JP2015181486A - catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a catheter capable of achieving both slipperiness and push-in performance.SOLUTION: A catheter 10 has an outer tube 80 which can be inserted into an organism lumen. The outer tube 80 includes: an outer tube tip 82 where projections 83 which protrude outward on an external surface in a profile orthogonal to an axial line X of the outer tube 80 and intermediate parts 84 having larger curvature than the projections 83 are alternately disposed; and an outer tube base end portion 81 which is disposed nearer to a base end than the outer tube tip 82 and in which salients 86 and concavities 85 are alternately disposed side by side on an external surface in a profile parallel to the axial line X of the outer tube 80.

Description

Translated fromJapanese

本発明は生体管腔内に挿入するカテーテルに関する。  The present invention relates to a catheter that is inserted into a living body lumen.

心筋梗塞や狭心症の治療の際に狭窄した血管を拡張するために使用する各種カテーテルには、狭窄した血管に対する通過性が要求される。通過性を高めるために、カテーテルを構成するシャフトへ親水性材料を被覆（コーティング）したり、あるいはシャフトの形状や素材の選定により、血管内での滑り性を高める方法が知られている（例えば、特許文献１を参照）。  Various catheters used for dilating a stenotic blood vessel in the treatment of myocardial infarction or angina pectoris are required to be able to pass through the stenotic blood vessel. In order to improve the passage, there is known a method for improving the slipperiness in the blood vessel by coating (coating) a hydrophilic material on the shaft constituting the catheter or by selecting the shape and material of the shaft (for example, , See Patent Document 1).

特開２０１２−２１３６２７号公報JP2012-213627A

カテーテルシャフトの血管内滑り性を高めると、バックアップが取り難くなり、結果的に押し込み性（プッシャビリティ）が低下する虞がある。なお、バックアップとは、カテーテルのシャフトの一部を血管内壁面に接触させて、カテーテルの位置を安定的に維持できるように固定することを意味する。  If the intravascular slidability of the catheter shaft is increased, it is difficult to take backup, and as a result, the pushability may be reduced. Note that the back-up means that a part of the catheter shaft is brought into contact with the inner wall surface of the blood vessel and fixed so that the position of the catheter can be stably maintained.

本発明は、上述した課題に鑑みてなされ、高い滑り性および押し込み性を両立可能なカテーテルを提供することを目的とする。  This invention is made | formed in view of the subject mentioned above, and aims at providing the catheter which can make high slipperiness and pushability compatible.

上記目的を達成する本発明に係るカテーテルは、生体管腔内へ挿入可能なシャフトを備えるカテーテルであって、前記シャフトは、当該シャフトの軸線と直交する断面において外表面に外側へ突出する突出部および前記突出部よりも曲率が大きい中間部が交互に配置される第１の部位と、前記第１の部位よりも基端側に設けられ、前記シャフトの軸線と平行な断面において外表面に凹部および凸部が交互に並んで配置される第２の部位と、を有する。  The catheter according to the present invention that achieves the above object is a catheter including a shaft that can be inserted into a living body lumen, and the shaft protrudes outward on the outer surface in a cross section orthogonal to the axis of the shaft. And a first portion where intermediate portions having a curvature larger than that of the projecting portion are alternately arranged, and a recess portion formed on the outer surface in a cross section parallel to the axis of the shaft. And a second portion where the convex portions are alternately arranged.

上記のように構成したカテーテルは、生体管腔内へ挿入する際に、第１の部位の突出部が管腔壁面と接触しやすくなるとともに中間部が管腔壁面と接触し難くなるため、管腔壁面に対する接触面積が減少し、接触抵抗が低減して滑り性を高めることができる。さらに、カテーテルは、生体管腔内へ挿入する際に、第１の部位よりも基端側に設けられる第２の部位の凸部が管腔壁面と接触して適度な接触抵抗が得られ、バックアップ力を高めて、結果として押し込み性をも高めることができる。  When the catheter configured as described above is inserted into a living body lumen, the protruding portion of the first portion is likely to come into contact with the lumen wall surface and the intermediate portion is difficult to contact with the lumen wall surface. The contact area with respect to the cavity wall surface is reduced, the contact resistance is reduced, and the slipperiness can be increased. Furthermore, when the catheter is inserted into the living body lumen, the convex portion of the second part provided on the proximal end side with respect to the first part comes into contact with the lumen wall surface, and an appropriate contact resistance is obtained. The backup power can be increased, and as a result, the pushability can be improved.

前記第１の部位は、前記シャフトの軸線と平行な断面において外表面が平滑であるようにすれば、第１の部位の滑り性をより向上させることができる。  If the outer surface of the first part is smooth in a cross section parallel to the axis of the shaft, the slipping property of the first part can be further improved.

前記第１の部位は、基端側へ向かって前記突出部の曲率と前記中間部の曲率との差が徐々に小さくなるようにすれば、第１の部位の外表面は、先端側ほど接触抵抗が小さく、基端側へ向かうにしたがって接触抵抗が徐々に大きくなるため、第１の部位の先端側においては滑り性を高めつつ、第１の部位の基端側においては、滑り性を低減させてバックアップ力の低下を抑制して、良好な押し込み性を得ることができる。  If the difference between the curvature of the projecting portion and the curvature of the intermediate portion is gradually reduced toward the proximal end side, the outer surface of the first portion is more in contact with the first portion toward the distal end side. Since the resistance is small and the contact resistance gradually increases toward the base end side, the slip performance is reduced on the base end side of the first portion while the slip performance is enhanced on the tip end side of the first portion. Thus, it is possible to suppress the decrease in the backup force and obtain a good pushability.

前記第２の部位は、基端側へ向かって前記凸部の高さ、前記凹部の深さ、前記凸部の軸線方向における密度、および前記凹部の軸線方向における密度の少なくとも１つが、軸線方向に沿って徐々に変化するようにすれば、第２の部位の外表面の接触抵抗を、軸線に沿って徐々に変化させることができ、軸線方向の部位に応じて適切なバックアップ力を設定することができる。  In the second portion, at least one of a height of the convex portion, a depth of the concave portion, a density in the axial direction of the convex portion, and a density in the axial direction of the concave portion toward the base end side is an axial direction. The contact resistance of the outer surface of the second part can be gradually changed along the axis, and an appropriate backup force is set according to the part in the axial direction. be able to.

前記第２の部位は、先端方向へ移動する際の接触抵抗が、基端方向へ移動する際の接触抵抗よりも小さいようにすれば、カテーテルが先端方向へ移動する際には低い接触抵抗によって押し込み性が損なわれず、かつカテーテルが基端方向へ移動する際に適度な接触抵抗が得られてバックアップ力を高め、押し込み性を高めることができる。  If the contact resistance when moving in the distal direction is smaller than the contact resistance when moving in the proximal direction, the second part has a low contact resistance when the catheter moves in the distal direction. The pushability is not impaired, and when the catheter moves in the proximal direction, an appropriate contact resistance is obtained, the backup force is increased, and the pushability can be enhanced.

前記凸部の頂点を挟んで先端側の前記凹部に向かう先端側傾斜面の前記軸線に対する傾斜角は、前記凸部の頂点を挟んで基端側の前記凹部に向かう基端側傾斜面の前記軸線に対する傾斜角よりも小さいようにすれば、先端側傾斜面および基端側傾斜面の傾斜角の差によって、第２の部位が先端方向へ移動する際の接触抵抗を、基端方向へ移動する際の接触抵抗よりも小さくすることができる。  The inclination angle with respect to the axis of the distal-side inclined surface facing the concave portion on the distal end side across the vertex of the convex portion is the angle of inclination of the proximal-side inclined surface facing the concave portion on the proximal side across the vertex of the convex portion. If the inclination angle is smaller than the inclination angle with respect to the axis, the contact resistance when the second region moves in the distal direction is moved in the proximal direction due to the difference in inclination angle between the distal inclined surface and the proximal inclined surface. It can be made smaller than the contact resistance at the time.

