WO2024070593A1

WO2024070593A1 - Guiding catheter

Info

Publication number: WO2024070593A1
Application number: PCT/JP2023/032873
Authority: WO
Inventors: 敏彦地搗; なつみ大橋; 聖人伊藤; 共貴大島
Original assignee: 株式会社グッドマン
Priority date: 2022-09-30
Filing date: 2023-09-08
Publication date: 2024-04-04

Abstract

A guiding catheter that comprises a lumen and has a tubular body (2) extending between the base and the tip (2D). The tubular body (2) comprises a shaft part (21) extending from the base, a loop part (22) adjacent to the side of the tip (2D) relative to the shaft part (21), and a protrusion part (23) adjacent to the side of the tip (2D) relative to the loop part (22) and linearly extending to the tip (2D). When a therapeutic catheter is inserted into the lumen of the guiding catheter, the guiding catheter can guide the therapeutic catheter toward various vessels.

Description

Guiding Catheter

The present invention relates to a guiding catheter.

A guiding catheter for use in treating the coronary arteries has been proposed. For example, Patent Document 1 discloses a guiding catheter having first to third curved portions. When the guiding catheter is placed inside the body, the third curved portion engages with the wall of the aortic arch, and the second curved portion contacts the wall of the ascending aorta. The tip portion extends toward the orifice of the right coronary artery. When a treatment catheter is inserted into the guiding catheter in this state, the treatment catheter is guided from the tip portion toward the right coronary artery. This makes it possible to treat the right coronary artery with the treatment catheter.

JP 7-506282 A

The guiding catheter described in Patent Document 1 can only guide a treatment catheter toward a coronary artery. In contrast, there is a demand for a guiding catheter that can guide a treatment catheter toward other blood vessels, such as the brachiocephalic artery, left common carotid artery, and left subclavian artery connected to the aortic arch, and the external jugular vein, left common jugular vein, and internal jugular vein connected to the superior vena cava.

The object of the present invention is to provide a guiding catheter capable of guiding a therapeutic catheter toward various blood vessels.

The guiding catheter according to the present invention is a guiding catheter having an inner lumen and a tubular body extending between a base end and a tip end, the tubular body being characterized by having a shaft portion extending from the base end, a loop portion adjacent to the tip end side of the shaft portion, and a protrusion adjacent to the tip end side of the loop portion and extending in a straight line to the tip end.

Let us take an example where a guiding catheter is used to guide a treatment catheter to various arteries connected to the aortic arch and various veins connected to the superior vena cava (hereinafter referred to as "target blood vessels"). In this case, the user can easily position the shaft portion, loop portion, and protrusion portion inside the body so that the tip portion faces the target blood vessel. Therefore, the user can properly guide the treatment catheter toward the target blood vessel by inserting the treatment catheter into the lumen of the guiding catheter. In this way, the guiding catheter can properly guide the treatment catheter toward various blood vessels.

In the present invention, the shaft portion has a first straight portion extending in a straight line, a first curved portion adjacent to the tip side of the first straight portion and curved, and at least a part of a second straight portion adjacent to the tip side of the first curved portion and extending in a straight line, the loop portion has a second curved portion adjacent to the tip side of the second straight portion and curved, and the protruding portion may have at least a part of a third straight portion adjacent to the tip side of the second curved portion, extending in a straight line to the tip, and intersecting with the second straight portion. Take as an example a case where a guiding catheter is used for the purpose of guiding a treatment catheter to a target blood vessel. In this case, the user can easily position the first straight portion, the first curved portion, the second straight portion, the second curved portion, and the third straight portion in the body so that the tip is facing the target blood vessel. Therefore, the user can properly guide the treatment catheter toward the target blood vessel by inserting the treatment catheter into the lumen of the guiding catheter.

In the present invention, the shaft portion may have the first straight portion, the first curved portion, and a portion of the second straight portion, and the loop portion may have the other portion of the shaft portion excluding the portion of the second straight portion, and the second curved portion. In this case, the guiding catheter can stably maintain the shape of the loop portion.

In the present invention, when viewed from one side in a direction perpendicular to a plane including the first straight line portion, the first curved line portion, and the second straight line portion, the second straight line portion and the third straight line portion intersect at a first intersection point, and an angle between a half line extending from the first intersection point along the second straight line portion toward the base end portion and a half line extending from the first intersection point along the third straight line portion toward the tip end portion may be 45 degrees or more and 100 degrees or less. In this case, the guiding catheter can reduce the radius of curvature at the boundary portion of the second curved portion with the second straight line portion and at the boundary portion of the second curved portion with the third straight line portion. Therefore, the guiding catheter can stably maintain the curved state of the second curved portion.

In the present invention, the radius of curvature of the second curved portion may be 8 mm or more and 10 mm or less. In this case, the guiding catheter can stably maintain the curved state of the second curved portion.

In the present invention, when viewed from one side in an orthogonal direction perpendicular to a plane including the first straight portion, the first curved portion, and the second straight portion, the second straight portion and the third straight portion may intersect at a first intersection, and a portion of the second straight portion corresponding to the first intersection and a portion of the third straight portion corresponding to the first intersection may be separated in the orthogonal direction. In this case, the guiding catheter can increase the degree of freedom of the direction in which the tip portion faces within the body. Therefore, the guiding catheter can appropriately guide the treatment catheter toward the target blood vessel even when there are individual differences in the arrangement of blood vessels.

In the present invention, the direction in which the third straight portion extends from the end on the base end side toward the end on the tip end side may be inclined with respect to a plane extending along the first straight portion, the first curved portion, and the second straight portion. In this case, the guiding catheter can orient the tip in a direction different from the direction along the plane inside the body. This allows the guiding catheter to have a higher degree of freedom in the direction in which the tip can be pointed inside the body.

In the present invention, a first straight line extending along the first straight line portion and a second straight line extending along the second straight line portion may intersect at a second intersection point, and an angle between a half line extending from the second intersection point along the first straight line toward the first straight line portion and a half line extending from the second intersection point along the second straight line toward the second straight line portion may be 120 degrees or more and 179 degrees or less. In this case, the guiding catheter can position the first curved portion disposed within a blood vessel curved in an arc near the inner wall of the blood vessel.

In the present invention, the radius of curvature of the first curved portion may be 20 mm or more. In this case, when the guiding catheter is placed in a blood vessel that is curved in an arc, the first curved portion can be positioned near the inner wall of the blood vessel.

In the present invention, the second straight section may be shorter than the third straight section. In this case, the guiding catheter can stabilize the direction in which the tip is facing, and therefore the guidance direction of the treatment catheter can be stabilized.

In the present invention, the hardness of the first straight portion, the first curved portion, and the second straight portion may be a first hardness, the hardness of the second curved portion and the third straight portion may be a second hardness, and the first hardness may be harder than the second hardness. The guiding catheter can achieve good pushability by making the first hardness harder than the second hardness. Also, the guiding catheter can extend the second curved portion by, for example, passing a hard catheter through the lumen, by making the second hardness softer than the first hardness. In this case, the user can easily reach the tip portion to the desired location in the blood vessel.

In the present invention, the second hardness includes a first portion hardness that is the hardness of the second curved portion and a second portion hardness that is the hardness of the third straight portion, and the first portion hardness may be harder than the first portion hardness and the second portion hardness, and the first portion hardness may be harder than the second portion hardness. In this case, the guiding catheter can improve operability by the user by freely changing the orientation of the third straight portion and the tip portion according to the shape of the blood vessel in the body while maintaining the curved state of the second curved portion.

