Medical devices

Abstract

To improve the visibility of the tip. [Solution] The medical device comprises a main body and a reading unit connected to the tip of the main body and entering the lesion, the reading unit comprising a loop-shaped loop and a marker unit disposed inside the loop and having radiopaque properties.

Description

Technical Field

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

Background Art

[0002] When treating stenotic or occluded portions (hereinafter referred to as "lesion portions") in blood vessels, a guide wire is used. Known guide wires have a loop at the tip. (See, for example, Patent Document 1).

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] There is room for improvement in the visibility of the tip portion of known guide wires.

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

Means for Solving the Problems

[0006] The medical device disclosed by this specification includes a main body portion, and a leading portion connected to the tip of the main body portion and entering the lesion portion, and the leading portion includes a loop-shaped loop portion and a marker portion disposed inside the loop portion and having radiopacity.

Brief Description of the Drawings

[0007] [Figure 1] Plan view of the guide wire according to the first embodiment [Figure 2] Side view of the guide wire according to the first embodiment [Figure 3]A cross-sectional view showing the guide wire of the first embodiment cut along the line III-III in Figure 2. [Figure 4] Cross-sectional view showing the guide wire of the first embodiment cut along the line IV-IV in Figure 1. [Figure 5] A magnified partial plan view showing the area within frame F in Figure 1. [Figure 6] A flowchart showing an example of a guide wire manufacturing method according to the first embodiment. [Figure 7] An explanatory diagram showing an example of a guide wire manufacturing method according to the first embodiment. [Figure 8] An explanatory diagram showing an example of a guide wire manufacturing method according to the first embodiment. [Figure 9] An explanatory diagram showing an example of a guide wire manufacturing method according to the first embodiment. [Figure 10] An explanatory diagram showing an example of a treatment method using a guidewire according to the first embodiment. [Figure 11] An explanatory diagram showing an example of a treatment method using a guidewire according to the first embodiment. [Figure 12] This is a schematic diagram illustrating an example of how the guidewire of the first embodiment appears under fluoroscopy. [Figure 13] This is a schematic diagram illustrating an example of how the guidewire of the first embodiment appears under fluoroscopy. [Figure 14] This is a schematic diagram illustrating an example of how the guidewire of the first embodiment appears under fluoroscopy. [Figure 15] A partially enlarged plan view showing the leading portion and its vicinity in the guide wire of the second embodiment. [Figure 16] Cross-sectional view showing the guide wire of the second embodiment cut along the line XVI-XVI in Figure 15. [Figure 17] A partially enlarged plan view showing the leading portion and its vicinity in the guide wire of the third embodiment. [Figure 18] A cross-sectional view showing the guide wire of the third embodiment cut along the line XVIII-XVIII in Figure 17. [Figure 19]Partial enlarged plan view showing the leading portion and the portion in its vicinity in the guide wire of the fourth embodiment [Figure 20] Cross-sectional view showing the guide wire of the fourth embodiment cut along the line XX-XX in FIG. 19 [Figure 21] Flowchart showing an example of the manufacturing method of the guide wire of the fourth embodiment [Figure 22] Explanatory drawing showing an example of the manufacturing method of the guide wire of the fourth embodiment [Figure 23] Explanatory drawing showing an example of the manufacturing method of the guide wire of the fourth embodiment

Mode for Carrying Out the Invention

[0008] (First Embodiment) The first embodiment will be described with reference to FIGS. 1 to 14. The guide wire 100 of the present embodiment is a medical device inserted into a living body lumen for treating a lesion in the living body lumen. The living body lumen includes tubular organs of the human body such as blood vessels, digestive tracts, ureters, organs, and bile ducts. In the guide wire 100, the positive Z-axis direction side is the tip side inserted into the body, and the negative Z-axis direction side is the proximal side operated by a technician such as a doctor. The tip side is also referred to as the distal side, and the proximal side is also referred to as the proximal side. In each figure, the illustration of a part of the guide wire 100 may be omitted. FIGS. 1, 2, and 3 show the state in which the guide wire 100 is in a straight line parallel to the Z-axis. The guide wire 100 has flexibility to the extent that it can be curved. These points are the same in the following figures.

