Medical device, and method for manufacturing a medical device

Abstract

To improve safety. [Solution] The medical device comprises a main body and a reading section connected to the tip of the main body and entering the lesion, the reading section comprising a loop-shaped loop section formed by a coil in which wire is wound in a spiral shape.

Description

Technical Field

[0005] , [Figure 1] ,

[0007] , , [Figure 2]

[0001] The technology disclosed in this specification relates to medical devices and methods for manufacturing medical devices.

Background Art

[0002] When treating a stenosis or occlusion (hereinafter referred to as a "lesion") in a blood vessel, a guide wire is used. A known guide wire includes an elongated member. The elongated member has a first portion with a first diameter and a second portion with a second diameter, and a loop is formed in the second portion. (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 safety of known guide wires.

[0005] This specification discloses a technology capable of solving the above 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 formed by a coil in which a wire is spirally wound.

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 of 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] Figure 3 shows a magnified section of the area within frame F. [Figure 5] Figure 4 shows a magnified section of the area within circle R. [Figure 6] Partially enlarged perspective view of the wire used in the coil of the first embodiment. [Figure 7] A flowchart 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 guide wire manufacturing method 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] An explanatory diagram showing an example of a treatment method using a guidewire according to the first embodiment. [Figure 13] A partially enlarged cross-sectional view showing the leading portion and its vicinity in the guide wire of the second embodiment, cut at the same position as line III-III in Figure 2. [Figure 14] A flowchart showing an example of a guide wire manufacturing method according to the second embodiment. [Figure 15] An explanatory diagram showing an example of a guide wire manufacturing method according to the second embodiment. [Figure 16] An explanatory diagram showing an example of a guide wire manufacturing method according to the second embodiment. [Figure 17] A cross-sectional view showing the guide wire of the third embodiment cut at the same position as line III-III in Figure 2. [Figure 18] A flowchart showing an example of a guide wire manufacturing method according to the third embodiment. [Figure 19] An explanatory diagram showing an example of a guide wire manufacturing method according to the third embodiment. [Figure 20] Explanatory drawing showing an example of a method for manufacturing a guide wire according to the third embodiment [Figure 21] Explanatory drawing showing an example of a method for manufacturing a guide wire according to the third embodiment [Figure 22] Explanatory drawing showing an example of a method for manufacturing a guide wire according to the third embodiment [Figure 23] Partial enlarged cross-sectional view showing the leading portion and the portion in its vicinity of the guide wire according to the fourth embodiment, cut at the same position as the line III-III in FIG. 2 [Figure 24] Partial enlarged cross-sectional view showing the leading portion and the portion in its vicinity of the guide wire according to the fifth embodiment, cut at the same position as the line III-III in FIG. 2 [Figure 25] Partial enlarged perspective view of the wire used for the coil according to the fifth embodiment [Figure 26] Partial enlarged cross-sectional view showing the leading portion and the portion in its vicinity of the guide wire according to the sixth embodiment, cut at the same position as the line III-III in FIG. 2

MODE FOR CARRYING OUT THE INVENTION

[0008] (First Embodiment) The first embodiment will be described with reference to FIGS. 1 to 12. The guide wire 100 of the present embodiment is a medical device inserted into a living body lumen in order to treat 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 distal end side inserted into the body, and the negative Z-axis direction side is the proximal end side operated by a technician such as a doctor. The distal end side is also referred to as the distal side, and the proximal end side is also referred to as the proximal side. In each figure, illustration of a part of the guide wire 100 may be omitted. FIGS. 1, 2, and 3 show a state in which the guide wire 100 is in a straight line parallel to the Z-axis. The guide wire 100 has flexibility enough to be curved. These points are the same in the following figures.

[0009] In this specification, for the guide wire 100 and its components, the tip end is referred to as the "tip," the tip and its vicinity as the "tip portion," the base end is referred to as the "base end," and the base end and its vicinity as the "base end portion." The cross-section of the guide wire 100 and its components means a cross-section perpendicular to the longitudinal direction. The longitudinal section of the guide wire 100 and its components means a cross-section parallel to the central axis in the longitudinal direction. For the guide wire 100 and its components, the direction perpendicular to the longitudinal direction is referred to as the radial direction. The outer diameter of the guide wire 100 and its components means the width along the radial direction.

[0010] The guidewire 100 is a medical device inserted into a biological lumen such as a blood vessel. The total length of the guidewire 100 is, for example, 1000 mm or more and 3000 mm or less.

