WO2016047365A1 - Guidewire - Google Patents

Guidewire Download PDF

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Publication number
WO2016047365A1
WO2016047365A1 PCT/JP2015/074303 JP2015074303W WO2016047365A1 WO 2016047365 A1 WO2016047365 A1 WO 2016047365A1 JP 2015074303 W JP2015074303 W JP 2015074303W WO 2016047365 A1 WO2016047365 A1 WO 2016047365A1
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WO
WIPO (PCT)
Prior art keywords
guide wire
fragile
end side
flat plate
core
Prior art date
Application number
PCT/JP2015/074303
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French (fr)
Japanese (ja)
Inventor
豊 田野
泰直 大谷
Original Assignee
テルモ株式会社
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Publication date
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Publication of WO2016047365A1 publication Critical patent/WO2016047365A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires

Definitions

  • the present invention relates to a guide wire used for guiding a catheter into a body cavity, particularly into a blood vessel.
  • the guide wire can be used for treatment of a site where surgical operation is difficult such as PTCA (Percutaneous Transluminal Coronary Angioplasty), treatment for the purpose of minimally invasive to the human body, or cardiovascular angiography. It is used when guiding a catheter used for examinations into the blood vessel.
  • PTCA is a treatment method for securing a blood flow path by dilating a stenotic site of a coronary artery with a balloon or the like.
  • the balloon catheter In PTCA, the balloon catheter is guided to the stenosis site by inserting the guide wire to the vicinity of the stenosis site of the blood vessel with the tip of the guide wire protruding from the tip of the balloon catheter. At that time, the guide wire needs to select and pass through a meandering or branched blood vessel, a narrowed blood vessel, or the like. Therefore, the guide wire used for PTCA is required to have excellent flexibility (blood vessel followability) in order to follow the blood vessel shape and not damage the blood vessel wall.
  • tip shaping may be performed before the guide wire is inserted into the blood vessel.
  • a doctor or the like is bent with a finger into a predetermined shape (for example, J shape) with the distal end portion of the guide wire in accordance with the shape of a branch blood vessel or the like, and is shaped. Therefore, the guide wire is required to be able to easily shape the tip as described above.
  • Patent Literature 1 has proposed a guide wire having the following configuration.
  • the guide wire of Patent Document 1 includes a long core part and a coil installed so as to cover the tip side of the core part, and a plate height (plate thickness) of 2 at the tip side of the core part. It has the flat plate part formed with the board width more than double.
  • the present invention has been developed to solve such a problem, and the problem is to provide a guide wire having excellent tip shapeability.
  • a guide wire according to the present invention is a guide wire having a core portion made of a long flexible material, and the core portion is a main body formed on the base end side. And a flat plate portion formed on the front end side, a first weakened portion extending linearly on one or both surfaces of the flat plate portion, and a second extending linearly and intersecting the first weakened portion.
  • a fragile portion is formed, and a plurality of the first fragile portions and the second fragile portions are formed in a lattice shape.
  • the guide wire according to the present invention is provided so as to cover the distal end side of the core portion, and includes a coil portion formed by forming a strand in a spiral shape, and the core portion and the coil portion are fixed on the distal end side. It is preferable. Moreover, it is preferable that the guide wire which concerns on this invention is equipped with the resin coating part which consists of a resin material formed so that the front end side of the said core part may be covered.
  • the first fragile portion and the second fragile portion are oblique fragile portions formed in a direction inclined with respect to the plate width direction, and the first fragile portion is inclined. It is preferable that the direction and the inclination direction of the second fragile portion are opposite directions.
  • the guide wire according to the present invention is a folded line portion produced when the first fragile portion and the second fragile portion are bent along the plate thickness direction of the flat plate portion and then returned to the flat plate state. Preferably there is.
  • the core portion is provided with the flat plate portion on the distal end side of the core portion, and the plurality of first fragile portions and second fragile portions are formed in a lattice shape on the flat plate portion. Since the flexibility at the distal end side of the guide wire is improved, the flexibility at the distal end portion of the guide wire is improved. Moreover, since the flexibility at the distal end portion of the guide wire is improved, it is easy to shape the distal end portion of the guide wire in accordance with the shape of the branch blood vessel or the like.
  • the flexibility on the distal end side of the guide wire is improved and the distal end shaping is facilitated, so that the minute shaping intended by a doctor or the like can be achieved.
  • FIG. 3 is an end view of the core portion taken along line AA shown in FIG. 2.
  • FIG. 3 is an end view of the core portion taken along line BB shown in FIG. 2.
  • the distal end side refers to the blood vessel insertion side of the guide wire
  • the proximal end side refers to the side on which a doctor or the like operates the guide wire.
  • a guide wire (hereinafter referred to as a wire) 1 is a long object including a core portion 2 ⁇ / b> A, and the core portion 2 ⁇ / b> A includes a main body portion 3 and a flat plate portion 5.
  • the 1st weak part 51 and the 2nd weak part 52 are formed in the single side
  • the total length of the wire 1 is not particularly limited, and is preferably 200 to 5000 mm, for example.
  • the wire 1 is provided with the coil part 6 installed so that the core part 2A may be covered, and the core part 2A and the coil part 6 are being fixed by the front end side.
  • a fixing method it is preferable to fix with a fixing material (fixing part) 72 such as solder (brazing material) or adhesive, but the fixing part 72 may be formed by welding.
  • fixing material fixing part
  • the core portion 2 ⁇ / b> A is made of a long object having flexibility.
  • the core portion 2A is preferably made of an elastic metal material such as a Ni—Ti alloy or stainless steel in consideration of the flexibility and strength of the wire 1.
  • the core portion 2A includes a main body portion 3, a transition portion 4, and a flat plate portion 5 in order from the proximal end side to the distal end side.
  • the flat plate portion 5 includes a plurality of first fragile portions 51 and second portions. A fragile portion 52 is formed.
  • the core part 2A may not include the transition part 4.
  • the main body 3 is composed of a rod-like (non-flat plate) long object.
  • the shape of the cross section of the main body 3 (the YZ axis plane and the cross section perpendicular to the length direction) is preferably substantially circular (see FIG. 5).
  • the main body 3 includes a large-diameter portion 31 having a constant outer diameter from the proximal end side toward the distal end side, a first taper portion 32 whose outer diameter gradually decreases toward the distal end side, and a constant outer diameter. It is preferable to include a middle diameter portion 33 having a second outer diameter, a second taper portion 34 whose outer diameter gradually decreases toward the distal end side, and a small diameter portion 35 having a constant outer diameter.
  • the first taper As the tapered portion formed between the portions having a constant outer diameter (between the large diameter portion 31 and the medium diameter portion 33 and between the medium diameter portion 33 and the small diameter portion 35), the first taper is used. Although two of the part 32 and the 2nd taper part 34 were described, the taper part is not limited to two, What is necessary is just to form at least 1 part. In addition, a large-diameter portion 36 having the same outer diameter as the large-diameter portion 31 but having a different constituent material may be joined to the large-diameter portion 31 by a joint portion (welded portion) 37.
  • the method for joining the large-diameter portion 31 and the large-diameter portion 36 is not particularly defined, but includes friction welding, spot welding using a laser, butt resistance welding such as upset welding, joining with a tubular joining member, and the like. .
  • the transition portion 4 connects the main body portion 3 and the flat plate portion 5, and crosses a rectangle from a cross section (see FIG. 5) such as a circle from the proximal end side toward the distal end side. This is a portion that gradually changes to the surface (see FIG. 6).
  • the length of the transition part 4 is preferably 1 to 20 mm.
  • the transition portion 4 is preferably produced together with the flat plate portion 5 by pressing the distal end side of the rod-shaped main body portion 3, preferably the distal end side having a reduced diameter, with a mold or the like.
  • the flat plate portion 5 has a rectangular cross section (in order to give the wire 1 (core portion 2 ⁇ / b> A) flexibility and facilitate the tip shape of the wire tip portion ( (See FIG. 6).
  • the flat plate portion 5 preferably has a plate length of 1 to 30 mm, a plate width of 0.1 to 0.5 mm, and a plate thickness of 0.01 to 0.06 mm. Further, the plate width of the flat plate portion 5 may increase or decrease toward the front end side, and the plate thickness may increase or decrease toward the front end side.
  • the flat plate portion 5 is fixed to the coil portion 6 with a fixing material (fixing portion) 72 or the like at the tip side.
  • fixing material fixing portion
  • a first fragile portion 51 that extends linearly and a second fragile portion 52 that extends linearly and intersects the first fragile portion are formed on one surface (upper surface 5a) of the flat plate portion 5.
  • the 1 weak part 51 and the 2nd weak part 52 are formed in the grid
  • the intersection angle ⁇ between the first fragile portion 51 and the second fragile portion 52 on the tip side is preferably 10 to 80 degrees.
