JP2007075531A - Medical guide wire - Google Patents

Medical guide wire Download PDF

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Publication number
JP2007075531A
JP2007075531A JP2005270864A JP2005270864A JP2007075531A JP 2007075531 A JP2007075531 A JP 2007075531A JP 2005270864 A JP2005270864 A JP 2005270864A JP 2005270864 A JP2005270864 A JP 2005270864A JP 2007075531 A JP2007075531 A JP 2007075531A
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coil
core wire
wire
guide wire
tip
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Takeshi Ishikawa
毅 石川
Hiroyuki Asano
寛幸 浅野
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Piolax Medical Devices Inc
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Piolax Medical Devices Inc
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Priority to JP2005270864A priority Critical patent/JP2007075531A/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
    • A61M2025/09091—Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part

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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 has excellent resilience at its front end part and in which a core wire is hardly deformed, and a coil and a core wire are securely coated with a resin film. <P>SOLUTION: The guide wire 10 has the core wire 20 with its front end parts 22 with a smaller diameter than that of the main body part 21, and the coil 30 provided on the outer periphery of the front end parts 22 of the core wire 20. The coil is composed of a tightly wound coil made of a radiation-non-transmitting wire, and the base end part side 31 of the coil 30 is fixed to the front end parts 22 of the core wire 20. Furthermore, the front end part side 32 of the coil is fixed to and integrated with the top end 22a of the core wire 20, and the resin-film 40 is formed over all the circumference of the coil 30 and the core wire 20, in such a manner that a gap 35 is provided on the inside of the coil 30. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

本発明は、例えば血管、尿管、胆管、気管などの人体の管状器官にカテーテルを挿入する際、カテーテルの先端を目的箇所に導くために用いられる医療用ガイドワイヤに関する。   The present invention relates to a medical guide wire used to guide the distal end of a catheter to a target location when the catheter is inserted into a human tubular organ such as a blood vessel, a ureter, a bile duct, or a trachea.

近年、血管、尿管、胆管、気管などの人体の管状器官における検査・治療のため、カテーテルを挿入して造影剤などの薬剤を投与したり、カテーテルを通して鉗子等によって組織の一部を採取したりすることが行われている。カテーテルの挿入に際しては、管状器官内に、まず、比較的細くて柔軟なガイドワイヤを挿入し、ガイドワイヤの先端を目的箇所に到達させた後、このガイドワイヤの外周に沿ってカテーテルを挿入し、ガイドワイヤを抜き出すようにしている。   In recent years, for inspection and treatment of human tubular organs such as blood vessels, ureters, bile ducts, trachea, etc., a catheter is inserted to administer contrast agents, etc., or a portion of tissue is collected with forceps through the catheter. Has been done. When inserting a catheter, a relatively thin and flexible guide wire is first inserted into the tubular organ, and after the distal end of the guide wire reaches the target location, the catheter is inserted along the outer periphery of the guide wire. The guide wire is pulled out.

このガイドワイヤとしては、目的とする管状器官内に無理なく挿入できる程度の細さ、管状器官内壁を損傷しないような先端部の柔軟性、管状器官内に押し込むことができる程度の本体部の剛性、カテーテル及び管状器官内での滑り性、血栓付着防止性などを兼ね備えたものが望まれている。   The guide wire is thin enough to be inserted into the target tubular organ without difficulty, flexible at the tip so as not to damage the inner wall of the tubular organ, and rigid at the body enough to be pushed into the tubular organ. What has been desired is a combination of slipperiness within a catheter and a tubular organ, prevention of thrombus adhesion, and the like.

そして、ガイドワイヤの先端部の柔軟性を向上させるため、先端部にコイルを装着させるといった試みが種々なされており、例えば、下記特許文献１には、本体部と、該本体部よりも細径でほぼ均一な外径を有している先端部と、該本体部と該先端部の間のテーパー状に縮径している移行部とからなる超弾性芯線と、該芯線の先端部に密着して設けられた塑性変形するＸ線造影性金属コイルと、該造影性金属コイルと該芯線の少なくとも一部を被覆して実質的に平滑な外表面を形成する合成樹脂製被覆部材と、該合成樹脂製被覆部材の少なくとも一部を覆う親水性潤滑層とからなるガイドワイヤが開示されている。   In order to improve the flexibility of the distal end portion of the guide wire, various attempts have been made to attach a coil to the distal end portion. For example, Patent Document 1 listed below has a main body portion and a diameter smaller than that of the main body portion. A super elastic core wire comprising a tip portion having a substantially uniform outer diameter, a transition portion having a tapered diameter between the main body portion and the tip portion, and a close contact with the tip portion of the core wire An X-ray contrast-enhanced metal coil that is plastically deformed, and a synthetic resin coating member that covers at least a part of the contrast-enhanced metal coil and the core wire to form a substantially smooth outer surface; A guide wire comprising a hydrophilic lubricating layer covering at least a part of a synthetic resin coating member is disclosed.

