WO2022092001A1 - ガイドワイヤおよびガイドワイヤの製造方法 - Google Patents
ガイドワイヤおよびガイドワイヤの製造方法 Download PDFInfo
- Publication number
- WO2022092001A1 WO2022092001A1 PCT/JP2021/039235 JP2021039235W WO2022092001A1 WO 2022092001 A1 WO2022092001 A1 WO 2022092001A1 JP 2021039235 W JP2021039235 W JP 2021039235W WO 2022092001 A1 WO2022092001 A1 WO 2022092001A1
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- WO
- WIPO (PCT)
- Prior art keywords
- guide wire
- tip
- flat plate
- base end
- plate portion
- Prior art date
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09108—Methods for making a guide wire
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/0915—Guide wires having features for changing the stiffness
- A61M2025/09158—Guide wires having features for changing the stiffness when heated
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09175—Guide wires having specific characteristics at the distal tip
Definitions
- the present invention relates to a guide wire and a method for manufacturing the guide wire.
- a guide wire is a medical device used to guide various catheters that treat a stenosis that occurs in a blood vessel such as a coronary artery to the stenosis.
- the guide wire needs to go through the complicated curved or bifurcated part of the blood vessel and pass through the narrowed part. Therefore, the tip of the guide wire is required to have flexibility, resilience to external force, and kink resistance. To satisfy these requirements, the tip of the guide wire is made of a superelastic alloy such as Ni—Ti alloy.
- the surgeon imparts a desired shape to the tip of the guide wire for the purpose of improving the operability of the guide wire in the blood vessel and the selectivity of the blood vessel at the bifurcation. (Shaping) may occur. Therefore, it is preferable that the tip of the guide wire can be easily shaped.
- the tip of the guide wire is made of a superelastic alloy, if the superelasticity is high, even if the operator applies an external force for shaping, the shape will be restored to the shape before shaping when the external force is removed. It is difficult for the operator to give the desired shape.
- Patent Document 1 discloses a technique in which the tip of a guide wire made of a superelastic alloy is cold-worked or heat-treated to reduce superelasticity and enable shaping of the tip of the guidewire. ing.
- the shape retention property which is the property of retaining the shape at the time of shaping.
- the guide wire inserted into the blood vessel receives an external force when the tip of the guide wire hits the blood vessel wall or the stenosis.
- the guide wire whose superelasticity at the tip portion is excessively lowered is plastically deformed into a shape different from the shape at the time of shaping.
- the guide wire has reduced operability and blood vessel selectivity. If the tip of the guide wire is plastically deformed during operation in the blood vessel, the surgeon will have to remove the guide wire from the blood vessel and reshape it or replace it with another guide wire. It becomes complicated. This prolongs the procedure time and increases the burden on the surgeon and the patient.
- the magnitude of the external force that the guide wire receives in the blood vessel is smaller than the external force applied by the operator for shaping. Therefore, the tip of the guide wire can be deformed by the large force applied by the surgeon for shaping, but the physical properties that can be restored to the shape at the time of shaping without plastic deformation by the small force applied during the procedure.
- the tip of the guide wire has both shapeability that allows the shape to be shaped into a desired shape before being inserted into the blood vessel and shape retention that allows the shape during shaping to be maintained against an external force applied in the blood vessel. Must have.
- At least one embodiment of the present invention has been made in view of the above circumstances, and specifically, it has a shapeability capable of shaping into a desired shape and a shape at the time of shaping against an external force applied in a blood vessel. It is an object of the present invention to provide a guide wire having a shape-retaining property and a method for manufacturing the guide wire.
- the guide wire according to the present embodiment includes a long core member having a flat plate portion at the tip, and the flat plate portion has an elastic deformation work rate of 46.0% or more and 59.5% or less and a maltens hardness. It is made of a Ni—Ti alloy having a power of 1300 N / mm 2 or more and 3000 N / mm 2 or less.
- the method for manufacturing a guide wire according to the present embodiment is a method for manufacturing a guide wire provided with a core member, in the longitudinal direction from the flat plate portion and the base end of the flat plate portion with respect to the tip end portion of the core member.
- the elastic deformation work rate is 46.0% or more for at least a part of the flat plate portion and the transition portion in the step of performing cold working so as to have a transition portion extending along the proximal end side 59. It includes a step of performing a heat treatment so that the Martens hardness is 1300 N / mm 2 or more and 3000 N / mm 2 or less at 5% or less.
- a large force applied by the operator for shaping by controlling the elastic deformation power and the maltens hardness at the tip of the guide wire made of Ni—Ti alloy within a predetermined range.
- the guide wire can be shaped by the operator, and can be restored to the shape at the time of shaping even if the tip portion is subjected to an external force that can deform the tip portion in the blood vessel.
- the guide wire can maintain the high operability and blood vessel selectivity imparted by the shaping even during the procedure.
- the operator does not need to remove the guide wire from the blood vessel and reshape it or replace it with another guide wire, so that the procedure can be easily performed.
- the procedure time is shortened, and the burden on the operator and the patient can be reduced.
- the direction in which the guide wire 100 is in a natural state is defined.
- the "long axis direction” is the direction in which the guide wire 100 extends and is the direction along the central axis C of the guide wire 100 (the left-right direction in the figure).
- the "radial direction” is a direction in which the core portion is separated or approaches the core portion in an axially orthogonal cross section (cross section) with the major axis direction of the guide wire 100 as a reference axis.
- the “circumferential direction” is the rotation direction with the long axis direction of the core portion as the reference axis.
- the "thickness direction” is the direction in which the short side of the rectangle in the cross-sectional view of the flat plate portion 11g extends (front / depth direction in the figure) when the tip of the guide wire 100 has the flat plate portion 11g.
- the "width direction” is the direction in which the long side of the rectangle in the cross-sectional view of the flat plate portion 11g extends (vertical direction in the figure) when the tip of the guide wire 100 has the flat plate portion 11g.
- the side where the guide wire 100 is inserted into the blood vessel is referred to as the "tip side", and the side opposite to the tip side (the side gripped by the operator) is referred to as the "base end side”.
- the part including a certain range along the long axis direction from the tip (tip) is referred to as the "tip portion”
- the portion including a certain range in the long axis direction from the proximal end (most proximal end) is referred to as the "base end portion”.
- the guide wire 100 is a medical device to be inserted into a blood vessel in order to guide a catheter or a stent for performing endovascular treatment to a stenosis portion.
- the guide wire 100 can also be used by being inserted into a living lumen (vascular, ureter, bile duct, oviduct, hepatic duct, etc.) other than a blood vessel depending on the purpose of treatment.
- the guide wire 100 As shown in FIG. 1 or 2, the guide wire 100 according to the present embodiment has a long core member 10, a lumen body 20 that covers the periphery of the tip portion of the core member 10, and a lumen body 20 as a core. It has a fixing portion 30 fixed to the member 10 and a covering layer 40 covering each member including the core member 10.
- a covering layer 40 covering each member including the core member 10.
- the core member 10 includes a first core portion 11 and a second core portion 12 arranged on the proximal end side of the first core portion 11 and joined to the first core portion 11.
- the first core portion 11 is a long member extending from the tip of the second core portion 12 to the tip side of the guide wire 100 along the long axis direction.
- the first core portion 11 has a first joint portion 11a, a first outer diameter constant portion 11b, a first taper portion 11c, and a second outer diameter in order from the base end to the tip side of the first core portion 11.
- a fixed portion 11d, a second tapered portion 11e, a transition portion 11f, and a flat plate portion 11g are provided, and each portion is integrally formed.
- the first joint portion 11a is a portion to be joined to the second joint portion 12b of the second core portion 12, which will be described later.
- the outer diameter of the first joint portion 11a is larger than the outer diameter of the first outer diameter constant portion 11b and is substantially equal to the outer diameter of the second joint portion 12b.
- the outer diameter of the first joint portion 11a and the outer diameter of the second joint portion 12b are larger than the outer diameter of the base portion 12a of the first outer diameter constant portion 11b and the second core portion 12. That is, the area of the joint surface 13 between the first joint portion 11a and the second joint portion 12b is larger than that of the first outer diameter constant portion 11b and the base portion 12a.
- the stress acting on the joint surface 13 when the guide wire 100 is bent is dispersed in the first outer diameter constant portion 11b and the base portion 12a whose outer diameter is smaller than that of the joint surface 13, and the stress is concentrated on the joint surface 13. Can be suppressed. Therefore, the core member 10 can obtain a high joining strength on the joining surface 13.
- the first outer diameter constant portion 11b extends from the tip of the first joint portion 11a to the base end of the first tapered portion 11c by a predetermined length.
- the outer diameter of the first outer diameter constant portion 11b is substantially constant and is substantially equal to the outer diameter of the base portion 12a of the second core portion 12.
- the first tapered portion 11c extends from the tip of the first constant outer diameter portion 11b to the base end of the second constant outer diameter portion 11d by a predetermined length.
- the first tapered portion 11c has a tapered shape in which the outer diameter gradually decreases toward the tip end side from the first outer diameter constant portion 11b.
- the tapered shape of the first tapered portion 11c can be formed by mechanically grinding the first core portion 11 with a grindstone or etching with an acid.
- the second outer diameter constant portion 11d extends a predetermined length from the tip of the first tapered portion 11c to the base end of the second tapered portion 11e.
- the outer diameter of the second outer diameter constant portion 11d is substantially constant and smaller than the outer diameter of the first outer diameter constant portion 11b.
- the second tapered portion 11e extends a predetermined length from the tip of the second outer diameter constant portion 11d to the base end of the transition portion 11f.
