WO2003086523A1 - Guide wire for medical treatment - Google Patents

Guide wire for medical treatment Download PDF

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Publication number
WO2003086523A1
WO2003086523A1 PCT/JP2003/004487 JP0304487W WO03086523A1 WO 2003086523 A1 WO2003086523 A1 WO 2003086523A1 JP 0304487 W JP0304487 W JP 0304487W WO 03086523 A1 WO03086523 A1 WO 03086523A1
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WO
WIPO (PCT)
Prior art keywords
distal end
end side
wire
coil spring
joined
Prior art date
Application number
PCT/JP2003/004487
Other languages
French (fr)
Japanese (ja)
Inventor
Takashi Kawabata
Seiji Shimura
Original Assignee
Japan Lifeline Co., Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Japan Lifeline Co., Ltd filed Critical Japan Lifeline Co., Ltd
Publication of WO2003086523A1 publication Critical patent/WO2003086523A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09058Basic structures of guide wires
    • A61M2025/09083Basic structures of guide wires having a coil around a core

Definitions

  • the present invention relates to a medical guidewire for guiding a medical device such as a catheter used for treatment or examination to a predetermined position in a body cavity such as a blood vessel, and more particularly, to a medical guidewire having a distal end.
  • a medical guidewire that excels in flexibility and that transmits rotational torque at the proximal end to the distal end, and has excellent operability and insertion characteristics.
  • the catheter may need to be inserted into the vessel for treatment or testing.
  • a catheter is generally excellent in flexibility, and it is difficult to push a catheter to a predetermined position inside a blood vessel by itself. Therefore, it is common practice to insert a guide wire into the blood vessel in advance and guide the catheter to a predetermined position in the blood vessel along the guide wire.
  • the guide wire needs to be inserted into a meandering blood vessel so as not to damage the inner wall of the blood vessel.
  • the outer diameter of the guide wire at the distal end portion is made smaller than that of the other portions, and a coil spring is attached to the outer periphery of the distal end portion.
  • the present invention has been made in view of such circumstances, and has as its object that the guide wire has sufficient bending flexibility at the distal end, and furthermore, the rotational torque at the proximal end is good up to the distal end.
  • An object of the present invention is to provide a low-cost medical guidewire that is excellent in operability and insertion characteristics, is easy to manufacture, and is easy to manufacture.
  • a medical guidewire according to the present invention includes:
  • a main body having a distal end side small diameter portion and a proximal end side large diameter portion having an outer diameter relatively larger than the distal end side small diameter portion;
  • a medical guidewire attached to the outer periphery of a small-diameter portion on the distal end side of the wire body along an axial direction, and having a coil spring joined to the wire body at a proximal end and a distal end.
  • the coil elements constituting the coil spring are spot-joined to each other at at least one force point at a pitch of 100 or less.
  • the coil element constituting the coil spring is spot-joined at at least one force point at a pitch of 100 or less. Therefore, the rotational torque transmitted from the large-diameter portion on the proximal end side of the wire body together with the small-diameter portion on the distal end side is transmitted through the coil spring without impairing the flexibility of the coil spring. Transmits well to the distal end. Therefore, the medical guidewire of the present invention transmits the rotational torque on the proximal end side well to the distal end side, and is excellent in operability and insertion characteristics.
  • the coil elements are spot-joined to each other by spot welding. It is easy to manufacture and low cost because it only needs to be done.
  • the coil element means a unit of one turn of a coil-shaped wire rod constituting a coil spring.
  • One pitch means one unit in the axial direction of the coil element in one round.
  • the cross-section of the coiled wire constituting the coil spring is not particularly limited, and is generally circular, but may be rectangular, square, or another shape.
  • the coil elements are spot-joined at one or more places in 1 to 10 pitches.
  • the spot joining portions joined in a spot manner are offset at a predetermined angle in the circumferential direction at positions adjacent to each other in the axial direction.
  • the present invention by offsetting the spot joints at a predetermined angle in the circumferential direction at positions adjacent to each other in the axial direction, it is possible to reduce the anisotropy in the flexibility of the coil spring, and to reduce the orientation in all directions. And excellent flexibility can be obtained. As a result, the insertion characteristics of the medical guidewire are improved.
  • FIG. 1 is a cross-sectional side view of a main part of a medical guidewire according to one embodiment of the present invention
  • FIG. 2A is a side view of the coil spring shown in FIG. 1
  • FIG. 2B is a view shown in FIG. — Cross section along the ⁇ ⁇ line
  • FIG. 3 is a schematic view showing an example of use of the guide wire shown in FIG. [0014]
  • the medical guide wire 2 has a wire having a distal end side small diameter portion 4a having an outer diameter smaller than the proximal end side large diameter portion 4b. It has a main body 4.
  • the wire main body 4 is integrally formed of a wire having a substantially circular cross section, and is tapered from the proximal end large diameter portion 4b to the distal end small diameter portion 4a.
