guidewire

Abstract

A guide wire is provided in which a core portion at a front end side is connected to a core portion at a base end side by a tubular connecting component, wherein the guide wire has improved passability at a curved portion of a blood vessel and can suppress the load on the blood vessel and damage to the blood vessel. At least one of the base end taper portion (112a) of the first core portion (11) and the front end taper portion (122b) of the second core portion (12) has a continuous taper portion (13), which includes, in the longitudinal direction, a first connecting taper portion (13a) arranged at a position closest to the base end of the first core portion (11) or the front end of the second core portion (12), and a second connecting taper portion (13b) arranged adjacent to the first connecting taper portion (13a) on a side farther from the base end of the first core portion (11) or the front end of the second core portion (12) and having an inclination angle (θ) different from that of the first connecting taper portion (13a). In addition, the continuous tapered portion (13) has a fitting portion (60) in which the outer surface of the first connecting tapered portion (13a) is fitted into the inner surface of the end portion of the connecting member (50).

Description

Technical Field

[0001] The present invention relates to guide wires. Background Art

[0002] A guide wire is a medical device used to guide various catheters for treating a stenosis occurring in a blood vessel to the stenosis.

[0003] Guidewires need to navigate the complex bends and branches of blood vessels and pass through stenosis. Therefore, it is desirable to have a guidewire with low bending rigidity on the side (front end) where it is inserted into the blood vessel to improve vascular selectivity and safety, and a guidewire with high bending rigidity on the side (base end) where the operator performs the operation to ensure pushability and torque transmission. Therefore, a guidewire is known that uses a core component formed by connecting metal cores with different outer diameters and material properties to each other so that the front end and base end have different characteristics.

[0004] Patent Document 1 below discloses a guidewire in which a distal core portion and a proximal core portion are connected by inserting small diameter portions provided at the distal core portion and the proximal core portion into the lumen of a tubular connecting member.

[0005] Prior art literature

[0006] Patent Literature

[0007] Patent Document 1: WO2006 / 002199 Summary of the Invention

[0008] Problems to be solved by the invention

[0009] When a guide wire passes through a curved portion of a blood vessel, the guide wire bends so as to be pushed against the inner wall outside the curved portion of the blood vessel, moving while in contact with the inner surface of the blood vessel. At this time, if the radius of curvature of the curved guide wire is large, the contact area between the guide wire and the inner surface of the blood vessel becomes larger. Therefore, the guide wire's ability to pass through the curved portion of the blood vessel decreases, and the load on the blood vessel increases. In particular, for a guide wire using a core component that connects the core components to each other using a tubular connecting component, if the end of the connecting component has a step difference equivalent to the wall thickness of the connecting component, there is a concern that the blood vessel may be damaged due to the contact between the end of the connecting component and the inner surface of the blood vessel.

[0010] At least one embodiment of the present invention is made in view of the above situation. Specifically, a guide wire is provided, in which a core part on the front end side is connected to a core part on the base end side by a tubular connecting component, the passability at the curved part of the blood vessel is improved, and the load on the blood vessel and damage to the blood vessel can be suppressed.

[0011] Solutions to Problems

[0012] The guide wire of this embodiment is a guide wire that uses a tubular connecting component to connect the base end of the first core part and the front end of the second core part arranged on the base end side of the above-mentioned first core part, wherein the base end of the above-mentioned first core part has a base end cone part whose outer diameter gradually decreases toward the base end, and the front end of the above-mentioned second core part has a front end cone part whose outer diameter gradually decreases toward the front end, and at least one of the above-mentioned base end cone part and the above-mentioned front end cone part has a continuous cone part, which includes a first connecting cone part arranged at the position closest to the base end of the above-mentioned first core part or the front end of the above-mentioned second core part in the long axis direction of the above-mentioned guide wire, and a second connecting cone part arranged adjacent to the above-mentioned first connecting cone part on the side far from the base end of the above-mentioned first core part or the front end of the above-mentioned second core part and having an inclination angle different from that of the above-mentioned first connecting cone part, and the above-mentioned continuous cone part has a fitting part in which the outer surface of the above-mentioned first connecting cone part is fitted with the inner surface of the end part of the above-mentioned connecting component.

[0013] Effects of the Invention

[0014] According to one embodiment of the present invention, the guide wire changes along the rigidity of the major axis direction of the guide wire at the boundary position of the 1st connecting taper portion and the 2nd connecting taper portion that form a continuous taper portion.Thus, the radius of curvature when the guide wire passes through the curved portion of the blood vessel diminishes, thereby can reduce the contact area of ​​the guide wire and the inner surface of the blood vessel.Therefore, the passability of the guide wire at the curved portion of the blood vessel improves, and the load brought to the blood vessel is reduced.In addition, the chance that the end of the connecting component of the guide wire contacts with the inner surface of the blood vessel reduces, even therefore even if there is a step difference suitable with the wall thickness of the connecting component at the end of the connecting component, also can suppress the damage of the blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 This is a schematic plan view of the guide wire according to this embodiment.

[0016] Figure 2 It is a partial cross-sectional view in the longitudinal direction of the guide wire according to the present embodiment when viewed from the thickness direction.

[0017] Figure 3 It is a schematic cross-sectional view of the periphery of the connecting component of the guide wire according to the present embodiment.

[0018] Figure 4 It is a schematic partial cross-sectional view of a connection portion between the first core portion and the connection member of the guide wire according to the present embodiment.

[0019] Figure 5 It is a schematic partial cross-sectional view of a connection portion between the second core portion of the guide wire and the connection member according to the present embodiment.

[0020] Figure 6 This is a diagram schematically showing an example of the curved shape of the guide wire when the guide wire is inserted into the channel of the trial instrument. DETAILED DESCRIPTION

[0021] Below, with reference to the attached Figure 1 The embodiments shown here are for the purpose of exemplifying the technical concept of the present invention and are not intended to limit the present invention. In addition, other embodiments, examples, and application technologies that can be implemented by those skilled in the art without departing from the gist of the present invention are all included in the scope and gist of the present invention, and are included in the technical solutions described in the claims and their equivalents.

[0022] Furthermore, the drawings attached to this specification are schematically shown with appropriate changes to the scale, aspect ratio, shape, etc. relative to the actual objects for ease of illustration and understanding, but these are merely examples and do not limit the interpretation of the present invention.

[0023] In this specification, for the sake of convenience, the direction of the guide wire 100 is defined as the direction when the guide wire 100 is in a natural state (a state in which the guide wire 100 extends straight without external force). Figure 1 In the figure, the "long axis direction" is the direction in which the guide wire 100 extends, and is set to the direction along the central axis C of the guide wire 100 (the left-right direction in the figure). The "radial direction" is set to the direction away from or approaching the core part 10 in the axially orthogonal section (cross section) of the core part with the long axis direction of the guide wire 100 as the reference axis. The "circumferential direction" is set to the rotation direction with the long axis direction of the core part 10 as the reference axis. For the "thickness direction", in the case where the front end of the guide wire 100 has a flat plate portion 11g, it is set to the direction in which the short side of the rectangle when observing the cross section of the flat plate portion 11g is extended (the near-front and depth direction in the figure). For the "width direction", in the case where the front end of the guide wire 100 has a flat plate portion 11g, it is set to the direction in which the long side of the rectangle when observing the cross section of the flat plate portion 11g is extended (the up-down direction in the figure).

[0024] The side of the guide wire 100 inserted into the blood vessel is referred to as the "front end side," and the side opposite to the front end side (the side held by the operator) is referred to as the "base end side." Furthermore, the portion encompassing a certain range along the longitudinal axis from the front end (the most front end) is referred to as the "front end," and the portion encompassing a certain range along the longitudinal axis from the base end (the most base end) is referred to as the "base end."

[0025] In the following description, when ordinal numbers such as “first” and “second” are used for explanation, these are used for convenience only and do not define any order unless otherwise specified.

[0026] The guide wire 100 of this embodiment is a medical device inserted into a blood vessel in order to guide a catheter or stent for intravascular treatment to a stenotic portion. In addition, the guide wire 100 can also be used to be inserted into other biological lumens (blood vessels, ureters, bile ducts, fallopian tubes, hepatic ducts, etc.) other than blood vessels according to the purpose of treatment.

[0027] [structure]

[0028] like Figure 1 or Figure 2 As shown, the guide wire 100 of this embodiment includes: a long core member 10; a tubular lumen 20 covering the periphery of the front end portion of the core member 10; a fixing portion 30 fixing the tubular lumen 20 to the core member 10; and a covering layer 40 covering the various components including the core member 10. In addition, the guide wire 100 includes: a connecting member 50 connecting the first core member 11 and the second core member 12; a fitting portion 60 formed when the first core member 11 or the second core member 12 is connected to the connecting member 50; and a connecting and fixing portion 70 for increasing the connection strength between the core member 10 and the connecting member 50. The various components of the guide wire 100 will be described in detail below.

[0029] Core components

[0030] The core member 10 includes a first core portion 11, a second core portion 12 disposed on the base end side of the first core portion 11, and a tubular connecting member 50 connecting the first core portion 11 and the second core portion 12. The first core portion 11 and the second core portion 12 are connected by inserting the base end portion of the first core portion 11 into the front end portion of the connecting member 50 and inserting the front end portion of the second core portion 12 into the base end portion of the connecting member 50. A fitting portion 60 is formed at the contact portion between the core member 10 and the connecting member 50.

[0031] The first core portion 11 is an elongated member extending along the longitudinal direction of the distal end of the guide wire 100. The first core portion 11 includes, in order from the base end toward the distal end thereof, a first connecting portion 11a, a first constant outer diameter portion 11b, a first tapered portion 11c, a second constant outer diameter portion 11d, a second tapered portion 11e, a transition portion 11f, and a flat plate portion 11g, each of which is integrally formed.

