CN211705592U

CN211705592U - Guide wire

Info

Publication number: CN211705592U
Application number: CN202020155482.9U
Authority: CN
Inventors: 大岩智哉
Original assignee: Terumo Corp
Current assignee: Terumo Corp
Priority date: 2019-03-13
Filing date: 2020-02-07
Publication date: 2020-10-20
Anticipated expiration: 2030-02-07
Also published as: JP2020146187A

Abstract

The utility model provides a seal wire specifically is the seal wire that can make two above coils not damaged and twine easily. The wire winding device comprises a front end coil formed by winding a1 st wire rod and surrounding a core material and a base end coil formed by winding a2 nd wire rod and surrounding the core material at the base end side of the front end coil, wherein the base end part of the 1 st wire rod and the front end part of the 2 nd wire rod are connected in an alternate arrangement mode, a normal vector of a1 st maximum projection surface with the largest orthographic projection area of a1 st end surface positioned at the base end of the 1 st wire rod is inclined relative to a normal vector of a1 st orthogonal surface which passes through a1 st intersection point of the 1 st end surface and the 1 st axial center of the 1 st wire rod and is orthogonal to the 1 st axial center, and a normal vector of a2 nd maximum projection surface with the largest orthographic projection area of a2 nd end surface positioned at the 2 nd end surface of the 2 nd wire rod is inclined relative to a normal vector of a2 nd orthogonal surface which passes through a2 nd intersection point of the 2 nd end surface and the.

Description

Guide wire

Technical Field

The present invention relates to a guide wire for guiding a long medical instrument inserted into a living body and a method for manufacturing the same.

Background

In recent years, an operation of inserting a long medical instrument (for example, a catheter) from a blood vessel of a lower limb, an arm, a wrist, or the like to perform treatment has been performed. In such an operation, the guide wire is inserted into the vicinity of the lesion site in front of the catheter. The catheter is then advanced over the guidewire to the lesion. Then, the operator treats the lesion site through the catheter.

The guide wire generally includes a core member, a coil formed by winding a wire around the outer periphery of the core member, and a fixing member for fixing the core member and the coil. The coil may be formed of two or more coils. For example, patent document 1 discloses a guidewire having a distal-side coil and a proximal-side coil. The base end portion of the distal-side coil and the distal end portion of the proximal-side coil are connected in a state in which the wire materials of the respective coils are alternately arranged and intertwined with each other.

Documents of the prior art

Patent document

Patent document 1: japanese laid-open patent publication (JP 2015-181487)

SUMMERY OF THE UTILITY MODEL

Problem to be solved by utility model

When the wire materials of two or more coils are intertwined with each other, the end surfaces of the wire materials may collide with each other, and the coils may be deformed or broken.

The present invention has been made to solve the above problems, and an object of the present invention is to provide a guide wire in which two or more coils can be easily wound without damage, and a method for manufacturing the same.

Means for solving the problems

To achieve the above object, the guide wire of the present invention is characterized by having: a long core material having a distal end portion and a proximal end portion; a front end coil formed by winding a1 st wire material and surrounding a front end portion of the core material; and a base coil formed by winding a2 nd wire rod and surrounding a distal end portion of the core member on a base end side of the distal coil, the distal coil having a1 st distal end surface on a base end of the 1 st wire rod, the base coil having a2 nd distal end surface on a distal end of the 2 nd wire rod, the base end portion of the 1 st wire rod and the distal end portion of the 2 nd wire rod being connected in an alternating arrangement, a normal vector of a1 st maximum projection surface which is a surface having a largest orthographic projection area of the 1 st distal end surface being inclined with respect to a normal vector of a1 st orthogonal surface passing through a1 st intersection point where the 1 st distal end surface intersects with a1 st axis of the 1 st wire rod and being orthogonal to the 1 st axis, a normal vector of a2 nd maximum projection surface which is a surface having a largest orthographic projection area of the 2 nd distal end surface being inclined with respect to a normal vector of the 2 nd orthogonal surface, wherein the 2 nd orthogonal surface passes through a2 nd intersection point where the 2 nd end surface intersects with the 2 nd axial center of the 2 nd wire rod and is orthogonal to the 2 nd axial center.

The above object is achieved by a method for manufacturing a guide wire of the present invention, comprising: a long core material having a distal end portion and a proximal end portion; a front end coil formed by winding a1 st wire material and surrounding a front end portion of the core material; a base end coil formed by winding a2 nd wire rod and surrounding a tip end portion of the core material on a base end side of the tip end coil; and a fixing member that fixes the distal end coil and the proximal end coil to the core material, the method for manufacturing the guide wire being characterized by comprising: preparing the tip coil, wherein a normal vector of a1 st maximum projection surface, which is a surface having a maximum orthographic projection area of the 1 st end surface of the tip coil, is inclined with respect to a normal vector of a1 st orthogonal surface that passes through a1 st intersection point where the 1 st end surface intersects with a1 st axis of the 1 st wire rod and is orthogonal to the 1 st axis; preparing the base coil in which a normal vector of a2 nd maximum projection surface, which is a surface having a maximum orthographic projection area of the 2 nd distal end surface of the base coil, is inclined with respect to a normal vector of a2 nd orthogonal surface that passes through a2 nd intersection point where the 2 nd distal end surface intersects with a2 nd axial center of the 2 nd wire rod and is orthogonal to the 2 nd axial center; a step of relatively rotating a1 st wire rod on a base end side of the tip coil and a2 nd wire rod on a tip end side of the base coil so as to be alternately arranged in a longitudinal direction; and a step of filling the fixing member in a gap between at least a part of the 1 st wire and the 2 nd wire which are alternately arranged, and fixing the tip coil and the base coil to the core material by the fixing member.

Effect of the utility model

In the guide wire and the manufacturing method thereof configured as described above, when the 1 st wire and the 2 nd wire are alternately arranged in the longitudinal direction so that the tip coil and the base coil are relatively rotated, the 1 st tip surface and the 2 nd tip surface are less likely to collide and can be smoothly screwed in. Therefore, the guide wire can easily wind two or more coils without damage.

In the 1 st orthogonal surface and the 2 nd orthogonal surface, a direction perpendicular to the center line and toward the center line of the distal end coil or the proximal end coil, an opposite direction of the inner direction, a direction perpendicular to the inner direction and having a component toward the proximal end side, a direction opposite to the proximal end direction, a vector projecting onto the 1 st orthogonal surface a normal vector facing away from the 1 st distal end surface among normal vectors of the 1 st maximum projection surface may be defined as a1 st oblique direction vector, and a vector projecting onto the 2 nd orthogonal surface a normal vector facing away from the 2 nd distal end surface among normal vectors of the 2 nd maximum projection surface may be defined as a2 nd oblique direction vector, when the 1 st orthogonal surface and the 2 nd orthogonal surface are superimposed such that the inner direction, the outer direction, the distal direction, and the proximal direction of each surface coincide with each other, the 1 st oblique direction vector and the 2 nd oblique direction vector face in opposite directions. Thus, when the 1 st wire and the 2 nd wire are alternately arranged in the longitudinal direction, the 1 st end surface and the 2 nd end surface are less likely to collide with each other and can be smoothly screwed in.