  • the material of the wire body 4 is not particularly limited, metals such as stainless steel (for example, SUS316, SUS304), gold, platinum, aluminum, tungsten, tantalum, and alloys thereof are exemplified. In form, it is composed of stainless steel.
  • the total length of the wire body 4 varies depending on the purpose of use and the like, and is not particularly limited.
  • a coil spring 12 is mounted on the outer periphery of the small diameter portion 4 a on the distal end side of the wire main body 4.
  • the axial length L 0 of the coil spring 12 is, for example, about 30 to 800 m.
  • the outer diameter of the large diameter portion 4b on the proximal end side of the wire body 4 is not particularly limited, but is about 0.10 to 0.90 mm.
  • the outer diameter of the distal end side small diameter portion 4a is not particularly limited, but is preferably about 1/5 to 1/2 the outer diameter of the proximal end side large diameter portion 4b. It is.
  • a spherical or hemispherical ball portion 10 is joined to the distal end of the distal end side small diameter portion 4 a of the wire main body 4.
  • the ball portion 10 is a portion for smoothing the distal end portion of the guide wire 2 so as to prevent the inner wall of the body cavity from being damaged when the guide wire 2 is inserted into a body cavity such as a blood vessel. Stopper at the distal end.
  • the ball portion 10 is made of, for example, a metal such as tin, silver, or gold, and is joined to the distal end of the distal-end-side small-diameter portion 4a by means of welding or joining.
  • the outer diameter of the ball portion 10 is preferably approximately 0.5 to 2 times the outer diameter of the large-diameter portion 4 b on the proximal end side of the wire body 4. [0 0 1 8]
  • the distal end 14 of the coil spring 12 is joined to the back surface of the ball portion 10 by means of welding or joining.
  • the proximal end 16 of the coil spring 12 is joined to the outer periphery of the wire body 4 near the proximal end of the small-diameter portion 4a on the distal end side by means of welding or joining.
  • the outer peripheral surface of the wire main body 4 may be integrally covered with a biocompatible coating film.
  • a biocompatible coating film include, but are not particularly limited to, ordinary polymers used for medical purposes, such as olefins such as polyethylene, nitrogen-containing polymers such as polyimide and polyamide, and siloxane polymers.
  • the coating film is not limited to the polymer, and may be an inorganic coating film such as silicon carbide, carbon such as light-emitting carbon and diamond-like carbon.
  • a plurality of coil elements (units of one circumference of the coil spring) connected in the axial direction so as to constitute the coil spring 12
  • the elements 12a are spot-joined to each other at at least one point below the pitch of 100 (100 turns).
  • every two pitches along the axial direction of the coil spring 12 and as shown in FIG.
  • the coil elements 12a adjacent to each other in the axial direction are spot welded to each other, and a spot joint 18 is formed.
  • the spot joints 18 are offset at a predetermined angle 6> in the circumferential direction at positions adjacent to each other in the axial direction.
  • the predetermined angle 0 varies depending on the number of spots and is not particularly limited. However, it is desirable that the predetermined angle 0 be distributed substantially uniformly in the circumferential direction over the entire length of the coil. By setting the angle 6> as described above, the coil spring 12 can have excellent flexibility in all directions. [0022]
  • spot welding is not particularly limited, spot laser welding is preferably used. Although the specific conditions of the spot laser welding are not particularly limited, for example, the following conditions are exemplified.
  • a YAG laser is used, and a laser beam focused by an optical system to a diameter of 50/1 is used.
  • the pulse width of the laser is approximately 10-3 sec, the number of pulses is 10PPS (pulse / sec), the output is 10 W.
  • the outer diameter of the coil spring 12 is not particularly limited, but is preferably equal to or less than the outer diameter of the ball portion 10.
  • the outer diameter of the wire constituting the coil spring 12 is not particularly limited, but is preferably 20 to 15 Om, and more preferably 50 to 100 m.
  • the total length L 0 of the coil spring 12 is preferably 30 to 800 thighs.
  • the material of the coil spring 12 is not particularly limited, and may be a radiation contrast material or a radiation non-contrast material.
  • the radiation non-contrast material is not particularly limited, but is mainly exemplified by stainless steel (for example, SUS 316 and SUS 304).
  • the rotating torque transmitted from the large-diameter portion 4b on the proximal end side of the wire main body 4 is transmitted to the distal end without impairing the flexibility of the coil spring 12.
  • the power is well transmitted to the ball portion 10 mounted on the most distal end of the wire main body 4 via the coil spring 12. Therefore, the medical guidewire 2 of the present embodiment transmits the rotational torque on the proximal end side well to the distal end side, and is excellent in operability and insertion characteristics. Therefore, it is easy to freely change the bending direction of the ball portion 10 attached to the most distal end of the wire main body 4.
  • Fig. 3 for example, As in the case of insertion from the aorta 22 of the root to the coronary artery of the heart 20, it can be easily followed and inserted into a blood vessel having a strongly bent portion near the distal end of the wire.
  • the coil elements 12a are spot-joined to each other at a few places in the axial direction of the coil spring 12 by, for example, spot welding from the outer periphery. Because it is only necessary, it is easy to manufacture and low cost.