  • the linear 1st and 2nd weak parts 51 and 52 are formed in linear form, you may form in the shape of a curve.
  • the upper surface 5a is a surface serving as an inner peripheral surface when the wire tip is curved.
  • the plurality of first and second fragile portions 51 and 52 are fold line portions, groove portions, half slit portions, and the like, and are preferably fold line portions.
  • the 1st and 2nd broken line parts 51 and 52 of upper surface 5a are produced by the following methods, for example. As shown in FIGS. 3 and 4, the flat plate portion 5 is bent in the plate thickness direction in a direction that is a bending direction when the wire is used, and specifically, the upper surface 5a is bent so as to be an inner peripheral surface of the bending. Thereafter, by returning to the flat plate state, linear creases are formed only on the upper surface 5a of the flat plate portion 5 having a large deformation amount, and the first and second bent line portions 51 and 52 are produced.
  • the plurality of first and second fold line portions 51 and 52 may be formed after the production of the plurality of first fold line portions 51, or the second fold line portion 51 and the second fold line portion 51 may be manufactured. The production of the bent line portions 52 may be performed alternately.
  • the groove portion as the fragile portion is produced by, for example, pressing a mold having a mold surface on which a convex portion is formed onto the upper surface 5a of the flat plate portion 5.
  • the half slit part as a weak part is produced by forming the slit which does not penetrate to the upper surface 5a of the flat plate part 5 to the lower surface 5b by laser processing.
  • the plurality of first and second fragile portions 51 and 52 are oblique fragile portions formed in a direction inclined with respect to the plate width direction, and the first fragile portion 51 is inclined. It is preferable that the direction and the inclination direction of the second fragile portion 52 are opposite directions.
  • the inclination angles ⁇ and ⁇ of the plurality of first and second fragile portions 51 and 52 are preferably 5 to 80 degrees.
  • the inclination angles ⁇ and ⁇ of the plurality of first and second fragile portions 51 and 52 are preferably the same angle from the base end side toward the tip end side, but may be increased or decreased.
  • the inclination angle ⁇ and the inclination angle ⁇ may be the same angle or different angles.
  • one of the first fragile portion 51 and the second fragile portion 52 has an inclination angle ⁇ , ⁇ of 0 degrees (parallel to the plate width direction) or 90 degrees (parallel to the plate length direction).
  • a certain weak part may be sufficient, and the inclination angle (alpha) of the 1st weak part 51 may be 0 degree
  • the distances T1 and T2 between the adjacent first and second weak parts 51 and 52 are preferably 0.01 to 10 mm.
  • the plurality of intervals T1 and T2 are preferably the same interval from the proximal end side toward the distal end side, but may be increased or decreased. Note that the interval T1 and the interval T2 may be the same interval or different intervals.
  • the first and second weakened portions 51, 52 are adjusted by adjusting the crossing angle ⁇ , the inclination angles ⁇ , ⁇ , and the intervals T1, T2, and from the proximal side toward the distal side, the first The density of the second fragile portions 51 and 52 may be dense or sparse.
  • the 1st and 2nd weak parts 51 and 52 are formed over the whole length direction of the flat plate part 5, as shown in FIG. 2, the base end part side, center part, or front-end
  • the first and second fragile portions 51 and 52 may be formed not only in the flat plate portion 5 but also in the transition portion 4.
  • the plurality of first and second fragile portions 51 and 52 are formed in a lattice shape on one surface (upper surface 5a) of the flat plate portion 5, so that the flexibility of the flat plate portion 5 is achieved. And the flexibility at the tip of the wire 1 is also improved. And since the softness
  • first and second fragile portions 51 and 52 are formed on one side (upper surface 5a) of the flat plate portion 5, when shaping the tip of the wire 1, the upper surface 5a side is closer to the lower surface side 5b. Shape shaping becomes easy, and fine shape intended by a doctor or the like becomes possible.
  • the coil portion 6 is a coil that is installed so as to cover the distal end side of the core portion 2 ⁇ / b> A and is formed by forming a strand in a spiral shape.
  • the coil may be a so-called densely wound coil in which adjacent strands are in contact with each other or a coil in which adjacent strands are separated from each other.
  • the coil portion 6 is fixed to the core portion 2A (flat plate portion 5) with a fixing material (fixing portion) 72 or the like at the tip side.
  • the material constituting the strand is not particularly defined, but is preferably a metal material such as stainless steel or Pt—Ni alloy.
  • the size of the coil portion 6 is not particularly defined and varies depending on the purpose of use of the wire 1.
  • the coil portion 6 preferably has a coil outer diameter of 0.2 to 0.5 mm and a coil length of 10 to 1000 mm.
  • the outer diameter of the coil is preferably the same diameter in the length direction of the wire 1, but may be decreased toward the distal end side of the wire 1.
  • the coil portion 6 may be a combination of two or more metal materials.
  • the coil portion 6 includes a first coil portion 61 made of a stainless steel wire on the proximal end side and a second coil portion made of a Pt—Ni alloy wire made of a radiopaque material on the distal end side. 62, and both the coil parts 61 and 62 may be joined by welding, adhesion or the like at the boundary part 63 between the first coil part 61 and the second coil part 62. Thereby, the front end side of the wire 1 becomes easy to visually recognize under X-ray fluoroscopy.
  • the wire 1 As shown in FIG. 1, it is sufficient for the wire 1 to have the core portion 2A and the coil portion 6 fixed at one point on the tip side, but the core portion 2A and the coil portion 6 are fixed at a plurality of locations. It is preferable.
  • the distal end side of the core portion 2 ⁇ / b> A (flat plate portion 5) and the distal end side of the coil portion 6 (second coil portion 62) are fixed by a fixing material (fixing portion) 72.
  • the intermediate part of the core part 2A (the base end side of the transition part 4, the small diameter part 35, and the distal end side of the second taper part 34) and the intermediate part of the coil part 6 (boundary part 63) are fixed materials (
  • the fixed portion 73 is fixed, and the intermediate portion of the core portion 2A (the proximal end side of the medium diameter portion 33 and the distal end side of the first tapered portion 32) and the proximal end of the coil portion 6 (first coil portion 61).
  • the side is fixed with a fixing material (fixing part) 71.
  • the fixing materials (fixing portions) 71, 72, 73 are solder (brazing material), an adhesive, and the like.
  • the fixing method of the core portion 2A and the coil portion 6 is not limited to the fixing material (fixing portion) 71, 72, 73 as described above, and the fixing portions 71, 72, 73 may be formed by welding. Good.
  • the wire 1 preferably includes a resin coating portion 8 formed so as to cover at least the surface of the coil portion 6 on the tip side.
  • the resin coating portion 8 includes part or all of the surface of the wire, that is, the entire surface of the second coil portion 62, the coil portion 6 (the first coil portion 61, the boundary portion 63, and the second coil). It is preferable to cover the entire surface of the portion 62) or the entire surface of the proximal end portion of the coil portion 6 and the core portion 2A.
  • the resin coating portion 8 is preferably made of a resin material such as a fluorine-based resin, a maleic anhydride-based polymer substance, or polyurethane.
  • the thickness of the resin coating portion 8 is preferably 0.001 to 0.05 mm. Since the wire 1 is covered with the resin coating portion 8 as described above, the friction resistance (sliding resistance) of the wire 1 is reduced, so that the operability in the blood vessel is improved.
  • the guide wire uses the core portion 2B (see FIG. 7) instead of the core portion 2A (see FIGS. 1 and 2) of the first embodiment, and not only one side (upper surface 5a) of the flat plate portion 5, A plurality of first and second fragile portions 51 and 52 are formed in a lattice shape on both surfaces (upper surface 5a and lower surface 5b).
  • description is abbreviate
  • the first and second fragile portions 51 and 52 of the lower surface 5b are preferably formed alternately with the first and second fragile portions 51 and 52 of the upper surface 5a, but at the same position. It may be formed.
  • the first and second fragile portions 51, 52 on the lower surface 5b are the first and second fragile portions 51, 52 whose crossing angle ⁇ , inclination angles ⁇ , ⁇ and intervals T1, T2 (see FIG. 2) are the upper surface 5a.
  • T1, T2 are the upper surface 5a.
  • the first and second weakened portions 51 and 52 of the lower surface 5b are fold line portions, groove portions, half-slit portions, etc., and are preferably fold line portions.
  • the types of the first and second fragile portions 51, 52 on the lower surface 5b are preferably the same as the first and second fragile portions 51, 52 on the upper surface 5a, but may be different. That is, when the broken line portion is formed as the fragile portion on the upper surface 5a, the fragile portion of the lower surface 5b is preferably a broken line portion.
