JP2020039377A - Guide wire - Google Patents

Abstract

To provide a guide wire that enables reduction in penetration resistance in penetrating a lesioned part of a narrow section or the like and has secured flexibility.SOLUTION: A guide wire 10 comprises a coil member 200 including a first region 210, a second region 220, and a third region 230 along an axial direction of a core wire 100 from a tip to a base. In the first region, a first inclined part having an outer shape increasing from the tip to the base is formed by increasing an outer diameter of a first linear body 206 forming the coil member from the tip to the base. In the second region, a second inclined part having an outer shape decreasing from the tip to the base is formed by decreasing the outer diameter of the first linear body forming the coil member from the tip to the base. In a boundary part between the first region and the second region, a maximal outer shape part 240 having the maximal outer shape is formed. An inner diameter d1 formed by the coil member in the first region is the approximately same as an inner diameter d2 formed by the coil member in the second region.SELECTED DRAWING: Figure 3

Description

  The present invention relates to a guidewire.

  2. Description of the Related Art A guide wire is widely known as a medical instrument for guiding a medical device (such as a balloon catheter) used for treatment of a stenosis or the like formed in a body lumen such as a blood vessel in a living body. Generally, a guide wire includes a core wire serving as a core material, and a coil member disposed on the distal end side of the core wire.

  A guide wire is required to have various performances depending on its use. One of the performances required for a guidewire is penetrability (passability) with respect to a constricted portion.

  In connection with the above-described problem, Patent Literature 1 listed below proposes a guide wire including a coil member formed in a tapered shape such that the outer shape decreases from a base end toward a distal end. The guide wire is formed with a tapered shape whose outer shape becomes smaller toward the distal end side, so that a pushing force (pushability) applied to the stenotic portion from the distal end side of the guide wire is increased.

  Further, in order to impart the taper shape to the coil member, the guide wire described in Patent Literature 1 changes the outer diameter of a linear body (coil wire) forming the coil member from the distal end side to the proximal end side of the coil member. It is gradually increasing toward. The inner diameter of the coil member (the diameter of the lumen formed inside the coil member) changes so as to gradually increase from the distal end toward the proximal end according to the change in the outer diameter of the linear body. . Therefore, the inner diameter of the coil member is relatively small on the distal end side of the tapered shape, and the inner diameter of the coil member is relatively large on the proximal end side of the tapered shape.

JP 2007-135645 A

  According to the guide wire described in Patent Document 1, the penetrability of the guide wire to the stenosis portion is favorably improved. However, for example, when the stenosis is formed relatively long along the direction of extension of the blood vessel, when the guide wire penetrates the stenosis, the guide wire extends over a relatively long range from the distal end to the proximal end of the coil member. Through resistance. For this reason, in order to improve the penetration of the guide wire into the constricted portion, the pushing force applied to the constricted portion from the distal end side of the guide wire is improved, and the penetration resistance when penetrating the constricted portion is reduced. Is also required.

  Further, in the guide wire described in Patent Literature 1, since the inner diameter of the coil member at the distal end side of the tapered portion is smaller than the inner diameter of the other portion of the coil member, it is difficult to secure flexibility at the distal end side of the coil member. .

  An object of the present invention is to provide a guidewire that can reduce penetration resistance when penetrating a lesion such as a stenosis, and that ensures flexibility.

  The guide wire according to the present invention includes a core wire, and a coil member fixed to at least a distal end portion of the core wire, wherein the coil member extends from the distal end toward the proximal end along the axial direction of the core wire, and The first region has a first region, a second region, and a third region, and the first region is formed by increasing the outer diameter of a linear body forming the coil member from the distal end to the proximal end, thereby increasing the outer diameter of the linear body. Forming a first inclined portion having an outer shape that increases from the distal end to the proximal end by decreasing the outer diameter of a linear body that forms the coil member from the distal end toward the proximal end. Forming a second inclined portion having a smaller outer shape toward the first region, a boundary portion between the first region and the second region forms a maximum outer shape portion in which the outer shape of the coil member is the largest, and in the first region Inside the coil member Is substantially the same inner diameter as said coil member is formed in the second region.

  According to the guide wire of the present invention, the pushing force on the constriction can be increased by the first region of the coil member. The second region of the coil member reduces the penetration resistance that the guide wire receives from the constriction when pushed into the constriction following the first region of the coil member. Therefore, the guide wire of the present invention has further improved penetrability to the constriction.

  In addition, the guide wire of the present invention controls (shapes) the outer shape of the coil member while maintaining the inner diameter formed by the coil member by adjusting the outer diameter of the linear body forming the coil member. , Flexibility can be secured.

  Further, in the guide wire of the present invention, the inner diameter formed by the coil member is maintained substantially the same in the first region, the second region, and the maximum outer shape portion formed at the boundary between the first region and the second region. When forming the maximum outer shape, the outer shape of the maximum outer shape of the coil member does not become excessively large. Thus, the guide wire can suppress the concentration of stress on the maximum outer shape when the coil member penetrates the constriction. For this reason, the guide wire of the present invention has a further improved pushability to the constricted portion, and furthermore, it is possible to prevent the linear body of the coil member forming the maximum outer shape portion from climbing to the base end side.

