Medical devices

Abstract

To improve the permeability of medical devices to lesions. [Solution] The medical device comprises a long main body and a reading portion connected to the tip of the main body and entering the lesion. When viewed from a first direction perpendicular to the axial direction of the main body, the outer edge of the reading portion satisfies at least one of the following conditions: (1) having a first end located at the tip of the reading portion and a second end located on the opposite side of the central axis of the main body from the first end in a second direction perpendicular to the axial direction of the main body and the first direction, and the second end being convex toward the tip side; and (2) having a straight portion extending in the second direction.

Description

Technical Field

[0001] The technology disclosed in this specification relates to medical devices.

Background Art

[0002] Known medical devices have a loop at the tip (see, for example, Patent Document 1).

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] There is room for improvement in the passageability of medical devices through lesions.

[0005] This specification discloses a technology capable of solving the above-described problems.

Means for Solving the Problems

[0006] The technology disclosed in this specification can be realized, for example, in the following forms.

[0007] The medical device disclosed in this specification includes an elongated main body portion and a leading portion connected to the tip of the main body portion and entering a lesion. When viewed from a first direction orthogonal to the axial direction of the main body portion, the outer edge of the leading portion satisfies at least one of the following two conditions: (1) a first condition that the outer edge has a first end portion located at the tip of the leading portion and a second end portion located on the opposite side of the first end portion across the central axis of the main body portion in a second direction orthogonal to each of the axial direction of the main body portion and the first direction, and the second end portion is convex toward the tip side; and (2) a second condition that the outer edge has a straight portion extending in the second direction. [Brief explanation of the drawing]

[0008] [Figure 1] This diagram schematically shows the configuration of the guide wire in the first embodiment. [Figure 2] This diagram schematically shows the configuration of the guide wire in the first embodiment. [Figure 3] This diagram schematically shows the configuration of the guide wire in the first embodiment. [Figure 4] This diagram schematically shows the configuration of the guide wire in the first embodiment. [Figure 5] A flowchart illustrating an example of a treatment method using a guidewire. [Figure 6] An explanatory diagram showing an example of a treatment method using a guidewire. [Figure 7] An explanatory diagram showing an example of a treatment method using a guidewire. [Figure 8] An explanatory diagram showing an example of a treatment method using a guidewire. [Figure 9] This is an explanatory diagram illustrating the configuration of the guide wire in the second embodiment. [Figure 10] This is an explanatory diagram illustrating the configuration of the guide wire in the third embodiment. [Figure 11] This is an explanatory diagram illustrating the configuration of the guide wire in the fourth embodiment. [Figure 12] This is an explanatory diagram schematically showing the configuration of the guide wire in the fifth embodiment. [Figure 13] This is an explanatory diagram illustrating the configuration of the guide wire in the sixth embodiment. [Figure 14] This is an explanatory diagram illustrating the configuration of the guide wire in the seventh embodiment. [Modes for carrying out the invention]

[0009] A. First Embodiment: (Basic configuration of guidewire 100) Figures 1 to 4 are schematic diagrams illustrating the configuration of the guidewire 100 in the first embodiment. Each figure shows mutually orthogonal XYZ axes for specifying direction. Figure 1 shows the appearance of the guidewire 100 in the X-axis direction. Figure 2 shows the appearance of the guidewire 100 in the Y-axis direction. Figure 3 shows the YZ longitudinal section of the guidewire 100. Figure 4 shows the YZ longitudinal section of the tip of the guidewire 100. In the guidewire 100, the positive Z-axis side is the tip side (distal side) that is inserted into the body. In the guidewire 100, the negative Z-axis side is the proximal end (proximal side) that is manipulated by the surgeon. In each figure, some parts of the guidewire 100 may be omitted from the illustration. In Figures 1 to 3, the guidewire 100 is shown in a straight line parallel to the Z-axis. The guidewire 100 has enough flexibility to bend. These points are the same in subsequent figures. The X-axis direction is an example of the first direction. The Y-axis direction is an example of a second direction.

[0010] In this specification, for the guide wire 100 and its components, the tip end is referred to as the "tip," the tip and its vicinity as the "tip portion," the base end is referred to as the "base end," and the base end and its vicinity as the "base end portion." The cross-section of the guide wire 100 and its components means a cross-section perpendicular to the longitudinal direction. The longitudinal section of the guide wire 100 and its components means a cross-section parallel to the central axis in the longitudinal direction. For the guide wire 100 and its components, the direction perpendicular to the longitudinal direction is referred to as the "radial direction." The outer diameter of the guide wire 100 and its components means the width along the radial direction. In this specification, for the guide wire 100 and its components, the length along the Y-axis direction is sometimes specifically referred to as the "width," and the length along the X-axis direction is sometimes specifically referred to as the "thickness."

[0011] The guidewire 100 is a long medical device inserted into a biological lumen such as a blood vessel. The total length of the guidewire 100 is, for example, between 1000 mm and 3000 mm. The guidewire 100 is an example of a medical device.

[0012] The guide wire 100 includes a main body portion 10 and a leading portion 20.

[0013] The main body portion 10 is an elongated portion extending along the central axis Ax. In the present embodiment, the central axis Ax of the main body portion 10 coincides with the central axis of the guide wire 100. The proximal end 15 of the main body portion 10 coincides with the proximal end of the guide wire 100. A spiral groove 18 is formed on the outer peripheral surface 17 of the distal end portion of the main body portion 10.

[0014] The leading portion 20 is connected to the distal end 16 of the main body portion 10. The proximal end 27 of the leading portion 20 is connected to the distal end 16 of the main body portion 10. The leading portion 20 can be expressed as a leading part, a drill part, a crushing part, a peeling part, an entry part, a peeler, a shaver, etc. The distal end 23 of the leading portion 20 coincides with the distal end of the guide wire 100. The leading portion 20 is loop-shaped surrounding a through hole 24 extending in the X-axis direction. The surface of the leading portion 20 may have an edge or may not have an edge. An edge is a boundary (ridge line) between two surfaces. The leading portion 20 enters the lesion while rotating around the central axis Ax. The leading portion 20 entering the lesion can be expressed as passing through the lesion, drilling the lesion, crushing the lesion, peeling the lesion, separating the lesion, diving into the lesion, entering the lesion, etc. The length L20 of the leading portion 20 along the central axis Ax is, for example, 0.2 mm or more and 2.0 mm or less. The length L20 of the leading portion 20 may be 0.3 mm or more and 1.5 mm or less, or may be 0.4 mm or more and 1.0 mm or less. In the view in the X-axis direction, the end portion on the positive Y-axis side at the proximal end 27 of the leading portion 20 is referred to as the first end portion 27E1, and the end portion on the negative Y-axis side at the proximal end 27 of the leading portion 20 is referred to as the second end portion 27E2.