  • the first and second bent line portions 51 and 52 of the lower surface 5b are produced by the following method, for example. As shown in FIGS. 8 and 9, the flat plate portion 5 having the first and second bent line portions 51 and 52 formed on the upper surface 5a is in the plate thickness direction, but in the direction opposite to the bending direction when using the wire. Bending, specifically, the lower surface 5b is bent so as to be the inner peripheral surface of the bending. Thereafter, by returning to the flat plate state, a linear crease is formed only on the lower surface 5b of the flat plate portion 5 with a large amount of deformation, and the first and second bent line portions 51 and 52 are produced.
  • the first and second fold line portions 51 and 52 on the lower surface 5b may be formed after the completion of the production of the plurality of first fold line portions 51.
  • the production of the two folded lines 52 may be performed alternately.
  • the plurality of first and second fragile portions 51 and 52 are formed in a lattice shape on both surfaces (the upper surface 5a and the lower surface 5b) of the flat plate portion 5 as described above. Since the flexibility of the guide wire is further improved, the flexibility of the distal end portion of the guide wire is further improved, and the distal end shaping of the guide wire is further facilitated. Thereby, the fine shape which a doctor etc. intends becomes possible.
  • the wire surface is a resin coating portion 8 Examples are covered.
  • the guide wire 1 includes a resin coating portion 9 instead of the coil portion 6 in the first embodiment including the core portion 2A.
  • the guide wire 1 may be provided with the resin coating
  • the resin coating part 9 is demonstrated and description other than that is abbreviate
  • the resin coating portion 9 is formed so as to cover the distal end side of the core portion 2A or the core portion 2B, and is made of a resin material.
  • the resin material include a fluorine-based resin and polyurethane, and polyurethane is preferable.
  • the resin coating portion 9 is preferably formed such that the tip side is thicker than the base side, and preferably 0.001 to 0.05 mm. Moreover, it is preferable that the resin coating
  • the tip of the guide wire is protruded from the tip of the guiding catheter, and in that state, the guide wire is inserted into the femoral artery by the Seldinger method, and inserted into the right coronary artery through the aorta, aortic arch, and right coronary artery opening.
  • the guide wire With the guiding catheter left at the opening of the right coronary artery, only the guide wire is advanced further in the right coronary artery to pass through the vascular stenosis, and stops at the position where the tip of the guide wire exceeds the vascular stenosis. . Thereby, the passage of the balloon catheter for expanding the stenosis is secured.
  • the tip of the balloon catheter inserted from the proximal end side of the guide wire is protruded from the tip of the guiding catheter, further advanced along the guide wire, inserted into the right coronary artery from the right coronary artery opening, and the balloon Stop when the balloon of the catheter reaches the position of the vascular stenosis.
  • a balloon expansion fluid is injected from the proximal end side of the balloon catheter, the balloon is expanded, and the vascular stenosis is expanded.
  • deposits such as cholesterol deposited on the vascular stenosis, are physically expanded and the blood flow obstruction is eliminated.
  • the balloon catheter is moved in the proximal direction together with the guide wire, and the balloon catheter, the guide wire and the guiding catheter are extracted from the blood vessel.
  • the PTCA procedure is completed.

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Abstract

A guidewire according to the present invention is provided with a core portion (2A) comprising an elongated body having flexibility, the core portion (2A) comprising a main body portion (3) formed at a base end side and a plate portion (5) formed at a tip side, characterized in that a first fragile portion (51) extending linearly and a second fragile portion (52) extending linearly and intersecting with the first fragile portion (51) are formed on one surface or both surfaces of the plate portion (5), and in that a plurality of first fragile portions (51) and second fragile portions (52) are formed in a lattice pattern.

Description

ガイドワイヤGuide wire
 本発明は、体腔内、特に血管内にカテーテルを誘導する際に使用されるガイドワイヤに関する。 The present invention relates to a guide wire used for guiding a catheter into a body cavity, particularly into a blood vessel.
 ガイドワイヤは、例えばPTCA(Percutaneous Transluminal Coronary Angioplasty:経皮的冠状動脈血管形成術)のような外科的手術が困難な部位の治療、人体への低侵襲を目的とした治療、または、心臓血管造影などの検査に用いられるカテーテルを血管内に誘導する際に使用される。PTCAは、冠状動脈の狭窄部位をバルーン等で拡張して、血液流路を確保する治療方法である。 The guide wire can be used for treatment of a site where surgical operation is difficult such as PTCA (Percutaneous Transluminal Coronary Angioplasty), treatment for the purpose of minimally invasive to the human body, or cardiovascular angiography. It is used when guiding a catheter used for examinations into the blood vessel. PTCA is a treatment method for securing a blood flow path by dilating a stenotic site of a coronary artery with a balloon or the like.
 PTCAでは、ガイドワイヤの先端部をバルーンカテーテルの先端部より突出させた状態で、ガイドワイヤを血管の狭窄部位付近まで挿入することによって、バルーンカテーテルを狭窄部位に誘導する。その際、ガイドワイヤは、蛇行または分岐した血管、狭窄した血管等を選択し、通過する必要がある。したがって、PTCAに用いられるガイドワイヤには、血管形状に追従でき、血管壁を傷つけないために、優れた柔軟性(血管追従性)が要求される。 In PTCA, the balloon catheter is guided to the stenosis site by inserting the guide wire to the vicinity of the stenosis site of the blood vessel with the tip of the guide wire protruding from the tip of the balloon catheter. At that time, the guide wire needs to select and pass through a meandering or branched blood vessel, a narrowed blood vessel, or the like. Therefore, the guide wire used for PTCA is required to have excellent flexibility (blood vessel followability) in order to follow the blood vessel shape and not damage the blood vessel wall.
 また、PTCAでは、ガイドワイヤを屈曲、分岐した血管へ追従させるために、ガイドワイヤを血管内に挿入する前に、先端形状付けが行われることがある。具体的には、ガイドワイヤの先端部を分岐血管等の形状に合わせて医師等が手指で所定の形状(例えば、J型)に曲げて形状付けを行う。したがって、ガイドワイヤには、前記のような先端形状付けも容易に行えることが要求される。 In addition, in PTCA, in order to follow a guide wire that is bent and branched, tip shaping may be performed before the guide wire is inserted into the blood vessel. Specifically, a doctor or the like is bent with a finger into a predetermined shape (for example, J shape) with the distal end portion of the guide wire in accordance with the shape of a branch blood vessel or the like, and is shaped. Therefore, the guide wire is required to be able to easily shape the tip as described above.
 従来、PTCAに用いられるガイドワイヤとして、特許文献1には、以下のような構成を備えたガイドワイヤが提案されている。特許文献1のガイドワイヤは、長尺物からなるコア部と、コア部の先端側を覆うように設置されたコイルとを備え、コア部の先端側には板高さ(板厚)の2倍以上の板幅で形成された平板部を有する。 Conventionally, as a guide wire used in PTCA, Patent Literature 1 has proposed a guide wire having the following configuration. The guide wire of Patent Document 1 includes a long core part and a coil installed so as to cover the tip side of the core part, and a plate height (plate thickness) of 2 at the tip side of the core part. It has the flat plate part formed with the board width more than double.
国際公開第2009/126656号International Publication No. 2009/126656
 特許文献1のガイドワイヤにおいては、板厚の薄い平板部をコア部の先端側に備えることによって、ガイドワイヤの先端部が柔軟となり、安全性および血管追従性の向上がある程度期待できる。しかしながら、このような柔軟性を有するガイドワイヤであっても、先端形状付け性において十分であるとはいえなかった。 In the guide wire of Patent Document 1, by providing a thin flat plate portion on the distal end side of the core portion, the distal end portion of the guide wire becomes flexible and safety and blood vessel followability can be expected to some extent. However, even a guide wire having such flexibility has not been sufficient in tip shapeability.
 そこで、本発明は、このような問題を解決すべく創案されたもので、その課題は優れた先端形状付け性を有するガイドワイヤを提供することにある。 Therefore, the present invention has been developed to solve such a problem, and the problem is to provide a guide wire having excellent tip shapeability.
 前記課題を解決するために、本発明に係るガイドワイヤは、可撓性を有する長尺物からなるコア部を備えたガイドワイヤであって、前記コア部は、基端側に形成された本体部と、先端側に形成された平板部とを備え、前記平板部の片面または両面には、線状に延びる第1脆弱部と、線状に延びて前記第1脆弱部と交差する第2脆弱部とが形成され、複数の前記第1脆弱部と前記第2脆弱部とが格子状に形成されていることを特徴とする。 In order to solve the above-mentioned problems, a guide wire according to the present invention is a guide wire having a core portion made of a long flexible material, and the core portion is a main body formed on the base end side. And a flat plate portion formed on the front end side, a first weakened portion extending linearly on one or both surfaces of the flat plate portion, and a second extending linearly and intersecting the first weakened portion. A fragile portion is formed, and a plurality of the first fragile portions and the second fragile portions are formed in a lattice shape.