In the present invention, the guiding catheter may be used to guide a treatment catheter, which is inserted through the lumen toward the tip, to target blood vessels including the brachiocephalic artery, left common carotid artery, and left subclavian artery, which are connected to the aortic arch, and the external jugular vein, left common jugular vein, and internal jugular vein, which are connected to the superior vena cava. In this case, the guiding catheter can easily guide the treatment catheter toward the target blood vessel, allowing the treatment catheter to treat the target blood vessel and the blood vessels beyond it.

In the present invention, the shaft portion has a first straight portion extending linearly, a first curved portion adjacent to the tip side of the first straight portion and curved, and at least a part of a second straight portion adjacent to the tip side of the first curved portion and extending linearly, the loop portion has a second curved portion adjacent to the tip side of the second straight portion and curved, the protruding portion has at least a part of a third straight portion adjacent to the tip side of the second curved portion, extending linearly to the tip and intersecting with the second straight portion, a part of the first straight portion is disposed in the descending aorta, the first curved portion is disposed in the aortic arch, the second straight portion, the second curved portion, and the third straight portion are disposed in the ascending aorta, and the tip portion may be disposed toward the outer circumferential wall of the ascending aorta. In this case, the guiding catheter can guide the treatment catheter extending from the tip portion toward the outside of the lumen to the target blood vessel via the ascending aorta.

In the present invention, the shaft portion has a first straight portion extending linearly, a first curved portion adjacent to the tip side of the first straight portion and curved, and at least a portion of a second straight portion adjacent to the tip side of the first curved portion and extending linearly, the loop portion has a second curved portion adjacent to the tip side of the second straight portion and curved, the protruding portion has at least a portion of a third straight portion adjacent to the tip side of the second curved portion, extending linearly to the tip and intersecting with the second straight portion, a portion of the first straight portion may be disposed in the descending aorta, the first curved portion, the second straight portion, and the second curved portion may be disposed in the aortic arch, and the third straight portion may be disposed in the target blood vessel. In this case, the guiding catheter can directly guide the treatment catheter extending from the tip portion toward the outside of the lumen toward the target blood vessel.

FIG. 1 is a diagram showing a guiding catheter 1. 2 is a cross-sectional view taken along line II of FIG. 1, seen from the direction of the arrows. 2 is a cross-sectional view taken along line II-II of FIG. 1, seen from the direction of the arrows. This is a view of the pipe body 2 as viewed from one side V1 in the perpendicular direction V. 1 is a view of the tube 2 as viewed from the other side T2 in the first planar direction T. FIG. 1 is a view of the vicinity of the tip portion 2D of the tube 2 as viewed from one side V1 in the perpendicular direction V. FIG. 13 is a view of the vicinity of the tip portion 2D of the tube 2 as viewed from the other side T2 in the first planar direction T. FIG. This is a view of the pipe body 2 as viewed from one side V1 in the perpendicular direction V. 1 is a view of the tube 2 as viewed from the other side T2 in the first planar direction T. FIG. 1A to 1C are diagrams showing the first step in the first to third use examples of the guiding catheter 1. 11A to 11C are diagrams showing the second step in the first to third use examples of the guiding catheter 1. A figure showing the third step in the first use example of the guiding catheter 1. A figure showing the fourth step in the first use example of the guiding catheter 1. A figure showing the third step in the second use example of the guiding catheter 1. A figure showing the fourth step in the second use example of the guiding catheter 1. A figure showing the fifth step in the second use example of the guiding catheter 1. A figure showing the third step in the third example of use of the guiding catheter 1. A figure showing the fourth step in the third example of use of the guiding catheter 1. A figure showing the fifth step in the third example of use of the guiding catheter 1. 1 is a table showing the experimental results of Experiment 1. 13 is a table showing the experimental results of Experiment 2.

An embodiment of the guiding catheter 1 according to the present invention will be described with reference to the drawings. The drawings are used to explain the technical features that may be adopted by the present invention. The configuration of the device described is not intended to be limiting, but is merely an illustrative example.

<Outline of the Guiding Catheter 1>
The guiding catheter 1 guides various catheters (hereinafter referred to as "treatment catheters") used for treating lesions toward the lesions within blood vessels. The guiding catheter 1 in this embodiment is used to guide treatment catheters toward the carotid arteries (brachiocephalic artery, left common carotid artery, left subclavian artery) connected to the aortic arch, and the external jugular vein, left common jugular vein, and internal jugular vein connected to the superior vena cava. Specific examples of treatment catheters include balloon catheters, guiding catheters, guidewires, suction catheters, microcatheters, contrast catheters, stent retrievers, stents, coils, and the like. Note that treatment catheters that are guided by the guiding catheter 1 are not limited to the above specific examples. Treatment catheters include various well-known catheters used for treating lesions.

As shown in FIG. 1, the guiding catheter 1 comprises a tubular body 2 and a connector 80. The tubular body 2 is a long, thin tube, and has an inner lumen 20 (see FIG. 2). One end of the tubular body 2 is called the "base end 2P," and the other end of the tubular body 2 is called the "tip end 2D." The tubular body 2 is flexible and deforms in response to an external force. When no external force is acting on the tubular body 2, the area near the tip end 2D is curved (see FIG. 4, etc.). FIG. 1 shows the guiding catheter 1 in a state in which the tubular body 2 is extended straight in response to an external force. The length L11 of the tubular body 2 is, for example, approximately 83 to 85 cm.

A connector 80 is connected to the base end 2P of the tube 2. The connector 80 has a connector body 81 and a reinforcing tube 82. The connector body 81 is provided for manipulating the tube 2 and for passing a therapeutic catheter or the like through the tube 2. The connector body 81 is held by the user when in use. The reinforcing tube 82 reinforces the connection between the base end 2P of the tube 2 and the connector body 81.

<Tube body 2>
As shown in Figs. 2 and 3, the tubular body 2 has an inner tube 8A, a braided body 8B, and an outer tube 8C.

The inner tube 8A has a cylindrical shape. One example of the material of the inner tube 8A is fluororesin. The inner tube 8A has an inner cavity 20 that extends between the base end 2P and the tip end 2D. Hereinafter, an imaginary line that passes through the center of the inner cavity 20 and extends between the tip end 2D and the base end 2P is referred to as the "center line C." In the radial direction centered on the center line C, the side close to the center line C is referred to as the "inner side," and the side away from the center line C is referred to as the "outer side."

The braided body 8B is disposed on the outer side of the inner layer tube 8A. The braided body 8B is formed by forming a braided wire, in which multiple metallic strands are woven, into a cylindrical shape and then cutting both ends of the braided body 8B. As an example, the material of the braided body 8B is SUS304. The braided body 8B is not provided in a portion of the tube 2, including the tip portion 2D. As an example, the length L31 of the portion of the tube 2 where the braided body 8B is not provided is approximately 0.5 mm.

The outer tube 8C has a cylindrical shape centered on the center line C. The outer tube 8C covers the inner tube 8A and the braided body 8B from the outside.

The outer layer tube 8C has four parts made of different materials. As shown in FIG. 1, the tube 2 includes a soft tip section 201, a first middle tube section 202, a second middle tube section 203, and a main tube section 204, which correspond to the four parts of the outer layer tube 8C. The soft tip section 201, the first middle tube section 202, the second middle tube section 203, and the main tube section 204 are arranged in this order from the tip section 2D side to the base section 2P side. The material of the part of the outer layer tube 8C that corresponds to the soft tip section 201 of the tube 2 is, for example, nylon elastomer. A contrast medium may be added to the part of the outer layer tube 8C that corresponds to the soft tip section 201 of the tube 2. The material of the parts of the outer layer tube 8C that correspond to the first middle tube section 202, the second middle tube section 203, and the main tube section 204 of the tube 2 is, for example, polyester elastomer. The soft tip section 201, the first middle tube section 202, the second middle tube section 203, and the main tube section 204 of the tube body 2 each have a different hardness.