[0015] The maximum outer diameter Dx of the reading unit 20 is larger than the thickness T2 of the reading unit 20 at the maximum outer diameter position Px. That is, the reading unit 20 is flat as a whole. The thickness T2 of the reading unit 20 at the maximum outer diameter position Px is smaller than the maximum outer diameter D1 of the tip 16 of the main body unit 10. The thickness T2 of the reading unit 20 at the maximum outer diameter position Px is, for example, 0.02 mm or more and 0.3 mm or less. The thickness T2 of the reading unit 20 at the maximum outer diameter position Px may be 0.04 mm or more and 0.2 mm or less, or may be 0.06 mm or more and 0.1 mm or less. The maximum outer diameter Dx of the reading unit 20 is, for example, 1.2 times or more the thickness T2 of the reading unit 20 at the maximum outer diameter position Px. The maximum outer diameter Dx of the reading unit 20 may be 1.5 times or more the thickness T2 of the reading unit 20 at the maximum outer diameter position Px, or may be 1.8 times or more.

[0016] The maximum outer diameter Dx of the leading portion 20 is measured as follows. The measurer observes the guide wire 100 from the side. In this embodiment, the side is the Y-axis direction. The measurer searches for an angle in which the front portion and the back portion of the leading portion 20 overlap, and the back portion is not visible. For example, the measurer searches for an angle in which the portion between the second end 27E2 and the tip 23 is not visible if both of the following two conditions are met. The first condition is that the portion between the first end 27E1 and the tip 23 is located on the front side. The second condition is that the portion between the second end 27E2 and the tip 23 is located on the back side. The invisibility of the portion between the second end 27E2 and the tip 23 is caused by the overlap between the portion between the first end 27E1 and the tip 23 and the portion between the second end 27E2 and the tip 23. Next, the measurer photographs the guide wire 100 using a microscope along a viewpoint rotated 90 degrees around the central axis Ax from this viewpoint. The operator sets the microscope's magnification to 200x or higher. The operator measures the outer diameter of the leading section 20 at three measurement positions on the captured image where the leading section 20 is thought to have its maximum outer diameter Dx. Specifically, at each measurement position, the operator draws a pair of parallel lines that pass through a pair of ends in the outer diameter direction of the leading section 20 and are perpendicular to the outer diameter direction, and measures the distance between these pairs of lines. The operator adopts the maximum value among the measurement results at the three measurement positions as the maximum outer diameter Dx of the leading section 20.

[0017] (Treatment method using guidewire 100) Figure 5 is a flowchart showing an example of a treatment method using a guidewire 100. Figures 6 to 8 are explanatory diagrams showing an example of a treatment method using a guidewire 100. As shown in Figures 7 and 8, in the treatment method using a guidewire 100, the operator inserts the leading portion 20 of the guidewire 100 into the lesion 220 within the blood vessel 200. The lesion 220 is, for example, a highly calcified lesion. The lesion 220 is, for example, a chronic total occlusion lesion. The length L0 of the lesion 220 along the extension direction of the blood vessel 200 is, for example, 100 mm or more and 500 mm or less. The length of the lesion 220 may be 150 mm or more and 450 mm or less, or 200 mm or more and 400 mm or less.

[0018] As shown in Figure 6, the lesion 220 to be treated is located, for example, in a blood vessel 200 in the lower limb of a human. Figure 6 shows a lesion 220 occurring in the lower leg region. In this treatment method, a technique called a crossover is used, in which, for example, the blood vessel 200 is accessed from the groin of the opposite leg 251, which is the leg opposite to the target leg 252, which is the leg in which the lesion 220 is located, and then the lesion 220 on the target leg 252 is approached. The method of inserting the guidewire 100 into the blood vessel 200 to approach the lesion 220 occurring in the lower leg region does not have to be a crossover. The approach method may also be an antegrade approach in which the guidewire 100 is inserted from the blood vessel 200 in the groin of the target leg 252 where the lesion 220 is located and the guidewire 100 is advanced along the blood flow. The approach method may also be an antegrade approach in which the guidewire 100 is inserted from the blood vessel 200 in the arm and the guidewire 100 is advanced along the blood flow. This approach may also be a retrograde approach in which the guidewire 100 is inserted into either a blood vessel 200 in the ankle or in the top of the foot of the target leg 252 where the lesion 220 is located, and the guidewire 100 is advanced against the flow of blood. The location for inserting the guidewire 100 into the blood vessel 200 is not limited to the aforementioned locations. When inserting the guidewire 100 from a blood vessel 200 in the arm, the surgeon may select a blood vessel 200 in the wrist as the insertion site for the guidewire 100. When inserting the guidewire 100 from a blood vessel 200 in the leg, the surgeon may select the superficial aorta or popliteal artery as the insertion site for the guidewire 100. The guidewire 100 is not limited to treating lesions 220 occurring in the subknee region, but can also be used to treat lesions 220 occurring in other locations, such as the iliac artery.

[0019] First, the surgeon inserts a lead guidewire into the blood vessel 200 (S110). Unlike the guidewire 100 in this embodiment, the lead guidewire is a known guidewire that does not have a leading portion 20. The lead guidewire is also called a workhorse guidewire or first-choice guidewire. The surgeon inserts the lead guidewire into the blood vessel 200 through a sheath (not shown) placed at the puncture site 230 (see Figure 7) of the opposite leg 251. The surgeon advances the lead guidewire to just before the lesion 220 in the blood vessel 200 of the target leg 252.

[0020] Next, the surgeon inserts the catheter 120 into the blood vessel 200 along the lead guidewire (S120). The surgeon then advances the catheter 120 (see Figure 7) to just before the lesion 220 in the blood vessel 200.

[0021] Next, the surgeon withdraws the lead guidewire from the blood vessel 200 (S130). Then, the surgeon inserts the guidewire 100 into the catheter 120 inserted into the blood vessel 200, with the leading portion 20 at the front (S140, Figure 7). The surgeon advances the guidewire 100 to just before the lesion 220 in the blood vessel 200. When advancing the guidewire 100, the surgeon may or may not rotate the guidewire 100 around the central axis Ax.

[0022] Next, the surgeon rotates the guidewire 100 and advances it toward the tip, thereby entering the leading portion 20 of the guidewire 100 into the lesion 220 (S150, Figure 8). When the surgeon grasps the proximal end of the guidewire 100 and rotates the guidewire 100 around the central axis Ax, the leading portion 20 located at the tip of the guidewire 100 also rotates around the central axis Ax. The leading portion 20, rotating within the lesion 220, excavates by cutting through the lesion 220. In this embodiment, during the guidewire advancement step (S150), the surgeon advances the leading portion 20 until it has passed through the lesion 220. If the leading portion 20 has an edge, when the leading portion 20 rotates around the central axis Ax with the edge in contact with the lesion 220, the edge scrapes the lesion 220. As the edge scrapes away the lesion 220, the leading portion 20 enters the space created, forming a through-hole in the lesion 220. As described above, a spiral groove 18 is formed on the outer circumferential surface 17 of the main body 10. Due to the presence of this groove 18, the main body 10 has a function (referred to as the "lesion discharge function") to discharge small pieces of the lesion 220 generated by the contact between the rotating leading portion 20 and the lesion 220 from the tip side to the proximal end side of the main body 10. The guidewire 100 advancement step (S150) is performed while no other medical devices have passed over the lesion 220.

