catheter
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2026-01-15
- Publication Date
- 2026-08-13
Smart Images
Figure JP2026000965_13082026_PF_FP_ABST
Abstract
Description
Catheter
[0001] This disclosure relates to a catheter.
[0002] A catheter that can be inserted into blood vessels or the like to examine and treat lesions in 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.
[0003] Japanese Patent Application Laid-Open No. 2022-164846
[0004] An Rx type catheter having a cross-section in which two lumens are arranged side by side is delivered to the lesion 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 within the guiding catheter, resulting in a deterioration in the delivery performance of the catheter or damage to the catheter. Therefore, an object to be solved by this disclosure is to provide a catheter that can suppress entanglement between the catheter and the guide wire inserted into the catheter.
[0005] A 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, comprising: 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 a handle disposed at the proximal end of the catheter body, the handle having a cross-sectional shape in a cross section perpendicular to the longitudinal direction having a minor axis and a major axis, wherein the direction of the minor axis or the direction of the major axis of the handle is perpendicular to the direction of alignment 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 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 any of the following [2] to
[10] . [2] The catheter according to [1], wherein the cross-sectional figure is the cross-sectional figure at the position where the outer diameter of the handle is maximum. [3] The catheter according to [1] or [2], wherein when the catheter is placed on a horizontal surface, the direction of the long axis of the cross-sectional figure of the handle is perpendicular to the horizontal direction. [4] The catheter according to [1] or [2], wherein when the catheter is placed on a horizontal surface, the direction of the long axis of the cross-sectional figure of the handle is parallel to the horizontal direction. [5] The catheter according to any one of [1] to [4], wherein in a cross section perpendicular to the longitudinal direction of the catheter body 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, the direction of alignment of the first lumen and the second lumen is the direction of extension of a straight line passing through a first position on the quarter circumference of the first inner surface that is farther from the centroid of the second lumen and a second position on the quarter circumference of the second inner surface that is farther from the centroid of the first lumen. [6] The catheter according to any one of [1] to [5], wherein the first lumen and the second lumen do not move relative to each other in the longitudinal direction. [7] The catheter according to any one of [1] to [6], wherein the first lumen and the second lumen are aligned in the radial direction over the entire length of the section in the longitudinal direction in which both the first lumen and the second lumen are present. [8] The catheter according to any one of [1] to [6], wherein the first lumen is contained within the second lumen at the most distal position of the location where the first inner surface is present around its entire circumference and the second inner surface is present around its entire circumference. [9] The catheter according to any one of [1] to [8], wherein a guide portion is provided on the surface of the handle to guide the position of the guidewire inserted into the first lumen relative to the second lumen.
[10] The catheter according to [9], wherein the guide portion is a protrusion provided on the surface of the handle.
[0007] With the above catheter, even if the entire portion of the catheter containing the second lumen is inserted into the guiding catheter, the operator can estimate the alignment of the first and second lumens from the direction of the handle, thus preventing entanglement between the guidewire inserted into the second lumen and the catheter. Furthermore, because entanglement is prevented, it is expected that the ease of pushing in other medical tools inserted into the first lumen will also improve.
[0008] Figure 1 is a schematic diagram of a catheter according to an embodiment of the present disclosure, 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 a 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 a 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 the line VI-VI. Figure 7 is a cross-sectional view of the catheter of Figure 5 along the 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 example of the catheter of Figure 1, and is a schematic diagram showing an example of a balloon catheter. Figure 11 is a cross-sectional view of the catheter in Figure 10 along the line XI-XI. Figure 12 is a cross-sectional view of the catheter in Figure 10 along the line XII-XII. Figure 13 is a cross-sectional view of the catheter in Figure 12 with the alignment of the first and second lumens added. Figure 14 is an end view of the XIV-XIV section of the catheter in Figure 1, showing the structure of the handle. Figure 15 is an end view of the XV-XV section of the catheter in Figure 10, showing the structure of the handle. Figure 16 is a side view showing a modified example of the handle in Figure 1. Figure 17 is an end view of the XVII-XVII section of the handle in Figure 16. Figure 18 is an end view of a modified example of the handle in Figure 15. Figure 19 is a side view showing another modified example of the handle in Figure 1. Figure 20 is an end view of the XX-XX section of the handle in Figure 19. Figure 21 is a side view showing a modified example of the handle in Figure 19. Figure 22 is a cross-sectional end view of the handle from Figure 21, specifically the section between XXII and XXII. Figure 23 is a cross-sectional end view showing a modified version of the handle from Figure 22. Figure 24 is a cross-sectional end view showing a modified version of the handle from Figure 17. Figure 25 is a cross-sectional end view showing yet another modified version of the handle from Figure 17. Figure 26 is a cross-sectional end view showing yet another modified version of the handle from Figure 17.
