JPH09294810A - Catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To omit the complicated inspection process for confirming whether a strand is protruded or not, remarkably improve safety and quality assurance, and promote the cost reduction by providing a resin intermediate layer between the outer periphery of a metal braid and the inner periphery of an outer tube. SOLUTION: This catheter 1 made of a flexible extra fine tube is constituted of a metal braid 4 braided with a stainless extra fine wire strand 5 into a net shape and wound on the outer periphery and a resin outer tube 3 containing a resin inner tube layer 2 inserted with an extra fine guide wire at the central portion. A thin resin intermediate layer 7 is inserted between the metal braid 4 and the outer layer tube 3 to form a tube body, and the inner layer tube 2 wound with the metal braid 4, the intermediate layer 7, and the outer layer tube 3 are integrated to form the catheter 1 made of a single extra fine tube. The catheter l has a uniform diameter and is smooth, and it can form the tube outer periphery where no strand 5 is protruded at all.

Description

【発明の詳細な説明】Detailed Description of the Invention

【０００１】[0001]

【発明の属する技術分野】本発明は、患者の冠状動脈内
に挿入して、造影用カテーテルまたはバルーンカテーテ
ル等のガイド用として使用する医療器具のカテーテルに
関するものである。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a catheter of a medical instrument which is inserted into a coronary artery of a patient and used as a guide for an imaging catheter or a balloon catheter.

【０００２】[0002]

【従来の技術】医療器具のカテーテル１は（図２参
照）、金属製編組物４を外周に巻き着けたテフロン等の
樹脂製の内層管２に、ポリアミドまたはポリウレタンの
樹脂製の外層管３を積層した多層構造の可撓性極細管か
らなる基本構造を有し、その先端部分から血管内に挿入
して（時に少し回転させながら）患者の冠状動脈の所定
位置へ到達させてセットし、血管造影等の所定の治療を
行うようになっている。2. Description of the Related Art A catheter 1 of a medical instrument (see FIG. 2) has a resin inner layer tube 2 made of Teflon or the like with a metal braid 4 wrapped around an outer layer tube 3 made of a polyamide or polyurethane resin. It has a basic structure consisting of flexible multilayer ultrafine tubules that are stacked, and is inserted into the blood vessel from its tip (sometimes rotated a little) to reach a predetermined position of the patient's coronary artery and set. A predetermined treatment such as contrast enhancement is performed.

【０００３】そして、その金属製編組物４は、曲りくね
った複雑な径路の血管内に挿入されるカテーテル１に、
応分の剛性と弾性（曲げ変形からの復元弾性）を付与す
るためのもので、編組した素線５が容易にほぐれて弾性
を喪失しないように、内層管２に巻き着けた金属製編組
物４の端部は、素線５の相互をバット溶着して内層管２
と外層管３との層間に介在配設される。Then, the metal braid 4 is attached to the catheter 1 to be inserted into a blood vessel having a tortuous and complicated path.
A metal braid 4 wound around the inner layer tube 2 so as to impart appropriate rigidity and elasticity (recovery elasticity from bending deformation) so that the braided wire 5 is not easily loosened and loses elasticity. The ends of the inner layer pipe 2 are formed by butt welding the wires 5 to each other.
Is disposed between the outer layer tube 3 and the outer layer tube 3.

【０００４】[0004]

【発明が解決しようとする課題】以上の従来のカテーテ
ル１は、長尺幅広に編成した金属製編組物４を所定サイ
ズにカットすると共に、そのカット部分の素線５の先端
を相互に溶着した後に内層管２に巻き着けられる。しか
し、（図２の（Ｂ）参照）切断による編組拘束の解放と
溶着応力等によって、内層管２へ巻き着けた金属製編組
物４の端部が外方へ膨らむ膨大形状６を呈する定性があ
る。従って、その部分の外層管３が膨らんで外径の均一
性を阻害すると共に、その膨大形状６の部分の素線５が
外層管３の外周から突き出す場合があり、このような状
態のものは血管内への挿入性が低下すると共に、血管壁
の損傷をもたらすことになる。In the above-mentioned conventional catheter 1, the metal braid 4 knitted in a long and wide shape is cut into a predetermined size, and the ends of the strands 5 of the cut portion are welded to each other. After that, it is wrapped around the inner layer tube 2. However (see FIG. 2 (B)), due to the release of the braid restraint by cutting, the welding stress, etc., it is qualitative that the end portion of the metal braid 4 wound around the inner layer tube 2 has an enormous shape 6 that bulges outward. is there. Therefore, the outer layer tube 3 in that portion may swell and hinder the uniformity of the outer diameter, and the wire 5 in the enlarged shape portion 6 may protrude from the outer periphery of the outer layer tube 3. The insertability into the blood vessel is reduced and the blood vessel wall is damaged.

