Method for manufacturing a medical device, and medical device

Abstract

To improve the strength of the loop portion in medical devices. [Solution] The method for manufacturing a medical device involves forming a through hole in a flat portion of a workpiece having a flat portion, thereby manufacturing an entry member that enters a lesion, and having a loop portion surrounding the through hole, and joining the entry member and a long body such that the through hole faces a predetermined direction intersecting the axial direction of the long body.

Description

Technical Field

[0001] The technology disclosed in this specification relates to a method for manufacturing a medical device and a medical device.

Background Art

[0002] Known medical devices have a loop portion at the tip. The loop portion is formed by folding back an elongated member (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 was room for improvement in the strength of the loop portion in the medical device.

[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 method for manufacturing a medical device disclosed in this specification manufactures an entry member having a loop portion surrounding the through hole, which is an entry member for entering a lesion, by forming a through hole in the flat portion of a work member having a flat portion, and joins the entry member and a long member so that the through hole faces a predetermined direction intersecting the axial direction of the long member.

Brief Description of the Drawings

[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] This diagram schematically shows the configuration of the guide wire in the first embodiment. [Figure 6] This diagram schematically shows the configuration of the guide wire in the first embodiment. [Figure 7] A flowchart illustrating 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] An explanatory diagram showing an example of a treatment method using a guidewire. [Figure 10] An explanatory diagram showing an example of a treatment method using a guidewire. [Figure 11] A flowchart showing an example of a guide wire manufacturing method. [Figure 12] An explanatory diagram showing an example of a guidewire manufacturing method. [Figure 13] This is an explanatory diagram illustrating the configuration of the guide wire in the second embodiment. [Figure 14] This is an explanatory diagram illustrating the configuration of the guide wire in the third embodiment. [Figure 15] This is an explanatory diagram illustrating the configuration of the guide wire in the fourth embodiment. [Figure 16] This is an explanatory diagram schematically showing the configuration of the guide wire in the fifth embodiment. [Figure 17] This is an explanatory diagram illustrating the configuration of the guide wire in the sixth embodiment. [Figure 18] This is an explanatory diagram illustrating the configuration of the guide wire in the seventh embodiment. [Figure 19] This is an explanatory diagram schematically showing the configuration of the guide wire in the eighth embodiment. [Figure 20] Explanatory drawing schematically showing the configuration of the guide wire according to the 9th embodiment [Figure 21] Explanatory drawing schematically showing the configuration of the guide wire according to the 10th embodiment [Figure 22] Explanatory drawing schematically showing the configuration of the guide wire of a modification

Mode for Carrying Out the Invention

[0009] A. First Embodiment: (Basic Configuration of Guide Wire 100) Figs. 1 to 6 are explanatory drawings schematically showing the configuration of the guide wire 100 in the first embodiment. In each figure, XYZ axes orthogonal to each other for specifying directions are shown. Fig. 1 shows the appearance of the guide wire 100 as viewed in the X-axis direction. Fig. 2 shows the appearance of the guide wire 100 as viewed in the Y-axis direction. Fig. 3 shows the YZ longitudinal section of the guide wire 100. Fig. 4 shows the YZ longitudinal section of the tip portion of the guide wire 100. Fig. 5 shows the XY cross section of the guide wire 100 at the position of V-V in Fig. 4. Fig. 6 shows the XZ longitudinal section of the guide wire 100 at the position of VI-VI in Fig. 4. It shows the appearance of the tip portion of the guide wire 100 as viewed in the Y-axis direction. In the guide wire 100, the positive Z-axis side is the tip side (distal side) inserted into the body. In the guide wire 100, the negative Z-axis side is the proximal side (proximal side) operated by the operator. In each figure, some illustrations of the guide wire 100 may be omitted. Figs. 1 to 3 show the state in which the guide wire 100 is in a straight line parallel to the Z-axis. The guide wire 100 has flexibility enough to be curved. These points are the same in the subsequent figures. The X-axis direction is an example of a predetermined direction.

[0010] In this specification, for the guide wire 100 and each of its components, the end on the tip side is referred to as the "tip", the tip and its vicinity are referred to as the "tip portion", the end on the proximal end side is referred to as the "proximal end", and the proximal end and its vicinity are referred to as the "proximal end portion". The cross-section of the guide wire 100 and each of its components means a cross-section orthogonal to the longitudinal direction. The longitudinal cross-section of the guide wire 100 and each of its components means a cross-section parallel to the central axis in the longitudinal direction. For the guide wire 100 and each of its components, the direction orthogonal to the longitudinal direction is referred to as the "radial direction". The outer diameter of the guide wire 100 and each of its components means the length along the radial direction. In this specification, for the guide wire 100 and each of its components, the length along the Y-axis direction may be particularly referred to as the "width", and the length along the X-axis direction may be particularly referred to as the "thickness".

[0011] The guide wire 100 is a long medical device inserted into a living body lumen such as a blood vessel. The total length of the guide wire 100 is, for example, 1000 mm or more and 3000 mm or less. The guide wire 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 a long portion extending along the central axis Ax. In this 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 tip portion of the main body portion 10.