 本発明に係るガイドワイヤは、前記コア部の先端側を覆うように設置され、素線を螺旋状に形成してなるコイル部を備え、前記コア部と前記コイル部とが先端側で固定されていることが好ましい。また、本発明に係るガイドワイヤは、前記コア部の先端側を覆うように形成された樹脂材料からなる樹脂被覆部を備えていることが好ましい。 The guide wire according to the present invention is provided so as to cover the distal end side of the core portion, and includes a coil portion formed by forming a strand in a spiral shape, and the core portion and the coil portion are fixed on the distal end side. It is preferable. Moreover, it is preferable that the guide wire which concerns on this invention is equipped with the resin coating part which consists of a resin material formed so that the front end side of the said core part may be covered.
 本発明に係るガイドワイヤは、前記第1脆弱部および前記第2脆弱部が、板幅方向に対して傾斜する方向に形成された斜線状の脆弱部であって、前記第1脆弱部の傾斜方向と前記第2脆弱部の傾斜方向とが反対方向であることが好ましい。また、本発明に係るガイドワイヤは、前記第1脆弱部および前記第2脆弱部が、前記平板部を板厚方向に沿って折り曲げ、その後、平板状態に戻した際に作製される折線部であることが好ましい。 In the guide wire according to the present invention, the first fragile portion and the second fragile portion are oblique fragile portions formed in a direction inclined with respect to the plate width direction, and the first fragile portion is inclined. It is preferable that the direction and the inclination direction of the second fragile portion are opposite directions. In addition, the guide wire according to the present invention is a folded line portion produced when the first fragile portion and the second fragile portion are bent along the plate thickness direction of the flat plate portion and then returned to the flat plate state. Preferably there is.
 本発明に係るガイドワイヤによれば、コア部の先端側に平板部を備え、その平板部に複数の第1脆弱部と第2脆弱部とが格子状に形成されていることによって、コア部の先端側での柔軟性が向上するため、ガイドワイヤの先端部での柔軟性が向上する。また、ガイドワイヤの先端部での柔軟性が向上するため、分岐血管等の形状に合わせてガイドワイヤの先端部を形状付けることが容易なものとなる。 According to the guide wire of the present invention, the core portion is provided with the flat plate portion on the distal end side of the core portion, and the plurality of first fragile portions and second fragile portions are formed in a lattice shape on the flat plate portion. Since the flexibility at the distal end side of the guide wire is improved, the flexibility at the distal end portion of the guide wire is improved. Moreover, since the flexibility at the distal end portion of the guide wire is improved, it is easy to shape the distal end portion of the guide wire in accordance with the shape of the branch blood vessel or the like.
 本発明に係るガイドワイヤによれば、ガイドワイヤの先端側での柔軟性が向上すると共に、先端形状付けも容易となるため、医師等の意図する微細な形状付けが可能となる。 According to the guide wire according to the present invention, the flexibility on the distal end side of the guide wire is improved and the distal end shaping is facilitated, so that the minute shaping intended by a doctor or the like can be achieved.
本発明のガイドワイヤの第1実施形態を示す部分縦断面図である。It is a fragmentary longitudinal cross-section which shows 1st Embodiment of the guide wire of this invention. 図1に示すガイドワイヤのコア部の先端側での平面図である。It is a top view in the front end side of the core part of the guide wire shown in FIG. 図2に示す平板部の片面(上面)に第1脆弱部を形成する方法を模式的に示す側面図である。It is a side view which shows typically the method of forming a 1st weak part in the single side | surface (upper surface) of the flat plate part shown in FIG. 図2に示す平板部の片面(上面)に第2脆弱部を形成する方法を模式的に示す側面図である。It is a side view which shows typically the method of forming a 2nd weak part in the single side | surface (upper surface) of the flat plate part shown in FIG. 図2に示すA-A線におけるコア部の端面図である。FIG. 3 is an end view of the core portion taken along line AA shown in FIG. 2. 図2に示すB-B線におけるコア部の端面図である。FIG. 3 is an end view of the core portion taken along line BB shown in FIG. 2. 本発明のガイドワイヤの第2実施形態を示すコア部の先端側での側面図である。It is a side view in the front end side of the core part which shows 2nd Embodiment of the guide wire of this invention. 図7に示す平板部の下面に第1脆弱部を形成する方法を模式的に示す側面図である。It is a side view which shows typically the method of forming a 1st weak part in the lower surface of the flat plate part shown in FIG. 図7に示す平板部の下面に第2脆弱部を形成する方法を模式的に示す側面図である。It is a side view which shows typically the method of forming a 2nd weak part in the lower surface of the flat plate part shown in FIG. 本発明のガイドワイヤの第3実施形態を示す部分縦断面図である。It is a fragmentary longitudinal cross-section which shows 3rd Embodiment of the guide wire of this invention.
 本発明に係るガイドワイヤの第1実施形態について、図面を参照して詳細に説明する。なお、本発明において、先端側とはガイドワイヤの血管挿入側を言い、基端側とは医師等がガイドワイヤの操作を行う側を言う。 A first embodiment of the guide wire according to the present invention will be described in detail with reference to the drawings. In the present invention, the distal end side refers to the blood vessel insertion side of the guide wire, and the proximal end side refers to the side on which a doctor or the like operates the guide wire.
 図1に示すように、ガイドワイヤ(以下、ワイヤと称す)1は、コア部2Aを備えた長尺物であって、コア部2Aは本体部3と平板部5とを備え、平板部5の片面(上面5a)には第1脆弱部51と第2脆弱部52とが形成されている。ワイヤ1の全長は、特に規定されず、例えば、200~5000mmが好ましい。また、ワイヤ1は、コア部2Aを覆うように設置されたコイル部6を備え、コア部2Aとコイル部6とが先端側で固定されていることが好ましい。固定方法としては、半田(ろう材)、接着材等の固定材料(固定部)72で固定されることが好ましいが、溶接で固定部72を形成してもよい。以下、各構成について説明する。 As shown in FIG. 1, a guide wire (hereinafter referred to as a wire) 1 is a long object including a core portion 2 </ b> A, and the core portion 2 </ b> A includes a main body portion 3 and a flat plate portion 5. The 1st weak part 51 and the 2nd weak part 52 are formed in the single side | surface (upper surface 5a). The total length of the wire 1 is not particularly limited, and is preferably 200 to 5000 mm, for example. Moreover, it is preferable that the wire 1 is provided with the coil part 6 installed so that the core part 2A may be covered, and the core part 2A and the coil part 6 are being fixed by the front end side. As a fixing method, it is preferable to fix with a fixing material (fixing part) 72 such as solder (brazing material) or adhesive, but the fixing part 72 may be formed by welding. Each configuration will be described below.
<コア部>
 図1、図2に示すように、コア部2Aは、可撓性を有する長尺物からなる。そして、コア部2Aは、ワイヤ1の柔軟性および強度を考慮して、Ni-Ti合金、ステンレス鋼等の弾性金属材料からなることが好ましい。そして、コア部2Aは、基端側から先端側に向かって順に、本体部3と、移行部4と、平板部5とを備え、平板部5には複数の第1脆弱部51と第2脆弱部52とが形成されている。なお、コア部2Aは、移行部4を備えていなくてもよい。
<Core part>
As shown in FIGS. 1 and 2, the core portion 2 </ b> A is made of a long object having flexibility. The core portion 2A is preferably made of an elastic metal material such as a Ni—Ti alloy or stainless steel in consideration of the flexibility and strength of the wire 1. The core portion 2A includes a main body portion 3, a transition portion 4, and a flat plate portion 5 in order from the proximal end side to the distal end side. The flat plate portion 5 includes a plurality of first fragile portions 51 and second portions. A fragile portion 52 is formed. The core part 2A may not include the transition part 4.
(本体部)
 図1、図2に示すように、本体部3は、棒状(非平板形状)の長尺物から構成される。本体部3の横断面(YZ軸平面であって、長さ方向に垂直な断面)の形状は、略円形状(図5参照)であることが好ましい。また、本体部3は、基端側から先端側に向かって、一定の外径を有する大径部31と、先端側に向かって外径が漸減する第1テーパ部32と、一定の外径を有する中径部33と、先端側に向かって外径が漸減する第2テーパ部34と、一定の外径を有する小径部35とを備えることが好ましい。
(Main body)
As shown in FIGS. 1 and 2, the main body 3 is composed of a rod-like (non-flat plate) long object. The shape of the cross section of the main body 3 (the YZ axis plane and the cross section perpendicular to the length direction) is preferably substantially circular (see FIG. 5). The main body 3 includes a large-diameter portion 31 having a constant outer diameter from the proximal end side toward the distal end side, a first taper portion 32 whose outer diameter gradually decreases toward the distal end side, and a constant outer diameter. It is preferable to include a middle diameter portion 33 having a second outer diameter, a second taper portion 34 whose outer diameter gradually decreases toward the distal end side, and a small diameter portion 35 having a constant outer diameter.