【０００５】そこで、素線５の突き出しによる安全性阻
害を未然防止するためには、金属製編組物４の端部が内
在している部位の外層管３の外周を拡大鏡によって「突
き出し素線の存在・不存在」を入念に手作業検査せざる
を得なくなる。しかし、その検査作業は線材径が概ね
０．０７５粍直径の丸線材（または０．０３粍厚さ×
０．１５粍幅の角線材）の極微量突き出しを確認するミ
クロ検査となるので、多大の検査工数を要する上、突き
出し存在のものが「突出し線不存在の良品」として誤認
されるおそれがあり、品質信頼性に欠ける。Therefore, in order to prevent the safety from being hindered by the protrusion of the strand 5, the outer periphery of the outer layer tube 3 at the portion where the end portion of the metal braid 4 is present is magnified by the "extension strand". There is no choice but to perform a manual inspection carefully for "presence / absence". However, the inspection work is a round wire with a wire diameter of approximately 0.075 mm (or 0.03 mm thick ×
Since it is a micro inspection to confirm the very small amount of protrusion of 0.15 mould width square wire), a lot of inspection man-hours are required and there is a possibility that the protrusion is misidentified as "good product without protrusion line". , Lacks quality reliability.

【０００６】本発明は、以上の従来技術の難点を解消す
るカテーテルを提供するものである。The present invention provides a catheter which overcomes the above-mentioned drawbacks of the prior art.

【０００７】[0007]

【課題を解決するための手段】以上の技術課題を解決す
る本発明のカテーテルは「金属製編組物を外周に巻き着
けた樹脂製の内層管と、前記内層管を内包する樹脂製の
外層管からなるカテーテルにおいて、前記金属製編組物
の外周と前記外層管の内周との間に、樹脂製の中間層を
設けた構造」になっている。The catheter of the present invention which solves the above technical problems is described as follows: "A resin inner layer tube in which a metal braid is wrapped around the outer periphery, and a resin outer layer tube including the inner layer tube. And a resin intermediate layer is provided between the outer circumference of the metal braid and the inner circumference of the outer layer tube.

【０００８】即ち、本発明のカテーテルは、前記の中間
層を設けることによって、金属製編組物の端部にあらわ
れる膨大変形と素線の突き出しを押え込み、外層管の外
形を膨出部不存在の一様管形の円滑管にすると共に、外
層管からの該素線の突き出しを防止する構造が特徴であ
り、その技術意図から、必要に応じて、その中間層を金
属製編組物の上に生成した後、その中間層の外周に外層
管を生成する成形手段が採られる。That is, in the catheter of the present invention, by providing the above-mentioned intermediate layer, the enormous deformation appearing at the end of the metal braid and the protrusion of the wire are suppressed, and the outer layer tube has no bulging portion. The structure is characterized by a uniform tubular smooth tube and a structure that prevents the strands of wire from protruding from the outer layer tube. From the technical intention, the intermediate layer may be placed on a metal braid, if necessary. After the formation, a forming means for forming an outer layer pipe on the outer circumference of the intermediate layer is adopted.