[0014] The leading portion 20 is connected to the tip 16 of the main body 10. The base end 27 of the leading portion 20 is connected to the tip 16 of the main body 10. The leading portion 20 can be described as a leading section, drill section, crushing section, peeling section, entry section, peeler, shaver, etc. The tip 23 of the leading portion 20 coincides with the tip of the guide wire 100. The leading portion 20 is loop-shaped and surrounds a through hole 24 extending in the X-axis direction. The surface of the leading portion 20 may or may not have an edge. An edge is the boundary (ridge) between two surfaces. The leading portion 20 rotates around the central axis Ax and enters the lesion. The entry of the leading portion 20 into the lesion can be described as crossing through the lesion, drilling through the lesion, crushing the lesion, peeling away the lesion, digging 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 also be 0.3 mm or more and 1.5 mm or less, or 0.4 mm or more and 1.0 mm or less. In the view along the X axis, the end of the leading portion 20 on the positive Y axis side at the base end 27 is called the first end 27E1, and the end of the leading portion 20 on the negative Y axis side at the base end 27 is called the second end 27E2.

[0015] The maximum outer diameter Dx of the leading portion 20 is greater than the thickness T2 of the leading portion 20 at the maximum outer diameter position Px. That is, the leading portion 20 is flattened overall. The thickness T2 of the leading portion 20 at the maximum outer diameter position Px is smaller than the maximum outer diameter D1 of the tip 16 of the main body portion 10. The thickness T2 of the leading portion 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 leading portion 20 at the maximum outer diameter position Px may be 0.04 mm or more and 0.2 mm or less, or 0.06 mm or more and 0.1 mm or less. The maximum outer diameter Dx of the leading portion 20 is, for example, 1.2 times or more the thickness T2 of the leading portion 20 at the maximum outer diameter position Px. The maximum outer diameter Dx of the leading portion 20 may be 1.5 times or more the thickness T2 of the leading portion 20 at the maximum outer diameter position Px, or it 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 7 is a flowchart showing an example of a treatment method using a guidewire 100. Figures 8 to 10 are explanatory diagrams showing an example of a treatment method using a guidewire 100. As shown in Figures 9 and 10, 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 8, the lesion 220 to be treated is located, for example, in a blood vessel 200 in the lower limb of a human. Figure 8 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 8) 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 9) 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 9). 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 advances the guidewire 100 toward the tip while rotating it, thereby causing the leading portion 20 of the guidewire 100 to enter the lesion 220 (S150, Figure 10). 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 first wire 48, a second 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. The coil 50 is an example of a long body.

[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 first wire 48 is a linear member. The leading portion 20 includes the first wire 48. In this embodiment, the main body portion 10 includes a portion of the proximal end of the first wire 48. The first wire 48 is a member that enters the lesion portion 220 in treatment using the guide wire 100. The first wire 48 is an example of an entry member.

[0030] The first wire 48 has a loop portion 481 and a root portion 482. The loop portion 481 is an annular portion located on the tip side of the first wire 48. The loop portion 481 is flattened in shape. The maximum width mw481 of the loop portion 481 in the X-axis direction view is longer than the thickness t481 of the loop portion 481 in the Y-axis direction view. A through hole 484 is formed in the first wire 48. The through hole 484 penetrates the first wire 48 in the X-axis direction, which intersects with the axial direction of the main body portion 10. The loop portion 481 surrounds the through hole 484. The through hole 484 forms at least a part of the through hole 24 of the leading portion 20. The root portion 482 is the portion of the loop portion 481 that extends from the base end toward the base end. As shown in Figure 6, the thickness t481 of the loop portion 481 in the X-axis direction is smaller than the thickness t482 of the root portion 482 in the X-axis direction. The ratio of thickness t481 to thickness t482, t481 / t482, is, for example, 0.2 or more and 0.95 or less. t481 / t482 may also be 0.4 or more and 0.9 or 0.5 or more and 0.8 or less. The thickness t481 of the loop portion 481 in the X-axis direction may be greater than or equal to the thickness t482 of the root portion 482 in the X-axis direction. A hole 482H extending in the axial direction of the main body portion 10 is formed in the root portion 482.

[0031] For example, a metal can be used as the material for forming the first wire 48. In this embodiment, a radiopaque material such as platinum, gold, tungsten, tantalum, rhenium, iridium, or any of these alloys can be used as the material for forming the first wire 48. In other words, in this embodiment, the first wire 48 is radiopaque. For example, a radiopaque material such as stainless steel (SUS302, SUS304, SUS316, etc.), Ni-Ti alloy, or piano wire may be used as the material for forming the first wire 48. The first wire 48 may be formed entirely from the same material, or each part may be formed from different materials.

[0032] The first wire 48 is inserted into the hollow of the coil 50. The coil 50 covers a portion of the proximal end of the first wire 48.

[0033] The second wire 40 is a linear member. The main body 10 includes the second wire 40. The second wire 40 is located on the proximal end side of the first wire 48. The tip of the second wire 40 is connected to the proximal end of the first wire 48. The proximal end of the second wire 40 is located at the proximal end of the main body 10. The proximal end side of the second wire 40 is the part that is grasped by the operator.

[0034] The second wire 40 has a large diameter section 41, a first tapered section 42, an intermediate diameter section 43, a second tapered section 44, and a small diameter section 47. In the second wire 40, the large diameter section 41, the first tapered section 42, the intermediate diameter section 43, the second tapered section 44, and the small diameter section 47 are arranged in this order from the base end to the tip end of the guide wire 100.

[0035] 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.

[0036] 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.

