JP2023180260A - guide wire - Google Patents

Abstract

To provide a guide wire in which a core part on a tip side and a core part on a base end side are connected by a tubular connection member, the guide wire capable of improving passage properties in a curved part of a blood vessel and suppressing a load applied to the blood vessel and damage to the blood vessel.SOLUTION: A guide wire comprises a continuous taper part 13 having: a first connection taper part 13a which is configured so that at least one of a base end taper part 112 on a first core part 11 and a tip taper part 122b of a second core part 12 is arranged closest to a base end of the first core part 11 or a tip of the second core prat 12 in a longitudinal axis direction: and a second connection taper part 13b which is arranged adjacent to a far side from the base end of the first core part 11 or the tip of the second core part 12 with respect to the first connection taper part 13a, and has an inclination angle θ different from an inclination angle of the first connection taper part 13a. The continuous taper part 13 has a fitting part 60 where an outer surface of the first connection taper part 13a and an inner surface of an end of a connection member 50 are fitted.SELECTED DRAWING: Figure 3

Description

TECHNICAL FIELD The present invention relates to guidewires.

A guide wire is a medical device used to guide various catheters to treat a stenosis occurring within a blood vessel.

Guidewires must navigate complex curves and bifurcations in blood vessels and pass through stenoses. Therefore, the guide wire has low bending rigidity on the side where it is inserted into the blood vessel (distal side) to improve vessel selectivity and safety, and the side where the surgeon operates it (proximal side) has low bending rigidity and torque. High bending rigidity is required to ensure transferability. Therefore, a guide wire is known that uses a core member in which metal core parts having different outer diameters and material properties are connected so that the distal end side and the proximal end side have different characteristics.

Patent Document 1 below discloses that the distal core section and the proximal core section are connected by inserting small diameter sections provided in the distal core section and the proximal core section into the inner cavity of a tubular connecting member. A guidewire is disclosed that connects a portion of the guidewire.

WO2006/002199 publication

When the guide wire passes through the curved portion of the blood vessel, the guide wire curves so as to be pressed against the inner wall outside the curved portion of the blood vessel, and moves while coming into contact with the inner surface of the blood vessel. At this time, if the radius of curvature of the curved guide wire is large, the contact area between the guide wire and the inner surface of the blood vessel becomes large. Therefore, the guidewire has reduced passageability at the curved portion of the blood vessel and an increased load on the blood vessel. In particular, in a guidewire using a core member in which the core parts are connected to each other by a tubular connecting member, if the end of the connecting member has a step corresponding to the wall thickness of the connecting member, the end of the connecting member may be inserted into the blood vessel. Contact with surfaces may damage blood vessels.

At least one embodiment of the present invention has been made in view of the above-mentioned circumstances, and specifically relates to a guide wire in which a core portion on the distal side and a core portion on the proximal side are connected by a tubular connecting member. Another object of the present invention is to provide a guide wire that has improved passage through curved portions of blood vessels and can suppress load on blood vessels and damage to blood vessels.

The guide wire according to the present embodiment is a guide in which a proximal end of a first core part and a distal end part of a second core part disposed on the proximal side of the first core part are connected by a tubular connecting member. In the wire, the proximal end of the first core part has a proximal tapered part whose outer diameter gradually decreases toward the proximal end, and the distal end of the second core part has an outer diameter that gradually decreases toward the distal end. has a distal tapered portion that gradually decreases, and at least one of the proximal tapered portion and the distal tapered portion is located at the proximal end of the first core portion or the second core portion in the longitudinal direction of the guide wire. a first connecting tapered portion disposed closest to the distal end of the connecting tapered portion; and a first connecting tapered portion disposed adjacent to the proximal end of the first core portion or a side far from the distal end of the second core portion with respect to the first connecting tapered portion. , a continuous taper section including a second connection taper section having an inclination angle different from that of the first connection taper section, the continuous taper section connecting the outer surface of the first connection taper section and the end of the connection member. It has a fitting part that fits with the inner surface of the part.

According to one embodiment of the present invention, the stiffness of the guide wire along the longitudinal direction of the guide wire changes at a boundary position between the first connecting taper part and the second connecting taper part that form the continuous taper part. This reduces the radius of curvature of the guidewire when it passes through the curved portion of the blood vessel, so the contact area between the guidewire and the inner surface of the blood vessel can be reduced. Therefore, the guidewire has improved passage through the curved portion of the blood vessel, and the load on the blood vessel is reduced. In addition, the guide wire reduces the chance that the end of the connecting member comes into contact with the inner surface of the blood vessel, so even if the end of the connecting member has a step corresponding to the wall thickness of the connecting member, Damage can be suppressed.

FIG. 1 is a schematic plan view of a guide wire according to the present embodiment. FIG. 2 is a partial cross-sectional view of the guide wire according to the present embodiment in the longitudinal direction when viewed from the thickness direction. FIG. 3 is a schematic cross-sectional view of the vicinity of the connecting member of the guide wire according to the present embodiment. FIG. 2 is a schematic partial cross-sectional view of a connecting portion between a first core portion and a connecting member of the guide wire according to the present embodiment. FIG. 3 is a schematic partial cross-sectional view of a connecting portion between a second core portion and a connecting member of the guide wire according to the present embodiment. FIG. 3 is a diagram schematically showing an example of the curved shape of the guide wire when the guide wire is inserted into the passage of the test instrument.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown here are exemplified to embody the technical idea of the present invention, and are not intended to limit the present invention. In addition, all other possible embodiments, 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 within the scope and gist of the present invention, and are described in the claims. inventions and their equivalents.

Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented schematically by changing the scale, vertical/width dimensional ratio, shape, etc. from the actual thing as appropriate, but these are merely examples. However, this does not limit the interpretation of the present invention.

In this specification, for convenience of explanation, the direction when the guide wire 100 is in a natural state (a state in which it is stretched straight without applying any external force) is defined. 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 "radial direction" refers to a direction in which the guide wire 100 moves away from or approaches the core member 10 in an axis-orthogonal cross section (cross section) of the core section with the longitudinal direction of the guide wire 100 as a reference axis. The "circumferential direction" is a rotational direction with the longitudinal direction of the core member 10 as a reference axis. When the tip of the guide wire 100 has the flat plate part 11g, the "thickness direction" is the direction in which the short side of the rectangle in the cross-sectional view of the flat plate part 11g extends (the front and depth directions in the figure). When the tip of the guide wire 100 has the flat plate part 11g, the "width direction" is the direction in which the long side of the rectangle in the cross-sectional view of the flat plate part 11g extends (vertical direction in the figure).

Further, the side where the guide wire 100 is inserted into the blood vessel is referred to as the "distal side," and the side opposite to the distal side (the side gripped by the operator) is referred to as the "proximal side." In addition, the part that includes a certain range along the long axis direction from the tip (the most distal end) is defined as the "distal part," and the part that includes a certain range in the long axis direction from the proximal end (most proximal end) is called the "proximal end part." shall be.

In the following description, when ordinal numbers such as "first" and "second" are used, unless otherwise specified, these are used for convenience and do not define any order.

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

[composition]
As shown in FIG. 1 or 2, the guide wire 100 according to the present embodiment includes an elongated core member 10, a lumen body 20 that covers the distal end of the core member 10, and a lumen body 20 that covers the periphery of the distal end of the core member 10. It has a fixing part 30 that is fixed to the member 10 and a coating layer 40 that covers each member including the core member 10. The guide wire 100 also includes a connecting member 50 that connects the first core part 11 and the second core part 12, and a connecting member 50 that is formed when the first core part 11 or the second core part 12 is connected to the connecting member 50. It has a fitting part 60 and a connection fixing part 70 for increasing the connection strength between the core member 10 and the connection member 50. Each part of the guidewire 100 will be described in detail below.

