JP2009172229A - Guide wire core, manufacturing method of this core, and medical guide wire using this core - Google Patents

Guide wire core, manufacturing method of this core, and medical guide wire using this core Download PDF

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JP2009172229A
JP2009172229A JP2008015295A JP2008015295A JP2009172229A JP 2009172229 A JP2009172229 A JP 2009172229A JP 2008015295 A JP2008015295 A JP 2008015295A JP 2008015295 A JP2008015295 A JP 2008015295A JP 2009172229 A JP2009172229 A JP 2009172229A
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guide wire
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JP5386088B2 (en
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Susumu Sakamoto
進 坂本
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    • 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
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • 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

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  • Pulmonology (AREA)
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical guide wire 2 which shows excellent straightness, restoring characteristics, and torque transmission properties. <P>SOLUTION: The guide wire 2 is equipped with a cover 8, the core 10, a coil 12, and a fixing material 14. The core 10 has a diameter which is gradually reduced toward a distal end 4 in a tapered part 18. The core 10 is made of austenite stainless steel. In manufacturing the guide wire 2, wire drawing is performed on a wire rod. The wire rod is subjected to low-temperature annealing. In the low-temperature annealing, the wire rod is exposed to an atmospheric temperature of 500°C or higher and 600°C or lower. The core 10 is obtained by performing the final wire drawing on the wire rod. The degree of processing in the final wire drawing is 40% or higher. The core 10 is corrected to be straight and is processed to be tapered. The guide wire 2 is obtained after the coil 12 is wound around the core 10, which is further covered with the cover 8. The core 10 shows a tensile strength of 2,400 MPa or higher and a twisting value of 28 times or more. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

本発明は、血管、消化管、気管のような体腔に挿入されるカテーテル等を案内する医療用ガイドワイヤに関する。詳細には、本発明は、このガイドワイヤの芯の改良に関する。   The present invention relates to a medical guide wire for guiding a catheter or the like inserted into a body cavity such as a blood vessel, a digestive tract, or a trachea. Specifically, the present invention relates to an improvement in the core of this guide wire.

カテーテルが用いられた検査及び治療では、血管にガイドワイヤが挿入される。このガイドワイヤに沿ってカテーテルが血管に挿入される。カテーテルはガイドワイヤに案内されつつ、血管内を進む。カテーテルの先端が所定位置に達した後、ガイドワイヤが血管から抜かれる。このカテーテルを通じて、造影剤等が投与される。ガイドワイヤの一例が、特開２００３−３４２６９６公報に開示されている。   In examination and treatment using a catheter, a guide wire is inserted into a blood vessel. A catheter is inserted into the blood vessel along this guide wire. The catheter advances through the blood vessel while being guided by the guide wire. After the tip of the catheter reaches a predetermined position, the guide wire is withdrawn from the blood vessel. A contrast medium or the like is administered through this catheter. An example of a guide wire is disclosed in Japanese Patent Laid-Open No. 2003-342696.

ガイドワイヤは、芯とこの芯を被覆するカバーとからなる。ガイドワイヤは人体に用いられるものなので、芯には耐食性が必要である。芯には、耐食性に優れたオーステナイト系ステンレス鋼が好んで用いられている。   The guide wire includes a core and a cover that covers the core. Since the guide wire is used for the human body, the core must have corrosion resistance. For the core, austenitic stainless steel having excellent corrosion resistance is preferably used.

芯は、線材に複数回の伸線が施されることで得られる。これらの伸線により、線材は徐々に細径化し、かつ長尺化する。伸線では、加工硬化が生じる。伸線後の芯の組織には、加工歪みが存在する。   The core is obtained by drawing the wire several times. By these wire drawing, the wire is gradually reduced in diameter and lengthened. In wire drawing, work hardening occurs. There is a processing strain in the core structure after drawing.