The 1 st oblique direction vector is oriented in a front end side range centered on the front end direction and having an effective angle of 20 degrees on both sides in the 1 st orthogonal plane, and the 2 nd oblique direction vector is oriented in a base end side range centered on the base end direction and having an effective angle of 20 degrees on both sides in the 2 nd orthogonal plane. Thus, when the 1 st wire and the 2 nd wire are alternately arranged in the longitudinal direction, the 1 st end surface and the 2 nd end surface are less likely to collide with each other and can be smoothly screwed in. In addition, the 1 st end face guides the 2 nd end face to the inter-wire gap of the front end coil by its inclination. Further, the 2 nd end face guides the 1 st end face to the inter-wire gap of the base end coil by its inclination. Therefore, the base end portion of the tip coil and the tip end portion of the base end coil can be easily intertwined with each other.

The 1 st oblique direction vector may be oriented in an outer side range of the 1 st orthogonal plane having an effective angle of 20 degrees with respect to the outer direction as a center and on both sides thereof, and the 2 nd oblique direction vector may be oriented in an inner side range of the 2 nd orthogonal plane having an effective angle of 20 degrees with respect to the inner direction as a center and on both sides thereof. Thus, when the 1 st wire and the 2 nd wire are alternately arranged in the longitudinal direction, the 1 st end surface and the 2 nd end surface are less likely to collide with each other and can be smoothly screwed in.

The 1 st oblique direction vector may be oriented in an inner side range of the 1 st orthogonal plane having an effective angle of 20 degrees with respect to the inner direction as a center and on both sides thereof, and the 2 nd oblique direction vector may be oriented in an outer side range of the 2 nd orthogonal plane having an effective angle of 20 degrees with respect to the outer direction as a center and on both sides thereof. Thus, when the 1 st wire and the 2 nd wire are alternately arranged in the longitudinal direction, the 1 st end surface and the 2 nd end surface are less likely to collide with each other and can be smoothly screwed in.

The 1 st oblique direction vector may be oriented within a base end side range centered on the base end direction and having an effective angle of 20 degrees on both sides in the 1 st orthogonal plane, and the 2 nd oblique direction vector may be oriented within a tip end side range centered on the tip end direction and having an effective angle of 20 degrees on both sides in the 2 nd orthogonal plane. Thus, when the 1 st wire and the 2 nd wire are alternately arranged in the longitudinal direction, the 1 st end surface and the 2 nd end surface are less likely to collide with each other and can be smoothly screwed in.

Among the normal vectors of the 1 st maximum projection surface, a normal vector directed in a direction away from the 1 st end surface may be inclined at 5 to 45 degrees with respect to a normal vector directed in a direction away from the 1 st end surface among the normal vectors of the 1 st orthogonal surface, and a normal vector directed in a direction away from the 2 nd end surface among the normal vectors of the 2 nd maximum projection surface may be inclined at 5 to 45 degrees with respect to a normal vector directed in a direction away from the 2 nd end surface among the normal vectors of the 2 nd orthogonal surface. If the inclination angle of the normal vector of the 1 st maximum projection plane and the 2 nd maximum projection plane is larger than 45 degrees, the fixing member in a flowable state excessively flows into the inter-wire gap of the coil or the gap between the core material and the coil, and therefore the 1 st end surface and the 2 nd end surface easily protrude from the fixing member. If the inclination angle of the normal vector of the 1 st maximum projection surface and the 2 nd maximum projection surface is less than 5 degrees, it is difficult to make the 1 st end surface and the 2 nd end surface face the mutual inter-wire gap of the coils, and thus it is difficult to obtain the effect of mitigating the collision of the 1 st end surface and the 2 nd end surface.

Drawings

Fig. 1 is a top view illustrating an embodiment of a guidewire.

Fig. 2 is a cross-sectional view illustrating the guide wire of the embodiment.

Fig. 3(a) shows a state in which the distal end coil and the proximal end coil are wound according to the embodiment, and fig. 3(B) shows a state before the distal end coil and the proximal end coil are wound according to the embodiment.

Fig. 4 is an enlarged perspective view showing the base end portion of the tip coil.

Fig. 5 is an enlarged perspective view showing the distal end portion of the base end coil.

Fig. 6 is a view showing the inclination direction vector in the orthogonal plane, (a) is a view showing the 1 st inclination direction vector of the leading end coil in the 1 st orthogonal plane, and (B) is a view showing the 2 nd inclination direction vector of the base end coil in the 2 nd orthogonal plane.

Fig. 7 is a plan view showing a state before the leading coil and the base coil of modification 1 are wound.

Fig. 8(a) is a view showing a1 st oblique direction vector of the tip coil in the 1 st orthogonal surface in the 1 st modification, and fig. 8(B) is a view showing a2 nd oblique direction vector of the base coil in the 2 nd orthogonal surface in the 1 st modification.

Fig. 9 is a plan view showing a state before the tip coil and the base coil of modification 2 are wound.

Fig. 10(a) is a view showing a1 st oblique direction vector of the tip coil in the 1 st orthogonal surface in the 2 nd modification, and fig. 10(B) is a view showing a2 nd oblique direction vector of the base coil in the 2 nd orthogonal surface in the 2 nd modification.

Fig. 11 is a plan view showing a state before the tip coil and the base coil of modification 3 are wound.

Fig. 12(a) is a view showing a1 st oblique direction vector of the tip coil in the 1 st orthogonal surface in modification 3, and fig. 12(B) is a view showing a2 nd oblique direction vector of the base coil in the 2 nd orthogonal surface in modification 3.

Description of the reference numerals

10 guide wire

20 core material

40 front end coil

41 st wire rod

42 1 st end face

50 base end coil

51 nd 2 nd wire rod

52 nd end face 2

60 fixing element

Normal vector of 1 st maximum projection plane of A1

Normal vector of 2 nd maximum projection plane of A2

B1 Tilt 1 Direction vector

B2 Tilt 2 Direction vector

C center line

1 st intersection of D1

D2 intersection 2

Normal vector of 1 st orthogonal plane of E1

Normal vector of 2 nd orthogonal plane of E2

P1 orthogonal plane 1

P2 orthogonal plane 2

Base end side range of S1

Front end side range of S2

Internal lateral extent of S3

Outer lateral extent of S4

Effective angle of alpha

X1 base direction

X2 front end direction

Y1 internal direction

Y2 external direction

Z1 Axis 1

Z2 Axis 2

Detailed Description

Embodiments of the present invention will be described below with reference to the drawings. The dimensions of the drawings are exaggerated for convenience of explanation and differ from actual dimensions. In the present specification and the drawings, the same reference numerals are given to components having substantially the same functional configuration, and redundant description is omitted. In the present specification, the side of the guide wire inserted into the blood vessel is referred to as the "distal end side", and the side of the hand to be operated is referred to as the "proximal end side".