前記シャフトは、前記第１の部位および前記第２の部位の間に、前記第１の部位から連続する前記突出部および前記中間部が形成されるとともに、前記第２の部位から連続する前記凹部および前記凸部が形成される混合部を有するようにすれば、混合部において、シャフトの先端から基端にわたってシャフトの形状が連続的に変化することになり、接触抵抗のみならず、シャフトの物性の変化も連続的に変化する。このため、第１の部位、混合部および第２の部位の各々の境界において応力が集中し難くなり、キンクの発生を抑制できるとともに、シャフトの破損等を抑制して安全性を高めることができる。  In the shaft, the protrusion and the intermediate portion that are continuous from the first portion are formed between the first portion and the second portion, and the concave portion that is continuous from the second portion is formed. If the mixing portion is formed with the convex portions, the shape of the shaft continuously changes from the distal end to the proximal end of the shaft in the mixing portion, and not only the contact resistance but also the physical properties of the shaft. The change of changes continuously. For this reason, it becomes difficult for stress to concentrate at the boundary of each of the first part, the mixing part, and the second part, so that the occurrence of kinks can be suppressed and the shaft can be prevented from being damaged and the safety can be improved. .

前記第１の部位は、親水性材料が被覆されるようにすれば、滑り性が要求される第１の部位の接触抵抗をより低下させて、滑り性をより向上させることができる。  If the first part is coated with a hydrophilic material, the contact resistance of the first part requiring slipperiness can be further reduced, and slippery can be further improved.

第１実施形態に係るカテーテルを示す平面図である。It is a top view which shows the catheter which concerns on 1st Embodiment.図１のＡ−Ａ線に沿う横断面図である。It is a cross-sectional view which follows the AA line of FIG.第１実施形態に係るカテーテルの外管先端部の縦断面図である。It is a longitudinal cross-sectional view of the outer tube distal end portion of the catheter according to the first embodiment.図１のＢ−Ｂ線に沿う横断面図である。It is a cross-sectional view which follows the BB line of FIG.第１実施形態に係るカテーテルの外管基端部の縦断面図である。It is a longitudinal cross-sectional view of the outer tube proximal end portion of the catheter according to the first embodiment.第１実施形態に係るカテーテルの変形例の外管先端部を示す横断面図である。It is a cross-sectional view which shows the outer tube | pipe tip part of the modification of the catheter which concerns on 1st Embodiment.第１実施形態に係るカテーテルの他の変形例の外管基端部を示す縦断面図である。It is a longitudinal cross-sectional view which shows the outer tube | pipe proximal end of the other modification of the catheter which concerns on 1st Embodiment.第２実施形態に係るカテーテルを示す平面図である。It is a top view which shows the catheter which concerns on 2nd Embodiment.図８のＣ−Ｃ線に沿う横断面図である。It is a cross-sectional view which follows the CC line of FIG.図８のＤ−Ｄ線に沿う横断面図である。It is a cross-sectional view which follows the DD line | wire of FIG.図８のＥ−Ｅ線に沿う横断面図である。It is a cross-sectional view which follows the EE line of FIG.図８のＦ−Ｆ線に沿う横断面図である。It is a cross-sectional view which follows the FF line of FIG.第３実施形態に係るカテーテルの外管基端部を示す縦断面図である。It is a longitudinal cross-sectional view which shows the outer tube | pipe proximal end part of the catheter which concerns on 3rd Embodiment.第３実施形態に係るカテーテルの変形例の外管基端部を示す縦断面図である。It is a longitudinal cross-sectional view which shows the outer tube | pipe proximal end of the modification of the catheter which concerns on 3rd Embodiment.第３実施形態に係るカテーテルの他の変形例の外管基端部を示す縦断面図である。It is a longitudinal cross-sectional view which shows the outer tube | pipe proximal end of the other modification of the catheter which concerns on 3rd Embodiment.第４実施形態に係るカテーテルを示す平面図である。It is a top view which shows the catheter which concerns on 4th Embodiment.第４実施形態に係るカテーテルの外管基端部を示す縦断面図である。It is a longitudinal cross-sectional view which shows the outer tube | pipe proximal end part of the catheter which concerns on 4th Embodiment.図１７のＧ−Ｇ線に沿う横断面図である。It is a cross-sectional view which follows the GG line of FIG.図１７のＨ−Ｈ線に沿う横断面図である。It is a cross-sectional view which follows the HH line of FIG.

以下、図面を参照して、本発明の実施の形態を説明する。なお、図面の寸法比率は、説明の都合上、誇張されて実際の比率とは異なる場合がある。  Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.

なお、以下の説明において、カテーテルの手元側を「基端側」、挿入される側を「先端側」と称す。また、「カテーテル」は、医療用に使用される管体を含むものを表すものである。カテーテルの用途は治療用に限定されず、例えば検査用であってもよい。
＜第１実施形態＞In the following description, the proximal side of the catheter is referred to as “proximal end side”, and the inserted side is referred to as “distal end side”. The “catheter” represents one including a tube used for medical purposes. The use of the catheter is not limited to treatment, and may be for examination, for example.
<First Embodiment>

第１実施形態に係るカテーテル１０は、例えばＰＴＣＡ用の拡張カテーテル（バルーンカテーテル）や、ステントを縮径状態で狭窄部まで搬送し、狭窄部にて拡径、留置して狭窄部を拡張維持するためのカテーテル（ステント運搬用カテーテル）として使用される。カテーテル１０は、図１に示すように、長尺なカテーテル本体２０と、カテーテル本体２０の先端に設けられるバルーン３０と、カテーテル本体２０の基端に固着されたハブ４０と、耐キンクプロテクタ５０と、Ｘ線不透過部材６０とを有している。また、カテーテル本体２０の外表面には、親水性材料で構成された親水性被覆層７０が被覆（コーティング）される。  Thecatheter 10 according to the first embodiment conveys, for example, an expansion catheter (balloon catheter) for PTCA or a stent to a stenosis portion in a reduced diameter state, and expands and maintains the stenosis portion by expanding the diameter and placing it in the stenosis portion. Used as a catheter (stent delivery catheter). As shown in FIG. 1, thecatheter 10 includes along catheter body 20, aballoon 30 provided at the distal end of thecatheter body 20, ahub 40 fixed to the proximal end of thecatheter body 20, and akink protector 50. And an X-rayopaque member 60. The outer surface of thecatheter body 20 is coated (coated) with ahydrophilic coating layer 70 made of a hydrophilic material.

カテーテル本体２０は、先端および基端が開口した管状体である外管８０（シャフト）と、外管８０の内部に配置される内管９０とを備えている。外管８０および内管９０の間には、バルーン３０を拡張するための拡張用流体が流通する拡張ルーメン２１が形成されており、内管９０の内側には、ガイドワイヤーが挿通されるガイドワイヤールーメン２２が形成されている。  Thecatheter body 20 includes an outer tube 80 (shaft) that is a tubular body having an open front end and a base end, and aninner tube 90 disposed inside theouter tube 80. Anexpansion lumen 21 through which an expansion fluid for expanding theballoon 30 circulates is formed between theouter tube 80 and theinner tube 90. Inside theinner tube 90, a guide wire through which a guide wire is insertedLumen 22 is formed.

