Guiding catheter
The guiding catheter with a shaft, loop, and projection design enhances its ability to guide therapeutic catheters to multiple blood vessels by ensuring stable shape maintenance and flexible orientation, addressing the limitations of existing catheters.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- NIPRO VASCULAR CORP
- Filing Date
- 2023-09-08
- Publication Date
- 2026-06-17
AI Technical Summary
Existing guiding catheters are limited in their ability to guide treatment catheters to various blood vessels beyond the coronary artery, such as the brachiocephalic artery, left common carotid artery, left subclavian artery, external jugular vein, and left common jugular vein, due to their fixed design.
A guiding catheter with a tubular body featuring a shaft portion, loop portion, and projection portion, allowing for flexible positioning and orientation to guide therapeutic catheters to various blood vessels by incorporating multiple straight and curved sections with adjustable hardness and curvature, enabling stable maintenance of shape and increased directionality.
The catheter can effectively guide therapeutic catheters to diverse vessels like the brachiocephalic artery, left common carotid artery, and left subclavian artery, providing stable guidance and ease of operation by adapting to individual vascular arrangements.
Smart Images

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Abstract
Description
Technical Field
[0001] The present invention relates to a guiding catheter.
Background Art
[0002] Guiding catheters for use in coronary artery treatment have been proposed. For example, Patent Document 1 discloses a guiding catheter having first to third curved portions. When the guiding catheter is disposed in 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 distal end portion extends toward the ostium of the right coronary artery. In this state, when a treatment catheter is inserted into the guiding catheter, the treatment catheter is guided from the distal end portion toward the right coronary artery. Thus, treatment of the right coronary artery with the treatment catheter becomes possible.
Prior Art Documents
Patent Documents
[0003]
Patent Document 1
Summary of the Invention
[0004] In the guiding catheter described in Patent Document 1, it is only possible to guide a treatment catheter toward the coronary artery. In contrast, there is a desire for a guiding catheter capable of guiding a treatment catheter toward other blood vessels, for example, 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.
[0005] An object of the present invention is to provide a guiding catheter capable of guiding a treatment catheter toward various blood vessels.
[0006] The guiding catheter according to the present invention is a guiding catheter having a lumen and a tubular body extending between a proximal end and a distal end, wherein the tubular body comprises a shaft portion extending from the proximal end, a loop portion adjacent to the distal end side with respect to the shaft portion, and a projection portion adjacent to the distal end side with respect to the loop portion and extending linearly to the distal end.
[0007] Let's take the example of a guiding catheter being used to guide a therapeutic catheter into various arteries connected to the aortic arch or various veins connected to the superior vena cava (hereinafter referred to as "target vessels"). In this case, the user can easily position the shaft, loop, and projection within the body so that the tip is facing the target vessel. Therefore, by inserting the therapeutic catheter into the lumen of the guiding catheter, the user can appropriately guide the therapeutic catheter toward the target vessel. In this way, guiding catheters can appropriately guide therapeutic catheters toward various vessels.
[0008] 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 extending in a straight line adjacent to the tip side of the first curved portion and curved; 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 the second straight portion. For example, consider the case where a guiding catheter is used for the purpose of guiding a therapeutic catheter into 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 appropriately guide the therapeutic catheter toward the target blood vessel by inserting the therapeutic catheter into the lumen of the guiding catheter.
[0009] In the present invention, the shaft portion may have the first straight portion, the first curved portion, and a part of the second straight portion, and the loop portion may have the other portion of the shaft portion excluding the part 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.
[0010] In the present invention, when viewed from one side in a direction perpendicular to the plane including the first straight section, the first curved section, and the second straight section, the second straight section and the third straight section intersect at a first intersection, and the angle between the half-line extending from the first intersection along the second straight section toward the base end and the half-line extending from the first intersection along the third straight section toward the tip end 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 section with the second straight section, and at the boundary portion of the second curved section with the third straight section. Therefore, the guiding catheter can stably maintain the curved state of the second curved section.
[0011] 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.
[0012] In the present invention, when viewed from one side in a direction perpendicular to the plane including the first straight section, the first curved section, and the second straight section, the second straight section and the third straight section may intersect at a first intersection, and the portion of the second straight section corresponding to the first intersection and the portion of the third straight section corresponding to the first intersection may be separated in the direction of the orthogonal section. In this case, the guiding catheter can increase the degree of freedom of the direction its tip faces within the body. Therefore, even if there are individual differences in the arrangement of blood vessels, the guiding catheter can appropriately guide the therapeutic catheter toward the target blood vessel.
[0013] In the present invention, the direction in which the third straight portion extends from the end on the base side toward the end on the tip side may be inclined with respect to the plane extending along the first straight portion, the first curved portion, and the second straight portion. In this case, the guiding catheter can orient its tip in a direction different from the direction along the plane within the body. This increases the degree of freedom in which the tip of the guiding catheter can orient itself within the body.
[0014] In the present invention, the first straight line extending along the first straight section and the second straight line extending along the second straight section intersect at a second intersection, and the angle between the half-line extending from the second intersection along the first straight line toward the first straight section and the half-line extending from the second intersection along the second straight line toward the second straight section may be 120 degrees or more and 179 degrees or less. In this case, the guiding catheter can be positioned so that the first curved section, which is placed in an arc-shaped blood vessel, is near the inner wall of the blood vessel.
[0015] In the present invention, the radius of curvature of the first curved portion may be 20 mm or more. In this case, the guiding catheter can be positioned in the curved blood vessel, with the first curved portion positioned near the inner wall of the blood vessel.
[0016] 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 its tip faces, thereby stabilizing the guidance direction of the therapeutic catheter.
[0017] In the present invention, the hardness of the first straight section, the first curved section, and the second straight section is a first hardness, and the hardness of the second curved section and the third straight section is a second hardness, and the first hardness may be harder than the second hardness. By making the first hardness harder than the second hardness, the guiding catheter can achieve good pushability. Alternatively, by making the second hardness softer than the first hardness, the second curved section of the guiding catheter can be extended, for example, by passing a rigid catheter through the lumen. In this case, the user can easily reach the tip of the catheter at the target site in the blood vessel.
[0018] In the present invention, the second hardness includes a first partial hardness which is the hardness of the second curved portion and a second partial hardness which is the hardness of the third straight portion, wherein the first hardness may be harder than the first partial hardness and the second partial hardness, and the first partial hardness may be harder than the second partial hardness. In this case, the guiding catheter can be made easier to operate by the user by freely changing the orientation of the third straight portion and the tip portion according to the shape of the blood vessels in the body, while maintaining the curved state of the second curved portion.
[0019] In the present invention, a therapeutic catheter, with its lumen facing the tip, may be used to guide target vessels, including the brachiocephalic artery, left common carotid artery, and left subclavian artery connected to the aortic arch, as well as the external jugular vein, left common jugular vein, and internal jugular vein connected to the superior vena cava. In this case, the guiding catheter can easily guide the therapeutic catheter toward the target vessel, allowing the target vessel and vessels beyond it to be treated by the therapeutic catheter.
