinal direction x, but it may also be positioned on the outer surface of the distal portion. The catheter body 2 is the part of the catheter 1 that has a tubular structure, and it is preferable that it is the part of the catheter 1 other than the handle 8.

[0076] The marker portion 60 only needs to be located in the proximal part of the catheter body 2, and may be located in the first cylindrical portion 10, the second cylindrical portion 20, the third cylindrical portion 40, the outer member 30, or two or more of these members. Figures 1 and 5 show an example where the marker portion 60 is located in the third cylindrical portion 40, while Figures 10 and 11 show an example where the marker portion 60 is located in the first cylindrical portion 10.

[0077] The marker portion 60 only needs to be arranged along the longitudinal direction x, and may also extend in the circumferential direction z.

[0078] The marker section 60 preferably includes one or more markers. The marker section 60 may have only one marker, or it may include multiple markers arranged along the longitudinal direction x to facilitate estimation of the alignment direction 2P.

[0079] In the marker section 60, one or more markers may be arranged continuously or intermittently.

[0080] Multiple markers may be arranged at equal or unequal intervals along the longitudinal direction x.

[0081] In the marker section 60, the same type of marker may be repeatedly arranged in the longitudinal direction x, or different types of markers may be arranged alternately in the longitudinal direction x.

[0082] As shown in Figures 1, 5, 10, 11, 15-17, and 24-29, the marker portion 60 may have a protrusion 61 on the outer surface of the catheter body 2. The protrusion 61 is provided to project radially outward from the outer surface of the catheter body 2. Even if the marker portion 60 has a protrusion 61, the user can intuitively estimate the alignment direction 2P of the first lumen 11 and the second lumen 21 by touch alone, without visually inspecting the marker portion 60.

[0083] Examples of the protrusions 61 include ridges (Figures 15, 16, 24, 25, etc.) and projections (Figure 17) on the outer surface of the catheter body 2. To facilitate estimation of the alignment direction 2P, it is preferable that the marker portion 60 be a ridge on the outer surface of the catheter body 2.

[0084] The protrusion 61 is preferably rounded at its outer end in the radial direction y. The shape of the protrusion is not particularly limited and may be columnar, hemispherical, frustoconical, conical, etc. The protrusion preferably has a height direction parallel to the radial direction y, a longitudinal direction x, and a width direction perpendicular to the longitudinal direction x. The protrusion may be formed such that its width narrows from the inside to the outside in the radial direction y.

[0085] The height of the protrusion 61 is not particularly limited, but for example, it can be 0.1 μm or more and 10 μm or less.

[0086] It is preferable that there are multiple protrusions as the convex portion 61. It is preferable that the multiple protrusions are located on the outer surface of the catheter body 2 at intervals of 5 μm to 10 μm. It is preferable that the multiple protrusions are aligned in the longitudinal direction x, and also in the circumferential direction z.

[0087] The protrusions 61 may consist of one or more ridges. The protrusions may extend in the longitudinal direction x, in the circumferential direction z, or spirally around the central axis in the longitudinal direction x of the catheter body 2.

[0088] The protrusions 61 can be formed by mechanical processing such as embossing or rolling, chemical treatment such as etching or electroplating, applying a coating material containing nanoparticles such as silica, titanium oxide, or carbon nanotubes, or by methods such as physical vapor deposition, 3D printing, laser, or plasma.

[0089] The protrusion 61 is preferably made of resin, metal, or a combination thereof. The constituent materials of the protrusion 61 can be found in the description of the constituent materials of the first cylindrical portion 10, the second cylindrical portion 20, the outer member 30, and the third cylindrical portion 40.

[0090] The protrusion 61 and the catheter body 2 may be integrally formed, or the protrusion 61 may be formed by fixing it to the outer surface of the catheter body 2 after the catheter body 2 has been formed. The method of fixing the protrusion 61 to the outer surface of the catheter body 2 is not particularly limited, and methods such as bonding or welding can be used.

[0091] Preferably, the portion of the catheter body on which the protrusion 61 is provided and the protrusion 61 are made of the same material. This makes it less likely for the protrusion 61 to unintentionally detach from the catheter body 2. Alternatively, the protrusion 61 and the catheter body 2 may be made of different materials, provided that the materials of the protrusion 61 and the catheter body 2 have a certain degree of compatibility.

