JP2006271677A - Medical guidewire - Google Patents

Medical guidewire Download PDF

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JP2006271677A
JP2006271677A JP2005094940A JP2005094940A JP2006271677A JP 2006271677 A JP2006271677 A JP 2006271677A JP 2005094940 A JP2005094940 A JP 2005094940A JP 2005094940 A JP2005094940 A JP 2005094940A JP 2006271677 A JP2006271677 A JP 2006271677A
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distal end
end side
proximal end
side member
wire
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Isato Nishimura
勇人 西村
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Tokusen Kogyo Co Ltd
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Tokusen Kogyo Co Ltd
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Priority to JP2005094940A priority Critical patent/JP2006271677A/en
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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
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical guide wire which keeps the distal end portion excellent in conformability, and the proximal end portion following to the distal end portion excellent in torque transmitting property, and shows a reduced change in outer diameter near the joint including a joint for connecting the distal end portion and the proximal end portion. <P>SOLUTION: The distal end side member 12 of the medical purpose guide wire has a part worked in a tapered shape so as to taper toward the distal end side end face 12a, the long hole 13 into which the distal end side member 11 can be inserted is provided in the axial line direction of the proximal end member 12 in the distal end side end face 12a of the proximal end member 12, the part of the distal end side member 11 including the distal end side end face 11a is inserted into the long hole 13, the gap 15 into which a brazing filler metal 14 can intrude is formed between the distal end side member 11 and the distal end side end face 12a of the proximal end side member 12, the coiled wire material 16 having substantially the same outer diameter of the distal end side end face 12a of the proximal end side member 12 is secured so as to cover a part of the outer periphery of the distal end side member 11, the distal end member 11 and the proximal end side member 12 is connected by the brazing filler metal 14 intruding from the gap 15. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

本発明は、治療や検査を必要とする血管、消化管、気管、その他体腔（以下「要治療管」という）内に導入される細い管状のカテーテルを案内するのに用いられる医療用ガイドワイヤ（以下「ガイドワイヤ」ともいう）に関し、特に、先端部と基端部とを性能の異なる金属線材で構成した医療用ガイドワイヤに関する。   The present invention relates to a medical guide wire used for guiding a thin tubular catheter introduced into a blood vessel, a digestive tract, a trachea, or other body cavity (hereinafter referred to as “treatment tube”) requiring treatment or examination. Hereinafter, the present invention also relates to a medical guide wire having a distal end portion and a proximal end portion made of metal wires having different performances.

治療や検査を必要とする人体の要治療管内にカテーテルを導入する際には、カテーテルの導入に先だって医療用ガイドワイヤを所要部位まで導入している。医療用ガイドワイヤとして重要な性能は、手元操作によって要治療管内にスムーズに挿入できて、カテーテルを目的部位に正確に案内導入できることである。このため、医療用ガイドワイヤには、その先端部が複雑に蛇行する要治療管内に対応し、且つ要治療管の内壁を傷つけることなく挿入し得る形態順応性を備えるとともに、先端部に続く基端部が手元での微妙な操作量でも先端部に正確にトルクを伝達するトルク伝達性を備えていることが要求される。   When a catheter is introduced into a treatment tube of a human body that requires treatment or examination, a medical guide wire is introduced to a required site prior to introduction of the catheter. An important performance as a medical guide wire is that it can be smoothly inserted into a treatment-needed tube by hand operation, and the catheter can be guided and introduced accurately to the target site. For this reason, the medical guide wire has a form conformability that can be inserted into a treatment-needed tube whose tip portion is meandering in a complicated manner without damaging the inner wall of the treatment-needed tube. The end portion is required to have a torque transmission property that accurately transmits torque to the tip portion even with a slight operation amount at hand.

医療用ガイドワイヤの構造は用途に応じて各種のものがあるが、例えば、図４に示すように、所定長さの芯材３０の周囲を合成樹脂３１で被覆したものが知られている。芯材３０には、ガイドワイヤとしての挿入部分に柔軟性を付与するため、先端部３２は先端に向かって次第に断面積が減少する先細状に形成されている。   There are various types of medical guidewires depending on the application. For example, as shown in FIG. 4, a structure in which a core material 30 having a predetermined length is covered with a synthetic resin 31 is known. In the core member 30, in order to give flexibility to an insertion portion as a guide wire, the distal end portion 32 is formed in a tapered shape whose cross-sectional area gradually decreases toward the distal end.

上記芯材には、ステンレス鋼線またはピアノ線が従来から用いられている。しかし、この種の芯材を用いたガイドワイヤは、先端部分を先細形状にしても柔軟性に欠け、複雑に蛇行する分岐血管等に対しては適用し難いという問題があった。   Conventionally, a stainless steel wire or a piano wire has been used as the core material. However, the guide wire using this type of core material has a problem that it is difficult to apply to a branching blood vessel or the like that meanders in a complicated manner even if the tip portion is tapered.

そこで、芯材として、超弾性合金であるＮｉ−Ｔｉ系合金などを用いたガイドワイヤが提案されている。超弾性合金からなる芯材は、柔軟でかなりの範囲までの変形（約８％の歪み）に対しても復元性を有するため、手元操作中、折れ曲がりが生じ難く、且つ曲がりぐせがつきにくいなどの利点を有しているが、芯材が超弾性の単一材料からなるため、全体として形態順応性を充分に備えているが、伝達可能トルク及びねじり剛性がステンレス鋼線またはピアノ線に比較して劣るため、基端部のトルク伝達性に難点がある。   Therefore, a guide wire using a Ni—Ti alloy, which is a superelastic alloy, as a core material has been proposed. The core material made of superelastic alloy is flexible and has resilience to deformation up to a considerable range (approximately 8% strain). Therefore, it is difficult to bend during hand operation and difficult to bend. Although the core material is made of a single superelastic material, it has sufficient shape adaptability as a whole, but its transmittable torque and torsional rigidity are comparable to stainless steel wire or piano wire. Therefore, there is a difficulty in torque transmission at the base end.

このように、ガイドワイヤとして必要とされる形態順応性とトルク伝達性を一種類の材料で満たすことは困難である。そこで、図５に示すように、特許文献１には、ガイドワイヤの先端側部材と基端側部材を異なる材料で構成し、形態順応性の良好な金属線材から形成された先端側部材とトルク伝達性に優れた金属線材から形成された基端側部材とを接合して１本のガイドワイヤとすることが提案されている。   Thus, it is difficult to satisfy the form adaptability and torque transmission required for the guide wire with one kind of material. Therefore, as shown in FIG. 5, Patent Document 1 discloses that the distal end side member and the proximal end side member of the guide wire are made of different materials, and the distal end side member formed from a metal wire having good form adaptability and torque. It has been proposed to join a proximal end member formed of a metal wire having excellent transmission properties to form one guide wire.

図５に示す従来のガイドワイヤ１は、材料の異なる第１ワイヤ２（先端側部材）と第２ワイヤ３（基端側部材）とからなり、第１ワイヤ２の細径部４に形成された第一切欠部５と第２ワイヤ３の細径部６に形成された第２切欠部７とが互いに重なり合った状態に配置され、この重なり合った部分の外周を覆うように管状接続部材８が設けられ、第１ワイヤ２の細径部４および第２ワイヤ３の細径部６の外周面と管状接続部材８の内周面との間の隙間にはロウ材９が充填されて第１ワイヤ２と第２ワイヤ３が接合されている。
特開２００４−１６３５９号公報 A conventional guide wire 1 shown in FIG. 5 includes a first wire 2 (distal end side member) and a second wire 3 (proximal end side member) made of different materials, and is formed in the small diameter portion 4 of the first wire 2. The second notch portion 5 and the second notch portion 7 formed in the narrow diameter portion 6 of the second wire 3 are arranged so as to overlap each other, and the tubular connecting member 8 covers the outer periphery of the overlapping portion. And a gap between the outer peripheral surface of the small diameter portion 4 of the first wire 2 and the small diameter portion 6 of the second wire 3 and the inner peripheral surface of the tubular connecting member 8 is filled with the brazing material 9. 1 wire 2 and 2nd wire 3 are joined.
JP 2004-16359 A

図５に示すガイドワイヤのように、先端側（挿入側）と基端側（操作側）を異なる部材で構成し、形態順応性の良好な金属線材から形成された先端側部材と、トルク伝達性に優れた金属線材から形成された基端側部材とを接合して１本のガイドワイヤとすると、形態順応性とトルク伝達性を備えたガイドワイヤを得ることは可能である。しかし、このようにガイドワイヤを２種類の部材で接合した構成とする場合、図５に示すガイドワイヤ１では、第１ワイヤ２と第２ワイヤ３が、接合部の外周に配置した管状接続部材８の内周面と第１ワイヤ２および第２ワイヤ３の各外周面との間の隙間に充填されたロウ材９で接合される構成であるため、この接合部の外径がその前後のワイヤ径よりも太くなるため、要治療管の内壁を傷つけることなくスムーズに挿入することが困難になる。   Like the guide wire shown in FIG. 5, the distal end side (insertion side) and the proximal end side (operation side) are configured with different members, and the distal end side member formed from a metal wire having good form adaptability, and torque transmission When a proximal end member formed of a metal wire having excellent properties is joined to form a single guide wire, it is possible to obtain a guide wire having form conformability and torque transmission. However, when the guide wire is configured to be joined by two types of members in this way, in the guide wire 1 shown in FIG. 5, the tubular connection member in which the first wire 2 and the second wire 3 are arranged on the outer periphery of the joined portion. 8 and the outer peripheral surface of each of the first wire 2 and the second wire 3 are joined by a brazing material 9 filled in the gap between the inner peripheral surface of the first wire 2 and the second wire 3. Since it becomes thicker than the wire diameter, it becomes difficult to insert smoothly without damaging the inner wall of the treatment tube.

