CN116367879A

CN116367879A - Guide wire

Info

Publication number: CN116367879A
Application number: CN202180071128.5A
Authority: CN
Inventors: 吉本彩加; 松田贵之
Original assignee: Terumo Corp
Current assignee: Terumo Corp
Priority date: 2020-11-12
Filing date: 2021-11-10
Publication date: 2023-06-30
Also published as: JP2023180260A; WO2022102653A1

Abstract

Provided is a guide wire wherein the trafficability of a bent portion of a blood vessel is improved and the load on the blood vessel and the damage to the blood vessel can be suppressed, in the guide wire wherein a tip-side core portion and a base-side core portion are connected by a tubular connecting member. At least one of the base end taper portion (112 a) of the 1 st core portion (11) and the tip end taper portion (122 b) of the 2 nd core portion (12) has a continuous taper portion (13) including a 1 st connection taper portion (13 a) arranged at a position closest to the base end of the 1 st core portion (11) or the tip end of the 2 nd core portion (12) in the long axis direction, and a 2 nd connection taper portion (13 b) arranged adjacent to the 1 st connection taper portion (13 a) on a side distant from the base end of the 1 st core portion (11) or the tip end of the 2 nd core portion (12) and having an inclination angle (θ) different from the 1 st connection taper portion (13 a). The continuous taper portion (13) has a fitting portion (60) in which the outer surface of the 1 st connection taper portion (13 a) is fitted to the inner surface of the end portion of the connection member (50).

Description

Guide wire

Technical Field

The present invention relates to guidewires.

Background

A guidewire is a medical instrument used for guiding various catheters for treatment of a stenosed region generated in a blood vessel to the stenosed region.

The guidewire needs to be advanced in the complex bends and branches of the vessel and through the stenosis. Therefore, the guide wire is required to have low bending rigidity on the side to be inserted into the blood vessel (distal end side) in order to improve the vascular selectivity and safety, and high bending rigidity on the side to be operated by the operator (proximal end side) in order to secure the pushability and torque transmissibility. Therefore, a guide wire is known which uses a core member in which metal cores having different outer diameters and material characteristics are connected to each other so that the tip end side and the base end side have different characteristics.

Patent document 1 discloses a guide wire in which a tip-side core portion and a base-side core portion are connected by inserting small diameter portions provided in the tip-side core portion and the base-side core portion, respectively, into a lumen of a tubular connecting member.

Prior art literature

Patent literature

Patent document 1: WO2006/002199

Disclosure of Invention

Problems to be solved by the invention

When the guide wire passes through the curved portion of the blood vessel, the guide wire is curved so as to be pressed against the inner wall outside the curved portion of the blood vessel, and moves while being in contact with the inner surface of the blood vessel. At this time, if the radius of curvature of the curved guide wire is large, the contact area between the guide wire and the inner surface of the blood vessel becomes large. Thus, the passability of the guidewire at the curved portion of the blood vessel decreases, and the load imposed on the blood vessel increases. In particular, in the case of a guide wire using a core member in which cores are connected to each other by a tubular connecting member, if the end of the connecting member has a layer difference corresponding to the wall thickness of the connecting member, there is a fear that the end of the connecting member is in contact with the inner surface of the blood vessel, and the blood vessel is damaged.

In view of the above, at least one embodiment of the present invention provides a guide wire in which a distal end side core portion and a proximal end side core portion are connected by a tubular connecting member, wherein the passage of a blood vessel at a curved portion is improved, and a load on the blood vessel and damage to the blood vessel can be suppressed.

Means for solving the problems

The guide wire according to the present embodiment is a guide wire in which a proximal end portion of a 1 st core portion is connected to a distal end portion of a 2 nd core portion disposed on a proximal end side of the 1 st core portion by a tubular connection member, wherein the proximal end portion of the 1 st core portion has a proximal end tapered portion having a gradually decreasing outer diameter toward a proximal end, the distal end portion of the 2 nd core portion has a distal end tapered portion having a gradually decreasing outer diameter toward a distal end, at least one of the proximal end tapered portion and the distal end tapered portion has a continuous tapered portion including a 1 st connection tapered portion disposed at a position closest to the proximal end of the 1 st core portion or the distal end of the 2 nd core portion in a longitudinal direction of the guide wire, and a 2 nd connection tapered portion disposed adjacent to the 1 st connection tapered portion on a side distant from the proximal end of the 1 st core portion or the distal end of the 2 nd core portion and having an inclination different from the 1 st connection tapered portion, and the continuous tapered portion has a fitting portion of an outer surface of the 1 st connection tapered portion with an inner surface of the connection member.

Effects of the invention

According to one embodiment of the present invention, the guide wire changes in rigidity along the longitudinal direction of the guide wire at the boundary position between the 1 st connecting taper portion and the 2 nd connecting taper portion forming the continuous taper portion. Thus, the radius of curvature of the guide wire when passing through the curved portion of the blood vessel is reduced, and the contact area between the guide wire and the inner surface of the blood vessel can be reduced. Thus, the passability of the guidewire at the curved portion of the blood vessel is improved, and the load imposed on the blood vessel is reduced. Further, since the chance of the end portion of the connecting member of the guide wire coming into contact with the inner surface of the blood vessel is reduced, even when the end portion of the connecting member has a layer difference corresponding to the wall thickness of the connecting member, damage to the blood vessel can be suppressed.

Drawings

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 of the present embodiment in the longitudinal direction as viewed from the thickness direction.

Fig. 3 is a schematic cross-sectional view of the periphery of the connecting member of the guide wire according to the present embodiment.

Fig. 4 is a schematic partial cross-sectional view of a connection portion between the 1 st core portion of the guide wire according to the present embodiment and the connection member.

Fig. 5 is a schematic partial cross-sectional view of a connection portion between the 2 nd core portion of the guide wire according to the present embodiment and a connection member.

Fig. 6 is a view 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.

Detailed Description

Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the accompanying drawings. The embodiments described herein are exemplified to embody the technical idea of the present invention, and do not limit the present invention. Other embodiments, examples, operation techniques, and the like which can be implemented by those skilled in the art without departing from the gist of the present invention are included in the scope and gist of the present invention, and the claims and their equivalents are included therein.

In the drawings attached in the present specification, for ease of illustration and understanding, the scale, the ratio of the dimensions in the horizontal and vertical directions, the shape, and the like may be changed appropriately with respect to the actual object, but the present invention is not limited to the explanation by way of example only.

In this specification, for convenience of description, a direction in the case where the guide wire 100 is in a natural state (a state in which the guide wire extends straight without an external force) is defined. In fig. 1, the "longitudinal direction" is a direction in which the guide wire 100 extends, and is a direction along the central axis C of the guide wire 100 (left-right direction in the drawing). The "radial direction" is defined as a direction away from or toward the core member 10 in an axial orthogonal cross section (cross section) of the core portion with the longitudinal direction of the guide wire 100 as a reference axis. The "circumferential direction" is a rotation direction about the major axis direction of the core member 10 as a reference axis. In the case where the flat plate portion 11g is provided at the distal end of the guide wire 100, the "thickness direction" is a direction in which the short side of the rectangle extends when the flat plate portion 11g is viewed in cross section (the front-side and depth directions in the drawing). In the case where the tip of the guide wire 100 has the flat plate portion 11g, the "width direction" is a direction in which the long side of the rectangle extends (vertical direction in the drawing) when the flat plate portion 11g is viewed in cross section.

The side of the guide wire 100 to be inserted into the blood vessel is referred to as "distal end side", and the opposite side (the side to be gripped by the operator) to the distal end side is referred to as "proximal end side". The portion including a certain range in the longitudinal direction from the distal end (distal-most end) is referred to as a "distal end", and the portion including a certain range in the longitudinal direction from the proximal end (proximal-most end) is referred to as a "proximal end".

In the following description, when the ordinal numbers such as "1 st" and "2 nd" are given, unless otherwise indicated, they are used for convenience only and do not specify any order.

The guidewire 100 of the present embodiment is a medical device that is inserted into a blood vessel to guide a catheter or stent for intravascular treatment to a stricture. The guide wire 100 can be used by being inserted into a lumen of a living body other than a blood vessel (a vessel, a urinary tract, a bile duct, a fallopian tube, a hepatic duct, or the like) for therapeutic purposes.

Structure

As shown in fig. 1 or 2, the guide wire 100 of the present embodiment includes: a long-sized core member 10; a lumen 20 covering the periphery of the distal end portion of the core member 10; a fixing portion 30 fixing the lumen 20 to the core member 10; and a cover layer 40 covering the respective members including the core member 10. The guide wire 100 further includes: a connection member 50 connecting the 1 st core 11 and the 2 nd core 12; a fitting portion 60 formed when the 1 st core portion 11 or the 2 nd core portion 12 is connected to the connecting member 50; and a connection fixing portion 70 for improving the connection strength of the core member 10 and the connection member 50. The portions of the guidewire 100 are described in detail below.

Core part

The core member 10 includes a 1 st core portion 11, a 2 nd core portion 12 disposed on the base end side of the 1 st core portion 11, and a tubular connecting member 50 connecting the 1 st core portion 11 and the 2 nd core portion 12. The 1 st core 11 and the 2 nd core 12 are connected by inserting the base end portion of the 1 st core 11 into the front end portion of the connecting member 50 and inserting the front end portion of the 2 nd core 12 into the base end portion of the connecting member 50. A fitting portion 60 is formed at a contact portion between the core member 10 and the connection member 50.

The 1 st core 11 is a long member extending in the longitudinal direction toward the tip end of the guide wire 100. The 1 st core 11 includes, in order from the base end toward the tip end side of the 1 st core 11, a 1 st connecting portion 11a, a 1 st outer diameter constant portion 11b, a 1 st taper portion 11c, a 2 nd outer diameter constant portion 11d, a 2 nd taper portion 11e, a transition portion 11f, and a flat plate portion 11g, each of which is integrally formed.

