JP2017153615A - Guide wire and manufacturing method for the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a guide wire which can easily shape and re-shape a guide wire end part into a desired shape, and a manufacturing method for the same.SOLUTION: A guide wire 10 has a base part 21 and a core wire 20 provided with an end part 23 smaller in diameter than the base part 21. On a surface S1 seen from one direction side in a circumferential direction of the end part 23 of the core wire 20, a heat denaturation part 50 more strongly heat denatured on a surface S2 seen from the other direction side in the circumferential direction is provided. The heat denaturation part 50 is formed intermittently along an axial direction of the core wire 20. The manufacturing method intermittently radiates laser from the one direction side in the circumferential direction of the end part 23 of the core wire 20 along the axial direction of the core wire 20 and forms the heat denaturation part 50.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a guide wire used when a catheter or the like is inserted into a predetermined position of a human body organ such as a bile duct, a pancreatic duct, a blood vessel, a ureter, and a trachea, or a human body tissue.

  For some time, we have inserted a catheter into a tubular organ of the human body such as the bile duct, pancreatic duct, blood vessel, ureter, trachea, etc., injected a drug solution, expanded the diameter of a tubular organ occluded with a balloon catheter, or placed a stent. It has been done. In these operations, first, a guide wire is inserted into a tubular organ to reach a predetermined position, and a catheter, a balloon catheter, a tube holding a stent, and the like are moved along the outer periphery thereof.

  In this type of guide wire, it is easy to insert into a bent tubular organ, or to select and insert a predetermined branch tube at a branching portion where the tubular organ branches, and further, depending on the tip of the guide wire. In order to prevent the inner wall of the tubular organ from being damaged, the distal end portion of the guide wire may be bent into a predetermined shape (J shape, angle shape, etc.) in advance. In addition, if a bent guide wire is inserted into a tubular organ with a bent tip, but the bent shape does not fit the purpose of use, the guide wire is once pulled out of the tubular organ and stretched to the original shape. In some cases, it may be bent due to its shape (referred to as reshaping).

  As such a guide wire that can be bent, for example, in Patent Document 1 below, the outer periphery of a core wire made of a shape memory alloy is coated with a synthetic resin film, and the tip of the core wire is formed to have a predetermined length, A catheter guide wire is disclosed in which the tip is annealed to facilitate plastic deformation. It is described that annealing is performed by placing only the tip of the core wire in an electric furnace or a salt bath.

  As a method for annealing the guide wire, paragraph 0075 of FIG. 2 and FIG. 15 describe that the annealing process is performed by irradiating only the end portion of the guide wire with a laser beam.

Japanese Utility Model Publication No. 3-24144 JP-T-2002-531707 gazette

  By the way, when the guide wire tip is bent and bent, the guide wire tip is brought into contact with a shaping tool such as a shaping mandrel and rubbed with a user's finger or the like, so that a desired direction can be obtained. It is shaped to bend into a shape.

  However, in the catheter guide wire of Patent Document 1, since the tip of the core wire is annealed by putting it in an electric furnace, a salt bath, etc., the entire tip of the core wire is annealed, so that plastic deformation easily occurs. When forming, there is a problem that it is difficult to bend in a certain direction and bends three-dimensionally. In addition, since the entire tip end portion of the core wire is easily plastically deformed, there is a disadvantage that it is difficult to stretch and reshape even if it is attempted to stretch the guide wire tip portion once shaped to the original shape.

  In Patent Document 2, the tip of the guide wire is annealed by a laser beam. However, as shown in FIGS. 15 and 16 of Patent Document 2, for example, the entire circumference of the tip of the guide wire is heated by the laser beam. In this case, there is also a problem that it is difficult to determine the shaping direction of the guide wire tip and to reshape it.

  Accordingly, an object of the present invention is to provide a guide wire and a method for manufacturing the guide wire, which can easily shape the tip end portion of the guide wire into a desired shape and can be easily reshaped.

  In order to achieve the above object, one of the present invention includes a core wire having a base portion and a tip portion having a diameter smaller than that of the base portion, and the tip portion of the core wire is viewed from one circumferential side. The surface is provided with a heat-denatured portion that is more strongly heat-denatured with respect to the surface viewed from the other direction side in the circumferential direction, and the heat-denatured portion is continuously or along the axial direction of the core wire. It is characterized by being formed intermittently.

  In the guide wire of this invention, it is preferable that the surface seen from the other direction side of the said circumferential direction in the front-end | tip part of the said core wire is not heat-denatured.