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

The first core portion 11 is an elongated member that extends along the longitudinal direction toward the distal end of the guide wire 100 . The first core portion 11 includes, in order from the base end to the distal end side of the first core portion 11, a first connecting portion 11a, a first constant outer diameter portion 11b, a first tapered portion 11c, and a second outer diameter portion. It includes a fixed portion 11d, a second tapered portion 11e, a transition portion 11f, and a flat plate portion 11g, and each portion is integrally formed.

The first connecting portion 11a is a portion connected to a second connecting portion 12b of the second core portion 12, which will be described later, via a connecting member 50. The first connecting portion 11a extends a predetermined length from the base end of the first core portion 11 to the base end of the first constant outer diameter portion 11b. The outer diameter of the first connecting portion 11a is smaller than the outer diameter of the first constant outer diameter portion 11b over the entire first connecting portion 11a. The first connecting portion 11a includes, in order from the proximal end to the distal end of the first core portion 11, a proximal connecting outer diameter constant portion 111a and a proximal tapered portion 112a, as shown in FIGS. 3 and 4. . Note that the first connecting portion 11a may have another tapered portion or a constant outer diameter portion in addition to the proximal tapered portion 112a.

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

The proximal tapered portion 112a extends a predetermined length from the distal end of the proximal connection constant outer diameter portion 111a to the proximal end of the first constant outer diameter portion 11b. In the guide wire 100 according to the present embodiment, the proximal tapered portion 112a has a first connecting tapered portion 13a and a second connecting tapered portion 13b in order from the distal end of the proximal connecting constant outer diameter portion 111a toward the distal side. Continuous tapered portions 13 are arranged adjacent to each other in the longitudinal direction. The second connecting tapered portion 13b is disposed adjacent to the first connecting tapered portion 13a on the side far from the base end of the first core portion 11 in the longitudinal direction. The first connecting tapered portion 13a and the second connecting tapered portion 13b have different inclination angles θ. In this specification, "inclination angle θ" refers to the angle formed by the central axis C or an imaginary line parallel to the central axis C and the outer surface of each tapered portion in a longitudinal section passing through the central axis C of the guide wire 100. A corner.

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

The continuous tapered portion 13 functioning as the proximal tapered portion 112a has a stepwise tapered shape in which a plurality of tapered portions having different inclination angles θ are successively arranged in the longitudinal direction. The outer surface of the first connecting tapered portion 13 a forming the continuous tapered portion 13 has a fitting portion 60 in a portion that contacts the inner surface of the tip portion of the connecting member 50 .

The first connecting tapered portion 13a extends a predetermined length from the distal end of the proximal connecting constant outer diameter portion 111a to the proximal end of the second connecting tapered portion 13b. The first connection tapered portion 13a has a tapered shape in which the outer diameter gradually increases from the proximal connection constant outer diameter portion 111a toward the distal end side. The outer diameter of the proximal end of the first connecting tapered portion 13a is equal to the outer diameter d1 of the proximal end connecting constant outer diameter 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 portion of the first connecting tapered portion 13a is inserted into the inner cavity 51 of the connecting member 50. The tapered shape of the first connecting tapered portion 13a can be formed by mechanically polishing the first core portion 11 with a grindstone or etching with an acid.

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

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

The second tapered portion 11e extends a predetermined length from the tip of the second constant outer diameter 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 constant outer diameter portion 11d toward the transition portion 11f. The tapered shape of the second tapered portion 11e can be formed by mechanically grinding the first core portion 11 with a 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 type of cold working. The cross-sectional shape of the transition part 11f in a plane view (cross-sectional view) orthogonal to the long axis direction is a circle with an outer diameter approximately equal to that of the second tapered part 11e on the proximal end side, but from the proximal end side It gradually deforms from a circular shape to a rectangular shape as it goes toward the distal end side, and forms a rectangular shape that is approximately the same shape as the flat plate portion 11g at the distal end side. The distal end portion of the transition portion 11f has approximately the same thickness and width as the base end portion of the flat plate portion 11g, and forms a continuous surface with the flat plate portion 11g. Note that the "thickness" of the flat plate part 11g is the length of the short side of the rectangle in a cross-sectional view of the flat plate part 11g, and the "width" of the flat plate part 11g is the length of the long side of the rectangle in the cross-sectional view of the flat plate part 11g. Satoru.

The flat plate portion 11g extends a predetermined length from the tip of the transition portion 11f to the tip of the guide wire 100. 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 approximately 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 when viewed from the thickness direction is formed into a rectangular shape with a rounded tip. Therefore, the width of the flat plate portion 11g is approximately constant from the tip to the tip side of the transition portion 11f, but becomes smaller in the rounded portion. Note that 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, but may be a rounded rectangle with rounded corners.

Note that 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 or a constant outer diameter from the distal end to the proximal end.

The second core portion 12 is an elongated member extending from the connecting member 50 toward the proximal end of the guide wire 100 . As shown in FIGS. 3 and 5, the second core section 12 includes an extension section 14, a base section 12a, and a second connection section 12b in this order from the base end to the distal end side of the second core section 12. , each part is integrally formed.

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

The base portion 12a extends a predetermined length from the base end of the second connecting portion 12b to the distal end of the extension portion 14. The outer diameter of the base portion 12a is substantially constant and substantially equal to the outer diameter of the first constant outer diameter 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 a predetermined length from the tip of the second core portion 12 to the tip of the base portion 12a. The outer diameter of the second connecting portion 12b is smaller than the outer diameter of the base portion 12a throughout the second connecting portion 12b. The second connecting portion 12b includes, in order from the distal end of the second core portion 12 toward the proximal end, a distal end connection constant outer diameter portion 121b and a distal tapered portion 122b. In addition to the tip tapered part 122b, the second connecting part 12b may have another tapered part or a constant outer diameter part.

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

The distal end tapered portion 122b extends a predetermined length from the base end of the distal end connection constant outer diameter portion 121b to the distal end of the base portion 12a. The distal end tapered portion 122b has a tapered shape in which the outer diameter gradually increases from the distal end connection constant outer diameter portion 121b toward the proximal end. In the guidewire 100 according to this embodiment, the distal end 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 constant outer diameter portion 121b. The outer diameter of the proximal end of the tapered tip portion 122b is equal to the outer diameter of the base portion 12a. Therefore, only a portion of the tapered tip portion 122b is inserted into the lumen 51 of the connecting member 50, as shown in FIG. Note that the tip tapered portion 122b may be a continuous tapered portion 13. The outer surface of the distal end tapered portion 122b has a fitting portion 60 in a portion that contacts the inner surface of the proximal end portion of the connecting member 50.

The inclination angle θ3 of the tip tapered portion 122b of the second core portion 12 is larger than the inclination angle θ1 of the first connecting tapered portion 13a of the first core portion 11, and the inclination angle θ3 of the second connecting tapered portion 13b of the first core portion 11 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 the first connecting tapered portion 13a of the first core portion 11, and longer than the second connecting tapered portion 13b. The length of the tip tapered portion 122b is 19 mm to 25 mm.

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

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

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 part 11 and the second core part 12 are made of superelastic alloy such as Ni-Ti alloy, SUS302, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS43. 0F etc. It can be made of various metal materials such as stainless steel, piano wire, and cobalt alloys. Moreover, it is preferable that the first core part 11 be formed of a material having lower rigidity than the material of the second core part 12 . As an example, the first core part 11 is made of a Ni-Ti alloy, and the second core part 12 is made of stainless steel. Note that the materials forming the first core part 11 and the second core part 12 are not limited to the above-mentioned examples. Moreover, the first core part 11 and the second core part 12 may be formed of the same material.

