JP2007089901A - Guide wire and its manufacturing method - Google Patents

Guide wire and its manufacturing method Download PDF

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JP2007089901A
JP2007089901A JP2005285008A JP2005285008A JP2007089901A JP 2007089901 A JP2007089901 A JP 2007089901A JP 2005285008 A JP2005285008 A JP 2005285008A JP 2005285008 A JP2005285008 A JP 2005285008A JP 2007089901 A JP2007089901 A JP 2007089901A
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tip
distal end
guide wire
end side
distal
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JP4834367B2 (en
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Takashi Kawabata
隆司 川端
Ryoichi Okumura
亮一 奥村
Hironori Kawasaki
浩範 河崎
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Japan Lifeline Co Ltd
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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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22042—Details of the tip of the guide wire
    • A61B2017/22044—Details of the tip of the guide wire with a pointed tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22094—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for for crossing total occlusions, i.e. piercing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09108—Methods for making a guide wire

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  • 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)
  • Materials For Medical Uses (AREA)

Abstract

<P>PROBLEM TO BE SOLVED: To provide a guide wire having superior operability, torque transmission property, and a large penetration force and easily and safely passed even to a chronic complete obstruction lesion and a calcified lesion, and to provide a manufacturing method of an economical guide wire dispensing with work such as soldering a distal end tip. <P>SOLUTION: This guide wire 3 comprises a distal end side small diameter part 1 and a proximal side large diameter part 2 having the outer diameter larger than the distal end side small diameter part, and has a wire core wire; and is characterized in that the distal end side tip 4 has a projection 5 at its forefront. This manufacturing method of the guide wire 3 is characterized in filling a mold having a cavity of the distal end side tip 4 having the projection at its forefront with molten metal, molten thermoplastic resin or thermosetting resin, inserting the distal end side small diameter part 1 of the guide wire core wire in the mold, solidifying the molten metal, the molten thermoplastic resin or the thermosetting resin in the mold, and forming the distal end side tip 4 at the tip of the distal end side small diameter part. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

本発明は、ガイドワイヤ及びその製造方法に関する。さらに詳しくは、本発明は、操作性とトルク伝達性が良好であり、穿通力が大きく、慢性完全閉塞病変や石灰化病変に対しても、容易かつ安全に通過させることができるガイドワイヤ、及び、先端チップのハンダ付けなどの作業を必要としない経済的なガイドワイヤの製造方法に関する。   The present invention relates to a guide wire and a manufacturing method thereof. More specifically, the present invention provides a guide wire that has good operability and torque transmission, has a large penetration force, and can easily and safely pass through even a chronic total occlusion lesion or a calcified lesion. The present invention also relates to an economical guide wire manufacturing method that does not require work such as soldering of a tip.

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。
ガイドワイヤには、押し込み抵抗が少なく、血管などを傷つけることなく、ガイドワイヤを容易に前進させることができる挿入性、手元側の回転力が先端まで伝わりやすく、血管の分岐選択で、狙いの血管に前進させることができるトルク伝達性、使用時に血管の湾曲箇所の通過による変形で永久ひずみを起さず、先の屈曲分岐を選択しやすい低永久ひずみ性、先端側の摩擦係数が小さく、表面が平滑で、ステントストラットなどに引っかかりにくい非トラップ性などの特性が要求される。
血管内の慢性完全閉塞病変や石灰化病変に対してガイドワイヤを通過させるためには、穿通力及び操作性が必要とされる。しかし、従来のガイドワイヤは、ガイドワイヤの先端部の剛性を増加させる、つまりワイヤ芯線の外径を太くすることにより穿通力を高めるために、操作性の低下は度外視されていた。図１３は、従来のガイドワイヤによる事故の一例の説明図である。血管７内に存在する慢性完全閉塞病変８に対して、ガイドワイヤ３が押し進められている。慢性完全閉塞病変が硬く、ガイドワイヤが慢性完全閉塞病変を通過し得ないと、ガイドワイヤが曲がって血管を突き破ってしまう場合がある。また、ワイヤ芯線の外径が太いと、トルク伝達性が悪く、血管の分岐を選択しにくく、内膜下に潜ったときにそのことが手に伝わる感触で分かりにくく、内膜下に潜ったときに偽腔が大きくなりやすい。 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.
The guide wire has low push-in resistance and can easily advance the guide wire without damaging the blood vessel, etc., and the rotational force on the proximal side can be easily transmitted to the tip. Torque transferability that can be advanced to the surface, low permanent strain that does not cause permanent distortion due to deformation caused by passage through the curved portion of the blood vessel when in use, easy to select the previous bending branch, low friction coefficient on the tip side, surface Therefore, characteristics such as non-trapping properties that are smooth and difficult to catch on stent struts are required.
In order to allow the guide wire to pass through a chronic complete occlusion lesion or calcification lesion in a blood vessel, penetration force and operability are required. However, in the conventional guide wire, in order to increase the penetration force by increasing the rigidity of the distal end portion of the guide wire, that is, by increasing the outer diameter of the wire core wire, the decrease in operability has been exaggerated. FIG. 13 is an explanatory diagram of an example of an accident caused by a conventional guide wire. The guide wire 3 is pushed forward against the chronic total occlusion lesion 8 existing in the blood vessel 7. If the chronic total occlusion lesion is hard and the guide wire cannot pass through the chronic total occlusion lesion, the guide wire may bend and break through the blood vessel. Also, if the outer diameter of the wire core is thick, the torque transmission is poor, it is difficult to select the branch of the blood vessel, it is difficult to understand when touching under the intima Sometimes the false lumen tends to grow.