伸線後の芯は、湾曲している。この芯に、真直矯正が施される。典型的な真直矯正は、捻回加工である。捻回加工では、芯に引張り荷重が付加されつつ、芯が捻られる。この捻回加工により、芯の真直性が高められる。真直性に優れた芯により、真直性に優れたガイドワイヤが得られる。真直性に優れたガイドワイヤは、血管への挿入時の操作性に優れる。真直性に優れたガイドワイヤにより、カテーテルが円滑に案内される。真直矯正後の芯の組織には、加工歪みが存在する。   The core after drawing is curved. Straightness correction is applied to this core. A typical straightening is a twisting process. In the twisting process, the core is twisted while a tensile load is applied to the core. This twisting process improves the straightness of the core. A guide wire excellent in straightness can be obtained by a core excellent in straightness. A guide wire excellent in straightness is excellent in operability when inserted into a blood vessel. The catheter is smoothly guided by the guide wire having excellent straightness. Processing distortion exists in the core structure after straightening.

真直矯正後の芯は、焼鈍に供される。焼鈍により、伸線及び真直矯正で生じた歪みが除去される。   The core after straightening is subjected to annealing. By annealing, distortion caused by wire drawing and straightening is removed.

血管は曲がっているので、この血管に挿入されたガイドワイヤは曲げられる。この曲げにより芯に塑性変形が生じると、その後の検査や治療に支障を来す。芯には、曲げに対する復元性が要求される。   Since the blood vessel is bent, the guide wire inserted into the blood vessel is bent. If plastic deformation occurs in the core due to this bending, it will hinder subsequent examination and treatment. The core is required to have bendability.

ガイドワイヤが血管に挿入された状態で、医師は、このガイドワイヤの体外に位置する部位を操作する。この操作において、医師がガイドワイヤを回転させる。この回転のトルクは、ガイドワイヤの先端に伝達される。芯には、トルク伝達性が要求される。
特開２００３−３４２６９６公報 With the guide wire inserted into the blood vessel, the doctor operates a portion of the guide wire located outside the body. In this operation, the doctor rotates the guide wire. This rotational torque is transmitted to the tip of the guide wire. The core is required to have torque transmission.
JP 2003-342696 A

復元性及びトルク伝達性は、芯の強度と相関する。伸線における加工度が高い場合、加工硬化により強度に優れた芯が得られる。しかし、加工度が高い場合、芯の延性が不足する。延性に劣る芯は、真直矯正に耐えられない。同様の問題は、カテーテルによる検査及び治療以外の用途に用いられるガイドワイヤにも生じている。   Restorability and torque transmission correlate with the strength of the core. When the degree of processing in wire drawing is high, a core excellent in strength can be obtained by work hardening. However, when the degree of processing is high, the ductility of the core is insufficient. A core with poor ductility cannot withstand straightening. Similar problems occur with guidewires used for applications other than catheter inspection and treatment.

本発明の目的は、真直性、復元性及びトルク伝達性に優れた芯及びこの芯を用いた医療用ガイドワイヤの提供にある。   An object of the present invention is to provide a core excellent in straightness, restoration, and torque transmission and a medical guide wire using the core.

本発明に係るガイドワイヤ用芯の製造方法は、
（１）オーステナイト系ステンレス鋼からなる線材に、伸線を施す工程、
（２）この線材を低温焼鈍に供する工程
及び
（３）この線材に最終伸線を施す工程
を含む。 A method for manufacturing a guidewire core according to the present invention includes:
(1) A step of drawing a wire made of austenitic stainless steel,
(2) including a step of subjecting the wire to low-temperature annealing, and (3) a step of subjecting the wire to final drawing.

好ましくは、低温焼鈍（２）において、線材は、５００℃以上６００℃以下の雰囲気温度に曝される。好ましくは、最終伸線（３）における加工度は、４０％以上である。   Preferably, in the low temperature annealing (2), the wire is exposed to an atmospheric temperature of 500 ° C. or higher and 600 ° C. or lower. Preferably, the degree of processing in the final wire drawing (3) is 40% or more.