- the second tapered portion 11e has a tapered shape in which the outer diameter gradually decreases from the second outer diameter constant portion 11d toward the transition portion 11f.
- the tapered shape of the second tapered portion 11e can be formed by mechanically grinding the first core portion 11 with a grindstone or etching with an acid.
- the transition portion 11f extends a predetermined length from the tip of the second tapered portion 11e to the base end of the flat plate portion 11g. As shown in FIG. 3A or FIG. 3B, the transition portion 11f forms a wedge shape in which the thickness gradually decreases and the width gradually increases from the second tapered portion 11e toward the flat plate portion 11g.
- the wedge shape of the transition portion 11f can be formed by pressing the first core portion 11 having a circular cross-sectional shape, which is a kind of cold working.
- the cross-sectional shape of the transition portion 11f in the plan view (cross-sectional view) orthogonal to the major axis direction is a circle having an outer diameter substantially equal to that of the second tapered portion 11e on the proximal end side, but from the proximal end side. It gradually deforms from a circle to a rectangle toward the tip side, and forms a rectangle having substantially the same shape as the flat plate portion 11 g on the tip side.
- the tip portion of the transition portion 11f has a thickness and width substantially equal to the base end portion of the flat plate portion 11g, and forms a continuous surface with the flat plate portion 11g.
- 3B is a virtual line that separates the regions of the flat plate portion 11g, the transition portion 11f, and the second tapered portion 11e.
- the "thickness" of the flat plate portion 11g is the length of the short side of the rectangle in the cross-sectional view of the flat plate portion 11g
- the "width” of the flat plate portion 11g is the length of the long side of the rectangle in the cross-sectional view of the flat plate portion 11g.
- the flat plate portion 11g extends from the tip of the transition portion 11f to the tip of the guide wire 100 by a predetermined length.
- the flat plate portion 11g is formed by pressing the first core portion 11 having a circular cross-sectional shape. Therefore, the flat plate portion 11g has a rectangular cross-sectional shape.
- the thickness of the flat plate portion 11g is substantially constant from the tip of the transition portion 11f to the tip of the flat plate portion 11g. As shown in FIGS. 3A and 3B, the shape of the flat plate portion 11g seen from the thickness direction is formed into a rounded rectangle at the tip of the flat plate portion 11g. Therefore, the width of the flat plate portion 11g is substantially constant from the tip of the transition portion 11f toward the tip side, but becomes smaller in the rounded portion.
- the width of the flat plate portion 11g may be constant from the tip of the transition portion 11f to the tip of the flat plate portion 11g.
- the cross-sectional shape of the flat plate portion 11g is not limited to a rectangle, and may be a rounded rectangle having an R shape at the corner portion.
- the structure of the first core portion 11 is not limited to the above.
- the first core portion 11 may have a constant outer shape and a constant outer diameter from the tip end to the base end.
- At least the region where the flat plate portion 11g is located (preferably at least a part of the flat plate portion 11g and the transition portion 11f) has both shapeability and shape retention.
- the second core portion 12 is a long member extending from the proximal end of the first core portion 11 to the proximal end side of the guide wire 100.
- the second core portion 12 includes a base portion 12a and a second joint portion 12b in order from the base end to the tip end side of the second core portion 12, and each portion is integrally formed.
- the base portion 12a extends from the base end of the second joint portion 12b toward the base end side of the guide wire 100 by a predetermined length.
- the outer diameter of the base portion 12a is substantially constant, and is substantially equal to the outer diameter of the first outer diameter constant portion 11b.
- the second joint portion 12b is a portion to be joined to the first joint portion 11a.
- the outer diameter of the second joint portion 12b is larger than the outer diameter of the base portion 12a and is equal to the outer diameter of the first joint portion 11a.
- the first joint portion 11a and the second joint portion 12b can be joined by welding, brazing, and soldering.
- the total length of the guide wire 100 in the major axis direction is 1000 mm to 4500 mm.
- the length of the first core portion 11 is 150 mm to 1000 mm.
- the total length of the first joint portion 11a and the first outer diameter constant portion 11b is 10 mm to 300 mm.
- the length of the first tapered portion 11c is 10 mm to 100 mm.
- the length of the second outer diameter constant portion 11d is 10 mm to 300 mm.
- the length of the second tapered portion 11e is 10 mm to 100 mm.
- the length of the transition portion 11f is 1 mm to 20 mm.
- the length of the flat plate portion 11 g is 1 mm to 20 mm.
- the outer diameters of the first joint portion 11a and the first outer diameter constant portion 11b are 0.2 mm to 1 mm.
- the outer diameters of the first tapered portion 11c and the second outer diameter constant portion 11d are 0.1 mm to 1 mm.
- the outer diameter of the second tapered portion 11e is 0.05 mm to 1 mm.
- the thickness of the transition portion 11f is 0.01 mm to 1 mm, and the width is 0.05 mm to 1 mm.
- the thickness of the flat plate portion 11 g is 0.01 mm to 1 mm, and the width is 0.05 mm to 1 mm.
- the length of the second core portion 12 is 850 mm to 3500 mm.
- the outer diameter of the second core portion 12 is 0.2 mm to 1 mm.
- the first core portion 11 and the second core portion 12 are superelastic alloys such as Ni—Ti alloys, SUS302, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS424, SUS430F, etc. It can be formed from various metal materials such as stainless steel, piano wire, and cobalt-based alloys. Further, the first core portion 11 is preferably formed of a material having a lower rigidity than the material of the second core portion 12. As an example, the first core portion 11 is made of Ni—Ti alloy and the second core portion 12 is made of stainless steel. The material forming the first core portion 11 and the second core portion 12 is not limited to the above example. Further, the first core portion 11 and the second core portion 12 may be formed of the same material.
- the core member 10 may be formed of one continuous member instead of being formed of a plurality of members such as the first core portion 11 and the second core portion 12.
- the lumen body 20 is a member formed by spirally winding a wire rod around a core member 10.
- the lumen body 20 is formed of a first coil 21 and a second coil 22 arranged on the proximal end side of the first coil 21.
- the first coil 21 is arranged from the tip end to the intermediate portion of the first core portion 11.
- the second coil 22 is arranged from the intermediate portion of the first core portion 11 to the proximal end side.
- the lumen body 20 may be formed by one coil.
- the lumen body 20 may be formed by three or more coils.
- the first coil 21 surrounds the first core portion 11 of the core member 10 and is fixed to the first core portion 11.
- the first coil 21 is arranged coaxially with the first core portion 11.
- the length of the first coil 21 is 3 mm to 60 mm.
- the first coil 21 is formed by spirally winding the wire rod so as to have a gap between the adjacent wire rods.
- the gap between the adjacent wires of the first coil 21 is 1 ⁇ m to 10 ⁇ m. It is preferable that the gaps between the adjacent wires of the first coil 21 are evenly spaced.
- the second coil 22 surrounds the first core portion 11 of the core member 10 and is fixed to the first core portion 11.
- the second coil 22 is arranged coaxially with the first core portion 11.
- the length of the second coil 22 is 10 mm to 400 mm.
- the second coil 22 has a wire rod so as to have a gap between the tightly wound portion in which the wire rod is spirally wound tightly and the adjacent wire rods so as not to have a gap between the adjacent wire rods.
- the tightly wound portion of the second coil 22 is located at the tip end portion and the proximal end portion of the second coil 22, and the loosely wound portion is the tightly wound portion on the distal end side and the tightly wound portion on the proximal end side. Located in between.
- the second coil 22 may be composed of only a tightly wound portion without having a loosely wound portion.
- the base end of the first coil 21 and the tip of the second coil 22 are partially intertwined. That is, the wire rod at the base end portion of the first coil 21 and the wire rod at the tip end portion of the second coil 22 are arranged alternately along the long axis direction. As a result, it is possible to prevent the first coil 21 and the second coil 22 from being separated from each other.
- the length at which the base end portion of the first coil 21 and the tip end portion of the second coil 22 are entangled is 0.1 mm to 2 mm.
- the first coil 21 and the second coil 22 have the same winding direction so that they can be entangled with each other.
- the outer diameters of the wires of the first coil 21 and the second coil 22 are 20 ⁇ m to 90 ⁇ m, preferably 30 ⁇ m to 70 ⁇ m.
- the outer diameter of the wire rod forming the first coil 21 is larger than the outer diameter of the wire rod forming the second coil 22.
- the wire rod forming the first coil 21 and the second coil 22 may be not only one wire rod but also a stranded wire composed of two or more wire rods.
- the wire rods of the first coil 21 and the second coil 22 are not particularly limited, but can be formed of stainless steel, superelastic alloys, cobalt-based alloys, metals such as gold, platinum, and tungsten, or alloys containing these.
- the first coil 21 is made of a platinum-based alloy that is more flexible and has higher contrast than the second coil 22, and the material of the second coil 22 is made of stainless steel.
- Platinum-based alloys such as Pt—Ir, Pt—Ni, and Pt—W are preferably used.
- the outer diameters of the first coil 21 and the second coil 22 are constant from the tip end to the base end, respectively.
- the outer diameter of the first coil 21 and the outer diameter of the second coil 22 are substantially equal to each other. Therefore, the outer diameter of the lumen body 20 is substantially constant from the tip end to the base end.
- the outer diameters of the first coil 21 and the second coil 22 are 0.15 mm to 2 mm.
- the material forming the wire rod constituting the first coil 21 and the second coil 22, the outer diameter of the wire rod, the cross-sectional shape of the wire rod, the pitch of the wire rod, and the like can be appropriately selected according to the purpose of the guide wire 100.