また、下記特許文献２には、先端部が本体部に比して小径とされた弾性材料からなる芯線と、この芯線の先端部の少なくとも一部を被覆する樹脂チューブと、この樹脂チューブ外周を被覆する親水性樹脂膜とを有し、芯線の最先端部外周にＸ線不透過性の金属コイルが装着され、前記樹脂チューブ及び前記親水性樹脂膜が施された部分の外径が、前記芯線の本体部の製品外径よりも細く、かつ、前記金属コイルの外周を包み込むように前記樹脂チューブが被覆されている医療用ガイドワイヤが開示されている。
特許第３２８８６１９号明細書 特開２０００−１３５２８９号公報 In Patent Document 2 below, a core wire made of an elastic material whose tip is smaller in diameter than the main body, a resin tube covering at least a part of the tip of the core, and an outer periphery of the resin tube A hydrophilic resin film to be coated, a metal coil impermeable to X-rays is attached to the outer periphery of the most distal end portion of the core wire, and the outer diameter of the portion where the resin tube and the hydrophilic resin film are applied is A medical guide wire that is thinner than the product outer diameter of the main body portion of the core wire and is covered with the resin tube so as to wrap around the outer periphery of the metal coil is disclosed.
Japanese Patent No. 3288619 JP 2000-135289 A

しかしながら、上記特許文献１のように、ガイドワイヤの芯線に密着するようにコイルを装着させた場合、先端部に充分な柔軟性を付与することができない。また、芯線とコイルとが密着していることから、先端部の変形に追従して芯線も変形していき、例えば血管内に挿入させやすくするため予め所定の形状に付形したとしても、血管の蛇行部分や、カテーテルを通すことで付形した形状が変形して付形形状を維持しにくく、血管などの体内における挿入性や、血管の分岐部における血管選択性が劣る傾向があった。   However, when the coil is mounted so as to be in close contact with the core wire of the guide wire as in Patent Document 1, sufficient flexibility cannot be imparted to the distal end portion. In addition, since the core wire and the coil are in close contact with each other, the core wire is also deformed following the deformation of the distal end portion. For example, even if the core wire is shaped in advance to be easily inserted into the blood vessel, the blood vessel The shape formed by passing the meandering portion and the catheter is deformed and it is difficult to maintain the shaped shape, and there is a tendency that the insertability in the body such as a blood vessel and the blood vessel selectivity at the branching portion of the blood vessel are inferior.

また、上記特許文献２のように、ガイドワイヤの芯線とコイルとを樹脂チューブで被覆した場合、芯線及びコイルとの樹脂チューブとの密着性が劣るため、ガイドワイヤ基端部の操作を先端部に伝える際の回転伝達性が劣る傾向があった。また、芯線と樹脂チューブとの間に生じた密着不良の箇所で樹脂チューブが伸びたり、蛇腹状となったりすることがあった。   Moreover, when the core wire and the coil of the guide wire are covered with the resin tube as in Patent Document 2, the adhesion of the core wire and the coil to the resin tube is inferior. There was a tendency for rotation transmission to be poor. In addition, the resin tube may be stretched or bellows-like at a location with poor adhesion generated between the core wire and the resin tube.

したがって、本発明の目的は、先端部の柔軟性に優れ、かつ、芯線が変形しにくく、樹脂膜がコイル及び芯線にしっかりと被着されている医療用ガイドワイヤを提供することである。   Therefore, an object of the present invention is to provide a medical guide wire that has excellent flexibility at the distal end portion, is difficult to deform the core wire, and has a resin film firmly attached to the coil and the core wire.

上記目的を達成するため、本発明の第１は、先端部が本体部に比して小径とされた芯線と、この芯線の先端部外周に設けられたコイルとを有するガイドワイヤにおいて、前記コイルは、放射線不透過性の線材からなる密着巻きコイルであり、前記コイルの基端部側は前記芯線の先端部に固着され、かつ、前記コイルの先端部側は前記芯線の最先端と固着して一体となっており、前記コイル及び前記芯線の全周にわたって、前記コイルの内部に空隙が設けられた状態で樹脂膜が形成されていることを特徴とする医療用ガイドワイヤを提供するものである。   In order to achieve the above object, according to a first aspect of the present invention, there is provided a guide wire having a core wire whose tip is smaller in diameter than the main body and a coil provided on the outer periphery of the tip of the core. Is a tightly wound coil made of a radiopaque wire, the proximal end side of the coil being fixed to the distal end portion of the core wire, and the distal end side of the coil being fixed to the forefront of the core wire The medical guide wire is characterized in that a resin film is formed over the entire circumference of the coil and the core wire in a state where a gap is provided inside the coil. is there.

上記第１の発明によれば、コイルの基端部側が、芯線の先端部に固着され、前記コイルの先端部側は前記芯線の最先端と固着して一体となっているので、コイルの内部に空隙を充分確保することできる。その結果、ガイドワイヤ先端部の柔軟性を向上させることができる。また、ガイドワイヤ先端部を屈曲させた際に、コイルの内部の空隙で、芯線はできるだけ屈曲しない経路をとることができ、局部的に強く曲げられることが防止される。このため、芯線の先端部を体内に挿入させやすいように予め付形したとしても、その付形形状が挿入過程で変形されにくく、付形形状を維持できるので、血管等の分岐部における選択性を良好なものとすることができる。   According to the first aspect of the invention, the proximal end side of the coil is fixed to the distal end portion of the core wire, and the distal end side of the coil is fixed to and integrated with the foremost end of the core wire. A sufficient gap can be secured. As a result, the flexibility of the guide wire tip can be improved. In addition, when the distal end portion of the guide wire is bent, a path in which the core wire is not bent as much as possible can be taken in the space inside the coil, and it is prevented that the guide wire is bent strongly. For this reason, even if the tip of the core wire is shaped in advance so that it can be easily inserted into the body, the shaped shape is not easily deformed during the insertion process, and the shaped shape can be maintained. Can be made good.

また、放射線不透過性の線材からなる密着巻きコイルを用いたので、放射線造影による先端部の位置確認を良好にすることができる。更に、押出し成形によって樹脂膜を形成した場合であっても、コイルの内部に樹脂が侵入して充填されることがないので、コイル内に空隙を十分確保できる。   In addition, since the close-wound coil made of a radiopaque wire is used, the position of the tip can be confirmed by radiography. Furthermore, even when the resin film is formed by extrusion molding, the resin does not enter and fill the inside of the coil, so that a sufficient gap can be secured in the coil.