外管８０は、ハブ４０から先端方向へ延びる外管基端部８１（第２の部位）と、外管基端部８１から先端方向へ延びる外管先端部８２（第１の部位）とを備えている。  Theouter tube 80 includes an outer tube proximal end portion 81 (second portion) extending from thehub 40 in the distal direction and an outer tube distal end portion 82 (first portion) extending from the outer tubeproximal end portion 81 in the distal direction. I have.

外管先端部８２は、図２に示すように、外管８０の軸線Ｘと直交する断面において外表面が多角形（本実施形態では六角形）で形成されている。外管先端部８２の多角形の角部に対応する部位が、径方向の外側へ突出する突出部８３を構成し、多角形の辺に対応する部位が、突出部８３よりも曲率が大きい中間部８４を構成しており、突出部８３および中間部８４が周方向に交互に配置されている。なお、突出部８３は、鋭利に形成されずに曲面で形成されることが好ましいが、鋭利に形成されてもよく、または面取りされて形成されてもよい。突出部８３が鋭利に形成されても、外管８０の材料が柔軟であるため、生体組織への負担は比較的小さい。  As shown in FIG. 2, the outer surface of the outer tubedistal end portion 82 is formed in a polygonal shape (in this embodiment, a hexagonal shape) in a cross section perpendicular to the axis X of theouter tube 80. The portion corresponding to the polygonal corner of theouter tube tip 82 constitutes a protrudingportion 83 protruding outward in the radial direction, and the portion corresponding to the side of the polygon has a larger curvature than the protrudingportion 83. Thepart 84 is comprised and theprotrusion part 83 and theintermediate part 84 are alternately arrange | positioned in the circumferential direction. In addition, although it is preferable that theprotrusion part 83 is formed in a curved surface instead of being sharply formed, it may be formed sharply or chamfered. Even if the protrudingportion 83 is sharply formed, the burden on the living tissue is relatively small because the material of theouter tube 80 is flexible.

突出部８３の曲率（曲率半径の逆数）は、特に限定されないが、１〜１０００（１／ｍｍ）であることが好ましく、１．２〜５００（１／ｍｍ）であることがより好ましく、２〜１００（１／ｍｍ）であることがさらに好ましい。曲率が大きくなると、接触抵抗が減少するが、突出部８３が鋭利となって接触する生体組織への負担が大きくなる。曲率が小さくなると、接触する生体組織への負担が小さくなるが、血管と接触する面積が増加し、押し込み性（プッシャビリティ）が低下する。なお、本実施形態では、突出部８３および中間部８４の曲率は、軸線Ｘに沿ういずれの位置においても略一定となっているが、位置によって異なってもよい。  The curvature of the protrusion 83 (the reciprocal of the radius of curvature) is not particularly limited, but is preferably 1 to 1000 (1 / mm), more preferably 1.2 to 500 (1 / mm). More preferably, it is -100 (1 / mm). When the curvature increases, the contact resistance decreases, but theprotrusion 83 becomes sharp and the burden on the living tissue that comes into contact increases. When the curvature is reduced, the burden on the living tissue that comes into contact is reduced, but the area in contact with the blood vessel is increased, and the pushability is reduced. In the present embodiment, the curvatures of the protrudingportion 83 and theintermediate portion 84 are substantially constant at any position along the axis X, but may vary depending on the position.

また、外管先端部８２は、図３に示すように、外管８０の軸線Ｘと平行な断面において外表面が平滑となっており、凹凸形状が形成されていない。  Further, as shown in FIG. 3, the outer tubedistal end portion 82 has a smooth outer surface in a cross section parallel to the axis X of theouter tube 80, and is not formed with an uneven shape.

外管先端部８２の軸線Ｘに沿う長さは、特に限定されず、カテーテル１０の用途によって適宜設定されることが好ましいが、例えば１００〜５００ｍｍである。外管先端部８２の最大外径（六角形の角部における外径）は、特に限定されず、カテーテル１０の用途によって適宜設定されることが好ましいが、例えば１００〜５００ｍｍである。  The length along the axis X of the outer tubedistal end portion 82 is not particularly limited, and is preferably set as appropriate depending on the use of thecatheter 10, but is, for example, 100 to 500 mm. The maximum outer diameter (the outer diameter at the hexagonal corner) of the outer tubedistal end portion 82 is not particularly limited, and is preferably set as appropriate depending on the use of thecatheter 10, and is, for example, 100 to 500 mm.

外管基端部８１は、図４に示すように、外管８０の軸線Ｘと直交する断面において外表面が円形で形成されている。また、外管基端部８１は、図５に示すように、外管８０の軸線Ｘと平行な断面において、凸部８６および凹部８５が交互に並んで配置されている。各々の凸部８６および凹部８５は、外管８０の外周面を３６０度にわたって環状に形成されている。凸部８６は、凸部８６の頂点を挟んで先端側の凹部８５に向かう先端側傾斜面８７と、凸部８６の頂点を挟んで基端側の凹部８５に向かう基端側傾斜面８８とを備えている。先端側傾斜面８７の軸線Ｘに対する傾斜角αは、基端側傾斜面８８の軸線Ｘに対する傾斜角βよりも小さい。  As shown in FIG. 4, the outer tubebase end portion 81 has a circular outer surface in a cross section orthogonal to the axis X of theouter tube 80. Further, as shown in FIG. 5, the outer tubebase end portion 81 hasconvex portions 86 andconcave portions 85 arranged alternately in a cross section parallel to the axis X of theouter tube 80. Each of theconvex portions 86 and theconcave portions 85 is formed in an annular shape on the outer peripheral surface of theouter tube 80 over 360 degrees. Theconvex portion 86 includes a distal-sideinclined surface 87 that faces the distal-sideconcave portion 85 across the vertex of theconvex portion 86, and a proximal-sideinclined surface 88 that faces the proximal-sideconcave portion 85 across the vertex of theconvex portion 86. It has. The inclination angle α with respect to the axis X of the distal-sideinclined surface 87 is smaller than the inclination angle β with respect to the axis X of the proximal-sideinclined surface 88.

凸部８６の高さ（凹部８５の深さ）は、特に限定されないが、例えば０．００１〜０．２００ｍｍであることが好ましく、より好ましくは０．００５〜０．１００ｍｍであり、さらに好ましくは０．０１０〜０．０５０ｍｍである。  The height of the convex portion 86 (depth of the concave portion 85) is not particularly limited, but is preferably 0.001 to 0.200 mm, more preferably 0.005 to 0.100 mm, and still more preferably. It is 0.010-0.050 mm.

傾斜角αは、特に限定されないが、例えば１〜８５度であることが好ましく、より好ましくは１０〜６０度であり、さらに好ましくは１５〜４５度である。傾斜角βは、特に限定されないが、傾斜角αより大きいことが好ましく、より好ましくは傾斜角αよりも１０度以上大きく、さらに好ましくは傾斜角αよりも４５度以上大きい。なお、傾斜角βは、傾斜角αと等しくてもよい。また、傾斜角βは、９０度を超えてもよい。凸部８６の頂点は、鋭利に形成されてもよく、曲面で形成されてもよく、または面取りされてもよい。凸部８６の頂点が鋭利であっても、凸部８６が小さく、かつ外管８０の材料が柔軟であるため、生体組織への負担は小さい。なお、凸部８６の頂点が面取りされていれば、生体組織への負担を低減でき、凸部８６の頂点が曲面で形成されていれば、生体組織への負担をより低減できる。  Although inclination angle (alpha) is not specifically limited, For example, it is preferable that it is 1-85 degree | times, More preferably, it is 10-60 degree, More preferably, it is 15-45 degree. The inclination angle β is not particularly limited, but is preferably larger than the inclination angle α, more preferably 10 degrees or more larger than the inclination angle α, and still more preferably 45 degrees larger than the inclination angle α. Note that the inclination angle β may be equal to the inclination angle α. Further, the inclination angle β may exceed 90 degrees. The vertex of theconvex part 86 may be sharply formed, may be formed with a curved surface, or may be chamfered. Even if the apex of theconvex portion 86 is sharp, theconvex portion 86 is small and the material of theouter tube 80 is flexible, so the burden on the living tissue is small. In addition, if the vertex of theconvex part 86 is chamfered, the burden on a biological tissue can be reduced, and if the vertex of theconvex part 86 is formed with a curved surface, the burden on the biological tissue can be further reduced.