[0009] The contents of this disclosure will be described in more detail below based on the embodiments described below. However, the contents of this disclosure are not limited by the embodiments described below, and it is certainly possible to implement the disclosure 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 this disclosure. In addition, hatching and component reference numerals may be omitted in the drawings for convenience, in which case refer to the specification or other drawings. Furthermore, the dimensions of various components in the drawings may differ from the actual dimensions, as priority is given to helping to understand the features of this disclosure.
[0010] The catheter according to this embodiment is a catheter having a longitudinal direction and a radial direction, comprising 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 a handle disposed at the proximal end of the catheter body, the handle having a cross-sectional shape in a cross section perpendicular to the longitudinal direction having a minor axis and a major axis, wherein the direction of the minor axis or the major axis of the handle is perpendicular to the direction of alignment of the first lumen and the second lumen in the radial direction at the most proximal position where the first inner surface and the second inner surface are present around the entire circumference. With this catheter, even if the entire portion of the catheter having the second lumen is inserted into a guiding catheter, the operator can estimate the direction of alignment of the first lumen and the second lumen from the orientation of the handle, thereby preventing entanglement between the guidewire inserted into the second lumen and the catheter. Furthermore, because tangling can be prevented, it is expected to improve the ease of inserting other medical tools into the first lumen.
[0011] A catheter according to an embodiment will be described with reference to Figures 1 to 26. Figure 1 is a schematic diagram of a catheter according to an embodiment of the present disclosure, 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, and the catheter is a schematic diagram showing an example of a balloon catheter. Figure 11 is a cross-sectional view of the catheter in Figure 10 along the line XI-XI. Figure 12 is a cross-sectional view of the catheter in Figure 10 along the line XII-XII. Figure 13 is a cross-sectional view of the catheter in Figure 12 with the alignment of the first and second lumens added. Figure 14 is an end view of the XIV-XIV section of the catheter in Figure 1, showing the structure of the handle. Figure 15 is an end view of the XV-XV section of the catheter in Figure 10, showing the structure of the handle. Figure 16 is a side view showing a modified version of the handle in Figure 1. Figure 17 is an end view of the XVII-XVII section of the handle in Figure 16. Figure 18 is an end view of a section showing a modified version of the handle in Figure 15. Figure 19 is a side view showing another modified version of the handle in Figure 1. Figure 20 is an end view of the XX-XX section of the handle in Figure 19. Figure 21 is a side view showing a modified version of the handle in Figure 19. Figure 22 is an end view of the XXII-XXII section of the handle in Figure 21. Figure 23 is an end view of a section showing a modified version of the handle in Figure 22. Figure 24 is an end view of a section showing a modified version of the handle in Figure 17. Figure 25 is an end view of a section showing another modified version of the handle in Figure 17.Figure 26 is a cross-sectional end view showing yet another modification of the handle of Figure 17. As shown in Figures 1 and 10, the catheter 1 has a catheter body 2 and a handle 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 guiding catheter 70 that 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 70 as shown in Figure 2 is inserted into the body, a guidewire 75 is inserted from the proximal side of the guiding catheter 70 (for example, a Y-connector as shown in Figure 2), and catheter 1 is inserted into the guiding catheter 70 along the guidewire 75 as shown in Figure 3. Although not shown, by making catheter 1 protrude from the distal end of the guiding catheter 70, treatment and other procedures can be performed on the lesion using catheter 1 or medical tools 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, and 10, 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 in the 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 60. 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 60 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 and 10, the catheter body 2 has a first lumen 11 and a second lumen 21, and the proximal end 21A of the second lumen 21 is located distal to that of the first lumen 11. More specifically, it is preferable that the proximal end 21A of the second lumen 21 is located distal to that of the proximal end of the first lumen 11.