[0023] After the leading portion 20 of the guidewire 100 has passed the lesion 220, the operator advances a catheter (not shown) along the guidewire 100 to the position of the lesion 220. Then the operator withdraws the guidewire 100. When withdrawing the guidewire 100, the operator may or may not rotate the guidewire 100 around its central axis Ax.

[0024] Subsequently, the surgeon inserts a guidewire for an adjunct device (not shown) into the blood vessel 200 and advances it until the tip of the guidewire passes the lesion 220. The surgeon then advances the adjunct device to the location of the lesion 220, following the guidewire. The adjunct device may be, for example, an atherectomy device, a balloon catheter, or a stent.

[0025] (Detailed configuration of guide wire 100) As shown in Figure 3, the guide wire 100 has a wire 40 and a coil 50.

[0026] The coil 50 is a cylindrical member in which one or more wires are wound in a spiral shape. The main body 10 includes the coil 50. The outer diameter of the coil 50 is, for example, 0.1 mm or more and 0.6 mm or less. The outer diameter of the coil 50 may be 0.2 mm or more and 0.5 mm or less, or 0.3 mm or more and 0.4 mm or less. The outer diameter of the coil 50 may be 1.00 mm or more and 2.00 mm or less, or 1.10 mm or more and 1.65 mm or less, or 1.20 mm or more and 1.35 mm or less. In this embodiment, the outer diameter of the coil 50 is constant over the entire length of the coil 50. The coil 50 may have a tapered shape in which the outer diameter of the coil 50 gradually decreases from the base end to the tip, or a tapered shape in which the outer diameter of the coil 50 gradually decreases from the tip to the base end. A spiral groove 53 is formed on the outer circumferential surface 52 of the coil 50. In this embodiment, the coil 50 is Z-wound, and the direction of travel of the groove 53 is also the direction of the Z-wound. Due to the presence of the helical groove 53, a helical groove 18 is formed on the outer circumferential surface 17 of the main body 10. The tip of the coil 50 coincides with the tip 16 of the main body 10.

[0027] The wire forming the coil 50 may be a single strand or a stranded wire made by twisting multiple strands together. In this embodiment, the coil 50 is a multi-strand coil in which multiple wires are wound together. In this embodiment, each wire forming the coil 50 is a stranded wire.

[0028] For example, metal can be used as the material for forming the coil 50. More specifically, radiotransparent materials such as stainless steel (SUS302, SUS304, SUS316, etc.), Ni-Ti alloys, and piano wire, or radiopaque materials such as platinum, gold, tungsten, and any of these alloys can be used. The coil 50 may be formed entirely from the same material, or each part may be formed from different materials.

[0029] The wire 40 is a linear member. The wire 40 has a base portion 40A, a folded portion 40B, and a loop portion 40C. In the wire 40, the base portion 40A, the loop portion 40C, and the folded portion 40B are arranged in this order from the first end 40E1 to the second end 40E2 of the wire 40. The base portion 40A and the loop portion 40C are continuous in the longitudinal direction of the wire 40. The loop portion 40C and the folded portion 40B are continuous in the longitudinal direction of the wire 40. The main body portion 10 includes the base portion 40A and the folded portion 40B of the wire 40. The leading portion 20 includes the loop portion 40C of the wire 40.

[0030] The base portion 40A is a part of the wire 40. The proximal end of the base portion 40A is located at the proximal end of the main body portion 10. The proximal end of the base portion 40A is the part that is grasped by the operator. The tip of the base portion 40A is located at the tip of the main body portion 10.

[0031] The base portion 40A has a large diameter portion 41, a first tapered portion 42, an intermediate diameter portion 43, a second tapered portion 44, and a small diameter portion 47. In the base portion 40A, the large diameter portion 41, the first tapered portion 42, the intermediate diameter portion 43, the second tapered portion 44, and the small diameter portion 47 are arranged in this order from the base end to the tip end of the guide wire 100.

[0032] The large diameter portion 41 is a rod-shaped portion having a substantially constant outer diameter. The outer diameter (maximum width) of the large diameter portion 41 is, for example, approximately 0.2 mm or more and 3.0 mm or less. The first tapered portion 42 is a portion in which the diameter gradually decreases from the boundary with the large diameter portion 41 toward the boundary with the intermediate diameter portion 43. The intermediate diameter portion 43 is a rod-shaped portion having a substantially constant outer diameter smaller than the outer diameter of the large diameter portion 41. The second tapered portion 44 is a portion in which the diameter gradually decreases from the boundary with the intermediate diameter portion 43 toward the boundary with the small diameter portion 47. In this embodiment, the second tapered portion 44 includes a base-end second tapered portion 45 and a tip-end second tapered portion 46 located toward the tip than the base-end second tapered portion 45. The small diameter portion 47 is a rod-shaped portion having a substantially constant outer diameter smaller than the outer diameter of the intermediate diameter portion 43.

[0033] In this embodiment, the rate of change of the outer diameter along the longitudinal direction (hereinafter referred to as "gradient") in the base end second tapered portion 45 and the tip end second tapered portion 46 are different from each other. For example, the gradient of the base end second tapered portion 45 is steeper than the gradient of the tip end second tapered portion 46. The gradient of the base end second tapered portion 45 may be gentler than the gradient of the tip end second tapered portion 46, or it may be the same as the gradient of the tip end second tapered portion 46. In this embodiment, the gradients in the first tapered portion 42 and the second tapered portion 44 are different from each other. For example, the gradient of the first tapered portion 42 is steeper than the gradient of the second tapered portion 44. The gradient of the first tapered portion 42 may be gentler than the gradient of the second tapered portion 44, or it may be the same as the gradient of the second tapered portion 44.

[0034] The folded portion 40B is a part of the wire 40 that is different from the base portion 40A. The folded portion 40B has a portion that faces the base portion 40A in the Y-axis direction, which intersects the axial direction of the main body portion 10. The base end of the folded portion 40B is located closer to the tip than the base end of the base portion 40A. The tip of the folded portion 40B is located at the tip of the main body portion 10.

