Medical device medical wire, medical device, and medical device medical wire manufacturing method

Abstract

A wire for a medical device, the wire being provided with: a prescribed region having a coating film exhibiting at least a prescribed color; and a specific region having a coating film exhibiting at least a specific color, the specific color being different from the predetermined color.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority and the benefits of Japanese Patent Application No. 2023-191450 filed on November 9, 2023, and priority and the benefits of Japanese Patent Application No. 2024-101898 filed on June 25, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to a metal wire for medical equipment, medical equipment and a method for manufacturing the metal wire for medical equipment. Background Art

[0004] A guidewire used when inserting a catheter or the like into a blood vessel is known. In such a guidewire, a wire (metal wire) formed by a superelastic alloy such as nickel-titanium alloy is sometimes used as a core material. Superelastic alloys have the property of being difficult to be subjected to habitual bending (bending tendency). It is known that nickel-titanium alloys lose their superelastic properties by heat treatment, making it easy to be subjected to habitual bending. For example, in International Publication No. 2020 / 161832 and Patent Gazette No. 2017-153615, a guidewire is disclosed that utilizes such properties to improve shaping performance by heat treating the metal wire. "Metal wire" is also referred to as a core, a wire, a core wire, a mandrel, and a metal wire for medical devices. Summary of the invention

[0005] Problems to be solved by the invention

[0006] In this way, metal wires are sometimes processed by utilizing the change in the physical properties of metals caused by heat treatment. As methods for heat treating metal wires, methods such as annealing using an electric furnace or heat treatment using a laser are known. In the above patent documents, no consideration is given to changing the degree of ease of adding a habitual bend.

[0007] Such issues are not limited to medical devices inserted into the vascular system and the metal wires used in these medical devices, but are common to medical devices inserted into various organs in the human body, such as the lymphatic system, biliary system, urinary system, respiratory system, digestive system, endocrine glands, and reproductive organs, and the metal wires used in these medical devices.

[0008] Means of solving problems

[0009] The present disclosure has been made to solve at least a part of the above-mentioned problems, and can be implemented as the following aspects.

[0010] (1) According to one aspect of the present disclosure, there is provided a metal wire for medical devices. The metal wire for medical devices includes: a predetermined region having a coating exhibiting a predetermined color; and a specific region having a coating exhibiting a specific color. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 This is a diagram for explaining the shaping test.

[0012] Figure 2 is a table showing the physical properties of each region of the metal wire.

[0013] Figure 3 It is an explanatory diagram illustrating the configuration of the medical device according to the first embodiment.

[0014] Figure 4 It is a graph showing the relationship between the thickness of the coating and the color.

[0015] Figure 5 This is a diagram showing an example of the tip end portion of the wire.

[0016] Figure 6 This is a diagram showing an example of the surface structure of the tip end portion of the metal wire.

[0017] Figure 7 This is an enlarged view of the front end of the wire.

[0018] Figure 8 is a flow chart illustrating a method of manufacturing a medical device.

[0019] Fig. 9 This is a diagram showing an example of the tip end portion of the metal wire according to the second embodiment.

[0020] Fig.10 This is a diagram showing an example of the tip end portion of the metal wire according to the third embodiment.

[0021] Fig.11 This is a diagram showing an example of the tip end portion of the metal wire according to the fourth embodiment.

[0022] Fig.12 This is a diagram showing an example of the tip end portion of the metal wire according to the fifth embodiment.

[0023] Fig.13 This is a diagram showing an example of the tip end portion of the metal wire according to the sixth embodiment.

[0024] Fig.14 This is a diagram showing an example of the tip end portion of the metal wire according to the seventh embodiment.

[0025] Fig.15This is a diagram showing an example of the tip end portion of the metal wire according to the eighth embodiment.

[0026] Fig.16 It is an enlarged view of the front end portion of the metal wire according to the ninth embodiment.

[0027] Fig.17 : is a flowchart showing a method for manufacturing a medical device according to a ninth embodiment.

[0028] Fig.18 It is an enlarged view of the front end portion of the metal wire according to the tenth embodiment.

[0029] Fig.19 1 is a flowchart showing a method for manufacturing a medical device according to a tenth embodiment.

[0030] Fig. 20 It is an enlarged view of the front end portion of the metal wire according to the eleventh embodiment.

[0031] Fig.21 It is a line graph showing the thickness of the coating at the front end portion. DETAILED DESCRIPTION

[0032] By heat treating the metal wire, the shaping performance can be improved. The following is a shaping test of the metal wire with different physical properties, the first region, the second region and the unheat-treated portion. The results show that the first region is most likely to be subjected to habitual bending, and the second region is less likely to be subjected to habitual bending than the first region.

[0033] Figure 1 This is a diagram for explaining the shaping test. Figure 1 (A) shows a test tool used in the shaping test. The test tool is a measuring device 200 of the shaping angle θ. The measuring device 200 has a base 211, a flat plate 213, a pin 215 and a clamping mechanism 217. The flat plate 213 is placed on the base 211, and its upper surface is a plane 212. The pin 215 is supported slidably in the up-down direction relative to a support 214 provided on the base 211, and the clamping mechanism 217 is supported slidably in the up-down direction relative to a support rod 216 provided on the base 211. The pin 215 has a spherical protrusion extending downward in the vertical direction. The diameter Φ215 of the protrusion of the pin 215 is 0.5 mm. The metal wire as the sample SW is a wire having a first region, a second region and an unheat-treated portion, and the first region, the second region and the unheat-treated portion are formed by changing the heat treatment conditions for the wire made of nickel-titanium alloy.

[0034] The steps of the shaping test are described. The operator sets the sample SW of the measurement object on the measuring device 200. Specifically, the operator fixes the position of the sample SW at a predetermined distance (about 250mm to 300mm) from the front end to the clamping mechanism 217, and sets it to the following state: the sample SW extends downward from the position fixed by the clamping mechanism 217, hits the plane 212, and extends from this position in the horizontal direction on the plane 212. The operator presses the part of the sample SW that contacts the plane 212 toward the plane 212 with the convex part of the pin 215, and places the weight 218 on the pin 215. Thus, a load of 1N is applied to the sample SW toward the plane 212 through the pin 215. In this state, the operator pulls the sample SW from the plane 212 in the orthogonal direction by moving the clamping mechanism 217 upward along the support rod 216. The pulling length is set to about 2mm.

[0035] For example, when the operator wants to measure the shaping angle θ of the first region of the sample SW, the operator can give a shaped shape to the pulled portion by pulling out the central portion of the first region. The operator measures the angle of the curved portion SWC in the first region of the sample SW as the shaping angle θ. Figure 1 (C) and Figure 1 (D) is a diagram for explaining the method of measuring the shaping angle θ. The operator draws a virtual extension line VL1 and a virtual extension line VL2. The virtual extension line VL1 is obtained by drawing a tangent to a straight portion of the sample SW located closer to the front end side than the curved portion SWC, and the virtual extension line VL2 is obtained by drawing a tangent to a straight portion of the sample SW located closer to the base end side than the curved portion SWC. The straight portion refers to the unbent portion of the sample SW. The operator measures the angle θ on the side away from the curved portion SWC among the angles of the intersection of the virtual extension line VL1 and the virtual extension line VL2, and sets it as the shaping angle θ.

[0036] Figure 1 (B) shows the results of the shaping test (shaping angle θ at each pulled portion of sample SW). Figure 2: is a table showing the physical properties of each region of the metal wire as the sample SW. The shaping angle θ of the first region is 60°. The first region is heat-treated at a first temperature. The thickness of the oxide film of the first region is 100 nm or more. The oxide film of the first region presents at least one color selected from the first color group. The first color group includes green, cyan, magenta and yellow. The shaping angle θ of the second region is 18°. The second region is heat-treated at a second temperature. The thickness of the oxide film of the second region is 10 nm or more and 30 nm or less. The oxide film of the second region presents at least one color selected from the third color group. The third color group includes purple and gold. It is inferred that the shaping angle θ of the transition region is greater than 18° and less than 60°. The transition region is formed by the heat applied to the first region being conducted on the sample SW. It is inferred that the heat treatment temperature of the transition region is lower than the first temperature and higher than the second temperature. The thickness of the oxide film of the transition region is thicker than 30 nm and thinner than 100 nm. The oxide film of the transition region presents at least one color selected from the second color group. The second color group includes blue and white. The shaping angle θ of the unheat-treated portion is 9°. The thickness of the oxide film of the unheat-treated portion is about 0 nm. The unheat-treated portion presents at least one color selected from the fourth color group. The fourth color group includes gray and silver. The magnitude relationship between the first temperature and the second temperature is that the first temperature>the second temperature.

[0037] from Figure 1 (B) and Figure 2 It can be seen that the following correlation is obtained: the thicker the oxide film of the metal wire, the larger the shaping angle θ (the angle of additional habit). The thickness and color of the oxide film have the following correlation. In other words, it can be seen that the color of the oxide film has a correlation with the ease of adding habitual bending. Figure 2 As shown, for the transition area between the first area and the second area, regarding the shaping angle θ, it is inferred that the relationship of the first area>transition area>second area is established. The first area is equivalent to the "prescribed area". The transition area is equivalent to the "specific area". The second area is equivalent to the "predetermined area". The first temperature is equivalent to the "prescribed temperature". The second temperature is equivalent to the "specific temperature".

[0038] Taking advantage of this, in each of the embodiments described below, a medical device was successfully produced in which the degree of ease with which a habitual bend is imparted was changed.

[0039] <First embodiment>

[0040] Figure 3This is an explanatory diagram illustrating the structure of a medical device 1 according to a first embodiment. The medical device 1 is a guide wire. The medical device 1 is used when inserting other medical devices (catheters, etc.) into blood vessels or digestive organs, etc. The medical device 1 includes a first metal wire 10. The medical device 1 includes a second metal wire 20. The medical device 1 includes a coil 40. The medical device 1 includes a front end tip 51. The medical device 1 includes a base end side joint 52. The front end portion 100 of the first metal wire 10 has a coating formed by heat treatment. In the medical device 1, the ease with which the front end portion 100 is added with a habitual bend (shaping performance) is improved.