外管８０および内管９０は、ある程度の可撓性を有する材料により形成されることが好ましく、そのような材料としては、例えば、ナイロン、ポリエステル、ポリアミド、ポリウレタン、ポリオレフィン、熱可塑性フッ素樹脂等である。外管８０および内管９０の構成材料は、同一でもよく、異なってもよい。  Theouter tube 80 and theinner tube 90 are preferably formed of a material having a certain degree of flexibility. Examples of such a material include nylon, polyester, polyamide, polyurethane, polyolefin, thermoplastic fluororesin, and the like. is there. The constituent materials of theouter tube 80 and theinner tube 90 may be the same or different.

親水性被覆層７０は、外管８０の外管先端部８２を被覆し、かつ外管基端部８１を被覆していない。親水性被覆層７０は、外管８０の血管内での滑り性を向上させる。なお、親水性被覆層７０が形成される範囲は、外管先端部８２の全体であってもよく、一部であってもよく、外管基端部８１の一部を含んでもよい。一例として、親水性被覆層７０は、外管８０の先端から基端方向へ３２０〜４００ｍｍの範囲でコーティングされる。  Thehydrophilic coating layer 70 covers the outer tubedistal end portion 82 of theouter tube 80 and does not cover the outer tubeproximal end portion 81. Thehydrophilic coating layer 70 improves the slipperiness of theouter tube 80 in the blood vessel. The range in which thehydrophilic coating layer 70 is formed may be the entire outer tubedistal end portion 82, a part thereof, or may include a part of the outer tubeproximal end portion 81. As an example, thehydrophilic coating layer 70 is coated in the range of 320 to 400 mm from the distal end of theouter tube 80 toward the proximal end.

親水性被覆層７０が湿潤すると、潤滑性を生じて摩擦抵抗（摺動抵抗）が低減し、血管等の生体管腔内での滑り性が向上する。  When thehydrophilic coating layer 70 is wetted, lubricity is generated, frictional resistance (sliding resistance) is reduced, and slipperiness in a living body lumen such as a blood vessel is improved.

親水性被覆層７０を構成する親水性材料としては、例えば、セルロース系高分子物質、ポリエチレンオキサイド系高分子物質、無水マレイン酸系高分子物質（例えば、メチルビニルエーテル−無水マレイン酸共重合体のような無水マレイン酸共重合体）、アクリルアミド系高分子物質（例えば、ポリアクリルアミド、ポリグリシジルメタクリレート−ジメチルアクリルアミド（ＰＧＭＡ−ＤＭＡＡ）のブロック共重合体）、水溶性ナイロン、ポリビニルアルコール、ポリビニルピロリドン等が挙げられる。  Examples of the hydrophilic material constituting thehydrophilic coating layer 70 include a cellulose polymer material, a polyethylene oxide polymer material, and a maleic anhydride polymer material (for example, methyl vinyl ether-maleic anhydride copolymer). Maleic anhydride copolymer), acrylamide polymer (for example, polyacrylamide, block copolymer of polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA)), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone and the like. It is done.

バルーン３０は、拡張可能な管状の部材であり、先端側が内管９０に接着され、基端側が外管８０に接着されており、バルーン３０の内部が、拡張ルーメン２１に連通している。  Theballoon 30 is an expandable tubular member, the distal end side is bonded to theinner tube 90, the proximal end side is bonded to theouter tube 80, and the inside of theballoon 30 communicates with theexpansion lumen 21.

バルーン３０は、ある程度の可撓性を有する材料により形成されることが好ましく、そのような材料としては、例えば、ポリエチレン、ポリプロピレン、ポリブテン、エチレン−プロピレン共重合体、エチレン−酢酸ビニル共重合体、アイオノマー、あるいはこれら二種以上の混合物等のポリオレフィンや、軟質ポリ塩化ビニル樹脂、ポリアミド、ポリアミドエラストマー、ポリエステル、ポリエステルエラストマー、ポリウレタン、フッ素樹脂等の熱可塑性樹脂、シリコーンゴム、ラテックスゴム等が使用できる。  Theballoon 30 is preferably formed of a material having a certain degree of flexibility. Examples of such a material include polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, Polyolefins such as ionomers or mixtures of two or more thereof, soft polyvinyl chloride resins, polyamides, polyamide elastomers, polyesters, polyester elastomers, polyurethanes, fluororesins and other thermoplastic resins, silicone rubbers, latex rubbers and the like can be used.

ハブ４０は、外管８０の拡張ルーメン２１と連通して拡張用流体を流入出させる第１開口部４１と、ガイドワイヤールーメン２２と連通してガイドワイヤーを挿入する第２開口部４２とを備えている。  Thehub 40 includes afirst opening 41 that communicates with theexpansion lumen 21 of theouter tube 80 and allows the expansion fluid to flow in and out, and asecond opening 42 that communicates with theguide wire lumen 22 and inserts the guide wire. ing.

耐キンクプロテクタ５０は、カテーテル本体２０とハブ４０とを連結している部分に被せられる。耐キンクプロテクタ５０は、弾性材料からなり、カテーテル本体２０とハブ４０とを連結している部分の付近での折れ曲がり（キンク）を防止することができる。  Thekink protector 50 is put on a portion where thecatheter body 20 and thehub 40 are connected. Thekink protector 50 is made of an elastic material, and can prevent bending (kinking) in the vicinity of a portion connecting thecatheter body 20 and thehub 40.

Ｘ線不透過部材６０は、バルーン３０内に位置する内管９０の外表面に固定される環状の部材であり、本実施形態では、２カ所に設けられている。Ｘ線不透過部材６０が設けられることで、カテーテル１０を体内へ挿入した際に、カテーテル１０の位置をＸ線透視下で確認することができる。  The X-rayimpermeable member 60 is an annular member fixed to the outer surface of theinner tube 90 located in theballoon 30, and is provided at two locations in this embodiment. By providing theradiopaque member 60, the position of thecatheter 10 can be confirmed under fluoroscopy when thecatheter 10 is inserted into the body.

Ｘ線不透過部材６０の材料としては、例えば、硫酸バリウム、酸化ビスマス、タングステン、プラチナ、プラチナ−イリジウム合金等である。  Examples of the material of the X-rayopaque member 60 include barium sulfate, bismuth oxide, tungsten, platinum, and a platinum-iridium alloy.

次に、第１実施形態に係るカテーテル１０の作用について説明する。  Next, the operation of thecatheter 10 according to the first embodiment will be described.