The length L21 of the soft tip portion 201 of the tube body 2 is, for example, approximately 3.5 mm. The length L22 of the first middle tube portion 202 of the tube body 2 is, for example, approximately 15 mm. The length L23 of the second middle tube portion 203 of the tube body 2 is, for example, approximately 50 mm.

As shown in FIG. 3, the diameter of the lumen 20 in a cross section of the inner layer tube 8A cut along a plane perpendicular to the center line C corresponds to the inner diameter L41 of the tube 2. The inner diameter L41 of the tube 2 is, for example, 2.3 mm. The diameter of the outer side surface in a cross section of the outer layer tube 8C cut along a plane perpendicular to the center line C corresponds to the outer diameter L42 of the tube 2. The outer diameter L42 of the tube 2 is, for example, 2.73 mm.

Figure 4 shows the portion of the tube 2 near the tip 2D when no external force is acting on it. The tube 2 has a shaft portion 21, a loop portion 22, and a protrusion 23. The loop portion 22 has an annular shape and is located near the tip 2D. The shaft portion 21 is adjacent to the loop portion 22 on the side of the base end 2P and extends toward the base end 2P. The protrusion 23 is adjacent to the loop portion 22 on the side of the tip 2D and extends linearly toward the tip 2D.

The shaft portion 21 has a first straight portion 31, a first curved portion 41, and a part of the second straight portion 32. The loop portion 22 has the second straight portion 32 except for the part included in the shaft portion 21, and a second curved portion 42. The protruding portion 23 has a third straight portion 33. The first straight portion 31, the second straight portion 32, and the third straight portion 33 are collectively referred to as the "plurality of straight portions 3". Each of the multiple straight portions 3 extends linearly. The first curved portion 41 and the second curved portion 42 are collectively referred to as the "plurality of curved portions 4". Each of the multiple curved portions 4 is curved.

The first straight portion 31 is a portion of the tube 2 between position Q1, which is spaced from the tip 2D toward the base end 2P, and position Q2 on the tip 2D side relative to position Q1. The first curved portion 41 is a portion of the tube 2 between position Q2 and position Q3 on the tip 2D side relative to position Q2. The first curved portion 41 is adjacent to the tip 2D side of the first straight portion 31. The second straight portion 32 is a portion of the tube 2 between position Q3 and position Q4 on the tip 2D side relative to position Q3. The second straight portion 32 is adjacent to the tip 2D side of the first curved portion 41. The second curved portion 42 is a portion of the tube 2 between position Q4 and position Q5 on the tip 2D side relative to position Q4. The second curved portion 42 is adjacent to the tip 2D side of the second straight portion 32. The third straight portion 33 is a portion of the tube 2 between position Q5 and the tip 2D. The third straight section 33 is adjacent to the tip 2D side of the second curved section 42.

As shown in FIG. 5, the first straight portion 31, the first curved portion 41, and the second straight portion 32 are arranged along the same imaginary plane H. The direction perpendicular to the plane H is called the "orthogonal direction V." One side of the orthogonal direction V is called the "one side V1," and the other side of the orthogonal direction V is called the "other side V2." FIG. 4 corresponds to the state in which the tubular body 2 of the guiding catheter 1 is viewed from one side V1 of the orthogonal direction V.

As shown in FIG. 4, when viewed from one side V1 of the orthogonal direction V, the direction along the first curved portion 41 from the base end 2P side toward the tip end 2D side (hereinafter referred to as the "curving direction Y41") coincides with the counterclockwise direction. The direction along the second curved portion 42 from the base end 2P side toward the tip end 2D side (hereinafter referred to as the "curving direction Y42") coincides with the counterclockwise direction. When viewed from one side V1 of the orthogonal direction V, the curving direction Y41 of the first curved portion 41 and the curving direction Y42 of the second curved portion 42 coincide with each other. In other words, the first curved portion 41 and the second curved portion 42 curve in the same direction.

The first curved portion 41 includes a partial curved portion 411 with a radius of curvature of 120 mm and a partial curved portion 412 with a radius of curvature of 31 mm. The partial curved portion 411 is adjacent to the tip 2D side of the first straight portion 31. The partial curved portion 412 is adjacent to the base 2P side of the second straight portion 32. Position Q23 of the boundary between the partial

curved portions

411, 412 is located approximately in the center of positions Q2 and Q3 of the first curved portion 41, more specifically, slightly closer to the base 2P side than the center of positions Q2 and Q3. It is preferable that the radius of curvature of the first curved portion 41 is 20 mm or more overall.

The direction parallel to the plane H and perpendicular to the center line C of the first straight portion 31 is called the "first planar direction T". In the first planar direction T, the side on which the first curved portion 41, the second straight portion 32, the second curved portion 42, and the third straight portion 33 are arranged with respect to the first straight portion 31 is called the "one side T1", and the side opposite the one side T1 is called the "other side T2". The direction parallel to the plane H (see FIG. 5) and the center line C of the first straight portion 31 is called the "second planar direction U". In the second planar direction U, the side of the tip portion 2D is called the "one side U1". In the second planar direction U, the side of the base end portion 2P is called the "other side U2".

As shown in FIG. 6, a virtual line extending along the center line C of the first straight line portion 31 is defined as a "first straight line S1". A virtual line extending along the center line C of the second straight line portion 32 is defined as a "second straight line S2". The first straight line S1 and the second straight line S2 intersect at a second intersection point X2. A virtual half line extending from the second intersection point X2 along the first straight line S1 toward the first straight line portion 31 is defined as a "half line K1". A virtual half line extending from the second intersection point X2 along the second straight line S2 toward the second straight line portion 32 is defined as a "half line K2". The angle formed by the half lines K1 and K2 is represented as "θ12". The angle θ12 corresponds to the angle formed between the first straight line portion 31 and the second straight line portion 32. The angle θ12 is approximately 120 degrees. It is preferable that angle θ12 be greater than or equal to 120 degrees and less than or equal to 179 degrees.

4, the second curved portion 42 includes a partial curved portion 421 having a radius of curvature of 16 mm, a partial curved portion 422 having a radius of curvature of 8 mm, and a partial curved portion 423 having a radius of curvature of 26 mm. The partial curved portion 421 is adjacent to the tip portion 2D side of the second straight portion 32. The partial curved portion 423 is adjacent to the base end portion 2P side of the third straight portion 33. The partial curved portion 422 is disposed between the partial

curved portions

421, 423. A position Q41 of the boundary between the partial

curved portions

421, 422 is located closer to the base end portion 2P than approximately the center between the positions Q4 and Q5 of the second curved portion 42. The position Q41 coincides with a point of the second curved portion 42 where the maximum value is reached toward one side U1 in the second planar direction U. Position Q42 of the boundary between partial

curved portions

422 and 423 is located closer to tip 2D than approximately the center of positions Q4 and Q5 of second curved portion 42.

As shown in FIG. 5, the end of the second curved portion 42 near the tip 2D side is located on one side V1 in the perpendicular direction V with respect to the plane H. The extension direction of the third straight portion 33 is inclined with respect to the plane H. The third straight portion 33 extends from the end on the base end 2P side toward the end on the tip 2D side, inclining to one side V1 in the perpendicular direction V with respect to the plane H. As shown in FIG. 4, the third straight portion 33 is located on one side T1 in the first planar direction T with respect to the first straight portion 31.