[0020] 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; the projection portion has 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 the second straight portion; the part of the first straight portion is located in the descending aorta, the first curved portion is located in the aortic arch, the second straight portion, the second curved portion, and the third straight portion are located in the ascending aorta, and the tip may be located toward the outer wall of the ascending aorta. In this case, the guiding catheter can guide a therapeutic catheter extending from the tip toward the outside of the lumen to the target vessel via the ascending aorta.
[0021] 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 extending in a straight line adjacent to the tip side of the first curved portion; the loop portion has a second curved portion adjacent to the tip side of the second straight portion and curved; the projection portion has 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 the second straight portion; the part of the first straight portion may be located in the descending aorta; the first curved portion, the second straight portion, and the second curved portion may be located in the aortic arch; and the third straight portion may be located in the target vessel. In this case, the guiding catheter can directly guide a therapeutic catheter extending from the tip outward toward the lumen toward the target vessel. [Brief explanation of the drawing]
[0022] [Figure 1] This is a diagram showing guiding catheter 1. [Figure 2] This is a cross-sectional view of line II in Figure 1, taken from the direction of the arrow. [Figure 3] It is a cross-sectional view seen from the arrow direction along the line II-II in FIG. 1. [Figure 4] It is a view seen from one side V1 in the orthogonal direction V of the tubular body 2. [Figure 5] It is a view seen from the other side T2 in the first plane direction T of the tubular body 2. [Figure 6] It is a view seen from one side V1 in the orthogonal direction V of the vicinity of the tip 2D of the tubular body 2. [Figure 7] It is a view seen from the other side T2 in the first plane direction T of the vicinity of the tip 2D of the tubular body 2. [Figure 8] It is a view seen from one side V1 in the orthogonal direction V of the tubular body 2. [Figure 9] It is a view seen from the other side T2 in the first plane direction T of the tubular body 2. [Figure 10] It is a view showing the first step in the first to third usage examples of the guiding catheter 1. [Figure 11] It is a view showing the second step in the first to third usage examples of the guiding catheter 1. [Figure 12] It is a view showing the third step in the first usage example of the guiding catheter 1. [Figure 13] It is a view showing the fourth step in the first usage example of the guiding catheter 1. [Figure 14] It is a view showing the third step in the second usage example of the guiding catheter 1. [Figure 15] It is a view showing the fourth step in the second usage example of the guiding catheter 1. [Figure 16] It is a view showing the fifth step in the second usage example of the guiding catheter 1. [Figure 17] It is a view showing the third step in the third usage example of the guiding catheter 1. [Figure 18] It is a view showing the fourth step in the third usage example of the guiding catheter 1. [Figure 19] It is a view showing the fifth step in the third usage example of the guiding catheter 1. [Figure 20]This table shows the experimental results for Experiment 1. [Figure 21] This table shows the experimental results for Experiment 2. [Modes for carrying out the invention]
[0023] Embodiments of the guiding catheter 1 according to the present invention will be described with reference to the drawings. The drawings are used to illustrate the technical features that the present invention may adopt. The configuration of the device described is not intended to be the sole limiting factor, but is merely an illustrative example.
[0024] <Overview of Guiding Catheter 1> The guiding catheter 1 guides various catheters used to treat lesions (hereinafter referred to as "therapeutic catheters") towards the lesion within the blood vessel. In this embodiment, the guiding catheter 1 is used in particular to guide therapeutic catheters towards 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 therapeutic catheters include balloon catheters, guiding catheters, guidewires, suction catheters, microcatheters, contrast catheters, stent retrievers, stents, coils, etc. The therapeutic catheters that the guiding catheter 1 guides are not limited to the above specific examples. Therapeutic catheters include a variety of well-known catheters used to treat lesions.
[0025] As shown in Figure 1, the guiding catheter 1 comprises a tubular body 2 and a connector 80. The tubular body 2 is a long, slender tube with a lumen 20 (see Figure 2). One end of the tubular body 2 is called the "proximal end 2P," and the other end is called the "tip end 2D." The tubular body 2 is flexible and deforms in response to external forces. When no external force is acting on the tubular body 2, the area near the tip end 2D is curved (see Figure 4, etc.). Figure 1 shows the guiding catheter 1 in a state where the tubular body 2 is straightened in response to an external force. The length L11 of the tubular body 2 is approximately 83-85 cm as an example.
[0026] A connector 80 is connected to the proximal end 2P of the tubular body 2. The connector 80 has a connector body 81 and a reinforcing tube 82. The connector body 81 is provided for manipulating the tubular body 2 or passing a therapeutic catheter or the like through the tubular body 2. The connector body 81 is used by being grasped by the user. The reinforcing tube 82 reinforces the connection between the proximal end 2P of the tubular body 2 and the connector body 81.
[0027] <Tube body 2> As shown in Figures 2 and 3, the pipe body 2 has an inner layer tube 8A, a braided body 8B, and an outer layer tube 8C.
[0028] The inner layer tube 8A has a cylindrical shape. The material of the inner layer tube 8A is, for example, fluororesin. The inner layer tube 8A has a lumen 20 that extends between the base end 2P and the tip end 2D. Hereinafter, a virtual line that passes through the center of the lumen 20 and extends between the tip end 2D and the base end 2P will be called the "center line C". In the radial direction centered on the center line C, the side close to the center line C will be called the "inside", and the side away from the center line C will be called the "outside".
[0029] The braided body 8B is positioned on the outer side of the inner layer tube 8A. The braided body 8B is formed by shaping a braided wire, which is made of multiple metal strands, into a cylinder and cutting both ends of it. The material of the braided body 8B is, for example, SUS304. The braided body 8B is not provided in a portion of the pipe body 2, including the tip 2D. The length L31 of the portion of the pipe body 2 where the braided body 8B is not provided is, for example, approximately 0.5 mm.
[0030] The outer layer tube 8C has a cylindrical shape centered on the center line C. The outer layer tube 8C covers the inner layer tube 8A and the braided body 8B from the outside.
[0031] The outer layer tube 8C has four parts made of different materials. As shown in Figure 1, the tube body 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, each corresponding to one of 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 to the base section 2P. The material of the part of the outer layer tube 8C corresponding to the soft tip section 201 of the tube body 2 is, for example, nylon elastomer. A contrast agent may be added to the part of the outer layer tube 8C corresponding to the soft tip section 201 of the tube body 2. The material of the parts of the outer layer tube 8C corresponding to the first middle tube section 202, the second middle tube section 203, and the main tube section 204 of the tube body 2 is, for example, polyester elastomer. The hardness of 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 are all different.
[0032] The length L21 of the soft tip section 201 of the tube body 2 is approximately 3.5 mm, for example. The length L22 of the first middle tube section 202 of the tube body 2 is approximately 15 mm, for example. The length L23 of the second middle tube section 203 of the tube body 2 is approximately 50 mm, for example.