[0009] In this specification, for the guide wire 100 and each of its components, the end on the distal side is referred to as the "distal end", the distal end and its vicinity are referred to as the "distal part", the end on the proximal side is referred to as the "proximal end", and the proximal end and its vicinity are referred to as the "proximal part". The cross section of the guide wire 100 and each of its components means a section orthogonal to the longitudinal direction. The longitudinal section of the guide wire 100 and each of its components means a section parallel to the central axis in the longitudinal direction. For the guide wire 100 and each of its components, the direction orthogonal to the longitudinal direction is referred to as the radial direction. The outer diameter of the guide wire 100 and each of its components means the width along the radial direction.

[0010] The guide wire 100 is a medical device to be inserted into a living body lumen such as a blood vessel. The total length of the guide wire 100 is, for example, 1000 mm or more and 3000 mm or less.

[0011] As shown in FIGS. 1 and 2, the guide wire 100 has a main body portion 10 and a leading portion 20.

[0012] The main body portion 10 is an elongated portion extending along the central axis Ax. The central axis Ax is an example of an axis. In the present embodiment, the central axis Ax of the main body portion 10 coincides with the central axis of the guide wire 100. The proximal end 15 of the main body portion 10 coincides with the proximal end of the guide wire 100.

[0013] The leading portion 20 can be described as a leading section, drill section, crushing section, peeling section, entry section, peeler, shaver, etc. The leading portion 20 has a base end 27 connected to the tip 16 of the main body 10, and a tip end 23 on the opposite side of the base end 27. The tip end 23 of the leading portion 20 coincides with the tip of the guide wire 100. For convenience, in the following description, the surface visible when viewing the leading portion 20 from the positive X-axis direction will be referred to as the top surface, and the surface visible when viewing the leading portion 20 from the negative X-axis direction will be referred to as the bottom surface. The surface of the leading portion 20 may or may not have an edge. An edge is the boundary between two surfaces. The leading portion 20 enters the lesion while rotating around the central axis Ax. The entry of the leading portion 20 into the lesion can be described as crossing, passing through, drilling, crushing, peeling, separating, burrowing into, or entering the lesion. The length L20 of the leading portion 20 along the central axis Ax is, for example, 0.2 mm or more and 2.0 mm or less. The length L20 of the leading portion 20 may also be 0.3 mm or more and 1.5 mm or less, or 0.4 mm or more and 1.0 mm or less.

[0014] As shown in Figure 3, the guide wire 100 comprises a core wire 40 and a coil 50.

[0015] The coil 50 is a cylindrical member in which one or more wires are wound in a spiral. In this embodiment, the coil 50 is a multi-wire coil in which multiple wires are wound. The outer diameter of the coil 50 is, for example, 0.1 mm or more and 0.6 mm or less. The outer diameter of the coil 50 may be 0.2 mm or more and 0.5 mm or less, or 0.3 mm or more and 0.4 mm or less. The outer diameter of the coil 50 may be 1.00 mm or more and 2.00 mm or less, or 1.10 mm or more and 1.65 mm or less, or 1.20 mm or more and 1.35 mm or less. In this embodiment, the outer diameter of the coil 50 is constant along its entire length. The coil 50 may have a tapered shape in which the outer diameter gradually decreases from the base end to the tip, or a tapered shape in which the outer diameter gradually decreases from the tip to the base end. The tip 51 of the coil 50 is approximately the same as the tip 16 of the main body 10.

[0016] The wire forming the coil 50 may be a single strand or a stranded wire made by twisting together multiple strands. In this embodiment, the wire forming the coil 50 is a stranded wire.

[0017] The material of coil 50 is, for example, metal. The material of coil 50 may be a material that transmits radiation or a material that does not transmit radiation. Materials that transmit radiation may be, for example, stainless steel such as SUS302, SUS304, SUS316, Ni-Ti alloy, or piano wire. Materials that do not transmit radiation may be, for example, platinum, gold, tungsten, or an alloy of any of these. Coil 50 may be formed entirely of the same material, or each part may be formed of different materials.

[0018] The core wire 40 is a linear member. The core wire 40 has a large diameter portion 41, a first tapered portion 42, an intermediate diameter portion 43, a second tapered portion 44, a first small diameter portion 45, a loop portion 46, and a second small diameter portion 47. The large diameter portion 41, the first tapered portion 42, the intermediate diameter portion 43, the second tapered portion 44, the first small diameter portion 45, the loop portion 46, and the second small diameter portion 47 are connected in this order from the base end of the core wire 40.

