Medical device, and method for manufacturing a medical device

Abstract

To improve permeability to the lesion. [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 having a protrusion on its surface.

Description

Technical Field

[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 passageability of known guide wires with respect to lesions.

[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 a lesion, and the leading portion has a plurality of convex portions on its surface.

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] 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 R1. [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] 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 13] Figure 12 shows a magnified section of the area within circle R2. [Figure 14] A flowchart showing an example of a guide wire manufacturing method according to the second embodiment. [Figure 15] A partially enlarged perspective view showing the leading portion and its vicinity in the guide wire of the third embodiment. [Figure 16] A partially enlarged cross-sectional view showing the guide wire of the third embodiment, cut along the line XVI-XVI in Figure 15. [Figure 17] A partially enlarged perspective view showing the leading portion and its vicinity in the guide wire of the fourth embodiment. [Figure 18] A partially enlarged perspective view showing the leading portion and its vicinity in the guide wire of the fifth embodiment. [Modes for carrying out the invention]

[0008] (First Embodiment) The first embodiment will be described with reference to FIGS. 1 to 11. The guide wire 100 of this 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 end side operated by a technician such as a doctor. The tip 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 where 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 constituent members, the end on the tip side is referred to as the "tip", the tip and its vicinity are referred to as the "tip portion", the end on the proximal end side is referred to as the "proximal end", and the proximal end and its vicinity are referred to as the "proximal end portion". The cross-section of the guide wire 100 and each of its constituent members means a cross-section orthogonal to the longitudinal direction. The longitudinal cross-section of the guide wire 100 and each of its constituent members means a cross-section parallel to the central axis in the longitudinal direction. For the guide wire 100 and each of its constituent members, 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 constituent members means the width along the radial direction.

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

[0011] As shown in FIGS. 1 and 2, the guide wire 10 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. 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 expressed as a leading part, a drill part, a crushing part, a peeling part, an entry part, a peeler, a shaver, etc. The leading portion 20 has a proximal end 27 connected to the distal end 16 of the main body portion 10 and a distal end 23 opposite to the proximal end 27. The distal end 23 of the leading portion 20 coincides with the distal end 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 leading portion 20 entering the lesion can be expressed as passing through the lesion, drilling the lesion, crushing the lesion, peeling the lesion, separating the lesion, diving into the lesion, entering the lesion, etc. The length L20 of the leading portion 20 along the central axis Ax is, for example, 0.2 mm or more and 2.0 mm or less. The length L20 of the leading portion 20 may be 0.3 mm or more and 1.5 mm or less, or may be 0.4 mm or more and 1.0 mm or less.

[0014] As shown in FIG. 3, the guide wire 100 includes 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. The loop portion 46 is an example of a base portion.

[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-shaped" 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 with its major axis along the direction of the central axis Ax is missing, 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 be partially distorted. The space inside the loop portion 46 is a through hole 24 extending in the X-axis direction. 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 the shape of 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 the shape of 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 of the part of the core wire 40 that becomes the loop portion 46 is circular. The surface of the loop portion 46 has an outer circumferential surface 46S1 and an inner circumferential surface 46S2. The inner circumferential surface 46S2 is the portion of the surface of the loop portion 46 that faces the internal space of the loop portion 46, and the outer circumferential surface 46S1 is the remaining portion of the surface of the loop portion 46 excluding the inner circumferential surface 46S2.

[0023] 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.

[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] 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, and 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 and the reinforcing portion 72.

[0026] 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.