It is a partial longitudinal section showing a guide wire concerning an embodiment of the present invention. It is a figure which expands and shows the front-end | tip part of a guide wire. It is sectional drawing which expands and shows a core wire and a coil member. It is sectional drawing which expands and shows a part of linear body which forms a coil member. FIG. 4 is a cross-sectional view schematically illustrating a state before a guide wire is penetrated into a stenosis portion, for explaining an operation of the guide wire. FIG. 9 is a cross-sectional view schematically illustrating a state after the guide wire has been penetrated through a stenosis portion, for explaining the operation of the guide wire.

  Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. The following description does not limit the technical scope and the meaning of the terms described in the claims. In addition, the dimensional ratios in the drawings are exaggerated for convenience of description, and may be different from the actual ratios.

  FIG. 1 is a partial longitudinal sectional view (a sectional view along the axial direction of the guide wire 10) showing the guide wire 10 according to the embodiment, FIG. 2 is an enlarged view showing a distal end portion of the guide wire 10 in FIG. FIG. 3 is an enlarged view for explaining the inner diameter of the coil member 200 of the guide wire 10, and FIG. 4 is a view for explaining the outer diameter of the linear body 205 forming the coil member 200. FIGS. 5 and 6 are views for explaining the operation of the guidewire.

  As shown in FIG. 1, the guide wire 10 has a long core wire 100 having flexibility, and a coil member 200 fixed to at least the distal end portion 101 of the core wire 100.

  In the description of the present specification, the longitudinal direction (the left-right direction in FIG. 1) of the core wire 100 is defined as the axial direction, and is indicated by a chain line A1. Further, the side of the guidewire 10 that is introduced into the living body (intravascular) is defined as the distal side (the left side in FIG. 1), and the end side opposite to the distal side is defined as the proximal side (the right side in FIG. 1). I do. Further, in this specification, the distal end means a portion including a certain range in the axial direction from the distal end (most distal end), and the base end means a certain range in the axial direction from the proximal end (most proximal end). Means a part including.

  In the following description, the structural description of the guidewire 10 (the description regarding the shape, dimensions, and the like) will be described by taking, as an example, a state in which no external force is applied to the guidewire 10. That is, the structural features of the guidewire 10 described in the present embodiment are provided on the guidewire 10 at least in a state where no external force is applied to the guidewire 10.

  As shown in FIGS. 1 and 2, the coil member 200 is formed by a linear body 205 that is spirally wound around the core wire 100 along the circumferential direction of the core wire 100. The coil member 200 is disposed so as to cover the distal end side of the core wire 100 (the distal end side of the first core portion 110 described later) in a certain range along the axial direction.

  The coil member 200 is formed of a close-wound coil in which the linear body 205 is wound without any gap. However, the coil member 200 may be formed of, for example, a loosely wound coil in which a gap is formed between adjacent portions of the linear body 205. Further, the coil member 200 may be formed, for example, by a coil having both a densely wound portion and a loosely wound portion at an arbitrary position. When a gap is formed in the coil member 200, the size of the gap (the length along the axial direction) can be set to any size.

  As shown in FIG. 2, the coil member 200 includes a first linear body 206 disposed on the distal end side in the axial direction, and a second line disposed on the proximal end side in the axial direction with respect to the first linear body 206. And a shape body 207. 2, illustration of a first coating layer 310 and a second coating layer 320, which will be described later, is omitted to simplify the description.

  The coil member 200 has a first region 210, a second region 220, and a third region 230 from the distal end to the proximal end along the axial direction of the core wire 100.

  The first region 210 of the coil member 200 and the second region 220 of the coil member 200 are formed by the first linear body 206. Further, the first linear body 206 is formed of one continuous member.

  The above “one continuous member” means that the linear body is formed as one member at the stage of being prepared as a member for forming the coil member 200. For example, a linear body formed by joining a plurality of members made of different types of materials in a stage before forming the coil member 200 is included in “one continuous member”, but the first linear body 206 What is fixed (connected) at the stage of forming the coil member 200, such as the second linear body 207, is not included in “one continuous member”.

  The third region 230 of the coil member 200 includes a second linear body 207 different from the first linear body 206. The first linear body 206 and the second linear body 207 are fixed via an intermediate fixing part 170 described later.

  As shown in FIGS. 3 and 4, the first region 210 of the coil member 200 is formed by increasing the outer diameter of the first linear body 206 forming the coil member 200 from the distal end toward the proximal end, thereby increasing the outer diameter from the distal end. A first inclined portion whose outer shape increases toward the base end is formed. In other words, the first region 210 of the coil member 200 forms a tapered portion in which the outer shape of the coil member 200 gradually decreases toward the distal end.

  The second region 220 of the coil member 200 is configured such that the outer diameter of the first linear body 206 forming the coil member 200 decreases from the distal end to the proximal end, so that the outer shape decreases from the distal end to the proximal end. Two inclined portions are formed. In other words, the second region 220 of the coil member 200 forms a tapered portion in which the outer shape of the coil member 200 gradually decreases toward the base end side.

  The boundary between the first region 210 of the coil member 200 and the second region 220 of the coil member 200 forms a maximum outer portion 240 where the outer shape of the coil member 200 is the largest. That is, the outer shape of the coil member 200 is largest at the boundary between the base end of the first region 210 and the front end of the second region 220.

  The third region 230 of the coil member 200 forms a linear portion extending from the distal end to the proximal end with a substantially constant outer shape.