[0021] As shown in Figures 6, 7, 11, and 12, 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 even 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 10, 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 10, 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, 12, and 13, in the 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 10, 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 the 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 cylindrical portion 10 and / or the second cylindrical 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 cylindrical portion 10 and the second cylindrical portion 20 are made of resin tubing. The constituent materials of the first cylindrical portion 10 and / or the second cylindrical portion 20 can be described by referring to the description of the constituent materials of the catheter body 2. The first cylindrical portion 10 and the second cylindrical 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 part 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 10, 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 and 10, 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. Here, the columnar shape includes a shape in which the periphery of the first cylindrical portion 10 and the second cylindrical portion 20 is filled with the material of the outer member 30 and no gap is formed between the first cylindrical portion 10 or the second cylindrical portion 20 and the outer member 30, while the cylindrical shape includes a shape in which a gap is formed between the first cylindrical portion 10 or the second cylindrical portion 20 and the outer member 30.
[0041] As shown in Figures 1, 4 to 8, the outer member 30 has a columnar shape containing resin and extends in the longitudinal direction x, 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 shapes of the first lumen 11 and the second lumen 21 that extend 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 first cylindrical portion 10 and a second cylindrical portion 20 that are superimposed in the radial direction y with a resin tube, heating it, and welding it together, or the columnar body may be formed by injection molding the first cylindrical portion 10 and the second cylindrical portion 20 that are superimposed in the radial direction y.
[0044] As shown in Fig. 4, it is preferable that the distal end 30B of the outer member 30 is located on the distal side of the distal end 20B of the second cylindrical portion 20. By arranging the outer member 30 formed of a flexible material in this way, the flexibility of the portion on the distal side of the distal end 20B of the second cylindrical portion 20 can be improved.
[0045] It is preferable that at least a part 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 it difficult for the outer member 30 to bend or twist. Examples of the fixing mode include welding, adhesion, etc.
[0046] As shown in Fig. 5, the catheter 1 may further have a third cylindrical portion 40 extending in the longitudinal direction x. The third cylindrical portion 40 preferably encloses the first cylindrical portion 10 on the proximal side of the second lumen 21. More preferably, the third cylindrical portion 40 encloses the first cylindrical portion 10 on the proximal side of the proximal end 21A of the second lumen 21. Specifically, the third cylindrical portion 40 has a third lumen 41 extending in the longitudinal direction x, and a part of the first cylindrical portion 10 is preferably arranged in the third lumen 41. The third cylindrical portion 40 can form a double tube structure (coaxial structure), and while protecting the first cylindrical portion 10, the pushability can be improved. Specifically, the third cylindrical portion 40 preferably has a fixing portion fixed to the first cylindrical portion 10 at the distal end portion and a non-fixing portion not fixed to the first cylindrical portion 10 on the proximal side of the fixing portion. Also, the third cylindrical portion 40 preferably has a fixing portion fixed to the handle 60 at the proximal end portion.
[0047] The third cylindrical portion 40 is preferably located on the proximal side of the proximal end 20A of the second cylindrical portion 20. Thereby, the outer diameter of the third cylindrical portion 40 can be reduced.
[0048] The third cylindrical portion 40 preferably contains the same resin as the outer member 30 or a harder resin, and more preferably consists of a harder resin. The pushability can be improved with a harder resin. Also, the distal end of the third cylindrical portion 40 and the proximal end of the outer member 30 are preferably fixed to each other.
[0049] Regarding the structure of the third cylindrical portion 40, reference can be made to the description of the structure of the catheter body 2. Regarding the constituent material of the third cylindrical portion 40, reference can be made to the description of the constituent material of the catheter body 2.
[0050] As shown in FIG. 9, in the catheter 1, the outer member 30 is cylindrical and has a lumen 31 extending in the longitudinal direction x. At least a part of the first cylindrical portion 10 and at least a part of the second cylindrical portion 20 are preferably arranged in the lumen 31. Thereby, the first cylindrical portion 10 and the second cylindrical portion 20 can be protected, and due to the gaps between the outer member 30 and the first cylindrical portion 10 and between the outer member 30 and the second cylindrical portion 20, each cylindrical portion can move to some extent, so that the force of the guide wire 75 from the inside of the catheter 1 can be released. As a result, it is easy to prevent the guide wire 75 from breaking through. The distal end portion of the first cylindrical portion 10 is preferably fixed to the outer member 30. At least one of the distal end portion and the proximal end portion of the second cylindrical portion 20 is preferably fixed to the outer member 30. Thereby, the cylindrical outer member 30 is less likely to be bent or twisted. Inside 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] As shown in FIGS. 6 and 7, in the catheter body 2, the first cylindrical portion 10 and the second cylindrical portion 20 are preferably fixed to each other. Thereby, the first lumen 11 and the second lumen 21 can be configured not to move relative to each other.