As shown in fig. 1 to 3(a), the guide wire 10 of the present embodiment includes: a long-sized core material 20; a front end coil 40 surrounding the front end of the core material 20; a base end coil 50 disposed on the base end side of the tip end coil 40; a fixing member 60 for fixing the front end coil 40 and the base end coil 50 to the core member 20; and a cover layer 70.

The core 20 includes a base end shaft 21 and a tip end shaft 30 located on the tip end side of the base end shaft 21. The base shaft 21 includes a main body shaft 22 and a base end coupling portion 23 disposed at the front end of the main body shaft 22. The main shaft 22 has a substantially constant outer diameter from the base end toward the tip end. The base end coupling portion 23 is formed with a larger outer diameter than the main body shaft 22.

The distal end shaft 30 is a long member extending from the distal end of the base end shaft 21 to the distal end side. The distal end shaft 30 includes a distal end coupling portion 31, a large diameter portion 32, a1 st tapered portion 33, a middle diameter portion 34, a2 nd tapered portion 35, a small diameter portion 36, a wedge portion 37, and a flat plate portion 38 from the distal end of the proximal end shaft 21 toward the distal end side. The distal end coupling portion 31 is a portion to be coupled to the proximal end coupling portion 23 of the proximal end shaft 21. The outer diameter of the distal end coupling portion 31 is larger than the outer diameter of the large diameter portion 32 and is equal to the outer diameter of the proximal end coupling portion 23. The large diameter portion 32 has a substantially constant outer diameter from the base end toward the tip end side. The outer diameter of the large-diameter portion 32 substantially coincides with the outer diameter of the main body shaft 22. The outer diameters of the distal end coupling portion 31 and the base end coupling portion 23 to be joined are larger than the outer diameters of the main body shaft 22 and the large diameter portion 32. Therefore, the joining strength of the distal end shaft 30 and the proximal end shaft 21 can be improved. The 1 st tapered portion 33 has an outer diameter that decreases from the large diameter portion 32 toward the intermediate diameter portion 34 on the tip end side. The outer diameter of the intermediate diameter portion 34 is constant. The outer diameter of the intermediate diameter portion 34 is smaller than the outer diameter of the large diameter portion 32. The 2 nd taper portion 35 has an outer diameter decreasing from the small diameter portion 36 on the tip end side of the small diameter portion 34. The small diameter portion 36 has a constant outer diameter smaller than the outer diameter of the medium diameter portion 34. The wedge portion 37 has a thickness that decreases as it goes from the front end of the small diameter portion 36 to the flat plate portion 38 on the front end side and a width that increases as it goes to the front end side. The flat plate portion 38 has a constant thickness and a constant width.

The overall length of the guide wire 10 in the longitudinal direction is not particularly limited, and is, for example, 300 to 4500 mm.

The outer diameter (the thickness of the thickest part in the cross section in the case of a non-circular cross section) of the base end shaft 21 is not particularly limited, and is, for example, 0.2 to 2 mm. The outer diameter of the distal end portion of the distal end shaft 30 (the thickness of the thickest portion in the cross section in the case of a non-circular cross section) is not particularly limited, and is, for example, 0.03mm to 1 mm.

As the material of the tip shaft 30 and the base shaft 21, various metal materials such as Ni — Ti alloy, stainless steel such as SUS302, SUS304, SUS303, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, and SUS430F, piano wire, cobalt alloy, and super-elastic alloy can be used. The front end shaft 30 is preferably formed of a material having lower rigidity than the material of the base end shaft 21. For example, the tip shaft 30 is made of a Ni — Ti alloy, and the base shaft 21 is made of stainless steel. The material of the distal end shaft 30 and the proximal end shaft 21 is not limited to the above example. The distal end shaft 30 and the proximal end shaft 21 may be formed of the same material.

The tip coil 40 is a member in which a1 st wire 41 (element wire) is spirally wound. The distal end coil 40 is disposed on the distal end side of the proximal end coil 50. The front end coil 40 surrounds the front end shaft 30 of the core member 20, and fixes the front end portion and the base end portion to the front end shaft 30. The coil outer diameter of the leading coil 40 is preferably constant from the leading end to the base end, but may not be constant. The coil outer diameter of the leading-end coil 40 is preferably constant at least in a range including the 1 st end surface 42 on the base end side.

The base coil 50 is a member in which a2 nd wire material 51 (element wire) is spirally wound on the base end side of the tip coil 40. The base end coil 50 surrounds the tip end shaft 30 of the core member 20, and fixes the tip end portion and the base end portion to the tip end shaft 30. The coil outer diameter of the base end coil 50 is preferably constant from the tip end to the base end, but may not be constant. The coil outer diameter of the base end coil 50 is preferably constant at least in a range including the 2 nd end surface 52 on the distal end side. The base end coil 50 is disposed coaxially with the distal end shaft 30. The distal coil 40 and the proximal coil 50 have substantially the same coil outer diameter. The base end portion of the tip coil 40 and the tip end portion of the base end coil 50 are intertwined with each other. That is, the 1 st wire 41 at the base end of the tip coil 40 and the 2 nd wire 51 at the tip end of the base coil 50 are alternately arranged in the longitudinal direction. By intertwining the distal end coil 40 and the base end coil 50 in this manner, the distal end coil 40 and the base end coil 50 are prevented from being separated from each other. The winding directions of the front end coil 40 and the base end coil 50 are uniform so as to be intertwined with each other. The constituent material of the wire rods constituting the distal end coil 40 and the proximal end coil 50, the outer diameter of the wire rods, the cross-sectional shape of the wire rods, the pitch of the wire rods, and the like can be appropriately selected according to the purpose of the guide wire 10.

As shown in fig. 3, 4, and 6(a), the 1 st end surface 42 of the 1 st wire 41, which is located at the base end side end, is inclined with respect to the 1 st orthogonal surface P1 orthogonal to the 1 st axial center Z1 of the 1 st wire 41. The 1 st axial center Z1 is an axis passing through the centers (or the centers of gravity) of the respective cross sections of the 1 st wire rod 41 connected in the longitudinal direction. The 1 st orthogonal plane P1 passes through the 1 st intersection D1 of the 1 st axial center Z1 and the 1 st end surface 42 and is orthogonal to the 1 st axial center Z1.

As shown in fig. 3, 5, and 6(B), the 2 nd end surface 52 of the 2 nd wire 51, which is positioned at the distal end side, is inclined with respect to the 2 nd orthogonal surface P2 orthogonal to the 2 nd axial center Z2 of the 2 nd wire 51. The 2 nd axial center Z2 of the 2 nd wire 51 is an axis passing through the centers (or the centers of gravity) of the respective cross sections of the 2 nd wire 51 connected in the longitudinal direction. The 2 nd orthogonal plane P2 passes through the 2 nd intersection D2 of the 2 nd axial center Z2 and the 2 nd end surface 52 and is orthogonal to the 2 nd axial center Z2.

As shown in fig. 3 to 5, on the 1 st and 2 nd orthogonal planes P1 and P2, a direction perpendicular to the center line C of the tip coil 40 or the base coil 50 is defined as an inner direction Y1, and a direction opposite to the inner direction Y1 is defined as an outer direction Y2. On the 1 st orthogonal plane P1 and the 2 nd orthogonal plane P2, a direction orthogonal to the inner direction Y1 and the outer direction Y2 and having a component toward the base end side is defined as a base end direction X1, and a direction opposite to the base end direction X1 is defined as a tip end direction X2.