  In the description of the present specification, the outer shape of the coil member 200 is represented by a tangent line (outer line) 200A connecting each outer surface of the linear body 205 forming the coil member 200 (see FIGS. 2 and 3). . The outer shape of the coil member 200 refers to the outer shape of the coil member 200 in a state where the first coating layer 310 and the second coating layer 320 described later are not arranged, that is, the outer shape of the coil member 200 in the state shown in FIG. means.

  In each drawing, the inner surface of the coil member 200 is represented by a tangent line 200B connecting each inner surface of the linear body 205 forming the coil member 200.

  The first linear body 206 forming the first region 210 of the coil member 200 and the second region 220 of the coil member 200 has higher contrast than the second linear body 207 forming the third region 230 of the coil member 200. have. Therefore, the first region 210 and the second region 220 have higher contrast than the third region 230.

  When adjusting the magnitude relation of the contrast in each of the regions 210, 220, and 230 of the coil member 200 as described above, the first linear body 206 can be formed of, for example, a material having radiopaque properties. . As the material having radiopaque properties, for example, platinum, gold, silver, titanium, tungsten, cobalt, an alloy containing these, or the like can be used. On the other hand, the second linear body 207 can be formed of a material having lower X-ray opacity than the first linear body 206. As such a material, for example, stainless steel, a superelastic alloy, or the like can be used. The material forming the linear bodies 206 and 207 may be subjected to processing such as quenching.

  As shown in FIG. 1, the core wire 100 includes a first core portion 110 arranged on the distal end side in the axial direction, and a second core portion arranged on the base end side of the first core portion 110 and connected to the first core portion 110. And a two-core unit 120.

  As shown in FIGS. 2 and 3, the first core portion 110 of the core wire 100 has a first tapered portion 111 formed in a tapered shape whose outer shape decreases toward the distal end, and a base end side of the first tapered portion 111. A second tapered portion 112 formed in a tapered shape whose outer shape decreases toward the base end; and a constant outer shape portion 113 formed on the base end side of the second tapered portion 112 and extending with a substantially constant outer shape. ,have.

  At the boundary between the first tapered portion 111 of the first core portion 110 of the core wire 100 and the second tapered portion 112 of the first core portion 110 of the core wire 100, the maximum outer shape at which the outer shape of the first core portion 110 is the largest A part 140 is formed.

  At least a part of the first taper portion 111 of the first core portion 110 is arranged so as to overlap the first region 210 of the coil member 200 in the circumferential direction of the core wire 100. Further, at least a part of the second tapered portion 112 of the first core portion 110 is disposed so as to overlap the second region 220 of the coil member 200 in the circumferential direction of the core wire 100. Further, the maximum outer portion 140 of the first core portion 110 is arranged so as to overlap the maximum outer portion 240 of the coil member 200 in the circumferential direction of the core wire 100.

  As a constituent material of the first core portion 110 of the core wire 100, for example, a Ni-Ti alloy, stainless steel, or a superelastic alloy can be used.

  As shown in FIG. 1, the second core portion 120 of the core wire 100 has a tapered distal end portion 121 whose outer shape decreases toward the distal end side, and a large diameter formed on the proximal end side of the distal end portion 121. And a part 122.

  As a constituent material of the second core portion 120 of the core wire 100, for example, stainless steel or a cobalt-based alloy can be used. Note that the first core portion 110 and the second core portion 120 may be formed of the same or the same type of metal material (for example, the main metal material in the alloy is the same).

  The first core portion 110 and the second core portion 120 can be connected by, for example, a method such as welding. In addition, the core wire 100 can be configured by, for example, one continuous member, or can be configured by connecting three or more members.

  As shown in FIG. 2, the linear member 205 forming the coil member 200 and the first core portion 110 of the core wire 100 are fixed to the distal end side fixing portion 160 and the intermediate fixing portion disposed closer to the base end side than the distal end side fixing portion 160. It is fixed via three fixing portions of a portion 170 and a proximal fixing portion 180 disposed closer to the proximal side than the intermediate fixing portion 170.

  The distal end side fixing portion 160 includes a distal end portion (a distal end portion of the first core portion 110) 101 of the core wire 100 and a portion (a portion of the coil member 200) disposed most distally in the first linear body 206 forming the coil member 200. The portion (the portion forming the tip of the first region 210) 206a is fixed.

  The distal end side fixing portion 160 is formed in a tapered shape in which the outer shape is reduced while being curved in a convex shape toward the distal end. In addition, the length of the distal end side fixing portion 160 in the axial direction, the curvature curved toward the distal end side, and the like are not particularly limited, and can be appropriately changed.

  The intermediate fixing part 170 fixes three members of the first linear body 206, the second linear body 207, and the first core part 110. Specifically, the intermediate fixing portion 170 is a portion disposed at the most proximal end in the first linear body 206 forming the coil member 200 (a portion forming the proximal end of the second region 220 of the coil member 200). 206b and the base end of the second tapered portion 112 of the first core portion 110 of the core wire 100 are fixed. In addition, the intermediate fixing portion 170 includes a portion 206 b disposed at the most proximal end of the first linear body 206 (a portion forming a proximal end of the second region 220 of the coil member 200) 206 b and a second linear body 206. A portion 207a (the portion forming the distal end of the third region 230 of the coil member 200) disposed at the most distal end in 207 is fixed.