[0032] The first connecting portion 11a is a portion connected to the second connecting portion 12b of the second core portion 12 described later via the connecting member 50. The first connecting portion 11a extends from the base end of the first core portion 11 to the base end of the first outer diameter constant portion 11b with a predetermined length. The outer diameter of the first connecting portion 11a is smaller than the outer diameter of the first outer diameter constant portion 11b throughout the entire range of the first connecting portion 11a. Figure 3 and Figure 4As shown, the first core portion 11 includes a base end connecting constant outer diameter portion 111a and a base end tapered portion 112a in order from the base end toward the front end.

[0033] The base end connection outer diameter constant portion 111a extends from the base end of the first core portion 11 to the base end of the base end tapered portion 112a by a predetermined length. The outer diameter d1 of the base end connection outer diameter constant portion 111a is substantially constant and smaller than the inner diameter of the connecting member 50. The outer diameter d1 of the base end connection outer diameter constant portion 111a is 0.2 mm to 0.6 mm. Figure 4 As shown, the entire proximal end connection constant outer diameter portion 111 a is disposed in the inner cavity 51 of the connection member 50 .

[0034] The base end taper 112a extends from the front end of the base end connecting the constant outer diameter portion 111a to the base end of the first constant outer diameter portion 11b by a specified length. In the guide wire 100 of this embodiment, the base end taper 112a is a continuous taper 13 in which the first connecting taper 13a and the second connecting taper 13b are arranged adjacent to each other in the long axis direction from the front end of the base end connecting the constant outer diameter portion 111a toward the front end side. The second connecting taper 13b is arranged adjacent to the first connecting taper 13a on the side far from the base end of the first core portion 11 in the long axis direction. The first connecting taper 13a and the second connecting taper 13b have different inclination angles θ. In addition, in this specification, "inclination angle θ" refers to the angle formed by the center axis C or an imaginary line parallel to the center axis C and the outer surface of each taper in a longitudinal section passing through the center axis C of the guide wire 100.

[0035] The outer diameter of the base end of the base end taper 112a is equal to the outer diameter d1 of the base end connecting constant outer diameter portion 111a. The outer diameter of the leading end of the base end taper 112a is equal to the outer diameter of the first constant outer diameter portion 11b. Furthermore, the number of tapered portions forming the continuous taper 13 may be two or more. Alternatively, the base end taper 112a may be a single taper having a single inclination angle θ.

[0036] The continuous taper portion 13, which functions as the base taper portion 112a, has a stepped taper shape formed by continuously arranging multiple tapers having different inclination angles θ along the longitudinal direction. The outer surface of the first connecting taper portion 13a forming the continuous taper portion 13 has a fitting portion 60 at the portion in contact with the inner surface of the distal end portion of the connecting member 50.

[0037] The first connecting cone 13a extends from the front end of the base end connecting outer diameter constant portion 111a to the base end of the second connecting cone 13b with a predetermined length. The first connecting cone 13a is in a tapered shape with the outer diameter gradually increasing from the base end connecting outer diameter constant portion 111a toward the front end side. The outer diameter of the base end of the first connecting cone 13a is equal to the outer diameter d1 of the base end connecting outer diameter constant portion 111a. The outer diameter d2 of the front end of the first connecting cone 13a is larger than the inner diameter of the connecting component 50. Therefore, the first connecting cone 13a is as Figure 4 As shown, only a portion of the first connection tapered portion 13a is inserted into the inner cavity 51 of the connection member 50. The tapered shape of the first connection tapered portion 13a can be formed by mechanically grinding the first core portion 11 with a grinding wheel or etching with acid.

[0038] The second connecting cone 13b extends from the front end of the first connecting cone 13a to the base end of the first outer diameter constant portion 11b with a predetermined length. The second connecting cone 13b has a tapered shape with an outer diameter gradually increasing from the front end of the first connecting cone 13a toward the front end side. The outer diameter of the base end of the second connecting cone 13b is equal to the outer diameter d2 of the front end of the first connecting cone 13a. Therefore, the second connecting cone 13b is not arranged in the inner cavity 51 of the connecting component 50. The outer diameter d3 of the front end of the second connecting cone 13b is equal to the outer diameter of the first outer diameter constant portion 11b. The tapered shape of the second connecting cone 13b can be formed by mechanical grinding based on a grinding wheel or etching based on acid on the first core portion 11.

[0039] The first constant outer diameter portion 11b extends a predetermined length from the distal end of the first connecting portion 11a to the proximal end of the first tapered portion 11c. The first constant outer diameter portion 11b has a substantially constant outer diameter that is substantially equal to the outer diameter of the proximal portion 12a of the second core portion 12.

[0040] The first tapered portion 11c extends a predetermined length from the distal end of the first constant outer diameter portion 11b to the proximal end of the second constant outer diameter portion 11d. The first tapered portion 11c has a tapered shape with the outer diameter gradually decreasing from the first constant outer diameter portion 11b toward the distal end. The tapered shape of the first tapered portion 11c can be formed by mechanically grinding the first core portion 11 with a grinding wheel or etching with acid.

[0041] The second constant outer diameter portion 11d extends from the distal end of the first tapered portion 11c to the proximal end of the second tapered portion 11e by a predetermined length. The outer diameter of the second constant outer diameter portion 11d is substantially constant and smaller than the outer diameter of the first constant outer diameter portion 11b.

[0042] The second tapered portion 11e extends a predetermined length from the distal end of the second constant outer diameter portion 11d to the proximal end of the transition portion 11f. The second tapered portion 11e has a tapered shape with the outer diameter gradually decreasing from the second constant outer diameter portion 11d toward the transition portion 11f. The tapered shape of the second tapered portion 11e can be formed by mechanically grinding the first core portion 11 with a grinding wheel or etching with acid.

[0043] The transition portion 11f extends from the front end of the second conical portion 11e to the base end of the flat plate portion 11g for a specified length. The transition portion 11f has a wedge shape with a thickness gradually decreasing and a width gradually increasing from the second conical portion 11e toward the flat plate portion 11g. The wedge shape of the transition portion 11f can be formed by performing a stamping process as a type of cold working on the first core portion 11 having a circular cross-sectional shape. When observed from a surface perpendicular to the major axis direction (when observing the cross section), the cross-sectional shape of the transition portion 11f is a circle with an outer diameter roughly equal to that of the second conical portion 11e on the base end side, but gradually deforms from a circle to a rectangle as it moves from the base end side toward the front end side, and has a rectangular shape roughly the same as that of the flat plate portion 11g on the front end side. The front end portion of the transition portion 11f has a thickness and width roughly equal to those of the base end portion of the flat plate portion 11g, forming a surface continuous with the flat plate portion 11g. The “thickness” of the flat plate portion 11g is the length of the short side of the rectangle when the flat plate portion 11g is viewed in cross section, and the “width” of the flat plate portion 11g is the length of the long side of the rectangle when the flat plate portion 11g is viewed in cross section.

[0044] The flat portion 11g extends from the front end of the transition portion 11f to the front end of the guide wire 100 by a specified length. The flat portion 11g is formed by stamping the first core portion 11 having a circular cross-sectional shape. Therefore, the cross-sectional shape of the flat portion 11g is formed into a rectangular shape. The thickness of the flat portion 11g is approximately constant from the front end of the transition portion 11f to the front end of the flat portion 11g. The shape of the flat portion 11g observed from the thickness direction is formed into a rectangle with rounded corners at the front end of the flat portion 11g. Therefore, the width of the flat portion 11g is approximately constant from the front end of the transition portion 11f toward the front end side, but becomes smaller at the part with rounded corners. In addition, the width of the flat portion 11g can also be constant from the front end of the transition portion 11f to the front end of the flat portion 11g. The cross-sectional shape of the flat portion 11g is not limited to a rectangle, and can also be a rounded rectangle with R-shaped corners.

[0045] The structure of the first core portion 11 is not limited to the above. For example, the first core portion 11 may have a constant outer shape and a constant outer diameter from the distal end to the proximal end.

[0046] The second core portion 12 is a long member extending from the connecting member 50 to the base end side of the guide wire 100. Figure 3 and Figure 5As shown, the second core portion 12 includes an extension portion 14 , a base portion 12 a , and a second connecting portion 12 b in this order from the base end toward the front end, and these portions are integrally formed.

[0047] The extension portion 14 is a portion for connecting to a separately prepared extension wire in order to extend the full length of the guide wire 100. The extension portion 14 extends from the base end of the base 12a toward the base end of the guide wire 100 by a predetermined length. The extension portion 14 has a shape with a gradually decreasing outer diameter from the base 12a toward the base end and having a plurality of curved portions. Alternatively, the extension portion 14 may be omitted.

[0048] The base portion 12a extends a predetermined length from the base end of the second connecting portion 12b to the distal end of the extension portion 14. The base portion 12a has a substantially constant outer diameter, which is substantially equal to the outer diameter of the first constant outer diameter portion 11b of the first core portion 11.

[0049] The second connecting portion 12b is a portion connected to the first connecting portion 11a of the first core portion 11 via the connecting component 50. The second connecting portion 12b extends from the front end of the second core portion 12 to the front end of the base portion 12a with a specified length. The outer diameter of the second connecting portion 12b is smaller than the outer diameter of the base portion 12a within the entire range of the second connecting portion 12b. The second connecting portion 12b has a front end connecting outer diameter constant portion 121b and a front end tapered portion 122b in sequence from the front end of the second core portion 12 toward the base end side. In addition, the second connecting portion 12b may also have other tapered portions and / or outer diameter constant portions on the basis of the front end tapered portion 122b.

[0050] The distal end connection constant outer diameter portion 121b extends a predetermined length from the distal end of the second core portion 12 to the distal end of the distal tapered portion 122b. The distal end connection constant outer diameter portion 121b has a substantially constant outer diameter that is smaller than the inner diameter of the connecting member 50. Furthermore, the outer diameter of the distal end connection constant outer diameter portion 121b is substantially equal to the outer diameter d1 of the proximal end connection constant outer diameter portion 111a of the first core portion 11. The outer diameter of the distal end connection constant outer diameter portion 121b is 0.2 mm to 0.6 mm.