[0019] The large diameter section 41 is a rod-shaped portion having a substantially constant outer diameter. The outer diameter of the large diameter section 41 is, for example, about 0.2 mm to 3.0 mm. The intermediate diameter section 43 is located closer to the tip than the large diameter section 41 and is a rod-shaped portion having a substantially constant outer diameter smaller than the outer diameter of the large diameter section 41. The first tapered section 42 is located between the large diameter section 41 and the intermediate diameter section 43 and is a portion where the diameter gradually decreases from the boundary with the large diameter section 41 towards the boundary with the intermediate diameter section 43. The first thin diameter section 45, the loop section 46, and the second thin diameter section 47 are located closer to the tip than the intermediate diameter section 43 and are rod-shaped portions having a substantially constant outer diameter smaller than the outer diameter of the intermediate diameter section 43. The second tapered section 44 is located between the intermediate diameter section 43 and the first thin diameter section 45 and is a portion where the diameter gradually decreases from the boundary with the intermediate diameter section 43 towards the boundary with the first thin diameter section 45.

[0020] Of the core wire 40, the second tapered portion 44, the first thin-diameter portion 45, and the second thin-diameter portion 47 are inserted inside the coil 50.

[0021] The loop portion 46 is the part of the core wire 40 between the first small diameter portion 45 and the second small diameter portion 47, and is located towards the tip of the coil 50. The loop portion 46 is bent into a loop shape. More specifically, the loop portion 46 extends from the tip of the first small diameter portion 45, curving toward the tip, is folded back at the tip, and extends curving toward the base end. In this specification, "loop shape" includes not only cases where the loop portion has only a closed ring, but also cases where the loop portion has a shape in which a part of the ring is missing, or where a part of the loop portion extends outward from the ring. In this embodiment, most of the loop portion 46, excluding both ends, forms a shape in which a part of an ellipse is missing, with the major axis oriented along the central axis Ax, and both ends extend substantially linearly toward the base end. In this embodiment, there is a gap between the two ends of the loop portion 46. The two ends of the loop portion 46 may be in contact or may intersect. The shape of the ring formed by the loop portion 46 may be circular, partially circular, elliptical, rectangular, parallelogram, trapezoidal, rhombus, etc., and may have a distorted shape in part. The tip of the loop portion 46 coincides with the tip 23 of the leading portion 20.

[0022] The shape of the cross-section of the core wire 40 at each position can be any shape. The shape of the cross-section of the core wire 40 at each position may be circular, partially circular, elliptical, rectangular, parallelogram, trapezoidal, rhombus, etc. A partially circular is one half of a circle divided into two equal parts by a chord. The outer edge of a partially circular consists of an arc and a line segment connecting the two ends of the arc. A partially circular may be, for example, a semicircle, a fragmented circle, or a bow shape. A semicircle is one half of a circle divided into two equal parts by a chord passing through the center of the circle. A fragmented circle is the larger half of a circle divided into two by a chord that does not pass through the center of the circle. A bow shape is the smaller half of a circle divided into two by a chord that does not pass through the center of the circle. The cross-section of the core wire 40 is not limited to the exact shapes described above, but may be approximately the shapes described above. The shape of the cross-section may differ at each position along the longitudinal direction of the core wire 40. In this embodiment, the shape of the cross-section at each position of the core wire 40 is circular.

[0023] The material of the core wire 40 is, for example, a metal. The material of the core wire 40 may be a material that transmits radiation or a material that does not transmit radiation. Materials that transmit radiation may be, for example, stainless steel such as SUS302, SUS304, SUS316, Ni-Ti alloy, or piano wire. Materials that do not transmit radiation may be, for example, tungsten or tungsten alloy. The core wire 40 may be formed entirely of the same material, or each part may be formed of different materials.

[0024] The tip of the coil 50 is joined to the core wire 40 by a tip-side joining material 71. A portion of the tip-side joining material 71 extends inside the coil 50, joining a portion of the first small diameter portion 45, a portion of the second small diameter portion 47, and the tip of the coil 50. Another portion of the tip-side joining material 71 forms a reinforcing portion 72 that protrudes from the tip 51 of the coil 50 toward the tip. The reinforcing portion 72 covers both ends of the loop portion 46. This reinforcing portion 72 reinforces the connection point between the leading portion 20 and the main body portion 10. The base end of the coil 50 is joined to the core wire 40 by a base-side joining material 74. The coil 50 may also be joined to the core wire 40 via joining materials formed at other locations. The materials for the tip-side joining material 71 and the base-side joining material 74 are, for example, solder, brazing material, or adhesive. The solder may be, for example, an Au-Sn alloy, Sn-Ag alloy, Sn-Pb alloy, or Pb-Ag alloy. The brazing material may be, for example, an aluminum alloy brazing material, a silver brazing material, or a gold brazing material. The adhesive may be, for example, an epoxy adhesive.