As shown in FIG. 4, the normal vector A1 of the 1 st maximum projection surface of the 1 st tip surface 42 is inclined at the 1 st inclination angle θ 1 with respect to the normal vector E1 of the 1 st orthogonal surface P1. The 1 st maximum projection plane is a projection plane having the largest area of the forward projection of the 1 st distal end surface 42. The orthographic projection of the 1 st end surface 42 is a figure generated by points at which a straight line passing through each point on the 1 st end surface 42 and perpendicular to the projection plane intersects the projection plane. The directions of the normal vector a1 and the normal vector E1 are directions away from the 1 st end surface 42, and the 1 st inclination angle θ 1 is an acute angle. In the present embodiment, the 1 st end surface 42 is a plane, and therefore the 1 st maximum projection plane coincides with the 1 st end surface 42. The 1 st inclination angle θ 1 is not particularly limited, but is preferably 5 to 45 degrees. If the 1 st inclination angle θ 1 is larger than 45 degrees, the fixing member in a flowable state excessively flows into the inter-wire gap of the coil and between the core 20 and the coil, and therefore the 1 st end surface 42 easily protrudes from the intermediate fixing member 62. If the 1 st inclination angle θ 1 is less than 5 degrees, it is difficult to guide the 1 st end surface 42 and the 2 nd end surface 52 to the inter-wire gap between the coils, and therefore it is difficult to obtain an effect of mitigating the collision of the 1 st end surface 42 and the 2 nd end surface 52. The inter-wire gap is a gap between the wires adjacent to each other along the central axis C on a cross section including the central axis C of the coil.

As shown in fig. 6(a), the 1 st oblique direction vector B1, which is obtained by projecting the normal vector a1 of the 1 st maximum projection plane onto the 1 st orthogonal plane P1, is directed into the front end side range S2 centered on the front end direction X2 and having a predetermined effective angle α on both sides. The 1 st oblique direction vector B1 is a vector indicating the direction in which the 1 st distal end surface 42 faces. Therefore, even in the case where the 1 st tip surface 42 is not planar, the direction in which the 1 st tip surface 42 faces as a whole can be determined from the 1 st oblique direction vector B1. The effective angle α is an angle indicating a range in which the 1 st end surface 42 (or the 2 nd end surface 52 described later) exerts substantially the same effect. The effective angle α is, for example, 20 degrees, preferably an angle lower than 20 degrees, more preferably 15 degrees, and further preferably 10 degrees. If the effective angle α is 20 degrees or less, the 1 st oblique direction vector B1 includes a vector oriented in the distal direction X2 as a main component. Therefore, the 1 st end surface 42 can exert substantially the same effect within its range.

The 1 st end surface 42 is not limited to a plane. The 1 st end surface 42 may have a curved surface at least in part or may be formed of a plurality of flat surfaces having different inclination angles with respect to the 1 st axial center Z1. Even if the 1 st tip surface 42 is not a plane, the normal vector a1 and the 1 st inclined direction vector B1 can be determined from the 1 st maximum projection surface where the projection area from the 1 st tip surface 42 is the largest.

As shown in FIG. 5, the normal vector A2 of the 2 nd maximum projection surface of the 2 nd tip surface 52 is inclined at the 2 nd inclination angle θ 2 with respect to the normal vector E2 of the 2 nd orthogonal surface P2. The 2 nd maximum projection plane is a projection plane having the largest area of the forward projection of the 2 nd distal end surface 52. The orthographic projection of the 2 nd end surface 52 is a figure generated by points at which a straight line passing through each point on the 2 nd end surface 52 and perpendicular to the projection surface intersects the projection surface. The directions of the normal vector a2 and the normal vector E2 are divided into directions away from the 2 nd tip surface 52, and the 2 nd inclination angle θ 2 is an acute angle. In the present embodiment, since the 2 nd end surface 52 is a plane, the 2 nd maximum projection surface coincides with the 2 nd end surface 52. The 2 nd inclination angle θ 2 is not particularly limited, but is preferably 5 to 45 degrees. If the 2 nd inclination angle θ 2 is larger than 45 degrees, the fixing member in a flowable state excessively flows into the inter-wire gap of the coil and between the core 20 and the coil, and therefore the 2 nd end surface 52 easily protrudes from the intermediate fixing member 62. If the 2 nd inclination angle θ 2 is less than 5 degrees, it is difficult to guide the 1 st end surface 42 and the 2 nd end surface 52 to the mutual inter-wire gap of the coils, and therefore it is difficult to obtain an effect of alleviating the collision of the 1 st end surface 42 and the 2 nd end surface 52.

As shown in fig. 6(B), the 2 nd oblique direction vector B2, which projects the normal vector a2 of the 2 nd maximum projection plane onto the 2 nd orthogonal plane P2, is directed toward both sides within the base end side range S1 including the predetermined effective angle α with the base end direction X1 as the center. The 2 nd oblique direction vector B2 is a vector as an index indicating the direction in which the 2 nd distal end surface 52 faces. Therefore, even in the case where the 2 nd tip surface 52 is not planar, the direction in which the 2 nd tip surface 52 faces as a whole can be determined by the 2 nd oblique direction vector B2. The effective angle α is an angle indicating a range in which the 2 nd end surface 52 exerts substantially the same effect. If the effective angle α is 20 degrees or less, the 2 nd oblique direction vector B2 includes a vector toward the base direction X1 as a main component. Therefore, the 2 nd end surface 52 can exert substantially the same effect within this range.

The 2 nd end surface 52 is not limited to a plane. The 2 nd end surface 52 may have a curved surface at least in part or may be formed of a plurality of flat surfaces having different inclination angles with respect to the 2 nd axial center Z2. Even if the 2 nd tip surface 52 is not a plane, the normal vector a2 and the 2 nd inclination direction vector B2 can be determined from the 2 nd maximum projection surface where the projection area from the 2 nd tip surface 52 is the largest.

The base end of the distal end coil 40 and the distal end of the proximal end coil 50 are joined to the distal end shaft 30 by a fixing member 60 in a state in which the 1 st wire 41 and the 2 nd wire 51 are alternately arranged in the longitudinal direction and intertwined with each other.

The material of the distal end coil 40 and the proximal end coil 50 is not particularly limited, and for example, a metal such as stainless steel, a super-elastic alloy, a cobalt alloy, gold, platinum, or tungsten, or an alloy containing the above metals can be used. For example, Pt — Ni alloy, which is softer and has higher contrast than the base coil 50, can be used as the material of the distal coil 40, and stainless steel can be used as the material of the base coil 50. The materials of the distal coil 40 and the proximal coil 50 may be the same. In addition, the coil 40 may be formed of one coil. The coil 40 may be formed of three or more coils.