[0051] The front end cone 122b extends from the base end of the front end connected to the constant outer diameter portion 121b to the front end of the base 12a by a specified length. The front end cone 122b is in a tapered shape with the outer diameter gradually increasing from the front end connected to the constant outer diameter portion 121b toward the base end side. In the guide wire 100 of this embodiment, the front end cone 122b is a single cone. The outer diameter of the front end of the front end cone 122b is equal to the outer diameter of the front end connected to the constant outer diameter portion 121b. The outer diameter of the base end of the front end cone 122b is equal to the outer diameter of the base 12a. Therefore, the front end cone 122b is as Figure 5As shown, only a portion of the distal tapered portion 122b is inserted into the inner cavity 51 of the connecting member 50. Alternatively, the distal tapered portion 122b may be a continuous tapered portion 13. The distal tapered portion 122b has a fitting portion 60 at a portion of its outer surface that contacts the inner surface of the base end portion of the connecting member 50.

[0052] The inclination angle θ3 of the front end tapered portion 122b of the second core portion 12 is greater than the inclination angle θ1 of the first connecting tapered portion 13a of the first core portion 11, and less than the inclination angle θ2 of the second connecting tapered portion 13b of the first core portion 11. The inclination angle θ3 of the front end tapered portion 122b is 0.10° to 0.17°. Furthermore, the length of the front end tapered portion 122b of the second core portion 12 is shorter than the first connecting tapered portion 13a of the first core portion 11, and longer than the second connecting tapered portion 13b. The length of the front end tapered portion 122b is 19 mm to 25 mm.

[0053] Here, a specific example of the dimensions of the guide wire 100 is described. The total length of the guide wire 100 in the longitudinal direction is 1000 mm to 4500 mm. The length of the first core portion 11 is 150 mm to 1000 mm. The combined length of the first connecting portion 11a and the first constant outer diameter portion 11b is 10 mm to 300 mm. The length of the first tapered portion 11c is 10 mm to 100 mm. The length of the second constant outer diameter portion 11d is 10 mm to 300 mm. The length of the second tapered portion 11e is 10 mm to 100 mm. The length of the transition portion 11f is 1 mm to 20 mm. The length of the flat portion 11g is 1 mm to 20 mm.

[0054] The outer diameters of the first connecting portion 11a and the first constant outer diameter portion 11b are 0.2 mm to 1 mm. The outer diameters of the first tapered portion 11c and the second constant outer diameter portion 11d are 0.1 mm to 1 mm. The outer diameter of the second tapered portion 11e is 0.05 mm to 1 mm. The thickness of the transition portion 11f is 0.01 mm to 1 mm, and the width is 0.05 mm to 1 mm. The thickness of the flat plate portion 11g is 0.01 mm to 1 mm, and the width is 0.05 mm to 1 mm.

[0055] The length of the second core portion 12 is 850 mm to 3500 mm, and the outer diameter of the second core portion 12 is 0.2 mm to 1 mm.

[0056] The first core portion 11 and the second core portion 12 can be formed by various metal materials such as stainless steel, piano wire, cobalt alloy such as superelastic alloy, SUS302, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, etc. In addition, the first core portion 11 is preferably formed by a material lower than the material of the second core portion 12 in terms of rigidity. As an example, the first core portion 11 is formed by Ni-Ti alloy, and the second core portion 12 is formed by stainless steel. In addition, the material forming the first core portion 11 and the second core portion 12 is not limited to the above example. In addition, the first core portion 11 and the second core portion 12 also can be formed by the same material.

[0057] 〈Tube cavity〉

[0058] The tubular cavity 20 is a component formed by winding a wire into a spiral shape relative to the core member 10. In the present embodiment, the tubular cavity 20 is formed by a first coil 21 and a second coil 22 arranged on the base end side of the first coil 21. The first coil 21 is arranged from the front end to the middle part of the first core part 11. The second coil 22 is arranged from the middle part to the base end side of the first core part 11. In addition, the tubular cavity 20 can also be formed by one coil. The tubular cavity 20 can also be formed by three or more coils.

[0059] The first coil 21 surrounds the first core portion 11 of the core member 10 and is fixed to the first core portion 11. The first coil 21 is arranged coaxially with the first core portion 11. The length of the first coil 21 is 3 mm to 60 mm.

[0060] The first coil 21 is formed by spirally winding a wire with gaps between adjacent wires. The gaps between adjacent wires in the first coil 21 are 1 μm to 10 μm. The gaps between adjacent wires in the first coil 21 are preferably set to be equal intervals.

[0061] The second coil 22 surrounds the first core portion 11 of the core member 10 and is fixed to the first core portion 11. The second coil 22 is arranged coaxially with the first core portion 11. The length of the second coil 22 is 10 mm to 400 mm.

[0062] The second coil 22 is formed as a densely wound portion in which the wire is tightly wound into a spiral shape with no gaps between adjacent wires. Alternatively, the second coil 22 may include a densely wound portion and a sparsely wound portion in which the wire is loosely wound into a spiral shape with gaps between adjacent wires. In the case of the sparsely wound portion, the densely wound portion of the second coil 22 is located at the front end and the base end of the second coil 22, with the sparsely wound portion located between the densely wound portion on the front end side and the densely wound portion on the base end side.

[0063] The base end portion of the first coil 21 and the front end portion of the second coil 22 are arranged in a contact state. In addition, the base end portion of the first coil 21 and the front end portion of the second coil 22 can also be partially wound together. In this case, the wire material of the base end portion of the first coil 21 and the wire material of the front end portion of the second coil 22 are arranged alternately along the longitudinal direction. Thus, the separation of the first coil 21 and the second coil 22 is suppressed. The length of the base end portion of the first coil 21 and the front end portion of the second coil 22 wound together is 0.1mm to 2mm. The winding directions of the first coil 21 and the second coil 22 are consistent so that they can be wound together.

[0064] The outer diameter of the wire forming the first coil 21 and the second coil 22 is 20 μm to 90 μm, preferably 30 μm to 70 μm. In this embodiment, the outer diameter of the wire forming the first coil 21 is larger than the outer diameter of the wire forming the second coil 22. Furthermore, the wire forming the first coil 21 and the second coil 22 may be not only a single wire but also a twisted wire composed of two or more wires.

[0065] The wire materials of the first coil 21 and the second coil 22 are not particularly limited and can be made of metals such as stainless steel, superelastic alloys, cobalt-based alloys, gold, platinum, tungsten, or alloys containing these metals. For example, the first coil 21 is made of a platinum-based alloy, which is softer and has higher radiopaque properties than the second coil 22, while the second coil 22 is made of stainless steel. Suitable platinum-based alloys include Pt-Ir, Pt-Ni, and Pt-W.

[0066] The outer diameters of the first coil 21 and the second coil 22 are preferably constant from the distal end to the proximal end. In this embodiment, the outer diameters of the first coil 21 and the second coil 22 are approximately equal. Therefore, the outer diameter of the lumen 20 is approximately constant from the distal end to the proximal end. The outer diameters of the first coil 21 and the second coil 22 are 0.15 mm to 2 mm.

[0067] The materials, outer diameters, cross-sectional shapes, and spacing of the wires constituting the first and second coils 21 and 22 can be appropriately selected depending on the purpose of the guidewire 100. The cross-sectional shape of the wire is preferably circular, but may also be elliptical, polygonal, or the like. The center of the cross section of a wire that is not circular can be the centroid of the cross section of the wire.

[0068] 〈Fixed part〉

[0069] The fixing portion 30 is a component for fixing the lumen body 20 to the core member 10. In the guide wire 100 of this embodiment, the fixing portion 30 includes a front end fixing portion 31 for fixing the front end of the lumen body 20 to the core member 10, an intermediate fixing portion 32 for fixing the middle portion of the lumen body 20 to the core member 10, and a base end fixing portion 33 for fixing the base end of the lumen body 20 to the core member 10.

[0070] The material forming the fixing portion 30 is brazing material or solder. Examples of brazing material include gold brazing material and silver brazing material. Examples of solder material include Sn-Ag alloy solder and Sn-Pb alloy solder. The material forming the fixing portion 30 may also be an adhesive.

[0071] The distal end fixing portion 31 fixes the distal end portion of the first coil 21 to the flat plate portion 11g of the first core portion 11. The distal end fixing portion 31 is located at the distal end of the guide wire 100, and has a smooth outer surface formed in a substantially hemispherical shape.

[0072] The intermediate fixing portion 32 fixes the base end of the first coil 21 and the tip end of the second coil 22 to the second tapered portion 11e of the first core 11. The intermediate fixing portion 32 is provided in the first core 11 at a position where the base end of the first coil 21 and the tip end of the second coil 22 contact each other.

[0073] In the case where the base end portion of the first coil 21 and the front end portion of the second coil 22 are partially wound together, the base end portion of the first coil 21 and the front end portion of the second coil 22 may also be fixed via the tubular member 32a. The tubular member 32a is arranged between the inner circumferential surface of the tubular body 20 and the outer circumferential surface of the core member 10. The tubular member 32a coaxially fixes the tubular body 20 and the core member 10 by reducing the gap between the inner circumferential surface of the tubular body 20 and the outer circumferential surface of the core member 10. In the guide wire 100 of this embodiment, the outer diameter of the front end portion of the tubular member 32a is smaller than the outer diameter of the base end portion of the tubular member 32a. Thus, as Figure 2 As shown, the first coil 21 having a small inner diameter and the second coil 22 having a large inner diameter can be coaxially fixed relative to the core member 10. The outer diameter of the front end portion of the tubular member 32a and the outer diameter of the base end portion of the tubular member 32a can be appropriately selected according to the inner diameter of the first coil 21 and the inner diameter of the second coil 22. The tubular member 32a can be formed of a metal or resin material.

[0074] The proximal end fixing portion 33 fixes the proximal end portion of the second coil 22 to the second constant outer diameter portion 11 d of the first core portion 11 .