  The proximal-side fixing portion 180 includes a portion (a portion that forms the proximal end of the third region 230 of the coil member 200) 207b disposed at the most proximal end in the second linear body 207 that forms the coil member 200; The fixed outer shape portion 113 of the first core portion 110 of the core wire 100 is fixed.

  Each of the fixing portions 160, 170, and 180 can be formed of, for example, solder or an adhesive formed into a predetermined shape.

  As shown in FIG. 1, a first coating layer 310 is provided on the outer surface of the coil member 200. The first coating layer 310 is made of, for example, a cellulose-based polymer, a polyethylene oxide-based polymer, or a maleic anhydride-based polymer (for example, a maleic anhydride copolymer such as a methyl vinyl ether-maleic anhydride copolymer). ), A known acrylamide polymer (for example, polyacrylamide, a block copolymer of polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA)), a water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone and the like. can do.

  As shown in FIG. 1, a second coating layer 320 is provided on the outer surface of the second core portion 120 of the core wire 100. The second coating layer 320 can be formed of, for example, a fluorine-based resin such as PTFE or ETFE.

  The thickness of each of the coating layers 310 and 320 is not particularly limited, but may be, for example, about 0.1 to 100 μm.

  Next, dimensions and the like of each part of the coil member 200 will be described.

  As shown in FIG. 3, the inner diameter d1 of the first region 210 of the coil member 200 (the inner diameter formed by the coil member 200) is equal to the inner diameter d2 of the second region 220 of the coil member 200 and the third region 230 of the coil member 200. It is substantially the same as the inner diameter d3.

  The phrase “the inner diameters are substantially the same” means that the flexibility of each of the regions 210, 220, and 230 of the coil member 200 is the same so that the flexibility of the respective inner diameters is not significantly different due to the difference in the inner diameters. I do. For example, differences in dimensions based on manufacturing tolerances are included in the above substantially the same range. Further, “substantially the same” regarding dimensions other than the inner diameter described in the present specification means that they are the same within a range that does not impair the effects of the invention, and at least differences in dimensions based on manufacturing tolerances are substantially the same. Shall be included.

  As shown in FIG. 4, the outside of each part of the first linear body 206 forming the first region 210 of the coil member 200 (the wire part of the linear body 205 indicated by a circle in a sectional view along the axial direction). The diameter increases from the distal end to the proximal end.

  The first region 210 of the coil member 200 is formed by five portions 206a, 206d, 206e, 206f, and 206c arranged from the distal end side to the intermediate portion in the first linear body 206. In the portion 206c disposed most proximally in the first region 210, a part on the distal side is included in the first region 210, and a part on the proximal side is included in the second region 220. .

  The outer diameter of each part of the first linear body 206 forming the second region 220 of the coil member 200 decreases from the distal end to the proximal end.

  The second region 220 of the coil member 200 is formed by four portions 206c, 206g, 206h, and 206b arranged from the intermediate portion to the base end side in the first linear body 206. As described above, the portion 206c of the first linear body 205 that is disposed at the most distal end of the second region 220 has a part on the distal end side included in the first region 210 and a part on the proximal end side. It is included in the second area 220.

  In the first linear body 206, on the base end side of the portion 206b forming the base end of the second region 220 of the coil member 200, an intermediate fixing portion 170 is interposed (see FIG. 2), A portion 207a that forms the tip of the third region 230 of the coil member 200 in the shape body 207 is arranged.

  The outer diameter of each portion of the second linear body 207 forming the third region 230 of the coil member 200 is substantially the same. Therefore, the outer shape of the third region 230 of the coil member 200 is linear in the axial direction.

  The outer diameter Df1 of the portion 206a of the first linear body 206 that forms the distal end of the first region 210 of the coil member 200 forms the base end of the second region 220 of the coil member 200 in the first linear body 206. It is substantially the same as the outer diameter Df2 of the portion 206b to be formed.

  The outer diameter Df2 of the portion 206b of the first linear body 206 forming the base end of the second region 220 of the coil member 200 is equal to the distal end of the third region 230 of the coil member 200 in the second linear body 207. Is substantially the same as the outer diameter Df3 of the portion 207a that forms Since the second linear body 207 has substantially the same outer diameter at each portion in the axial direction, the second linear body 207 is located outside the portion 207b that forms the base end of the third region 230 of the coil member 200 in the second linear body 207. The diameter Df4 is substantially the same as the outer diameter Df3 of the portion 207a of the second linear body 207 that forms the tip of the third region 230 of the coil member 200. That is, in the present embodiment, the outer diameters Df1, Df2, Df3, and Df4 of the respective portions of the linear body 205 are substantially the same.

  The guide wire 10 has the following effects by defining the outer diameters Df1, Df2, Df3, and Df4 of the respective portions of the linear body 205 as described above.

  The outer diameter Df2 of the portion 206b forming the base end of the second region 220 of the coil member 200 in the first linear body 206 forms the distal end of the third region 230 of the coil member 200 in the second linear body 207. It is substantially the same as the outer diameter Df3 of the portion 207a to be formed. For this reason, the guide wire 10 can suppress an increase in a physical property step (a width of change in rigidity) at the boundary between the first linear body 206 and the second linear body 207. Thereby, the guide wire 10 can prevent the core wire 100 from being damaged or broken at the boundary between the first linear body 206 and the second linear body 207.