そして、本発明のガイドワイヤは、コイル及び前記芯線の全周にわたって樹脂膜がしっかりと密着して形成されているので、基端部の操作を先端部に伝える際の回転伝達性が良好で、樹脂膜が伸びてたるんだり、蛇腹状となったりすることもない。   And since the resin film is formed in close contact with the coil and the entire circumference of the core wire, the guide wire of the present invention has good rotation transmission when transmitting the operation of the proximal end to the distal end, The resin film is not stretched and sagged or bellows.

本発明の第２は、前記第１の発明において、前記コイルの基端部側は前記芯線の該コイルの内径よりも小さい部分に固着されており、前記コイルの基端部側の内径と、前記芯線の該コイルの基端部側が固着された部分の外径との差が、０．０２〜０．２ｍｍである医療用ガイドワイヤを提供するものである。   According to a second aspect of the present invention, in the first aspect, the proximal end side of the coil is fixed to a portion of the core wire that is smaller than the inner diameter of the coil, and the inner diameter of the coil on the proximal end side; A medical guide wire in which a difference from an outer diameter of a portion of the core wire to which a proximal end side of the coil is fixed is 0.02 to 0.2 mm is provided.

上記第２の発明によれば、コイルの基端部側の内径と、芯線の該コイルの基端部側が固着された部分の外径との差を上記範囲とすることで、コイル内に空隙を充分設けることができ、その結果、先端部が柔軟で曲がりやすいものありながら、先端部の芯線が変形しにくく、体内の狭窄部における挿入性や、分岐部における血管選択性等に優れたカテーテルとすることができる。   According to the second aspect of the present invention, the difference between the inner diameter on the proximal end side of the coil and the outer diameter of the portion of the core wire to which the proximal end side of the coil is fixed is within the above range, so that there is a gap in the coil. As a result, the catheter is excellent in insertion property at the constricted part in the body, blood vessel selectivity at the branch part, etc. It can be.

本発明の第３は、前記第１又は２の発明において、前記樹脂膜が押出し成形によって形成されている医療用ガイドワイヤを提供するものである。   According to a third aspect of the present invention, there is provided the medical guide wire according to the first or second aspect, wherein the resin film is formed by extrusion molding.

上記第３の発明によれば、コイル及び前記芯線の全周にわたって樹脂膜が押出成形によって被着されているので、芯線及びコイルに対し、樹脂膜が空隙を生じることなくしっかりと密着しており、基端部の操作を先端部に伝える際の回転伝達性が良好で、樹脂膜が伸びてたるんだり、蛇腹状となったりすることもない。   According to the third invention, since the resin film is applied by extrusion molding over the entire circumference of the coil and the core wire, the resin film is firmly attached to the core wire and the coil without generating a gap. Rotational transmission at the time of transmitting the operation of the proximal end portion to the distal end portion is good, and the resin film does not stretch or become bellows.

本発明のガイドワイヤによれば、芯線の先端部外周に装着されたコイルの内部に空隙が形成されているので、ガイドワイヤ先端部の柔軟性を向上させると共に、芯線が強く曲げられることを防止して、ガイドワイヤ先端部の付形形状を維持することができる。   According to the guide wire of the present invention, since the gap is formed inside the coil attached to the outer periphery of the tip end portion of the core wire, the flexibility of the tip end portion of the guide wire is improved and the core wire is prevented from being bent strongly. As a result, the shape of the guide wire tip can be maintained.

また、コイル及び前記芯線の全周にわたって樹脂膜がしっかりと密着して形成されているので、ガイドワイヤ基端部の操作を先端部に伝える際の回転伝達性が良好であり、樹脂膜が伸びてたるんだり、蛇腹状となったりすることもない。   In addition, since the resin film is tightly formed over the entire circumference of the coil and the core wire, the rotation transmission property when the operation of the guide wire proximal end portion is transmitted to the distal end portion is good, and the resin film is stretched. There is no sagging or bellows.

図１〜４には本発明によるガイドワイヤの一実施形態が示されている。図１は同ガイドワイヤの側面図、図２は同ガイドワイヤの側断面図、図３は同ガイドワイヤの先端部の一部を拡大した側断面図、図４は屈曲した血管内における同ガイドワイヤの使用状態を示す説明図である。   1 to 4 show an embodiment of a guide wire according to the present invention. 1 is a side view of the guide wire, FIG. 2 is a side sectional view of the guide wire, FIG. 3 is a side sectional view in which a part of the distal end portion of the guide wire is enlarged, and FIG. 4 is the guide in a bent blood vessel. It is explanatory drawing which shows the use condition of a wire.

図１、２に示すように、このガイドワイヤ１０は、芯線２０と、芯線２０の先端部２２の外周に装着されたコイル３０と、芯線２０の先端部２２及びコイル３０を被覆する樹脂膜４０とで主として構成され、コイル３０の内部に空隙３５を有している。   As shown in FIGS. 1 and 2, the guide wire 10 includes a core wire 20, a coil 30 attached to the outer periphery of the tip portion 22 of the core wire 20, and a resin film 40 that covers the tip portion 22 of the core wire 20 and the coil 30. And has a gap 35 inside the coil 30.

この実施形態の場合、芯線２０は、本体部２１と、テーパー部２２ａと、縮径部２２ｂとで構成されており、テーパー部２２ａと、縮径部２２ｂとが、本発明における先端部２２を構成している。   In the case of this embodiment, the core wire 20 is comprised by the main-body part 21, the taper part 22a, and the diameter reducing part 22b, and the taper part 22a and the diameter reducing part 22b are the tip parts 22 in this invention. It is composed.