A position Q5 corresponding to the boundary between the second curved portion 42 and the third straight portion 33 overlaps with the second straight portion 32 when viewed from one side V1 of the perpendicular direction V. The end of the second curved portion 42 on the tip end 2D side and the end of the third straight portion 33 on the base end 2P side intersect with the second straight portion 32 at position Q5. Hereinafter, as shown in FIG. 6, the point where the boundary portion between the second curved portion 42 and the third straight portion 33 intersects with the second straight portion 32 is referred to as the "first intersection X1."

When viewed from one side V1 of the orthogonal direction V, an imaginary half-line extending from the first intersection X1 along the second straight portion 32 toward the base end 2P side is defined as a "half-line K5". An imaginary half-line extending from the first intersection X1 along the third straight portion 33 toward the tip end 2D side is defined as a "half-line K6". The angle formed by the half-lines K5 and K6 is represented as "θ23". θ23 corresponds to the angle formed between the second straight portion 32 and the third straight portion 33. The angle θ23 is approximately 80 degrees. It is preferable that the angle θ23 is greater than or equal to 45 degrees and less than or equal to 100 degrees.

As shown in FIG. 7, a virtual straight line extending in the perpendicular direction V through the first intersection X1 (see FIG. 6) is defined as a "third straight line S3". The second straight line portion 32, the second curved line portion 42, and the third straight line portion 33 are separated in the perpendicular direction V at the position of the first intersection X1. More specifically, the following is performed. An intersection portion 321 including a portion of the second straight line portion 32 that intersects with the third straight line S3 is defined. An intersection portion 331 including a portion of the second curved line portion 42 and the third straight line portion 33 that intersects with the third straight line S3 is defined. The intersection portion 321 corresponds to the position of the first intersection X1 of the second straight line portion 32. The intersection portion 331 corresponds to the position of the first intersection X1 of the second curved line portion 42 and the third straight line portion 33. At this time, the

intersection portions

321 and 331 are separated in the perpendicular direction V.

8, a point Y1 is defined as a maximum point toward one side T1 of the first planar direction T in the second curved portion 42. In the first planar direction T, a distance L51 between the center line C of the first straight portion 31 and the point Y1 corresponds to the maximum width of the tube body 2 in the first planar direction T. The distance L51 is, for example, about 45 mm. The distance L52 in the first planar direction T between a point of the second curved portion 42 that is a maximum point toward one side U1 of the second planar direction U, i.e., a position Q41 of the boundary between the partial

curved portions

421, 422 and the center line C of the first straight portion 31 is, for example, 37 mm. The distance L53 in the first planar direction T between the position Q41 and the position Q23 is, for example, 35 mm. The distance L54 in the first planar direction T between the position Q41 and the position Q3 is, for example, 21 mm. The distance L55 in the first planar direction T between position Q41 and position Q5 is, for example, 12.1 mm. The distance L56 in the first planar direction T between position Q41 and tip portion 2D is, for example, 18 mm.

The distance L61 in the second planar direction U between position Q2 and position Q23 is, for example, approximately 21.8 mm. The distance L62 in the second planar direction U between position Q23 and position Q3 is, for example, approximately 20.6 mm. The distance L63 in the second planar direction U between position Q41 and position Q3 is, for example, approximately 10.2 mm. The distance L64 in the second planar direction U between position Q41 and position Q5 is, for example, approximately 4.7 mm. The distance L65 in the second planar direction U between position Q41 and tip 2D is, for example, approximately 7 mm.

The central angle of partial curved portion 421 is denoted as "θ31". As an example, central angle θ31 is 54 degrees. The central angle of partial curved portion 422 is denoted as "θ32". As an example, central angle θ32 is 223.5 degrees.

The length of the second straight portion 32 is approximately 10 mm. The length of the third straight portion 33 is approximately 13 mm. The length of the second straight portion 32 is shorter than the length of the third straight portion 33.

As shown in FIG. 9, the distance L71 in the perpendicular direction V between the plane H and the tip 2D is, for example, 6.2 mm. A point Y3 is defined as a maximum on the second curved portion 42 toward the other side U2 in the second planar direction U. The distance L72 in the second planar direction U between the tip 2D and point Y3 is, for example, approximately 23 mm.

The main tube section 204 (see FIG. 1) of the tube body 2 is formed by the first straight section 31, the first curved section 41, and the second straight section 32. The hardness value of the main tube section 204 is referred to as the "first hardness J1". The second middle tube section 203 (see FIG. 1) of the tube body 2 is formed by the second curved section 42. The hardness value of the second middle tube section 203 is referred to as the "first partial hardness J21". The first middle tube section 202 and the soft tip section 201 of the tube body 2 are formed by the third straight section 33. The hardness values of the first middle tube section 202 and the soft tip section 201 are referred to as the "second partial hardness J22". The first partial hardness J21 and the second partial hardness J22 are collectively referred to as the "second partial hardness J2".

The first hardness J1 is harder than the first partial hardness J21 and the second partial hardness J22 (J1>J21, J1>J22). In other words, the first hardness J1 is harder than the second partial hardness J2 (J1>J2). Therefore, the first straight portion 31, the first curved portion 41, and the second straight portion 32 are harder than the second curved portion 42 and the third straight portion 33. Also, the first partial hardness J21 is harder than the second partial hardness J22 (J21>J22). Therefore, the second curved portion 42 is harder than the third straight portion 33. In other words, the first hardness J1, the first partial hardness J21, and the second partial hardness J22 satisfy the magnitude relationship of "J1>J21>J22".

<Use of the guiding catheter 1>
Examples of use (first, second, and third use examples) in which the guiding catheter 1 is used will be described. The guiding catheter 1 is used to guide the treatment catheter 5 to the brachiocephalic artery 91, the left common carotid artery 92, and the left subclavian artery 93 (see Figs. 10 to 19; hereinafter referred to as "target blood vessels 90") connected to the aortic arch 9B. A shape-retaining catheter for retaining the shape of the tubular body 2 or a treatment catheter 5 is inserted into the lumen 20 of the guiding catheter 1. As the shape-retaining catheter, a guiding catheter, a guidewire, or the like is used. The shape-retaining catheter is harder than the treatment catheter 5. Therefore, when the shape-retaining catheter is inserted into the lumen 20, a part of the shaft portion 21 and the loop portion 22 of the tubular body 2 are deformed, and the first curved portion 41 and the second curved portion 42 are extended straight. In this case, the tubular body 2 is extended in a straight line over the entire area of the shaft portion 21, the loop portion 22, and the protruding portion 23 (see Fig. 1). On the other hand, when the treatment catheter 5 is inserted into the lumen 20, the shaft portion 21, the loop portion 22, and the protruding portion 23 of the tubular body 2 each maintain the shape they have when nothing is inserted into the lumen 20. Therefore, the tubular body 2 is curved at the first curved portion 41 and the second curved portion 42 (see FIG. 4).

<First use example>
10 to 13, a first use example of the guiding catheter 1 will be described. In the first use example, the guiding catheter 1 is used to guide a treatment catheter 5 to a brachiocephalic artery 91 as a target blood vessel 90.

The tubular body 2 of the guiding catheter 1 is inserted into the femoral artery, starting from the tip 2D, using a sheath, with the shape-retaining catheter inserted into the lumen 20. As shown in FIG. 10, the tubular body 2 passes through the descending aorta 9A in a straight, extended state, and moves toward the aortic arch 9B and ascending aorta 9C (arrow Z11). As shown in FIG. 11, after the tip 2D of the tubular body 2 reaches the aortic arch 9B, it curves along the inner wall of the aortic arch 9B and moves further toward the ascending aorta 9C (arrow Z12).

