Guidewire shaping tool and guidewire shaping method

Abstract

To provide a guide wire shaping tool and a guide wire shaping method capable of obtaining even easiness of shaping processing of a guide wire and even shaping quality regardless of a direction of a core wire inside the guide wire, which is inserted into the guide wire shaping tool.SOLUTION: A guide wire shaping tool includes: an inlet path part 23 as a substantially columnar space for passing a guide wire by inserting a tip of the guide wire into an opening 22; a shaping part 25 as a space communicated with the inlet path part via an outlet part 24 as a part positioned in the deepest portion in the inlet path part, and expanded flatly from the outlet part; an annular inner wall 25a for forming an inner circumferential portion of the shaping part; an extended line crossing part 26 in the inner wall, as an inner wall crossing while making an obtuse angle with an extended line C' of a central line C of the inlet path part; and an obtuse angle side inner wall part 27 in the inner wall, as an inner wall extending from the outlet part to the extended line crossing part and an inner wall at a side at which an obtuse angle is made between the extended line and itself.SELECTED DRAWING: Figure 8

Description

[Technical Field]

[0001] The present invention relates to a guidewire shaping tool and a method for shaping a guidewire, and more particularly to a guidewire shaping tool for inserting and shaping a guidewire into a shaping section, which is a flattened space, and a method for shaping a guidewire using this guidewire shaping tool. [Background technology]

[0002] Conventionally, there is a guidewire shaping tool configured to insert the tip of a guidewire into the opening of an entrance passage and then press the tip protruding from the entrance passage against a die to shape it into a desired shape (Patent Document 1).

[0003] A guidewire is a flexible wire-like device, such as a catheter introducer, that facilitates insertion and placement in a blood vessel. Therefore, by using a guidewire shaper, the user can fold back the tip of the guidewire, thereby reducing the risk of the guidewire damaging the inner wall of the patient's blood vessel. Furthermore, since mechanical shaping using the guidewire shaper does not require a heat treatment process or a chemical treatment process, the user can perform the shaping process in a medical setting, such as an operating room, eliminating the need for a specific work location.

[0004] The inventor of the present invention is the same as the inventor of the invention related to International Application No. PCT / JP2020 / 027748, whose international publication date is January 28, 2021. The patent application to which this specification is attached must be filed within one year from the above-mentioned international publication date. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2014-68965 Summary of the Invention [Problem to be solved by the invention]

[0006] Some guidewires have a flat core wire inside to ensure their robustness. Figure 1 shows examples of guidewires with such a flat core wire, with Figure 1(a) showing an example of a guidewire in which a metal corewire is covered with a resin plastic jacket, and Figure 1(b) showing an example of a guidewire in which a coil is wound around the corewire. Examples of materials for the metal corewire include stainless steel, and examples of materials for the plastic jacket include polytetrafluoroethylene.

[0007] In the case of a guidewire having such a flat core wire, the ease of bending the guidewire varies depending on the relationship between the bending direction of the guidewire and the longitudinal or transverse direction of the corewire in its cross section. Specifically, when the transverse direction of the corewire in its cross section coincides with the up-down direction, as shown in the upper diagram of Figure 2(a), i.e., when the longitudinal direction and the bending direction of the guidewire are the same, as shown in the lower diagram of Figure 2(a), the guidewire is difficult to bend left and right, and a large force must be applied to forcibly bend it. Conversely, when the longitudinal direction of the corewire in its cross section coincides with the up-down direction, as shown in the upper diagram of Figure 2(b), i.e., when the transverse direction and the bending direction of the guidewire are the same, as shown in the lower diagram of Figure 2(b), the guidewire is easier to bend left and right than in the case of Figure 2(a).

[0008] In contrast, for example, plastic jackets are often colored, making it difficult to determine the longitudinal or lateral direction of the core wire in cross section simply by looking at the guidewire from the outside. Therefore, when inserting a guidewire into a guidewire shaping tool to shape its tip, if the core wire happens to be oriented in a direction that makes it easy to bend, as in Figure 2(b), shaping is easy. However, if the core wire is oriented in a direction that makes it difficult to bend, as in Figure 2(a), shaping efficiency is poor, and it may not always be possible to shape the guidewire into the desired shape. Thus, the difficulty of shaping the guidewire and the quality of the shaping vary depending on the direction of the core wire.

[0009] In view of these problems, the present invention aims to provide a guidewire shaping tool and a guidewire shaping method that, when folding back the tip of a guidewire, can achieve uniform ease of shaping and uniform shaping quality for the guidewire, regardless of the direction of the core wire inside the guidewire inserted into the guidewire shaping tool. [Means for solving the problem]

[0010] The present invention provides an inlet passage portion which is a substantially columnar space through which a tip of a guide wire is inserted into an opening and through which the guide wire passes; a shaping portion which is a space which communicates with the inlet passage portion via an outlet portion which is the innermost portion of the inlet passage portion and which spreads flat from the outlet portion; an annular inner wall which forms an inner circumferential portion of the shaping portion; an extension line intersection portion which is an inner wall of the inner wall that intersects with an extension line of a center line of the inlet passage portion at an obtuse angle; and an extension line intersection portion which is an inner wall extending from the outlet portion to the extension line intersection portion and which intersects with the extension line at an obtuse angle. The guide wire shaping device has an obtuse-angle side inner wall portion, which is the inner wall on the angled side, and an acute-angle side inner wall portion, which is the inner wall from the exit portion to the extension line intersection portion and is the inner wall on the side that forms an acute angle with the extension line, and as the guide wire is fed through the opening, the tip, which is inserted sequentially into the entrance passage portion and the shaping portion, abuts near the extension line intersection portion, and at this abutment, bends toward the obtuse angle side and slides along the obtuse-angle side inner wall portion, so that the entire device is arranged in a ring shape.

[0011] As a result of extensive research, the present inventors discovered that when the tip of an inserted guidewire hits the vicinity of the intersection of the extension lines and slides along the inner wall while bending toward an obtuse angle, the guidewire rotates 90° about its central axis, even if the flat core wire inside the guidewire is positioned as shown in FIG. 2(a) , with the longitudinal direction of its cross section and the bending direction of the guidewire being approximately the same. This led to the completion of the present invention. As a result of this rotation, the transverse direction of the core wire cross section and the bending direction of the guidewire become the same, making the guidewire more easily bendable than before the rotation. Furthermore, the inventors discovered that even if the longitudinal direction of the core wire cross section and the bending direction of the guidewire are not the same but form an angle of 90° or less, the guidewire still rotates by an angle of 90° or less. Similarly, as a result of this rotation, the transverse direction of the core wire cross section and the bending direction of the guidewire become the same, making the guidewire more easily bendable than before the rotation.

