JP2019195576A - Method for manufacturing balloon catheter with rod-shaped core material inserted - Google Patents
Method for manufacturing balloon catheter with rod-shaped core material inserted Download PDFInfo
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- JP2019195576A JP2019195576A JP2018092264A JP2018092264A JP2019195576A JP 2019195576 A JP2019195576 A JP 2019195576A JP 2018092264 A JP2018092264 A JP 2018092264A JP 2018092264 A JP2018092264 A JP 2018092264A JP 2019195576 A JP2019195576 A JP 2019195576A
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- shaped core
- balloon catheter
- core material
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- 239000011162 core material Substances 0.000 title claims abstract description 55
- 238000000034 method Methods 0.000 title claims abstract description 10
- 238000004519 manufacturing process Methods 0.000 title claims description 11
- 230000001681 protective effect Effects 0.000 claims abstract description 44
- 238000003780 insertion Methods 0.000 description 4
- 230000037431 insertion Effects 0.000 description 4
- 239000011347 resin Substances 0.000 description 4
- 229920005989 resin Polymers 0.000 description 4
- 239000000463 material Substances 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- -1 polyethylene Polymers 0.000 description 2
- 239000004677 Nylon Substances 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
Abstract
Description
本発明は、バルーンに保護管が被さったバルーンカテーテルのガイドワイヤールーメンに、棒状芯材を挿入する、棒状芯材が挿入されたバルーンカテーテルの製造方法に関するものである。 The present invention relates to a method for manufacturing a balloon catheter in which a rod-shaped core material is inserted, and a rod-shaped core material is inserted into a guide wire lumen of a balloon catheter having a balloon covered with a protective tube.
一般的なバルーンカテーテルは、近位から遠位に亘るチューブ状部材、近位側に流体を導入する開口部、バルーンカテーテル遠位側に周方向に拡張されるバルーンが配置される。チューブ状部材は近位側から遠位側へ亘るガイドワイヤールーメンと近位側から遠位側のバルーンにつながるルーメンを含む。 A general balloon catheter is provided with a tubular member extending from the proximal side to the distal side, an opening for introducing fluid to the proximal side, and a balloon that is expanded in the circumferential direction on the distal side of the balloon catheter. The tubular member includes a guidewire lumen extending from the proximal side to the distal side and a lumen leading to the balloon from the proximal side to the distal side.
バルーンカテーテル製造工程において、図１ａに示すようにバルーン部位を保護するために保護管２が被せられる。バルーンカテーテル遠位部を十分に保護するため、保護管の遠位端はバルーンカテーテル遠位端４より遠位側に位置する。 In the balloon catheter manufacturing process, as shown in FIG. 1a, a protective tube 2 is covered to protect the balloon site. In order to sufficiently protect the distal portion of the balloon catheter, the distal end of the protective tube is located distal to the balloon catheter distal end 4.
バルーンカテーテルのチューブ部分は柔軟性の高い樹脂から形成されるため、形状保持を行うべく、棒状芯材をバルーンカテーテルのルーメンに通す。図１ｂで示すように、棒状芯材３は一般的にバルーン全長より長く、バルーンカテーテル遠位端４からガイドワイヤールーメン５に挿入される。棒状芯材３はガイドワイヤールーメン５に挿入可能な形状を有する。棒状芯材３はバルーンカテーテル遠位端４に挿入する側の反対側に保護管２の内径より大きいサイズの頭部（大径部）（図示せず）を有していても良い。頭部は棒状芯材３がガイドワイヤールーメン５の近位端側に行きすぎないようストッパーの役割を果たす。棒状芯材３はバルーン部分を保護する保護管２の遠位端に棒状芯材３の頭部が接するまで挿入される。 Since the tube portion of the balloon catheter is formed of a highly flexible resin, the rod-shaped core member is passed through the lumen of the balloon catheter in order to maintain the shape. As shown in FIG. 1 b, the rod-shaped core member 3 is generally longer than the entire length of the balloon, and is inserted into the guide wire lumen 5 from the distal end 4 of the balloon catheter. The rod-shaped core member 3 has a shape that can be inserted into the guide wire lumen 5. The rod-shaped core member 3 may have a head (large diameter portion) (not shown) having a size larger than the inner diameter of the protective tube 2 on the side opposite to the side inserted into the balloon catheter distal end 4. The head serves as a stopper so that the rod-shaped core 3 does not go too far to the proximal end side of the guide wire lumen 5. The rod-shaped core 3 is inserted until the head of the rod-shaped core 3 comes into contact with the distal end of the protective tube 2 that protects the balloon portion.