なお、芯線２０としては、先端部２２が本体部２１に比して小径となっているものであれば特に限定は無く、例えば、図５（ａ）に示すような先端部２２がテーパー状に縮径されているものや、同図（ｂ）に示すような先端部２２がテーパー部２２ａを介さずに段状に縮径されているものなどであってもよい。   The core wire 20 is not particularly limited as long as the distal end portion 22 has a smaller diameter than the main body portion 21. For example, the distal end portion 22 as shown in FIG. The diameter may be reduced, or the tip part 22 as shown in FIG. 5B may be reduced in a step shape without using the taper part 22a.

芯線２０の材質としては、特に限定されないが、超弾性材料、ステンレス、ピアノ線などの弾性材料が好ましく用いられる。超弾性材料としては、Ｎｉ−Ｔｉ合金、Ｃｕ−Ｚｎ−Ｘ（Ｘ＝Ａｌ，Ｆｅ等）合金、Ｎｉ−Ｔｉ−Ｘ（Ｘ＝Ｆｅ，Ｃｕ，Ｖ，Ｃｏ等）合金等が挙げられる。   Although it does not specifically limit as a material of the core wire 20, Elastic materials, such as a superelastic material, stainless steel, and a piano wire, are used preferably. Examples of superelastic materials include Ni—Ti alloys, Cu—Zn—X (X = Al, Fe, etc.) alloys, Ni—Ti—X (X = Fe, Cu, V, Co, etc.) alloys, and the like.

また、芯線２０は、熱間鍛造、熱間圧延、冷間加工などの公知の方法によって所定の線径の線材に加工したものを用いることができる。   Moreover, the core wire 20 can use what was processed into the wire of a predetermined | prescribed wire diameter by well-known methods, such as hot forging, hot rolling, and cold work.

なお、本体部２１の外周には、滑り性、血栓付着防止性を付与するため、疎水性樹脂膜が被覆されていてもよい。このような疎水性樹脂膜としては、例えばシリコン樹脂、フッ素系樹脂等が好ましく採用される。   The outer periphery of the main body 21 may be covered with a hydrophobic resin film in order to provide slipperiness and thrombus adhesion prevention. As such a hydrophobic resin film, for example, a silicon resin, a fluorine resin, or the like is preferably employed.

芯線２０の先端部２２の外周には、コイル３０が配置され、コイル３０の基端部側３１は、芯線２０の先端部２２のコイル３０の内径よりも小さい部分に、ロウ付け、半田付け、溶接接着などによって接合されている。この実施形態ではテーパー部２２ａの途中の部分に、ロウ材５０によって接合されている。また、コイル３０の先端部側３２は、芯線２０の最先端２２ｃとロウ材５１で接合されている。その結果、芯線２０の先端部２２外周と、コイル３０の内周との間に空隙３５が形成されている。   The coil 30 is disposed on the outer periphery of the distal end portion 22 of the core wire 20, and the proximal end portion side 31 of the coil 30 is brazed, soldered to a portion smaller than the inner diameter of the coil 30 of the distal end portion 22 of the core wire 20, Joined by welding or the like. In this embodiment, the brazing material 50 is joined to the middle portion of the tapered portion 22a. Further, the distal end portion side 32 of the coil 30 is joined to the most distal end 22 c of the core wire 20 by a brazing material 51. As a result, a gap 35 is formed between the outer periphery of the distal end portion 22 of the core wire 20 and the inner periphery of the coil 30.

コイル３０は、放射線不透過性の材料からなる密着巻きである。このように、密着巻きにすることによって、後の工程において、樹脂膜４０を押出し成形した際、コイル３０の線材の隙間に樹脂が入り込みにくいので、コイル３０と芯線２０との間に樹脂が充填されにくく、コイル３０と芯線２０との間に充分な空隙３５を設けることができる。   The coil 30 is a close winding made of a radiopaque material. In this way, when the resin film 40 is extruded and formed in a subsequent process, the resin is less likely to enter the gap between the wires of the coil 30 in the subsequent process, so that the resin is filled between the coil 30 and the core wire 20. Therefore, a sufficient gap 35 can be provided between the coil 30 and the core wire 20.

コイル３０を形成する放射線不透過性の材料としては、例えば、Ａｕ、Ｐｔ、Ａｇ、Ｂｉ、Ｗ、又はこれらの金属を含有する合金等が挙げられる。   Examples of the radiopaque material forming the coil 30 include Au, Pt, Ag, Bi, W, and alloys containing these metals.

なお、芯線２０及び／又はコイル３０の線材としては、図６に示すような外周に配置された超弾性合金ｂと、その中心部に配置された放射線不透過性材料ａとで構成される線材が特に好ましい。この場合、外周に配置された超弾性合金ｂと中心部に配置された放射線不透過性材料ａは、一体であっても、別体で相対的に移動可能であってもよい。   In addition, as a wire of the core wire 20 and / or the coil 30, the wire comprised by the superelastic alloy b arrange | positioned at the outer periphery as shown in FIG. 6, and the radiopaque material a arrange | positioned in the center part. Is particularly preferred. In this case, the superelastic alloy b disposed on the outer periphery and the radiopaque material a disposed on the central portion may be integral or may be relatively movable separately.

上記中心部に配置された放射線不透過性材料ａとしては、Ａｕ、Ｐｔ、Ａｇ、Ｂｉ、Ｗ、又はこれらの金属を含有する合金等が用いられ、外周に配置された超弾性合金ｂとしては、Ｎｉ−Ｔｉ系の形状記憶合金等が好ましく用いられる。また、図６における中心部に配置された放射線不透過性材料ａの直径Ｘと、線材の直径Ｙとの関係は、中心部に配置された放射線不透過性材料ａの横断面積が線材の横断面積に対して１０〜４０％の範囲となるように設定することが好ましい。   As the radiopaque material a disposed in the central portion, Au, Pt, Ag, Bi, W, or an alloy containing these metals is used, and as the superelastic alloy b disposed on the outer periphery, Ni-Ti-based shape memory alloys and the like are preferably used. Further, the relationship between the diameter X of the radiopaque material a disposed at the center in FIG. 6 and the diameter Y of the wire is such that the cross-sectional area of the radiopaque material a disposed at the center is crossed by the wire. It is preferable to set it in a range of 10 to 40% with respect to the area.