[0041] For ease of explanation, Figure 3 Contains parts where the relative proportions of the sizes of various structural components are different from the actual ones. Figure 3 Contains exaggerated portions of each structural member. Figure 3 The axis O (single-dot chain line) is an axis passing through the center of the medical device 1. The axis O coincides with the axes passing through the centers of the first metal wire 10, the second metal wire 20, and the coil 40. The axis O may also be different from the center axes of the above-mentioned structural members. Figure 3 In the figure, mutually orthogonal XYZ axes are illustrated. The X axis corresponds to the length direction of the medical device 1. The Y axis corresponds to the thickness direction of the medical device 1. The Z axis corresponds to the width direction of the medical device 1. Figure 3 The left side (-X axis direction) of the medical device 1 and each structural member is called the "front end side". Figure 3 The right side (+X axis direction) of the medical device 1 and each structural member is called the "base side". For the medical device 1 and each structural member, the end on the front end side is called the "front end", and the front end and its vicinity are called the "front end". The end on the base end side is called the "base end", and the base end and its vicinity are called the "base end". The front end side is inserted into the body, and the base end side is operated by the operator. These points are in Figure 3 This is also common in the following figures.

[0042] The first metal wire 10 is a metal wire for medical equipment. The first metal wire 10 is arranged on the front end side of the medical equipment 1. The first metal wire 10 is arranged closer to the front end side than the second metal wire 20. The first metal wire 10 is formed of, for example, a nickel-titanium alloy or an alloy of nickel-titanium and other metals. The first metal wire 10 has a first part 11, a second part 12, a third part 13, a fourth part 14 and a fifth part 15 in sequence from the front end side toward the base end side. The thickness, width and length of each part can be determined arbitrarily.

[0043] The first portion 11 is a portion of the first metal wire 10 located at the front end side. The first portion 11 is a portion of the first metal wire 10 with the smallest thickness. In the first portion 11, a coating containing titanium oxide is formed on the surface. The first portion 11 is subjected to a stamping process for improving the ease of being subjected to habitual bending (plasticity). The details will be described later. Hereinafter, the entire first portion 11 except for a portion on the base end side is referred to as the "front end portion 100 of the first metal wire 10". The front end portion 100 of the first metal wire 10 is sometimes simply referred to as the "front end portion 100".

[0044] The second portion 12 is a portion of the first metal wire 10 located between the first portion 11 and the third portion 13. The third portion 13 is a portion of the first metal wire 10 located between the second portion 12 and the fourth portion 14. The fourth portion 14 is a portion of the first metal wire 10 located between the third portion 13 and the fifth portion 15. The thickness of the second portion 12 becomes thinner toward the front end. The thickness of the third portion 13 becomes thinner toward the front end. The thickness of the fourth portion 14 becomes thinner toward the front end. The rate of change of the thickness of the second portion 12, the rate of change of the thickness of the third portion 13, and the rate of change of the thickness of the fourth portion 14 are different from each other. The fifth portion 15 is a portion of the first metal wire 10 located at the most proximal side. The fifth portion 15 has a substantially cylindrical shape and is the portion of the first metal wire 10 where the thickness is the largest.

[0045] In the present embodiment, "substantially constant" is synonymous with "approximately constant", and means that it is approximately constant while allowing for deviations due to manufacturing errors, etc. Similarly, "approximately cylindrical shape / approximately truncated cone shape" is synonymous with "approximately cylindrical shape / approximately truncated cone shape", and means that it is approximately the shape while allowing for deviations due to manufacturing errors, etc. In the present embodiment, "same" and "equal" are not limited to the case of strict consistency, and mean that differences due to manufacturing errors, etc. are allowed.

[0046] The second metal wire 20 is arranged on the base end side of the medical device 1. The second metal wire 20 is arranged closer to the base end side than the first metal wire 10. The second metal wire 20 is a substantially cylindrical member having a constant outer diameter. The outer diameter of the second metal wire 20 is the same as the outer diameter of the fifth portion 15 of the first metal wire 10. The second metal wire 20 is formed of a material having a larger Young's modulus in a linear deformation region than the first metal wire 10, for example, a stainless steel alloy such as SUS304 and SUS316.

[0047] The joint portion 30 is a portion formed by joining the first wire 10 and the second wire 20 by welding. The joint portion 30 may also be formed by the first wire 10 and the second wire 20 by a method different from welding, for example, the first wire 10 and the second wire 20 are fixed by a fixing member. The member to which the first wire 10 and the second wire 20 are joined is a core shaft. The joint portion 30 is formed between the base end surface of the fifth portion 15 of the first wire 10 and the front end surface of the second wire 20. In the example shown in the figure, the joint portion 30 is a plane that is substantially perpendicular to the axis O. The joint portion 30 may also be inclined relative to the axis O. The first wire 10 and the second wire 20 are fixed by the joint portion 30.

[0048] In the first wire 10, the distal ends of the first portion 11, the second portion 12, and the third portion 13 are covered by the coil 40. In the first wire 10, the proximal end of the third portion 13, the fourth portion 14, and the fifth portion 15 are not covered by the coil 40 and are exposed from the coil 40. The proximal end of the second wire 20 is used when the operator grasps the medical device 1.

[0049] The coil 40 is formed by a wire 41 wound into a spiral shape and has a roughly cylindrical shape. The coil 40 can be a single-strand coil formed by winding a wire into a single strand. The coil 40 can also be a multi-strand coil formed by winding a plurality of wires into multiple strands. The coil 40 can also be a single-strand twisted wire coil formed by winding a stranded wire with a plurality of wires twisted into a single strand. The coil 40 can also be a multi-strand twisted wire coil formed by using a plurality of twisted wires with a plurality of wires twisted and each twisted wire is wound into multiple strands. The wire diameter of the wire 41 of the coil 40, the outer diameter and inner diameter of the coil 40, and the length of the coil 40 can be determined arbitrarily.

[0050] The wire 41 can be formed, for example, from stainless steel alloys such as SUS304 and SUS316, nickel-titanium alloys, piano wire, radiopaque alloys such as nickel-chromium alloys and cobalt alloys, gold, platinum, tungsten, alloys of these elements (e.g., platinum-nickel alloys), and other radiopaque alloys, as well as known materials other than the above.

[0051] The front end tip 51 is provided at the front end of the medical device 1. The front end tip 51 integrally holds the front end of the first portion 11 of the first metal wire 10 and the front end of the coil 40. The base end side joint 52 faces the middle portion of the medical device 1. The base end side joint 52 integrally holds a part of the third portion 13 of the first metal wire 10 and the base end of the coil 40. The front end tip 51 is formed by any bonding agent, for example, by metal solder such as silver solder, gold solder, zinc, Sn-Ag alloy, Au-Sn alloy, etc. The base end side joint 52 is formed by any bonding agent, for example, by metal solder such as silver solder, gold solder, zinc, Sn-Ag alloy, Au-Sn alloy, etc. The front end tip 51 and the base end side joint 52 may use the same bonding agent or different bonding agents.

[0052] Below, use Figures 4 to 7 , the coating formed on the front end portion 100 of the first metal wire 10 and the detailed structure of the front end portion 100 are described. Figure 3 When a metal wire containing titanium (Ti) such as a nickel-titanium alloy or an alloy of nickel-titanium and other metals is heat-treated, titanium is oxidized to form a titanium oxide film on the surface of the metal wire. Hereinafter, the titanium oxide film is also referred to simply as a "film".

[0053] Figure 4 is a graph showing the relationship between the thickness of the coating and the color. The higher the heat treatment temperature, the thicker the coating formed on the metal wire. The lower the heat treatment temperature, the thinner the coating formed on the metal wire. The thickness of the coating is related to the heat treatment temperature. The thickness of the coating is related to the appearance color of the metal wire. Figure 4 As shown, when the coating is "green", the coating is the thickest; when the coating is "blue-green", the coating is the second thickest; when the coating is "purple", the coating is the third thickest; when the coating is "yellow", the coating is the fourth thickest; when the coating is "white", the coating is the fifth thickest; when the coating is "blue", the coating is the sixth thickest; when the coating is "purple", the coating is the seventh thickest; when the coating is "gold", the coating is the eighth thickest. When no heat treatment is performed and no coating is formed, the appearance color of the metal wire is either gray or silver.

[0054] In the present embodiment, "green" includes, in addition to green (Green), various colors of green series such as lime green and sky green (Sky green). "Blue-green" includes, in addition to peacock green, various colors of intermediate colors such as aquamarine and turquoise that are equivalent to green and blue. "Red-purple" includes, in addition to crimson (Claret), various colors of intermediate colors such as plum red (Plum) and magenta that are equivalent to red and purple. "Yellow" includes, in addition to yellow (Yellow), various colors of yellow series such as lemon yellow and tawny. "White" includes, in addition to white (White), various colors of white series such as silvery white and milky white. "Blue" includes, in addition to blue (Blue), various colors of blue series such as cyan (Cyan) and navy blue (Navy blue). "Purple" includes, in addition to purple (Purple), various colors of purple series such as violet and grape color. "Gold" includes, in addition to bronze, various colors of gold series such as light fawn and beige.

[0055] The color of the coating can be visually identified from the appearance of the heat-treated metal wire. Specifically, the operator uses a digital microscope "VHX-7000" (manufactured by Keyence Co., Ltd.) to take a photo of the appearance of the heat-treated metal wire. Then, the operator identifies the color of the coating by visually confirming the photographed appearance. That is, the color of the coating is the color under the light environment of the digital microscope VHX-7000. The confirmation location of the oxide coating (the location where the appearance photo is taken) is the side surface observed from the Y-axis direction (described later). Figure 7 (B) shown in the side). The first color group C1 includes green, cyan, magenta and yellow. At least one color selected from the first color group C1 is a specified color. The second color selected from the first color group is a second specified color. The third color selected from the first color group is a third specified color. The fourth color selected from the first color group is a fourth specified color. The third color group C3 includes purple and gold. At least one color selected from the third color group C3 is a predetermined color. The second color selected from the third color group C3 is a second predetermined color. The second color group C2 includes white and blue. The two colors selected from the second color group are a specific color and a second specific color. The thickness of the coating of the first color group C1 is relatively thick. The thickness of the coating of the third color group C3 is relatively thin. The thickness of the coating of the second color group C2 is thinner than the thickness of the coating of the first color group C1, and thicker than the thickness of the coating of the third color group C3.

[0056] That is, Figure 4As shown in the upper half of , the thickness of the coating in the first area is relatively thick. The thickness of the coating in the second area is relatively thin. The thickness of the coating in the transition area is thinner than the thickness of the coating in the first area, and thicker than the thickness of the coating in the second area. In other words, the thickness of the coating in the first area is thicker than the thickness of the coating in the transition area. The thickness of the coating in the first area is thicker than the thickness of the coating in the second area. The thickness of the coating in the transition area is thicker than the thickness of the coating in the second area. The operator can determine the "thickness of the coating" by the following steps. Specifically, the operator randomly determines three different locations in the length direction within the area as the object. The operator measures the thickness of the coating for each of the three determined locations. The operator calculates the average value of the coating thicknesses at the three measured locations. The operator sets the calculated average value as the thickness of the coating in the area.