[0033] As shown in Figure 3, the diameter of the lumen 20 in the cross-section obtained by cutting the inner layer tube 8A with a plane perpendicular to the center line C corresponds to the inner diameter L41 of the tube body 2. The inner diameter L41 of the tube body 2 is 2.3 mm as an example. The diameter of the outer side surface in the cross-section obtained by cutting the outer layer tube 8C with a plane perpendicular to the center line C corresponds to the outer diameter L42 of the tube body 2. The outer diameter L42 of the tube body 2 is 2.73 mm as an example.
[0034] Figure 4 shows the vicinity of the tip 2D of the tube 2 when no external force is acting on it. The tube 2 has a shaft portion 21, a loop portion 22, and a projection portion 23. The loop portion 22 is annular and is located near the tip 2D. The shaft portion 21 is adjacent to the base portion 2P of the loop portion 22 and extends toward the base portion 2P. The projection portion 23 is adjacent to the tip 2D of the loop portion 22 and extends linearly toward the tip 2D.
[0035] 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 remaining part of the second straight portion 32, excluding the part included in the shaft portion 21, and the 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 "multiple straight portions 3". Each of the multiple straight portions 3 extends in a straight line. The first curved portion 41 and the second curved portion 42 are collectively referred to as "multiple curved portions 4". Each of the multiple curved portions 4 is curved.
[0036] The first straight section 31 is the portion of the pipe body 2 between position Q1, which is spaced apart from the tip end 2D towards the base end 2P, and position Q2, which is on the tip end 2D side relative to position Q1. The first curved section 41 is the portion of the pipe body 2 between position Q2 and position Q3, which is on the tip end 2D side relative to position Q2. The first curved section 41 is adjacent to the tip end 2D side relative to the first straight section 31. The second straight section 32 is the portion of the pipe body 2 between position Q3 and position Q4, which is on the tip end 2D side relative to position Q3. The second straight section 32 is adjacent to the tip end 2D side relative to the first curved section 41. The second curved section 42 is the portion of the pipe body 2 between position Q4 and position Q5, which is on the tip end 2D side relative to position Q4. The second curved section 42 is adjacent to the tip end 2D side relative to the second straight section 32. The third straight section 33 is the portion of the pipe body 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.
[0037] As shown in Figure 5, the first straight section 31, the first curved section 41, and the second straight section 32 are arranged along the same virtual plane H. The direction perpendicular to plane H is called the "orthogonal direction V". One side of the orthogonal direction V is called "side V1", and the other side of the orthogonal direction V is called "side V2". Figure 4 corresponds to the view of the tubular body 2 of the guiding catheter 1 from side V1 of the orthogonal direction V.
[0038] As shown in Figure 4, when viewed from one side V1 in the orthogonal direction V, the direction along the first curved section 41 from the base end 2P to the tip end 2D (hereinafter referred to as "curving direction Y41") coincides with the counterclockwise direction. The direction along the second curved section 42 from the base end 2P to the tip end 2D (hereinafter referred to as "curving direction Y42") coincides with the counterclockwise direction. When viewed from one side V1 in the orthogonal direction V, the curving direction Y41 of the first curved section 41 and the curving direction Y42 of the second curved section 42 coincide. In other words, the first curved section 41 and the second curved section 42 curve in the same direction.
[0039] The first curved section 41 includes a partial curved section 411 with a radius of curvature of 120 mm and a partial curved section 412 with a radius of curvature of 31 mm. The partial curved section 411 is adjacent to the tip end 2D side of the first straight section 31. The partial curved section 412 is adjacent to the base end 2P side of the second straight section 32. The boundary position Q23 of the partial curved sections 411 and 412 is located approximately in the center of positions Q2 and Q3 of the first curved section 41, more specifically, slightly closer to the base end 2P side than the center of positions Q2 and Q3. The radius of curvature of the first curved section 41 is preferably 20 mm or more overall.
[0040] The direction parallel to plane H and perpendicular to the center line C of the first straight section 31 is called the "first plane direction T". Of the first plane direction T, the side on which the first curved section 41, the second straight section 32, the second curved section 42, and the third straight section 33 are arranged relative to the first straight section 31 is called "side T1", and the side opposite to side T1 is called "other side T2". The direction parallel to plane H (see Figure 5) and parallel to the center line C of the first straight section 31 is called the "second plane direction U". Of the second plane direction U, the side of the tip 2D is called "side U1". Of the second plane direction U, the side of the base 2P is called "other side U2".
[0041] As shown in Figure 6, a hypothetical straight line extending along the center line C of the first straight section 31 is defined as the "first straight line S1". A hypothetical straight line extending along the center line C of the second straight section 32 is defined as the "second straight line S2". The first straight line S1 and the second straight line S2 intersect at the second intersection X2. A hypothetical half-line extending from the second intersection X2 along the first straight line S1 toward the first straight section 31 is defined as the "half-line K1". A hypothetical half-line extending from the second intersection X2 along the second straight line S2 toward the second straight section 32 is defined as the "half-line K2". The angle between half-lines K1 and K2 is denoted as "θ12". The angle θ12 corresponds to the angle between the first straight section 31 and the second straight section 32. The angle θ12 is approximately 120 degrees. The angle θ12 is preferably between 120 degrees and 179 degrees.
[0042] As shown in Figure 4, the second curved section 42 includes a partial curved section 421 with a radius of curvature of 16 mm, a partial curved section 422 with a radius of curvature of 8 mm, and a partial curved section 423 with a radius of curvature of 26 mm. Partial curved section 421 is adjacent to the tip end 2D side of the second straight section 32. Partial curved section 423 is adjacent to the base end 2P side of the third straight section 33. Partial curved section 422 is positioned between partial curved sections 421 and 423. The boundary position Q41 of partial curved sections 421 and 422 is located closer to the base end 2P than approximately the center of positions Q4 and Q5 in the second curved section 42. Position Q41 coincides with the point in the second curved section 42 that is maximized toward one side U1 in the second planar direction U. The boundary position Q42 of the partial curve sections 422 and 423 is located on the side of the tip section 2D, rather than approximately the center of positions Q4 and Q5 in the second curve section 42.
[0043] As shown in Figure 5, the end of the second curved section 42 near the tip 2D is located on one side V1 in the direction V perpendicular to the plane H. The direction in which the third straight section 33 extends is inclined with respect to the plane H. The third straight section 33 extends from the end on the base 2P side toward the end on the tip 2D side, inclined on one side V1 in the direction V perpendicular to the plane H. As shown in Figure 4, the third straight section 33 is located on one side T1 in the first planar direction T relative to the first straight section 31.
[0044] Position Q5, which corresponds to the boundary between the second curved section 42 and the third straight section 33, coincides with the second straight section 32 when viewed from one side V1 in the orthogonal direction V. The end of the second curved section 42 on the side of the tip 2D, and the end of the third straight section 33 on the side of the base 2P, intersect the second straight section 32 at position Q5. Hereinafter, as shown in Figure 6, the point where the boundary portion of the second curved section 42 and the third straight section 33 intersects with the second straight section 32 is referred to as the "first intersection point X1".