本発明は、操作性とトルク伝達性が良好であり、穿通力が大きく、慢性完全閉塞病変や石灰化病変に対しても、容易かつ安全に通過させることができるガイドワイヤ、及び、先端チップのハンダ付けなどの作業を必要としない経済的なガイドワイヤの製造方法を提供することを目的としてなされたものである。   The present invention has good operability and torque transmission, large penetration force, and can easily and safely pass a chronic total occlusion lesion or a calcified lesion, and a tip tip The object of the present invention is to provide an economical guide wire manufacturing method that does not require any work such as soldering.

本発明者らは、上記の課題を解決すべく鋭意研究を重ねた結果、ガイドワイヤの遠位端側先端チップの最先端に突起を設けることにより、慢性完全閉塞病変などに弱い力で突起を突き刺すことができ、突起が突き刺さったのち遠位端側先端チップを押し進めて穿通することができるので、ガイドワイヤの芯線を細くして操作性とトルク伝達性を向上し、容易かつ安全に慢性完全閉塞病変などを穿通することが可能となることを見いだし、この知見に基づいて本発明を完成するに至った。
すなわち、本発明は、
（１）遠位端側小径部と、遠位端側小径部よりも外径が大きい近位端側大径部とからなるワイヤ芯線を有するガイドワイヤにおいて、遠位端側先端チップが、その最先端に突起を有することを特徴とするガイドワイヤ、
（２）遠位端側先端チップが、回転対称軸を有しない(１)記載のガイドワイヤ、
（３）遠位端側先端チップが、表面に螺旋形状の溝を有する(１)記載のガイドワイヤ、
（４）突起が遠位端側先端チップの中に収納され、突起に押込み圧を加えたときに、突起が遠位端側先端チップから突出する(１)記載のガイドワイヤ、及び、
（５）最先端に突起を有する遠位端側先端チップのキャビティを有する型に、溶融金属、溶融熱可塑性樹脂又は熱硬化性樹脂を充填し、該型にガイドワイヤ芯線の遠位端側小径部を挿入し、型内の溶融金属、溶融熱可塑性樹脂又は熱硬化性樹脂を固化することにより、遠位端側小径部の先端に遠位端側先端チップを形成することを特徴とするガイドワイヤの製造方法、
を提供するものである。 As a result of intensive studies to solve the above problems, the present inventors have provided a protrusion at the tip of the distal end tip tip of the guide wire, so that the protrusion can be formed with a weak force against a chronic complete occlusion lesion or the like. It can be pierced, and after the protrusion has been pierced, the distal tip tip can be pushed through and penetrated, so the guide wire is thinned to improve operability and torque transmission, and easily and safely It has been found that it is possible to penetrate an obstructed lesion, and the present invention has been completed based on this finding.
That is, the present invention
(1) In a guide wire having a wire core composed of a distal-end-side small-diameter portion and a proximal-end-side large-diameter portion having a larger outer diameter than the distal-end-side small-diameter portion, A guide wire characterized by having a protrusion at the forefront,
(2) The guide wire according to (1), wherein the distal tip tip tip does not have an axis of rotational symmetry.
(3) The guide wire according to (1), wherein the distal end side tip has a spiral groove on the surface,
(4) The guide wire according to (1), wherein the protrusion is housed in the distal end side tip, and the protrusion protrudes from the distal end tip when pressure is applied to the protrusion, and
(5) A mold having a distal end tip tip cavity having a protrusion at the foremost end is filled with molten metal, molten thermoplastic resin or thermosetting resin, and the distal end side small diameter of the guide wire core wire is filled in the mold. The distal end tip tip is formed at the distal end of the distal end small diameter portion by inserting the portion and solidifying the molten metal, molten thermoplastic resin or thermosetting resin in the mold. Wire manufacturing method,
Is to provide.

本発明のガイドワイヤは、遠位端側先端チップの最先端に突起を有するので、慢性完全閉塞病変などに接触面積の小さい突起が当たり、弱い力で突き刺さって穿通の起点となり、次いで接触面積の大きい遠位端側先端チップが押し進められるので、ガイドワイヤにより正常血管壁を突き破ることが防止され、安全に施術することができる。本発明のガイドワイヤは、弱い力で押し進めることができるので、ワイヤ芯線を細くすることが可能であり、ガイドワイヤの操作性とトルク伝達性を向上することができる。本発明のガイドワイヤの製造方法によれば、遠位端側先端チップの形成と同時にワイヤ芯線の先端に接合することができ、手作業によるハンダ付けなどの必要がないので、ガイドワイヤを経済的に製造することができる。   Since the guide wire of the present invention has a protrusion at the tip of the distal end tip tip, a protrusion with a small contact area hits a chronic complete occlusion lesion or the like, and is pierced with a weak force to become a starting point of penetration, and then the contact area Since the large distal tip tip is pushed forward, the guide wire is prevented from breaking through the normal blood vessel wall and can be safely treated. Since the guide wire of the present invention can be pushed by a weak force, the wire core wire can be made thin, and the operability and torque transmission performance of the guide wire can be improved. According to the guide wire manufacturing method of the present invention, it is possible to join the tip end of the wire core wire simultaneously with the formation of the distal end side tip, and there is no need for manual soldering. Can be manufactured.