本発明に係る医療用ガイドワイヤの製造方法は、
（１）オーステナイト系ステンレス鋼からなる線材に、伸線を施す工程、
（２）この線材を低温焼鈍に供する工程、
（３）この線材に最終伸線を施して芯を得る工程、
（４）この芯に真直矯正を施す工程
及び
（５）この芯をカバーで被覆する工程
を含む。 A method for producing a medical guide wire according to the present invention includes:
(1) A step of drawing a wire made of austenitic stainless steel,
(2) A step of subjecting this wire to low-temperature annealing,
(3) A step of obtaining a core by subjecting this wire to final drawing,
(4) including a step of straightening the core and (5) a step of covering the core with a cover.

本発明に係るガイドワイヤ用芯は、２４００ＭＰａ以上の引張強さと、２８回以上の捻回値とを有する。   The core for a guide wire according to the present invention has a tensile strength of 2400 MPa or more and a twist value of 28 times or more.

本発明に係る製造方法では、最終伸線に先立ち、低温焼鈍がなされる。この低温焼鈍と最終伸線とにより、芯の延性と強度とが両立される。この芯は、捻回加工に耐える。この芯により、真直性に優れたガイドワイヤが得られうる。この芯は、復元性及びトルク伝達性にも優れる。   In the manufacturing method according to the present invention, low-temperature annealing is performed prior to final wire drawing. This low temperature annealing and the final wire drawing make it possible to achieve both ductility and strength of the core. This core is resistant to twisting. With this core, a guide wire having excellent straightness can be obtained. This core is also excellent in resilience and torque transmission.

以下、適宜図面が参照されつつ、好ましい実施形態に基づいて本発明が詳細に説明される。   Hereinafter, the present invention will be described in detail based on preferred embodiments with appropriate reference to the drawings.

図１は、本発明の一実施形態に係るガイドワイヤ２が示された断面図である。図１において、左端が先端４であり、右端が後端６である。このガイドワイヤ２は、カバー８、芯１０、コイル１２及び固着材１４を備えている。このガイドワイヤ２の全長は、典型的には１５００ｍｍから２３００ｍｍである。このガイドワイヤ２の線径（太さ）は、典型的には０．３０ｍｍから０．６０ｍｍである。   FIG. 1 is a cross-sectional view showing a guide wire 2 according to an embodiment of the present invention. In FIG. 1, the left end is the front end 4, and the right end is the rear end 6. The guide wire 2 includes a cover 8, a core 10, a coil 12, and a fixing material 14. The total length of the guide wire 2 is typically 1500 mm to 2300 mm. The diameter (thickness) of the guide wire 2 is typically 0.30 mm to 0.60 mm.

カバー８は、芯１０を覆っている。カバー８は、合成樹脂からなる。典型的な合成樹脂は、テフロン（登録商標）樹脂である。カバーにより、血管へガイドワイヤが挿入されるときの円滑性が達成される。   The cover 8 covers the core 10. The cover 8 is made of a synthetic resin. A typical synthetic resin is Teflon (registered trademark) resin. The cover achieves smoothness when the guide wire is inserted into the blood vessel.

芯１０は、主部１６とテーパー部１８とを備えてる。主部１６における線径は、実質的に一定である。主部における線径は、典型的には０．２５ｍｍから０．５０ｍｍである。テーパー部１８は、先端４に向かって縮径している。芯１０は、オーステナイト系ステンレス鋼からなる。   The core 10 includes a main portion 16 and a tapered portion 18. The wire diameter in the main portion 16 is substantially constant. The wire diameter in the main part is typically 0.25 mm to 0.50 mm. The tapered portion 18 is reduced in diameter toward the distal end 4. The core 10 is made of austenitic stainless steel.

コイル１２は、テーパー部１８に巻かれている。コイル１２は、テーパー部１８の柔軟性を損なうことなく、テーパー部１８を補強する。固着材１４は、芯１０に固定されている。   The coil 12 is wound around the tapered portion 18. The coil 12 reinforces the tapered portion 18 without impairing the flexibility of the tapered portion 18. The fixing material 14 is fixed to the core 10.

