JP5280263B2 - Guide wire - Google Patents

Guide wire Download PDF

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JP5280263B2
JP5280263B2 JP2009074911A JP2009074911A JP5280263B2 JP 5280263 B2 JP5280263 B2 JP 5280263B2 JP 2009074911 A JP2009074911 A JP 2009074911A JP 2009074911 A JP2009074911 A JP 2009074911A JP 5280263 B2 JP5280263 B2 JP 5280263B2
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tip portion
tip
distal end
wire
guide wire
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JP2010227136A (en
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浩範 河崎
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Japan Lifeline Co Ltd
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Japan Lifeline Co Ltd
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Abstract

<P>PROBLEM TO BE SOLVED: To provide technology, achieving reduction in time required for replacement work of a guide wire inserted in a blood vessel or the like and lowering of operation cost. <P>SOLUTION: The guide wire 10 includes a first distal end part 20 as one distal end area and a second distal end part 30 as the other distal end area on the opposite side to the first distal end part 20. The proximal end of the first distal end part 20 and the proximal end of the second distal end part 30 are bonded to each other, and the insert direction of the guide wire 10 is changed to insert both the distal end of the first distal end part 20 and the distal end of the second distal end part 30 in a lumen such as a blood vessel. Since the outside diameter of the first distal end part 20 is smaller than that of the second distal end part 30, the first distal end part 20 has higher flexibility than the second distal end part 30. <P>COPYRIGHT: (C)2011,JPO&amp;INPIT

Description

本発明は、医療用のガイドワイヤに関する。   The present invention relates to a medical guide wire.

経皮的冠動脈形成術（ＰＴＣＡ）、ステント植え込み術などの治療や、心臓血管造影などの検査においては、カテーテルが血管内の所定位置まで挿入される。カテーテルは柔軟な材質で形成されており、カテーテルを挿入する血管は複雑な形状に屈曲しているので、カテーテルのみでは、血管内の所定位置まで押し込むことは困難である。そのために、血管内にガイドワイヤを挿入し、そのガイドワイヤに沿ってカテーテルを血管内の所定位置まで押し進めることが行われている。   In treatments such as percutaneous coronary angioplasty (PTCA) and stent implantation, and examinations such as cardiovascular angiography, a catheter is inserted to a predetermined position in the blood vessel. The catheter is made of a flexible material, and the blood vessel into which the catheter is inserted is bent into a complicated shape. Therefore, it is difficult to push the catheter into a predetermined position within the blood vessel. For this purpose, a guide wire is inserted into the blood vessel, and the catheter is pushed along the guide wire to a predetermined position in the blood vessel.

特開２００２−０９５７５５号公報JP 2002-095755 A

ガイドワイヤが挿入される血管の形状は患者によって異なる。このため、通常、医師は柔軟性や潤滑性に起因して操作性が異なるガイドワイヤを準備しておき、患者の血管への挿入に適したガイドワイヤが見つかるまで複数のガイドワイヤを使用している。   The shape of the blood vessel into which the guide wire is inserted varies depending on the patient. For this reason, doctors typically prepare guidewires with different operability due to flexibility and lubricity, and use multiple guidewires until a guidewire suitable for insertion into a patient's blood vessel is found. Yes.

ガイドワイヤの血管内に挿入した後、別のガイドワイヤを使用する場合には、ガイドワイヤの交換作業が必要となる。この交換作業に要する時間が手術時間の長時間化の要因となっていた。また、挿入に適したガイドワイヤを決めるまでに複数のガイドワイヤが使用されるため、ガイドワイヤの使用本数の増加による手術費用の増大を招いていた。   When another guide wire is used after being inserted into the blood vessel of the guide wire, the guide wire needs to be replaced. The time required for this replacement work was a factor in lengthening the operation time. In addition, since a plurality of guide wires are used until a guide wire suitable for insertion is determined, the operation cost is increased due to an increase in the number of guide wires used.

本発明はこうした課題に鑑みてなされたものであり、その目的は、血管等への挿入されるガイドワイヤの交換作業に要する時間を短縮するとともに、手術費用の低減を図ることのできる技術の提供にある。   The present invention has been made in view of these problems, and an object of the present invention is to provide a technique capable of shortening the time required for exchanging a guide wire inserted into a blood vessel or the like and reducing the operation cost. It is in.

本発明のある態様は、ガイドワイヤである。当該ガイドワイヤは、血管等の管腔内に挿入可能な第１の先端部と、前記第１の先端部の反対側に前記第１の先端部と分離して設けられ、血管等の管腔内に挿入可能な第２の先端部と、一方の開口に、近位端側に向けて径が徐々に小さくなる、前記第１の先端部の近位端部分が挿入された状態で固定され、他方の開口に、近位端側に向けて径が徐々に小さくなる、前記第２の先端部の近位端部分が前記第１の先端部の近位端部分との間に隙間が生じるように挿入された状態で固定される中空円筒状の接続部材と、を備え、前記第１の先端部と前記第２の先端部とで、柔軟性、摩擦抵抗および先端湾曲形状のうち少なくとも一つの特性が異なり、前記第１の先端部を構成する材料が前記第２の先端部を構成する材料と異なり、前記第１の先端部と前記第２の先端部とで、表面の親水性が異なっていることを特徴とする。 One embodiment of the present invention is a guide wire. The guide wire is provided with a first tip portion that can be inserted into a lumen such as a blood vessel and a first tip portion that is separated from the first tip portion on the opposite side of the first tip portion. A second tip portion that can be inserted into the first tip portion is fixed to one opening in a state in which the proximal end portion of the first tip portion is inserted into the first opening, and the diameter gradually decreases toward the proximal end side. In the other opening, the diameter gradually decreases toward the proximal end side, and a gap is formed between the proximal end portion of the second tip portion and the proximal end portion of the first tip portion. A hollow cylindrical connecting member fixed in the inserted state, and at least one of flexibility, frictional resistance, and tip bending shape between the first tip portion and the second tip portion. one of the characteristics are different, different from the material of the material constituting the first tip constituting the second tip, the first tip portion In the second tip portion, wherein the hydrophilic surface is different.