[0052] As shown in FIG. 9, the first cylindrical portion 10 and the second cylindrical portion 20 may not 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 the inside of the catheter 1 can be released. As a result, it is easy to prevent the guide wire 75 from breaking through.
[0053] As shown in Figures 4 to 7, 10 and 12, 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 to 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 10, 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.
[0054] As shown in Figures 5 and 10, 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.
[0055] As shown in Figures 10 and 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 the entire circumference, the first lumen 11 may be enclosed within the second lumen 21. As shown in Figure 10, 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 10, at the most distal position 2N among the locations where the first inner surface 12 and the second inner surface 22 are present around the 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.
[0056] 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.
[0057] 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 direction, radial direction, and circumferential direction 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.
[0058] As shown in Figure 10, 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.
[0059] 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.
[0060] 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.
[0061] 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.
[0062] Figures 8 and 13 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.
[0063] The alignment direction 2P is not limited to the direction of extension of the straight line connecting 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, but rather means the direction in which the first lumen 11 and the second lumen 21 are arranged within a range in which the user of the catheter 1 can visually perceive continuity. The centroid 11C of the first lumen 11 is the centroid of the cross-sectional figure of the first lumen 11, and the centroid 21C of the second lumen 21 is the centroid of the cross-sectional figure of the second lumen 21.
[0064] As shown in Figures 8 and 13, in a cross-section perpendicular to the longitudinal direction x of the catheter body 2 at position 2M, the alignment direction 2P of the first lumen 11 and the second lumen 21 is preferably the direction of extension of a straight line passing through a first position on the quarter-circumferential portion 12R of the first inner surface 12 that is farther from the centroid 21C of the second lumen 21, and a second position on the quarter-circumferential portion 22R of the second inner surface 22 that is farther from the centroid 11C of the first lumen 11. Figures 8 and 13 show the alignment direction 2P1 of the straight line connecting the centroid 11C of the first lumen 11 and the centroid 21C of the second lumen 21, the alignment direction 2P2 which is most inclined clockwise with respect to the alignment direction 2P1, and the alignment direction 2P3 which is most inclined counterclockwise with respect to the alignment direction 2P1. Even if the first lumen 11 and the second lumen 21 are not positioned such that the direction of the straight line connecting the centroid 11C of the first lumen 11 and the centroid 21C of the second lumen 21 is strictly perpendicular (90°) to the direction of the minor axis SD or the major axis LD of the handle 60 in a cross section perpendicular to the longitudinal direction x of the catheter body 2 at position 2M, that is, the effect can be achieved regardless of whether the alignment direction 2P is one of the above directions 2P1, 2P2, or 2P3. The first position is any position on the quarter circumference portion 12R of the first inner surface 12 that is far from the centroid 21C of the second lumen 21. The second position is any position on the quarter circumference portion 22R of the second inner surface 22 that is far from the centroid 11C of the first lumen 11.
[0065] As shown in Figures 8 and 13, in a cross-section perpendicular to the longitudinal direction x of the catheter body 2 at position 2M, the alignment direction 2P of the first lumen 11 and the second lumen 21 may be a direction within a range of 45° clockwise and counterclockwise with respect to the reference direction (0°), where the direction of extension of the straight line connecting the centroid 11C of the first lumen 11 and the centroid 21C of the second lumen 21 is taken as the reference direction.
[0066] As shown in Figures 8 and 13, in a cross-section perpendicular to the longitudinal direction x of the catheter body 2 at position 2M, the alignment direction 2P of the first lumen 11 and the second lumen 21 may be the extension direction 2P1 of a straight line passing through the centroid 11C of the first lumen 11 and the centroid 21C of the second lumen 21.
[0067] 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.
[0068] 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.