【０００９】[0009]

【作用】以上の構成の本発明のカテーテルは、金属製編
組物の膨大変形によって中間層が部分膨形しても、その
中間層の後工程の外層管の押し出し成形によって、その
部分膨形を外層管の肉厚によって吸収するので、外層管
の外周は膨出部分不存在の一様管径滑らかな外周に成形
できる。In the catheter of the present invention having the above-mentioned structure, even if the intermediate layer is partially expanded due to the enormous deformation of the metal braid, the partially expanded shape of the intermediate layer can be obtained by extrusion molding the outer layer pipe in the post-process. Since it is absorbed by the thickness of the outer layer pipe, the outer periphery of the outer layer pipe can be formed to have a smooth outer periphery with no bulging portion.

【００１０】そして、その中間層によって金属製編組物
の膨大変形と素線の突き出しを押え込むと共に、その中
間層から突き出す素線が存在しても、その突き出し部分
は外層管の層内に吸収される。そして、例えば、外層管
の押し出し成形のとき、中間層の外周を矯正ローラーで
押え付けたり、ダイス通過による突き出し素線の除去処
理ができるので、金属製編組物の素線突き出しが全く存
在しない美麗高品質の管体外周に成形できる。The intermediate layer suppresses the enormous deformation of the metal braid and the protrusion of the wire, and even if there is a wire protruding from the intermediate layer, the protruding portion is absorbed in the layer of the outer layer pipe. To be done. And, for example, when extrusion molding of the outer layer tube, the outer circumference of the intermediate layer can be pressed with a straightening roller, and the protruding strands can be removed by passing through a die, so that there is no strand protrusion of the metal braid. Can be molded on the outer periphery of high quality pipe.

【００１１】[0011]

【発明の実施の形態】以上の本発明のカテーテルは以下
の実施例のように実施される。BEST MODE FOR CARRYING OUT THE INVENTION The catheter of the present invention described above is implemented as in the following examples.

【００１２】[0012]

【実施例】本発明一実施例のカテーテル１を示す図１を
参照して詳しく説明する。即ち、ステンレス極細線の素
線５を網状に編組した金属製編組物４を外周に巻き着け
ると共に、中心部分に極細線のガイドワイヤ（図示しな
い）を挿通する樹脂製の内層管２と、この内層管２を包
み込む樹脂製の外層管３からなる可撓性極細管体のカテ
ーテル１において、その金属製編組物４と外層管３との
間には、薄肉樹脂製の中間層７が管体をなして介装さ
れ、金属製編組物４を巻着した内層管２と中間層７と外
層管３が一体となって単一極細管のカテーテル１を構成
している。DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT A catheter 1 according to an embodiment of the present invention will be described in detail with reference to FIG. That is, a metal braid 4 in which a stainless ultrafine wire 5 is braided in a mesh shape is wound around the outer periphery, and an inner tube 2 made of resin is inserted into the center portion of which an ultrafine wire guide wire (not shown) is inserted. In a catheter 1 which is a flexible ultrafine tubular body made of a resin outer layer tube 3 enclosing the inner layer tube 2, a thin resin intermediate layer 7 is provided between the metal braid 4 and the outer layer tube 3. The inner layer tube 2 around which the metal braid 4 is wound, the intermediate layer 7, and the outer layer tube 3 are integrated to form a single ultrafine catheter 1.

【００１３】そして、この実施例のカテーテル１は、予
め別途成形して所要サイズにカットして、そのカット部
分の素線５端を相互溶着した金属製編組物４を巻き着け
た内層管２の外周に、公知の樹脂押し出し成形によって
中間層７が成形され、しかるのち、その中間層７の外周
に、同じく押し出し成形法によって外層管３が成形され
る。そして、内層管２はテフロン製・中間層７と外層管
３は６ナイロンまたは１２ナイロン製であり、内層管２
の内直径：２．１５粍・外層管３の外直径：２．７０粍
にして、中間層７の肉厚：０．０８粍・外層管３の肉
厚：０．１４５粍、の寸法諸元である。The catheter 1 of this embodiment is separately molded in advance and cut into a required size, and the inner layer tube 2 around which the metal braid 4 having the ends of the strands 5 of the cut portion welded together is wound. The intermediate layer 7 is molded on the outer periphery by a known resin extrusion molding, and then the outer layer tube 3 is molded on the outer periphery of the intermediate layer 7 by the extrusion molding method. The inner layer tube 2 is made of Teflon. The middle layer 7 and the outer layer tube 3 are made of 6 nylon or 12 nylon.
Inner diameter: 2.15 grit, outer layer tube 3 outer diameter: 2.70 grit, middle layer 7 wall thickness: 0.08 grit, outer layer tube 3 wall thickness: 0.145 grit It is the original.

