JP2022077836A - Guide wire - Google Patents

Abstract

To provide a guide wire in which a core part on the tip end side and a core part on the base end side are connected to each other with a tubular connection member, that achieves a smooth outer surface of a weld part between the core parts and the connection member, and achieves high connection strength.SOLUTION: A base end part of a first core part 11 includes a base end tapered part 112a whose outer diameter decreases gradually toward the base end. A connection fixing part 70 for fixing the base end tapered part 112a and a connection member 50 is a weld part where the base end tapered part 112a and the connection member 50 are welded. The center of the weld part is provided at a position where a ratio r of a distance in a radial direction between an outer surface of the base end tapered part 112a and an inner surface of the connection member 50 to a wall thickness t of the connection member 50 is 0.01-0.05.SELECTED DRAWING: Figure 3

Description

The present invention relates to a guide wire.

A guide wire is a medical device used to guide various catheters for treating a stenosis formed in a blood vessel to the stenosis.

The guide wire must travel through the complex bends and branches of the blood vessel and through the stenosis. Therefore, the guide wire has low flexural rigidity on the side where it is inserted into the blood vessel (tip side) in order to improve blood vessel selectivity and safety, and on the side operated by the operator (base end side), it has indentability and torque. High flexural rigidity is required to ensure transmission. Therefore, a guide wire using a core member in which metal core portions having different outer diameters and material characteristics are connected to each other so that the distal end side and the proximal end side have different characteristics is known.

In the following Patent Document 1, by inserting small diameter portions provided in the core portion on the distal end side and the core portion on the proximal end side into the lumen of the tubular connecting member, the core portion on the distal end side and the core on the proximal end side are inserted. A guide wire connected to the portion is disclosed.

WO2006 / 002199 Gazette

In a guide wire in which the core portion on the tip side and the core portion on the proximal end side are connected by a connecting member, laser welding may be performed on the end portion of the connecting member in order to increase the connection strength between the core portion and the connecting member. .. However, in laser welding, if the distance between the materials to be welded is inappropriate, the outer surface of the welded portion may have irregularities, resulting in poor appearance or insufficient connection strength. Further, when the connection between the core member and the connecting member is only laser welding, the guide wire does not have sufficient connection strength, and the connection between the core member and the connecting member may be disconnected during the operation.

At least one embodiment of the present invention has been made in view of the above circumstances, and specifically, in a guide wire in which a core portion on the distal end side and a core portion on the proximal end side are connected by a tubular connecting member. It is an object of the present invention to provide a guide wire having a smooth outer surface of a welded portion between a core portion and a connecting member and having high connection strength.

The guide wire according to the present embodiment is a guide in which the base end portion of the first core portion and the tip end portion of the second core portion arranged on the base end side of the first core portion are connected by a tubular connecting member. The base end portion of the first core portion of the wire has a proximal end taper portion whose outer diameter gradually decreases toward the proximal end, and the connection fixing portion for fixing the proximal end taper portion and the connecting member is a base. It is a welded part where the end taper part and the connecting member are welded, and the center of the welded part is the ratio of the radial distance between the outer surface of the base end tapered part and the inner surface of the connecting member to the wall thickness of the connecting member. It is provided at a position of 0.01 or more and 0.05 or less.

According to one embodiment of the present invention, the guide wire is formed at a position where the welded portion is formed at a position where the distance between the outer surface of the base end tapered portion and the inner surface of the connecting member is appropriate, so that the metal melts. The gas generated at that time can escape from the tip end side and the base end side of the connection fixing portion, and blow holes, pits, cracks, etc. are less likely to occur. As a result, the guide wire has a smooth outer surface of the welded portion between the first core portion and the connecting member, and the connection strength is high.

It is a schematic plan view of the guide wire which concerns on this embodiment. It is a partial cross-sectional view in the long axis direction when the guide wire which concerns on this embodiment is seen from the thickness direction. It is the schematic sectional drawing around the connecting member of the guide wire which concerns on this embodiment. It is a schematic partial sectional view of the connection part of the 1st core part of the guide wire and the connection member which concerns on this embodiment. It is a schematic partial sectional view of the connection part of the 2nd core part of the guide wire which concerns on this embodiment, and the connection member.

Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown here are examples for embodying the technical idea of the present invention, and do not limit the present invention. In addition, all other feasible forms, examples, operational techniques, etc. that can be considered by those skilled in the art without departing from the gist of the present invention are included in the scope and gist of the present invention, and are described in the claims. It is included in the scope of the invention and its equality.

Further, the drawings attached to the present specification may be represented schematically by changing the scale, aspect ratio, shape, etc. from the actual product for convenience of illustration and comprehension. However, it does not limit the interpretation of the present invention.

In the present specification, for convenience of explanation, a direction is defined when the guide wire 100 is in a natural state (a state in which an external force is not applied and the guide wire 100 is straightened). In FIG. 1, the "long axis direction" is the direction in which the guide wire 100 extends and is the direction along the central axis C of the guide wire 100 (the left-right direction in the figure). The "diameter direction" is a direction in which the core member 10 is separated or approaches in an axially orthogonal cross section (cross section) of the core portion with the major axis direction of the guide wire 100 as a reference axis. The "circumferential direction" is a rotation direction with the major axis direction of the core member 10 as a reference axis. The "thickness direction" is the direction in which the short side of the rectangle in the cross-sectional view of the flat plate portion 11g extends (front / depth direction in the figure) when the tip of the guide wire 100 has the flat plate portion 11g. The "width direction" is the direction in which the long side of the rectangle in the cross-sectional view of the flat plate portion 11g extends (vertical direction in the figure) when the tip of the guide wire 100 has the flat plate portion 11g.

Further, the side where the guide wire 100 is inserted into the blood vessel is referred to as the "tip side", and the side opposite to the tip side (the side gripped by the operator) is referred to as the "base end side". In addition, the part including a certain range along the long axis direction from the tip (tip) is referred to as the "tip portion", and the portion including a certain range in the long axis direction from the proximal end (most proximal end) is referred to as the "base end portion". And.

In the following description, when the explanations are given with ordinal numbers such as "first" and "second", they are used for convenience and do not specify any order unless otherwise specified.

The guide wire 100 according to the present embodiment is a medical device to be inserted into a blood vessel in order to guide a catheter or a stent for performing endovascular treatment to a stenosis portion. The guide wire 100 can also be used by being inserted into a living lumen (vascular duct, ureter, bile duct, oviduct, hepatic duct, etc.) other than a blood vessel depending on the purpose of treatment.

[Constitution]
As shown in FIG. 1 or 2, the guide wire 100 according to the present embodiment has a long core member 10, a lumen body 20 that covers the periphery of the tip portion of the core member 10, and a lumen body 20 as a core. It has a fixing portion 30 fixed to the member 10 and a covering layer 40 covering each member including the core member 10. Further, the guide wire 100 is formed when the connecting member 50 connecting the first core portion 11 and the second core portion 12 is connected to the first core portion 11 or the second core portion 12 and the connecting member 50. It has a fitting portion 60 and a connection fixing portion 70 for increasing the connection strength between the core member 10 and the connection member 50. Hereinafter, each part of the guide wire 100 will be described in detail.

<Core member>
The core member 10 is a tubular connection that connects the first core portion 11, the second core portion 12 arranged on the proximal end side of the first core portion 11, and the first core portion 11 and the second core portion 12. It has a member 50 and. In the first core portion 11 and the second core portion 12, the base end portion of the first core portion 11 is inserted into the tip end portion of the connecting member 50, and the tip end portion of the second core portion 12 is the base end portion of the connecting member 50. It is connected by being inserted into. A fitting portion 60 is formed at a contact portion between the core member 10 and the connecting member 50.

The first core portion 11 is a long member extending along the long axis direction toward the tip end side of the guide wire 100. The first core portion 11 has a first connection portion 11a, a first outer diameter constant portion 11b, a first taper portion 11c, and a second outer diameter in order from the base end to the tip side of the first core portion 11. A fixed portion 11d, a second tapered portion 11e, a transition portion 11f, and a flat plate portion 11g are provided, and each portion is integrally formed.

The first connection portion 11a is a portion connected to the second connection portion 12b of the second core portion 12, which will be described later, via the connection member 50. The first connection 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 by 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 over the entire first connecting portion 11a. As shown in FIGS. 3 and 4, the first connection portion 11a includes a proximal end connection outer diameter constant portion 111a and a proximal end taper portion 112a in order from the proximal end to the distal end side of the first core portion 11. .. The first connecting portion 11a may have another tapered portion or a constant outer diameter portion in addition to the base end tapered portion 112a.

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 connection member 50. The outer diameter d1 of the base end connection outer diameter constant portion 111a is 0.2 mm to 0.6 mm. As shown in FIG. 4, the proximal end connection outer diameter constant portion 111a is arranged in the lumen 51 of the connecting member 50 as a whole of the proximal end connection outer diameter constant portion 111a.

The proximal end tapered portion 112a extends from the tip of the proximal end connection outer diameter constant portion 111a to the proximal end of the first outer diameter constant portion 11b by a predetermined length. In the guide wire 100 according to the present embodiment, the proximal end tapered portion 112a has the first connecting tapered portion 13a and the second connecting tapered portion 13b in order from the distal end to the distal end side of the proximal end connection outer diameter constant portion 111a. It is a continuous taper portion 13 arranged adjacent to each other in the major axis direction. The second connection taper portion 13b is arranged adjacent to the first connection taper portion 13a on the side far from the base end of the first core portion 11 in the long axis direction. The first connection taper portion 13a and the second connection taper portion 13b have different inclination angles θ. In the present specification, the “inclination angle θ” is formed by a virtual line parallel to the central axis C or the central axis C and the outer surface of each tapered portion in a vertical cross section passing through the central axis C of the guide wire 100. Refers to the horn.