[0011] As shown in Figures 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 a long section that extends along the central axis Ax. In this embodiment, the central axis Ax of the main body portion 10 coincides with the central axis of the guide wire 100. The base end 15 of the main body portion 10 coincides with the base 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. 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, digging 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, a first coil 50, and a second coil 60. The first coil 50 is an example of a cylindrical body. The second coil 60 is an example of a coil.

[0015] The first coil 50 is a cylindrical member in which one or more wires are wound in a spiral. In this embodiment, the first coil 50 is a multi-wire coil in which multiple wires are wound. The outer diameter of the first coil 50 is, for example, 0.1 mm or more and 0.6 mm or less. The outer diameter of the first 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 first 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 first coil 50 is constant along its entire length. The first 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.

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

[0017] The material of the first coil 50 is, for example, a metal. The material of the first 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. The first 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 section 41, a first tapered section 42, an intermediate diameter section 43, a second tapered section 44, and a small diameter section 45. The large diameter section 41, the first tapered section 42, the intermediate diameter section 43, the second tapered section 44, and the small diameter section 45 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 small diameter section 45 is located closer to the tip than the intermediate diameter section 43 and is a rod-shaped portion 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 small 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 small diameter section 45.

[0020] 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, partial circular, elliptical, rectangular, parallelogram, trapezoidal, rhombus, etc. A partial circular is one half of a circle divided into two equal parts by a chord. The outer edge of a partial circular consists of an arc and a line segment connecting the two ends of the arc. A partial circular may also 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.

[0021] The material of the core wire 40 is, for example, metal. More specifically, the material of the core wire 40 may be, for example, stainless steel such as SUS302, SUS304, SUS316, Ni-Ti alloy, or piano wire. The core wire 40 may be formed entirely from the same material, or each part may be formed from a different material.

[0022] The core wire 40 is inserted inside the first coil 50. In other words, a portion of the core wire 40 is covered by the first coil 50. In this embodiment, the second tapered portion 44 and the small diameter portion 45 of the core wire 40 are covered by the first coil 50.

[0023] The second coil 60 is a coil in which one or more wires 601 are wound in a spiral shape. The wire forming the second coil 60 may be a single strand or a stranded wire in which multiple strands are twisted together. In this embodiment, the wire 601 forming the second coil 60 is a stranded wire in which multiple strands 602 are twisted together, as shown in Figure 5. In drawings other than Figure 5, the wire 601 is shown in a simplified manner for clarity. In this embodiment, the coil diameter of the second coil 60 is substantially constant along the entire length of the second coil 60. The second coil 60 is a tightly wound coil in which adjacent parts of the wire 601 are wound in contact with each other. One end of the second coil 60 is connected to the tip of the narrow-diameter section 45.

[0024] As shown in Figures 3 and 4, the second coil 60 includes a first end 61, a second end 62, and a loop portion 63.

[0025] The first end 61 includes one end of the second coil 60 connected to the narrow diameter portion 45 and is inserted inside the first coil 50. The second end 62 is the end of the second coil 60 opposite to the first end 61 and is also inserted inside the first coil 50. The first end 61 and the second end 62 extend substantially in a straight line along the central axis Ax.

[0026] The loop portion 63 is the part of the second coil 60 between the first end portion 61 and the second end portion 62, and is located closer to the tip than the first coil 50. The loop portion 63 is bent into a loop shape. More specifically, the loop portion 63 extends from the tip of the first end portion 61, 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 to the outside of the ring. In this embodiment, most of the loop portion 63, excluding both ends, forms a shape in which a part of an ellipse with its major axis along the direction of the central axis Ax is missing, and both ends extend substantially in a straight line toward the base end. In this embodiment, there is a gap between the two ends of the loop portion 63. The two ends of the loop portion 63 may be in contact or may intersect. The shape of the ring formed by the loop portion may be circular, partially circular, elliptical, rectangular, parallelogram, trapezoidal, rhombus, etc., and a part of these shapes may be distorted. The space inside the loop portion 63 is a through hole 24 extending in the X-axis direction. The tip of the loop portion 63 coincides with the tip 23 of the leading portion 20. Because the loop portion 63 has a curved shape, as shown in Figure 5, there is a gap C1 between adjacent parts of the wire 601 on the outer circumference side of the loop portion 63. In this embodiment, the curvature of the loop portion 63 is larger near the tip 23 of the leading portion 20 compared to other parts, and the gap C1 is also relatively larger near the tip 23.

