Medical device, and method for manufacturing a medical device

Abstract

The strength of the guide wire is improved. [Solution] The medical device comprises a main body and a reading part connected to the tip of the main body and entering the lesion, wherein the main body has a coil part in which a portion of the wire is wound in a spiral shape, and the reading part has a loop part which is the other portion of the wire and extends toward the tip side beyond the tip of the coil part.

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. Known guide wires include a loop 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 strength 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. The main body portion includes a coil portion in which a wire is spirally wound, and the leading portion has a loop portion that is a part of the wire and extends toward the tip side of the tip of the coil portion.

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] A partially enlarged plan view showing the loop portion and its vicinity in the coil member of the first embodiment. [Figure 5] A flowchart showing an example of a guide wire manufacturing method according to the first embodiment. [Figure 6] An explanatory diagram 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 treatment method using a guidewire according to the first embodiment. [Figure 9] An explanatory diagram showing an example of a treatment method using a guidewire according to the first embodiment. [Figure 10] A partially enlarged plan view showing the leading portion and its vicinity in the guide wire of the second embodiment. [Figure 11] A partially enlarged cross-sectional view showing the leading portion and its vicinity in the guide wire of the third embodiment, cut at the same position as line III-III in Figure 2. [Figure 12] A partially enlarged plan view showing the leading portion and its vicinity in the guide wire of the fourth embodiment. [Figure 13] A partially enlarged plan view showing the leading portion and its vicinity in the guide wire of the fifth embodiment. [Figure 14] A partially enlarged side view showing the leading portion and its vicinity in the guide wire of the fifth embodiment. [Figure 15] A partially enlarged plan view showing the leading portion and its vicinity in the guide wire of the sixth embodiment. [Figure 16] A partially enlarged side view showing the leading portion and its vicinity in the guide wire of the sixth embodiment. [Figure 17] A partially enlarged plan view showing the leading portion and its vicinity in the guide wire of the seventh embodiment. [Figure 18] A partially enlarged side view showing the leading portion and its vicinity in the guide wire of the seventh embodiment. [Figure 19] A partially enlarged plan view showing the leading portion and its vicinity in the guide wire of the eighth embodiment. [Modes for carrying out the invention]

[0008] (First Embodiment) The first embodiment will be described with reference to Figures 1 to 9. The guidewire 100 of this embodiment is a medical device inserted into a biological lumen to treat a lesion in the biological lumen. The biological lumen includes tubular organs of the human body such as blood vessels, the digestive tract, ureters, organs, and bile ducts. In the guidewire 100, the positive Z-axis side is the tip side that is inserted into the body, and the negative Z-axis side is the proximal end side that is manipulated by a surgeon such as a physician. The tip side is also called the distal end, and the proximal end side is also called the proximal end. In each figure, the illustration of a part of the guidewire 100 may be omitted. In Figures 1, 2, and 3, the guidewire 100 is shown in a straight line parallel to the Z-axis. The guidewire 100 has enough flexibility to bend. 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 FIGS. 1 and 2, the guide wire 100 has a main body portion 10 and a leading portion 20.

[0012] The main body portion 10 is an elongated portion extending along the central axis Ax. 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. [[ID=**9]]

[0013] [[ID=**10]] [[ID=**11]]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 tip 23 of the leading portion 20 coincides with the tip of the guide wire 100. The surface of the leading portion 20 may have an edge 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, scraping 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 member 50. [[ID=1**6]] [[ID=1**7]]

[0015] [[ID=1**8]] [[ID=1**9]] [[ID=2**0]]

[0016] [[ID=2**1]]

[0016] Note: There seems to be some formatting issues with the original text where some line numbers are repeated in a way that might be incorrect. I've translated it as accurately as possible while trying to maintain the structure. If you have any further clarification on the original text's formatting, please let me know. 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.

[0017] 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.

[0018] 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.

[0019] The coil member 50 is formed from a single wire 500. The wire forming the coil member 50 may be a single strand or a stranded wire made by twisting together multiple strands.