上記態様において、前記第１の先端部および前記第２の先端部のいずれか一方の側に、当該先端部を識別するための標識が設けられていてもよい。 In the above embodiment, prior Symbol either side of the first tip portion and the second tip portion may be labeled are provided for identifying the tip.

本発明によれば、血管等への挿入されるガイドワイヤの交換作業に要する時間を短縮するとともに、手術費用の低減を図ることができる。   ADVANTAGE OF THE INVENTION According to this invention, while reducing the time which replacement | exchange operation | movement of the guide wire inserted in the blood vessel etc. requires, it can aim at reduction of operation cost.

実施の形態１に係るガイドワイヤの構成を示す外観図である。FIG. 3 is an external view illustrating a configuration of a guide wire according to the first embodiment. 実施の形態２に係るガイドワイヤの構成を示す外観図である。6 is an external view showing a configuration of a guide wire according to Embodiment 2. FIG. 第１の先端部を構成するワイヤ芯線と第２の先端部を構成するワイヤ芯線との接合部分の構成を示す断面図である。It is sectional drawing which shows the structure of the junction part of the wire core wire which comprises a 1st front-end | tip part, and the wire core wire which comprises a 2nd front-end | tip part. 実施の形態３に係るガイドワイヤの構成を示す外観図である。FIG. 6 is an external view illustrating a configuration of a guide wire according to a third embodiment.

以下、本発明の実施の形態を図面を参照して説明する。なお、すべての図面において、同様な構成要素には同様の符号を付し、適宜説明を省略する。   Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same reference numerals are given to the same components, and the description will be omitted as appropriate.

（実施の形態１）
図１は、実施の形態１に係るガイドワイヤの構成を示す外観図である。ガイドワイヤ１０は、一方の先端領域である第１の先端部２０と、第１の先端部２０とは反対側の先端領域である第２の先端部３０とを備える。第１の先端部２０の近位端と、第２の先端部３０の近位端とが接合されており、ガイドワイヤ１０の挿入方向を変えることにより、第１の先端部２０の遠位端を血管等の管腔内に挿入することと、第２の先端部３０の遠位端を血管等の管腔内に挿入することの両方が可能である。 (Embodiment 1)
FIG. 1 is an external view showing a configuration of a guide wire according to the first embodiment. The guide wire 10 includes a first tip portion 20 that is one tip region, and a second tip portion 30 that is a tip region opposite to the first tip portion 20. The proximal end of the first tip 20 is joined to the proximal end of the second tip 30, and the distal end of the first tip 20 is changed by changing the insertion direction of the guide wire 10. Can be inserted into a lumen such as a blood vessel, and the distal end of the second tip 30 can be inserted into a lumen such as a blood vessel.

第１の先端部２０は、ワイヤ芯線２１、コイル２２およびボール部２３を備える。   The first tip portion 20 includes a wire core wire 21, a coil 22, and a ball portion 23.

ワイヤ芯線２１は、近位端側大径部２４と近位端側大径部２４より外径が小さい遠位端側小径部２５とを有する。ワイヤ芯線２１全体の長さは、特に制限はなく、ガイドワイヤ１０の使用目的に応じて適宜選択することができるが、通常は８００〜３,５００ｍｍである。遠位端側小径部２５の長さは、それぞれ、たとえば、１００〜５００ｍｍである。ワイヤ芯線２１の材料としては、ＳＵＳ３０４、ＳＵＳ３１６などのステンレス鋼線、ＮｉＴｉなどの超弾性合金を用いることができる。   The wire core wire 21 has a proximal end side large diameter portion 24 and a distal end side small diameter portion 25 having an outer diameter smaller than that of the proximal end side large diameter portion 24. The length of the entire wire core wire 21 is not particularly limited and can be appropriately selected according to the purpose of use of the guide wire 10, but is usually 800 to 3,500 mm. The length of the distal end side small diameter portion 25 is, for example, 100 to 500 mm. As a material for the wire core wire 21, a stainless steel wire such as SUS304 or SUS316, or a superelastic alloy such as NiTi can be used.