図２は、図１のガイドワイヤ２の製造方法の一例が示されたフロー図である。この製造方法では、まず線材が準備される（ＳＴＥＰ１）。この線材は、１回又は複数回の伸線によって得られる。   FIG. 2 is a flowchart showing an example of a method for manufacturing the guide wire 2 of FIG. In this manufacturing method, first, a wire is prepared (STEP 1). This wire is obtained by one or more wire drawing.

この線材に、溶体化処理がなされる（ＳＴＥＰ２）。溶体化処理では、線材が加熱される。加熱により、炭素及び合金元素が固溶状態になる。加熱温度は、例えば１０５０℃である。その後、線材は急冷される。この溶体化処理により、炭化物等の析出が見られないオーステナイト組織が得られる。この組織は、加工性に優れる。   This wire is subjected to a solution treatment (STEP 2). In the solution treatment, the wire is heated. By heating, carbon and alloy elements are in a solid solution state. The heating temperature is, for example, 1050 ° C. Thereafter, the wire is rapidly cooled. By this solution treatment, an austenite structure in which precipitation of carbides and the like is not observed is obtained. This structure is excellent in processability.

この線材に、伸線が施される（ＳＴＥＰ３）。伸線により、線材が細径化し、かつ長尺化する。この伸線は、冷間塑性加工である。伸線には、既知の伸線機が用いられうる。伸線では、加工硬化が生じる。伸線後の線材の組織には、加工歪みが存在する。   The wire is drawn (STEP 3). Wire drawing reduces the diameter and lengthens the wire. This wire drawing is cold plastic working. A known wire drawing machine can be used for the wire drawing. In wire drawing, work hardening occurs. Processing distortion exists in the structure of the wire after drawing.

この線材に、低温焼鈍が施される（ＳＴＥＰ４）。低温焼鈍には、インライン炉が好適に用いられる。このインライン炉に線材が通されて、この線材が加熱される。その後に線材は、空気中で冷却される。   This wire is subjected to low temperature annealing (STEP 4). An in-line furnace is suitably used for low-temperature annealing. The wire is passed through the in-line furnace, and the wire is heated. Thereafter, the wire is cooled in air.

この線材に、最終伸線が施される（ＳＴＥＰ５）。最終伸線により、線材がさらに細径化し、かつ長尺化して、芯１０が得られる。この最終伸線は、冷間塑性加工である。最終伸線には、既知の伸線機が用いられうる。好ましくは、伸線機はダイヤモンドダイスを備える。伸線は、通常は湿式でなされる。最終伸線では、加工硬化が生じる。この加工硬化に起因して、芯１０は優れた強度を有する。   The wire is subjected to final drawing (STEP 5). By the final wire drawing, the wire is further reduced in diameter and lengthened, and the core 10 is obtained. This final wire drawing is cold plastic working. A known wire drawing machine can be used for the final wire drawing. Preferably, the wire drawing machine comprises a diamond die. Drawing is usually performed by a wet method. In the final wire drawing, work hardening occurs. Due to this work hardening, the core 10 has excellent strength.

この芯１０に真直矯正が施される（ＳＴＥＰ６）。典型的な真直矯正は、捻回加工である。捻回加工では、芯１０に引張り荷重が付加されつつ、芯１０が捻られる。この捻回加工により、芯１０の真直性が高められる。真直性に優れた芯１０により、真直性に優れたガイドワイヤ２が得られる。捻回加工に代えて、芯１０に他の真直矯正がなされてもよい。他の真直矯正としては、ローラ方式加工及びロータリー方式加工が例示される。   Straightness correction is performed on the core 10 (STEP 6). A typical straightening is a twisting process. In the twisting process, the core 10 is twisted while a tensile load is applied to the core 10. This twisting process improves the straightness of the core 10. The guide wire 2 excellent in straightness can be obtained by the core 10 excellent in straightness. Instead of the twisting process, other straightness correction may be performed on the core 10. Examples of other straightness corrections include roller processing and rotary processing.