この線材は、中心部に配置された放射線不透過性材料ａ及び外周に配置された超弾性合金ｂで形成されているので、管状器官の屈曲部に自然に曲がって対応することが可能な柔軟性と、コイル３０の位置をＸ線透視カメラ等の放射線造影によって視認できる視認性とを兼ね備えている。   Since this wire is formed of the radiopaque material a disposed at the center and the superelastic alloy b disposed at the outer periphery, the wire can be flexibly adapted to bend at the bent portion of the tubular organ. And the visibility which can visually recognize the position of the coil 30 by radiography such as an X-ray fluoroscopic camera.

コイル３０の線径は、φ０．０３〜φ０．０８ｍｍが好ましい。また、コイル３０の外径Ｄは、φ０．１６〜φ０．４０ｍｍが好ましい。コイル３０の外径Ｄがφ０．１６ｍｍ未満であると、コイル３０の内周と芯線２０の先端部外周との空隙を十分にとることができず、外径Ｄがφ０．４０ｍｍを超えると、芯線との空隙が大きすぎて、ロウ付などによる接合が不十分になりがちである。   The wire diameter of the coil 30 is preferably φ0.03 to φ0.08 mm. The outer diameter D of the coil 30 is preferably φ0.16 to φ0.40 mm. When the outer diameter D of the coil 30 is less than φ0.16 mm, a sufficient gap between the inner periphery of the coil 30 and the outer periphery of the tip end portion of the core wire 20 cannot be taken, and when the outer diameter D exceeds φ0.40 mm, The gap with the core wire is too large, and joining by brazing tends to be insufficient.

また、コイル３０の長さＬは２０〜４００ｍｍが好ましい。コイル３０の長さＬが２０ｍｍ未満では、柔軟な先端部の長さを十分にとることができず、長さＬが４００ｍｍを超えると、柔軟な先端部が長すぎて操作性が低下してしまう。   The length L of the coil 30 is preferably 20 to 400 mm. If the length L of the coil 30 is less than 20 mm, the length of the flexible tip cannot be taken sufficiently, and if the length L exceeds 400 mm, the flexible tip is too long and the operability is reduced. End up.

コイル３０の基端部側３１は、芯線２０の先端部２２のコイル３０の内径よりも小さい部分にロウ材５０によって接合されており、コイル３０の基端部側３１の内径Ｄ１と、芯線２０のコイル３０の基端部側３１が固着された部分の外径Ｄ２との差が、０．０２〜０．２ｍｍであることが好ましく、より好ましくは０．０４〜０．１８ｍｍである。上記Ｄ１とＤ２の差を上述のようにすることで、コイル３０内に充分な空隙３５を保持させることができ、ガイドワイヤ先端部に充分な柔軟性をもたせることができる。 Proximal end 31 of the coil 30 is joined by brazing material 50 in the portion smaller than the inner diameter of the coil 30 of tip 22 of the core wire 20, the inner diameter D 1 of the proximal end 31 of the coil 30, the core wire difference proximal end 31 of the coil 30 to the outer diameter D 2 of the fixed portion 20 is preferably from 0.02 to 0.2 mm, more preferably at 0.04~0.18mm . By making the difference between D 1 and D 2 as described above, a sufficient gap 35 can be held in the coil 30, and a sufficient flexibility can be imparted to the distal end portion of the guide wire.

図１、２に示すように、コイル３０及び芯線２０の先端部２２の外周には、押出成形によって樹脂膜４０が被覆されている。樹脂膜４０としては、ポリウレタン、ポリエーテルブロックアミド、ポリエチレン、ポリ塩化ビニル、ポリエステル、ポリプロピレン、ポリアミド、ポリスチレン、フッ素系樹脂、シリコン樹脂等が挙げられる。   As shown in FIGS. 1 and 2, a resin film 40 is coated on the outer periphery of the coil 30 and the distal end portion 22 of the core wire 20 by extrusion molding. Examples of the resin film 40 include polyurethane, polyether block amide, polyethylene, polyvinyl chloride, polyester, polypropylene, polyamide, polystyrene, fluorine resin, and silicon resin.

樹脂膜４０は、例えば、金型に設けられた穴に、溶融した樹脂を、芯線２０とコイル３０とを一緒に通過させて、所定の速度で引き抜くなどの押出し成形方法や樹脂チューブを被せて収縮する方法等により被覆できる。   For example, the resin film 40 is covered with an extrusion method or a resin tube in which a molten resin is passed through the core wire 20 and the coil 30 together and drawn at a predetermined speed in a hole provided in a mold. It can be coated by a shrinking method or the like.