[0037] For example, metal can be used as the material for forming the second wire 40. More specifically, stainless steel (SUS302, SUS304, SUS316, etc.), Ni-Ti alloy, piano wire, etc., can be used. The second wire 40 may be formed entirely from the same material, or each part may be formed from different materials. The second wire 40 may be formed from the same material as the first wire 48, or from a different material than the first wire 48.

[0038] The second wire 40 is inserted into the hollow of the coil 50. The coil 50 covers at least a portion of the tip end of the second wire 40.

[0039] The coil 50 is joined to the root portion 482 of the first wire 48 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 first wire 48 is 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 481 of the first wire 48 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 first wire 48 via joining members formed at other locations. The coil 50 may also be joined to the second wire 40. For example, metal solder (such as Au-Sn alloy, Sn-Ag alloy, Sn-Pb alloy, Pb-Ag alloy), brazing material (such as aluminum alloy brazing, silver brazing, gold brazing), adhesive (such as epoxy adhesive) can be used as the forming material for the tip-side joining member 61 and the base-side joining member 62.

[0040] 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 in the direction perpendicular to the central 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 in the direction perpendicular to the central 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.

[0041] 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.

[0042] 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.

[0043] In this embodiment, as shown in Figure 4, the tip of the second wire 40 is positioned in the hole 482H of the root portion 482 of the first wire 48. This connects the tip of the second wire 40 to the base portion of the first wire 48.

[0044] In this embodiment, as shown in Figure 4, the width of the loop portion 481 differs from one another at each position around the through hole 484 in the loop portion 481. For example, when viewing the guide wire 100 along the X-axis direction, the shortest distance L1 from the first position P1 on the outer edge of the through hole 484 to the outer edge of the loop portion 481 is shorter than the shortest distance L2 from the second position P2 on the outer edge of the through hole 484 to the outer edge of the loop portion 481. The width of the loop portion 481 may be equal at each position around the through hole 484 in the loop portion 481.

[0045] In this embodiment, as shown in Figure 5, in a cross section perpendicular to the outer edge of the through hole 484 in the loop portion 481, the inner circumferential surface 481SI and the outer circumferential surface 481SO of the loop portion 481 are in a straight line. The inner circumferential surface 481SI is inclined at a predetermined angle with respect to the outer circumferential surface 481SO. In this embodiment, in the XY cross section perpendicular to the axial direction of the main body portion 10, which is a cross section perpendicular to the outer edge of the through hole 484 in the loop portion 481, the inner circumferential surface 481SI is inclined at a predetermined angle with respect to the outer circumferential surface 481SO. The predetermined angle is, for example, 10° or more and 60° or less. The predetermined angle may be 15° or more and 45° or less, or 20° or more and 45° or less. The inner circumferential surface 481SI may be parallel to the outer circumferential surface 481SO. As shown in Figure 5, the loop portion 481 has an edge at the intersection IS of the outer peripheral surface 481SO of the loop portion 481 and the surface 481S that intersects the outer peripheral surface 481SO.

[0046] (Method of manufacturing guide wire 100) Figure 11 is a flowchart showing an example of a method for manufacturing the guide wire 100. Figure 12 is an explanatory diagram showing an example of a method for manufacturing the guide wire 100. The guide wire 100 of this embodiment can be manufactured, for example, by the following manufacturing method.

[0047] First, the worker prepares the workpiece 48m (S210). The workpiece 48m is the component that will become the first wire 48 after processing. Specifically, the workpiece 48m is the first wire 48 in which the through hole 484 has not yet been formed. The worker prepares the workpiece 48m (see Figure 12) by cutting out a plate made of a radiopaque material such as platinum, tantalum, rhenium, iridium, or tungsten.

[0048] Next, the worker manufactures the first wire 48 by forming through holes 484 in the flattened portion 481m of the workpiece 48m (S220, Figure 12). The worker may form through holes 484 in the flattened portion 481m by cutting the processing area PA in the flattened portion 481m with, for example, a drill. The worker may form through holes 484 in the flattened portion 481m by irradiating the processing area PA in the flattened portion 481m with, for example, a laser. The worker manufactures the loop portion 481 and the first wire 48 by the above-described process. When manufacturing the loop portion 481, the worker may form through holes 484 at each position around the through holes 484 in the loop portion 481 such that the width of the loop portion 481 differs from one another. Specifically, the worker may form the through-hole 484 in the flattened portion 481m such that, when viewing the guide wire 100 along the X-axis direction, the shortest distance L1 from a first position P1 on the outer edge of the through-hole 484 to the outer edge of the loop portion 481 is shorter than the shortest distance L2 from a second position P2 on the outer edge of the through-hole 484 to the outer edge of the loop portion 481. When manufacturing the loop portion 481, the worker may form the through-hole 484 such that the inner circumferential surface 481SI is inclined at a predetermined angle with respect to the outer circumferential surface 481SO.

[0049] Next, the worker inserts the second wire 40 into the coil 50 (S230). The worker prepares the second wire 40 and inserts the second wire 40 into the hollow part of the coil 50.

[0050] Next, the worker inserts the tip of the second wire 40 into the base 482 of the first wire 48 (S240). The worker then forms a hole 482H in the base 482 of the first wire 48, for example, after step S220. The worker then inserts the thin-diameter tip 47 of the second wire 40 into the hole 482H in the base 482. This connects the first wire 48 and the second wire 40. The worker may weld the first wire 48 and the second wire 40 to increase the joint strength between them.