[0092] The marker portion 60 may have an opening located on the outer surface of the catheter body 2. Examples of openings include through grooves or holes penetrating the peripheral wall of the catheter body 2, and recesses such as grooves (bottomed grooves) or blind holes located on the outer surface of the catheter body 2. To facilitate estimation of the alignment direction 2P, it is preferable that the marker portion 60 is a groove located on the outer surface of the catheter body 2. Figures 18 and 19 show an example where the marker portion 60 is a bottomed groove 62 located on the outer surface 40D of the third cylindrical portion 40. By having an opening in the marker portion 60, the user can intuitively estimate the alignment direction 2P of the first lumen 11 and the second lumen 21 by touch alone, without visually inspecting the marker portion 60.

[0093] The opening can be formed using a cutting tool such as a cutter or a laser irradiation device.

[0094] The marker portion 60 may be a colored layer containing paint that is included in the catheter body 2. Figure 20 shows an example where the marker portion 60 is the outermost colored layer 63 located in the radial direction y of the third cylindrical portion 40. By visually identifying the marker portion 60, the user can estimate the alignment direction 2P of the first lumen 11 and the second lumen 21.

[0095] To make the marker portion 60 easily visible to the user, it is preferable that the colored layer be located on the outermost side in a cross-section perpendicular to the longitudinal direction x of the catheter body 2.

[0096] The colored layer may be composed of a material containing an elastomer and a coloring agent. It is preferable that the colored layer be formed by mixing pigments of a color easily observable by the user. For example, it is preferable that the color of the colored layer of the catheter body 2 differs from the color of the layers other than the colored layer. Different colors mean that at least one of the hue, lightness, and saturation as defined in JIS Z8721 differs. The same applies to the following descriptions.

[0097] The marker portion 60 may have at least one of letters, figures, symbols, or patterns. By forming the marker portion 60 in this way, the user can estimate the alignment direction 2P of the first lumen 11 and the second lumen 21. Such a marker portion 60 can be applied to the catheter body 2 by methods such as coating or printing. The shape of the figure may be, for example, a line shape, a dot shape, a circle shape, an oval shape, a polygon shape, an irregular shape, or a shape that combines two or more of these. Figure 21 shows an example in which a substantially circular marker portion 60 is arranged by applying a coloring agent to the outer surface of the third cylindrical portion 40.

[0098] Although not shown in the figures, the marker portion 60 may have a scale extending in the longitudinal direction x. The scale may have an axis extending along the longitudinal direction x and auxiliary lines intersecting the axis. The marker portion 60 may function as a scale.

[0099] Although not shown in the diagram, the catheter body 2 has a third cylindrical portion 40, and the marker portion 10 is positioned on the outer surface 10D of the first cylindrical portion 10, but does not necessarily have to be positioned on the outer surface 40D of the third cylindrical portion 40. In this case, it is preferable that the third cylindrical portion 40 is made of a light-transmitting resin. The light-transmitting resin is not particularly limited as long as it transmits visible light, and is preferably made of synthetic resins such as acrylic resin, polycarbonate resin, polystyrene resin, polyamide resin, or polyolefin resin. By positioning the marker portion 60 in this way, interference between the marker portion 60 and other components can be prevented during the procedure.

[0100] In the examples described so far, the marker portion 60 is arranged as part of the third cylindrical portion 30 or the first cylindrical portion 10. In another embodiment, as shown in Figures 22 and 23, the marker portion 60 may be composed of an attachment component 64 that is fixedly attached or detachably attached to the catheter body 2. The attachment component 64 is a separate component from the first cylindrical portion 10, the second cylindrical portion 20, the outer member 30, and the third cylindrical portion 40. Only a part of the attachment component 64 may function as the marker portion 60, or the entire attachment component 64 may function as the marker portion 60.

[0101] The attachment component 64 can be attached to the catheter body 2 by means of fitting it in from the outer circumference of the catheter body 2, wrapping it around the outer circumference of the catheter body 2, or clamping the outer circumference of the catheter body 2.