[0027] 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 in the Y-axis direction. The measurer searches for an angle in the loop section 46 where the front and back portions overlap and the back portion is not visible. For example, the measurer searches for an angle in which the portion between the second thin section 47 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 thin section 45 and the tip 23 is on the front side. The second condition is that the portion between the second thin section 47 and the tip 23 is on the back side. The invisibility of the portion between the second thin section 47 and the tip 23 is caused by the overlap between the portion between the first thin section 45 and the tip 23 and the portion between the second thin section 47 and the tip 23. Next, the measurer photographs the guide wire 100 using a microscope along a viewpoint rotated 90 degrees around the central axis Ax from this viewpoint. The operator sets the microscope's magnification to 200x or higher. The operator measures the outer diameter of the leading section 20 at three measurement positions on the captured image where the leading section 20 is thought to have its maximum outer diameter D2. Specifically, at each measurement position, the operator draws a pair of parallel lines that pass through a pair of ends in the outer diameter direction of the leading section 20 and are perpendicular to the outer diameter direction, and measures the distance between these pairs of lines. The operator adopts the maximum value among the measurement results at the three measurement positions as the maximum outer diameter D2 of the leading section 20.

[0028] As shown in Figure 4, the loop portion 46 comprises a widened portion 461 having an outer diameter larger than the maximum outer diameter D1 of the tip 16 of the main body portion 10, and a tip portion 462 located closer to the tip than the widened portion 461.

[0029] As shown in Figure 5, a plurality of protrusions 48 are arranged on the surface of the loop portion 46. The protrusions 48 are formed by particles 60 attached to the surface of the loop portion 46. The particles 60 are an example of attached material. Each protrusion 48 may contain one particle 60 or two or more. The heights of the plurality of protrusions 48 are non-uniform. That is, the plurality of protrusions 48 include a first protrusion 481 having a first height H1 and a second protrusion 482 having a second height H2 different from the first height H1.

[0030] The protrusions 48 may be arranged on the entire surface of the loop portion 46, or only partially. Two adjacent protrusions 48 may be separated from each other, or they may be in contact. The protrusions 48 may be arranged on the surface of the widening portion 461, on the surface of the tip portion 462, on both the surface of the widening portion 461 and the surface of the tip portion 462, or on different parts from both the surface of the widening portion 461 and the surface of the tip portion 462. The protrusions 48 may be arranged on the outer circumferential surface 46S1 of the widening portion 461, or on the outer circumferential surface 46S1 of the tip portion 462. In this embodiment, the protrusions 48 are arranged on both the outer circumferential surface 46S1 of the widening portion 461 and the outer circumferential surface 46S1 of the tip portion 462.

[0031] The material of particle 60 may be, for example, metal, ceramic, diamond, or cermet.

[0032] Next, an example of a method for manufacturing the guide wire 100 described above will be explained.

[0033] First, the core wire 40 is passed through the coil 50, with the tip of the core wire 40 protruding from the coil 50 towards the tip (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 a tip-side joining material 71. Subsequently, the core wire 40 is joined to the base end of the coil 50 by a base-side joining material 74 (S130, Figure 8). After joining, the loop portion 46 is subjected to a blasting process in which abrasive particles are projected from a nozzle N provided in a blasting device toward the loop portion 46, thereby adhering particles 60 to the surface of the loop portion 46 (S140, Figure 9). This forms a convex portion 48. For example, the guide wire 100 of this embodiment is manufactured by the above process.

[0034] The process of depositing material onto the surface of the loop portion 46 may be a process other than blasting. The process of depositing material may be, for example, a thermal spraying process in which a material that has been partially melted by heating is sprayed, or a diamond electrodeposition process in which diamond abrasive grains are fixed to the surface of the object by electroplating.

[0035] Next, an example of a treatment method using a catheter 120 equipped with the guidewire 100 described above will be explained.

[0036] 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.

[0037] 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. At this time, the protrusions 48 catch on the lesion 220, suppressing the slippage of the guide wire 100, and allowing the lesion 220 to be cut efficiently. As a result, the passability of the leading section 20 through the lesion 220 is improved. In particular, since the protrusions 48 are positioned on the widened section 461 and the tip section 462 of the loop section 46, which are more likely to come into contact with the lesion 220, the excavation performance of the leading section 20 through the lesion 220 is improved. In addition, because the protrusion 48 is provided on the outer circumferential surface 46S1 of the tip portion 462, the protrusion 48 easily catches on the lesion portion 220. As a result, the leading portion 20 is prevented from slipping and spinning freely on the surface of the lesion portion 220. Furthermore, the protrusion 48 creates minute cracks in the lesion portion 220, so that the scraped-off lesion portion 220 becomes small fragments. This reduces the possibility that the lesion portion 220 will get stuck around the leading portion 20 and hinder its rotation.