The coil outer diameters of the front end coil 40 and the base end coil 50 are not particularly limited, and are, for example, 0.2 to 2 mm. The length of the front end coil 40 is not particularly limited, and is, for example, about 3 to 60 mm. The length of the base coil 50 is not particularly limited, and is, for example, about 10 to 400 mm. The length of the base end portion of the tip coil 40 and the tip end portion of the base end coil 50 intertwined with each other is not particularly limited, and is, for example, about 0.1 to 2 mm.

The pitch between the tip coil 40 and the base coil 50 is not particularly limited, but is preferably less than 2mm, and more preferably 0.05 mm. The adjacent wires may have a gap therebetween or may be in contact with each other. The base end portion of the tip coil 40 is preferably intertwined with the base end coil 50, and therefore has a larger pitch than the tip end portion of the tip coil 40. The distal end portion of the base end coil 50 and the distal end coil 40 are intertwined with each other, and therefore preferably have a pitch approximately equal to the pitch of the proximal end portion of the distal end coil 40. The cross-sectional shapes of the 1 st wire 41 and the 2 nd wire 51 are preferably circular, but are not limited thereto, and may be, for example, elliptical, quadrangular, or the like. The outer diameters (the thickness of the thickest portion in the cross section in the case of a non-circular cross section) of the 1 st wire 41 and the 2 nd wire 51 are not particularly limited, and are, for example, 0.02 to 0.9 mm.

The fixing member 60 is a member for fixing the leading end coil 40 or the base end coil 50 to the core member 20. The fixing member 60 includes a front end fixing member 61, an intermediate fixing member 62, and a base end fixing member 63. The distal end fixing member 61 fixes the distal end portion of the distal end coil 40 to the flat plate portion 38 of the distal end shaft 30. The distal end fixing member 61 is positioned at the foremost end of the guide wire 10, and has a substantially hemispherical outer surface. The intermediate fixing member 62 is fixed to the 2 nd taper portion 35 of the distal end shaft 30 in a state in which the base end portion of the distal end coil 40 and the distal end portion of the base end coil 50 are intertwined with each other. The base end fixing member 63 fixes the base end of the base end coil 50 to the intermediate diameter portion 34 of the distal end shaft 30. The material of the fixing member 60 is not particularly limited, and examples thereof include aluminum alloy solder, silver solder, gold solder, zinc, Sn-Pb alloy, Pb-Ag alloy, Sn-Ag alloy solder, and thermoplastic resin. In this case, the fixing member 60 flows into the fixing region in a flowable state melted by heating. Alternatively, the material of the fixing member 60 may be an adhesive. In this case, the adhesive flows into the fixing region in a flowable state before curing.

The cover layer 70 includes: a1 st cover layer 71 that covers a portion located closer to the base end side than the base end coil 50 of the core material 20; and a2 nd cover layer 72 that covers the tip coil 40, the base coil 50, the fixing member 60, and a part of the core 20. The 1 st cover layer 71 is formed of a low friction material that reduces friction. Examples of the low-friction material include fluorine-based resins such as Polytetrafluoroethylene (PTFE), silicone-based resins, and hydrophilic polymers. Examples of the hydrophilic polymer include a cellulose-based polymer, a polyethylene oxide-based polymer, a maleic anhydride-based polymer (for example, a maleic anhydride copolymer such as a methyl vinyl ether-maleic anhydride copolymer), an acrylamide-based polymer (for example, a block copolymer of polyacrylamide and glycidyl methacrylate-dimethylacrylamide), a water-soluble nylon, polyvinyl alcohol, polyvinyl pyrrolidone, and derivatives thereof. The hydrophilic polymer forms a strong water-fixing layer on the surface thereof, exhibits high affinity for blood in a blood vessel and a blood vessel wall surface, and exhibits low friction (low friction coefficient). The 2 nd coating 72 is formed of a friction reducing hydrophilic polymer. As the hydrophilic polymer forming the 2 nd cover layer 72, a hydrophilic polymer applicable to the 1 st cover layer 71 described above can be used. The material of the 1 st cover layer 71 and the material of the 2 nd cover layer 72 may be the same or different. The 1 st cover layer 71 and/or the 2 nd cover layer 72 may also be partially formed of two or more materials. The 1 st cover layer 71 and/or the 2 nd cover layer 72 may not be provided.

When the guide wire 10 is manufactured, the distal end coil 40 and the proximal end coil 50 are wound. Therefore, as shown in fig. 3(B), the tip end portion of the core member 20 is inserted inside the tip end coil 40 and the base end coil 50 in a state where the center lines C of the tip end coil 40 and the base end coil 50 are substantially aligned. Then, the center lines of the core member 20, the front end coil 40, and the base end coil 50 are substantially aligned. The distal end coil 40 is disposed on the distal end side of the proximal end coil 50. Next, the 1 st wire 41 on the base end side of the distal end coil 40 and the 2 nd wire 51 on the distal end side of the proximal end coil 50 are relatively rotated around the center line C and brought close to each other. Thereby, the 1 st wire 41 is screwed into the inter-wire gap of the base end coil 50 from the 1 st distal end surface 42. Further, the 2 nd wire 51 is screwed into the inter-wire gap of the front end coil 40 from the 2 nd end surface 52. At this time, as shown in fig. 6, the 1 st inclined direction vector B1 of the distal end coil 40 is directed into the distal end side range S2 in the distal end direction X2 (see fig. 6 a), and the 2 nd inclined direction vector B2 of the base end coil 50 is directed into the base end side range S1 in the base end direction X1 (see fig. 6B). Therefore, when the 1 st orthogonal plane P1 and the 2 nd orthogonal plane P2 are aligned and compared so that the inner direction Y1, the outer direction Y2, the distal direction X2, and the proximal direction X1 of the respective planes coincide with each other, the 1 st oblique direction vector B1 and the 2 nd oblique direction vector B2 are directed substantially in opposite directions. That is, the 1 st end surface 42 of the distal end coil 40 and the 2 nd end surface 52 of the proximal end coil 50 face in substantially opposite directions. As a result, the 1 st end surface 42 and the 2 nd end surface 52 are less likely to collide and smoothly screw in. Therefore, deformation and breakage of the distal end coil 40 and the proximal end coil 50 can be suppressed. As shown in fig. 3(B) and 4, the 1 st end surface 42 of the leading end coil 40 is inclined so as to guide the 2 nd end surface 52 to the inter-wire gap of the leading end coil 40. As shown in fig. 3(B) and 5, the 2 nd distal end surface 52 of the base end coil 50 is inclined so as to guide the 1 st distal end surface 42 to the inter-wire gap of the base end coil 50. Therefore, the base end portion of the tip coil 40 and the tip end portion of the base end coil 50 can be easily intertwined with each other. Next, the distal end coil 40 and the proximal end coil 50 are fixed to the core 20 by the distal end fixing member 61, the intermediate fixing member 62, and the proximal end fixing member 63. The intermediate fixing member 62 fills the gap between the 1 st wire 41 and the 2 nd wire 51 entangled with each other, and fixes the base end portion of the tip coil 40 and the tip end portion of the base coil 50 to the tip shaft 30. Next, unnecessary portions of the fixing member 60 are cut off as needed. A cover layer 70 is then formed to complete the manufacture of the guidewire 10.