  In the guide wire of this invention, it is preferable that the said heat | fever denatured part cross | intersects the axial center of the said core wire, and is arrange | positioned at predetermined intervals along the axial direction.

  In the guide wire of the present invention, it is preferable that a portion where the heat-denatured portions are densely arranged at the tip portion of the core wire is divided in the axial direction of the core wire.

  On the other hand, another aspect of the present invention is a method of manufacturing a guide wire having a base and a core wire provided with a tip portion having a diameter smaller than that of the base portion, from one direction side in the circumferential direction of the tip portion of the core wire, Continuously and / or intermittently along the axial direction of the core wire, irradiate a laser with a higher output than the other side in the circumferential direction of the tip or irradiate the laser for a long time, A heat-denatured part is formed.

  According to the present invention, the surface of the tip of the core wire seen from one side in the circumferential direction is provided with a heat-denaturing portion that is more strongly heat-denatured than the surface seen from the other direction in the circumferential direction. Since this heat-denatured portion becomes easier to bend than other portions of the core wire, the tip portion of the guide wire is formed by forming the heat-denatured portion continuously or intermittently along the axial direction of the core wire. When forming a shape, it becomes easy to bend and bend in a predetermined direction with the heat-denatured portion inside, and the guide wire can be easily shaped into a desired shape. In addition, when the guide wire tip is shaped into a predetermined shape and then shaped into a different shape (reshaping), the guide wire tip is reshaped after being returned to the shape before shaping. Since the bending direction is determined with the inner side of the guide wire, it is possible to easily return the tip end portion of the guide wire to the shape before shaping and to facilitate reshaping.

1 shows a first embodiment of a guide wire according to the present invention, and is a cross-sectional view thereof. The guide wire is shown, (a) is a plan view of the core wire, (b) is a side view of the core wire. It is sectional drawing at the time of seeing from the cross section orthogonal to an axial direction of the front-end | tip part of the core wire of the same guide wire. In the same guide wire, it is sectional drawing of the state where the front-end | tip part was shaped. It is a top view which shows 2nd Embodiment of the guide wire which concerns on this invention. It is a top view which shows 3rd Embodiment of the guide wire which concerns on this invention. It is a top view which shows 4th Embodiment of the guide wire which concerns on this invention. It is a top view which shows 5th Embodiment of the guide wire which concerns on this invention. It is a top view which shows 6th Embodiment of the guide wire which concerns on this invention. It is explanatory drawing which shows one Embodiment of the manufacturing method of the guide wire which concerns on this invention. It is a photograph which shows the state before shaping of an Example and a comparative example. It is a photograph which shows the state after shaping of an Example and a comparative example. It is an enlarged photograph of the front-end | tip part of an Example.

  Hereinafter, an embodiment of a guide wire according to the present invention will be described with reference to the drawings. 1 to 3 show a first embodiment of a guide wire according to the present invention.

  As shown in FIG. 1, the guide wire 10 of this embodiment includes a core wire 20, a coil member 30 attached to the outer periphery of the core wire 20, and a resin layer 40 that covers the outer periphery of the core wire 20 and the coil member 30. Have. However, the guide wire of the present invention may have a structure in which one or both of the coil member 30 and the resin layer 40 do not exist (for example, only the core wire), and is not particularly limited.

  The core wire 20 is a so-called round wire having a circular cross section, and is provided on a base portion 21 extending at a predetermined length with a constant outer diameter D1 (see FIG. 2 (b)), and on the distal end side of the base portion 21. The tip portion 23 has a smaller diameter than the base portion 21. The tip portion 23 is a straight line having a taper portion 25 that extends while being gradually reduced in diameter from the tip end of the base portion 21 toward the tip end of the core wire, and a constant outer diameter D2 from the tip end of the taper portion 25 (see FIG. 2B). And a small-diameter portion 27 extending in a shape. In addition, as the front-end | tip part 23, the taper taper shape which the diameter may reduce gradually toward the front-end | tip may be sufficient as it, and it may be made into the step-like structure which diameter-reduces gradually toward the front-end | tip, and is not specifically limited.

  The outer diameter D1 of the base portion 21 is preferably 0.25 to 1.00 mm, and more preferably 0.30 to 0.70 mm. Further, the outer diameter D2 of the small diameter portion 27 is preferably 0.05 to 0.35 mm, and more preferably 0.06 to 0.15 mm. Furthermore, the length L1 of the small-diameter portion 27 (the length from the foremost end of the core wire 20 to the tip of the tapered portion 25) is preferably 3 to 100 mm, and more preferably 10 to 50 mm. Further, the length L2 of the taper portion 25 (the length from the tip of the taper portion 25 to the tip of the base portion 21) is preferably 70 to 500 mm, and more preferably 100 to 300 mm.