[0038] 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 16 of the main body portion 10 and entering the lesion portion 220. The leading portion 20 has a plurality of protrusions 48 on its surface. With this configuration, the passability to the lesion portion 220 is improved.

[0039] In this embodiment, the leading portion 20 comprises a loop portion 46 and particles 60 adhering to the surface of the loop portion 46. The protrusion 48 includes the particles 60. With this configuration, the protrusion 48 can be easily formed on the leading portion 20.

[0040] In this embodiment, the leading section 20 includes a widening section 461 having an outer diameter larger than the maximum outer diameter D1 of the tip 16 of the main body section 10, and a tip section 462 located closer to the tip than the widening section 461. A convex portion 48 is arranged on both the widening section 461 and the tip section 462. With this configuration, the excavation efficiency of the lesion section 220 is improved.

[0041] In this embodiment, the plurality of protrusions 48 include a first protrusion 481 and a second protrusion 482. The first protrusion 481 has a first height H1. The second protrusion 482 has a second height H2 which is different from the first height H1.

[0042] In this embodiment, the leading section 20 includes a loop-shaped loop section 46, and a protrusion 48 is arranged on the surface of the loop section 46. With this configuration, the guide wire 100 can be manufactured efficiently.

[0043] In the manufacturing method of the guide wire 100 of this embodiment, a protrusion 48 is formed on the surface of the loop portion 46 provided on the leading portion 20 by adhering particles 60 to the surface of the loop portion 46. With this configuration, the protrusion 48 can be easily formed on the leading portion 20.

[0044] (Second Embodiment) A second embodiment will be described with reference to Figure 12-14. In this embodiment, the configuration of the leading section 20A of the guide wire 100A 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.

[0045] The guide wire 10A of this embodiment comprises a coil 50 and a core wire 40A, similar to the first embodiment. The core wire 40A has a portion from a large diameter portion 41 to a first small diameter portion 45, a loop portion 46A, and a second small diameter portion 47, similar to the first embodiment. The loop portion 46A is a loop-shaped portion formed by a part of the core wire 40A, similar to the first embodiment. The detailed configuration of the loop portion 46A is the same as the first embodiment, except that it has a recess 49 and a protrusion 48A, which will be described later, instead of the protrusion 48 of the first embodiment.

[0046] The main body 10 includes the portion of the core wire 40A from the large diameter portion 41 to the first small diameter portion 45, and 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 20A includes a loop portion 46A formed from a portion of the core wire 40A and a reinforcing portion 72. Similar to the first embodiment, the loop portion 46A includes a widened portion 461A having an outer diameter larger than the maximum outer diameter D1 of the tip 16 of the main body 10, and a tip portion 462A located closer to the tip than the widened portion 461A.

[0047] As shown in Figure 13, a plurality of recesses 49 are arranged on the surface of the loop portion 46A. On the surface of the loop portion 46A, the portion that is partitioned by the plurality of recesses 49 and protrudes beyond the recesses 49 is a convex portion 48A. The convex portion 48A may be arranged on the entire surface of the loop portion 46A or on a portion of it. The convex portion 48A may be arranged on the surface of the widening portion 461A, on the surface of the tip portion 462A, on both the surface of the widening portion 461A and the surface of the tip portion 462A, or on a portion different from both the surface of the widening portion 461A and the surface of the tip portion 462A. Similar to the first embodiment, the plurality of convex portions 48A may include a first convex portion 481A and a second convex portion 482A of different heights.

[0048] Next, we will describe an example of a method for manufacturing the guide wire 100A mentioned above.