- the cross-sectional shape of the wire is preferably circular, but may be elliptical, polygonal, or the like.
- the center of the cross section of the wire whose cross-sectional shape is not circular can be the center of gravity of the cross section of the wire.
- the fixing portion 30 is a member for fixing the lumen body 20 to the core member 10.
- the fixing portion 30 includes a tip fixing portion 31 for fixing the tip of the lumen body 20 to the core member 10, an intermediate fixing portion 32 for fixing the intermediate portion of the lumen body 20 to the core member 10, and a tube. It has a proximal end fixing portion 33 for fixing the proximal end of the lumen 20 to the core member 10.
- the material forming the fixing portion 30 is a brazing material or a soldering material.
- the brazing material includes gold brazing and silver brazing.
- Examples of the solder material include Sn—Ag alloy-based solder and Sn—Pb alloy-based solder.
- the material forming the fixing portion 30 may be an adhesive.
- the tip fixing portion 31 fixes the tip portion of the first coil 21 to the flat plate portion 11g of the first core portion 11.
- the tip fixing portion 31 is located at the tip of the guide wire 100, and the outer surface is smoothly formed into a substantially hemispherical shape.
- the intermediate fixing portion 32 fixes the base end portion of the first coil 21 and the tip end portion of the second coil 22 to the second tapered portion 11e of the first core portion 11 via the tubular member 32a.
- the intermediate fixing portion 32 is provided at a position where the base end portion of the first coil 21 and the tip end portion of the second coil 22 are entangled in the first core portion 11.
- the tubular member 32a is arranged between the inner peripheral surface of the lumen body 20 and the outer peripheral surface of the core member 10.
- the tubular member 32a coaxially fixes the lumen body 20 and the core member 10 by reducing the gap between the inner peripheral surface of the lumen body 20 and the outer peripheral surface of the core member 10.
- the outer diameter of the tip end portion of the tubular member 32a is smaller than the outer diameter of the base end portion of the tubular member 32a.
- the outer diameter of the tip end portion of the tubular member 32a and the outer diameter of the base end portion of the tubular member 32a may be appropriately selected according to the inner diameter of the first coil 21 and the inner diameter of the second coil 22.
- the tubular member 32a can be formed of a metal or resin material.
- the guide wire 100 does not have to include the tubular member 32a.
- the base end fixing portion 33 fixes the base end portion of the second coil 22 to the second outer diameter constant portion 11d of the first core portion 11.
- the coating layer 40 includes a first coating layer 41, a second coating layer 42, and a third coating layer 43.
- the coating layer 40 can be formed of a material that can reduce the friction that occurs between the guide wire 100 and the blood vessel or catheter. As a result, the covering layer 40 improves the operability and safety of the guide wire 100.
- the first covering layer 41 covers the outer surface of each portion (luminous body 20, fixing portion 30) provided in the first core portion 11 and a part of the first core portion 11 (second outer diameter constant portion 11d). ing.
- the second covering layer 42 covers the portion of the core member 10 located on the proximal end side of the lumen body 20.
- the second covering layer 42 covers the base end portion (first tapered portion 11c, first outer diameter constant portion 11b) of the first core portion 11 and the outer surface of the second core portion 12. That is, the second covering layer 42 is covered with a portion of the core member 10 located on the proximal end side of the lumen body 20 except for the first joining portion 11a and the second joining portion 12b.
- the third coating layer 43 covers the outer surfaces of the first joint portion 11a and the second joint portion 12b.
- the second covering layer 42 may cover the entire portion of the core member 10 located on the proximal end side of the luminal body 20. In that case, the third coating layer 43 is not provided. Alternatively, the second covering layer 42 does not have to cover a part of the portion of the core member 10 located on the proximal end side of the luminal body 20. In that case, the third coating layer 43 may be provided at a portion not covered by the second coating layer 42.
- the first coating layer 41 can be formed of a hydrophilic polymer.
- the hydrophilic polymer forming the first coating layer 41 is a cellulose-based polymer substance, a polyethylene oxide-based polymer substance, or a maleic anhydride-based polymer substance (for example, malean anhydride such as a methylvinyl ether-maleic anhydride copolymer).
- Acid copolymers acrylamide-based polymer substances (eg, polyacrylamides, block copolymers of glycidyl methacrylate-dimethylacrylamide), water-soluble nylons, polyvinyl alcohols, polyvinylpyrrolidones, and derivatives thereof.
- the second coating layer 42 and the third coating layer 43 can be made of a low friction material.
- the low friction material include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyester (PET, PBT, etc.), polyamide, polyimide, polyurethane, polystyrene, polycarbonate, silicone resin, fluororesin (PTFE, ETFE, etc.), or these.
- the material forming the first coating layer 41, the second coating layer 42, and the third coating layer 43 is not limited to the above.
- the first coating layer 41, the second coating layer 42, and the third coating layer 43 may be formed of different materials along the major axis direction of the core member 10, respectively.
- the material that covers the tip end portion of the first core portion 11 and the material that covers the base end portion of the first core portion 11 may be different.
- the number of each of the first coating layer 41, the second coating layer 42 and the third coating layer 43 may be plural. It should be noted that any one of the first coating layer 41, the second coating layer 42, and the third coating layer 43 may not be provided.
- the tip of the guide wire 100 has both shapeability and shape retention.
- the shapeability is a property that enables the operator to shape the tip of the guide wire 100.
- the guide wire 100 is given a desired shape to the tip portion by shaping, so that the operability of the guide wire 100 in the blood vessel and the blood vessel selectivity at the bifurcation portion are improved.
- the shape imparted to the guide wire 100 by shaping depends on the inner diameter and shape of the patient's blood vessels. Therefore, it is preferable that the guide wire 100 can be easily shaped into a desired shape. That is, excellent shapeability is required.
- the shape retention property is a property that the shape given to the tip of the guide wire 100 by the operator by shaping is maintained during the operation of the guide wire 100 in the blood vessel.
- the shape given to the guide wire 100 by shaping is a curved shape, and the radius of curvature thereof is large with respect to the inner diameter of the blood vessel. Therefore, the guide wire 100 is deformed according to the inner diameter and shape of the blood vessel. Further, the guide wire 100 may be unintentionally bent in a U shape when the tip end portion abuts on the blood vessel wall at the bifurcation portion or is caught by the stent. Further, the guide wire 100 may be intentionally bent into a U shape for the purpose of preventing perforation of blood vessels when passing through the narrowed portion.
- the tip of the guide wire 100 receives an external force such that the tip can be deformed during the operation in the blood vessel. If the stability of the guide wire 100 with respect to an external force is low, the guide wire 100 undergoes plastic deformation, cannot maintain the shape imparted by the shape of the operator, and deteriorates operability and blood vessel selectivity. Deformation of the tip of the guidewire requires the operator to remove the guidewire from the blood vessel and reshape it. If it is deformed to the point where it is difficult to reshape it, it will need to be replaced with another guide wire. This prolongs the procedure time and increases the burden on the surgeon and the patient.
- the guide wire 100 has resilience that can be restored to the shape given by the shape of the operator if the external force is removed even if the guide wire 100 is deformed by receiving an external force during the operation in the blood vessel. That is, the guide wire 100 is required to have excellent shape retention.
- the guide wire 100 which has both shapeability and shape retention, controls the elastic deformation power and maltens hardness of the tip of the guide wire 100 made of Ni—Ti alloy within a predetermined range. can get.
- the elastic deformation work rate and the Martens hardness are calculated from the load displacement curve obtained in the instrumentation indentation hardness test for the flat plate portion 11 g of the guide wire 100.
- the elastic deformation power is the ratio of the elastic deformation work to the total work (the sum of the plastic deformation work and the elastic deformation work).
- the Martens hardness is a value obtained by dividing the test load by the surface area invaded by the indenter in the instrumentation indentation hardness test.
- a material with a high elastic deformation power has high shape restoration due to superelasticity. Therefore, even if an external force is applied, the flat plate portion 11g of the guide wire 100 made of a material having a high elastic deformation work rate can easily be restored to its original shape when the external force is removed. Therefore, the higher the elastic deformation power, the lower the shapeability of the flat plate portion 11g and the higher the shape retention. On the other hand, a material having a low elastic deformation power is likely to be plastically deformed. Therefore, the flat plate portion 11g made of a material having a low elastic deformation work rate is plastically deformed when an external force is applied, and its shape can be easily maintained even if the external force is removed. Therefore, the lower the elastic deformation power, the higher the shapeability of the flat plate portion 11g, but the lower the shape retention.
- a material with high Martens hardness is hard. Therefore, the flat plate portion 11g of the guide wire 100 made of a material having a large maltens hardness is unlikely to be deformed by an external force. Therefore, the larger the Martens hardness, the lower the shapeability of the flat plate portion 11g and the higher the shape retention. On the other hand, the flat plate portion 11g of the guide wire 100 made of a material having a low Martens hardness is liable to undergo plastic deformation even with a small external force received in the blood vessel. Therefore, the smaller the Martens hardness, the higher the shapeability and the lower the shape retention of the flat plate portion 11g.
- the magnitude of the external force received by the guide wire 100 in the blood vessel is smaller than the external force applied by the operator for shaping. Therefore, the tip of the guide wire 100 can be deformed by a large force applied by the operator for shaping, but can be restored to the shape at the time of shaping without plastic deformation by a small force applied during the procedure.
- By making it a physical property it is possible to have both shape-forming property and shape-retaining property.