The 1 st connecting portion 11a is a portion connected to a 2 nd connecting portion 12b of the 2 nd core portion 12 described later via a connecting member 50. The 1 st connecting portion 11a extends from the base end of the 1 st core portion 11 to the base end of the 1 st outer diameter constant portion 11b by a predetermined length. The outer diameter of the 1 st connecting portion 11a is smaller than the outer diameter of the 1 st outer diameter constant portion 11b in the entire range of the 1 st connecting portion 11 a. As shown in fig. 3 and 4, the 1 st connecting portion 11a includes a base end connecting outer diameter constant portion 111a and a base end tapered portion 112a in this order from the base end toward the tip end of the 1 st core portion 11. The 1 st connecting portion 11a may have another taper portion and/or an outer diameter constant portion in addition to the base end taper portion 112a.

The base end connection outer diameter constant portion 111a extends from the base end of the 1 st core 11 to the base end of the base end taper portion 112a by a prescribed length. The outer diameter d1 of the base end connection outer diameter constant portion 111a is substantially constant and smaller than the inner diameter of the connection member 50. The outer diameter d1 of the base end connecting outer diameter constant part 111a is 0.2mm to 0.6mm. As shown in fig. 4, the base end connection outer diameter constant portion 111a is disposed entirely within the inner cavity 51 of the connection member 50.

The base tapered portion 112a extends from the tip of the base-end-connection outer-diameter constant portion 111a to the base end of the 1 st outer-diameter constant portion 11b by a predetermined length. In the guide wire 100 according to the present embodiment, the proximal end tapered portion 112a is a continuous tapered portion 13 in which the 1 st connecting tapered portion 13a and the 2 nd connecting tapered portion 13b are disposed adjacent to each other in the longitudinal direction in order from the distal end of the proximal end connecting outer diameter constant portion 111a toward the distal end side. The 2 nd connection taper portion 13b is disposed adjacent to the 1 st connection taper portion 13a on the side distant from the base end of the 1 st core portion 11 in the longitudinal direction. The 1 st connection taper portion 13a and the 2 nd connection taper portion 13b have different inclination angles θ. In the present specification, the "inclination angle θ" refers to an angle formed between the central axis C or an imaginary line parallel to the central axis C and the outer surface of each taper portion in a longitudinal section passing through the central axis C of the guide wire 100.

The outer diameter of the base end taper 112a is equal to the outer diameter d1 of the base end connection outer diameter constant portion 111 a. The outer diameter of the tip of the base end taper portion 112a is equal to the outer diameter of the 1 st outer diameter constant portion 11 b. The number of tapered portions forming the continuous tapered portion 13 may be two or more. The base end taper 112a may be a single taper having one inclination angle θ.

The continuous taper portion 13 functioning as the base end taper portion 112a has a stepwise taper shape in which a plurality of taper portions having different inclination angles θ are continuously arranged in the longitudinal direction. The outer surface of the 1 st connection taper portion 13a forming the continuous taper portion 13 has a fitting portion 60 at a portion that contacts the inner surface of the front end portion of the connection member 50.

The 1 st connection taper portion 13a extends from the tip of the base end connection outer diameter constant portion 111a to the base end of the 2 nd connection taper portion 13b by a predetermined length. The 1 st connection taper portion 13a has a taper shape in which the outer diameter increases from the base end connection outer diameter constant portion 111a toward the tip end side. The outer diameter of the base end of the 1 st connection taper portion 13a is equal to the outer diameter d1 of the base end connection outer diameter constant portion 111 a. The outer diameter d2 of the front end of the 1 st connection taper portion 13a is larger than the inner diameter of the connection member 50. Accordingly, as shown in fig. 4, the 1 st connection taper portion 13a is only a part of the 1 st connection taper portion 13a is inserted into the inner cavity 51 of the connection member 50. The taper shape of the 1 st connection taper portion 13a can be formed by mechanically grinding the 1 st core portion 11 by a grinding wheel or etching by an acid.

The 2 nd connection tapered portion 13b extends from the tip end of the 1 st connection tapered portion 13a to the base end of the 1 st outer diameter constant portion 11b by a predetermined length. The 2 nd connection tapered portion 13b has a tapered shape in which the outer diameter increases from the tip end of the 1 st connection tapered portion 13a toward the tip end side. The outer diameter of the base end of the 2 nd connection taper portion 13b is equal to the outer diameter d2 of the tip end of the 1 st connection taper portion 13 a. Therefore, the 2 nd connection taper portion 13b is not disposed in the inner cavity 51 of the connection member 50. The outer diameter d3 of the tip end of the 2 nd connection taper portion 13b is equal to the outer diameter of the 1 st outer diameter constant portion 11 b. The taper shape of the 2 nd connection taper portion 13b can be formed by mechanically grinding the 1 st core portion 11 by a grinding wheel or etching by an acid.

The 1 st outer diameter constant portion 11b extends from the tip end of the 1 st connecting portion 11a to the base end of the 1 st tapered portion 11c by a predetermined length. The 1 st outer diameter constant portion 11b has an outer diameter substantially constant and substantially equal to the outer diameter of the base portion 12a of the 2 nd core portion 12.

The 1 st taper portion 11c extends from the tip of the 1 st constant outer diameter portion 11b to the base end of the 2 nd constant outer diameter portion 11d by a predetermined length. The 1 st tapered portion 11c has a tapered shape in which the outer diameter decreases gradually from the 1 st outer diameter constant portion 11b toward the distal end side. The taper shape of the 1 st taper portion 11c can be formed by mechanically grinding the 1 st core portion 11 by a grinding wheel or etching by an acid.

The 2 nd outer diameter constant portion 11d extends from the tip end of the 1 st tapered portion 11c to the base end of the 2 nd tapered portion 11e by a predetermined length. The 2 nd outer diameter constant portion 11d has an outer diameter substantially constant and smaller than that of the 1 st outer diameter constant portion 11 b.

The 2 nd taper portion 11e extends from the tip end of the 2 nd outer diameter constant portion 11d to the base end of the transition portion 11f by a predetermined length. The 2 nd taper portion 11e has a taper shape in which the outer diameter gradually decreases from the 2 nd outer diameter constant portion 11d toward the transition portion 11 f. The taper shape of the 2 nd taper portion 11e can be formed by mechanically grinding the 1 st core portion 11 by a grinding wheel or etching by an acid.

The transition portion 11f extends from the tip end of the 2 nd tapered portion 11e to the base end of the flat plate portion 11g by a predetermined length. The transition portion 11f has a wedge shape gradually decreasing in thickness and gradually increasing in width from the 2 nd taper portion 11e toward the flat plate portion 11 g. The wedge-like shape of the transition portion 11f can be formed by press working as one of cold working on the 1 st core portion 11 having a circular cross-sectional shape. The cross-sectional shape of the transition portion 11f when viewed from a plane orthogonal to the longitudinal direction (when viewed in cross-section) is circular with an outer diameter substantially equal to that of the 2 nd tapered portion 11e on the base end side, but gradually deforms from circular to rectangular as going from the base end side to the tip end side, and is rectangular with a shape substantially equal to that of the flat plate portion 11g on the tip end side. The front end portion of the transition portion 11f has a thickness and a width substantially equal to those of the base end portion of the flat plate portion 11g, and forms a surface continuous with the flat plate portion 11 g. The "thickness" of the flat plate portion 11g is the length of the short side of the rectangle when the flat plate portion 11g is viewed in cross section, and the "width" of the flat plate portion 11g is the length of the long side of the rectangle when the flat plate portion 11g is viewed in cross section.

The flat plate portion 11g extends from the distal end of the transition portion 11f to the distal end of the guide wire 100 by a predetermined length. The flat plate portion 11g is formed by press working the 1 st core portion 11 having a circular cross-sectional shape. Therefore, the cross-sectional shape of the flat plate portion 11g is formed in a rectangular shape. The thickness of the flat plate portion 11g is substantially constant from the front end of the transition portion 11f to the front end of the flat plate portion 11 g. The flat plate portion 11g is formed in a rectangular shape with rounded corners at the front end of the flat plate portion 11g as viewed from the thickness direction. Therefore, the width of the flat plate portion 11g is substantially constant from the tip end of the transition portion 11f toward the tip end side, but becomes smaller at the rounded portion. The width of the flat plate portion 11g may be constant from the tip of the transition portion 11f to the tip of the flat plate portion 11 g. The cross-sectional shape of the flat plate portion 11g is not limited to a rectangle, and may be a rounded rectangle having an R shape at the corner.

Further, the configuration of the 1 st core 11 is not limited to the above. For example, the 1 st core 11 may have a constant outer shape and a constant outer diameter from the front end to the base end.

The 2 nd core 12 is a long member extending from the connection member 50 toward the base end side of the guide wire 100. As shown in fig. 3 and 5, the 2 nd core 12 includes an extension portion 14, a base portion 12a, and a 2 nd connecting portion 12b in this order from the base end toward the distal end side of the 2 nd core 12, and the respective portions are integrally formed.

The extension portion 14 is a portion to be connected to an extension wire prepared separately in order to extend the entire length of the guide wire 100. The extension 14 extends from the proximal end of the base 12a toward the proximal end of the guide wire 100 by a predetermined length. The extension portion 14 has a shape having a plurality of curved portions, with an outer diameter gradually decreasing from the base portion 12a toward the base end side. Further, the extension portion 14 may not be provided.

The base portion 12a extends from the base end of the 2 nd connecting portion 12b to the tip end of the extension portion 14 by a predetermined length. The outer diameter of the base 12a is substantially constant and substantially equal to the outer diameter of the 1 st outer diameter constant portion 11b of the 1 st core 11.

The 2 nd connection portion 12b is a portion connected to the 1 st connection portion 11a of the 1 st core portion 11 via the connection member 50. The 2 nd connecting portion 12b extends from the front end of the 2 nd core portion 12 to the front end of the base portion 12a by a predetermined length. The outer diameter of the 2 nd connecting portion 12b is smaller than the outer diameter of the base portion 12a in the entire range of the 2 nd connecting portion 12 b. The 2 nd connecting portion 12b includes a distal end connecting outer diameter constant portion 121b and a distal end tapered portion 122b in this order from the distal end of the 2 nd core portion 12 toward the proximal end side. The 2 nd connecting portion 12b may have another taper portion and/or an outer diameter constant portion in addition to the tip taper portion 122b.