<Luminous body>
The lumen body 20 is a member formed by winding a wire rod around the core member 10 in a spiral shape. In this embodiment, the lumen body 20 is formed of a first coil 21 and a second coil 22 disposed on the base end side of the first coil 21. The first coil 21 is arranged from the tip of the first core part 11 to the middle part. The second coil 22 is arranged from the middle part of the first core part 11 to the base end side. Note that 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 part 11 of the core member 10 and is fixed to the first core part 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 with gaps between adjacent wires. The gap between adjacent wire rods of the first coil 21 is 1 μm to 10 μm. It is preferable that the gaps between adjacent wire rods of the first coil 21 be set at equal intervals.

The second coil 22 surrounds the first core part 11 of the core member 10 and is fixed to the first core part 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 part in which the wire rods are tightly wound in a spiral shape so that there are no gaps between adjacent wire rods. Note that the second coil 22 may have a tightly wound portion and a sparsely wound portion in which the wires are loosely wound in a spiral shape so as to have a gap between adjacent wire rods. In the case where the second coil 22 has a loosely wound portion, the closely wound portion of the second coil 22 is located at the distal end and the proximal end of the second coil 22, and the loosely wound portion is located between the closely wound portion on the distal side and the closely wound portion on the proximal end. Located between the windings.

The base end of the first coil 21 and the distal end of the second coil 22 are arranged in contact with each other. Note that the base end of the first coil 21 and the distal end of the second coil 22 may be partially intertwined. In this case, the wire rods at the base end of the first coil 21 and the wire rods at the tip end of the second coil 22 are arranged alternately along the longitudinal direction. This suppresses separation of the first coil 21 and the second coil 22 from each other. The intertwined length of the proximal end of the first coil 21 and the distal end of the second coil 22 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 intertwined.

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 this embodiment, the outer diameter of the wire forming the first coil 21 is larger than the outer diameter of the wire forming the second coil 22. Further, the wire forming the first coil 21 and the second coil 22 may be not only one wire but also a stranded wire consisting of two or more wires.

The wire rods of the first coil 21 and the second coil 22 are not particularly limited, but can be formed of metals such as stainless steel, superelastic alloys, cobalt-based alloys, 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 properties than the second coil 22, and the second coil 22 is made of stainless steel. As the platinum-based alloy, Pt--Ir, Pt--Ni, Pt--W, etc. are preferably used.

It is preferable that the outer diameters of the first coil 21 and the second coil 22 are each constant from the distal end to the proximal end. In this embodiment, the outer diameter of the first coil 21 and the outer diameter of the second coil 22 are approximately equal. Therefore, the outer diameter of the lumen body 20 is substantially constant from the distal end to the proximal end. The outer diameter of the first coil 21 and the second coil 22 is 0.15 mm to 2 mm.

The material forming the wires constituting the first coil 21 and the second coil 22, the outer diameter of the wires, the cross-sectional shape of the wires, the pitch of the wires, etc. can be selected as appropriate depending on the purpose of the guidewire 100. Further, the cross-sectional shape of the wire is preferably circular, but may be oval, polygonal, or the like. The center of the cross-section of a wire whose cross-sectional shape is not circular may be the center of gravity of the cross-section of the wire.

<Fixed part>
The fixing part 30 is a member for fixing the lumen body 20 to the core member 10. In the guidewire 100 according to the present embodiment, the fixing section 30 includes a distal end fixing section 31 that fixes the distal end of the lumen body 20 to the core member 10 , and an intermediate fixing section 31 that fixes the middle part of the lumen body 20 to the core member 10 . portion 32 and a proximal end fixing portion 33 that fixes the proximal end of the lumen body 20 to the core member 10.

The material forming the fixing part 30 is a brazing material or a solder material. Brazing materials include gold solder and silver solder. Examples of the solder material include Sn--Ag alloy solder and Sn--Pb alloy solder. The material forming the fixing part 30 may be an adhesive.

The tip fixing part 31 fixes the tip of the first coil 21 to the flat plate part 11g of the first core part 11. The distal end fixing portion 31 is located at the most distal end of the guide wire 100, and has a smooth, substantially hemispherical outer surface.

The intermediate fixing portion 32 fixes the base end portion of the first coil 21 and the distal 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 in the first core portion 11 at a position where the base end portion of the first coil 21 and the distal end portion of the second coil 22 are in contact with each other.

When the base end of the first coil 21 and the distal end of the second coil 22 are arranged to be partially intertwined, the base end of the first coil 21 and the distal end of the second coil 22 are It may be fixed via the cylindrical member 32a. The cylindrical member 32a is arranged between the inner circumferential surface of the lumen body 20 and the outer circumferential surface of the core member 10. The cylindrical 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 this embodiment, the outer diameter of the distal end of the cylindrical member 32a is smaller than the outer diameter of the proximal end of the cylindrical member 32a. Thereby, 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 distal end of the cylindrical member 32a and the outer diameter of the proximal end of the cylindrical member 32a may be appropriately selected depending on the inner diameter of the first coil 21 and the inner diameter of the second coil 22. The cylindrical member 32a can be made of metal or resin material.

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

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

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

The second coating layer 42 covers a portion of the first core portion 11 located closer to the proximal end than the lumen body 20 . The second coating layer 42 covers the outer surface of the base end portion (first tapered portion 11c, first constant outer diameter 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 coating layer 40. Note that the coating layer 40 can also be provided on a portion not covered with the coating layer 40.

The first coating layer 41 can be formed of a low friction material. Examples of low friction materials include hydrophilic polymers and silicone resins. The hydrophilic polymer forming the first coating layer 41 may be a cellulose-based polymer material, a polyethylene oxide-based polymer material, or a maleic anhydride-based polymer material (for example, a maleic anhydride polymer such as a methyl vinyl ether-maleic anhydride copolymer). Examples include acid copolymers), acrylamide-based polymers (eg, polyacrylamide, glycidyl methacrylate-dimethylacrylamide block copolymers), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone, and derivatives thereof.

The second coating layer 42 and the third coating layer 43 can be formed from a low-friction material. Examples of low-friction materials include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyesters (PET, PBT, etc.), polyamides, polyimides, polyurethanes, polystyrene, polycarbonates, silicone resins, fluororesins (PTFE, ETFE, etc.), or these. Composite materials include:

Note that the materials for forming the first covering layer 41, the second covering layer 42, and the third covering layer 43 are not limited to the above. The first covering layer 41, the second covering layer 42, and the third covering layer 43 may be formed of different materials along the longitudinal direction of the core member 10, respectively. For example, in the first coating layer 41, the distal end of the first core portion 10 is formed of silicone resin, and the proximal end of the first core portion 10 is formed of hydrophilic polymer. Moreover, the number of layers of each of the first coating layer 41, the second coating layer 42, and the third coating layer 43 may be plural. Note that any one of the first coating layer 41, the second coating layer 42, and the third coating layer 43 may not be provided.

<Connection member>
The connecting member 50 is a member that connects the base end portion of the first core portion 11 and the distal 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 into the connecting member 50 by inserting and pushing the proximal end side of the proximal tapered portion 112a of the first connecting portion 11a into the inner cavity 51 from the distal end of the connecting member 50. The second core part 12 is fitted into the connecting member 50 by inserting and pushing the distal end side of the distal end tapered part 122b of the second connecting part 12b into the inner cavity 51 from the base end of the connecting member 50. Thereby, the connecting member 50 can connect the first core part 11 and the second core part 12. In a state where the first core part 11 and the second core part 12 are connected via the connecting member 50, the base end of the first core part 11 (base end connection constant outer diameter part 111a) and the distal end of the second core part 12 (Tip connection constant outer diameter portion 121b) is spaced apart within the inner cavity 51 of the connection member 50.