- Martens hardness is larger than elastic deformation work rate. Therefore, it is not possible to improve both the shape-forming property and the shape-retaining property by controlling only the elastic deformation power, and it is particularly necessary to appropriately control the Martens hardness.
- the flat plate portion 11g of the guide wire 100 is Ni—Ti having an elastic deformation work rate of 46.0% to 59.5% and a Martens hardness of 1300 N / mm 2 to 3000 N / mm 2 . Formed from an alloy.
- the tip of the guide wire 100 in which the flat plate portion 11 g has the elastic deformation work rate and the maltens hardness in the above range can be deformed by a large force applied by the operator for shaping, but a small force applied during the procedure. Has physical properties that can be restored to the shape at the time of shaping without plastic deformation.
- the guide wire 100 can be shaped by the operator, and can be restored to the shape at the time of shaping even if the tip portion is subjected to an external force that can deform the tip portion in the blood vessel. Therefore, the guide wire can maintain the high operability and blood vessel selectivity imparted by the shaping even during the procedure.
- the operator can easily perform the procedure. As a result, the procedure time is shortened, and the burden on the operator and the patient can be reduced.
- the flat plate portion 11 g of the guide wire 100 has an elastic deformation work rate of 46.0% to 59.5% and a maltens hardness of 1300 N / mm 2 to 2120 N / mm 2 .
- the flat plate portion 11 g of the guide wire 100 has an elastic deformation work rate in the range of 46.0% to 59.5% and a Martens hardness in the range of 1300 N / mm 2 to 2120 N / mm 2 . Since the flat plate portion 11g of the first core portion 11 becomes more flexible, the shapeability is further improved.
- the tip portion of the core member 10 is heat-treated in order to keep the elastic deformation work rate and the maltens hardness of the flat plate portion 11g within the above ranges.
- the flat plate portion 11g is formed by pressing the tip of the first core portion 11 made of Ni—Ti alloy.
- the flat plate portion 11 g after the press working has a lower superelasticity than the Ni—Ti alloy before the press working due to the strain introduced by the working. Therefore, the flat plate portion 11g after the press working has a low elastic deformation work rate and therefore low shape retention.
- strain is removed from the flat plate portion 11g and the superelasticity is improved.
- the flat plate portion 11g has a high elastic deformation work rate and improved shape retention.
- the flat plate portion 11 g after the press working is harder due to work hardening as compared with the Ni—Ti alloy before the press working.
- the flat plate portion 11 g after the press working has a high maltens hardness, so that the shapeability is low.
- the flat plate portion 11 g becomes soft.
- the flat plate portion 11g has a small Martens hardness and improved shapeability.
- the guide wire 100 is subjected to heat treatment on the pressed flat plate portion 11 g to determine the elastic deformation work rate and the maltens hardness of the tip portion of the guide wire 100 formed of the Ni—Ti alloy. It can be controlled to a range. Thereby, the guide wire 100 can have both shapeability and shape retention.
- the heat treatment is preferably applied to at least a part of the flat plate portion 11g of the first core portion 11 and the transition portion 11f. That is, the guide wire 100 according to the present embodiment has a heat treatment region H that continuously extends from the tip of the flat plate portion 11g to at least a part of the transition portion 11f along the major axis direction. One end of the heat treatment region H of the guide wire 100 coincides with the tip of the flat plate portion 11g, and the other end is located at the transition portion 11f.
- the heat treatment region H refers to a region in which an oxide film is formed on at least a part of the outer surface of the first core member in the circumferential direction by the heat treatment.
- the guide wire 100 has an oxide film formed on the outer surface of the guide wire 100 from the tip of the flat plate portion 11g to at least a part of the transition portion 11f along the major axis direction. Further, in the present specification, the total length from one end to the other end of the heat treatment region H along the major axis direction of the guide wire 100 is referred to as a heat treatment length.
- the heat treatment length of the guide wire 100 is longer than the length along the major axis direction of the flat plate portion 11 g.
- the guide wire 100 has a heat treatment region H that continuously extends from the tip of the flat plate portion 11g to at least a part of the transition portion 11f, thereby suppressing a sudden change in rigidity along the long axis direction of the guide wire 100.
- FIGS. 4A and 4C are views schematically showing the rigidity of the tip portion of the first core portion 11 when the guide wire 100 is heat-treated.
- the point cloud appearing on the outer surface of the first core portion 11 expresses the high and low rigidity, and the denser the points, the lower the rigidity, and the sparser the points, the more the rigidity. Represents that becomes higher.
- the flat plate portion 11g has a flat plate shape having a small thickness. Therefore, the rigidity of the flat plate portion 11g is low and constant along the long axis direction.
- the transition portion 11f has a wedge shape in which the thickness gradually increases and the width gradually decreases from the flat plate portion 11g toward the second taper portion 11e. Therefore, the rigidity of the transition portion 11f is equal to that of the flat plate portion 11g at the tip, and gradually increases from the tip to the base end.
- the rigidity of the heat-treated portion of the first core portion 11 is reduced. Therefore, as shown in FIG. 4B, when only a part of the flat plate portion 11g is heat-treated, the rigidity of the flat plate portion 11g changes abruptly at the position of the base end of the heat treatment region H. Alternatively, when only the flat plate portion 11g is heat-treated, the rigidity of the first core portion 11 suddenly changes at the boundary between the flat plate portion 11g and the transition portion 11f. The guide wire 100 is liable to bend at a point where the rigidity suddenly changes along the long axis direction, and is liable to cause prolapse. In the present embodiment, as shown in FIG.
- the flat plate portion 11g is heat-treated over the entire length, and in addition, a part of the transition portion 11f is also heat-treated.
- the guide wire 100 suppresses a sudden change in rigidity along the long axis direction, and the prolapse resistance is improved.
- the portion on the proximal end side of the tip of the guide wire 100 is locally bent, and the bent portion is from the main trunk to the side branch. It means a state deviating to the tip side from the branch.
- the pushing force and torque applied to the base end of the guide wire 100 are transmitted only to the bent portion, so that the operator advances the tip of the guide wire 100 to the tip of the side branch. Will be difficult. Further, since the tip of the catheter advanced along the guide wire 100 is guided to the bent portion, it becomes difficult for the operator to advance the catheter to the side branch.
- the base end of the heat treatment region H of the guide wire 100 is preferably located at the transition portion 11f. That is, it is preferable that the base end of the heat treatment region H of the guide wire 100 is not located at the second tapered portion 11e.
- the second tapered portion 11e that has not been cold-worked is heat-treated, its superelasticity is lowered and plastic deformation is likely to occur. As a result, the guide wire 100 is likely to be kinked in the blood vessel.
- FIG. 4C only the cold-worked flat plate portion 11g and the transition portion 11f are heat-treated. As a result, the guide wire 100 is suppressed from plastic deformation due to a decrease in superelasticity, and the kink resistance is improved.
- the ratio of the length of the guide wire 100 along the major axis direction from the tip of the transition portion 11f to the base end of the heat treatment region H in the length along the major axis direction of the transition portion 11f is 10% or more and 100% or less. Is preferable. Thereby, the guide wire 100 can improve the prolapse resistance and the kink resistance while having the shape forming property and the shape retention property.
- the portion of the first core portion 11 that has not been cold-processed such as the second tapered portion 11e, is heat-treated.
- the portion of the first core portion 11 that has not been cold-processed is heat-treated, the superelasticity is lowered and the first core portion 11 is easily plastically deformed.
- the guide wire 100 is likely to be kinked in the blood vessel. Further, when the heat treatment length is shorter than the above range and only the flat plate portion 11g is heat-treated, the rigidity of the first core portion 11 or at the boundary between the flat plate portion 11g and the transition portion 11f is suddenly changed. Prolapse is likely to occur.
- the ratio of the length of the guide wire 100 along the major axis direction from the tip of the transition portion 11f to the base end of the heat treatment region H in the length along the major axis direction of the transition portion 11f is 55% or more and 65% or less. Is more preferable. As a result, the guide wire 100 can further improve the prolapse resistance and the kink resistance while having shapeability and shape retention.
- the length along the long axis direction from the tip of the transition portion 11f to the base end of the heat treatment region H exceeds 65% of the length along the long axis direction of the transition portion 11f, the transition portion 11f becomes rigid due to the heat treatment. The length of the reduced part becomes longer.
- the guide wire 100 when the guide wire 100 is pushed in with the tip of the guide wire 100 inserted from the main trunk to the side branch, the pushing force is not transmitted to the tip of the guide wire 100 and the transition portion 11f is located on the main trunk. It bends at, and prolapse is likely to occur.
- the transition portion 11f when the length along the major axis direction from the tip of the transition portion 11f to the base end of the heat treatment region H is less than 55% of the length along the major axis direction of the transition portion 11f, the transition portion 11f has rigidity. The length of the high part becomes longer.
- the base end of the heat treatment region H is arranged at the tip end portion of the transition portion 11f having low rigidity, the rigidity of the guide wire 100 suddenly changes at the base end of the heat treatment region H, and prolapse is likely to occur.
- the length along the major axis direction from the tip of the transition portion 11f to the base end of the heat treatment region H is set to 55% or more and 65% or less of the length along the major axis direction of the transition portion 11f.
- the temperature at which the heat treatment is performed is 300 ° C. to 650 ° C.
- the time is in the range of 3 to 60 minutes.
- the heat treatment has the effect of softening 11 g of the flat plate portion hardened by cold working and making it easy to deform, and removing the strain from the flat plate portion 11 g whose superelasticity has decreased due to the strain introduced by cold working, and appropriately superimposing. It has the effect of improving elasticity. Therefore, the heat treatment is particularly effective as a method for imparting shapeability and shape retention to the guide wire 100.