[0057] Figure 5 FIG. 1 is a diagram showing an example of the tip portion 100 of the first metal wire 10 . Figure 5 (A) is a line graph showing the color of the coating of the tip portion 100 by hatched lines. Figure 5 (B) is a photograph of the front end portion 100. The line graph corresponds to the photograph. Figure 5 The line diagram and the photograph both show the width direction of the flat shape of the first metal wire 10. As shown in the figure, the front end portion 100 of the first metal wire 10 has portions 91a to 91l from the front end toward the base end. As the letters attached to the end progress according to a, b, and c, the position of the first metal wire 10 in the length direction moves toward the base end side. In the unheat-treated portion at the front end of the first metal wire 10, all or part of it can be cut and excluded when manufacturing the medical device 1 using the first metal wire 10. The unheat-treated portion at the front end of the first metal wire 10 can also be used directly without cutting when manufacturing the medical device 1 using the first metal wire 10. In the case of using the first metal wire 10 to make a guide wire, a front end tip can also be set on the unheat-treated portion.

[0058] As shown in the figure, part 91a is a silver color indicating unheat-treated. Part 91b has a blue coating. Part 91c has a white coating. Part 91d has a yellow coating. Part 91e has a magenta coating. Part 91f has a green coating. Part 91g has a cyan coating. Part 91h has a magenta coating. Part 91i has a white coating. Part 91j has a blue coating. Part 91k has a purple coating. Part 91l has a gold coating. Figure 5 In (A), for the sake of convenience, the boundary between a certain part and other parts adjacent to the certain part is clearly indicated. Figure 5 As shown in (B), the boundary between a certain part and other parts can also be a gradual transition of the color of the coating. Figure 5As shown in (B), the color of the coating of each portion 91b to 91l (including not only the color itself but also the tone and texture) and the color gradation at the boundary between each portion 91b to 91l are manifested by heat treatment of the metal wire.

[0059] The "first region A1" is a region located in the center of the tip 100 of the first metal wire 10. The first region A1 has a coating of a color included in the first color group C1 (specifically, at least one of green, cyan, magenta, and yellow).

[0060] The "front end transition region AT1" is a region at a different position from the first region A1 in the length direction. The front end transition region AT1 is located closer to the front end side of the first metal wire 10 than the first region A1. The front end transition region AT1 has a coating of a color included in the second color group C2 (specifically, at least one of white and blue). The front end transition region AT1 is adjacent to the front end of the first region A1. The "base end transition region AT2" is a region at a different position from the first region A1 in the length direction. The base end transition region AT2 is located closer to the base end side of the first metal wire 10 than the first region A1. The base end transition region AT2 has a coating of a color included in the second color group C2 (specifically, at least one of white and blue). The base end transition region AT2 is adjacent to the base end of the first region A1. The region having a coating of a color included in the second color group C2 is the transition region AT. The front end transition region AT1 is the transition region AT. The base end transition region AT2 is the transition region AT. The coating of the transition area AT (the front end transition area AT1 and the base end transition area AT2) presents a gradient including the colors (white and blue) included in the second color group C2. In the transition area AT, the white coating is located closer to the first area A1 than the blue coating. The front end transition area corresponds to the "front end specific area". The base end transition area corresponds to the "base end specific area".

[0061] The "second area A2" is an area at a different position from the first area A1 in the length direction. When viewed from the transition area AT (specifically, the base end side transition area AT2) of the first metal wire 10, the second area A2 is located on the opposite side of the first area A1. The second area A2 has a coating of a color included in the third color group C3 (specifically, at least one of purple and gold). The second area A2 is adjacent to the base end of the transition area AT. The second area A2 is adjacent to the base end of the base end side transition area AT2. The second area A2 is located at a position closer to the base end side of the first metal wire 10 than the first area A1. The second area A2 is arranged at a position away from the first area A1 in the length direction of the first metal wire 10.

[0062] Fig.21It is a line graph showing the thickness of the coating of the distal end portion 100 . Fig.21 and Figure 5 The line graph of (A) corresponds to . Fig.21 1 shows the width direction of the flat shape of the first metal wire 10. Fig.21 In the figure, for the sake of explanation, the first metal wire 10 is indicated by a dotted line, and the thickness of the coating is emphasized, and the coating formed on the first metal wire 10 is indicated by a solid line. Fig.21 It can be seen that the thickness CT of the coating in the first area A1 is relatively thick. The thickness of the coating in the second area A2 is relatively thin. The thickness of the coating in the transition area AT1 and the transition area AT2 is thinner than the thickness of the coating in the first area A1, and thicker than the thickness of the coating in the second area A2. In other words, the thickness CT of the coating in the first area A1 is thicker than the thickness of the coating in the transition area AT1 and the transition area AT2. The thickness CT of the coating in the first area A1 is thicker than the thickness of the coating in the second area A2. The thickness of the coating in the transition area AT1 and the transition area AT2 is thicker than the thickness of the coating in the second area A2. As shown in the figure, the first area A1 includes a plurality of portions 91d to 91h with different coating thicknesses. Similarly, the transition area AT1 and the transition area AT2 include a plurality of portions 91b, 91c, 91i, and 91j with different coating thicknesses. The second area A2 includes a plurality of portions 91k and 91l with different coating thicknesses. The above-mentioned relationship in thickness of the coating also holds true, for example, between the thinnest coating portion 91d of the first region A1 and the thickest coating portions 91c and 91i of the transition region AT1 and the transition region AT2. This is also true when comparing the transition region AT1 and the transition region AT2 with the second region A2. The above-mentioned relationship in thickness of the coating also holds true, for example, between the thinnest coating portions 91b and 91j of the transition region AT1 and the transition region AT2 and the thickest coating portion 91k of the second region A2.

[0063] like Figure 2 As shown, with respect to the first area A1, the shaping angle θ during the shaping test is 60°. With respect to the transition area AT, the shaping angle θ during the shaping test is greater than 18° and less than 60°. With respect to the second area A2, the shaping angle θ during the shaping test is 18°. With respect to the unheat-treated portion, the shaping angle θ during the shaping test is 9°. The shaping angle θ during the shaping test of the first area A1 is larger than that of the transition area AT. The shaping angle θ during the shaping test of the first area A1 is larger than that of the second area A2.

[0064] Figure 6 1 is a diagram showing an example of the surface structure of the tip portion 100 of the first metal wire 10 . Figure 6The following is an image obtained by observing the first region A1 of the first metal wire 10 using a TEM (transmission electron microscope) “JEM-2100F” (manufactured by JEOL Ltd.). Figure 6 (A) is a line graph of the first area A1 obtained by TEM. Figure 6 (B) is a photograph of the first area A1 obtained by TEM. Figure 6 (A) and Figure 6 (B) shows the same image.

[0065] like Figure 6 As shown in (A) and (B), on the surface of the heat-treated first metal wire 10, as the titanium oxide film is formed, surface segregation occurs to form layers. The outermost layer is the titanium oxide film CO1. The thickness T1 of the film CO1 of the first area A1 of the first metal wire 10 is greater than 100 nm. The method for obtaining the thickness T1 of the film CO1 is described. The operator selects the color (in the thinnest color) of the first area A1 of the first metal wire 10 to indicate the thickness of the film. Figure 5 The portion (yellow in the case of the first metal wire 10 shown) is observed with a TEM, and the thickness T1 of the coating CO1 is obtained by measuring the thickness of the portion where the coating is relatively thin in the image obtained by the TEM.

[0066] In the first metal wire 10, the thickness T1 of the coating CO1 in the first region A1 is thicker than the thickness of the coating in the transition region AT. A method of obtaining the coating thickness in the transition region AT is described below. The operator selects the color indicating the thickest coating thickness (in Figure 5 The portion (white in the case of the first metal wire 10 shown) is observed using a TEM, and the thickness of the coating in the transition region AT is obtained by measuring the thickness of a relatively thick portion of the coating in the image obtained by the TEM.

[0067] In the first metal wire 10, the thickness of the coating in the second region A2 is not less than 10 nm and not more than 30 nm. For the lower limit of the coating thickness in the second region A2, the operator selects the color indicating the thinnest coating thickness (in Figure 5 The portion (gold in the case of the first metal wire 10 shown) is observed with a TEM, and the thickness of the portion where the coating is relatively thin is measured in the image obtained by the TEM. For the upper limit value of the coating thickness of the second area A2, the operator selects the color indicating the thickest coating thickness (in the Figure 5 In the case of the first metal wire 10 shown, a portion (purple) was observed using a TEM, and the thickness of a portion where the coating was relatively thick was measured in an image obtained by the TEM.

[0068] exist Figure 6In the cross-sectional views of the first metal wire 10 shown in (A) and (B), any position in the outermost layer (titanium oxide film CO1) is set as the first position P1. Any position in the second layer from the outside is set as the second position P2. At this time, the titanium content at the first position P1 is greater than the titanium content at the second position P2 (titanium: first position P1> second position P2). The nickel (Ni) content at the second position P2 is greater than the nickel content at the first position P1 (nickel: first position P1<second position P2). The titanium content refers to the mass content. The nickel content refers to the mass content.

[0069] The above-mentioned deviation of titanium and nickel is caused by the surface segregation of titanium on the surface of the first metal wire 10 accompanying the heat treatment. Figure 6 In (A) and (B), the contents of titanium and nickel in the first position P1 and the second position P2 are described for the first region A1 of the first metal wire 10. In the transition region AT and the second region A2 of the first metal wire 10, the titanium content in the first position P1> the second position P2 and the nickel content in the first position P1< the second position P2 are the same as in the first region A1.

[0070] Figure 7 It is an enlarged view of the front end portion 100 of the first metal wire 10 . Figure 7 (A) shows a side view of the front end portion 100 as seen from the Z-axis direction. Figure 7 (B) shows a side view of the front end portion 100 as viewed from the Y-axis direction. Figure 7 , the illustration of the coil 40 is omitted. The first part 11 is a flat shape having a first stamping part 111, a transition part 112, and a second stamping part 113. The first stamping part 111 is a portion that has been stamped at a first cross-sectional reduction rate. The first stamping part 111 has a relatively wide flat shape. The second stamping part 113 is a portion that has been stamped at a second cross-sectional reduction rate, and the second cross-sectional reduction rate is smaller than the first cross-sectional reduction rate. The second stamping part 113 is closer to a cylinder than the first stamping part 111. The second stamping part 113 has an elliptical cylindrical shape. The transition part 112 is a portion between the first stamping part 111 and the second stamping part 113, where the cross-sectional reduction rate and the outer shape gradually change.