[0102] The shape of the mounting component 64 is not particularly limited, but examples include a band shape, a ring shape, a clip shape, etc. The ring shape also includes an open ring shape with a notch, i.e., a C-shaped cross-section.

[0103] If the attachment component 64 has an opening ring portion 64A that fits onto the outer circumference of the catheter body 2, it is preferable that the opening ring portion 64A is openable and closable. Therefore, it is preferable that the opening ring portion 64A is made of an elastic material. This makes it easier to attach and detach the attachment component 64 to the catheter body 2. When not in use, the attachment component 64 can also be removed from the catheter body 2.

[0104] The mounting component 64 may be made of resin, metal, or a combination thereof.

[0105] The surface of the mounting component 64 may have a protrusion 64B extending in the longitudinal direction x. The protrusion 64B may function as a marker portion 60. In this case, by visually observing the protrusion 64B of the mounting component 64, the user can more easily estimate the alignment direction 2P of the first lumen 11 and the second lumen 21.

[0106] The protrusion 64B can be any portion that protrudes radially outward from the surface of the catheter body 2. The protrusion 64B may be a projection or a ridge.

[0107] The protrusion 64B may be made of the same material as the mounting component 64, or it may be made of a different material than the mounting component 64. The protrusion 64B may be made of resin, metal, or a combination thereof.

[0108] As shown in Figure 23, the protrusion 64B may have a first portion 64B1 extending radially outward in the y direction from the surface of the catheter body 2, and a second portion 64B2 extending radially outward in the y direction from the surface of the catheter body 2 in a direction different from the direction of extension of the first portion 64B1. As an example of the shape of such a protrusion 64B, one example is to form the protrusion 64B to be substantially L-shaped in a cross section perpendicular to the longitudinal direction x. In the radial direction y, one end of the first portion 64B1 and one end of the second portion 64B2 are fixed to the opening ring portion 64A, and the other end of the first portion 64B1 and the other end of the second portion 64B2 are located radially outward in the y direction.

[0109] The attachment component 64 is preferably elastic, and it is preferable that the opening ring portion 64A opens when the protrusion 64B is pinched. It is also preferable that the opening ring portion 64A returns to its original shape when the pinch of the protrusion 64B is released. By configuring the attachment component 64 in this way, it is possible to easily attach and detach the attachment component 64 to the catheter body 2.

[0110] Although not shown in the diagram, a medical tool such as a guidewire may be placed in the space 65 formed by the first part 64B1 and the second part 64B2 of the protrusion 64B, which have a roughly L-shaped cross-section. This prevents the guidewire 75 inserted into the second lumen 21 from becoming entangled with the catheter 1.

[0111] Although not shown in the figures, the mounting part 64 may have at least one of the above-mentioned protrusions, openings, colored layers, letters, figures, symbols, patterns, or scales attached to it.

[0112] Although not shown in the figures, the marker portion 60 may comprise one or more X-ray opaque markers. The X-ray opaque markers are markers containing an X-ray opaque material, and it is preferable that they consist of an X-ray opaque material. The X-ray opaque material preferably includes lead, barium, iodine, tungsten, gold, platinum, iridium, platinum-iridium alloy, stainless steel, titanium, cobalt-chromium alloy, palladium, tantalum, or a combination thereof.

[0113] If the marker portion 60 is equipped with an X-ray opaque marker, the X-ray opaque marker may be ring-shaped, have a C-shaped cross-section with a part of the ring cut out, or the like. If the X-ray opaque marker as the marker portion 60 is ring-shaped, it is preferable that the marker colors are different on the half-circumferential portion of the ring on the first lumen 11 side and the half-circumferential portion on the second lumen side, in order to facilitate estimation of the alignment direction 2P of the first lumen 11 and the second lumen 21.

[0114] The following describes the preferred arrangement of the marker portion 60 in the catheter body 2.

[0115] The marker portion 60 may be distributed over the entire circumferential z direction of the catheter body 2, but it is preferable that it be distributed over only a portion of the circumferential z direction. This makes it easier for the user to determine the orientation of the catheter body 2, and thus easier to estimate the alignment direction 2P of the first lumen 11 and the second lumen 21. In other words, it becomes easier to estimate the position of the second lumen 21 in the circumferential z direction relative to the first lumen 11.