[0025] A marker portion 60 is positioned inside the loop portion 46. In this embodiment, the marker portion 60 is an elliptical disc shape. As shown in Figure 4, the marker portion 60 has a first surface 61 and a second surface 62 opposite to the first surface. In this embodiment, the first surface 61 and the second surface are both flat surfaces. In this embodiment, the first surface 61 and the second surface 62 are parallel to each other. More specifically, both the first surface 61 and the second surface 62 are parallel to the YZ plane. That is, when the Y-axis direction is the first direction and the X-axis direction is the second direction of the two directions perpendicular to the Z-axis direction, which is the extension direction of the central axis Ax, the first surface 61 and the second surface 62 are parallel to the first direction. In this embodiment, the first surface 61 and the second surface are smoothly connected to the surface of the loop portion 46 without any steps. The outer edge 61E of the first surface 61 and the outer edge 62E of the second surface 62 are provided along the portion of the loop portion 46 where the outer diameter DL in the second direction is maximum. The outer diameter DL in the second direction is determined as follows: As shown in Figure 4, a virtual line LL is set that passes through the loop portion 46 and extends along the second direction. The distance between two points PL1 and PL2 where the virtual line LL intersects with the surface of the loop portion 46 is the outer diameter DL in the second direction. In this embodiment, the entire marker portion 60 is housed inside the loop portion 46. Of the outer circumferential surface of the marker portion 60, a portion on the base end side is in contact with the tip-side joining material 71. The majority of the remaining outer circumferential surface of the marker portion 60 is in direct contact with the surface of the loop portion 46 and is joined to the loop portion 46.

[0026] The marker portion 60 includes a flattened portion 63 in which the outer diameter Dm1 in the first direction is larger than the outer diameter Dm2 in the second direction. The outer diameters Dm1 and Dm2 at a certain position on the marker portion 60 are determined as follows. As shown in Figure 4, a virtual line L1 is set that passes through the position Px where the outer diameters Dm1 and Dm2 are to be determined and extends along the first direction, and a virtual line L2 is set that passes through position Px and extends along the second direction. The distance between two points P1 and P2 where the virtual line L1 intersects with the surface of the marker portion 60 is defined as the outer diameter Dm1 in the first direction. The distance between two points P3 and P4 where the virtual line L2 intersects with the surface of the marker portion 60 is defined as the outer diameter Dm2 in the second direction. In this embodiment, the outer diameter Dm2 in the second direction is equal to the thickness of the marker portion 60, which is expressed as the distance between the first surface 61 and the second surface 62. In this embodiment, as shown in Figure 5, the majority of the marker portion 60, excluding a part near the tip and a part near the base, is a flattened portion 63.

[0027] The material of the marker portion 60 is a material that does not transmit radiation. The material of the marker portion 60 may be, for example, an Au-Sn alloy or platinum brazing material.

[0028] The main body 10 includes the portion of the core wire 40 from the large diameter portion 41 to the first small diameter portion 45, the second small diameter portion 47, the coil 50, the portion of the tip-side joining member 71 excluding the reinforcing portion 72, and the base-side joining member 74. The leading portion 20 includes a loop portion 46 formed from a part of the core wire 40, a reinforcing portion 72, and a marker portion 60.

[0029] Next, an example of a method for manufacturing the guide wire 100 described above will be explained.

[0030] First, the core wire 40 is passed through the coil 50, with the tip of the core wire 40 protruding from the coil 50 (S110). Next, the tip of the core wire 40 is bent into a loop shape using a pin P to form a loop portion 46 (S120, Figure 7). After bending, the first small diameter portion 45 and the second small diameter portion 47 of the core wire 40 are inserted into the coil 50 and joined to the coil 50 by the tip-side joining material 71. Subsequently, the core wire 40 is joined to the base end of the coil 50 by the base-side joining material 74 (S130, Figure 8). After joining, the marker portion 60 is formed by filling the inside of the loop portion 46 with solder (S140, Figure 9). For example, the guide wire 100 of this embodiment is manufactured by the above process.