[0027] The material of the second coil 60 is, for example, a metal. The material of the second coil 60 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, nickel, 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. In this embodiment, the material of the second coil 60 is a material that does not transmit radiation. The second coil 60 may be formed entirely of the same material, or each part may be formed of different materials.

[0028] The tip of the first coil 50 is joined to the second coil 60 by a tip-side joining member 71. The tip-side joining member 71 is an example of a joining member. Part of the tip-side joining member 71 is embedded inside the first coil 50, joining part of the first end 61, part of the second end 62, and the tip of the first coil 50. Another part of the tip-side joining member 71 is a reinforcing portion 72 that protrudes from the tip 51 of the first coil 50 toward the tip. The reinforcing portion 72 covers both ends of the loop portion 63. This reinforcing portion 72 reinforces the connection point between the leading portion 20 and the main body portion 10. The connection portion between the second coil 60 and the core wire 40 is located inside the first coil 50. The connection portion between the second coil 60 and the core wire 40 may be embedded inside the tip-side joining member 71, or it may be located on the base end side of the tip-side joining member 71. The base end of the first coil 50 is joined to the core wire 40 by a base-side joining member 74. The first coil 50 may also be joined to the core wire 40 via joining members formed at other locations. The materials for the tip-side joining member 71 and the base-side joining member 74 are, for example, solder, brazing material, and 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.

[0029] The main body 10 includes a core wire 40, a first coil 50, a first end 61, a second end 62, the portion of the tip-side connecting member 71 excluding the reinforcing portion 72, and a base-side connecting member 74. The leading portion 20 includes a loop portion 63 and a reinforcing portion 72.

[0030] As shown in Figure 1, in a view along the X-axis, the outer diameter of the leading portion 20 changes along the central axis Ax. Specifically, the outer diameter of the leading portion 20 at its base end 27 is approximately the same as the maximum outer diameter D1 of the tip 16 of the main body 10. The outer diameter of the leading portion 20 gradually decreases from the base end 27 toward the tip, then gradually increases to a maximum outer diameter D2 at the maximum outer diameter position Px, and then gradually decreases from the maximum outer diameter position Px toward the tip 23 of the leading portion 20. The maximum outer diameter D2 of the leading portion 20 is, for example, 0.2 mm or more and 1.0 mm or less. The maximum outer diameter D2 of the leading portion 20 may also be 0.3 mm or more and 0.8 mm or less, or 0.4 mm or more and 0.6 mm or less. The maximum outer diameter D2 of the leading portion 20 may be 1.00 mm or more and 3.00 mm or less, 1.20 mm or more and 2.50 mm or less, or 1.50 mm or more and 2.00 mm or less.

[0031] The maximum outer diameter D2 of the leading section 20 is measured as follows. The measurer observes the guide wire 100 from the side. In this embodiment, the side is the Y-axis direction. The measurer searches for an angle in the second coil 60 where the front portion and the back portion overlap, and the back portion is not visible. For example, the measurer searches for an angle in which the portion between the second end 62 and the tip 23 is not visible if both of the following two conditions are met. The first condition is that the portion between the first end 61 and the tip 23 is on the front side. The second condition is that the portion between the second end 62 and the tip 23 is on the back side. The invisibility of the portion between the second end 62 and the tip 23 is caused by the overlap between the portion between the first end 61 and the tip 23 and the portion between the second end 62 and the tip 23. Next, the measurer photographs the guide wire 100 using a microscope along a viewpoint rotated 90 degrees around the central axis Ax from this viewpoint. The measurer sets the magnification of the microscope to 200x or more. The measurer measures the outer diameter of the leading section 20 at three measurement positions on the captured image where the leading section 20 is thought to have its maximum outer diameter D2. Specifically, at each measurement position, the measurer draws a pair of parallel lines that pass through a pair of ends in the outer diameter direction of the leading section 20 and are perpendicular to the outer diameter direction, and measures the distance between these pairs of lines. The measurer adopts the maximum value among the measurement results at the three measurement positions as the maximum outer diameter D2 of the leading section 20.

[0032] As shown in Figure 1, the leading portion 20 has a maximum outer diameter D2 that is larger than the maximum outer diameter D1 of the tip 16 of the main body portion 10. In this embodiment, the maximum outer diameter D2 of the leading portion 20 coincides with the maximum outer diameter of the loop portion 63.

[0033] Next, an example of a method for manufacturing the guide wire 100 described above will be explained.