[0020] As shown in Figures 3 and 4, the coil member 50 comprises a coil portion 510 and a loop portion 520. The coil portion 510 is a cylindrical portion of the wire 500 in which most of the wire, excluding the tip, is wound in a spiral shape. The coil portion 510 surrounds a part of the core wire 40. In this embodiment, the second tapered portion 44 and the small diameter portion 45 of the core wire 40 are covered by the coil portion 510. The second tapered portion 44 and the small diameter portion 45 and the coil portion 510 are spaced apart. That is, there is a gap C1 between the second tapered portion 44 and the small diameter portion 45 and the coil portion 510.

[0021] The outer diameter of the coil portion 510 is, for example, 0.1 mm or more and 0.6 mm or less. The outer diameter of the coil portion 510 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 portion 510 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 portion 510 is constant along its entire length. The coil portion 510 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 portion 510 is approximately the same as the tip 16 of the main body portion 10.

[0022] The loop portion 520 is a loop-shaped portion formed by the part of the wire 500 that is closer to the tip of the coil portion 510. The loop portion 520 extends at an angle to the outermost turn 511 of the coil portion 510. The loop portion 520 includes the tip 23 of the leading portion 20. In other words, the loop portion 520 extends from the tip 51 of the coil portion 510, curving to the tip 23 of the leading portion 20, then folds back at the tip 23 and curves to the vicinity of the tip 51 of the coil portion 510. In this embodiment, the loop portion 520 is substantially circular, having an outer diameter approximately equal to the outer diameter of the coil portion 510. In this specification, "loop-shaped" includes not only cases where the loop portion is a closed ring, but also cases where there is a gap between the ends of the loop portion or where the ends of the loop portion intersect. In this embodiment, the loop portion 520 has a base portion 521 which is the boundary position with the coil portion 510, and a first end portion 522 on the opposite side of the base portion 521. The base portion 521 is the part of the loop portion 520 that is located on the tip side of the tip 51 of the coil portion 510, and is adjacent to the tip 51 of the coil portion 510. The first end portion 522 is the end portion of the wire 500. There is a gap between the base portion 521 and the first end portion 522. The first end portion 522 and the coil portion 510 are separated. That is, there is a gap C2 between the first end portion 522 and the coil portion 510. The first end portion 522 is located on the tip side of the coil portion 510.

[0023] The material of the coil member 50 is, for example, metal. The material of the coil member 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 coil member 50 may be formed entirely of the same material, or each part may be formed of different materials.

[0024] The tip of the coil section 510 is joined to the core wire 40 by a tip-side joining member 71. The tip-side joining member 71 extends inside the coil section 510 and joins a part of the small-diameter section 45 to the tip of the coil section 510. The base end of the coil section 510 is joined to the core wire 40 by a base-side joining member 74. The coil section 510 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, Au-Sn alloy, Sn-Ag alloy, Sn-Pb alloy, or Pb-Ag alloy. The brazing material may be, for example, aluminum alloy brazing material, silver brazing material, or gold brazing material. The adhesive may be, for example, an epoxy adhesive.

[0025] The main body 10 includes a core wire 40, a coil section 510, a tip-side connecting member 71, and a base-side connecting member 74. The leading section 20 includes a loop section 520.

[0026] Next, an example of a method for manufacturing the guide wire 100 described above will be explained.

[0027] First, a wire 500, which will be the material for the coil member 50, is prepared (S110). This wire 500 is wound in a spiral shape to form a material coil 550 (S120, Figure 6). Next, the tip of the wire 500 is formed into a loop shape (S130, Figure 6). Specifically, one turn 551 located at the very tip of the material coil 550 is raised so that it forms an angle with another turn 552 located next to it. As a result, the raised turn 551 becomes a loop portion 520, and the remaining portion becomes a coil portion 510. Next, the tip of the core wire 40 is inserted into the coil portion 510 (S140, Figure 7). Next, the core wire 40 is joined to the coil portion 510 by a tip-side joining member 71 and a base-side joining member 74 (S150, Figure 7). For example, the guide wire 100 of this embodiment is manufactured by the above process.

[0028] Next, an example of a treatment method using a catheter 120 equipped with the guidewire 100 described above will be explained.

[0029] 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 8). 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.

[0030] 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 9). 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.