[0071] The thickness T111 of the first stamping portion 111 is thinner than the thickness T113 of the second stamping portion 113. The thickness T1121 of the transition portion 112 at the front end of the transition portion 112 is equal to the thickness T111 of the first stamping portion 111. The thickness T1122 of the transition portion 112 at the base end of the transition portion 112 is equal to the thickness T113 of the second stamping portion 113. The thickness T112 of the transition portion 112 gradually becomes thicker from its front end to the base end. The thickness of the stamping portion refers to the following distance, that is, in the front end portion 100 of the first metal wire 10, when the surface with a larger area is set as the main surface and the surface orthogonal to the main surface is set as the side surface, the vertical distance from one main surface to another main surface.

[0072] A coating based on heat treatment is formed on the first stamping part 111, the transition part 112 and the entire part except the base end of the second stamping part 113. In the example shown in the figure, the front end side of the front end of the first stamping part 111 is an unheat-treated part. A front end side transition area AT1 is formed on the base end side of the front end of the first stamping part 111. A first area A1 is formed between the central part of the first stamping part 111 and the base end. A base end side transition area AT2 is formed between the front end and the base end of the transition part 112. A second area A2 is formed on the entire part of the second stamping part 113 except the base end. The thickness of the first metal wire 10 in the first area A1 is thinner than the thickness of the first metal wire 10 in the second area A2. The thickness of the first metal wire 10 in the base end side transition area AT2 gradually becomes thicker from its front end to the base end. The thickness of the first metal wire 10 in the first area A1 is thinner than the thickness of the first metal wire 10 in the base end side transition area AT2. The thickness of the first metal wire 10 in the base end side transition area AT2 is thinner than the thickness of the first metal wire 10 in the second area A2. The corresponding relationship among the first area A1, transition area AT, second area A2, first punching part 111, transition part 112 and second punching part 113 is only an example and can be changed arbitrarily.

[0073] Generally speaking, in a guidewire, in order to reduce the front end load, the outer diameter of the core wire is sometimes tapered to a cone toward the front end, or in order to improve the permeability, the outer diameter of the coil body is sometimes tapered to a cone toward the front end. In this case, since the bending strain amount will decrease due to the reduction of the metal thickness, the shaping angle will become smaller toward the front end of the guidewire. Even if the outer diameter of the core wire or the coil body is set to be the same, the shaping angle is only the same from the front end to the base end of the guidewire. Therefore, in the existing guidewires, most of them are the following shaping shapes: a shaping shape that makes the shaping angle smaller toward the front end, and a shaping shape that makes the shaping angle the same. In the case of using the first metal wire 10 of the present embodiment to make a guidewire, unlike in the past, even if the thickness of the core wire is reduced toward the front end, the shaping angle of the guidewire can be increased toward the front end. Therefore, in the guidewire using the first metal wire 10 of the present embodiment, the selectivity of small branch blood vessels such as peripheral blood vessels can be improved.

[0074] At the front end portion 100 of the first metal wire 10, the coating (the first region A1, the transition region AT, and the second region A2) is formed in the thickness direction of the flat shape of the first metal wire 10. In other words, the coating is formed on the surfaces 111a, 112a, and 113a in the thickness direction of the first metal wire 10. At the front end portion 100 of the first metal wire 10, the coating (the first region A1, the transition region AT, and the second region A2) is formed in the width direction of the flat shape of the first metal wire 10. In other words, the coating is formed on the surfaces 111b, 112b, and 113b in the width direction of the first metal wire 10.

[0075] The front end tip 51 (dashed line) is attached to the front end side of the front end portion 100 of the first metal wire 10 more toward the front end than the first area A1. Specifically, the front end tip 51 is attached to the front end transition area AT1 provided more toward the front end than the first area A1. In the example shown in the figure, the base end of the front end tip 51 is located slightly more toward the front end than the base end of the front end transition area AT1. The base end of the front end tip 51 may also be located at any position within the range of the front end transition area AT1.

[0076] Figure 8 is a flow chart showing a method for manufacturing the medical device 1. In step S10, the operator prepares a metal wire made of a nickel-titanium alloy. The metal wire may also be made of an alloy of nickel-titanium and other metals. In step S12, the operator performs a stamping process on the front end of the metal wire. In step S12, as shown in FIG. Figure 7 As described in (A) and (B) of FIG. 1 , the punching process is performed multiple times to form the first punched portion 111, the transition portion 112, and the second punched portion 113. In step S12, the punching process may be performed only once.

[0077] In process S14, the operator performs heat treatment on the first region A1 at the first temperature. The heat treatment is carried out by "laser heat treatment", which is a process of heating the wire by irradiating it with high-power laser. The first temperature can be determined arbitrarily. The heat treatment can also be carried out by other heat treatment methods (for example, heat treatment using a heating furnace). The result of process S14 is the formation of a coating film in the first region A1 and the transition regions AT (front-end side transition region AT1, base-end side transition region AT2). That is, the coating film in the transition regions AT (front-end side transition region AT1, base-end side transition region AT2) is formed by the heat conducted on the wire from the heat generated by the laser irradiated on the first region A1. The heat treatment degree of the first region A1 is stronger than that of the transition regions AT. The degree of ease of applying a habitual bend to the first region A1 is stronger than that of the transition regions AT. Process S14 is a process of forming a coating film in the first region A1 and the transition regions AT. The color of the coating film in the first region A1 is a color included in the first color group C1. The color of the coating film in the transition regions AT is a color included in the second color group C2. The color of the coating film in the first region A1 and the color of the coating film in the transition regions AT are manifested by the first heat treatment.

[0078] In process S18, the operator performs heat treatment on the second region A2 at the second temperature. The second region A2 is located closer to the base-end side than the first region A1. The second region A2 is located closer to the base-end side than the base-end side transition region AT2. The heat treatment at the second temperature is carried out by laser heat treatment. The heat treatment at the second temperature can also be carried out by other heat treatment methods (for example, heat treatment using a heating furnace). The second temperature is lower than the first temperature (first temperature > second temperature). The first temperature and the second temperature can be measured by using a radiation thermometer to measure the temperature of the wire during heat treatment. The result of process S18 is the formation of a coating film in the second region A2. As a result of performing heat treatment at the second temperature lower than the first temperature, the heat treatment degree of the second region A2 is weaker than that of the first region A1. Furthermore, the degree of ease of applying a habitual bend to the second region A2 is weaker than that of the first region A1. Process S18 is a process of forming a coating film in the second region A2. The color of the coating film in the second region A2 is a color included in the third color group C3. The color of the coating film in the second region A2 is manifested by the second heat treatment.

[0079] In processes S14 and S18, in either case where the output of the laser is set to be the same (output: S14 = S18) for heat treatment and where the magnitude relationship is set to be the opposite (output: S14 < S18) for heat treatment, the relationship of the first temperature > the second temperature also holds. This is because, for the wire after stamping Figure 7As a result of irradiating the XZ plane shown in (B) with laser light, the irradiation area in step S14 (the area of ​​the first punching portion 111 and the transition portion 112) is larger than the irradiation area in step S18 (the area of ​​the second punching portion 113). In this embodiment, the irradiation diameter of the laser light is larger than Figure 7 (B) The width of the first punching portion 111.

[0080] In step S22, the operator inspects the color of the coating in the first area A1, the transition area AT, and the second area A2. Specifically, the color of the coating is inspected according to the following steps a1 and a2. Steps a1 and a2 do not need to be performed consecutively. Specifically, step a1 can also be performed before step S14. Step S22 is a step for inspecting the color of the coating in the first area A1, the transition area AT, and the second area A2.

[0081] (a1) The color of the coating in the first area A1 is different from the color included in the first color group C1 ( Figure 4 ) and the color of the coating in the transition area AT is the same as the color included in the second color group C2 ( Figure 4 ), the operator determines that the heat treatment of step S14 has been completed normally. In any case where the color of the coating in the first area A1 does not correspond to any of the colors included in the first color group C1, and the color of the coating in the transition area AT does not correspond to any of the colors included in the second color group C2, the operator determines that the heat treatment of step S14 has not been completed normally.

[0082] (a2) The color of the coating in the second area A2 and the color included in the third color group C3 ( Figure 4 ), the operator determines that the heat treatment in step S18 has been completed normally. If the color of the coating in the second area A2 does not correspond to any of the colors included in the third color group C3, the operator determines that the heat treatment in step S18 has not been completed normally.

[0083] Through the above steps S10 to S22, the Figure 3The first metal wire 10 described in the above. Steps S10 to S22 are a method for manufacturing the metal wire 10 for medical devices. The metal wire 10 for medical devices manufactured through the steps S10 to S22 has a coating of a color included in the first color group C1 that is developed by heat treatment of the metal wire, a coating of a color included in the second color group C2 that is developed by heat treatment of the metal wire, and a coating of a color included in the third color group C3 that is developed by heat treatment of the metal wire. With respect to the metal wire 10 for medical devices manufactured through the steps S10 to S22, by inspecting each color of the coating (the color included in the first color group C1, the color included in the second color group C2, and the color included in the third color group C3), it is confirmed that the heat treatment has been completed normally. According to step S22, when manufacturing a plurality of first metal wires 10, even when using a plurality of metal wires having variations in size or surface state, the amount of heat applied to each metal wire (the degree of heat treatment) can be accurately and easily grasped, so that the first metal wire 10 with stable quality can be obtained.

[0084] In step S24, the operator prepares the coil 40. In step S26, the operator joins the front end portion 100 (specifically, the front end transition region AT1) of the first metal wire 10 to the front end of the coil 40 by any bonding agent, for example, by metal solder such as silver solder, gold solder, zinc, Sn-Ag alloy, Au-Sn alloy, etc., thereby forming a front end tip 51. Since the titanium oxide film has a property of low solder wettability, when the front end tip 51 is formed in the portion (first region A1) where the titanium oxide film is formed thicker, the front end tip 51 may be separated from the first metal wire 10 during use. Therefore, in step S26, it is preferable to form the front end tip 51 closer to the front end side than the portion (first region A1) where the titanium oxide film is formed thicker of the first metal wire 10. The portion (non-heat-treated portion) of the first metal wire 10 where the titanium oxide film is not formed has a property that it is difficult to add a habitual bend due to the superelastic property of the first metal wire 10. The portion of the first metal wire 10 where the titanium oxide film is formed relatively thin (the front end side transition area AT1) has the property of being more difficult to be subjected to habitual bending than the portion where the titanium oxide film is formed thicker (the first area A1). Therefore, in the case where the front end tip 51 is formed in the portion where the titanium oxide film is not formed (the non-heat-treated portion), since the front end side transition area AT1 adjacent to the front end tip 51 is less likely to be subjected to habitual bending than the first area A1, the ease of use during use may be reduced. Therefore, in step S26, it is more preferable to form the front end tip 51 in the portion where the titanium oxide film is formed relatively thin (the front end side transition area AT1), and the front end tip 51 is adjacent to the first area A1. In step S26, the front end tip 51 may also be formed on the basis of removing the coating of the front end side transition area AT1. Finally, the operator joins the first metal wire 10 and the second metal wire 20 to form the joint 30.