また、近年の医療技術の急速な進歩に伴って、複雑な分岐血管に対しても適用できるようにするため、医療用ガイドワイヤには、先端部の形態順応性と基端部のトルク伝達性を、より一層向上することが求められている。そして、ガイドワイヤ先端部は、より一層細い血管内に挿入できるようにすることが要望されており、細径血管内にスムーズに挿入できるようにするためには先端部と基端部との接合部の外径変化を一層滑らかにすることが必要で、その接合部の長手方向位置が最先端部に近づけば近づくほど、接合部の外径変化が小さいことが好ましい。   In addition, due to the rapid advancement of medical technology in recent years, the medical guidewire has a conformability at the distal end and a torque transmission at the proximal end so that it can be applied to complex branch vessels. There is a need to further improve the above. The guide wire distal end is required to be able to be inserted into a thinner blood vessel, and the distal end and the proximal end are joined to be smoothly inserted into the small diameter blood vessel. It is necessary to further smooth the outer diameter change of the joint, and it is preferable that the outer diameter change of the joint is smaller as the longitudinal position of the joint approaches the frontmost part.

本発明は従来の技術の有するこのような問題点に鑑みてなされたものであって、その目的は、先端部が形態順応性に優れ、先端部に引き続く基端部がトルク伝達性に優れ、先端部と基端部とを接合する接合部を含む接合部付近の外径変化が小さい医療用ガイドワイヤを提供することにある。   The present invention has been made in view of such problems of the prior art, and its purpose is that the distal end portion is excellent in form adaptability, and the proximal end portion following the distal end portion is excellent in torque transmission, An object of the present invention is to provide a medical guide wire having a small outer diameter change in the vicinity of a joint including a joint that joins a distal end and a base end.

上記目的を達成するために本発明の医療用ガイドワイヤは、形態順応性の良好な金属線材から形成された先端側部材と、トルク伝達性に優れた金属線材から形成された基端側部材とを有し、先端側部材の基端側端面と基端側部材の先端側端面とに介在させた接合材料により両部材を接合してなる医療用ガイドワイヤにおいて、基端側部材は先端側端面に向かって先細となるようにテーパ状に加工された部分を有し、基端側部材の先端側端面には先端側部材を挿入可能な長孔を基端側部材の軸線方向に設け、上記長孔内に基端側端面を含む先端側部材の一部を挿入し、基端側部材の先端側端面との間にロウ材の浸入可能な隙間を介在させて基端側部材の先端側端面の外径と略同じ外径の接続部材を先端側部材の一部の外周を覆うように取り付け、上記隙間から浸入したロウ材により先端側部材と基端側部材とが接合されていることを特徴としている。   In order to achieve the above object, a medical guide wire of the present invention includes a distal end member formed from a metal wire having good form adaptability, and a proximal end member formed from a metal wire excellent in torque transmission. In the medical guide wire formed by joining both members with a joining material interposed between the proximal end face of the distal end member and the distal end face of the proximal end member, the proximal end member is the distal end face A long hole into which the distal end side member can be inserted is provided in the axial direction of the proximal end member on the distal end side end surface of the proximal end side member. Insert a part of the distal end side member including the proximal end surface into the elongated hole, and insert a brazing material intrusion gap between the distal end end surface of the proximal end member and the distal end side of the proximal end member Attach a connection member with the same outer diameter as the outer diameter of the end face so that it covers the outer periphery of part of the tip side member It is characterized in that the front part and the proximal member are joined by brazing material which has entered from the gap.

このように、基端側部材は先端側端面に向かって先細となるようにテーパ状に加工された部分を有し、基端側部材の先端側端面の軸線方向に設けた長孔には基端側端面を含む先端側部材の一部を挿入し、基端側部材の先端側端面の外径と略同じ外径の接続部材により先端側部材の一部の外周を覆うようにしたので、先端部と基端部とを接合する接合部を含む接合部付近の外径変化が小さいので、細い血管内に挿入するに際しても接合部が障害となりにくく、スムーズに挿入することが可能になる。   Thus, the proximal end member has a portion that is tapered so as to taper toward the distal end surface, and a base hole is provided in the long hole provided in the axial direction of the distal end surface of the proximal end member. Since a part of the distal end side member including the end side end face is inserted and the outer periphery of a part of the distal end side member is covered with a connecting member having an outer diameter substantially the same as the outer diameter of the distal end side end face of the proximal end member, Since the change in the outer diameter in the vicinity of the joined portion including the joined portion joining the distal end portion and the proximal end portion is small, the joined portion is less likely to be an obstacle when inserted into a thin blood vessel, and can be smoothly inserted.

さらに、接続部材が基端側部材に引き続く先端側部材の一部の外周を覆っているので、手元での微妙な操作を正確に先端部に伝達することが可能になる。すなわち、先端側部材は形態順応性の良好な金属線材から形成されているので、基端側部材に比べてやや剛性が低い。そのため、基端側部材の操作に対応して先端側部材を要治療管内にスムーズに挿入できないことがある。しかし、接続部材は基端側部材に引き続く先端側部材の一部の外周を覆っているので、基端側部材から先端側部材に至る剛性の変化が滑らかになり、基端部での手元操作を正確に先端部に伝達し、柔軟で形態順応性に優れた先端部を随意に要治療管内に挿入することが可能になる。   Furthermore, since the connection member covers the outer periphery of a part of the distal end side member that continues from the proximal end side member, it is possible to accurately transmit a delicate operation at hand to the distal end portion. That is, since the distal end side member is formed of a metal wire having good form adaptability, the rigidity is slightly lower than that of the proximal end side member. Therefore, the distal end side member may not be smoothly inserted into the treatment-needed tube corresponding to the operation of the proximal end side member. However, since the connecting member covers the outer periphery of a part of the distal end member following the proximal end member, the change in rigidity from the proximal end member to the distal end member becomes smooth, and the proximal operation at the proximal end portion Can be accurately transmitted to the distal end portion, and the distal end portion having flexibility and excellent conformability can be arbitrarily inserted into the treatment-needed tube.

長孔内面および長孔内に挿入される先端側部材外周には、ロウ材の浸入前に予めＮｉメッキが施されていることが好ましい。ロウ材による接合面の密着強度を向上することができるからである。   The inner surface of the long hole and the outer periphery of the tip side member inserted into the long hole are preferably pre-plated with Ni before the brazing material enters. This is because the adhesion strength of the joining surface by the brazing material can be improved.

また、接合材料としてロウ材に代えて接着剤により先端側部材と基端側部材を接合することもできる。すなわち、形態順応性の良好な金属線材から形成された先端側部材と、トルク伝達性に優れた金属線材から形成された基端側部材とを有し、先端側部材の基端側端面と基端側部材の先端側端面とに介在させた接合材料により両部材を接合してなる医療用ガイドワイヤにおいて、基端側部材は先端側端面に向かって先細となるようにテーパ状に加工された部分を有し、基端側部材の先端側端面には先端側部材を挿入可能な長孔を基端側部材の軸線方向に設け、基端側端面を含む先端側部材の一部の外周に接着剤を塗布してその先端側部材を上記長孔内に挿入し、基端側部材の先端側端面に対面する位置を起点として基端側部材の先端側端面の外径と略同じ外径の接続部材を先端側部材の一部の外周を覆うように取り付け、上記接着剤により先端側部材と基端側部材とが接合されていることが好ましい。   Moreover, it can replace with a brazing material as a joining material, and can join a front end side member and a base end side member with an adhesive agent. That is, it has a distal end side member formed from a metal wire having good form adaptability and a proximal end member formed from a metal wire excellent in torque transmission, and includes a proximal end surface and a base surface of the distal end side member. In a medical guide wire in which both members are joined to each other by a joining material interposed between the distal end surface of the end side member, the proximal end member is tapered so as to taper toward the distal end surface. A long hole into which the distal end side member can be inserted is provided in the axial direction of the proximal end member on the distal end side surface of the proximal end member, and is provided on the outer periphery of a part of the distal end side member including the proximal end end surface. Apply the adhesive and insert the distal end side member into the elongated hole. The outer diameter is approximately the same as the outer diameter of the distal end surface of the proximal end member, starting from the position facing the distal end surface of the proximal end member. Attach the connecting member to cover the outer periphery of a part of the tip side member, and It is preferable that the member and the proximal member is joined.