本発明のガイドワイヤは、遠位端側小径部と、遠位端側小径部よりも外径が大きい近位端側大径部とからなるワイヤ芯線を有するガイドワイヤにおいて、遠位端側先端チップが、その最先端に突起を有するガイドワイヤである。
図１は、本発明のガイドワイヤの一態様の側面図である。遠位端側小径部１と遠位端側小径部よりも外径が大きい近位端側大径部２からなるワイヤ芯線を有するガイドワイヤ３の遠位端側先端チップ４が、その最先端に突起５を有する。本態様のガイドワイヤは、ワイヤ芯線の遠位端側小径部が、コイルスプリング６により覆われている。
図２は、図１に示す態様のガイドワイヤの説明図である。血管７内に発生した慢性完全閉塞病変８に対してガイドワイヤ３が押し進められると、遠位端側先端チップ４の最先端の突起５が慢性完全閉塞病変に突き刺さる。突起は、慢性完全閉塞病変との接触面積が小さいので、弱い力で慢性完全閉塞病変に突き刺さり、遠位端側先端チップの穿通の起点となり、次いで慢性完全閉塞病変との接触面積が大きい遠位端側先端チップが押し進められて、硬い閉塞部分であっても穿っていく。このために、図１３に示すようなガイドワイヤが曲がって正常血管壁を突き破る事故の発生を防止することができる。慢性完全閉塞病変と接触する面積の小さい突起により、遠位端側先端チップの位置を正確に制御することができる。また、弱い力で慢性完全閉塞病変に突起を突き刺すことができるので、ワイヤ芯線の外径を細くすることができる。ワイヤ芯線の外径が細いと、湾曲した血管内でも柔軟に追従し、ガイドワイヤの操作性とトルク伝達性が向上する。 The guide wire according to the present invention is a guide wire having a wire core wire composed of a distal end side small diameter portion and a proximal end side large diameter portion having an outer diameter larger than that of the distal end side small diameter portion. The tip is a guide wire having a protrusion at its tip.
FIG. 1 is a side view of one embodiment of the guide wire of the present invention. The distal end tip tip 4 of the guide wire 3 having a wire core composed of the distal end side small diameter portion 1 and the proximal end side large diameter portion 2 having a larger outer diameter than the distal end side small diameter portion is the most advanced. Has a protrusion 5. In the guide wire of this aspect, the small diameter portion on the distal end side of the wire core wire is covered with the coil spring 6.
FIG. 2 is an explanatory diagram of the guide wire in the embodiment shown in FIG. When the guide wire 3 is pushed forward with respect to the chronic total occlusion lesion 8 generated in the blood vessel 7, the most advanced projection 5 of the distal end tip tip 4 is pierced into the chronic total occlusion lesion. Since the protrusion has a small contact area with the chronic total occlusion lesion, the chronic total occlusion lesion is pierced with a weak force, becomes the starting point for the penetration of the distal tip tip, and then the distal with the large contact area with the chronic total occlusion lesion Even if it is a hard obstruction | occlusion part, the end tip tip is pushed forward and is pierced. For this reason, it is possible to prevent the occurrence of an accident in which the guide wire is bent and breaks through the normal blood vessel wall as shown in FIG. The position of the distal tip can be accurately controlled by a small area protrusion in contact with the chronic total occlusion lesion. Moreover, since the projection can be pierced into the chronic complete occlusion lesion with a weak force, the outer diameter of the wire core wire can be reduced. When the outer diameter of the wire core wire is thin, it can flexibly follow even inside a curved blood vessel, and the operability and torque transmission performance of the guide wire are improved.