[0069] The X-ray opaque marker is preferably ring-shaped. The X-ray opaque marker is preferably made up of an X-ray opaque material, and more preferably made up 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.
[0070] As shown in Figures 1 and 10, the handle 60 is located at the proximal end of the catheter body 2. The handle 60 is the part that the user grasps with their hand when operating the catheter 1, and by grasping and pressing the handle 60, the catheter 1 can be inserted into the body. The handle 60 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.
[0071] The handle 60 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.
[0072] The handle 60 should have a shape and size that is easy for the user to grasp. The handle 60 may, for example, have a cylindrical shape. As shown in Figures 14 and 15, it is preferable that the handle 60 has a hollow portion 61 extending in the longitudinal direction x. It is preferable that the hollow portion 61 is in communication with the first lumen 11. It is preferable that the handle 60 has a fluid injection portion (not shown) in communication with the hollow portion 61. A syringe or the like may be connected to the fluid injection portion of the handle 60 for injecting fluids such as fluid for expanding the balloon 50 into the first lumen 11, contrast agent, or drug solution.
[0073] The handle 60 may have a bifurcated structure. In that case, it is preferable that a fluid injection section is provided on one of the bifurcated ends.
[0074] The handle 60 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.
[0075] The proximal end of the catheter body 2 is preferably located within the handle 60. This improves pushability.
[0076] The handle 60 has a cross-sectional shape with a minor axis and a major axis in a cross-section perpendicular to the longitudinal direction x. The direction of the minor axis SD or the direction of the major axis LD of the handle 60 is perpendicular to 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. With the catheter 1 described above, even if the entire portion of the catheter 1 having the second lumen 21 is inserted into the guiding catheter 70, the operator can estimate the alignment direction 2P of the first lumen 11 and the second lumen 21 from the orientation of the handle 60, thus preventing entanglement between the guidewire 75 inserted into the second lumen 21 and the catheter 1. Furthermore, because entanglement is prevented, it is expected that the ease of pushing in other medical tools inserted into the first lumen 11 will also be improved.
[0077] The handle 60 has a cross-sectional shape with a major axis and a minor axis. The major axis refers to the length of the major axis direction LD of the outer circumference of the handle 60 (the maximum outer diameter of the outer edge), and the minor axis refers to the length of the minor axis direction SD of the outer circumference of the handle 60, which is perpendicular to the major axis of the handle 60.
[0078] The handle 60 only needs to have a cross-sectional shape with a major axis and a minor axis in at least a portion of its length in the longitudinal direction x. The handle 60 may have a cross-sectional shape with a major axis and a minor axis in a portion of its length in the longitudinal direction x, but the cross-sectional shape of other portions of its length in the longitudinal direction x may not have a minor axis and a major axis. That is, the cross-sectional shape of other portions of its length in the longitudinal direction x may have a non-flattened shape.
[0079] The cross-sectional figure is preferably the cross-sectional figure at the position where the outer diameter of the handle 60 is maximum. Here, the outer diameter of the handle 60 refers to the equivalent diameter of a circle. If there are multiple positions where the outer diameter of the handle 60 is maximum, or if the outer diameter of the handle 60 is maximum in a predetermined range in the longitudinal direction x (range 65 in Figure 1), as shown in Figures 1 and 10, it is more preferable that the cross-sectional figure be the cross-sectional figure at the central position 65M in the longitudinal direction within the range 65 where the outer diameter of the handle 60 is maximum. The position where the outer diameter of the handle 60 is maximum may be an intermediate point in the longitudinal direction x from the proximal end to the distal end of the handle 60, the central position of the handle 60 in the longitudinal direction x, or the position of the proximal end of the handle 60.
[0080] At the position where the outer diameter of the handle 60 is maximum, the flatness (aspect ratio) of the cross-sectional figure of the handle 60 should be greater than 1.0, preferably 1.2 or greater, more preferably 1.5 or greater, even more preferably 2.0 or greater, and preferably 10 or less, more preferably 8.0 or less, and even more preferably 5.0 or less. The flatness is the value obtained by dividing the length of the major axis of the cross-sectional figure of the handle 60 by the length of the minor axis.
[0081] As shown in Figures 14 and 15, the direction SD of the short axis of the handle 60 may be perpendicular to the direction 2P of alignment 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.