上記と同様に、先端部と基端部とを接合する接合部を含む接合部付近の外径変化が小さいので、細い血管内に挿入するに際しても接合部が障害となりにくく、スムーズに挿入することが可能になり、また、接続部材は基端側部材に引き続く先端側部材の一部の外周を覆っているので、基端側部材から先端側部材に至る剛性の変化が滑らかになり、基端部での手元操作を正確に先端部に伝達し、柔軟で形態順応性に優れた先端部を随意に要治療管内に挿入することが可能になるからである。   Similar to the above, the change in the outer diameter in the vicinity of the joint, including the joint that joins the distal end and the base end, is small. In addition, since the connecting member covers the outer periphery of a part of the distal end side member following the proximal end side member, the change in rigidity from the proximal end member to the distal end side member becomes smooth, and the proximal end This is because it is possible to accurately transmit the hand operation at the head portion to the tip portion, and to arbitrarily insert the tip portion that is flexible and has excellent form adaptability into the treatment-needed tube.

さらに、先端側部材は最先端部に向かって先細となるようにテーパ状に加工されていることが好ましい。細い血管内への挿入が一層スムーズにできるからである。   Furthermore, it is preferable that the tip side member is processed into a taper shape so as to be tapered toward the most distal end portion. This is because insertion into a thin blood vessel can be performed more smoothly.

本発明の医療用ガイドワイヤは上記のように構成されているので、次の効果を奏する。
（１）請求項１および３記載の発明によれば、先端部と基端部とを接合する接合部を含む接合部付近の外径変化が小さいので、細い血管内に挿入するに際しても接合部が障害となりにくく、スムーズに挿入することが可能になるとともに、接続部材は基端側部材に引き続く先端側部材の一部の外周を覆っているので、基端側部材から先端側部材に至る剛性の変化が滑らかになり、基端部での手元操作を正確に先端部に伝達し、柔軟で形態順応性に優れた先端部を随意に要治療管内に挿入することが可能になる。
（２）請求項２記載の発明によれば、ロウ材による接合面の密着強度を向上することができる。
（３）請求項４記載の発明によれば、柔軟で形態順応性に優れた先端部をよりスムーズに要治療管内に挿入することが可能である。 Since the medical guide wire of the present invention is configured as described above, the following effects can be obtained.
(1) According to the first and third aspects of the invention, since the change in the outer diameter in the vicinity of the joint including the joint that joins the distal end and the base end is small, the joint can be inserted into a thin blood vessel. Since the connection member covers the outer periphery of a part of the distal end member following the proximal end member, the rigidity from the proximal end member to the distal end side member can be reduced. Therefore, the hand operation at the proximal end portion is accurately transmitted to the distal end portion, and the distal end portion that is flexible and excellent in form adaptability can be arbitrarily inserted into the treatment requiring tube.
(2) According to the invention described in claim 2, the adhesion strength of the joint surface by the brazing material can be improved.
(3) According to the invention described in claim 4, it is possible to more smoothly insert the distal end portion that is flexible and excellent in form adaptability into the treatment-needed tube.

以下に、本発明の好ましい実施形態について詳細に説明する。   Hereinafter, preferred embodiments of the present invention will be described in detail.

形態順応性の良好な金属線材としては、限定されるものではないが、例えば、Ｎｉ−Ｔｉ系合金、Ｃｕ−Ａｌ−Ｎｉ系合金、Ｃｕ−Ｚｎ−Ａｌ系合金などを挙げることができる。   Examples of the metal wire having good form adaptability include, but are not limited to, a Ni—Ti alloy, a Cu—Al—Ni alloy, a Cu—Zn—Al alloy, and the like.

トルク伝達性に優れた金属線材としては、限定されるものではないが、例えば、ステンレス鋼、ピアノ線などを用いることができる。中でも、高珪素ステンレス鋼を好ましく用いることができる。この高珪素ステンレス鋼の組成を重量％で表した場合、Ｃ＝０．０８％以下、Ｓｉ＝３．０〜５．０％、Ｍｎ＝３．０％以下、Ｎｉ＝４．０〜１２．０％、Ｃｒ＝１２．０〜２４．０％、Ｍｏ＝０．９〜２．０％、Ｃｕ＝０．５〜２．０％で、残部が鉄および不可避的不純物からなるものを用いることができる。この高珪素ステンレス鋼は、引張り強さや衝撃値が高く、強靱性に富んだ材料であり、優れたトル伝達性が要求される基端部の材料として好ましい。この高珪素ステンレス鋼は析出硬化系のステンレス鋼であり、高強靱性を珪素の働きに依存するものであって、充分な強靭性を付与するには３％以上の珪素を含有する必要があるが、炭素の含有は不必要であるばかりでなく含有量が高くなって０．０８％を超えると靭性が低下する。また、珪素が５％を超えても靭性が低下する傾向を示すので避けるべきである。モリブデンはフェライト生成元素であり、銅およびマンガンはオーステナイト生成元素であることが知られており、上記範囲内でモリブデンと銅とマンガンを含有することにより、オーステナイトとフェライトの２相組織が得られ、耐食性が向上する。   Although it does not limit as a metal wire material excellent in torque transmissibility, For example, stainless steel, a piano wire, etc. can be used. Among these, high silicon stainless steel can be preferably used. When the composition of this high silicon stainless steel is expressed by weight%, C = 0.08% or less, Si = 3.0-5.0%, Mn = 3.0% or less, Ni = 4.0-12. Use 0%, Cr = 12.0 to 24.0%, Mo = 0.9 to 2.0%, Cu = 0.5 to 2.0%, the balance being iron and inevitable impurities Can do. This high silicon stainless steel is a material having high tensile strength and impact value and high toughness, and is preferable as a material for a base end portion that requires excellent torability. This high silicon stainless steel is a precipitation hardening type stainless steel, and its high toughness depends on the action of silicon, and in order to give sufficient toughness, it is necessary to contain 3% or more of silicon. However, not only is the content of carbon unnecessary, but if the content increases and exceeds 0.08%, the toughness decreases. Further, even if silicon exceeds 5%, the toughness tends to be lowered and should be avoided. Molybdenum is a ferrite-forming element, and copper and manganese are known to be austenite-generating elements. By containing molybdenum, copper, and manganese within the above range, a two-phase structure of austenite and ferrite is obtained. Corrosion resistance is improved.

接続部材としては、ステンレス鋼、ＴｉまたはＴｉ系合金、アルミニウムもしくはアルミニウム系合金、マグネシウムもしくはマグネシウム系合金、Ｎｉ−Ｔｉ系合金、Ｃｕ系合金、またはＮｉ系合金は、いずれもロウ材との接着性が良好で適度の弾性および引張り強度を備えているので、接続部材を構成する材料として好ましく用いることができる。また、接続部材の形状としては、例えば、パイプ、パイプに多数の孔をあけたもの、メッシュ状パイプ（線材をパイプ状に編んだもの）、コイル状線材（線材をコイル状に巻いたもの）などを用いることができる。   As the connecting member, stainless steel, Ti or Ti alloy, aluminum or aluminum alloy, magnesium or magnesium alloy, Ni-Ti alloy, Cu alloy, or Ni alloy are all adhesive to the brazing material. Therefore, it can be preferably used as a material constituting the connecting member. The shape of the connecting member is, for example, a pipe, a pipe having a large number of holes, a mesh-like pipe (a wire knitted into a pipe), a coiled wire (a wire wound in a coil) Etc. can be used.