この芯１０が、所定長さに切断される（ＳＴＥＰ７）。さらにこの芯１０に、テーパー加工が施される（ＳＴＥＰ８）。テーパー加工では、芯１０の先端の近傍が研削される。典型的には、センターレス研削機によって研削がなされる。研削により、芯１０にテーパー部１８が形成される。このテーパー部１８に、コイル１２が巻かれる（ＳＴＥＰ９）。さらに、芯１０、コイル１２及び固着材１４が、既知の方法にて合成樹脂で被覆される（ＳＴＥＰ１０）。被覆により、カバー８が形成される。   The core 10 is cut into a predetermined length (STEP 7). Further, the core 10 is subjected to taper processing (STEP 8). In the taper processing, the vicinity of the tip of the core 10 is ground. Typically, grinding is performed by a centerless grinder. A tapered portion 18 is formed on the core 10 by grinding. The coil 12 is wound around the tapered portion 18 (STEP 9). Further, the core 10, the coil 12, and the fixing material 14 are coated with a synthetic resin by a known method (STEP 10). The cover 8 is formed by the covering.

この製造方法では、最終伸線（ＳＴＥＰ５）に先立ち、低温焼鈍（ＳＴＥＰ４）がなされる。通常の塑性加工では、加工硬化が延性の低下を招く。本発明に係る製造方法では、低温焼鈍がなされるので、最終伸線により、強度が高められるばかりか、意外にも延性が飛躍的に向上する。塑性加工によって延性が向上する理由は詳細には不明であるが、低温焼鈍と最終伸線との組み合わせにより、金属組織に何らかの変化が生じるためと思われる。この低温焼鈍と最終伸線との組み合わせにより、芯１０の延性と強度とが両立される。この芯１０は、高度の真直矯正に耐えうる。この芯１０により、真直性に優れたガイドワイヤ２が得られうる。この芯１０は、復元性及びトルク伝達性にも優れる。   In this manufacturing method, low temperature annealing (STEP 4) is performed prior to final wire drawing (STEP 5). In normal plastic working, work hardening causes a decrease in ductility. In the manufacturing method according to the present invention, low-temperature annealing is performed, so that not only the strength is increased by the final wire drawing, but also the ductility is unexpectedly improved dramatically. The reason why the ductility is improved by plastic working is unknown in detail, but it seems that some change occurs in the metal structure due to the combination of low temperature annealing and final wire drawing. The combination of the low temperature annealing and the final wire drawing achieves both ductility and strength of the core 10. The core 10 can withstand a high degree of straightening. With the core 10, the guide wire 2 excellent in straightness can be obtained. The core 10 is also excellent in restoration property and torque transmission property.

低温焼鈍（ＳＴＥＰ４）における雰囲気温度は、５００℃以上６００℃以下が好ましい。雰囲気温度が５００℃以上である焼鈍とその後の最終伸線とにより、芯１０に十分な延性が付与される。この観点から、雰囲気温度は５２５℃以上がより好ましい。雰囲気温度が６００℃以下である焼鈍により、線材の軟化が抑制され、強度に優れた芯１０が得られる。この観点から、雰囲気温度は５７５℃以下がより好ましい。   The ambient temperature in the low temperature annealing (STEP 4) is preferably 500 ° C. or more and 600 ° C. or less. Sufficient ductility is imparted to the core 10 by annealing at an atmospheric temperature of 500 ° C. or higher and subsequent final wire drawing. In this respect, the atmospheric temperature is more preferably 525 ° C. or higher. By annealing at an atmospheric temperature of 600 ° C. or lower, the softening of the wire is suppressed and the core 10 having excellent strength is obtained. In this respect, the ambient temperature is more preferably 575 ° C. or lower.