 一定の外径を有する部分の間(大径部31と中径部33との間、および、中径部33と小径部35との間)に形成されるテーパ部として、前記では第1テーパ部32と第2テーパ部34の2つを記載したが、テーパ部は、2つに限定されず、少なくとも1つ形成すればよい。また、大径部31と外径が同一で構成材料が異なる大径部36を、接合部(溶接部)37で大径部31に接合してもよい。なお、大径部31と大径部36との接合方法としては、特に規定されないが、摩擦圧接、レーザを用いたスポット溶接、アプセット溶接等の突き合わせ抵抗溶接、管状接合部材による接合等が挙げられる。 As the tapered portion formed between the portions having a constant outer diameter (between the large diameter portion 31 and the medium diameter portion 33 and between the medium diameter portion 33 and the small diameter portion 35), the first taper is used. Although two of the part 32 and the 2nd taper part 34 were described, the taper part is not limited to two, What is necessary is just to form at least 1 part. In addition, a large-diameter portion 36 having the same outer diameter as the large-diameter portion 31 but having a different constituent material may be joined to the large-diameter portion 31 by a joint portion (welded portion) 37. The method for joining the large-diameter portion 31 and the large-diameter portion 36 is not particularly defined, but includes friction welding, spot welding using a laser, butt resistance welding such as upset welding, joining with a tubular joining member, and the like. .
(移行部)
 図1、図2に示すように、移行部4は、本体部3と平板部5とを繋ぎ、基端側から先端側に向かって、円形等の横断面(図5参照)から矩形の横断面(図6参照)に次第に変化する部分である。そして、移行部4の長さは1~20mmが好ましい。移行部4は、棒状の本体部3の先端側、好ましくは細径化された先端側を金型等によってプレスすることによって、平板部5と共に作製することが好ましい。
(Migration Department)
As shown in FIGS. 1 and 2, the transition portion 4 connects the main body portion 3 and the flat plate portion 5, and crosses a rectangle from a cross section (see FIG. 5) such as a circle from the proximal end side toward the distal end side. This is a portion that gradually changes to the surface (see FIG. 6). The length of the transition part 4 is preferably 1 to 20 mm. The transition portion 4 is preferably produced together with the flat plate portion 5 by pressing the distal end side of the rod-shaped main body portion 3, preferably the distal end side having a reduced diameter, with a mold or the like.
(平板部)
 図1、図2に示すように、平板部5は、ワイヤ1(コア部2A)に柔軟性を持たせると共に、ワイヤ先端部の先端形状付けが容易となるように、矩形状の横断面(図6参照)を有する細長い板状の平板から構成されている。平板部5は、板長さが1~30mm、板幅が0.1~0.5mm、板厚が0.01~0.06mmであることが好ましい。また、平板部5の板幅は先端側に向かって増大または減少してもよく、板厚も先端側に向かって増大または減少してもよい。また、平板部5は、その先端側は固定材料(固定部)72等でコイル部6に固定されている。なお、平板部5の横断面の形状は、プレスによって作製するため、横断面の両端は少し丸みが残り略矩形状となる。但し、説明の便宜上、図6では丸みを省略する。
(Plate part)
As shown in FIGS. 1 and 2, the flat plate portion 5 has a rectangular cross section (in order to give the wire 1 (core portion 2 </ b> A) flexibility and facilitate the tip shape of the wire tip portion ( (See FIG. 6). The flat plate portion 5 preferably has a plate length of 1 to 30 mm, a plate width of 0.1 to 0.5 mm, and a plate thickness of 0.01 to 0.06 mm. Further, the plate width of the flat plate portion 5 may increase or decrease toward the front end side, and the plate thickness may increase or decrease toward the front end side. The flat plate portion 5 is fixed to the coil portion 6 with a fixing material (fixing portion) 72 or the like at the tip side. In addition, since the shape of the cross section of the flat plate part 5 is produced by pressing, both ends of the cross section are slightly rounded and become substantially rectangular. However, for convenience of explanation, rounding is omitted in FIG.
 また、平板部5の片面(上面5a)には、線状に延びる第1脆弱部51と、線状に延びて第1脆弱部と交差する第2脆弱部52とが形成され、複数の第1脆弱部51と第2脆弱部52とが格子状に形成されている。そして、第1脆弱部51と第2脆弱部52との先端側での交差角度θは、10~80度が好ましい。また、線状の第1および第2脆弱部51、52は、直線状に形成されているが、曲線状に形成されたものであってもよい。ここで、上面5aは、ワイヤ先端部が湾曲した際の内周面となる面である。 Further, on one surface (upper surface 5a) of the flat plate portion 5, a first fragile portion 51 that extends linearly and a second fragile portion 52 that extends linearly and intersects the first fragile portion are formed. The 1 weak part 51 and the 2nd weak part 52 are formed in the grid | lattice form. The intersection angle θ between the first fragile portion 51 and the second fragile portion 52 on the tip side is preferably 10 to 80 degrees. Moreover, although the linear 1st and 2nd weak parts 51 and 52 are formed in linear form, you may form in the shape of a curve. Here, the upper surface 5a is a surface serving as an inner peripheral surface when the wire tip is curved.
 複数の第1および第2脆弱部51、52は、折線部、溝部、半スリット部等であって、折線部であることが好ましい。
 上面5aの第1および第2折線部51、52は、例えば、以下のような方法で作製される。図3、図4に示すように、平板部5を、板厚方向でワイヤ使用の際の湾曲方向となる方向に折り曲げ、具体的には上面5aが折り曲げの内周面となるように折り曲げる。その後、平板状態に戻すことによって、変形量が大きい平板部5の上面5aにのみに線状の折れ跡が形成され第1および第2折線部51、52が作製される。なお、複数の第1および第2折線部51、52は、複数の第1折線部51の作製終了後に第2折線部52を作製してもよいし、第1折線部51の作製と第2折線部52の作製とを交互に行ってもよい。
The plurality of first and second fragile portions 51 and 52 are fold line portions, groove portions, half slit portions, and the like, and are preferably fold line portions.
The 1st and 2nd broken line parts 51 and 52 of upper surface 5a are produced by the following methods, for example. As shown in FIGS. 3 and 4, the flat plate portion 5 is bent in the plate thickness direction in a direction that is a bending direction when the wire is used, and specifically, the upper surface 5a is bent so as to be an inner peripheral surface of the bending. Thereafter, by returning to the flat plate state, linear creases are formed only on the upper surface 5a of the flat plate portion 5 having a large deformation amount, and the first and second bent line portions 51 and 52 are produced. The plurality of first and second fold line portions 51 and 52 may be formed after the production of the plurality of first fold line portions 51, or the second fold line portion 51 and the second fold line portion 51 may be manufactured. The production of the bent line portions 52 may be performed alternately.
 図示しないが、脆弱部としての溝部は、例えば、凸部が形成された型面を有する金型を平板部5の上面5aにプレスすることによって作製される。また、脆弱部としての半スリット部は、平板部5の上面5aに、下面5bまで貫通しないスリットをレーザ加工等によって形成することによって作製される。 Although not shown, the groove portion as the fragile portion is produced by, for example, pressing a mold having a mold surface on which a convex portion is formed onto the upper surface 5a of the flat plate portion 5. Moreover, the half slit part as a weak part is produced by forming the slit which does not penetrate to the upper surface 5a of the flat plate part 5 to the lower surface 5b by laser processing.
 図2に示すように、複数の第1および第2脆弱部51、52は、板幅方向に対して傾斜する方向に形成された斜線状の脆弱部であって、第1脆弱部51の傾斜方向と第2脆弱部52の傾斜方向とが反対方向であることが好ましい。 As shown in FIG. 2, the plurality of first and second fragile portions 51 and 52 are oblique fragile portions formed in a direction inclined with respect to the plate width direction, and the first fragile portion 51 is inclined. It is preferable that the direction and the inclination direction of the second fragile portion 52 are opposite directions.
 複数の第1および第2脆弱部51、52の傾斜角度α、βは、5~80度であることが好ましい。また、複数の第1および第2脆弱部51、52の傾斜角度α、βは、基端側から先端側に向けて同一角度であることが好ましいが、増大または減少するようにしてもよい。なお、傾斜角度αと傾斜角度βとは、同一角度であっても、異なる角度であってもよい。
 なお、図示しないが、第1脆弱部51および第2脆弱部52のいずれか一方が、傾斜角度α、βが0度(板幅方向に平行)または90度(板長さ方向に平行)である脆弱部であってもよいし、第1脆弱部51の傾斜角度αが0度、第2脆弱部52の傾斜角度βが90度であってもよい。
The inclination angles α and β of the plurality of first and second fragile portions 51 and 52 are preferably 5 to 80 degrees. In addition, the inclination angles α and β of the plurality of first and second fragile portions 51 and 52 are preferably the same angle from the base end side toward the tip end side, but may be increased or decreased. The inclination angle α and the inclination angle β may be the same angle or different angles.