[0012] Thus, regardless of the orientation of the core wire inside the guidewire when inserted into the guidewire shaping tool of the present invention, the guidewire can be easily bent by hitting the vicinity of the intersection of the extension lines and sliding along the inner wall. Therefore, the guidewire shaping tool of the present invention can achieve uniform ease of shaping the guidewire and uniform shaping quality.

[0013] The acute-angle side inner wall portion may have a shape that bulges out in a direction away from the extension line.

[0014] That is, because the inner wall of the guidewire shaping tool of the present invention has an acute-angled inner wall portion that bulges away from the extension line, when the tip of the guidewire slides along the inner wall while bending toward the obtuse angle, the portion of the guidewire connected to the tip can bend so as to approach or contact the acute-angled inner wall portion. As a result, the tip can slide smoothly while forming a shallower angle with respect to the wall surface direction of the inner wall compared to when the connected portion is not curved. This allows the guidewire to rotate more easily and be shaped more efficiently.

[0015] Thus, the guidewire shaping tool of the present invention provides uniform ease of shaping and uniform shaping quality for the guidewire.

[0016] Furthermore, the exit portion has a width that allows the guide wire to be positioned in two places, and includes an obtuse-angle side exit portion which is one side portion of the exit portion that has a substantially straight inner wall that is continuous with the obtuse-angle side inner wall portion, an acute-angle side exit portion which is one side portion of the exit portion opposite the obtuse-angle side exit portion, and a holding portion configured to press and hold the tip and its vicinity at the obtuse-angle side exit portion against the main body of the guide wire shaping device, so that the guide wire is partially pulled out from the opening while the tip and its vicinity remain held by the holding portion, and a portion of the guide wire that is arranged in a ring inside the shaping portion is discharged through the acute-angle side exit portion, and the remainder is shaped into a ring with a smaller diameter.

[0017] A user of the guidewire shaping tool of the present invention feeds a guidewire, slides the tip of the guidewire along the obtuse-angle inner wall portion, and reaches the exit portion. Then, reversely, pulls the guidewire partially out of the opening. In this way, the ring diameter of the guidewire inside the shaping portion is reduced, thereby shaping the guidewire into a ring shape. At this time, the holding portion holds the tip of the guidewire, thereby reliably fixing the position of the tip. Furthermore, because the tip is held at the obtuse-angle exit portion on one side, the guidewire to be pulled out can be passed through the acute-angle exit portion on the other side. This allows the ring diameter of the guidewire to be reduced more efficiently for shaping.

[0018] Furthermore, the obtuse angle side outlet portion and the acute angle side outlet portion may each have an obtuse angle side outlet facing portion and an acute angle side outlet facing portion, which are inner walls facing each other, and a portion including the acute angle side outlet facing portion and an acute angle side outlet adjacent portion, which is a portion of the acute angle side inner wall portion adjacent to the acute angle side outlet facing portion, may be nested, and the valve may have a sliding portion that can slide along a groove-shaped rail portion provided in a direction perpendicular to the center line, and the sliding portion may slide to widen the gap between the obtuse angle side outlet facing portion and the acute angle side outlet facing portion and the gap between the obtuse angle side inner wall portion and the acute angle side outlet adjacent portion.

[0019] Incidentally, when inserting a guidewire into a blood vessel, bending the tip into a J-shape reduces the strain on the blood vessel. However, when bending a guidewire into a J-shape, if the force applied to bend the guidewire is too great, a large amount of stress in a specific direction remains after plastic deformation. This can lead to a state in which the folded portion of the guidewire hangs down after being removed from the guidewire shaping tool. In other words, when the guidewire is bent toward an obtuse angle and the tip is folded back along the inner wall of the obtuse angle side, the folded portion and the guidewire are further bent in the folded direction. This state in which excessive stress in a specific direction remains due to plastic deformation is also referred to as a "stressed" state.

[0020] In particular, when the annular diameter of the guidewire is reduced and shaped, if the distance between the obtuse-angle side outlet facing portion and the acute-angle side outlet facing portion and the distance between the obtuse-angle side inner wall portion and the acute-angle side inner wall portion are narrow, the curvature of the annular portion of the guidewire being fed is small. Therefore, the guidewire is subjected to strong bending when fed with such a small curvature. As a result, the folded-back portion of the guidewire is likely to bend unnecessarily.

[0021] In contrast, the guidewire shaping tool of the present invention can shape the guidewire being fed so that it forms a gentle curve by sliding the sliding portion and widening the gap between the obtuse-angle side outlet-facing portion and the acute-angle side outlet-facing portion, which is part of the sliding portion, and the gap between the obtuse-angle side inner wall portion and the acute-angle side outlet-adjacent portion, which is part of the sliding portion, thereby increasing the curvature of the folded-back portion. This reduces the strain applied to the guidewire and prevents the folded-back portion from bending in a drooping manner.

[0022] Furthermore, in the guidewire shaping tool of the present invention, the sliding portion can slide along the rail portion, so the distance between them can be freely changed. This allows the curvature of the folded portion to be adjusted, and the degree of bending or warping of the folded portion can be adjusted according to the user's desire. "Warping" here refers to the state in which the folded portion of the guidewire warps in the opposite direction to the direction of folding.

[0023] Thus, the guidewire shaper of the present invention can be more easily shaped into a desired shape.

[0024] In addition, each of the main bodies may be configured so that it is divided into a first main body portion and a second main body portion, the inlet passage portion and the shaping portion are recessed in the first dividing surface which is the dividing surface of the first main body portion, and the first dividing surface and the second dividing surface which is the dividing surface of the second main body portion can freely overlap or separate.