コイル２２は、ワイヤ芯線２１の遠位端側小径部２５の周囲に設けられている。コイル２２の外径は、近位端側大径部２４と同等である。コイル２２の外径を近位端側大径部２４と同等とすることにより、第１の先端部２０の遠位端から近位端までの表面の凹凸を低減し、ガイドワイヤ１０の挿入性を向上させることができる。コイル２２の素線としては、ＳＵＳ３０４、ＳＵＳ３１６などのステンレス鋼線を用いることができる。ステンレス鋼線には、引張強度が大きい線種があり、Ｘ線透過性を有するのでＸ線透視の妨げとならず、細線の入手も容易である。コイル２２の遠位端側には、Ｐｔ−８Ｗ、Ｐｔ−７ＮｉなどのＸ線不透過材料を用いることが望ましい。これによれば、ガイドワイヤ１０を体内に挿入してＸ線透視を行う場合の造影性を向上させ、ガイドワイヤ１０の遠位端の位置を容易に視認することができる。コイル２２の素線の直径は、たとえば、０.０３〜０.０８ｍｍである。コイル２２の素線の直径が０.０３ｍｍ未満であると、強度が不足し、ガイドワイヤ用のコイルスプリングへの加工も困難となるおそれがある。コイル２２の素線の直径が０.０８ｍｍを超えると、ガイドワイヤ１０の外径が太くなりすぎるおそれがある。   The coil 22 is provided around the distal end side small diameter portion 25 of the wire core wire 21. The outer diameter of the coil 22 is equivalent to that of the proximal end side large diameter portion 24. By making the outer diameter of the coil 22 equal to that of the proximal-end-side large-diameter portion 24, surface irregularities from the distal end to the proximal end of the first tip portion 20 are reduced, and the insertion property of the guide wire 10 is reduced. Can be improved. As the wire of the coil 22, a stainless steel wire such as SUS304 or SUS316 can be used. Stainless steel wires have line types with high tensile strength and have X-ray permeability, so that they do not hinder X-ray fluoroscopy, and it is easy to obtain fine wires. It is desirable to use a radiopaque material such as Pt-8W or Pt-7Ni on the distal end side of the coil 22. According to this, it is possible to improve the contrast when the guide wire 10 is inserted into the body and perform X-ray fluoroscopy, and the position of the distal end of the guide wire 10 can be easily visually confirmed. The diameter of the wire of the coil 22 is, for example, 0.03 to 0.08 mm. If the diameter of the wire of the coil 22 is less than 0.03 mm, the strength is insufficient, and it may be difficult to process the coil spring for the guide wire. If the diameter of the wire of the coil 22 exceeds 0.08 mm, the outer diameter of the guide wire 10 may be too large.

ボール部２３は、ワイヤ芯線２１の遠位端に設けられている。ボール部２３は、遠位端面が滑らかな曲面で構成されている。遠位端にボール部２３を設けることにより、ガイドワイヤ１０の遠位端を滑らかにし、血管の内壁を損傷することなく、血管内を押し進めることができる。ボール部２３の材質に特に制限はなく、例えば、白金、金などの金属を挙げることができる。ボール部２３のワイヤ芯線２１の遠位端への接合方法に特に制限はなく、例えば、溶接、ろう付けなどを挙げることができる。   The ball portion 23 is provided at the distal end of the wire core wire 21. The ball portion 23 has a curved surface with a smooth distal end surface. By providing the ball portion 23 at the distal end, the distal end of the guide wire 10 can be smoothed and pushed inside the blood vessel without damaging the inner wall of the blood vessel. There is no restriction | limiting in particular in the material of the ball | bowl part 23, For example, metals, such as platinum and gold | metal | money, can be mentioned. There is no restriction | limiting in particular in the joining method to the distal end of the wire core wire 21 of the ball | bowl part 23, For example, welding, brazing, etc. can be mentioned.

第１の先端部２０は、摩擦抵抗の低い樹脂で被覆されていることが好ましい。第１の先端部２０を樹脂で被覆することにより、第１の先端部２０の凹凸が低減されるため、第１の先端部２０の潤滑性、挿入性とトルク伝達性を向上することができる。摩擦抵抗の低い樹脂としては、たとえば、フッ素樹脂、ポリアセタール、ポリエチレンなどが挙げられる。   It is preferable that the 1st front-end | tip part 20 is coat | covered with resin with low frictional resistance. By covering the first tip portion 20 with resin, the unevenness of the first tip portion 20 is reduced, so that the lubricity, insertion property and torque transmission property of the first tip portion 20 can be improved. . Examples of the resin having low frictional resistance include a fluororesin, polyacetal, and polyethylene.

また、第１の先端部２０の遠位端と第２の先端部３０の遠位端とで潤滑性、挿入性を変えることにより、第１の先端部２０を挿入用の遠位端として用いた場合と第２の先端部３０を挿入用の遠位端として用いた場合とで異なる挿入性を実現することができる。   Further, by changing the lubricity and insertion property between the distal end of the first tip 20 and the distal end of the second tip 30, the first tip 20 can be used as a distal end for insertion. Different insertability can be achieved between the case where the second tip 30 is used and the case where the second tip 30 is used as the distal end for insertion.

また、当該樹脂の表面に親水性ポリマーを被覆することにより、第１の先端部２０の潤滑性または挿入性をさらに向上させることができる。親水性ポリマーで被覆する方法に特に制限はなく、たとえば、３官能性成分を含むポリエチレングリコールとジイソシアネート化合物との反応、ポリエチレングリコールと３官能性成分を含むポリイソシアネート化合物との反応、ポリエチレングリコールジ(メタ)アクリレートの重合反応などにより、架橋構造を有する親水性ポリマーの被覆を形成することができる。なお、上述した樹脂は親水性ポリマーと架橋しやすいため、親水性ポリマーの被覆を容易にすることができる。   Moreover, the lubricity or insertion property of the first tip portion 20 can be further improved by coating the surface of the resin with a hydrophilic polymer. The method for coating with a hydrophilic polymer is not particularly limited. For example, the reaction between polyethylene glycol containing a trifunctional component and a diisocyanate compound, the reaction between polyethylene glycol and a polyisocyanate compound containing a trifunctional component, polyethylene glycol di ( A coating of a hydrophilic polymer having a crosslinked structure can be formed by a polymerization reaction of (meth) acrylate. In addition, since the resin described above is easily cross-linked with the hydrophilic polymer, the coating with the hydrophilic polymer can be facilitated.

