JP2005270250A

JP2005270250A - Tube for medical use

Info

Publication number: JP2005270250A
Application number: JP2004085978A
Authority: JP
Inventors: Yuji Omori; 裕司大森
Original assignee: Kawasumi Laboratories Inc
Current assignee: SB Kawasumi Laboratories Inc
Priority date: 2004-03-24
Filing date: 2004-03-24
Publication date: 2005-10-06

Abstract

PROBLEM TO BE SOLVED: To provide a tube for a medical use capable of providing a function as a contrasting marker on a part of a distal end by forming a part of a reinforcing member by a radiopaque member. SOLUTION: For the tube (1) for the medical use, the reinforcing member (4) is embedded in an outer layer (3) or an inner layer (2) or the reinforcing member (4) is arranged between the inner layer (2) and the outer layer (3), the reinforcing member (4) is composed of a single wire in which a wire end part composed of a radiolucent member (5) and the radiopaque member (6) is welded and drawn, and at least a part of the distal end part of the reinforcing member (4) is formed of the radiopaque member (6). COPYRIGHT: (C)2006,JPO&NCIPI

Description

本発明は、例えば、心臓またはその周辺組織の血管造影、肝臓、膵臓、胆管などの生体器官の造影用カテーテル、心臓または脳血管内薬剤投与用カテーテル、脳血管等に塞栓術をほどこすための塞栓術用カテーテルなどの血管内挿入用カテーテル、胸腔、腹腔などに挿入、留置されるソラシックカテーテル、トロッカーカテーテル、ガイデイングカテーテル、ドレーンチューブ、気管に挿入、留置される気管内チューブなどの医療用チューブに関する。 The present invention is, for example, for embolizing an angiography of a heart or its surrounding tissues, a catheter for contrasting a biological organ such as the liver, pancreas, bile duct, a catheter for administering a heart or cerebrovascular drug, a cerebral blood vessel, etc. Medical devices such as catheters for intravascular insertion such as catheters for embolization, solasic catheters, trocar catheters, guiding catheters, drain tubes, and endotracheal tubes inserted and indwelled in the trachea. Regarding the tube.

例えば、現在市販されているカテーテルは、図４に示すように、内層２２の前方にパイプ状（円筒状）もしくは、コイル状の放射線不透過部材２６（造影マーカー）を配置し、当該放射線不透過部材２６の後方に、補強部材２５（スプリングコイル等）を配置し、当該内層２２に外層２３を被覆している。
これにより放射線（Ｘ線）透視時において、先端部のみ、造影性を有し、かつ後方は、補強部材２５が配置されているためキンクしにくいという特徴がある。
しかしながら、当該カテーテルは、放射線不透過部材２６（造影マーカー）と補強部材２５（スプリングコイル等）を別々に作製しているため、これらの部材間でカテーテル（チューブ）がキンクしやすく、かつ、放射線不透過部材２６（造影マーカー）と、補強部材２５（スプリングコイル等）とは別に、装着しなければならないので、作業に非常に手間がかかる。
また図４のように、放射線不透過部材２６（造影マーカー）をパイプ状（円筒状）にした場合、パイプ部分では、曲げることができないため、必然的に長さ（幅）が限定され、仮に、パイプ部分を長く（大きく）した場合、カテーテル（チューブ）が曲がらなくなってしまうという懸念が指摘される。 For example, as shown in FIG. 4, a commercially available catheter has a pipe-shaped (cylindrical) or coil-shaped radiopaque member 26 (contrast marker) disposed in front of the inner layer 22, and the radiopaque. A reinforcing member 25 (a spring coil or the like) is disposed behind the member 26, and the inner layer 22 is covered with the outer layer 23.
Thus, at the time of radiographic (X-ray) fluoroscopy, only the distal end portion has contrast, and the rear side is characterized by being difficult to kink because the reinforcing member 25 is disposed.
However, since the radiopaque member 26 (contrast marker) and the reinforcing member 25 (spring coil or the like) are separately manufactured in the catheter, the catheter (tube) is easily kinked between these members, and radiation Since the impermeable member 26 (contrast marker) and the reinforcing member 25 (spring coil or the like) must be attached separately, it takes much work.
Further, as shown in FIG. 4, when the radiopaque member 26 (contrast marker) is formed in a pipe shape (cylindrical shape), the pipe portion cannot be bent, so the length (width) is inevitably limited. There is a concern that the catheter (tube) will not bend when the pipe portion is made long (large).