- the method of imparting shapeability and shape retention to the tip of the core member 10 is not limited to heat treatment, and any other method can be used as long as the elastic deformation work rate and the Martens hardness can be within the above ranges. The method of may be applied.
- the guide wire 100 includes a long core member 10 having a flat plate portion 11g at the tip, and the flat plate portion 11g has an elastic deformation work rate of 46.0% or more and 59.5%. It is made of a Ni—Ti alloy having a Martens hardness of 1300 N / mm 2 or more and 3000 N / mm 2 or less.
- the guide wire 100 can be deformed by a large force applied by the operator for shaping, but can be restored to the shape at the time of shaping without being plastically deformed by a small force applied during the procedure. Can have. That is, the guide wire 100 can have both shapeability and shape retention. As a result, the guide wire 100 can be shaped by the operator, and can be restored to the shape at the time of shaping even if the tip portion is subjected to an external force that can deform the tip portion in the blood vessel. Therefore, the guide wire 100 can maintain the high operability and blood vessel selectivity imparted by the shaping even during the procedure.
- the operator can easily perform the procedure. As a result, the procedure time is shortened, and the burden on the operator and the patient can be reduced.
- the guide wire 100 may be configured so that the maltens hardness is 1300 N / mm 2 or more and 2120 N / mm 2 or less.
- the flat plate portion 11g of the first core portion 11 at the tip of the core member 10 becomes more flexible, so that the shapeability is further improved.
- the core member 10 of the guide wire 100 includes a flat plate portion 11g and a transition portion 11f extending from the base end of the flat plate portion 11g toward the base end side in the major axis direction in order from the tip end side.
- the core member 10 may have a heat treatment region H extending from the tip of the flat plate portion 11g to at least a part of the transition portion 11f.
- the first core portion 11 can suppress a sudden change in rigidity along the long axis direction at the base end of the heat treatment region H, so that the first core portion 11 has shapeability and shape retention. Prolap resistance and kink resistance can be improved.
- the ratio of the length along the long axis direction from the tip end of the transition portion 11f to the base end of the heat treatment region H to the length along the long axis direction of the transition portion 11f may be 10% or more and 100% or less.
- the guide wire 100 can improve the prolapse resistance and the kink resistance while having shapeability and shape retention.
- the ratio of the length along the long axis direction from the tip end of the transition portion 11f to the base end of the heat treatment region H to the length along the long axis direction of the transition portion 11f is , 55% or more and 65% or less.
- the guide wire 100 can further suppress a sudden change in rigidity along the long axis direction of the guide wire 100, so that the prolapse resistance and the kink resistance can be further improved.
- the method for manufacturing the guide wire 100 includes the core member 10, and the flat plate portion 11 g and the base end along the long axis direction from the base end of the flat plate portion 11 g with respect to the tip end portion of the core member 10.
- the elastic deformation work rate is 46.0% or more and 59.5% or less with respect to the step of performing cold working so as to have the transition portion 11f extending to the side and at least a part of the flat plate portion 11g and the transition portion 11f. It also includes a step of performing a heat treatment so that the Martens hardness is 1300 N / mm 2 or more and 3000 N / mm 2 or less.
- the guide wire 100 manufactured by the above method can be deformed by a large force applied by the operator for shaping, but can be restored to the shape at the time of shaping without being plastically deformed by a small force applied during the procedure. Can have. That is, the guide wire 100 can have both shapeability and shape retention. As a result, the guide wire 100 can be shaped by the operator, and can be restored to the shape at the time of shaping even if the tip portion is subjected to an external force that can deform the tip portion in the blood vessel. Therefore, the guide wire 100 can maintain the high operability and blood vessel selectivity imparted by the shaping even during the procedure.
- the heat treatment has the effect of softening 11 g of the flat plate portion hardened by cold working and making it easy to deform, and removing strain from the flat plate portion 11 g whose superelasticity has decreased due to the strain introduced by cold working is appropriate. Has the effect of improving superelasticity. Therefore, the heat treatment is particularly effective as a method for imparting shapeability and shape retention to the guide wire 100.
- Table 1 shows the manufacturing conditions of Examples 1 to 16
- Table 2 shows the manufacturing conditions of Comparative Examples 1 to 4.
- the "heat treatment ratio” in Tables 1 and 2 is the length along the long axis direction from the tip of the transition portion 11f to the base end of the heat treatment region H, which occupies the length along the long axis direction of the transition portion 11f. It is the ratio of.
- Step 1 The tip of the first core portion 11 (Ni content 54 mass% to 57 mass%) made of Ni—Ti alloy was tapered so that the outer diameter gradually decreased from the proximal end side to the distal end side. The outer diameter of the cutting edge was 80 ⁇ m.
- Step 2 A range of 16 mm was pressed from the tip of the first core portion 11 toward the base end side to form a flat plate portion 11g and a transition portion 11f. At this time, the flat plate portion 11 g was formed in a range of 9 mm from the tip end side of the guide wire 100 toward the base end side, and was formed into a constant flat plate shape with a thickness of 27 ⁇ m.
- Step 3 The range of 7 mm from the base end of the flat plate portion 11 g toward the base end side was defined as the transition portion 11f, and the wedge shape was formed in which the thickness increased toward the base end side.
- Step 3 Heat treatment was performed in a range of 12.5 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- Step 4 A luminal body 20 composed of a first coil 21 and a second coil 22 was arranged around a part of the second outer diameter constant portion 11d from the flat plate portion 11g of the first core portion 11.
- the first coil 21 a coil having a length of 28 mm to 32 mm formed by winding a wire rod made of a platinum-based alloy (outer diameter: 0.340 mm to 0.350 mm, wire rod diameter: 58 ⁇ m to 60 ⁇ m) was used.
- a coil having a length of 210 mm to 220 mm formed by winding a stainless steel wire rod (outer diameter: 0.340 mm to 0.350 mm, wire rod diameter: 38 ⁇ m to 40 ⁇ m) was used.
- the tip of the first coil 21 was fixed to the flat plate portion 11g of the first core portion 11 with silver wax.
- the base end portion of the first coil 21 and the tip end portion of the second coil 22 were fixed to the second tapered portion 11e of the first core portion 11 with Sn—Ag alloy solder via a metal tubular member 32a.
- the base end portion of the second coil 22 was fixed to the second outer diameter constant portion 11d of the first core portion 11 with Sn—Ag alloy solder.
- the first core portion 11 and the second core portion 12 were joined by butt resistance welding.
- the outer surface of a part of the first coil 21, the second coil 22, and the second outer diameter constant portion 11d was coated with a hydrophilic polymer to form the first coating layer 41.
- the outer surfaces of the first outer diameter constant portion 11b, the first taper portion 11c, and the second core portion 12 of the first core portion 11 were coated with a fluororesin to form the second coating layer 42.
- the outer surfaces of the first joint portion 11a and the second joint portion 12b were coated with a silicone resin to form a third coating layer 43.
- the guide wires of Examples 2 to 16 were manufactured as follows.
- the guide wires of Examples 2 to 6 and 9 to 16 were manufactured in the same manner as in Example 1 for Step 1, Step 2, and Steps 4 to 6, and Step 3 was manufactured as follows.
- step 3 heat treatment was performed in a range of 13.0 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- step 3 heat treatment was performed in a range of 13.8 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- step 3 heat treatment was performed in a range of 13.6 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- step 3 heat treatment was performed in a range of 12.8 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- step 3 heat treatment was performed in a range of 13.3 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- step 3 heat treatment was performed in a range of 7.2 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- step 3 heat treatment was performed in a range of 9.3 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- step 3 heat treatment was performed in a range of 10.3 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- step 3 heat treatment was performed in a range of 11.7 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- step 3 heat treatment was performed in a range of 14.4 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- step 3 heat treatment was performed in a range of 16.0 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- step 3 heat treatment was performed in a range of 18.9 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- step 3 heat treatment was performed in a range of 20.6 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- Step 2 A range of 16 mm was pressed from the tip of the first core portion 11 toward the base end side to form a flat plate portion 11g and a transition portion 11f.
- the flat plate portion 11 g was formed in a range of 13 mm from the tip end side of the guide wire 100 toward the base end side, and was formed into a constant flat plate shape with a thickness of 32 ⁇ m.
- the range of 3 mm from the base end of the flat plate portion 11 g toward the base end side was defined as the transition portion 11f, and the wedge shape was formed in which the thickness increased toward the base end side.
- Step 3 Heat treatment was performed in a range of 13.6 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- Step 2 A range of 16 mm was pressed from the tip of the first core portion 11 toward the base end side to form a flat plate portion 11g and a transition portion 11f.
- the flat plate portion 11 g was formed in a range of 13 mm from the tip end side of the guide wire 100 toward the base end side, and was formed into a constant flat plate shape with a thickness of 32 ⁇ m.
- the range of 3 mm from the base end of the flat plate portion 11 g toward the base end side was defined as the transition portion 11f, and the wedge shape was formed in which the thickness increased toward the base end side.
- Step 3 Heat treatment was performed in a range of 13.7 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- Comparative Examples 1 to 4 were manufactured as follows. In addition, Step 1, Step 2, Step 4 to Step 6 of Comparative Example 1 and Comparative Example 2 were manufactured in the same manner as in Example 1, and Step 3 was manufactured as follows.
- step 3 the first core portion 11 pressed in step 2 was not heat-treated.