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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

A guide wire for medical treatment, comprising a wire body (4) having a distal end side small diameter part (4a) and a proximal end side large diameter part (4b) having an outer diameter rather larger than the distal end side small diameter part (4a) and a coiled spring (12) fitted to the outer periphery of the distal end side small diameter part (4a) of the wire body (4) along the axial direction and connected to the wire body (4) at the proximity and distal ends, wherein coil elements (12a) forming the coiled spring (12) are spot-welded to each other at least at one position every 100 pitches or less.

Description

明 細 書 医療用ガイドワイヤ  Description Medical guidewire
【0 0 0 1】 [0 0 0 1]
技術分野 Technical field
本発明は、 治療や検査のために用いられるカテーテルなどの医療器具を血管な どの体腔内の所定位置へと案内するための医療用ガイドワイヤに係り、 さらに詳 しくは、 遠位端部の可撓性に優れ、 しかも近位端側での回転トルクが遠位端側に まで良好に伝達し、 操作性および挿入特性に優れた医療用ガイドワイヤに関する The present invention relates to a medical guidewire for guiding a medical device such as a catheter used for treatment or examination to a predetermined position in a body cavity such as a blood vessel, and more particularly, to a medical guidewire having a distal end. A medical guidewire that excels in flexibility and that transmits rotational torque at the proximal end to the distal end, and has excellent operability and insertion characteristics.
【0 0 0 2】 [0 0 0 2]
背景技術 Background art
治療や検査のために、 カテーテルを血管内の所定位置まで挿入しなければなら ない場合がある。 カテーテルは、 一般に柔軟性に優れており、 カテ一テル単独で は、 血管の内部の所定位置まで押し込むことは困難である。 そこで、 血管内に予 めガイ ドワイヤを揷入しておき、 そのガイドワイヤに沿ってカテーテルを血管内 の所定位置まで案内することが一般的に行われている。  The catheter may need to be inserted into the vessel for treatment or testing. A catheter is generally excellent in flexibility, and it is difficult to push a catheter to a predetermined position inside a blood vessel by itself. Therefore, it is common practice to insert a guide wire into the blood vessel in advance and guide the catheter to a predetermined position in the blood vessel along the guide wire.
【 0 0 0 3】  [0 0 0 3]
ガイ ドワイヤは、 血管の内壁を傷付けないように、 曲がりくねった血管内に揷 入される必要がある。 また、 ガイドワイヤの先端部を、 心臓近くの動脈血管内に 位置させる場合には、 ガイドワイヤの先端部は、 R = 2 0 mm以下に折り曲げら れる部分を通過させることが多い。 この場合に永久変形をきたすとその先への送 り込みが不自由になる。 したがって、 ガイドワイヤは、 特に先端部分 (遠位端部 分) において可撓性に優れていることが重要である。  The guide wire needs to be inserted into a meandering blood vessel so as not to damage the inner wall of the blood vessel. In addition, when the distal end of the guidewire is located in an arterial blood vessel near the heart, the distal end of the guidewire often passes through a portion bent to R = 20 mm or less. In this case, if permanent deformation occurs, it will be difficult to send the material beyond that point. Therefore, it is important that the guidewire has excellent flexibility, particularly at the distal end (distal end).
【0 0 0 4】  [0 0 0 4]
そこで、 従来のガイドワイヤとして、 遠位端部分のガイドワイヤの外径を、 他 の部分よりも小さくすると共に、 その遠位端部の外周にコイルスプリングを装着 し、 遠位端部分の可撓性の向上を図ったガイドワイヤが提案されている。  Therefore, as a conventional guide wire, the outer diameter of the guide wire at the distal end portion is made smaller than that of the other portions, and a coil spring is attached to the outer periphery of the distal end portion. There has been proposed a guide wire which improves the performance.
【 0 0 0 5】 しかしながら、 遠位端部分のガイドワイヤの外径を、 他の部分よりも小さくす ると、 操作側端部である近位端部での回転トルクが、 遠位端まで良好に伝達する ことが困難になる。 そのため、 ガイドワイヤの遠位端部を、 その軸廻りに所定角 度で回転させることが困難になり、 血管などの体腔内でのガイドワイヤの揷入性 が低下するおそれがある。 [0 0 0 5] However, if the outer diameter of the guide wire at the distal end portion is made smaller than that at the other portions, the rotational torque at the proximal end portion, which is the operation side end, can be transmitted well to the distal end. It becomes difficult. Therefore, it becomes difficult to rotate the distal end of the guide wire around the axis at a predetermined angle, and there is a possibility that the penetration of the guide wire into a body cavity such as a blood vessel may be reduced.
【0 0 0 6】  [0 0 0 6]