[0035] The loop portion 40C is a part of the wire 40 that is distinct from the base portion 40A and the folded portion 40B. The loop portion 40C is located between the base portion 40A and the folded portion 40B in the longitudinal direction of the wire 40. The loop portion 40C is loop-shaped when viewed in the X-axis direction. The loop portion 40C surrounds the through hole 24 in the leading portion 20. In this embodiment, the outer edge of the loop portion 40C is heart-shaped when viewed in the X-axis direction (see Figure 4). More specifically, the loop portion 40C extends from the boundary position 40P1, which is the boundary position with the base portion 40A, toward the bending position 40P2, which is located toward the tip and radially outward from the boundary position 40P1. The loop portion 40C extends from the bending position 40P2 toward the bending position 40P3, which is located toward the base end and radially inward from the bending position 40P2. The bending position 40P3 is located on the central axis Ax. The loop portion 40C extends from the bending position 40P3 toward the bending position 40P4, which is located further forward than the bending position 40P3 and on the opposite side of the central axis Ax from the bending position 40P2. The loop portion 40C extends from the bending position 40P4 toward the base end toward the boundary position 40P5, which is located further back than the bending position 40P4 and radially inward, and is the boundary position with the folded-back portion 40B. Boundary positions 40P1 and 40P5 are the base ends of the loop portion 40C. The base ends of the loop portion 40C are located at the base end of the leading portion 20. Bending positions 40P2 and 40P4 are the tips of the loop portion 40C. The tips of the loop portion 40C are located at the tips of the leading portion 20.

[0036] For example, metal can be used as the material for forming the wire 40. More specifically, stainless steel (SUS302, SUS304, SUS316, etc.), Ni-Ti alloy, piano wire, etc., can be used. The wire 40 may be formed entirely from the same material, or each part may be formed from different materials.

[0037] The wire 40 is inserted into the hollow of the coil 50. The coil 50 covers at least a portion of the tip side of the base portion 40A and the folded portion 40B.

[0038] The coil 50 is joined to the wire 40 via a tip-side joining member 61 formed at the tip of the coil 50 and a base-side joining member 62 formed at the base end of the coil 50. The base portion 40A and the folded portion 40B are connected to the coil 50 via the tip-side joining member 61. The tip-side joining member 61 protrudes from the tip 51 of the coil 50 toward the tip side. The loop portion 40C is connected to the coil 50 via the portion of the tip-side joining member 61 that protrudes from the tip 51 of the coil 50. The coil 50 may also be joined to the wire 40 via joining members formed at other locations. Examples of materials used to form the tip-side joining member 61 and the base-side joining member 62 include metal solder (Au-Sn alloy, Sn-Ag alloy, Sn-Pb alloy, Pb-Ag alloy, etc.), brazing material (aluminum alloy brazing, silver brazing, gold brazing, etc.), and adhesive (epoxy adhesive, etc.).

[0039] The leading portion 20 has a reinforcing portion 28 located at the connection point with the main body portion 10. The reinforcing portion 28 reinforces the connection point between the leading portion 20 and the main body portion 10. In this embodiment, the reinforcing portion 28 is formed from the portion of the tip-side joining material 61 that protrudes toward the tip side from the tip 51 of the coil 50. The reinforcing portion 28 may also be formed by the welded portion between the leading portion 20 and the main body portion 10. A constriction 29 is formed on the outer circumferential surface of the reinforcing portion 28. That is, in a part of the reinforcing portion 28 (for example, the base end), the width of the reinforcing portion 28 in the direction perpendicular to the axis Ax decreases toward the tip of the reinforcing portion 28, and in another part of the reinforcing portion 28 (for example, the tip), the width of the reinforcing portion 28 in the direction perpendicular to the axis Ax increases toward the tip of the reinforcing portion 28. For this reason, the outer circumferential surface of the reinforcing portion 28 has a curved surface that is recessed toward the radially inward side of the reinforcing portion 28.

[0040] As shown in Figure 1, the guide wire 100 comprises a first coating 31 and a second coating 32. The first coating 31 covers at least a portion of the leading portion 20. The first coating 31 may also cover a portion of the main body portion 10. In this embodiment, the first coating 31 covers a region R31 formed by the entire leading portion 20 and the tip portion of the main body portion 10. The second coating 32 covers at least a portion of the main body portion 10. In this embodiment, the second coating 32 covers a region R32 which is the intermediate portion of the main body portion 10 excluding the tip and base portions. Region R32 is located on the base end side of region R31. The slipperiness of the first coating 31 is different from that of the second coating 32. For example, the slipperiness of the first coating 31 is lower than that of the second coating 32. The first coating 31 is, for example, hydrophobic and is formed of silicone. The second coating 32 is, for example, hydrophilic and is formed from polyvinylpyrrolidone, polyacrylic acid, polyacrylamide, polyvinyl alcohol, maleic anhydride copolymer, hyaluronic acid, etc.

[0041] The guide wire 100 further comprises a third coating 33. The third coating 33 covers at least a portion of the main body 10. In this embodiment, the third coating 33 covers region R33, which is the base end of the main body 10. Region R33 is located on the base end side of region R32. The third coating 33 is formed of, for example, PTFE.

[0042] As shown in Figure 4, when viewed from the X-axis direction perpendicular to the axial direction of the main body 10, the outer edge of the leading portion 20 satisfies the following first condition. Condition 1: The leading portion 20 has a first end P1 located at the tip 23, and a second end P2 that is convex towards the tip side, located on the opposite side of the central axis Ax of the main body 10 in the Y-axis direction which is perpendicular to the axial direction and the X-axis direction of the main body 10, respectively. In this embodiment, the first end P1 coincides with the bending position 40P2 in the wire 40. In this embodiment, the second end P2 coincides with the bending position 40P4 in the wire 40. As shown in Figure 4, the leading portion 20 has a recess P3 between the first end P1 and the second end P2 in the Y-axis direction. The recess P3 is a portion that is recessed towards the base end than each of the first end P1 and the second end P2. In this embodiment, the recess P3 coincides with the bending position 40P3 in the wire 40. The recess P3 is located on the central axis Ax.

[0043] In this embodiment, the curvature at the first end P1 is equal to the curvature at the second end P2. More specifically, the area around the first end P1 is curved when viewed in the X-axis direction. The area around the second end P2 is curved when viewed in the X-axis direction. The degree of curvature of the loop portion 40C around the first end P1 and the degree of curvature of the loop portion 40C around the second end P2 are equivalent. The curvature at the first end P1 may be greater than the curvature at the second end P2, or it may be less than the curvature at the second end P2.