図３は、本発明のガイドワイヤの遠位端側先端チップの一態様の正面図、側面図、Ａ−Ａ線断面図及びＢ−Ｂ線断面図である。本態様の遠位端側先端チップは中心軸に対して回転対称なので、正面図と側面図は同じ形状である。本態様の遠位端側先端チップ４は、その最先端に突起５を有する。
図４は、本発明のガイドワイヤの遠位端側先端チップの他の態様の正面図、側面図、Ａ−Ａ線断面図及びＢ−Ｂ線断面図である。本態様の遠位端側先端チップの最先端の突起は遠位端側先端チップと滑らかな曲面でつながり、かつ先が尖っている。先が尖った突起を付けることにより、より弱い力で突起を慢性完全閉塞病変などに突き刺すことができ、より正確に位置決めすることができる。
本発明のガイドワイヤは、遠位端側先端チップが回転対称軸を有しない形状とすることができる。図５は、本発明のガイドワイヤの遠位端側先端チップの他の態様の正面図、側面図、Ａ−Ａ線断面図及びＢ−Ｂ線断面図である。本態様の遠位端側先端チップは、ほぼ楕円柱を楕円の短軸を通る平面で切断した形状であり、回転対称軸を有しない。図６は、本発明のガイドワイヤの遠位端側先端チップの他の態様の正面図、側面図、Ａ−Ａ線断面図及びＢ−Ｂ線断面図である。本態様の遠位端側先端チップは、円柱の先端を二つの平面で削り取った形状であり、回転対称軸を有しない。
遠位端側先端チップが回転対称軸を有すると、遠位端側先端チップの突起を慢性完全閉塞病変などに突き刺したのち、ガイドワイヤ芯線を回転させても突起が病変などの中で空転するおそれがある。遠位端側先端チップが回転対称軸を有しない形状とすると、遠位端側先端チップの突起を病変などに突き刺したのちワイヤ芯線を回転させることにより、突起を突き刺した病変部などの破壊が進み、遠位端側先端チップの穿通の効果的な起点が形成される。また、遠位端側先端チップが回転対称軸を有しない形状とすることにより、穿通の方向性の制御が容易になる。 FIG. 3 is a front view, a side view, a cross-sectional view taken along line AA, and a cross-sectional view taken along line BB of an embodiment of the distal end tip tip of the guide wire of the present invention. Since the distal tip tip of this embodiment is rotationally symmetric with respect to the central axis, the front view and the side view have the same shape. The distal end tip tip 4 of this embodiment has a protrusion 5 at its tip.
FIG. 4 is a front view, a side view, a cross-sectional view taken along line AA, and a cross-sectional view taken along line BB of another embodiment of the distal tip tip tip of the guide wire of the present invention. The most advanced protrusion of the distal end tip in this aspect is connected to the distal tip with a smooth curved surface and has a sharp point. By attaching a sharp-pointed protrusion, the protrusion can be pierced into a chronic complete occlusion lesion or the like with a weaker force, and can be positioned more accurately.
The guide wire of the present invention can be shaped such that the distal tip tip does not have a rotational symmetry axis. FIG. 5 is a front view, a side view, a cross-sectional view taken along line AA, and a cross-sectional view taken along line BB of another embodiment of the distal end tip tip of the guide wire of the present invention. The distal end tip tip of this aspect has a shape obtained by cutting an elliptical column approximately along a plane passing through the minor axis of the ellipse, and does not have a rotational symmetry axis. FIG. 6 is a front view, a side view, a cross-sectional view taken along line AA, and a cross-sectional view taken along line BB of another embodiment of the distal end tip tip of the guide wire of the present invention. The distal end tip tip of this aspect has a shape obtained by scraping the tip of a cylinder in two planes and does not have a rotational symmetry axis.
If the distal tip tip has an axis of rotational symmetry, the protrusion on the distal tip tip pierces into a chronic complete occlusion lesion, and the projection spins in the lesion even if the guide wire core is rotated. There is a fear. If the distal tip tip has a shape that does not have a rotational symmetry axis, the protrusion of the distal tip tip is pierced into the lesion, and then the wire core is rotated, so that the lesion or the like piercing the projection is destroyed. As a result, an effective starting point for penetration of the distal tip is formed. In addition, when the distal end tip has a shape that does not have a rotational symmetry axis, the directionality of the penetration can be easily controlled.

本発明のガイドワイヤは、遠位端側先端チップの表面に螺旋形状の溝を設けることができる。螺旋形状の溝は、遠位端側先端チップの表面又はその最先端の突起の表面に設けることができ、あるいは、遠位端側先端チップの表面及びその最先端の突起の表面に設けることができる。また、螺旋形状の溝は、遠位端側先端チップの表面又はその最先端の突起の表面に部分的に設けることができ、あるいは、全面的に設けることができる。
図７は、本発明のガイドワイヤの遠位端側先端チップの他の態様の正面図及び側面図である。本態様のガイドワイヤは、遠位端側先端チップの最先端の突起の表面に、全面的に螺旋形状の溝が設けられている。本態様の遠位端側先端チップは、螺旋形状の溝の細部を除けば中心軸に対して回転対称なので、正面図と側面図はほぼ同じ形状である。図８は、本発明のガイドワイヤの遠位端側先端チップの他の態様の正面図及び側面図である。本態様のガイドワイヤは、遠位端側先端チップの先端側の表面に、部分的に螺旋形状の溝が設けられている。本態様の遠位端側先端チップは、螺旋形状の溝の細部を除けば中心軸に対して回転対称なので、正面図と側面図はほぼ同じ形状である。
遠位端側先端チップの最先端の突起の表面に螺旋形状の溝を設けると、突起を慢性完全閉塞病変などに突き刺したのちに、ガイドワイヤ芯線を回転させることにより、螺旋形状の溝がネジとしてはたらき、突起を病変などの内部に押し進めて、遠位端側先端チップの穿通の効果的な起点が形成される。遠位端側先端チップの表面に螺旋形状の溝を設けると、ガイドワイヤ芯線を回転させることにより、螺旋形状の溝がネジとしてはたらき、慢性完全閉塞病変などを削り取りながら前進し、遠位端側先端チップにより効果的に慢性完全閉塞病変などが穿通される。 The guide wire of the present invention can be provided with a spiral groove on the surface of the distal tip tip. The spiral groove can be provided on the surface of the distal tip tip or its most prominent protrusion, or it can be provided on the surface of the distal tip tip and its most prominent protrusion. it can. Further, the spiral groove can be partially provided on the surface of the distal end tip tip or the surface of the most prominent protrusion, or can be provided entirely.
FIG. 7 is a front view and a side view of another embodiment of the distal tip tip tip of the guide wire of the present invention. In the guide wire of this aspect, a spiral groove is provided on the entire surface of the most prominent protrusion of the distal tip tip. Since the distal tip tip of this embodiment is rotationally symmetric with respect to the central axis except for the details of the spiral groove, the front view and the side view have substantially the same shape. FIG. 8 is a front view and a side view of another embodiment of the distal tip tip tip of the guide wire of the present invention. The guide wire of this aspect is provided with a partially helical groove on the distal surface of the distal tip tip. Since the distal tip tip of this embodiment is rotationally symmetric with respect to the central axis except for the details of the spiral groove, the front view and the side view have substantially the same shape.
When a spiral groove is provided on the surface of the most distal protrusion on the distal tip, the spiral groove is screwed by rotating the guide wire core after the protrusion is pierced into a chronic complete occlusion lesion, etc. As a result, the protrusion is pushed into a lesion or the like to form an effective starting point for penetration of the distal tip tip. When a spiral groove is provided on the surface of the distal end tip tip, the spiral groove works as a screw by rotating the guide wire core, and advances while scraping off chronic complete occlusion lesions. The tip completely effectively penetrates a chronic total occlusion lesion or the like.