  Further, a portion 206a of the first linear body 206 that forms the distal end of the first region 210 of the coil member 200 has the smallest outer diameter as compared with other portions of the first linear body 206. For this reason, when the guide wire 10 is pushed into the constriction S from the distal end side of the coil member 200, it prevents the portion 206a located at the foremost end of the coil member 200 from riding on another portion 206d adjacent to the proximal end side. it can.

  The outer diameter Df1 of the portion 206a forming the distal end of the first region 210 of the coil member 200 in the first linear member 206, and the base end of the second region 220 of the coil member 200 in the first linear member 206 are formed. The outer diameter Df2 of the portion 206b can be formed, for example, from 0.02 mm to 0.1 mm. Further, the outer diameter Ds of the portion 206c of the first linear body 206 that forms the maximum outer shape portion 240 of the coil member 200 can be set to, for example, 0.04 mm to 0.2 mm. The outer diameter of the first linear body 206 other than the above-described portions is the length in the axial direction of the first region 210 and the second region 220, and the first linear body of the portion forming the first region 210 and the second region 220. It can be formed in an arbitrary size according to the number of turns 206 and the like.

  The outer diameters Df3 and Df4 of the respective portions 207a and 207b forming the third region 230 of the coil member 200 in the second linear body 207 are formed to be 0.02 mm to 0.1 mm similarly to the outer diameters Df1 and Df2. can do.

  As shown in FIG. 3, the maximum outer shape portion 240 of the coil member 200 is located substantially at the axial center position of the portion 206 c having the largest outer diameter in the first linear body 206 (in the first linear body 206, It is formed at a position passing through the central portion c1 of the portion 206c forming the outer shape portion 240 and extending along a perpendicular line H perpendicular to the axis of the core wire 100).

  Since the coil member 200 is spirally wound around the axis of the core wire 100, the maximum outer portion 240 of the coil member 200 extends along the spiral shape of the coil member 200. That is, in the cross-sectional views shown in FIGS. 2 and 3, the maximum outer shape portion 240 extends obliquely spirally from the upper side of the drawing to the lower side of the drawing.

  For this reason, in the present embodiment, the outer dimension Dm along the direction orthogonal to the axial direction of the largest outer part 240 is the perpendicular H passing through the center c1 of the part 206c of the first linear body 206 forming the largest outer part 240. , The length is defined as the length of a range delimited by a virtual line 200A indicating the outer shape of the coil member 200 (see FIG. 3). In addition, the outer dimension Dm along the direction orthogonal to the axial direction of the largest outer part 240 is, for example, the outer diameter of the largest outer part 240 when the axially orthogonal cross section of the largest outer part 240 is formed in a circular shape.

  Referring to FIG. 3, outer dimension Dm along a direction orthogonal to the axial direction of maximum outer portion 240 can be formed, for example, in a range of 0.28 mm to 0.80 mm.

  The outer dimension D1 of the first region 210 of the coil member 200 can be set, for example, such that the minimum portion on the distal end side is 0.25 mm to 0.61 mm and the maximum portion on the proximal end side is 0.27 mm. It can be formed to 0.79 mm. In addition, the outer dimension D2 of the second region 220 of the coil member 200 can be formed, for example, such that the largest portion on the distal side is 0.27 mm to 0.79 mm and the smallest portion on the proximal side is 0.25 mm. It can be formed to 0.61 mm.

  The outer dimension D3 of the third region 230 of the coil member 200 is, for example, 0.24 mm to 0.60 mm, and can be formed to have a constant size along the axial direction.

  The inner diameter d1 of the first region 210 of the coil member 200, the inner diameter d2 of the second region 220 of the coil member 200, and the inner diameter d3 of the third region 230 of the coil member 200 are, for example, 0.2 mm to 0.4 mm. Can be formed.

  Referring to FIG. 2, the length L1 of the first region 210 of the coil member 200 along the axial direction may be formed, for example, longer than the length L2 of the second region 220 of the coil member 200 along the axial direction. it can.

  When the relationship between the length L1 and the length L2 is adjusted as described above, the total length along the axial direction of the coil member 200 (the length along the axial direction of the portion where the coil member 200 is wound around the core wire 100) is determined. Thus, a longer length L1 along the axial direction of the first region 210 whose outer shape decreases toward the distal end side is secured. Thereby, the guide wire 10 can form the distal end of the coil member 200 at a more acute angle (shape toward the distal end) toward the distal end side.

  The length L3 of the coil member 200 along the axial direction of the third region 230 is, for example, the sum of the length L1 of the first region 210 along the axial direction and the length L2 of the second region 220 along the axial direction. It can be formed longer than the length.

  When the relationship between the lengths L1, L2, and L3 is adjusted as described above, the ratio of the length L3 of the third region 230 along the axial direction to the total length of the coil member 200 along the axial direction increases. As a result, the portion of the coil member 200 where the first region 210 and the second region 220 are formed is formed closer to the distal end side of the coil member 200.

  In order to form the first region 210 and the second region 220 on the more distal end side of the coil member 200, for example, the third region 230 has a length of 50% or more of the entire length along the axial direction of the coil member 200. Preferably, it is formed.