- step 3 heat treatment was performed in a range of 13.7 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- Comparative Example 3 and Comparative Example 4 were manufactured as follows. Comparative Example 3 and Comparative Example 4 were manufactured in the same manner as in Example 1 for Step 1 and Steps 4 to 6, and Step 2 and Step 3 were manufactured as follows.
- Step 2 A range of 16 mm was pressed from the tip of the first core portion 11 toward the base end side to form a flat plate portion 11g and a transition portion 11f.
- the flat plate portion 11 g was formed in a range of 13 mm from the tip end side of the guide wire 100 toward the base end side, and was formed into a constant flat plate shape with a thickness of 32 ⁇ m.
- the range of 3 mm from the base end of the flat plate portion 11 g toward the base end side was defined as the transition portion 11f, and the wedge shape was formed in which the thickness increased toward the base end side.
- Step 3 Heat treatment was performed in a range of 14.3 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- Step 2 A range of 16 mm was pressed from the tip of the first core portion 11 toward the base end side to form a flat plate portion 11g and a transition portion 11f.
- the flat plate portion 11 g was formed in a range of 13 mm from the tip end side of the guide wire 100 toward the base end side, and was formed into a constant flat plate shape with a thickness of 32 ⁇ m.
- the range of 3 mm from the base end of the flat plate portion 11 g toward the base end side was defined as the transition portion 11f, and the wedge shape was formed in which the thickness increased toward the base end side.
- Step 3 Heat treatment was performed in a range of 13.0 mm from the cutting edge of the first core portion 11 pressed in step 2 toward the base end side.
- the shaping test was carried out as follows. First, a portion of the guide wire 100 having a tip of 5 mm was sandwiched between a silicone rubber plate placed on a substantially horizontal plane and a stainless steel round bar ( ⁇ 0.7 mm), and the round bar was pressed with a load of 100 g. Next, the guide wire 100 was pulled out vertically from the silicone rubber plate, and the shape of the tip portion of the guide wire 100 was visually observed. The evaluation was " ⁇ " when the tip of the guide wire 100 after the test was significantly deformed compared to before the test, " ⁇ " when it was deformed but the degree was small, and " ⁇ " when it was not deformed. ⁇ ”.
- the shape retention test was carried out as follows.
- the guide wire 100 was deformed and shaped with a radius of curvature of 3.5 mm from a position 2 mm to a position 7 mm from the tip of the guide wire 100.
- the shaped guide wire 100 was inserted into a U-shaped passage having a radius of curvature of 15 mm, rotated alternately left and right for a total of 10 turns, and then pulled out to confirm the shape of the tip of the guide wire 100.
- the evaluation is based on the shape when the vertical line is drawn from the tip of the guide wire 100 to the central axis C and the distance between the vertical line foot before the test and the vertical line foot after the test on the central axis C is within 1 mm.
- the guide wire 100 receives a larger external force as the radius of curvature of the U-shaped passage becomes smaller, and it becomes difficult to maintain the shape at the time of shaping.
- the prolapse resistance test was carried out as follows. First, a branch model 200 made of a silicone resin tube shown in FIG. 5A was prepared.
- the branch model 200 includes a main trunk 210 and a plurality of side branches 220 arranged along the long axis direction of the main trunk 210.
- the inner diameter of the main trunk 210 was 3 mm, and the inner diameter of the side branch 220 was 2 mm.
- the tip of the guide wire 100 was shaped. As shown in FIG. 5B, the shaping is a shape deformed by about 135 ° in the same direction at each of the first bending point P1 at a position 1 mm from the tip of the guide wire 100 and the second bending point P2 at a position 5 mm. And said.
- the guide wire 100 was inserted into each side branch 220 from the insertion port 200a of the branch model 200 filled with water. Of the side branches 220 into which the guide wire 100 could be inserted, the maximum angle ⁇ was recorded. When the maximum angle ⁇ into which the guide wire 100 can be inserted is small, it can be said that prolapse is likely to occur.
- the evaluation is “ ⁇ ” when the maximum angle ⁇ is ⁇ ⁇ 100 ° among the side branches 220 into which the guide wire 100 can be inserted, and “ ⁇ ” when the angle ⁇ is 100 ° ⁇ ⁇ 110 °. , When the angle ⁇ is 110 ° ⁇ ⁇ 120 °, it is set as “ ⁇ ”.
- the kink resistance test was carried out as follows. As shown in FIG. 6, a stenosis model 300 was prepared in which one of the tubes having an inner diameter of 2.5 mm was used as a closed end. The tip of the guide wire 100 was shaped into the shape shown in FIG. 5B. The tip of the guide wire 100 was inserted from the open end of the stenosis model 300 filled with water, and was brought into contact with the closed end like the guide wire 100 shown by the two-dot broken line in FIG. Next, the guide wire 100 was pushed in in the direction of the tip by 10 mm while applying torque, and the tip of the guide wire 100 was bent into a U shape like the guide wire 100 shown by the solid line in FIG.
- the “bending height L” is a guide wire 100 before shaping (straight line state) on a plane passing through the central axis C of the guide wire 100 when the guide wire 100 is in a natural state. Refers to the length from the tip of the guide wire 100 to the tip of the guide wire 100 after the kink resistance test. The evaluation was " ⁇ " when the bending height L of the guide wire 100 after the kink resistance test was less than 4 mm, and "x" when the bending height L was 4 mm or more.
- Table 3 shows the evaluation results of Examples 1 to 16, and Table 4 shows the evaluation results of Comparative Examples 1 to 4.
- "ND" in the table means unmeasured.
- the guide wires 100 of Comparative Examples 1 to 4 had "x" as the result of either the shapeability test or the shape retention test.
- the result of the shape retention test was " ⁇ ", but the result of the shapeability test was "x”. It is presumed that the guide wire 100 of Comparative Example 1 could not be shaped because the Martens hardness was larger than the upper limit of Condition 1 and was harder than that of Examples 1 to 16. It is presumed that the guide wire 100 of Comparative Example 4 could not be shaped because the elastic deformation work rate was larger than the upper limit of Condition 1 and the superelasticity was higher than that of Examples 1 to 16.
- the guide wires 100 of Comparative Example 2 and Comparative Example 3 had a shapeability test result of " ⁇ ", but a shape retention test result of " ⁇ ". .. Since the Martens hardness of the guide wire 100 of Comparative Example 2 is smaller than the lower limit of Condition 1 and is softer than that of Examples 1 to 16, it is presumed that plastic deformation easily occurred. Since the elastic deformation work rate of the guide wire 100 of Comparative Example 3 is smaller than the lower limit of Condition 1 and the superelasticity is lower than that of Examples 1 to 16, it is presumed that plastic deformation has occurred.
- the guide wire 100 in which the flat plate portion 11 g is made of Ni—Ti alloy satisfying the above condition 1 has both shapeability and shape retention.
- the guide wire 100 of Examples 1 to 3 has a shaping test result of “ ⁇ ”, and the guide wires 100 of Examples 4 to 16 have a shaping test.
- the result of was " ⁇ ".
- the elastic deformation work rate of the Ni—Ti alloy of the flat plate portion 11 g is 46.0% or more and 59.5% or less
- the Martens hardness is 1300 N / mm 2 or more. It was 2120 N / mm 2 or less (Condition 2). It is presumed that the guide wires 100 of Examples 1 to 3 were harder than the guide wires 100 of Examples 4 to 16 and difficult to shape because the maltens hardness was larger than the upper limit of the condition 2. Will be done.
- the guide wire 100 in which the flat plate portion 11g is made of Ni—Ti alloy satisfying the above condition 2 is further excellent in both shapeability and shape retention.
- the heat treatment ratio is smaller than the lower limit of the condition 3, and a part of the flat plate portion 11g or the flat plate portion 11g and the tip end side of the transition portion 11f are used. Only a small part is heat treated. Therefore, as shown in FIG. 4B, it is presumed that the guide wires 100 of Examples 9 and 10 have a sharp change in rigidity near the boundary between the flat plate portion 11g and the transition portion 11f, and the prolapse resistance is lowered. Will be done.
- the guide wire 100 of Example 4 and Examples 6 to 8 had a prolapse resistance test result of " ⁇ ".
- the result of the prolapse resistance test was " ⁇ ".
- the guide wires 100 of Examples 4 and 6 to 8 are all in the long axis direction from the tip of the transition portion 11f to the base end of the heat treatment region H, which occupy the length along the long axis direction of the transition portion 11f.
- the ratio of the length along the above is 55% or more and 65% or less (condition 4).
- the base end of the heat treatment region H is arranged at the tip end portion of the transition portion 11f having a heat treatment ratio smaller than the lower limit value of the condition 4 and low rigidity. Therefore, it is presumed that the guide wire 100 of Example 12 has a sharp change in rigidity at the base end of the heat treatment region H, and the prolapse resistance is lowered.
- the heat treatment ratio is larger than the upper limit of the condition 4, and the length of the portion where the rigidity is lowered by the heat treatment in the transition portion 11f is long. Therefore, it is presumed that the guide wire 100 of the thirteenth embodiment is difficult to transmit the pushing force to the tip of the guide wire 100, and the prolapse resistance is lowered.
- the ratio of the length along the major axis direction from the tip of the transition portion 11f to the base end of the heat treatment region H to the length along the major axis direction of the transition portion 11f satisfies the above condition 3 and is more preferable.
- the guide wire 100 satisfying the above condition 4 was excellent in prolapse resistance.
- the guide wire 100 of Example 1, Examples 3 to 4, and Examples 6 to 14 had a kink resistance test result of “ ⁇ ”.
- the result of the kink resistance test was "x”.