[0034] First, the core wire 40, the first coil 50, and the second coil 60 are prepared as separate components (S110, Figure 8). Next, the core wire 40 is passed through the first coil 50, and positioned so that its tip protrudes from the first coil 50 (S120, Figure 8). Next, the base end of the second coil 60 is joined to the tip of the core wire 40, for example, by welding (S130, Figure 8). At the time of joining, the second coil 60 is not bent and is in a straight state. After joining, the second coil 60 is bent into a loop shape using a pin P (S140, Figure 9). After bending, the first end 61 and the second end 62 of the second coil 60 are inserted into the first coil 50 and joined to the tip of the first coil 50 by the tip-side joining material 71. Next, the core wire 40 is joined to the base end of the first coil 50 by the base end joining material 74 (S150, Figure 10). For example, the guide wire 100 of this embodiment is manufactured by the above process.

[0035] In the manufacturing method of the guide wire 100 of this embodiment, a core wire 40 and a second coil 60 formed as a separate component from the core wire 40 are joined together. With this configuration, a guide wire 100 having a leading portion 20 with a loop portion 63 formed by the second coil 60 can be easily manufactured.

[0036] In the above method for manufacturing the guide wire 100, the properties of the guide wire 100 change as the length of the second coil 60 and the length of the core wire 40 change. In other words, by appropriately setting the length of the second coil 60 and the length of the core wire 40, it is possible to obtain a guide wire 100 with desired properties.

[0037] Next, an example of a treatment method using a catheter 120 equipped with the guidewire 100 described above will be explained.

[0038] 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.

[0039] 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.

[0040] The leading portion 20 has a certain degree of flexibility so that the guidewire 100 does not damage the blood vessel 200 as it advances through the vessel. In this embodiment, the loop portion 63 is formed by a second coil 60 around which the wire 601 is wound. Such a loop portion 63 is highly flexible and easily deformed with small forces. In other words, when the loop portion 63 abuts against the inner wall of the blood vessel 200, it deforms easily, thereby reducing the load applied to the inner wall of the blood vessel 200 from the leading portion 20. As a result, safety is improved. In addition, the wire 601 is a stranded wire in which multiple strands 602 are twisted together. When the wire 601 is a stranded wire, it is more flexible and less prone to breakage than when the wire is a single strand. Therefore, safety is further enhanced.

[0041] When the guidewire 100 passes through the lesion 220, the leading section 20 is required to efficiently excavate the lesion 220 as it advances. In this embodiment, since the second coil 60 is a tightly wound coil, a certain degree of rigidity is ensured in the loop section 63. As a result, the lesion 220 is efficiently cut. Furthermore, there is a gap C1 between adjacent parts of the wire 601 that make up the loop section 63. When the lesion 220 enters this gap C1, the wire 601 is more likely to catch on the lesion 220, so the lesion 220 is efficiently cut. As a result, the passability of the leading section 20 through the lesion 220 is improved. In addition, the maximum outer diameter D2 of the leading section 20 is larger than the maximum outer diameter D1 of the tip 16 of the main body 10. In other words, there is a relatively large gap between the tip 16 of the main body 10 and the inner wall of the blood vessel 200. Therefore, small fragments of the lesion 220, generated by contact between the leading portion 20 and the lesion 220, are smoothly discharged through this gap from the tip side to the proximal end side of the main body 10. As a result, the obstruction of excavation by the leading portion 20 by the small fragments of the lesion 220 is suppressed, and the passability of the leading portion 20 through the lesion 220 is improved.

[0042] To enable the leading section 20 to efficiently excavate the lesion 220, the guide wire 100 has high torque transmission capabilities. Torque transmission capabilities refer to the ability to smoothly transmit torque to the tip when the proximal end is rotated by a surgeon, such as a physician. In this embodiment, the main body 10 includes a core wire 40 connected to the second coil 60. With this configuration, when the proximal end of the guide wire 100 is rotated by a surgeon, the torque is smoothly transmitted to the second coil 60 by the core wire 40. As a result, good torque transmission capabilities are ensured.

[0043] 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 used, for example. The fluoroscopy device is, for example, an X-ray fluoroscopy device. In this embodiment, the second coil 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.

[0044] As described above, the guide wire 100 of this embodiment comprises a main body portion 10 and a leading portion 20 connected to the tip of the main body portion 10 and entering the lesion portion 220. The leading portion 20 comprises a loop-shaped loop portion 63 formed by a second coil 60 around which the wire 601 is wound. With this configuration, safety is improved.

[0045] In this embodiment, the main body 10 includes a core wire 40 connected to the second coil 60. This configuration ensures good torque transmission.