[0049] First, the core wire 40A is passed through the coil 50, with the tip of the core wire 40A protruding from the coil 50 towards the tip (S210). Next, the tip of the core wire 40A is bent into a loop shape using a pin P to form a loop portion 46A (S220). After bending, the first small diameter portion 45 and the second small diameter portion 47 of the core wire 40A are inserted into the coil 50 and joined to the coil 50 by the tip-side joining material 71. Subsequently, the core wire 40A is joined to the base end of the coil 50 by the base-side joining material 74 (S230). The steps from step S210 to step S230 are the same as the steps from step S110 to step S130 in the first embodiment. After the completion of step S230, a recess 49 is formed by partially recessing the surface of the loop portion 46A (S240). For example, the guide wire 100A of this embodiment is manufactured by the above steps.

[0050] The method for partially indenting the surface of the loop portion 46A may be a mechanical surface roughening treatment in which the surface of the loop portion 46A is partially removed by blasting or polishing with sandpaper. The method may also be a chemical surface roughening treatment in which the surface of the loop portion 46A is partially dissolved by an etching agent. The method may also be an electrical surface roughening treatment in which the surface of the loop portion 46A is partially dissolved by immersing the loop portion 46A in an electrolytic polishing solution and passing an electric current through the loop portion 46A with the loop portion 46A as one electrode.

[0051] As described above, the guide wire 100A of this embodiment comprises a main body portion 10 and a leading portion 20A, similar to the first embodiment. The leading portion 20A has a plurality of protrusions 48A on its surface. With this configuration, the passability of the leading portion 20A through the lesion portion 220 is improved.

[0052] In this embodiment, the leading portion 20A is provided with a plurality of recesses 49 that are recessed from the surface. The portion that is partitioned by the plurality of recesses 49 and protrudes from the recesses 49 is the convex portion 48A. In the manufacturing method of the guide wire 100 of this embodiment, the convex portion 48A is formed by partially recessing the surface of the loop portion 46A provided on the leading portion 20A. With this configuration, the convex portion 48A can be easily formed on the leading portion 20A.

[0053] (Third embodiment) A third embodiment will be described with reference to Figures 15 and 16. In this embodiment, the configuration of the leading section 20B of the guide wire 100B 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 description is omitted.

[0054] The guide wire 100B of this embodiment comprises a coil 50 and a core wire 40B, similar to the first embodiment. The core wire 40B comprises a portion from a large diameter portion 41 to a first small diameter portion 45, similar to the first embodiment. The core wire 40B further comprises a paddle portion 46B. The paddle portion 46B is connected to the tip of the first small diameter portion 45 and is a portion that protrudes from the coil 50 toward the tip. The paddle portion 46B is an example of a base portion. The paddle portion 46B comprises a plate portion 463 and a rod portion 464. The plate portion 463 is a plate-shaped portion that does not have a through hole. The outer shape of the plate portion 463 may be circular, partially circular, elliptical, rectangular, parallelogram, trapezoidal, rhombus, etc., and a part of these shapes may be distorted. In this embodiment, the plate portion 463 is a substantially elliptical flat plate. The rod portion 464 is a linear portion connecting the plate portion 463 and the first small diameter portion 45. The paddle portion 46B may be formed, for example, by press-forming the tip of a wire material that will be used as the core wire 40B. As shown in Figure 16, a plurality of protrusions 48 are arranged on the surface of the plate portion 463. The protrusions 48 are formed by particles 60 adhering to the surface of the plate portion 463, similar to the first embodiment.

[0055] The main body 10 includes the portion of the core wire 40B 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 20B includes the paddle portion 46B formed from a part of the core wire 40B, and the reinforcing portion 72.

[0056] As described above, the guide wire 100B of this embodiment comprises a main body portion 10 and a leading portion 20B, similar to the first embodiment. The leading portion 20B has a plurality of protrusions 48 on its surface. With this configuration, the passage of the leading portion 20B through the lesion portion 220 is improved.