- the guide wires 100 of Examples 1, Examples 3 to 4, and Examples 6 to 14 all have a heat treatment region H from the tip of the transition portion 11f occupying the length along the major axis direction of the transition portion 11f.
- the ratio of the length along the major axis direction to the base end is 10% or more and 100% or less (condition 3).
- the heat treatment ratio is larger than the upper limit of the condition 3, and the heat treatment is performed up to the portion not cold-processed.
- the core member 10 is made of a Ni—Ti alloy, when a portion that has not been cold-processed is heat-treated, the superelasticity is lowered and plastic deformation is likely to occur. Therefore, it is presumed that the guide wires 100 of Examples 15 and 16 have reduced kink resistance.
- the guide wire 100 in which the heat treatment ratio in the transition portion 11f satisfies the above condition 3 was excellent in kink resistance.
- 10 core members 11 1st core part (11a 1st joint part, 11b 1st outer diameter constant part, 11c 1st taper part, 11d 2nd outer diameter constant part, 11e 2nd taper part, 11f transition part, 11g flat plate part), 12 2nd core part (12a base part, 12b 2nd joint part), 13 Joint surface, 20 luminal body, 21 1st coil, 22 Second coil, 30 Fixed part, 31 Tip fixing part, 32 Intermediate fixing part (32a cylindrical member), 33 Base end fixing part, 40 coating layer, 41 First coating layer, 42 Second coating layer, 43 Third coating layer, 100 guide wire, C central axis, H heat treatment area.
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Abstract
Description
図1または図2に示すように、本実施形態に係るガイドワイヤ100は、長尺なコア部材10と、コア部材10の先端部の周囲を覆う管腔体20と、管腔体20をコア部材10に固定する固定部30と、コア部材10を含む各部材を覆う被覆層40と、を有している。以下、ガイドワイヤ100の各部について詳述する。
コア部材10は、第1コア部11と、第1コア部11の基端側に配置され、第1コア部11に接合された第2コア部12と、を備えている。
管腔体20は、線材をコア部材10に対して螺旋状に巻回してなる部材である。本実施形態において、管腔体20は、第1コイル21と、第1コイル21の基端側に配置される第2コイル22で形成される。第1コイル21は、第1コア部11の先端から中間部にかけて配置される。第2コイル22は、第1コア部11の中間部から基端側にかけて配置される。なお、管腔体20は、1つのコイルにより形成してもよい。管腔体20は、3つ以上のコイルにより形成してもよい。
固定部30は、管腔体20をコア部材10に固定するための部材である。固定部30は、本実施形態では、管腔体20の先端をコア部材10に固定する先端固定部31と、管腔体20の中間部をコア部材10に固定する中間固定部32と、管腔体20の基端をコア部材10に固定する基端固定部33と、を有する。
被覆層40は、第1被覆層41、第2被覆層42および第3被覆層43を備えている。被覆層40は、ガイドワイヤ100と血管やカテーテルとの間に生じる摩擦を低減し得る材料によって形成できる。これにより、被覆層40は、ガイドワイヤ100の操作性や安全性を向上させる。
以上説明したように、本実施形態に係るガイドワイヤ100は、先端に平板部11gを有する長尺なコア部材10を備え、平板部11gは、弾性変形仕事率が46.0%以上59.5%以下であり、かつマルテンス硬さが1300N/mm2以上3000N/mm2以下であるNi-Ti合金からなる。
以下、実施例および比較例に係るガイドワイヤ100の製造について説明する。なお、各実施例と各比較例において、工程3で実施される熱処理は、温度を300℃~650℃の範囲、時間を3分~60分の範囲で実施した。
(工程1)
Ni-Ti合金製の第1コア部11(Ni含有量54mass%~57mass%)の先端部に、基端側から先端側に向かって外径が漸減するテーパー加工を施した。最先端部の外径は、80μmであった。
(工程2)
第1コア部11の先端から基端側に向かって16mmの範囲をプレスし、平板部11gおよび移行部11fを形成した。この際、ガイドワイヤ100の先端から基端側に向かって9mmの範囲を平板部11gとし、厚みが27μmで一定の平板形状に形成した。平板部11gの基端から基端側に向かって7mmの範囲を移行部11fとし、基端側に向かうにつれて厚みが増すクサビ形状とした。
(工程3)
工程2にてプレスした第1コア部11の最先端から基端側に向かって12.5mmの範囲に熱処理を施した。
(工程4)
第1コア部11の平板部11gから第2外径一定部11dの一部の周囲に、第1コイル21と第2コイル22からなる管腔体20を配置した。第1コイル21は、白金系合金製の線材(外径:0.340mm~0.350mm、線材径:58μm~60μm)を巻回して形成した長さ28mm~32mmのコイルを使用した。第2コイル22は、ステンレス鋼製の線材(外径:0.340mm~0.350mm、線材径:38μm~40μm)を巻回して形成した長さ210mm~220mmのコイルを使用した。第1コイル21の先端部は、第1コア部11の平板部11gに銀ロウで固定した。第1コイル21の基端部と第2コイル22の先端部は、金属製の筒状部材32aを介して、第1コア部11の第2テーパー部11eにSn-Ag合金はんだで固定した。第2コイル22の基端部は、第1コア部11の第2外径一定部11dにSn-Ag合金はんだで固定した。
(工程5)
第1コア部11と第2コア部12を、突き合わせ抵抗溶接により接合した。
(工程6)
第1コイル21、第2コイル22および第2外径一定部11dの一部の外表面を親水性ポリマーで被覆し、第1被覆層41を形成した。第1コア部11の第1外径一定部11b、第1テーパー部11cおよび第2コア部12の外表面をフッ素系樹脂で被覆し、第2被覆層42を形成した。第1接合部11aと第2接合部12bの外表面をシリコーン樹脂で被覆し、第3被覆層43を形成した。
工程3は、工程2にてプレスした第1コア部11の最先端から基端側に向かって13.0mmの範囲に熱処理を施した。
工程3は、工程2にてプレスした第1コア部11の最先端から基端側に向かって13.8mmの範囲に熱処理を施した。
工程3は、工程2にてプレスした第1コア部11の最先端から基端側に向かって13.6mmの範囲に熱処理を施した。
工程3は、工程2にてプレスした第1コア部11の最先端から基端側に向かって12.8mmの範囲に熱処理を施した。
工程3は、工程2にてプレスした第1コア部11の最先端から基端側に向かって13.3mmの範囲に熱処理を施した。
工程3は、工程2にてプレスした第1コア部11の最先端から基端側に向かって7.2mmの範囲に熱処理を施した。
工程3は、工程2にてプレスした第1コア部11の最先端から基端側に向かって9.3mmの範囲に熱処理を施した。
工程3は、工程2にてプレスした第1コア部11の最先端から基端側に向かって10.3mmの範囲に熱処理を施した。
工程3は、工程2にてプレスした第1コア部11の最先端から基端側に向かって11.7mmの範囲に熱処理を施した。
工程3は、工程2にてプレスした第1コア部11の最先端から基端側に向かって14.4mmの範囲に熱処理を施した。
工程3は、工程2にてプレスした第1コア部11の最先端から基端側に向かって16.0mmの範囲に熱処理を施した。
工程3は、工程2にてプレスした第1コア部11の最先端から基端側に向かって18.9mmの範囲に熱処理を施した。
工程3は、工程2にてプレスした第1コア部11の最先端から基端側に向かって20.6mmの範囲に熱処理を施した。
(工程2)
第1コア部11の先端から基端側に向かって16mmの範囲をプレスし、平板部11gおよび移行部11fを形成した。この際、ガイドワイヤ100の先端から基端側に向かって13mmの範囲を平板部11gとし、厚みが32μmで一定の平板形状に形成した。平板部11gの基端から基端側に向かって3mmの範囲を移行部11fとし、基端側に向かうにつれて厚みが増すクサビ形状とした。
(工程3)
工程2にてプレスした第1コア部11の最先端から基端側に向かって13.6mmの範囲に熱処理を施した。
(工程2)
第1コア部11の先端から基端側に向かって16mmの範囲をプレスし、平板部11gおよび移行部11fを形成した。この際、ガイドワイヤ100の先端から基端側に向かって13mmの範囲を平板部11gとし、厚みが32μmで一定の平板形状に形成した。平板部11gの基端から基端側に向かって3mmの範囲を移行部11fとし、基端側に向かうにつれて厚みが増すクサビ形状とした。