The tip end connection outer diameter constant portion 121b extends from the tip end of the 2 nd core portion 12 to the tip end of the tip end tapered portion 122b by a predetermined length. The outer diameter of the distal end connection outer diameter constant portion 121b is substantially constant and smaller than the inner diameter of the connection member 50. The outer diameter of the distal end connecting outer diameter constant portion 121b is substantially equal to the outer diameter d1 of the proximal end connecting outer diameter constant portion 111a of the 1 st core 11. The outer diameter of the distal end connecting outer diameter constant portion 121b is 0.2mm to 0.6mm.

The tip taper portion 122b extends from the base end of the tip-end-connection outer diameter-constant portion 121b to the tip end of the base 12a by a predetermined length. The distal end tapered portion 122b has a tapered shape in which the outer diameter increases from the distal end connecting outer diameter constant portion 121b toward the proximal end side. In the guide wire 100 of the present embodiment, the distal end taper 122b is a single taper. The outer diameter of the tip end tapered portion 122b is equal to the outer diameter of the tip end connection outer diameter constant portion 121 b. The outer diameter of the base end of the front end taper 122b is equal to the outer diameter of the base 12 a. Accordingly, as shown in fig. 5, only a portion of the front end taper 122b is inserted into the inner cavity 51 of the connection member 50. The tip taper 122b may be a continuous taper 13. The outer surface of the distal taper portion 122b has a fitting portion 60 at a portion that contacts the inner surface of the base end portion of the connection member 50.

The inclination angle θ3 of the tip end taper portion 122b of the 2 nd core portion 12 is larger than the inclination angle θ1 of the 1 st connecting taper portion 13a of the 1 st core portion 11 and smaller than the inclination angle θ2 of the 2 nd connecting taper portion 13b of the 1 st core portion 11. The inclination angle θ3 of the tip taper 122b is 0.10 ° to 0.17 °. The tip tapered portion 122b of the 2 nd core portion 12 is shorter than the 1 st connecting tapered portion 13a of the 1 st core portion 11 and longer than the 2 nd connecting tapered portion 13 b. The length of the tip taper 122b is 19mm to 25mm.

Specific dimensional examples of the guide wire 100 will be described. The total length of the guide wire 100 in the longitudinal direction is 1000mm to 4500mm. The length of the 1 st core 11 is 150mm to 1000mm. The length of the 1 st connecting part 11a and the 1 st constant outer diameter part 11b together is 10 mm-300 mm. The 1 st taper 11c has a length of 10mm to 100mm. The length of the 2 nd outer diameter constant part 11d is 10mm to 300mm. The length of the 2 nd taper portion 11e is 10mm to 100mm. The length of the transition portion 11f is 1mm to 20mm. The length of the flat plate portion 11g is 1mm to 20mm.

The 1 st connecting portion 11a and the 1 st outer diameter constant portion 11b have an outer diameter of 0.2mm to 1mm. The 1 st taper portion 11c and the 2 nd constant outer diameter portion 11d have an outer diameter of 0.1mm to 1mm. The 2 nd taper 11e has an outer diameter of 0.05mm to 1mm. The thickness of the transition portion 11f is 0.01mm to 1mm, and the width is 0.05mm to 1mm. The thickness of the flat plate portion 11g is 0.01mm to 1mm, and the width is 0.05mm to 1mm.

The length of the 2 nd core 12 is 850mm to 3500mm. The 2 nd core 12 has an outer diameter of 0.2mm to 1mm.

The 1 st core 11 and the 2 nd core 12 can be formed of a super elastic alloy such as a ni—ti based alloy, various metal materials such as SUS302, SUS304, SUS303, SUS316L, SUS J1, SUS316J1L, SUS, SUS430, SUS434, SUS444, SUS429, SUS430F, and various stainless steel such as a steel wire and a cobalt based alloy. Further, the 1 st core 11 is preferably formed of a material having lower rigidity than the material of the 2 nd core 12. For example, the 1 st core 11 is made of a ni—ti alloy, and the 2 nd core 12 is made of stainless steel. The materials forming the 1 st core 11 and the 2 nd core 12 are not limited to the above examples. The 1 st core 11 and the 2 nd core 12 may be formed of the same material.

Lumen body

The lumen 20 is formed by winding a wire around the core member 10 in a spiral shape. In the present embodiment, the lumen 20 is formed of the 1 st coil 21 and the 2 nd coil 22 arranged on the base end side of the 1 st coil 21. The 1 st coil 21 is disposed from the front end of the 1 st core 11 to the intermediate portion. The 2 nd coil 22 is disposed from the middle portion of the 1 st core 11 to the base end side. In addition, lumen 20 may also be formed from one coil. Lumen 20 may also be formed from more than three coils.

The 1 st coil 21 surrounds the 1 st core 11 of the core member 10 and is fixed to the 1 st core 11. The 1 st coil 21 is arranged coaxially with the 1 st core 11. The length of the 1 st coil 21 is 3mm to 60mm.

The 1 st coil 21 is formed by winding wires in a spiral shape with a gap between adjacent wires. The gap between adjacent wires of the 1 st coil 21 is 1 μm to 10 μm. The gaps between adjacent wires of the 1 st coil 21 are preferably set to be equally spaced.

The 2 nd coil 22 surrounds the 1 st core 11 of the core member 10 and is fixed to the 1 st core 11. The 2 nd coil 22 is arranged coaxially with the 1 st core 11. The length of the 2 nd coil 22 is 10mm to 400mm.

The 2 nd coil 22 is formed as a tightly wound portion in which the wires are tightly wound in a spiral shape without a gap between adjacent wires. The 2 nd coil 22 may have a closely wound portion and a loosely wound portion in which the wires are loosely wound in a spiral shape with a gap between adjacent wires. In the case of having the loose-wound portion, the close-wound portion in the 2 nd coil 22 is located at the distal end portion and the proximal end portion of the 2 nd coil 22, and the loose-wound portion is located between the close-wound portion on the distal end side and the close-wound portion on the proximal end side.

The base end portion of the 1 st coil 21 and the tip end portion of the 2 nd coil 22 are arranged in contact. The proximal end portion of the 1 st coil 21 and the distal end portion of the 2 nd coil 22 may be partially wound together. In this case, the wires at the base end portion of the 1 st coil 21 and the wires at the tip end portion of the 2 nd coil 22 are alternately arranged along the longitudinal direction. Thereby, separation of the 1 st coil 21 and the 2 nd coil 22 is suppressed. The length of the winding of the base end portion of the 1 st coil 21 and the tip end portion of the 2 nd coil 22 is 0.1mm to 2mm. The 1 st coil 21 and the 2 nd coil 22 are wound in the same winding direction so as to be wound together.

The outer diameters of the wires of the 1 st coil 21 and the 2 nd coil 22 are 20 μm to 90 μm, preferably 30 μm to 70 μm. In the present embodiment, the outer diameter of the wire forming the 1 st coil 21 is larger than the outer diameter of the wire forming the 2 nd coil 22. The wires forming the 1 st coil 21 and the 2 nd coil 22 may be not only one wire but also a twisted wire composed of two or more wires.

The wires of the 1 st coil 21 and the 2 nd coil 22 are not particularly limited, and may be formed of a metal such as stainless steel, super-elastic alloy, cobalt-based alloy, gold, platinum, tungsten, or an alloy containing these metals. For example, the 1 st coil 21 is a platinum alloy softer and more highly contrasting than the 2 nd coil 22, and the material of the 2 nd coil 22 is made of stainless steel. The platinum alloy is preferably Pt-Ir, pt-Ni, pt-W or the like.

The outer diameters of the 1 st coil 21 and the 2 nd coil 22 are preferably constant from the tip end to the base end. In the present embodiment, the outer diameter of the 1 st coil 21 is substantially equal to the outer diameter of the 2 nd coil 22. Thus, the outer diameter of the lumen 20 is substantially constant from the distal end to the proximal end. The outer diameters of the 1 st coil 21 and the 2 nd coil 22 are 0.15mm to 2mm.

The material for forming the wires constituting the 1 st coil 21 and the 2 nd coil 22, the outer diameter of the wires, the cross-sectional shape of the wires, the pitch of the wires, and the like can be appropriately selected according to the purpose of the guide wire 100. The cross-sectional shape of the wire rod is preferably circular, but may be elliptical, polygonal, or the like. The center of the cross section of the wire rod having a cross section shape other than a circle can be the center of gravity of the cross section of the wire rod.

Fixing part

The fixing portion 30 is a member for fixing the lumen 20 to the core member 10. In the guide wire 100 of the present embodiment, the fixing portion 30 includes a distal end fixing portion 31 for fixing the distal end of the lumen 20 to the core member 10, an intermediate fixing portion 32 for fixing the intermediate portion of the lumen 20 to the core member 10, and a proximal end fixing portion 33 for fixing the proximal end of the lumen 20 to the core member 10.

The material forming the fixing portion 30 is solder or solder. The solder includes gold solder, silver solder, and the like. The solder material includes Sn-Ag alloy solder, sn-Pb alloy solder, and the like. The material forming the fixing portion 30 may be an adhesive.

The distal end fixing portion 31 fixes the distal end portion of the 1 st coil 21 to the flat plate portion 11g of the 1 st core 11. The distal end fixing portion 31 is positioned at the forefront end of the guide wire 100, and the outer surface is smoothly formed in a substantially hemispherical shape.

The intermediate fixing portion 32 fixes the base end portion of the 1 st coil 21 and the tip end portion of the 2 nd coil 22 to the 2 nd taper portion 11e of the 1 st core portion 11. The intermediate fixing portion 32 is provided in the 1 st core portion 11 at a position where the base end portion of the 1 st coil 21 and the tip end portion of the 2 nd coil 22 are in contact.

When the base end portion of the 1 st coil 21 and the tip end portion of the 2 nd coil 22 are partially wound and disposed, the base end portion of the 1 st coil 21 and the tip end portion of the 2 nd coil 22 may be fixed via the tubular member 32 a. The tubular member 32a is disposed between the inner peripheral surface of the lumen 20 and the outer peripheral surface of the core member 10. The tubular member 32a fixes the lumen 20 and the core member 10 coaxially by reducing a gap between the inner peripheral surface of the lumen 20 and the outer peripheral surface of the core member 10. In the guide wire 100 of the present embodiment, the outer diameter of the distal end portion of the tubular member 32a is smaller than the outer diameter of the proximal end portion of the tubular member 32 a. Thus, as shown in fig. 2, the 1 st coil 21 having a small inner diameter and the 2 nd coil 22 having a large inner diameter can be coaxially fixed to the core member 10. The outer diameter of the distal end portion of the tubular member 32a and the outer diameter of the proximal end portion of the tubular member 32a may be appropriately selected in accordance with the inner diameter of the 1 st coil 21 and the inner diameter of the 2 nd coil 22. The tubular member 32a can be formed of a metal or a resin material.