第２の先端部３０は、ワイヤ芯線３１、コイル３２およびボール部３３を備える。   The second tip portion 30 includes a wire core wire 31, a coil 32, and a ball portion 33.

ワイヤ芯線３１は、近位端側大径部３４と近位端側大径部３４より外径が小さい遠位端側小径部３５とを有する。ワイヤ芯線３１全体の長さは、特に制限はなく、ガイドワイヤ１０の使用目的に応じて適宜選択することができるが、通常は８００〜３,５００ｍｍである。また、遠位端側小径部３５の長さは、たとえば、１００〜５００ｍｍである。ワイヤ芯線３１の材料としては、ＳＵＳ３０４、ＳＵＳ３１６などのステンレス鋼線、ＮｉＴｉなどの超弾性合金を用いることができる。   The wire core 31 has a proximal end side large diameter portion 34 and a distal end side small diameter portion 35 having an outer diameter smaller than that of the proximal end side large diameter portion 34. The length of the entire wire core 31 is not particularly limited and can be appropriately selected according to the purpose of use of the guide wire 10, but is usually 800 to 3,500 mm. Moreover, the length of the distal end side small diameter portion 35 is, for example, 100 to 500 mm. As a material of the wire core wire 31, a stainless steel wire such as SUS304 or SUS316, or a superelastic alloy such as NiTi can be used.

なお、近位端側大径部３４の近位端は、テーパ状となっており、近位端側大径部３４の最近位（第１の先端部２０との接合面）における外径は、第１の先端部２０の近位端側大径部２４の径と同等になっている。これによれば、外径の異なるワイヤ芯線の接合部分において、外径が急激に変化することが抑制されるため、ガイドワイヤ１０にトルクをかけたときに当該接合部分にかかる負荷を低減することができる。この結果、ガイドワイヤ１０全体の強度、耐久性等の特性を向上させることができる。   The proximal end of the proximal end side large-diameter portion 34 is tapered, and the outer diameter of the proximal end side large-diameter portion 34 at the most proximal position (joint surface with the first tip portion 20) is The diameter of the large diameter portion 24 on the proximal end side of the first tip portion 20 is the same. According to this, since the outer diameter is suppressed from changing suddenly at the joint portion of the wire core wires having different outer diameters, the load applied to the joint portion when torque is applied to the guide wire 10 can be reduced. Can do. As a result, characteristics such as the strength and durability of the entire guide wire 10 can be improved.

コイル３２は、ワイヤ芯線３１の遠位端側小径部３５の周囲に設けられている。コイル３２の外径は、近位端側大径部３４と同等である。コイル３２の素線の材料および形状は、コイル２２と同様である。   The coil 32 is provided around the distal end side small diameter portion 35 of the wire core wire 31. The outer diameter of the coil 32 is the same as that of the proximal end side large diameter portion 34. The material and shape of the wire of the coil 32 are the same as those of the coil 22.

ボール部３３は、ワイヤ芯線３１の遠位端に設けられている。ボール部３３の構造および機能は、ボール部２３と同様である。   The ball portion 33 is provided at the distal end of the wire core wire 31. The structure and function of the ball part 33 are the same as those of the ball part 23.

第１の先端部２０の近位端側大径部２４の外径は、たとえば０．２５４〜０．９１４ｍｍである。第２の先端部３０の近位端側大径部３４の外径は、たとえば、０．２５４〜０．９１４ｍｍの範囲で第１の先端部２０の近位端側大径部２４の外径より大きい値である。すなわち、本実施の形態では、第１の先端部２０の外径が第２の先端部３０に比べて細いため、第１の先端部２０の方が第２の先端部３０に比べて柔軟性が高くなっており、ガイドワイヤ挿入時の操作感が手元により伝えやすくなっている。これに対して、相対的に剛性が高い第２の先端部３０を用いた場合には、血管内の閉塞部分等の硬い部分にガイドワイヤを押し通しやすくすることができる。また、相対的に摩擦抵抗が高い第２の先端部３０は、ガイドワイヤをゆっくり押し進める必要がある場合や、血管内である程度滑らずに留めておきたい場合などの使用に適している。   The outer diameter of the proximal end side large diameter portion 24 of the first tip portion 20 is, for example, 0.254 to 0.914 mm. The outer diameter of the proximal end side large diameter portion 34 of the second tip portion 30 is, for example, in the range of 0.254 to 0.914 mm, the outer diameter of the proximal end side large diameter portion 24 of the first tip portion 20. Greater value. In other words, in the present embodiment, since the outer diameter of the first tip portion 20 is thinner than that of the second tip portion 30, the first tip portion 20 is more flexible than the second tip portion 30. The feeling of operation when inserting the guide wire is easier to convey at hand. On the other hand, when the second tip portion 30 having a relatively high rigidity is used, the guide wire can be easily pushed through a hard portion such as a closed portion in the blood vessel. The second tip portion 30 having a relatively high frictional resistance is suitable for use when it is necessary to push the guide wire slowly, or when it is desired to keep the guide wire without sliding to some extent.