Although not shown, one of the first fragile portion 51 and the second fragile portion 52 has an inclination angle α, β of 0 degrees (parallel to the plate width direction) or 90 degrees (parallel to the plate length direction). A certain weak part may be sufficient, and the inclination angle (alpha) of the 1st weak part 51 may be 0 degree | times, and the inclination angle (beta) of the 2nd weak part 52 may be 90 degree | times.
 隣接する第1および第2脆弱部51、52間の間隔T1、T2は、0.01~10mmであることが好ましい。複数の間隔T1、T2は、基端側から先端側に向けて同一間隔であることが好ましいが、増大または減少するようにしてもよい。なお、間隔T1と間隔T2は、同一間隔であっても、異なる間隔であってもよい。 The distances T1 and T2 between the adjacent first and second weak parts 51 and 52 are preferably 0.01 to 10 mm. The plurality of intervals T1 and T2 are preferably the same interval from the proximal end side toward the distal end side, but may be increased or decreased. Note that the interval T1 and the interval T2 may be the same interval or different intervals.
 図示しないが、前記した複数の第1および第2脆弱部51、52の交差角度θ、傾斜角度α、β、間隔T1、T2を調整して、基端側から先端側に向けて、第1および第2脆弱部51、52の密度を密または疎にしてもよい。また、第1および第2脆弱部51、52は、図2に示すように平板部5の長さ方向の全体にわたって形成されていることが好ましいが、基端部側、中央部または先端部側の一部に形成されていてもよい。さらに、第1および第2脆弱部51、52は、平板部5だけでなく、移行部4にも形成されていてもよい。 Although not shown in the drawing, the first and second weakened portions 51, 52 are adjusted by adjusting the crossing angle θ, the inclination angles α, β, and the intervals T1, T2, and from the proximal side toward the distal side, the first The density of the second fragile portions 51 and 52 may be dense or sparse. Moreover, although it is preferable that the 1st and 2nd weak parts 51 and 52 are formed over the whole length direction of the flat plate part 5, as shown in FIG. 2, the base end part side, center part, or front-end | tip part side It may be formed in a part. Further, the first and second fragile portions 51 and 52 may be formed not only in the flat plate portion 5 but also in the transition portion 4.
 本発明のワイヤ1においては、前記のように、平板部5の片面(上面5a)に複数の第1および第2脆弱部51、52を格子状に形成することによって、平板部5の柔軟性が向上し、ワイヤ1の先端部での柔軟性も向上する。そして、ワイヤ1の先端部の柔軟性が向上するため、分岐血管等の形状に合わせてワイヤ1の先端部を形状付けることが容易なものとなる。その結果、本発明のワイヤ1では、先端形状付け性が向上する。また、平板部5の片面(上面5a)に第1および第2脆弱部51、52を形成することによって、ワイヤ1の先端形状付けを行う際に、下面側5bに比べて上面5a側への形状付けが容易となり、医師等の意図する微細な形状付けが可能となる。 In the wire 1 of the present invention, as described above, the plurality of first and second fragile portions 51 and 52 are formed in a lattice shape on one surface (upper surface 5a) of the flat plate portion 5, so that the flexibility of the flat plate portion 5 is achieved. And the flexibility at the tip of the wire 1 is also improved. And since the softness | flexibility of the front-end | tip part of the wire 1 improves, it becomes easy to shape the front-end | tip part of the wire 1 according to shapes, such as a branch blood vessel. As a result, in the wire 1 of the present invention, the tip shapeability is improved. In addition, by forming the first and second fragile portions 51 and 52 on one side (upper surface 5a) of the flat plate portion 5, when shaping the tip of the wire 1, the upper surface 5a side is closer to the lower surface side 5b. Shape shaping becomes easy, and fine shape intended by a doctor or the like becomes possible.
<コイル部>
 図1に示すように、コイル部6は、コア部2Aの先端側を覆うように設置され、素線を螺旋状に形成してなるコイルである。そして、コイルは、隣接する素線同士が接触したいわゆる密巻きしたものや、隣接する素線同士が離間したもののいずれでもよい。また、コイル部6は、その先端側が固定材料(固定部)72等でコア部2A(平板部5)に固定されている。
<Coil part>
As shown in FIG. 1, the coil portion 6 is a coil that is installed so as to cover the distal end side of the core portion 2 </ b> A and is formed by forming a strand in a spiral shape. The coil may be a so-called densely wound coil in which adjacent strands are in contact with each other or a coil in which adjacent strands are separated from each other. Further, the coil portion 6 is fixed to the core portion 2A (flat plate portion 5) with a fixing material (fixing portion) 72 or the like at the tip side.
 素線を構成する材料は、特に規定されないが、ステンレス鋼、Pt-Ni合金等の金属材料であることが好ましい。また、コイル部6のサイズは、特に規定されず、ワイヤ1の使用目的によって異なる。PTCAに使用されるワイヤ1では、コイル部6のコイル外径が0.2~0.5mm、コイル長さが10~1000mmであることが好ましい。コイル外径は、ワイヤ1の長さ方向に同一径であることが好ましいが、ワイヤ1の先端側に向かって減少していてもよい。 The material constituting the strand is not particularly defined, but is preferably a metal material such as stainless steel or Pt—Ni alloy. Further, the size of the coil portion 6 is not particularly defined and varies depending on the purpose of use of the wire 1. In the wire 1 used for PTCA, the coil portion 6 preferably has a coil outer diameter of 0.2 to 0.5 mm and a coil length of 10 to 1000 mm. The outer diameter of the coil is preferably the same diameter in the length direction of the wire 1, but may be decreased toward the distal end side of the wire 1.
 コイル部6は、2種以上の金属材料を組み合わせたものであってもよい。例えば、コイル部6は、基端側にステンレス鋼製の素線からなる第1コイル部61と、先端側にX線不透過材料であるPt-Ni合金製の素線からなる第2コイル部62とを備え、第1コイル部61と第2コイル部62との境界部63で両コイル部61、62を溶接、接着等で接合したものであってもよい。これにより、ワイヤ1の先端側がX線透視下で視認しやすくなる。 The coil portion 6 may be a combination of two or more metal materials. For example, the coil portion 6 includes a first coil portion 61 made of a stainless steel wire on the proximal end side and a second coil portion made of a Pt—Ni alloy wire made of a radiopaque material on the distal end side. 62, and both the coil parts 61 and 62 may be joined by welding, adhesion or the like at the boundary part 63 between the first coil part 61 and the second coil part 62. Thereby, the front end side of the wire 1 becomes easy to visually recognize under X-ray fluoroscopy.
 次に、本発明のワイヤ1の第1実施形態の変形例について説明する。
 図1に示すように、ワイヤ1は、コア部2Aとコイル部6とが先端側の1箇所で固定されていれば十分であるが、コア部2Aとコイル部6とが複数個所で固定されていることが好ましい。
Next, the modification of 1st Embodiment of the wire 1 of this invention is demonstrated.
As shown in FIG. 1, it is sufficient for the wire 1 to have the core portion 2A and the coil portion 6 fixed at one point on the tip side, but the core portion 2A and the coil portion 6 are fixed at a plurality of locations. It is preferable.
 例えば、図1に示すように、ワイヤ1は、コア部2A(平板部5)の先端側とコイル部6(第2コイル部62)の先端側とが固定材料(固定部)72で固定され、コア部2Aの途中の部位(移行部4の基端側、小径部35、および、第2テーパ部34の先端側)とコイル部6の途中の部位(境界部63)とが固定材料(固定部)73で固定され、コア部2Aの途中の部位(中径部33の基端側、および、第1テーパ部32の先端側)とコイル部6(第1コイル部61)の基端側とが固定材料(固定部)71で固定されている。 For example, as shown in FIG. 1, in the wire 1, the distal end side of the core portion 2 </ b> A (flat plate portion 5) and the distal end side of the coil portion 6 (second coil portion 62) are fixed by a fixing material (fixing portion) 72. The intermediate part of the core part 2A (the base end side of the transition part 4, the small diameter part 35, and the distal end side of the second taper part 34) and the intermediate part of the coil part 6 (boundary part 63) are fixed materials ( The fixed portion 73 is fixed, and the intermediate portion of the core portion 2A (the proximal end side of the medium diameter portion 33 and the distal end side of the first tapered portion 32) and the proximal end of the coil portion 6 (first coil portion 61). The side is fixed with a fixing material (fixing part) 71.