The outer diameter of the base end of the base end tapered portion 112a is equal to the outer diameter d1 of the base end connection outer diameter constant portion 111a. The outer diameter of the tip of the base end tapered portion 112a is equal to the outer diameter of the first outer diameter constant portion 11b. The number of tapers forming the continuous taper portion 13 may be two or more. Further, the base end tapered portion 112a may be a single tapered portion having one inclination angle θ.

The continuous taper portion 13 that functions as the base end taper portion 112a has a stepwise tapered shape in which a plurality of tapered portions having different inclination angles θ are continuously arranged in the major axis direction. The outer surface of the first connecting tapered portion 13a forming the continuous tapered portion 13 has a fitting portion 60 at a portion in contact with the inner surface of the tip portion of the connecting member 50.

The first connection tapered portion 13a extends a predetermined length from the tip of the proximal connection outer diameter constant portion 111a to the proximal end of the second connection tapered portion 13b. The first connection tapered portion 13a has a tapered shape in which the outer diameter gradually increases from the proximal end connection outer diameter constant portion 111a toward the tip side. The outer diameter of the base end of the first connection tapered portion 13a is equal to the outer diameter d1 of the base end connection outer diameter constant portion 111a. The outer diameter d2 of the tip of the first connecting tapered portion 13a is larger than the inner diameter of the connecting member 50. Therefore, as shown in FIG. 4, only a part of the first connection taper portion 13a of the first connection taper portion 13a is inserted into the lumen 51 of the connection member 50. The tapered shape of the first connection tapered portion 13a can be formed by performing mechanical polishing with a grindstone or etching with an acid on the first core portion 11.

The second connection taper portion 13b extends a predetermined length from the tip of the first connection taper portion 13a to the base end of the first outer diameter constant portion 11b. The second connection taper portion 13b has a tapered shape in which the outer diameter gradually increases from the tip end of the first connection taper portion 13a toward the tip end side. The outer diameter of the base end of the second connection taper portion 13b is equal to the outer diameter d2 of the tip of the first connection taper portion 13a. Therefore, the second connecting tapered portion 13b is not arranged in the lumen 51 of the connecting member 50. The outer diameter d3 of the tip of the second connection tapered portion 13b is equal to the outer diameter of the first outer diameter constant portion 11b. The tapered shape of the second connecting tapered portion 13b can be formed by performing mechanical polishing with a grindstone or etching with an acid on the first core portion 11.

The first outer diameter constant portion 11b extends from the tip end of the first connection portion 11a to the base end of the first taper portion 11c by a predetermined length. The outer diameter of the first outer diameter constant portion 11b is substantially constant and is substantially equal to the outer diameter of the base portion 12a of the second core portion 12.

The first tapered portion 11c extends a predetermined length from the tip of the first constant outer diameter portion 11b to the base end of the second constant outer diameter portion 11d. The first tapered portion 11c has a tapered shape in which the outer diameter gradually decreases toward the tip side from the first outer diameter constant portion 11b. The tapered shape of the first tapered portion 11c can be formed by mechanically grinding the first core portion 11 with a grindstone or etching with an acid.

The second outer diameter constant portion 11d extends a predetermined length from the tip of the first tapered portion 11c to the base end of the second tapered portion 11e. The outer diameter of the second outer diameter constant portion 11d is substantially constant and smaller than the outer diameter of the first outer diameter constant portion 11b.

The second tapered portion 11e extends a predetermined length from the tip of the second outer diameter constant portion 11d to the base end of the transition portion 11f. The second tapered portion 11e has a tapered shape in which the outer diameter gradually decreases from the second outer diameter constant 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 grindstone or etching with an acid.

The transition portion 11f extends a predetermined length from the tip of the second tapered portion 11e to the base end of the flat plate portion 11g. The transition portion 11f has a wedge shape in which the thickness gradually decreases and the width gradually increases from the second tapered portion 11e toward the flat plate portion 11g. The wedge shape of the transition portion 11f can be formed by pressing the first core portion 11 having a circular cross-sectional shape, which is a kind of cold working. The cross-sectional shape of the transition portion 11f in the plan view (cross-sectional view) orthogonal to the major axis direction is a circle having an outer diameter substantially equal to that of the second tapered portion 11e on the proximal end side, but from the proximal end side. It gradually deforms from a circle to a rectangle toward the tip side, and forms a rectangle having substantially the same shape as the flat plate portion 11g on the tip side. The tip portion of the transition portion 11f has a thickness and width substantially equal to the base end portion of the flat plate portion 11g, and forms a continuous surface with the flat plate portion 11g. The "thickness" of the flat plate portion 11g is the length of the short side of the rectangle in the cross-sectional view of the flat plate portion 11g, and the "width" of the flat plate portion 11g is the length of the long side of the rectangle in the cross-sectional view of the flat plate portion 11g. Sato.

The flat plate portion 11g extends from the tip of the transition portion 11f to the tip of the guide wire 100 by a predetermined length. The flat plate portion 11g is formed by pressing the first core portion 11 having a circular cross-sectional shape. Therefore, the flat plate portion 11g has a rectangular cross-sectional shape. The thickness of the flat plate portion 11g is substantially constant from the tip of the transition portion 11f to the tip of the flat plate portion 11g. The shape of the flat plate portion 11g seen from the thickness direction is formed into a rounded rectangle at the tip of the flat plate portion 11g. Therefore, the width of the flat plate portion 11g is substantially constant from the tip of the transition portion 11f toward the tip side, but becomes smaller in the rounded portion. The width of the flat plate portion 11g may be constant from the tip of the transition portion 11f to the tip of the flat plate portion 11g. The cross-sectional shape of the flat plate portion 11g is not limited to a rectangle, and may be a rounded rectangle having an R shape at the corner portion.

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 tip end to the base end.

The second core portion 12 is a long member extending from the connecting member 50 to the proximal end side of the guide wire 100. As shown in FIGS. 1 and 2, the second core portion 12 includes an extension portion 14, a base portion 12a, and a second connection portion 12b in order from the base end to the tip side of the second core portion 12. , Each part is integrally formed.

The extension portion 14 is a portion for connecting to an extension wire separately prepared in order to extend the total length of the guide wire 100. The extension portion 14 extends from the base end of the base portion 12a toward the base end side of the guide wire 100 by a predetermined length. The extension portion 14 has an outer diameter gradually decreasing from the base portion 12a toward the base end side, and has a shape having a plurality of bent portions. The extension portion 14 may not be provided.

The base portion 12a extends from the base end of the second connecting portion 12b to the tip of the extension portion 14 by a predetermined length. The outer diameter of the base portion 12a is substantially constant, and is substantially equal to the outer diameter of the first outer diameter constant portion 11b of the first core portion 11.

The second connecting portion 12b is a portion connected to the first connecting portion 11a of the first core portion 11 via the connecting member 50. The second connecting portion 12b extends from the tip of the second core portion 12 to the tip of the base portion 12a by a predetermined length. The outer diameter of the second connecting portion 12b is smaller than the outer diameter of the base portion 12a over the entire second connecting portion 12b. The second connection portion 12b includes a tip connection outer diameter constant portion 121b and a tip taper portion 122b in order from the tip of the second core portion 12 toward the proximal end side. The second connecting portion 12b may have another tapered portion or a constant outer diameter portion in addition to the tip tapered portion 122b.

The tip connection outer diameter constant portion 121b extends from the tip of the second core portion 12 to the tip of the tip taper portion 122b by a predetermined length. The outer diameter of the tip connection outer diameter constant portion 121b is substantially constant and smaller than the inner diameter of the connection member 50. Further, the outer diameter of the tip connection outer diameter constant portion 121b is substantially equal to the outer diameter d1 of the proximal end connection outer diameter constant portion 111a of the first core portion 11. The outer diameter of the tip connection outer diameter constant portion 121b is 0.2 mm to 0.6 mm.

The tip tapered portion 122b extends for a predetermined length from the base end of the tip connection outer diameter constant portion 121b to the tip of the base portion 12a. The tip tapered portion 122b has a tapered shape in which the outer diameter gradually increases from the tip connection outer diameter constant portion 121b toward the proximal end side. In the guide wire 100 according to the present embodiment, the tip tapered portion 122b is a single tapered portion. The outer diameter of the tip of the tip tapered portion 122b is equal to the outer diameter of the tip connection outer diameter constant portion 121b. The outer diameter of the base end of the tip tapered portion 122b is equal to the outer diameter of the base portion 12a. Therefore, as shown in FIG. 5, only a part of the tip tapered portion 122b of the tip tapered portion 122b is inserted into the lumen 51 of the connecting member 50. The tip taper portion 122b may be a continuous taper portion 13. The outer surface of the tip tapered portion 122b has a fitting portion 60 at a portion in contact with the inner surface of the base end portion of the connecting member 50.