[0046] In this embodiment, the main body 10 further comprises a first coil 50. The connection portion between the second coil 60 and the core wire 40 is located inside the first coil 50. With this configuration, the connection portion between the second coil 60 and the core wire 40 is protected by the first coil 50.

[0047] In this embodiment, the maximum outer diameter D2 of the leading portion 20 is larger than the maximum outer diameter D1 of the tip 16 of the main body portion 10. With this configuration, the passage of the leading portion 20 through the lesion portion 220 is improved.

[0048] In this embodiment, the second coil 60 is radiopaque. This configuration improves the visibility of the reading section 20 under radiofluoroscopy.

[0049] In this embodiment, at the tip 23 of the leading portion 20, there is a gap C1 between adjacent portions of the wire 601. This configuration improves the passage of the leading portion 20 through the lesion 220.

[0050] In this embodiment, the wire 601 is a stranded wire in which multiple strands 602 are twisted together. This configuration further enhances safety.

[0051] In this embodiment, the second coil 60 is a tightly wound coil in which adjacent portions of the wire 601 are wound in contact with each other. With this configuration, the passage of the leading portion 20 through the lesion portion 220 is improved.

[0052] In the manufacturing method of the guide wire 100 of this embodiment, a core wire 40 and a second coil 60 formed as a separate component from the core wire 40 are joined together. With this configuration, a guide wire 100 having a loop portion 63 formed by the second coil 60 can be easily manufactured. In addition, it becomes easy to impart desired properties to the guide wire 100.

[0053] (Second Embodiment) A second embodiment will be described with reference to Figure 13-16. In this embodiment, the guide wire 100A has some differences in the configuration of the core wire 40A and the second coil 60A compared to the first embodiment. In this embodiment, components identical to those in the first embodiment are denoted by the same reference numerals and their description is omitted.

[0054] As shown in Figure 13, the guide wire 100A of this embodiment comprises a core wire 40A, a first coil 50, and a second coil 60A. The second coil 60A is an example of a coil.

[0055] The core wire 40A has the same configuration as the first embodiment, except that the tip of the small-diameter portion 45A is closer to the tip 51 of the first coil 50 than in the first embodiment. The second coil 60A has the same configuration as the first embodiment, except that the base end of the first end 61A and the base end of the second end 62A are closer to the tip 51 of the first coil 50 than in the first embodiment.

[0056] The tip of the first coil 50 is joined to the core wire 40A by a tip-side joining member 71. A portion of the tip-side joining member 71 extends inside the first coil 50, joining the first end 61A, the second end 62A, and the tip of the first coil 50. The first end 61A, the second end 62A, and the tip of the narrow-diameter section 45A are embedded inside the tip-side joining member 71. Another portion of the tip-side joining member 71 is a reinforcing portion 72 that protrudes from the tip 51 of the first coil 50 toward the tip. The reinforcing portion 72 covers both ends of the loop section 63.

[0057] The main body 10A includes a core wire 40A, a first coil 50, a first end 61A, a second end 62A, the tip-side connecting member 71 excluding the reinforcing portion 72, and a base-side connecting member 74. The leading portion 20A includes a loop portion 63 and a reinforcing portion 72.

[0058] Next, we will describe an example of a method for manufacturing the guide wire 100A mentioned above.

[0059] First, the core wire 40A, the first coil 50, and the second coil 60A are prepared as separate components (S210). Next, the second coil 60A is bent into a loop shape using a pin P (S220, Figure 15). After bending, the first end 61A and the second end 62A of the second coil 60A, and the core wire 40A are inserted into the first coil 50 (S230, Figure 16). Next, the first end 61A, the second end 62A, and the tip of the core wire 40A are joined to the tip of the first coil 50 by a tip-side joining member 71. Subsequently, the core wire 40A is joined to the base end of the first coil 50 by a base-side joining member 74 (S240, Figure 16). For example, the guide wire 100 of this embodiment is manufactured by the above process.

[0060] As described above, the guide wire 100A of this embodiment comprises a main body portion 10A and a leading portion 20A, similar to the first embodiment. The leading portion 20A includes a loop-shaped loop portion 63 formed by a second coil 60A around which the wire 601 is wound. This configuration improves safety.

[0061] The guide wire 100A of this embodiment further includes a tip-side joining member 71 that joins the first coil 50 and the core wire 40A. The first end 61A and the second end 62A of the second coil 60A are embedded inside the tip-side joining member 71. With this configuration, only the tip portion of the guide wire 100A is formed by the second coil 60A. This increases the design flexibility of the main body 10A. In addition, it becomes possible to position the core wire 40A near the tip of the main body 10A. This ensures good torque transmission.