[0075] Covering layer

[0076] The covering layer 40 includes a first covering layer 41, a second covering layer 42, and a third covering layer 43. The covering layer 40 can be formed of a material that can reduce friction between the guide wire 100 and the blood vessel or catheter. Thus, the covering layer 40 improves the operability and safety of the guide wire 100.

[0077] The first covering layer 41 covers the outer surfaces of the portions (the lumen 20 and the fixing portion 30 ) provided in the first core portion 11 and a portion (the second constant outer diameter portion 11 d ) of the first core portion 11 .

[0078] The second covering layer 42 covers the portion of the first core portion 11 located proximally relative to the lumen 20. The second covering layer 42 covers the outer surface of the proximal end portion of the first core portion 11 (the first tapered portion 11c and the first constant outer diameter portion 11b).

[0079] The third covering layer 43 covers the outer surface of the base portion 12 a of the second core portion.

[0080] The first connecting portion 11a of the first core portion 11, the connecting member 50, and the second connecting portion 12b of the second core portion 12 are not covered by the covering layer 40. In addition, the covering layer 40 may be provided in a portion not covered by the covering layer 40.

[0081] The first cover layer 41 can be formed from a low-friction material. Examples of low-friction materials include hydrophilic polymers and silicone resins. Examples of hydrophilic polymers forming the first cover layer 41 include cellulose-based polymers, polyethylene oxide-based polymers, maleic anhydride-based polymers (e.g., maleic anhydride copolymers such as methyl vinyl ether-maleic anhydride copolymers), acrylamide-based polymers (e.g., polyacrylamide, glycidyl methacrylate-dimethylacrylamide block copolymers), water-soluble nylon, polyvinyl alcohol, polyvinyl pyrrolidone, and derivatives thereof.

[0082] The second cover layer 42 and the third cover layer 43 can be formed of a low-friction material. Examples of the low-friction material include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyesters (such as PET and PBT), polyamides, polyimides, polyurethanes, polystyrene, polycarbonates, silicone resins, fluororesins (such as PTFE and ETFE), and composite materials thereof.

[0083] In addition, the materials forming the first covering layer 41, the second covering layer 42 and the third covering layer 43 are not limited to the above. The first covering layer 41, the second covering layer 42 and the third covering layer 43 can also be formed by different materials along the long axis direction of the core component 10. For example, in the first covering layer 41, the front end portion of the first core portion 11 is formed by silicone resin, and the base end portion of the first core portion 11 is formed by a hydrophilic polymer. In addition, the number of layers of the first covering layer 41, the second covering layer 42 and the third covering layer 43 can also be multiple layers. In addition, any one of the first covering layer 41, the second covering layer 42 and the third covering layer 43 can also be not provided.

[0084] 〈Connecting parts〉

[0085] The connection member 50 is a member that connects the proximal end portion of the first core portion 11 and the distal end portion of the second core portion 12. The connection member 50 is a metal tube having a predetermined length and an inner cavity 51.

[0086] The first core portion 11 is engaged with the connecting member 50 by inserting the base end side of the base end tapered portion 112a of the first connecting portion 11a from the front end of the connecting member 50 and pushing it into the inner cavity 51. The second core portion 12 is engaged with the connecting member 50 by inserting the front end side of the front end tapered portion 122b of the second connecting portion 12b from the base end of the connecting member 50 and pushing it into the inner cavity 51. Thus, the connecting member 50 can connect the first core portion 11 and the second core portion 12. When the first core portion 11 and the second core portion 12 are connected via the connecting member 50, the base end of the first core portion 11 (the base end connected to the constant outer diameter portion 111a) and the front end of the second core portion 12 (the front end connected to the constant outer diameter portion 121b) are separated in the inner cavity 51 of the connecting member 50.

[0087] Before mating, the outer diameter of the connecting member 50 is approximately constant from the distal end to the proximal end, ranging from 0.3 mm to 0.8 mm. The inner diameter of the connecting member 50 is approximately constant from the distal end to the proximal end, ranging from 0.2 mm to 0.6 mm. The wall thickness t of the connecting member 50 is 0.03 mm to 0.10 mm. The length of the connecting member 50 is 5 mm to 200 mm.

[0088] Examples of metals that can be used to form the connecting member 50 include superelastic alloys such as stainless steel, Ni-Cr alloys, Ni-Ti alloys, Ni-Al alloys, and Cu-Zn alloys. The metal that can be used to form the connecting member 50 is preferably a superelastic alloy, more preferably a Ni-Ti alloy. This reduces the risk of kinking the guidewire 100 at the location of the connecting member 50. Furthermore, since the connecting member 50 is formed from the same metal as the core member 10, welding the connecting member 50 to the core member 10 facilitates securement.

[0089] 〈Fitting part〉

[0090] The interlocking portion 60 is the contact portion between the core member 10 and the connecting member 50. The interlocking portion 60 includes a front end interlocking portion 61 as a contact portion between the base end portion of the first core member 11 and the front end portion of the connecting member 50, and a base end interlocking portion 62 as a contact portion between the front end portion of the second core member 12 and the base end portion of the connecting member 50. The interlocking portion 60 is formed when the first core member 11 and the connecting member 50 are interlocked and when the second core member 12 and the connecting member 50 are interlocked, so that the connection between the first core member 11 and the connecting member 50 and the connection between the second core member 12 and the connecting member 50 become firm.

[0091] The distal end fitting portion 61 is the contact portion between the first core portion 11 and the connecting member 50. After the base end connecting constant outer diameter portion 111a of the first core portion 11 and a portion of the first connecting tapered portion 13a are inserted into the inner cavity 51 of the connecting member 50 and the first connecting tapered portion 13a is brought into contact with the distal end of the connecting member 50, a predetermined fitting pressure is applied to push the first core portion 11 into the inner cavity 51 of the connecting member 50, thereby fitting the first core portion 11 and the connecting member 50. Thus, the distal end fitting portion 61 is formed at the portion where the outer surface of the first connecting tapered portion 13a of the first core portion 11 contacts the inner surface of the distal end portion of the connecting member 50.

[0092] The front end engaging portion 61 preferably has an open (flared) shape, in which the connecting member 50 extends radially outward along the outer surface of the first connecting cone 13a. When the first core 11 is engaged with the connecting member 50, the first core 11 is pushed into the inner cavity 51 of the connecting member 50, causing the front end of the connecting member 50 to assume an open shape, in which the connecting member 50 extends radially outward along the outer surface of the first connecting cone 13a. Therefore, the inner and outer diameters of the connecting member 50 in the front end engaging portion 61 are larger than those of the connecting member 50 before engagement. When the front end of the connecting member 50 is not in an open shape, only the inner surface of the front end of the connecting member 50 contacts the outer surface of the first connecting cone 13a. Therefore, the front end engaging portion 61 is formed only in a small area near the front end of the connecting member 50. When the front end of the connecting member 50 is in an open shape, the area of ​​the front end engaging portion 61 is larger than when the front end of the connecting member 50 is not in an open shape. Therefore, by setting the front end fitting portion 61 in an open shape, the first core portion 11 and the connecting component 50 are firmly fitted. In addition, by setting the front end fitting portion 61 in an open shape, the guide wire 100 can suppress the concentration of stress on the front end of the connecting component 50 during bending, thereby making it difficult for the guide wire 100 to bend starting from the front end of the connecting component 50. On the other hand, when the first core portion 11 and the connecting component 50 are fitted together, if the first core portion 11 is pushed too far into the inner cavity 51 of the connecting component 50, the front end of the connecting component 50 will not be able to withstand the deformation and will be damaged. Therefore, the length of the front end fitting portion 61 in the longitudinal direction is preferably 0.1 mm to 3.0 mm.

[0093] When the first core portion 11 is fitted into the connecting member 50, the base end connecting outer diameter constant portion 111a of the first core portion 11 and a portion of the first connecting tapered portion 13a are arranged in the inner cavity 51 of the connecting member 50. Since the first connecting portion 11a of the first core portion 11 has the base end connecting outer diameter constant portion 111a, the length of the first core portion 11 arranged in the inner cavity 51 of the connecting member 50 becomes longer than when the first connecting portion 11a is formed only by the base end tapered portion 112a. Thus, since the separation distance between the first core portion 11 and the second core portion 12 in the inner cavity 51 of the connecting member 50 can be shortened, the core member 10 can suppress a local reduction in rigidity at the portion where the first core portion 11 and the second core portion 12 are separated in the inner cavity 51 of the connecting member 50.

[0094] The proximal end fitting portion 62 is the contact portion between the second core portion 12 and the connecting member 50. After the distal end connecting constant outer diameter portion 121b and a portion of the distal end tapered portion 122b of the second core portion 12 are inserted into the inner cavity 51 of the connecting member 50 and the distal end tapered portion 122b is brought into contact with the proximal end of the connecting member 50, a predetermined fitting pressure is applied and the second core portion 12 is pushed into the inner cavity 51 of the connecting member 50, thereby fitting the second core portion 12 and the connecting member 50. Thus, the proximal end fitting portion 62 is formed at the portion where the outer surface of the distal end tapered portion 122b of the second core portion 12 contacts the inner surface of the proximal end portion of the connecting member 50.

[0095] In the fitting of the second core 12 and the connecting member 50, the same effect as that of the fitting of the first core 11 and the connecting member 50 is obtained by setting the base end of the connecting member 50 to an open shape. The length of the base end fitting portion 62 in the longitudinal direction is 0.1 mm to 3.0 mm.

[0096] When the second core portion 12 is fitted into the connecting member 50, a portion of the front end connecting outer diameter constant portion 121b and the front end tapered portion 122b of the second core portion 12 is disposed in the inner cavity 51 of the connecting member 50. Since the second connecting portion 12b of the second core portion 12 has the front end connecting outer diameter constant portion 121b, the length of the second core portion 12 disposed in the inner cavity 51 of the connecting member 50 becomes longer than when the second connecting portion 12b is formed only by the front end tapered portion 122b. Thus, since the separation distance between the first core portion 11 and the second core portion 12 in the inner cavity 51 of the connecting member 50 can be shortened, the core member 10 can suppress a local reduction in rigidity at the portion where the first core portion 11 and the second core portion 12 are separated in the inner cavity 51 of the connecting member 50.