第１実施形態に係るカテーテル１０は、外管先端部８２に、外管８０の軸線Ｘと直交する断面において外側へ突出する突出部８３と、突出部８３よりも曲率が大きい中間部８４が交互に配置されている。このため、カテーテル１０を血管内へ挿入した際に、外管先端部８２の突出部８３が血管壁面と接触しやすくなるとともに、中間部８４が血管壁面と接触し難くなる。このため、外管先端部８２の血管壁面に対する接触面積を減少させることができ、接触抵抗を低減させて、血管内での滑り性を高めることができる。さらに、カテーテル１０は、外管基端部８１に、外管８０の軸線Ｘと平行な断面において凹部８５および凸部８６が交互に並んで配置されている。このため、カテーテル１０を血管内へ挿入した際に、外管基端部８１の凸部８６が血管壁面と接触して適度な接触抵抗が得られ、バックアップ力が高まり、押し込み性を高めることができる。このように、滑り性が要求される先端部位の血管内での滑り性を外管先端部８２により高めつつも、滑り性が高まることにより生じやすいバックアップ力の低下を、外管先端部８２よりも基端側に位置して押し込み力を先端側へ伝達する外管基端部８１により補完することが可能となり、良好な押し込み性をも提供できる。  In thecatheter 10 according to the first embodiment, the outer tubedistal end portion 82 is alternately provided with a protrudingportion 83 protruding outward in a cross section orthogonal to the axis X of theouter tube 80 and anintermediate portion 84 having a larger curvature than the protrudingportion 83. Is arranged. For this reason, when thecatheter 10 is inserted into the blood vessel, the protrudingportion 83 of the outer tubedistal end portion 82 easily comes into contact with the blood vessel wall surface, and theintermediate portion 84 hardly comes into contact with the blood vessel wall surface. For this reason, the contact area with respect to the vascular wall surface of the outer tube | pipe front-end | tippart 82 can be reduced, a contact resistance can be reduced and the slipperiness in a blood vessel can be improved. Further, in thecatheter 10, theconcave portions 85 and theconvex portions 86 are alternately arranged at the outer tubeproximal end portion 81 in a cross section parallel to the axis X of theouter tube 80. For this reason, when thecatheter 10 is inserted into the blood vessel, theconvex portion 86 of the outer tubeproximal end portion 81 comes into contact with the blood vessel wall surface, so that an appropriate contact resistance is obtained, the backup force is increased, and the pushability is increased. it can. As described above, the outer tubedistal end portion 82 reduces the back-up force that tends to occur due to the increased slipperiness while the outer tubedistal end portion 82 increases the slipperiness in the blood vessel of the distal end portion where the slipperiness is required. Further, it is possible to supplement the outer tubeproximal end portion 81 which is located on the proximal end side and transmits the pushing force to the distal end side, and can provide good pushability.

また、外管先端部８２は、外管８０の軸線Ｘと平行な断面において外表面が平滑であるため、外管先端部８２の血管内での滑り性をより向上させることができる。  Moreover, since the outer surface of the outer tubedistal end portion 82 is smooth in a cross section parallel to the axis X of theouter tube 80, the slippage of the outer tubedistal end portion 82 in the blood vessel can be further improved.

また、凸部８６の頂点を挟んで先端側の凹部８５に向かう先端側傾斜面８７の軸線Ｘに対する傾斜角αが、当該凸部８６の頂点を挟んで基端側の凹部８５に向かう基端側傾斜面８８の軸線Ｘに対する傾斜角βよりも小さいため、外管基端部８１が血管壁面（接触対象物）に対して先端方向へ滑る場合の接触抵抗を、基端方向へ滑る場合の接触抵抗よりも小さくすることができる。このため、カテーテル１０が先端方向へ移動する際には低い接触抵抗によって押し込み性が損なわれず、かつカテーテル１０が基端方向へ移動する際に適度な接触抵抗が得られてバックアップ力を高め、押し込み性を高めることができる。  In addition, the inclination angle α with respect to the axis X of the distal-sideinclined surface 87 that faces the distal-sideconcave portion 85 across the vertex of theconvex portion 86 is the proximal end toward the proximal-sideconcave portion 85 across the vertex of theconvex portion 86. Since the inclination angle β of the side inclinedsurface 88 with respect to the axis X is smaller than the contact resistance when the outer tubeproximal end portion 81 slides in the distal direction with respect to the blood vessel wall surface (contact object), It can be made smaller than the contact resistance. Therefore, when thecatheter 10 moves in the distal direction, the pushability is not impaired due to the low contact resistance, and when thecatheter 10 moves in the proximal direction, an appropriate contact resistance is obtained to increase the backup force and push in. Can increase the sex.

また、外管先端部８２は、親水性被覆層７０が被覆されるため、滑り性が要求される外管先端部８２の接触抵抗をより低下させて、滑り性をより向上させることができる。なお、本実施形態における外管先端部８２は、突出部８３および中間部８４が形成されるため、仮に親水性被覆層７０が設けられずとも、高い滑り性を備えることができる。  Moreover, since the outer tube | pipe front-end | tippart 82 is coat | covered with thehydrophilic coating layer 70, the contact resistance of the outer pipe | tube front-end | tippart 82 in which slipperiness is requested | required can be reduced more, and slipperiness can be improved more. In addition, since theprotrusion part 83 and theintermediate part 84 are formed in the outer tube | pipe front-end | tippart 82 in this embodiment, even if thehydrophilic coating layer 70 is not provided, it can be provided with high slipperiness.

なお、本実施形態では、外管先端部８２の外表面が軸線Ｘと直交する断面において六角形で形成されるが、多角形であれば角の数は限定されない。また、外管先端部８２の外表面に形成される多角形は、正多角形でなくてもよい。また、図６に示す変形例のように、外管先端部８２Ａの外表面が軸線Ｘと直交する断面において星形となり、中間部８４Ａの曲率が負（マイナス）となってもよい。中間部８４Ａの曲率が負となれば、中間部８４Ａが血管壁面にさらに接触し難くなり、滑り性をさらに高めることができる。  In the present embodiment, the outer surface of theouter tube tip 82 is formed in a hexagonal shape in a cross section orthogonal to the axis X, but the number of corners is not limited as long as it is a polygon. Further, the polygon formed on the outer surface of the outer tubedistal end portion 82 may not be a regular polygon. Further, as in the modification shown in FIG. 6, the outer surface of the outer tubedistal end portion 82A may have a star shape in a cross section orthogonal to the axis X, and the curvature of theintermediate portion 84A may be negative (minus). If the curvature of theintermediate portion 84A is negative, theintermediate portion 84A becomes more difficult to contact the blood vessel wall surface, and the slipperiness can be further improved.

また、外管８０および内管９０の少なくとも一方が、複数層で構成されたり、線状体や網状体からなる補強層が設けられてもよい。  Further, at least one of theouter tube 80 and theinner tube 90 may be formed of a plurality of layers, or a reinforcing layer made of a linear body or a net-like body may be provided.

また、傾斜角αが、傾斜角β以上であってもよい。また、凸部および凹部は、外管の外表面に沿って螺旋状に形成されてもよい。  Further, the inclination angle α may be equal to or larger than the inclination angle β. Further, the convex portion and the concave portion may be formed in a spiral shape along the outer surface of the outer tube.

また、図７に示す変形例のように、外管基端部８１Ａの凸部８６Ａは、軸線Ｘに沿って間隔を開けて設けられてもよい。この場合、凸部８６Ａ同士の間に形成される平坦な部位が、凹部８５Ａを構成する。また、凹部が、軸線Ｘに沿って間隔を開けて設けられてもよい。この場合、凹部同士の間に形成される平坦な部位が、凸部を構成する。
＜第２実施形態＞Further, as in the modification shown in FIG. 7, theconvex portions 86 </ b> A of the outer tubebase end portion 81 </ b> A may be provided along the axis X with a space therebetween. In this case, the flat site | part formed betweenconvex part 86A comprises the recessedpart 85A. In addition, the recesses may be provided at intervals along the axis X. In this case, the flat site | part formed between recessed parts comprises a convex part.
Second Embodiment

第２実施形態に係るカテーテル１００は、外管先端部１１１の外表面の形状のみが、第１実施形態に係るカテーテル１０と異なる。なお、第１実施形態と同一の機能を有する部位には、同一の符号を付し、重複を避けるため、説明を省略する。  Thecatheter 100 according to the second embodiment differs from thecatheter 10 according to the first embodiment only in the shape of the outer surface of the outer tubedistal end portion 111. Note that parts having the same functions as those of the first embodiment are denoted by the same reference numerals, and description thereof is omitted to avoid duplication.