As a modification 1 of the embodiment, as shown in fig. 7 and 8, the 1 st diagonal direction vector B1 of the 1 st end surface 42 of the leading end coil 40 is directed within an inner side range S3 centered on the inner direction Y1 and having a predetermined effective angle α on both sides thereof (see fig. 8 a). The 2 nd diagonal direction vector B2 of the 2 nd distal end surface 52 of the base coil 50 is directed into an outer range S4 centered on the outer direction Y2 and having a predetermined effective angle α on each side (see fig. 8B).

When the distal coil 40 and the base coil 50 are wound, the 1 st wire 41 on the base end side of the distal coil 40 and the 2 nd wire 51 on the distal end side of the base coil 50 are relatively rotated around the center line C of the coils and brought close to each other. Thereby, the 1 st wire 41 is screwed into the inter-wire gap of the base end coil 50 from the 1 st distal end surface 42. Further, the 2 nd wire 51 is screwed into the inter-wire gap of the front end coil 40 from the 2 nd end surface 52. At this time, the 1 st distal end surface 42 of the distal end coil 40 and the 2 nd distal end surface 52 of the proximal end coil 50 face in substantially opposite directions. As a result, the 1 st end surface 42 and the 2 nd end surface 52 are less likely to collide with each other and are smoothly screwed in. Therefore, deformation and breakage of the distal end coil 40 and the proximal end coil 50 can be suppressed.

The 1 st inclined direction vector B1 of the 1 st end surface 42 may be directed toward the outer side range S4, and the 2 nd inclined direction vector B2 of the 2 nd end surface 52 may be directed toward the inner side range S3. In such a configuration, the 1 st end surface 42 and the 2 nd end surface 52 are also less likely to collide with each other and can be smoothly screwed in.

As a modification 2 of the embodiment, as shown in fig. 9 and 10, the 1 st diagonal direction vector B1 of the 1 st distal end surface 42 of the distal end coil 40 is directed within the proximal end side range S1 centered on the proximal end direction X1 and having a predetermined effective angle α on both sides thereof (see fig. 10 a). The 2 nd diagonal direction vector B2 of the 2 nd distal end surface 52 of the proximal end coil 50 is directed within the distal end side range S2 centered on the distal end direction X2 and including the predetermined effective angle α on both sides thereof (see fig. 10B).

When the distal coil 40 and the base coil 50 are wound, the 1 st wire 41 on the base end side of the distal coil 40 and the 2 nd wire 51 on the distal end side of the base coil 50 are relatively rotated around the center line C of the coils and brought close to each other. Thereby, the 1 st wire 41 is screwed into the inter-wire gap of the base end coil 50 from the 1 st distal end surface 42. Further, the 2 nd wire 51 is screwed into the inter-wire gap of the front end coil 40 from the 2 nd end surface 52. At this time, the 1 st distal end surface 42 of the distal end coil 40 and the 2 nd distal end surface 52 of the proximal end coil 50 face in substantially opposite directions. As a result, the 1 st end surface and the 2 nd end surface are less likely to collide with each other and smoothly screw in. Therefore, deformation and breakage of the distal end coil 40 and the proximal end coil 50 can be suppressed.

As a modification 3 of the embodiment, as shown in fig. 11 and 12, the 1 st wire 41 of the distal end coil 40 is thicker than the 2 nd wire 51 of the proximal end coil 50. The 1 st oblique direction vector B1 of the 1 st end surface 42 of the leading end coil 40 is directed within the outer range S4 that is centered on the outer direction Y2 and includes the predetermined effective angle α on both sides (see fig. 12 a). The 2 nd diagonal direction vector B2 of the 2 nd distal end surface 52 of the base coil 50 is directed within the internal side range S3 centered on the internal direction Y1 and including the predetermined effective angle α on both sides (see fig. 12B). The coil outer diameter of the distal coil 40 substantially matches the coil outer diameter of the proximal coil 50. Therefore, the 2 nd axial center Z2 of the 2 nd wire 51 thinner than the 1 st wire 41 is farther from the coil center line C than the 1 st axial center Z1 of the 1 st wire 41.

When the distal coil 40 and the base coil 50 are wound, the 1 st wire 41 on the base end side of the distal coil 40 and the 2 nd wire 51 on the distal end side of the base coil 50 are relatively rotated around the center line C of the coils and brought close to each other. Thereby, the 1 st wire 41 starts to be screwed into the inter-wire gap of the base end coil 50 from the 1 st tip surface 42. Further, the 2 nd wire 51 is screwed into the inter-wire gap of the front end coil 40 from the 2 nd end surface 52. At this time, the 1 st distal end surface 42 of the distal end coil 40 and the 2 nd distal end surface 52 of the proximal end coil 50 face in substantially opposite directions. As a result, the 1 st end surface and the 2 nd end surface are less likely to collide with each other and smoothly screw in. Since the 2 nd wire 51 is thinner than the 1 st wire 41, the 2 nd axial center Z2 needs to be arranged at a position farther from the coil center line C than the 1 st axial center 1 in order to match the coil outer diameters of the tip coil 40 and the base coil 50. In the 3 rd modification, the 1 st distal end face 42 faces into the outer side range S4, and the 2 nd distal end face 52 faces into the inner side range S3. Therefore, when the 1 st wire 41 and the 2 nd wire 51 are screwed in, the base end coil 50 is easily guided to the outside of the front end coil 40. Therefore, the 2 nd axial center Z2 can be easily disposed at a position farther from the center line C of the coil than the 1 st axial center Z1.

The 1 st wire 41 may be thinner than the 2 nd wire 51. In this case, in order to match the coil outer diameters of the tip coil 40 and the base coil 50, the 1 st axial center Z1 needs to be disposed at a position farther from the coil center line C than the 2 nd axial center Z2. Therefore, it is preferable that the 1 st inclined direction vector B1 of the 1 st tip face 42 is directed toward the inside of the inside side range S3, and the 2 nd inclined direction vector B2 of the 2 nd tip face 52 is directed toward the outside of the outside side range S4.

As described above, the guide wire 10 of the present embodiment includes: a long core member 20 having a distal end portion and a proximal end portion; a front end coil 40 formed by winding the 1 st wire 41 and surrounding a front end portion of the core 20; and a base end coil 50 formed by winding a2 nd wire 51 and surrounding the tip end portion of the core member 20 on the base end side of the tip end coil 40, the tip end coil 40 having a1 st tip end surface 42 on the base end of the 1 st wire 41, the base end coil 50 having a2 nd tip end surface 52 on the tip end of the 2 nd wire 51, the base end portion of the 1 st wire 41 and the tip end portion of the 2 nd wire 51 being connected in an alternating arrangement, a normal vector A1 of a1 st maximum projection surface which is a surface having a largest orthographic projection area of the 1 st tip end surface 42 passing through a1 st intersection D1 of the 1 st tip end surface 42 and a1 st axial center Z1 of the 1 st wire 41, and is inclined with respect to a normal vector E1 of a1 st orthogonal plane P1 orthogonal to the 1 st axial center Z1, and a normal vector A2 of a2 nd maximum projection plane which is a plane having a maximum orthographic projection area of the 2 nd end surface 52 passes through a2 nd intersection D2 of the 2 nd end surface 52 and the 2 nd axial center Z2 of the 2 nd wire rod 51 and is inclined with respect to a normal vector E2 of a2 nd orthogonal plane P2 orthogonal to the 2 nd axial center Z2.