The inclination angle θ3 of the tip taper portion 122b of the second core portion 12 is larger than the inclination angle θ1 of the first connection taper portion 13a of the first core portion 11, and the inclination angle of the second connection taper portion 13b of the first core portion 11 It is smaller than θ2. The inclination angle θ3 of the tip tapered portion 122b is 0.10 ° to 0.17 °. Further, the length of the tip tapered portion 122b of the second core portion 12 is shorter than that of the first connecting tapered portion 13a of the first core portion 11 and longer than that of the second connecting tapered portion 13b. The length of the tip tapered portion 122b is 19 mm to 25 mm.

Here, a specific dimensional example of the guide wire 100 will be described. The total length of the guide wire 100 in the major axis direction is 1000 mm to 4500 mm. The length of the first core portion 11 is 150 mm to 1000 mm. The total length of the first connecting portion 11a and the first outer diameter constant 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 outer diameter constant 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 plate portion 11 g is 1 mm to 20 mm.

The outer diameters of the first connecting portion 11a and the first outer diameter constant portion 11b are 0.2 mm to 1 mm. The outer diameters of the first tapered portion 11c and the second outer diameter constant 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 11 g is 0.01 mm to 1 mm, and the width is 0.05 mm to 1 mm.

The length of the second core portion 12 is 850 mm to 3500 mm. The outer diameter of the second core portion 12 is 0.2 mm to 1 mm.

The first core portion 11 and the second core portion 12 are superelastic alloys such as Ni—Ti alloys, SUS302, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS424, SUS430F, etc. It can be formed from various metal materials such as stainless steel, piano wire, and cobalt-based alloys. Further, the first core portion 11 is preferably formed of a material having a lower rigidity than the material of the second core portion 12. As an example, the first core portion 11 is made of Ni—Ti alloy and the second core portion 12 is made of stainless steel. The material forming the first core portion 11 and the second core portion 12 is not limited to the above example. Further, the first core portion 11 and the second core portion 12 may be formed of the same material.

<Lumen body>
The lumen body 20 is a member formed by spirally winding a wire rod around a core member 10. In the present embodiment, the lumen body 20 is formed of a first coil 21 and a second coil 22 arranged on the proximal end side of the first coil 21. The first coil 21 is arranged from the tip end to the intermediate portion of the first core portion 11. The second coil 22 is arranged from the intermediate portion of the first core portion 11 to the proximal end side. The lumen body 20 may be formed by one coil. The lumen body 20 may be formed by three or more coils.

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.

The first coil 21 is formed by spirally winding a wire rod so as to have a gap between adjacent wire rods. The gap between the adjacent wires of the first coil 21 is 1 μm to 10 μm. It is preferable that the gaps between the adjacent wires of the first coil 21 are evenly spaced.

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.

The second coil 22 is formed as a tightly wound portion in which the wires are spirally and tightly wound so as not to have a gap between adjacent wires. The second coil 22 may have a tightly wound portion and a loosely wound portion spirally and loosely wound so that the wire rods have a gap between adjacent wire rods. When the second coil 22 has a loosely wound portion, the tightly wound portion of the second coil 22 is located at the tip end portion and the proximal end portion of the second coil 22, and the loosely wound portion is a tightly wound portion on the distal end side and a dense winding portion on the proximal end side. Located between the windings.

The base end portion of the first coil 21 and the tip end portion of the second coil 22 are arranged in contact with each other. The base end portion of the first coil 21 and the tip end portion of the second coil 22 may be partially entangled with each other. In this case, the wire rod at the base end portion of the first coil 21 and the wire rod at the tip end portion of the second coil 22 are arranged alternately along the long axis direction. As a result, the separation between the first coil 21 and the second coil 22 is suppressed. The length at which the base end portion of the first coil 21 and the tip end portion of the second coil 22 are entangled is 0.1 mm to 2 mm. The first coil 21 and the second coil 22 have the same winding direction so that they can be entangled with each other.

The outer diameters of the wires of the first coil 21 and the second coil 22 are 20 μm to 90 μm, preferably 30 μm to 70 μm. In the present embodiment, the outer diameter of the wire rod forming the first coil 21 is larger than the outer diameter of the wire rod forming the second coil 22. Further, the wire rod forming the first coil 21 and the second coil 22 may be not only one wire rod but also a stranded wire composed of two or more wire rods.

The wire rods of the first coil 21 and the second coil 22 are not particularly limited, but can be formed of stainless steel, superelastic alloys, cobalt-based alloys, metals such as gold, platinum, and tungsten, or alloys containing these. As an example, the first coil 21 is made of a platinum-based alloy that is more flexible and has higher contrast than the second coil 22, and the material of the second coil 22 is made of stainless steel. Platinum-based alloys such as Pt—Ir, Pt—Ni, and Pt—W are preferably used.

It is preferable that the outer diameters of the first coil 21 and the second coil 22 are constant from the tip end to the base end, respectively. In the present embodiment, the outer diameter of the first coil 21 and the outer diameter of the second coil 22 are substantially equal to each other. Therefore, the outer diameter of the lumen body 20 is substantially constant from the tip end to the base end. The outer diameters of the first coil 21 and the second coil 22 are 0.15 mm to 2 mm.

The material forming the wire rod constituting the first coil 21 and the second coil 22, the outer diameter of the wire rod, the cross-sectional shape of the wire rod, the pitch of the wire rod, and the like can be appropriately selected according to the purpose of the guide wire 100. The cross-sectional shape of the wire is preferably circular, but may be elliptical, polygonal, or the like. The center of the cross section of the wire whose cross-sectional shape is not circular can be the center of gravity of the cross section of the wire.

<Fixed part>
The fixing portion 30 is a member for fixing the lumen body 20 to the core member 10. In the guide wire 100 according to the present embodiment, the fixing portion 30 is an intermediate fixing portion 31 for fixing the tip of the lumen body 20 to the core member 10 and an intermediate fixing portion for fixing the intermediate portion of the lumen body 20 to the core member 10. It has a portion 32 and a proximal end fixing portion 33 for fixing the proximal end of the lumen body 20 to the core member 10.

The material forming the fixing portion 30 is a brazing material or a soldering material. The brazing material includes gold brazing and silver brazing. Examples of the solder material include Sn—Ag alloy-based solder and Sn—Pb alloy-based solder. The material forming the fixing portion 30 may be an adhesive.

The tip fixing portion 31 fixes the tip portion of the first coil 21 to the flat plate portion 11g of the first core portion 11. The tip fixing portion 31 is located at the tip of the guide wire 100, and the outer surface is smoothly formed into a substantially hemispherical shape.

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

When the base end portion of the first coil 21 and the tip end portion of the second coil 22 are partially intertwined and arranged, the base end portion of the first coil 21 and the tip end portion of the second coil 22 may be arranged. It may be fixed via the tubular member 32a. The tubular member 32a is arranged between the inner peripheral surface of the lumen body 20 and the outer peripheral surface of the core member 10. The tubular member 32a coaxially fixes the lumen body 20 and the core member 10 by reducing the gap between the inner peripheral surface of the lumen body 20 and the outer peripheral surface of the core member 10. In the guide wire 100 according to the present embodiment, the outer diameter of the tip end portion of the tubular member 32a is smaller than the outer diameter of the base end portion of the tubular member 32a. As a result, as shown in FIG. 2, the first coil 21 having a small inner diameter and the second coil 22 having a large inner diameter can be coaxially fixed to the core member 10. The outer diameter of the tip end portion of the tubular member 32a and the outer diameter of the base end portion of the tubular member 32a may 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.

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

<Coating layer>
The coating layer 40 includes a first coating layer 41, a second coating layer 42, and a third coating layer 43. The coating layer 40 can be formed of a material that can reduce the friction generated between the guide wire 100 and the blood vessel or catheter. As a result, the covering layer 40 improves the operability and safety of the guide wire 100.

The first covering layer 41 covers the outer surface of each portion (luminous body 20, fixing portion 30) provided in the first core portion 11 and a part of the first core portion 11 (second outer diameter constant portion 11d). ing.

The second covering layer 42 covers the portion of the first core portion 11 located on the proximal end side of the lumen body 20. The second coating layer 42 covers the outer surface of the base end portion (first tapered portion 11c, first outer diameter constant portion 11b) of the first core portion 11.

The third coating layer 43 covers the outer surface of the base portion 12a of the second core portion.

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 with the covering layer 40. The coating layer 40 may be provided at a portion not covered by the coating layer 40.

The first coating layer 41 can be formed of a low friction material. Examples of the low friction material include hydrophilic polymers and silicone resins. The hydrophilic polymer forming the first coating layer 41 is a cellulose-based polymer substance, a polyethylene oxide-based polymer substance, or a maleic anhydride-based polymer substance (for example, malean anhydride such as a methylvinyl ether-maleic anhydride copolymer). Acid copolymers), acrylamide-based polymer substances (eg, polyacrylamides, block copolymers of glycidyl methacrylate-dimethylacrylamide), water-soluble nylons, polyvinyl alcohols, polyvinylpyrrolidones, and derivatives thereof.

The second coating layer 42 and the third coating 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, polyester (PET, PBT, etc.), polyamide, polyimide, polyurethane, polystyrene, polycarbonate, silicone resin, fluororesin (PTFE, ETFE, etc.), or these. Composite material of.

The materials forming the first coating layer 41, the second coating layer 42, and the third coating layer 43 are not limited to the above. The first coating layer 41, the second coating layer 42, and the third coating layer 43 may be formed of different materials along the major axis direction of the core member 10, respectively. For example, in the first coating layer 41, the tip end portion of the first core portion is formed of a silicone resin, and the base end portion of the first core portion is formed of a hydrophilic polymer. Further, the number of each of the first coating layer 41, the second coating layer 42 and the third coating layer 43 may be plural. It should be noted that any one of the first coating layer 41, the second coating layer 42, and the third coating layer 43 may not be provided.