[0025] That is, the second divided surface of the second main body portion can be freely overlapped or separated from the first divided surface of the first main body portion, in which the entrance passage portion and the shaping portion are recessed, so that the first divided surface and the second divided surface come into close contact so as to overlap when shaping the guidewire, thereby enabling the guidewire to be accurately guided. Furthermore, when removing the guidewire from the guidewire shaping tool after shaping, or when cleaning or maintaining the entrance passage portion, the divided surfaces can be exposed so as to be separated, facilitating work. [Effects of the Invention]

[0026] As described above, the present invention provides a guidewire shaping tool that allows for uniform ease of shaping and consistent shaping quality regardless of the direction of the core wire inside the guidewire inserted into the guidewire shaping tool. The present invention also provides a guidewire shaping tool and a guidewire shaping method that allow for efficient shaping into any desired shape, including folding back into a J-shape. [Brief explanation of the drawings]

[0027] [Figure 1] (a) The left image shows a cross section of a guidewire with a plastic jacket surrounding a core wire, and the right image shows a longitudinal section of the same guidewire. (b) The left image shows a cross section of a guidewire with a coil wound around a core wire, and the right image shows a longitudinal section of the same guidewire. [Figure 2] (a) The upper figure shows a cross section of a guidewire when the longitudinal direction of the core wire is the same as the bending direction of the guidewire, and the lower figure shows the same longitudinal section of the guidewire. (b) The upper figure shows a cross section of a guidewire when the transverse direction of the core wire is the same as the bending direction of the guidewire, and the lower figure shows the same longitudinal section of the guidewire. [Figure 3] 1A and 1B are a plan view and a front view, respectively, of a guidewire shaping tool according to the present invention; [Figure 4] A J-shaped guidewire is shown. [Figure 5] 1A and 1B are a left and right side views of a guide wire shaping tool according to the present invention, respectively; [Figure 6] 1 shows a plan view of the guidewire shaper of the present invention with the slide removed. [Figure 7] (a) shows a rear view of the slide section, and (b) shows a plan view of the same. [Figure 8] 1 shows a plan view of the guidewire shaper of the present invention with the slide portion in its rearmost position. [Figure 9] 1A is a plan view of the guide wire shaping tool of the present invention with the sliding portion slightly slid forward, and FIG. 1B is an enlarged plan view of the same guide wire shaping tool. [Figure 10] 1A is an enlarged plan view of the guidewire shaping device of the present invention, with the slide portion and holding portion omitted, and FIG. 1B is an enlarged plan view of the guidewire shaping device of the present invention, with the tip of the guidewire returned to the exit portion. [Figure 11](a) shows a plan view of the holding part, (b) shows a left side view of the holding part, and (c) shows a front view of the holding part. [Figure 12] 1 shows a plan view of an embodiment of a guidewire shaper of the present invention. [Figure 13] 1 shows a plan view of the guidewire shaper of the present invention with a guidewire being advanced through the entrance passageway. [Figure 14] 10 shows a plan view of the guidewire shaping tool of the present invention in a state where the guidewire has been further advanced and the tip thereof is advancing to the right in the shaping portion. [Figure 15] 1 shows a plan view of a guidewire shaper of the present invention in the state where the guidewire is being looped; [Figure 16] 1 shows a plan view of the guidewire shaper of the present invention with the guidewire folded back. [Figure 17] 1 is a plan view of the guidewire shaping tool of the present invention, showing a state in which the ring diameter of the guidewire remaining inside the shaping portion is gradually reduced. [Figure 18] 18 shows an enlarged plan view of the guidewire shaper of FIG. 17. [Figure 19] 19 shows an enlarged plan view of FIG. 18 with the holding portion and guide wire omitted. [Figure 20] 10 is a plan view of the guidewire shaping tool of the present invention with the sliding portion further slid and the guidewire further pulled out. FIG. [Figure 21] 21 shows an enlarged plan view of the guidewire shaper of FIG. 20. [Figure 22] (a) The guidewire is further bent along with the folded portion. (b) The guidewire is bent back along with the folded portion. [Figure 23] 1 shows the guidewire shaping tool of the present invention in a state where the shaping has been completed after the guidewire has been pulled out. [Figure 24] 1 shows a flow diagram of a guidewire shaping method of the present invention. [Figure 25] 10 is a left side view of a guidewire shaper according to an embodiment of the present invention, in which the retaining portion is inserted from below upward. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0028] An embodiment of the present invention will be illustrated using the drawings. In FIG. 3, 11 denotes a guidewire shaper. This guidewire shaper 11 is used to shape the guidewire shown in FIGS. 1 and 2 into a J-shape, as in the example shown in FIG. 4. The guidewire is indicated by the symbol W in the figures from FIG. 10(b) onwards, which will be described below. In each figure, arrow U indicates the upward direction U of the guidewire shaper 11 in the vertical direction. Arrow D indicates the downward direction D in the vertical direction. The upward side is referred to as the upper side, and the downward side is referred to as the lower side. Arrow L indicates the leftward direction in the horizontal direction. Arrow R indicates the rightward direction in the horizontal direction. The leftward side is referred to as the left side, and the rightward side is referred to as the right side. Arrow F indicates the forward direction in the front-to-back direction. Arrow B indicates the backward direction in the front-to-back direction. The forward-facing side is referred to as the front side, and the backward-facing side is referred to as the rear side.

[0029] The guidewire shaping tool 11 has a main body 13 shown in the plan view of FIG. 3(a). As shown in the front view of FIG. 3(b), this main body 13 is divided vertically into a first main body portion 14 located on the lower side and a second main body portion 15 located on the upper side. The first dividing surface 14a, which is the dividing surface of the first main body portion 14, and the second dividing surface 15a, which is the dividing surface of the second main body portion 15, are approximately horizontal planes. The first main body portion 14 is formed from a synthetic resin such as polyether ether ketone (PEEK) that has properties such as impact resistance, abrasion resistance, heat resistance, and high dimensional accuracy. The second main body portion 15 is formed from a highly transparent synthetic resin such as acrylic resin. Because the second main body portion 15 is transparent and can be seen through from above, the structure on the first dividing surface 14a is represented by solid lines in the plan view.

[0030] The first body 14 and the second body 15 are joined by hinges or bolts and nuts. Therefore, the first divided surface 14a and the second divided surface 15a can be freely overlapped or separated by opening and closing the hinges or attaching and detaching the bolts and nuts.

[0031] The guidewire shaping tool 11 also includes a sliding section 16 and a holding section 17. The sliding section 16 is formed in a shape combining a substantially trapezoidal columnar solid that is flat in the vertical direction and a substantially rectangular parallelepiped solid that is longitudinal in the front-to-rear direction and flat in the vertical direction, and a portion of the rear side is fitted into a groove recessed in the first dividing surface 14a. The holding section 17 is formed in a substantially rectangular columnar shape that is longitudinal in the vertical direction, and a portion of the lower side is fitted into a hole 15b that penetrates the second main body section 15 in the vertical direction.

[0032] FIG. 5(a) shows a left side view of the guidewire shaping tool 11, and FIG. 5(b) shows a right side view. FIG. 6 shows a plan view with the slide portion 16 removed. The first main body portion 14 has a groove-shaped rail portion 21 that is provided in the front-to-rear direction and into which a portion of the rear side of the slide portion 16 is fitted. The rail portion 21 is recessed downward in the first dividing surface 14a as shown in FIGS. 5(a) and 5(b), and has a left-facing side wall 21a, a right-facing side wall 21a, and an upward-facing bottom wall 21b as shown in FIG. 6. These side walls 21a and bottom wall 21b have a planar surface in the front-to-rear direction. The rail portion 21 has a flat shape in the vertical direction, and its vertical depth is greater than the depth of the shaping portion 25.