[0044] In this embodiment, in the axial direction of the main body 10, the distance d1 from the tip 16 of the main body 10 to the first end P1 is equal to the distance d2 from the tip 16 of the main body 10 to the second end P2. In other words, the second end P2 is located at the tip 23 of the leading portion 20. The tip 16 of the main body 10 can be the tip of the coil if the main body 10 has a coil. In this embodiment, the distance sd1 in the Y-axis direction from the central axis Ax of the main body 10 to the first end P1 is equal to the distance sd2 in the Y-axis direction from the central axis Ax of the main body 10 to the second end P2. In this embodiment, the distance d40 in the Y-axis direction from the first end P1 to the second end P2 is greater than the width w10 in the Y-axis direction of the tip of the main body 10. The ratio of distance d40 to width w10, d40 / w10, is, for example, 1.1 or more and 2.0 or less. d40 / w10 may be 1.2 or greater and 1.8 or less, or 1.25 or greater and 1.5 or less. The distance d40 may be equal to the width w10, or it may be less than the width w10. In this embodiment, in the Y-axis direction, the first end P1 and the second end P2 are each further from the central axis Ax of the main body 10 than the Y-axis ends 16E1 and 16E2 of the tip of the main body 10. In the Y-axis direction, at least one of the first end P1 and the second end P2 may be closer to the central axis Ax of the main body 10 than the Y-axis ends 16E1 and 16E2 of the tip of the main body 10.

[0045] (Method of manufacturing guide wire 100) The guide wire 100 of this embodiment can be manufactured by, for example, the following manufacturing method. First, the worker prepares the wire 40. Next, the worker inserts the wire 40 into the hollow part of the coil 50. At this time, the worker positions the wire 40 in the hollow part of the coil 50 such that a part of the tip of the wire 40 protrudes from the tip of the coil 50. Next, the worker bends the portion of the wire 40 that protrudes from the tip of the coil 50 into a loop shape. This forms the base portion 40A, the folded portion 40B, and the loop portion 40C of the wire 40, respectively. Next, the worker inserts the portion of the wire 40 corresponding to the folded portion 40B into the hollow part of the coil 50.

[0046] Next, the worker joins the wire 40 and the coil 50. Specifically, in order to join the wire 40 to the coil 50, the worker forms a tip-side joining member 61 and a base-side joining member 62 using a joining material such as solder. The joining material is supplied, for example, from between the strands of the coil 50 to the inside of the coil 50. The tip-side joining member 61 that protrudes from the tip of the coil 50 towards the tip side forms a reinforcing portion 28. Through the joining process, a guide wire 100 having a leading portion 20 with a reinforcing portion 28 and a main body portion 10 is manufactured.

[0047] (Effects of this embodiment) As described above, the guide wire 100 of this embodiment comprises a long main body portion 10 and a leading portion 20 connected to the tip 16 of the main body portion 10 and entering the lesion portion 220. When viewed from the X-axis direction perpendicular to the axial direction of the main body portion 10, the outer edge of the leading portion 20 satisfies the first condition that it has a first end P1 located at the tip 23 of the leading portion 20 and a second end P2 located on the opposite side of the central axis Ax of the main body portion 10 from the first end P1 in the Y-axis direction, which is perpendicular to the axial direction and the X-axis direction of the main body portion 10, and the second end P2 is convex toward the tip side. With the guide wire 100 of this embodiment, since the outer edge of the leading portion 20 has a first end P1 and a second end P2, the leading portion 20 is more likely to catch on the lesion portion 220, and the passability of the guide wire 100 through the lesion portion 220 is improved.

[0048] In the guide wire 100 of this embodiment, the curvature at the first end P1 is equal to the curvature at the second end P2. According to the guide wire 100 of this embodiment, the leading portion 20 is more likely to catch on the lesion portion 220, and the passage of the guide wire 100 through the lesion portion 220 is improved.

[0049] In the guide wire 100 of this embodiment, the distance d1 from the tip 16 of the main body 10 to the first end P1 in the axial direction of the main body 10 is equal to the distance d2 from the tip 16 of the main body 10 to the second end P2. According to the guide wire 100 of this embodiment, the leading portion 20 is more likely to catch on the lesion portion 220, and the passability of the guide wire 100 through the lesion portion 220 is improved.

[0050] In the guide wire 100 of this embodiment, the distance sd1 in the Y-axis direction from the central axis Ax of the main body 10 to the first end P1 is equal to the distance sd2 in the Y-axis direction from the central axis Ax of the main body 10 to the second end P2. According to the guide wire 100 of this embodiment, the leading portion 20 is more likely to catch on the lesion portion 220, and the passability of the guide wire 100 through the lesion portion 220 is improved.

[0051] In the guide wire 100 of this embodiment, the distance d40 in the Y-axis direction from the first end P1 to the second end P2 is greater than the width w10 in the Y-axis direction of the tip of the main body 10. According to the guide wire 100 of this embodiment, the leading portion 20 can efficiently excavate the lesion portion 220, and the passability of the guide wire 100 through the lesion portion 220 is improved.

[0052] In the guide wire 100 of this embodiment, in the Y-axis direction, the first end P1 and the second end P2 are each further from the central axis Ax of the main body 10 than the Y-axis ends 16E1 and 16E2 of the tip of the main body 10. According to the guide wire 100 of this embodiment, the leading portion 20 can efficiently excavate the lesion portion 220, and the passage of the guide wire 100 through the lesion portion 220 is improved.

[0053] B. Second Embodiment: Figure 9 is a schematic diagram illustrating the configuration of the guide wire 100a of the second embodiment. Figure 9 shows a YZ longitudinal section of the tip of the guide wire 100a. In the following, for components of the guide wire 100a of the second embodiment that are the same as those of the guide wire 100 of the first embodiment, the same reference numerals are used, and their descriptions will be omitted as appropriate.

[0054] In the guide wire 100a of the second embodiment, the configuration of the leading portion 20a differs from that of the leading portion 20 in the guide wire 100 of the first embodiment. Specifically, the leading portion 20a includes a loop portion 40Ca. The loop portion 40Ca extends from the boundary position 40P1 toward a bending position 40P2a located toward the tip and radially outward from the boundary position 40P1. The loop portion 40Ca extends from the bending position 40P2a toward a bending position 40P3a located toward the base and radially inward from the bending position 40P2a. The loop portion 40Ca extends from the bending position 40P3a toward a bending position 40P4a located toward the tip and on the opposite side of the central axis Ax from the bending position 40P2a. The loop portion 40Ca extends from the bending position 40P4a to the boundary position 40P5, which is located further to the base end and radially inward than the bending position 40P4a. The bending position 40P2a is the tip of the loop portion 40Ca. The bending position 40P4a is located further to the base end than the bending position 40P2a.

[0055] When viewed from the X-axis direction, the outer edge of the leading portion 20a satisfies the first condition, similar to the outer edge of the leading portion 20 in the first embodiment. In this embodiment, the first end P1a coincides with the bending position 40P2a on the wire 40a. In this embodiment, the second end P2a coincides with the bending position 40P4a on the wire 40a. In this embodiment, the recess P3a coincides with the bending position 40P3a on the wire 40a.

[0056] In this embodiment, the curvature at the first end P1a is smaller than the curvature at the second end P2a. More specifically, the curvature of the loop portion 40Ca around the first end P1a is gentler than the curvature of the loop portion 40Ca around the second end P2a. The curvature at the first end P1a may be greater than the curvature at the second end P2a, or it may be equal to the curvature at the second end P2a.