  Examples of the core wire 20 include Ni—Ti alloys, Ni—Ti—X (X = Fe, Cu, V, Co, Cr, Mn, Nb, etc.) alloys, Cu—Zn—X (X = Al). , Fe, etc.) Superelastic alloys such as alloys, stainless steel, piano wire, etc. can be used, or X made of W, Pt, Ti, Pd, Rh, Au, Ag, Bi, Ta, and alloys thereof. A radiopaque metal can also be used. Among the above, it is preferable to use Ni—Ti engagement gold, Ni—Ti—X alloy, and stainless steel.

  As shown in FIG. 1, the coil member 30 has a distal end side fixed to the distal end of the small-diameter portion 27 of the core wire 20 via a fixing portion 31, and a proximal end side tapered to the core wire 20 via a fixing portion 33. By being fixed to the middle part of the part 25, it is mounted on the outer periphery of the tip part 23 of the core wire 20. In addition, although the coil member 30 of this embodiment is loosely wound and the resin layer 40 has entered inside thereof, the coil member may be closely wound and the inside thereof may be a gap, and the shapeability of the guide wire tip portion As long as the configuration can be maintained.

  The material of the coil member 30 is, for example, an X-ray made of W (gold-plated tungsten), W, Pt, Ti, Pd, Rh, Au, Ag, Bi, Ta, an alloy thereof, or the like plated with Au. Impervious metal, Ni-Ti alloy, Ni-Ti-X (X = Fe, Cu, V, Co, Cr, Mn, Nb, etc.) alloy, Cu-Zn-X (X = Al, Fe, etc.) A superelastic alloy such as an alloy, stainless steel, or the like can be used. On the other hand, examples of the fixing portions 31 and 33 include an ultraviolet curable acrylate resin, a silicone-based adhesive, a modified silicone-based adhesive, an epoxy resin-based adhesive, an acrylate-based adhesive, and a urethane resin-based adhesive. Alternatively, a brazing material such as Sn or Ag brazing can be used.

  Further, the resin layer 40 of this embodiment covers the entire guide wire including the core wire 20 and the coil member 30, and has substantially the same outer diameter from the guide wire distal end to the proximal end (see FIG. 1). . However, the resin layer 40 may be a shape that covers only the coil member 30 even if it is not attached to the entire guide wire, and the outer diameter is not the same outer diameter from the distal end to the proximal end, For example, it may be a tapered shape, and is not particularly limited. Furthermore, the outer periphery of the resin layer 40 is covered with a hydrophilic resin film 45 (see FIG. 1).

  The resin layer 40 is made of, for example, polyurethane, nylon elastomer, polyether block amide, polyethylene, polyvinyl chloride, vinyl acetate, polytetrafluoroethylene (PTFE), perfluoroalkoxy resin (PFA), tetrafluoroethylene- Fluorine resins such as a hexafluoropropylene copolymer (FEP) and a tetrafluoroethylene-ethylene copolymer (ETFE) can be employed. On the other hand, the hydrophilic resin film 45 can employ, for example, a hydrophilic resin such as polyvinyl pyrrolidone, polyethylene glycol, and methyl vinyl ether maleic anhydride copolymer.

  And in the guide wire 10 of this embodiment, as shown to Fig.2 (a), (b), it is the surface S1 (henceforth only "" of the front-end | tip part 23 of the core wire 20 seen from the one direction side of the circumferential direction. The surface S1 ”) is provided with a heat-denaturing portion 50 that is more strongly heat-denatured with respect to the surface S2 (hereinafter also simply referred to as“ surface S2 ”) viewed from the other direction side in the circumferential direction. The heat-denatured portion 50 has a structure formed intermittently along the axial direction of the core wire 20.

  By providing the heat-denatured portion 50, when the distal end portion 23 of the guide wire 10 is formed, the heat-denatured portion 50 can be bent in a predetermined direction with the heat-denatured portion 50 inside (see FIG. 4). In addition, as seen from one direction side in the circumferential direction of the tip end portion of the core wire, as shown by an arrow in FIG. 3, a direction from the predetermined position in the circumferential direction of the core wire 20 toward the axis C of the core wire 20 (core wire 20 In the direction perpendicular to the axis C). Moreover, when it sees from the other direction side of the circumferential direction of the front-end | tip part of a core wire, it is the circumferential direction of the core wire 20, Comprising: It faces to the axial center C of the core wire 20 from the position different from the position where the said surface S1 is visible. That means looking in the direction.