<Connecting member>
The connecting member 50 is a member that connects the base end portion of the first core portion 11 and the tip end portion of the second core portion 12. The connecting member 50 is a metal tube having a predetermined length and a lumen 51.

The first core portion 11 is fitted with the connecting member 50 by inserting the proximal end side of the proximal end tapered portion 112a of the first connecting portion 11a into the lumen 51 from the tip of the connecting member 50 and pushing it in. The second core portion 12 is fitted with the connecting member 50 by inserting the tip end side of the tip tapered portion 122b of the second connecting portion 12b into the lumen 51 from the proximal end of the connecting member 50 and pushing it in. As a result, the connecting member 50 can connect the first core portion 11 and the second core portion 12. In a state where 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 (base end connection outer diameter constant portion 111a) and the tip of the second core portion 12 (Tip connection outer diameter constant portion 121b) are separated in the lumen 51 of the connecting member 50.

Before fitting, the outer diameter of the connecting member 50 is substantially constant from the tip end to the base end of the connecting member 50, and is 0.3 mm to 0.8 mm. The inner diameter of the connecting member 50 is substantially constant from the tip end to the base end of the connecting member 50, and is 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.

Examples of the metal forming 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 forming the connecting member 50 is preferably a superelastic alloy, more preferably a Ni—Ti alloy. As a result, the guide wire 100 is less likely to be kinked at the position of the connecting member 50. Further, by forming the connecting member 50 with the same metal as the core member 10, the connecting member 50 and the core member 10 can be easily fixed by welding.

<Fitting portion>
The fitting portion 60 is a contact portion between the core member 10 and the connecting member 50. The fitting portion 60 includes a tip fitting portion 61 which is a contact portion between the base end portion of the first core portion 11 and the tip end portion of the connecting member 50, and the tip end portion of the second core portion 12 and the base end of the connecting member 50. It has a base end fitting portion 62, which is a contact portion with the portion. The fitting portion 60 is formed when the first core portion 11 and the connecting member 50 are fitted and when the second core portion 12 and the connecting member 50 are fitted, and the first core portion 11 and the connecting member 50 and the second are formed. The connection between the core portion 12 and the connecting member 50 is strengthened.

The tip fitting portion 61 is a contact portion between the first core portion 11 and the connecting member 50. The first core portion 11 and the connecting member 50 are formed by inserting a part of the base end connection outer diameter constant portion 111a and the first connection tapered portion 13a of the first core portion 11 into the lumen 51 of the connecting member 50, and first. After the connection taper portion 13a and the tip of the connection member 50 are brought into contact with each other, a predetermined fitting pressure is applied to push the first core portion 11 into the lumen 51 of the connection member 50 to be fitted. As a result, the tip fitting portion 61 is formed at a portion where the outer surface of the first connection tapered portion 13a of the first core portion 11 and the inner surface of the tip portion of the connection member 50 are in contact with each other.

The tip fitting portion 61 preferably has a flare shape in which the connecting member 50 extends radially outward along the outer surface of the first connecting tapered portion 13a. When the first core portion 11 and the connecting member 50 are fitted to each other, the tip portion of the connecting member 50 is first connected to the connecting member 50 by pushing the first core portion 11 into the lumen 51 of the connecting member 50. The flare shape extends outward in the radial direction along the outer surface of the tapered portion 13a. Therefore, the inner diameter and the outer diameter of the connecting member 50 in the tip fitting portion 61 are larger than those of the connecting member 50 before fitting. When the tip of the connecting member 50 is not flared, only the inner surface of the tip of the connecting member 50 comes into contact with the outer surface of the first connecting tapered portion 13a. Therefore, the tip fitting portion 61 is formed only in a small region near the tip of the connecting member 50. When the tip portion of the connecting member 50 has a flare shape, the area of the tip fitting portion 61 is larger than that when the tip portion of the connecting member 50 does not have a flare shape. Therefore, by forming the tip fitting portion 61 into a flare shape, the first core portion 11 and the connecting member 50 are firmly fitted. Further, by forming the tip fitting portion 61 into a flare shape, the guide wire 100 can suppress the concentration of stress on the tip of the connecting member 50 at the time of bending, so that kinking starting from the tip of the connecting member 50 is unlikely to occur. Become. On the other hand, in the fitting of the first core portion 11 and the connecting member 50, if the first core portion 11 is pushed too much into the lumen 51 of the connecting member 50, the tip portion of the connecting member 50 cannot withstand the deformation and is damaged. do. Therefore, the length of the tip fitting portion 61 in the major axis direction is preferably 0.1 mm to 3.0 mm.

When the first core portion 11 and the connecting member 50 are fitted together, the lumen 51 of the connecting member 50 is filled with a portion of the base end connection outer diameter constant portion 111a and the first connection taper portion 13a of the first core portion 11. Is placed. Since the first connection portion 11a of the first core portion 11 has the proximal end connection outer diameter constant portion 111a, the length of the first core portion 11 arranged in the lumen 51 of the connection member 50 is the first connection portion. 11a is longer than the case where it is formed only by the base end tapered portion 112a. As a result, the separation distance between the first core portion 11 and the second core portion 12 in the lumen 51 of the connecting member 50 can be shortened, so that the core member 10 is separated from the first core portion 11 in the lumen 51 of the connecting member 50. It is possible to suppress a local decrease in rigidity at a portion separated from the second core portion 12.

The base end fitting portion 62 is a contact portion between the second core portion 12 and the connecting member 50. The second core portion 12 and the connecting member 50 are formed by inserting a part of the tip connecting outer diameter constant portion 121b and the tip tapered portion 122b of the second core portion 12 into the lumen 51 of the connecting member 50, and forming the tip tapered portion 122b. After contacting the base end of the connecting member 50, a predetermined fitting pressure is applied to push the second core portion 12 into the lumen 51 of the connecting member 50 for fitting. As a result, the proximal end fitting portion 62 is formed at the portion where the outer surface of the tip tapered portion 122b of the second core portion 12 and the inner surface of the proximal end portion of the connecting member 50 are in contact with each other.

Even in the fitting of the second core portion 12 and the connecting member 50, by forming the base end portion of the connecting member 50 into a flare shape, the same effect as the fitting of the first core portion 11 and the connecting member 50 described above is obtained. Is obtained. The length of the base end fitting portion 62 in the major axis direction is 0.1 mm to 3.0 mm.

When the second core portion 12 and the connecting member 50 are fitted together, a part of the tip connection outer diameter constant portion 121b and the tip taper portion 122b of the second core portion 12 is arranged in the lumen 51 of the connecting member 50. Lumen. Since the second connection portion 12b of the second core portion 12 has the tip connection outer diameter constant portion 121b, the length of the second core portion 12 arranged in the lumen 51 of the connection member 50 is the second connection portion 12b. Is longer than the case where is formed only by the tip tapered portion 122b. As a result, the separation distance between the first core portion 11 and the second core portion 12 in the lumen 51 of the connecting member 50 can be shortened, so that the core member 10 is separated from the first core portion 11 in the lumen 51 of the connecting member 50. It is possible to suppress a local decrease in rigidity at a portion separated from the second core portion 12.

The fitting of the first core portion 11 and the connecting member 50 and the fitting of the second core portion 12 and the connecting member 50 are performed by mechanical fitting by a fitting machine. The mechanical fitting by the fitting machine may be fitted with a constant fitting pressure (pushing force), or may be varied stepwise. The fitting of the first core portion 11 and the connecting member 50 and the fitting of the second core portion 12 and the connecting member 50 may be performed by a human hand, and the human hand and the fitting machine may be fitted together. It may be used together.

<Connection fixing part>
The core member 10 and the connecting member 50 are fixed by the connecting fixing portion 70. The connection fixing portion 70 includes a tip connection fixing portion 71 for fixing the tip portion of the connection member 50 to the first core portion 11, and a base end connection fixing portion 72 for fixing the base end portion of the connection member 50 to the second core portion 12. And have.

The tip connection fixing portion 71 fixes the tip portion of the connection member 50 to the first connection taper portion 13a of the first core portion 11. By providing the tip connection fixing portion 71 in addition to the tip fitting portion 61, the first core portion 11 and the connection member 50 can be firmly connected. The tip connection fixing portion 71 is provided at a position separated from the tip fitting portion 61 on the proximal end side in the long axis direction. As a result, there are two fixing points between the first core portion 11 and the connecting member 50 when viewed along the long axis direction, the tip fitting portion 61 and the tip connecting fixing portion 71. Therefore, the first core portion 11 And the connecting member 50 can be more firmly connected. It is preferable that two tip connection fixing portions 71 are provided at positions facing each other in the radial direction of the connection member 50.

The tip connection fixing portion 71 is preferably a welded portion formed by laser welding. In laser welding, the connecting member 50 and the first connecting tapered portion 13a can be fixed without changing the outer diameter of the connecting member 50, so that the influence of the tip connecting fixing portion 71 on the function of the guide wire 100 can be reduced. The welded portion has a substantially circular shape with a radius of 0.05 mm to 0.40 mm centered on the laser irradiation point P.