[0045] In a view from one side V1 in the orthogonal direction V, a hypothetical half-line extending from the first intersection X1 along the second straight section 32 toward the base end 2P is defined as "half-line K5". A hypothetical half-line extending from the first intersection X1 along the third straight section 33 toward the tip end 2D is defined as "half-line K6". The angle between half-lines K5 and K6 is denoted as "θ23". θ23 corresponds to the angle between the second straight section 32 and the third straight section 33. The angle θ23 is approximately 80 degrees. Preferably, the angle θ23 is between 45 degrees and 100 degrees.
[0046] As shown in Figure 7, a hypothetical straight line extending in the orthogonal direction V through the first intersection X1 (see Figure 6) is defined as the "third straight line S3". The second straight section 32, the second curved section 42, and the third straight section 33 are separated in the orthogonal direction V at the position of the first intersection X1. More specifically, the following is defined: An intersection 321 is defined, which includes the portion of the second straight section 32 that intersects with the third straight line S3. An intersection 331 is defined, which includes the portions of the second curved section 42 and the third straight section 33 that intersect with the third straight line S3. Intersection 321 corresponds to the position of the first intersection X1 in the second straight section 32. Intersection 331 corresponds to the position of the first intersection X1 in the second curved section 42 and the third straight section 33. At this time, intersections 321 and 331 are separated in the orthogonal direction V.
[0047] As shown in Figure 8, a point Y1 is defined in the second curved section 42 that is maximized toward one side T1 in the first planar direction T. In the first planar direction T, the distance L51 between the center line C of the first straight section 31 and point Y1 corresponds to the maximum width of the pipe body 2 in the first planar direction T. The distance L51 is approximately 45 mm as an example. In the second curved section 42, the distance L52 in the first planar direction T between the point that is maximized toward one side U1 in the second planar direction U, i.e., position Q41 at the boundary of the partial curved sections 421 and 422, and the center line C of the first straight section 31 is approximately 37 mm as an example. The distance L53 in the first planar direction T between position Q41 and position Q23 is approximately 35 mm as an example. The distance L54 in the first planar direction T between position Q41 and position Q3 is approximately 21 mm as an example. The distance L55 between position Q41 and position Q5 in the first planar direction T is, for example, 12.1 mm. The distance L56 between position Q41 and tip 2D in the first planar direction T is, for example, 18 mm.
[0048] The distance L61 in the second planar direction U between position Q2 and position Q23 is approximately 21.8 mm as an example. The distance L62 in the second planar direction U between position Q23 and position Q3 is approximately 20.6 mm as an example. The distance L63 in the second planar direction U between position Q41 and position Q3 is approximately 10.2 mm as an example. The distance L64 in the second planar direction U between position Q41 and position Q5 is approximately 4.7 mm as an example. The distance L65 in the second planar direction U between position Q41 and tip 2D is approximately 7 mm as an example.
[0049] The central angle of the partial curve section 421 is denoted as "θ31". For example, the central angle θ31 is 54 degrees. The central angle of the partial curve section 422 is denoted as "θ32". For example, the central angle θ32 is 223.5 degrees.
[0050] The length of the second straight section 32 is approximately 10 mm. The length of the third straight section 33 is approximately 13 mm. The length of the second straight section 32 is shorter than the length of the third straight section 33.
[0051] As shown in Figure 9, the distance L71 in the orthogonal direction V between the plane H and the tip 2D is, for example, 6.2 mm. A point Y3 is defined in the second curved section 42 that is maximized toward the other side U2 in the second plane direction U. The distance L72 in the second plane direction U between the tip 2D and point Y3 is, for example, approximately 23 mm.
[0052] The main tube section 204 of the tube body 2 (see Figure 1) is formed by a first straight section 31, a first curved section 41, and a second straight section 32. The hardness value of the main tube section 204 is referred to as "first hardness J1". The second middle tube section 203 of the tube body 2 (see Figure 1) is formed by a second curved section 42. The hardness value of the second middle tube section 203 is referred to as "first partial hardness J21". The first middle tube section 202 and the soft tip section 201 of the tube body 2 are formed by a third straight section 33. The hardness value of the first middle tube section 202 and the soft tip section 201 is referred to as "second partial hardness J22". The first partial hardness J21 and the second partial hardness J22 are collectively referred to as "second hardness J2".
[0053] 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 hardness J2 (J1>J2). Therefore, the first straight section 31, the first curved section 41, and the second straight section 32 are harder than the second curved section 42 and the third straight section 33. Also, the first partial hardness J21 is harder than the second partial hardness J22 (J21>J22). Therefore, the second curved section 42 is harder than the third straight section 33. In other words, the first hardness J1, the first partial hardness J21, and the second partial hardness J22 satisfy the inequality relationship "J1>J21>J22".
[0054] <How to use guiding catheter 1> Examples of use when guiding catheter 1 is used (first example, second example, third example) will be described. Guiding catheter 1 is used to guide the therapeutic catheter 5 into the brachiocephalic artery 91, left common carotid artery 92, and left subclavian artery 93 (see Figures 10 to 19; hereinafter referred to as "target vessel 90") which are connected to the aortic arch 9B. A shaping catheter or therapeutic catheter 5 is inserted into the lumen 20 of guiding catheter 1 to maintain the shape of the tubular body 2. Guiding catheters and guidewires are used as shaping catheters. Shaping catheters are stiffer than therapeutic catheters 5. Therefore, when the shaping 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 straightened. In this case, the tube 2 extends in a straight line across the entire length of the shaft portion 21, the loop portion 22, and the protruding portion 23 (see Figure 1). On the other hand, when the therapeutic catheter 5 is inserted into the lumen 20, the shaft portion 21, the loop portion 22, and the protruding portion 23 of the tube 2 maintain their shapes as they would be if nothing were inserted into the lumen 20. As a result, the tube 2 becomes curved at the first curved portion 41 and the second curved portion 42 (see Figure 4).
[0055] <1st usage example> Referring to Figures 10 to 13, the first example of use of guiding catheter 1 will be described. In the first example of use, guiding catheter 1 is used to guide the therapeutic catheter 5 into the brachiocephalic artery 91, which is the target vessel 90.
[0056] The tubular body 2 of the guiding catheter 1 is inserted into the femoral artery using a sheath, starting from the tip 2D, with the shape-retaining catheter inserted into the lumen 20. As shown in Figure 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 Figure 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).
[0057] When the tip 2D of the tube 2 reaches the ascending aorta 9C, the shape-retaining catheter is withdrawn from the lumen 20. In response to the withdrawal of the shape-retaining catheter from the lumen 20, the tube 2 bends at the first curved section 41 and the second curved section 42, forming the shaft section 21, the loop section 22, and the protruding section 23. The user rotates the shaft section 21 along the center line C so that the protruding section 23 (third straight section 33) protrudes toward the outer wall 900 of the ascending aorta 9C. Then, as shown in Figure 12, the user moves the tube 2 further downward toward the ascending aorta 9C (arrow Z13).