先端側部材と基端側部材を接合するロウ材としては、接合対象材料に濡れやすく、接合作業に適した溶融温度範囲を持ち、接合界面の隙間に毛細管力により浸入し、継手として必要な機械的、電気的、化学的性質を有することが好ましい。限定されるものではないが、硬ロウ材としては、アルミニウム合金ロウ、リン銅ロウ、銀ロウ、金ロウなどがあり、軟ロウ材としては、亜鉛、鉛などの単体金属、Ｓｎ−Ｐｂ系合金、Ｃｄ−Ｚｎ系合金、Ｐｂ−Ａｇ系合金、Ｓｎ−Ａｇ系合金などを挙げることができる。中でもステンレス鋼やＮｉとの相溶性に優れた銀ロウが好ましい。銀ロウは流動性が高いので、毛細管現象により僅かな隙間に瞬時に流れ込むことが可能であるという点で、本発明のロウ材として好ましく用いることができる。さらに、医療用途であるということを考慮すると、カドミウムを含まず且つ低融点のものが好ましい。融点が低ければ、加熱時間も短くて済むので、加熱による接合部近傍の金属線材の特性変化をより小さく抑えることができるからである。   As a brazing material that joins the tip side member and the base end side member, it is easy to get wet with the material to be joined, has a melting temperature range suitable for joining work, penetrates into the gap at the joining interface by capillary force, and is a machine necessary as a joint It preferably has electrical, electrical and chemical properties. Although not limited, examples of hard brazing materials include aluminum alloy brazing, phosphor copper brazing, silver brazing, and gold brazing, and soft brazing materials include single metals such as zinc and lead, Sn-Pb alloys. , Cd—Zn alloys, Pb—Ag alloys, Sn—Ag alloys, and the like. Among these, silver solder excellent in compatibility with stainless steel and Ni is preferable. Since silver brazing has high fluidity, it can be preferably used as the brazing material of the present invention in that it can instantaneously flow into a small gap by capillary action. Furthermore, considering that it is a medical use, those having no cadmium and having a low melting point are preferable. This is because if the melting point is low, the heating time can be shortened, so that the change in the characteristics of the metal wire near the joint due to heating can be further suppressed.

鉛を含まない軟ロウ材は融点が非常に低く（約２００〜２８０℃）、溶融接合に際しての接合部近傍の金属線材の特性変化をより小さく抑えることができるという点では好ましい。ところが、ガイドワイヤの全体が合成樹脂（例えば、ポリテトラフルオロエチレン（ＰＴＦＥ））で被覆されることがある。このＰＴＦＥ被膜の被覆は約２５０〜３００℃の温度で行われるため、この被覆時の温度で溶融するような融点の低いロウ材は好ましくない。そこで、少なくとも、ＰＴＦＥ被膜被覆時の加熱温度よりも高い融点を有するロウ材が好ましい。   A soft brazing material containing no lead is preferable in that it has a very low melting point (about 200 to 280 ° C.) and can suppress a change in the properties of the metal wire near the joint during fusion joining. However, the entire guide wire may be covered with a synthetic resin (for example, polytetrafluoroethylene (PTFE)). Since the PTFE coating is performed at a temperature of about 250 to 300 ° C., a brazing material having a low melting point that melts at the coating temperature is not preferable. Therefore, a brazing material having a melting point higher than the heating temperature at the time of coating the PTFE film is preferred.

ロウ接に際しては、接合対象材料と溶融ロウが濡れやすくなるように、接合界面に存在する酸化物のような物質を溶解、除去し、さらに酸化の防止のためにフラックスを使用することが好ましい。ロウ接のための熱源としては、例えば、高周波誘導加熱、抵抗加熱、超音波などを挙げることができるが、極く短時間の加熱によりロウ材を溶融して接合部の隙間に充填することができるという点で、高周波誘導加熱が好ましい。高周波誘導加熱によれば、ピンポイントに電磁波エネルギーを集中させて局部的な加熱ができるので、極く短時間でロウ材を溶融させて接合部の隙間に充填させることができる。その結果、ロウ材充填時の加熱によって接合部近傍の金属線材の特性が変化するのを抑えることができるという効果がある。   At the time of brazing, it is preferable to dissolve and remove a substance such as an oxide present at the joining interface so that the material to be joined and the molten solder are easily wetted, and further use a flux to prevent oxidation. Examples of the heat source for brazing include high-frequency induction heating, resistance heating, and ultrasonic waves. However, the brazing material can be melted and filled in the joints by heating for a very short time. High frequency induction heating is preferable in that it can be performed. According to the high-frequency induction heating, the electromagnetic energy can be concentrated at the pinpoint and the local heating can be performed, so that the brazing material can be melted and filled in the gap of the joint in a very short time. As a result, there is an effect that it is possible to suppress a change in the characteristics of the metal wire near the joint due to heating at the time of filling the brazing material.

先端側部材の直径は、限定されるものではないが、０．１〜０．３４mm程度とし、最先端部に向けて先細となるようなテーパ形状とすることは、先端部の剛性変化を滑らかにして先端部の柔軟性を高める上で好ましい。なお、医療用ガイドワイヤの直径は規格により０.３４mmと定められている。   The diameter of the tip side member is not limited, but it is about 0.1 to 0.34 mm, and the taper shape that tapers toward the most distal part smoothens the rigidity change of the tip part. Thus, it is preferable for increasing the flexibility of the tip. The diameter of the medical guide wire is set to 0.34 mm according to the standard.

限定されるものではないが、ガイドワイヤの全長（先端側部材と基端側部材の合計長さ）は１５００〜１８００mm程度とし、先端側部材の長さは５０〜５００mm程度とすることが、ガイドワイヤの操作性を高める上で好ましい。   Although not limited, the guide wire has a total length (the total length of the distal end side member and the proximal end side member) of about 1500 to 1800 mm, and the length of the distal end side member is about 50 to 500 mm. It is preferable for improving the operability of the wire.

基端側部材の先端側端面の軸線方向に設ける長孔の直径は、限定されるものではないが、挿入される先端側部材の直径よりも僅かに大きくし、具体的には０．０８〜０．３０mm程度とし、長孔に挿入する先端側部材の長さは、１〜１０mm程度が好ましく、この先端側部材の長さよりも僅かに大きくなる程度に長孔の長さを設定するのが好ましい。ロウ材の浸入する隙間を確保するためである。   The diameter of the long hole provided in the axial direction of the distal end side end surface of the proximal end side member is not limited, but is slightly larger than the diameter of the inserted distal end side member, specifically 0.08 to The length of the tip side member inserted into the long hole is preferably about 1 to 10 mm, and the length of the slot is set to be slightly larger than the length of the tip side member. preferable. This is to ensure a clearance for the brazing material to enter.

先端側部材と基端側部材を接合する接着剤としては、フェノール樹脂系、エポキシ樹脂系、ポリウレタン系、クロロプレン系、ニトリルゴム系の接着剤を挙げることができる。これらの中でも、エポキシ樹脂系接着剤とニトリルゴム系接着剤を好ましく用いることができる。ニトリルゴムは、各種ゴムの中で極性が最も大きく、この特性は接着剤としての大きな特徴となり、金属などの極性材料に対する接着力が高い。しかし反面、強力な溶剤を使っているので、塗装面を侵しやすく、プラスチックなどは膨れやひび割れを起こすことがある。エポキシ樹脂系接着剤は揮発性の溶剤を含まないから、硬化後もほとんど収縮せず、接着層の膜厚が大きくても亀裂が入らず、接着力が低下しないという特徴があるので、より好ましい。   Examples of the adhesive that joins the distal end side member and the proximal end side member include phenol resin-based, epoxy resin-based, polyurethane-based, chloroprene-based, and nitrile rubber-based adhesives. Among these, an epoxy resin adhesive and a nitrile rubber adhesive can be preferably used. Nitrile rubber has the largest polarity among various rubbers, and this characteristic is a great feature as an adhesive, and has high adhesion to polar materials such as metals. However, because it uses a strong solvent, it tends to attack the painted surface, and plastics may swell and crack. Since the epoxy resin adhesive does not contain a volatile solvent, it hardly shrinks even after curing, and even if the film thickness of the adhesive layer is large, there is a feature that it does not crack and the adhesive force does not decrease, which is more preferable. .

以下に本発明の実施例を説明するが、本発明は下記実施例に限定されるものでなく、本発明の技術的範囲を逸脱しない限り、適宜修正や変更が可能である。   Examples of the present invention will be described below, but the present invention is not limited to the following examples, and modifications and changes can be made as appropriate without departing from the technical scope of the present invention.

図１（ａ）は、所定長さ（１６００mm）の本発明の医療用ガイドワイヤ１０の断面を含む側面図であり、上記したように、ガイドワイヤ１０の長さは用途に応じて１５００〜１８００mmの範囲で選択される。   FIG. 1A is a side view including a cross section of the medical guide wire 10 of the present invention having a predetermined length (1600 mm). As described above, the length of the guide wire 10 is 1500-1800 mm depending on the application. The range is selected.