[0082] As shown in Figures 16 to 18, it is preferable that the direction LD of the long axis of the handle 60 is perpendicular to the direction 2P of alignment 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.
[0083] When the catheter 1 is placed on a horizontal surface, it is preferable that the direction LD of the major axis of the cross-sectional shape of the handle 60 is perpendicular to the horizontal direction h, as shown in Figures 14 and 15. In Figures 14 and 15, the left-right direction of the paper is the horizontal direction h. This makes it easier for the major axis portion of the handle 60 to come into contact with medical tools such as the guide wire 75 inserted into the second lumen 21, thus making it easier to restrict the direction in which the guide wire 75 extends. As a result, the guide wire 75 is less likely to ride up into the second cylindrical portion 20, and entanglement between the guide wire 75 and the catheter 1 can be prevented.
[0084] When the catheter 1 is placed on a horizontal surface, the direction of the major axis LD of the cross-sectional shape of the handle 60 may be parallel to the horizontal direction h, as shown in Figures 16 to 18.
[0085] The specific shape of the handle 60 is not particularly limited, but as shown in Figures 14 and 15, the handle 60 may have a cylindrical portion 66 having a hollow section that communicates with the first lumen 11, and a wing portion 67 extending radially outward from the cylindrical portion 66.
[0086] The cylindrical portion 66 may have a circular, oval, polygonal, or other shape in its cross-section in the radial direction y. The hollow portion of the cylindrical portion 66 can function as the hollow portion 61 of the handle 60 described above.
[0087] The blade portion 67 preferably has a flattened shape. In the radial direction y, the blade portion 67 preferably extends in the direction LD of the long axis of the handle 60.
[0088] The flattened wing portion 67 preferably has a longitudinal direction p and a thickness direction q perpendicular to the longitudinal direction p in the radial direction y. In the thickness direction q, the thickness of the wing portion 67 is preferably thinner than the maximum diameter of the cylindrical portion 66. By designing the wing portion 67 in this way, the operator can estimate the alignment direction 2P of the first lumen 11 and the second lumen 21 from the orientation of the handle 60, thereby preventing entanglement between the guide wire 75 inserted into the second lumen 21 and the catheter 1. Furthermore, because entanglement is prevented, it is also expected that the ease of pushing in other medical tools inserted into the first lumen 11 will be improved.
[0089] The handle 60 preferably has one or more wing portions 67. If the handle 60 has two wing portions 67, it is preferable that the wing portions 67 are located on a straight line passing through the axis center in the longitudinal direction x of the cylindrical portion 66 and are arranged at two locations equidistant from the axis center.
[0090] As shown in Figures 19 to 26, the surface of the handle 60 may have a guide portion 68 that guides the position of the guide wire 75 inserted into the second lumen 21 relative to the first lumen 11. By providing the guide portion 68 in this way, the guide wire 75 is less likely to ride up onto the second cylindrical portion 20, and entanglement between the guide wire 75 inserted into the second lumen 21 and the catheter 1 can be prevented.
[0091] The guide portion 68 may be arranged one or more times on the surface of the handle 60.
[0092] As shown in Figures 19 to 26, the guide portion 68 is preferably a protrusion 69 located on the surface of the handle 60.
[0093] The protrusion 69 can be any portion that protrudes radially outward from the surface of the handle 60. The protrusion 69 can be a projection or a ridge.
[0094] The protrusion 69 may be located on the cylindrical portion 66, but it is preferable that it be located on the wing portion 67. When the longitudinal direction p of the wing portion 67 is divided into two equal parts in the radial direction y, the protrusion 69 may be located on the outer portion of the wing portion 67, or it may be located so as to straddle the outer portion and the inner portion.
[0095] The protrusion 69 preferably protrudes in the direction of the short axis SD of the handle 60 in a cross-section in the radial direction y, but it may also protrude in the direction of the long axis LD.
[0096] The protrusion 69 may be made of the same material as the handle 60, or it may be made of a different material. The protrusion 69 may be made of resin, metal, or a combination thereof.
[0097] As shown in Figures 21, 22, and 25, the protrusion 69 may have a first portion 69A extending radially outward from the surface of the handle 60, and a second portion 69B extending from the first portion 69A in a different direction from the first portion 69. For example, one such shape is formed in which the protrusion 69 is substantially L-shaped in a cross section perpendicular to the longitudinal direction x of the handle 60. The second portion 69B may extend along the circumferential direction z. Also, as shown in Figures 22 and 25, the direction of extension of the second portion 69B may be perpendicular to the direction of extension of the first portion 69A. The second portion 69B may extend from the outer end of the first portion 69 in the radial direction y.