[0031] 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 main body portion 10 comprises a coil portion 510 in which a wire 500 is wound in a spiral shape. The leading portion 20 is a part of the wire 500 and has a loop portion 520 that extends toward the tip side beyond the tip 51 of the coil portion 510. With this configuration, since there is no joint between the main body portion 10 and the leading portion 20, the strength of the guide wire 100 is improved.

[0032] In this embodiment, the loop portion 520 includes a first end portion 522 that includes the end of the wire 500. The first end portion 522 is located on the tip side of the coil portion 510.

[0033] In this embodiment, the main body 10 includes a core wire 40 connected to the coil section 510. The core wire 40 and the coil section 510 are spaced apart.

[0034] In this embodiment, the first end portion 522 and the coil portion 510 are separated.

[0035] (Second Embodiment) A second embodiment will be described with reference to Figure 10. In this embodiment, the guide wire 100A has some differences in the configuration of the coil member 50A 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 descriptions are omitted.

[0036] As shown in Figure 10, the guide wire 100A of this embodiment comprises a core wire 40 and a coil member 50A. The coil member 50A is formed from a single wire 500A, similar to the first embodiment. The coil member 50A has the same configuration as the first embodiment, except that the first end 522A of the loop portion 520A is joined to the tip 51 of the coil portion 510. The method of joining the first end 522A and the coil portion 510 may be, for example, welding or soldering.

[0037] The guide wire 100A of this embodiment, like the first embodiment, comprises a main body portion 10 and a leading portion 20A connected to the tip of the main body portion 10 and entering the lesion portion 220. The main body portion 10 comprises a coil portion 510 in which a wire 500A is wound in a spiral shape. The leading portion 20A is a part of the wire 500A and has a loop portion 520A that extends toward the tip side beyond the tip 51 of the coil portion 510. With this configuration, the strength of the guide wire 100A is improved.

[0038] In this embodiment, the first end portion 522A is joined to the tip portion 51 of the coil portion 510. This configuration improves the strength of the loop portion 520A.

[0039] (Third embodiment) A third embodiment will be described with reference to Figure 11. In this embodiment, the guide wire 100B has some differences in the configuration of the coil member 50B 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.

[0040] As shown in Figure 11, the guide wire 100B of this embodiment comprises a core wire 40 and a coil member 50B. The coil member 50B is formed from a single wire 500B, similar to the first embodiment. The coil member 50B comprises a coil portion 510, a loop portion 520B, and a second end portion 530. The coil portion 510 is a cylindrical portion of the wire 500B, similar to the first embodiment, in which most of the wire 500B, excluding the tip portion, is wound in a spiral shape. The loop portion 520B is a loop-shaped portion formed from the wire 500B on the tip side of the coil portion 510. The loop portion 520B comprises a base portion 521, which is the boundary position with the coil portion 510, and a first end portion 522B on the opposite side of the base portion 521. The detailed shape of the loop portion 520B is the same as in the first embodiment, except that the first end portion 522B extends to the tip 51 of the coil portion 510. The second end portion 530 is the end portion of the wire 500B that extends from the first end portion 522B of the loop portion 520B and is located inside the coil portion 510.

[0041] The guide wire 100B of this embodiment, like the first embodiment, comprises a main body portion 10B and a leading portion 20B connected to the tip of the main body portion 10B and entering the lesion portion 220. The main body portion 10B comprises a coil portion 510 in which a wire 500B is wound in a spiral shape. The leading portion 20B is a part of the wire 500B and has a loop portion 520B that extends toward the tip side beyond the tip 51 of the coil portion 510. With this configuration, the strength of the guide wire 100B is improved.

[0042] In this embodiment, the guide wire 100B is connected to the loop portion 520B and further includes a second end portion 530 which includes the end of the wire 500B. The second end portion 530 is located inside the coil portion 510. With this configuration, the second end portion 530 is less likely to get caught on the inner wall of the blood vessel 200. As a result, the safety of the guide wire 100B is increased.

[0043] (Fourth Embodiment) A fourth embodiment will be described with reference to Figure 12. In this embodiment, the guide wire 100C has some differences in the configuration of the leading section 20C 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 descriptions are omitted.