[0116] As can be seen from Figures 1 and 2, in the longitudinal direction x, the catheter body 2 has a first portion that is inserted into the medical device 70 and a second portion that is proximal to the first portion and is not inserted into the medical device 70, and it is preferable that the marker portion 60 is located in the second portion. An example of the medical device 70 is a guiding catheter.

[0117] It is preferable that the marker portion 60 is located on the outermost component in the radial direction y of the catheter body 2 at the proximal end of the catheter body 2. However, other components may be located outside the marker portion 60 in the radial direction y.

[0118] In catheter 1, the marker portion 60 may be exposed or covered by a component other than the marker portion 60.

[0119] When the third tube portion 40 is located at the outermost position in the radial direction y at the proximal end of the catheter body 2, it is preferable that the marker portion 60 be positioned on the third tube portion 40.

[0120] As shown in Figures 1, 5, and 15-21, the catheter body 2 has a first cylindrical portion 10 having a first lumen 11, and a third cylindrical portion 40 that encloses the first cylindrical portion 10 proximal to the second lumen 21, and it is preferable that the marker portion 60 is located on the outer surface 40D of the third cylindrical portion 40. Since the third cylindrical portion 40 is easily located on the outer side in the radial direction y of the catheter body 2, the placement of the marker portion 60 on the third cylindrical portion 40 makes it easier for the user to see the marker portion 60.

[0121] The first cylindrical portion 10 has a first section 13 located proximal to the second lumen 21 in the longitudinal direction x, and the marker portion 60 is preferably positioned in the section of the third cylindrical portion 40 that overlaps with the first section 13 in the longitudinal direction x. This allows the user to intuitively estimate the alignment direction 2P of the first lumen 11 and the second lumen 21.

[0122] The marker portion 60 is preferably positioned from the distal end to the proximal end of the portion of the third cylindrical portion 40 that overlaps with the first section 13 in the longitudinal direction x. This makes it easier to see the marker portion 60 even when the catheter body 2 is inserted into the second lumen 21.

[0123] As shown in Figure 26, the marker portion 60 is preferably positioned on the outer surface 40D of the proximal portion of the third cylindrical portion 40, on the side closer to the second lumen 21. In Figure 26, the range 47 in which the marker portion 60 is preferably positioned is indicated by a double arrow. This makes it easier for the user to recognize that the side of the third cylindrical portion 40 in the circumferential direction z where the marker portion 60 is positioned is the side of the second lumen 21, and thus allows them to intuitively estimate the alignment direction 2P of the first lumen 11 and the second lumen 21.

[0124] As shown in Figure 27, the marker portion 60 may be positioned on the outer surface 40D of the proximal portion of the third cylindrical portion 40, on the side furthest from the second lumen 21. In Figure 27, the range 48 in which the marker portion 60 is preferably positioned is indicated by a double arrow. By positioning the marker portion 60 on the side furthest from the second lumen 21, even if the marker portion 60 has a shape such as a convex portion, interference between the marker portion 60 and the medical tool inserted into the second lumen 21 is suppressed, while making it easier for the user to estimate the alignment direction 2P of the first lumen 11 and the second lumen 21.

[0125] As shown in Figures 1, 5, 15-21, 26, and 27, the marker portion 60 is preferably positioned only within a range of ±45° in the circumferential direction of the third cylindrical portion 40, centered on the alignment direction 2P of the first lumen 11 and the second lumen 21. It is more preferably positioned only within a range of ±30° in the circumferential direction z of the third cylindrical portion 40, and even more preferably within a range of ±15° in the circumferential direction z of the third cylindrical portion 40. By positioning the marker portion 60 so that it falls within a specific range in the circumferential direction, the user can intuitively estimate the alignment direction 2P of the first lumen 11 and the second lumen 21.

[0126] When the first cylindrical portion 10 is located at the outermost position in the radial direction y at the proximal end of the catheter body 2, it is preferable that the marker portion 60 be positioned on the first cylindrical portion 10.