It is preferable that the outer surface of the first connection taper portion 13a and the inner surface of the connection member 50 are radially separated on the tip end side and the proximal end side of the tip connection fixing portion 71. In laser welding, a predetermined laser is applied to a metal to be welded to melt and solidify the metal, thereby connecting the materials to be welded to each other. Therefore, when the tip connection fixing portion 71 is provided at a position adjacent to the tip fitting portion 61 between the first core portion 11 and the connection member 50 and the tip fitting portion 61, the first core portion 11 and the connection member 50 are provided. If the radial distance from the metal is too short, the gas generated when the metal melts remains in the tip connection fixing portion 71, and blow holes, pits, cracks, and the like are likely to occur. As a result, the tip connection fixing portion 71 has irregularities on the outer surface, resulting in a poor appearance or insufficient fixing strength. Since the outer diameter of the first connection tapered portion 13a gradually decreases toward the proximal end side, the radial distance between the first core portion 11 and the connecting member 50 is from the tip of the connecting member 50 to the proximal end side. It gets longer as you go. Therefore, when the tip connection fixing portion 71 is provided at a position separated from the tip of the connection member 50 by a predetermined distance or more, the radial distance between the first core portion 11 and the connection member 50 is too long, so that the molten metal is formed. Spreads in the space between the first core portion 11 and the connecting member 50, and the outer surface tends to be dented. As a result, the tip connection fixing portion 71 has a poor appearance. Further, since the contact area between the first core portion 11 and the connecting member 50 and the molten metal becomes small, the tip connecting fixing portion 71 has insufficient fixing strength.

In the guide wire 100 according to the present embodiment, the tip connection fixing portion 71 has a radial direction in which the outer surface of the first connection taper portion 13a and the inner surface of the connection member 50 are on the tip end side and the base end side of the tip end connection fixing portion 71. It is installed at a position separated from the wire. Therefore, the gas generated when the metal melts can escape from the tip end side and the proximal end side of the tip connection fixing portion 71, and blow holes, pits, cracks, and the like are less likely to occur. Further, since the molten metal appropriately spreads in 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 can be obtained.

In this way, the position where the outer surface of the first connection taper portion 13a and the inner surface of the connection member 50 are radially separated from each other on the tip end side and the base end side of the tip end connection fixing portion 71. By forming the guide wire 100, the outer surface of the welded portion between the first core portion 11 and the connecting member 50 is smooth and the connection strength is high.

The distance S in the long axis direction from the tip 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 welded portion is provided at a position of 2.5 mm to 4.0 mm from the tip of the connecting member 50 to the proximal end side in the major axis direction. As a result, the tip connection fixing portion 71 (welded portion) is formed in the range of 2.0 mm to 4.5 mm from the tip of the connection member 50 to the proximal end side in the major axis direction. Further, the radial distance H between the outer surface of the first connection taper portion 13a and the inner surface of the connection member 50 at the laser irradiation point P for forming the tip connection fixing portion 71 is 0.0005 mm to 0.0017 mm. It is preferable to have. As a result, the tip connection fixing portion 71 (welded portion) is formed in a radial distance between the outer surface of the first connection taper portion 13a and the inner surface of the connection member 50 in the range of 0.0001 mm to 0.0021 mm. .. By forming the tip connection fixing portion 71 in the above range, the tip portion of the connection member 50 can be firmly connected to the first core portion 11 and can have a smooth outer surface with small irregularities.

The ratio r (r = H / t) of the radial distance H between the outer surface of the first connection taper portion 13a and the inner surface of the connection member 50 with respect to the wall thickness t of the connection member 50 at the laser irradiation point P is 0. It is preferably 01 or more and 0.05 or less, and more preferably 0.010 or more and 0.034 or less. That is, the center of the welded portion is preferably provided at a position where the ratio r is 0.01 or more and 0.05 or less, and more preferably 0.010 or more and 0.034 or less. When the ratio r is equal to or higher than the lower limit value, the gas generated when the metal melts can escape from the tip connection fixing portion 71 in the tip connection fixing portion 71, so that blow holes, pits, cracks, etc. are less likely to occur. Become. Further, when the ratio r is not more than the upper limit value, the amount of metal melted by the laser irradiation of the tip connection fixing portion 71 becomes sufficient with respect to the volume of the space between the first core portion 11 and the connecting member 50. The outer surface is less likely to be dented. Further, since the contact area between the first core portion 11 and the connecting member 50 and the molten metal becomes large, the strength of fixing the tip connecting fixing portion 71 is improved. By setting the ratio r to the above range, the tip 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.

The base end connection fixing portion 72 fixes the base end portion of the connection member 50 to the tip taper portion 122b of the second core portion 12. By providing the proximal end connection fixing portion 72 in addition to the proximal end fitting portion 62, the second core portion 12 and the connecting member 50 can be more firmly connected. The connection material 72a forming the base end connection fixing portion 72 is a brazing material or a solder material. The brazing material includes gold brazing and silver brazing. Examples of the solder material include Sn—Ag alloy-based solder and Sn—Pb alloy-based solder. The connecting material 72a may be an adhesive.

The base end connection fixing portion 72 is arranged adjacent to the base end side of the base end fitting portion 62 between the second core portion 12 and the connection member 50, and is outward from the base end of the connection member 50 toward the base end side. It has a tapered shape with a gradually decreasing diameter. As a result, the step corresponding to the wall thickness t of the connecting member 50 at the proximal end of the connecting member 50 becomes smaller, so that it is possible to prevent the tip of the catheter from being damaged when the catheter is inserted from the proximal end side of the guide wire 100. .. The tapered shape of the base end connection fixing portion 72 can be formed by mechanically polishing the outer surface of the connection material 72a.

The guide wire 100 according to the present embodiment is arranged on the base end taper portion 112a of the first core portion 11 adjacent to the first connection taper portion 13a and the tip end side of the first connection taper portion 13a, and is first connected. It has a continuous tapered portion 13 composed of a second connecting tapered portion 13b having an inclination angle θ different from that of the tapered portion 13a. As a result, a rigidity change point in which the rigidity along the long axis direction of the guide wire 100 changes is formed at the boundary position between the first connection taper portion 13a and the second connection taper portion 13b forming the continuous taper portion 13. In the guide wire 100, a part of the continuous tapered portion 13 on the proximal end side of the first connecting tapered portion 13a is arranged in the lumen 51 of the connecting member 50, and the second connecting tapered portion 13b is the lumen of the connecting member 50. Not placed at 51. Therefore, the rigidity change point is arranged at a position on the tip side of the guide wire 100 with respect to the tip of the connecting member 50.

When the guide wire 100 having such a configuration is curved, the radius of curvature from the rigidity change point due to the continuous tapered portion 13 to the tip of the connecting member 50 becomes small. Therefore, the guide wire 100 having the rigidity change point on the tip side of the tip of the connecting member 50 due to the continuous taper portion 13 passes through the curved portion of the blood vessel as compared with the guide wire 100 having no continuous taper portion 13. The contact area between the guide wire 100 and the inner surface of the blood vessel can be reduced. Therefore, the guide wire 100 improves the passability in the curved portion of the blood vessel and reduces the load applied to the blood vessel. Since the guide wire 100 has a reduced chance of the end of the connecting member 50 coming into contact with the inner surface of the blood vessel, even if the end of the connecting member 50 has a step corresponding to the wall thickness t of the connecting member 50. , Can suppress the damage of blood vessels.

In the guide wire 100, the first core portion 11 is formed of a superelastic alloy, and the continuous tapered portion 13 is arranged at the base end tapered portion 112a of the first core portion 11. Superelastic alloys are less likely to undergo plastic deformation. By arranging the continuous taper portion 13 in the first core portion 11 made of the superelastic alloy, the guide wire 100 has a small radius of curvature from the rigidity change point due to the continuous taper portion 13 to the tip of the connecting member 50. , Hard to reach kink.

In the first core portion 11, the inclination angle θ1 of the first connection taper portion 13a that fits with the connection member 50 is preferably 0.01 ° <θ1 <0.05 °. A part of the first connection tapered portion 13a on the proximal end side is arranged in the lumen 51 of the connecting member 50. As the inclination angle θ1 of the first connection taper portion 13a is reduced, the length of the first connection taper portion 13a arranged in the lumen 51 of the connection member 50 becomes longer. Therefore, the first connection taper portion 13a can shorten the separation distance between the first core portion 11 and the second core portion 12 in the lumen 51 of the connecting member 50 by making the inclination angle θ1 smaller than a predetermined angle. .. As a result, the guide wire 100 can suppress a local decrease in rigidity at a portion of the lumen 51 of the connecting member 50 where the first core portion 11 and the second core portion 12 are separated from each other.

When the first core portion 11 and the connecting member 50 are fitted, the portion of the first connecting portion 11a arranged in the lumen 51 of the connecting member 50 has a function of supporting the connecting member 50. Therefore, the length of the first connecting tapered portion 13a arranged in the lumen 51 of the connecting member 50 becomes long, so that the connecting member 50 is less likely to bend due to the fitting pressure, and plastic deformation occurs. Can be suppressed. As a result, the guide wire 100 has high straightness and torque transmission is improved. Further, since the first core portion 11 and the connecting member 50 can be fitted with a high fitting pressure, the first core portion 11 and the connecting member 50 can be fitted more firmly.