[0058] When the tip 2D reaches approximately the vertical center of the ascending aorta 9C, the movement of the tube body 2 stops. As shown in Figure 13, the portion 311 of the first straight section 31 of the tube body 2, excluding the portion 312 adjacent to the first curved section 41, is located within the descending aorta 9A. The first curved section 41 of the tube body 2, and the portion 312 of the first straight section 31 adjacent to the first curved section 41, are located within the aortic arch 9B, near the inner circumferential wall 911. The second straight section 32, the second curved section 42, and the third straight section 33 of the tube body 2 are located within the ascending aorta 9C. The tip 2D of the tube body 2 faces the outer circumferential wall 900 of the ascending aorta 9C.
[0059] The user inserts the therapeutic catheter 5 into the connector body 81 of the guiding catheter 1. The therapeutic 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. Even when the therapeutic catheter 5 is inserted into the lumen 20, the tubular body 2 remains curved at the first curved section 41 and the second curved section 42, maintaining the formation of the shaft section 21, loop section 22, and protruding section 23.
[0060] The therapeutic catheter 5, delivered from the tip 2D, moves toward the outer wall 900 of the ascending aorta 9C. After reaching the outer wall 900, the therapeutic catheter 5 further moves upward along the outer wall 900 toward the aortic arch 9B. After reaching the aortic arch 9B, the therapeutic catheter 5 enters the brachiocephalic artery 91 connected to the aortic arch 9B (arrow Z14). Once inside the brachiocephalic artery 91, the therapeutic catheter 5 treats lesions in the right subclavian artery and right common carotid artery connected to the brachiocephalic artery 91, or lesions in cerebral blood vessels connected to the ends of the right subclavian artery and right common carotid artery.
[0061] <Second usage example> Referring to Figures 14 to 16, a second example of the use of guiding catheter 1 will be described. In the second example of use, guiding catheter 1 is used to guide the therapeutic catheter 5 into the brachiocephalic artery 91 as the target vessel 90, similar to the first example of use.
[0062] Following the same steps as in Figures 10 and 11 of the first use example, the tip 2D of the tube 2 reaches the ascending aorta 9C. The shape-retaining catheter is withdrawn from the lumen 20. In response to the withdrawal of the shape-retaining catheter from the lumen 20, the tube 2 curves at the first curved section 41 and the second curved section 42, forming the shaft section 21, the loop section 22, and the projection section 23. The second curved section 42 and the third straight section 33 of the tube 2 are positioned within the ascending aorta 9C. The user rotates the shaft section 21 along the center line C so that the projection section 23 (third straight section 33) protrudes toward the outer wall 900 of the ascending aorta 9C. As shown in Figure 14, the tip 2D of the tube 2 is now facing the outer wall 900 of the ascending aorta 9C.
[0063] In this state, the user applies a force to the tube 2 in a direction that pulls it out of the femoral artery. As shown in Figure 15, the second curved section 42 and the third straight section 33 of the tube 2 move upward from the ascending aorta 9C toward the aortic arch 9B, along the outer wall 900 of the ascending aorta 9C and the outer wall 901 of the aortic arch 9B (arrow Z21). The third straight section 33 of the tube 2 reaches the brachiocephalic artery 91 which is connected to the aortic arch 9B. Subsequently, the third straight section 33 of the tube 2 enters the brachiocephalic artery 91.
[0064] As shown in Figure 16, the portion 313 of the first straight section 31 of the tube body 2, excluding the portion 314 adjacent to the first curved section 41, is located within the descending aorta 9A. The second curved section 42, the second straight section 32, the first curved section 41, and the portion 314 of the first straight section 31 adjacent to the first curved section 41 are located within the aortic arch 9B. The third straight section 33 is located within the brachiocephalic artery 91.
[0065] The therapeutic catheter 5 is inserted through the connector body 81 of the guiding catheter 1. The therapeutic 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. Even when the therapeutic catheter 5 is inserted into the lumen 20, the curved state of the first curved section and the second curved section 42 in the tubular body 2 is maintained.
[0066] As shown in Figure 16, the therapeutic catheter 5, delivered from the tip 2D, enters the brachiocephalic artery 91 (arrow Z22). Once inside the brachiocephalic artery 91, the therapeutic catheter 5 treats lesions in the right subclavian artery and right common carotid artery connected to the brachiocephalic artery 91, or lesions in cerebral blood vessels, etc., connected to the ends of the right subclavian artery and right common carotid artery.
[0067] <3rd usage example> Referring to Figures 17 to 19, a third example of use of guiding catheter 1 will be described. In this third example of use, guiding catheter 1 is used to guide the therapeutic catheter 5 into the left common carotid artery 92, which is the target vessel 90.
[0068] Following the same steps as in Figures 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 withdrawn from the lumen 20. In response to the withdrawal of the shape-retaining catheter from the lumen 20, the tube 2 curves at the first curved section 41 and the second curved section 42, forming the shaft section 21, the loop section 22, and the projection section 23. The second curved section 42 and the third straight section 33 of the tube 2 are positioned within the aortic arch 9B. The user rotates the shaft section 21 along the centerline C so that the projection section 23 (third straight section 33) protrudes toward section 901A of the outer wall 901 of the aortic arch 9B, between the connections between the brachiocephalic artery 91 and the left common carotid artery 92. As shown in Figure 17, the tip 2D of the tube 2 is now facing toward section 901A.
[0069] In this state, the user applies a force to the tube 2 in a direction that pulls it out of the femoral artery. As shown in Figure 18, the second curved section 42 and the third straight section 33 of the tube 2 move to the left along the portion 901A of the outer wall 900 of the ascending aorta 9C, from the aortic arch 9B toward the descending aorta 9A (arrow Z31). The third straight section 33 of the tube 2 reaches the left common carotid artery 92, which is connected to the aortic arch 9B. Subsequently, the third straight section 33 of the tube 2 enters the left common carotid artery 92.
[0070] As shown in Figure 19, the first straight section 31 of the tubular body 2 is located within the descending aorta 9A. The second curved section 42, the second straight section 32, and the first curved section 41 of the tubular body 2 are located within the aortic arch 9B. The third straight section 33 of the tubular body 2 is located within the left common carotid artery 92.
[0071] The therapeutic catheter 5 is inserted through the connector body 81 of the guiding catheter 1. The therapeutic 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. Even when the therapeutic catheter 5 is inserted into the lumen 20, the curved state of the first curved section and the second curved section 42 in the tubular body 2 is maintained.
[0072] As shown in Figure 19, the therapeutic catheter 5, delivered from the tip 2D, enters the left common carotid artery 92 (arrow Z32). Once inside the left common carotid artery 92, the therapeutic catheter 5 treats lesions in the left common carotid artery 92, or lesions in cerebral blood vessels or other vessels connected to the end of the left common carotid artery 92.