[0062] In the manufacturing method of the guide wire 100 of this embodiment, the core wire 40A, the second coil 60A formed as a separate component from the core wire 40A, and the first coil 50 are joined together by a tip-side joining material 71. With this configuration, a guide wire 100A having a loop portion 63 formed by the second coil 60A can be easily manufactured.

[0063] (Third embodiment) A third embodiment will be described with reference to Figure 17-22. The guide wire 100B of this embodiment differs from the first embodiment in that the second coil 46, which has a loop portion 49, and the core wire 40B are integrally formed as a single component. The second coil 46 is an example of a coil. In this embodiment, components identical to those in the first embodiment are denoted by the same reference numerals and their description is omitted.

[0064] As shown in Figure 17, the guide wire 100B of this embodiment comprises a wire member 400 and a first coil 50. The wire member 400 comprises a core wire 40B and a second coil 46.

[0065] The core wire 40B has a large diameter section 41, a first tapered section 42, an intermediate diameter section 43, a second tapered section 44B, a first small diameter section 45B, and a second coil 46. The large diameter section 41, the first tapered section 42, the intermediate diameter section 43, the second tapered section 44B, and the first small diameter section 45B are arranged in this order from the base end of the core wire 40B.

[0066] The portion from the large diameter portion 41 to the intermediate diameter portion 43 is the same as in the first embodiment. The first small diameter portion 45B is located closer to the tip than the intermediate diameter portion 43 and is a thin, wire-like portion having a substantially constant outer diameter smaller than the outer diameter of the intermediate diameter portion 43. The second tapered portion 44B is located between the intermediate diameter portion 43 and the first small diameter portion 45B and is a portion in which the diameter gradually decreases from the boundary with the intermediate diameter portion 43 towards the boundary with the first small diameter portion 45B.

[0067] The second coil 46 is formed by spirally winding a thin wire-shaped second diameter portion 401, which is connected to the tip of the first diameter portion 45B of the wire member 400. The second diameter portion 401 is an example of a wire and a diameter portion. In this embodiment, the wire diameter of the second diameter portion 401 is equal to the outer diameter of the first diameter portion 45B. The second coil 46 may be a tightly wound coil in which adjacent portions of the second diameter portion 401 are in contact with each other, or it may be a loosely wound coil in which there are gaps between adjacent portions of the second diameter portion 401. In this embodiment, the coil diameter of the second coil 46 is substantially constant along the entire length of the second coil 46.

[0068] The second coil 46 comprises a first end 47, a second end 48, and a loop portion 49. The first end 47 is the end of the second coil 46 that is connected to the first narrow-diameter portion 45B and is inserted inside the first coil 50. The second end 48 is the end of the second coil 46 opposite to the first end 61 and is inserted inside the first coil 50.

[0069] The loop portion 49 is the part of the second coil 46 between the first end 47 and the second end 48, and is located closer to the tip than the first coil 50. The loop portion 49 is bent into a loop shape, similar to the first embodiment. The detailed shape of the loop portion 49 is the same as that of the loop portion 63 in the first embodiment.

[0070] The tip of the first coil 50 is joined to the wire member 400 by a tip-side joining member 71. A portion of the tip-side joining member 71 extends inside the first coil 50 and joins the first end 47, the second end 48, and the tip of the first coil 50. Another portion of the tip-side joining member 71 forms a reinforcing portion 72 that protrudes from the first coil 50 toward the tip. The reinforcing portion 72 covers both ends of the loop portion 49. The connection portion between the second coil 46 and the core wire 40B is located inside the first coil 50. The connection portion between the second coil 46 and the core wire 40B may be embedded inside the tip-side joining member 71, or it may be located on the base end side of the tip-side joining member 71.

[0071] The main body 10B includes a core wire 40B, a first coil 50, a first end 47, a second end 48, the portion of the tip-side connecting member 71 excluding the reinforcing portion 72, and a base-side connecting member 74. The leading portion 20B includes a loop portion 49 and a reinforcing portion 72.

[0072] Next, we will describe an example of a method for manufacturing the guide wire 100B mentioned above.