  As an example that satisfies the above dimensional relationship regarding the length of the coil member 200, when the length (total length) along the axial direction of the guide wire 10 is, for example, 1750 mm to 3050 mm, the length along the axial direction of the coil member 200 (Overall length) can be formed, for example, in a range of 191 mm to 310 mm. In this case, the length L1 along the axial direction of the first region 210 can be formed, for example, in a range from 0.5 mm to 30 mm. The length L2 along the axial direction of the second region 220 can be formed, for example, in a range from 0.5 mm to 30 mm. The length L3 of the third region 230 along the axial direction can be formed, for example, in a range of 190 mm to 250 mm. It is preferable that the length L1 of the first region 210 of the coil member 200 along the axial direction be longer than the length L2 of the second region 220 of the coil member 200 along the axial direction.

  Next, the operation of the guidewire 10 will be described with reference to FIGS. FIGS. 5 and 6 are schematic cross-sectional views showing states before and after pushing the guidewire 10 through the stenosis S formed in the blood vessel.

  As shown in FIG. 5, when the surgeon pushes the guide wire 10 toward the stenosis S toward the distal end, the guide wire 10 is pushed into the stenosis S from the distal end of the first region 210 of the coil member 200. It is. In the coil member 200 of the guide wire 10, since the outer shape of the first region 210 located at the forefront decreases from the base end to the tip end, the pushing force on the constriction S is increased. Thus, the surgeon or the like can smoothly push the guidewire 10 into the stenosis S.

  As shown in FIG. 6, the surgeon or the like further pushes the guide wire 10 into the stenosis S, so that the second region 220 of the coil member 200 follows the first region 210 of the coil member 200. To enter.

  Since the outer shape of the second region 220 of the coil member 200 of the guide wire 10 decreases toward the base end side, when the second region 220 moves inside the narrowed portion S, the second region 220 and the narrowed portion S And the contact area between them becomes smaller. As a result, the penetration resistance that the second region 220 of the coil member 200 receives from the constricted portion S decreases. Thereby, the surgeon or the like can easily push the second region 220 following the first region 210 and the third region 230 following the second region 220 of the coil member 200 into the stenosis S, The guide wire 10 can be moved smoothly within the stenosis S.

  Further, since the guide wire 10 controls (shapes) the outer shape of the coil member 200 by adjusting the outer diameter of the first linear body 206 forming the coil member 200, the respective regions 210 and 220 of the coil member 200 are formed. , 230, the inner diameters d1, d2, and d3 can be maintained at predetermined sizes, and flexibility can be ensured. Further, in the guide wire 10, the inner diameter d1 of the first region 210 of the coil member 200 and the inner diameter d2 of the second region 220 of the coil member 200 are substantially the same. That is, since the guide wire 10 does not have an excessively large inner diameter at the maximum outer portion 240 of the coil member 200, an increase in the outer shape of the maximum outer portion 240 due to an increase in the inner diameter of the coil member 200 is suppressed. For this reason, in the guide wire 10, when the coil member 200 penetrates the constriction S, the stress concentration applied to the maximum outer portion 240 of the coil member 200 is reduced. Thereby, the guide wire 10 has a further improved pushability of the guide wire 10 into the narrowed portion S, and the first linear body 206 (206c) forming the maximum outer shape portion 240 rides on the proximal end side. Can be prevented.

  As described above, the guide wire 10 according to the present embodiment includes the core wire 100 and the coil member 200 fixed to at least the distal end portion 101 of the core wire 100. The coil member 200 is disposed in the axial direction of the core wire 100. , A first region 210, a second region 220, and a third region 230 from the distal end to the proximal end. The first region 210 of the coil member 200 is formed by increasing the outer diameter of the first linear body 206 forming the coil member 200 from the distal end to the proximal end, so that the outer shape increases from the distal end to the proximal end. One inclined portion is formed, and the second region 220 of the coil member 200 is formed from the distal end to the proximal end by decreasing the outer diameter of the first linear body 206 forming the coil member 200 from the distal end to the proximal end. A second inclined portion whose outer shape becomes smaller toward the outside is formed, and the boundary between the first region 210 of the coil member 200 and the second region 220 of the coil member 200 forms a maximum outer portion 240 where the outer shape of the coil member 200 becomes the largest. Has formed. The inside diameter d1 formed by the coil member 200 in the first region 210 of the coil member 200 is substantially the same as the inside diameter d2 formed by the coil member 200 in the second region 220 of the coil member 200.

  In the guide wire 10 configured as described above, the first region 210 of the coil member 200 can increase the pushing force on the constriction S. The second region 220 of the coil member 200 reduces the penetration resistance that the guide wire 10 receives from the constriction S when being pushed into the constriction S following the first region 210 of the coil member 200. Therefore, the guide wire 10 has further improved penetrability to the constricted portion S.

  The guide wire 10 controls (shapes) the outer shape of the coil member 200 while maintaining the inner diameter formed by the coil member 200 by adjusting the outer diameter of the first linear body 206 forming the coil member 200. Therefore, flexibility can be secured. For example, in order to control the outer shape of the coil member, when the outer diameter of the linear member forming the coil member is made constant and the winding diameter (winding diameter) of the linear member is increased, the inner diameter formed by the coil member becomes The distal end of the first inclined portion and the proximal end of the second inclined portion must be smaller than other portions of the coil member. A portion of the coil member having an inner diameter smaller than other portions reduces the flexibility of the coil member. The guide wire 10 according to the present embodiment can prevent the flexibility of the coil member 200 from decreasing as described above.