[0033] 7(a) and 7(b), the slide portion 16 has a left side surface 16a and a right side surface 16a in the front-rear and up-down directions, and a bottom surface 16b in the front-rear and left-right directions. The left and right side surfaces 16a, 16a of the slide portion 16 contact the left and right side walls 21a, 21a, and the bottom surface 16b contacts the bottom wall 21b, and the slide portion 16 can slide in the front-rear direction by sliding on the rail portion 21. The vertical height of the slide portion 16 is approximately the same as the vertical depth of the rail portion 21.

[0034] FIG. 8 is a plan view showing the sliding portion 16 in its rearmost position, with the holding portion 17 omitted for clarity. The first main body portion 14 has an opening 22 recessed rightward from its left side as shown in FIG. 5( a). The opening 22 forms a semi-conical space with a rightward apex. The tip of the guidewire W is inserted into this opening 22. An entrance passage portion 23, which is a generally columnar space extending in the left-right direction as shown in FIG. 8, is formed so as to communicate with the opening 22. The entrance passage portion 23 is recessed downward in the first divided surface 14 a. The entrance passage portion 23 has an exit portion 24, which is the innermost portion of the entrance passage portion 23 as viewed from the opening 22. That is, the exit portion 24 is located at the rightmost position of the entrance passage portion 23.

[0035] Next, the first main body portion 14 has a shaping portion 25 that communicates with the inlet passage portion 23 and spreads out to the right from the outlet portion 24. The shaping portion 25 is recessed downward in the first divided surface 14a, similar to the inlet passage portion 23. The shaping portion 25 forms a flat space in the vertical direction, as shown by hidden lines in the side views of Figures 5(a) and (b). The shaping portion 25 has a substantially annular inner wall 25a that forms its inner periphery.

[0036] Here, an extension C' of the center line C of the inlet passage portion 23 intersects with the inner wall 25a. The portion of the inner wall 25a where this intersects is called the extension line intersection portion 26. The extension line C' does not intersect with the inner wall 25a at a right angle, but intersects with it at an obtuse angle at the extension line intersection portion 26. As shown in FIG. 8 , the extension line C' forms an obtuse angle with the inner wall 25a on the rear side of the extension line intersection portion 26. At the same time, the extension line C' forms an acute angle with the inner wall 25a on the front side of the extension line intersection portion 26. In the example of FIG. 8 , the extension line C' intersects with the inner wall 25a at an angle of 129.0° at the extension line intersection portion 26. Of these inner walls 25a, the inner wall 25a that extends from the outlet portion 24 through the rear side to the extension line intersection portion 26 and intersects with the extension line C' at an obtuse angle is called the obtuse angle-side inner wall portion 27. The inner wall 25a extending from the outlet 24 through the front side to the extension line intersecting portion 26 and intersecting with the extension line C' at an acute angle is called an acute angle side inner wall portion 28.

[0037] The acute angle side inner wall portion 28 has a shape that bulges forward, that is, in a direction away from the extension line C', as shown by the thick arrow in FIG.

[0038] As shown in FIG. 7(b), the sliding portion 16 has a rear end portion 31 that protrudes rearward. As shown in FIG. 7(a), the rear end portion 31 is located at an upper portion of the sliding portion 16 relative to the vertical thickness. The left side surface of the rear end portion 31 is called the stop surface 31a. When the sliding portion 16 is positioned at the rearmost position as shown in FIG. 8, the rear end portion 31 intersects with the center line C, and the guidewire W entering the entrance passage portion 23 to the right through the opening 22 is prevented from further entry by the stop surface 31a. In contrast, FIG. 9(a) shows a state in which the sliding portion 16 is slid slightly forward. In this state, the back surface 31b of the rear end portion 31 is contiguous with the front end surface of the inner wall of the entrance passage portion 23 to the left of the exit portion 24, or is located slightly forward of the entrance passage portion 23, so the guidewire W is not prevented from entering by the stop surface 31a. This state is called the open state of the inlet passage portion 23.

[0039] A back surface 31b of the rear end portion 31 constitutes a portion facing the acute-angle side outlet, which will be described later.

[0040] 9(b) is an enlarged plan view of the holding portion 17 in the open state, shown by imaginary lines. In this figure, the back surface 31b of the rear end portion 31 is continuous with the front end surface 23a of the inner wall of the inlet passage portion 23 on the left side of the outlet portion 24.

[0041] 10(a) is an enlarged plan view of the vicinity of the exit portion 24, with the sliding portion 16 and the holding portion 17 omitted. The exit portion 24 has a width in the front-to-rear direction that allows a guidewire W (not shown) to be placed in two positions, front and rear. This exit portion 24 is composed of an obtuse-angle-side exit portion 32, which is one side portion having a substantially linear inner wall 32a that is continuous with the obtuse-angle-side inner wall portion 27, and an acute-angle-side exit portion 33, which is one side portion opposite the obtuse-angle-side exit portion 32. In this way, the obtuse-angle-side exit portion 32 is arranged side by side on the rear side, and the acute-angle-side exit portion 33 is arranged side by side on the front side.

[0042] The left end of the obtuse-angle side outlet 32 ​​is closed by a blocking portion 32b. On the other hand, the acute-angle side outlet 33 is provided at a position extending the inlet passage 23 to the right, and its left end communicates with the inlet passage 23.

[0043] FIG. 10(b) shows a state in which the guidewire W enters the entrance passage 23 to the right, curves counterclockwise inside the shaping portion 25, and then the tip Wa returns to the exit portion 24. At this time, because the acute-angle side exit 33 is occupied by the front guidewire W, the tip Wa enters the obtuse-angle side exit portion 32 and is then stopped by the blocking portion 32b, moving rightward. Because the exit portion 24 thus has an upper obtuse-angle side exit portion 32 and a lower acute-angle side exit portion 33, the guidewire W can be positioned in two positions, front and rear. Of the two front and rear guidewires W shown in FIG. 10(b), the guidewire W that returns to the rear exit portion 24 is called the rear guidewire Wb and is positioned inside the obtuse-angle side exit portion 32. The tip Wa forms part of the rear guidewire Wb. The other front guidewire W is called the front guidewire Wf, and the guidewire Wf passes left and right through the acute-angle side exit portion 33.