Further, the first connection taper portion 13a is provided between the outer surface of the first connection taper portion 13a and the inner surface of the connection member 50 at the tip end portion of the connection member 50 by making the inclination angle θ1 smaller than the upper limit value. The distance becomes shorter. As a result, the tip portion of the connecting member 50 is effectively supported by the first connecting tapered portion 13a, so that damage to the connecting member 50 during fitting is suppressed. Further, when the inclination angle θ1 of the first connection taper portion 13a is smaller than the upper limit value, the tip portion of the connection member 50 is easily deformed into a shape along the outer surface of the first connection taper portion 13a at the time of fitting. Therefore, it becomes easy to form the flare-shaped tip fitting portion 61. On the other hand, when the inclination angle θ1 of the first connection taper portion 13a is equal to or greater than the upper limit value, the rate of change in the outer diameter of the first connection taper portion 13a becomes large. Therefore, the rigidity of the guide wire 100 suddenly changes along the major axis direction in the vicinity of the boundary between the proximal end connection outer diameter constant portion 111a and the first connection taper portion 13a, and is easily kinked. Further, when the inclination angle θ1 of the first connection taper portion 13a is not more than the lower limit value, it becomes difficult to determine the position between the first connection taper portion 13a and the connection member 50 at the time of fitting, and the tip fitting portion 61 is desired. It becomes difficult to form in the position.

As described above, the inclination angle θ of the tapered portion fitted with the connecting member 50 (inclination angle θ1 of the first connecting tapered portion 13a) is preferably smaller than a predetermined angle. However, if the base end tapered portion 112a is a single tapered portion having a small inclination angle θ, the guide wire 100 has a long portion having an outer diameter smaller than that of the first constant outer diameter constant portion 11b on the tip end side of the connecting member 50. Will be done. In the portion where the outer diameter of the guide wire 100 is small, the difference between the outer diameter of the guide wire 100 and the inner diameter of the catheter becomes large, so that the supportability of the guide wire 100 to the catheter is lowered. Further, since the rigidity of the portion where the outer diameter of the guide wire 100 is small also decreases, the pushability of the guide wire 100 decreases.

The guide wire 100 has a first outer diameter constant portion from the tip of the connecting member 50 as compared with the case where the proximal end tapered portion 112a is a continuous tapered portion 13 and the proximal end tapered portion 112a is a single tapered portion. The length of the portion having a small outer diameter up to 11b is shortened. As a result, the guide wire 100 is suppressed from being lowered in supportability and pushability with respect to the catheter. Further, when the guide wire 100 grips and fits the first outer diameter constant portion 11b of the first core portion 11, the distance between the first core portion 11 and the connecting member 50 can be shortened. Therefore, the first core portion 11 can be easily inserted into the connecting member 50 at the time of fitting, and the possibility of damage to the first core portion 11 and the connecting member 50 is reduced. As a result, the guide wire 100 has a high straightness and the torque transmission property is improved. Further, the length of the portion of the first core portion 11 covered with the second covering layer 42 can be increased. As a result, the guide wire 100 has a small frictional resistance with the blood vessel, and the passability in the blood vessel is improved.

In the continuous taper portion 13, the inclination angle θ2 of the second connection taper portion 13b is larger than the inclination angle θ1 of the first connection taper portion 13a. As a result, the first core portion 11 can provide a rigidity change point due to the continuous taper portion 13 while reducing the change in rigidity of the first connection portion 11a along the major axis direction. When the inclination angle θ2 of the second connection taper portion 13b is smaller than the inclination angle θ1 of the first connection taper portion 13a, the length of the portion having a small outer diameter from the tip of the connection member 50 to the first outer diameter constant portion 11b is set. Since the effect of shortening is reduced, it becomes difficult to obtain the effect of using the base end tapered portion 112a as the continuous tapered portion 13.

The inclination angle θ2 of the second connection tapered portion 13b is preferably 0.1 ° <θ2 <2.5 °. As a result, the rigidity along the major axis direction in the vicinity of the boundary between the first connection taper portion 13a and the second connection taper portion 13b gradually changes, so that the guide wire 100 can suppress the kink at the proximal end taper portion 112a.

The first connection taper portion 13a and the second connection taper portion 13b have different lengths. The length L2 of the first connection taper portion 13a is preferably longer than the length L3 of the second connection taper portion 13b. The length L2 of the first connection tapered portion 13a is 25 mm to 33 mm. The length L3 of the second connection tapered portion 13b is 1 mm to 7 mm.

By making the length L2 of the first connection taper portion 13a longer than the length L3 of the second connection taper portion 13b, the first core portion 11 is arranged in the lumen 51 of the connection member 50. The length of the portion 13a can be increased, and the length from the tip of the connecting member 50 to the first outer diameter constant portion 11b can be shortened. When the length of the first connection tapered portion 13a arranged in the lumen 51 of the connecting member 50 becomes long, the separation distance between the first core portion 11 and the second core portion 12 in the lumen 51 of the connecting member 50 becomes short. Therefore, the guide wire 100 can suppress a local decrease in rigidity at a portion of the lumen 51 of the connecting member 50 where the first core portion 11 and the second core portion 12 are separated from each other. Further, since the length of the portion having a small outer diameter from the tip of the connecting member 50 to the first constant outer diameter portion 11b is shortened, the guide wire 100 is suppressed from being lowered in supportability and pushability with respect to the catheter.

When the first core portion 11 and the connecting member 50 are fitted, the portion of the first connecting portion 11a arranged in the lumen 51 of the connecting member 50 has a function of supporting the connecting member 50. Therefore, the length of the first connecting tapered portion 13a arranged in the lumen 51 of the connecting member 50 becomes long, so that the connecting member 50 is less likely to bend due to the fitting pressure, and the plastic deformation of the connecting member 50 is suppressed. can. Further, when the guide wire 100 grips and fits the first outer diameter constant portion 11b of the first core portion 11, the distance between the first core portion 11 and the connecting member 50 can be shortened. Therefore, the first core portion 11 can be easily inserted into the connecting member 50 at the time of fitting, and the possibility of damage to the first core portion 11 and the connecting member 50 is reduced. As a result, the guide wire 100 has high straightness and torque transmission is improved.

Further, by shortening the length from the tip of the connecting member 50 to the first outer diameter constant portion 11b, the length of the portion covered by the second covering layer 42 can be increased in the first core portion 11. As a result, the frictional resistance of the guide wire 100 is reduced, and the passability in the blood vessel is improved.

[Production method]
Next, a method of manufacturing the guide wire 100 according to the present embodiment will be described. In the following, the step of connecting the first core portion 11 and the second core portion 12 to the connecting member 50 will be described, and the description of other steps for manufacturing the guide wire 100 will be omitted.

(Step 1)
In step 1, a part of the base end connection outer diameter constant portion 111a of the first core portion 11 and the first connection taper portion 13a of the first core portion 11 is inserted into the lumen 51 of the connection member 50 from the tip end side of the connection member 50. Is the process of inserting. By inserting a part of the first connection taper portion 13a of the first core portion 11 into the lumen 51 of the connection member 50, the outer surface of the first connection taper portion 13a of the first core portion 11 becomes the connection member 50. Contact with the inner surface of the tip.

(Step 2)
Step 2 is a step of fitting the first core portion 11 and the connecting member 50. In step 2, a part of the base end connection outer diameter constant portion 111a of the first core portion 11 and a part of the first connection taper portion 13a of the first core portion 11 is inserted into the lumen 51 of the connection member 50, and the first With the outer surface of the first connecting tapered portion 13a of the core portion 11 and the inner surface of the tip portion of the connecting member 50 in contact with each other, the first core portion 11 and the connecting member 50 are moved so as to be relatively close to each other. .. Due to the relative movement between the first core portion 11 and the connecting member 50, a part of the base end connection outer diameter constant portion 111a of the first core portion 11 and the first connection tapered portion 13a of the first core portion 11 is connected to the connecting member 50. It is pushed toward the proximal end side of the lumen 51 of the. Further, when pushing a part of the base end connection outer diameter constant portion 111a of the first core portion 11 and the first connection taper portion 13a of the first core portion 11 toward the base end side of the connection member 50, a predetermined fitting is performed. By applying pressure, the tip portion of the connecting member 50 becomes a flare shape that spreads radially outward along the outer surface of the first connecting tapered portion 13a of the first core portion 11. As a result, the outer surface of the first connection taper portion 13a of the first core portion 11 is brought into contact with the outer surface of the first connection taper portion 13a of the first core portion 11 and the inner surface of the tip portion of the connection member 50. And the inner surface of the tip of the connecting member 50 can be fitted to form a tip fitting portion 61. The work of pushing the first core portion 11 into the connecting member 50 can be performed by using a known fitting machine 200.

(Step 3)
In step 3, the tip connection fixing portion 71 that irradiates the outer surface of the connection member 50 with a laser from the radial outside of the connection member 50 to fix the connection member 50 and the first connection taper portion 13a of the first core portion 11. This is the process of forming (welded portion). At this time, the laser irradiation point P is predetermined from the position where the outer surface of the first connection tapered portion 13a of the first core portion 11 and the inner surface of the tip portion of the connection member 50 are in contact with each other to the proximal end side of the connection member 50. The position should be separated by a distance. The laser is irradiated to a position separated by a predetermined distance from the position where the outer surface of the first connection taper portion 13a of the first core portion 11 and the inner surface of the tip portion of the connection member 50 are in contact with the base end side of the connection member 50. By doing so, the tip connection fixing portion 71 can be formed at a position separated from the tip of the connection member 50 by a predetermined distance. By irradiating the connecting member 50 with the laser at two locations facing each other in the radial direction, the tip connection fixing portion 71 can be provided at the two locations. The work of irradiating the connecting member 50 with a laser can be performed using a known laser irradiation device.