本発明のガイドワイヤは、突起が遠位端側先端チップの中に収納され、突起に押込み圧を加えたときに、突起が遠位端側先端チップから突出する構造とすることができる。図９は、本発明のガイドワイヤの遠位端側先端チップの他の態様の中心軸を通る平面で切断した断面図、Ａ−Ａ線断面図及びＢ−Ｂ線断面図である。本態様の遠位端側先端チップは、その最先端の突起５が基部９を有し、基部が遠位端側先端チップの中の空間に収容されてバネ１０により押し下げられ、通常は突起５が遠位端側先端チップ４の中に収納されている。本態様のガイドワイヤは、突起が遠位端側先端チップの中に収納された状態で血管などの中を押し進められ、遠位端が慢性完全閉塞病変などに到達したときに突起の基部に力を加えて遠位端側先端チップの最先端から突起を突出させる。血管など中を押し進めるときは、突起が突出していないので、血管内膜などを傷つけるおそれが少なく、ガイドワイヤを円滑に押し進めることができる。   The guide wire of the present invention may have a structure in which the protrusion is housed in the distal end tip tip, and the protrusion protrudes from the distal end tip tip when a pressing pressure is applied to the protrusion. FIG. 9 is a cross-sectional view taken along a plane passing through the central axis of another embodiment of the distal end tip tip of the guide wire of the present invention, a cross-sectional view taken along line AA, and a cross-sectional view taken along line BB. The distal end tip of this aspect has a base 9 at its most advanced projection 5, and the base is received in a space in the distal tip tip and is pushed down by a spring 10. Is housed in the distal tip tip 4. The guide wire of this aspect is pushed through the blood vessel or the like with the protrusion housed in the distal tip tip, and when the distal end reaches a chronic complete occlusion lesion or the like, the force is applied to the base of the protrusion. To project the protrusion from the tip of the distal tip tip. When pushing the inside of a blood vessel or the like, since the protrusion does not protrude, there is little risk of damaging the intima of the blood vessel and the guide wire can be pushed forward smoothly.

本発明のガイドワイヤの製造方法においては、最先端に突起を有する遠位端側先端チップのキャビティを有する型に、溶融金属、溶融熱可塑性樹脂又は熱硬化性樹脂を充填し、該型にガイドワイヤの遠位端側小径部を挿入し、型内の溶融金属、溶融熱可塑性樹脂又は熱硬化性樹脂を固化することにより、遠位端側小径部の先端に遠位端側先端チップを形成する。
本発明方法に用いる金属としては、例えば、ステンレス鋼、放射線不透過材料、純チタン、チタン合金、Ｃｏ−Ｃｒ−Ｍｏ合金などを挙げることができる。本発明方法に用いる熱可塑性樹脂としては、例えば、ポリエチレン、ポリアミド、ポリカーボネート、フッ素樹脂などを挙げることができる。本発明方法に用いる熱硬化性樹脂としては、例えば、メラミン樹脂、エポキシ樹脂などを挙げることができる。本発明方法においては、型に挿入するガイドワイヤ芯線の遠位端側小径部の最末端の径をわずかに太くして、遠位端側先端チップのワイヤ芯線からの脱落を防止することが好ましい。
図１０は、本発明のガイドワイヤの製造方法の一態様の説明図である。金型１１に、最先端に突起を有する遠位端側先端チップのキャビティ１２が設けられている。この金型のキャビティに熱硬化性樹脂１３が充填され、加熱溶融される。熱硬化性樹脂が半硬化状態になったとき、ガイドワイヤ芯線の遠位端側小径部（図示しない。）を挿入し、この状態で熱硬化性樹脂を完全硬化させたのち、金型から取り出すことにより、その最先端に突起を有する遠位端側先端チップを備えたガイドワイヤを得ることができる。本発明方法によれば、手間がかかり、熟練を要する作業である遠位端側先端チップの溶接、ロウ付け、ハンダ付けなどを省いて、経済的にガイドワイヤを製造することができる。 In the guide wire manufacturing method of the present invention, a mold having a distal end tip tip cavity having a projection at the foremost end is filled with molten metal, molten thermoplastic resin or thermosetting resin, and the mold is guided. Insert the distal end side small diameter part of the wire and solidify the molten metal, molten thermoplastic resin or thermosetting resin in the mold to form the distal end side tip at the tip of the distal end small diameter part To do.
Examples of the metal used in the method of the present invention include stainless steel, a radiopaque material, pure titanium, a titanium alloy, and a Co—Cr—Mo alloy. Examples of the thermoplastic resin used in the method of the present invention include polyethylene, polyamide, polycarbonate, and fluororesin. Examples of the thermosetting resin used in the method of the present invention include melamine resin and epoxy resin. In the method of the present invention, it is preferable that the distal end diameter of the distal end side small diameter portion of the guide wire core wire to be inserted into the mold is slightly increased to prevent the distal end tip tip from falling off the wire core wire. .
FIG. 10 is an explanatory diagram of one embodiment of the guide wire manufacturing method of the present invention. The mold 11 is provided with a distal end tip tip cavity 12 having a protrusion at the tip. The mold cavity is filled with the thermosetting resin 13 and melted by heating. When the thermosetting resin is in a semi-cured state, a small diameter portion (not shown) on the distal end side of the guide wire core wire is inserted, and in this state, the thermosetting resin is completely cured and then taken out from the mold. Thus, it is possible to obtain a guide wire including a distal end side tip having a protrusion at the tip. According to the method of the present invention, it is possible to economically manufacture a guide wire by omitting welding, brazing, soldering, etc. of the distal end tip tip, which is laborious and requires skill.