  Further, the heat-denatured portion 50 in this embodiment is formed with a predetermined width W (see FIG. 2B) along the axial direction of the distal end portion 23 of the core wire 20 and with a predetermined length along the circumferential direction. It has a strip shape. The belt-shaped heat-denatured portion 50 extends in the circumferential direction with a length of about a half circumference so as to intersect the axis C of the core wire 20 (see FIG. 3). Furthermore, a plurality of the heat-denatured portions 50 having the above-described belt shape are arranged at a predetermined interval I (see FIG. 2B) along the axial direction of the core wire 20. In this embodiment, the heat-denatured portion 50 is provided in a range from a position away from the distal end surface of the small-diameter portion 27 by a predetermined length to an intermediate portion of the tapered portion 25. Note that the heat-denatured portion may be provided continuously along the axial direction of the core wire 20 and is not particularly limited (this will be described in an embodiment described later).

  Furthermore, in this embodiment, the surface S2 of the distal end portion 23 of the core wire 20 viewed from the other side in the circumferential direction is not thermally denatured. However, the surface S2 on the other direction side of the distal end portion 23 of the core wire 20 may be heat-denatured as long as the degree of heat denaturation is lower than that of the heat-denatured portion 50. In short, the surface S2 is provided on the one-side surface S1. It suffices that the heat-denatured portion 50 is a structure that is strongly heat-denatured with respect to the surface S2 on the other direction side.

  The heat-denatured portion 50 is formed by a predetermined heat treatment. For example, as in a guide wire manufacturing method to be described later, a laser is applied to the surface S1 of the tip portion 23 of the core wire 20 by a predetermined laser irradiation device (see FIG. 10), or a flame caused by combustion gas is applied to the tip of the core wire 20 Such as partially spraying on the surface S1 of the part 23, masking the portions other than the heat-denatured portion and performing heat treatment, and further applying a current to the heating wire to locally heat-treat the heating wire. By performing heat treatment (so-called annealing), a heat-denatured portion can be formed on the surface S1 of the tip portion 23 of the core wire 20.

  In the present invention, the term “heat-denatured portion” means that the tensile strength at the tip portion of the core wire provided with the heat-denatured portion is 50 to 90% with respect to the tensile strength at the tip portion of the core wire not having the heat-denatured portion. It means that it is a portion that has been heat-denatured by heat treatment so that it is preferably 60 to 86%.

  That is, the heat-denatured portion provided on the circumferential surface unidirectional surface S1 of the distal end portion 23 of the core wire 20 has a lower tensile strength and is harder than the structure before the heat treatment or the circumferential surface on the other surface S2. It has the properties of being low in length, soft and highly malleable.

  If the tensile strength is less than 50%, the tensile strength at the tip of the core wire is low, and there is a concern that the insertion property and torque transmission of the guide wire may be reduced. If the tensile strength exceeds 90%, It becomes difficult to improve the shaping performance of the tip.

  Moreover, as shown in FIG.2 (b), it is preferable that the width W of the heat-denaturing part 50 is 0.5-20 mm, and it is more preferable that it is 1-10 mm.

  Further, as shown in FIG. 3, when the distal end portion 23 of the core wire 20 is viewed from the axial cross section, the circumferential length R of the heat-denatured portion 50 is the length of the entire circumference of the core wire in that portion. 17 to 75% is preferable, and 50 to 60% is more preferable. In addition, the heat-denaturing part 50 in this embodiment is formed in the length of about half of the perimeter of a core wire (refer FIG. 3).

  Moreover, it is preferable that the space | interval I of the adjacent heat-denaturing parts 50 and 50 is 0.3-10 mm, and it is more preferable that it is 0.5-5 mm (refer FIG.2 (b)).

  FIG. 5 shows a second embodiment of the guide wire according to the present invention. Note that substantially the same parts as those of the above-described embodiment are denoted by the same reference numerals, and description thereof is omitted.