発明の開示 Disclosure of the invention
本発明は、 このような実状に鑑みてなされ、 その目的は、 ガイ ドワイヤの遠位 端部における屈曲柔軟性が十分であり、 しかも近位端側での回転トルクが遠位端 側にまで良好に伝達し、 操作性および挿入特性に優れ、 しかも、 製造が容易であ り、 低コストの医療用ガイ ドワイヤを提供することである。  The present invention has been made in view of such circumstances, and has as its object that the guide wire has sufficient bending flexibility at the distal end, and furthermore, the rotational torque at the proximal end is good up to the distal end. An object of the present invention is to provide a low-cost medical guidewire that is excellent in operability and insertion characteristics, is easy to manufacture, and is easy to manufacture.
【0 0 0 7】  [0 0 0 7]
上記目的を達成するために、 本発明に係る医療用ガイドワイヤは、  In order to achieve the above object, a medical guidewire according to the present invention includes:
遠位端側小径部と前記遠位端側小径部よりも比較的に大きい外径を有する近位 端側大径部とを持つヮィャ本体と、  A main body having a distal end side small diameter portion and a proximal end side large diameter portion having an outer diameter relatively larger than the distal end side small diameter portion;
前記ワイヤ本体の遠位端側小径部の外周に軸方向に沿って装着され、 近位端と 遠位端とにおいて前記ワイヤ本体に接合してあるコイルスプリングとを有する医 療用ガイドワイヤであって、  A medical guidewire attached to the outer periphery of a small-diameter portion on the distal end side of the wire body along an axial direction, and having a coil spring joined to the wire body at a proximal end and a distal end. hand,
前記コイルスプリングを構成するコイル要素相互が、 1 0 0ピヅチ以下に少な くとも 1力所以上で、 スポット的に接合してあることを特徴とする。  The coil elements constituting the coil spring are spot-joined to each other at at least one force point at a pitch of 100 or less.
【0 0 0 8】  [0 0 0 8]
本発明に係る医療用ガイ ドワイヤは、 コイルスプリングを構成するコイル要素 が、 1 0 0ピヅチ以下に少なくとも 1力所以上で、 スポヅト的に接合してある。 したがって、 コイルスプリングの可撓性を損なうことなく、 ワイヤ本体の近位端 側大径部から伝達される回転トルクが、 遠位端側小径部と共に、 コイルスプリン グを介して、 ワイヤ本体の最遠位端にまで良好に伝達する。 したがって、 本発明 の医療用ガイドワイヤは、 近位端側での回転トルクが遠位端側にまで良好に伝達 し、 操作性および挿入特性に優れている。 しかも、 コイルスプリングの軸方向の 数力所において、 スポット溶接などで、 コイル要素の相互をスポット的に接合す ればよいのみであるため、 製造が容易であり、 低コストである。 In the medical guide wire according to the present invention, the coil element constituting the coil spring is spot-joined at at least one force point at a pitch of 100 or less. Therefore, the rotational torque transmitted from the large-diameter portion on the proximal end side of the wire body together with the small-diameter portion on the distal end side is transmitted through the coil spring without impairing the flexibility of the coil spring. Transmits well to the distal end. Therefore, the medical guidewire of the present invention transmits the rotational torque on the proximal end side well to the distal end side, and is excellent in operability and insertion characteristics. In addition, at several places in the axial direction of the coil spring, the coil elements are spot-joined to each other by spot welding. It is easy to manufacture and low cost because it only needs to be done.
【0 0 0 9】  [0 0 0 9]
なお、 本発明において、 コイル要素とは、 コイルスプリングを構成するコイル 状に卷回された線材における 1周単位を意味する。 1ピッチとは、 その 1周単位 のコイル要素の軸方向 1単位を意味する。 本発明では、 コイルスプリングを構成 するコイル状線材の横断面は、 特に限定されず、 一般には円形であるが、 長方形、 四角形、 あるいはその他の形状であっても良い。  In the present invention, the coil element means a unit of one turn of a coil-shaped wire rod constituting a coil spring. One pitch means one unit in the axial direction of the coil element in one round. In the present invention, the cross-section of the coiled wire constituting the coil spring is not particularly limited, and is generally circular, but may be rectangular, square, or another shape.
【0 0 1 0】  [0 0 1 0]
好ましくは、 前記コィル要素相互が、 1〜 1 0ピヅチに 1力所以上で、 スポヅ ト的に接合してある。  Preferably, the coil elements are spot-joined at one or more places in 1 to 10 pitches.
好ましくは、 スポット的に接合してあるスポット接合部が、 軸方向に隣り合う 位置で、 周方向に所定角度でオフセットしてある。  Preferably, the spot joining portions joined in a spot manner are offset at a predetermined angle in the circumferential direction at positions adjacent to each other in the axial direction.
【0 0 1 1】  [0 0 1 1]