図１（ａ）において、ガイドワイヤ１０は形態順応性の良好なＮｉ−Ｔｉ系合金（Ｎｉが５１％で残部がＴｉ）の金属線材から形成された先端側部材１１と、トルク伝達性に優れた高珪素ステンレス鋼の金属線材から形成された基端側部材１２とを有している。この実施例１において、後記する長孔１３内に挿入される部分を除く先端側部材１１の長さは１５０mmである。先端側部材１１の基端側端面１１ａの直径は０．１９mm、最先端部１１ｂの直径は０．１８mmであり、先端側部材１１は最先端部１１ｂに向かって先細となるようにテーパ状に加工されている。さらに、最先端部１１ｂは曲面状に形成されており、要治療管内に挿入された場合に、最先端部１１ｂにより要治療管の内壁が傷つかないように配慮されている。   In FIG. 1 (a), a guide wire 10 is excellent in torque transferability with a distal end side member 11 formed of a metal wire of a Ni-Ti alloy (Ni is 51% and the balance is Ti) having good form adaptability. And a proximal end member 12 formed of a high-silicon stainless steel metal wire. In Example 1, the length of the distal end side member 11 excluding the portion inserted into the long hole 13 to be described later is 150 mm. The diameter of the proximal end surface 11a of the distal end side member 11 is 0.19 mm, the diameter of the most distal end portion 11b is 0.18 mm, and the distal end side member 11 is tapered so as to taper toward the distal end portion 11b. Has been processed. Furthermore, the most advanced portion 11b is formed in a curved shape, and when inserted into the treatment-needed tube, consideration is given to prevent the inner wall of the treatment-needed tube from being damaged by the most advanced portion 11b.

基端側部材１２の先端側端面１２ａの直径は０．３０mmであり、この先端側端面１２ａに向かって直径が０．３４mmである外周上の位置１２ｂから先細となるようにテーパ状に加工されている（外周上の位置１２ｂから右方の基端側部材１２の直径は０．３４mmである）。この実施例１におけるテーパ状加工部の長さＭは１５０mmであるが、Ｍは３０〜３００mmの範囲で選択することが好ましい。テーパ状加工部の長さＭが３０mmより短くなると、基端側部材１２から先端側部材１１に至る剛性変化の滑らかさに欠け、テーパ状加工部の長さＭが３００mmより長くなると、基端側部材１２から先端側部材１１に至る剛性変化の滑らかさはそれほど向上しないが、テーパ状に加工するための加工コストの大きな上昇を招いてしまうからである。   The diameter of the front end side end surface 12a of the base end side member 12 is 0.30 mm, and it is tapered so as to taper from the position 12b on the outer periphery having a diameter of 0.34 mm toward the front end side end surface 12a. (The diameter of the base end side member 12 on the right side from the position 12b on the outer periphery is 0.34 mm). The length M of the tapered processed portion in Example 1 is 150 mm, but M is preferably selected in the range of 30 to 300 mm. When the length M of the tapered processed portion is shorter than 30 mm, the rigidity change from the proximal end member 12 to the distal end member 11 is not smooth, and when the length M of the tapered processed portion is longer than 300 mm, the proximal end This is because the smoothness of the change in rigidity from the side member 12 to the distal end side member 11 is not improved so much, but the processing cost for processing into a tapered shape is greatly increased.

高珪素ステンレス鋼の基端側部材１２は、次に説明するようなプロセスを経て製造された。すなわち、重量％で、Ｃ＝０．０２％、Ｓｉ＝３．５％、Ｍｎ＝２．０％、Ｎｉ＝６．０％、Ｃｒ＝１６．０％、Ｍｏ＝１．０％、Ｃｕ＝１．５％で、残部が鉄および不可避的不純物からなる組成の直径６．０mmの線材を直径０．３４mmに縮径し、この直径０．３４mmの高珪素ステンレス鋼製の線材に機械加工により真直加工を施した後、０〜６００℃の温度下で１０分間保持するという熱処理を行うことにより基端側部材１２を得た。そして、センタレス研削により、基端側部材１２の先端部にテーパ加工を施した。   The base end side member 12 of high silicon stainless steel was manufactured through a process as described below. That is, by weight%, C = 0.02%, Si = 3.5%, Mn = 2.0%, Ni = 6.0%, Cr = 16.0%, Mo = 1.0%, Cu = A wire rod having a composition of 1.5% and the balance consisting of iron and unavoidable impurities and having a diameter of 6.0 mm is reduced to a diameter of 0.34 mm, and this high silicon stainless steel wire rod having a diameter of 0.34 mm is machined. After performing straight processing, the base end side member 12 was obtained by performing the heat processing of hold | maintaining for 10 minutes at the temperature of 0-600 degreeC. And the taper process was given to the front-end | tip part of the base end side member 12 by centerless grinding.

なお、図１（ａ）に示すガイドワイヤ１０の全体を合成樹脂で被覆することができ、先端側部材１１のみを合成樹脂で被覆することもできる。その合成樹脂としては、ポリエチレン、ポリエステル、ポリプロピレン、ポリウレタン、シリコンゴム、ポリテトラフルオロエチレンなどを用いることができる。   In addition, the whole guide wire 10 shown to Fig.1 (a) can be coat | covered with a synthetic resin, and only the front end side member 11 can also be coat | covered with a synthetic resin. As the synthetic resin, polyethylene, polyester, polypropylene, polyurethane, silicon rubber, polytetrafluoroethylene, or the like can be used.

図１（ｂ）に拡大して示すように、基端側部材１２の先端側端面１２ａには、基端側端面１１ａを含む先端側部材１１の一部を挿入可能が長孔１３が基端側部材１２の軸線方向に設けられている。この実施例１における長孔１３の直径ｄは０．２０mmであり、長さＬは２．００mmである。長さＬは直径ｄの１０倍程度が、ガイドワイヤの操作性を損なわず、しかも、先端側部材１１と基端側部材１２との良好な接合を確保する上で好ましい。この長孔１３は、本実施例では放電加工により形成したが、ドリル加工により長孔１３を形成することもできる。   As shown in an enlarged view in FIG. 1B, a part of the distal end side member 11 including the proximal end side end surface 11a can be inserted into the distal end side end surface 12a of the proximal end side member 12. It is provided in the axial direction of the side member 12. The diameter d of the long hole 13 in Example 1 is 0.20 mm, and the length L is 2.00 mm. The length L is preferably about 10 times the diameter d without impairing the operability of the guide wire, and is preferable for ensuring good bonding between the distal end side member 11 and the proximal end side member 12. Although the long hole 13 is formed by electric discharge machining in the present embodiment, the long hole 13 can also be formed by drilling.

基端側部材１２の先端側端面１２ａとの間にロウ材（銀ロウ）１４が浸入可能な隙間１５を介在させて基端側部材１２の先端側端面１２ａの外径（０．３０mm）と同じ外径（０．３０mm）の接続部材（コイル状線材）１６が先端側部材１１の一部の外周を覆うように取り付けられている。なお、ロウ材１４は、隙間１５を覆うようにリング状に配置されている。図１（ｃ）に拡大して示すように、隙間１５から浸入したロウ材１４が基端側部材１２と長孔１３内に挿入された先端側部材１１との間の隙間に流入して先端側部材１１と基端側部材１２がロウ接され、一部のロウ材１４はコイル状線材１６と先端側部材１１との隙間にも流入してコイル状線材１６は先端側部材１１とロウ接される（図１（ｃ）の灰色の着色部がロウ接部分を示す）。しかし、コイル状線材１６と先端側部材１１とのロウ接部分の長さは先端側部材１１と基端側部材１２とのロウ接部分の長さに比べて充分に短くなるように接合部が加熱されるので、コイル状線材１６の可撓性が損なわれることはない。ロウ材１４による接合密着強度を向上するために、長孔１３の内面および長孔１３内に挿入される先端側部材１１の外周には、ロウ材１４の浸入前に予めＮｉメッキが施されている。コイル状線材１６は、ＳＵＳ３０４製の厚さｔが０．０５mmで、幅ｗが０．１５mmである矩形断面（図１（ｄ）参照）の平バネであり、全長Ｎは１５mmである。   An outer diameter (0.30 mm) of the distal end surface 12a of the proximal end member 12 is interposed between the distal end surface 12a of the proximal end member 12 with a gap 15 through which a brazing material (silver brazing) 14 can enter. A connection member (coiled wire) 16 having the same outer diameter (0.30 mm) is attached so as to cover a part of the outer periphery of the distal end side member 11. The brazing material 14 is arranged in a ring shape so as to cover the gap 15. As shown in an enlarged view in FIG. 1 (c), the brazing material 14 that has entered from the gap 15 flows into the gap between the base end side member 12 and the tip end side member 11 inserted into the long hole 13, and The side member 11 and the base end side member 12 are brazed, and a part of the brazing material 14 also flows into the gap between the coiled wire 16 and the distal end member 11 so that the coiled wire 16 is brazed to the distal end member 11. (A gray colored portion in FIG. 1C indicates a brazing portion). However, the length of the brazed portion between the coiled wire 16 and the distal end side member 11 is sufficiently shorter than the length of the brazed portion between the distal end side member 11 and the proximal end member 12. Since it is heated, the flexibility of the coiled wire 16 is not impaired. In order to improve the bonding adhesion strength by the brazing material 14, the inner surface of the long hole 13 and the outer periphery of the distal end side member 11 inserted into the long hole 13 are preliminarily plated with Ni before the brazing material 14 enters. Yes. The coiled wire 16 is a flat spring having a rectangular cross section (see FIG. 1D) having a thickness t of 0.05 mm and a width w of 0.15 mm made of SUS304, and the total length N is 15 mm.