[0073] First, a material wire 410, which will be the material for the core wire 40B, is prepared. The core wire 40B and a second thin-diameter portion 401 connected to the core wire 40B are formed by, for example, drawing this material wire 410 (S310, Figure 19). Next, the material wire 410 after drawing is passed through the first coil 50, and the second thin-diameter portion 401 is positioned so that it protrudes from the tip side of the first coil 50 (S320, Figure 19). Next, the second thin-diameter portion 401 is wound to form the second coil 46 (S330, Figure 20). Next, the second coil 46 is bent into a loop shape using a pin P (S340, Figure 21). After bending, the first end 47 and the second end 48 of the second coil 46 are inserted into the first coil 50 and joined to the tip of the first coil 50 by a tip-side joining material 71. Next, the core wire 40B is joined to the base end of the first coil 50 by the base end joining material 74 (S350, Figure 22). For example, the guide wire 100 of this embodiment is manufactured by the above process.

[0074] As described above, the guide wire 100B of this embodiment comprises a main body portion 10B and a leading portion 20B, similar to the first embodiment. The leading portion 20B includes a loop-shaped loop portion 49 formed by a second coil 46 around which a second thin-diameter portion 401 is wound. This configuration improves safety.

[0075] In the manufacturing method of the guide wire 100B of this embodiment, the material wire 410, which will be the material for the core wire 40B, is processed to form the core wire 40B and a second thin-diameter portion 401 connected to the core wire 40B. Next, the second thin-diameter portion 401 is wound to form a second coil 46. Then, the second coil 46 is bent into a loop to form the leading portion 20B. With this configuration, there is no need to join the core wire 40B and the second coil 46, thus simplifying the manufacturing process.

[0076] (Fourth Embodiment) A fourth embodiment will be described with reference to Figure 23. In the guide wire 100C of this embodiment, the configuration of the second coil 60C differs from that of the first embodiment. The second coil 60C is an example of a coil. In this embodiment, components identical to those in the first embodiment are denoted by the same reference numerals and their description is omitted.

[0077] The second coil 60C of this embodiment is the same as that of the first embodiment, except that it is a loosely wound coil wound in the wire 601 such that there are gaps between adjacent portions. The second coil 60C, like the first embodiment, includes a first end portion 61C, a second end portion 62C, and a loop portion 63C. Because the second coil 60C is a loosely wound coil, the size of the gap C2 between adjacent portions in the wire 601 is larger than that of the first embodiment, where the second coil 60 is a tightly wound coil.

[0078] The guide wire 100C of this embodiment comprises a main body portion 10C and a leading portion 20C, similar to the first embodiment. The leading portion 20C includes a loop-shaped loop portion 63C formed by a second coil 60C around which the wire 601 is wound. This configuration improves safety.

[0079] In this embodiment, the second coil 60C is a loosely wound coil in which there are gaps between adjacent portions of the wire 601. This further increases the flexibility of the loop portion 63. In addition, the gaps C2 between adjacent portions of the wire 601 are relatively large, making it easier for the wire 601C to catch on the lesion portion 220. As a result, safety and ease of passage through the lesion portion 220 are achieved simultaneously.

[0080] (Fifth embodiment) A fifth embodiment will be described with reference to Figures 24-25. In this embodiment, the guide wire 100D differs from that of the first embodiment in the configuration of the second coil 60D. The second coil 60D is an example of a coil. In this embodiment, components identical to those in the first embodiment are denoted by the same reference numerals and their descriptions are omitted.

[0081] The second coil 60D of this embodiment is the same as that of the first embodiment, except that the wire 601D is a single strand and the cross-sectional shape of the wire 601D is rectangular. The second coil 60D, like that of the first embodiment, includes a first end 61D, a second end 62D, and a loop portion 63D.

[0082] The guide wire 100D of this embodiment comprises a main body portion 10D and a leading portion 20D, similar to the first embodiment. The leading portion 20D includes a loop-shaped loop portion 63D formed by a second coil 60D around which a wire 601D is wound. This configuration improves safety.

[0083] In this embodiment, since the cross-sectional shape of the wire 601D in the second coil 60D is rectangular, an edge E exists on the surface of the loop portion 63D, which is the boundary between the two surfaces of the wire 601. Therefore, the wire 601C is more likely to catch on the lesion portion 220. As a result, the passage of the leading portion 20D through the lesion portion 220 is improved. In addition, the second coil 60D, in which the cross-sectional shape of the wire 601D is rectangular, has the same rigidity but is smaller in size compared to a coil in which the cross-sectional shape of the wire is circular. Therefore, the leading portion 20D is made more compact.

[0084] (Sixth Embodiment) A sixth embodiment will be described with reference to Figure 26. In this embodiment, the configuration of the connection portion between the second coil 60 and the core wire 40E in the guide wire 100E differs from that of 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.