以下に、実施例を挙げて本発明をさらに詳細に説明するが、本発明はこれらの実施例によりなんら限定されるものではない。
実施例１
図１に示す全長１,８００ｍｍ、外径０.２６４ｍｍのガイドワイヤを作製した。ワイヤ芯線の材質はＳＵＳ３１６であり、近位端から１,５００ｍｍまでが外径０.２６０ｍｍ、１,５００〜１,６００ｍｍが外径０.１８０ｍｍ、１,６００〜１,７５０ｍｍが外径０.１００ｍｍ、１,７５０ｍｍから遠位端までが外径０.０６０ｍｍとした。外径０.２６０ｍｍ、ピッチ０.０９ｍｍのＳＵＳ３１６のコイルスプリングを、コイルスプリングの中心軸に垂直な平面で、長さ３００ｍｍに切断し、ワイヤ芯線の遠位端側小径部に装着した。
図１０に示す形状の最先端に直径０.０４０ｍｍ、長さ０.０５０ｍｍの突起を有する直径０.２７０ｍｍ、長さ０.３００ｍｍの遠位端側先端チップのキャビティを有する金型に、エポキシ樹脂を充填し、加熱して溶融重合させ、半硬化状態となったとき、上記のワイヤ芯線の遠位端を金型内のエポキシ樹脂に挿入して、さらに加熱を続け、エポキシ樹脂を完全硬化させた。硬化したエポキシ樹脂からなる遠位端側先端チップを金型から引き出し、バリを取って仕上げした。次いで、遠位端から２８０ｍｍの部分を、３官能成分を含有するポリエチレングリコールとヘキサメチレンジイソシアネートとの反応により、厚さ０.００２ｍｍの架橋親水性ポリマーで被覆し、遠位端から３００ｍｍの位置より近位端までを、厚さ０.００２ｍｍのポリテトラフルオロエチレンで被覆し、ガイドワイヤを完成した。
図１１に示す人の冠状動脈を模倣したポリテトラフルオロエチレン製のモデルを３７℃の恒温水槽に浸漬し、モデルの入口Ｂに、内径４ｍｍ、長さ１,５００ｍｍのポリエチレンチューブを接続した。このポリエチレンチューブを経由してモデル内にガイドワイヤを挿入し、モデルの出口Ａからガイドワイヤの遠位端をわずかに露出させた。ガイドワイヤの遠位端にリボンを結び付け、ガイドワイヤの遠位端側に湾曲を与えた状態で、ガイドワイヤの近位端側をモーターにより時計回り方向に７２０°回転させ、遠位端のリボンの動きをビデオカメラを用いて撮影し、遠位端の回転の状態を測定した。 Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited to these examples.
Example 1
A guide wire having a total length of 1,800 mm and an outer diameter of 0.264 mm shown in FIG. 1 was produced. The material of the wire core is SUS316, the outer diameter from the proximal end to 1,500 mm is 0.260 mm, 1,500 to 1,600 mm is the outer diameter 0.180 mm, and 1,600 to 1,750 mm is the outer diameter 0. The outer diameter from 100 mm, 1,750 mm to the distal end was 0.060 mm. A SUS316 coil spring having an outer diameter of 0.260 mm and a pitch of 0.09 mm was cut into a length of 300 mm on a plane perpendicular to the central axis of the coil spring, and mounted on the distal end side small diameter portion of the wire core wire.
An epoxy resin is applied to a die having a distal end tip cavity having a diameter of 0.270 mm and a length of 0.300 mm having a projection of 0.040 mm in diameter and 0.050 mm in length at the forefront of the shape shown in FIG. When the polymer is heated and melt polymerized, and the resin is semi-cured, insert the distal end of the wire core into the epoxy resin in the mold and continue heating to completely cure the epoxy resin. It was. The distal end tip tip made of a cured epoxy resin was pulled out of the mold and finished with burrs. Next, a portion of 280 mm from the distal end is coated with a cross-linked hydrophilic polymer having a thickness of 0.002 mm by reaction of polyethylene glycol containing trifunctional components with hexamethylene diisocyanate, and from a position 300 mm from the distal end. The guide wire was completed by covering the proximal end with polytetrafluoroethylene having a thickness of 0.002 mm.
A polytetrafluoroethylene model imitating a human coronary artery shown in FIG. 11 was immersed in a constant temperature water bath at 37 ° C., and a polyethylene tube having an inner diameter of 4 mm and a length of 1,500 mm was connected to the inlet B of the model. A guide wire was inserted into the model via this polyethylene tube, exposing the distal end of the guide wire slightly from the outlet A of the model. With the ribbon tied to the distal end of the guide wire and the distal end side of the guide wire being curved, the proximal end side of the guide wire is rotated 720 ° clockwise by a motor, and the ribbon at the distal end The movement of the camera was photographed using a video camera, and the state of rotation of the distal end was measured.