[0044] 11(a), (b), and (c) respectively show a plan view, a left side view, and a front view of the holding portion 17. A portion of the lower side of the holding portion 17 is fitted into the hole 15b of the second main body portion 15. The holding portion 17 also has a lower end portion 34 that protrudes downward. In plan view, the lower end portion 34 has a width that is approximately half the width of the holding portion 17 in the left-right direction and is located toward the left, and has a depth that is approximately half the depth of the holding portion 17 in the front-to-back direction and is located toward the front. The back surface of the lower end portion 34 is formed so that the depth decreases toward the bottom.

[0045] The lower end portion 34 has a recessed portion 35 formed in a partially cylindrical shape in the left-right direction on its bottom surface. This recessed portion 35 can push the distal end Wa and the guidewire W in its vicinity downward from above when the holding portion 17, represented by imaginary lines in the plan view of Figure 10(b), descends along the hole 15b. At this time, the distal end Wa and the guidewire W in its vicinity are supported from below by the first main body portion 14, which corresponds to the bottom wall of the obtuse-angle side outlet portion 32, and are therefore pressed against the main body 13 by the lower end portion 34 and held therein.

[0046] However, because the recessed portion 35 is narrow in the left-right direction, the holding portion 17 can push downward only the rear guidewire Wb placed inside the obtuse angle side exit portion 32, but does not push the front guidewire Wf. Therefore, while the rear guidewire Wb remains in the obtuse angle side exit portion 32, the front guidewire Wf can move freely in the left-right direction within the acute angle side exit portion 33.

[0047] 12 shows an example of dimensions in a plan view of an embodiment of the guidewire shaping tool 11. Here, extension line C' intersects with inner wall 25a at an angle of 129.0°. However, extension line C' may intersect with inner wall 25a at an angle other than 129.0°, and may intersect at an angle of about 129.0° as long as tip end Wa slides along obtuse-angle side inner wall portion 26 without getting caught as guidewire W is advanced.

[0048] The guidewire shaping method S100, which involves a user folding back the distal end Wa of the guidewire W using the guidewire shaping tool 11 of the present invention and shaping the distal end into a J-shape, is shown below using the plan views and enlarged plan views of Figures 13 to 21 and 23. In these figures, the holding portion 17 is shown by imaginary lines, and structures that are normally hidden by the holding portion 17 when viewed from above are also shown by solid lines. The guidewire shaping method S100 is also shown by the flow diagram of Figure 24.

[0049] 13 shows a state in which the first body portion 14 and the second body portion 15 are joined in the vertical direction. The process of preparing the guidewire shaping tool 11 and joining these body portions 14 and 15 is called a preparation process S110.

[0050] Here, the second divided surface 15a of the second main body portion 15 can be freely overlapped or separated from the first divided surface 14a of the first main body portion 14, in which the entrance passage portion 23 and the shaping portion 25 are recessed, so that when shaping the guide wire W, the first divided surface 14a and the second divided surface 15a are closely fitted together so as to overlap, allowing the guide wire W to be accurately guided.

[0051] FIG. 13 shows a state in which the user inserts the distal end Wa into the opening 22 and feeds the guidewire W from outside the guidewire shaper 11 through the entrance passage 23 to the right. The direction of advancement of the guidewire W is indicated by an arrow. In this figure, the slide portion 16 has moved to the rearmost position on the rail portion 21, as in FIG. 8 . Therefore, the distal end Wa cannot advance further to the right than the stop surface 31a of the slide portion 16. The process from inserting the guidewire W into the opening 22 in this manner until the distal end Wa hits the blocking portion 32b and is stopped, as shown in FIG. 16 (described later), is called the feeding step S120. In this feeding step S120, the holding portion 17 is raised, and the lower end 34 does not touch the guidewire W.

[0052] FIG. 14 shows the state in which the user slides the sliding portion 16 slightly forward, leaving the entrance passage 23 open as shown in FIGS. 9(a) and 9(b). In this state, the guidewire W can be fed further rightward, and the tip Wa advances rightward through the shaping portion 25 via the acute-angle side exit portion 33. The elevated holding portion 17 does not impede the advancement of the guidewire W. The tip Wa then advances substantially along the extension line C' and abuts near the extension line intersection 26. The angle between the guidewire W and the inner wall 25a when the tip Wa abuts near the extension line intersection 26 is substantially the same as the angle between the extension line C' and the inner wall 25a. In this example, the angle between the guidewire W and the obtuse-angle side inner wall 27 is 129.0°, an obtuse angle. The inventors discovered that upon abutment, the guidewire W naturally bends toward the side that forms an obtuse angle with its traveling direction. As a result, the tip Wa comes into contact with the vicinity of the extension line intersection 26, and then bends counterclockwise in the drawing and slides along the obtuse-angle side inner wall portion 27. Then, the guidewire W in the shaping portion 25 bends so that the entire guidewire W is arranged in a circular shape.

[0053] 13 shows an example in which the sliding portion 16 is initially positioned at the rearmost position, but the sliding portion 16 may be positioned slightly forward from the beginning, leaving the entrance passage 23 open. In this case, the user can advance the tip Wa into the shaping portion 25 from the beginning without sliding the sliding portion 16.

[0054] Here, the present inventors, after extensive research, discovered that when the tip Wa of the inserted guidewire W hits the vicinity of the extension line intersection 26 and slides along the obtuse-angle inner wall portion 27 while bending toward the obtuse-angle side, the guidewire W rotates 90° about its central axis, even if the flat core wire C inside the guidewire W has a cross-sectional longitudinal direction that is substantially identical to the front-to-rear direction and is positioned as shown in FIG. 2( a). As a result of this rotation, the cross-sectional longitudinal direction of the core wire C becomes substantially identical to the up-down direction, making the guidewire W more easily bendable. Furthermore, the present inventors discovered that even if the cross-sectional longitudinal direction of the core wire C and the bending direction of the guidewire W are not identical but form an angle of 90° or less, the guidewire W still rotates by an angle of 90° or less. Similarly, as a result of this rotation, the cross-sectional longitudinal direction of the core wire C becomes substantially identical to the up-down direction, making the guidewire W more easily bendable than before the rotation.

[0055] In this way, regardless of the orientation of the core wire C inside the guidewire W when it is inserted into the guidewire shaping tool 11, the guidewire W can change its posture so that it becomes easier to bend by hitting the vicinity of the extension line intersection 26 and sliding along the obtuse-angle side inner wall portion 27. Therefore, the guidewire shaping tool 11 can achieve uniform ease of shaping the guidewire W and uniform shaping quality.