また特許文献１（特開平０７−１９４７０７）には、内層と外層間に剛性付与体（本発明の補強部材に相当）を配置した医療用チューブの発明が記載されている。当該剛性付与体は複数本の金属線からなる線状体により、網目状に形成されている。
しかしながら特許文献１の発明では、キンク性の向上は、図れるものの造影性については、明記されていない。 Patent Document 1 (Japanese Patent Application Laid-Open No. 07-194707) describes a medical tube invention in which a rigid body (corresponding to a reinforcing member of the present invention) is disposed between an inner layer and an outer layer. The rigidity imparting body is formed in a mesh shape by a linear body made of a plurality of metal wires.
However, although the invention of Patent Document 1 can improve the kink property, it does not specify the contrast property.

特開平０７−１９４７０７号公報（図１から５）JP 07-194707 A (FIGS. 1 to 5)

本発明が解決しようとする問題点は、放射線不透過部材（造影マーカー）と補強部材（スプリングコイル等）を別部材で作製する場合は、これらの部材間にキンクが生じやすい点、従来の複数本の金属線からなる線状体（剛性付与体）では、先端部に造影性を付与することができない点である。 The problem to be solved by the present invention is that when a radiopaque member (contrast marker) and a reinforcing member (spring coil or the like) are produced as separate members, kinks are likely to occur between these members. In a linear body (rigidity imparting body) made of a metal wire, the contrast cannot be imparted to the tip.

そこで本発明者は以上の課題を解決するために、鋭意検討を重ねた結果次の発明に到達した。
［１］本発明は、補強部材（４）を外層（３）もしくは内層（２）に埋設するかまたは補強部材（４）を内層（２）と外層（３）の間に配置し、
当該補強部材（４）は放射線透過部材（５）と放射線不透過部材（６）よりなる線材端部を溶着し、かつ伸線した単一線からなり、
当該補強部材（４）の少なくとも先端部の一部を放射線不透過部材（６）で形成した医療用チューブ（１）を提供する。
［２］本発明は、前記補強部材（４）をコイル状または編み込み状にして、内層（２）に埋設するかまたは補強部材（４）を内層（２）と外層（３）の間に配置した医療用チューブ（１）を提供する。 Therefore, as a result of intensive studies to solve the above problems, the present inventor has reached the following invention.
[1] The present invention embeds the reinforcing member (4) in the outer layer (3) or the inner layer (2) or arranges the reinforcing member (4) between the inner layer (2) and the outer layer (3),
The reinforcing member (4) consists of a single wire that is welded and drawn at the ends of the wire consisting of the radiation transmitting member (5) and the radiation opaque member (6),
Provided is a medical tube (1) in which at least a part of the distal end portion of the reinforcing member (4) is formed of a radiopaque member (6).
[2] In the present invention, the reinforcing member (4) is coiled or braided and embedded in the inner layer (2) or the reinforcing member (4) is disposed between the inner layer (2) and the outer layer (3). Provided is a medical tube (1).

（１）補強部材４の一部を放射線不透過部材６より形成しているので、先端の一部に造影マーカーとしての機能を持たせることができる。
（２）補強部材４を放射線透過部材５と放射線不透過部材６よりなる線材端部を溶着し、かつ伸線した単一線で形成しているため、放射線透過部材５と放射線不透過部材６の間でキンクすることがない。
（３）補強部材４を長く形成することにより、放射線不透過部材６の長さを調整できる。 (1) Since a part of the reinforcing member 4 is formed of the radiopaque member 6, a part of the tip can have a function as a contrast marker.
(2) Since the reinforcing member 4 is formed by a single wire that is welded and drawn at the ends of the wire consisting of the radiation transmitting member 5 and the radiation opaque member 6, the radiation transmitting member 5 and the radiation opaque member 6 There is no kinking between them.
(3) The length of the radiopaque member 6 can be adjusted by forming the reinforcing member 4 long.