第２実施形態に係るカテーテル１００の外管１１０の外管先端部１１１（第１の部位）は、図８〜１２に示すように、外管１１０の軸線Ｘと直交する断面において外表面が多角形（本実施形態では六角形）で形成されている。外管先端部１１１の多角形の角部に対応する部位が、径方向の外側へ突出する突出部１１２を構成し、多角形の辺に対応する部位が、突出部１１２よりも曲率が大きい中間部１１３を構成しており、突出部１１２および中間部１１３が周方向に交互に配置されている。そして、外管先端部１１１は、突出部１１２の曲率が、基端側へ向かって徐々に小さくなっており、突出部１１２の曲率と中間部１１３の曲率との差が、基端側へ向かって徐々に小さくなっている。  The outer tube distal end portion 111 (first portion) of theouter tube 110 of thecatheter 100 according to the second embodiment has a large outer surface in a cross section orthogonal to the axis X of theouter tube 110 as shown in FIGS. It is formed in a square shape (in this embodiment, a hexagon). The portion corresponding to the polygonal corner of theouter tube tip 111 constitutes a protrudingportion 112 protruding outward in the radial direction, and the portion corresponding to the side of the polygon has a larger curvature than the protrudingportion 112. Thepart 113 is comprised and theprotrusion part 112 and theintermediate part 113 are alternately arrange | positioned in the circumferential direction. In the outer tubedistal end portion 111, the curvature of the projectingportion 112 gradually decreases toward the proximal end side, and the difference between the curvature of the projectingportion 112 and the curvature of theintermediate portion 113 is directed toward the proximal end side. Gradually getting smaller.

次に、第２実施形態に係るカテーテル１００の作用について説明する。  Next, the operation of thecatheter 100 according to the second embodiment will be described.

第２実施形態に係るカテーテル１００は、外管先端部１１１の突出部１１２の曲率と、中間部１１３の曲率との差が、基端側へ向かって徐々に小さくなっているため、カテーテル１００を血管内へ挿入した際に、曲率の差が大きい先端側では、中間部１１３が血管壁面と接触し難いために接触面積が減少する程度が大きく、曲率の差が小さい基端側では、曲率の差が大きい先端側と比較して、中間部１１３もある程度血管壁面と接触しやすくなるために、先端側と比較して接触面積が減少する程度が小さい。このため、外管先端部１１１の外表面は、先端側ほど接触抵抗が小さく、基端側へ向かうにしたがって、接触抵抗が徐々に大きくなる。このため、外管先端部１１１の先端側においては、血管内滑り性を高めつつ、外管先端部１１１の基端側においては、滑り性を低減させてバックアップ力の低下を抑制して、良好な押し込み性を得ることができる。  In thecatheter 100 according to the second embodiment, the difference between the curvature of the protrudingportion 112 of the outer tubedistal end portion 111 and the curvature of theintermediate portion 113 is gradually reduced toward the proximal end side. When inserted into a blood vessel, on the distal end side where the difference in curvature is large, theintermediate portion 113 is difficult to contact the blood vessel wall surface, so the contact area is reduced to a large extent, and on the proximal end side where the difference in curvature is small, the curvature is reduced. Compared to the distal end side where the difference is large, theintermediate portion 113 is also likely to come into contact with the blood vessel wall surface to some extent. For this reason, the contact resistance of the outer surface of the outer tubedistal end portion 111 is smaller toward the distal end side and gradually increases toward the proximal end side. For this reason, on the distal end side of the outer tubedistal end portion 111, while improving the slippage in the blood vessel, on the proximal end side of the outer tubedistal end portion 111, the slipping property is reduced to suppress a decrease in the backup force. Pushability can be obtained.

このため、滑り性が要求されるカテーテル１００の先端側の部位において高い滑り性を付与しつつ、バックアップ力が要求されるカテーテル１００の基端側の部位において滑り性を低減させて、良好な押し込み性を得ることができる。  For this reason, while providing high slipperiness in the site | part of the front end side of thecatheter 100 in which slipperiness is requested | required, slipperiness is reduced in the site | part of the base end side of thecatheter 100 in which backup force is requested | required, and favorable push-in Sex can be obtained.

また、外管先端部１１１の突出部１１２の曲率と、中間部１１３の曲率との差が、基端側へ向かって徐々に小さくなることで、外管先端部１１１の基端側の形状が、外管基端部８１の形状に近くなるため、外管先端部１１１と外管基端部８１との境界において形状変化が小さくなり、接触抵抗のみならず、外管１１０の物性の変化も小さくなる。このため、外管先端部１１１と外管基端部８１との境界において応力が集中し難くなり、キンクの発生を抑制できるとともに、外管１１０の破損等を抑制して安全性を向上できる。
＜第３実施形態＞In addition, the difference between the curvature of the protrudingportion 112 of the outer tubedistal end portion 111 and the curvature of theintermediate portion 113 gradually decreases toward the proximal end, so that the shape of the proximal end side of the outer tubedistal end portion 111 is reduced. Since the shape is close to the shape of the outer tubebase end portion 81, the change in shape is reduced at the boundary between the outer tubetip end portion 111 and the outer tubebase end portion 81, and not only the contact resistance but also the physical property change of theouter tube 110 is also changed. Get smaller. For this reason, it is difficult for stress to concentrate at the boundary between the outer tubedistal end portion 111 and the outer tubeproximal end portion 81, and the occurrence of kinks can be suppressed, and damage to theouter tube 110 can be suppressed to improve safety.
<Third Embodiment>

第３実施形態に係るカテーテル１２０は、外管基端部１３１の外表面の形状のみが、第１実施形態に係るカテーテル１０と異なる。なお、第１実施形態と同一の機能を有する部位には、同一の符号を付し、重複を避けるため、説明を省略する。  Thecatheter 120 according to the third embodiment is different from thecatheter 10 according to the first embodiment only in the shape of the outer surface of the outer tubeproximal end portion 131. Note that parts having the same functions as those of the first embodiment are denoted by the same reference numerals, and description thereof is omitted to avoid duplication.

第３実施形態に係るカテーテル１２０の外管１３０の外管基端部１３１（第２の部位）は、外管１３０の軸線Ｘと直交する断面において外表面が円形で形成されており、外管１３０の軸線Ｘと平行な断面において、図１３に示すように、凸部１３３および凹部１３２が交互に並んで配置されている。各々の凸部１３３および凹部１３２は、外管１３０の外周面を３６０度にわたって環状に形成されている。外管基端部１３１は、基端側の凹部１３２ほど深さが徐々に深くなっており、これにより、凸部１３３も基端側ほど高くなっている。  The outer tube proximal end portion 131 (second portion) of the outer tube 130 of thecatheter 120 according to the third embodiment has a circular outer surface in a cross section orthogonal to the axis X of the outer tube 130. As shown in FIG. 13, theconvex portions 133 and theconcave portions 132 are alternately arranged in a cross section parallel to the axis X of 130. Eachconvex part 133 and theconcave part 132 are formed in an annular shape over the outer peripheral surface of the outer tube 130 over 360 degrees. The outer tubeproximal end portion 131 gradually becomes deeper as theconcave portion 132 on the proximal end side, and accordingly, theconvex portion 133 becomes higher toward the proximal end side.

次に、第３実施形態に係るカテーテル１２０の作用について説明する。  Next, the operation of thecatheter 120 according to the third embodiment will be described.