スポヅト接合部の数が、 コイルスプリングの外周で密になりすぎると、 コイル スプリングの可撓性が低下する傾向にあり、 粗になり過ぎると、 コイルスプリン グを介しての回転トルクの伝達が困難になる傾向にある。 したがって、 上記の範 囲内が好ましい。  If the number of spot joints is too close to the outer circumference of the coil spring, the flexibility of the coil spring tends to decrease, and if it is too coarse, it is difficult to transmit the rotational torque via the coil spring. Tends to be. Therefore, the above range is preferable.
【0 0 1 2】  [0 0 1 2]
また、 本発明において、 スポット接合部を、 軸方向に隣り合う位置で、 周方向 に所定角度でオフセヅトさせることで、 コイルスプリングの可撓性における異方 向性を低減することができ、 あらゆる方向で可撓性に優れたものとすることがで きる。 その結果、 医療用ガイドワイヤの挿入特性が向上する。  Further, in the present invention, by offsetting the spot joints at a predetermined angle in the circumferential direction at positions adjacent to each other in the axial direction, it is possible to reduce the anisotropy in the flexibility of the coil spring, and to reduce the orientation in all directions. And excellent flexibility can be obtained. As a result, the insertion characteristics of the medical guidewire are improved.
【0 0 1 3】  [0 0 1 3]
図面の簡単な説明 BRIEF DESCRIPTION OF THE FIGURES
以下、 本発明を、 図面に示す実施形態に基づき説明する。 ここにおいて、 図 1は本発明の一実施形態に係る医療用ガイドワイヤの要部断面側面図、 図 2 Aは図 1に示すコイルスプリングの側面図、 図 2 Bは図 2 Aに示す Π Β— Π Β線に沿う断面図、  Hereinafter, the present invention will be described based on embodiments shown in the drawings. Here, FIG. 1 is a cross-sectional side view of a main part of a medical guidewire according to one embodiment of the present invention, FIG. 2A is a side view of the coil spring shown in FIG. 1, and FIG. 2B is a view shown in FIG. — Cross section along the Β 、 line,
図 3は図 1に示すガイドワイヤの使用例を示す概略図である。 【0014】 FIG. 3 is a schematic view showing an example of use of the guide wire shown in FIG. [0014]
発明を実施するための最良の態様 BEST MODE FOR CARRYING OUT THE INVENTION
図 1に示すように、 本発明の 1実施形態に係る医療用ガイ ドワイヤ 2は、 近位 端側大径部 4 bに比較して細い外径の遠位端側小径部 4 aを持つワイャ本体 4を 有する。 ワイヤ本体 4は、 横断面が略円形の線材で一体的に構成してあり、 近位 端側大径部 4 bから遠位端側小径部 4 aに向けてテーパ状に細くなつている。  As shown in FIG. 1, the medical guide wire 2 according to one embodiment of the present invention has a wire having a distal end side small diameter portion 4a having an outer diameter smaller than the proximal end side large diameter portion 4b. It has a main body 4. The wire main body 4 is integrally formed of a wire having a substantially circular cross section, and is tapered from the proximal end large diameter portion 4b to the distal end small diameter portion 4a.
【0015】  [0015]
ワイヤ本体 4の材質としては、 特に限定されないが、 ステンレス (たとえば S US 3 16、 SUS 304) 、 金、 白金、 アルミニウム、 タングステン、 タンタ ルまたはこれらの合金などの金属が例示されるが、 本実施形態では、 ステンレス で構成してある。  Although the material of the wire body 4 is not particularly limited, metals such as stainless steel (for example, SUS316, SUS304), gold, platinum, aluminum, tungsten, tantalum, and alloys thereof are exemplified. In form, it is composed of stainless steel.
【0016】  [0016]
ワイヤ本体 4の全長は、 使用目的などに応じて変化し、 特に限定されないが、 たとえば 80〜 350 c m程度である。 ワイャ本体 4の遠位端側小径部 4 aの外 周には、 コイルスプリング 12が装着してある。 コイルスプリング 12の軸方向 長さ L 0は、 たとえば 30〜800顧程度である。  The total length of the wire body 4 varies depending on the purpose of use and the like, and is not particularly limited. A coil spring 12 is mounted on the outer periphery of the small diameter portion 4 a on the distal end side of the wire main body 4. The axial length L 0 of the coil spring 12 is, for example, about 30 to 800 m.
ワイヤ本体 4における近位端側大径部 4 bの外径は、 特に限定されないが、 0. 10〜0. 90mm程度である。 また、 遠位端側小径部 4 aの外径は、 特に限定さ れないが、 近位端側大径部 4bの外径に対して、 好ましくは 1/5~1/2程度 の外径である。  The outer diameter of the large diameter portion 4b on the proximal end side of the wire body 4 is not particularly limited, but is about 0.10 to 0.90 mm. The outer diameter of the distal end side small diameter portion 4a is not particularly limited, but is preferably about 1/5 to 1/2 the outer diameter of the proximal end side large diameter portion 4b. It is.
【0017】  [0017]