[0057] In this embodiment, in the axial direction of the main body 10, the second end P2a is located closer to the base end than the first end P1a. In this embodiment, the distance sd1a in the Y-axis direction from the central axis Ax of the main body 10 to the first end P1a is different from the distance sd2a in the Y-axis direction from the central axis Ax of the main body 10 to the second end P2a. Specifically, distance sd1a is longer than distance sd2a. Distance sd1a may be shorter than distance sd2a.

[0058] As described above, in the guide wire 100a of this embodiment, the outer edge of the leading portion 20a satisfies the first condition, and the curvature at the first end P1a is smaller than the curvature at the second end P2a. With the guide wire 100a of this embodiment, the first end P1a, which has relatively small curvature, can easily excavate the lesion 220, thus improving the passability of the guide wire 100a through the lesion 220.

[0059] In the guide wire 100a of this embodiment, the second end P2a is located closer to the proximal end than the first end P1a. With the guide wire 100a of this embodiment, the leading portion 20a is more likely to catch on the lesion portion 220, improving the passability of the guide wire 100a through the lesion portion 220.

[0060] In the guide wire 100a of this embodiment, the distance sd1a in the Y-axis direction from the central axis Ax of the main body 10 to the first end P1a is different from the distance sd2a in the Y-axis direction from the central axis Ax of the main body 10 to the second end P2a. With the guide wire 100a of this embodiment, the leading portion 20a is more likely to catch on the lesion portion 220, and the passability of the guide wire 100a through the lesion portion 220 is improved.

[0061] C. Third Embodiment: Figure 10 is an explanatory diagram schematically showing the configuration of the guide wire 100b of the third embodiment. Figure 10 shows the YZ longitudinal section of the tip of the guide wire 100b. In the following, for the configuration of the guide wire 100b of the third embodiment that is the same as that of the guide wire 100 of the first embodiment, the same reference numerals are used and their explanations are omitted as appropriate.

[0062] In the guide wire 100b of the third embodiment, the configuration of the leading portion 20b differs from that of the leading portion 20 in the guide wire 100 of the first embodiment. More specifically, the leading portion 20b includes a loop portion 40Cb. The outer edge of the loop portion 40Cb in this embodiment is substantially triangular. More specifically, the loop portion 40Cb extends from boundary position 40P1 toward end 40P6, which is located further forward and radially outward than boundary position 40P1. From end 40P6, the loop portion 40Cb extends linearly parallel to the Y-axis toward end 40P7, which is located on the opposite side of end 40P6 across the central axis Ax. From end 40P7, the loop portion 40Cb extends toward the base end to boundary position 40P5, which is located further back and radially inward than end 40P7.

[0063] As shown in Figure 10, when viewed from the X-axis direction perpendicular to the axial direction of the main body 10, the outer edge of the leading portion 20b satisfies the following second condition. Second condition: It has a straight section SP extending in the Y-axis direction. In this embodiment, the straight section SP coincides with the portion of the loop section 40Cb extending from end 40P6 to end 40P7. In this embodiment, the straight section SP is parallel to the Y-axis direction. That is, the straight section SP is perpendicular to the central axis Ax of the main body section 10. In this embodiment, the straight section SP faces the tip side of the guide wire 100b. In this specification, "straight section" includes not only strictly straight sections but also shapes that deviate slightly from a straight line due to unavoidable circumstances such as manufacturing errors.

[0064] As described above, the guide wire 100b of this embodiment comprises a long main body portion 10 and a leading portion 20b connected to the tip 16 of the main body portion 10 and entering the lesion portion 220. The second condition is that when viewed from the X-axis direction perpendicular to the axial direction of the main body portion 10, the outer edge of the leading portion 20b has a straight portion SP extending in the Y-axis direction. With the guide wire 100 of this embodiment, because the outer edge of the leading portion 20b has a straight portion SP, the leading portion 20b is more likely to catch on the lesion portion 220, and the passability of the guide wire 100b through the lesion portion 220 is improved.

[0065] In the guide wire 100b of this embodiment, the straight section SP is perpendicular to the central axis Ax of the main body 10. With the guide wire 100 of this embodiment, the leading section 20b is more likely to catch on the lesion 220, improving the passability of the guide wire 100b through the lesion 220.

[0066] D. Fourth Embodiment: Figure 11 is a schematic diagram illustrating the configuration of the guide wire 100c of the fourth embodiment. Figure 11 shows the YZ longitudinal section of the tip of the guide wire 100c. In the following, for components of the guide wire 100c of the fourth embodiment that are the same as those of the guide wire 100b of the third embodiment, the same reference numerals are used, and their descriptions will be omitted as appropriate.

[0067] In the guide wire 100c of the fourth embodiment, the configuration of the leading portion 20c differs from that of the leading portion 20b in the guide wire 100b of the third embodiment. Specifically, the leading portion 20c includes a loop portion 40Cc in the wire 40c. The outer edge of the loop portion 40Cc in this embodiment is substantially triangular. The loop portion 40Cc extends from boundary position 40P1 toward end 40P6c, which is located further forward and radially outward than boundary position 40P1. The loop portion 40Cc extends linearly from end 40P6c toward end 40P7c, which is further forward than end 40P6c and on the opposite side of end 40P6c across the central axis Ax. The loop portion 40Cc extends toward the base end toward boundary position 40P5, which is located further back and radially inward than end 40P7c.

[0068] The outer edge of the leading portion 20c in the fourth embodiment satisfies the second condition, similar to the outer edge of the leading portion 20b in the third embodiment. In this embodiment, the straight portion SPc coincides with the portion of the loop portion 40Cc extending from end 40P6c to end 40P7c. In this embodiment, the straight portion SPc extends in the Y-axis direction while having a predetermined angle with respect to the Y-axis direction perpendicular to the axial direction of the main body portion 10. The predetermined angle is, for example, 45° or less. The predetermined angle may be 30° or less, or 15° or less. As in this embodiment, the straight portion may have a predetermined angle with respect to the Y-axis direction.

[0069] The loop portion 40Cc has a tip portion 40CD located at the tip 23 of the leading portion 20c. In this embodiment, the tip portion 40CD is located at the end of the straight portion SPc in the Y-axis direction. As shown in Figure 11, the distance d40B between the position of the tip portion 40CD and the position of the folded portion 40B in the Y-axis direction is shorter than the distance d40A between the position of the tip portion 40CD and the position of the base portion 40A in the Y-axis direction. In other words, in the Y-axis direction, the base portion 40A and the folded portion 40B are located on opposite sides of the central axis Ax. The tip portion 40CD is located on the same side as the folded portion 40B with respect to the central axis Ax.