第３実施形態に係るカテーテル１２０は、基端側の凹部１３２ほど深さが徐々に深くなっており、これにより、凸部１３３も基端側ほど高くなっているため、カテーテル１２０を血管内へ挿入した際に、凹部１３２が深く凸部１３３が高い先端側ほど、血管壁面と接触した際の接触抵抗が大きくなっている。このように、外管基端部１３１の外表面の接触抵抗を軸線Ｘ方向の部位に応じて変化させることで、軸線Ｘ方向の部位に応じて適切なバックアップ力を設定することができる。特に、外管基端部１３１の基端側においてはバックアップ力が高められるとともに、外管基端部１３１の先端側においてはバックアップ力が抑えられることで、バックアップ力が要求されるカテーテル１２０の基端側の部位において高いバックアップ力を付与しつつ、滑り性が要求されるカテーテル１２０の先端側の部位においてはバックアップ力を低減させて、良好な押し込み性を得ることができる。  In thecatheter 120 according to the third embodiment, the depth is gradually increased toward theconcave portion 132 on the proximal end side, and thus theconvex portion 133 is also increased toward the proximal end side. When inserted, the distal end side where theconcave portion 132 is deeper and theconvex portion 133 is higher has a higher contact resistance when contacting the blood vessel wall surface. In this way, by changing the contact resistance of the outer surface of the outer tubebase end portion 131 according to the site in the axis X direction, an appropriate backup force can be set according to the site in the axis X direction. In particular, the back-up force is increased at the proximal end side of the outer tubeproximal end portion 131 and the backup force is suppressed at the distal end side of the outer tubeproximal end portion 131, so that the base of thecatheter 120 that requires the backup force is required. While providing a high back-up force at the end portion, the back-up force can be reduced at the distal end portion of thecatheter 120 where slipperiness is required, and good pushability can be obtained.

なお、第３実施形態に係るカテーテル１２０の変形例として、図１４に示すように、軸線Ｘに沿って基端側ほど外管基端部１３１Ａの接触抵抗が大きくなるように、基端側の凸部１３３Ａほど高さを高くし、これにより、凹部１３２Ａも基端側ほど深くなってもよい。  As a modified example of thecatheter 120 according to the third embodiment, as shown in FIG. 14, the proximal end side contact resistance of the outer tubeproximal end portion 131 </ b> A increases along the axial line X toward the proximal end side. The height of the convex portion 133A may be increased, and thus the concave portion 132A may also be deeper toward the proximal end side.

また、第３実施形態に係るカテーテル１２０の他の変形例として、図１５に示すように、軸線Ｘに沿って基端側ほど外管基端部１３１Ｂの接触抵抗が大きくなるように、基端側の凸部１３３Ｂおよび凹部１３２Ｂほど、密度（凸部１３３Ｂまたは凹部１３２Ｂの、軸線Ｘに沿う単位長さ当たりの数）が高くなってもよい。  As another modification of thecatheter 120 according to the third embodiment, as shown in FIG. 15, the proximal end is set so that the contact resistance of the outer tubeproximal end portion 131 </ b> B increases toward the proximal end along the axis X. The density (the number of the convex portions 133B or the concave portions 132B per unit length along the axis X) may be higher as the convex portions 133B and the concave portions 132B are closer.

また、上述した凸部の高さ、凹部の深さ、凸部の密度、および凹部の密度の少なくとも２つを、組み合わせて変化させてもよい。
＜第４実施形態＞Further, at least two of the height of the convex portion, the depth of the concave portion, the density of the convex portion, and the density of the concave portion described above may be changed in combination.
<Fourth embodiment>

第４実施形態に係るカテーテル１４０は、図１６に示すように、混合部１５１を有する点で、前述の他の実施形態と異なる。なお、前述の他の実施形態と同様の機能を有する部位には、同一の符号を付し、重複を避けるため、説明を省略する。  As shown in FIG. 16, thecatheter 140 according to the fourth embodiment is different from the other embodiments described above in that it has amixing unit 151. Note that portions having the same functions as those of the other embodiments described above are denoted by the same reference numerals, and description thereof is omitted to avoid duplication.

第４実施形態に係るカテーテル１４０の外管１５０は、第２実施形態の構成と同様の外管先端部１１１と、第３実施形態の構成と同様の外管基端部１３１と、外管先端部１１１および外管基端部１３１の間に設けられる混合部１５１とを有している。  Theouter tube 150 of thecatheter 140 according to the fourth embodiment includes an outer tubedistal end portion 111 similar to the configuration of the second embodiment, an outer tubeproximal end portion 131 similar to the configuration of the third embodiment, and an outer tube distal end. And a mixingportion 151 provided between theportion 111 and the outer tubebase end portion 131.

外管先端部１１１（第１の部位）は、第２実施形態と同様に、突出部１１２の曲率が基端側へ向かって徐々に小さくなっており、突出部１１２の曲率と中間部１１３の曲率との差が、基端側へ向かって徐々に小さくなっている（図９〜１２を参照）。  As in the second embodiment, the outer tube distal end portion 111 (first portion) has a gradually decreasing curvature toward the proximal end, and the curvature of the protrudingportion 112 and that of theintermediate portion 113 are reduced. The difference from the curvature gradually decreases toward the base end side (see FIGS. 9 to 12).

外管基端部１３１（第２の部位）は、第３実施形態と同様に、基端側の凹部１３２ほど深さが徐々に深くなり、かつ、凸部１３３も基端側ほど高くなっており、基端側ほど接触抵抗が大きくなっている（図１３を参照）。  As in the third embodiment, the outer tube proximal end portion 131 (second portion) gradually becomes deeper as theconcave portion 132 on the proximal end side, and theconvex portion 133 becomes higher toward the proximal end side. Thus, the contact resistance increases toward the base end side (see FIG. 13).

混合部１５１は、図１７〜１９に示すように、外管先端部１１１から連続する突出部１５２および中間部１５３を備えるとともに、外管基端部１３１から連続する凹部１５４および凸部１５５を備えている。  As shown in FIGS. 17 to 19, themixing unit 151 includes a protrudingportion 152 and anintermediate portion 153 that are continuous from the outer tubedistal end portion 111, and includes aconcave portion 154 and aconvex portion 155 that are continuous from the outer tubebase end portion 131. ing.

混合部１５１は、突出部１５２の曲率が、外管先端部１１１から連続して、基端側へ向かって徐々に小さくなっており、突出部１５２の曲率と中間部１５３の曲率との差が、基端側へ向かって徐々に小さくなっている。さらに、混合部１５１は、外管基端部１３１から連続して、先端側の凹部１５４ほど深さが徐々に浅くなり、かつ凸部１５５も先端側ほど低くなっており、基端側ほど接触抵抗が大きくなっている。  In the mixingportion 151, the curvature of the projectingportion 152 is continuously reduced from thedistal end portion 111 of the outer tube toward the proximal end side, and the difference between the curvature of the projectingportion 152 and the curvature of theintermediate portion 153 is different. , Gradually decreasing toward the base end side. Further, the mixingportion 151 is continuous from the outer tubeproximal end portion 131, and the depth gradually becomes shallower as theconcave portion 154 on the distal end side, and theconvex portion 155 becomes lower toward the distal end side, and contacts the proximal end side. Resistance is increasing.

次に、第４実施形態に係るカテーテル１４０の作用について説明する。  Next, the operation of thecatheter 140 according to the fourth embodiment will be described.