When the tip 2D of the tubular body 2 reaches the ascending aorta 9C, the shape-retaining catheter is removed from the lumen 20. In response to the shape-retaining catheter being removed from the lumen 20, the tubular body 2 is curved at the first curved portion 41 and the second curved portion 42, and the shaft portion 21, the loop portion 22, and the protruding portion 23 are formed. The user rotates the shaft portion 21 along the center line C so that the protruding portion 23 (third straight portion 33) protrudes toward the outer peripheral wall 900 of the ascending aorta 9C. Then, as shown in FIG. 12, the user moves the tubular body 2 further downward toward the ascending aorta 9C (arrow Z13).

When the tip 2D reaches a position approximately in the vertical center of the ascending aorta 9C, the movement of the tube 2 is stopped. As shown in FIG. 13, the first straight portion 31 of the tube 2, except for the portion 312 adjacent to the first curved portion 41, is disposed within the descending aorta 9A. The first curved portion 41 of the tube 2 and the portion 312 of the first straight portion 31 adjacent to the first curved portion 41 are disposed near the inner peripheral wall 911 within the aortic arch 9B. The second straight portion 32, the second curved portion 42, and the third straight portion 33 of the tube 2 are disposed within the ascending aorta 9C. The tip 2D of the tube 2 faces the outer peripheral wall 900 of the ascending aorta 9C.

The user inserts the treatment catheter 5 into the connector body 81 of the guiding catheter 1. The treatment catheter 5 passes through the lumen 20 of the tubular body 2 toward the tip 2D and is delivered to the outside from the tip 2D. Note that even when the treatment catheter 5 is inserted into the lumen 20, the tubular body 2 is curved at the first curved portion 41 and the second curved portion 42, and the shaft portion 21, the loop portion 22, and the protrusion portion 23 are maintained in a formed state.

The treatment catheter 5 delivered from the tip 2D moves toward the outer peripheral wall 900 of the ascending aorta 9C. After reaching the outer peripheral wall 900, the treatment catheter 5 further moves upward along the outer peripheral wall 900 toward the aortic arch 9B. After reaching the aortic arch 9B, the treatment catheter 5 enters the brachiocephalic artery 91 connected to the aortic arch 9B (arrow Z14). The treatment catheter 5 that has entered the brachiocephalic artery 91 treats lesions in the right subclavian artery and right common carotid artery connected to the brachiocephalic artery 91, or lesions in the cerebral blood vessels connected to the ends of the right subclavian artery and right common carotid artery.

<Second example of use>
14 to 16, a second use example of the guiding catheter 1 will be described. In the second use example, the guiding catheter 1 is used to guide the treatment catheter 5 to the brachiocephalic artery 91 as the target blood vessel 90, similarly to the first use example.

10 and 11 in the first use example, the tip 2D of the tube 2 reaches the ascending aorta 9C. The shape-retaining catheter is removed from the lumen 20. As the shape-retaining catheter is removed from the lumen 20, the tube 2 is curved at the first curved portion 41 and the second curved portion 42, and the shaft portion 21, the loop portion 22, and the protruding portion 23 are formed. The second curved portion 42 and the third straight portion 33 of the tube 2 are placed in the ascending aorta 9C. The user rotates the shaft portion 21 along the center line C so that the protruding portion 23 (third straight portion 33) protrudes toward the outer peripheral wall 900 of the ascending aorta 9C. As shown in FIG. 14, the tip 2D of the tube 2 faces the outer peripheral wall 900 of the ascending aorta 9C.

In this state, the user applies force to the tube 2 in a direction to pull the tube 2 out of the femoral artery. As shown in FIG. 15, the second curved portion 42 and the third straight portion 33 of the tube 2 move upward from the ascending aorta 9C toward the aortic arch 9B, along the outer peripheral wall 900 of the ascending aorta 9C and the outer peripheral wall 901 of the aortic arch 9B (arrow Z21). The third straight portion 33 of the tube 2 reaches the brachiocephalic artery 91, which connects to the aortic arch 9B. The third straight portion 33 of the tube 2 then enters the brachiocephalic artery 91.

As shown in FIG. 16, the first straight portion 31 of the tube 2, excluding a portion 314 adjacent to the first

curved portion

41, 313, is disposed within the descending aorta 9A. The second curved portion 42, the second straight portion 32, the first curved portion 41, and the portion 314 of the first straight portion 31 adjacent to the first curved portion 41 of the tube 2 are disposed within the aortic arch 9B. The third straight portion 33 is disposed within the brachiocephalic artery 91.

The treatment catheter 5 is inserted through the connector body 81 of the guiding catheter 1. The treatment catheter 5 passes through the lumen 20 of the tubular body 2 toward the tip 2D, and is delivered to the outside from the tip 2D. Note that even when the treatment catheter 5 is inserted through the lumen 20, the first curved portion and the second curved portion 42 of the tubular body 2 remain curved.

As shown in FIG. 16, the treatment catheter 5 delivered from the tip 2D enters the brachiocephalic artery 91 (arrow Z22). The treatment catheter 5 that has entered the brachiocephalic artery 91 treats lesions in the right subclavian artery and right common carotid artery that connect to the brachiocephalic artery 91, or treats lesions in cerebral blood vessels, etc., that connect to the ends of the right subclavian artery and right common carotid artery.

<Third use example>
17 to 19, a third use example of the guiding catheter 1 will be described. In the third use example, the guiding catheter 1 is used to guide a treatment catheter 5 into a left common carotid artery 92 as a target blood vessel 90.

10 and 11 in the first use example, the tip 2D of the tube 2 reaches the aortic arch 9B. The shape-retaining catheter is removed from the lumen 20. As the shape-retaining catheter is removed from the lumen 20, the tube 2 is curved at the first curved portion 41 and the second curved portion 42, and the shaft portion 21, the loop portion 22, and the protruding portion 23 are formed. The second curved portion 42 and the third straight portion 33 of the tube 2 are placed in the aortic arch 9B. The user rotates the shaft portion 21 along the center line C so that the protruding portion 23 (third straight portion 33) protrudes toward the portion 901A between the connection portions of the brachiocephalic artery 91 and the left common carotid artery 92 of the outer peripheral wall 901 of the aortic arch 9B. As shown in FIG. 17, the tip 2D of the tube 2 faces the portion 901A.

In this state, the user applies force to the tube 2 in a direction to pull the tube 2 out of the femoral artery. As shown in FIG. 18, the second curved portion 42 and the third straight portion 33 of the tube 2 move leftward along portion 901A of the outer peripheral wall 900 of the ascending aorta 9C from the aortic arch 9B toward the descending aorta 9A (arrow Z31). The third straight portion 33 of the tube 2 reaches the left common carotid artery 92, which connects to the aortic arch 9B. The third straight portion 33 of the tube 2 then enters the left common carotid artery 92.

As shown in FIG. 19, the first straight portion 31 of the tube 2 is positioned within the descending aorta 9A. The second curved portion 42, the second straight portion 32, and the first curved portion 41 of the tube 2 are positioned within the aortic arch 9B. The third straight portion 33 of the tube 2 is positioned within the left common carotid artery 92.

As shown in FIG. 19, the treatment catheter 5 delivered from the tip 2D enters the left common carotid artery 92 (arrow Z32). The treatment catheter 5 that has entered the left common carotid artery 92 treats a lesion in the left common carotid artery 92, or treats a lesion in a cerebral blood vessel or the like that is connected to the end of the left common carotid artery 92.