  The guide wire 10A of this embodiment is different from the previous embodiment in the structure of the heat-denatured portion. That is, the heat-denatured portion 51 of this embodiment extends linearly along the axial direction of the core wire 20 in the range from the most distal end of the small diameter portion 27 of the distal end portion 23 of the core wire 20 to the middle portion of the tapered portion 25. A plurality of heat-denatured portions 51 are provided at predetermined intervals along the circumferential direction of the core wire 20. Although FIG. 5 is a plan view, the bottom surface side of the core wire 20 is not thermally denatured.

  FIG. 6 shows a third embodiment of the guide wire according to the present invention. Note that substantially the same parts as those of the above-described embodiment are denoted by the same reference numerals, and description thereof is omitted.

  The guide wire 10B of this embodiment is also different from the above embodiment in the structure of the heat-denatured portion. That is, the heat-denatured portion 52 of this embodiment is formed in a strip shape that is inclined at a predetermined angle with respect to the axis C of the core wire 20 and is formed along the circumferential direction of the core wire 20. In the range from the most distal end of the small diameter portion 27 of the distal end portion 23 of the core wire 20 to the middle portion of the taper portion 25, a plurality of them are arranged at predetermined intervals along the axial direction of the core wire 20. In addition, although FIG. 6 is a top view, the bottom face side of the core wire 20 is not thermally denatured.

  FIG. 7 shows a fourth embodiment of the guide wire according to the present invention. Note that substantially the same parts as those of the above-described embodiment are denoted by the same reference numerals, and description thereof is omitted.

  The guide wire 10C of this embodiment is also different from the previous embodiment in the structure of the heat-denatured portion. That is, in this embodiment, with respect to the heat-denatured portions 52 that are inclined with respect to the axis of the core wire 20 and are arranged at predetermined intervals in the axial direction, And a plurality of belt-shaped heat-denaturing portions 53 that are inclined so as to intersect with each other and are arranged at predetermined intervals in the axial direction. Each of the heat-denatured portions 52 and 53 is formed in a range from the most distal end of the small diameter portion 27 of the distal end portion 23 of the core wire 20 to the middle portion of the tapered portion 25. Although FIG. 7 is a plan view, the bottom side of the core wire 20 is not thermally denatured.

  FIG. 8 shows a fifth embodiment of the guide wire according to the present invention. Note that substantially the same parts as those of the above-described embodiment are denoted by the same reference numerals, and description thereof is omitted.

  The guide wire 10D of this embodiment is also different from the previous embodiment in the structure of the heat-denatured portion. That is, in this embodiment, a plurality of strip-shaped heat-denatured portions 50 similar to the first embodiment, and a plurality of straight-line heat-denatured portions 51 similar to the second embodiment, Has a combined structure. Although FIG. 8 is a plan view, the bottom surface side of the core wire 20 is not thermally denatured.

  FIG. 9 shows a sixth embodiment of the guide wire according to the present invention. Note that substantially the same parts as those of the above-described embodiment are denoted by the same reference numerals, and description thereof is omitted.

  The guide wire 10E of this embodiment is different from the previous embodiment in the structure of the heat-denatured portion. In this embodiment, the tip 23 of the core wire 20 has a structure in which portions where heat-denatured portions are concentrated are separately arranged in the axial direction of the core wire 20. In this embodiment, a heat-denatured portion 53 that is densely provided with a predetermined length from the tip of the small-diameter portion 27 of the distal end portion 23 of the core wire 20 toward the base portion 21 side, and the distal end portion 23 of the core wire 20. In the range from the proximal end side of the small-diameter portion 27 to the middle portion of the tapered portion 25, a heat-denatured portion 54 provided densely with a predetermined length is provided, and two heats are generated in the axial direction of the core wire 20. The denatured portions 53 and 54 are arranged separately. In this embodiment, the two heat-denaturing parts 53 and 54 are arranged separately. However, the structure may be divided into three or more heat-denaturing parts and is not particularly limited. FIG. 9 is a plan view, but the bottom surface side of the core wire 20 is not thermally denatured.

  Next, an embodiment of the guide wire manufacturing method of the present invention for manufacturing the guide wire of each of the above embodiments will be described.

  For example, the guide wire is manufactured by using a known laser irradiation device as shown in FIG. 10 from one circumferential side of the distal end portion 23 of the core wire 20 along the axial direction of the core wire 20. And / or intermittently irradiate a high-power laser from the other side in the circumferential direction of the distal end portion 23 of the core wire 20, or irradiate the laser for a long time. Is formed.

  This laser irradiation apparatus has a laser irradiation unit 60 that can irradiate a laser with a predetermined output and can move at a predetermined speed in a predetermined direction. In addition, the distal end portion 23 of the core wire 20 of the guide wire is fixed below the laser irradiation unit 60.