[0085] As shown in Figure 26, the guide wire 100E of this embodiment comprises a core wire 40E, a first coil 50, and a second coil 60.

[0086] The core wire 40E of this embodiment has the same configuration as the first embodiment, except that the outer diameter of the small-diameter portion 45E is smaller than the inner diameter of the second coil 60. The tip of the small-diameter portion 45E coincides with the tip of the core wire 40E. The tip of the small-diameter portion 45E is positioned inside the first end portion 61. The tip of the small-diameter portion 45E is joined to the first end portion 61. The method of joining the small-diameter portion 45E and the first end portion 61 may be, for example, welding or soldering.

[0087] The guide wire 100E of this embodiment comprises a main body 10E and a leading portion 20, similar to the first embodiment. The leading portion 20 includes a loop-shaped loop portion 63 formed by a second coil 60 around which a wire 601 is wound. This configuration improves safety.

[0088] In this embodiment, the tip of the core wire 40E is positioned inside the second coil 60, and the second coil 60 and the tip of the core wire 40E are joined together. With this configuration, the joint strength between the second coil 60 and the core wire 40E is increased.

[0089] (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) The guide wire does not need to have a first coil. (2) The method of connecting the main body and the coil may differ from the method of joining using the tip-side joining material 71. For example, the coil may be fixed to the main body by covering the main body and the coil with a tubular member and crimping them together. (3) In the first and third embodiments, the connection portion between the second coil 60 and the core wire 40 (40B) may be embedded inside the tip-side connecting member 71, or it may be located on the base end side of the tip-side connecting member 71. This also applies to the fourth, fifth, and sixth embodiments. (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 leading section (20) includes a loop-shaped loop section (63) formed by a coil (60) in which a wire (601) is wound in a spiral shape. Medical devices (100).

2. A medical device (100) according to claim 1, The main body (10) includes a core wire (40) connected to the coil (60). Medical devices (100).

3. A medical device (100) according to claim 2, The main body (10) further comprises a cylindrical body (50), The connection portion between the coil (60) and the core wire (40) is located inside the cylindrical body (50). Medical devices (100).

4. A medical device (100A) according to claim 3, The system further comprises a joining material (71) for joining the cylindrical body (50) and the core wire (40A), The end of the coil (60A) is embedded inside the joining material (71). Medical device (100A).

5. A medical device (100E) according to any one of claims 2 to 4, The tip of the core wire (40E) is positioned inside the coil (60E), and the coil (60E) and the tip of the core wire (40E) are joined together. Medical devices (100).

6. A medical device (100B) according to any one of claims 2 to 4, The coil (60) and the core wire (40B) are integrally formed as a single component. Medical device (100B).

7. A medical device (100) according to any one of claims 1 to 6, The maximum outer diameter (D2) of the leading portion (20) is greater than the maximum outer diameter (D1) of the tip (16) of the main body portion (10). Medical devices (100).

8. A medical device (100) according to any one of claims 1 to 7, The coil (60) is radiopaque. Medical devices (100).

9. A medical device (100) according to any one of claims 1 to 8, At the tip (23) of the leading portion (20), there is a gap (C1) between adjacent parts of the wire (601). Medical devices (100).

10. A medical device (100) according to any one of claims 1 to 9, The aforementioned wire (601) is a stranded wire in which multiple strands (602) are twisted together. Medical devices (100).

11. A medical device (100D) according to any one of claims 1 to 9, The cross-section of the aforementioned wire (601D) is rectangular. Medical device (100D).

12. A medical device (100C) according to any one of claims 1 to 11, The coil (60C) is a loosely wound coil in which there is a gap (C2) between adjacent portions of the wire (601C). Medical device (100C).

13. A medical device (100) according to any one of claims 1 to 11, The coil (60) is a tightly wound coil in which adjacent portions of the wire (601) are wound in contact with each other. Medical devices (100).

14. 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 leading portion (20) includes a loop portion (63) formed by at least a portion of the coil (60) around which the wire (601) is wound, The main body (10) includes a core wire (40) connected to the coil (60), A method for manufacturing a medical device (100), The core wire (40) and the coil (60), which is formed as a separate component from the core wire (40), are joined together. A method for manufacturing a medical device (100).

15. A method for manufacturing the medical device (100A) according to claim 14, The main body (10) further comprises a cylindrical body (50), The core wire (40A), the coil (60A), and the cylindrical body (50) are joined together by a joining material (71). A method for manufacturing a medical device (100A).

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