Before fitting, the outer diameter of the connecting member 50 is approximately constant from the distal end to the proximal end of the connecting member 50, and is 0.3 mm to 0.8 mm. The inner diameter of the connecting member 50 is approximately constant from the distal end to the proximal end 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 connection member 50 include superelastic alloys such as stainless steel, Ni-Cr alloy, Ni-Ti alloy, Ni-Al alloy, and Cu-Zn alloy. The metal forming the connecting member 50 is preferably a superelastic alloy, and more preferably a Ni--Ti alloy. Thereby, the guide wire 100 is less likely to kink at the position of the connecting member 50. Further, by forming the connecting member 50 with the same type of 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 that is a contact portion between the proximal end of the first core portion 11 and the distal end of the connecting member 50, and a distal fitting portion 61 that is a contact portion between the proximal end of the first core portion 11 and the distal end of the connecting member 50, and a contact portion between the distal end of the second core portion 12 and the proximal end of the connecting member 50. It has a proximal end fitting part 62 which is a contact part with the part. 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 is formed when the first core portion 11 and the connecting member 50 and the second To strengthen the connection between the core part 12 and the connecting member 50.

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

It is preferable that the tip fitting portion 61 has a flared shape in which the connecting member 50 spreads outward in the radial direction so that the connecting member 50 follows the outer surface of the first connecting tapered portion 13a. When the first core part 11 and the connecting member 50 are fitted together, the distal end of the connecting member 50 is pushed into the inner cavity 51 of the connecting member 50, so that the connecting member 50 is connected to the first connecting member 50. The tapered portion 13a has a flared shape that spreads outward in the radial direction along the outer surface of the tapered portion 13a. Therefore, the inner diameter and outer diameter of the connecting member 50 at the tip fitting portion 61 are larger than the connecting member 50 before fitting. When the distal end of the connecting member 50 is not flared, only the inner surface of the distal end of the connecting member 50 contacts the outer surface of the first connecting tapered portion 13a. Therefore, the tip fitting portion 61 is formed only in a small area near the tip of the connecting member 50. When the distal end of the connecting member 50 is flared, the area of the distal end fitting portion 61 is larger than when the distal end of the connecting member 50 is not flared. Therefore, by forming the tip fitting portion 61 into a flared shape, the first core portion 11 and the connecting member 50 are firmly fitted. Furthermore, by forming the tip fitting portion 61 into a flared shape, the guide wire 100 can suppress stress concentration at the tip of the connecting member 50 when bent, so that kinking starting from the tip of the connecting member 50 is less likely to occur. Become. On the other hand, when the first core part 11 and the connecting member 50 are fitted together, if the first core part 11 is pushed too far into the inner cavity 51 of the connecting member 50, the distal end of the connecting member 50 cannot withstand the deformation and is damaged. do. Therefore, the length of the tip fitting portion 61 in the longitudinal direction is preferably 0.1 mm to 3.0 mm.

When the first core part 11 and the connecting member 50 are fitted together, the inner cavity 51 of the connecting member 50 includes a portion of the proximal end connecting outer diameter constant part 111a and the first connecting tapered part 13a of the first core part 11. is placed. Since the first connecting portion 11a of the first core portion 11 has the proximal connection constant outer diameter portion 111a, the length of the first core portion 11 disposed in the inner cavity 51 of the connecting member 50 is 11a is longer than when it is formed of only the proximal tapered portion 112a. Thereby, the separation distance between the first core part 11 and the second core part 12 in the inner cavity 51 of the connecting member 50 can be shortened, so that the core member 10 can be separated from the first core part 11 in the inner cavity 51 of the connecting member 50. It is possible to suppress a local decrease in rigidity in 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 part 12 and the connecting member 50 are connected by inserting a part of the tip connecting outer diameter constant part 121b and the tip tapered part 122b of the second core part 12 into the inner cavity 51 of the connecting member 50. After bringing the proximal end of the connecting member 50 into contact, a predetermined fitting pressure is applied to push the second core portion 12 into the inner cavity 51 of the connecting member 50, thereby fitting the second core portion 12 into the inner cavity 51 of the connecting member 50. As a result, a proximal end fitting portion 62 is formed at a portion where the outer surface of the distal end 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.

Also in the fitting between the second core part 12 and the connecting member 50, by making the proximal end of the connecting member 50 into a flared shape, the same effect as in the fitting between the first core part 11 and the connecting member 50 described above can be obtained. is obtained. The length of the proximal end fitting portion 62 in the longitudinal direction is 0.1 mm to 3.0 mm.

When the second core portion 12 and the connecting member 50 are fitted together, a portion of the constant outer diameter portion 121b and the tapered tip portion 122b of the second core portion 12 are disposed in the inner cavity 51 of the connecting member 50. Ru. Since the second connecting portion 12b of the second core portion 12 has the tip connection constant outer diameter portion 121b, the length of the second core portion 12 disposed in the inner cavity 51 of the connecting member 50 is is longer than when it is formed only by the tip tapered portion 122b. Thereby, the separation distance between the first core part 11 and the second core part 12 in the inner cavity 51 of the connecting member 50 can be shortened, so that the core member 10 can be separated from the first core part 11 in the inner cavity 51 of the connecting member 50. It is possible to suppress a local decrease in rigidity in a portion separated from the second core portion 12.

The fitting between the first core part 11 and the connecting member 50 and the fitting between the second core part 12 and the connecting member 50 are performed by mechanical fitting using a fitting machine. Mechanical fitting by a fitting machine may be performed with a constant fitting pressure (pushing force) or may be varied in steps. Note that the fitting between the first core portion 11 and the connecting member 50 and the fitting between the second core portion 12 and the connecting member 50 may be performed manually, and the fitting between the first core portion 11 and the connecting member 50 may be performed manually. May be used together.

<Connection fixing part>
The core member 10 and the connection member 50 are fixed by a connection fixing part 70. The connection fixing section 70 includes a distal end connection fixing section 71 that fixes the distal end of the connecting member 50 to the first core section 11 , and a proximal end connecting fixing section 72 that fixes the proximal end of the connecting member 50 to the second core section 12 . and has.

The tip connection fixing part 71 fixes the tip of the connection member 50 to the first connection tapered part 13a of the first core part 11. By providing the tip connection fixing portion 71 in addition to the tip fitting portion 61, the first core portion 11 and the connecting member 50 can be firmly connected. The distal end connection fixing portion 71 is provided at a position spaced from the distal end fitting portion 61 toward the proximal end in the longitudinal direction. As a result, the first core portion 11 and the connecting member 50 are fixed at two locations, the tip fitting portion 61 and the tip connection fixing portion 71, when viewed along the longitudinal direction. and the connecting member 50 can be more firmly connected. It is preferable that two tip connection fixing portions 71 be provided at positions facing each other in the radial direction of the connection member 50.

It is preferable that the tip connection fixing part 71 is a welded part formed by laser welding. Since laser welding can fix the connecting member 50 and the first connecting tapered portion 13a without changing the outer diameter of the connecting member 50, the influence of the tip connecting fixing portion 71 on the function of the guide wire 100 can be reduced. The welded portion is approximately circular with a radius of 0.05 mm to 0.40 mm centered on the laser irradiation point P.