[0085] According to the metal wire 10 for medical devices and the medical device 1 having the metal wire 10 for medical devices, there are a first region A1, a transition region AT2 on the base end side, and a second region A2, which change the degree of heat treatment, that is, the degree of ease of adding habitual bending from the front end side to the base end side. As described above, the degree of heat treatment (the degree of ease of adding habitual bending) is in the relationship of first region A1>transition region AT>second region A2, and becomes stronger toward the front end side. Therefore, it is possible to provide a medical device 1 that can give a plastic shape with a curvature that increases toward the front end side. As a result, it is easy for the operator to select a desired blood vessel at the branching site of the blood vessel during surgery using the medical device 1.

[0086] As described above, according to the first embodiment, the metal wire for medical devices 10 includes the first region A1 and the transition region AT ( Figure 5). Therefore, it is possible to provide a metal wire 10 for medical devices that changes the degree of heat treatment, that is, the degree of easiness of adding habitual bending, and achieves a gradual change in physical properties. Since the color of the coating in the first area A1 is different from the color of the coating in the transition area AT, the easiness of adding habitual bending to the metal wire 10 for medical devices can be identified by the appearance (color) of the first metal wire 10.

[0087] According to the metal wire for medical devices 10 of the first embodiment, the coating of the transition region AT has a gradation including two colors of the colors included in the second color group C2 ( Figure 5 ). Therefore, even in the transition area AT of the first metal wire 10, the degree of heat treatment can be changed, that is, the degree of ease of being added with habitual bending can be changed, and the physical properties can be gradually changed. The degree of gradual change of the physical properties in the transition area AT can be identified by the appearance of the first metal wire 10 (gradual change from white to blue).

[0088] Furthermore, according to the first embodiment, the metal wire for medical device 10 includes a second region A2 ( Figure 5 ). Therefore, it is possible to provide a metal wire 10 for medical devices that can achieve a more subtle gradual change in physical properties by further changing the degree of heat treatment, that is, the ease of adding habitual bending. Since the color of the coating of the second area A2 is different from that of the first area A1 and the transition area AT, the ease of adding habit to the metal wire 10 for medical devices can be identified by the appearance (color) of the first metal wire 10.

[0089] In addition, according to the first embodiment, the content of titanium in the first position P1 located relatively outside the second position P2 (in other words, near the surface of the medical wire 10) is high, so it is possible to improve the biocompatibility and corrosion resistance of the medical wire 10. In addition, according to the first embodiment, the content of nickel in the first position P1 located relatively outside the second position P2 (in other words, near the surface of the medical wire 10) is low, so it is possible to improve biocompatibility.

[0090] Furthermore, according to the first embodiment, the thickness of the coating in the first region A1 is 100 nm or more, so the ease of adding habitual bending (shaping performance) of the medical device metal wire 10 can be further improved. In addition, according to the first embodiment, the thickness of the coating in the first region A1 is thicker than the thickness of the coating in the transition region AT, so the first region A1 is easier to add habitual bending than the transition region AT. Furthermore, according to the first embodiment, the thickness of the coating in the second region A2 is 10 nm or more and 30 nm or less, so it is possible to provide a medical device metal wire 10 that makes the degree of ease of adding habitual bending in the second region A2 smaller than that in the first region A1 to achieve a more delicate gradual change in physical properties.

[0091] In addition, according to the medical device 1 of the first embodiment, since the front end tip 51 is attached to the front end side of the first region A1 of the medical device wire 10, the brazing work for forming the front end tip 51 becomes easy, and the medical device wire 10 is difficult to be separated from the front end tip 51. As a result, the medical device 1 can be manufactured more easily, and the safety of the medical device 1 can be improved.

[0092] Furthermore, according to the medical device 1 of the first embodiment, since the front end tip 51 is installed in the front end side transition area AT1, the brazing work for forming the front end tip 51 becomes easy, and the medical device wire 10 is difficult to be separated from the front end tip 51. In addition, since the front end tip 51 is installed in the front end side transition area AT1 provided closer to the front end side than the first area A1, the ease of being added with habitual bending (shaping performance) of the medical device 1 can be improved.

[0093] In addition, according to the manufacturing method of the metal wire 10 for medical devices of the first embodiment, the first region A1 and the transition region AT having different coating colors are formed by heat treating the metal wire (step S14). Therefore, the metal wire 10 for medical devices having gradually changed physical properties can be manufactured by a single heat treatment.

[0094] Furthermore, according to the manufacturing method of the metal wire 10 for medical devices of the first embodiment, the second region A2 is formed by performing heat treatment (step S18) on the metal wire closer to the base end than the first region A1. Therefore, by performing the two heat treatments of step S14 and step S18, the metal wire 10 for medical devices that further realizes a gradual change in physical properties can be manufactured. Since the temperature (second temperature) of the heat treatment for forming the second region A2 is lower than the temperature (first temperature) of the heat treatment for forming the first region A1 and the transition region AT, the thickness of the coating of the first region A1 and the thickness of the coating of the second region A2 can be easily changed.

[0095] In addition, according to the method for manufacturing the metal wire 10 for medical devices of the first embodiment, since the color of the coating of the first region A1 and the color of the coating of the transition region AT are different from each other, by checking the appearance of the metal wire (specifically, the color of the coating of the first region A1 and the color of the coating of the transition region AT), it is possible to easily determine whether the heat treatment of step S14 has been completed normally (step S22). As a result, the metal wire 10 for medical devices with stable quality can be manufactured. By checking the appearance of the first metal wire 10 (specifically, the color of the coating of the second region A2), it is possible to easily determine whether the heat treatment of step S18 for forming the second region A2 has been completed normally (step S22). As a result, the metal wire 10 for medical devices with stable quality can be manufactured.

[0096] <Second embodiment>

[0097] Fig. 9 1 is a diagram showing an example of the front end portion 100A of the first metal wire 10A of the second embodiment. The medical device 1 may also include the first metal wire 10A described below instead of the first metal wire 10 described in the first embodiment. The color of the coating in the first area A1, transition area AT, and second area A2 of the front end portion 100A of the first metal wire 10A is different from that in the first embodiment. Fig. 9 (A) is a line graph showing the color of the coating of the tip portion 100A by hatched lines. Fig. 9 (B) is a photograph of the front end portion 100A. The line graph corresponds to the photograph. Fig. 9 Both the line graph and the photograph show the width direction of the flat shape of the first metal wire 10A.

[0098] As shown in the figure, part 92a is a silver color indicating unheated treatment. Part 92b has a blue coating. Part 92c has a white coating. Part 92d has a yellow coating. Part 92e has a magenta coating. Part 92f has a green coating. Part 92g has a magenta coating. Part 92h has a yellow coating. Part 92i has a white coating. Part 92j has a blue coating. Part 92k has a purple coating. For example, Fig. 9 As shown in (B), part 92g may be light purple. Part 92k may be purple with a golden hue toward the base end. Fig. 9 As shown in (B), in the first area A1, films of the same color (yellow and magenta in the example shown in the figure) may appear repeatedly.

[0099] The central portion of the front end portion 100A of the first metal wire 10A is the first region A1, and the first region A1 has a coating of the colors included in the first color group C1 (specifically, green, magenta, and yellow). Closer to the front end side than the first region A1 is the front end side transition region AT1, and the front end side transition region AT1 has a coating of the colors included in the second color group C2 (specifically, white and blue). Closer to the base end side than the first region A1 is the base end side transition region AT2, and the base end side transition region AT2 has a coating of the colors included in the second color group C2 (specifically, white and blue). When viewed from the transition region AT (specifically, the base end side transition region AT2), the side opposite to the first region A1 is the second region A2, and the second region A2 has a coating of the color included in the third color group C3 (specifically, purple).

[0100] In this way, the colors of the coatings in the first area A1, transition area AT, and second area A2 of the tip 100A of the first metal wire 10A, the order of appearance of the colors, and the combination of colors when there are multiple colors can be changed in various ways. Figure 4 In the transition area AT, as long as a coating of at least one color among the colors included in the first color group C1 described in the above is formed, Figure 4 In the second area A2, as long as at least one of the colors included in the second color group C2 described in the above is formed, Figure 4 The lengths of the first area A1, the transition area AT, and the second area A2 in the longitudinal direction and the lengths of each part can also be determined arbitrarily. In such a second embodiment of the metal wire for medical devices 10A, the same effects as those of the first embodiment can also be achieved.

[0101] <Third Embodiment>

[0102] Fig.10 1 is a diagram showing an example of the front end portion 100B of the first metal wire 10B of the third embodiment. The medical device 1 may also include the first metal wire 10B described below instead of the first metal wire 10 described in the first embodiment. The color of the coating in the first area A1, transition area AT, and second area A2 of the front end portion 100B of the first metal wire 10B is different from that in the first embodiment. Fig.10 (A) is a line graph showing the color of the coating of the tip portion 100B by hatched lines. Fig.10 (B) is a photograph of the front end portion 100B. The line graph corresponds to the photograph. Fig.10 Both the line graph and the photograph show the width direction of the flat shape of the first metal wire 10B.

[0103] As shown in the figure, part 93a is silver, which indicates that the heat treatment has not been carried out. Part 93b has a blue coating. Part 93c has a white coating. Part 93d has a yellow coating. Part 93e has a magenta coating. Part 93f has a yellow coating. Part 93g has a white coating. Part 93h has a blue coating. Part 93i has a purple coating. Part 93j has a gold coating. For example, Fig.10 As shown in (B), portion 93f may also be a reddish and uneven yellow.