Although detailed explanations are omitted, when treating a lesion in the left subclavian artery 93 connected to the aortic arch 9B, or when treating a lesion in a cerebral blood vessel or the like connected to the end of the left subclavian artery 93, the treatment catheter 5 is guided to the left subclavian artery 93 through the same process as in the third use example. Also, when treating a lesion in the external jugular vein, left common jugular vein, and internal jugular vein connected to the superior vena cava, or when treating a lesion in a blood vessel or the like connected to the end of the external jugular vein, left common jugular vein, and internal jugular vein, the treatment catheter 5 is guided to each vein through the same process as in the first to third use examples.

<Experiment 1>
An experiment was conducted to optimize the angle θ23 (see FIG. 6 ) between the second straight portion 32 and the third straight portion 33 of the tubular body 2. Sample 1 with the angle θ23 set to 40 degrees, sample 2 with the angle θ23 set to 45 degrees, sample 3 with the angle θ23 set to 60 degrees, and sample 4 with the angle θ23 set to 80 degrees were prepared. As the shape-retaining catheter, "6F ENVOY" (Guiding Catheter Envoy/J&J Co.) was used. As the treatment catheter, "SOFIAFLOW" (Cerebral Thrombosis Aspiration Catheter/Terumo Co.) was used.

The following evaluations (1) to (3) were carried out, and the results are shown in FIG.
(1) Shape elongation evaluation The state of the tubular body 2 when the shape-retaining catheter was inserted into the lumen 20 was evaluated in three stages (Positive, Neutral, Negative). When the loop portion 22 opened and stretched linearly, it was evaluated as "Positive." When the loop portion 22 opened and stretched slightly curved, it was evaluated as "Neutral." When the loop portion 22 remained curved and did not stretch linearly, it was evaluated as "Negative."

(2) Shape retention evaluation The state of the tubular body 2 when the treatment catheter was inserted into the lumen 20 was evaluated in three stages (Positive, Neutral, Negative). When the loop portion 22 was maintained in a curved state, it was evaluated as "Positive". When the loop portion 22 was opened and the state in which the second straight portion 32 and the third straight portion 33 crossed each other was maintained, it was evaluated as "Neutral". When the loop portion 22 was opened and the state in which the second straight portion 32 and the third straight portion 33 crossed each other was eliminated, it was evaluated as "Negative".

(3) Shape restoration evaluation After the shape-retaining catheter was inserted into the lumen 20, the shape-retaining catheter was removed and a treatment catheter was inserted into the lumen 20 instead. The state of the tubular body 2 was evaluated in three stages (Positive, Neutral, Negative). When a loop portion 22 was formed, it was evaluated as "Positive." When a loop portion 22 was formed but the curvature was insufficient, it was evaluated as "Neutral." When a loop portion 22 was not formed, it was evaluated as "Negative."

From the results shown in FIG. 20, it was found that the larger the angle θ23 between the second straight portion 32 and the third straight portion 33, the more stably the shape of the loop portion 22 is maintained. It was also found that when the angle θ23 is at least 40 degrees or more, more preferably 45 degrees or more, the loop portion 22 can be stretched linearly when the shape-retaining catheter is inserted into the lumen 20. It was also found that by setting the angle θ23 to at least 60 degrees or more, the curved shape of the loop portion 22 can be maintained even when the treatment catheter is inserted into the lumen 20. It was also found that by setting the angle θ23 to at least 80 degrees or more, the tube 2 exhibits good characteristics in terms of the stretching, shape maintenance, and shape restoration of the loop portion 22. On the other hand, in order to smoothly move the shape-retaining catheter and the treatment catheter within the lumen 20, it is generally preferable that the angle θ23 is 100 degrees or less. From these results, it was found that the angle θ23 is preferably 40 degrees or more and 100 degrees or less.

<Experiment 2>
An experiment was conducted to optimize the hardness of the tube body 2. Three samples (samples 5, 6, and 7) were prepared. As sample 5, a tube body 2 was used in which the main tube portion 204 includes the first straight portion 31 and the first curved portion 41, the second middle tube portion 203 includes the second straight portion 32, and the first middle tube portion 202 includes the second curved portion 42 and the third straight portion. As sample 6, a tube body 2 was used in which the main tube portion 204 includes the first straight portion 31 and the first curved portion 41, the second middle tube portion 203 includes the second straight portion 32 and the second curved portion 42, and the first middle tube portion 202 includes the third straight portion. As sample 7, a tube body 2 was used in which the main tube portion 204 includes the first straight portion 31, the first curved portion 41, and the second straight portion 32, the second middle tube portion 203 includes the second curved portion 42, and the first middle tube portion 202 includes the third straight portion.

When each sample was used in the vascular model, the ability to guide the therapeutic catheter to the target blood vessel was evaluated on a three-point scale (Positive, Neutral, Negative). If the therapeutic catheter could be guided to the target blood vessel, it was evaluated as "Positive." If the therapeutic catheter could be guided to the target blood vessel but it took time, it was evaluated as "Neutral." If the therapeutic catheter could not be guided to the target blood vessel, it was evaluated as "Negative."

21, it was found that the treatment catheter could be properly guided to the target blood vessel, especially when sample 7 was used. One of the reasons for this is that pushability was improved by making the first straight portion 31, the first curved portion 41, and the second straight portion 32 the hardest. Another reason is that the shape of the loop portion 22 was stabilized by making the second curved portion 42 harder than the third straight portion 33. In addition, by making the third straight portion 33 the softest, there is also the advantage that the degree of freedom of the delivery direction can be increased when the treatment catheter is delivered from the lumen 20 through the tip portion 2D. From the above results, it was found that the treatment catheter can be properly guided to the target blood vessel by making the hardness of the first straight portion 31, the first curved portion 41, and the second straight portion 32 harder than the second curved portion 42 and the third straight portion 33, and by making the hardness of the second curved portion 42 harder than the third straight portion 33.

<Actions and Effects of the Present Embodiment>
As described above, the guiding catheter 1 is used for the purpose of guiding the treatment catheter 5 to the target blood vessel 90. In this case, the user can easily arrange the shaft portion 21 (the first straight portion 31, the first curved portion 41, and a part of the second straight portion 32), the loop portion 22 (the other part of the second straight portion 32, the second curved portion 42), and the protruding portion 23 (the third straight portion 33) so that the tip portion 2D faces the target blood vessel 90. Therefore, the user can appropriately guide the treatment catheter 5 toward the target blood vessel 90 by inserting the treatment catheter 5 into the lumen 20 of the guiding catheter 1. In this way, the guiding catheter 1 can appropriately guide the treatment catheter 5 toward various blood vessels including the target blood vessel 90. In particular, the guiding catheter 1 can easily guide the treatment catheter 5 to the brachiocephalic artery 91, the left common carotid artery 92, and the left subclavian artery 93 connected to the aortic arch 9B, as well as blood vessels connected to the ends of the external jugular vein, the left common jugular vein, and the internal jugular vein, and can appropriately perform treatment with the treatment catheter 5.

The shaft portion 21 of the guiding catheter 1 has a curved first curved portion 41. Therefore, the user can smoothly move the tip portion 2D toward the ascending aorta 9C by moving the tube body 2 along the curved aortic arch 9B. Furthermore, the user can easily grasp the position of the loop portion 22 relative to the shaft portion 21 by checking the direction in which the first curved portion 41 of the shaft portion 21 is curved. Therefore, the user can easily operate the tube body 2 so that the protrusion 23 protrudes toward the outer peripheral wall 900 of the ascending aorta 9C or the outer peripheral wall 901 of the aortic arch 9B.