[0057] (Fourth Embodiment) A fourth embodiment will be described with reference to Figure 17. In this embodiment, the configuration of the leading section 20C of the guide wire 100C 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 description is omitted.

[0058] The guide wire 10C of this embodiment comprises a coil 50 and a core wire 40C, similar to the first embodiment. The core wire 40C includes a loop portion 46C. The loop portion 46C is a loop-shaped portion formed by a part of the core wire 40C. The space inside the loop portion 46C is a through hole 24C extending in the X-axis direction. The main body portion 10 includes the core wire 40C excluding the loop portion 46, the coil 50, the tip-side joining member 71 excluding the reinforcing portion 72, and the base-side joining member 74. The leading portion 20C includes the loop portion 46C and the reinforcing portion 72.

[0059] The surface of the loop portion 46C includes an inner circumferential surface 46CS2 facing the through hole 24C and an outer circumferential surface 46CS1 positioned back-to-back with the inner circumferential surface 46CS2. In this embodiment, the inner circumferential surface 46CS2 and the outer circumferential surface 46CS1 are parallel to each other.

[0060] Multiple recesses 49C and multiple protrusions 48C are arranged on the surface of the loop portion 46C. In this embodiment, the multiple recesses 49C and multiple protrusions 48C are arranged on the outer peripheral surface 46CS1. Each recess 49C extends in a direction substantially perpendicular to the circumferential direction of the loop portion 46C. Such recesses 49C are formed, for example, by polishing the outer peripheral surface 46CS1 with sandpaper, and in doing so, by moving the sandpaper back and forth in a direction perpendicular to the circumferential direction of the loop portion 46C. Polishing with sandpaper may be performed before bending the core wire 40C to form the loop portion 46C, or after bending the core wire 40C to form the loop portion 46C. Each protrusion 48C is a portion that protrudes from the recesses 49C and is partitioned by two adjacent recesses 49C.

[0061] The guide wire 100C of this embodiment comprises a main body portion 10 and a leading portion 20C, similar to the first embodiment. The leading portion 20C has a plurality of protrusions 48C on its surface. With this configuration, the passage of the leading portion 20C through the lesion portion 220 is improved.

[0062] (Fifth embodiment) A fifth embodiment will be described with reference to Figure 18. In this embodiment, the configuration of the leading section 20D of the guide wire 100D 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.

[0063] The guide wire 10D of this embodiment includes a coil 50 and a core wire 40D, similar to the first embodiment. The core wire 40D includes a loop portion 46D. The loop portion 46D is a loop-shaped portion formed by a part of the core wire 40D. The space inside the loop portion 46D is a through hole 24D extending in the X-axis direction. The main body portion 10 includes the core wire 40D excluding the loop portion 46D, the coil 50, the tip-side joining member 71 excluding the reinforcing portion 72, and the base-side joining member 74. The leading portion 20C includes the loop portion 46C and the reinforcing portion 72.

[0064] The surface of the loop portion 46D includes an inner circumferential surface 46DS2 facing the through hole 24D and an outer circumferential surface 46DS1 positioned back-to-back with the inner circumferential surface 46DS2. In this embodiment, the inner circumferential surface 46DS2 and the outer circumferential surface 46DS1 are parallel to each other.

[0065] Multiple recesses 49D and multiple protrusions 48D are arranged on the surface of the loop portion 46D. In this embodiment, the multiple recesses 49D and multiple protrusions 48D are arranged on the outer circumferential surface 46DS1. Each recess 49D extends along the circumferential direction of the loop portion 46D. Such recesses 49D are formed, for example, by polishing the outer circumferential surface 46DS1 with sandpaper, while moving the sandpaper back and forth along the circumferential direction of the loop portion 46D. Polishing with sandpaper may be performed before bending the core wire 40D to form the loop portion 46D, or after bending the core wire 40D to form the loop portion 46D. Each protrusion 48D is a portion that protrudes from the recesses 49D, and is partitioned by two adjacent recesses 49D.