[0073] Although a detailed explanation is omitted, when treating lesions in the left subclavian artery 93 connected to the aortic arch 9B, or when treating lesions in cerebral blood vessels, etc., connected to the end of the left subclavian artery 93, the therapeutic catheter 5 is guided to the left subclavian artery 93 via the same procedure as in the third use example. Furthermore, when treating lesions in the external jugular vein, left common jugular vein, and internal jugular vein connected to the superior vena cava, or when treating lesions in blood vessels, etc., connected to the end of the external jugular vein, left common jugular vein, and internal jugular vein, the therapeutic catheter 5 is guided to each vein via the same procedure as in the first to third use examples.
[0074] <Experiment 1> Experiments were conducted to optimize the angle θ23 (see Figure 6) between the second straight section 32 and the third straight section 33 of the tube 2. Samples were prepared: Sample 1 with an angle θ23 of 40 degrees, Sample 2 with an angle θ23 of 45 degrees, Sample 3 with an angle θ23 of 60 degrees, and Sample 4 with an angle θ23 of 80 degrees. The "6F ENVOY" (Guiding Catheter Envoy / J&J) was used as the shape-retaining catheter. The "SOFIAFLOW" (Cerebral Thrombosis Aspiration Catheter / Terumo Corporation) was used as the therapeutic catheter.
[0075] The following evaluations (1) to (3) were performed. The results are shown in Figure 20. (1) Evaluation of shape elongation 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). If the loop portion 22 opened and extended in a straight line, it was evaluated as "Positive". If the loop portion 22 opened and was slightly curved, it was evaluated as "Neutral". If the loop portion 22 remained curved and did not extend in a straight line, it was evaluated as "Negative".
[0076] (2) Shape retention evaluation The state of the tubular body 2 when the therapeutic catheter was inserted into the lumen 20 was evaluated in three stages (Positive, Neutral, Negative). If the loop portion 22 remained curved, it was evaluated as "Positive". If the loop portion 22 opened and the state in which the second straight portion 32 and the third straight portion 33 intersected was maintained, it was evaluated as "Neutral". If the loop portion 22 opened and the state in which the second straight portion 32 and the third straight portion 33 intersected was resolved, it was evaluated as "Negative".
[0077] (3) Shape restoration evaluation The condition of the tubular body 2 was evaluated in three stages (Positive, Neutral, Negative) after the shaping catheter was inserted into the lumen 20, then removed, and a therapeutic catheter was inserted into the lumen 20 instead. If a loop portion 22 was formed, it was evaluated as "Positive". If a loop portion 22 was formed but the curvature was insufficient, it was evaluated as "Neutral". If a loop portion 22 was not formed, it was evaluated as "Negative".
[0078] The results shown in Figure 20 indicate that the larger the angle θ23 between the second straight section 32 and the third straight section 33, the more stably the shape of the loop section 22 is maintained. Furthermore, it was found that when the angle θ23 is at least 40 degrees, more preferably 45 degrees, the loop section 22 can be straightened when a shape-retaining catheter is inserted into the lumen 20. It was also found that by setting the angle θ23 to at least 60 degrees, the curved shape of the loop section 22 can be maintained even when a therapeutic catheter is inserted into the lumen 20. Moreover, it was revealed that by setting the angle θ23 to at least 80 degrees, the tube 2 exhibits good characteristics in terms of the elongation, shape retention, and shape restoration of the loop section 22. On the other hand, in order to allow smooth movement of the shape-retaining catheter or therapeutic catheter within the lumen 20, it is generally preferable that the angle θ23 be 100 degrees or less. From these results, it was found that it is preferable that the angle θ23 be between 40 degrees and 100 degrees.
[0079] <Experiment 2> Experiments were conducted to optimize the stiffness of the tube 2. Three samples (Samples 5, 6, and 7) were prepared. Sample 5 used a tube 2 in which the main tube section 204 included a first straight section 31 and a first curved section 41, the second middle tube section 203 included a second straight section 32, and the first middle tube section 202 included a second curved section 42 and a third straight section. Sample 6 used a tube 2 in which the main tube section 204 included a first straight section 31 and a first curved section 41, the second middle tube section 203 included a second straight section 32 and a second curved section 42, and the first middle tube section 202 included a third straight section. Sample 7 used a tube 2 in which the main tube section 204 included a first straight section 31, a first curved section 41, and a second straight section 32, the second middle tube section 203 included a second curved section 42, and the first middle tube section 202 included a third straight section.
[0080] In the vascular model, the ability to guide the therapeutic catheter into the target vessel was evaluated on a three-point scale (Positive, Neutral, Negative). If the therapeutic catheter could be guided into the target vessel, it was evaluated as "Positive." If the therapeutic catheter could be guided into the target vessel but it took time, it was evaluated as "Neutral." If the therapeutic catheter could not be guided into the target vessel, it was evaluated as "Negative."
[0081] As shown in Figure 21, it was found that, in particular, when sample 7 was used, the therapeutic catheter could be appropriately guided into the target blood vessel. One reason for this is that the pushability was improved by making the stiffness of the first straight section 31, the first curved section 41, and the second straight section 32 the stiffest. Another reason is that the shape of the loop section 22 was stabilized by making the stiffness of the second curved section 42 stiffer than that of the third straight section 33. Furthermore, making the third straight section 33 the softest has the advantage of increasing the degree of freedom in the direction of delivery when the therapeutic catheter is delivered from the lumen 20 through the tip section 2D. From these results, it has become clear that by making the stiffness of the first straight section 31, the first curved section 41, and the second straight section 32 stiffer than that of the second curved section 42 and the third straight section 33, and by making the stiffness of the second curved section 42 stiffer than that of the third straight section 33, the therapeutic catheter can be appropriately guided into the target blood vessel.
[0082] <Operation and effects of this embodiment> As described above, the guiding catheter 1 is used to guide the therapeutic catheter 5 into the target blood vessel 90. In this case, the user can easily position the shaft portion 21 (first straight portion 31, first curved portion 41, part of the second straight portion 32), the loop portion 22 (other part of the second straight portion 32, second curved portion 42), and the protruding portion 23 (third straight portion 33) so that the tip portion 2D is facing the target blood vessel 90. Therefore, by inserting the therapeutic catheter 5 into the lumen 20 of the guiding catheter 1, the user can appropriately guide the therapeutic catheter 5 toward the target blood vessel 90. In this way, the guiding catheter 1 can appropriately guide the therapeutic catheter 5 toward various blood vessels, including the target blood vessel 90. In particular, the guiding catheter 1 can easily guide the therapeutic catheter 5 to the brachiocephalic artery 91, left common carotid artery 92, and left subclavian artery 93, which are connected to the aortic arch 9B, as well as to the blood vessels connected to the ends of the external jugular vein, left common jugular vein, and internal jugular vein, allowing for appropriate treatment with the therapeutic catheter 5.
[0083] 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 2 along the curved aortic arch 9B. In addition, the user can easily understand 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 manipulate the tube 2 so that the protruding portion 23 protrudes toward the outer wall 900 of the ascending aorta 9C or the outer wall 901 of the aortic arch 9B.