ワイヤ本体 4における遠位端側小径部 4 aの先端には、 球又は半球状のボール 部 10が接合してある。 ボール部 10は、 ガイドワイヤ 2の先端部を滑らかにし て、 ガイドワイヤ 2を血管などの体腔内に挿入する際に、 体腔内壁の損傷を極力 防止するための部であると共に、 コイルスプリング 12の遠位端側ストヅパとな る。 このボール部 10は、 たとえばスズ、 銀、 金などの金属で構成してあり、 遠 位端側小径部 4 aの先端に、 溶接または口一付けなどの手段で接合してある。 ボ —ル部 10の外径は、 ワイヤ本体 4の近位端側大径部 4 bの外径に対して、 好ま しくは 0. 5〜2倍程度の外径である。 【0 0 1 8】 A spherical or hemispherical ball portion 10 is joined to the distal end of the distal end side small diameter portion 4 a of the wire main body 4. The ball portion 10 is a portion for smoothing the distal end portion of the guide wire 2 so as to prevent the inner wall of the body cavity from being damaged when the guide wire 2 is inserted into a body cavity such as a blood vessel. Stopper at the distal end. The ball portion 10 is made of, for example, a metal such as tin, silver, or gold, and is joined to the distal end of the distal-end-side small-diameter portion 4a by means of welding or joining. The outer diameter of the ball portion 10 is preferably approximately 0.5 to 2 times the outer diameter of the large-diameter portion 4 b on the proximal end side of the wire body 4. [0 0 1 8]
コイルスプリング 1 2の遠位端 1 4は、 ボール部 1 0の背面に対して溶接また は口一付けなどの手段で接合してある。 コイルスプリング 1 2の近位端 1 6は、 遠位端側小径部 4 aの近位端近傍において、 ワイヤ本体 4の外周に、 溶接または 口一付けなどの手段で接合してある。  The distal end 14 of the coil spring 12 is joined to the back surface of the ball portion 10 by means of welding or joining. The proximal end 16 of the coil spring 12 is joined to the outer periphery of the wire body 4 near the proximal end of the small-diameter portion 4a on the distal end side by means of welding or joining.
【0 0 1 9】  [0 0 1 9]
ワイヤ本体 4の外周面は、 生体適合性コーティング膜で一体的に被覆してあつ ても良い。 生体適合性コーティング膜としては、 特に限定されないが、 たとえば ポリエチレンなどのォレフィン類、 ポリイミドゃポリアミドなどの含窒素ポリマ 一、 シロキサンポリマーなど、 医療用として用いられる通常のポリマーなどが用 いられる。 また、 コーティング膜としては、 ポリマーに限定されず、 炭化珪素、 パイ口ライ トカーボンやダイアモンドライクカーボンなどのカーボンなど、 無機 物のコーティング膜であっても良い。  The outer peripheral surface of the wire main body 4 may be integrally covered with a biocompatible coating film. Examples of the biocompatible coating film include, but are not particularly limited to, ordinary polymers used for medical purposes, such as olefins such as polyethylene, nitrogen-containing polymers such as polyimide and polyamide, and siloxane polymers. Further, the coating film is not limited to the polymer, and may be an inorganic coating film such as silicon carbide, carbon such as light-emitting carbon and diamond-like carbon.
【0 0 2 0】  [0 0 2 0]
本実施形態では、 図 2 Aおよび図 2 Bに示すように、 コイルスプリング 1 2を 構成するように軸方向に繋がる複数のコイル要素 (コイルスプリングの一周の単 位) 1 2 aにおける隣接するコイル要素 1 2 aの相互が、 1 0 0ピヅチ (1 0 0 周の卷回) 以下に少なくとも 1力所以上で、 スポット的に接合してある。 図示す る例では、 図 2 Aに示すように、 コイルスプリング 1 2の軸方向に沿って 2ピヅ チ毎に、 図 2 Bに示すように、 1 8 0度の対称位置に 2点で、 軸方向に隣接する コイル要素 1 2 aの相互が、 スポヅト溶接してあり、 スポヅト接合部 1 8が形成 してある。  In this embodiment, as shown in FIG. 2A and FIG. 2B, a plurality of coil elements (units of one circumference of the coil spring) connected in the axial direction so as to constitute the coil spring 12 The elements 12a are spot-joined to each other at at least one point below the pitch of 100 (100 turns). In the example shown in the figure, as shown in FIG. 2A, every two pitches along the axial direction of the coil spring 12, and as shown in FIG. The coil elements 12a adjacent to each other in the axial direction are spot welded to each other, and a spot joint 18 is formed.
【 0 0 2 1 1  [0 0 2 1 1
しかも、 スポヅ ト接合部 1 8は、 図 2 Aおよび図 2 Bに示すように、 軸方向に 隣り合う位置で、 周方向に所定角度 6>でオフセットしてある。 この所定角度 0は、 スポヅトの数によって変化し特に限定されないが、 コイル全長に亘つて、 円周方 向に、 ほぼ均一に分布することが望ましい。 この角度 6>を前記のようにすること で、 コイルスプリング 1 2を、 あらゆる方向で可撓性に優れたものとすることが できる。 【0022】 Moreover, as shown in FIGS. 2A and 2B, the spot joints 18 are offset at a predetermined angle 6> in the circumferential direction at positions adjacent to each other in the axial direction. The predetermined angle 0 varies depending on the number of spots and is not particularly limited. However, it is desirable that the predetermined angle 0 be distributed substantially uniformly in the circumferential direction over the entire length of the coil. By setting the angle 6> as described above, the coil spring 12 can have excellent flexibility in all directions. [0022]