図１は本発明の医療用チューブの斜視図（断面図）、図２は本発明の医療用チューブの分解図、図３は補強部材の作製方法の概略図である。
［医療用チューブ１］
本発明の医療用チューブ１は、図１に例示するように補強部材４を外層３もしくは内層２に埋設するかまたは補強部材４を内層２と外層３の間に配置し、当該補強部材４は放射線透過部材５と放射線不透過部材６よりなる線材端部を溶着し、かつ伸線した単一線であり、当該補強部材４の少なくとも先端部の一部を放射線不透過部材６で形成している。図１及び図２の例示では、補強部材４を内層２の外周に巻着し、外層３を構成する壁面内に埋設しているが、補強部材４を内層２を構成する壁面内に埋設するかまたは内層２と内層３を構成する壁面の両方に埋設しても良い。
［補強部材４］
補強部材４は図３（Ａ）、（Ｂ）、（Ｃ）に例示するように、放射線透過性材料（放射線透過部材５）と放射線不透過性材料（放射線不透過部材６）からなる線材の端部を溶着し、これを伸線して単一線としたものである。
具体的には、特許２９８１９７６号（［００１６］から［００１８］及び図１）、特許３０８０４８３号（［０００９］及び図２参照）等の公知の方法で製造することができる。
この単一線をコイル状または編み込み状にして、図１及び図２に例示するように、補強部材４を内層２と外層３の間に配置しても良いし、補強部材４を内層２もしくは、外層３に埋設しても良い。
［放射線透過部材５と放射線不透過部材６の材料］
放射線透過部材５は、ステンレス鋼（例えばＳＵＳ３０４）、放射線不透過部材６は、白金、金、鉛、タングステン、イリジウムまたはこれらの合金等が使用される。
［内層２と外層３の形成材料］
内層２の形成材料としては、ある程度の可撓性を有するものが好ましく、例えば、ポリエチレン、ポリプロピレン、エチレンープロピレン共重合体などを用いたポリオレフィンエラストマー、ポリ塩化ビニル、エチレン−酢酸ビニル共重合体、ポリアミド、ポリアミドエラストマー、ポリウレタン、フッ素系樹脂（ＰＦＡ、ＰＴＦＥ、ＥＴＦＥ）、シリコーンゴム、ラテックスゴム等が使用できる。好ましくはポリアミド、あるいは、ポリアミドエラストマーが使用される。
外層３の形成材料としては、内層形成材料と接着性を有するものが好ましく、内層の形成に用いた樹脂と同質または近似したものが好ましい。例えば、ポリエチレン、ポリプロピレン、エチレンープロピレン共重合体などを用いたポリオレフィン、ポリ塩化ビニル、エチレン−酢酸ビニル共重合体、ポリアミド、ポリアミドエラストマー、ポリウレタン、フッ素系樹脂（ＰＦＡ、ＰＴＦＥ、ＥＴＦＥ）、シリコーンゴム、ラテックスゴム等が使用できる。好ましくはポリアミド、あるいは、ポリアミドエラストマーが使用される。 FIG. 1 is a perspective view (cross-sectional view) of a medical tube of the present invention, FIG. 2 is an exploded view of the medical tube of the present invention, and FIG. 3 is a schematic view of a method for producing a reinforcing member.
[Medical tube 1]
In the medical tube 1 of the present invention, as illustrated in FIG. 1, the reinforcing member 4 is embedded in the outer layer 3 or the inner layer 2, or the reinforcing member 4 is disposed between the inner layer 2 and the outer layer 3. A wire end consisting of a radiation transmitting member 5 and a radiation opaque member 6 is welded and drawn, and a single wire is formed, and at least a part of the tip of the reinforcing member 4 is formed of the radiation opaque member 6. . In the illustration of FIG. 1 and FIG. 2, the reinforcing member 4 is wound around the outer periphery of the inner layer 2 and is embedded in the wall surface constituting the outer layer 3, but the reinforcing member 4 is embedded in the wall surface constituting the inner layer 2. Or you may embed to both the wall surface which comprises the inner layer 2 and the inner layer 3. FIG.
[Reinforcing member 4]
As illustrated in FIGS. 3A, 3 B, and 3 C, the reinforcing member 4 is a wire made of a radiation transmissive material (radiation transmissive member 5) and a radiation opaque material (radiation opacity member 6). The ends are welded and drawn to form a single line.
Specifically, it can be produced by a known method such as Japanese Patent No. 2981976 ([0016] to [0018] and FIG. 1) and Japanese Patent No. 3080483 (see [0009] and FIG. 2).
The single wire may be coiled or braided, and the reinforcing member 4 may be disposed between the inner layer 2 and the outer layer 3 as illustrated in FIGS. 1 and 2, or the reinforcing member 4 may be disposed in the inner layer 2 or It may be embedded in the outer layer 3.
[Material of the radiation transmissive member 5 and the radiation opaque member 6]
The radiation transmitting member 5 is made of stainless steel (for example, SUS304), and the radiation opaque member 6 is made of platinum, gold, lead, tungsten, iridium, or an alloy thereof.
[Formation material of inner layer 2 and outer layer 3]
As a material for forming the inner layer 2, a material having a certain degree of flexibility is preferable. For example, polyolefin elastomer, polyvinyl chloride, ethylene-vinyl acetate copolymer using polyethylene, polypropylene, ethylene-propylene copolymer, Polyamide, polyamide elastomer, polyurethane, fluororesin (PFA, PTFE, ETFE), silicone rubber, latex rubber and the like can be used. Polyamide or polyamide elastomer is preferably used.
As the material for forming the outer layer 3, a material having adhesiveness with the inner layer forming material is preferable, and a material having the same quality as or similar to the resin used for forming the inner layer is preferable. For example, polyolefin, polyvinyl chloride, ethylene-vinyl acetate copolymer, polyethylene, polypropylene, ethylene-propylene copolymer, polyamide, polyamide elastomer, polyurethane, fluororesin (PFA, PTFE, ETFE), silicone rubber Latex rubber can be used. Polyamide or polyamide elastomer is preferably used.