[0084] The tubular body 2 of the guiding catheter 1 has a projection 23 near the tip 2D, which includes a third linear section 33 that extends in a straight line. This makes it easy to direct the orientation of the therapeutic catheter 5 as it is delivered from the tip 2D to the outside of the lumen 20. Therefore, the user can easily guide the therapeutic catheter 5 into the target blood vessel 90 using the guiding catheter 1.
[0085] The shaft portion 21 of the guiding catheter 1 includes a part 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 an annular shape, particularly at the boundary portion of the loop portion 22 with the shaft portion 21.
[0086] The angle θ23 between the second straight section 32 and the third straight section 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 section 32 and the second curved section 42, and at the boundary between the third straight section 33 and the second curved section 42. In other words, the second curved section 42 will bend sharply at these boundary sections, so the guiding catheter 1 can stably maintain the curved state of the second curved section 42. Furthermore, the second curved section 42 includes a partial curved section 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 section 42, especially at the partial curved section 422.
[0087] The intersection 321 of the second linear section 32 corresponding to the position of the first intersection X1 and the intersection 331 of the third linear section 33 corresponding to the position of the first intersection X1 are separated in the orthogonal direction V. Furthermore, the direction in which the third linear section 33 extends from the end on the proximal end 2P side toward the end on the distal end 2D side is inclined with respect to the plane H. In this case, the guiding catheter 1 can orient its distal end 2D in a direction different from the direction along the plane H. Therefore, the guiding catheter 1 can increase the degree of freedom in the direction of its distal end 2D, so that even if the arrangement of the target blood vessel 90 differs from patient to patient, the therapeutic catheter 5 can be appropriately guided toward the target blood vessel 90.
[0088] The angle θ12 between the first straight section 31 and the second straight section 32 is approximately 120 degrees. Also, the radius of curvature of the first curved section 41 is 20 mm or more. In this case, the guiding catheter 1 can position the first curved section 41, which is placed within the arc-shaped 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 section 21 within the aortic arch 9B.
[0089] Since the second straight section 32 is shorter than the third straight section 33, the guiding catheter 1 can stabilize the direction in which the tip section 2D, located at the tip of the third straight section 33, faces. Therefore, the guiding catheter 1 can stabilize the direction of guidance for the therapeutic catheter 5.
[0090] In the guiding catheter 1, the first stiffness J1, which is the stiffness of the first straight section 31, the first curved section 41, and the second straight section 32, is stiffer than the second stiffness J2, which is the stiffness of the second curved section 42 and the third straight section 33. In this case, the guiding catheter 1 can achieve good pushability. Also, since the second stiffness J2 is softer than the first stiffness J1, the second curved section 42 can be easily extended by passing a shape-retaining catheter through the lumen 20. In this case, the user can easily pass the tip 2D through, for example, the descending aorta 9A to reach the aortic arch 9B and the ascending aorta 9C.
[0091] Furthermore, in the guiding catheter 1, the first partial stiffness J21, which is the stiffness of the second curved section 42, is stiffer than the second partial stiffness J22, which is the stiffness of the third straight section 33. In this case, the guiding catheter 1 can maintain the curved state of the second curved section 42 while freely changing the orientation of the third straight section 33 and the tip section 2D according to the shape of the target blood vessel 90 and the aortic arch 9B, thereby improving the user's operability.
[0092] In the first use case, portion 311 of the first straight section 31 is positioned within the descending aorta 9A. The first curved section 41 and portion 312 of the first straight section 31 are positioned within the aortic arch 9B. The second straight section 32, the second curved section 42, and the third straight section 33 are positioned within the ascending aorta 9C. In this case, the guiding catheter 1 can guide the therapeutic catheter 5, which is delivered from the tip 2D toward the outside of the lumen 20, through the ascending aorta 9C to the brachiocephalic artery 91.
[0093] In the second use case, portion 313 of the first straight section 31 is positioned within the descending aorta 9A. The second curved section 42, the second straight section 32, the first curved section 41, and portion 314 of the first straight section 31 are positioned within the aortic arch 9B. The third straight section 33 is positioned within the brachiocephalic artery 91. In this case, the guiding catheter 1 can directly guide the therapeutic catheter 5, which has been delivered from its tip 2D toward the outside of the lumen 20, toward the left common carotid artery 92 or the left subclavian artery 93.
[0094] <Variation> The present invention is not limited to the embodiments described above, and various modifications are possible. The parameters such as length and angle exemplified in the embodiments described above are examples, and other values may be used. The relationship between the lengths of multiple different parts is an example, 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 therapeutic catheter 5 into blood vessels other than the brachiocephalic artery 91, left common carotid artery 92, and left subclavian artery 93 connected to the aortic arch 9B, or the external jugular vein, left common jugular vein, and internal jugular vein connected to the superior vena cava.
[0095] The shaft portion 21 of the tube body 2 does not have to have a first curved portion 41, and may have only a first straight portion 31 and a second straight portion 32. The loop portion 22 of the tube body 2 does not have to have a second straight portion 32, and may have only a second curved portion 42. The projection portion 23 of the tube body 2 may have a part of the second curved portion 42 and a third straight portion 33. The shaft portion 21 and the projection portion 23 may have no straight portions and be formed only from curved portions.
[0096] The loop section 22 of the pipe body 2 may have a part of the second straight section 32, a second curved section 42, and a part of the third straight section 33. In this case, the second straight section 32 and the third straight section 33 may intersect at the first intersection X1. The second straight section 32 and the third straight section 33 may be separated in the orthogonal direction V at the first intersection X1.
[0097] The portion of the second curved section 42 adjacent to the second straight section 32 may intersect with the third straight section 33, forming the first intersection X1. The second straight section 32 may intersect with the portion of the second curved section 42 adjacent to the third straight section 33, forming the first intersection X1. The portion of the second curved section 42 adjacent to the second straight section 32 and the portion adjacent to the third straight section 33 may intersect, forming the first intersection X1.
[0098] The angle θ23 between the second straight section 32 and the third straight section 33 is preferably 45 degrees or more and 100 degrees or less, but it does not have to be within this range. The angle θ23 may be less than 45 degrees or greater than 100 degrees.
[0099] The first curved section 41 includes a partial curved section 411 with a radius of curvature of 120 mm and a partial curved section 412 with a radius of curvature of 31 mm. In contrast, the radius of curvature of the first curved section 41 may be a common value throughout the entire area. The radius of curvature of the first curved section 41 is preferably 20 mm or more, but it is not limited to this range. The radius of curvature of the first curved section 41 may be less than 20 mm.
[0100] The second curved section 42 includes a partial curved section 421 with a radius of curvature of 16 mm, a partial curved section 422 with a radius of curvature of 8 mm, and a partial curved section 423 with a radius of curvature of 26 mm. Here, the radius of curvature of the second curved section 42 is preferably 8 mm or more and 10 mm or less in order to stably maintain the curved state of the second curved section 42. For this reason, the radii of curvature of the partial curved sections 421 and 423 of the second curved section 42 may also be 8 mm or more and 10 mm or less. The radius of curvature of the second curved section 42 may be a common value throughout the entire area. The radius of curvature of the second curved section 42 is preferably 8 mm or more and 10 mm or less, but it is not limited to this range. The radius of curvature of the second curved section 42 may be less than 8 mm or greater than 10 mm.