スポヅト溶接としては、 特に限定されないが、 スポットレーザ溶接が好ましく 用いられる。 スポヅトレ一ザ溶接の具体的な条件としては、 特に限定されないが、 たとえば下記のような条件が例示される。  Although spot welding is not particularly limited, spot laser welding is preferably used. Although the specific conditions of the spot laser welding are not particularly limited, for example, the following conditions are exemplified.
レーザとしては、 YAGレーザが用いられ、 光学系でレーザ光を 50/ Π1径に 集光したものが用いられる。 レーザのパルス幅は、 10— 3秒程度であり、 パルス 数は、 10PPS (pulse/sec) であり、 出力は 10Wである。 As the laser, a YAG laser is used, and a laser beam focused by an optical system to a diameter of 50/1 is used. The pulse width of the laser is approximately 10-3 sec, the number of pulses is 10PPS (pulse / sec), the output is 10 W.
【 0023】  [0023]
コイルスプリング 12の外径は、 特に限定されないが、 ボール部 10の外径と 同程度以下が好ましい。 コイルスプリング 12を構成する線材の外径は、 特に限 定されないが、 好ましくは 20〜15 O m, さらに好ましくは 50〜100〃 mの範囲である。 コイルスプリング 12の全長 L 0は、 好ましくは 30〜800 腿でめる。  The outer diameter of the coil spring 12 is not particularly limited, but is preferably equal to or less than the outer diameter of the ball portion 10. The outer diameter of the wire constituting the coil spring 12 is not particularly limited, but is preferably 20 to 15 Om, and more preferably 50 to 100 m. The total length L 0 of the coil spring 12 is preferably 30 to 800 thighs.
【0024】  [0024]
コイルスプリング 12の材質は、 特に限定されず、 放射線造影材でも、 放射線 非造影材でも良い。 放射線造影材としては、 白金、 白金合金 (たとえば Pt/I r = 93/7) 、 金、 金一銅合金、 タングステン、 タンタルなどの X線に対する 造影性が良好な材質が例示される。 また、 放射線非造影材としては、 特に限定さ れないが、 ステンレス (たとえば SUS 316、 SUS 304) などが主として 例示される。  The material of the coil spring 12 is not particularly limited, and may be a radiation contrast material or a radiation non-contrast material. Examples of the radiological contrast material include platinum, a platinum alloy (for example, Pt / Ir = 93/7), gold, a copper-copper alloy, tungsten, and tantalum, which have a good X-ray contrast property. The radiation non-contrast material is not particularly limited, but is mainly exemplified by stainless steel (for example, SUS 316 and SUS 304).
【 0025】  [0025]
本実施形態に係る医療用ガイ ドワイヤ 2では、 コィルスプリング 12の可撓性 を損なうことなく、 ワイヤ本体 4の近位端側大径部 4 bから伝達される回転トル クが、 遠位端側小径部 4 aと共に、 コイルスプリング 12を介して、 ワイャ本体 4の最遠位端に装着してあるボール部 10にまで良好に伝達する。 したがって、 本実施形態の医療用ガイドワイヤ 2は、 近位端側での回転トルクが遠位端側にま で良好に伝達し、 操作性および挿入特性に優れている。 そのため、 ワイヤ本体 4 の最遠位端に装着してあるボール部 10の屈曲 向を自由に変化させることが容 易である。 その結果、 たとえば図 3に示すように、 ガイドワイヤ 2を、 足の付け 根部分の大動脈 2 2から心臓 2 0の冠状動脈の部分まで挿入する際などのように、 ワイヤの先端付近で強い曲がり部分を有する血管内へも容易に追随して挿入する ことができる。 In the medical guide wire 2 according to the present embodiment, the rotating torque transmitted from the large-diameter portion 4b on the proximal end side of the wire main body 4 is transmitted to the distal end without impairing the flexibility of the coil spring 12. Along with the side small diameter portion 4a, the power is well transmitted to the ball portion 10 mounted on the most distal end of the wire main body 4 via the coil spring 12. Therefore, the medical guidewire 2 of the present embodiment transmits the rotational torque on the proximal end side well to the distal end side, and is excellent in operability and insertion characteristics. Therefore, it is easy to freely change the bending direction of the ball portion 10 attached to the most distal end of the wire main body 4. As a result, as shown in Fig. 3, for example, As in the case of insertion from the aorta 22 of the root to the coronary artery of the heart 20, it can be easily followed and inserted into a blood vessel having a strongly bent portion near the distal end of the wire.
【 0 0 2 6】  [0 0 2 6]
また、 本実施形態のガイドワイヤ 2では、 その製造に際し、 コィルスプリング 1 2の軸方向の数力所において、 外周からスポヅト溶接などで、 コイル要素 1 2 aの相互をスポヅ ト的に接合すればよいのみであるため、 製造が容易であり、 低 コストである。  In the guide wire 2 of the present embodiment, the coil elements 12a are spot-joined to each other at a few places in the axial direction of the coil spring 12 by, for example, spot welding from the outer periphery. Because it is only necessary, it is easy to manufacture and low cost.
【 0 0 2 7】  [0 0 2 7]
なお、 本発明は、 上述した実施形態に限定されるものではなく、 本発明の範囲 内で種々に改変することができる。  Note that the present invention is not limited to the above-described embodiment, and can be variously modified within the scope of the present invention.