[0127] As shown in Figures 10, 11, 24, 25, 28, and 29, the catheter body 2 has a first cylindrical portion 10 having a first lumen 11, and the first cylindrical portion 10 has a first section 13 located proximal to the second lumen 21 in the longitudinal direction x, and it is preferable that the marker portion 60 is located in the first section 13 of the first cylindrical portion 10. This allows the user to intuitively estimate the alignment direction 2P of the first lumen 11 and the second lumen 21.

[0128] The marker portion 60 is preferably positioned from the distal end to the proximal end of the first section 13 of the first tube portion 10. This makes it easier to see the marker portion 60 even when the catheter body 2 is inserted into the second lumen 21.

[0129] As shown in Figure 28, the marker portion 60 may be positioned on the outer surface 10D of the proximal portion of the first cylindrical portion 10, on the side closer to the second lumen 21. In Figure 28, the range 17 in which the marker portion 60 is preferably positioned is indicated by a double arrow. This makes it easier for the user to recognize that the side of the circumferential direction z of the first cylindrical portion 10 where the marker portion 60 is positioned is the side of the second lumen 21, and thus allows them to intuitively estimate the alignment direction 2P of the first lumen 11 and the second lumen 21.

[0130] As shown in Figure 29, the marker portion 60 may be positioned on the outer surface 10D of the proximal portion of the first cylindrical portion 10, on the side furthest from the second lumen 21. In Figure 29, the range 18 in which the marker portion 60 is preferably positioned is indicated by a double arrow. By positioning the marker portion 60 on the side furthest from the second lumen 21, even if the marker portion 60 has a shape such as a convex portion, interference between the marker portion 60 and the medical tool inserted into the second lumen 21 is suppressed, while making it easier for the user to estimate the alignment direction 2P of the first lumen 11 and the second lumen 21.

[0131] As shown in Figures 25, 28, and 29, the marker portion 60 is preferably positioned only within a range of ±45° in the circumferential direction of the first cylindrical portion 10, centered on the alignment direction 2P of the first lumen 11 and the second lumen 21. It is more preferably positioned only within a range of ±30° in the circumferential direction z of the first cylindrical portion 10, and even more preferably within a range of ±15° in the circumferential direction z of the first cylindrical portion 10. By positioning the marker portion 60 so that it falls within a specific range in the circumferential direction z, the user can intuitively estimate the alignment direction 2P of the first lumen 11 and the second lumen 21.

[0132] If the catheter body 2 has a second tube portion 20 having a second lumen 21, it is preferable that the marker portion 60 is not provided in the second tube portion 20, as shown in Figures 1, 10, and 11. During the procedure, the second tube portion 20 is inserted into a medical device 70 such as a guiding catheter, so it is not necessary to provide the marker portion 60 in the second tube portion 20.

[0133] As shown in Figures 23 and 24, when an attachment component 64 is attached to the catheter body 2 as a marker portion 60, the attachment component 64 is preferably fixed to the first cylindrical portion 10 or the third cylindrical portion 40, more preferably to the proximal portion of the first cylindrical portion 10 or the proximal portion of the third cylindrical portion 40, and even more preferably to the proximal end of the first cylindrical portion 10 or the proximal end of the third cylindrical portion 40.

[0134] In the longitudinal direction x, the proximal end of the mounting component 64 may be in contact with the distal end of the handle 8, or it may be separated from the distal end of the handle 8.

[0135] Preferably, the attachment component 64 is attached to the catheter body 2 such that its proximal end is located within 5 cm of the distal end of the handle 8, more preferably within 3 cm, and even more preferably within 1 cm. By attaching the attachment component 64 in this position, the attachment component 64 does not get in the way when inserting the catheter body 2 into the medical device 70 during the procedure. [Explanation of Symbols]