The base end fixing portion 33 fixes the base end portion of the 2 nd coil 22 to the 2 nd outer diameter constant portion 11d of the 1 st core portion 11.

Cover layer

The cover layer 40 includes a 1 st cover layer 41, a 2 nd cover layer 42, and a 3 rd cover layer 43. The cover 40 can be formed of a material that reduces friction generated between the guidewire 100 and the vessel, catheter. Thus, the cover 40 improves the operability and safety of the guidewire 100.

The 1 st cover layer 41 covers the outer surfaces of the portions (the lumen 20, the fixing portion 30) provided in the 1 st core portion 11 and a portion (the 2 nd outer diameter constant portion 11 d) of the 1 st core portion 11.

The 2 nd cover layer 42 covers a portion of the 1 st core 11 located on the proximal end side with respect to the lumen 20. The 2 nd coating layer 42 covers the outer surface of the base end portion (1 st taper portion 11c, 1 st outer diameter constant portion 11 b) of the 1 st core portion 11.

The 3 rd cover layer 43 covers the outer surface of the base 12a of the 2 nd core.

The 1 st connection portion 11a of the 1 st core 11, the connection member 50, and the 2 nd connection portion 12b of the 2 nd core 12 are not covered with the cover layer 40. In addition, the cover layer 40 may be provided at a portion not covered with the cover layer 40.

The 1 st cover layer 41 can be formed of a low friction material. Examples of the low friction material include hydrophilic polymers and silicones. Examples of the hydrophilic polymer forming the 1 st cover layer 41 include cellulose-based polymer, polyethylene oxide-based polymer, maleic anhydride-based polymer (for example, maleic anhydride copolymer such as methyl vinyl ether-maleic anhydride copolymer), acrylamide-based polymer (for example, polyacrylamide, block copolymer of glycidyl methacrylate-dimethylacrylamide), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone, and derivatives thereof.

The 2 nd and 3 rd cover layers 42 and 43 can be formed of a low friction material. Examples of the low friction material include polyolefin such as polyethylene and polypropylene, polyvinyl chloride, polyester (PET, PBT, etc.), polyamide, polyimide, polyurethane, polystyrene, polycarbonate, silicone, fluororesin (PTFE, ETFE, etc.), and a composite material thereof.

The material for forming the 1 st cover layer 41, the 2 nd cover layer 42, and the 3 rd cover layer 43 is not limited to the above. The 1 st cover layer 41, the 2 nd cover layer 42, and the 3 rd cover layer 43 may be formed of different materials along the longitudinal direction of the core member 10. For example, in the 1 st cover layer 41, the tip end portion of the 1 st core portion 11 is formed of silicone, and the base end portion of the 1 st core portion 11 is formed of a hydrophilic polymer. The number of layers of the 1 st cover layer 41, the 2 nd cover layer 42, and the 3 rd cover layer 43 may be plural. Further, any of the 1 st cover layer 41, the 2 nd cover layer 42, and the 3 rd cover layer 43 may not be provided.

Connecting parts

The connection member 50 is a member that connects the base end portion of the 1 st core portion 11 and the tip end portion of the 2 nd core portion 12. The connection member 50 is a metal tube having a predetermined length and an inner cavity 51.

The 1 st core 11 is fitted to the connection member 50 by inserting and pushing the base end side of the base end taper portion 112a of the 1 st connection portion 11a from the tip end of the connection member 50 into the cavity 51. The 2 nd core portion 12 is fitted to the connection member 50 by inserting and pushing the distal end side of the distal end tapered portion 122b of the 2 nd connection portion 12b from the base end of the connection member 50 into the inner cavity 51. Thereby, the connection member 50 can connect the 1 st core 11 and the 2 nd core 12. In a state where the 1 st core 11 and the 2 nd core 12 are connected via the connecting member 50, the base end (base end connecting outer diameter constant portion 111 a) of the 1 st core 11 and the tip end (tip end connecting outer diameter constant portion 121 b) of the 2 nd core 12 are separated within the inner cavity 51 of the connecting member 50.

Before fitting, the outer diameter of the connecting member 50 is substantially constant from the tip to the base of the connecting member 50, and is 0.3mm to 0.8mm. The inner diameter of the connecting member 50 is substantially constant from the tip end to the base end of the connecting member 50 and is 0.2mm to 0.6mm. The wall thickness t of the connection member 50 is 0.03mm to 0.10mm. The length of the connection member 50 is 5mm to 200mm.

The metal forming the connection member 50 may be a super-elastic alloy such as stainless steel, a Ni-Cr-based alloy, a Ni-Ti-based alloy, a Ni-Al-based alloy, or a Cu-Zn-based alloy. The metal forming the connection member 50 is preferably a super elastic alloy, and more preferably a ni—ti based alloy. Thus, the guide wire 100 is less likely to cause kinking at the position of the connecting member 50. In addition, the connection member 50 is formed of the same metal as the core member 10, so that the connection member 50 and the core member 10 can be easily fixed by welding.

Fitting part

The fitting portion 60 is a contact portion between the core member 10 and the connection member 50. The fitting portion 60 has a distal end fitting portion 61 as a contact portion between the distal end portion of the 1 st core portion 11 and the distal end portion of the connecting member 50, and a proximal end fitting portion 62 as a contact portion between the distal end portion of the 2 nd core portion 12 and the proximal end portion of the connecting member 50. The fitting portion 60 is formed when the 1 st core 11 is fitted with the connecting member 50 and when the 2 nd core 12 is fitted with the connecting member 50, so that the connection of the 1 st core 11 with the connecting member 50 and the connection of the 2 nd core 12 with the connecting member 50 become firm.

The tip fitting portion 61 is a contact portion between the 1 st core portion 11 and the connecting member 50. After the base end connection outer diameter constant portion 111a and a part of the 1 st connection taper portion 13a of the 1 st core portion 11 are inserted into the inner cavity 51 of the connection member 50 and the 1 st connection taper portion 13a is brought into contact with the distal end of the connection member 50, a predetermined fitting pressure is applied to push the 1 st core portion 11 into the inner cavity 51 of the connection member 50, whereby the 1 st core portion 11 is fitted into the connection member 50. Thus, the tip fitting portion 61 is formed at a portion where the outer surface of the 1 st connection taper portion 13a of the 1 st core portion 11 contacts the inner surface of the tip portion of the connection member 50.

The distal end fitting portion 61 preferably has a flared (horn) shape in which the connecting member 50 spreads radially outward so as to follow the outer surface of the 1 st connecting taper portion 13 a. When the 1 st core 11 is fitted to the connecting member 50, the distal end portion of the connecting member 50 is formed in an expanded shape that expands radially outward so that the connecting member 50 follows the outer surface of the 1 st connecting taper portion 13a by pushing the 1 st core 11 into the inner cavity 51 of the connecting member 50. Therefore, the inner diameter and outer diameter of the connecting member 50 in the distal end fitting portion 61 are larger than those of the connecting member 50 before fitting. In the case where the front end portion of the connection member 50 is not in the open shape, only the inner surface of the front end of the connection member 50 in the connection member 50 is in contact with the outer surface of the 1 st connection taper portion 13 a. Therefore, the tip fitting portion 61 is formed only in a minute region near the tip of the connecting member 50. When the distal end portion of the connecting member 50 is in the open shape, the area of the distal end fitting portion 61 is larger than when the distal end portion of the connecting member 50 is not in the open shape. Therefore, the distal end fitting portion 61 is formed in an open shape, whereby the 1 st core 11 is firmly fitted to the connecting member 50. In addition, by forming the distal end fitting portion 61 in an open shape, the guide wire 100 can suppress stress concentration at the distal end of the connecting member 50 during bending, and therefore kinking starting from the distal end of the connecting member 50 is less likely to occur. On the other hand, when the 1 st core 11 is pushed too far into the inner cavity 51 of the connecting member 50 during fitting of the 1 st core 11 and the connecting member 50, the distal end portion of the connecting member 50 is not deformed and is broken. Therefore, the length of the distal end fitting portion 61 in the longitudinal direction is preferably 0.1mm to 3.0mm.

When the 1 st core 11 is fitted to the connecting member 50, the base end connection outer diameter constant portion 111a and a part of the 1 st connection taper portion 13a of the 1 st core 11 are disposed in the inner cavity 51 of the connecting member 50. Since the 1 st connection portion 11a of the 1 st core portion 11 has the base end connection outer diameter constant portion 111a, the length of the 1 st core portion 11 disposed in the inner cavity 51 of the connection member 50 is longer than in the case where the 1 st connection portion 11a is formed only by the base end taper portion 112 a. Thus, since the separation distance between the 1 st core 11 and the 2 nd core 12 in the inner cavity 51 of the connecting member 50 can be shortened, the core member 10 can suppress a local decrease in rigidity at the portion where the 1 st core 11 and the 2 nd core 12 are separated in the inner cavity 51 of the connecting member 50.

The base end fitting portion 62 is a contact portion between the 2 nd core portion 12 and the connecting member 50. After inserting the tip end connection outer diameter constant portion 121b and a part of the tip end tapered portion 122b of the 2 nd core portion 12 into the inner cavity 51 of the connecting member 50 and bringing the tip end tapered portion 122b into contact with the base end of the connecting member 50, a predetermined fitting pressure is applied and the 2 nd core portion 12 is pushed into the inner cavity 51 of the connecting member 50, whereby the 2 nd core portion 12 is fitted into the connecting member 50. Thus, the base end fitting portion 62 is formed at a portion where the outer surface of the tip tapered portion 122b of the 2 nd core portion 12 contacts the inner surface of the base end portion of the connecting member 50.

In the fitting of the 2 nd core 12 to the connecting member 50, the base end portion of the connecting member 50 is formed in an expanded shape, so that the same effect as the fitting of the 1 st core 11 to the connecting member 50 is obtained. The length of the base end fitting portion 62 in the longitudinal direction is 0.1mm to 3.0mm.