[0031] Next, an example of a treatment method using a catheter 120 equipped with the guidewire 100 described above will be explained.

[0032] The surgeon inserts a lead guidewire (not shown) into the blood vessel 200 and advances it to just before the lesion 220. The lead guidewire is also called a workhorse guidewire or first-choice guidewire. Next, the surgeon inserts a catheter 120 into the blood vessel 200 along the lead guidewire. The surgeon advances the catheter 120 to just before the lesion 220 in the blood vessel 200. Next, the surgeon withdraws the lead guidewire from the blood vessel 200. Then, the surgeon inserts a guidewire 100 into the catheter 120 inserted into the blood vessel 200, with the leading portion 20 at the front (Figure 10). The surgeon advances the guidewire 100 to just before the lesion 220 in the blood vessel 200. When advancing the guidewire 100, the guidewire 100 may or may not be rotated around the central axis Ax.

[0033] Next, the surgeon advances the leading section 20 into the lesion 220 by rotating the guide wire 100 and advancing it toward the tip (Figure 11). When the surgeon grasps the proximal end of the guide wire 100 and rotates it around the central axis Ax, the leading section 20 located at the tip of the guide wire 100 also rotates around the central axis Ax. The leading section 20, rotating within the lesion 220, excavates by cutting through the lesion 220.

[0034] When the leading portion 20 progresses into the lesion portion 220 as described above, contrast imaging of the blood vessels 200 using a fluoroscopy device is utilized, for example. The fluoroscopy device is an X-ray fluoroscopy device. In this embodiment, the marker portion 60 is made of a material that does not transmit radiation and is radiopaque. Therefore, the position of the leading portion 20 can be easily visualized under fluoroscopy.

[0035] Furthermore, the marker portion 60 of this embodiment includes a flattened portion 63 in which the outer diameter Dm1 in the first direction is larger than the outer diameter Dm2 in the second direction. In other words, the marker portion 60 has a shape in which its appearance changes when the guide wire 100 is rotated around the central axis Ax while being observed from a certain direction. Under fluoroscopy, the appearance of the marker portion 60 changes with the rotation of the guide wire 100. When the upper surface of the guide wire 100 is facing directly towards the imaging device provided in the fluoroscopy apparatus, the marker portion 60 is most clearly visible, as shown in Figure 12. When the guide wire 100 is rotated around the central axis Ax from this state, the size of the marker portion 60 confirmed in the fluoroscopic image becomes smaller than when the upper surface of the guide wire 100 is facing directly towards the imaging device, as shown in Figure 13. Furthermore, when the guide wire 100 is rotated and its side faces the imaging device, the size of the marker portion 60 as seen in the fluoroscopic image becomes smallest, as shown in Figure 14. In this way, the orientation of the leading portion 20 can be easily determined by checking the appearance of the marker portion 60 in the fluoroscopic image. In addition, in this embodiment, since both the first surface 61 and the second surface 62 are flat surfaces, the change in the appearance of the marker portion 60 due to the rotation of the guide wire 100 is easy to see. As a result, the orientation of the leading portion 20 can be determined even more easily.

[0036] As described above, the guidewire 100 of this embodiment comprises a main body portion 10 and a leading portion 20 connected to the tip 16 of the main body portion 10 and entering the lesion portion 220. The leading portion 20 comprises a loop-shaped loop portion 46 and a radiopaque marker portion 60 positioned inside the loop portion 46. With this configuration, the visibility of the leading portion 20 under radiofluoroscopy is improved.

[0037] In this embodiment, the main body 10 extends along the central axis Ax. The marker portion 60 has a flattened portion 63 in which the outer diameter Dm1 in a first direction perpendicular to the central axis Ax is larger than the outer diameter Dm2 in a second direction perpendicular to the central axis Ax and the first direction. With this configuration, the orientation of the reading portion 20 can be easily determined under radiofluoroscopy.

[0038] In this embodiment, the marker portion 60 has a first surface 61 and a second surface 62 opposite to the first surface 61. The first surface 61 is a flat surface. With this configuration, the reading portion 20 moves smoothly within the biological lumen. In addition, the orientation of the reading portion 20 under fluoroscopy can be determined more easily.

[0039] In this embodiment, the outer edge 61E of the first surface 61 is provided along the portion of the loop portion 46 where the outer diameter DL in the second direction is maximum. With this configuration, the leading portion 20 moves smoothly through the biological lumen.