(Step 4)
In step 4, a part of the tip connection outer diameter constant portion 121b of the second core portion 12 and the tip taper portion 122b of the second core portion 12 are inserted into the lumen 51 of the connection member 50 from the base end side of the connection member 50. It is a process to do. By inserting a part of the tip tapered portion 122b of the second core portion 12 into the lumen 51 of the connecting member 50, the outer surface of the tip tapered portion 122b of the second core portion 12 becomes the inside of the tip portion of the connecting member 50. Contact the surface.

(Step 5)
Step 5 is a step of fitting the second core portion 12 and the connecting member 50. In step 5, a part of the tip connection outer diameter constant portion 121b of the second core portion 12 and a part of the tip taper portion 122b of the second core portion 12 are inserted into the lumen 51 of the connecting member 50, and the second core portion 12 is inserted. With the outer surface of the tip tapered portion 122b and the inner surface of the base end portion of the connecting member 50 in contact with each other, the second core portion 12 and the connecting member 50 are moved so as to be relatively close to each other. By moving the second core portion 12 and the connecting member 50 relative to each other, a part of the tip connecting outer diameter constant portion 121b of the second core portion 12 and the tip tapered portion 122b of the second core portion 12 is formed in the lumen 51 of the connecting member 50. It is pushed toward the tip side of. Further, when pushing a part of the tip connection outer diameter constant portion 121b of the second core portion 12 and the tip taper portion 122b of the second core portion 12 toward the tip side of the connection member 50, a predetermined fitting pressure is applied. As a result, the base end portion of the connecting member 50 has a flare shape that extends radially outward along the outer surface of the tip tapered portion 122b of the second core portion 12. As a result, the outer surface of the tip tapered portion 122b of the second core portion 12 and the connecting member are in contact with the outer surface of the tip tapered portion 122b of the second core portion 12 and the inner surface of the base end portion of the connecting member 50. It is possible to form a proximal end fitting portion 62 in which the inner surface of the proximal end portion of 50 is fitted. The work of pushing the second core portion 12 into the connecting member 50 can be performed by using a known fitting machine 200.

(Step 6)
Step 6 is a step of forming a base end connection fixing portion 72 for fixing the base end portion of the connecting member 50 and the tip tapered portion 122b of the second core portion 12. The base end connection fixing portion 72 can be formed by applying the connection material 72a to the outer surface of the tip taper portion 122b of the second core portion 12 in the vicinity of the base end of the connection member 50.

(Step 7)
Step 7 is a step of mechanically polishing the outer surface of the connection material 72a forming the proximal end connection fixing portion 72 to form a tapered shape in which the outer diameter gradually decreases from the proximal end to the proximal end side of the connecting member 50. The work of mechanically polishing the outer surface of the connecting material 72a can be performed using a known polishing machine.

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

[Action effect]
As described above, the guide wire 100 according to the present embodiment has a base end portion of the first core portion 11 and a tip end portion of the second core portion 12 arranged on the base end side of the first core portion 11. , A guide wire 100 connected by a tubular connecting member 50, wherein the proximal end portion of the first core portion 11 has a proximal end tapered portion 112a whose outer diameter gradually decreases toward the proximal end, and the proximal end tapered portion. The connection fixing portion 70 for fixing the 112a and the connecting member 50 is a welded portion in which the proximal end tapered portion 112a and the connecting member 50 are welded, and the center of the welded portion is the proximal end with respect to the wall thickness t of the connecting member 50. It is provided at a position where the ratio r of the radial distance between the outer surface of the tapered portion 112a and the inner surface of the connecting member 50 is 0.01 or more and 0.05 or less.

With such a configuration, the guide wire 100 is formed at a position where the distance between the outer surface of the base end tapered portion 112a and the inner surface of the connecting member 50 is appropriate, so that the guide wire 100 is formed when the metal is melted. The gas can escape from the tip end side and the base end side of the connection fixing portion 70, and blow holes, pits, cracks, etc. are less likely to occur. As a result, the guide wire 100 has a smooth outer surface of the welded portion (tip connection fixing portion 71) between the first core portion 11 and the connecting member 50, and the connection strength is high.

Further, the first core portion 11 of the guide wire 100 according to the present embodiment has a fitting portion 60 that is fitted by contacting the outer surface of the base end tapered portion 112a with the inner surface of the end portion of the connecting member 50. The fitting portion 60 may have a flare shape in which the connecting member 50 extends radially outward along the outer surface of the proximal end tapered portion 112a.

With such a configuration, in the guide wire 100, since the first core portion 11 of the guide wire and the connecting member 50 are fixed by the fitting portion 60 (tip fitting portion 61) in addition to the welded portion, the welded portion It is connected more firmly than when it is fixed only by. Further, since the fitting portion 60 has a flare shape, the area of the fitting portion 60 can be increased, so that the first core portion 11 and the connecting member 50 are firmly fitted. Further, since it is possible to suppress the concentration of stress on the tip of the connecting member 50 at the time of bending, the guide wire 100 is less likely to be kinked starting from the tip of the connecting member 50.

Further, the base end tapered portion 112a of the guide wire 100 according to the present embodiment is the first connection tapered portion 13a arranged at a position closest to the base end of the first core portion 11 in the long axis direction of the guide wire 100. , A continuous tapered portion 13 including a second connecting tapered portion 13b arranged adjacent to the tip end side of the first connecting tapered portion 13a and having a different inclination angle θ from the first connecting tapered portion 13a, and fitted. Both the portion 60 and the welded portion (tip connection fixing portion 71) may be provided in the first connection taper portion 13a.

With such a configuration, the rigidity of the guide wire 100 changes along the major axis direction of the guide wire 100 at the boundary position between the first connection taper portion 13a and the second connection taper portion 13b forming the continuous taper portion 13. As a result, the radius of curvature of the guide wire 100 when passing through the curved portion of the blood vessel becomes small, so that the contact area between the guide wire 100 and the inner surface of the blood vessel can be reduced. Therefore, the guide wire 100 improves the passability in the curved portion of the blood vessel and reduces the load applied to the blood vessel. Further, the guide wire 100 may have a step corresponding to the wall thickness t of the connecting member 50 at the end of the connecting member 50 because the chance that the end of the connecting member 50 comes into contact with the inner surface of the blood vessel is reduced. However, damage to blood vessels can be suppressed.

Further, in the guide wire 100 according to the present embodiment, the inclination angle θ2 of the second connection taper portion may be larger than the inclination angle θ1 of the first connection taper portion in the continuous taper portion.

With such a configuration, the guide wire 100 can provide a rigidity change point due to the continuous taper portion 13 while reducing the change in rigidity of the first connection portion 11a along the major axis direction.

Further, in the guide wire 100 according to the present embodiment, the length of the first connection taper portion in the major axis direction may be longer than the length of the second connection tapered portion in the major axis direction in the continuous taper portion.

With such a configuration, the guide wire 100 has a long length of the first connecting tapered portion 13a arranged in the lumen 51 of the connecting member 50, and a length from the tip of the connecting member 50 to the first outer diameter constant portion 11b. Can be shortened. As a result, the guide wire 100 suppresses a decrease in local rigidity, a decrease in support for the catheter, and a decrease in pushability. Further, since the guide wire 100 reduces the possibility of plastic deformation or breakage of the connecting member 50 when the first core portion 11 and the connecting member 50 are fitted, the straightness is increased and the torque transmission property is improved. .. Further, the guide wire 100 has a longer portion of the first core portion 11 covered with the second covering layer 42, so that the passageability in the blood vessel is improved.

Hereinafter, the present invention will be specifically described with reference to Examples, but the scope of the present invention is not limited to the following Examples.

[Manufacturing of guide wire]
The guide wire 100 of Example 1 was manufactured as follows. As for the manufacturing process, steps 1 to 3 in the above-mentioned manufacturing method of the guide wire 100 were carried out.

The first core portion 11 of the guide wire 100 of Example 1 was formed by processing a metal wire made of a Ni—Ti alloy. The first connection portion 11a of the first core portion 11 is formed so as to have a proximal end connection outer diameter constant portion 111a and a proximal end taper portion 112a. The base end tapered portion 112a is formed into a single tapered portion having only the first connecting tapered portion 13a. The outer diameter d1 of the base end connection outer diameter constant portion 111a was 0.22 mm, and the outer diameter of the tip of the base end taper portion 112a (the outer diameter d2 of the tip of the first connection taper portion 13a) was 0.340 mm. The length L1 of the base end connection outer diameter constant portion 111a was 15 mm, and the length of the base end taper portion 112a (the length L2 of the first connection taper portion 13a) was 80 mm. The inclination angle θ of the base end taper portion 112a (inclination angle θ1 of the first connection taper portion 13a) was 0.04 °.

As the connecting member 50, a pipe made of Ni—Ti alloy having an outer diameter of 0.350 mm, an inner diameter of 0.255 m, a wall thickness of t0.048 mm, and a length of 35 mm was used.

In step 1, the tester holds the first core portion 11 and the connecting member 50 in his / her hand, and from the tip end side of the connecting member 50, the base end connecting outer diameter constant portion 111a and the first core portion 11 of the first core portion 11 The first core portion 11 and the connecting member 50 were fitted by inserting a part of the base end tapered portion 112a and pushing it strongly.