[0051] Next, the worker joins the first wire 48 and the coil 50 (S250). To join the first wire 48 and 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. This joins the first wire 48 and the coil 50. At this time, the worker joins the first wire 48 and the coil 50 so that the through hole 484 faces in a direction that intersects the axial direction of the coil 50. 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.

[0052] (Effects of this embodiment) As described above, the manufacturing method of the guide wire 100 of this embodiment involves forming a through hole 484 in the flat portion 481m of a workpiece 48m having a flat portion 481m, thereby manufacturing a first wire 48 that enters the lesion portion 220 and has a loop portion 481 surrounding the through hole 484. The first wire 48 and the coil 50 are then joined so that the through hole 484 faces in the X-axis direction, which intersects the axial direction of the coil 50. Compared to a guide wire manufacturing method that forms a loop portion by, for example, folding back an elongated member, the manufacturing method of the guide wire 100 of this embodiment can manufacture a loop portion 481 with a stable structure and improve the strength of the loop portion 481 in the guide wire 100. In other words, in a loop portion formed by, for example, folding back an elongated member, the position of the end of the elongated member is not easily determined, which can make the structure of the loop portion unstable. The loop portion 481 manufactured by the guide wire 100 manufacturing method of this embodiment can be manufactured by forming a through hole 484 in the flat portion 481m, thus enabling the manufacture of a loop portion 481 with a stable structure. The guide wire 100 manufacturing method of this embodiment makes it possible to easily manufacture loop portions 481 having various structures. In other words, the guide wire 100 manufacturing method of this embodiment makes it easier to manufacture the loop portion 481 with any structure compared to a method of manufacturing a loop portion by, for example, folding a slender member. Specifically, the guide wire 100 manufacturing method of this embodiment makes it easy to, for example, reduce the curvature at any position in the loop portion 481, reduce the thickness t481, or change only the thickness at any position in the loop portion 481.

[0053] In the manufacturing method of the guide wire 100 of this embodiment, a through hole 484 is formed in the flat portion 481m by cutting the flat portion 481m. Compared with a guide wire manufacturing method that forms a loop portion by, for example, folding back an elongated member, the manufacturing method of the guide wire 100 of this embodiment can produce a loop portion 481 with a stable structure and improve the strength of the loop portion 481 in the guide wire 100.

[0054] In the method for manufacturing the guide wire 100 of this embodiment, a laser is irradiated onto the flattened portion 481m to form a through hole 484 in the flattened portion 481m. Compared with a guide wire manufacturing method that forms a loop portion by, for example, folding back an elongated member, the method for manufacturing the guide wire 100 of this embodiment can produce a loop portion 481 with a stable structure and improve the strength of the loop portion 481 in the guide wire 100.

[0055] In the manufacturing method of the guide wire 100 of this embodiment, when the guide wire 100 is viewed along the X-axis direction, the through hole 484 is formed in the flattened portion 481m such that the shortest distance L1 from a first position P1 on the outer edge of the through hole 484 to the outer edge of the loop portion 481 is shorter than the shortest distance L2 from a second position P2 on the outer edge of the through hole 484 to the outer edge of the loop portion 481. The manufacturing method of the guide wire 100 of this embodiment makes it possible to manufacture a loop portion 481 that has a thinned portion, thereby facilitating the excavation of the lesion portion 220.

[0056] In the manufacturing method of the guide wire 100 of this embodiment, in a cross section perpendicular to the outer edge of the through hole 484 in the loop portion 481, the inner circumferential surface 481SI and the outer circumferential surface 481SO of the loop portion 481 are straight lines, and the through hole 484 is formed in the flattened portion 481m such that the inner circumferential surface 481SI is inclined with respect to the outer circumferential surface 481SO. In the manufacturing method of the guide wire 100 of this embodiment, for example, by making the angle between the inner circumferential surface 481SI and the surface 481S that intersects the inner circumferential surface 481SI less than 90 degrees, an acute edge can be formed at the intersection of the inner circumferential surface 481SI and the surface 481S. This makes it possible to manufacture a loop portion 481 that facilitates the excavation of the lesion portion 220.

[0057] 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. The leading portion 20 includes a first wire 48 that enters the lesion portion 220, and the first wire 48 has a loop portion 481 surrounding a through hole 484 that penetrates the first wire 48 in the X-axis direction intersecting the axial direction of the main body portion 10. Compared to a guide wire having a loop portion formed by, for example, folding back an elongated member, the structure of the loop portion 481 is more stable and the strength of the loop portion 481 is improved. In other words, in a loop portion formed by, for example, folding back an elongated member, the position of the end of the elongated member is not easily determined, which can make the structure of the loop portion unstable. The guide wire 100 of this embodiment has a loop portion 481 surrounding a through hole 484 that penetrates the first wire 48, so the structure of the loop portion 481 is stable.

[0058] In the guide wire 100 of this embodiment, when the guide wire 100 is viewed along the X-axis direction, the shortest distance L1 from the first position P1 on the outer edge of the through hole 484 to the outer edge of the loop portion 481 is shorter than the shortest distance L2 from the second position P2 on the outer edge of the through hole 484 to the outer edge of the loop portion 481. According to the guide wire 100 of this embodiment, since a part of the loop portion 481 is thin, it becomes easier to excavate the lesion portion 220 with the loop portion 481 having the thin part.