[0097] The first core portion 11 and the connecting member 50 are engaged with each other, and the second core portion 12 and the connecting member 50 are engaged with each other by mechanical engagement using an engagement machine. The mechanical engagement using the engagement machine can be engaged with a fixed engagement pressure (pushing force), or the engagement pressure can be varied in a stepped manner. In addition, the first core portion 11 and the connecting member 50 and the second core portion 12 and the connecting member 50 can also be engaged with each other manually, or both manually and an engagement machine can be used simultaneously.

[0098] <Connection and fixing part>

[0099] The core member 10 and the connecting member 50 are fixed by the connecting fixing portion 70. The connecting fixing portion 70 includes a distal connecting fixing portion 71 that fixes the distal end of the connecting member 50 to the first core 11 and a proximal connecting fixing portion 72 that fixes the proximal end of the connecting member 50 to the second core 12.

[0100] The front end connection fixing portion 71 fixes the front end portion of the connecting component 50 to the first connecting cone 13a of the first core portion 11. By providing the front end connection fixing portion 71 on the basis of the front end fitting portion 61, the first core portion 11 and the connecting component 50 can be firmly connected. The front end connection fixing portion 71 is provided at a position separated from the front end fitting portion 61 toward the base end side in the longitudinal direction. As a result, the fixing portion between the first core portion 11 and the connecting component 50 when viewed along the longitudinal direction becomes the front end fitting portion 61 and the front end connection fixing portion 71, so that the first core portion 11 and the connecting component 50 can be more firmly connected. It is preferred that two front end connection fixing portions 71 are provided at radially opposite positions along the connecting component 50.

[0101] The distal connecting and fixing portion 71 is preferably a weld formed by laser welding. Laser welding secures the connecting member 50 to the first connecting tapered portion 13a without changing the outer diameter of the connecting member 50, thereby minimizing the effect of the distal connecting and fixing portion 71 on the function of the guidewire 100. The weld is generally circular with a radius of 0.05 mm to 0.40 mm centered at the laser irradiation point P.

[0102] The outer surface of the first connecting tapered portion 13a and the inner surface of the connecting member 50 are preferably radially separated on the distal and proximal sides of the distal connecting fixing portion 71. In laser welding, the metal being welded is irradiated with a predetermined laser beam, causing the metal to melt and solidify, thereby joining the welded materials. Therefore, if the distal connecting fixing portion 71 is located between the first core portion 11 and the distal fitting portion 61 of the connecting member 50, or adjacent to the distal fitting portion 61, the radial distance between the first core portion 11 and the connecting member 50 is too short. Gas generated during the melting of the metal is likely to remain in the distal connecting fixing portion 71, potentially causing pores, pits, cracks, and the like. This can result in unevenness on the outer surface of the distal connecting fixing portion 71, resulting in a poor appearance and insufficient fixing strength. Since the outer diameter of the first connecting tapered portion 13a gradually decreases toward the proximal end, the radial distance between the first core portion 11 and the connecting member 50 increases from the distal end of the connecting member 50 toward the proximal end. Therefore, if the front end connecting and fixing portion 71 is positioned at a position more than a predetermined distance away from the front end of the connecting member 50, the radial distance between the first core portion 11 and the connecting member 50 becomes excessively long, causing molten metal to spread within the space between the first core portion 11 and the connecting member 50, making the outer surface more susceptible to dents. This results in a poor appearance of the front end connecting and fixing portion 71. Furthermore, the contact area between the first core portion 11 and the connecting member 50 and the molten metal becomes smaller, resulting in insufficient fixing strength of the front end connecting and fixing portion 71.

[0103] In the guidewire 100 of this embodiment, the front connecting and fixing portion 71 is positioned such that the outer surface of the first connecting cone 13a and the inner surface of the connecting member 50 are radially separated at the front and base ends of the front connecting and fixing portion 71. Therefore, gas generated during metal melting also escapes from the front and base ends of the front connecting and fixing portion 71, making it difficult to generate pores, pits, cracks, etc. Furthermore, since the molten metal appropriately expands within the space between the first core portion 11 and the connecting member 50, the outer surface of the connecting member 50 becomes smooth, and sufficient connection strength is achieved.

[0104] By forming the front end connecting fixing portion 71 at a position where the outer surface of the first connecting cone 13a and the inner surface of the connecting component 50 are radially separated on the front end side and the base end side of the front end connecting fixing portion 71, the outer surface of the welding portion between the first core portion 11 of the guide wire 100 and the connecting component 50 becomes smooth and the connection strength is high.

[0105] The distance S in the longitudinal direction from the front end of the connecting member 50 to the laser irradiation point P is preferably 2.5 mm to 4.0 mm. That is, the center of the weld is located at a position 2.5 mm to 4.0 mm away from the front end of the connecting member 50 toward the base end in the longitudinal direction. Thus, the front end connecting and fixing portion 71 (weld) is formed in a range of 2.0 mm to 4.5 mm from the front end of the connecting member 50 toward the base end in the longitudinal direction. In addition, the radial distance H between the outer surface of the first connecting cone 13a and the inner surface of the connecting member 50 at the laser irradiation point P for forming the front end connecting and fixing portion 71 is preferably 0.0005 mm to 0.0017 mm. Thus, the radial distance between the outer surface of the first connecting cone 13a and the inner surface of the connecting member 50 is 0.0001 mm to 0.0021 mm. By forming the distal end connecting and fixing portion 71 in the above-mentioned range, the distal end portion of the connecting member 50 can be firmly connected to the first core portion 11 and can have a smooth outer surface with small irregularities.

[0106] The ratio r (r=H / t) of the radial distance H between the outer surface of the first connection taper 13a and the inner surface of the connection member 50 at the laser irradiation point P relative to the wall thickness t of the connection member 50 is preferably 0.01 to 0.05, more preferably 0.010 to 0.034. That is, the center of the weld is preferably located at a position where the ratio r is 0.01 to 0.05, more preferably 0.010 to 0.034. By setting the ratio r above the lower limit, gases generated during metal melting can escape from the front connection fixing portion 71, thus reducing the formation of pores, pits, cracks, etc. in the front connection fixing portion 71. Furthermore, by setting the ratio r below the upper limit, the amount of metal melted by laser irradiation in the front connection fixing portion 71 is sufficient relative to the volume of the space between the first core portion 11 and the connection member 50, reducing the formation of depressions on the outer surface. In addition, since the contact area between the first core portion 11 and the connecting member 50 and the molten metal increases, the fixing strength of the front end connecting fixing portion 71 is improved. By setting the ratio r within the above range, the front end portion of the connecting member 50 can be firmly connected to the first core portion 11 and can have a smooth outer surface with small irregularities.

[0107] The base end connection fixing portion 72 secures the base end of the connecting member 50 to the distal tapered portion 122b of the second core portion 12. Providing the base end connection fixing portion 72 in addition to the base end fitting portion 62 allows for a more secure connection between the second core portion 12 and the connecting member 50. The connecting material 72a forming the base end connection fixing portion 72 is a brazing material or a solder material. Examples of the brazing material include gold brazing material and silver brazing material. Examples of the solder material include Sn-Ag alloy solder and Sn-Pb alloy solder. Alternatively, the connecting material 72a may be an adhesive.

[0108] The proximal end connecting and fixing portion 72 is disposed adjacent to the proximal end of the second core portion 12 and the proximal end fitting portion 62 of the connecting member 50 and has a tapered shape with an outer diameter gradually decreasing from the proximal end toward the proximal side of the connecting member 50. This reduces the step difference at the proximal end of the connecting member 50, which corresponds to the wall thickness t of the connecting member 50. This can prevent damage to the distal end of the catheter when the catheter is inserted from the proximal side of the guidewire 100. The tapered shape of the proximal end connecting and fixing portion 72 can be achieved by mechanically polishing the outer surface of the connecting material 72a.

[0109] The guide wire 100 of this embodiment has a continuous cone 13 at the base end cone 112a of the first core portion 11, and the continuous cone 13 is composed of a first connecting cone 13a and a second connecting cone 13b arranged adjacent to the front end side of the first connecting cone 13a and having an inclination angle θ different from that of the first connecting cone 13a. As a result, a rigidity change point is formed at the boundary position between the first connecting cone 13a and the second connecting cone 13b forming the continuous cone 13, where the rigidity along the long axis direction of the guide wire 100 changes. In the guide wire 100, a portion of the base end side of the first connecting cone 13a in the continuous cone 13 is arranged in the inner cavity 51 of the connecting component 50, and the second connecting cone 13b is not arranged in the inner cavity 51 of the connecting component 50. Therefore, the rigidity change point is arranged at a position on the front end side of the guide wire 100 compared to the front end of the connecting component 50.

[0110] The guide wire 100 thus constructed has a smaller radius of curvature from the rigidity change point obtained based on the continuous taper 13 to the front end of the connecting component 50 when bending. Therefore, the guide wire 100 having a rigidity change point at a position closer to the front end side than the front end of the connecting component 50 due to the continuous taper 13 can reduce the contact area between the guide wire 100 and the inner surface of the blood vessel when passing through the curved portion of the blood vessel compared to the guide wire 100 without the continuous taper 13. Therefore, the passability of the guide wire 100 at the curved portion of the blood vessel is improved, and the load imposed on the blood vessel is reduced. Since the chance of the end of the connecting component 50 of the guide wire 100 contacting the inner surface of the blood vessel is reduced, even if the end of the connecting component 50 has a step difference equivalent to the wall thickness t of the connecting component 50, damage to the blood vessel can be suppressed.