 ここで、固定材料(固定部)71、72、73は、半田(ろう材)、接着剤等である。なお、コア部2Aとコイル部6との固定方法は、前記のような固定材料(固定部)71、72、73によるものに限らず、溶接で固定部71、72、73を形成してもよい。 Here, the fixing materials (fixing portions) 71, 72, 73 are solder (brazing material), an adhesive, and the like. The fixing method of the core portion 2A and the coil portion 6 is not limited to the fixing material (fixing portion) 71, 72, 73 as described above, and the fixing portions 71, 72, 73 may be formed by welding. Good.
 図1に示すように、ワイヤ1は、コイル部6の少なくとも先端側の表面を覆うように形成された樹脂被覆部8を備えることが好ましい。 As shown in FIG. 1, the wire 1 preferably includes a resin coating portion 8 formed so as to cover at least the surface of the coil portion 6 on the tip side.
 具体的には、樹脂被覆部8は、前記したワイヤの表面の一部または全部、すなわち、第2コイル部62の全表面、コイル部6(第1コイル部61、境界部63および第2コイル部62)の全表面、または、コイル部6とコア部2Aの基端側部位の全表面を覆うことが好ましい。 Specifically, the resin coating portion 8 includes part or all of the surface of the wire, that is, the entire surface of the second coil portion 62, the coil portion 6 (the first coil portion 61, the boundary portion 63, and the second coil). It is preferable to cover the entire surface of the portion 62) or the entire surface of the proximal end portion of the coil portion 6 and the core portion 2A.
 樹脂被覆部8は、フッ素系樹脂、無水マレイン酸系高分子物質、ポリウレタン等の樹脂材料からなることが好ましい。また、樹脂被覆部8の厚みは0.001~0.05mmが好ましい。このような樹脂被覆部8で覆われていることによって、ワイヤ1は、摩擦抵抗(摺動抵抗)が低減するため、血管内での操作性が向上する。 The resin coating portion 8 is preferably made of a resin material such as a fluorine-based resin, a maleic anhydride-based polymer substance, or polyurethane. The thickness of the resin coating portion 8 is preferably 0.001 to 0.05 mm. Since the wire 1 is covered with the resin coating portion 8 as described above, the friction resistance (sliding resistance) of the wire 1 is reduced, so that the operability in the blood vessel is improved.
 次に、本発明に係るガイドワイヤの第2実施形態について説明する。
 ガイドワイヤは、第1実施形態のコア部2A(図1、図2参照)に代えてコア部2B(図7参照)を使用するもので、平板部5の片面(上面5a)だけでなく、両面(上面5aおよび下面5b)に複数の第1および第2脆弱部51、52が格子状に形成されている。
 なお、平板部5の下面5bに第1および第2脆弱部51、52が形成されていること以外の事項については、第1実施形態の構成と同様であるので説明は省略する。
Next, a second embodiment of the guide wire according to the present invention will be described.
The guide wire uses the core portion 2B (see FIG. 7) instead of the core portion 2A (see FIGS. 1 and 2) of the first embodiment, and not only one side (upper surface 5a) of the flat plate portion 5, A plurality of first and second fragile portions 51 and 52 are formed in a lattice shape on both surfaces (upper surface 5a and lower surface 5b).
In addition, since it is the same as that of the structure of 1st Embodiment about matters other than the 1st and 2nd weak parts 51 and 52 being formed in the lower surface 5b of the flat plate part 5, description is abbreviate | omitted.
 図7に示すように、下面5bの第1および第2脆弱部51、52は、上面5aの第1および第2脆弱部51、52と、互い違いに形成されることが好ましいが、同一位置に形成されていてもよい。また、下面5bの第1および第2脆弱部51、52は、交差角度θ、傾斜角度α、βおよび間隔T1、T2(図2参照)が上面5aの第1および第2脆弱部51、52と同一であることが好ましいが、異なるものであってもよい。 As shown in FIG. 7, the first and second fragile portions 51 and 52 of the lower surface 5b are preferably formed alternately with the first and second fragile portions 51 and 52 of the upper surface 5a, but at the same position. It may be formed. The first and second fragile portions 51, 52 on the lower surface 5b are the first and second fragile portions 51, 52 whose crossing angle θ, inclination angles α, β and intervals T1, T2 (see FIG. 2) are the upper surface 5a. Are preferably the same, but may be different.
 下面5bの第1および第2脆弱部51、52は、折線部、溝部、半スリット部等であって、折線部であることが好ましい。下面5bの第1および第2脆弱部51、52の種類は、上面5aの第1および第2脆弱部51、52と同一であることが好ましいが、異なるものであってもよい。すなわち、上面5aに脆弱部として折線部が形成されている場合には、下面5bの脆弱部は折線部であることが好ましい。 The first and second weakened portions 51 and 52 of the lower surface 5b are fold line portions, groove portions, half-slit portions, etc., and are preferably fold line portions. The types of the first and second fragile portions 51, 52 on the lower surface 5b are preferably the same as the first and second fragile portions 51, 52 on the upper surface 5a, but may be different. That is, when the broken line portion is formed as the fragile portion on the upper surface 5a, the fragile portion of the lower surface 5b is preferably a broken line portion.
 下面5bの第1および第2折線部51、52は、例えば、以下のような方法で作製される。図8、図9に示すように、上面5aに第1および第2折線部51、52が形成された平板部5を、板厚方向であるが、ワイヤ使用の際の湾曲方向と逆方向に折り曲げ、具体的には下面5bが折り曲げの内周面となるように折り曲げる。その後、平板状態に戻すことによって、変形量が大きい平板部5の下面5bにのみに線状の折れ跡が形成され第1および第2折線部51、52が作製される。なお、下面5bの第1および第2折線部51、52は、複数の第1折線部51の作製終了後に第2折線部52を作製してもよいし、第1折線部51の作製と第2折線部52の作製とを交互に行ってもよい。また、下面5bの第1および第2折線部51、52は、上面5aと下面5bの第1および第2折線部51、52の作製を交互に行うことによって作製してもよい。 The first and second bent line portions 51 and 52 of the lower surface 5b are produced by the following method, for example. As shown in FIGS. 8 and 9, the flat plate portion 5 having the first and second bent line portions 51 and 52 formed on the upper surface 5a is in the plate thickness direction, but in the direction opposite to the bending direction when using the wire. Bending, specifically, the lower surface 5b is bent so as to be the inner peripheral surface of the bending. Thereafter, by returning to the flat plate state, a linear crease is formed only on the lower surface 5b of the flat plate portion 5 with a large amount of deformation, and the first and second bent line portions 51 and 52 are produced. The first and second fold line portions 51 and 52 on the lower surface 5b may be formed after the completion of the production of the plurality of first fold line portions 51. The production of the two folded lines 52 may be performed alternately. Moreover, you may produce the 1st and 2nd broken line parts 51 and 52 of the lower surface 5b by performing alternately production of the 1st and 2nd bent line parts 51 and 52 of the upper surface 5a and the lower surface 5b.
 本発明のガイドワイヤにおいては、前記のように平板部5の両面(上面5aおよび下面5b)に複数の第1および第2脆弱部51、52が格子状に形成されることによって、平板部5の柔軟性がさらに向上するため、ガイドワイヤの先端部の柔軟性がさらに向上すると共に、ガイドワイヤの先端形状付けがさらに容易となる。それにより、医師等の意図する微細な形状付けが可能となる。 In the guide wire of the present invention, the plurality of first and second fragile portions 51 and 52 are formed in a lattice shape on both surfaces (the upper surface 5a and the lower surface 5b) of the flat plate portion 5 as described above. Since the flexibility of the guide wire is further improved, the flexibility of the distal end portion of the guide wire is further improved, and the distal end shaping of the guide wire is further facilitated. Thereby, the fine shape which a doctor etc. intends becomes possible.
 本発明のガイドワイヤの第2実施形態の変形例としては、第1実施形態と同様に、コア部2Bとコイル部6とが複数個所で固定されている例、ワイヤ表面が樹脂被覆部8で覆われている例が挙げられる。 As a modification of the second embodiment of the guide wire of the present invention, as in the first embodiment, an example in which the core portion 2B and the coil portion 6 are fixed at a plurality of locations, the wire surface is a resin coating portion 8 Examples are covered.
 次に、本発明のガイドワイヤの第3実施形態について説明する。
 図10に示すように、ガイドワイヤ1は、コア部2Aを備えた第1実施形態におけるコイル部6の代わりに樹脂被覆部9を備えている。また、図示しないが、ガイドワイヤ1は、コア部2B(図7参照)を備えた第2実施形態におけるコイル部6の代わりに樹脂被覆部9を備えていてもよい。
 なお、樹脂被覆部9以外の第1または第2実施形態の構成については前記と同様であるので、樹脂被覆部9について説明し、それ以外の説明は省略する。
Next, a third embodiment of the guide wire of the present invention will be described.