[0101] The intersection 321 of the second straight section 32 corresponding to the position of the first intersection X1 and the intersection 331 of the third straight section 33 corresponding to the position of the first intersection X1 may be in contact. The direction in which the third straight section 33 extends from the end on the base end 2P side toward the end on the tip end 2D side may extend parallel to the plane H.
[0102] The angle θ12 between the first straight section 31 and the second straight section 32 is preferably 120 degrees or more and 179 degrees or less, but it is not limited to this range. The angle θ12 may be less than 120 degrees or greater than 179 degrees.
[0103] The relationship between the hardness of the first straight section 31, the first curved section, the second straight section 32, the second curved section 42, and the third straight section 33 of the pipe body 2 is not limited to the above embodiment. For example, the first straight section 31, the first curved section, the second straight section 32, the second curved section 42, and the third straight section 33 may become progressively softer in this order. The hardness of the second curved section 42 and the third straight section 33 may be the same, and this hardness may be softer than the first straight section 31, the first curved section 41, and the second straight section 32. The hardness of the loop section 22 may be softer than the hardness of the shaft section 21, and the hardness of the protruding section 23 may be softer than the hardness of the loop section 22.
[0104] <Other> The radii of curvature of the partial curve sections 411 and 412 included in the first curve section 41, and the partial curve sections 421-423 included in the second curve section 42, as well as the overall radii of curvature of the first curve section 41 and the second curve section 42, are measured as follows: First, a hypothetical circular arc approximating the curve extending along the center line C of each section is defined, and then a hypothetical circle having part of the defined circular arc is further defined. Next, the radius of the defined hypothetical circle is measured. The measured radius is taken as the radius of curvature of the corresponding curve section.
Claims
1. A guiding catheter having a lumen and a tubular body extending between a proximal end and a distal end, The aforementioned pipe body is A shaft portion extending from the base end, A loop portion adjacent to the tip portion with respect to the shaft portion, A protruding portion adjacent to the tip portion of the loop portion and extending linearly to the tip portion, Equipped with, A therapeutic catheter, with its lumen facing the tip, is used to guide target vessels, including the brachiocephalic artery, left common carotid artery, and left subclavian artery connected to the aortic arch, as well as the external jugular vein, left common jugular vein, and internal jugular vein connected to the superior vena cava. The aforementioned shaft portion is A first straight section extending in a straight line, A first curved section is adjacent to the tip end of the first straight section and is curved, A second straight section, which extends linearly adjacent to the tip of the first curved section and is adjacent to the tip of the first curved section, It has, The aforementioned loop section is It has a curved second curved section adjacent to the tip side of the second straight section, The aforementioned protrusion is It has at least a portion of a third straight section that is adjacent to the tip side of the second curved section, extends linearly to the tip, and intersects with the second straight section, A portion of the first straight section is located in the descending aorta, The first curved section is positioned in the aortic arch, The second straight section, the second curved section, and the third straight section are arranged in the ascending aorta. The aforementioned tip is positioned toward the outer circumferential wall of the ascending aorta. A guiding catheter characterized by the following features.
2. A guiding catheter having a lumen and a tubular body extending between a proximal end and a distal end, The aforementioned pipe body is A shaft portion extending from the base end, A loop portion adjacent to the tip portion with respect to the shaft portion, A protruding portion adjacent to the tip portion of the loop portion and extending linearly to the tip portion, Equipped with, A therapeutic catheter, with its lumen facing the tip, is used to guide target vessels, including the brachiocephalic artery, left common carotid artery, and left subclavian artery connected to the aortic arch, as well as the external jugular vein, left common jugular vein, and internal jugular vein connected to the superior vena cava. The aforementioned shaft portion is A first straight section extending in a straight line, A first curved section is adjacent to the tip end of the first straight section and is curved, A second straight section, which extends linearly adjacent to the tip of the first curved section and is adjacent to the tip of the first curved section, It has, The aforementioned loop section is It has a curved second curved section adjacent to the tip side of the second straight section, The aforementioned protrusion is It has at least a portion of a third straight section that is adjacent to the tip side of the second curved section, extends linearly to the tip, and intersects with the second straight section, A portion of the first straight section is located in the descending aorta, The first curved section, the second straight section, and the second curved section are arranged in the aortic arch, The third linear portion is positioned in the target blood vessel. A guiding catheter characterized by the following features.
3. The aforementioned shaft portion is Having the first straight section, the first curved section, and a part of the second straight section, The aforementioned loop section is The shaft portion includes the part of the second straight portion excluding a portion of the second curved portion. A guiding catheter according to claim 1 or 2.
4. When viewed from one side in a direction perpendicular to the plane including the first straight section, the first curved section, and the second straight section, The second straight section and the third straight section intersect at the first intersection, The guiding catheter according to claim 1 or 2, characterized in that the angle between a half-line extending from the first intersection along the second straight section toward the proximal end and a half-line extending from the first intersection along the third straight section toward the tip end is 45 degrees or more and 100 degrees or less.
5. The guiding catheter according to claim 1 or 2, characterized in that the radius of curvature of the second curved portion is 8 mm or more and 10 mm or less.
6. When viewed from one side in a direction perpendicular to the plane including the first straight section, the first curved section, and the second straight section, the second straight section and the third straight section intersect at the first intersection point. The portion of the second straight section corresponding to the first intersection and the portion of the third straight section corresponding to the first intersection are separated in the orthogonal direction. A guiding catheter according to claim 1 or 2.
7. The guiding catheter according to claim 1 or 2, characterized in that the direction in which the third straight portion extends from the end on the base side toward the end on the tip side is inclined with respect to a plane extending along the first straight portion, the first curved portion, and the second straight portion.
8. The first straight line extending along the first straight section and the second straight line extending along the second straight section intersect at the second intersection point. The guiding catheter according to claim 1 or 2, characterized in that the angle between a half-line extending from the second intersection along the first straight line toward the first straight section and a half-line extending from the second intersection along the second straight line toward the second straight section is 120 degrees or more and 179 degrees or less.
9. The guiding catheter according to claim 1 or 2, characterized in that the radius of curvature of the first curved portion is 20 mm or more.
10. The guiding catheter according to claim 1 or 2, characterized in that the second straight portion is shorter than the third straight portion.
11. The hardness of the first straight section, the first curved section, and the second straight section is the first hardness. The hardness of the second curved section and the third straight section is second hardness. The first hardness is harder than the second hardness. A guiding catheter according to claim 1 or 2.
12. The second hardness is, The hardness of the first partial hardness is the hardness of the second curved section, The hardness of the third straight section is the second partial hardness and Includes, The first hardness is harder than the first partial hardness and the second partial hardness, and the first partial hardness is harder than the second partial hardness. The guiding catheter according to feature 11.