第１の先端部２０および第２の先端部３０の柔軟性は、ガイドワイヤの先端を弾性変形域内で屈曲させたときの最大荷重（gf）（先端荷重という）により評価される。   The flexibility of the first tip portion 20 and the second tip portion 30 is evaluated by the maximum load (gf) (referred to as the tip load) when the tip of the guide wire is bent in the elastic deformation region.

第１の先端部２０の先端荷重は、たとえば、０．４〜２．０ｇｆ（高柔軟タイプ）または２．２〜３．０ｇｆ（中間タイプ）である。第２の先端部３０の先端荷重は、たとえば、２．２〜３．０ｇｆ（中間タイプ）または３．０ｇｆ以上（高剛性タイプ）である。なお、第１の先端部２０が高柔軟タイプの場合には、第２の先端部３０は、中間タイプまたは高剛性タイプであり、第１の先端部２０が中間タイプの場合には、第２の先端部３０は、高剛性タイプである。   The tip load of the first tip portion 20 is, for example, 0.4 to 2.0 gf (highly flexible type) or 2.2 to 3.0 gf (intermediate type). The tip load of the second tip portion 30 is, for example, 2.2 to 3.0 gf (intermediate type) or 3.0 gf or more (high rigidity type). In addition, when the 1st front-end | tip part 20 is a highly flexible type, the 2nd front-end | tip part 30 is a middle type or a highly rigid type, and when the 1st front-end | tip part 20 is an intermediate type, it is 2nd. The tip portion 30 is of a high rigidity type.

第１の先端部２０の側に、視覚により認知可能な識別標識４０が設けられている。本実施の形態では、識別標識４０は、柔軟性がより高い第１の先端部２０であることを示す標識として設置されている。視覚により認知可能とする場合には、識別標識４０は、たとえば、周囲と色を変えればよい。識別標識４０の色は、特に限定されないが、赤や黄色などの警告色を用いることにより視認性を高めることができる。具体的には、第１の先端部２０にポリテトラフルオロエチレン（ＰＴＦＥ）などの樹脂が被覆されている場合には識別標識４０の領域において、周囲と色が異なる樹脂を被覆してもよい。または、第１の先端部２０に樹脂が被覆されている場合には、識別標識４０の領域において当該樹脂を剥離してもよい。   An identification mark 40 that can be visually recognized is provided on the first tip 20 side. In the present embodiment, the identification mark 40 is installed as a mark indicating that the first tip portion 20 is more flexible. In the case where it can be recognized visually, the identification mark 40 may be changed in color from the surroundings, for example. The color of the identification mark 40 is not particularly limited, but the visibility can be enhanced by using a warning color such as red or yellow. Specifically, when the first tip portion 20 is coated with a resin such as polytetrafluoroethylene (PTFE), the region of the identification mark 40 may be coated with a resin having a different color from the surroundings. Or when the 1st front-end | tip part 20 is coat | covered with resin, you may peel the said resin in the area | region of the identification mark 40. FIG.

また、識別標識４０は、ワイヤ芯線２１の遠位端側小径部２５が設けられた領域の外周面に設けられていてもよい。この場合、たとえば、第１の先端部２０が樹脂で被覆されている場合には、遠位端側小径部２５の領域において樹脂の色を変えてもよい。また、遠位端側小径部２５の領域においてコイル２２が露出している場合には、コイル２２の色を変えてもよい。   Further, the identification mark 40 may be provided on the outer peripheral surface of the region where the distal end side small diameter portion 25 of the wire core wire 21 is provided. In this case, for example, when the first tip portion 20 is covered with resin, the color of the resin may be changed in the region of the distal end side small diameter portion 25. Further, when the coil 22 is exposed in the region of the distal end side small diameter portion 25, the color of the coil 22 may be changed.

なお、識別標識４０は、第１の先端部２０と第２の先端部３０とを区別できればよく、識別標識４０を剛性がより高い第２の先端部３０の側に設けてもよい。   In addition, the identification mark 40 should just distinguish the 1st front-end | tip part 20 and the 2nd front-end | tip part 30, and the identification mark 40 may be provided in the 2nd front-end | tip part 30 side with higher rigidity.

以上説明したガイドワイヤ１０によれば、ガイドワイヤの一方の先端のみならず他方の先端を血管等の管腔内に挿入することができる。さらに、一本のガイドワイヤで柔軟性、摩擦抵抗、潤滑性、操作性、せん通性、病変通過性が異なる先端部を利用可能であるため、ガイドワイヤを操作する医師は、ガイドワイヤを取り替える手間を掛けることなく、血管の状態に合う柔軟性等を有する先端部を選択することができる。このため、ガイドワイヤの挿入に要する時間を短縮することが可能となるとともに、使用されるガイドワイヤの数が減るため、手術費用の低減を図ることができる。また、ガイドワイヤを製造する場合には、滅菌を要するガイドワイヤの本数が減るため、ガイドワイヤの滅菌回数を減らすことができ、製造コストを低減することができる。   According to the guide wire 10 described above, not only one tip of the guide wire but also the other tip can be inserted into a lumen such as a blood vessel. In addition, a single guidewire can be used with tips that vary in flexibility, frictional resistance, lubricity, operability, penetration, and pathology, so the physician operating the guidewire can replace the guidewire. It is possible to select a tip having flexibility or the like that matches the state of the blood vessel without taking time and effort. For this reason, it is possible to shorten the time required for insertion of the guide wire and reduce the number of guide wires to be used, thereby reducing the operation cost. In the case of manufacturing a guide wire, since the number of guide wires that need to be sterilized is reduced, the number of guide wire sterilizations can be reduced, and the manufacturing cost can be reduced.