低温焼鈍（ＳＴＥＰ４）において線材が上記雰囲気温度に曝される時間は、芯１０の所望の特性値が得られるように、適宜調整される。好ましい時間は、２０秒以上である。時間が２０秒以上である低温焼鈍とその後の最終伸線とにより、芯１０に十分な延性が付与される。この観点から、時間は３０秒以上がより好ましい。時間が過大であると生産性が阻害されるので、時間は３０分以下が好ましく、６０秒以下がより好ましい。時間の調整は、インライン炉の長さの調整及びこのインライン炉を進行する線材の速度の調整によって達成されうる。   The time during which the wire is exposed to the ambient temperature in the low temperature annealing (STEP 4) is appropriately adjusted so that a desired characteristic value of the core 10 can be obtained. A preferred time is 20 seconds or more. Sufficient ductility is imparted to the core 10 by low-temperature annealing with a time of 20 seconds or longer and subsequent final wire drawing. In this respect, the time is more preferably 30 seconds or longer. If the time is excessive, productivity is hindered, so the time is preferably 30 minutes or less, more preferably 60 seconds or less. Adjustment of the time can be achieved by adjusting the length of the in-line furnace and adjusting the speed of the wire traveling through the in-line furnace.

最終伸線（ＳＴＥＰ５）における加工度は、４０％以上が好ましい。加工度が４０％以上である最終伸線により、十分な加工硬化が生じ、強度に優れた芯１０が得られる。この観点から、加工度は６０％以上がより好ましい。芯１０の延性の観点から、加工度は８０％以下が好ましく、７２％以下が特に好ましい。加工度Ｒは、下記の数式によって算出される。
R = (1 - (D1 / D0) * 2) * 100
この数式において、Ｄ０は最終伸線前の線径を表し、Ｄ１は最終伸線後の線径を表す。 The degree of processing in the final wire drawing (STEP 5) is preferably 40% or more. With the final wire drawing having a workability of 40% or more, sufficient work hardening occurs and the core 10 having excellent strength is obtained. In this respect, the processing degree is more preferably 60% or more. From the viewpoint of ductility of the core 10, the degree of processing is preferably 80% or less, and particularly preferably 72% or less. The processing degree R is calculated by the following mathematical formula.
R = (1-(D1 / D0) * 2) * 100
In this equation, D0 represents the wire diameter before the final wire drawing, and D1 represents the wire diameter after the final wire drawing.

最終伸線（ＳＴＥＰ５）の後であって、真直矯正（ＳＴＥＰ６）の前の芯１０の引張強さは、２４００ＭＰａ以上が好ましい。この芯１０により、復元性及びトルク伝達性に優れたガイドワイヤ２が得られる。この観点から、引張強さは２５００ＭＰａが好ましい。復元性及びトルク伝達性の観点からは、引張強さは大きいほど好ましい。引張強さが過大である芯１０は延性に劣るので、引張強さは３０００ＭＰａ以下が好ましい。引張強さは、「ＪＩＳ Ｚ ２２４１」の規定に準拠して測定される。   The tensile strength of the core 10 after the final wire drawing (STEP 5) and before straightening (STEP 6) is preferably 2400 MPa or more. With this core 10, a guide wire 2 having excellent restoring properties and torque transmission properties can be obtained. In this respect, the tensile strength is preferably 2500 MPa. From the viewpoints of restoring properties and torque transmission properties, the higher the tensile strength, the better. Since the core 10 having an excessive tensile strength is inferior in ductility, the tensile strength is preferably 3000 MPa or less. The tensile strength is measured in accordance with the provisions of “JIS Z 2241”.

最終伸線（ＳＴＥＰ５）の後であって、真直矯正（ＳＴＥＰ６）の前の芯１０の捻回値は、２８回以上が好ましい。この芯１０は、強度の真直矯正に耐えうる。この観点から、捻回値は３６回以上がより好ましい。真直矯正に耐えうるとの観点からは、捻回値は大きいほど好ましい。   The twist value of the core 10 after the final wire drawing (STEP 5) and before straightening (STEP 6) is preferably 28 times or more. The core 10 can withstand straightening of strength. In this respect, the twist value is more preferably 36 times or more. From the standpoint of being able to withstand straightening, a larger twist value is preferable.