[0066] The guide wire 100D of this embodiment comprises a main body portion 10 and a leading portion 20D, similar to the first embodiment. The leading portion 20D has a plurality of protrusions 48D on its surface. With this configuration, the passage of the leading portion 20D through the lesion portion 220 is improved.

[0067] (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) A portion of the protrusion may be located in a part of the reading section that is different from the loop section. Alternatively, a portion of the protrusion may be located in the main body. (2) The loop portion may be formed as a separate component from the core wire and connected to the main body. The same applies to the paddle portion. (3) The plate portion does not have to be flat. For example, the plate portion may be a plate with a concave surface. (4) The plate portion may have recesses that are indented from the surface, and the portion that is divided by these recesses and protrudes from the recesses may be a convex portion. (5) The medical device may have a coating that covers the surface of the reading portion. In that case, the coating only needs to have a thickness less than the height of the protrusion. (6) The leading section does not need to have a widening section with an outer diameter larger than the outer diameter of the tip of the main body. (7) The protrusions may be arranged regularly or irregularly. (8) 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 reading portion (20) has a protrusion (48) on its surface. Medical device (100).

2. A medical device (100) according to claim 1, The reading unit (20) is Base (46) and, The deposit (60) attached to the surface of the base (46), Equipped with, The protrusion (48) includes the attached substance (60), Medical device (100).

3. A medical device (100A) according to claim 1, The reading portion (20A) is provided with a recess (49) that is recessed from the surface, The portion that is demarcated by the recess (49) and protrudes from the recess (49) is the protrusion (48A). Medical device (100A).

4. A medical device (100) according to any one of claims 1 to 3, The aforementioned protrusion (48) is a first protrusion (481) having a first height, It further includes a second protrusion (482) having a second height different from the first height, Medical device (100).

5. A medical device (100) according to any one of claims 1 to 4, The leading portion (20) includes a widening portion (461) having an outer diameter larger than the outer diameter of the tip (16) of the main body portion (10). The protrusion (48) is arranged on the widened portion (461). Medical device (100).

6. A medical device (100) according to any one of claims 1 to 5, The reading unit (20) is The widened portion (461) has an outer diameter larger than the outer diameter of the tip (16) of the main body portion (10), The tip portion (462) is located closer to the tip (16) than the widened portion (461), Equipped with, The tip portion (462) is provided with the protrusion (48). Medical device (100).

7. A medical device (100) according to any one of claims 1 to 6, The reading section (20) includes a loop-shaped loop section (46), The protrusion (48) is arranged on the surface of the loop portion (46). Medical device (100).

8. A medical device (100B) according to any one of claims 1 to 6, The leading portion (20B) includes a plate-shaped portion (463) that does not have a through hole. The protrusion (48B) is arranged on the surface of the plate portion (463). Medical device (100B).

9. A medical device (100C) according to any one of claims 1 to 8, The aforementioned protrusion (48C) is linear in shape and extends in a direction perpendicular to the circumferential direction of the loop portion (46C). Medical device (100C).

10. A medical device (100D) according to any one of claims 1 to 8, The aforementioned protrusion (48D) is linear in shape and extends in the circumferential direction of the loop portion (46D). Medical device (100D).

11. Main body (10) and A reading unit (20) is connected to the tip (16) of the main body (10) and enters the lesion (220), A method for manufacturing a medical device (100) comprising, A protrusion (48) is formed on the surface of the base (46) provided on the reading portion (20) by adhering a substance (60) to the surface of the base (46). A method for manufacturing a medical device (100).

12. Main body (10) and A reading unit (20A) is connected to the tip (16) of the main body (10) and enters the lesion (220), A method for manufacturing a medical device (100A) equipped with, A protrusion (48A) is formed on the surface of the reading portion (20A) by partially recessing the surface of the reading portion (20A). A method for manufacturing a medical device (100A).

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