[0104] The central portion of the front end portion 100B of the first metal wire 10B is the first region A1, and the first region A1 has a coating of the colors included in the first color group C1 (specifically, magenta and yellow). The front end side transition region AT1 is closer to the front end side than the first region A1, and the front end side transition region AT1 has a coating of the colors included in the second color group C2 (specifically, white and blue). The base end side transition region AT2 is closer to the base end side than the first region A1, and the base end side transition region AT2 has a coating of the colors included in the second color group C2 (specifically, white and blue). When viewed from the transition region AT (specifically, the base end side transition region AT2), the side opposite to the first region A1 is the second region A2, and the second region A2 has a coating of the color included in the third color group C3 (specifically, purple).

[0105] In this way, various changes can be made to the color of the coating in the first area A1, transition area AT, and second area A2 of the front end portion 100B of the first metal wire 10B, the order of appearance of the colors, and the combination of colors when there are multiple colors. The lengths in the longitudinal direction of the first area A1, transition area AT, and second area A2 and the lengths of each part can also be arbitrarily determined. In such a third embodiment of the metal wire for medical devices 10B, the same effects as those of the first embodiment can be achieved.

[0106] <Fourth embodiment>

[0107] Fig.11 1 is a diagram showing an example of the front end portion 100C of the first metal wire 10C of the fourth embodiment. The medical device 1 may also include the first metal wire 10C described below instead of the first metal wire 10 described in the first embodiment. The color of the coating in the first area A1, transition area AT, and second area A2 of the front end portion 100C of the first metal wire 10C is different from that in the first embodiment. Fig.11 (A) is a line graph showing the color of the coating of the tip portion 100C by hatched lines. Fig.11 (B) is a photograph of the front end portion 100C. The line graph corresponds to the photograph. Fig.11 Both the line graph and the photograph show the width direction of the flat shape of the first metal wire 10C.

[0108] As shown in the figure, part 94a is a silver color indicating unheated treatment. Part 94b has a blue coating. Part 94c has a white coating. Part 94d has a yellow coating. Part 94e has a magenta coating. Part 94f has a yellow coating. Part 94g has a white coating. Part 94h has a blue coating. Part 94i has a purple coating. Part 94j has a gold coating. For example, Fig.11 As shown in (B), part 94d and part 94f may also be light yellow.

[0109] The central portion of the front end portion 100C of the first metal wire 10C is the first region A1, and the first region A1 has a coating of the colors included in the first color group C1 (specifically, magenta and yellow). The front end side transition region AT1 is closer to the front end side than the first region A1, and the front end side transition region AT1 has a coating of the colors included in the second color group C2 (specifically, white and blue). The base end side transition region AT2 is closer to the base end side than the first region A1, and the base end side transition region AT2 has a coating of the colors included in the second color group C2 (specifically, white and blue). When viewed from the transition region AT (specifically, the base end side transition region AT2), the side opposite to the first region A1 is the second region A2, and the second region A2 has a coating of the colors included in the third color group C3 (specifically, purple and gold).

[0110] In this way, various changes can be made to the color of the coating in the first area A1, transition area AT, and second area A2 of the front end portion 100C of the first metal wire 10C, the order of appearance of the colors, and the combination of colors when there are multiple colors. The lengths in the longitudinal direction of the first area A1, transition area AT, and second area A2 and the lengths of each part can also be arbitrarily determined. In such a fourth embodiment of the metal wire for medical devices 10C, the same effects as those of the first embodiment can be achieved.

[0111] <Fifth embodiment>

[0112] Fig.12 1 is a diagram showing an example of a front end portion 100D of a first metal wire 10D according to a fifth embodiment. The medical device 1 may also include a first metal wire 10D described below instead of the first metal wire 10 described in the first embodiment. The color of the coating in the first region A1, transition region AT, and second region A2 of the front end portion 100D of the first metal wire 10D is different from that in the first embodiment. Fig.12 (A) is a line graph showing the color of the coating of the tip portion 100D by hatched lines. Fig.12 (B) is a photograph of the front end portion 100D. The line graph corresponds to the photograph. Fig.12Both the line graph and the photograph show the width direction of the flat shape of the first metal wire 10D.

[0113] As shown in the figure, part 95a is a silver color indicating unheated treatment. Part 95b has a blue coating. Part 95c has a white coating. Part 95d has a yellow coating. Part 95e has a magenta coating. Part 95f has a green coating. Part 95g has a magenta coating. Part 95h has a yellow coating. Part 95i has a white coating. Part 95j has a blue coating. Part 95k has a purple coating. Part 95l has a gold coating. For example, Fig.12 As shown in (B), the portion 95d and the portion 95i may be yellowish white, and the portion 95f may be light green.

[0114] The central portion of the front end portion 100D of the first metal wire 10D is the first region A1, and the first region A1 has a coating of the colors included in the first color group C1 (specifically, green, magenta, and yellow). The front end side transition region AT1 is closer to the front end side than the first region A1, and the front end side transition region AT1 has a coating of the colors included in the second color group C2 (specifically, white and blue). The base end side transition region AT2 is closer to the base end side than the first region A1, and the base end side transition region AT2 has a coating of the colors included in the second color group C2 (specifically, white and blue). When viewed from the transition region AT (specifically, the base end side transition region AT2), the side opposite to the first region A1 is the second region A2, and the second region A2 has a coating of the colors included in the third color group C3 (specifically, purple and gold).

[0115] In this way, various changes can be made to the color of the coating in the first area A1, transition area AT, and second area A2 of the front end portion 100D of the first metal wire 10D, the order of appearance of the colors, and the combination of colors when there are multiple colors. The lengths in the longitudinal direction of the first area A1, transition area AT, and second area A2 and the lengths of each part can also be arbitrarily determined. In such a fifth embodiment of the metal wire for medical devices 10D, the same effects as those of the first embodiment can be achieved.

[0116] <Sixth embodiment>

[0117] Fig.13 1 is a diagram showing an example of the front end portion 100E of the first metal wire 10E of the sixth embodiment. The medical device 1 may also include the first metal wire 10E described below instead of the first metal wire 10 described in the first embodiment. The color of the coating in the first area A1, transition area AT, and second area A2 of the front end portion 100E of the first metal wire 10E is different from that in the first embodiment. Fig.13(A) is a line graph showing the color of the coating of the front end portion 100E by hatched lines. Fig.13 (B) is a photograph of the front end portion 100E. The line graph corresponds to the photograph. Fig.13 Both the line graph and the photograph show the width direction of the flat shape of the first metal wire 10E.

[0118] As shown in the figure, part 96a is silver, which indicates that the heat treatment has not been carried out. Part 96b has a blue coating. Part 96c has a white coating. Part 96d has a yellow coating. Part 96e has a white coating. Part 96f has a blue coating. Part 96g has a purple coating. Part 96h has a gold coating. For example, Fig.13 As shown in (B), part 96d may also be yellow with brown. Part 96e may also be dark white.

[0119] The central portion of the front end portion 100E of the first metal wire 10E is the first region A1, and the first region A1 has a coating of a color included in the first color group C1 (specifically, yellow). The front end side transition region AT1 is closer to the front end side than the first region A1, and the front end side transition region AT1 has a coating of a color included in the second color group C2 (specifically, white and blue). The base end side transition region AT2 is closer to the base end side than the first region A1, and the base end side transition region AT2 has a coating of a color included in the second color group C2 (specifically, white and blue). When viewed from the transition region AT (specifically, the base end side transition region AT2), the side opposite to the first region A1 is the second region A2, and the second region A2 has a coating of a color included in the third color group C3 (specifically, purple and gold).

[0120] In this way, various changes can be made to the color of the coating in the first area A1, transition area AT, and second area A2 of the front end portion 100E of the first metal wire 10E, the order of appearance of the colors, and the combination of colors when there are multiple colors. The lengths in the longitudinal direction of the first area A1, transition area AT, and second area A2 and the lengths of each part can also be arbitrarily determined. In such a sixth embodiment of the metal wire for medical devices 10E, the same effects as those of the first embodiment can be achieved.

[0121] <Seventh embodiment>

[0122] Fig.14 1 is a diagram showing an example of the front end portion 100F of the first metal wire 10F of the seventh embodiment. The medical device 1 may also include the first metal wire 10F described below instead of the first metal wire 10 described in the first embodiment. The color of the coating in the first area A1, transition area AT, and second area A2 of the front end portion 100F of the first metal wire 10F is different from that in the first embodiment. Fig.14 (A) is a line graph showing the color of the coating of the front end portion 100F by hatched lines. Fig.14 (B) is a photograph of the front end portion 100F. The line graph corresponds to the photograph. Fig.14 Both the line graph and the photograph show the width direction of the flat shape of the first metal wire 10F.

[0123] As shown in the figure, part 97a is a silver color indicating unheat-treated. Part 97b has a blue coating. Part 97c has a white coating. Part 97d has a yellow coating. Part 97e has a magenta coating. Part 97f has a cyan coating. Part 97g has a magenta coating. Part 97h has a green coating. Part 97i has a magenta coating. Part 97j has a yellow coating. Part 97k has a white coating. Part 97l has a blue coating. Part 97m has a purple coating. Part 97n has a gold coating. For example, Fig.14 As shown in (B), the red-purple color of part 97e and part 97g and the blue-green color of part 97f can also be mixed and interwoven into a mottled appearance.

[0124] The central portion of the front end portion 100F of the first metal wire 10F is the first region A1, and the first region A1 has a coating of the colors included in the first color group C1 (specifically, green, cyan, magenta, and yellow). The front end side transition region AT1 is closer to the front end side than the first region A1, and the front end side transition region AT1 has a coating of the colors included in the second color group C2 (specifically, white and blue). The base end side transition region AT2 is closer to the base end side than the first region A1, and the base end side transition region AT2 has a coating of the colors included in the second color group C2 (specifically, white and blue). When viewed from the transition region AT (specifically, the base end side transition region AT2), the side opposite to the first region A1 is the second region A2, and the second region A2 has a coating of the colors included in the third color group C3 (specifically, purple and gold).

[0125] In this way, various changes can be made to the color of the coating in the first area A1, transition area AT, and second area A2 of the front end portion 100F of the first metal wire 10F, the order of appearance of the colors, and the combination of colors when there are multiple colors. The lengths in the longitudinal direction of the first area A1, transition area AT, and second area A2 and the lengths of each part can also be arbitrarily determined. In such a seventh embodiment of the metal wire for medical devices 10F, the same effects as those of the first embodiment can be achieved.