The tubular body 2 of the guiding catheter 1 has a protrusion 23 near the tip 2D, which includes a third straight portion 33 that extends linearly. This makes it easy to orient the treatment catheter 5 that is delivered from the tip 2D to the outside of the lumen 20. Therefore, the user can easily use the guiding catheter 1 to guide the treatment catheter 5 to the target blood vessel 90.

The shaft portion 21 of the guiding catheter 1 includes a portion of the second straight portion 32, and the loop portion 22 includes the remaining portion of the second straight portion 32 excluding the portion included in the shaft portion 21. In other words, the loop portion 22 is connected to the shaft portion 21 via the second straight portion 32. In this case, the guiding catheter 1 can stably maintain the annular shape of the loop portion 22, particularly at the boundary with the shaft portion 21.

The angle θ23 between the second straight portion 32 and the third straight portion 33 is approximately 80 degrees. In this case, the guiding catheter 1 can reduce the radius of curvature at the boundary between the second straight portion 32 and the second curved portion 42 and at the boundary between the third straight portion 33 and the second curved portion 42. In other words, the second curved portion 42 curves sharply at these boundary portions, so the guiding catheter 1 can stably maintain the curved state of the second curved portion 42. In addition, the second curved portion 42 includes a partial curved portion 422 with a radius of curvature of 8 mm. This allows the guiding catheter 1 to stably maintain the curved state of the second curved portion 42, especially at the partial curved portion 422.

The intersection 321 of the second straight portion 32 corresponding to the position of the first intersection point X1 and the intersection 331 of the third straight portion 33 corresponding to the position of the first intersection point X1 are spaced apart in the perpendicular direction V. Furthermore, the direction in which the third straight portion 33 extends from the end on the base end 2P side toward the end on the tip end 2D side is inclined with respect to the plane H. In this case, the guiding catheter 1 can point the tip end 2D in a direction different from the direction along the plane H. Therefore, the guiding catheter 1 can increase the degree of freedom of the direction in which the tip end 2D points, and therefore can appropriately guide the treatment catheter 5 toward the target blood vessel 90 even when the position of the target blood vessel 90 differs from patient to patient.

The angle θ12 between the first straight portion 31 and the second straight portion 32 is approximately 120 degrees. Furthermore, the radius of curvature of the first curved portion 41 is 20 mm or more. In this case, the guiding catheter 1 can position the first curved portion 41, which is disposed within the arc-shaped curved aortic arch 9B, near the inner circumferential wall 911 of the curved aortic arch 9B. In this case, the guiding catheter 1 can stabilize the position of the shaft portion 21 within the aortic arch 9B.

Because the second straight section 32 is shorter than the third straight section 33, the guiding catheter 1 can stabilize the direction of the tip section 2D provided at the tip of the third straight section 33. Therefore, the guiding catheter 1 can stabilize the guidance direction of the treatment catheter 5.

In the guiding catheter 1, the first hardness J1, which is the hardness of the first straight portion 31, the first curved portion 41, and the second straight portion 32, is harder than the second hardness J2, which is the hardness of the second curved portion 42 and the third straight portion 33. In this case, the guiding catheter 1 can achieve good pushability. In addition, since the second hardness J2 is softer than the first hardness J1, the second curved portion 42 can be easily extended by passing the shape-retaining catheter through the lumen 20. In this case, the user can easily pass the tip portion 2D through the descending aorta 9A, for example, to reach the aortic arch 9B and the ascending aorta 9C.

Furthermore, in the guiding catheter 1, the first portion stiffness J21, which is the stiffness of the second curved portion 42, is harder than the second portion stiffness J22, which is the stiffness of the third straight portion 33. In this case, the guiding catheter 1 can improve the operability for the user by freely changing the orientation of the third straight portion 33 and the tip portion 2D according to the shape of the target blood vessel 90 and the aortic arch 9B while maintaining the curved state of the second curved portion 42.

In the first use example, the portion 311 of the first straight portion 31 is positioned within the descending aorta 9A. The first curved portion 41 and the portion 312 of the first straight portion 31 are positioned within the aortic arch 9B. The second straight portion 32, the second curved portion 42, and the third straight portion 33 are positioned within the ascending aorta 9C. In this case, the guiding catheter 1 can guide the treatment catheter 5, which has been delivered from the tip portion 2D toward the outside of the lumen 20, to the brachiocephalic artery 91 via the ascending aorta 9C.

In the second use example, the portion 313 of the first straight portion 31 is placed in the descending aorta 9A. The second curved portion 42, the second straight portion 32, the first curved portion 41, and the portion 314 of the first straight portion 31 are placed in the aortic arch 9B. The third straight portion 33 is placed in the brachiocephalic artery 91. In this case, the guiding catheter 1 can directly guide the treatment catheter 5, which is delivered from the tip portion 2D toward the outside of the lumen 20, toward the left common carotid artery 92 or the left subclavian artery 93.

<Modification>
The present invention is not limited to the above embodiment, and various modifications are possible. The parameters such as length and angle exemplified in the above embodiment are merely examples, and other values may be used. The relationship of lengths in different parts is merely examples, and other relationships may be used. For example, the second straight section 32 may be longer than the third straight section 33. The guiding catheter 1 may be used to guide the treatment catheter 5 to blood vessels other than the brachiocephalic artery 91, the left common carotid artery 92, and the left subclavian artery 93 connected to the aortic arch 9B, and the external jugular vein, the left common jugular vein, and the internal jugular vein connected to the superior vena cava.

The shaft portion 21 of the tube body 2 may not have the first curved portion 41, and may have only the first straight portion 31 and the second straight portion 32. The loop portion 22 of the tube body 2 may not have the second straight portion 32, and may have only the second curved portion 42. The protruding portion 23 of the tube body 2 may have a part of the second curved portion 42 and the third straight portion 33. The shaft portion 21 and the protruding portion 23 may not have straight portions, and may be formed only from curved portions.

The loop portion 22 of the tube body 2 may have a part of the second straight portion 32, a second curved portion 42, and a part of the third straight portion 33. In this case, the second straight portion 32 and the third straight portion 33 may intersect at the first intersection point X1. The second straight portion 32 and the third straight portion 33 may be spaced apart in the orthogonal direction V at the first intersection point X1.

The first intersection X1 may be formed by the intersection of a portion of the second curved portion 42 close to the second straight line portion 32 and the third straight line portion 33. The first intersection X1 may be formed by the intersection of the second straight line portion 32 and a portion of the second curved portion 42 close to the third straight line portion 33. The first intersection X1 may be formed by the intersection of a portion of the second curved portion 42 close to the second straight line portion 32 and a portion of the second curved portion 42 close to the third straight line portion 33.

The angle θ23 between the second straight portion 32 and the third straight portion 33 is preferably greater than or equal to 45 degrees and less than or equal to 100 degrees, but does not have to be within this range. The angle θ23 may be less than 45 degrees or greater than 100 degrees.

The first curved portion 41 includes a partial curved portion 411 with a radius of curvature of 120 mm and a partial curved portion 412 with a radius of curvature of 31 mm. In contrast, the radius of curvature of the first curved portion 41 may be a common value over the entire area. The radius of curvature of the first curved portion 41 is preferably 20 mm or more, but does not have to be within this range. The radius of curvature of the first curved portion 41 may be smaller than 20 mm.