捻回値は、「ＪＩＳ Ｇ ３５２２」の「ねじり試験」の規定に準拠して測定される。この試験では、芯１０の両端がつかまれる。つかみ間隔は、線径の１００倍である。たわまない程度に芯１０が緊張した状態で、つかみの一方が同一方向に回転させられる。芯１０が破断したときの回転数が、捻回値である。   The twist value is measured in accordance with the provisions of the “twist test” of “JIS G 3522”. In this test, both ends of the core 10 are grasped. The gripping interval is 100 times the wire diameter. One of the grips is rotated in the same direction in a state where the lead 10 is tensioned to such an extent that it does not bend. The rotation speed when the core 10 is broken is a twist value.

本発明に係る製造方法では、最終伸線（ＳＴＥＰ５）の後の焼鈍は行われないことが好ましい。この焼鈍が行われないことにより、引張強さの大きな芯１０が得られる。   In the manufacturing method according to the present invention, it is preferable that annealing after the final wire drawing (STEP 5) is not performed. By not performing the annealing, the core 10 having a large tensile strength is obtained.

本発明に係る芯１０に適した鋼種としては、ＳＵＳ２０１、ＳＵＳ２０１、ＳＵＳ３０１、ＳＵＳ３０２、ＳＵＳ３０４、ＳＵＳ３０５、ＳＵＳ３０９、ＳＵＳ３１０、ＳＵＳ３１６、ＳＵＳ３１７、ＳＵＳ３２１、ＳＵＳ３４７及びＳＵＳＸＭ１５が例示される。特に、汎用性に優れたＳＵＳ３０４が好適に用いられうる。   Examples of steel types suitable for the core 10 according to the present invention include SUS201, SUS201, SUS301, SUS302, SUS304, SUS305, SUS309, SUS310, SUS316, SUS317, SUS321, SUS347, and SUSXM15. In particular, SUS304 having excellent versatility can be suitably used.

以下、実施例によって本発明の効果が明らかにされるが、この実施例の記載に基づいて本発明が限定的に解釈されるべきではない。   Hereinafter, the effects of the present invention will be clarified by examples. However, the present invention should not be construed in a limited manner based on the description of the examples.

［実施例１］
鋼種がＳＵＳ３０４である線材に伸線を施し、線径を２．０ｍｍとした。この線材に溶体化処理を行った。この溶体化処理において、線材は１０５０℃の温度に保持された。この線材に再度の伸線を行い、線径を０．５２ｍｍとした。この線材に、インライン炉による低温焼鈍を施した。インライン炉の雰囲気温度は、５００℃であった。線材は、３６秒間、この雰囲気に曝された。この線材に最終伸線を施し、線径が０．３４ｍｍであるガイドワイヤ用の芯を得た。 [Example 1]
A wire rod having a steel type of SUS304 was drawn to a wire diameter of 2.0 mm. The wire was subjected to a solution treatment. In this solution treatment, the wire was kept at a temperature of 1050 ° C. This wire was again drawn to a wire diameter of 0.52 mm. This wire was subjected to low temperature annealing in an in-line furnace. The atmospheric temperature of the in-line furnace was 500 ° C. The wire was exposed to this atmosphere for 36 seconds. This wire was subjected to final drawing to obtain a guide wire core having a wire diameter of 0.34 mm.

［実施例２から７］
インライン炉の雰囲気温度を下記の表１に示される通りとした他は実施例１と同様にして、芯を得た。 [Examples 2 to 7]
A core was obtained in the same manner as in Example 1 except that the ambient temperature of the in-line furnace was changed as shown in Table 1 below.

［比較例１］
線材に低温焼鈍を施さなかった他は実施例１と同様にして、芯を得た。 [Comparative Example 1]
A core was obtained in the same manner as in Example 1 except that the wire was not annealed at low temperature.