[0070] As described above, in the guide wire 100c of this embodiment, the outer edge of the leading portion 20c satisfies the second condition, and the straight portion SPc extends in the Y-axis direction while having a predetermined angle with respect to the Y-axis direction. With the guide wire 100c of this embodiment, the leading portion 20c is more likely to catch on the lesion portion 220, and the passability of the guide wire 100c through the lesion portion 220 is improved.

[0071] In the guide wire 100c of this embodiment, the main body 10 includes a base portion 40A, which is a part of the wire 40c, and a folded portion 40B, which is a part of the wire 40c different from the base portion 40A, and whose base end is located closer to the tip than the base end of the base portion 40A. The leading portion 20c is a part of the wire 40c different from the base portion 40A and the folded portion 40B, and includes a loop portion 40Cc located between the base portion 40A and the folded portion 40B of the wire 40c. The loop portion 40Cc has a tip portion 40CD located at the tip 23 of the leading portion 20c. The distance d40B between the position of the tip portion 40CD and the position of the folded portion 40B in the Y-axis direction is shorter than the distance d40A between the position of the tip portion 40CD and the position of the base portion 40A in the Y-axis direction. According to the guide wire 100c of this embodiment, the leading portion 20c is more likely to catch on the lesion portion 220, improving the passability of the guide wire 100c through the lesion portion 220.

[0072] E. Fifth Embodiment: Figure 12 is a schematic diagram illustrating the configuration of the guide wire 100d of the fifth embodiment. Figure 12 shows the YZ longitudinal section of the tip of the guide wire 100d. In the following, for components of the guide wire 100d of the fifth embodiment that are the same as those of the guide wire 100b of the third embodiment, the same reference numerals are used, and their descriptions will be omitted as appropriate.

[0073] In the fifth embodiment of the guide wire 100d, the configuration of the leading portion 20d differs from that of the leading portion 20b in the third embodiment of the guide wire 100b. Specifically, the leading portion 20d includes a loop portion 40Cd in the wire 40d. The outer edge of the loop portion 40Cd in this embodiment is substantially triangular. The loop portion 40Cd extends from boundary position 40P1 toward end 40P6d, which is located further forward and radially outward than boundary position 40P1. The loop portion 40Cd extends linearly from end 40P6d toward end 40P7d, which is located further back than end 40P6d and on the opposite side of end 40P6d across the central axis Ax. The loop portion 40Cd extends toward the base end toward boundary position 40P5, which is located further back and radially inward than end 40P7d.

[0074] The outer edge of the leading portion 20d in the fifth embodiment satisfies the second condition, similar to the outer edge of the leading portion 20b in the third embodiment. In this embodiment, the straight portion SPd coincides with the portion of the loop portion 40Cd extending from end 40P6d to end 40P7d. In this embodiment, the straight portion SPd extends in the Y-axis direction while having a predetermined angle with respect to the Y-axis direction perpendicular to the axial direction of the main body portion 10. The predetermined angle is, for example, 45° or less. The predetermined angle may be 30° or less, or 15° or less. As in this embodiment, the straight portion may have a predetermined angle with respect to the Y-axis direction.

[0075] The loop portion 40Cd has a tip portion 40CDd located at the tip 23 of the leading portion 20d. In this embodiment, the tip portion 40CDd is located at the end of the straight portion SPd in ​​the Y-axis direction. As shown in Figure 12, the distance d40Ad between the position of the tip portion 40CDd and the position of the base portion 40A in the Y-axis direction is shorter than the distance d40Bd between the position of the tip portion 40CDd and the position of the folded portion 40B in the Y-axis direction. In other words, in the Y-axis direction, the base portion 40A and the folded portion 40B are located on opposite sides of the central axis Ax. The tip portion 40CDd is located on the same side as the base portion 40A with respect to the central axis Ax.

[0076] As described above, in the guide wire 100d of this embodiment, the main body 10 includes a base portion 40A, which is a part of the wire 40d, and a folded portion 40B, which is a part of the wire 40d different from the base portion 40A, and whose base end is located closer to the tip than the base end of the base portion 40A. The leading portion 20d is a part of the wire 40d different from the base portion 40A and the folded portion 40B, and includes a loop portion 40Cd located between the base portion 40A and the folded portion 40B of the wire 40d. The loop portion 40Cd has a tip portion 40CDd located at the tip 23 of the leading portion 20d. The distance d40Ad between the position of the tip portion 40CDd and the position of the base portion 40A in the Y-axis direction is shorter than the distance d40Bd between the position of the tip portion 40CDd and the position of the folded portion 40B in the Y-axis direction. According to the guide wire 100d of this embodiment, the leading portion 20d is more likely to catch on the lesion portion 220, improving the passability of the guide wire 100d through the lesion portion 220.

[0077] F. Sixth Embodiment: Figure 13 is a schematic diagram illustrating the configuration of the guide wire 100e of the sixth embodiment. Figure 13 shows a YZ longitudinal section of the tip of the guide wire 100e. In the following, for components of the guide wire 100e of the sixth embodiment that are the same as those of the guide wire 100 of the first embodiment, the same reference numerals are used, and their descriptions will be omitted as appropriate.

[0078] The guide wire 100e of the sixth embodiment differs from the wire 40 in the first embodiment in the configuration of the wire 40e. Instead of having a folded portion 40B and a loop portion 40C as in the first embodiment, the wire 40e has a loop portion 48 that is continuous with the tip of the base portion 40A. A through hole 484 is formed in the loop portion 48 through which the wire 40d passes in the X-axis direction. In other words, the loop portion 48 is loop-shaped, surrounding the through hole 484 when viewed in the X-axis direction. The outer edge of the loop portion 48 is heart-shaped, similar to the outer edge of the loop portion 40C in the first embodiment. Therefore, the leading portion 20e has a first end P1e, a second end P2e, and a recess P3e. The outer edge of the through hole 484 is approximately triangular when viewed in the X-axis direction. The shape of the outer edge of the loop portion 48 and the shape of the outer edge of the through hole 484 are not similar to each other. As in this embodiment, the first end and the second end do not necessarily coincide with the wire's folding position. Also, as in this embodiment, the outer edge of the loop and the outer edge of the through hole do not necessarily have to be similar to each other.

[0079] G. Seventh Embodiment: Figure 14 is a schematic diagram illustrating the configuration of the guide wire 100f of the seventh embodiment. Figure 14 shows the YZ longitudinal section of the tip of the guide wire 100f. In the following, for components of the guide wire 100f of the seventh embodiment that are the same as those of the guide wire 100e of the sixth embodiment, the same reference numerals are used, and their descriptions will be omitted as appropriate.