[0040] In this embodiment, the second surface 62 is also a flat surface, and the outer edge 62E of the second surface 62 is provided along the portion of the loop 46 where the outer diameter DL in the second direction is maximum. With this configuration, the leading portion 20 moves smoothly within the biological lumen. In addition, the orientation of the leading portion 20 under fluoroscopy can be determined more easily.

[0041] In this embodiment, at least a portion of the marker portion 60 is in direct contact with the loop portion 46. This configuration improves the bonding strength between the marker portion 60 and the loop portion 46.

[0042] (Second Embodiment) A second embodiment will be described with reference to Figures 15 and 16. In this embodiment, the guide wire 100A has a different configuration from the first embodiment in the marker portion 60A. In this embodiment, components identical to those in the first embodiment are denoted by the same reference numerals and their descriptions are omitted.

[0043] The leading portion 20A includes a loop portion 46 and a marker portion 60A, similar to the first embodiment. The marker portion 60A is located inside the loop portion 46, similar to the first embodiment. The marker portion 60A has a first surface 61A and a second surface 62A opposite to the first surface 61A. In this embodiment, the first surface 61A is a convex surface with its central portion convex outward. Similarly, the second surface 62A is a convex surface with its central portion convex outward.

[0044] In this embodiment, as in the first embodiment, the visibility of the leading portion 20A is improved in the guide wire 100A.

[0045] (Third embodiment) A third embodiment will be described with reference to Figures 17 and 18. In this embodiment, the guide wire 100B has a different configuration from that of the first embodiment in the marker portion 60B. In this embodiment, components identical to those in the first embodiment are denoted by the same reference numerals and their description is omitted.

[0046] The reading section 20B includes a loop section 46 and a marker section 60B, similar to the first embodiment. The marker section 60B is located inside the loop section 46, similar to the first embodiment. The marker section 60B has a first surface 61B and a second surface 62B opposite to the first surface 61B. In this embodiment, the first surface 61B is a concave surface with its central portion recessed inward. Similarly, the second surface 62B is a concave surface with its central portion recessed inward.

[0047] In this embodiment, as in the first embodiment, the visibility of the leading portion 20B is improved in the guide wire 100A.

[0048] (Fourth Embodiment) A fourth embodiment will be described with reference to Figures 19 to 23. The guide wire 100C of this embodiment has a main body portion 10C and a leading portion 20C, similar to the first embodiment. In this embodiment, components identical to those in the first embodiment are denoted by the same reference numerals and their descriptions are omitted.

[0049] As shown in Figure 19, the guide wire 100C of this embodiment comprises a core wire 40C, a coil 50, a tip member 80, and a marker portion 60C. The core wire 40C has the same configuration as the core wire 40 of the first embodiment, except that it does not have a loop portion 46 and a second small diameter portion 47.

[0050] The tip member 80 comprises a loop portion 81 and a connecting portion 86. As shown in Figure 19, the connecting portion 86 is a cylindrical portion extending along the central axis Ax. The base end of the connecting portion 86 is inserted inside the coil 50. The tip of the first small diameter portion 45 is inserted inside the connecting portion 86 and joined to the connecting portion 86, for example, by welding.

[0051] The loop portion 81 is a loop-shaped part that is connected to the tip of the connecting portion 86 and is located on the tip side of the coil 50. The shape of the ring formed by the loop portion 81 may be circular, partially circular, elliptical, rectangular, parallelogram, trapezoidal, rhombus, etc., and a part of these shapes may be distorted. In this embodiment, the loop portion 81 is an elliptical ring having a through hole 82 in the center and having its major axis oriented along the central axis Ax. The tip of the loop portion 81 coincides with the tip 23 of the leading portion 20C.

[0052] The cross-sectional shape of the loop portion 81 can be any shape. The cross-sectional shape of the loop portion 81 may be circular, partially circular, elliptical, rectangular, parallelogram, trapezoidal, rhombus, etc. In this embodiment, as shown in Figure 20, the cross-sectional shape of the loop portion 81 is rectangular. The loop portion 81 has a third surface 83 and a fourth surface 84. The third surface 83 is a flat surface. The fourth surface 84 is a flat surface opposite to the third surface 83. The fourth surface 84 is parallel to the third surface 83. The through hole 82 penetrates between the third surface 83 and the fourth surface 84.