［医療用チューブ１の製造］
次に医療用チューブ１の製造方法の一例について説明する。
（１）内層２の外周に、補強部材４（放射線透過部材５と放射線不透過部材６よりなる線材端部を溶着し、かつ伸線した単一線よりなる）をコイル状に装着する。
（２）（１）の内層２の外周に（公知の手段により、補強部材４が外層３を構成する壁面内に埋没するように）外層３を被冠する。 [Manufacture of medical tube 1]
Next, an example of the manufacturing method of the medical tube 1 is demonstrated.
(1) On the outer periphery of the inner layer 2, a reinforcing member 4 (consisting of a single wire that is welded and drawn at the end of a wire made of a radiation transmitting member 5 and a radiation opaque member 6) is attached in a coil shape.
(2) The outer layer 3 is crowned on the outer periphery of the inner layer 2 of (1) (so that the reinforcing member 4 is buried in the wall surface constituting the outer layer 3 by a known means).

本発明の医療用チューブの斜視図（断面図）The perspective view (sectional view) of the medical tube of the present invention 本発明の医療用チューブの分解図Exploded view of the medical tube of the present invention 補強部材の作製方法の概略図Schematic diagram of a method for manufacturing a reinforcing member 従来の医療用チューブの分解図Exploded view of a conventional medical tube

符号の説明Explanation of symbols

１医療用チューブ
２内層
３外層
４補強部材
５放射線透過部材
６放射線不透過部材 DESCRIPTION OF SYMBOLS 1 Medical tube 2 Inner layer 3 Outer layer 4 Reinforcement member 5 Radiation transmission member 6 Radiation opaque member

Claims

補強部材（４）を外層（３）もしくは内層（２）に埋設するかまたは補強部材（４）を内層（２）と外層（３）の間に配置し、
当該補強部材（４）は放射線透過部材（５）と放射線不透過部材（６）よりなる線材端部を溶着し、かつ伸線した単一線からなり、
当該補強部材（４）の少なくとも先端部の一部を放射線不透過部材（６）で形成した、ことを特徴とする医療用チューブ（１）。 The reinforcing member (4) is embedded in the outer layer (3) or the inner layer (2) or the reinforcing member (4) is disposed between the inner layer (2) and the outer layer (3),
The reinforcing member (4) consists of a single wire that is welded and drawn at the ends of the wire consisting of the radiation transmitting member (5) and the radiation opaque member (6),
A medical tube (1), wherein at least a part of the distal end portion of the reinforcing member (4) is formed of a radiopaque member (6).

前記補強部材（４）をコイル状または編み込み状にして、内層（２）に埋設するかまたは補強部材（４）を内層（２）と外層（３）の間に配置した、ことを特徴とする医療用チューブ（１）。 The reinforcing member (4) is coiled or knitted and embedded in the inner layer (2) or the reinforcing member (4) is disposed between the inner layer (2) and the outer layer (3). Medical tube (1).