  And in this embodiment, after irradiating laser for a predetermined time from the one direction side of the peripheral direction of the front-end | tip part 23 in the predetermined location of the front-end | tip part 23 of the core wire 20, an output is turned off and laser irradiation is stopped, The laser irradiation unit 60 is moved repeatedly in the predetermined direction along the axial direction of the core wire 20 and the laser irradiation is repeated repeatedly. Alternatively, the tip of the tip end portion 23 of the core wire 20 is A plurality of thermal denaturations are performed by continuously performing laser irradiation by moving the laser irradiation unit 60 in a predetermined direction along the axial direction of the core wire 20 while irradiating laser from one circumferential side of the unit 23. A part is formed.

  In this embodiment, the laser irradiation unit 60 is movable. However, the laser irradiation unit may be fixed and the guide wire side may be moved, or both the laser irradiation unit and the guide wire may be moved. It is sufficient that the laser irradiation unit can be moved relative to the guide wire.

  Moreover, it is preferable that the output of a laser is 3-10W, and it is more preferable that it is 5-8W. Moreover, the moving speed (relative moving speed) of the laser with respect to the core wire 20 is preferably 20 to 60 mm / second, and more preferably 30 to 50 mm / second.

  1 to 4, the guide wire 10 </ b> B of the third embodiment of FIG. 6, and the guide wire 10 </ b> C of the fourth embodiment of FIG. 7, with respect to the axis of the core wire 20. A thermally denatured portion is formed by irradiation of a laser that moves in a tolerance direction, and the guide wire 10A of the second embodiment in FIG. 5 and the guide wire 10E of the sixth embodiment in FIG. 9 move in the axial direction of the core wire 20. In the guide wire 10D of the fifth embodiment in FIG. 8, the laser irradiation that moves in the direction intersecting the axis of the core wire 20 and the axial direction of the core wire 20 are formed. A heat-denatured part is formed by combining with the irradiation of a laser that moves to.

  As described above, after providing the heat-denatured portion 50 at the distal end portion 23 of the core wire 20, the coil member 30 is attached to the outer periphery of the distal end portion 23 of the core wire 20 via the fixing portion 31 and the fixing portion 33. The guide wire 10 as shown in FIG. 1 can be manufactured by covering the outer periphery of the core wire 20 or the coil member 30 with the resin layer 40 and covering the outer periphery with the hydrophilic resin film 45.

  In addition, in the manufacturing method in the said embodiment, while irradiating a laser to the one direction side of the circumferential direction of the front-end | tip part 23 of the core wire 20, it does not irradiate the laser to the other direction side of the circumferential direction of the front-end | tip part 23. The laser beam is irradiated to one side in the circumferential direction of the tip portion 23 of the core wire 20, and a laser having a lower output than the one direction side in the circumferential direction of the tip portion 23 is applied to the other direction side in the circumferential direction of the tip portion 23. Irradiation or laser irradiation may be performed in a short time, and these are from one direction side in the circumferential direction of the distal end portion of the core wire in the manufacturing method of the present invention than from the other direction side in the circumferential direction of the distal end portion. In other words, it means a constituent requirement that a high output laser is irradiated or a laser is irradiated for a long time.

  Next, a method for using the guide wire of the present invention having the above structure will be described.

  In the following description, the guide wire 10 of the first embodiment is described as an example. However, this is for convenience, and the guide wires 10A, 10B, 10C, 10D, and 10E of other embodiments are used. The same applies to.

  In this embodiment, the guide wire 10 is a catheter or a stent placed at a predetermined position of various blood vessels, various tubular organs such as bile ducts, pancreatic ducts, ureters and trachea, and human tissues such as body cavities. It can be used when performing, and there are no particular limitations on the location of use.

  In use, the distal end portion of the guide wire 10 is reciprocally moved while pressing the shaping tool such as a shaping mandrel against the outer periphery of the distal end portion of the guide wire, for example, the figure As shown in FIG. 4, it can be shaped so as to form a substantially J-shape. Note that the distal end portion of the guide wire 10 may be shaped like a loop or an angle of a predetermined angle, and is not particularly limited. Of course, the guide wire tip may be shaped with the fingers of the user without using a shaping tool.