As shown in FIG. 10, the guide wire 1 includes a resin coating portion 9 instead of the coil portion 6 in the first embodiment including the core portion 2A. Moreover, although not shown in figure, the guide wire 1 may be provided with the resin coating | coated part 9 instead of the coil part 6 in 2nd Embodiment provided with the core part 2B (refer FIG. 7).
In addition, since the structure of 1st or 2nd embodiment other than the resin coating part 9 is the same as that of the above, the resin coating part 9 is demonstrated and description other than that is abbreviate | omitted.
 樹脂被覆部9は、コア部2Aまたはコア部2Bの先端側を覆うように形成され、樹脂材料からなる。樹脂材料としては、フッ素系樹脂、ポリウレタン等が挙げられ、ポリウレタンが好ましい。樹脂被覆部9は、その厚さが基端側よりも先端側が厚く形成されていることが好ましく、0.001~0.05mmであることが好ましい。また、樹脂被覆部9は、その先端側が丸く形成されていることが好ましい。 The resin coating portion 9 is formed so as to cover the distal end side of the core portion 2A or the core portion 2B, and is made of a resin material. Examples of the resin material include a fluorine-based resin and polyurethane, and polyurethane is preferable. The resin coating portion 9 is preferably formed such that the tip side is thicker than the base side, and preferably 0.001 to 0.05 mm. Moreover, it is preferable that the resin coating | coated part 9 is formed in the front end side roundly.
 このような樹脂被覆部9を備えることによって、ガイドワイヤ1を使用する際、コア部2Aまたはコア部2Bで血管壁を損傷することが抑制されるため、安全性が向上する。また、ガイドワイヤ1は、摩擦抵抗(摺動抵抗)が低減するため、血管内での操作性も向上する。 By providing such a resin coating portion 9, when the guide wire 1 is used, damage to the blood vessel wall by the core portion 2A or the core portion 2B is suppressed, and thus safety is improved. Further, since the guide wire 1 has reduced frictional resistance (sliding resistance), the operability in the blood vessel is also improved.
 次に、本発明のガイドワイヤの使用方法について、PTCAを例にとって説明する。
 ガイドワイヤの先端をガイディングカテーテルの先端から突出させ、その状態でセルジンガー法により大腿動脈内に挿入し、大動脈、大動脈弓、右冠状動脈開口部を経て右冠状動脈内に挿入する。ガイディングカテーテルを右冠状動脈開口部の位置に残したまま、ガイドワイヤのみを右冠状動脈内でさらに進めて血管狭窄部を通過させ、ガイドワイヤの先端が血管狭窄部を越えた位置で停止する。これにより、狭窄部拡張用のバルーンカテーテルの通路が確保される。
Next, a method for using the guide wire of the present invention will be described taking PTCA as an example.
The tip of the guide wire is protruded from the tip of the guiding catheter, and in that state, the guide wire is inserted into the femoral artery by the Seldinger method, and inserted into the right coronary artery through the aorta, aortic arch, and right coronary artery opening. With the guiding catheter left at the opening of the right coronary artery, only the guide wire is advanced further in the right coronary artery to pass through the vascular stenosis, and stops at the position where the tip of the guide wire exceeds the vascular stenosis. . Thereby, the passage of the balloon catheter for expanding the stenosis is secured.
 次に、ガイドワイヤの基端側から挿通されたバルーンカテーテルの先端をガイディングカテーテルの先端から突出させ、さらにガイドワイヤに沿って進め、右冠状動脈開口部から右冠状動脈内に挿入し、バルーンカテーテルのバルーンが血管狭窄部の位置に到達したところで停止する。 Next, the tip of the balloon catheter inserted from the proximal end side of the guide wire is protruded from the tip of the guiding catheter, further advanced along the guide wire, inserted into the right coronary artery from the right coronary artery opening, and the balloon Stop when the balloon of the catheter reaches the position of the vascular stenosis.
 次に、バルーンカテーテルの基端側からバルーン拡張用の流体を注入して、バルーンを拡張させ、血管狭窄部を拡張する。このようにすることによって、血管狭窄部に付着堆積しているコレステロール等の堆積物は物理的に押し広げられ、血流阻害が解消される。 Next, a balloon expansion fluid is injected from the proximal end side of the balloon catheter, the balloon is expanded, and the vascular stenosis is expanded. By doing in this way, deposits, such as cholesterol deposited on the vascular stenosis, are physically expanded and the blood flow obstruction is eliminated.
 バルーン内からバルーン拡張用の流体を抜き取り、バルーンを収縮させる。次いで、バルーンカテーテルをガイドワイヤと共に基端方向へ移動して、血管よりバルーンカテーテル、ガイドワイヤおよびガイディングカテーテルを抜き取る。以上により、PTCAの手技が終了する。 ¡Pull out the balloon expansion fluid from inside the balloon and deflate the balloon. Next, the balloon catheter is moved in the proximal direction together with the guide wire, and the balloon catheter, the guide wire and the guiding catheter are extracted from the blood vessel. Thus, the PTCA procedure is completed.
 1   ガイドワイヤ(ワイヤ)
 2A、2B コア部
 3   本体部
 4   移行部
 5   平板部
 51  第1脆弱部(第1折線部)
 52  第2脆弱部(第2折線部)
 6   コイル部
 8、9 樹脂被覆部
1 Guide wire (wire)
2A, 2B Core part 3 Body part 4 Transition part 5 Flat plate part 51 1st weak part (1st broken line part)
52 2nd weak part (2nd broken line part)
6 Coil part 8, 9 Resin coating part

Claims (5)

  1.  可撓性を有する長尺物からなるコア部を備えたガイドワイヤであって、
     前記コア部は、基端側に形成された本体部と、先端側に形成された平板部とを備え、
     前記平板部の片面または両面には、線状に延びる第1脆弱部と、線状に延びて前記第1脆弱部と交差する第2脆弱部とが形成され、複数の前記第1脆弱部と前記第2脆弱部とが格子状に形成されていることを特徴とするガイドワイヤ。
    A guide wire having a core portion made of a flexible long object,
    The core portion includes a main body portion formed on the base end side, and a flat plate portion formed on the tip end side,
    A first fragile portion extending linearly and a second fragile portion extending linearly and intersecting the first fragile portion are formed on one surface or both surfaces of the flat plate portion, and a plurality of the first fragile portions, The guide wire, wherein the second fragile portion is formed in a lattice shape.
  2.  前記ガイドワイヤは、前記コア部の先端側を覆うように設置され、素線を螺旋状に形成してなるコイル部を備え、前記コア部と前記コイル部とが先端側で固定されていることを特徴とする請求項1に記載のガイドワイヤ。 The guide wire is provided so as to cover the distal end side of the core portion, and includes a coil portion formed by forming a strand in a spiral shape, and the core portion and the coil portion are fixed on the distal end side. The guide wire according to claim 1.
  3.  前記ガイドワイヤは、前記コア部の先端側を覆うように形成された樹脂材料からなる樹脂被覆部を備えていることを特徴とする請求項1に記載のガイドワイヤ。 2. The guide wire according to claim 1, wherein the guide wire includes a resin coating portion made of a resin material so as to cover a distal end side of the core portion.
  4.  前記第1脆弱部および前記第2脆弱部は、板幅方向に対して傾斜する方向に形成された斜線状の脆弱部であって、前記第1脆弱部の傾斜方向と前記第2脆弱部の傾斜方向とが反対方向であることを特徴とする請求項1ないし請求項3のいずれか一項に記載のガイドワイヤ。 The first fragile portion and the second fragile portion are slanted fragile portions formed in a direction inclined with respect to the plate width direction, and the inclination direction of the first fragile portion and the second fragile portion are The guide wire according to any one of claims 1 to 3, wherein an inclination direction is an opposite direction.
  5.  前記第1脆弱部および前記第2脆弱部は、前記平板部を板厚方向に沿って折り曲げ、その後、平板状態に戻した際に作製される折線部であることを特徴とする請求項1に記載のガイドワイヤ。 The said 1st weak part and the said 2nd weak part are the fold line parts produced when the said flat plate part is bend | folded along a plate | board thickness direction, and is returned to a flat plate state after that. Guide wire as described.
PCT/JP2015/074303 2014-09-26 2015-08-27 Guidewire WO2016047365A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2014-196651 2014-09-26
JP2014196651 2014-09-26

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011110384A (en) * 2009-11-30 2011-06-09 Patentstra Co Ltd Medical guide wire, method of manufacturing the same, and assembly of medical guide wire and microcatheter or balloon catheter and guiding catheter

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011110384A (en) * 2009-11-30 2011-06-09 Patentstra Co Ltd Medical guide wire, method of manufacturing the same, and assembly of medical guide wire and microcatheter or balloon catheter and guiding catheter

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