[0053] The coil 50 is joined to the core wire 40C by a tip-side joining member 71 and a base-side joining member 74, similar to the first embodiment. A portion of the tip-side joining member 71 extends inside the coil 50 and joins a portion of the first narrow-diameter portion 45, a portion of the connecting portion 86, and the tip of the coil 50. Another portion of the tip-side joining member 71 forms a reinforcing portion 72 that protrudes from the coil 50 toward the tip. The reinforcing portion 72 covers the portion of the connecting portion 86 that protrudes from the coil 50 toward the tip.

[0054] The marker portion 60C is located inside the through hole 82 in the loop portion 81. In this embodiment, the marker portion 60C is elliptical and disc-shaped. As shown in Figure 20, the marker portion 60C has a first surface 61C and a second surface 62C opposite to the first surface 61C. In this embodiment, the first surface 61C and the second surface 62C are flat surfaces. The first surface 61C and the second surface 62C are parallel to each other. The outer edge 62CE of the first surface 61C and the outer edge 62CE of the second surface 62C are provided along the portion of the loop portion 46 where the outer diameter DLC in the second direction is maximum. In this embodiment, the first surface 61C is in the same plane as the third surface 83 of the loop portion 81 and connects smoothly to the third surface 83 without any steps. The second surface 62C is in the same plane as the fourth surface 84 of the loop portion 81 and connects smoothly to the fourth surface 84 without any steps. The outer circumferential surface of the marker portion 60C is in direct contact with the inner circumferential surface of the through hole 82. Similar to the first embodiment, the marker portion 60C includes a flattened portion 63C in which the outer diameter Dm1C in the first direction is larger than the outer diameter Dm2C in the second direction.

[0055] The material of the tip member 80 is, for example, metal. The material of the tip member 80 may be a material that transmits radiation or a material that does not transmit radiation. Materials that transmit radiation may be, for example, stainless steel such as SUS302, SUS304, SUS316, Ni-Ti alloy, or piano wire. Materials that do not transmit radiation may be, for example, platinum, gold, tungsten, or tungsten alloy. The tip member 80 may be formed entirely from the same material, or each part may be formed from different materials.

[0056] The material of the marker portion 60C is, for example, a metal. The material of the marker portion 60C is a material that does not transmit radiation. The radiation-impermeable material may be, for example, platinum, gold, tungsten, or an alloy of any of these. In this embodiment, the tip member 80 and the marker portion 60C contain the same material.

[0057] The main body 10C includes a core wire 40C, a coil 50, the portion of the tip-side connecting member 71 excluding the reinforcing portion 72, the base-side connecting member 74, and the portion of the connecting portion 86 inserted into the coil 50. The leading portion 20C includes a loop portion 81, the portion of the connecting portion 86 protruding from the coil 50 toward the tip, the reinforcing portion 72, and a marker portion 60C.

[0058] Next, we will describe an example of a method for manufacturing the above-mentioned guidewire 100C.

[0059] First, the tip member 80 and the marker portion 60C are prepared (S210). The tip member 80 is formed, for example, as follows. First, a metal plate is punched out so that it has an annular portion that will become a loop portion 81 and a rectangular plate-shaped portion that will become a connecting portion 86. Next, the portion that will become the connecting portion 86 is bent into a cylindrical shape. The marker portion 60C is formed, for example, by punching out a metal plate. Next, the core wire 40C is passed through the coil 50 so that the tip of the core wire 40C protrudes from the coil 50 towards the tip side (S220, Figure 22). Next, the connecting portion 86 is joined to the first small diameter portion 45 (S230, Figure 22). Next, the first small diameter portion 45 and the connecting portion 86 are inserted into the coil 50 and joined to the coil 50 by the tip-side joining material 71. Next, the core wire 40C is joined to the base end of the coil 50 by the base end joining material 74 (S240, Figure 23). After joining, the marker portion 60C is housed inside the through hole 82 and joined to the loop portion 81, for example, by welding (S250, Figure 23). For example, the guide wire 100C of this embodiment is manufactured by the above process.

[0060] In this embodiment, the tip member 80, including the loop portion 81, is formed as a separate component from the core wire 40C and is joined to the core wire 40C. Therefore, there is no need to select a material for the loop portion 81 that is compatible with the core wire 40C, increasing the freedom of material selection for the loop portion 81. In this embodiment, the tip member 80 and the marker portion 60C are made of the same material. This increases the bonding strength between the loop portion 81 and the marker portion 60C.