[0111] The first core portion 11 of the guidewire 100 is formed of a superelastic alloy, and the continuous tapered portion 13 is disposed at the base tapered portion 112a of the first core portion 11. Superelastic alloys are resistant to plastic deformation. By disposing the continuous tapered portion 13 within the first core portion 11 formed of a superelastic alloy, the guidewire 100 is less likely to kink even when the radius of curvature from the point of rigidity change due to the continuous tapered portion 13 to the distal end of the connecting member 50 decreases.

[0112] In the first core portion 11, the inclination angle θ1 of the first connecting cone 13a that is engaged with the connecting component 50 is preferably 0.01°<θ1<0.05°. A portion of the base end side of the first connecting cone 13a is arranged in the inner cavity 51 of the connecting component 50. As the inclination angle θ1 of the first connecting cone 13a decreases, the length of the first connecting cone 13a arranged in the inner cavity 51 of the connecting component 50 becomes longer. Therefore, the first connecting cone 13a can shorten the separation distance between the first core portion 11 and the second core portion 12 in the inner cavity 51 of the connecting component 50 by making the inclination angle θ1 smaller than the prescribed angle. As a result, the guide wire 100 can suppress the local reduction in rigidity at the portion where the first core portion 11 and the second core portion 12 are separated in the inner cavity 51 of the connecting component 50.

[0113] When the 1st core portion 11 and the connecting component 50 are fitted, the part of the 1st connecting portion 11a that is configured in the inner cavity 51 of the connecting component 50 has the function of supporting the connecting component 50. Therefore, by making the length of the 1st connection taper 13a that is configured in the inner cavity 51 of the connecting component 50 elongate, the connecting component 50 is difficult to produce the deflection of the connecting component 50 caused by the fitting pressure, and plastic deformation can be suppressed. As a result, the straightness of the guide wire 100 becomes higher, and torque transmission improves. In addition, owing to can be fitted with the 1st core portion 11 and the connecting component 50 with high fitting pressure, the 1st core portion 11 and the connecting component 50 can be fitted more firmly.

[0114] Furthermore, by setting the inclination angle θ1 of the first connecting taper 13a to be less than the upper limit, the distance between the outer surface of the first connecting taper 13a at the front end of the connecting member 50 and the inner surface of the connecting member 50 is shortened. As a result, the front end of the connecting member 50 is effectively supported by the first connecting taper 13a, thereby preventing damage to the connecting member 50 during engagement. Furthermore, if the inclination angle θ1 of the first connecting taper 13a is less than the upper limit, the front end of the connecting member 50 is easily deformed into a shape that conforms to the outer surface of the first connecting taper 13a during engagement, thereby easily forming an open front end engaging portion 61. On the other hand, if the inclination angle θ1 of the first connecting taper 13a is greater than the upper limit, the rate of change of the outer diameter at the first connecting taper 13a increases. Consequently, the guidewire 100 experiences a sharp change in rigidity along the longitudinal axis near the boundary between the base end connecting constant outer diameter portion 111a and the first connecting taper 13a, making it susceptible to kinking. If the inclination angle θ1 of the first connection tapered portion 13a is equal to or smaller than the lower limit, it is difficult to determine the positions of the first connection tapered portion 13a and the connection member 50 during fitting, making it difficult to form the distal end fitting portion 61 at a desired position.

[0115] As described above, the inclination angle θ of the tapered portion that engages with the connecting member 50 (the inclination angle θ1 of the first connecting tapered portion 13a) is preferably less than a predetermined angle. However, if the base end tapered portion 112a is configured as a single tapered portion with a small inclination angle θ, the guide wire 100 has a longer portion at the distal end of the connecting member 50 having an outer diameter smaller than that of the first outer diameter constant portion 11b. The portion with a smaller outer diameter of the guide wire 100 increases the difference between the outer diameter of the guide wire 100 and the inner diameter of the catheter, thereby reducing the support provided by the guide wire 100 to the catheter. Furthermore, the rigidity of the portion with a smaller outer diameter of the guide wire 100 also decreases, thereby reducing the pushability of the guide wire 100.

[0116] By designating the base end taper 112a as a continuous taper 13, the guidewire 100 shortens the length of the smaller outer diameter portion from the distal end of the connecting component 50 to the first constant outer diameter portion 11b compared to a case where the base end taper 112a is a single taper. This reduces the reduction in the guidewire 100's support and pushability for the catheter. Furthermore, when the guidewire 100 is engaged by gripping the first constant outer diameter portion 11b of the first core 11, the distance between the first core 11 and the connecting component 50 can be shortened. This facilitates insertion of the first core 11 into the connecting component 50 during engagement, reducing the likelihood of damage to the first core 11 and the connecting component 50. This improves the straightness of the guidewire 100 and enhances torque transmission. Furthermore, the first core 11 can be extended in length by the portion covered by the second covering layer 42. This reduces frictional resistance between the guidewire 100 and the blood vessel, improving its ability to pass through the blood vessel.

[0117] In the continuous tapered portion 13, the inclination angle θ2 of the second connecting tapered portion 13b is greater than the inclination angle θ1 of the first connecting tapered portion 13a. This allows the first core portion 11 to reduce the change in rigidity along the long axis of the first connecting portion 11a while also providing a point of change in rigidity based on the continuous tapered portion 13. If the inclination angle θ2 of the second connecting tapered portion 13b is smaller than the inclination angle θ1 of the first connecting tapered portion 13a, the effect of shortening the length of the small outer diameter portion from the distal end of the connecting member 50 to the first constant outer diameter portion 11b is reduced, making it difficult to achieve the benefits of having the base end tapered portion 112a as the continuous tapered portion 13.

[0118] The inclination angle θ2 of the second connecting tapered portion 13b is preferably 0.1°<θ2<2.5°. Thus, the rigidity along the longitudinal direction near the boundary between the first connecting tapered portion 13a and the second connecting tapered portion 13b changes smoothly, so that the guide wire 100 can suppress kinking at the proximal end tapered portion 112a.

[0119] The first connecting taper 13a and the second connecting taper 13b have different lengths. The length L2 of the first connecting taper 13a is preferably longer than the length L3 of the second connecting taper 13b. The length L2 of the first connecting taper 13a is 25 mm to 33 mm. The length L3 of the second connecting taper 13b is 1 mm to 7 mm.

[0120] By setting the length L2 of the first connecting tapered portion 13a to be longer than the length L3 of the second connecting tapered portion 13b, the length of the first core portion 11 disposed within the lumen 51 of the connecting component 50 can be increased, thereby shortening the length from the distal end of the connecting component 50 to the first constant outer diameter portion 11b. As the length of the first connecting tapered portion 13a disposed within the lumen 51 of the connecting component 50 increases, the separation distance between the first core portion 11 and the second core portion 12 within the lumen 51 of the connecting component 50 decreases. This allows the guidewire 100 to suppress a local decrease in rigidity at the portion where the first core portion 11 and the second core portion 12 are separated within the lumen 51 of the connecting component 50. Furthermore, since the length of the portion with a smaller outer diameter from the distal end of the connecting component 50 to the first constant outer diameter portion 11b is shortened, the guidewire 100 can suppress a decrease in its support and pushability for the catheter.

[0121] When the first core portion 11 is engaged with the connecting component 50, the portion of the first connecting portion 11a disposed in the inner cavity 51 of the connecting component 50 has the function of supporting the connecting component 50. Therefore, by lengthening the length of the first connecting cone 13a disposed in the inner cavity 51 of the connecting component 50, it is difficult to produce the bending of the connecting component 50 caused by the engaging pressure, and the plastic deformation of the connecting component 50 can be suppressed. In addition, when the guide wire 100 is engaged by holding the first outer diameter constant portion 11b of the first core portion 11, the distance between the first core portion 11 and the connecting component 50 can be shortened. Therefore, for the first core portion 11, the first core portion 11 is easily inserted into the connecting component 50 during engagement, and the possibility of damage to the first core portion 11 and the connecting component 50 is reduced. As a result, the straightness of the guide wire 100 is increased and the torque transmission performance is improved.

[0122] Furthermore, by shortening the length from the distal end of the connecting member 50 to the first constant outer diameter portion 11b, the first core portion 11 can increase the length of the portion covered by the second covering layer 42. This reduces the frictional resistance of the guide wire 100 and improves its passability through blood vessels.

[0123] [Manufacturing method]

[0124] Next, a method for manufacturing the guide wire 100 of this embodiment will be described. The following describes a process for connecting the first core portion 11 and the second core portion 12 with the connecting member 50 , and descriptions of other processes for manufacturing the guide wire 100 are omitted.

[0125] (Process 1)

[0126] Step 1 is a step of inserting the base end connection constant outer diameter portion 111a of the first core portion 11 and a portion of the first connection tapered portion 13a of the first core portion 11 into the inner cavity 51 of the connection member 50 from the front end side of the connection member 50. By inserting a portion of the first connection tapered portion 13a of the first core portion 11 into the inner cavity 51 of the connection member 50, the outer surface of the first connection tapered portion 13a of the first core portion 11 contacts the inner surface of the front end portion of the connection member 50.

[0127] (Process 2)

[0128] Step 2 is a step of fitting the first core portion 11 and the connecting member 50. In step 2, the first core portion 11 and the connecting member 50 are moved relatively close to each other, with the proximal end connecting constant outer diameter portion 111a of the first core portion 11 and a portion of the first connecting tapered portion 13a of the first core portion 11 inserted into the inner cavity 51 of the connecting member 50 and the outer surface of the first connecting tapered portion 13a of the first core portion 11 in contact with the inner surface of the distal end portion of the connecting member 50. The relative movement of the first core portion 11 and the connecting member 50 pushes the proximal end connecting constant outer diameter portion 111a of the first core portion 11 and a portion of the first connecting tapered portion 13a of the first core portion 11 toward the proximal end side of the inner cavity 51 of the connecting member 50. In addition, when the base end connecting the constant outer diameter portion 111a of the first core portion 11 and a portion of the first connecting cone 13a of the first core portion 11 are pushed toward the base end side of the connecting component 50, by applying a predetermined fitting pressure, the front end portion of the connecting component 50 becomes an open shape that expands radially outward along the outer surface of the first connecting cone 13a of the first core portion 11. As a result, a front end fitting portion 61 in which the outer surface of the first connecting cone 13a of the first core portion 11 and the inner surface of the front end portion of the connecting component 50 are fitted together can be formed at the portion where the outer surface of the first connecting cone 13a of the first core portion 11 contacts the inner surface of the front end portion of the connecting component 50. In addition, the operation of pushing the first core portion 11 into the connecting component 50 can be performed using a known fitting machine 200.