比較例１
全長１,８００ｍｍ、外径０.４５７ｍｍのガイドワイヤを作製した。ワイヤ芯線の材質はＳＵＳ３１６であり、近位端から１,５００ｍｍまでが外径０.４５３ｍｍ、１,５００〜１,６００ｍｍが外径０.３１０ｍｍ、１,６００〜１,７５０ｍｍが外径０.１７３ｍｍ、１,７５０ｍｍから遠位端までが外径０.１００ｍｍとした。外径０.４５７ｍｍ、ピッチ０.３ｍｍのＳＵＳ３１６のコイルスプリングを、コイルスプリングの中心軸に垂直な平面で、長さ３００ｍｍに切断し、ワイヤ芯線の遠位端側小径部に装着し、遠位端に直径０.４５７ｍｍの半球状の白金の先端チップをろう付けし、さらに、コイルスプリングの遠位端側の末端を先端チップに、近位端側の末端をワイヤ芯線にろう付けした。次いで、遠位端から２８０ｍｍの部分を、３官能成分を含有するポリエチレングリコールとヘキサメチレンジイソシアネートとの反応により、厚さ０.００２ｍｍの架橋親水性ポリマーで被覆し、遠位端から３００ｍｍの位置より近位端までを、厚さ０.００２ｍｍのポリテトラフルオロエチレンで被覆し、ガイドワイヤを完成した。
図１１に示す人の冠状動脈を模倣したポリテトラフルオロエチレン製のモデルを３７℃の恒温水槽に浸漬し、モデルの入口Ｂに、内径４ｍｍ、長さ１,５００ｍｍのポリエチレンチューブを接続した。このポリエチレンチューブを経由してモデル内にガイドワイヤを挿入し、モデルの出口Ａからガイドワイヤの遠位端をわずかに露出させた。ガイドワイヤの遠位端にリボンを結び付け、ガイドワイヤの遠位端側に湾曲を与えた状態で、ガイドワイヤの近位端側をモーターにより時計回り方向に７２０°回転させ、遠位端のリボンの動きをビデオカメラを用いて撮影し、遠位端の回転の状態を測定した。
実施例１と比較例１の近位端側回転角度と遠位端側回転角度の関係を、図１２に示す。 Comparative Example 1
A guide wire having a total length of 1,800 mm and an outer diameter of 0.457 mm was produced. The material of the wire core is SUS316, the outer diameter from the proximal end to 1,500 mm is 0.453 mm, 1,500 to 1,600 mm is the outer diameter 0.310 mm, and 1,600 to 1,750 mm is the outer diameter 0.3. The outer diameter from 173 mm, 1,750 mm to the distal end was 0.100 mm. A SUS316 coil spring having an outer diameter of 0.457 mm and a pitch of 0.3 mm is cut into a length of 300 mm in a plane perpendicular to the central axis of the coil spring, and attached to the distal end side small diameter portion of the wire core wire. A hemispherical platinum tip having a diameter of 0.457 mm was brazed to the end, and the distal end of the coil spring was brazed to the tip, and the proximal end was brazed to the wire core. Next, a portion of 280 mm from the distal end is coated with a cross-linked hydrophilic polymer having a thickness of 0.002 mm by reaction of polyethylene glycol containing trifunctional components with hexamethylene diisocyanate, and from a position 300 mm from the distal end. The guide wire was completed by covering the proximal end with polytetrafluoroethylene having a thickness of 0.002 mm.
A polytetrafluoroethylene model imitating a human coronary artery shown in FIG. 11 was immersed in a constant temperature water bath at 37 ° C., and a polyethylene tube having an inner diameter of 4 mm and a length of 1,500 mm was connected to the inlet B of the model. A guide wire was inserted into the model via this polyethylene tube, exposing the distal end of the guide wire slightly from the outlet A of the model. With the ribbon tied to the distal end of the guide wire and the distal end side of the guide wire being curved, the proximal end side of the guide wire is rotated 720 ° clockwise by a motor, and the ribbon at the distal end The movement of the camera was photographed using a video camera, and the state of rotation of the distal end was measured.
The relationship between the proximal end side rotation angle and the distal end side rotation angle of Example 1 and Comparative Example 1 is shown in FIG.

本発明のガイドワイヤは、遠位端側先端チップの最先端に突起を有するので、慢性完全閉塞病変などに接触面積の小さい突起が当たり、弱い力で突き刺さって穿通の起点となり、次いで接触面積の大きい遠位端側先端チップが押し進められるので、ガイドワイヤにより正常血管壁を突き破ることが防止され、安全に施術することができる。本発明のガイドワイヤは、弱い力で押し進めることができるので、ワイヤ芯線を細くすることが可能であり、ガイドワイヤの操作性とトルク伝達性を向上することができる。本発明のガイドワイヤの製造方法によれば、遠位端側先端チップの形成と同時にワイヤ芯線の先端に接合することができ、手作業によるハンダ付けなどの必要がないので、ガイドワイヤを経済的に製造することができる。   Since the guide wire of the present invention has a protrusion at the tip of the distal end tip tip, a protrusion with a small contact area hits a chronic complete occlusion lesion or the like, and is pierced with a weak force to become a starting point of penetration, and then the contact area Since the large distal tip tip is pushed forward, the guide wire is prevented from breaking through the normal blood vessel wall and can be safely treated. Since the guide wire of the present invention can be pushed forward with a weak force, the wire core wire can be made thin, and the operability and torque transmission performance of the guide wire can be improved. According to the guide wire manufacturing method of the present invention, it is possible to join the tip end of the wire core wire simultaneously with the formation of the distal end side tip, and there is no need for manual soldering. Can be manufactured.