The outer surface of the first connecting tapered portion 13a and the inner surface of the connecting member 50 are preferably separated from each other in the radial direction on the distal end side and the proximal end side of the distal end connecting fixing portion 71. In laser welding, metals to be welded are irradiated with a predetermined laser beam to melt and solidify the metals, thereby connecting the materials to be welded together. Therefore, when the tip connection fixing part 71 is provided at the tip fitting part 61 between the first core part 11 and the connection member 50 or at a position adjacent to the tip fitting part 61, the tip connection fixing part 71 If the distance in the radial direction is too short, the gas generated when the metal melts will remain in the tip connection fixing part 71, making blowholes, pits, cracks, etc. likely to occur. As a result, the outer surface of the tip connection fixing part 71 becomes uneven, resulting in poor appearance and insufficient fixing strength. Since the outer diameter of the first connecting tapered portion 13a gradually decreases toward the proximal end, the radial distance between the first core portion 11 and the connecting member 50 increases from the distal end of the connecting member 50 to the proximal end. It gets longer as you go. Therefore, if the tip connection fixing part 71 is provided at a position apart from the tip of the connection member 50 by a predetermined distance or more, the radial distance between the first core part 11 and the connection member 50 is too long, and the molten metal spreads into the space between the first core portion 11 and the connecting member 50, and the outer surface tends to become depressed. As a result, the distal end connection fixing portion 71 has a poor appearance. Furthermore, since the contact area between the first core part 11 and the connecting member 50 and the molten metal becomes small, the strength of the fixing of the tip connection fixing part 71 becomes insufficient.

In the guide wire 100 according to the present embodiment, the distal end connection fixing section 71 is arranged so that the outer surface of the first connecting tapered section 13a and the inner surface of the connecting member 50 are arranged in a radial direction on the distal side and the proximal end side of the distal end connection fixing section 71. It is located at a distance from the Therefore, the gas generated when the metal melts can escape from the distal end side and the proximal end side of the distal end connection fixing part 71, making it difficult for blowholes, pits, cracks, etc. to occur. Further, since the molten metal spreads appropriately 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 is obtained.

In this way, the distal end connection fixing part 71 is located at a position where the outer surface of the first connecting tapered part 13a and the inner surface of the connecting member 50 are separated from each other in the radial direction on the distal end side and the proximal end side of the distal end connection fixing part 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 2.5 mm to 4.0 mm from the distal end of the connecting member 50 to the proximal end side in the longitudinal direction. As a result, the distal end connection fixing portion 71 (welded portion) is formed in a range of 2.0 mm to 4.5 mm from the distal end of the connecting member 50 toward the proximal end in the longitudinal direction. Further, the radial distance H between the outer surface of the first connecting tapered portion 13a and the inner surface of the connecting member 50 at the laser irradiation point P for forming the tip connecting fixing portion 71 is 0.0005 mm to 0.0017 mm. It is preferable that there be. As a result, the tip connection fixing portion 71 (welded portion) is formed such that the radial distance between the outer surface of the first connection tapered portion 13a and the inner surface of the connection member 50 is 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 of the radial distance H between the outer surface of the first connecting tapered portion 13a and the inner surface of the connecting member 50 to the wall thickness t of the connecting member 50 at the laser irradiation point P (r=H/t) is 0. It is preferably 0.01 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 weld is preferably provided at a position where the ratio r is 0.01 or more and 0.05 or less, more preferably 0.010 or more and 0.034 or less. When the ratio r is greater than or equal to the lower limit, gas generated when the metal melts can escape from the tip connection fixing portion 71, making it difficult for blowholes, pits, cracks, etc. to occur. Become. Further, since the ratio r is below the upper limit value, the amount of metal melted by laser irradiation in the tip connection fixing part 71 is sufficient for the volume of the space between the first core part 11 and the connection member 50, The outer surface is less prone to dents. Further, since the contact area between the first core portion 11 and the connecting member 50 and the molten metal is increased, the fixing strength of the tip connection fixing portion 71 is improved. By setting the ratio r within the above range, the distal end portion of the connecting member 50 can be firmly connected to the first core portion 11 and can have a smooth outer surface with small irregularities.

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

The proximal connection fixing part 72 is disposed adjacent to the proximal side of the proximal fitting part 62 between the second core part 12 and the connecting member 50, and extends outward from the proximal end of the connecting member 50 toward the proximal 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 is reduced, so that damage to the tip of the catheter can be suppressed when the catheter is inserted from the proximal end side of the guide wire 100. . The tapered shape of the proximal 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 adjacent to the first connection taper part 13a on the proximal tapered part 112a of the first core part 11 and the distal end side of the first connection taper part 13a. It has a continuous taper part 13 that is made up of a second connection taper part 13b having an inclination angle θ different from that of the taper part 13a. As a result, a stiffness change point where the stiffness along the longitudinal direction of the guide wire 100 changes is formed at the boundary position between the first connection taper part 13a and the second connection taper part 13b forming the continuous taper part 13. In the guide wire 100, a portion of the continuous tapered portion 13 on the proximal end side of the first connecting tapered portion 13a is disposed in the lumen 51 of the connecting member 50, and the second connecting tapered portion 13b is disposed in the lumen of the connecting member 50. 51. Therefore, the stiffness change point is located at a position closer to the distal end of the guide wire 100 than the distal end of the connecting member 50.

When the guide wire 100 having such a configuration is bent, the radius of curvature from the point of change in rigidity due to the continuous tapered portion 13 to the tip of the connecting member 50 becomes smaller. Therefore, the guidewire 100 that has a stiffness change point on the distal side of the distal end of the connecting member 50 due to the continuous tapered part 13 is more effective when passing through a curved part of a blood vessel, compared to the guidewire 100 that does not have the continuous tapered part 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 has improved passage through the curved portion of the blood vessel, and the load on the blood vessel is reduced. Even if the guide wire 100 has a step corresponding to the wall thickness t of the connecting member 50 at the end of the connecting member 50, the chances of the end of the connecting member 50 coming into contact with the inner surface of the blood vessel are reduced. , can suppress damage to 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 disposed at the proximal tapered portion 112a of the first core portion 11. Superelastic alloys are less likely to undergo plastic deformation. By arranging the continuous tapered part 13 in the first core part 11 made of a superelastic alloy, the guide wire 100 can be easily operated even when the radius of curvature from the point of change in rigidity due to the continuous tapered part 13 to the tip of the connecting member 50 becomes small. , hard to lead to kink.

In the first core portion 11, the inclination angle θ1 of the first connecting tapered portion 13a that fits into the connecting member 50 is preferably 0.01°<θ1<0.05°. A portion of the first connecting tapered portion 13 a on the proximal end side is disposed in the inner cavity 51 of the connecting member 50 . As the inclination angle θ1 of the first connecting tapered portion 13a decreases, the length of the first connecting tapered portion 13a disposed in the inner cavity 51 of the connecting member 50 becomes longer. Therefore, by making the inclination angle θ1 smaller than a predetermined angle, the first connecting tapered portion 13a can shorten the separation distance between the first core portion 11 and the second core portion 12 in the inner cavity 51 of the connecting member 50. . Thereby, the guide wire 100 can suppress a local decrease in rigidity in the portion of the inner cavity 51 of the connecting member 50 where the first core portion 11 and the second core portion 12 are separated.

When the first core portion 11 and the connecting member 50 are fitted together, the portion of the first connecting portion 11a disposed in the inner cavity 51 of the connecting member 50 has a function of supporting the connecting member 50. Therefore, by increasing the length of the first connecting tapered portion 13a disposed in the inner cavity 51 of the connecting member 50, the connecting member 50 is less likely to be bent due to fitting pressure, and plastic deformation is prevented. It can be suppressed. As a result, the guide wire 100 has high straightness and improves torque transmittance. Moreover, since it becomes possible to fit the first core part 11 and the connecting member 50 with high fitting pressure, the first core part 11 and the connecting member 50 can be fitted more firmly.