なお、樹脂膜４０の外周には、−ＯＨ、−ＣＯＮＨ２、−ＣＯＯＨ、−ＮＨ２、−ＣＯＯ−、−ＳＯ３ −などの親水性基を有する樹脂が更に被覆されていても良く、樹脂膜４０の表面に結合できる官能基を有するものが好ましく採用される。例えば、樹脂膜４０として、イソシアネート基が残存する樹脂を用いるか、イソシアネート基と反応性を有する樹脂を用い、イソシアネート基と反応性を有する樹脂を用いる場合には、更にイソシアネート基を有する化合物を反応させた後、これらのイソシアネート基を介して、親水性樹脂膜としてポリビニルピロリドン、ポリエチレングリコールなどを結合させてもよい。このような親水性樹脂膜の形成方法は、例えば、特開平５−１８４６６６号、特開平７−８００７８号、特開平７−１２４２６３号に詳しく示されている。 The outer periphery of the resin film 40 may be further coated with a resin having a hydrophilic group such as —OH, —CONH 2 , —COOH, —NH 2 , —COO − , —SO 3 —. Those having a functional group capable of binding to the surface of the film 40 are preferably employed. For example, when the resin film 40 is a resin having an isocyanate group remaining or a resin having reactivity with an isocyanate group and a resin having reactivity with an isocyanate group is used, a compound having an isocyanate group is further reacted. Then, polyvinyl pyrrolidone, polyethylene glycol or the like may be bonded as a hydrophilic resin film through these isocyanate groups. Such a method for forming a hydrophilic resin film is described in detail, for example, in JP-A-5-184666, JP-A-7-80078, and JP-A-7-124263.

次に、このガイドワイヤ１０の作用について説明する。図４には、このガイドワイヤ１０を血管１内に挿入し、血管１の屈曲２を通過させる状態が示されている。ガイドワイヤ１０の先端部には、コイル３０が取り付けられており、かつ、コイル３０と芯線２０との間には空隙３５が設けられているので、芯線２０の先端部２２は、コイル３０の内周で比較的自由に動ける状態となっている。このため、血管１の屈曲部２に沿ってガイドワイヤ１０の先端部が屈曲したとき、芯線２０の先端部２２は、コイル３０内周でできるだけ直線に近い経路を通って屈曲することができ、芯線２０の先端部２２の屈曲率を小さくすることができる。このため、屈曲部２において芯線２０が受ける応力を低減でき、ガイドワイヤ１０の先端部を予めくせ曲げ等して付形しておいた場合、屈曲部２において芯線２０を変形させることがなく、付形形状を維持することができる。   Next, the operation of the guide wire 10 will be described. FIG. 4 shows a state where the guide wire 10 is inserted into the blood vessel 1 and passes through the bend 2 of the blood vessel 1. Since the coil 30 is attached to the distal end portion of the guide wire 10 and the gap 35 is provided between the coil 30 and the core wire 20, the distal end portion 22 of the core wire 20 is connected to the inner portion of the coil 30. It is in a state where it can move relatively freely around the lap. For this reason, when the distal end portion of the guide wire 10 is bent along the bent portion 2 of the blood vessel 1, the distal end portion 22 of the core wire 20 can be bent through a path as close to a straight line as possible on the inner periphery of the coil 30, The bending rate of the tip portion 22 of the core wire 20 can be reduced. For this reason, the stress which the core wire 20 receives in the bending part 2 can be reduced, and when the front-end | tip part of the guide wire 10 is previously bent and bent etc., the core wire 20 is not deformed in the bending part 2, The shaped shape can be maintained.

また、コイル３０と芯線２０との間には空隙３５が設けられており、コイル３０と芯線２０とが互いに摺動できると共に、コイル３０の外径を比較的大きくすることができるので、ガイドワイヤ１０の先端部の柔軟性がより向上し、血管等の曲折した経路に挿入しやすく、血管内壁などの器官損傷を防止できる。   In addition, a gap 35 is provided between the coil 30 and the core wire 20 so that the coil 30 and the core wire 20 can slide with each other and the outer diameter of the coil 30 can be made relatively large. The flexibility of the tip of 10 is further improved, it is easy to insert into a bent path such as a blood vessel, and organ damage such as the inner wall of the blood vessel can be prevented.

更に、このガイドワイヤ１０においては、コイル３０を放射線不透過性の材料からなる密着巻きとしたことにより、放射線透視下における視認性を高めることができ、また、コイル３０の表面に樹脂を被覆する際、コイル３０と芯線２０との間に樹脂が充填されにくく、コイル３０と芯線２０との間に充分な空隙３５を設けることができる。   Furthermore, in this guide wire 10, the coil 30 is made of a tightly wound winding made of a radiopaque material, so that the visibility under radioscopy can be improved, and the surface of the coil 30 is coated with a resin. At this time, the resin is hardly filled between the coil 30 and the core wire 20, and a sufficient gap 35 can be provided between the coil 30 and the core wire 20.

（実施例１）
以下の工程により、図１、２に示すようなガイドワイヤ１０を製造した。芯線２０としては、ステンレスからなり、本体部２１の直径がφ０．３ｍｍ、先端部２２の縮径部２２ｂの直径がφ０．０６ｍｍ、全体の長さが３５０ｍｍ、先端部２２の長さが２０ｍｍのものを用いた。 Example 1
A guide wire 10 as shown in FIGS. 1 and 2 was manufactured by the following steps. The core wire 20 is made of stainless steel, the diameter of the main body 21 is φ0.3 mm, the diameter of the reduced diameter portion 22b of the tip 22 is φ0.06 mm, the entire length is 350 mm, and the length of the tip 22 is 20 mm. A thing was used.