［トルク伝達性］
長さが２ｍの芯の一端を回転させ、他端へのトルク伝達性を官能評価した。下記基準に従って、格付けを行った。この結果が、下記の表１に示されている。
Ａ：極めて良好
Ｂ：良好
Ｃ：やや不良 [Torque transmission]
One end of a core having a length of 2 m was rotated, and sensory evaluation of torque transmission to the other end was performed. Rating was performed according to the following criteria. The results are shown in Table 1 below.
A: Extremely good B: Good C: Somewhat bad

［加工容易性］
長さが２ｍの芯に捻回加工を施し、加工容易性を評価した。下記基準に従って、格付けを行った。この結果が、下記の表１に示されている。
Ａ：極めて容易
Ｂ：容易
Ｃ：やや困難
Ｄ：困難 [Ease of processing]
Twist processing was performed on a core having a length of 2 m, and processing ease was evaluated. Rating was performed according to the following criteria. The results are shown in Table 1 below.
A: Extremely easy B: Easy C: Somewhat difficult D: Difficult

Figure 2009172229
Figure 2009172229

表１に示されるように、各実施例の製造方法で得られた芯は、比較例の製造方法で得られた芯に比べて評価が高い。この評価結果から、本発明の優位性は明らかである。   As shown in Table 1, the core obtained by the manufacturing method of each example has a higher evaluation than the core obtained by the manufacturing method of the comparative example. From this evaluation result, the superiority of the present invention is clear.

本発明に係るガイドワイヤは、カテーテルが用いられた検査及び治療のみならず、種々の医療用途に用いられうる。   The guide wire according to the present invention can be used not only for examination and treatment using a catheter but also for various medical applications.

図１は、本発明の一実施形態に係るガイドワイヤが示された断面図である。FIG. 1 is a cross-sectional view illustrating a guide wire according to an embodiment of the present invention. 図２は、図１のガイドワイヤの製造方法の一例が示されたフロー図である。FIG. 2 is a flowchart showing an example of a method for manufacturing the guide wire of FIG.

符号の説明Explanation of symbols

２・・・ガイドワイヤ
８・・・カバー
１０・・・芯
１２・・・コイル
１４・・・固着材
１６・・・主部
１８・・・テーパー部 2 ... Guide wire 8 ... Cover 10 ... Core 12 ... Coil 14 ... Fixing material 16 ... Main part 18 ... Taper part

Claims (5)

オーステナイト系ステンレス鋼からなる線材に、伸線を施す工程、
この線材を低温焼鈍に供する工程
及び
この線材に最終伸線を施す工程
を含むガイドワイヤ用芯の製造方法。 A step of drawing a wire made of austenitic stainless steel,
A method for manufacturing a guide wire core, comprising a step of subjecting the wire to low-temperature annealing and a step of subjecting the wire to final drawing. 上記低温焼鈍において、線材が５００℃以上６００℃以下の雰囲気温度に曝される請求項１に記載の製造方法。   The manufacturing method according to claim 1, wherein the wire is exposed to an atmospheric temperature of 500 ° C. or more and 600 ° C. or less in the low temperature annealing. 上記最終伸線における加工度が４０％以上である請求項１又は２に記載の製造方法。   The manufacturing method according to claim 1 or 2, wherein a degree of processing in the final wire drawing is 40% or more. オーステナイト系ステンレス鋼からなる線材に、伸線を施す工程、
この線材を低温焼鈍に供する工程、
この線材に最終伸線を施して芯を得る工程、
この芯に真直矯正を施す工程
及び
この芯をカバーで被覆する工程
を含む医療用ガイドワイヤの製造方法。 A step of drawing a wire made of austenitic stainless steel,
A process of subjecting this wire to low-temperature annealing,
A process of obtaining a core by subjecting this wire to final drawing,
A method for producing a medical guide wire, comprising a step of straightening the core and a step of covering the core with a cover. 引張強さが２４００ＭＰａ以上であり、ＪＩＳ−Ｇ−３５２２のねじり試験の規定に準拠して線径の１００倍のつかみ間隔にて測定された捻回値が２８回以上であるガイドワイヤ用芯。   A guide wire core having a tensile strength of 2400 MPa or more and a twist value of 28 times or more measured at a gripping interval 100 times the wire diameter in accordance with the torsion test of JIS-G-3522.
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