  The inner diameter of the guide wire 10 formed by the coil member 200 is maintained substantially the same in the first region 210, the second region 220, and the maximum outer shape portion 240 formed at the boundary between the first region 210 and the second region 220. Therefore, when forming the maximum outer shape portion 240 of the coil member 200, the outer shape of the maximum outer shape portion 240 of the coil member 200 does not become excessively large. Thereby, when the coil member 200 penetrates the constricted part S, the guide wire 10 can suppress the stress concentration on the maximum outer shape part 240. For this reason, the guide wire 10 has further improved pushability into the constricted portion S, and furthermore, it is possible to prevent the portion 207c of the first linear body 206 that forms the maximum outer shape portion 240 from riding on the proximal end side. .

  Further, the core wire 100 is formed in a tapered shape whose outer shape becomes smaller toward the distal end, and a first taper arranged so that at least a part thereof overlaps the first region 210 of the coil member 200 in the circumferential direction of the core wire 100. A second taper portion that is formed in a tapered shape whose outer shape decreases toward the base end, and is arranged so that at least a part thereof overlaps the second region 220 of the coil member 200 in the circumferential direction of the core wire 100. 112.

  The first tapered portion 111 of the core wire 100 disposed so as to overlap the first region 210 of the coil member 200 in the circumferential direction of the core wire 100, together with the first region 210 of the coil member 200, pushes the guide wire 10 into the constricted portion S. Improve the performance. Further, the second tapered portion 112 of the core wire 100 disposed so as to overlap with the second region 220 of the coil member 200 in the circumferential direction of the core wire 100 forms the second tapered portion 112 on the core wire 100 when the guide wire 10 is pushed into the narrowed portion S. It is possible to reduce the occurrence of stress concentration at the one taper portion 111. The core wire 100 has a maximum outer shape at the boundary between the first taper portion 111 of the core wire 100 and the second taper portion 112 of the core wire 100. 140 is formed.

  Further, the guide wire 10 has an intermediate fixing portion 170 for fixing the coil member 200 and the base end of the second tapered portion 112 of the core wire 100. The intermediate fixing portion 170 moves the base end portion of the second taper portion 112, which is formed to have relatively lower rigidity than the other portions of the core wire 100, in the first taper portion 111 and the second taper portion 112, to the coil member 200. By fixing (connecting) the core wire 100 at the base end of the second tapered portion 112, breakage such as breakage of the core wire 100 is prevented.

  The guide wire 10 is formed such that a length L1 of the first region 210 of the coil member 200 along the axial direction is longer than a length L2 of the second region 220 of the coil member 200 along the axial direction. For this reason, the length L1 along the axial direction of the first region 210 whose outer shape decreases toward the distal end side is secured longer than the entire length of the coil member 200 along the axial direction. Thereby, the distal end shape of the coil member 200 can be formed at a more acute angle (shape toward the distal end) toward the distal end side. For this reason, the guide wire 10 has further improved pushability into the constricted portion S.

  The guide wire 10 has a length L3 along the axial direction of the third region 230 of the coil member 200 and a length L1 along the axial direction of the first region 210 of the coil member 200 and the length L1 of the second region 220 of the coil member 200. It is formed longer than the sum of the lengths L2 along the axial direction. Therefore, the portion of the coil member 200 where the first region 210 and the second region 220 are formed is formed closer to the distal end side of the coil member 200. Accordingly, the first region 210 and the second region 220 of the guide wire 10 arranged on the distal end side of the coil member 200 effectively improve the penetration of the constriction S.

  The guide wire 10 has an outer diameter of a portion 206 b that forms the base end of the second region 220 of the coil member 200 in the first linear member 206 and a third region of the coil member 200 in the second linear member 207. The outer diameter of a portion 207a forming the tip of 230 is substantially the same. For this reason, from the base end of the second region 220 where the outer shape decreases from the front end side to the base end side, to the front end of the third region 230, the coil member 200 is caused by the difference in outer diameter of the respective portions 206b and 207a. It is possible to suppress the increased physical property step (stiffness change width). Thus, the guide wire 10 can prevent breakage such as breakage at the boundary between the base end of the second region 220 of the coil member 200 and the front end of the third region 230 of the coil member 200.

  Further, the guide wire 10 has a distal end side fixing portion 160 for fixing the distal end portion 101 of the core wire 100 and the coil member 200. The distal-end-side fixing portion 160 is formed in a tapered shape in which the outer shape is reduced toward the distal end while being curved toward the distal end. As described above, in the guide wire 10, since the distal end side fixing portion 160 is formed in a tapered shape toward the distal end side, the pushing force on the stenosis portion S is further improved. Further, since the distal end side fixing portion 160 has a shape curved in a convex shape toward the distal end, when moving the guide wire 10 in a living body, a living body organ such as a blood vessel is moved from the distal end of the guide wire 10. Can be protected.

  Further, the first linear body 206 forming the first region 210 of the coil member 200 and the second region 220 of the coil member 200 is higher than the second linear body 207 forming the third region 230 of the coil member 200. It has a contrast property. For this reason, when the surgeon or the like penetrates the guide wire 10 through the stenosis S, it is possible to easily confirm a portion of the guide wire 10 having enhanced penetration on an X-ray image, and use the guide wire 10. Can be performed smoothly.

  Further, the first linear body 206 forming the first region 210 of the coil member 200 and the second region 220 of the coil member 200 is formed of one continuous member. By forming the first region 210 and the second region 220 with one continuous member, the manufacturing operation of the coil member 200 is facilitated.