[0056] 15 shows a state in which the user continues to feed the guidewire W to the right, causing the tip Wa to slide counterclockwise along the obtuse-angle-side inner wall portion 27, and causing the guidewire W as a whole to describe a loop shape within the shaping portion 25. The acute-angle-side inner wall portion 28, which is located on the opposite side of the obtuse-angle-side inner wall portion 27 with respect to the extension line C', has a shape that bulges forward, that is, away from the extension line C'.

[0057] Therefore, the portion of the guidewire W continuing from the distal end Wa can be curved so as to approach or contact the acute-angle side inner wall portion 28. As a result, compared to when the portion continuing from the distal end Wa is not curved, the distal end Wa can slide smoothly while forming a shallower angle with respect to the wall surface direction of the obtuse-angle side inner wall portion 27. This allows the guidewire W to rotate about its central axis more easily and to be shaped more efficiently. In this way, the guidewire shaping tool 11 can achieve uniform ease of shaping the guidewire W and uniform shaping quality.

[0058] 16 shows a state in which the user continues to feed the guidewire W, causing it to draw a large loop and bend counterclockwise within the shaping portion 25, with the tip Wa turning back while changing direction from upward to leftward. As a result, the tip Wa returns to the outlet portion 24. Then, as in FIG. 10(b), the tip Wa enters the obtuse-angle side outlet portion 32 and then hits the occlusion portion 32b, where it is stopped.

[0059] 16, after the tip Wa is stopped by the blocking portion 32b, the user lowers the holding portion 17 with his / her fingers and presses the recessed portion 35 downward against the guidewire W, thereby holding the guidewire W between the lower end portion 34 of the holding portion 17 and the first main body portion 14. The process from lowering the holding portion 17 to completing the shaping of the guidewire W as shown in FIG. 23, which will be described later, is called a pulling-out process S130.

[0060] In this withdrawal step S130, the rear guidewire Wb, including the tip Wa of the guidewire W and the vicinity thereof, is pressed downward and held by the holding portion 17. In this state, the user pulls the guidewire W protruding from the opening 22 to the left and withdraws it from the entrance passage 23. As a result, a portion of the guidewire W arranged in a ring shape inside the shaping portion 25 is discharged from the shaping portion 25 through the acute-angle side exit portion 33, as shown in FIG. 16. At this time, the front guidewire Wf is not pressed and can move freely leftward. The remaining portion of the guidewire W remaining inside the shaping portion 25 is shaped so that the ring diameter decreases as the ring circumference decreases.

[0061] In this way, the user of the guidewire shaping tool 11 first feeds the guidewire W, and after its tip Wa slides along the obtuse-angle side inner wall portion 27 and reaches the exit portion 24, the user then partially withdraws the guidewire W from the opening 22. The ring diameter of the guidewire W inside the shaping portion 25 is then reduced, thereby shaping the guidewire W into a ring shape. At this time, the holding portion 17 holds the rear guidewire Wb, thereby reliably fixing the position of the tip Wa. Furthermore, because the rear guidewire Wb is held at the obtuse-angle side exit portion 32 on one side, the front guidewire Wb to be withdrawn can be passed through the acute-angle side exit portion 33 on the other side. This allows the ring diameter of the guidewire W to be reduced more efficiently for shaping.

[0062] The user also begins to pull out the guide wire W from the opening 22, and pushes the slide portion 16 forward with his or her fingers to slide the rail portion 21 forward.

[0063] FIG. 17 shows the state in which the annular diameter of the remaining portion of the guidewire W remaining inside the shaping portion 25 is gradually reduced. FIG. 18 is an enlarged plan view of the exit portion 24 and the annular portion of the guidewire W in FIG. 17 . The obtuse-angle-side outlet-facing portion 41, which is the forward-facing inner wall of the obtuse-angle-side outlet 32, and the acute-angle-side outlet-facing portion 42, which is the rearward-facing inner wall of the acute-angle-side outlet 33, face each other in the front-to-rear direction. The portion of the acute-angle-side inner wall portion 28 adjacent to the acute-angle-side outlet-facing portion 42 is referred to as the acute-angle-side outlet-adjacent portion 43. The acute-angle-side outlet-adjacent portion 43 forms a slope that is positioned more forward toward the right. The acute-angle-side outlet-facing portion 42 and the acute-angle-side outlet-adjacent portion 43 form a part of the slide 16. In other words, the slide 16 including the acute-angle-side outlet-facing portion 42 and the acute-angle-side outlet-adjacent portion 43 is nested within the first main body portion 14. FIG. 19 is a diagram in which the holding portion 17 and the guidewire W are not shown in order to make the obtuse angle side outlet opposing portion 41 and the acute angle side outlet opposing portion 42 easier to see.

[0064] 17 and 18 , when the sliding portion 16 slides forward, the acute-angle-side outlet-facing portion 42 and the acute-angle-side outlet-adjacent portion 43 move forward by the distance of the slide. As a result, the distance between the obtuse-angle-side outlet-facing portion 41 and the acute-angle-side outlet-facing portion 42 increases in the front-to-rear direction, and the distance between the obtuse-angle-side inner wall portion 27 and the acute-angle-side outlet-adjacent portion 43 also increases in the front-to-rear direction. Therefore, the front guidewire Wf is positioned further forward than if the acute-angle-side outlet-facing portion 42 and the acute-angle-side outlet-adjacent portion 43 had not moved forward. In this way, the annular portion of the guidewire W can expand, and its curvature is greater than if they had not moved.

[0065] 20 shows a state in which the user has pulled the guidewire W further out of the opening 22 than in the states shown in FIGS. 17 and 18 and pushed the sliding portion 16 forward to slide the rail portion 21 further. FIG. 21 is an enlarged plan view, similar to FIG. 18, of the vicinity of the exit portion 24 and the annular portion of the guidewire W in FIG. 20. The step of widening the gap between the obtuse angle side exit facing portion 41 and the acute angle side exit facing portion 42 and the gap between the obtuse angle side inner wall portion 27 and the acute angle side exit adjacent portion 43 as described above is called an expansion step S131.

[0066] In this way, by sliding the sliding portion 16 further forward, the acute angle side outlet facing portion 42 and the acute angle side outlet adjacent portion 43 move further forward by the longer sliding distance. This further increases the distance between the obtuse angle side outlet facing portion 41 and the acute angle side outlet facing portion 42 in the front-to-rear direction, and also increases the distance between the obtuse angle side inner wall portion 27 and the acute angle side outlet adjacent portion 43 in the front-to-rear direction. Therefore, the curvature of the annular portion of the guidewire W is even greater than if the sliding portion 16 had not moved.