  At this time, in this guide wire 10, as shown in FIG. 2, the surface S1 of the distal end portion 23 of the core wire 20 viewed from one direction side in the circumferential direction and the surface S2 viewed from the other direction side in the circumferential direction. In contrast, a heat-denatured portion 50 that is more strongly heat-denatured is provided.

  Therefore, this heat-denatured portion 50 has a property that it has a lower tensile strength than other portions of the core wire 20 and is soft and has high ductility, and further, this heat-denatured portion 50 is arranged along the axial direction of the core wire 20. When the tip of the guide wire 10 is shaped via a shaping tool or the like as described above, as shown in FIG. This makes it easy to bend and bend the guide wire 10 into a desired shape.

  The guide wire 10 shaped as described above can be used as follows, for example.

  That is, the guide wire 10 is inserted into a medical tube such as a catheter or a sheath in a state where the distal end portion of the guide wire 10 is slightly stretched, and after the distal end portion of the guide wire 10 is inserted from the distal end opening thereof, the guide The medical tube can be moved to a desired position via the wire. Further, since the distal end portion of the guide wire 10 inserted from the distal end opening of the medical tube returns to the original shape, it can be easily inserted into the bent tubular organ, or the guide wire 10 can be easily held. By rotating the side (base end side), the direction of the distal end portion of the guide wire can be changed, and a predetermined tubular organ can be easily selected and inserted at a branching portion of the tubular organ or the like.

  At this time, depending on the shape of the tubular organ, the shaped shape of the distal end portion of the guide wire 10 may not be fitted to the insertion path and may be shaped into a different shape (reshaping). In this case, after pulling out the guide wire 10 from the tubular organ, the tip portion is returned to the shape before shaping and then reshaped. At this time, since the bending direction is determined at the distal end portion of the guide wire 10 with the heat-denatured portion 50 inside, it is possible to easily return the distal end portion of the guide wire 10 to the shape before shaping. The shape can be easily reshaped.

  Further, in this embodiment, as shown in FIG. 2B, the surface S2 of the distal end portion 23 of the core wire 20 viewed from the other side in the circumferential direction is not thermally denatured. While ensuring the formability of the distal end portion, it is possible to suppress a decrease in the tensile strength of the distal end portion 23 of the core wire 20, and it is possible to improve the reshape performance of the distal end portion of the guide wire 10.

  Further, as shown in FIGS. 2A and 2B, the heat-denatured portion 50 in this embodiment intersects the axis C of the core wire 20 and has a predetermined interval I along the axial direction of the core wire 20. Therefore, it is possible to easily control the area ratio of the heat-denatured portion 50 at the distal end portion 23 of the core wire 20, the shapeability of the distal end portion of the guide wire 10, and the distal end portion 23 of the core wire 20. It is possible to easily balance the tensile strength of. Further, when the distal end portion of the guide wire 10 is shaped, the axis of the shaping tool such as a shaping mandrel arranged so as to intersect the axis C of the core wire 20 is aligned with the heat-denatured portion 50, so that the guide It is possible to make it easier to shape the wire tip into a desired shape.

  Further, in the guide wire 10E of the sixth embodiment shown in FIG. 9, the distal end portion 23 of the core wire 20 has a structure in which portions where heat-denatured portions are densely arranged are arranged separately in the axial direction of the core wire 20. (Here, the two heat-denaturing parts 53 and 54 are arranged separately). As described above, when the portions where the heat-denatured portions are densely arranged at the tip portion 23 of the core wire 20 are arranged separately in the axial direction of the core wire 20, the tip portion 23 of the core wire 20 is attached along the axial direction. A portion that is easy to shape and a portion that is difficult to shape can be provided, and can be shaped into a bent shape in which a bent portion and a non-bent portion are mixed.

  On the other hand, as shown in FIG. 10, in the guide wire manufacturing method according to the present invention, continuously or intermittently along the axial direction of the core wire 20 from one circumferential side of the distal end portion 23 of the core wire 20. Since the heat-denatured portion is formed by irradiating the laser, the heat-denatured portion can be efficiently formed only on the circumferential surface S1 of the tip portion 23 of the core wire 20. it can.

  It should be noted that the present invention is not limited to the above-described embodiment, and various modified embodiments are possible within the scope of the present invention, and such an embodiment is also included in the scope of the present invention. .

1. Preparation of Sample (1) Production of Example The outer diameter D2 of the small diameter portion 27 is 0.15 mm, the length L1 of the small diameter portion 27 is 10 mm, and the outer diameter D1 of the base portion 21 is made of a Ni—Ti alloy. A guide wire of the example was manufactured by providing a heat-denatured portion 50 on the core wire 20 shown in FIG. The guide wire does not include the coil member 30, the resin layer 40, and the hydrophilic resin film 45.