[0061] As described above, in the guide wire 100C of this embodiment, the leading portion 20C comprises a loop-shaped loop portion 81 and a marker portion 60C that is disposed inside the loop portion 81 and is radiopaque. With this configuration, the visibility of the leading portion 20C is improved.

[0062] In this embodiment, the loop portion 81 and the marker portion 60C are made of the same material. This increases the bonding strength between the loop portion 81 and the marker portion 60C.

[0063] (modified version) The technologies disclosed herein are not limited to the embodiments described above and can be modified in various forms without departing from their essence, for example, the following modifications are possible. (1) Of the first surface and the second surface, one may be a flat surface and the other a convex surface, one may be a flat surface and the other a concave surface, or one may be a convex surface and the other a concave surface. (2) The outer shape of the marker portion does not have to match the shape of the inner circumferential surface of the loop portion; it is sufficient if it is a shape that can be placed inside the loop portion. For example, there may be a gap in part of the boundary between the marker portion and the loop portion. (3) The method for manufacturing the guide wire in the above embodiment is merely an example and can be modified in various ways. For example, the plate-shaped marker portion may be fixed inside the loop portion by press-fitting, by soldering, or by bonding with an adhesive. Alternatively, the loop portion may be formed by winding the tip of the core wire around the plate-shaped marker portion. Alternatively, the loop portion and the marker portion may be formed by a clad material in which a core material formed from the material of the marker portion and a coating layer that will be the material of the loop are joined together. (4) In the above embodiments, a guidewire 100 for treating lesions within blood vessels was used as an example. The techniques disclosed herein are similarly applicable to medical devices in general for treating lesions in biological tubular lumen.

Claims

1. Main body (10) and A reading unit (20) is connected to the tip (16) of the main body (10) and enters the lesion (220), Equipped with, The aforementioned reading unit (20) Loop-shaped loop section (46), A marker portion (60) is disposed inside the loop portion (46) and is radiopaque, Equipped with, Medical devices (100).

2. A medical device (100) according to claim 1, The main body (10) extends along the axis (Ax), The marker portion (60) includes a flattened portion (63) in which the outer diameter (Dm1) in a first direction perpendicular to the axis (Ax) is greater than the outer diameter (Dm2) in a second direction perpendicular to the axis (Ax) and the first direction. Medical devices (100).

3. A medical device (100) according to claim 1 or claim 2, The marker portion (60) The first surface (61) and, The first surface (61) and the second surface (62) opposite to it, It has, The first surface (61) is a flat surface. Medical devices (100).

4. A medical device (100) according to claim 3, The main body (10) extends along the axis (Ax), When the direction perpendicular to the aforementioned axis (Ax) is defined as the first direction, and the direction perpendicular to both the aforementioned axis (Ax) and the first direction is defined as the second direction, The outer edge (61E) of the first surface (61) is provided along the portion of the loop portion (46) where the outer diameter (DL) in the second direction is maximum. Medical devices (100).

5. A medical device (100) according to claim 3 or claim 4, The second surface (62) is a flat surface, The main body (10) extends along the axis (Ax), When the direction perpendicular to the aforementioned axis (Ax) is defined as the first direction, and the direction perpendicular to both the aforementioned axis (Ax) and the first direction is defined as the second direction, The outer edge (62E) of the second surface (62) is provided along the portion of the loop portion (46) where the outer diameter (DL) in the second direction is maximum. Medical devices (100).

6. A medical device (100A) according to any one of claims 1 to 3, The marker portion (60A) is The first surface (61A) and, The first surface (61A) and the second surface (62A) opposite to it, It has, The second surface (62A) is a convex surface that is convex on the opposite side from the first surface (61A). Medical device (100A).

7. A medical device (100B) according to any one of claims 1 to 3, The marker portion (60B) is The first surface (61B) and, The first surface (61B) and the second surface (62B) opposite to it, It has, The second surface (62B) is a concave surface that is recessed toward the first surface (61B). Medical device (100B).

8. A medical device (100) according to any one of claims 1 to 7, At least a portion of the marker portion (60) is in direct contact with the loop portion (46). Medical devices (100).

9. A medical device (100C) according to claim 8, The marker portion (60C) and the loop portion (81) contain the same material. Medical device (100C).

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