また、識別標識４０が付されていることにより、第１の先端部２０と第２の先端部３０の識別が容易であり、ガイドワイヤを操作する医師は所望の先端部を迅速かつ確実に選択することができる。   Further, since the identification mark 40 is attached, it is easy to identify the first tip portion 20 and the second tip portion 30, and the doctor operating the guide wire selects the desired tip portion quickly and reliably. can do.

なお、本実施の形態では、外径が異なるワイヤ芯線２１、３１が接合されている。この場合、ガイドワイヤ１０の操作に用いられるトルカとよばれる保持具を外径が細い方のワイヤ芯線に装着すると、ワイヤ芯線の接合部分における負荷が増大する。このため、外径が大きい方のワイヤ芯線３１の所定位置にトルカを設置することが望ましい。しかし、ワイヤ芯線２１、３１の外径の違いは目視で判断するのが難しい。このため、外径がより大きいワイヤ芯線３１の方に外径識別用の標識（図示せず）を設けることが好適である。外径識別用の標識（図示せず）は、目視可能であればよく、たとえば、周囲と色を変えることが挙げられる。外径識別用の標識を設ける位置は、トルカの設置に適した領域であることが望ましい。これによれば、トルカの設置位置を容易に決めることができるため、トルカ設置に要する手間および時間を短縮することができる。また、上述した識別標識４０を第２の先端部３０の側に設ける場合には、外径識別用の標識が識別標識４０を兼ねてもよい。   In the present embodiment, wire core wires 21 and 31 having different outer diameters are joined. In this case, if a holder called a torquer used for the operation of the guide wire 10 is attached to the wire core wire having a smaller outer diameter, the load at the joint portion of the wire core wire increases. For this reason, it is desirable to install a torquer at a predetermined position of the wire core wire 31 having a larger outer diameter. However, it is difficult to visually determine the difference in outer diameter between the wire cores 21 and 31. For this reason, it is preferable to provide a marker (not shown) for identifying the outer diameter on the wire core 31 having a larger outer diameter. The outer diameter identification mark (not shown) may be visible, for example, changing its surroundings and color. The position where the outer diameter identification mark is provided is preferably an area suitable for the installation of ToruCa. According to this, since the installation position of ToruCa can be determined easily, the effort and time required for ToruCa installation can be shortened. When the identification mark 40 described above is provided on the second tip portion 30 side, the outer diameter identification mark may also serve as the identification mark 40.

（実施の形態２）
図２は、実施の形態２に係るガイドワイヤの構成を示す外観図である。実施の形態２のガイドワイヤ１０の第１の先端部２０の構成は実施の形態１と同様である。 (Embodiment 2)
FIG. 2 is an external view showing a configuration of a guide wire according to the second embodiment. The configuration of the first tip portion 20 of the guide wire 10 of the second embodiment is the same as that of the first embodiment.

本実施の形態では、第２の先端部３０の近位端側大径部３４の外径は第１の先端部２０の近位端側大径部２４の外径と同等である。すなわち、本実施の形態の第２の先端部３０の形状自体は、第１の先端部２０と同様である。ただし、第１の先端部２０を構成するワイヤ芯線２１およびコイル２２は、第２の先端部３０を構成するワイヤ芯線３１およびコイル３２に比べて柔軟性が高い材料で形成されている。たとえば、具体的には、より柔軟性が高い第１の先端部２０では、ワイヤ芯線２１、コイル２２としてそれぞれＮｉＴｉなどの超弾性合金などを用い、より剛性が高い（柔軟性が低い）第２の先端部３０では、ワイヤ芯線３１、コイル３２として、それぞれＳＵＳ３０４、ＳＵＳ３１６などのステンレス鋼線を用いることができる。   In the present embodiment, the outer diameter of the proximal end side large diameter portion 34 of the second tip portion 30 is equal to the outer diameter of the proximal end side large diameter portion 24 of the first tip portion 20. That is, the shape of the second tip portion 30 of the present embodiment is the same as that of the first tip portion 20. However, the wire core wire 21 and the coil 22 constituting the first tip portion 20 are made of a material having higher flexibility than the wire core wire 31 and the coil 32 constituting the second tip portion 30. For example, specifically, in the first tip portion 20 having higher flexibility, a superelastic alloy such as NiTi is used as the wire core wire 21 and the coil 22, respectively, so that the second is higher in rigidity (lower in flexibility). In the tip portion 30, stainless steel wires such as SUS304 and SUS316 can be used as the wire core wire 31 and the coil 32, respectively.