Using the laser marker MD-S9910 manufactured by Keyence Corporation at the distal end portion 23 of the core wire 20, the laser output is changed (65 to 95%) as shown in Table 1 below, and FIG. Examples 1 to 8 were produced, provided with a plurality of heat-denatured portions 50 similar to the embodiment shown. Note that the laser solvent of the laser marker is Nd / YVO ₄ , the wavelength thereof is 532 nm, and the average output is 6 W (30 kHz).

  The width W of the heat-denatured portion 50 is 1.5 mm, and the interval I between the adjacent heat-denatured portions 50, 50 is 0.5 mm. Table 1 below summarizes the manufacturing conditions of Examples 1 to 8. FIG. 11 shows an enlarged photograph of the tip portion of Example 7, and FIG. 13 shows an enlarged photograph of the heat-denatured portion.

(2) Manufacture of Comparative Example A guide wire of a comparative example was manufactured in which the heat-denatured portion 50 was not provided and the other portions were the same as in the above example. FIG. 11 shows an enlarged photograph of the tip of this comparative example.

2. Tensile test Examples 6 and 7 and comparative examples were set in a well-known tensile tester, and the tensile strength was measured. The grip length of the core wire by the chuck is 5 mm, the length between the upper and lower chucks is 100 mm, and the tensile speed is 100 mm / second. Three were measured for the comparative examples and five were measured for each of Examples 6 and 7. The results are shown in Table 2 below. Table 1 also shows the tensile strength ratios of Examples 6 and 7 when the tensile strength of the comparative example is 100%. In addition, the same test was done about Example 5 and 8, and the ratio of the tensile strength was written together in Table 1.

3. Formability confirmation test The base side of each example and comparative example is clamped by a predetermined clamping block, and the tip side of each example and comparative example is placed on its axis with a shaping tool having an outer diameter of 0.9 mm. It was shaped by sliding it along the direction, and the degree of shaping was visually confirmed. The results are also shown in Table 1. Moreover, the photograph which compared the shaping property of a comparative example and Example 7 is shown by FIG. Of the items of shapeability shown in Table 1, “x” indicates the lowest shapeability, “△” indicates that the shapeability is better than “x”, and “○” indicates that the shapeability is low. It is better than the case of “Δ”, and “◎” means that the shapeability is the best.

4). Test results As a result of the above test, it was found that the example having the heat-denatured portion had higher shapeability than the comparative example having no heat-denatured portion, and the heat-denatured portion contributed to the shaping performance (Table). 1). Further, it was found that the tensile strength decreases as the laser output increases, but the shaping performance tends to improve. This is thought to be due to the fact that as the laser output increases, the structure of the heat-denatured portion softens and the tensile strength decreases, but conversely, the spreadability is improved.

10, 10A, 10B, 10C, 10D, 10E Guide wire 20 Core wire 21 Base portion 23 Tip portion 25 Tapered portion 27 Small diameter portion 30 Coil member 40 Resin layer 45 Hydrophilic resin films 50, 51, 52, 53, 54 Thermally modified portions

Claims (5)

It has a core wire provided with a base portion and a tip portion having a diameter smaller than that of the base portion,
A heat-denatured portion that is more strongly heat-denatured than the surface seen from the other direction side in the circumferential direction is provided on the surface of the tip portion of the core wire seen from one direction side in the circumferential direction. The guide wire is characterized in that the portion is formed continuously or intermittently along the axial direction of the core wire.   The guide wire according to claim 1, wherein a surface of the tip end portion of the core wire viewed from the other direction side in the circumferential direction is not thermally denatured.   3. The guide wire according to claim 1, wherein the heat-denatured portion intersects the axis of the core wire and is disposed at a predetermined interval along the axial direction.   The guide wire according to any one of claims 1 to 3, wherein a portion where the heat-denatured portions are concentrated is arranged separately at an end portion of the core wire in an axial direction of the core wire. A method for manufacturing a guide wire having a base and a core wire provided with a tip having a diameter smaller than that of the base,
Irradiate laser with higher output than the other direction side in the circumferential direction of the tip portion continuously and / or intermittently along the axial direction of the core wire from one circumferential side of the tip portion of the core wire. Or a method for producing a guide wire, wherein the heat-denatured portion is formed by irradiating a laser for a long time.