Furthermore, by making the inclination angle θ1 smaller than the upper limit value, the first connecting tapered portion 13a is configured such that the distance between the outer surface of the first connecting tapered portion 13a and the inner surface of the connecting member 50 at the distal end portion of the connecting member 50 is reduced. The distance becomes shorter. Thereby, the leading end 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 connecting tapered portion 13a is smaller than the upper limit value, the tip of the connecting member 50 easily deforms into a shape that follows the outer surface of the first connecting tapered portion 13a when mating. Therefore, it becomes easier to form the flared tip fitting portion 61. On the other hand, when the inclination angle θ1 of the first connecting tapered portion 13a is greater than or equal to the upper limit value, the rate of change in the outer diameter of the first connecting tapered portion 13a increases. Therefore, in the guide wire 100, the rigidity along the longitudinal direction changes rapidly near the boundary between the proximal connection constant outer diameter portion 111a and the first connection tapered portion 13a, and the guide wire 100 is likely to kink. Further, if the inclination angle θ1 of the first connecting tapered portion 13a is less than the lower limit value, it becomes difficult to determine the position of the first connecting tapered portion 13a and the connecting member 50 when they are fitted, and the tip fitting portion 61 can be adjusted to the desired position. It becomes difficult to form in position.

As described above, the inclination angle θ of the tapered portion that fits into the connection member 50 (the inclination angle θ1 of the first connection tapered portion 13a) is preferably smaller than a predetermined angle. However, if the proximal tapered portion 112a is a single tapered portion with a small inclination angle θ, the guide wire 100 has a long portion on the distal end side of the connecting member 50 that has a smaller outer diameter than the first constant outer diameter portion 11b. I will do it. In a 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 support of the guide wire 100 for the catheter is reduced. In addition, the rigidity of the portion of the guide wire 100 with a small outer diameter is reduced, so that the pushability of the guide wire 100 is reduced.

By making the proximal tapered part 112a a continuous tapered part 13, the guide wire 100 has a first constant outer diameter part from the distal end of the connecting member 50, compared to a case where the proximal tapered part 112a is a single taper part. The length of the small outer diameter portion up to 11b is shortened. As a result, the guide wire 100 is prevented from deteriorating in its ability to support the catheter and its ability to be pushed into the catheter. Further, when the guide wire 100 grips the first constant outer diameter portion 11b of the first core portion 11 and fits them together, the distance between the first core portion 11 and the connecting member 50 can be shortened. Therefore, the first core part 11 can be easily inserted into the connecting member 50 during fitting, and the possibility of damage to the first core part 11 and the connecting member 50 is reduced. This increases the straightness of the guide wire 100 and improves torque transmittance. Furthermore, the length of the portion of the first core portion 11 covered with the second covering layer 42 can be increased. Thereby, the frictional resistance between the guide wire 100 and the blood vessel is reduced, and the passageability within the blood vessel is improved.

In the continuous tapered 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. Thereby, the first core portion 11 can provide a point of change in rigidity due to the continuous taper portion 13 while reducing the change in rigidity along the longitudinal direction of the first connecting portion 11a. 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 small outer diameter portion from the tip of the connection member 50 to the first constant outer diameter portion 11b is Since the effect of shortening is reduced, it becomes difficult to obtain the effect of making the proximal tapered portion 112a a continuous tapered portion 13.

The inclination angle θ2 of the second connecting tapered portion 13b is preferably 0.1°<θ2<2.5°. As a result, the stiffness along the longitudinal direction near the boundary between the first connecting tapered portion 13a and the second connecting tapered portion 13b changes gradually, so that the guide wire 100 can suppress kinking at the proximal tapered portion 112a.

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

By making the length L2 of the first connection taper part 13a longer than the length L3 of the second connection taper part 13b, the first core part 11 can be formed into a first connection taper disposed in the inner cavity 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 constant outer diameter portion 11b can be decreased. As the length of the first connecting tapered portion 13a disposed in the inner cavity 51 of the connecting member 50 becomes longer, the separation distance between the first core portion 11 and the second core portion 12 in the inner cavity 51 of the connecting member 50 becomes shorter. Therefore, the guide wire 100 can suppress a local decrease in rigidity in the portion of the inner cavity 51 of the connecting member 50 where the first core portion 11 and the second core portion 12 are separated from each other. In addition, since the length of the small outer diameter portion from the distal end of the connecting member 50 to the first constant outer diameter portion 11b is shortened, the guide wire 100 is prevented from deteriorating in its ability to support and push into the catheter.

When the first core portion 11 and the connecting member 50 are fitted together, the portion of the first connecting portion 11a disposed in the inner cavity 51 of the connecting member 50 has a function of supporting the connecting member 50. Therefore, by increasing the length of the first connecting tapered portion 13a disposed in the inner cavity 51 of the connecting member 50, the connecting member 50 is less likely to bend due to the fitting pressure, and plastic deformation of the connecting member 50 is suppressed. can. Further, when the guide wire 100 grips the first constant outer diameter portion 11b of the first core portion 11 and fits them together, the distance between the first core portion 11 and the connecting member 50 can be shortened. Therefore, the first core part 11 can be easily inserted into the connecting member 50 during fitting, and the possibility of damage to the first core part 11 and the connecting member 50 is reduced. As a result, the guide wire 100 has high straightness and improves torque transmittance.

Furthermore, by shortening the length from the tip of the connecting member 50 to the first constant outer diameter portion 11b, the length of the portion of the first core portion 11 covered with the second coating layer 42 can be increased. This reduces the frictional resistance of the guide wire 100 and improves its ability to pass through the blood vessel.

[Production method]
Next, a method for manufacturing the guide wire 100 according to this embodiment will be described. In addition, below, the process of connecting the 1st core part 11 and the 2nd core part 12 with respect to the connection member 50 is demonstrated, and the description of other processes for manufacturing the guide wire 100 is abbreviate|omitted.

(Step 1)
Step 1 is to insert a portion of the proximal connecting outer diameter constant portion 111a of the first core portion 11 and the first connecting tapered portion 13a of the first core portion 11 into the inner cavity 51 of the connecting member 50 from the distal end side of the connecting member 50. This is the process of inserting. By inserting a part of the first connecting tapered part 13a of the first core part 11 into the inner cavity 51 of the connecting member 50, the outer surface of the first connecting tapered part 13a of the first core part 11 becomes the same as that of the connecting 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 together. In step 2, the proximal end connection constant outer diameter portion 111a of the first core portion 11 and a portion of the first connection tapered portion 13a of the first core portion 11 are inserted into the inner cavity 51 of the connection member 50, and the first While the outer surface of the first connecting tapered portion 13a of the core portion 11 and the inner surface of the tip of the connecting member 50 are 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 part 11 and the connecting member 50, the proximal end connecting outer diameter constant part 111a of the first core part 11 and a part of the first connecting tapered part 13a of the first core part 11 are connected to the connecting member 50. is pushed toward the proximal end of the lumen 51 of the tube. Further, when pushing the proximal end connecting constant outer diameter portion 111a of the first core portion 11 and a part of the first connecting tapered portion 13a of the first core portion 11 toward the proximal end side of the connecting member 50, a predetermined fitting is achieved. By applying pressure, the distal end portion of the connecting member 50 takes on a flared shape that expands 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 connecting tapered portion 13a of the first core portion 11 is in contact with the outer surface of the first connecting tapered portion 13a of the first core portion 11 and the inner surface of the distal end portion of the connecting member 50. A tip fitting portion 61 can be formed in which the inner surface of the tip of the connecting member 50 fits together. Note that the operation of pushing the first core portion 11 into the connecting member 50 can be performed using a known fitting machine 200.