[0044] As shown in Figure 12, the guide wire 100C of this embodiment comprises a core wire 40 and a coil member 50C. The coil member 50C is formed from a single wire 500C, similar to the first embodiment. The coil member 50C comprises a coil portion 510 and a loop portion 520C. The coil portion 510 is a cylindrical portion of the wire 500C, with most of it, excluding the tip portion, wound in a spiral shape, similar to the first embodiment. The loop portion 520C is a loop-shaped portion of the wire 500C formed by the portion of the wire 500C closer to the tip than the coil portion 510. In this embodiment, the loop portion 520C is U-shaped, with the curved portion of the U facing the tip. In other words, the loop portion 520C extends along the central axis Ax and has two parallel straight portions 541 and 542, and a curved portion 543 that curves so as to be convex at its tip and connects the tips of the two straight portions 541 and 542. The loop portion 520C has a first end portion 522C that includes the end of the wire 500C. The first end portion 522C is separated from the coil portion 510.

[0045] The guide wire 100C of this embodiment, like the first embodiment, comprises a main body portion 10 and a leading portion 20C connected to the tip of the main body portion 10 and entering the lesion portion 220. The main body portion 10 comprises a coil portion 510 in which a wire 500C is wound in a spiral shape. The leading portion 20C is a part of the wire 500C and has a loop portion 520C that extends toward the tip side beyond the tip 51 of the coil portion 510. With this configuration, the strength of the guide wire 100C is improved.

[0046] (Fifth embodiment) A fifth embodiment will be described with reference to Figures 13 and 14. The guide wire 10D of this embodiment comprises a main body 10 and a leading portion 20D, similar to the first embodiment. In the guide wire 100D of this embodiment, some of the configuration of the leading portion 20D 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.

[0047] The guide wire 100D comprises a core wire 40 and a coil member 50D. The coil member 50D is formed from a single wire 500D, similar to the first embodiment. The coil member 50D comprises a coil portion 510 and a loop portion 520D. The loop portion 520D is a loop-shaped portion formed by the portion of the wire 500D that is closer to the tip of the coil portion 510. The loop portion 520D comprises a base portion 521D adjacent to the tip of the coil portion 510 and a first end portion 522D opposite to the base portion 521D. The main body portion 10 includes the core wire 40 and the coil portion 510. The leading portion 20D includes the loop portion 520D.

[0048] The loop portion 520D includes the tip 23 of the leading portion 20D. The loop portion 520D extends from the tip 51 of the coil portion 510, curving to the tip 23 of the leading portion 20D, where it folds back and curves to the vicinity of the tip 51 of the coil portion 510. In this embodiment, the loop portion 520D is approximately circular in shape, having an outer diameter slightly larger than the outer diameter of the coil portion 510. As shown in Figure 14, the tip 23 is located closer to the central axis Ax than to the base portion 521D. The position of the first end portion 522D and the position of the base portion 521D are different in the direction perpendicular to the long axis direction (Z axis direction) of the guide wire 100D (X axis direction). The distance between the central axis Ax and the first end portion 522D in the X axis direction is shorter than the distance between the central axis Ax and the base portion 521D in the X axis direction.

[0049] The guide wire 100D of this embodiment, like the first embodiment, comprises a main body portion 10 and a leading portion 20D connected to the tip of the main body portion 10 and entering the lesion portion 220. The main body portion 10 comprises a coil portion 510 in which a wire 500D is wound in a spiral shape. The leading portion 20D is a part of the wire 500D and has a loop portion 520D that extends toward the tip side beyond the tip 51 of the coil portion 510. With this configuration, the strength of the guide wire 100D is improved.

[0050] In this embodiment, the main body 10 extends along the central axis Ax. The loop portion 520D has a base portion 521D adjacent to the tip 51 of the coil portion 510. The loop portion 520D includes the tip 23 of the leading portion 20D. The tip 23 is located closer to the central axis Ax than the base portion 521D.

[0051] (Sixth Embodiment) A sixth embodiment will be described with reference to Figures 15 and 16. The guide wire 10E of this embodiment comprises a main body portion 10 and a leading portion 20E, similar to the first embodiment. The guide wire 100E of this embodiment is the same as the fifth embodiment, except that the loop portion 520E is twisted in a spiral shape.