The second curved portion 42 includes a partial curved portion 421 with a radius of curvature of 16 mm, a partial curved portion 422 with a radius of curvature of 8 mm, and a partial curved portion 423 with a radius of curvature of 26 mm. Here, the radius of curvature of the second curved portion 42 is preferably 8 mm or more and 10 mm or less in order to stably maintain the curved state of the second curved portion 42. Therefore, the radius of curvature of the partial

curved portions

421 and 423 of the second curved portion 42 may also be 8 mm or more and 10 mm or less. The radius of curvature of the second curved portion 42 may be a common value over the entire area. The radius of curvature of the second curved portion 42 is preferably 8 mm or more and 10 mm or less, but does not have to be within this range. The radius of curvature of the second curved portion 42 may be smaller than 8 mm or larger than 10 mm.

The intersection 321 of the second straight line portion 32 corresponding to the position of the first intersection point X1 and the intersection 331 of the third straight line portion 33 corresponding to the position of the first intersection point X1 may be in contact with each other. The direction in which the third straight line portion 33 extends from the end portion on the base end portion 2P side toward the end portion on the tip end portion 2D side may extend parallel to the plane H.

The angle θ12 between the first straight portion 31 and the second straight portion 32 is preferably greater than or equal to 120 degrees and less than or equal to 179 degrees, but does not have to be within this range. The angle θ12 may be less than 120 degrees or greater than 179 degrees.

The relationship in hardness between the first straight portion 31, the first curved portion, the second straight portion 32, the second curved portion 42, and the third straight portion 33 of the tube body 2 is not limited to the above embodiment. For example, the first straight portion 31, the first curved portion, the second straight portion 32, the second curved portion 42, and the third straight portion 33 may be gradually softer in this order. The second curved portion 42 and the third straight portion 33 may have the same hardness, and this hardness may be softer than the first straight portion 31, the first curved portion 41, and the second straight portion 32. The hardness of the loop portion 22 may be softer than the hardness of the shaft portion 21, and the hardness of the protruding portion 23 may be softer than the hardness of the loop portion 22.

＜Other＞
The radii of curvature of the partial

curved portions

411, 412 included in the first curved portion 41 and the partial curved portions 421-423 included in the second curved portion 42, as well as the overall radii of curvature of the first curved portion 41 and the second curved portion 42, are measured as follows. First, an imaginary arc that approximates a curve extending along the center line C of each portion is defined, and then an imaginary circle having the defined arc as a part thereof is further defined. Next, the radius of the defined imaginary circle is measured. The measured radius is taken as the radius of curvature of the corresponding curved portion.

Claims

A guiding catheter having a tubular body with an inner lumen and extending between a proximal end and a distal end,
The tube is
A shaft portion extending from the base end portion;
a loop portion adjacent to the tip portion side of the shaft portion;
a protrusion adjacent to the loop portion on the side of the tip portion and extending linearly to the tip portion;
A guiding catheter comprising:
The shaft portion is
A first straight portion extending straight,
a first curved portion adjacent to the tip portion side of the first straight portion and curved;
At least a portion of a second straight line portion that is adjacent to the tip end side of the first curved line portion and extends straight;
having
The loop portion is
a second curved portion adjacent to the tip portion with respect to the second straight portion,
The protrusion is
The guiding catheter according to claim 1, further comprising at least a portion of a third straight section that is adjacent to the tip end side of the second curved section, extends in a straight line to the tip end, and intersects with the second straight section.
The shaft portion is
The first straight portion, the first curved portion, and a part of the second straight portion,
The loop portion is
The guiding catheter according to claim 2 , further comprising: a portion other than a part of the second straight portion included in the shaft portion; and the second curved portion.
When viewed from one side in a direction perpendicular to a plane including the first straight line portion, the first curved line portion, and the second straight line portion,
the second straight line portion and the third straight line portion intersect at a first intersection point,
3. The guiding catheter according to claim 2, characterized in that an angle between a half line extending from the first intersection point along the second straight line portion toward the base end portion and a half line extending from the first intersection point along the third straight line portion toward the tip end portion is greater than or equal to 45 degrees and less than 100 degrees.
The guiding catheter according to claim 2, characterized in that the radius of curvature of the second curved portion is 8 mm or more and 10 mm or less.
When viewed from one side in an orthogonal direction orthogonal to a plane including the first straight line portion, the first curved line portion, and the second straight line portion, the second straight line portion and the third straight line portion intersect at a first intersection point,
The guiding catheter according to claim 2 , wherein a portion of the second straight portion corresponding to the first intersection and a portion of the third straight portion corresponding to the first intersection are spaced apart in the perpendicular direction.
The guiding catheter according to claim 2, characterized in that the direction in which the third straight section extends from the end on the base end side to the end on the tip end side is inclined with respect to a plane extending along the first straight section, the first curved section, and the second straight section.
a first straight line extending along the first straight line portion and a second straight line extending along the second straight line portion intersect at a second intersection point;
3. The guiding catheter according to claim 2, characterized in that an angle between a half line extending from the second intersection point along the first straight line toward the first straight line portion and a half line extending from the second intersection point along the second straight line toward the second straight line portion is greater than or equal to 120 degrees and less than or equal to 179 degrees.
The guiding catheter according to claim 2, characterized in that the radius of curvature of the first curved portion is 20 mm or more.
The guiding catheter according to claim 2, characterized in that the second straight portion is shorter than the third straight portion.
the first straight portion, the first curved portion, and the second straight portion have a first hardness;
the second curved portion and the third straight portion have a second hardness;
3. The guiding catheter according to claim 2, wherein the first hardness is harder than the second hardness.
The second hardness is
a first portion hardness which is the hardness of the second curved portion;
a second portion hardness that is the hardness of the third straight portion;
The guiding catheter according to claim 11, characterized in that the first hardness is harder than the first portion hardness and the second portion hardness, and the first portion hardness is harder than the second portion hardness.
The guiding catheter according to claim 1, characterized in that it is used to guide a treatment catheter, which is inserted through the lumen toward the tip, to target blood vessels including the brachiocephalic artery, left common carotid artery, and left subclavian artery, which are connected to the aortic arch, and the external jugular vein, left common jugular vein, and internal jugular vein, which are connected to the superior vena cava.
The shaft portion is
A first straight portion extending straight,
a first curved portion adjacent to the tip portion side with respect to the first straight portion and curved;
At least a portion of a second straight line portion that is adjacent to the tip end side of the first curved line portion and extends straight;
having
The loop portion is
a second curved portion adjacent to the tip portion with respect to the second straight portion,
The protrusion is
a third straight line portion that is adjacent to the tip end side of the second curved line portion, extends linearly to the tip end, and has at least a portion that intersects with the second straight line portion;
a portion of the first straight section is disposed in the descending aorta;
the first curved portion is disposed at the aortic arch;
the second straight portion, the second curved portion, and the third straight portion are disposed in the ascending aorta;
The guiding catheter according to claim 13, wherein the tip portion is disposed toward an outer peripheral wall of the ascending aorta.
The shaft portion is
A first straight portion extending straight,
a first curved portion adjacent to the tip portion side of the first straight portion and curved;
At least a portion of a second straight line portion that is adjacent to the tip end side of the first curved line portion and extends straight;
having
The loop portion is
a second curved portion adjacent to the tip portion with respect to the second straight portion,
The protrusion is
a third straight line portion that is adjacent to the tip end side of the second curved line portion, extends linearly to the tip end, and has at least a portion that intersects with the second straight line portion;
a portion of the first straight section is disposed in the descending aorta;
the first curved portion, the second straight portion, and the second curved portion are disposed at the aortic arch;
The guiding catheter according to claim 13 , wherein the third straight section is disposed in the target blood vessel.