[0059] In the guide wire 100 of this embodiment, in a cross-section perpendicular to the outer edge of the through hole 484 in the loop portion 481, the inner circumferential surface 481SI and the outer circumferential surface 481SO of the loop portion 481 are straight lines, and the inner circumferential surface 481SI is inclined with respect to the outer circumferential surface 481SO. According to the guide wire 100 of this embodiment, for example, the angle between the inner circumferential surface 481SI and the surface 481S that intersects the inner circumferential surface 481SI becomes less than 90 degrees, and an acute-angled edge is formed at the intersection of the inner circumferential surface 481SI and the surface 481S. This makes it easier to excavate the lesion portion 220 with the loop portion 481.

[0060] In the guide wire 100 of this embodiment, the loop portion 481 has an edge at the intersection IS of the outer peripheral surface 481SO of the loop portion 481 and the surface 481S that intersects the outer peripheral surface 481SO. According to the guide wire 100 of this embodiment, the leading portion 20 can more easily excavate the lesion portion 220.

[0061] In the guide wire 100 of this embodiment, the first wire 48 further has a root portion 482 extending from the base end of the loop portion 481 toward the base end, and the thickness t481 of the loop portion 481 in the X-axis direction is smaller than the thickness t482 of the root portion 482 in the X-axis direction. According to the guide wire 100 of this embodiment, the leading portion 20 can more easily excavate the lesion portion 220.

[0062] In the guide wire 100 of this embodiment, the first wire 48 is radiopaque. According to the guide wire 100 of this embodiment, since the first wire 48 is radiopaque, the visibility of the leading portion 20 is improved.

[0063] In the guide wire 100 of this embodiment, the main body portion 10 includes a second wire 40 whose tip is connected to the base end of the first wire 48 and whose base end is located at the base end of the main body portion 10. Compared to a guide wire having a loop portion formed by, for example, folding back an elongated member, the structure of the loop portion 481 is more stable and the strength of the loop portion 481 is improved.

[0064] In the guide wire 100 of this embodiment, the first wire 48 further has a root portion 482 that extends from the base end of the loop portion 481 toward the base end, and has a root portion 482H formed in which a hole 482H extending in the axial direction of the main body portion 10 is formed, and the tip portion of the second wire 40 is positioned in the hole 482H. According to the guide wire 100 of this embodiment, the structure of the loop portion 481 is more stable and the strength of the loop portion 481 is improved compared to a guide wire having a loop portion formed by, for example, folding back an elongated member.

[0065] B. Second Embodiment: Figure 13 is an explanatory diagram schematically showing the configuration of the guide wire 100a of the second embodiment. Figure 13 shows the 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 explanations will be omitted as appropriate.

[0066] In the guide wire 100a of the second embodiment, the configuration of the connection between the first wire 48a and the second wire 40a differs from the configuration of the connection between the first wire 48 and the second wire 40 in the guide wire 100 of the first embodiment. Specifically, the first wire 48a has a cross section 48S located at the base end of the first wire 48a. Cross section 48S is located at the base end of the root portion 482a of the first wire 48a. The second wire 40a has a cross section 40S located at the tip of the second wire 40a. Cross section 40S is located at the tip of the narrow diameter portion 47a of the second wire 40a. Cross section 48S is an example of a first cross section. Cross section 40S is an example of a second cross section.

[0067] The first wire 48a and the second wire 40a are connected by joining cross-sections 48S and 40S. The first wire 48a and the second wire 40a are joined to each other, for example, by welding. Cross-sections 48S and 40S are inclined at a predetermined angle with respect to a direction perpendicular to the axial direction of the main body 10. That is, the joining surface CS of cross-sections 48S and 40S is inclined at a predetermined angle with respect to a direction perpendicular to the axial direction of the main body 10. The predetermined angle is, for example, 10° or more and 60° or less. The predetermined angle may also be 15° or more and 45° or less, or 20° or more and 45° or less.

[0068] As described above, in the guide wire 100a of this embodiment, the first wire 48a and the second wire 40a are connected by joining the cross section 48S located at the base end of the first wire 48a and the cross section 40S located at the tip end of the second wire 40a. The joining surface CS between cross section 48S and cross section 40S is inclined with respect to a direction perpendicular to the axial direction of the main body 10. With the guide wire 100a of this embodiment, for example, the area of ​​the joining surface CS can be increased compared to a guide wire in which the joining surface is not inclined with respect to a direction perpendicular to the axial direction of the main body. Increasing the area of ​​the joining surface CS improves the joining strength between the first wire 48a and the second wire 40a.

[0069] C. Third Embodiment: Figure 14 is a schematic diagram illustrating the configuration of the guide wire 100b of the third embodiment. Figure 14 shows a YZ longitudinal section of the guide wire 100b. In the following, for components of the guide wire 100b of the third 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.

[0070] In the guide wire 100b of the third embodiment, the configuration of the first wire 48b differs from that of the first wire 48 in the guide wire 100 of the first embodiment. Specifically, the first wire 48b has a root portion 482b. The root portion 482b extends from the base end of the loop portion 481 toward the base end. The root portion 482b extends to the base end of the main body portion 10. That is, the guide wire 100b does not have the second wire 40 in the first embodiment, but instead the root portion 482b extends to the base end of the main body portion 10. The coil 50 covers the tip side of the root portion 482b. The tip of the root portion 482b is connected to the tip of the coil 50.