[0067] When the guidewire W is shaped by folding it back into a J-shape, if the force applied to bend it back is too great, a large amount of stress in a specific direction will remain after plastic deformation. This can result in the folded portion of the guidewire W being bent in a drooping manner after it is removed from the guidewire shaping tool 11 in the removal process described below. That is, when the guidewire W is shaped by folding back the distal end Wa along the obtuse-angle inner wall portion 27 while bending toward an obtuse angle, the folded portion will be further bent in the folded direction. An example of such a state in which the folded portion is further bent is shown in Figure 22(a). This state in which excessive stress in a specific direction due to plastic deformation remains is also referred to as a state in which "stress" has been applied.

[0068] In particular, when the annular diameter of the guidewire W is reduced and shaped, if the distance between the obtuse-angle-side outlet-facing portion 41 and the acute-angle-side outlet-facing portion 42 and the distance between the obtuse-angle-side inner wall portion 27 and the acute-angle-side inner wall portion 28 are narrow, the curvature of the annular portion of the guidewire W being fed is small. Therefore, when the guidewire W is fed with such a small curvature, it is subjected to strong strain. As a result, the folded-back portion of the guidewire tends to bend unnecessarily upward as shown in FIG. 22(a).

[0069] In contrast, the guidewire shaping tool 11 of the present invention can shape the guidewire W being fed so that it traces a gentle curve by sliding the sliding portion 16 to widen the gap between the obtuse-angle-side outlet-facing portion 41 and the acute-angle-side outlet-facing portion 42, which is part of the sliding portion 16, and the gap between the obtuse-angle-side inner wall portion 27 and the acute-angle-side outlet-adjacent portion 43, which is part of the sliding portion 16. As a result, the curvature of the folded-back portion can be increased. This reduces the strain applied to the guidewire W and prevents the folded-back portion from bending in a drooping manner, as shown in Figure 22(a).

[0070] Furthermore, in the guidewire shaping tool 11 of the present invention, the sliding portion 16 can slide along the rail portion 21, allowing the distance between them to be freely adjusted. This allows the curvature of the folded portion to be adjusted, allowing the degree of bending or camber of the folded portion to be adjusted appropriately according to the user's desire. "Camber" here refers to a state in which the folded portion of the guidewire cambers downward in the drawing, as shown in the example of Figure 22(b). This camber occurs when the guidewire W is pulled and drawn from the shaping portion 25 into the entrance passage 23, and is bent outward in a circular fashion, opposite to the direction inside the shaping portion 25. This portion is illustrated by the symbol S in Figure 21. As described above, the guidewire shaping tool 11 of the present invention can be more easily shaped into a desired shape.

[0071] FIG. 23 shows the state where the shaping of the guidewire W is completed after it has been pulled out. The steps leading up to this state are the pulling-out step S130. After the shaping is complete, the worker raises the holding portion 17 to stop holding the guidewire W by pressing it against the guidewire W. Then, the worker releases the connection between the first body portion 14 and the second body portion 15 by opening the hinges, removing the bolts and nuts, or the like. This exposes the first dividing surface 14a, and the worker removes the shaped guidewire W from the guidewire shaping tool 11. The steps from raising the holding portion 17 to removing the guidewire W from the guidewire shaping tool 11 are called the removing step S140.

[0072] In this way, in the guidewire shaping tool 11, the main body 13 is divided into the first main body portion 14 and the second main body portion 15, which can be freely joined and unjoined, allowing the user to easily remove the shaped guidewire W from the guidewire shaping tool 11. Then, to shape another guidewire W, the main body portions 14, 15 can be rejoined. Furthermore, the divided surfaces 14a, 15a can be exposed and separated from each other, facilitating cleaning, maintenance, etc. of the entrance passage portion 23, shaping portion 25, etc., as well as removing the guidewire W.

[0073] Although the embodiments of the present invention have been described above as examples, the present invention is not limited to these embodiments, and various modifications are possible without departing from the spirit of the present invention.

[0074] For example, while the above example illustrates an embodiment in which the retaining portion 17 is inserted downward from the top of the guidewire shaping tool 11, the retaining portion may also be inserted upward from the bottom of the guidewire shaping tool. Then, in the preparation step S110, a first main body portion 114, a second main body portion 115, and a retaining portion 117 that match this may be prepared. FIG. 25 shows a left side view of the guidewire shaping tool 111 in this different embodiment. In this guidewire shaping tool 111, a portion of the upper side of the retaining portion 117 is inserted into a hole 114b that vertically penetrates the first main body portion 114. By rising along the hole 114b, the retaining portion 117 can push the distal end Wa and the portion of the guidewire W in its vicinity upward from below. At this time, the distal end Wa and the portion of the guidewire W in its vicinity are supported from above by the second main body portion 115, and are therefore pressed against the main body and held by the retaining portion 117.

[0075] 23, the reciprocating movement of the sliding portion 16 may be repeated, or the feeding and pulling out of the guidewire W may be repeated, or both may be performed. At this time, the rear end portion 31 of the sliding portion 16 can push the folded portion of the guidewire W backward, and the user can finely adjust the shape as desired by gradually deforming this folded portion. [Industrial Applicability]

[0076] The present invention can be utilized in a guidewire shaping device and a guidewire shaping method for shaping a guidewire, which is a flexible wire-like device for facilitating insertion and placement of a catheter introducer or the like into a blood vessel. [Explanation of symbols]

[0077] 11,111 Guidewire attachment 13 Main Unit 14,114 First body part 14a First dividing surface 114b hole 15,115 Second body part 15a Second dividing surface 15b hole 16 Slide section 16a side 16b Bottom 17,117 Holding part 21 Rail section 21a side wall 21b Bottom wall 22 Opening 23 Entrance passage C Center line of entrance passage C´ Extension of the center line of the entrance passage 24 Exit section 25 Shaped part 25a inner wall 26 Extension Line Intersection 27 Obtuse angle side inner wall 28 Inner wall on acute angle side 31 Rear end 31a Stop surface 31b Back 32 Obtuse side outlet 32a inner wall 32b Occlusion 33 Acute angle side exit W Guidewire Wa tip Wb Posterior guidewire Wf Anterior guidewire 34 Lower end 35 Concave part 41 Opposite obtuse side exit 42 Acute angle side outlet facing part 43 Adjacent to acute angle side exit S100 Guidewire Shaping Method S110 Preparation process S120 Feeding process S130 Drawing process S131 Extended Step S140 Removal process

Claims

1. an entrance passage portion which is a substantially columnar space through which a tip of a guide wire is inserted and through which the guide wire passes; a shaping portion that is a space that communicates with the inlet passage portion via an outlet portion that is the innermost portion of the inlet passage portion and that spreads flatly from the outlet portion; an annular inner wall that forms an inner circumferential portion of the shaping portion; an extension line intersection portion of the inner wall, which is an inner wall that intersects with an extension line of a center line of the inlet passage portion at an obtuse angle; an obtuse-angle side inner wall portion that is an inner wall extending from the outlet portion to the extension line intersection portion and that forms an obtuse angle with the extension line; the inner wall has an acute-angle side inner wall portion which is an inner wall extending from the outlet portion to the extension line intersection portion and which is an inner wall on the side forming an acute angle with the extension line, As the guide wire is fed through the opening, the tip thereof, which is inserted sequentially through the entrance passage and the shaping portion, abuts near the intersection of the extension lines, and at this abutment, the tip bends toward the obtuse angle and slides along the obtuse angle side inner wall portion, so that the entire guide wire is arranged in a circular shape.