[0129] (Process 3)

[0130] Step 3 is a step of irradiating the outer surface of the connecting member 50 with a laser from the radially outer side of the connecting member 50 to form a front end connecting fixing portion 71 (welding portion) that fixes the connecting member 50 to the first connecting cone 13a of the first core 11. At this time, the laser irradiation point P is set to a position separated by a predetermined distance from the position where the outer surface of the first connecting cone 13a of the first core 11 contacts the inner surface of the front end portion of the connecting member 50 toward the base end side of the connecting member 50. By irradiating the laser from the position where the outer surface of the first connecting cone 13a of the first core 11 contacts the inner surface of the front end portion of the connecting member 50 toward the base end side of the connecting member 50, the front end connecting fixing portion 71 can be formed at a position separated by a predetermined distance from the front end of the connecting member 50. In addition, by irradiating the laser at two radially opposite locations of the connecting member 50, the front end connecting fixing portion 71 can be provided at these two locations. The operation of irradiating the connecting member 50 with a laser can be performed using a known laser irradiation device.

[0131] (Process 4)

[0132] Step 4 is a step of inserting the front end connection portion 121b of the second core portion 12 and a portion of the front end tapered portion 122b of the second core portion 12 from the base end side of the connecting member 50 into the inner cavity 51 of the connecting member 50. By inserting a portion of the front end tapered portion 122b of the second core portion 12 into the inner cavity 51 of the connecting member 50, the outer surface of the front end tapered portion 122b of the second core portion 12 contacts the inner surface of the front end portion of the connecting member 50.

[0133] (Process 5)

[0134] Step 5 is a step of fitting the second core portion 12 and the connecting member 50. In step 5, the second core portion 12 and the connecting member 50 are moved relatively close to each other, with the distal end connecting constant outer diameter portion 121b of the second core portion 12 and a portion of the distal end tapered portion 122b of the second core portion 12 inserted into the inner cavity 51 of the connecting member 50 and the outer surface of the distal end tapered portion 122b of the second core portion 12 in contact with the inner surface of the base end portion of the connecting member 50. By relatively moving the second core portion 12 and the connecting member 50, the distal end connecting constant outer diameter portion 121b of the second core portion 12 and a portion of the distal end tapered portion 122b of the second core portion 12 are pushed toward the distal end side of the inner cavity 51 of the connecting member 50. Furthermore, when the front end connecting outer diameter constant portion 121b of the second core portion 12 and a portion of the front end tapered portion 122b of the second core portion 12 are pushed toward the front end side of the connecting member 50, a predetermined fitting pressure is applied, so that the base end portion of the connecting member 50 becomes an open shape that expands radially outward along the outer surface of the front end tapered portion 122b of the second core portion 12. Thus, a base end fitting portion 62 can be formed in which the outer surface of the front end tapered portion 122b of the second core portion 12 and the inner surface of the base end portion of the connecting member 50 fit together at the portion where the outer surface of the front end tapered portion 122b of the second core portion 12 contacts the inner surface of the base end portion of the connecting member 50. Furthermore, the operation of pushing the second core portion 12 into the connecting member 50 can be performed using a known fitting machine 200.

[0135] (Process 6)

[0136] Step 6 is a step of forming a base end connection fixing portion 72 that fixes the base end of the connection member 50 to the distal end tapered portion 122b of the second core portion 12. The base end connection fixing portion 72 can be formed by applying a connection material 72a to the outer surface of the distal end tapered portion 122b of the second core portion 12 near the base end of the connection member 50.

[0137] (Process 7)

[0138] Step 7 is a step of mechanically grinding the outer surface of the connection material 72a forming the base end connection fixing portion 72 to form a tapered shape with an outer diameter gradually decreasing from the base end toward the base end side of the connection member 50. The operation of mechanically grinding the outer surface of the connection material 72a can be performed using a known grinder.

[0139] The guide wire 100 may be manufactured by replacing the order of steps 1 to 3 and steps 4 to 7. That is, the first core portion 11 may be connected to the connecting member 50 after the second core portion 12 is connected to the connecting member 50 .

[0140] [Effects]

[0141] As described above, the guide wire 100 of this embodiment is a guide wire 100 that utilizes a tubular connecting component 50 to connect the base end portion of the first core portion 11 to the front end portion of the second core portion 12 disposed on the base end side of the first core portion 11, wherein the base end portion of the first core portion 11 has a base end taper portion 112a whose outer diameter gradually decreases toward the base end, and the front end portion of the second core portion 12 has a front end taper portion 122b whose outer diameter gradually decreases toward the front end, and at least one of the base end taper portion 112a and the front end taper portion 122b is in the long axis direction of the guide wire 100. It has a continuous cone portion 13, which includes a first connecting cone portion 13a arranged at a position closest to the base end of the first core portion 11 or the front end of the second core portion 12, and a second connecting cone portion 13b arranged adjacent to the first connecting cone portion 13a on the side far from the base end of the first core portion 11 or the front end of the second core portion 12 and having an inclination angle θ different from that of the first connecting cone portion 13a. The continuous cone portion 13 has an interlocking portion 60 in which the outer surface of the first connecting cone portion 13a is interlocked with the inner surface of the end of the connecting component 50.

[0142] By such structure, guide wire 100 is connected to the boundary position of the 1st taper portion 13a and the 2nd taper portion 13b that forms continuous taper portion 13, and the rigidity along the major axis direction of guide wire 100 changes.Thus, the radius of curvature when guide wire 100 passes through from the curved portion of blood vessel diminishes, and therefore can reduce the contact area of ​​guide wire 100 and the inner surface of blood vessel.Therefore, the passability of guide wire 100 at the curved portion of blood vessel improves, and the load brought to blood vessel is reduced.In addition, guide wire 100 is owing to the chance that the end of connecting component 50 contacts with the inner surface of blood vessel, so even under the situation of the step difference suitable with the wall thickness t of connecting component 50 at the end of connecting component 50, also can suppress the damage of blood vessel.

[0143] In addition, the continuous tapered portion 13 of the guide wire 100 of the present embodiment may be disposed at the proximal tapered portion 112 a of the first core portion 11 , and the first core portion 11 may be formed of a superelastic alloy.

[0144] With such a structure, even when the curvature radius from the point of change in rigidity due to the continuous tapered portion 13 to the distal end of the connecting member 50 decreases, the guide wire 100 is less likely to kink.

[0145] In the guide wire 100 of the present embodiment, in the continuous tapered portion 13 , the inclination angle θ2 of the second connecting tapered portion 13 b may be larger than the inclination angle θ1 of the first connecting tapered portion 13 a .

[0146] With such a configuration, the guide wire 100 can reduce the change in rigidity along the longitudinal direction of the first connecting portion 11 a and provide a rigidity change point based on the continuous tapered portion 13 .

[0147] In the guide wire 100 of the present embodiment, in the continuous tapered portion 13 , the length of the first connecting tapered portion 13 a in the longitudinal direction may be longer than the length of the second connecting tapered portion 13 b in the longitudinal direction.

[0148] By such structure, guide wire 100 can increase the length of the 1st connection taper 13a that is configured in the inner chamber 51 of connecting component 50, shortens the length from the front end of connecting component 50 to the 1st external diameter constant portion 11b.Thus, guide wire 100 can suppress the rigidity reduction of local, the supporting property reduction of conduit, the pushability reduction.In addition, guide wire 100 is owing to the plastic deformation of connecting component 50 when the 1st core portion 11 and connecting component 50 are chimeric and the possibility reduction of breakage, so true straightness becomes higher, and torque transmission improves.And the length of guide wire 100 in the part that is covered by the 2nd covering layer 42 in the 1st core portion 11 is elongated, so the passability in blood vessel improves.

[0149] In addition, the connection fixing portion 70 for fixing the continuous tapered portion 13 of the guide wire 100 and the connection member 50 in this embodiment may be provided on the first connection tapered portion 13 a and at a position separated from the fitting portion 60 in the longitudinal direction.

[0150] With this structure, the first core 11 and the connecting member 50 are fixed at two locations, the fitting portion 60 and the distal end connecting and fixing portion 71 , when viewed along the longitudinal direction of the guide wire 100 . Therefore, the first core 11 and the connecting member 50 can be more firmly connected.

[0151] In addition, the outer surface of the first connection tapered portion 13 a of the guide wire 100 of the present embodiment and the inner surface of the connection member 50 may be separated in the radial direction at the distal end side and the proximal end side of the connection fixing portion 70 .

[0152] With such a structure, the outer surface of the connection member 50 including the connection fixing portion 70 of the guide wire 100 is smooth, and the connection strength between the first core portion 11 and the connection member 50 is high.

[0153] Furthermore, the fitting portion 60 of the guide wire 100 of the present embodiment may have a flared shape in which the connection member 50 expands radially outward along the outer surface of the first connection tapered portion 13 a .

[0154] With this structure, the guide wire 100 can increase the area of ​​the fitting portion 60, so the first core portion 11 is firmly fitted with the connecting member 50. In addition, it can suppress the concentration of stress on the front end of the connecting member 50 during bending, so the guide wire 100 is less likely to kink starting from the front end of the connecting member 50.

[0155] [Example]

[0156] Hereinafter, the present invention will be specifically described using examples, but the scope of the present invention is not limited to the following examples.