  As described above, the guidewire according to the present invention has been described through the embodiments. However, the present invention is not limited to the contents described in the specification, and can be appropriately changed based on the description in the claims. is there.

  For example, the number of turns of the linear member forming the coil member, the outer diameter of each portion of the linear member, and the like are not particularly limited as long as the first region, the second region, and the third region can be formed on the coil member.

  Further, the shape of the third region of the coil member has a constant outer shape, but the shape of the third region is not limited to such a shape. For example, the third region may be formed by an inclined portion in which the outer diameter of the linear body decreases toward the base end so that the outer shape decreases toward the base end. However, the maximum outer shape of the third region is preferably formed to be equal to or smaller than the base end of the second region from the viewpoint of improving the penetrability of the guide wire 10. Further, the inner diameter of the third region may not be the same as the inner diameter of the first region and the second region, and may not be a constant size along the axial direction.

  The dimensions of each part of the coil member (for example, the length of each region along the axial direction) and the dimensions of each part of the core wire (for example, the length of each part along the axial direction) are limited to those described in the specification. It is not changed and can be changed as appropriate. Further, the material for forming the coil member and the material for forming the core wire are not limited to those exemplified in the specification, and can be appropriately changed.

  Further, the guide wire may have a structure in which a plurality of layers are wound around the core wire in a double or triple manner. In such a configuration, the outer shape of the first region of the coil member and the outer shape of the second region of the coil member are formed by the outermost coil members. Further, in such a configuration, the inner diameter formed by the coil member is the inner diameter formed by the innermost coil member.

  Further, the coil member does not have to be formed by a single continuous member in which the linear body forming the first region and the linear body forming the second region are formed. For example, the first region and the maximum outer shape portion are formed by one linear body, and the second region is formed by another linear body. The first region is formed by one linear body, and the second region and the second region are formed by one linear body. The maximum outer portion may be formed by another linear body.

  Further, the shape of the core wire is not limited to the shape described with reference to the drawings. The core wire may have, for example, a shape that extends substantially linearly along the axial direction where the first taper portion and the second taper portion are not formed.

10 guide wire,
100 core wires,
101 tip of core wire,
110 first core part,
111 first taper portion,
112 second taper portion,
113 constant outer diameter part,
120 second core part,
140 Maximum outer diameter of core wire,
160 tip side fixed part,
170 intermediate fixing part,
180 base end fixed part,
200 coil members,
205 linear body,
206, 206a, 206b, 206c, 206d, 206e, 206f, 206g, 206h, a first linear body,
207, 207a, 207b second linear body,
210 first region (first inclined portion),
220 second region (second inclined portion);
230 third area,
240 maximum outer diameter of the coil member,
310 first coating layer,
320 second coating layer,
d1 the inner diameter of the first region,
d2 inner diameter of the second region,
d3 inner diameter of the third region,
L1 length of the first region along the axial direction,
L2 Length of the second region along the axial direction,
L3 Length of the third region along the axial direction,
S Stenosis.

Claims (9)

A core wire,
A coil member fixed to at least a distal end portion of the core wire,
The coil member has a first region, a second region, and a third region from a distal end toward a proximal end along an axial direction of the core wire,
The first region forms a first inclined portion whose outer shape increases from the distal end toward the proximal end by increasing the outer diameter of the linear body forming the coil member from the distal end toward the proximal end,
The second region forms a second inclined portion whose outer shape decreases from the distal end toward the proximal end by decreasing the outer diameter of the linear body forming the coil member from the distal end toward the proximal end,
A boundary portion between the first region and the second region forms a maximum outer shape portion where the outer shape of the coil member is the largest;
A guide wire, wherein an inner diameter formed by the coil member in the first region is substantially the same as an inner diameter formed by the coil member in the second region. The core wire,
A first tapered portion which is formed in a tapered shape whose outer shape decreases toward the tip, and is arranged so that at least a part thereof overlaps with the first region in a circumferential direction of the core wire;
It is formed in a tapered shape whose outer shape becomes smaller toward the base end, and has a second tapered portion arranged so that at least a part thereof overlaps with the second region in the circumferential direction of the core wire. The guidewire according to claim 1.   The guide wire according to claim 2, further comprising an intermediate fixing portion that fixes the coil member and a base end of a second tapered portion of the core wire.   The guidewire according to any one of claims 1 to 3, wherein a length of the first region along the axial direction is longer than a length of the second region along the axial direction.   The length of the third region along the axial direction is longer than the sum of the length of the first region along the axial direction and the length of the second region along the axial direction. Item 5. The guidewire according to any one of Items 1 to 4.   The outer diameter of the linear body forming the base end of the second region and the outer diameter of the linear body forming the distal end of the third region are substantially the same. Item 6. The guidewire according to any one of Items 1 to 5. A distal end side fixing portion for fixing the distal end portion of the core wire and the coil member,
The said front-end | tip fixing part is formed in the taper shape which becomes convex toward a front-end | tip, and becomes small in external shape toward a front-end | tip. Guide wire.   The linear body forming the first region and the linear body forming the second region have higher contrast than the linear body forming the third region. The guidewire according to any one of claims 1 to 7.   The linear body forming the first region and the linear body forming the second region are formed by one continuous member. The guidewire according to the section.