この芯線２０の先端部２２に、プラチナ合金からなり、線径φ０．０５ｍｍ、コイル外径φ０．２４ｍｍ、コイル内径φ０．１４ｍｍ、長さ５０ｍｍで、線材同士が密着して巻かれたコイル３０を配置して、コイル３０の基端部側３１を芯線２０の先端部２２のコイル３０の内径よりも小さい部分とロウ材５０で接合し、コイル３０の先端部側３２を芯線２０の最先端部２２ａとロウ材５１で接合して固着させた。このとき、図３における、コイル３０の基端部側３１の内径Ｄ１と、芯線２０のコイル３０の基端部側３１が固着された部分の外径Ｄ２との差が０．０８ｍｍとなるようにした。 A coil 30 made of a platinum alloy, wound with a wire diameter of 0.05 mm, a coil outer diameter of 0.24 mm, a coil inner diameter of 0.14 mm, and a length of 50 mm, in which the wire rods are closely attached to each other at the tip 22 of the core wire 20. It arranges, the base end part side 31 of the coil 30 is joined with the part smaller than the internal diameter of the coil 30 of the front-end | tip part 22 of the core wire 20 with the brazing material 50, and the front-end | tip part side 32 of the coil 30 is the most advanced part of the core wire 22a and brazing material 51 were joined and fixed. At this time, in FIG. 3, the inner diameter D 1 of the proximal end 31 of the coil 30, the difference between the outer diameter D 2 of the portion proximal end 31 of the coil 30 of the core wire 20 is fixed and a 0.08mm It was made to become.

そして、ウレタン樹脂を、押出機成形機を用いた押出し成形方法で、芯線２０及びコイル３０の全周にわたって被着して、樹脂膜４０を形成し、実施例１のガイドワイヤを得た。   Then, urethane resin was applied over the entire circumference of the core wire 20 and the coil 30 by an extrusion molding method using an extruder, and a resin film 40 was formed, whereby a guide wire of Example 1 was obtained.

（比較例１）
実施例１において、芯線２０の先端部２２に、コイル３０と芯線２０とが密着する、プラチナ合金からなり、線径φ０．０７ｍｍ、コイル外径φ０．２４ｍｍ、コイル内径φ０．１０ｍｍ、長さ５０ｍｍで、線材同士が密着して巻かれたコイル３０を配置して、コイル３０の基端部側３１を芯線２０の先端部２２とロウ材５０で接合し、コイル３０の先端部側３２を芯線２０の最先端部２２ａとロウ材５１で接合して固着させた以外は、実施例１と同様の条件で、比較例１のガイドワイヤを得た。 (Comparative Example 1)
In Example 1, the coil 30 and the core wire 20 are in close contact with the distal end portion 22 of the core wire 20 and are made of a platinum alloy. The wire diameter is 0.07 mm, the coil outer diameter is 0.24 mm, the coil inner diameter is 0.10 mm, and the length is 50 mm. Then, the coil 30 wound with the wires closely attached is arranged, the proximal end portion 31 of the coil 30 is joined to the distal end portion 22 of the core wire 20 with the brazing material 50, and the distal end portion 32 of the coil 30 is connected to the core wire. A guide wire of Comparative Example 1 was obtained under the same conditions as in Example 1 except that the 20 leading edge portions 22a and the brazing material 51 were joined and fixed.

実施例１、比較例1のガイドワイヤについて、それぞれ、先端柔軟性及び耐変形性について評価した。   The guidewires of Example 1 and Comparative Example 1 were evaluated for tip flexibility and deformation resistance, respectively.

＜先端柔軟性評価＞
ガイドワイヤ１０の最先端の部分を、５ｍｍ突出させた状態で、樹脂製の板６０に押し当てて、図７の矢印方向に沿って、０．５ｍｍ／分の速度で３ｍｍ押し込んだ際の抵抗荷重の最大値（突き当て最大荷重）を測定した。その結果を表１にまとめて示す。 <Advanced flexibility evaluation>
The resistance when the leading edge of the guide wire 10 is pressed 5 mm from the resin plate 60 and pressed 3 mm at a speed of 0.5 mm / min along the direction of the arrow in FIG. The maximum value of load (abutting maximum load) was measured. The results are summarized in Table 1.

表１に示すように、本発明のガイドワイヤは、芯線２０にコイル３０の線材が密着するように設置した比較例１のガイドワイヤと比較して、最大荷重が低く、先端部の柔軟性が良好であることがわかる。   As shown in Table 1, the guide wire of the present invention has a lower maximum load and flexibility at the tip than the guide wire of Comparative Example 1 installed so that the wire rod of the coil 30 is in close contact with the core wire 20. It turns out that it is favorable.

＜耐変形性評価＞
図８に示す、半径Ｒ＝２．５ｍｍの円弧を有する治具溝７０を純水で満たした状態で、ガイドワイヤ１０の先端９ｃｍの部分をトルクディバイスで把持し、把持部分までガイドワイヤ１０を治具溝７０に沿って挿入した。その後、治具溝７０へのガイドワイヤ１０の挿入、引き出しを連続して２０回繰り返し、先端部の変形具合を目視で確認した。その結果を図９に記す。 <Deformation resistance evaluation>
In a state where the jig groove 70 having a circular arc with a radius R = 2.5 mm shown in FIG. 8 is filled with pure water, the portion of the guide wire 10 having a tip of 9 cm is gripped with a torque device, and the guide wire 10 is held to the gripped portion. It was inserted along the jig groove 70. Thereafter, the insertion and withdrawal of the guide wire 10 into and from the jig groove 70 were continuously repeated 20 times, and the degree of deformation of the tip portion was visually confirmed. The result is shown in FIG.

図９に示すように、本発明のカテーテルは、芯線２０にコイル３０の線材が密着するように設置した比較例１のガイドワイヤと比較して、変形しにくく、形状維持性の高いことがわかる。   As shown in FIG. 9, it can be seen that the catheter of the present invention is less likely to be deformed and has higher shape maintainability than the guide wire of Comparative Example 1 installed so that the wire rod of the coil 30 is in close contact with the core wire 20. .