図３は、第１の先端部２０を構成するワイヤ芯線２１と第２の先端部３０を構成するワイヤ芯線３１との接合部分の構成を示す断面図である。本実施の形態では、第１の先端部２０を構成するワイヤ芯線２１と第２の先端部３０を構成するワイヤ芯線３１とが直に接合されておらず、図２、図３に示すように、中空円筒状の接続部材５０により接続されている。具体的には、接続部材５０の一方の開口部にワイヤ芯線２１の近位端を挿入した状態で、接続部材５０の一方の開口部とワイヤ芯線２１の近位端部分とがはんだなどの接合部材５２を用いて固定されている。一方、接続部材５０の他方の開口部にワイヤ芯線３１の近位端を挿入した状態で、接続部材５０の他方の開口部とワイヤ芯線３１の近位端部分とがはんだなどの接合部材５４を用いて固定されている。なお、接続部材５０の材料としては、ＮｉＴｉを用いることができる。   FIG. 3 is a cross-sectional view showing a configuration of a joint portion between the wire core wire 21 constituting the first tip portion 20 and the wire core wire 31 constituting the second tip portion 30. In the present embodiment, the wire core wire 21 constituting the first tip portion 20 and the wire core wire 31 constituting the second tip portion 30 are not directly joined, as shown in FIGS. They are connected by a connecting member 50 having a hollow cylindrical shape. Specifically, in a state where the proximal end of the wire core wire 21 is inserted into one opening of the connection member 50, the one opening of the connection member 50 and the proximal end portion of the wire core 21 are joined by solder or the like. It is fixed using the member 52. On the other hand, in a state where the proximal end of the wire core wire 31 is inserted into the other opening of the connection member 50, the other opening of the connection member 50 and the proximal end portion of the wire core wire 31 connect the bonding member 54 such as solder. It is fixed using. Note that NiTi can be used as the material of the connection member 50.

本実施の形態に係るガイドワイヤ１０によれば、ワイヤ芯線の外径を一定としつつ、第１の先端部２０の柔軟性を第２の先端部３０に比べてより柔軟にすることができ、第１の先端部２０を血管等に挿入する場合と、第２の先端部３０を血管等に挿入する場合とで異なる操作性を実現することができる。   According to the guide wire 10 according to the present embodiment, the flexibility of the first tip portion 20 can be made more flexible than the second tip portion 30 while keeping the outer diameter of the wire core wire constant. Different operability can be realized when the first tip portion 20 is inserted into a blood vessel or the like and when the second tip portion 30 is inserted into the blood vessel or the like.

なお、本実施の形態のように、第１の先端部２０と第２の先端部３０の外径が同等である場合には、ワイヤ芯線２１およびワイヤ芯線３１は１本のワイヤにより構成されてよい。   When the outer diameters of the first tip portion 20 and the second tip portion 30 are the same as in the present embodiment, the wire core wire 21 and the wire core wire 31 are configured by a single wire. Good.

（実施の形態３）
図４は、実施の形態３に係るガイドワイヤの構成を示す外観図である。第２の先端部３０の近位端側大径部３４の外径が第１の先端部２０の近位端側大径部２４の外径と同等であることを除き、実施の形態３のガイドワイヤ１０の構成は実施の形態１と同様である。すなわち、本実施の形態では、第１の先端部２０と第２の先端部３０とで柔軟性が同様になっている。 (Embodiment 3)
FIG. 4 is an external view showing a configuration of a guide wire according to the third embodiment. The outer diameter of the proximal end side large diameter portion 34 of the second tip portion 30 is the same as the outer diameter of the proximal end side large diameter portion 24 of the first tip portion 20, except for the third embodiment. The configuration of the guide wire 10 is the same as that of the first embodiment. That is, in the present embodiment, the first tip portion 20 and the second tip portion 30 have the same flexibility.

本実施の形態では、第１の先端部２０の遠位端が製造時に予めプレシェーピングが施されている。すなわち、第１の先端部２０と第２の先端部３０とで、先端湾曲形状が異なっている。これによれば、第１の先端部２０を血管等に挿入する側とすることにより、手術前にガイドワイヤ先端部分を手で曲げる手間を省くことができ、手術時間の短縮を図ることができる。   In the present embodiment, the distal end of the first tip 20 is pre-shaped at the time of manufacture. That is, the first distal end portion 20 and the second distal end portion 30 have different distal end bending shapes. According to this, by making the 1st front-end | tip part 20 into the side inserted in the blood vessel etc., the effort which bends a guide wire front-end | tip part by hand before an operation can be saved, and the operation time can be shortened. .

本発明は、上述の各実施の形態に限定されるものではなく、当業者の知識に基づいて各種の設計変更等の変形を加えることも可能であり、そのような変形が加えられた実施の形態も本発明の範囲に含まれうるものである。   The present invention is not limited to the above-described embodiments, and various modifications such as design changes can be added based on the knowledge of those skilled in the art. The form can also be included in the scope of the present invention.

たとえば、第１の先端部２０と第２の先端部３０とで、柔軟性、潤滑性、および先端湾曲形状のうち少なくとも一つの特性が異なっていればよく、柔軟性、潤滑性、および湾曲形状のうち複数の組み合わせの特性が異なっていてもよい。   For example, the first tip portion 20 and the second tip portion 30 may be different in at least one characteristic among flexibility, lubricity, and tip bending shape, such as flexibility, lubricity, and bending shape. Among them, the characteristics of a plurality of combinations may be different.

第１の先端部２０と第２の先端部３０とで、柔軟性を変えるための変形例として、第１の先端部２０と第２の先端部３０とで形状を同一とし、第１の先端部２０を構成する材料が、第２の先端部３０を構成する材料より柔軟性が高くてもよい。具体的には、より柔軟性が高い第１の先端部２０では、コア材としてＮｉＴｉなどの超弾性合金などを用い、より剛性が高い（柔軟性が低い）第２の先端部３０では、コア材として、ＳＵＳ３０４、ＳＵＳ３１６などのステンレス鋼線を用いることができる。   As a modification for changing the flexibility between the first tip portion 20 and the second tip portion 30, the first tip portion 20 and the second tip portion 30 have the same shape, and the first tip portion The material constituting the portion 20 may be more flexible than the material constituting the second tip portion 30. Specifically, in the first tip portion 20 having higher flexibility, a superelastic alloy such as NiTi is used as the core material, and in the second tip portion 30 having higher rigidity (lower flexibility), the core is used. A stainless steel wire such as SUS304 or SUS316 can be used as the material.