In step 2, the tester mechanically fitted the first core portion 11 fitted in step 1 and the connecting member 50 using a fitting machine. The tip of the connecting member 50 of the mechanically fitted guide wire 100 is formed with a flare-shaped tip fitting 61 that extends radially outward along the outer surface of the proximal tapered portion 112a.

In step 3, a laser irradiation device was used, and the laser irradiation point P was set at a position where the distance S in the long axis direction from the tip of the connecting member 50 to the laser irradiation point P was 2.5 mm, and laser irradiation was performed. Next, the tester set the laser irradiation point P at a position rotated by 180 ° in the circumferential direction of the first core portion 11 from the first laser irradiation point P, and irradiated the laser. The voltage value at the time of laser irradiation was 280 V, and the pulse width was 1.0 ms. The radius of the welded portion (tip connection fixing portion 71) formed by laser irradiation was 0.13 mm.

In the guide wires 100 of Examples 2 to 4, in step 3 of Example 1, the distance S in the long axis direction from the tip of the connecting member 50 to the laser irradiation point P is set to the value shown in Table 1, respectively. It was manufactured in the same manner as the guide wire 100 of Example 1 except that the guide wire 100 was used.

In the guide wire 100 of the fifth embodiment, the length of the base end tapered portion 112a in the guide wire 100 of the first embodiment is 15 mm, the inclination angle θ is 0.23 °, and the laser irradiation point is applied from the tip of the connecting member 50 in the step 3. It was manufactured in the same manner as the guide wire 100 of the first embodiment except that the distance S in the long axis direction to P was set to the value shown in Table 1.

For the guide wires of Comparative Examples 1 to 7, except that the distance S in the long axis direction from the tip of the connecting member to the laser irradiation point P was set to the value shown in Table 1 in step 3 of Example 1. Was manufactured in the same manner as the guide wire 100 of Example 1.

In the guide wires of Comparative Examples 8 to 12, the length of the base end tapered portion in the guide wire 100 of Example 1 is 15 mm, the inclination angle θ is 0.23 °, and laser irradiation is performed from the tip of the connecting member in step 3. It was manufactured in the same manner as the guide wire 100 of the first embodiment except that the distance S in the long axis direction to the point P was set to the value shown in Table 1, respectively.

As the guide wire of Comparative Example 13, a conventional guide wire in which the first core portion made of Ni—Ti alloy and the connecting member made of Ni—Ti alloy were connected was used. The first core portion of the guide wire of Comparative Example 13 had a first connecting portion composed of a base end tapered portion. The base end taper portion was a single taper portion composed of only the first connection taper portion. The outer diameter of the base end of the base end taper portion (outer diameter d1 of the constant base end connection outer diameter portion) is 0.232 mm, and the outer diameter of the tip of the base end taper portion (outer diameter d2 of the tip of the first connection taper portion). Was 0.347 mm. The length of the base end tapered portion (length L2 of the first connecting tapered portion 13a) was 9 mm. The inclination angle θ of the base end taper portion (inclination angle θ1 of the first connection taper portion 13a) was 0.38 °. Further, the tip connection fixing portion of the guide wire of Comparative Example 13 was a welded portion by laser irradiation. The welded portions of the guide wire of Comparative Example 13 were formed at four locations of 0.19 mm, 0.48 mm, 0.68 mm, and 0.97 mm from the tip of the connecting member to the proximal end side in the long axis direction. The radius of the welded portion (tip connection fixing portion 71) of the guide wire of Comparative Example 1 was 0.15 mm. As a result, the distances S in the long axis direction from the tip of the connecting member to the laser irradiation point P are 0.34 mm, 0.63 mm, 0.83 mm, and 1.12 mm.

[Test 1]
Test 1 is a test for confirming the appearance of the welded portion between the first core portion and the connecting member of the guide wires 100 of Examples 1 to 5 and the guide wires of Comparative Examples 1 to 13. As for the appearance of the guide wire, the presence or absence of an appearance defect in the welded portion was visually confirmed, and the appearance defect occurrence rate, which is the ratio of the appearance defect to the guide wire 100 subjected to the test 1, was determined.

[Test 2]
Test 2 is a test for confirming the connection strength between the guide wires 100 of Examples 1 to 5 and the guide wires of Comparative Examples 1 to 12. The connection strength was set to the maximum stress (kgf) when the guide wire 100 of Example 1 and the guide wires of Comparative Example 1 and Comparative Example 2 were broken when the tensile test was performed using the autograph. The tensile test was carried out under the conditions of a span of 400 mm and a speed of 0.5 mm / min.

The distance S in the long axis direction from the tip of the connecting member to the laser irradiation point P of the guide wires 100 of Examples 1 to 5 and the guide wires of Comparative Examples 1 to 13 and the first at the laser irradiation point P. The radial distance H between the outer surface of the connection taper portion (base end taper portion) and the inner surface of the connection member, the outer surface of the first connection taper portion (base end taper portion) and the connection member with respect to the wall thickness t of the connection member. Table 1 shows the ratio r of the radial distance H from the inner surface, the appearance defect occurrence rate, and the connection strength.

[result]
As shown in Table 1, the guide wires 100 of Examples 1 to 5 had a low appearance defect occurrence rate and a high connection strength. The guide wires 100 of Examples 1 to 5 include the outer surface of the proximal end tapered portion (first connecting tapered portion 13a) with respect to the wall thickness t of the connecting member 50 at the laser irradiation point P, and the inner surface of the connecting member 50. The ratio r of the radial distance H was in the range of 0.01 or more and 0.05 or less. On the other hand, the guide wires of Comparative Examples 1 to 4 having a ratio r smaller than 0.01 had high connection strength, but had a poor appearance due to blow holes in the welded portion. Further, the guide wires of Comparative Examples 5 to 12 having a ratio r larger than 0.05 caused an appearance defect due to a dent in the welded portion, and the connection strength was also lower than that of the guide wires 100 of Examples 1 to 5. ..

Further, in the guide wire of Comparative Example 13, the ratio r was larger than 0.05 in any of the welded portions, and the welded portion had a poor appearance due to a dent.

From the above, the ratio r of the radial distance H between the outer surface of the first connection taper portion 13a and the inner surface of the connection member 50 with respect to the wall thickness t of the connection member 50 at the laser irradiation point P is 0.01 or more and 0.05. In the guide wire 100 of Examples 1 to 5, which has the following range, particularly 0.010 or more and 0.034 or less, the welded portion is between the outer surface of the base end tapered portion 112a and the inner surface of the connecting member. It was confirmed that the outer surface of the welded portion between the first core portion 11 and the connecting member 50 is smooth and the connection strength is high because the distance between the first core portion 11 and the connecting member 50 is formed at an appropriate position.

10 core members,
11 1st core part (11a 1st connection part, 11b 1st outer diameter constant part, 11c 1st taper part, 11d 2nd outer diameter constant part, 11e 2nd taper part, 11f transition part, 11g flat plate part, 111a group End connection outer diameter constant part, 112a base end taper part),
12 2nd core part (12a base part, 12b 2nd connection part, 121b tip connection outer diameter constant part, 122b tip taper part),
13 Continuous taper part (13a first connection taper part, 13b second connection taper part),
14 Extension,
20 luminal body,
21 1st coil,
22 Second coil,
30 Fixed part,
31 Tip fixing part,
32 Intermediate fixing part,
33 Base end fixing part,
40 coating layer,
41 First coating layer,
42 Second coating layer,
43 Third coating layer,
50 Connection member,
51 lumen,
60 Fitting part,
61 Tip fitting part,
62 Base end fitting part,
70 Connection fixing part,
71 Tip connection fixing part,
72 Base end connection fixing part,
100 Guide wire C Central axis.

Claims (5)

A guide wire connecting the base end portion of the first core portion and the tip end portion of the second core portion arranged on the base end side of the first core portion with a tubular connecting member.
The proximal end portion of the first core portion has a proximal end tapered portion whose outer diameter gradually decreases toward the proximal end.
The connection fixing portion for fixing the proximal end tapered portion and the connecting member is a welded portion in which the proximal end tapered portion and the connecting member are welded together.
The center of the welded portion is provided at a position where the ratio of the radial distance between the outer surface of the base end tapered portion and the inner surface of the connecting member to the wall thickness of the connecting member is 0.01 or more and 0.05 or less. Guide wire. The first core portion has a fitting portion that fits by contacting the outer surface of the base end tapered portion with the inner surface of the end portion of the connecting member.
The guide wire according to claim 1, wherein the fitting portion has a flare shape in which the connecting member extends radially outward along the outer surface of the proximal end tapered portion. The base end taper portion is adjacent to a first connection taper portion arranged at a position closest to the base end of the first core portion in the long axis direction of the guide wire and the tip end side of the first connection taper portion. It has a continuous tapered portion including a second connecting tapered portion having an inclination angle different from that of the first connecting tapered portion.
The guide wire according to claim 1 or 2, wherein both the fitting portion and the welded portion are provided on the first connecting tapered portion. The guide wire according to claim 3, wherein in the continuous taper portion, the inclination angle of the second connection taper portion is larger than the inclination angle of the first connection taper portion. The guide wire according to claim 3 or 4, wherein in the continuous tapered portion, the length of the first connecting tapered portion in the major axis direction is longer than the length of the second connecting tapered portion in the major axis direction.

Images