(Step 3)
Step 3 is to irradiate the outer surface of the connecting member 50 with a laser from the radially outer side of the connecting member 50 to fix the connecting member 50 and the first connecting tapered portion 13a of the first core portion 11 at the tip connecting fixing portion 71. This is the process of forming a (welded part). At this time, the laser irradiation point P is set at a predetermined distance from the position where the outer surface of the first connecting tapered part 13a of the first core part 11 and the inner surface of the distal end of the connecting member 50 come into contact with each other toward the base end side of the connecting member 50. The positions are separated by a certain distance. Laser irradiation is applied to a position separated by a predetermined distance from the position where the outer surface of the first connecting tapered part 13a of the first core part 11 and the inner surface of the distal end of the connecting member 50 contact, toward the proximal end of the connecting 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. In addition, by irradiating a laser onto two radially opposing locations of the connecting member 50, the tip connection fixing portion 71 can be provided at the two locations. The operation of irradiating the connecting member 50 with a laser beam can be performed using a known laser irradiation device.

(Step 4)
Step 4 is to insert a portion of the tip connection constant outer diameter portion 121b of the second core portion 12 and the tip tapered portion 122b of the second core portion 12 into the inner cavity 51 of the connection member 50 from the proximal end side of the connection member 50. This is the process of By inserting a part of the tip tapered portion 122b of the second core portion 12 into the inner cavity 51 of the connecting member 50, the outer surface of the tip tapered portion 122b of the second core portion 12 is formed into the inner surface of the tip portion of the connecting member 50. contact with the surface.

(Step 5)
Step 5 is a step of fitting the second core portion 12 and the connecting member 50 together. In step 5, the tip connecting outer diameter constant portion 121b of the second core portion 12 and a portion of the tip tapered portion 122b of the second core portion 12 are inserted into the inner cavity 51 of the connecting member 50, and the tip end portion 122b of the second core portion 12 is inserted. With the outer surface of the distal end tapered portion 122b and the inner surface of the proximal 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 approach each other relatively. By relatively moving the second core part 12 and the connecting member 50, a portion of the constant outer diameter end connecting part 121b of the second core part 12 and the tapered end part 122b of the second core part 12 are connected to the inner lumen 50 of the connecting member 50. It is pushed towards the tip side. Furthermore, when pushing the constant tip connecting outer diameter portion 121b of the second core portion 12 and a portion of the tip tapered portion 122b of the second core portion 12 toward the tip side of the connecting member 50, a predetermined fitting pressure may be applied. As a result, the base end portion of the connecting member 50 takes on a flared shape that expands radially outward along the outer surface of the distal end tapered portion 122b of the second core portion 12. As a result, the outer surface of the distal end tapered part 122b of the second core part 12 and the connecting member A proximal end fitting portion 62 can be formed in which the inner surface of the proximal end portion of 50 is fitted. Note that the operation of pushing the second core portion 12 into the connecting member 50 can be performed using a known fitting machine 200.

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

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

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

[Effect]
As explained above, the guide wire 100 according to the present embodiment has a proximal end portion of the first core portion 11 and a distal end portion of the second core portion 12 disposed on the proximal end side of the first core portion 11. , a guide wire 100 connected by a tubular connecting member 50, in which the proximal end of the first core portion 11 has a proximal tapered portion 112a whose outer diameter gradually decreases toward the proximal end, and the second core portion The distal end portion of No. 12 has a distal tapered portion 122b whose outer diameter gradually decreases toward the distal end. The first connecting tapered part 13a is located closest to the proximal end of the first core part 11 or the distal end of the second core part 12, and the proximal end of the first core part 11 or the second It has a continuous taper part 13 including a second connection taper part 13b which is disposed adjacent to the side far from the tip of the core part 12 and has a different inclination angle θ from the first connection taper part 13a. has a fitting part 60 in which the outer surface of the first connecting tapered part 13a and the inner surface of the end of the connecting member 50 fit together.

With such a configuration, the guide wire 100 has a rigidity that changes along the longitudinal direction of the guide wire 100 at a boundary position between the first connecting tapered portion 13a and the second connecting tapered portion 13b that form the continuous tapered portion 13. Thereby, the radius of curvature of the guide wire 100 when passing through the curved portion of the blood vessel is reduced, 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 has improved passage through the curved portion of the blood vessel, and the load on the blood vessel is reduced. Furthermore, 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, since this reduces the chance that the end of the connecting member 50 comes into contact with the inner surface of the blood vessel. However, damage to blood vessels can be suppressed.

Further, the continuous tapered portion 13 of the guide wire 100 according to this embodiment is arranged at the proximal tapered portion 112a of the first core portion 11, and the first core portion 11 may be formed of a superelastic alloy.

With such a configuration, the guide wire 100 is unlikely to kink even if the radius of curvature from the point of change in rigidity due to the continuous taper portion 13 to the tip of the connecting member 50 becomes small.

Further, in the guide wire 100 according to the present embodiment, in the continuous tapered portion 13, the inclination angle θ2 of the second connection taper portion 13b may be larger than the inclination angle θ1 of the first connection taper portion 13a.

With such a configuration, the guide wire 100 can provide a stiffness change point due to the continuous tapered portion 13 while reducing changes in stiffness along the longitudinal direction of the first connecting portion 11a.

Further, in the guide wire 100 according to the present embodiment, in the continuous tapered portion 13, the length in the longitudinal direction of the first connecting tapered portion 13a is longer than the length in the longitudinal direction of the second connecting tapered portion 13b. good.

With such a configuration, the guide wire 100 has a long first connecting tapered portion 13a disposed in the inner cavity 51 of the connecting member 50, and a length from the distal end of the connecting member 50 to the first constant outer diameter portion 11b. The length can be shortened. As a result, the guidewire 100 is prevented from decreasing local rigidity, decreasing support for the catheter, and decreasing pushability. In addition, since the possibility of plastic deformation or damage of the connecting member 50 when the first core portion 11 and the connecting member 50 are fitted is reduced, the guide wire 100 has higher straightness and improves torque transmittance. . Furthermore, since the length of the portion of the first core portion 11 covered by the second coating layer 42 of the guide wire 100 is increased, the passage through the blood vessel is improved.

Further, the connection fixing part 70 that fixes the continuous tapered part 13 and the connection member 50 of the guide wire 100 according to the present embodiment is provided in the first connection taper part 13a and is spaced apart from the fitting part 60 in the longitudinal direction. It may be provided at a position where

With this configuration, in the guide wire 100, the first core portion 11 and the connecting member 50 are fixed at two points, the fitting portion 60 and the distal end connection fixing portion 71, when viewed along the longitudinal direction. Therefore, the first core portion 11 and the connecting member 50 can be connected more firmly.

Further, the outer surface of the first connecting tapered portion 13a of the guide wire 100 according to the present embodiment and the inner surface of the connecting member 50 may be separated from each other in the radial direction on the distal end side and the proximal end side of the connecting fixing portion 70. good.

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

Further, the fitting portion 60 of the guide wire 100 according to the present embodiment may have a flared shape in which the connecting member 50 expands radially outward along the outer surface of the first connecting tapered portion 13a.

With such a configuration, in the guide wire 100, 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. In addition, since stress can be suppressed from concentrating on the tip of the connecting member 50 during bending, the guide wire 100 is less likely to be kinked starting from the tip of the connecting member 50.

EXAMPLES Hereinafter, the present invention will be specifically explained with reference to examples, but the scope of the present invention is not limited to the following examples.