[0071] As described above, in the guide wire 100b of this embodiment, the first wire 48b further has a root portion 482b that extends from the base end of the loop portion 481 toward the base end, and the root portion 482b extends to the base end of the main body portion 10. The main body portion 10 includes a cylindrical coil 50 that covers the root portion 482b. The tip of the root portion 482b is connected to the tip of the coil 50. Compared to a guide wire having a loop portion formed by, for example, folding back an elongated member, the structure of the loop portion 481 is more stable and the strength of the loop portion 481 is improved.

[0072] D. Fourth Embodiment: Figure 15 is an explanatory diagram schematically showing the configuration of the guide wire 100c of the fourth embodiment. Figure 15 shows the YZ longitudinal section of the tip of the guide wire 100c. In the following, for the configuration of the guide wire 100c of the fourth 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.

[0073] In the guide wire 100c of the fourth embodiment, the configuration of the first wire 48c differs from that of the first wire 48 in the guide wire 100 of the first embodiment. The first wire 48c has a loop portion 481c. In view along the X-axis, the outer edge of the loop portion 481c is perfectly circular. In view along the X-axis, the outer edge of the through hole 484c is perfectly circular. The first wire 48c can be manufactured in the same manner as the first wire 48 of the first embodiment.

[0074] The method for manufacturing the guide wire 100 shown in the first embodiment facilitates the manufacture of a loop portion with a perfectly circular outer edge, such as the guide wire 100c of this embodiment.

[0075] E. Fifth Embodiment: Figure 16 is a schematic diagram illustrating the configuration of the guide wire 100d of the fifth embodiment. Figure 16 shows a 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 100 of the first embodiment, the same reference numerals are used, and their descriptions will be omitted as appropriate.

[0076] In the fifth embodiment of the guide wire 100d, the configuration of the first wire 48d differs from that of the first wire 48 in the guide wire 100 of the first embodiment. The first wire 48d has a loop portion 481d. In view along the X-axis, the outer edge of the loop portion 481d is substantially rhombic. In other words, the outer edge of the loop portion 481d has four straight portions 481Sd. In view along the X-axis, the outer edge of the through hole 484d is substantially rhombic. In other words, the outer edge of the through hole 484d has four straight portions 484Sd. The first wire 48d can be manufactured in the same manner as the first wire 48 of the first embodiment.

[0077] The method for manufacturing the guide wire 100 shown in the first embodiment facilitates the manufacture of a loop portion with a substantially rhombic outer edge, such as the guide wire 100d in this embodiment.

[0078] F. Sixth Embodiment: Figure 17 is a schematic diagram illustrating the configuration of the guide wire 100e of the sixth embodiment. Figure 17 shows the 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.

[0079] In the guide wire 100e of the sixth embodiment, the configuration of the first wire 48e differs from that of the first wire 48 in the guide wire 100 of the first embodiment. The first wire 48e has a loop portion 481e. In view along the X-axis, the outer edge of the loop portion 481e is approximately triangular. In other words, the outer edge of the loop portion 481e has three straight portions 481Se. In the X-axis direction, the outer edge of the through hole 484e is approximately triangular. In other words, the outer edge of the through hole 484e has three straight portions 484Se. The first wire 48e can be manufactured in the same manner as the first wire 48 of the first embodiment.

[0080] The method for manufacturing the guide wire 100 shown in the first embodiment facilitates the manufacture of loop portions with a substantially triangular outer edge, such as the guide wire 100e of this embodiment.

[0081] G. Seventh Embodiment: Figure 18 is an explanatory diagram schematically showing the configuration of the guide wire 100f of the seventh embodiment. Figure 18 shows the YZ longitudinal section of the tip of the guide wire 100f. In the following, for the configuration of the guide wire 100f of the seventh 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.

[0082] In the guide wire 100f of the seventh embodiment, the configuration of the first wire 48f differs from that of the first wire 48 in the guide wire 100 of the first embodiment. The first wire 48f has a loop portion 481f. In view along the X-axis, the loop portion 481f has an asymmetric structure with respect to the central axis Ax. The loop portion 481f is biased towards the negative Y-axis side rather than the positive Y-axis side with respect to the central axis Ax. In view along the X-axis, the outer edge of the through hole 484f has an asymmetric structure with respect to the central axis Ax. The through hole 484f is biased towards the negative Y-axis side rather than the positive Y-axis side with respect to the central axis Ax. The first wire 48f can be manufactured in the same manner as the first wire 48 of the first embodiment.

[0083] The method for manufacturing the guide wire 100 shown in the first embodiment facilitates the manufacture of loop portions with an asymmetrical structure with respect to the central axis of the main body, such as the guide wire 100f of this embodiment.

[0084] H. Eighth Embodiment: Figure 19 is a schematic diagram illustrating the configuration of the guide wire 100g of the eighth embodiment. Figure 19 shows the YZ longitudinal section of the tip of the guide wire 100g. In the following, for components of the guide wire 100g of the eighth embodiment that are the same as those of the guide wire 100 of the first embodiment, the same reference numerals are used, and their explanations will be omitted as appropriate.