[0126] <Eighth Embodiment>

[0127] Fig.151 is a diagram showing an example of a front end portion 100G of a first metal wire 10G according to an eighth embodiment. The medical device 1 may include a first metal wire 10G described below instead of the first metal wire 10 described in the first embodiment. The color of the coating in the first region A1, transition region AT, and second region A2 of the front end portion 100G of the first metal wire 10G is different from that in the first embodiment. Fig.15 (A) is a line graph showing the color of the coating of the tip portion 100G by hatched lines. Fig.15 (B) is a photograph of the tip portion 100G. The line graph corresponds to the photograph. Fig.15 Both the line graph and the photograph show the thickness direction of the flat shape of the first metal wire 10G.

[0128] As shown in the figure, part 98a is a silver color indicating unheated treatment. Part 98b has a blue coating. Part 98c has a white coating. Part 98d has a yellow coating. Part 98e has a magenta coating. Part 98f has a green coating. Part 98g has a magenta coating. Part 98h has a yellow coating. Part 98i has a white coating. Part 98j has a blue coating. Part 98k has a purple coating. Part 98l has a gold coating. For example, Fig.15 As shown in (B), the parts 98b to 981 may be colors with relatively high brightness (bright colors, light colors).

[0129] The central portion of the front end portion 100G of the first metal wire 10G is the first region A1, and the first region A1 has a coating of the colors included in the first color group C1 (specifically, green, magenta, and yellow). The front end side transition region AT1 is closer to the front end side than the first region A1, and the front end side transition region AT1 has a coating of the colors included in the second color group C2 (specifically, white and blue). The base end side transition region AT2 is closer to the base end side than the first region A1, and the base end side transition region AT2 has a coating of the colors included in the second color group C2 (specifically, white and blue). When viewed from the transition region AT (specifically, the base end side transition region AT2), the side opposite to the first region A1 is the second region A2, and the second region A2 has a coating of the colors included in the third color group C3 (specifically, purple and gold).

[0130] In this way, various changes can be made to the color of the coating in the first area A1, transition area AT, and second area A2 of the front end portion 100G of the first metal wire 10G, the order of appearance of the colors, and the combination of colors when there are multiple colors. The lengths in the longitudinal direction of the first area A1, transition area AT, and second area A2 and the lengths of each part can also be arbitrarily determined. In such an eighth embodiment of the metal wire for medical devices 10G, the same effects as those of the first embodiment can be achieved.

[0131] <Ninth embodiment>

[0132] Fig.16 This is an enlarged view of the front end portion 100H of the first metal wire 10H of the ninth embodiment. The medical device 1H of the ninth embodiment includes the first metal wire 10H described below instead of the first metal wire 10 described in the first embodiment. The difference from the first embodiment is that the first metal wire 10H does not have the front end transition area AT1 and the second area A2. Fig.16 (A) shows a side view of the front end portion 100H as seen from the Z-axis direction. Fig.16 (B) shows a side view of the front end portion 100H viewed from the Y-axis direction. Fig.16 In the figure, the coil 40 is omitted.

[0133] like Fig.16 As shown in (A) and (B) of FIG. 1 , in the medical device 1H, the front end tip 51 (dashed line) is attached to the front end side of the first region A1 in the front end portion 100H of the first metal wire 10H. In the example shown in the figure, the base end of the front end tip 51 is located slightly closer to the front end side than the front end of the first region A1. The base end of the front end tip 51 may be located at any position within the range closer to the front end side than the first region A1.

[0134] Fig.17 : is a flowchart showing a method for manufacturing the medical device 1H according to the ninth embodiment. Figure 8 The first embodiment shown is different in that step S18 is not performed and step S22H is performed instead of step S22. In step S22H, the operator checks the color of the coating in the first area A1 and the transition area AT. Specifically, the operator only performs step a1 described in the first embodiment and does not perform step a2.

[0135] In this way, the structure of the medical device 1H can be changed in various ways, and the first metal wire 10H can also have a first region A1 and a transition region AT (base end side transition region AT2) adjacent to the base end side of the first region A1. The first metal wire 10H can also have a first region A1 and a transition region AT (front end side transition region AT1) located on the front end side of the first region A1. The first metal wire 10H can also have a first region A1, a front end side transition region AT1, and a base end side transition region AT2. In such a ninth embodiment of the medical device 1H and the metal wire 10H for medical device, the same effects as those of the first embodiment can be achieved. According to the ninth embodiment of the metal wire 10H for medical device, since it does not have the second region A2, the step S18 of forming the second region A2 can be omitted ( Figure 8 ) and can simplify the inspection process ( Fig.17 : S22H). As a result, the manufacturing cost of the medical device 1H and the medical device wire 10H can be reduced.

[0136] <Tenth embodiment>

[0137] Fig.18 10I is an enlarged view of the front end portion 100I of the first metal wire 10I in the tenth embodiment. The medical device 1I of the tenth embodiment includes the first metal wire 10I described below instead of the first metal wire 10 described in the first embodiment. The difference from the first embodiment is that the first metal wire 10I does not have the first punching portion 111, the transition portion 112, and the second punching portion 113. Fig.18 (A) shows a side view of the front end portion 100I viewed from the Z-axis direction. Fig.18 (B) shows a side view of the front end portion 100I viewed from the Y-axis direction. Fig.18 In the figure, the coil 40 is omitted.

[0138] like Fig.18 As shown in (A) and (B), the front end portion 100I of the first metal wire 10I is not subjected to stamping, and the first portion 11I has a cylindrical shape. In other words, the shape of the first portion 11I viewed from the Z-axis direction is the same as the shape viewed from the Y-axis direction.

[0139] Fig.19 1 is a flowchart showing a method for manufacturing a medical device 1I according to a tenth embodiment. Figure 8 The first embodiment shown is different in that steps S12 and S22 are not performed. That is, according to this manufacturing method, the metal wire is not subjected to stamping but to heat treatment. According to this manufacturing method, it is not necessary to inspect the coating color of the first area A1, the transition area AT, and the second area A2.

[0140] In this way, the structure of the medical device 1I can be changed in various ways, and the front end portion 100I of the first metal wire 10I (the first portion 11I of the first metal wire 10I) can also be a round wire that is not punched. In the medical device 1I and the metal wire 10I for medical devices of the tenth embodiment, the same effects as those of the first embodiment can be achieved. According to the metal wire 10I for medical devices of the tenth embodiment, since the punching process S12 ( Figure 8 ) and inspection step S22( Figure 8 ), thereby reducing the manufacturing cost of the medical device 1I and the metal wire 10I for medical devices.

[0141] <Eleventh Embodiment>

[0142] Fig. 20This is an enlarged view of the distal end portion 100 of the first wire 10 of the eleventh embodiment. The medical device 1J of the eleventh embodiment includes a distal end tip 51J described below instead of the distal end tip 51 described in the first embodiment. The position where the distal end tip 51J is attached to the first wire 10 is different from that in the first embodiment. Fig. 20 (A) shows a side view of the front end portion 100 as seen from the Z-axis direction. Fig. 20 (B) shows a side view of the front end portion 100 as viewed from the Y-axis direction. Fig. 20 In the figure, the coil 40 is omitted.

[0143] like Fig. 20 As shown in (A) and (B), the front end tip 51J (dashed line) is attached to the front end portion 100 of the first metal wire 10 closer to the front end side than the first area A1 and closer to the front end side than the front end side transition area AT1. In the example shown in the figure, the base end of the front end tip 51J is located slightly closer to the front end side than the front end of the front end side transition area AT1.

[0144] In this way, the structure of the medical device 1J can be changed in various ways, and the front end tip 51J can be set at any position of the front end portion 100 of the first metal wire 10. In the example shown in the figure, the front end tip 51J is installed closer to the front end side than the front end side transition area AT1. However, the front end tip 51J can also be set in the first area A1 (for example, the front end portion of the first area A1). In such a medical device 1J of the eleventh embodiment, the same effect as the above-mentioned first embodiment can also be achieved.

[0145] <Modification of the present embodiment>

[0146] The present disclosure is not limited to the above-described embodiment, and can be implemented in various forms within the scope not departing from the gist of the present disclosure. For example, the following modifications are also possible.

[0147] [Modification 1]

[0148] In the above-mentioned first to eleventh embodiments, the structures of the medical devices 1, 1H, 1I, and 1J are illustrated. However, the structure of the medical device 1 can be changed in various ways. For example, the medical device 1 may also include a coating, and the coating is formed on the surface of the first metal wire 10, the second metal wire 20, and the coil 40 by any one of a hydrophilic resin and a hydrophobic resin. For example, the length of the coil 40 in the longitudinal direction, in other words, the range in which the coil 40 covers the first metal wire 10 can also be changed arbitrarily. For example, the medical device 1 may also include an intermediate joint between the front end tip 51 and the base end side joint 52, and the intermediate joint is used to join the first metal wire 10 with the coil 40. For example, the shape of the second metal wire 20 can be changed in various ways. The medical device 1 may not have the second metal wire 20. The medical device 1 may not have the coil 40.

[0149] [Modification 2]

[0150] In the above-mentioned first to eleventh embodiments, the structures of the metal wires 10 and 10A to 10I for medical devices are exemplified. However, the structure of the first metal wire 10 can be modified in various ways. For example, Figure 3 The shape of the first metal wire 10 described above is only an example and can be modified in various ways. For example, at least one of the second portion 12, the third portion 13, and the fourth portion 14 can be omitted. The third portion 13 can also be cylindrical instead of conical.

[0151] In the above embodiment, the entire first portion 11 of the first metal wire 10 except a portion on the base end side corresponds to the "front end portion 100 of the first metal wire 10". The range of the front end portion 100 can be changed in various ways. For example, the entire first portion 11 of the first metal wire 10 and a portion on the front end side of the second portion 12 can also correspond to the "front end portion 100".

[0152] In the above embodiment, the color pattern of the coating in the first area A1, transition area AT, and second area A2 of the front end portion 100 of the first metal wire 10 is exemplified. However, the color pattern of the coating in the first area A1, transition area AT, and second area A2 of the front end portion 100 is not limited to: forming a coating of at least one color included in the first color group C1 in the first area A1, forming a coating of at least one color included in the second color group C2 in the transition area AT, and forming a coating of at least one color included in the third color group C3 in the second area A2, and can be arbitrarily changed. The front end portion 100 of the first metal wire 10 may not include an unheat-treated portion.

[0153] In the above embodiment, the thickness T1 of the coating CO1 of the first region A1 of the first metal wire 10 is greater than 100 nm. The thickness T1 of the coating CO1 of the first region A1 may also be less than 100 nm. The thickness T1 of the coating CO1 of the first region A1 is thicker than the thickness of the coating of the transition region AT. The thickness T1 may also be thinner than the thickness of the coating of the transition region AT, or may be the same as the thickness of the coating of the transition region AT.