Claims

請 求 の 範 囲 The scope of the claims
1 . 遠位端側小径部と前記遠位端側小径部よりも比較的に大きい外径を 有する近位端側大径部とを持つワイャ本体と、 1. a wire body having a distal end side small diameter portion and a proximal end side large diameter portion having an outer diameter relatively larger than the distal end side small diameter portion;
前記ワイヤ本体の遠位端側小径部の外周に軸方向に沿って装着され、 近位端と 遠位端とにおいて前記ワイヤ本体に接合してあるコイルスプリングとを有する医 療用ガイドワイヤであって、  A medical guidewire attached to the outer periphery of a small-diameter portion on the distal end side of the wire body along an axial direction, and having a coil spring joined to the wire body at a proximal end and a distal end. hand,
前記コィルスプリングを構成するコィル要素相互が、 1 0 0ピヅチ以下に少な くとも 1力所以上で、 スポット的に接合してあることを特徴とする医療用ガイ ド ワイヤ。  A medical guide wire, characterized in that the coil elements constituting the coil spring are spot-joined to each other at at least one force point of less than 100 pitches.
2 . スポット的に接合してあるスポット接合部が、 軸方向に隣り合う位 置で、 周方向に所定角度でオフセットしてあることを特徴とする請求項 1に記載 の医療用ガイ ドワイヤ。 2. The medical guide wire according to claim 1, wherein the spot-joined portions joined in a spot manner are offset at a predetermined angle in a circumferential direction at positions adjacent to each other in the axial direction.
3 . 前記コイル要素相互が、 1〜1 0ピッチに 1力所以上で、 スポット 的に接合してある請求項 1または 2に記載の医療用ガイドワイヤ。 3. The medical guidewire according to claim 1, wherein the coil elements are spot-joined to each other at one or more places at 1 to 10 pitches.
4 . 前記ワイヤ本体の全長が、 8 0〜3 5 0 c mである請求項 1 ~ 3の いずれかに記載の医療用ガイ ドワイヤ。 4. The medical guide wire according to any one of claims 1 to 3, wherein the entire length of the wire main body is 80 to 350 cm.
5 . 前記コイルスプリングの軸方向長さが、 3 0〜 8 0 0腿である請求 項 1〜4のいずれかに記載の医療用ガイドワイヤ。 5. The medical guidewire according to any one of claims 1 to 4, wherein the coil spring has an axial length of 30 to 800 thighs.
6 . 前記ワイヤ本体における遠位端側小径部の先端には、 球又は半球状 のボール部が接合してある請求項 1〜 5のいずれかに記載の医療用ガイドワイヤ c 6. The medical guidewire c according to any one of claims 1 to 5, wherein a spherical or hemispherical ball portion is joined to a distal end of the distal end side small diameter portion of the wire main body.
7 . 前記コイルスプリングの遠位端が、 前記ボール部の背面に対して接 合してある請求項 6に記載の医療用ガイドワイヤ。 7. The medical guidewire according to claim 6, wherein a distal end of the coil spring is in contact with a back surface of the ball portion.
8 . 前記ワイヤ本体の外周面は、 生体適合性コ一ティング膜で一体的に 被覆してある請求項 1〜 7のいずれかに記載の医療用ガイドワイヤ。 8. The medical guidewire according to any one of claims 1 to 7, wherein an outer peripheral surface of the wire main body is integrally coated with a biocompatible coating film.
PCT/JP2003/004487 2002-04-12 2003-04-09 Guide wire for medical treatment WO2003086523A1 (en)

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WO2009076643A1 (en) * 2007-12-13 2009-06-18 Boston Scientific Scimed, Inc. Coil member for a medical device

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JP4834367B2 (en) * 2005-09-29 2011-12-14 日本ライフライン株式会社 Guide wire and manufacturing method thereof
US9550013B2 (en) 2009-03-19 2017-01-24 Japan Lifeline Co., Ltd. Medical guide wire
AU2010250563B2 (en) 2009-05-20 2015-07-02 Japan Lifeline Co., Ltd. Medical guide wire
JP5605949B2 (en) * 2011-03-30 2014-10-15 日本ライフライン株式会社 Medical guidewire
JP5957966B2 (en) * 2012-03-05 2016-07-27 住友ベークライト株式会社 Medical device and method for manufacturing medical device
JP2015036090A (en) * 2013-08-15 2015-02-23 朝日インテック株式会社 Coil body and guide wire using the same
JP7364369B2 (en) * 2019-06-21 2023-10-18 朝日インテック株式会社 guide wire

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JP2002336360A (en) * 2001-05-21 2002-11-26 Japan Lifeline Co Ltd Medical guide wire

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JP2002336360A (en) * 2001-05-21 2002-11-26 Japan Lifeline Co Ltd Medical guide wire

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WO2005035042A2 (en) * 2003-09-05 2005-04-21 Boston Scientific Limited Medical device coil
WO2005035042A3 (en) * 2003-09-05 2005-07-07 Scimed Life Systems Inc Medical device coil
WO2009076643A1 (en) * 2007-12-13 2009-06-18 Boston Scientific Scimed, Inc. Coil member for a medical device
US8157751B2 (en) 2007-12-13 2012-04-17 Boston Scientific Scimed, Inc. Coil member for a medical device

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