また、第１の先端部２０と第２の先端部３０とで、摩擦抵抗を変えるための変形例として、両者を樹脂コーティングし、この樹脂表面に第１の先端部２０と第２の先端部３０とで親水性が異なる親水性ポリマーを被覆してもよい。   Further, as a modification for changing the frictional resistance between the first tip portion 20 and the second tip portion 30, both of them are coated with resin, and the first tip portion 20 and the second tip portion are formed on the resin surface. 30 may be coated with a hydrophilic polymer having a different hydrophilicity.

また、第１の先端部２０と第２の先端部３０とで、先端湾曲形状を変えるための変形例として、第１の先端部２０および第２の先端部３０の両方の先端にプレシェーピングを施し、第１の先端部２０と第２の先端部３０とで湾曲した先端部分の曲率を変えてもよい。   Further, as a modification for changing the tip bending shape between the first tip portion 20 and the second tip portion 30, pre-shaping is performed on the tips of both the first tip portion 20 and the second tip portion 30. The curvature of the tip portion curved by the first tip portion 20 and the second tip portion 30 may be changed.

実施の形態２のように、第１の先端部２０と第２の先端部３０とでワイヤ芯線の径が同等である場合には、外径識別用の標識は不要であるが、トルカの設置に適した領域（たとえばガイドワイヤ１０の中心位置）にトルカ設置用の標識を設けてもよい。   When the diameters of the wire core wires are the same between the first tip portion 20 and the second tip portion 30 as in the second embodiment, a marker for identifying the outer diameter is not necessary. A marker for installing ToruCa may be provided in a region suitable for the above (for example, the center position of the guide wire 10).

１０ ガイドワイヤ、２０ 第１の先端部、２１ ワイヤ芯線、２２ コイル、３０ 第２の先端部、３１ ワイヤ芯線、３２ コイル、４０ 識別標識、５０ 接続部材。   DESCRIPTION OF SYMBOLS 10 Guide wire, 20 1st front-end | tip part, 21 Wire core wire, 22 coils, 30 2nd front-end | tip part, 31 Wire core wire, 32 coils, 40 Identification mark, 50 Connection member.

Claims (2)

血管等の管腔内に挿入可能な第１の先端部と、
前記第１の先端部の反対側に前記第１の先端部と分離して設けられ、血管等の管腔内に挿入可能な第２の先端部と、
一方の開口に、近位端側に向けて径が徐々に小さくなる、前記第１の先端部の近位端部分が挿入された状態で固定され、他方の開口に、近位端側に向けて径が徐々に小さくなる、前記第２の先端部の近位端部分が前記第１の先端部の近位端部分との間に隙間が生じるように挿入された状態で固定される中空円筒状の接続部材と、
を備え、
前記第１の先端部と前記第２の先端部とで、柔軟性、摩擦抵抗および先端湾曲形状のうち少なくとも一つの特性が異なり、
前記第１の先端部を構成する材料が前記第２の先端部を構成する材料と異なり、
前記第１の先端部と前記第２の先端部とで、表面の親水性が異なっていることを特徴とするガイドワイヤ。 A first tip that can be inserted into a lumen such as a blood vessel;
A second tip that is provided on the opposite side of the first tip from the first tip and can be inserted into a lumen such as a blood vessel;
In one opening, the diameter gradually decreases toward the proximal end side, and is fixed in a state where the proximal end portion of the first tip portion is inserted, and the other opening is directed toward the proximal end side. The hollow cylinder fixed in a state where the proximal end portion of the second tip portion is inserted so that a gap is formed between the proximal end portion of the first tip portion and the proximal end portion of the first tip portion. Connecting member in the form of
With
The first tip portion and the second tip portion are different in at least one characteristic among flexibility, friction resistance and tip bending shape,
The material constituting the first tip portion is different from the material constituting the second tip portion,
The guide wire, wherein the first tip portion and the second tip portion have different surface hydrophilicity. 前記第１の先端部および前記第２の先端部のいずれか一方の側に、当該先端部を識別するための標識が設けられている請求項１に記載のガイドワイヤ。   The guide wire according to claim 1, wherein a marker for identifying the tip portion is provided on one side of the first tip portion and the second tip portion.
JP2009074911A 2009-03-25 2009-03-25 Guide wire Expired - Fee Related JP5280263B2 (en)

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JP6399460B2 (en) * 2016-09-30 2018-10-03 株式会社エフエムディ Medical guidewire
JP6562143B2 (en) * 2018-08-24 2019-08-21 株式会社エフエムディ Medical guide wire and method of manufacturing the second core
JP6627023B2 (en) * 2018-08-24 2020-01-08 株式会社エフエムディ Medical guidewire
KR20230036992A (en) * 2021-09-08 2023-03-15 뉴라비 리미티드 Neuro access guide wire

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JPS60261465A (en) * 1984-06-08 1985-12-24 テルモ株式会社 Medical tube guide device
JPH0342935Y2 (en) * 1987-11-11 1991-09-09
JPH04108456A (en) * 1990-08-30 1992-04-09 Terumo Corp Guide wire for medical treatment
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