[0154] In the above embodiment, the thickness of the coating in the second region A2 of the first metal wire 10 is greater than 10 nm and less than 30 nm. The thickness of the coating in the second region A2 may be thinner than 10 nm. The thickness of the coating in the second region A2 may be thicker than 30 nm.

[0155] Figure 2 The result of the shaping test described in is only an example. The shaping angle θ when implementing the shaping test may also be: first area A1 = transition area AT. The shaping angle θ when implementing the shaping test may also be: first area A1 < transition area AT. The shaping angle θ when implementing the shaping test may also be: first area A1 = second area A2. The shaping angle θ when implementing the shaping test may also be: first area A1 < second area A2.

[0156] In the above embodiment, any position in the outermost layer (titanium oxide film CO1) is the first position P1, and any position in the second layer from the outside is the second position P2. However, as long as the first position P1 is located on the outside (the surface side of the first metal wire 10) than the second position P2, the first position P1 and the second position P2 can be set arbitrarily. In the above embodiment, the titanium content at the first position P1 is greater than the titanium content at the second position P2. The titanium content at the first position P1 may also be less than the titanium content at the second position P2. The titanium content at the first position P1 may also be the same as the titanium content at the second position P2. In the above embodiment, the nickel content at the first position P1 is less than the nickel content at the second position P2. The nickel content at the first position P1 may also be greater than the nickel content at the second position P2. The nickel content at the first position P1 may also be the same as the nickel content at the second position P2.

[0157] In the above embodiment, the medical device wire 10 is illustrated as being assembled in the medical device 1. However, the medical device wire 10 may be manufactured alone, in other words, it may be manufactured without the second wire 20, the coil 40, the front end tip 51, and the base end side joint 52.

[0158] [Variation 3]

[0159] The structures of the medical devices and the wires for medical devices of the first to eleventh embodiments and the structures of the medical devices and the wires for medical devices of the above-mentioned Modifications 1 and 2 may be appropriately combined. For example, the structure of the ninth embodiment (no second region A2, front end transition region AT1) may be combined with any of the first wires 10A to 10G of the second to eighth embodiments (the color patterns of the first region A1, transition region AT, and second region A2 are different), the structure of the tenth embodiment (no stamping, no inspection process), or the structure of the eleventh embodiment (different position of the front end tip 51) may be combined. For example, the structure of the tenth embodiment (no stamping, no inspection process) may be combined with the first wire 10H of the ninth embodiment (no second region A2, front end transition region AT1), or the structure of the eleventh embodiment (different position of the front end tip 51) may be combined. For example, the structure of the eleventh embodiment (different position of the front end tip 51) may be combined with the first wire 10I of the tenth embodiment (no stamping, no inspection process).

[0160] The present disclosure is described above based on implementation examples and variations. The implementation examples of the present disclosure described above are intended to facilitate understanding of the present disclosure and are not intended to limit the present disclosure. The present disclosure may be modified and improved without departing from the subject matter of the present disclosure and the claims, and the present disclosure includes its equivalents. If the technical feature is not described as indispensable in this specification, it may be appropriately deleted.

Claims

1. A metal wire for medical equipment, wherein: have: a prescribed area having a coating exhibiting at least a prescribed color; as well as The specific area has a coating exhibiting at least a specific color, and the specific color is different from the prescribed color.

2. The metal wire for medical equipment according to claim 1, wherein: The shaping angle of the specified area when the shaping test is carried out is greater than the shaping angle of the specific area when the shaping test is carried out.

3. The metal wire for medical device according to claim 1 or 2, wherein: The metal wire for medical devices further includes a predetermined region, the predetermined region being adjacent to the specific region and located on the opposite side of the prescribed region when viewed from the specific region, and the predetermined region having a coating exhibiting at least a predetermined color.

4. A metal wire for medical equipment, wherein: have: a prescribed area having a coating exhibiting at least a prescribed color; and A predetermined area has a coating exhibiting at least a predetermined color, and the predetermined color is different from the prescribed color.

5. The metal wire for medical equipment according to claim 4, wherein: The shaping angle of the specified area when implementing the shaping test is greater than the shaping angle of the predetermined area when implementing the shaping test.

6. The metal wire for medical device according to claim 4 or 5, wherein: The medical device wire further includes a specific region between the specified region and the predetermined region, and the specific region has a coating exhibiting at least a specific color.

7. The metal wire for medical device according to any one of claims 1 to 3 or claim 6, wherein: The coating in the specific area also presents a second specific color, which is different from the specific color.

8. A metal wire for medical equipment, wherein: have: a prescribed area having a coating exhibiting at least a prescribed color; A specific area, wherein the specific area has a coating having at least a specific color; as well as a predetermined area, the predetermined area being adjacent to the specific area and being located on a side opposite to the specified area when viewed from the specific area, the predetermined area having a coating having at least a predetermined color, The thickness of the coating in the prescribed area is thicker than the thickness of the coating in the specific area. The thickness of the coating in the specific area is thicker than the thickness of the coating in the predetermined area.

9. The metal wire for medical device according to claim 8, wherein The coating in the specific area also presents a second specific color, which is different from the specific color.

10. The metal wire for medical device according to any one of claims 3, 6 and 8, wherein: In a cross-sectional view of at least any one of the prescribed region, the specific region, and the predetermined region, a titanium content at a first position is greater than a titanium content at a second position inside the first position.

11. The metal wire for medical device according to any one of claims 3, 6, 8 and 10, wherein: In the cross-sectional view of at least any one of the prescribed region, the specific region, and the predetermined region, the nickel content at a second position is greater than the nickel content at a first position outside the second position.

12. The metal wire for medical device according to any one of claims 1 to 11, wherein: The thickness of the coating film in the predetermined region is 100 nm or more.

13. The metal wire for medical device according to any one of claims 1 to 3 or any one of claims 6 to 11, wherein: The thickness of the coating in the predetermined area is thicker than the thickness of the coating in the specific area.

14. The metal wire for medical device according to any one of claims 3 to 6, or any one of claims 8, 10 and 11, wherein: The thickness of the coating in the prescribed area is thicker than the thickness of the coating in the predetermined area.

15. The metal wire for medical device according to any one of claims 3, 6, 8, 10 and 11, wherein: The thickness of the coating in the specific area is thicker than the thickness of the coating in the predetermined area.

16. The metal wire for medical device according to any one of claims 3 to 6, or any one of claims 8 to 11, or any one of claims 14 and 15, wherein: The thickness of the coating in the predetermined region is greater than or equal to 10 nm and less than or equal to 30 nm.

17. The metal wire for medical device according to any one of claims 3 to 6, or any one of claims 8 to 11, or any one of claims 14 and 15, wherein: The thickness of the medical device wire in the prescribed region is thinner than the thickness of the medical device wire in the predetermined region.

18. The metal wire for medical device according to any one of claims 1 to 3, any one of claims 6 to 11, or any one of claims 13 to 15, wherein: The thickness of the medical device metal wire in the prescribed region is thinner than the thickness of the medical device metal wire in the specific region.

19. The metal wire for medical device according to any one of claims 3 and 6, or any one of claims 8 to 11, or any one of claims 13 to 15, wherein: The thickness of the metal wire for medical devices is in the order of the thinner area, namely, the prescribed area, the specific area, and the predetermined area.

20. The metal wire for medical device according to any one of claims 1 to 19, wherein: The medical device wire has a flat shape, The coating is formed along a thickness direction of the flat shape.

21. The metal wire for medical device according to any one of claims 1 to 20, wherein: The medical device wire has a flat shape, The coating film is formed along the width direction of the flat shape.

22. The metal wire for medical device according to any one of claims 1 to 21, wherein: The metal wire for medical devices includes an unheat-treated portion.

23. The metal wire for medical device according to any one of claims 1 to 22, wherein: The coating is a coating containing titanium oxide.

24. A medical device, wherein: have: The metal wire for medical device according to any one of claims 1 to 23; and A front end tip is attached to the front end side of the predetermined area of ​​the medical device wire.

25. The medical device of claim 24, wherein: A metal wire for medical device according to any one of claims 1 to 3, any one of claims 6 to 11, any one of claims 13 and 15, or any one of claims 18 and 19, The specific region of the medical device metal wire includes a front end specific region and a base end specific region, the front end specific region is arranged closer to the front end than the prescribed region, and the base end specific region is arranged closer to the base end than the prescribed region. The front end tip is installed in the front end side specific area.

26. A method for manufacturing a metal wire for medical equipment, wherein: include: The metal wire is subjected to heat treatment to form a coating having at least a predetermined color in a predetermined area; as well as A coating having at least a specific color is formed in a specific area.

27. The method for manufacturing a metal wire for medical devices according to claim 26, wherein: In order to determine whether the heat treatment has been completed normally, the color of the coating in the prescribed area and the color of the coating in the specific area are also checked.

28. The method for manufacturing a metal wire for medical devices according to claim 26 or 27, wherein: The temperature of the heat treatment for forming the prescribed region and the specific region is a prescribed temperature, The manufacturing method further includes forming a coating exhibiting at least a predetermined color in a predetermined region by performing a heat treatment at a specific temperature lower than the predetermined temperature on the base end side of the metal wire relative to the predetermined region.

29. The method for manufacturing a metal wire for medical devices according to claim 28, wherein: In order to determine whether the heat treatment for forming the predetermined area has been normally completed, the color of the coating film in the predetermined area is also checked.

30. A metal wire for medical equipment, wherein: have: a prescribed area having a coating exhibiting at least a prescribed color; as well as a specific area, wherein the specific area has a coating having at least a specific color, The coating in the predetermined area and the coating in the specific area are formed by heat-treating the metal wire for a medical device.

31. The metal wire for medical device according to claim 30, wherein: The temperature of the heat treatment for forming the prescribed region and the specific region is a prescribed temperature, The metal wire for medical equipment further has a predetermined area, which is located closer to the base end side of the metal wire than the specified area, and the predetermined area has a coating having at least a predetermined color, and the coating of the predetermined area is formed by heat treatment at a specific temperature lower than the specified temperature.

32. A metal wire for medical equipment, wherein: have: a predetermined region having a coating exhibiting at least a predetermined color and containing titanium oxide; A specific region having a coating exhibiting at least a specific color and a second specific color and containing titanium oxide; as well as a predetermined area, the predetermined area being adjacent to the specific area and being located on the opposite side of the specified area when viewed from the specific area, the predetermined area having a coating having at least a predetermined color and containing titanium oxide, The thickness of the coating in the prescribed area is thicker than the thickness of the coating in the specific area. The thickness of the coating in the specific area is thicker than the thickness of the coating in the predetermined area.

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