[0080] In the seventh embodiment, the guide wire 100f differs from the sixth embodiment in the configuration of the loop portion 48f in the wire 40f. The outer edge of the loop portion 48f is approximately triangular, similar to the outer edge of the loop portion 40Cc in the third embodiment. Therefore, the leading portion 20f has a straight portion SPf. The outer edge of the through hole 484f is approximately quadrilateral when viewed in the X-axis direction. The shape of the outer edge of the loop portion 48f and the shape of the outer edge of the through hole 484f are not similar to each other. As in this embodiment, the straight portion does not necessarily have to be a portion that extends linearly in the wire. As in this embodiment, the outer edge of the loop portion and the outer edge of the through hole do not have to be similar to each other.

[0081] H. Variant: The technologies disclosed herein are not limited to the embodiments described above and can be modified in various forms without departing from their essence, for example, the following modifications are possible.

[0082] The configuration of the guide wire 100 in the above embodiment is merely an example and can be modified in various ways. For example, the guide wire does not necessarily have to have at least one of the first coating 31, the second coating 32, and the third coating 33.

[0083] The leading portion does not necessarily have to have a through hole. In other words, the leading portion does not necessarily have to be loop-shaped.

[0084] The materials of each component in the above embodiment are merely examples and can be modified in various ways. The method for manufacturing the guide wire 100 in the above embodiment is merely an example and can be modified in various ways. The treatment method using the guide wire 100 in the above embodiment is merely an example and can be modified in various ways.

[0085] In the above embodiment, a guidewire 100 for treating lesions within blood vessels was used as an example. The techniques disclosed herein are similarly applicable to medical devices in general for treating lesions in biological tubular lumenes.

[0086] Each of the features described in each of the embodiments described above may be appropriately combined with other embodiments or modifications. Each of the features described in each of the modifications described above may be appropriately combined with embodiments or modifications. Each of the features described in each of the embodiments described above may be appropriately omitted. Each of the features described in each of the modifications described above may be appropriately omitted.

Claims

1. A medical device (100,100b), The elongated main body (10) and A reading unit (20) is connected to the tip (16) of the main body (10) and enters the lesion (220), Equipped with, When viewed from a first direction perpendicular to the axial direction of the main body (10), the outer edge of the leading portion (20) is, (1) The first condition is that the leading portion (20) has a first end (P1) located at the tip (23), and a second end (P2) located on the opposite side from the first end (P1) in a second direction perpendicular to the axial direction of the main body (10) and the first direction, with respect to the central axis (Ax) of the main body (10), and the second end (P2) is convex toward the tip side. (2) The second condition is that it has a straight section (SP) extending in the second direction, A medical device (100,100b) that satisfies at least one of the following conditions.

2. A medical device (100) according to claim 1, The outer edge of the leading portion (20) satisfies the first condition, A medical device (100) in which the curvature at the first end (P1) is equal to the curvature at the second end (P2).

3. A medical device (100a) according to claim 1, The outer edge of the leading portion (20a) satisfies the first condition, A medical device (100a) wherein the curvature at the first end (P1a) is smaller than the curvature at the second end (P2a).

4. A medical device (100) according to any one of claims 1 to 3, The outer edge of the leading portion (20) satisfies the first condition, A medical device (100) wherein, in the axial direction of the main body (10), the distance (d1) from the tip (16) of the main body (10) to the first end (P1) is equal to the distance (d2) from the tip (16) of the main body (10) to the second end (P2).

5. A medical device (100a) according to any one of claims 1 to 3, The outer edge of the leading portion (20a) satisfies the first condition, The second end (P2a) is located more proximal to the first end (P1a) of the medical device (100a).

6. A medical device (100) according to any one of claims 1 to 5, The outer edge of the leading portion (20) satisfies the first condition, A medical device (100) wherein the distance (sd1) in the second direction from the central axis (Ax) of the main body (10) to the first end (P1) is equal to the distance (sd2) in the second direction from the central axis (Ax) of the main body (10) to the second end (P2).

7. A medical device (100a) according to any one of claims 1 to 5, The outer edge of the leading portion (20a) satisfies the first condition, A medical device (100a) wherein the distance (sd1a) in the second direction from the central axis (Ax) of the main body (10) to the first end (P1a) is different from the distance (sd2a) in the second direction from the central axis (Ax) of the main body (10) to the second end (P2a).

8. A medical device (100) according to any one of claims 1 to 7, The outer edge of the leading portion (20) satisfies the first condition, A medical device (100) wherein the distance (d40) in the second direction from the first end (P1) to the second end (P2) is greater than the width (w10) of the tip portion of the main body (10) in the second direction.

9. A medical device (100) according to any one of claims 1 to 8, The outer edge of the leading portion (20) satisfies the first condition, A medical device (100) wherein, in the second direction, the first end (P1) and the second end (P2) are each further from the central axis (Ax) of the main body (10) than the ends (16E1, 16E2) of the tip portion of the main body (10) in the second direction.

10. A medical device (100b) according to claim 1, The outer edge of the leading portion (20b) satisfies the second condition, The linear portion (SP) is a medical device (100b) perpendicular to the central axis (Ax) of the main body portion (10).

11. A medical device (100c, 100d) according to claim 1, The outer edges of the leading portions (20c, 20d) satisfy the second condition, The linear portions (SPc, SPd) are medical devices (100c, 100d) that extend in the second direction while having a predetermined angle with respect to the second direction.

12. A medical device (100c) according to claim 1, The outer edge of the leading portion (20c) satisfies the second condition, The main body (10) is The base portion (40A) is a part of the wire (40c), The wire (40c) includes a folded portion (40B) which is a part different from the base portion (40A), and whose base end is located closer to the tip than the base end of the base portion (40A), The leading portion (20c) is a part of the wire (40c) that is different from the base portion (40A) and the folded portion (40B), and includes a loop portion (40Cc) located between the base portion (40A) and the folded portion (40B) of the wire (40c). The loop portion (40Cc) has a tip portion (40CD) located at the tip (23) of the leading portion (20c), A medical device (100c) in which the distance (d40B) between the position of the tip portion (40CD) and the position of the folded portion (40B) in the second direction is shorter than the distance (d40A) between the position of the tip portion (40CD) and the position of the base portion (40A) in the second direction.

13. A medical device (100d) according to claim 1, The outer edge of the leading portion (20d) satisfies the second condition, The main body (10) is The base portion (40A), which is a part of the wire (40d), The wire (40d) includes a folded portion (40B) which is a part different from the base portion (40A), and whose base end is located closer to the tip than the base end of the base portion (40A), The leading portion (20d) is a part of the wire (40d) that is different from the base portion (40A) and the folded portion (40B), and includes a loop portion (40Cd) located between the base portion (40A) and the folded portion (40B) of the wire (40d). The loop portion (40Cd) has a tip portion (40CDd) located at the tip (23) of the reading portion (20d), A medical device (100d) in which the distance (d40Ad) between the position of the tip portion (40CDd) and the position of the base portion (40A) in the second direction is shorter than the distance (d40Bd) between the position of the tip portion (40CDd) and the position of the folded portion (40B) in the second direction.

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