In the guide wire 10 configured as described above, when the 1 st wire 41 and the 2 nd wire 51 are alternately arranged in the longitudinal direction by relatively rotating the distal end coil 40 and the proximal end coil 50, the 1 st distal end surface 42 and the 2 nd distal end surface 52 are not likely to collide with each other and are smoothly screwed in. Therefore, the guide wire 10 can easily wind two or more coils without damage. In addition, since the guide wire 10 is less likely to be damaged, safety is improved.

In addition, on the 1 st orthogonal plane P1 and the 2 nd orthogonal plane P2, a direction which is perpendicular to the center line C and faces the center line C of the tip coil 40 or the base coil 50 is defined as an inner direction Y1, a direction opposite to the inner direction Y1 is defined as an outer direction Y2, a direction which is perpendicular to the inner direction Y1 and has a component facing the base end side is defined as a base end direction X1, a direction opposite to the base end direction X1 is defined as a tip direction X2, a vector which is projected onto the 1 st orthogonal plane P1 by a normal vector a1 of the 1 st maximum projection plane is defined as a1 st inclined direction vector B1, a vector which is projected onto the 2 nd orthogonal plane P2 by a normal vector a2 of the 2 nd maximum projection plane is defined as a2 nd inclined direction vector B2, and the 1 st orthogonal plane P1 and the 2 nd orthogonal plane P2 are overlapped with each other in the inner direction Y1, the outer direction Y2, the tip direction X2 and the base end direction 1 nd orthogonal plane P2, the 1 st tilt direction vector B1 is oriented in the opposite direction from the 2 nd tilt direction vector B2. Thus, when the 1 st wire 41 and the 2 nd wire 51 are alternately arranged in the longitudinal direction, the 1 st distal end surface 42 and the 2 nd distal end surface 52 are less likely to collide with each other and can be smoothly screwed in. By comparing the 1 st oblique direction vector B1 with the 2 nd oblique direction vector B2 in a state where the 1 st orthogonal plane P1 and the 2 nd orthogonal plane P2, which are different planes, are overlapped, the directions of the 1 st oblique direction vector B1 and the 2 nd oblique direction vector B2 when the 1 st tip surface 42 is in contact with the 2 nd tip surface 52 can be compared.

As shown in fig. 3 to 6, the 1 st oblique direction vector B1 is directed within a distal end side range S2 centered on the distal end direction X2 and having an effective angle α (for example, 20 degrees) on both sides thereof on the 1 st orthogonal plane P1, and the 2 nd oblique direction vector B2 is directed within a proximal end side range S1 centered on the proximal end direction X1 and having an effective angle α (for example, 20 degrees) on both sides thereof on the 2 nd orthogonal plane P2. Thus, when the 1 st wire 41 and the 2 nd wire 51 are alternately arranged in the longitudinal direction, the 1 st distal end surface 42 and the 2 nd distal end surface 52 are less likely to collide with each other, and can be smoothly screwed in. The 1 st end surface 42 guides the 2 nd end surface 52 to the inter-wire gap of the front end coil 40 by its inclination. The 2 nd distal end surface 52 guides the 1 st distal end surface 42 to the inter-wire gap of the proximal end coil 50 by its inclination. Therefore, the base end portion of the tip coil 40 and the tip end portion of the base end coil 50 can be easily intertwined with each other.

Further, a normal vector a1 of the normal vectors of the 1 st maximum projection surface facing in a direction away from the 1 st end surface 41 is inclined at 5 to 45 degrees with respect to a normal vector E1 of the normal vectors of the 1 st orthogonal surface P1 facing in a direction away from the 1 st end surface 41, and a normal vector a2 of the normal vectors of the 2 nd maximum projection surface facing in a direction away from the 2 nd end surface 51 is inclined at 5 to 45 degrees with respect to a normal vector E2 of the normal vectors of the 2 nd orthogonal surface P2 facing in a direction away from the 2 nd end surface 51. If the 1 st inclination angle θ 1 and the 2 nd inclination angle θ 2 are larger than 45 degrees, the fixing member in a flowable state excessively flows into the inter-wire gap of the coil and the gap between the core 20 and the coil, and therefore the 1 st end surface 42 and the 2 nd end surface 52 easily protrude from the intermediate fixing member 62. If the 1 st inclination angle θ 1 and the 2 nd inclination angle θ 2 are smaller than 5 degrees, it is difficult to guide the 1 st end surface 42 and the 2 nd end surface 52 to the mutual inter-wire gap of the coils, and therefore it is difficult to obtain an effect of alleviating the collision of the 1 st end surface 42 and the 2 nd end surface 52.

As shown in modification 1 shown in fig. 7 and 8, the 1 st oblique direction vector B1 may be directed within an inner side range S3 centered on the inner direction Y1 and having an effective angle α (for example, 20 degrees) on both sides in the 1 st orthogonal plane P1, and the 2 nd oblique direction vector B2 may be directed within an outer side range S4 centered on the outer direction Y2 and having an effective angle α (for example, 20 degrees) on both sides in the 2 nd orthogonal plane P2. Thus, when the 1 st wire 41 and the 2 nd wire 51 are alternately arranged in the longitudinal direction, the 1 st tip surface 42 and the 2 nd tip surface 52 are less likely to collide with each other, and can be smoothly screwed in.

As shown in modification 3 shown in fig. 11 and 12, the 1 st oblique direction vector B1 may be directed within an outer side range S4 centered on the outer direction Y2 and having an effective angle α (for example, 20 degrees) on both sides in the 1 st orthogonal plane P1, and the 2 nd oblique direction vector B2 may be directed within an inner side range S3 centered on the inner direction Y1 and having an effective angle α (for example, 20 degrees) on both sides in the 2 nd orthogonal plane P2. Thus, when the 1 st wire 41 and the 2 nd wire 51 are alternately arranged in the longitudinal direction, the 1 st tip surface 42 and the 2 nd tip surface 52 are less likely to collide with each other, and can be smoothly screwed in.

As shown in the 2 nd modification example shown in fig. 9 and 10, the 1 st oblique direction vector B1 may be directed within a base end side range S1 centered on the base end direction X1 and having an effective angle α (for example, 20 degrees) on both sides thereof on the 1 st orthogonal plane P1, and the 2 nd oblique direction vector B2 may be directed within a tip end side range S2 centered on the tip end direction X2 and having an effective angle α (for example, 20 degrees) on both sides thereof on the 2 nd orthogonal plane P2. Thus, when the 1 st wire 41 and the 2 nd wire 51 are alternately arranged in the longitudinal direction, the 1 st tip surface 42 and the 2 nd tip surface 52 are less likely to collide with each other, and can be smoothly screwed in.