この実施例１におけるコイル状線材１６の長さＮは１５mmであるが、Ｎは５〜３０mmの範囲で選択することが好ましい。コイル状線材１６の長さＮが５mmより短くなると、基端側部材１２から先端側部材１１に至る剛性変化の滑らかさに欠けるので、基端部での手元操作を正確に先端部に伝達することがやや難しくなる。一方、コイル状線材１６の長さＮが５０mmより長くなると、剛性の小さい先端側部材の長さが不足して先端部での微妙な動作をすることがやや難しくなる。   The length N of the coiled wire 16 in Example 1 is 15 mm, but N is preferably selected in the range of 5 to 30 mm. If the length N of the coiled wire 16 is shorter than 5 mm, the rigidity change from the base end side member 12 to the front end side member 11 is not smooth, so that the hand operation at the base end is accurately transmitted to the tip end. Things get a little difficult. On the other hand, when the length N of the coiled wire 16 is longer than 50 mm, the length of the distal end side member with low rigidity is insufficient, and it is somewhat difficult to perform a delicate operation at the distal end portion.

また、コイル状線材１６の厚さｔは０．０１〜０．１０mmとし、幅ｗは０．０７〜０．３０mmの矩形断面とすることが好ましい。適度の剛性を有することで、柔軟性と操作性を兼備することができるからである。   Moreover, it is preferable that the thickness t of the coiled wire 16 is 0.01 to 0.10 mm and the width w is 0.07 to 0.30 mm. This is because by having an appropriate rigidity, both flexibility and operability can be achieved.

隙間１５の寸法は、ロウ材が浸入可能な間隙であればよく、例えば、３〜１０μｍが好ましい。３〜１０μｍであれば、隙間に毛細管現象でロウ材１４が浸入しやすいからである。隙間１５の寸法が３μｍより小さくなると、ロウ材１４が浸入しにくくなるという不都合がある。一方、隙間１５の寸法が１０μｍより大きくなると、ロウ材の量が過大となってロウ材溶融のための加熱時間が長くなるので、ロウ接部近傍の先端側部材１１と基端側部材１２の金属特性が変化するという不都合があるからである。この実施例における隙間１５の最小寸法は６μｍ、最大寸法は１０μｍである。   The dimension of the gap 15 may be any gap that allows the brazing material to enter, and is preferably 3 to 10 μm, for example. This is because if the thickness is 3 to 10 μm, the brazing material 14 is likely to enter the gap due to capillary action. If the size of the gap 15 is smaller than 3 μm, there is an inconvenience that the brazing material 14 hardly enters. On the other hand, if the size of the gap 15 is larger than 10 μm, the amount of brazing material becomes excessive and the heating time for melting the brazing material becomes long. Therefore, the distal end side member 11 and the proximal end side member 12 near the brazing contact portion This is because there is a disadvantage that the metal characteristics change. In this embodiment, the gap 15 has a minimum dimension of 6 μm and a maximum dimension of 10 μm.

この実施例のガイドワイヤ１０は以下に説明するようにして製造した。まず、先端側部材１１と基端側部材１２をそれぞれ所定材料で所定寸法に形成し、図１（ａ）に示すように、基端側端面１１ａを含む先端側部材１１を長孔１３内に挿入し、隙間１５の寸法が上記範囲内に収まるようにコイル状線材１６を先端側部材１１の一部の外周を覆うように取り付け、コイル状線材１６と基端側部材１２の先端側端面１２ａとの間にロウ材（銀ロウ）１４を置いた状態で高周波誘導加熱装置（図示せず）によりコイル状線材１６を加熱した。符号１７は高周波誘導加熱装置のコイルを示す。   The guide wire 10 of this example was manufactured as described below. First, the distal end side member 11 and the proximal end side member 12 are respectively formed to have predetermined dimensions with a predetermined material, and the distal end side member 11 including the proximal end side end surface 11a is placed in the long hole 13 as shown in FIG. The coiled wire 16 is attached so as to cover a part of the outer periphery of the distal end side member 11 so that the dimension of the gap 15 falls within the above range, and the distal end side surface 12a of the coiled wire 16 and the proximal end side member 12 is attached. The coiled wire 16 was heated by a high-frequency induction heating device (not shown) with a brazing material (silver brazing) 14 placed between them. Reference numeral 17 denotes a coil of the high-frequency induction heating device.

この加熱により、図１（ｃ）に示すように、ロウ材１４が溶融して、長孔１３内に挿入された先端側部材１１と基端側部材１２との隙間に流入して先端側部材１１と基端側部材１２がロウ接され、一部のロウ材１４はコイル状線材１６と先端側部材１１との隙間にも流入してコイル状線材１６は先端側部材１１とロウ接され、かくして、先端側部材１１と基端側部材１２が接合された。先端側部材１１と基端側部材１２とのロウ接部分の長さ（約２mm）に比べてコイル状線材１６と先端側部材１１とのロウ接部分の長さ（約０．４mm）は充分に短いので、コイル状線材１６の可撓性が損なわれることはない。また、高周波誘導加熱装置による加熱であるため、ロウ材１４は溶融した瞬間に瞬時にして隙間１５を経て接合部に充填された。   By this heating, as shown in FIG. 1 (c), the brazing material 14 is melted and flows into the gap between the distal end side member 11 and the proximal end side member 12 inserted into the elongated hole 13, and the distal end side member. 11 and the base end side member 12 are brazed, a part of the brazing material 14 flows into the gap between the coiled wire 16 and the distal end member 11, and the coiled wire 16 is brazed with the distal end member 11, Thus, the distal end side member 11 and the proximal end side member 12 were joined. Compared with the length (about 2 mm) of the brazed portion between the distal end side member 11 and the proximal end side member 12, the length of the brazed portion between the coiled wire 16 and the distal end side member 11 (about 0.4 mm) is sufficient. Therefore, the flexibility of the coiled wire 16 is not impaired. Further, since the heating is performed by the high frequency induction heating device, the brazing material 14 is instantaneously filled into the joint portion via the gap 15 at the moment of melting.

加熱温度は、ロウ材１４の溶融温度に応じて設定することができ、一般的には、５５０〜９００℃であるが、ロウ材１４を構成する銀ロウの融点ならびにロウ接時のロウ接部近傍の先端側部材１１と基端側部材１２が受ける熱による金属特性の変化を考慮すると、６５０〜７００℃が好ましい。加熱温度をこのように設定し、高周波誘導加熱装置により接合部を局部的に加熱して熱源を集中し、接合部をピンポイントで加熱することで、ロウ接部近傍の金属線材への熱影響を最小限に抑えることができる。   The heating temperature can be set according to the melting temperature of the brazing material 14 and is generally 550 to 900 ° C., but the melting point of the silver brazing constituting the brazing material 14 and the brazing portion during brazing. Considering changes in metal properties due to heat received by the proximal end side member 11 and the proximal end side member 12 in the vicinity, 650 to 700 ° C. is preferable. The heating temperature is set in this way, the joint is locally heated by a high-frequency induction heating device, the heat source is concentrated, and the joint is heated at a pinpoint. Can be minimized.

また、要治療管内への挿入時の障害となる恐れがある突起部における外径変化を極力小さくするために、図１（ｃ）に示すように、最先端部に近いコイル状線材１６の端部材料にテーパ加工（幅方向に厚みが小さくなるように加工すること）１８を施すことは好ましい。   Further, in order to minimize the change in the outer diameter of the protrusion that may become an obstacle when inserted into the treatment tube, as shown in FIG. 1 (c), the end of the coiled wire 16 close to the most distal portion is used. It is preferable to subject the part material to taper processing (processing to reduce the thickness in the width direction) 18.