(工程3)
工程2にてプレスした第1コア部11の最先端から基端側に向かって13.7mmの範囲に熱処理を施した。
工程3は、工程2にてプレスした第1コア部11に対して熱処理を施さなかった。
工程3は、工程2にてプレスした第1コア部11の最先端から基端側に向かって13.7mmの範囲に熱処理を施した。
(工程2)
第1コア部11の先端から基端側に向かって16mmの範囲をプレスし、平板部11gおよび移行部11fを形成した。この際、ガイドワイヤ100の先端から基端側に向かって13mmの範囲を平板部11gとし、厚みが32μmで一定の平板形状に形成した。平板部11gの基端から基端側に向かって3mmの範囲を移行部11fとし、基端側に向かうにつれて厚みが増すクサビ形状とした。
(工程3)
工程2にてプレスした第1コア部11の最先端から基端側に向かって14.3mmの範囲に熱処理を施した。
(工程2)
第1コア部11の先端から基端側に向かって16mmの範囲をプレスし、平板部11gおよび移行部11fを形成した。この際、ガイドワイヤ100の先端から基端側に向かって13mmの範囲を平板部11gとし、厚みが32μmで一定の平板形状に形成した。平板部11gの基端から基端側に向かって3mmの範囲を移行部11fとし、基端側に向かうにつれて厚みが増すクサビ形状とした。
(工程3)
工程2にてプレスした第1コア部11の最先端から基端側に向かって13.0mmの範囲に熱処理を施した。
実施例1~実施例16、比較例1~比較例4にガイドワイヤ100に対する評価は、下記の通りに実施した。
-装置-
島津製作所社製 ダイナミック超微小剛性計DUH-211S
-測定条件-
・測定圧子:三角すい圧子(稜間角115°)設備付属品(Triangular115)
・環境条件:温度22±1℃
-測定方法および手順-
・試験方法:負荷-除荷試験(「計装化押し込み硬さ」ISO14577-1に準拠)
・押し込み深さ:0.5μm
・保持時間:0秒
・測定位置:平板部11gの厚み方向から見た平面に平行な断面の任意の10箇所
-算出方法-
各実施例および各比較例のガイドワイヤ100の弾性変形仕事率およびマルテンス硬さは、平板部11gの厚み方向から見た平面に平行な断面における任意の10箇所の測定値の平均値とした。弾性変形仕事率は小数点以下1桁とし、マルテンス硬さは整数とした。
形状付け試験は、以下の通りに実施した。まず、ガイドワイヤ100の先端5mmの部分を略水平面に載置したシリコーンゴム板とステンレス鋼製の丸棒(φ0.7mm)で挟み、丸棒を100gの荷重で押さえた。次に、ガイドワイヤ100をシリコーンゴム板から鉛直方向に引き抜き、ガイドワイヤ100の先端部の形状を目視にて観察した。評価は、試験後のガイドワイヤ100の先端部が試験前と比較して大きく変形していたものを「〇」、変形したがその程度が小さいものを「△」、変形しなかったものを「×」とした。
形状保持性試験は、以下の通りに実施した。ガイドワイヤ100の先端から2mmの位置から7mmの位置にかけて3.5mmの曲率半径で変形させ、シェイピングした。シェイピングしたガイドワイヤ100を15mmの曲率半径を有するU字状の通路に挿入し、左右交互に合計10回転させた後引き抜いて、ガイドワイヤ100の先端部の形状を確認した。評価は、ガイドワイヤ100の先端から中心軸Cに垂線を下したとき、中心軸C上における試験前の垂線の足と試験後の垂線の足との間の距離が1mm以内の場合は形状が保持できたとみなして「〇」、1mmより大きい場合は形状が保持できなかったとみなして「×」とした。なお、ガイドワイヤ100は、U字状の通路の曲率半径が小さくなるほど大きな外力を受け、シェイピング時の形状を保持しにくくなる。
耐プロラプス性試験は、以下の通りに実施した。まず、図5Aに示すシリコーン樹脂製のチューブからなる分岐モデル200を用意した。分岐モデル200は、本幹210と、本幹210の長軸方向に沿って配置された複数の側枝220を備えている。本幹210の内径は3mm、側枝220の内径は2mmとした。図5Aにおいて、本幹210の中心軸と側枝220の中心軸とがなす先端側の角度θ(θ1~θ7)は、θ1=90°、θ2=100°、θ3=110°、θ4=120°、θ5=130°、θ6=140°、θ7=150°とした。
耐キンク性試験は、以下の通りに実施した。図6に示すように、内径2.5mmの管の一方を閉塞端とした狭窄モデル300を用意した。ガイドワイヤ100の先端部を、図5Bに示した形状にシェイピングした。ガイドワイヤ100の先端を、水を満たした狭窄モデル300の開口端から挿入し、図6の2点破線で示すガイドワイヤ100のように閉塞端に突き当てた状態とした。次に、ガイドワイヤ100を、トルクを加えながら先端方向に10mm押し込み、図6の実線で示すガイドワイヤ100のようにガイドワイヤ100の先端部をU字状に折り曲げた。その後、長軸方向に10mm引いてU字状に折れ曲がっていない状態へ戻した。この操作を合計3回行った。ガイドワイヤ100へのトルクは、試験者がガイドワイヤ100の基端部を保持した状態で1回転させることによって加えた。ガイドワイヤ100を狭窄モデル300から抜去し、ガイドワイヤ100の曲げ高さLをデジタルマイクロスコープで確認した。「曲げ高さL」とは、図7に示すように、ガイドワイヤ100を自然状態としたときに、ガイドワイヤ100の中心軸Cを通る平面上において、シェイピング前(直線状態)のガイドワイヤ100の先端から、耐キンク性試験後のガイドワイヤ100の先端までの長さを指す。評価は、耐キンク性試験後のガイドワイヤ100の曲げ高さLが4mm未満の場合は「〇」、曲げ高さLが4mm以上の場合は「×」とした。
表3は、実施例1~実施例16の評価結果を、表4は、比較例1~比較例4の評価結果を示す。なお、表中の「ND」は、未測定を意味する。
表3に示すように、実施例1~実施例16のガイドワイヤ100は、形状付け性試験および形状保持性試験の両方の結果が「〇」または「△」のいずれかであった。実施例1~実施例16のガイドワイヤ100は、平板部11gのNi-Ti合金の弾性変形仕事率が46.0%以上59.5%以下であり、かつマルテンス硬さが1300N/mm2以上3000N/mm2以下(条件1)であった。
表3に示すように、実施例1、実施例3~実施例4、実施例6~実施例8、実施例11~実施例16のガイドワイヤ100は、耐プロラプス性試験の結果が「〇」または「△」のいずれかであった。一方、実施例9、実施例10のガイドワイヤ100は、耐プロラプス性試験の結果が「×」であった。実施例1、実施例3~実施例4、実施例6~実施例8、実施例11~実施例16のガイドワイヤ100は、いずれも、移行部11fの長軸方向に沿う長さに占める移行部11fの先端から熱処理領域Hの基端までの長軸方向に沿う長さの割合(熱処理割合)が、10%以上100%以下(条件3)となっている。これに対し、実施例9と実施例10のガイドワイヤ100は、いずれも、熱処理割合が条件3の下限値よりも小さく、平板部11gの一部または平板部11gと移行部11fの先端側のごく一部にのみ熱処理が施されている。そのため、実施例9と実施例10のガイドワイヤ100は、図4Bに示すように、平板部11gと移行部11fとの境界近傍において剛性の急激な変化が生じ、耐プロラプス性が低下したと推定される。
表3に示すように、実施例1、実施例3~実施例4、実施例6~実施例14のガイドワイヤ100は、耐キンク性試験の結果が「〇」であった。一方、実施例15、実施例16のガイドワイヤ100は、耐キンク性試験の結果が「×」であった。実施例1、実施例3~実施例4、実施例6~実施例14のガイドワイヤ100は、いずれも、移行部11fの長軸方向に沿う長さに占める移行部11fの先端から熱処理領域Hの基端までの長軸方向に沿う長さの割合が、10%以上100%以下(条件3)となっている。これに対し、実施例15、実施例16は、熱処理割合が条件3の上限値より大きく、冷間加工されていない部位まで熱処理されている。コア部材10は、Ni-Ti合金製であるため、冷間加工されていない部位が熱処理されると超弾性の低下が生じ、塑性変形しやすくなる。そのため、実施例15と実施例16のガイドワイヤ100は、耐キンク性が低下したと推定される。
11 第1コア部(11a 第1接合部、11b 第1外径一定部、11c 第1テーパー部、11d 第2外径一定部、11e 第2テーパー部、11f 移行部、11g 平板部)、
12 第2コア部(12a 基部、12b 第2接合部)、
13 接合面、
20 管腔体、
21 第1コイル、
22 第2コイル、
30 固定部、
31 先端固定部、
32 中間固定部(32a 筒状部材)、
33 基端固定部、
40 被覆層、
41 第1被覆層、
42 第2被覆層、
43 第3被覆層、
100 ガイドワイヤ、
C 中心軸、
H 熱処理領域。
Claims (6)
- 先端に平板部を有する長尺なコア部材を備え、
前記平板部は、弾性変形仕事率が46.0%以上59.5%以下であり、かつマルテンス硬さが1300N/mm2以上3000N/mm2以下であるNi-Ti合金からなる、ガイドワイヤ。 - 前記マルテンス硬さは、1300N/mm2以上2120N/mm2以下である、請求項1に記載のガイドワイヤ。
- 前記コア部材は、先端側から順に、前記平板部と、前記平板部の基端から長軸方向に沿って基端側に延在する移行部とを有し、
前記コア部材は、前記平板部の先端から前記移行部の少なくとも一部まで延在する熱処理領域を有する、請求項1または2に記載のガイドワイヤ。 - 前記移行部の長軸方向に沿う長さに占める、前記移行部の先端から前記熱処理領域の基端までの長軸方向に沿う長さの割合は、10%以上100%以下である、請求項3に記載のガイドワイヤ。
- 前記移行部の長軸方向に沿う長さに占める、前記移行部の先端から前記熱処理領域の基端までの長軸方向に沿う長さの割合は、55%以上65%以下である、請求項4に記載のガイドワイヤ。
- コア部材を備えたガイドワイヤの製造方法であって、
前記コア部材の先端部に対し、平板部と、前記平板部の基端から長軸方向に沿って基端側に延在する移行部とを有するように冷間加工を行う工程と、
前記平板部および前記移行部の少なくとも一部に対し、弾性変形仕事率が46.0%以上59.5%以下であり、かつマルテンス硬さが1300N/mm2以上3000N/mm2以下となるように熱処理を行う工程とを含む、ガイドワイヤの製造方法。
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