[Manufacture of guide wire]
The guidewire 100 of Example 1 was manufactured as follows. As for the manufacturing process, Step 1, Step 3, Step 4, Step 6, and Step 7 in the method for manufacturing the guide wire 100 described above were performed.

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

The second core portion 12 of the guide wire 100 was formed by processing a stainless steel metal wire. The second connecting portion 12b of the second core portion 12 was formed to have a tip connection constant outer diameter portion 121b and a tip tapered portion 122b. The tip tapered portion 122b was formed into a single tapered portion. The outer diameter of the constant outer diameter connecting portion 121b was 0.235 mm, and the outer diameter of the proximal end of the tapered tip portion 122b was 0.340 mm. The length of the tip connection constant outer diameter portion 121b was 5 mm, and the length of the tip tapered portion 122b was 25 mm. The inclination angle θ3 of the tip tapered portion 122b was 0.14.

As the connecting member 50, a Ni--Ti alloy pipe having an outer diameter of 0.350 mm, an inner diameter of 0.255 m, a wall thickness of 0.048 mm, and a length of 35 mm was used.

In step 1, the tester holds the first core part 11 and the connecting member 50 in his hands, and connects the proximal connection constant outer diameter part 111a of the first core part 11 to the constant outer diameter part 111a of the first core part 11 from the distal end side of the connecting member 50. The first core part 11 and the connecting member 50 were fitted by inserting a part of the first connecting tapered part 13a and pushing it strongly.

In step 3, the tester uses a laser irradiation device, sets the laser irradiation point P 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 is 2.5 mm, and irradiates the laser. did. Next, the tester set the laser irradiation point P at a position rotated by 180 degrees in the circumferential direction of the first core part 11 from the first laser irradiation point P, and irradiated the laser with the laser. The voltage value during laser irradiation was 280 V, and the pulse width was 1.0 ms.

In step 4, the tester holds the second core part 12 and the connecting member 50 in his/her hands, inserts a part of the tip tapered part 122b of the second core part 12 from the base end side of the connecting member 50, and pushes it firmly. As a result, the second core portion 12 and the connecting member 50 were fitted together.

In step 6, the proximal end connection fixing portion 72 for fixing the proximal end portion of the connecting member 50 and the distal end tapered portion 122b of the second core portion 12 was formed by soldering using solder as the connecting material 72a.

In step 7, the tester polished the surface of the proximal connection fixing part 72 made of the connection material 72a soldered in step 6 with a polisher, and formed it into a tapered shape whose outer diameter gradually decreases toward the proximal end. .

The guide wire 500 of Comparative Example 1 was manufactured according to the manufacturing process of the guide wire 100 described above. In Comparative Example 1, the first connecting portion 11a of the first core portion 11 was formed to have a constant outer diameter proximal connecting portion 111a and a proximal tapered portion 112a. The proximal tapered portion 112a was formed into a single tapered portion. The outer diameter d1 of the proximal end connection constant outer diameter portion 111a was 0.220 mm, and the outer diameter of the tip of the proximal end tapered portion 112a was 0.340 mm. The length of the proximal end connection constant outer diameter portion 111a was 15 mm, and the length of the proximal tapered portion 112a was 80 mm. The inclination angle θ of the proximal tapered portion 112a was 0.04°.

[Test 1]
Test 1 is a test to evaluate the behavior of the guide wire when passing through a curved portion. The guide wire 100 of Example 1 and the guide wire 500 of Comparative Example 1 were inserted into a test instrument 400 having a passage 410 (a tube with a diameter of 6 mm and a radius of curvature of 30 mm) having a U-shaped curved portion, and the first core portion and The behavior of the guide wire 100 when the region including the fitting portion with the connecting member passed through the curved portion was visually observed.

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

As shown in FIG. 6, when the guide wire 100 of Example 1 passed through the curved portion of the passage 410, the radius of curvature of the guide wire 100 was small, and the guide wire 100 passed through a position close to the inside of the curve of the passage 410. On the other hand, as shown in FIG. 6, when the guide wire 500 of Comparative Example 1 passed through the curved portion of the passage 410, the radius of curvature of the guide wire 100 became large, and the guide wire 100 passed through a position close to the outside of the curve of the passage 410. The guidewire 100 of Example 1 having the continuous tapered part 13 has a higher internal resistance between the guidewire 100 and the inside of the blood vessel when passing through a curved part of the blood vessel, compared to the guidewire 500 of Comparative Example 1 which does not have the continuous tapered part 13. The contact area with the surface was small. When the guide wire 100 is bent, the rigidity along the longitudinal direction of the guide wire 100 changes at the boundary position between the first connection taper part 13a and the second connection taper part 13b that form the continuous taper part 13. It is presumed that the radius of curvature from the point of change in rigidity due to the continuous taper portion 13 to the tip of the connecting member 50 has become smaller.

10 core member,
11 First core part (11a first connection part, 11b first constant outer diameter part, 11c first tapered part, 11d second constant outer diameter part, 11e second tapered part, 11f transition part, 11g flat plate part, 111a base End connection constant outer diameter part, 112a proximal tapered part),
12 second core part (12a base, 12b second connection part, 121b tip connection constant outer diameter part, 122b tip tapered part),
13 continuous taper part (13a first connection taper part, 13b second connection taper part),
14 extension,
20 Luminal body,
21 first coil,
22 second coil,
30 fixed part,
31 Tip fixing part,
32 intermediate fixed part,
33 proximal 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 Proximal fitting part,
70 connection fixing part,
71 Tip connection fixing part,
72 base end connection fixing part (72a connection material),
100 guide wire,
C central axis.

Claims (7)

A guide wire in which a proximal end portion of a first core portion and a distal end portion of a second core portion disposed on the proximal side of the first core portion are connected by a tubular connecting member,
The proximal end portion of the first core portion has a proximal tapered portion whose outer diameter gradually decreases toward the proximal end,
The tip of the second core portion has a tapered tip whose outer diameter gradually decreases toward the tip,
At least one of the proximal tapered portion and the distal tapered portion is disposed at a position closest to the proximal end of the first core portion or the distal end of the second core portion in the longitudinal direction of the guide wire. a first connecting tapered portion, which is disposed adjacent to the first connecting tapered portion on a side far from the proximal end of the first core portion or the distal end of the second core portion, and is different from the first connecting tapered portion; a continuous tapered portion including a second connecting tapered portion having an inclination angle;
The continuous tapered portion is a guide wire, and the continuous tapered portion has a fitting portion in which the outer surface of the first connection tapered portion and the inner surface of the end portion of the connection member fit together. The guidewire of claim 1, wherein the continuous tapered portion is disposed at the proximal tapered portion of the first core portion, and the first core portion is formed of a superelastic alloy. The guide wire according to claim 1 or 2, wherein in the continuous tapered portion, the second connecting tapered portion has a larger inclination angle than the first connecting tapered portion. 4. The continuous tapered portion according to claim 1, wherein the length of the first connecting tapered portion in the longitudinal direction is longer than the length of the second connecting tapered portion in the longitudinal direction. guide wire. The connecting fixing portion for fixing the continuous tapered portion and the connecting member is provided in the first connecting tapered portion and at a position spaced apart from the fitting portion in the longitudinal direction. The guide wire according to any one of the items. The guide wire according to claim 5, wherein the outer surface of the first connecting tapered portion and the inner surface of the connecting member are separated from each other in the radial direction on the distal end side and the proximal end side of the connecting fixing portion. The guide wire according to claim 5 or 6, wherein the fitting portion has a flared shape in which the connecting member expands radially outward along the outer surface of the first connecting tapered portion.