When the 2 nd core 12 is fitted to the connecting member 50, a part of the distal end connection outer diameter constant portion 121b and the distal end tapered portion 122b of the 2 nd core 12 is disposed in the inner cavity 51 of the connecting member 50. Since the 2 nd connecting portion 12b of the 2 nd core portion 12 has the distal end connecting outer diameter constant portion 121b, the length of the 2 nd core portion 12 disposed in the inner cavity 51 of the connecting member 50 is longer than in the case where the 2 nd connecting portion 12b is formed only by the distal end tapered portion 122 b. Thus, since the separation distance between the 1 st core 11 and the 2 nd core 12 in the inner cavity 51 of the connecting member 50 can be shortened, the core member 10 can suppress a local decrease in rigidity at the portion where the 1 st core 11 and the 2 nd core 12 are separated in the inner cavity 51 of the connecting member 50.

The fitting of the 1 st core 11 to the connection member 50 and the fitting of the 2 nd core 12 to the connection member 50 are performed by mechanical fitting by a fitting machine. The mechanical fitting by the fitting machine can be performed with a fixed fitting pressure (pushing force), or the fitting pressure can be varied stepwise. The fitting of the 1 st core 11 to the connecting member 50 and the fitting of the 2 nd core 12 to the connecting member 50 may be performed by a human hand, or a human hand and a fitting machine may be used simultaneously.

Connection fixing part

The core member 10 and the connection member 50 are fixed by the connection fixing portion 70. The connection fixing portion 70 includes a distal end connection fixing portion 71 for fixing the distal end portion of the connection member 50 to the 1 st core portion 11, and a proximal end connection fixing portion 72 for fixing the proximal end portion of the connection member 50 to the 2 nd core portion 12.

The distal end connection fixing portion 71 fixes the distal end portion of the connection member 50 to the 1 st connection taper portion 13a of the 1 st core portion 11. By providing the distal end connection fixing portion 71 in addition to the distal end fitting portion 61, the 1 st core 11 and the connection member 50 can be firmly connected. The distal end connecting and fixing portion 71 is provided at a position separated from the distal end fitting portion 61 toward the proximal end side in the longitudinal direction. As a result, the fixing portion between the 1 st core 11 and the connecting member 50 as viewed in the longitudinal direction is formed as two portions, i.e., the distal end fitting portion 61 and the distal end connecting and fixing portion 71, so that the 1 st core 11 and the connecting member 50 can be more firmly connected. The front-end connection fixing portions 71 are preferably provided at two positions opposite in the radial direction of the connection member 50.

The distal end connecting and fixing portion 71 is preferably a welded portion formed by laser welding. Since the laser welding can fix the connection member 50 to the 1 st connection taper portion 13a without changing the outer diameter of the connection member 50, the influence of the distal end connection fixing portion 71 on the function of the guide wire 100 can be reduced. The welded portion is substantially circular with a radius of 0.05mm to 0.40mm around the laser irradiation point P.

The outer surface of the 1 st connection taper portion 13a and the inner surface of the connection member 50 are preferably separated in the radial direction on the front end side and the base end side of the front end connection fixing portion 71. In laser welding, a metal as a material to be welded is irradiated with a predetermined laser beam to melt and solidify the metal, thereby connecting the materials to be welded. Therefore, if the distal end connecting and fixing portion 71 is provided at the position of the distal end fitting portion 61 between the 1 st core 11 and the connecting member 50 or adjacent to the distal end fitting portion 61, the radial distance between the 1 st core 11 and the connecting member 50 is too short, so that gas generated when the metal melts is liable to remain in the distal end connecting and fixing portion 71, and air holes, pits, cracks, and the like are liable to occur. As a result, the front end connection fixing portion 71 has irregularities on the outer surface, which results in poor appearance or insufficient fixing strength. Since the 1 st connection taper portion 13a gradually decreases in outer diameter toward the base end side, the radial distance between the 1 st core portion 11 and the connection member 50 becomes longer as it goes from the tip end of the connection member 50 toward the base end side. Therefore, if the distal end connecting and fixing portion 71 is provided at a position separated from the distal end of the connecting member 50 by a predetermined distance or more, the radial distance between the 1 st core 11 and the connecting member 50 becomes too long, and the molten metal spreads in the space between the 1 st core 11 and the connecting member 50, and the outer surface tends to be recessed. This causes the front end connection fixing portion 71 to have a poor appearance. Further, since the contact area between the 1 st core 11 and the connecting member 50 and the molten metal becomes small, the fixing strength of the distal end connecting and fixing portion 71 becomes insufficient.

In the guide wire 100 of the present embodiment, the distal end connection fixing portion 71 is provided at a position where the outer surface of the 1 st connection taper portion 13a and the inner surface of the connection member 50 are radially separated from each other on the distal end side and the proximal end side of the distal end connection fixing portion 71. Therefore, the gas generated during the metal melting also escapes from the distal end side and the proximal end side of the distal end connecting and fixing portion 71, and it is difficult to generate pores, pits, cracks, and the like. In addition, since the molten metal spreads moderately in the space between the 1 st core 11 and the connecting member 50, the outer surface of the connecting member 50 becomes smooth and a sufficient connection strength is obtained.

By forming the distal end connecting and fixing portion 71 at a position where the outer surface of the 1 st connecting taper portion 13a and the inner surface of the connecting member 50 are radially separated from each other on the distal end side and the proximal end side of the distal end connecting and fixing portion 71 in this manner, the outer surface of the welded portion between the 1 st core portion 11 of the guide wire 100 and the connecting member 50 becomes smooth and the connection strength is high.

The distance S in the longitudinal direction from the tip of the connecting member 50 to the laser irradiation point P is preferably 2.5mm to 4.0mm. That is, the center of the welded portion is located 2.5mm to 4.0mm away from the distal end of the connecting member 50 toward the base end side in the longitudinal direction. Thus, the distal end connecting and fixing portion 71 (welded portion) is formed in a range of 2.0mm to 4.5mm from the distal end of the connecting member 50 toward the base end side in the longitudinal direction. Further, the distance H between the outer surface of the 1 st connection taper portion 13a and the inner surface of the connection member 50 at the laser irradiation point P for forming the tip connection fixing portion 71 is preferably 0.0005mm to 0.0017mm in the radial direction. Thus, the distance between the outer surface of the 1 st connection taper portion 13a and the inner surface of the connection member 50 in the radial direction is in the range of 0.0001mm to 0.0021mm, by which the tip connection fixing portion 71 (welded portion) is formed. By forming the distal end connection fixing portion 71 in the above-described range, the distal end portion of the connection member 50 can be firmly connected to the 1 st core 11, and can have a smooth outer surface with small irregularities.

The ratio r (r=h/t) of the distance H in the radial direction between the outer surface of the 1 st connection taper portion 13a and the inner surface of the connection member 50 at the laser irradiation point P to the wall thickness t of the connection member 50 is preferably 0.01 to 0.05, more preferably 0.010 to 0.034. That is, the center of the welded portion is preferably set at a position where the ratio r is 0.01 to 0.05, more preferably at a position where the ratio r is 0.010 to 0.034. When the ratio r is equal to or greater than the lower limit value, the gas generated when the metal is melted can be released from the distal end connecting and fixing portion 71, and thus, the distal end connecting and fixing portion 71 is less likely to generate pores, pits, cracks, and the like. In addition, when the ratio r is equal to or less than the upper limit value, the amount of metal melted by the laser irradiation in the distal end connecting and fixing portion 71 becomes sufficient with respect to the volume of the space between the 1 st core portion 11 and the connecting member 50, and the outer surface is less likely to be dented. Further, since the contact area between the 1 st core 11 and the connecting member 50 and the molten metal becomes large, the fixing strength of the distal end connecting and fixing portion 71 is improved. By setting the ratio r to the above range, the tip end portion of the connecting member 50 can be firmly connected to the 1 st core 11, and can have a smooth outer surface with small irregularities.

The base end connection fixing portion 72 fixes the base end portion of the connection member 50 to the tip tapered portion 122b of the 2 nd core 12. By providing the base end connection fixing portion 72 in addition to the base end fitting portion 62, the 2 nd core portion 12 and the connecting member 50 can be more firmly connected. The connecting material 72a forming the base end connecting and fixing portion 72 is solder or solder. The solder is gold solder or silver solder, etc. The solder is Sn-Ag alloy solder, sn-Pb alloy solder, etc. The connecting material 72a may be an adhesive.

The proximal end connecting and fixing portion 72 is disposed adjacent to the proximal end side of the proximal end fitting portion 62 between the 2 nd core portion 12 and the connecting member 50, and has a tapered shape in which the outer diameter decreases from the proximal end toward the proximal end side of the connecting member 50. Accordingly, the level difference corresponding to the wall thickness t of the connection member 50 at the base end of the connection member 50 is reduced, and therefore, the tip damage of the catheter at the time of inserting the catheter from the base end side of the guidewire 100 can be suppressed. The tapered shape of the base end connection fixing portion 72 can be formed by mechanically polishing the outer surface of the connection material 72 a.

The guide wire 100 of the present embodiment has a continuous taper portion 13 at the base end taper portion 112a of the 1 st core portion 11, and the continuous taper portion 13 is composed of a 1 st connecting taper portion 13a and a 2 nd connecting taper portion 13b which is disposed adjacent to the 1 st connecting taper portion 13a on the tip end side thereof and has an inclination angle θ different from that of the 1 st connecting taper portion 13 a. Thus, a rigidity changing point is formed at the boundary position between the 1 st connecting taper portion 13a and the 2 nd connecting taper portion 13b forming the continuous taper portion 13, where the rigidity in the longitudinal direction of the guide wire 100 changes. In the guide wire 100, a part of the continuous taper portion 13 on the base end side of the 1 st connection taper portion 13a is disposed in the lumen 51 of the connection member 50, and the 2 nd connection taper portion 13b is not disposed in the lumen 51 of the connection member 50. Therefore, the rigidity changing point is disposed at a position closer to the distal end of the guide wire 100 than the distal end of the connecting member 50.