ロウ材の代わりに、接着剤により先端側部材１１と基端側部材１２を接合することもできる。すなわち、図１（ａ）において、ロウ材１４を除いて、基端側端面１１ａを含む先端側部材１１の一部の外周に上記接着剤を塗布してその接着剤を塗布した先端側部材１１を長孔１３内に挿入し、基端側部材１２の先端側端面１２ａに対面する位置を起点として（実質的に端面１２ａとの間に隙間がないようにして）、基端側部材１２の先端側端面１２ａの外径と略同じ外径の接続部材（コイル状線材１６）を先端側部材１１の一部の外周を覆うように取り付け、接着剤により先端側部材１１と基端側部材１２とを接合することもできる。なお、基端側部材１２の先端側端面１２ａに対面する位置にある一部のコイル状線材１６（コイル状線材１６の全長の１０〜２０％程度の部分）については、柔軟性を低下させずに操作性を確保するという点から先端側部材１１と上記接着剤により接合することが好ましい。「略同じ外径」とは、基端側部材１２またはコイル状線材１６に特別な物理的加工あるいは化学的加工を施すことにより、厳密に両部材が等しい外径になるような特別の処理を施さなかったという意味であり、「実質的に同じ外径であるということ」と同義である。   Instead of the brazing material, the distal end side member 11 and the proximal end side member 12 can be joined by an adhesive. That is, in FIG. 1A, except for the brazing material 14, the above-mentioned adhesive is applied to the outer periphery of a part of the distal-side member 11 including the proximal-side end surface 11a, and the distal-side member 11 is coated with the adhesive. Is inserted into the long hole 13, and the position facing the distal end surface 12 a of the proximal end member 12 is set as a starting point (substantially no gap between the end surface 12 a) and the proximal end member 12. A connection member (coiled wire 16) having an outer diameter substantially the same as the outer diameter of the distal end surface 12a is attached so as to cover a part of the outer periphery of the distal end member 11, and the distal end member 11 and the proximal end member 12 are bonded with an adhesive. Can also be joined. In addition, about one part coil-shaped wire 16 (part about 10-20% of the full length of the coil-shaped wire 16) in the position which faces the front end side end surface 12a of the base end side member 12, it does not reduce a softness | flexibility. In view of ensuring operability, it is preferable to join the tip side member 11 with the adhesive. The “substantially the same outer diameter” means that a special physical processing or chemical processing is applied to the base end side member 12 or the coiled wire 16 so that both members have exactly the same outer diameter. This means that it has not been applied, and is synonymous with “substantially the same outer diameter”.

次に、接合強度、トルク伝達性および曲げ性を従来のガイドワイヤと比較するために、比較例として図５に示す構造に類似する医療用ガイドワイヤを製造した。すなわち、第１ワイヤ２（実施例１の先端側部材１１に相当）を実施例１と同じ材料（Ｎｉ−Ｔｉ系合金）で直径０．２４mm、長さ１５０mmとし、第２ワイヤ３（実施例１の基端側部材１２に相当）を実施例１と同じ材料（高珪素ステンレス鋼）で直径０．２４mm、長さ１４５０mmとし、管状接続部材８（実施例１のコイル状線材１６に相当）を実施例１と同じ材料（ＳＵＳ３０４）で外径を０．３４mm、厚みを０．０５mm、長さを１５mmとし、ロウ材９充填用の隙間を隙間１５の最大寸法と最小寸法の平均値である８μｍに設定し、ロウ材（銀ロウ）を加熱して上記隙間に充填したものを製造した。
（１）接合強度
図１（ａ）に示す形状の本発明の医療用ガイドワイヤ１０と比較例の医療用ガイドワイヤについて、引張試験機による引張試験を行って各供試材の破断荷重を測定することにより、接合強度を比較した。その結果を以下の表１に示す。 Next, in order to compare the bonding strength, torque transmission, and bendability with a conventional guide wire, a medical guide wire similar to the structure shown in FIG. 5 was manufactured as a comparative example. That is, the first wire 2 (corresponding to the distal end side member 11 of Example 1) is made of the same material (Ni—Ti alloy) as in Example 1 and has a diameter of 0.24 mm and a length of 150 mm, and the second wire 3 (Example). 1) (corresponding to the coil member 16 of Example 1), the same material (high silicon stainless steel) as in Example 1 with a diameter of 0.24 mm and a length of 1450 mm. Is the same material (SUS304) as in Example 1, the outer diameter is 0.34 mm, the thickness is 0.05 mm, the length is 15 mm, and the gap for filling the brazing material 9 is the average value of the maximum and minimum dimensions of the gap 15. It was set to a certain 8 μm, and a brazing material (silver brazing) was heated to fill the gap.
(1) Bonding strength With respect to the medical guide wire 10 of the present invention having the shape shown in FIG. 1 (a) and the medical guide wire of the comparative example, a tensile test is performed by a tensile tester to measure the breaking load of each specimen. Thus, the bonding strength was compared. The results are shown in Table 1 below.

Figure 2006271677
Figure 2006271677

表１に明らかなように、本発明の医療用ガイドワイヤの接合強度は比較例のものに比べて極めて高く、本発明の医療用ガイドワイヤは強力に接合されることが分かる。
（２）トルク伝達性
図２はガイドワイヤのトルク伝達性を評価するための試験装置の概略斜視図である。図２に示す装置を用いて、図１（ａ）に示す形状の本発明の医療用ガイドワイヤと比較例の医療用ガイドワイヤについて、基端部１９にアーム２０を取り付け、このアーム２０を矢印方向に１０度づつゆっくりと１８０度回転させ、先端部２１に生じるトルクを先端部２１に取り付けたアーム２２を介して電子天秤２３により測定した。以下の表２には、上記方法により測定したトルクを比較例のガイドワイヤのものを１００とするトルク伝達性指数により示す。 As is apparent from Table 1, the bonding strength of the medical guide wire of the present invention is extremely higher than that of the comparative example, and it can be seen that the medical guide wire of the present invention is strongly bonded.
(2) Torque transmission property FIG. 2 is a schematic perspective view of a test apparatus for evaluating the torque transmission property of a guide wire. Using the apparatus shown in FIG. 2, an arm 20 is attached to the proximal end 19 of the medical guide wire of the present invention having the shape shown in FIG. The torque generated at the distal end portion 21 was measured by the electronic balance 23 via the arm 22 attached to the distal end portion 21. Table 2 below shows the torque measured by the above method as a torque transmission index with the guide wire of the comparative example as 100.

Figure 2006271677
Figure 2006271677

表２に明らかなように、本発明の医療用ガイドワイヤのトルク伝達性指数は比較例のものに比べて高く、本発明の医療用ガイドワイヤは優れたトルク伝達性を有していることが分かる。
（３）曲げ性
実際のガイドワイヤとしての操作性を知るために、以下に説明するような方法で曲げ性を調査した。すなわち、図３（ａ）に示すように、図１（ａ）に示す本発明の医療用ガイドワイヤを曲げると、基端側部材２４から先端側部材２５に至る剛性の変化が滑らかであるから、接合部２６を対称中心として、ほぼ真円に近い形状に曲げることができた。 As apparent from Table 2, the medical guidewire of the present invention has a higher torque transmission index than that of the comparative example, and the medical guidewire of the present invention has excellent torque transmission. I understand.
(3) Bendability In order to know the operability as an actual guide wire, the bendability was investigated by the method described below. That is, as shown in FIG. 3A, when the medical guide wire of the present invention shown in FIG. 1A is bent, the change in rigidity from the proximal end member 24 to the distal end member 25 is smooth. The bent portion 26 can be bent to a shape close to a perfect circle with the joint 26 as the center of symmetry.

しかし、比較例の医療用ガイドワイヤは、基端側部材と先端側部材の剛性が大きく異なるため、図３（ｂ）に示すように、比較例の医療用ガイドワイヤを曲げると、接合部２７が突出し、しかも接合部２７を境として、剛性の小さい先端側部材に相当する第１ワイヤ２の曲率半径が小さく、剛性の大きい基端側部材に相当する第２ワイヤ３の曲率半径が大きいという、いびつな形状になった。   However, since the rigidity of the proximal end member and the distal end side member of the medical guide wire of the comparative example is greatly different, as shown in FIG. 3B, when the medical guide wire of the comparative example is bent, the joint portion 27 The first wire 2 corresponding to the distal end side member having a low rigidity has a small radius of curvature and the curvature radius of the second wire 3 corresponding to the base end side member having a high rigidity is large with the joint portion 27 as a boundary. It became an irregular shape.

このように、本発明の医療用ガイドワイヤは基端側部材から先端側部材に至る剛性の変化が滑らかであり、基端側部材での操作を先端側部材にほぼ正確に伝達することが可能である。その結果、先端部を随意に要治療管内に挿入することができる。   As described above, the medical guide wire according to the present invention has a smooth change in rigidity from the proximal end member to the distal end member, and can transmit the operation on the proximal end member to the distal end member almost accurately. It is. As a result, the distal end portion can be optionally inserted into the treatment tube.