[0157] [Manufacturing of guide wires]

[0158] The guide wire 100 of Example 1 was manufactured as follows: In addition, regarding the manufacturing process, the step 1, the step 3, the step 4, the step 6, and the step 7 in the manufacturing method of the guide wire 100 described above were performed.

[0159] The first core portion 11 of the guide wire 100 is formed by processing a metal wire made of a Ni-Ti alloy. The first connecting portion 11a of the first core portion 11 is formed to have a base end connecting outer diameter constant portion 111a and a base end tapered portion 112a. The base end tapered portion 112a is formed as a continuous tapered portion 13 in which the first connecting tapered portion 13a and the second connecting tapered portion 13b are arranged adjacent to each other along the longitudinal direction. The outer diameter d1 of the base end connecting outer diameter constant portion 111a is 0.235mm, the outer diameter d2 of the front end of the first connecting tapered portion 13a is 0.279mm, and the outer diameter d3 of the front end of the second connecting tapered portion 13b is 0.340mm. The length L1 of the base end connecting outer diameter constant portion 111a is 4mm, the length L2 of the first connecting tapered portion 13a is 29mm, and the length L3 of the second connecting tapered portion 13b is 4mm. The inclination angle θ1 of the first connection tapered portion 13 a is 0.04°, and the inclination angle θ2 of the second connection tapered portion 13 b is 0.44°.

[0160] The second core portion 12 of the guidewire 100 is formed by processing a stainless steel wire. The second connecting portion 12b of the second core portion 12 is formed to include a front end connecting constant outer diameter portion 121b and a front end tapered portion 122b. The front end tapered portion 122b is formed as a single tapered portion. The outer diameter of the front end connecting constant outer diameter portion 121b is 0.235 mm, and the outer diameter of the base end of the front end tapered portion 122b is 0.340 mm. The length of the front end connecting constant outer diameter portion 121b is 5 mm, and the length of the front end tapered portion 122b is 25 mm. The inclination angle θ3 of the front end tapered portion 122b is 0.14.

[0161] The connection member 50 used was a Ni—Ti alloy tube having an outer diameter of 0.350 mm, an inner diameter of 0.255 mm, a wall thickness t of 0.048 mm, and a length of 35 mm.

[0162] In process 1, the tester holds the first core portion 11 and the connecting component 50, inserts the base end connecting outer diameter constant portion 111a of the first core portion 11 and a part of the first connecting cone portion 13a of the first core portion 11 from the front end side of the connecting component 50 and pushes them in with force, thereby fitting the first core portion 11 and the connecting component 50.

[0163] In step 3, the experimenter used a laser irradiation device to set the laser irradiation point P at a distance S of 2.5 mm in the longitudinal direction from the distal end of the connecting member 50 to the laser irradiation point P, and then performed laser irradiation. Next, the experimenter set the laser irradiation point P at a position 180° rotated in the circumferential direction of the first core portion 11 from the initial laser irradiation point P, and then performed laser irradiation. The voltage during laser irradiation was 280 V, and the pulse width was 1.0 ms.

[0164] In step 4 , the tester holds the second core 12 and the connecting member 50 , inserts a portion of the distal end tapered portion 122 b of the second core 12 from the proximal end side of the connecting member 50 , and forcefully pushes the second core 12 and the connecting member 50 together.

[0165] In step 6, the proximal end connection fixing portion 72 that fixes the proximal end portion of the connection member 50 to the distal end tapered portion 122 b of the second core portion 12 is formed by soldering using solder as the connection material 72 a .

[0166] In step 7, the tester grinds the surface of the proximal end connection fixing portion 72 made of the connection material 72a obtained by soldering in step 6 using a grinder to form it into a tapered shape with an outer diameter gradually decreasing toward the proximal end.

[0167] The guidewire 500 of Comparative Example 1 was manufactured according to the manufacturing process of the guidewire 100 described above. In Comparative Example 1, the first connecting portion 11a of the first core portion 11 is formed to include a base end connecting constant outer diameter portion 111a and a base end tapered portion 112a. The base end tapered portion 112a is formed as a single tapered portion. The outer diameter d1 of the base end connecting constant outer diameter portion 111a is 0.220 mm, and the outer diameter of the front end of the base end tapered portion 112a is 0.340 mm. The length of the base end connecting constant outer diameter portion 111a is 15 mm, and the length of the base end tapered portion 112a is 80 mm. The inclination angle θ of the base end tapered portion 112a is 0.04°.

[0168] [Test 1]

[0169] Test 1 evaluated the behavior of the guidewire when passing through a bend. The guidewire 100 of Example 1 and the guidewire 500 of Comparative Example 1 were inserted into a test device 400 having a passage 410 (a tube with a diameter of 6 mm and a radius of curvature of 30 mm) including a U-shaped bend. The behavior of the guidewire 100, including the mating portion between the first core and the connecting component, was visually observed as it passed through the bend.

[0170] [Results of Test 1]

[0171] Figure 61 is a diagram schematically showing an example of the curved shape of the guide wire when the guide wire 100 of Example 1 and the guide wire 500 of Comparative Example 1 are inserted into the passage 410 of the test instrument 400. Figure 6 In FIG. 1 , the solid line represents the guide wire 100 of Example 1, and the dotted line represents the guide wire 500 of Comparative Example 1.

[0172] like Figure 6 As shown, when the guide wire 100 of Example 1 passes through the curved portion of the passage 410, the guide wire 100 has a small curvature radius and passes through a position close to the inner side of the curve of the passage 410. Figure 6 As shown, when the guidewire 500 of Comparative Example 1 passes through the curved portion of the passage 410, the curvature radius of the guidewire 100 increases, and the guidewire 100 passes from a position closer to the outer side of the curve of the passage 410. Compared with the guidewire 500 of Comparative Example 1 without the continuous tapered portion 13, the contact area between the guidewire 100 and the inner surface of the blood vessel when passing through the curved portion of the blood vessel is smaller. It is inferred that because the rigidity of the guidewire 100 along the long axis direction of the guidewire 100 changes at the boundary position between the first connecting tapered portion 13a and the second connecting tapered portion 13b forming the continuous tapered portion 13, the curvature radius from the rigidity change point obtained by the continuous tapered portion 13 to the front end of the connecting component 50 decreases when the guidewire 100 is bent.

[0173] This application is based on Japanese patent application No. 2020-188863 filed on November 12, 2020, the disclosure of which is incorporated by reference in its entirety.

[0174] Description of Reference Numerals

[0175] 10: core component,

[0176] 11: 1st core part (11a: 1st connecting part, 11b: 1st outer diameter constant part, 11c: 1st tapered part, 11d: 2nd outer diameter constant part, 11e: 2nd tapered part, 11f: transition part, 11g: flat part, 111a: base end connecting outer diameter constant part, 112a: base end tapered part),

[0177] 12: Second core part (12a: base, 12b: second connecting part, 121b: front end connecting outer diameter constant part, 122b: front end tapered part),

[0178] 13: continuous taper (13a: first connecting taper, 13b: second connecting taper),

[0179] 14: extension,

[0180] 20: Lumen,

[0181] 21: 1st coil,

[0182] 22: 2nd coil,

[0183] 30: fixed part,

[0184] 31: front end fixing part,

[0185] 32: middle fixed part,

[0186] 33: base end fixing portion,

[0187] 40: Covering layer,

[0188] 41: 1st covering layer,

[0189] 42: 2nd covering layer,

[0190] 43: 3rd covering layer,

[0191] 50: connecting parts,

[0192] 51: Inner cavity,

[0193] 60: Chimeric part,

[0194] 61: front end fitting portion,

[0195] 62: Base end fitting part,

[0196] 70: Connecting fixed part,

[0197] 71: Front end connection fixing part,

[0198] 72: proximal end connection fixing portion (72a: connection material),

[0199] 100: guide wire,

[0200] C: Central axis.

Claims

1. A guide wire comprising a tubular connecting member connecting a base end portion of a first core portion to a front end portion of a second core portion disposed on the base end side of the first core portion, wherein: The base end portion of the first core portion has a base end taper portion whose outer diameter gradually decreases toward the base end. The front end portion of the second core portion has a front end tapered portion whose outer diameter gradually decreases toward the front end. At least one of the base end taper portion and the front end taper portion has a continuous taper portion, and the continuous taper portion includes: a first connecting taper portion, which is arranged at a position closest to the base end of the first core portion or the front end of the second core portion; and a second connecting taper portion, which is adjacent to the first connecting taper portion on the side far from the base end of the first core portion or the front end of the second core portion, and has an inclination angle different from that of the first connecting taper portion. The continuous tapered portion includes a fitting portion where an outer surface of the first connecting tapered portion fits with an inner surface of an end portion of the connecting member.

2. The guidewire according to claim 1, wherein The continuous tapered portion is disposed at the proximal tapered portion of the first core portion, and the first core portion is formed of a superelastic alloy.

3. The guidewire according to claim 1 or 2, wherein: In the continuous tapered portion, the inclination angle of the second connecting tapered portion is greater than the inclination angle of the first connecting tapered portion.

4. The guidewire according to claim 1 or 2, wherein In the continuous tapered portion, the length of the first connected tapered portion in the longitudinal direction is longer than the length of the second connected tapered portion in the longitudinal direction.

5. The guide wire according to claim 1 or 2, wherein: A connection fixing portion for fixing the continuous tapered portion and the connection member is provided on the first connection tapered portion and is provided at a position separated from the fitting portion in the longitudinal direction. The guide wire according to claim 5 , wherein: The outer surface of the first connection tapered portion and the inner surface of the connection member are separated in the radial direction at the distal end side and the proximal end side of the connection fixing portion.

7. The guide wire according to claim 5, wherein The fitting portion has a flared shape in which the connection member expands radially outward along the outer surface of the first connection tapered portion.

8. The guide wire according to claim 6, wherein The fitting portion has a flared shape in which the connection member expands radially outward along the outer surface of the first connection tapered portion.

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