本発明のガイドワイヤの一態様の側面図である。It is a side view of one mode of a guide wire of the present invention. 図１に示すガイドワイヤの説明図である。It is explanatory drawing of the guide wire shown in FIG. 本発明のガイドワイヤの遠位端側先端チップの一態様の正面図、側面図及び断面図である。It is the front view, side view, and sectional view of one mode of the distal tip tip tip of the guide wire of the present invention. 本発明のガイドワイヤの遠位端側先端チップの他の態様の正面図、側面図及び断面図である。It is the front view, side view, and sectional drawing of the other aspect of the distal end side tip tip of the guide wire of this invention. 本発明のガイドワイヤの遠位端側先端チップの他の態様の正面図、側面図及び断面図である。It is the front view, side view, and sectional drawing of the other aspect of the distal end side tip tip of the guide wire of this invention. 本発明のガイドワイヤの遠位端側先端チップの他の態様の正面図、側面図及び断面図である。It is the front view, side view, and sectional drawing of the other aspect of the distal end side tip tip of the guide wire of this invention. 本発明のガイドワイヤの遠位端側先端チップの他の態様の正面図及び側面図である。It is the front view and side view of another aspect of the distal end side tip tip of the guide wire of this invention. 本発明のガイドワイヤの遠位端側先端チップの他の態様の正面図及び側面図である。It is the front view and side view of another aspect of the distal end side tip tip of the guide wire of this invention. 本発明のガイドワイヤの遠位端側先端チップの他の態様の断面図である。It is sectional drawing of the other aspect of the distal end side front-end | tip tip of the guide wire of this invention. 本発明のガイドワイヤの製造方法の一態様の説明図である。It is explanatory drawing of the one aspect | mode of the manufacturing method of the guide wire of this invention. 実施例で用いた体腔モデルの説明図である。It is explanatory drawing of the body cavity model used in the Example. 実施例における近位端側回転角度と遠位端側回転角度の関係を示すグラフである。It is a graph which shows the relationship between the proximal end side rotation angle and the distal end side rotation angle in an Example. 従来のガイドワイヤによる事故の一例の説明図である。It is explanatory drawing of an example of the accident by the conventional guide wire.

符号の説明Explanation of symbols

１ 遠位端側小径部
２ 近位端側大径部
３ ガイドワイヤ
４ 遠位端側先端チップ
５ 突起
６ コイルスプリング
７ 血管
８ 慢性完全閉塞病変
９ 基部
１０ バネ
１１ 金型
１２ キャビティ
１３ 熱硬化性樹脂 DESCRIPTION OF SYMBOLS 1 Distal end side small diameter part 2 Proximal end side large diameter part 3 Guide wire 4 Distal end side tip tip 5 Protrusion 6 Coil spring 7 Blood vessel 8 Chronic complete occlusion lesion 9 Base 10 Spring 11 Mold 12 Cavity 13 Thermosetting resin

Claims (5)

遠位端側小径部と、遠位端側小径部よりも外径が大きい近位端側大径部とからなるワイヤ芯線を有するガイドワイヤにおいて、遠位端側先端チップが、その最先端に突起を有することを特徴とするガイドワイヤ。   In a guide wire having a wire core composed of a distal end side small diameter portion and a proximal end side large diameter portion having an outer diameter larger than that of the distal end side small diameter portion, the distal end side tip is at the forefront. A guide wire having a protrusion. 遠位端側先端チップが、回転対称軸を有しない請求項１記載のガイドワイヤ。   The guide wire according to claim 1, wherein the distal tip tip does not have an axis of rotational symmetry. 遠位端側先端チップが、表面に螺旋形状の溝を有する請求項１記載のガイドワイヤ。   The guide wire according to claim 1, wherein the distal tip tip has a spiral groove on the surface. 突起が遠位端側先端チップの中に収納され、突起に押込み圧を加えたときに、突起が遠位端側先端チップから突出する請求項１記載のガイドワイヤ。   The guide wire according to claim 1, wherein the protrusion is housed in the distal tip tip, and the protrusion protrudes from the distal tip when a pressing pressure is applied to the protrusion. 最先端に突起を有する遠位端側先端チップのキャビティを有する型に、溶融金属、溶融熱可塑性樹脂又は熱硬化性樹脂を充填し、該型にガイドワイヤ芯線の遠位端側小径部を挿入し、型内の溶融金属、溶融熱可塑性樹脂又は熱硬化性樹脂を固化することにより、遠位端側小径部の先端に遠位端側先端チップを形成することを特徴とするガイドワイヤの製造方法。   Fill the mold with the distal end tip tip cavity with protrusion at the end with molten metal, molten thermoplastic resin or thermosetting resin, and insert the distal end small diameter part of the guide wire core wire into the mold Then, a distal end tip tip is formed at the distal end of the distal end side small diameter portion by solidifying the molten metal, molten thermoplastic resin or thermosetting resin in the mold. Method.
JP2005285008A 2005-09-29 2005-09-29 Guide wire and manufacturing method thereof Expired - Fee Related JP4834367B2 (en)

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US11285299B2 (en) * 2019-10-31 2022-03-29 Abbott Cardiovascular Systems Inc. Mold for forming solder distal tip for guidewire

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