The guide wire 100 thus configured has a smaller radius of curvature from the point of change in rigidity obtained by the continuous taper portion 13 to the tip of the connecting member 50 when bent. Therefore, the guide wire 100 having the rigidity changing point at the distal end side of the distal end of the connecting member 50 due to the continuous taper portion 13 can reduce the contact area between the guide wire 100 and the inner surface of the blood vessel when passing through the curved portion of the blood vessel, as compared with the guide wire 100 having no continuous taper portion 13. Therefore, the passability of the guidewire 100 at the curved portion of the blood vessel is improved, and the load imposed on the blood vessel is reduced. Since the chance of the end of the connecting member 50 coming into contact with the inner surface of the blood vessel is reduced in the guide wire 100, even when the end of the connecting member 50 has a layer difference corresponding to the wall thickness t of the connecting member 50, damage to the blood vessel can be suppressed.

The 1 st core 11 of the guide wire 100 is formed of a super elastic alloy, and the continuous taper portion 13 is disposed at the base end taper portion 112a of the 1 st core 11. Superelastic alloys are difficult to plastically deform. By disposing the continuous taper portion 13 in the 1 st core portion 11 made of the super elastic alloy, kinking of the guide wire 100 is less likely to occur even when the radius of curvature from the rigidity change point obtained by the continuous taper portion 13 to the tip of the connecting member 50 becomes smaller.

In the 1 st core 11, the inclination angle θ1 of the 1 st connection taper portion 13a fitted to the connection member 50 is preferably 0.01 ° < θ1 < 0.05 °. A part of the 1 st connection taper portion 13a on the base end side is disposed in the cavity 51 of the connection member 50. The 1 st connection taper portion 13a becomes longer in length as the inclination angle θ1 is reduced, the 1 st connection taper portion 13a disposed in the inner cavity 51 of the connection member 50. Therefore, the 1 st connection taper portion 13a can shorten the separation distance between the 1 st core portion 11 and the 2 nd core portion 12 in the inner cavity 51 of the connection member 50 by making the inclination angle θ1 smaller than the predetermined angle. Thereby, the guide wire 100 can suppress a local decrease in rigidity at a portion where the 1 st core 11 and the 2 nd core 12 are separated in the lumen 51 of the connecting member 50.

When the 1 st core 11 is fitted to the connecting member 50, the portion of the 1 st 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 1 st connection taper portion 13a disposed in the inner cavity 51 of the connection member 50, the connection member 50 is less likely to flex due to the fitting pressure, and plastic deformation can be suppressed. As a result, the true straightness of the guide wire 100 is increased, and torque transmissibility is improved. Further, since the 1 st core 11 and the connecting member 50 can be fitted with a high fitting pressure, the 1 st core 11 and the connecting member 50 can be fitted more firmly.

Further, by setting the inclination angle θ1 to be smaller than the upper limit value, the 1 st connection taper portion 13a at the front end portion of the connection member 50 becomes shorter in distance between the outer surface of the 1 st connection taper portion 13a and the inner surface of the connection member 50. Accordingly, the distal end portion of the connecting member 50 is effectively supported by the 1 st connecting taper portion 13a, and therefore breakage of the connecting member 50 at the time of engagement is suppressed. If the inclination angle θ1 of the 1 st connection taper portion 13a is smaller than the upper limit value, the distal end portion of the connection member 50 is easily deformed into a shape along the outer surface of the 1 st connection taper portion 13a during fitting, and therefore the distal end fitting portion 61 having an open shape is easily formed. On the other hand, if the inclination angle θ1 of the 1 st connection taper portion 13a is equal to or greater than the upper limit value, the rate of change of the outer diameter of the 1 st connection taper portion 13a increases. Therefore, the guide wire 100 is liable to kink by rapidly changing its rigidity in the longitudinal direction in the vicinity of the boundary between the base end connecting the constant outer diameter portion 111a and the 1 st connecting taper portion 13 a. If the inclination angle θ1 of the 1 st connection taper portion 13a is equal to or less than the lower limit value, it is difficult to determine the positions of the 1 st connection taper portion 13a and the connection member 50 at the time of engagement, and it is difficult to form the distal end engagement portion 61 at a desired position.

As described above, the inclination angle θ of the taper portion fitted to the connecting member 50 (the inclination angle θ1 of the 1 st connecting taper portion 13 a) is preferably smaller than the predetermined angle. However, if the proximal tapered portion 112a is a single tapered portion having a small inclination angle θ, the guide wire 100 has a portion having a smaller outer diameter than the 1 st outer diameter constant portion 11b on the distal end side of the connecting member 50. In the portion of the guide wire 100 where the outer diameter is small, the difference between the outer diameter of the guide wire 100 and the inner diameter of the catheter increases, so that the support of the guide wire 100 to the catheter decreases. In addition, the rigidity of the portion of the guide wire 100 having a small outer diameter is also reduced, and thus the pushability of the guide wire 100 is reduced.

By setting the proximal end tapered portion 112a to the continuous tapered portion 13, the guide wire 100 is shortened in length from the tip of the connecting member 50 to the 1 st constant outer diameter portion 11b, as compared with the case where the proximal end tapered portion 112a is a single tapered portion. Thus, the guide wire 100 can suppress a decrease in the support property and the pushability of the catheter. Further, the guide wire 100 can shorten the distance between the 1 st core portion 11 and the connecting member 50 when the 1 st outer diameter constant portion 11b of the 1 st core portion 11 is gripped and engaged. Therefore, the 1 st core 11 is easy to insert into the connection member 50 when the 1 st core 11 is fitted, and the possibility of breakage of the 1 st core 11 and the connection member 50 is reduced. This increases the straightness of the guide wire 100 and improves torque transmissibility. Also, the 1 st core 11 can increase the length of the portion covered by the 2 nd cover layer 42. Thereby, frictional resistance between the guide wire 100 and the blood vessel is reduced, and the passage in the blood vessel is improved.

In the continuous taper portion 13, the inclination angle θ2 of the 2 nd connecting taper portion 13b is larger than the inclination angle θ1 of the 1 st connecting taper portion 13 a. Thus, the 1 st core 11 can set the rigidity change point obtained by the continuous taper portion 13 while reducing the change in rigidity in the longitudinal direction of the 1 st connecting portion 11 a. When the inclination angle θ2 of the 2 nd connection taper portion 13b is smaller than the inclination angle θ1 of the 1 st connection taper portion 13a, the effect of shortening the length of the portion from the tip of the connection member 50 to the 1 st constant outer diameter portion 11b, which is small in outer diameter, is reduced, and therefore it is difficult to obtain the effect based on the base end taper portion 112a being the continuous taper portion 13.

The inclination angle θ2 of the 2 nd connection taper portion 13b is preferably 0.1 ° < θ2 < 2.5 °. Thus, since the rigidity in the longitudinal direction in the vicinity of the boundary between the 1 st connecting taper portion 13a and the 2 nd connecting taper portion 13b gently varies, the guide wire 100 can suppress kinking at the base end taper portion 112 a.

The 1 st connection taper portion 13a and the 2 nd connection taper portion 13b have different lengths. The length L2 of the 1 st connection taper portion 13a is preferably longer than the length L3 of the 2 nd connection taper portion 13 b. The length L2 of the 1 st connection taper portion 13a is 25mm to 33mm. The length L3 of the 2 nd connecting taper portion 13b is 1mm to 7mm.

By setting the length L2 of the 1 st connection tapered portion 13a longer than the length L3 of the 2 nd connection tapered portion 13b, the 1 st core portion 11 can increase the length of the 1 st connection tapered portion 13a disposed in the inner cavity 51 of the connection member 50, and shorten the length from the tip of the connection member 50 to the 1 st outer diameter constant portion 11 b. If the length of the 1 st connection taper portion 13a disposed in the inner cavity 51 of the connection member 50 is increased, the separation distance between the 1 st core portion 11 and the 2 nd core portion 12 in the inner cavity 51 of the connection member 50 is shortened, and therefore, the guidewire 100 can suppress a local decrease in rigidity at a portion where the 1 st core portion 11 and the 2 nd core portion 12 are separated in the inner cavity 51 of the connection member 50. Further, since the length of the portion from the tip of the connecting member 50 to the 1 st constant outer diameter portion 11b is shortened, the guide wire 100 suppresses a decrease in the support property and pushability of the catheter.

When the 1 st core 11 is fitted to the connecting member 50, the portion of the 1 st 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 1 st connection taper portion 13a disposed in the inner cavity 51 of the connection member 50, the connection member 50 is less likely to be deformed by the fitting pressure, and plastic deformation of the connection member 50 can be suppressed. Further, the guide wire 100 can shorten the distance between the 1 st core portion 11 and the connecting member 50 when the 1 st outer diameter constant portion 11b of the 1 st core portion 11 is gripped and engaged. Therefore, with respect to the 1 st core 11, the 1 st core 11 is easily inserted into the connection member 50 at the time of fitting, and the possibility of breakage of the 1 st core 11 and the connection member 50 is reduced. As a result, the true straightness of the guide wire 100 is increased, and torque transmissibility is improved.

Further, by shortening the length from the tip of the connecting member 50 to the 1 st outer diameter constant portion 11b, the 1 st core portion 11 can be increased in length of the portion covered with the 2 nd cover layer 42. Thereby, the frictional resistance of the guide wire 100 is reduced, and the passage in the blood vessel is improved.

[ method of production ]

Next, a method for manufacturing the guide wire 100 according to the present embodiment will be described. The following description will be given of the process of connecting the 1 st core portion 11 and the 2 nd core portion 12 to the connecting member 50, and the description of other processes for manufacturing the guide wire 100 will be omitted.

(Process 1)

Step 1 is a step of inserting a part of the 1 st connection taper portion 13a of the 1 st core portion 11 and the 1 st outer diameter constant portion 111a from the distal end side of the connection member 50 into the cavity 51 of the connection member 50. By inserting a part of the 1 st connection taper portion 13a of the 1 st core portion 11 into the inner cavity 51 of the connection member 50, the outer surface of the 1 st connection taper portion 13a of the 1 st core portion 11 is in contact with the inner surface of the front end portion of the connection member 50.