[0085] In the guide wire 100g of the eighth embodiment, the configuration of the first wire 48g differs from that of the first wire 48 in the guide wire 100 of the first embodiment. The first wire 48g has a loop portion 481g. In view along the X-axis, the outer edge of the loop portion 481g is circular. In view along the X-axis, the outer edge of the through hole 484g is partially elliptical. Partially elliptical is the shape of one half of an ellipse divided by a chord. That is, when the guide wire 100g is viewed along the X-axis, the shape of the outer edge of the loop portion 481g and the shape of the outer edge of the through hole 484g are not similar to each other. In this embodiment, the fact that the shape of the outer edge of the loop portion 481g and the shape of the outer edge of the through hole 484g are "not similar to each other" means that even if the outer edge of the loop portion 481g is reduced in size, it will not match the shape of the outer edge of the through hole 484g. "Not similar to each other" means, for example, that if the shape of the outer edge of the loop portion 481g and the shape of the outer edge of the through hole 484g are polygons, then the ratio of their corresponding sides and their angles are not equal. The first wire 48g can be manufactured in the same manner as the first wire 48 of the first embodiment.

[0086] As described above, in the guide wire 100g of this embodiment, when the guide wire 100g is viewed along the X-axis direction, the shape of the outer edge of the loop portion 481g and the shape of the outer edge of the through hole 484g are not similar to each other. Compared to a guide wire having a loop portion formed by, for example, folding back an elongated member, the structure of the loop portion 481g is more stable and the strength of the loop portion 481 is improved.

[0087] The method for manufacturing the guide wire 100 shown in the first embodiment facilitates the manufacture of loop sections in which the shape of the outer edge of the loop section and the shape of the outer edge of the through-hole are not similar to each other, such as the guide wire 100g of this embodiment.

[0088] I. Ninth Embodiment: Figure 20 is a schematic diagram illustrating the configuration of the guide wire 100h of the ninth embodiment. Figure 20 shows the YZ longitudinal section of the tip of the guide wire 100h. In the following, for components of the guide wire 100h of the ninth 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.

[0089] In the guide wire 100h of the ninth embodiment, the configuration of the first wire 48h differs from that of the first wire 48 in the guide wire 100 of the first embodiment. The first wire 48h has a loop portion 481h. In view along the X-axis, the outer edge of the loop portion 481h is substantially rhombic. In view along the X-axis, the outer edge of the through hole 484h is substantially trapezoidal. That is, when the guide wire 100h is viewed along the X-axis, the shape of the outer edge of the loop portion 481h and the shape of the outer edge of the through hole 484h are not similar to each other. The first wire 48h can be manufactured in the same manner as the first wire 48 of the first embodiment.

[0090] The method for manufacturing the guide wire 100 shown in the first embodiment facilitates the manufacture of loop sections in which the shape of the outer edge of the loop section and the shape of the outer edge of the through-hole are not similar to each other, such as the guide wire 100h of this embodiment.

[0091] J. Tenth Embodiment: Figure 21 is a schematic diagram illustrating the configuration of the guide wire 100i of the tenth embodiment. Figure 21 shows a YZ longitudinal section of the tip of the guide wire 100i. In the following, for components of the guide wire 100i of the tenth 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.

[0092] In the guide wire 100i of the tenth embodiment, the configuration of the first wire 48i differs from that of the first wire 48 in the guide wire 100 of the first embodiment. The first wire 48i has a loop portion 481i. In view along the X-axis, the outer edge of the loop portion 481i is perfectly circular. In view along the X-axis, the outer edge of the through hole 484i is perfectly circular. A groove 486 is formed in the loop portion 481i. The groove 486 is formed on the surface of the loop portion 481i that faces the X-axis direction and intersects the axial direction of the main body portion 10. The groove 486 extends from the outer edge of the through hole 484i to the outer edge of the loop portion 481i. The first wire 48i can be manufactured in the same manner as the first wire 48 of the first embodiment. An operator can form the groove 486 in the loop portion 481i by cutting the surface of the loop portion 481i. The operator can form a groove 486 in the loop portion 481i by irradiating the surface of the loop portion 481i with a laser.

[0093] The method for manufacturing the guide wire 100 shown in the first embodiment facilitates the manufacture of a grooved loop portion, such as the guide wire 100i of this embodiment.

[0094] K. 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.

[0095] Figure 22 is an explanatory diagram schematically showing the configuration of a modified guide wire 100j. Figure 22 shows the XZ longitudinal section of guide wire 100j at the same position as the XZ longitudinal section of guide wire 100 shown in Figure 6. In the following, for the configuration of the modified guide wire 100j, components that are the same as those of guide wire 100 in the first embodiment will be denoted by the same reference numerals, and their explanations will be omitted as appropriate.

[0096] In the modified guide wire 100j, a through hole 484j is formed in the loop portion 481j of the first wire 48j. As shown in Figure 22, in the XZ cross section, the inner circumferential surface 481SIj and the outer circumferential surface 481SOj of the loop portion 481j are linear. The inner circumferential surface 481SIj is inclined at a predetermined angle with respect to the outer circumferential surface 481SOj. Thus, in a cross section parallel to the axial direction of the main body, which is perpendicular to the outer edge of the through hole in the loop portion, the inner circumferential surface of the loop portion may be inclined with respect to the outer circumferential surface of the loop portion. The inner circumferential surface of the loop portion may be inclined with respect to the outer circumferential surface of the loop portion over the entire circumference of the loop portion.

[0097] 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.

[0098] The method for manufacturing the guide wire 100 in the above embodiment is merely an example and can be modified in various ways. For example, the method for forming through holes in the flattened portion is not limited to cutting and laser irradiation.

[0099] The materials of each component in the above embodiment are merely examples 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.

[0100] 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.