[0052] The guide wire 100E comprises a core wire 40 and a coil member 50E. The coil member 50E is formed from a single wire 500E, similar to the first embodiment. The coil member 50E comprises a coil portion 510 and a loop portion 520E. The loop portion 520E has a ring that is slightly larger than the outer diameter of the coil portion 510 and twisted in a spiral shape. More specifically, the loop portion 520E comprises a base portion 521E adjacent to the tip 51 of the coil portion 510 and a first end portion 522E opposite to the base portion 521E. The loop portion 520E includes the tip 23 of the leading portion 20E. As shown in Figure 16, the portion of the loop portion 520E from the base portion 521E to the tip 23 curves as it approaches the tip 23, moving away from the tip 51 of the coil portion 510 and closer to the central axis Ax. In the loop section 520E, the portion from the tip 23 to the first end 522E curves as it approaches the first end 522E, moving closer to the tip 51 of the coil section 510 and further away from the central axis Ax. The tip 23 is located closer to the central axis Ax than the base 521E. The position of the first end 522E and the position of the base 521E are different in the direction perpendicular to the long axis (Z axis) of the guide wire 100E (X axis). The distance between the central axis Ax and the first end 522E in the X axis direction is shorter than the distance between the central axis Ax and the base 521E in the X axis direction.

[0053] The guide wire 100E of this embodiment, like the first embodiment, comprises a main body portion 10 and a leading portion 20E connected to the tip of the main body portion 10 and entering the lesion portion 220. The main body portion 10 comprises a coil portion 510 in which a wire 500E is wound in a spiral shape. The leading portion 20E is a part of the wire 500E and has a loop portion 520E that extends toward the tip side beyond the tip 51 of the coil portion 510. With this configuration, the strength of the guide wire 100E is improved.

[0054] In this embodiment, the main body 10 extends along the central axis Ax. The loop portion 520E has a base portion 521E adjacent to the tip 51 of the coil portion 510. The loop portion 520E includes the tip 23 of the leading portion 20E. The tip 23 is located closer to the central axis Ax than the base portion 521E.

[0055] (Seventh Embodiment) A seventh embodiment will be described with reference to Figures 17 and 18. The guide wire 10F of this embodiment comprises a main body portion 10 and a leading portion 20F, similar to the first embodiment. The guide wire 100F of this embodiment is the same as the fifth embodiment, except that a part of the loop portion 520F is twisted in a spiral shape.

[0056] The guide wire 100F comprises a core wire 40 and a coil member 50F. The coil member 50F is formed from a single wire 500F, similar to the first embodiment. The coil member 50F comprises a coil portion 510 and a loop portion 520F. The loop portion 520F has a spirally twisted shape in which a portion of the ring, which is slightly larger than the outer diameter of the coil portion 510, is twisted. More specifically, the loop portion 520F comprises a base portion 521F adjacent to the tip 51 of the coil portion 510 and a first end portion 522F opposite to the base portion 521F. The loop portion 520F includes the tip 23 of the leading portion 20F. As shown in Figure 18, the portion of the loop portion 520F from the base portion 521F to the tip 23 curves and extends in a direction along the central axis Ax, moving away from the tip 51 of the coil portion 510 as it approaches the tip 23. In the loop section 520F, the portion from the tip 23 to the first end 522F curves as it approaches the first end 522F, and also approaches the central axis Ax. In the loop section 520F, the portion from the tip 23 to the first end 522F is located closer to the central axis Ax than the base 521F. The position of the first end 522F and the position of the base 521F are different in the direction perpendicular to the long axis direction (Z axis direction) of the guide wire 100F (X axis direction). The distance between the central axis Ax and the first end 522F in the X axis direction is shorter than the distance between the central axis Ax and the base 521F in the X axis direction.

[0057] The guide wire 100F of this embodiment, like the first embodiment, comprises a main body portion 10 and a leading portion 20F connected to the tip of the main body portion 10 and entering the lesion portion 220. The main body portion 10 comprises a coil portion 510 in which a wire 500F is wound in a spiral shape. The leading portion 20F is a part of the wire 500F and has a loop portion 520F that extends toward the tip side beyond the tip 51 of the coil portion 510. With this configuration, the strength of the guide wire 100F is improved.

[0058] In this embodiment, the main body 10 extends along the central axis Ax. The loop portion 520F has a base portion 521F adjacent to the tip 51 of the coil portion 510. A portion of the loop portion 520F is located closer to the central axis Ax than the base portion 521F.