(Process 2)

Step 2 is a step of fitting the 1 st core 11 to the connecting member 50. In step 2, the 1 st core 11 and the connecting member 50 are moved relatively close to each other in a state in which the base end of the 1 st core 11 is connected to the constant outer diameter portion 111a and a part of the 1 st connecting tapered portion 13a of the 1 st core 11 is inserted into the inner cavity 51 of the connecting member 50 and the outer surface of the 1 st connecting tapered portion 13a of the 1 st core 11 is brought into contact with the inner surface of the distal end portion of the connecting member 50. By the relative movement of the 1 st core 11 and the connecting member 50, a part of the 1 st connection taper portion 13a of the 1 st core 11, which connects the outer diameter constant portion 111a and the 1 st core 11, is pushed in toward the base end side of the inner cavity 51 of the connecting member 50. When the base end connection outer diameter constant portion 111a of the 1 st core portion 11 and a part of the 1 st connection tapered portion 13a of the 1 st core portion 11 are pushed toward the base end side of the connection member 50, the tip end portion of the connection member 50 is formed in an expanded shape that expands radially outward so as to follow the outer surface of the 1 st connection tapered portion 13a of the 1 st core portion 11 by applying a predetermined fitting pressure. Thus, the distal end fitting portion 61 in which the outer surface of the 1 st connection tapered portion 13a of the 1 st core portion 11 is fitted to the inner surface of the distal end portion of the connecting member 50 can be formed at a portion where the outer surface of the 1 st connection tapered portion 13a of the 1 st core portion 11 is in contact with the inner surface of the distal end portion of the connecting member 50. The operation of pushing the 1 st core 11 into the connecting member 50 can be performed using a known fitting machine 200.

(step 3)

Step 3 is a step of irradiating the outer surface of the connecting member 50 with laser light from the radially outer side of the connecting member 50 to form a distal end connection fixing portion 71 (welded portion) for fixing the connecting member 50 to the 1 st connection taper portion 13a of the 1 st core portion 11. At this time, the laser irradiation point P is set to be a position separated from the position where the outer surface of the 1 st connection taper portion 13a of the 1 st core portion 11 contacts the inner surface of the distal end portion of the connection member 50 by a predetermined distance toward the base end side of the connection member 50. By irradiating laser light to a position separated by a predetermined distance from the outer surface of the 1 st connection taper portion 13a of the 1 st core portion 11 and the inner surface of the distal end portion of the connection member 50 toward the base end side of the connection member 50, the distal end connection fixing portion 71 can be formed at a position separated by a predetermined distance from the distal end of the connection member 50. Further, by irradiating laser light to two positions of the connection member 50 which are opposite to each other in the radial direction, the tip connection fixing portion 71 can be provided at the two positions. The operation of irradiating the connection member 50 with laser light can be performed using a known laser irradiation apparatus.

(Process 4)

Step 4 is a step of inserting a part of the distal end connection outer diameter constant portion 121b of the 2 nd core portion 12 and the distal end tapered portion 122b of the 2 nd core portion 12 into the inner cavity 51 of the connecting member 50 from the proximal end side of the connecting member 50. By inserting a part of the front end tapered portion 122b of the 2 nd core portion 12 into the inner cavity 51 of the connection member 50, the outer surface of the front end tapered portion 122b of the 2 nd core portion 12 is in contact with the inner surface of the front end portion of the connection member 50.

(Process 5)

Step 5 is a step of fitting the 2 nd core 12 to the connecting member 50. In step 5, the 2 nd core portion 12 and the connecting member 50 are moved relatively close to each other in a state in which the distal end of the 2 nd core portion 12 is connected to the outer diameter constant portion 121b and a part of the distal end tapered portion 122b of the 2 nd core portion 12 is inserted into the inner cavity 51 of the connecting member 50 and the outer surface of the distal end tapered portion 122b of the 2 nd core portion 12 is brought into contact with the inner surface of the proximal end portion of the connecting member 50. By relatively moving the 2 nd core portion 12 and the connecting member 50, a part of the distal end connecting the outer diameter constant portion 121b and the distal end tapered portion 122b of the 2 nd core portion 12 is pushed toward the distal end side of the inner cavity 51 of the connecting member 50. When the distal end of the 2 nd core portion 12 is pushed toward the distal end side of the connecting member 50 by connecting the outer diameter constant portion 121b and a part of the distal end tapered portion 122b of the 2 nd core portion 12, the base end portion of the connecting member 50 is formed in an expanded shape that expands radially outward so as to follow the outer surface of the distal end tapered portion 122b of the 2 nd core portion 12 by applying a predetermined fitting pressure. Thus, the base end fitting portion 62 where the outer surface of the tip end tapered portion 122b of the 2 nd core portion 12 is fitted to the inner surface of the base end portion of the connection member 50 can be formed at a portion where the outer surface of the tip end tapered portion 122b of the 2 nd core portion 12 is in contact with the inner surface of the base end portion of the connection member 50. The work of pushing the 2 nd core 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 base end connection fixing portion 72 for fixing the base end portion of the connection member 50 to the tip tapered portion 122b of the 2 nd core portion 12. The base end connection fixing portion 72 can be formed by applying the connection material 72a to the outer surface of the tip tapered portion 122b of the 2 nd core portion 12 near the base end of the connection member 50.

(Process 7)

Step 7 is a step of mechanically polishing the outer surface of the connecting material 72a forming the base end connecting and fixing portion 72 to form a tapered shape having an outer diameter gradually decreasing from the base end toward the base end side of the connecting member 50. The work of mechanically polishing the outer surface of the connecting material 72a can be performed using a known polishing machine.

The guide wire 100 may be manufactured in place of the steps 1 to 3 and the steps 4 to 7. That is, the 1 st core 11 may be connected to the connection member 50 after the 2 nd core 12 is connected to the connection member 50.

[ Effect of the invention ]

As described above, the guide wire 100 according to the present embodiment is a guide wire 100 in which the proximal end portion of the 1 st core portion 11 and the distal end portion of the 2 nd core portion 12 disposed on the proximal end side of the 1 st core portion 11 are connected by the tubular connecting member 50, wherein the proximal end portion of the 1 st core portion 11 has the proximal end tapered portion 112a having the outer diameter gradually decreasing toward the proximal end, the distal end portion of the 2 nd core portion 12 has the distal end tapered portion 122b having the outer diameter gradually decreasing toward the distal end, at least one of the proximal end tapered portion 112a and the distal end tapered portion 122b has the continuous tapered portion 13 in the longitudinal direction of the guide wire 100, and the continuous tapered portion 13 includes the 1 st connecting tapered portion 13a disposed at a position closest to the proximal end of the 1 st core portion 11 or the distal end of the 2 nd core portion 12, and the 2 nd connecting tapered portion 13b having the outer surface 60 in which the continuous tapered portion 13a is fitted with the proximal end portion of the connecting member 13 a.

With this structure, the guide wire 100 changes in rigidity in the longitudinal direction of the guide wire 100 at the boundary position between the 1 st connecting tapered portion 13a and the 2 nd connecting tapered portion 13b forming the continuous tapered portion 13. Thus, the radius of curvature of the guide wire 100 when passing through the curved portion of the blood vessel is reduced, and thus the contact area between the guide wire 100 and the inner surface of the blood vessel can be reduced. Therefore, the passability of the guidewire 100 at the curved portion of the blood vessel is improved, and the load imposed on the blood vessel is reduced. Further, since the chance of the end portion of the connection member 50 coming into contact with the inner surface of the blood vessel is reduced, the guide wire 100 can suppress damage to the blood vessel even when the end portion of the connection member 50 has a level difference corresponding to the wall thickness t of the connection member 50.

The continuous taper portion 13 of the guide wire 100 according to the present embodiment may be disposed in the proximal taper portion 112a of the 1 st core portion 11, and the 1 st core portion 11 may be formed of a super elastic alloy.

With such a structure, even when the radius of curvature from the rigidity changing point obtained by the continuous taper portion 13 to the tip of the connecting member 50 becomes small, the guide wire 100 is less likely to kink.

In the guide wire 100 of the present embodiment, the inclination angle θ2 of the 2 nd connecting taper portion 13b may be larger than the inclination angle θ1 of the 1 st connecting taper portion 13a in the continuous taper portion 13.

With this structure, the guide wire 100 can set the rigidity change point obtained by the continuous taper portion 13 while reducing the change in rigidity in the longitudinal direction of the 1 st connecting portion 11 a.

In the guide wire 100 of the present embodiment, the length of the continuous taper portion 13 in the longitudinal direction of the 1 st connecting taper portion 13a may be longer than the length of the 2 nd connecting taper portion 13b in the longitudinal direction.

With this structure, the guide wire 100 can increase the length of the 1 st connection taper portion 13a disposed in the lumen 51 of the connection member 50, and can shorten the length from the distal end of the connection member 50 to the 1 st outer diameter constant portion 11 b. Thus, the guidewire 100 can suppress a local decrease in rigidity, a decrease in support for a catheter, and a decrease in pushability. In addition, since the possibility of plastic deformation and breakage of the connection member 50 when the 1 st core 11 is fitted to the connection member 50 is reduced in the guide wire 100, the straightness is improved and the torque transmissibility is improved. Further, since the length of the portion of the guide wire 100 covered with the 2 nd cover layer 42 in the 1 st core 11 is increased, the intravascular permeability is improved.

The connection fixing portion 70 for fixing the continuous taper portion 13 of the guide wire 100 and the connection member 50 according to the present embodiment may be provided at the 1 st connection taper portion 13a and at a position separated from the fitting portion 60 in the longitudinal direction.

With this structure, the fixing portion between the 1 st core 11 and the connecting member 50 when the guide wire 100 is viewed in the longitudinal direction is two portions, i.e., the fitting portion 60 and the distal end connecting and fixing portion 71, so that the 1 st core 11 and the connecting member 50 can be connected more firmly.

The outer surface of the 1 st connection taper portion 13a of the guide wire 100 according to the present embodiment may be separated from the inner surface of the connection member 50 in the radial direction on the distal end side and the proximal end side of the connection fixing portion 70.

With this structure, the outer surface of the connection member 50 including the connection fixing portion 70 of the guide wire 100 is smooth, and the connection strength of the 1 st core 11 and the connection member 50 is high.

The fitting portion 60 of the guide wire 100 according to the present embodiment may have an expanded shape in which the connecting member 50 expands radially outward so as to follow the outer surface of the 1 st connection taper portion 13 a.