In the method for manufacturing the guide wire 10 of the present embodiment, the guide wire 10 includes: a long core member 20 having a distal end portion and a proximal end portion; a front end coil 40 formed by winding the 1 st wire 41 and surrounding a front end portion of the core 20; a base end coil 50 formed by winding the 2 nd wire 51 and surrounding the tip end of the core material 20 on the base end side of the tip end coil 40; and a fixing member 60 for fixing the distal end coil 40 and the proximal end coil 50 to the core member 20, wherein the method for manufacturing the guide wire 10 includes the steps of: preparing a tip coil 40 in which a normal vector a1 of a1 st maximum projection surface, which is a surface having a maximum orthographic projection area of the 1 st end surface 42 of the tip coil 40, passes through a1 st intersection D1 of the 1 st end surface 42 and the 1 st axial center Z1 of the 1 st wire rod 41 and is inclined with respect to a normal vector E1 of a1 st orthogonal surface P1 orthogonal to the 1 st axial center Z1; preparing a base coil 50 in which a normal vector a2 of a2 nd maximum projection surface, which is a maximum orthographic projection area of the 2 nd distal end surface 52 of the base coil 50, passes through a2 nd intersection D2 of the 2 nd distal end surface 52 and the 2 nd axial center Z2 of the 2 nd wire 51 and is inclined with respect to a normal vector E2 of a2 nd orthogonal surface P2 orthogonal to the 2 nd axial center Z2; a step of relatively rotating the 1 st wire 41 on the base end side of the distal end coil 40 and the 2 nd wire 51 on the distal end side of the proximal end coil 50 so as to be alternately arranged in the longitudinal direction; and a step of filling the fixing member 60 in a gap between at least a part of the 1 st wire 41 and the 2 nd wire 51 which are alternately arranged, and fixing the leading end coil 40 and the base end coil 50 to the core 20 by the fixing member 60.

In the method of manufacturing the guide wire 10 configured as described above, when the 1 st wire 41 and the 2 nd wire 51 are alternately arranged in the longitudinal direction by relatively rotating the distal end coil 40 and the proximal end coil 50, the 1 st distal end surface 42 and the 2 nd distal end surface 52 are less likely to collide with each other and can be smoothly screwed in. Therefore, two or more coils can be wound easily without damage. In addition, the manufactured guidewire 10 is less likely to be damaged, and therefore, the safety is improved. Further, since the fixing member 60 is filled in the gap between at least a part of the 1 st wire 41 and the 2 nd wire 51 which are alternately arranged, the 1 st wire 41 and the 2 nd wire 51 can be firmly fixed to the core 20.

The present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical spirit of the present invention. For example, the lumen of the living body into which the guide wire 10 is inserted is not limited to a blood vessel, but may be, for example, a vessel, a ureter, a bile duct, a fallopian tube, a hepatic duct, or the like.

The structure of the guide wire is not limited to the above-described embodiment. The coil, e.g. a guide wire, may also be covered by a resin.

Claims

1. A guidewire, comprising:

a long core material having a distal end portion and a proximal end portion;

a front end coil formed by winding a1 st wire material and surrounding a front end portion of the core material; and

a base end coil formed by winding a2 nd wire material and surrounding a tip end portion of the core material on a base end side of the tip end coil,

the front end coil has a1 st end surface at the base end of the 1 st wire,

the base end coil has a2 nd end surface at the tip of the 2 nd wire,

the base end portion of the 1 st wire and the tip end portion of the 2 nd wire are connected in an alternating arrangement,

a normal vector of a1 st maximum projection surface which is a surface having a maximum orthographic projection area of the 1 st end surface is inclined with respect to a normal vector of a1 st orthogonal surface which passes through a1 st intersection point where the 1 st end surface and a1 st axis of the 1 st wire rod intersect and is orthogonal to the 1 st axis,

a normal vector of a2 nd maximum projection surface which is a surface having a maximum orthographic projection area of the 2 nd end surface is inclined with respect to a normal vector of a2 nd orthogonal surface which passes through a2 nd intersection point where the 2 nd end surface and a2 nd axis of the 2 nd wire rod intersect and is orthogonal to the 2 nd axis.

2. The guidewire of claim 1,

in the 1 st orthogonal surface and the 2 nd orthogonal surface, a direction orthogonal to the center line toward the center line of the tip coil or the base coil is defined as an inner direction, a direction opposite to the inner direction is defined as an outer direction, a direction orthogonal to the inner direction and having a component toward a base end side is defined as a base end direction, and a direction opposite to the base end direction is defined as a tip end direction,

a vector projecting onto the 1 st orthogonal surface a normal vector of the normal vectors of the 1 st maximum projection surface that faces in a direction away from the 1 st end surface is defined as a1 st oblique direction vector, a vector projecting onto the 2 nd orthogonal surface a normal vector of the normal vectors of the 2 nd maximum projection surface that faces in a direction away from the 2 nd end surface is defined as a2 nd oblique direction vector,

when the 1 st orthogonal surface and the 2 nd orthogonal surface are superimposed such that the inner direction, the outer direction, the distal direction, and the proximal direction of each surface coincide with each other, the 1 st oblique direction vector and the 2 nd oblique direction vector face in opposite directions.

3. The guidewire of claim 2,

the 1 st oblique direction vector is directed within a range of a tip end side of the 1 st orthogonal plane centered on the tip end direction and having an effective angle of 20 degrees on both sides,

the 2 nd oblique direction vector is directed within a base end side range centered on the base end direction and having an effective angle of 20 degrees on both sides in the 2 nd orthogonal plane.

4. The guidewire of claim 2,

the 1 st oblique direction vector is oriented in an outer side range centered on the outer direction and having an effective angle of 20 degrees to both sides in the 1 st orthogonal plane,

the 2 nd oblique direction vector is directed within an inner side range centered on the inner direction and having an effective angle of 20 degrees on both sides in the 2 nd orthogonal plane.

5. The guidewire of claim 2,

the 1 st oblique direction vector is directed within an inner side range centered on the inner direction and having an effective angle of 20 degrees on both sides in the 1 st orthogonal plane,

the 2 nd oblique direction vector is oriented in an outer side range centered on the outer direction and having an effective angle of 20 degrees to both sides in the 2 nd orthogonal plane.

6. The guidewire of claim 2,

the 1 st oblique direction vector is directed within a base end side range centered on the base end direction and having an effective angle of 20 degrees on both sides in the 1 st orthogonal plane,

the 2 nd oblique direction vector is directed within a range of the tip side of the 2 nd orthogonal plane centered on the tip direction and having an effective angle of 20 degrees on both sides.

7. The guidewire of any one of claims 1-6,

a normal vector of the normal vectors of the 1 st maximum projection surface facing in a direction away from the 1 st end surface is inclined at 5 to 45 degrees with respect to a normal vector of the normal vectors of the 1 st orthogonal surface facing in a direction away from the 1 st end surface,

a normal vector of the normal vectors of the 2 nd maximum projection surface facing in a direction away from the 2 nd end surface is inclined at 5 to 45 degrees with respect to a normal vector of the normal vectors of the 2 nd orthogonal surface facing in a direction away from the 2 nd end surface.