[0136] 1: Catheter 2: Catheter body 2M: The most proximal position among the points where the first inner surface is present around its entire circumference and the second inner surface is present around its entire circumference. 2N: The most proximal position among the locations where the first inner surface is present around its entire circumference and the second inner surface is present around its entire circumference. 2P: Alignment direction of the first and second lumens 6A, 6B: Radiopaque markers 8: Handle 10:First cylinder part 10B: Distal end 10G: Distal opening 11: First Lumen 12: First inner surface 13: Section 1 20:Second cylinder part 20A: Proximal end 20B: Distal end 20D: External surface 20F: Proximal opening 20G: Distal opening 21: Second Lumen 22: Second inner peripheral surface 30:Outer member 31 lumens 35: Column body 40:Third cylinder part 41: Third Lumen 45: Distal shaft 46: Proximal shaft 50: Balloon 51: Straight pipe section 52: Distal tapered section 53: Proximal tapered section 54: Distal sleeve portion 55: Proximal sleeve portion 56: Tip 57: Connecting tube 60: Marker section 61: Convex part 62: Bottomed groove 63: Colored layer 64: Installed parts 64A: Opening ring section 64B: Convex part 64B1: 1st part 64B2:Second part 65: Space 70: Medical devices 75: Guidewire h:Horizontal direction x: Longest direction y: radial direction z: Circumferential direction

Claims

1. A catheter having a longitudinal direction and a radial direction, A catheter body having a first inner surface defining a first lumen, and a second inner surface defining a second lumen whose proximal end is distal to the first lumen and which does not move in the longitudinal direction relative to the first lumen, A catheter comprising: a marker portion disposed on the outer surface of the proximal portion of the catheter body and extending in the longitudinal direction, the marker portion indicating the radial alignment direction of the first lumen and the second lumen at the most proximal position among the locations where the first inner surface is present around its entire circumference and the second inner surface is present around its entire circumference.

2. In the longitudinal direction, the catheter body has a first portion that is inserted into a medical device, and a second portion that is located proximal to the first portion and is not inserted into the medical device. The catheter according to claim 1, wherein the marker portion is arranged in the second portion.

3. The catheter body has a first cylindrical portion having the first lumen, The first cylindrical portion has a first section located proximal to the second lumen in the longitudinal direction, The catheter according to claim 1 or 2, wherein the marker portion is located in the first section of the first cylindrical portion.

4. The catheter according to claim 3, wherein the marker portion is arranged from the distal end to the proximal end of the first section of the first cylindrical portion.

5. The catheter according to claim 1 or 2, wherein the marker portion is located on the outer surface of the proximal portion of the first cylindrical portion, on the side furthest from the second lumen.

6. The catheter according to claim 1 or 2, wherein the marker portion is located on the outer surface of the proximal portion of the first cylindrical portion, on the side closer to the second lumen.

7. The catheter according to claim 1 or 2, wherein the marker portion is arranged only within a range of ±45° in the circumferential direction of the first cylindrical portion, centered on the alignment direction of the first lumen and the second lumen.

8. The catheter body has a second cylindrical portion having the second lumen, The catheter according to claim 1 or 2, wherein the marker portion is not disposed in the second cylindrical portion.

9. The catheter body comprises a first cylindrical portion having the first lumen, and a third cylindrical portion enclosing the first cylindrical portion proximal to the second lumen. The catheter according to claim 1 or 2, wherein the marker portion is arranged on the outer surface of the third cylindrical portion.

10. The first cylindrical portion has a first section located proximal to the second lumen in the longitudinal direction, The catheter according to claim 9, wherein the marker portion is located in the portion of the third cylindrical portion that overlaps with the first section in the longitudinal direction.

11. The catheter according to claim 10, wherein the marker portion is arranged from the distal end to the proximal end of the portion of the third cylindrical portion that overlaps with the first section in the longitudinal direction.

12. The catheter according to claim 9, wherein the marker portion is located on the outer surface of the proximal portion of the third cylindrical portion, on the side furthest from the second lumen.

13. The catheter according to claim 9, wherein the marker portion is located on the outer surface of the proximal portion of the third cylindrical portion, on the side closer to the second lumen.

14. The catheter according to claim 9, wherein the marker portion is arranged only within a range of ±45° in the circumferential direction of the third cylindrical portion, centered on the alignment direction of the first lumen and the second lumen.

15. The catheter according to claim 1 or 2, wherein the marker portion is a protrusion arranged on the outer surface of the catheter body.

16. The catheter according to claim 1 or 2, wherein the marker portion is a groove disposed on the outer surface of the catheter body.

17. The catheter according to claim 1 or 2, wherein the marker portion includes a plurality of markers arranged along the longitudinal direction.

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