[0101] 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 method for manufacturing a medical device (100), An entry member (48) for entering a lesion (220) is manufactured by forming a through hole (484) in the flat portion (481m) of a workpiece (48m) having a flat portion (481m), and the entry member (48) has a loop portion (481) surrounding the through hole (484). A method for manufacturing a medical device (100), comprising joining the entry member (48) and the elongated body (50) such that the through hole (484) faces a predetermined direction intersecting the axial direction of the elongated body (50).

2. A method for manufacturing the medical device (100) described in claim 1, A method for manufacturing a medical device (100), comprising forming the through hole (484) in the flattened portion (481m) by cutting the flattened portion (481m).

3. A method for manufacturing the medical device (100) described in claim 1, A method for manufacturing a medical device (100), comprising irradiating the flattened portion (481m) with a laser to form the through-hole (484) in the flattened portion (481m).

4. A method for manufacturing a medical device (100) according to any one of claims 1 to 3, A method for manufacturing a medical device (100), comprising forming the through hole (484) in the flattened portion (481m) such that, when the medical device (100) is viewed along the predetermined direction, the shortest distance (L1) from a first position (P1) on the outer edge of the through hole (484) to the outer edge of the loop portion (481) is shorter than the shortest distance (L2) from a second position (P2) on the outer edge of the through hole (484) to the outer edge of the loop portion (481).

5. A method for manufacturing a medical device (100) according to any one of claims 1 to 4, In a cross-section perpendicular to the outer edge of the through hole (484) in the loop portion (481), The inner circumferential surface (481SI) and the outer circumferential surface (481SO) of the loop portion (481) are both straight lines. A method for manufacturing a medical device (100), comprising forming the through hole (484) in the flattened portion (481m) such that the inner circumferential surface (481SI) is inclined with respect to the outer circumferential surface (481SO).

6. A medical device (100), A long main body (10) and The reading section (20) is connected to the tip (16) of the main body (10), It includes an entry member (48) that enters the lesion (220), The entry member (48) has a loop portion (481) surrounding a through hole (484) that penetrates the entry member (48) in a predetermined direction intersecting the axial direction of the main body portion (10), and a leading portion (20), A medical device (100) equipped with [the following features].

7. A medical device (100) according to claim 6, When the medical device (100) is viewed along the predetermined direction, the shortest distance (L1) from the first position (P1) on the outer edge of the through hole (484) to the outer edge of the loop portion (481) is shorter than the shortest distance (L2) from the second position (P2) on the outer edge of the through hole (484) to the outer edge of the loop portion (481), wherein the medical device (100) is viewed along the predetermined direction, wherein the shortest distance (L1) is shorter than the shortest distance (L2) from the second position (P2) on the outer edge of the through hole (484) to the outer edge of the loop portion (481).

8. A medical device (100) according to claim 6 or claim 7, In a cross-section perpendicular to the outer edge of the through hole (484) in the loop portion (481), The inner circumferential surface (481SI) and the outer circumferential surface (481SO) of the aforementioned loop portion (481) are both straight lines. A medical device (100) in which the inner circumferential surface (481SI) is inclined with respect to the outer circumferential surface (481SO).

9. A medical device (100) according to any one of claims 6 to 8, A medical device (100) wherein, in a cross section perpendicular to the outer edge of the through hole (484) in the loop portion (481), the loop portion (481) has an edge at the intersection (IS) of the outer peripheral surface (481SO) of the loop portion (481) and the surface (481S) intersecting the outer peripheral surface (481SO).

10. A medical device (100g, 100h) according to any one of claims 6 to 9, When the medical device (100g, 100h) is viewed along the predetermined direction, the shape of the outer edge of the loop portion (481g, 481h) and the shape of the outer edge of the through hole (484g, 484h) are not similar to each other, in the medical device (100g, 100h).

11. A medical device (100) according to any one of claims 6 to 10, The entry member (48) further has a root portion (482) extending from the base end of the loop portion (481) toward the base end, A medical device (100) wherein the thickness of the loop portion (481) in the predetermined direction is smaller than the thickness of the root portion (482) in the predetermined direction.

12. A medical device (100) according to any one of claims 6 to 11, The entry member (48) is a medical device (100) that is radiopaque.

13. A medical device (100) according to any one of claims 6 to 12, The entry member (48) is the first wire (48), The medical device (100) includes a main body (10) and a second wire (40) whose tip is connected to the base end of the first wire (48) and whose base end is located at the base end of the main body (10).

14. A medical device (100) according to claim 13, The first wire (48) further has a root portion (482) that extends from the base end of the loop portion (481) toward the base end, and has a root portion (482) in which a hole (482H) extending in the axial direction of the main body portion (10) is formed. The tip of the second wire (40) is a medical device (100) positioned in the hole (482H).

15. A medical device (100a) according to claim 13, The first wire (48a) and the second wire (40a) are connected by joining a first cross section (48S) located at the base end of the first wire (48a) and a second cross section (40S) located at the tip end of the second wire (40a). A medical device (100a) wherein the joint surface (CS) between the first cross section (48S) and the second cross section (40S) is inclined with respect to a direction perpendicular to the axial direction of the main body (10).

16. A medical device (100b) according to any one of claims 6 to 12, The entry member (48b) further has a root portion (482b) that extends from the base end of the loop portion (481) toward the base end, and a root portion (482b) that extends to the base end of the main body portion (10), The main body (10) includes a cylindrical elongated body (50) that covers the base portion (482b), The tip of the base portion (482b) is a medical device (100b) connected to the tip of the elongated body (50).

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