第４実施形態に係るカテーテル１４０は、混合部１５１において、外管先端部１１１から連続して、突出部１５２の曲率と中間部１５３の曲率との差が基端側へ向かって徐々に小さくなるとともに、外管基端部１３１から連続して、先端側の凹部１５４ほど深さが徐々に浅くなり、かつ凸部１５５も先端側ほど低くなっている。このため、混合部１５１において、外管１５０の先端から基端にわたって、外管１５０の形状が連続的に変化することになり、接触抵抗のみならず、外管１５０の物性の変化も連続的に変化する。このため、外管先端部１１１、混合部１５１および外管基端部１３１の各々の境界において応力が集中し難くなり、キンクの発生を抑制するとともに、外管１５０の破損等を抑制して安全性が向上する。  In thecatheter 140 according to the fourth embodiment, the difference between the curvature of the protrudingportion 152 and the curvature of theintermediate portion 153 gradually decreases toward the proximal end side continuously from thedistal end portion 111 of the outer tube in the mixingportion 151. Continuing from the outer tubebase end portion 131, the depth of theconcave portion 154 on the distal end side becomes gradually shallower, and theconvex portion 155 is also lowered on the distal end side. For this reason, in themixing unit 151, the shape of theouter tube 150 continuously changes from the distal end to the proximal end of theouter tube 150, and not only the contact resistance but also the change in the physical properties of theouter tube 150 continuously. Change. This makes it difficult for stress to concentrate at the boundaries of the outer tubedistal end portion 111, the mixingportion 151, and the outer tubeproximal end portion 131, thereby preventing kinks from occurring and suppressing damage to theouter tube 150 and the like. Improves.

なお、本発明は、上述した実施形態のみに限定されるものではなく、本発明の技術的思想内において当業者により種々変更が可能である。例えば、上述した実施形態に係るカテーテルは、バルーン３０を有するバルーンカテーテルであるが、バルーンカテーテルでなくてもよく、生体管腔内に挿入可能なシャフトを有するカテーテルであれば、本発明を適用できる。  Note that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, the catheter according to the above-described embodiment is a balloon catheter having theballoon 30, but may not be a balloon catheter, and the present invention can be applied to any catheter having a shaft that can be inserted into a living body lumen. .

また、上述の各実施形態に係るカテーテルは、ガイドワイヤーがカテーテルの全長にわたって挿入されるオーバーザワイヤ型（Ｏｖｅｒ−ｔｈｅ−ｗｉｒｅ ｔｙｐｅ）であるが、ガイドワイヤーがカテーテルの先端部にのみ挿入されるラピッドエクスチェンジ型（Ｒａｐｉｄ ｅｘｃｈａｎｇｅ ｔｙｐｅ）であってもよい。  Moreover, although the catheter which concerns on each above-mentioned embodiment is an over-the-wire type (Over-the-wire type) in which a guide wire is inserted over the full length of a catheter, rapid in which a guide wire is inserted only in the tip part of a catheter It may be an exchange type (Rapid exchange type).

１０，１００，１２０，１４０ カテーテル、
２０ カテーテル本体、
７０ 親水性被覆層、
８０，１１０，１３０，１５０ 外管、
８１，８１Ａ，１１１，１３１，１３１Ａ、１３１Ｂ 外管基端部、
８２，８２Ａ 外管先端部、
８３，１１２，１５２ 突出部、
８４，８４Ａ，１１３，１５３ 中間部、
８５，８５Ａ，１３２，１３２Ａ，１３２Ｂ，１５４ 凹部、
８６，８６Ａ，１３３，１３３Ａ，１３３Ｂ，１５５ 凸部、
８７ 先端側傾斜面、
８８ 基端側傾斜面、
９０ 内管、
１５１ 混合部、
Ｘ 軸線。10, 100, 120, 140 catheter,
20 catheter body,
70 hydrophilic coating layer,
80, 110, 130, 150 outer pipe,
81, 81A, 111, 131, 131A, 131B outer tube proximal end,
82,82A outer tube tip,
83, 112, 152 protrusions,
84, 84A, 113, 153 middle part,
85, 85A, 132, 132A, 132B, 154 recess,
86, 86A, 133, 133A, 133B, 155 convex portion,
87 Tip side inclined surface,
88 base end side inclined surface,
90 inner pipe,
151 mixing section,
X axis.

Claims (8)

Translated fromJapanese

生体管腔内へ挿入可能なシャフトを備えるカテーテルであって、
前記シャフトは、
当該シャフトの軸線と直交する断面において外表面に外側へ突出する突出部および当該突出部よりも曲率が大きい中間部が交互に配置される第１の部位と、
前記第１の部位よりも基端側に設けられ、前記シャフトの軸線と平行な断面において外表面に凸部および凹部が交互に並んで配置される第２の部位と、を有するカテーテル。A catheter comprising a shaft that can be inserted into a body lumen,
The shaft is
In a cross section orthogonal to the axis of the shaft, the first portion where the protruding portion protruding outward on the outer surface and the intermediate portion having a larger curvature than the protruding portion are alternately arranged,
A catheter having a second portion provided on a proximal end side with respect to the first portion and having a convex portion and a concave portion alternately arranged on the outer surface in a cross section parallel to the axis of the shaft. 前記第１の部位は、前記シャフトの軸線と平行な断面において外表面が平滑である請求項１に記載のカテーテル。  The catheter according to claim 1, wherein the first portion has a smooth outer surface in a cross section parallel to the axis of the shaft. 前記第１の部位は、基端側へ向かって前記突出部の曲率と前記中間部の曲率との差が徐々に小さくなる請求項１または２に記載のカテーテル。  The catheter according to claim 1 or 2, wherein the difference between the curvature of the protruding portion and the curvature of the intermediate portion gradually decreases toward the proximal end side in the first portion. 前記第２の部位は、基端側へ向かって前記凸部の高さ、前記凹部の深さ、前記凸部の軸線方向における密度、および前記凹部の軸線方向における密度の少なくとも１つが、軸線方向に沿って徐々に変化する請求項１〜３のいずれか１項に記載のカテーテル。  In the second portion, at least one of a height of the convex portion, a depth of the concave portion, a density in the axial direction of the convex portion, and a density in the axial direction of the concave portion toward the base end side is an axial direction. The catheter according to any one of claims 1 to 3, which gradually changes along the axis. 前記第２の部位は、先端方向へ移動する際の接触抵抗が、基端方向へ移動する際の接触抵抗よりも小さい請求項１〜４のいずれか１項に記載のカテーテル。  The catheter according to any one of claims 1 to 4, wherein the second portion has a contact resistance when moving in the distal direction smaller than a contact resistance when moving in the proximal direction. 前記凸部の頂点を挟んで先端側の前記凹部に向かう先端側傾斜面の前記軸線に対する傾斜角は、前記凸部の頂点を挟んで基端側の前記凹部に向かう基端側傾斜面の前記軸線に対する傾斜角よりも小さい請求項５に記載のカテーテル。  The inclination angle with respect to the axis of the distal-side inclined surface facing the concave portion on the distal end side across the vertex of the convex portion is the angle of inclination of the proximal-side inclined surface facing the concave portion on the proximal side across the vertex of the convex portion. The catheter according to claim 5, wherein the catheter is smaller than an inclination angle with respect to the axis. 前記シャフトは、前記第１の部位および前記第２の部位の間に、前記第１の部位から連続する前記突出部および前記中間部が形成されるとともに前記第２の部位から連続する前記凹部および前記凸部が形成される混合部を有する請求項１〜６のいずれか１項に記載のカテーテル。  In the shaft, the protrusion and the intermediate portion that are continuous from the first portion are formed between the first portion and the second portion, and the recess that is continuous from the second portion and The catheter of any one of Claims 1-6 which has a mixing part in which the said convex part is formed. 前記第１の部位は、親水性材料が被覆される請求項１〜７のいずれか１項に記載のカテーテル。  The catheter according to any one of claims 1 to 7, wherein the first portion is coated with a hydrophilic material.

Images