[0059] (Eighth embodiment) The eighth embodiment will be described with reference to Figure 19. The guide wire 100G of this embodiment comprises a main body 10 and a leading portion 20G, similar to the first embodiment. The guide wire 100G of this embodiment differs from the first embodiment in some aspects of the configuration of the leading portion 20G. In this embodiment, components identical to those in the first embodiment are denoted by the same reference numerals and their description is omitted.

[0060] The guide wire 100G comprises a core wire 40 and a coil member 50G. The coil member 50G is formed from a single wire 500G, similar to the first embodiment. The coil member 50G has the same configuration as the first embodiment, except that its first end portion 522G intersects with the base portion 521.

[0061] The guide wire 100G of this embodiment, like the first embodiment, comprises a main body portion 10 and a leading portion 20G connected to the tip of the main body portion 10 and entering the lesion portion 220. The main body portion 10 comprises a coil portion 510 in which a wire 500G is wound in a spiral shape. The leading portion 20G is a part of the wire 500G and has a loop portion 520G that extends toward the tip side beyond the tip 51 of the coil portion 510. With this configuration, the strength of the guide wire 100G is improved.

[0062] (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 angle of the loop portion with respect to one turn at the tip of the coil portion is not limited to the above embodiment. For example, the loop portion may extend so that it moves away from the central axis of the coil portion as it approaches the tip. (2) The portion of the wire excluding the tip may be wound in a spiral shape, and then the tip may be bent to form a loop. (3) In the above embodiments, a guidewire 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 of the main body (10) and enters the lesion (220), Equipped with, The main body (10) includes a coil section (510) in which a wire (500) is wound in a spiral shape. The leading portion (20) is a part of the wire (500) and has a loop portion (520) that extends toward the tip beyond the tip (51) of the coil portion (510). Medical devices (100).

2. A medical device (100) according to claim 1, The loop portion (520) includes a first end portion (522) that includes the end of the wire (500), The first end (522) is located closer to the tip than the coil portion (510). Medical devices (100).

3. A medical device (100) according to claim 2, The first end portion (522) and the coil portion (510) are separated. Medical devices (100).

4. A medical device (100A) according to claim 1, The loop portion (520A) includes a first end portion (522A) that includes the end of the wire (500), The first end (522A) is joined to the coil portion (510). Medical device (100A).

5. A medical device (100B) according to claim 1, The loop portion (520B) is connected to a second end portion (530) which includes the end of the wire (500B), The second end portion (530) is located inside the coil portion (510). Medical device (100B).

6. A medical device (100) according to any one of claims 1 to 5, The main body (10) includes a core wire (40) connected to the coil (510), The core wire (40) and the coil portion (510) are separated. Medical devices (100).

7. A medical device (100D, 100E, 100F) according to any one of claims 1 to 6, The main body (10) extends along the axis (Ax), The aforementioned loop portion (520D, 520E, 520F) has a base portion (521D, 521E, 521F) adjacent to the tip (51) of the coil portion (510), At least a portion of the loop portion (520D, 520E, 520F) is located closer to the axis (Ax) than the base portion (521D, 521E, 521F). Medical devices (100D, 100E, 100F).

8. A medical device (100D, 100E) according to claim 7, The aforementioned loop portion (520D, 520E) includes the tip (23) of the aforementioned leading portion (20D, 20E), The tip (23) is located closer to the axis (Ax) than the base (521D, 521E). Medical devices (100D, 100E).

9. A medical device (100G) according to any one of claims 1 to 8, The loop portion (520G) has a base portion (521) adjacent to the tip (51) of the coil portion (510), The first end portion (522G) and the base portion (521) intersect, forming a medical device (100G).

10. 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 main body (10) includes a coil section (510) in which a wire (500) is wound in a spiral shape. The method for manufacturing a medical device (100) is such that the leading portion (20) is a part of the wire (500) and has a loop portion (520) that extends toward the tip side of the tip (51) of the coil portion (510), Prepare the wire material (500) that will be used for the coil member (50), The aforementioned wire (500) is wound in a spiral shape. The tip portion of the aforementioned wire (500) is formed into a loop shape. A method for manufacturing a medical device (100).

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