本発明のガイドワイヤの一実施形態の側面図である。It is a side view of one Embodiment of the guide wire of this invention. 同ガイドワイヤの側断面図である。It is a sectional side view of the same guide wire. 同ガイドワイヤの先端部の拡大図である。It is an enlarged view of the front-end | tip part of the guide wire. 本発明のガイドワイヤの使用例を示す説明図である。It is explanatory drawing which shows the usage example of the guide wire of this invention. 本発明で用いることのできる芯線の他の例を示す説明図である。It is explanatory drawing which shows the other example of the core wire which can be used by this invention. 本発明で用いることのできる線材の一例を示す説明図である。It is explanatory drawing which shows an example of the wire which can be used by this invention. 実施例における先端部柔軟性の測定方法を示す説明図である。It is explanatory drawing which shows the measuring method of the front-end | tip part softness | flexibility in an Example. 実施例における耐変形性試験に用いた治具の説明図である。It is explanatory drawing of the jig | tool used for the deformation resistance test in an Example. 実施例及び比較例の耐変形性試験の結果を示す写真である。It is a photograph which shows the result of the deformation resistance test of an Example and a comparative example.

符号の説明Explanation of symbols

１：血管
２：屈曲部
１０：ガイドワイヤ
２０：芯線
３０：コイル
３５：空隙
４０：樹脂膜
５０、５１：ロウ材 1: Blood vessel 2: Bent part 10: Guide wire 20: Core wire 30: Coil 35: Gap 40: Resin film 50, 51: Brazing material

Claims (3)

先端部が本体部に比して小径とされた芯線と、この芯線の先端部外周に設けられたコイルとを有するガイドワイヤにおいて、
前記コイルは、放射線不透過性の線材からなる密着巻きコイルであり、
前記コイルの基端部側は前記芯線の先端部に固着され、かつ、前記コイルの先端部側は前記芯線の最先端と固着して一体となっており、
前記コイル及び前記芯線の全周にわたって、前記コイルの内部に空隙が設けられた状態で樹脂膜が形成されていることを特徴とする医療用ガイドワイヤ。 In a guide wire having a core wire whose tip is smaller in diameter than the main body and a coil provided on the outer periphery of the tip of the core,
The coil is a tightly wound coil made of a radiopaque wire,
The proximal end side of the coil is fixed to the distal end portion of the core wire, and the distal end side of the coil is fixed to and integrated with the leading edge of the core wire,
A medical guide wire, wherein a resin film is formed in a state where a gap is provided inside the coil over the entire circumference of the coil and the core wire. 前記コイルの基端部側は前記芯線の該コイルの内径よりも小さい部分に固着されており、前記コイルの基端部側の内径と、前記芯線の該コイルの基端部側が固着された部分の外径との差が、０．０２〜０．２ｍｍである請求項１に記載の医療用ガイドワイヤ。   The base end side of the coil is fixed to a portion of the core wire that is smaller than the inner diameter of the coil, and the inner diameter of the coil on the base end side is fixed to the base end side of the coil of the core wire. The medical guide wire according to claim 1, wherein a difference from the outer diameter is 0.02 to 0.2 mm. 前記樹脂膜が押出し成形によって形成されている請求項１又は２に記載の医療用ガイドワイヤ。   The medical guide wire according to claim 1, wherein the resin film is formed by extrusion molding.
JP2005270864A 2005-09-16 2005-09-16 Medical guide wire Pending JP2007075531A (en)

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JP2010000222A (en) * 2008-06-20 2010-01-07 Piolax Medical Device:Kk Guide wire, and its manufacturing method
JP2011147573A (en) * 2010-01-21 2011-08-04 Asahi Intecc Co Ltd Medical guidewire
JP2011147572A (en) * 2010-01-21 2011-08-04 Asahi Intecc Co Ltd Medical guidewire
JP2017108331A (en) * 2015-12-11 2017-06-15 ウエストユニティス株式会社 Flexible arm
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JP2005211511A (en) * 2004-01-30 2005-08-11 Terumo Corp Guide wire

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JP2004249095A (en) * 2003-01-31 2004-09-09 Piolax Medical Device:Kk Guide wire
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Publication number Priority date Publication date Assignee Title
JP2010000222A (en) * 2008-06-20 2010-01-07 Piolax Medical Device:Kk Guide wire, and its manufacturing method
JP2011147573A (en) * 2010-01-21 2011-08-04 Asahi Intecc Co Ltd Medical guidewire
JP2011147572A (en) * 2010-01-21 2011-08-04 Asahi Intecc Co Ltd Medical guidewire
US8622933B2 (en) 2010-01-21 2014-01-07 Asahi Intecc Co., Ltd. Medical guidewire
JP2017108331A (en) * 2015-12-11 2017-06-15 ウエストユニティス株式会社 Flexible arm
WO2018042652A1 (en) 2016-09-05 2018-03-08 朝日インテック株式会社 Guide wire
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US10792474B2 (en) 2016-09-05 2020-10-06 Asahi Intecc Co., Ltd. Guidewire
JPWO2018185917A1 (en) * 2017-04-06 2020-02-13 朝日インテック株式会社 Tubular body and catheter provided with the tubular body
CN109803712A (en) * 2017-04-06 2019-05-24 朝日英达科株式会社 Tubular body and conduit with the tubular body
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JP2021514771A (en) * 2018-03-01 2021-06-17 北京佰▲為▼深科技▲発▼展有限公司 Pressure guide wire
US11849929B2 (en) 2018-03-01 2023-12-26 Beijing Bywave Sensing Technology Co., Ltd. Pressure guide wire
WO2020003503A1 (en) * 2018-06-29 2020-01-02 朝日インテック株式会社 Guide wire
CN112334179A (en) * 2018-06-29 2021-02-05 朝日英达科株式会社 Guide wire
JPWO2020003503A1 (en) * 2018-06-29 2021-06-10 朝日インテック株式会社 Guide wire
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US11931535B2 (en) 2018-06-29 2024-03-19 Asahi Intecc Co., Ltd. Guide wire

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