図１（ａ）は本発明の医療用ガイドワイヤの一実施例の断面を含む側面図、図１（ｂ）は図１（ａ）の基端側部材の先端側端面を含む部分を拡大して示す断面図、図１（ｃ）は図１（ａ）の接合部付近を拡大した図、図１（ｄ）はコイル状線材の断面図である。FIG. 1A is a side view including a cross section of an embodiment of the medical guide wire of the present invention, and FIG. 1B is an enlarged view of a portion including the distal end surface of the proximal end member in FIG. FIG. 1C is an enlarged view of the vicinity of the joint of FIG. 1A, and FIG. 1D is a cross-sectional view of the coiled wire. ガイドワイヤのトルク伝達性を評価するための試験装置の概略斜視図である。It is a schematic perspective view of the test apparatus for evaluating the torque transmission property of a guide wire. 図３（ａ）（ｂ）はガイドワイヤの曲げ性を比較する図である。FIGS. 3A and 3B are diagrams for comparing the bendability of guide wires. 従来の医療用ガイドワイヤの断面図である。It is sectional drawing of the conventional medical guidewire. 従来の別の医療用ガイドワイヤの接合部の断面図である。It is sectional drawing of the junction part of another conventional medical guide wire.

符号の説明Explanation of symbols

１０ 医療用ガイドワイヤ
１１ 先端側部材
１１ａ 基端側端面
１１ｂ 最先端部
１２ 基端側部材
１２ａ 先端側端面
１４ ロウ材
１５ 隙間
１６ 接続部材（コイル状線材）
１７ 高周波誘導加熱装置のコイル
１８ テーパ加工
１９ 基端部
２０ アーム
２１ 先端部
２２ アーム
２３ 電子天秤
２４ 基端側部材
２５ 先端側部材
２６ 接合部
２７ 接合部 DESCRIPTION OF SYMBOLS 10 Medical guide wire 11 Front end side member 11a Base end side end surface 11b Most advanced part 12 Base end side member 12a Front end side end surface 14 Brazing material 15 Crevice 16 Connection member (coiled wire)
DESCRIPTION OF SYMBOLS 17 Coil of high frequency induction heating apparatus 18 Taper process 19 Base end part 20 Arm 21 Front end part 22 Arm 23 Electronic balance 24 Base end side member 25 Front end side member 26 Junction part 27 Junction part

Claims (4)

形態順応性の良好な金属線材から形成された先端側部材と、トルク伝達性に優れた金属線材から形成された基端側部材とを有し、先端側部材の基端側端面と基端側部材の先端側端面との間に介在させた接合材料により両部材を接合してなる医療用ガイドワイヤにおいて、基端側部材は先端側端面に向かって先細となるようにテーパ状に加工された部分を有し、基端側部材の先端側端面には先端側部材を挿入可能な長孔を基端側部材の軸線方向に設け、上記長孔内に基端側端面を含む先端側部材の一部を挿入し、基端側部材の先端側端面との間にロウ材の浸入可能な隙間を介在させて基端側部材の先端側端面の外径と略同じ外径の接続部材を先端側部材の一部の外周を覆うように取り付け、上記隙間から浸入したロウ材により先端側部材と基端側部材とが接合されていることを特徴とする医療用ガイドワイヤ。    It has a distal end side member formed from a metal wire with good conformability and a proximal end member formed from a metal wire excellent in torque transmission, and the proximal end surface and the proximal end side of the distal end member In a medical guide wire formed by bonding both members with a bonding material interposed between the distal end side surfaces of the members, the proximal end member is processed into a taper shape so as to be tapered toward the distal end surface. The distal end side surface of the proximal end member is provided with a long hole into which the distal end side member can be inserted in the axial direction of the proximal end member, and the proximal end member includes the proximal end end surface in the elongated hole. Insert a part and insert a gap that allows the brazing material to enter between the distal end surface of the proximal end member, and connect the connecting member with the outer diameter substantially the same as the outer diameter of the distal end surface of the proximal end member. Installed to cover the outer periphery of part of the side member Medical guide wire, characterized in that the member is joined. 長孔内面および長孔内に挿入される先端側部材外周には、ロウ材の浸入前に予めＮｉメッキが施されていることを特徴とする請求項１記載の医療用ガイドワイヤ。   2. The medical guide wire according to claim 1, wherein the inner surface of the long hole and the outer periphery of the distal end side member inserted into the long hole are preliminarily plated with Ni before the brazing material enters. 形態順応性の良好な金属線材から形成された先端側部材と、トルク伝達性に優れた金属線材から形成された基端側部材とを有し、先端側部材の基端側端面と基端側部材の先端側端面との間に介在させた接合材料により両部材を接合してなる医療用ガイドワイヤにおいて、基端側部材は先端側端面に向かって先細となるようにテーパ状に加工された部分を有し、基端側部材の先端側端面には先端側部材を挿入可能な長孔を基端側部材の軸線方向に設け、基端側端面を含む先端側部材の一部の外周に接着剤を塗布してその先端側部材を上記長孔内に挿入し、基端側部材の先端側端面に対面する位置を起点として基端側部材の先端側端面の外径と略同じ外径の接続部材を先端側部材の一部の外周を覆うように取り付け、上記接着剤により先端側部材と基端側部材とが接合されていることを特徴とする医療用ガイドワイヤ。   It has a distal end side member formed from a metal wire with good conformability and a proximal end member formed from a metal wire excellent in torque transmission, and the proximal end surface and the proximal end side of the distal end member In a medical guide wire formed by bonding both members with a bonding material interposed between the distal end side surfaces of the members, the proximal end member is processed into a taper shape so as to be tapered toward the distal end surface. A long hole into which the distal end side member can be inserted is provided in the axial direction of the proximal end member on the distal end side surface of the proximal end member, and is provided on the outer periphery of a part of the distal end side member including the proximal end end surface. Apply the adhesive and insert the distal end side member into the elongated hole. The outer diameter is approximately the same as the outer diameter of the distal end surface of the proximal end member, starting from the position facing the distal end surface of the proximal end member. The connecting member is attached so as to cover the outer periphery of a part of the tip side member, and the tip side member is attached by the adhesive. The medical guidewire, wherein a base end side member is joined. 先端側部材は、最先端部に向かって先細となるようにテーパ状に加工されていることを特徴とする請求項１または３記載の医療用ガイドワイヤ。   The medical guidewire according to claim 1 or 3, wherein the distal end side member is processed into a taper shape so as to be tapered toward the most distal portion.
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011177231A (en) * 2010-02-26 2011-09-15 Patentstra Co Ltd Coiled structure used for medical treatment and method for manufacturing the same; and medical endoscope, medical treatment instrument and ultrasonic or optical interferometry diagnostic and medical treatment catheters using coiled structure for medical treatment
JP2012135383A (en) * 2010-12-24 2012-07-19 Asahi Intecc Co Ltd Guide wire
JP5517274B1 (en) * 2013-10-11 2014-06-11 株式会社エフエムディ Medical guidewire
CN109173012A (en) * 2018-11-14 2019-01-11 苏州海维尔医疗器械有限公司 Anti-scratch superslide seal wire, its method for coating and coating equipment

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH1157014A (en) * 1997-08-11 1999-03-02 Terumo Corp Guide wire
WO2003030982A2 (en) * 2001-10-05 2003-04-17 Boston Scientific Limited Composite guidewire
WO2004110542A2 (en) * 2003-05-27 2004-12-23 Boston Scientific Limited Medical device having segmented construction

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH1157014A (en) * 1997-08-11 1999-03-02 Terumo Corp Guide wire
WO2003030982A2 (en) * 2001-10-05 2003-04-17 Boston Scientific Limited Composite guidewire
WO2004110542A2 (en) * 2003-05-27 2004-12-23 Boston Scientific Limited Medical device having segmented construction

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011177231A (en) * 2010-02-26 2011-09-15 Patentstra Co Ltd Coiled structure used for medical treatment and method for manufacturing the same; and medical endoscope, medical treatment instrument and ultrasonic or optical interferometry diagnostic and medical treatment catheters using coiled structure for medical treatment
JP2012135383A (en) * 2010-12-24 2012-07-19 Asahi Intecc Co Ltd Guide wire
JP5517274B1 (en) * 2013-10-11 2014-06-11 株式会社エフエムディ Medical guidewire
CN109173012A (en) * 2018-11-14 2019-01-11 苏州海维尔医疗器械有限公司 Anti-scratch superslide seal wire, its method for coating and coating equipment

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