With this structure, the guide wire 100 can increase the area of the fitting portion 60, and therefore the 1 st core 11 is firmly fitted to the connecting member 50. Further, since stress concentration at the distal end of the connecting member 50 during bending can be suppressed, kinking starting from the distal end of the connecting member 50 is less likely to occur in the guide wire 100.

[ example ]

The present invention will be specifically described below with reference to examples, but the scope of the present invention is not limited to the examples.

[ production of guide wire ]

The guide wire 100 of example 1 was manufactured as follows. In the manufacturing process, the steps 1, 3, 4, 6, and 7 in the above-described method for manufacturing the guide wire 100 are performed.

The 1 st core 11 of the guide wire 100 is formed by processing a wire made of a ni—ti alloy. The 1 st connecting portion 11a of the 1 st core portion 11 is formed to have a base end connecting outer diameter constant portion 111a and a base end tapered portion 112a. The base end taper portion 112a is formed as a continuous taper portion 13 in which the 1 st connecting taper portion 13a and the 2 nd connecting taper portion 13b are adjacently arranged in the longitudinal direction. The outer diameter d1 of the base end connection outer diameter constant portion 111a is 0.235mm, the outer diameter d2 of the tip end of the 1 st connection taper portion 13a is 0.279mm, and the outer diameter d3 of the tip end of the 2 nd connection taper portion 13b is 0.340mm. The length L1 of the base end connecting outer diameter constant portion 111a is 4mm, the length L2 of the 1 st connecting taper portion 13a is 29mm, and the length L3 of the 2 nd connecting taper portion 13b is 4mm. The 1 st connection taper portion 13a has an inclination angle θ1 of 0.04 °, and the 2 nd connection taper portion 13b has an inclination angle θ2 of 0.44 °.

The 2 nd core 12 of the guide wire 100 is formed by processing a wire made of stainless steel. The 2 nd connecting portion 12b of the 2 nd core portion 12 is formed to have a front end connecting outer diameter constant portion 121b and a front end tapered portion 122b. The front end taper 122b is formed as a single taper. The outer diameter of the distal end connecting outer diameter constant portion 121b is 0.235mm, and the outer diameter of the base end of the distal end tapered portion 122b is 0.340mm. The length of the tip-end-connected outer diameter constant portion 121b is 5mm, and the length of the tip taper portion 122b is 25mm. The inclination angle θ3 of the tip taper 122b is 0.14.

The connecting member 50 was a Ni-Ti alloy tube having an outer diameter of 0.350mm, an inner diameter of 0.255m, a wall thickness t of 0.048mm, and a length of 35 mm.

In step 1, the 1 st core 11 and the connecting member 50 are held by a tester, and a part of the 1 st connecting taper portion 13a of the 1 st core 11 and the 1 st outer diameter constant portion 111a are inserted from the distal end side of the connecting member 50 and forcibly pushed in, whereby the 1 st core 11 and the connecting member 50 are fitted.

In step 3, the tester uses the laser irradiation apparatus to set the laser irradiation point P at a position where the distance S from the distal end of the connection member 50 to the laser irradiation point P in the longitudinal direction is 2.5mm, and irradiates the laser. Next, the tester sets the laser irradiation point P at a position rotated 180 ° in the circumferential direction from the first laser irradiation point P to the 1 st core 11, and irradiates the laser. The voltage value at the time of laser irradiation was 280V, and the pulse width was 1.0ms.

In step 4, the 2 nd core 12 and the connecting member 50 are held by the tester, and a part of the distal end tapered portion 122b of the 2 nd core 12 is inserted from the proximal end side of the connecting member 50 and forcibly pushed in, whereby the 2 nd core 12 and the connecting member 50 are fitted.

In step 6, the base end connection fixing portion 72 for fixing the base end portion of the connection member 50 to the tip tapered portion 122b of the 2 nd core portion 12 is formed by soldering using solder as the connection material 72 a.

In step 7, the tester grinds the surface of the base end connecting and fixing portion 72 made of the connecting material 72a obtained by soldering in step 6 with a grinder, and forms the surface into a tapered shape having an outer diameter gradually decreasing toward the base end side.

The guide wire 500 of comparative example 1 was manufactured according to the above-described manufacturing process of the guide wire 100. In comparative example 1, the 1 st connecting portion 11a of the 1 st core portion 11 is formed to have a base end connecting outer diameter constant portion 111a and a base end tapered portion 112a. The base end taper 112a is formed as a single taper. The outer diameter d1 of the base end connecting outer diameter constant portion 111a is 0.220mm, and the outer diameter of the tip end of the base end tapered portion 112a is 0.340mm. The length of the base end connecting outer diameter constant portion 111a is 15mm, and the length of the base end tapered portion 112a is 80mm. The inclination angle θ of the base end taper 112a is 0.04 °.

[ test 1]

Test 1 is a test for evaluating behavior of a guide wire when the guide wire passes through a bent 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 having a diameter of 6mm and a radius of curvature of 30 mm) including a U-shaped bent portion, and the behavior of the guide wire 100 when the region including the fitting portion between the 1 st core portion and the connecting member passed through the bent portion was visually observed.

[ results of experiment 1 ]

Fig. 6 is a diagram schematically showing an example of the bending shape of the guide wire 100 of example 1 and the guide wire 500 of comparative example 1 when they are inserted into the passage 410 of the test instrument 400. In fig. 6, the guide wire 100 of example 1 is shown in solid lines, and the guide wire 500 of comparative example 1 is shown in broken lines.

As shown in fig. 6, the guide wire 100 of example 1 has a small radius of curvature when passing through the curved portion of the passage 410, and passes through the guide wire 100 at 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 passes through the curved portion of the passage 410, the radius of curvature of the guide wire 100 increases, and passes through the position near the outside of the curve of the passage 410. The guide wire 100 of example 1 having the continuous taper portion 13 has a smaller contact area with the inner surface of the blood vessel when passing through the bent portion of the blood vessel than the guide wire 500 of comparative example 1 having no continuous taper portion 13. It is estimated that since the rigidity of the guide wire 100 in the longitudinal direction of the guide wire 100 changes at the boundary position between the 1 st connecting taper portion 13a and the 2 nd connecting taper portion 13b forming the continuous taper portion 13, the radius of curvature from the rigidity change point obtained by the continuous taper portion 13 to the tip of the connecting member 50 becomes smaller at the time of bending.

The present application is based on japanese patent application No. 2020-188863 filed on 11/12 of 2020, the disclosure of which is incorporated by reference in its entirety.

Description of the reference numerals

10: the core member is provided with a plurality of hollow core members,

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

12: the 2 nd core (12 a: base, 12b: 2 nd connecting portion, 121b: front end connecting outer diameter constant portion, 122b: front end taper portion),

13: continuous taper (13 a: 1 st connection taper, 13b: 2 nd connection taper),

14: an extension part is arranged on the upper surface of the upper cover,

20: the pipe cavity body is provided with a plurality of holes,

21: the 1 st coil is arranged on the first coil,

22: a 2 nd coil is arranged on the upper surface of the first coil,

30: a fixing part, a fixing part and a fixing part,

31: a front end fixing part, a front end fixing part and a front end fixing part,

32: a middle fixing part is arranged on the middle part,

33: a base end fixing part, a base end fixing part and a base end fixing part,

40: the covering layer is arranged on the surface of the base plate,

41: a 1 st cover layer is arranged on the surface of the first cover layer,

42: a 2 nd cover layer, which is arranged on the surface of the substrate,

43: a 3 rd cover layer, which is arranged on the surface of the substrate,

50: the connecting part is provided with a connecting part,

51: the inner cavity of the inner cavity is provided with a cavity,

60: a fitting portion for fitting the first and second engaging portions,

61: a front end embedded part is provided with a connecting part,

62: a base end fitting portion for fitting the base end,

70: the connecting and fixing part is connected with the connecting and fixing part,

71: the front end of the fixing part is connected with the fixing part,

72: the base end is connected with a fixing part (72 a: connecting material),

100: a guide wire is arranged on the inner side of the guide wire,

c: a central axis.

Claims

1. A guide wire in which a base end portion of a 1 st core portion is connected to a tip end portion of a 2 nd core portion disposed on a base end side of the 1 st core portion by a tubular connection member,

the base end portion of the 1 st core portion has a base end tapered portion having an outer diameter gradually decreasing toward the base end,

the front end portion of the 2 nd core portion has a front end tapered portion having an outer diameter gradually decreasing toward the front end,

at least one of the proximal taper portion and the distal taper portion has a continuous taper portion including, in a longitudinal direction of the guidewire: a 1 st connection taper portion disposed at a position closest to a base end of the 1 st core portion or a tip end of the 2 nd core portion; and a 2 nd connection taper portion disposed adjacent to the 1 st connection taper portion on a side distant from a base end of the 1 st core portion or a front end of the 2 nd core portion, having a different inclination angle from the 1 st connection taper portion,

the continuous taper portion has an engagement portion in which an outer surface of the 1 st connection taper portion is engaged with an inner surface of an end portion of the connection member.

2. The guidewire of claim 1, wherein,

the continuous taper is disposed at the base end taper of the 1 st core, the 1 st core being formed of a super elastic alloy.

3. The guidewire according to claim 1 or 2, wherein,

in the continuous taper, the inclination angle of the 2 nd connection taper is larger than the inclination angle of the 1 st connection taper.

4. The guidewire according to any one of claims 1 to 3, wherein,

in the continuous taper portion, a length in a major axis direction of the 1 st connection taper portion is longer than a length in a major axis direction of the 2 nd connection taper portion.

5. The guidewire of any one of claims 1-4, wherein,

and a connection fixing portion for fixing the continuous taper portion and the connection member is provided at the 1 st connection taper portion and at a position separated from the fitting portion in the longitudinal direction.

6. The guidewire of claim 5, wherein,

the outer surface of the 1 st connection taper portion and the inner surface of the connection member are separated in the radial direction on the front end side and the base end side of the connection fixing portion.

7. The guidewire of claim 5 or 6, wherein,

the fitting portion has an expanded shape in which the connecting member expands radially outward so as to follow the outer surface of the 1 st connecting taper portion.