[0098] As shown in Figures 23 and 26, the protrusion 69 may have an outward extension portion 69C extending radially outward from the surface of the handle 60, and a folded portion 69D that is folded back from the outward extension portion 69C toward the surface of the handle 60. In this case, the space formed between the folded portion 69D and the surface of the handle 60 makes it easier to position the guide wire 75, thereby preventing entanglement between the guide wire 75 inserted into the second lumen 21 and the catheter 1.
[0099] This application claims the benefit of priority based on Japanese Patent Application No. 2025-17834, filed on February 5, 2025. The entire specification of Japanese Patent Application No. 2025-17834, filed on February 5, 2025, is incorporated herein by reference.
[0100] 1: Catheter 2: Catheter body 2M: The most proximal position where the first inner surface and the second inner surface are present around the entire circumference 2N: The most distal position where the first inner surface and the second inner surface are present around the entire circumference 2P: Alignment direction of the first and second lumens 6A, 6B: Radiopaque markers 10: First tube 10B: Distal end 10D: Outer surface 10G: Distal opening 11: First lumen 12: First inner surface 20: Second tube 20A: Proximal end 20B: Distal end 20D: Outer surface 20F: Proximal opening 20G: Distal opening 21: Second lumen 22: Second inner surface 30: Outer member 31: Lumen 35: Column 40: Third tube 41: Third lumen 45: Distal shaft 46: Proximal shaft 50: Balloon 51: Straight section 52: Distal tapered section 53: Proximal tapered section 54: Distal sleeve section 55: Proximal sleeve section 56: Tip 57: Connecting tube 60: Handle 61: Hollow section 65: Range where the outer diameter of the handle is maximum 65M: Longitudinal center of the range where the outer diameter of the handle is maximum 66: Tube section 67: Wing section 68: Guide section 69: Convex section 69A: First section 69B: Second section 69C: Outward extension section 69D: Folded section 70: Guiding catheter 75: Guide wire h: Horizontal x: Longitudinal y: Radial z: Circumferential LD: Long axis direction SD: Short axis direction
Claims
1. A catheter having a longitudinal direction and a radial direction, comprising: 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 a handle disposed at the proximal end of the catheter body, the handle having a cross-sectional shape in a cross section perpendicular to the longitudinal direction having a minor axis and a major axis, wherein the direction of the minor axis or the direction of the major axis of the handle is perpendicular to the direction of alignment 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 its entire circumference.
2. The catheter according to claim 1, wherein the cross-sectional figure is the cross-sectional figure at the position where the outer diameter of the handle is maximum.
3. The catheter according to claim 1 or 2, wherein when the catheter is placed on a horizontal surface, the direction of the major axis of the cross-sectional shape of the handle is perpendicular to the horizontal direction.
4. The catheter according to claim 1 or 2, wherein when the catheter is placed on a horizontal surface, the direction of the major axis of the cross-sectional shape of the handle is parallel to the horizontal direction.
5. The catheter according to claim 1 or 2, in a cross section perpendicular to the longitudinal direction of the catheter body 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, the direction of alignment of the first lumen and the second lumen is the direction of extension of a straight line passing through a first position on the quarter circumference of the first inner surface that is farther from the centroid of the second lumen, and a second position on the quarter circumference of the second inner surface that is farther from the centroid of the first lumen.
6. The catheter according to claim 1 or 2, wherein the first lumen and the second lumen do not move relative to each other in the longitudinal direction.
7. The catheter according to claim 1 or 2, wherein the first lumen and the second lumen are aligned in the radial direction over the entire lengthwise section in which both the first lumen and the second lumen are present.
8. The catheter according to claim 1 or 2, wherein the second lumen is enclosed within the first lumen at the most distal 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.
9. The catheter according to claim 1 or 2, wherein a guide portion is provided on the surface of the handle for guiding the position of the guide wire inserted into the second lumen relative to the first lumen.
10. The catheter according to claim 9, wherein the guide portion is a protrusion disposed on the surface of the handle.