2. The guidewire shaping tool according to claim 1 , wherein the acute-angled inner wall portion has a shape that bulges out in a direction away from the extension line.

3. an obtuse-angle-side outlet portion, which is one side of the outlet portion having a width allowing the guide wire to be placed in two positions and which has a substantially linear inner wall continuous with the obtuse-angle-side inner wall portion; Similarly, an acute angle side outlet portion which is one side portion of the outlet portion opposite to the obtuse angle side outlet portion; a holding portion configured to press and hold the tip and its vicinity against the main body of the guidewire shaping tool at the obtuse angle side outlet portion, 3. The guide wire shaping device of claim 1, wherein the guide wire is partially pulled out of the opening while the tip and its vicinity remain held by the holding portion, and a portion of the guide wire arranged in a ring shape inside the shaping portion is discharged through the acute-angle side outlet portion, and the remaining portion is shaped into a ring with a smaller diameter.

4. the obtuse angle side outlet portion and the acute angle side outlet portion each have an obtuse angle side outlet opposing portion which are inner walls opposing each other, and the acute angle side outlet portion each have an acute angle side outlet opposing portion a portion including the acute angle side outlet opposing portion and an acute angle side outlet adjacent portion, which is a portion of the acute angle side inner wall portion adjacent to the acute angle side outlet opposing portion, nested within each other, and having a slide portion that is slidable along a groove-shaped rail portion that is provided in a direction perpendicular to the center line, The guide wire shaping device according to claim 3, wherein the sliding portion slides to widen the gap between the obtuse angle side outlet facing portion and the acute angle side outlet facing portion, and the gap between the obtuse angle side inner wall portion and the acute angle side outlet adjacent portion.

5. 2. The guidewire shaping device according to claim 1, wherein the guidewire shaping device is divided into a first main body portion and a second main body portion, the inlet passage portion and the shaping portion are recessed into the first dividing surface which is the dividing surface of the first main body portion, and each main body portion is configured so that the first dividing surface and the second dividing surface which is the dividing surface of the second main body portion can be freely overlapped or separated.

6. an entrance passage portion which is a substantially columnar space through which a tip of a guide wire is inserted and through which the guide wire passes; a shaping portion that is a space that communicates with the inlet passage portion via an outlet portion that is the innermost portion of the inlet passage portion and that spreads flatly from the outlet portion; an annular inner wall that forms an inner circumferential portion of the shaping portion; an extension line intersection portion of the inner wall, which is an inner wall that intersects with an extension line of a center line of the inlet passage portion at an obtuse angle; an obtuse-angle side inner wall portion that is an inner wall extending from the outlet portion to the extension line intersection portion and that forms an obtuse angle with the extension line; a preparation step of preparing a guidewire shaping tool having an acute-angle side inner wall portion, which is an inner wall extending from the exit portion to the extension line intersection portion and which is an inner wall on the side that forms an acute angle with the extension line; a feeding step of feeding the guide wire through the opening so that the tip of the guide wire, which is inserted sequentially through the entrance passage portion and the shaping portion, abuts near the extension line intersection portion, and at this abutment, bends toward the obtuse angle side, sliding along the obtuse angle side inner wall portion, and the entire guide wire is arranged in a circular shape.

7. In the preparation step, an obtuse-angle-side outlet portion, which is one side of the outlet portion having a width allowing the guide wire to be placed in two positions and which has a substantially linear inner wall continuous with the obtuse-angle-side inner wall portion; Similarly, an acute angle side outlet portion which is one side portion of the outlet portion opposite to the obtuse angle side outlet portion; a guidewire shaping tool having a holding portion configured to press and hold the tip and its vicinity against a main body of the guidewire shaping tool at the obtuse angle side outlet portion; 7. The guide wire shaping method according to claim 6, further comprising a withdrawal step in which, after the feeding step, the tip and its vicinity are held by the holding portion and the guide wire is partially withdrawn from the opening while remaining in that state, a portion of the guide wire arranged in a ring shape inside the shaping portion is discharged through the acute-angle side exit portion, and the remaining portion is shaped into a ring with a smaller diameter.

8. In the preparation step, the obtuse angle side outlet portion and the acute angle side outlet portion each have an obtuse angle side outlet opposing portion which are inner walls opposing each other, and the acute angle side outlet portion each have an acute angle side outlet opposing portion a guidewire shaping tool having a slide portion that is slidable along a groove-shaped rail portion provided in a direction perpendicular to the center line, the slide portion including the acute-angle-side outlet-facing portion and an acute-angle-side outlet-adjacent portion that is a portion of the acute-angle-side inner wall portion adjacent to the acute-angle-side outlet-facing portion being nested within the acute-angle-side outlet-adjacent portion; 8. The guidewire shaping method according to claim 7, wherein the pulling-out process further includes an expansion step of sliding the slide portion to widen the gap between the obtuse angle side outlet facing portion and the acute angle side outlet facing portion, and the gap between the obtuse angle side inner wall portion and the acute angle side outlet adjacent portion.

9. In the preparation step, the guidewire shaping tool is further prepared, which is divided into a first main body portion and a second main body portion, the inlet passage portion and the shaping portion are recessed in a first dividing surface that is a dividing surface of the first main body portion, and each main body portion is configured so that the first dividing surface and the second dividing surface that is a dividing surface of the second main body portion can be freely overlapped or separated, and the first main body portion and the second main body portion are joined together so that the first dividing surface and the second dividing surface overlap, 9. The guidewire shaping method according to claim 7 or 8, further comprising a removal step, after the pulling-out step, of releasing the bond between the first body portion and the second body portion so that the first dividing surface and the second dividing surface are separated after the guidewire has been shaped, and then removing the guidewire from the guidewire shaping tool.

Images