【００１４】以上の図１実施例のカテーテル１は前記の
作用があり、一様径にして滑らかであり、かつ、素線５
の突き出しが全く存在しない管外周のものに成形できる
ので、従来の煩雑な外周検査は無用となり、高品質低コ
ストのカテーテルを提供することができる。The catheter 1 of the embodiment shown in FIG. 1 has the above-mentioned function, has a uniform diameter, is smooth, and has a wire 5
Since it can be molded into a tube outer circumference having no protrusions, the conventional cumbersome outer circumference inspection is unnecessary, and a high quality and low cost catheter can be provided.

【００１５】なお、本発明のカテーテルは前記の実施例
に限定されず、内層管２・中間層７の外周をエッチング
処理等によって粗面になし、中間層７・外層管３の密着
性の向上を図ることがある。The catheter of the present invention is not limited to the above-mentioned embodiment, but the outer circumferences of the inner layer tube 2 and the intermediate layer 7 are roughened by etching or the like to improve the adhesion of the intermediate layer 7 and the outer layer tube 3. May be planned.

【００１６】[0016]

【発明の効果】以上の説明のとおり、本発明のカテーテ
ルは金属製編組物を外周に巻き着けた内層管からなるも
のにおいて、その金属製編組物の素線の突き出し不存在
の円滑美麗外周の管体に成形できるので、素線突き出し
存否を確認する煩雑な検査工程が省略されると共に、素
線突き出し不良混入のおそれがなく、医療用カテーテル
の安全性と品質保証性が一段と向上し、併せてカテーテ
ル１のコスト低減が促進できる有用な諸効果がある。As described above, the catheter of the present invention comprises an inner layer tube in which a metal braid is wrapped around the outer periphery thereof, and the metal braid has a smooth and beautiful outer periphery without the wire sticking out. Since it can be molded into a tubular body, the complicated inspection process for checking the presence or absence of wire extrusion is omitted, and there is no risk of defective wire extrusion, which further improves the safety and quality assurance of medical catheters. As a result, there are various useful effects that can reduce the cost of the catheter 1.

【図面の簡単な説明】[Brief description of drawings]

【図１】本発明一実施例のカテーテルの正面図FIG. 1 is a front view of a catheter according to an embodiment of the present invention.

【図２】従来のカテーテルを示し、（Ａ）はその正面
図、（Ｂ）は金属製編組物の膨大形状と突き出し状態を
示す正面図2A and 2B show a conventional catheter, in which FIG. 2A is a front view thereof, and FIG. 2B is a front view showing an enlarged shape and a protruding state of a metal braid.

【符号の説明】[Explanation of symbols]

１ カテーテル ２ 内層管 ３ 外層管 ４ 金属製編組物 ５ 素線 ６ 膨大形状 ７ 中間層 1 Catheter 2 Inner Layer Tube 3 Outer Layer Tube 4 Metal Braid 5 Elementary Wire 6 Enlarged Shape 7 Intermediate Layer

Claims (1)

【特許請求の範囲】[Claims] 【請求項１】 金属製編組物を外周に巻き着けた樹脂製
の内層管と、前記内層管を内包する樹脂製の外層管から
なるカテーテルにおいて、前記金属製編組物の外周と前
記外層管の内周との間に、樹脂製の中間層を設けた構造
を特徴とするカテーテル。1. A catheter comprising a resin inner layer tube having a metal braid wrapped around the outer periphery thereof and a resin outer layer tube enclosing the inner layer tube, wherein the outer periphery of the metal braid and the outer layer tube are A catheter characterized by a structure in which a resin intermediate layer is provided between the inner circumference and the inner circumference.