バルーンカテーテルの製造工程では、保護管が透明ではない場合、始めに棒状芯材をバルーン保護管に通し、その後にバルーンカテーテルの遠位端に棒状芯材を挿入し、バルーンにバルーン保護管をスライドさせ被せることによって、バルーンカテーテルに保護管と棒状芯材を装着させる。また、先にバルーンにバルーン保護管を被せる場合は、保護管が不透明であると、保護管を被せた後に棒状芯材をバルーンに入れようとしても、バルーンカテーテルの遠位端が見えず、挿入することが難しい。更にバルーンカテーテル遠位端のガイドワイヤールーメンのセンターの位置が必ずしもバルーン保護管のセンターと一致しないため、図１ｃで示すように棒状芯材を保護管のセンターと一致するように入れてもバルーンカテーテルの遠位端に入らないことがある。 In the manufacturing process of the balloon catheter, if the protective tube is not transparent, first pass the rod-shaped core material through the balloon protective tube, then insert the rod-shaped core material into the distal end of the balloon catheter, and slide the balloon protective tube into the balloon Then, the protective tube and the rod-shaped core are attached to the balloon catheter. In addition, when the balloon is covered with a balloon protective tube first, if the protective tube is opaque, the distal end of the balloon catheter cannot be seen even if an attempt is made to insert the rod-shaped core into the balloon after covering the protective tube. Difficult to do. Furthermore, since the position of the center of the guide wire lumen at the distal end of the balloon catheter does not necessarily coincide with the center of the balloon protective tube, the balloon catheter can be inserted even if a rod-shaped core member is aligned with the center of the protective tube as shown in FIG. May not enter the distal end.
特許文献１には内外二重管のチューブにおいて、内管を強制的にセンタリングし、ガイド機構を用いることにより棒状芯材を挿入する冶具について記載している。 Patent Document 1 describes a jig that forcibly centers an inner tube and inserts a rod-shaped core member by using a guide mechanism in an inner and outer double tube.
特許文献１に記載の冶具を用いる場合、一度外管に冶具を挿入する工程が入るが、チューブ径がミリからサブミリオーダーと小さく、さらに外管の内径に近いサイズの冶具を一旦外管に挿入する必要があるため、作業性がよくない。 When using the jig described in Patent Document 1, the process of inserting the jig once into the outer pipe is entered, but once the jig is inserted into the outer pipe, the diameter of the tube is as small as millimeters to sub-millimeters and the size is close to the inner diameter of the outer pipe. Workability is not good.
前述の課題を鑑みて、本発明の目的とするところは、簡易に、バルーンに保護管が被さったバルーンカテーテルのガイドワイヤールーメンに棒状芯材を挿入する方法を、提供することである。 In view of the above-described problems, an object of the present invention is to provide a method for easily inserting a rod-shaped core material into a guide wire lumen of a balloon catheter in which a protective tube is covered with a balloon.
すなわち本発明は、
（１）．バルーンに保護管が被せられ、棒状芯材がガイドワイヤールーメンに挿入されたバルーンカテーテルの製造方法であって、
バルーンカテーテルの遠位端もしくは遠位部と、保護管との間に、ニードル状器具を挿入することによってバルーンカテーテルの遠位端を保護管の内壁に接触させ、接触させた状態で棒状芯材をガイドワイヤールーメンに挿入する、棒状芯材が挿入されたバルーンカテーテルの製造方法、
（２）．ニードル状器具の先端がテーパー状である、（１）に記載の棒状芯材が挿入されたバルーンカテーテルの製造方法、
（３）．棒状芯材をガイドワイヤールーメンに挿入する際に、棒状芯材をニードル状器具に沿わせながら挿入する、請求項１もしくは２に記載の棒状芯材が挿入されたバルーンカテーテルの製造方法、
に関する。
That is, the present invention
(1). A balloon catheter is covered with a protective tube, and a rod-shaped core material is inserted into a guide wire lumen.
By inserting a needle-like instrument between the distal end or distal portion of the balloon catheter and the protective tube, the distal end of the balloon catheter is brought into contact with the inner wall of the protective tube, and the rod-shaped core material is in contact with the distal end. A method of manufacturing a balloon catheter in which a rod-shaped core material is inserted,
(2). The method for producing a balloon catheter into which the rod-shaped core material according to (1) is inserted, wherein the needle-like instrument has a tapered tip,
(3). The method for producing a balloon catheter into which the rod-shaped core material according to claim 1 or 2, wherein the rod-shaped core material is inserted along the needle-shaped instrument when the rod-shaped core material is inserted into the guide wire lumen,
About.
本発明の方法を用いると、バルーンに保護管が被さったバルーンカテーテルのガイドワイヤールーメンに、棒状芯材を簡単に挿入することができる。 When the method of the present invention is used, a rod-shaped core material can be easily inserted into a guide wire lumen of a balloon catheter having a balloon covered with a protective tube.
以下、本発明に係る器具の実施形態について図面を参照しつつ説明する。なお、便宜上、図面において符号を省略する場合もあるが、かかる場合、他の図面を参照するものとする。また、図面における種々部材の寸法は、便宜上、見やすいように調整されていることもある。 Hereinafter, an embodiment of an instrument according to the present invention will be described with reference to the drawings. For convenience, reference numerals may be omitted in the drawings, but in such a case, other drawings are referred to. Moreover, the dimension of the various members in drawing may be adjusted so that it may be easy to see for convenience.
＜第一の実施形態＞
バルーンカテーテルは図では同心円となるようチューブにバルーンが配置されているが特に限定せず、バルーンとチューブの中心がずれていてもよい。例えばバルーンがチューブの周方向の一部にのみ配置されている偏った形状のもの、あるいはバルーン自体の形状が周方向に対して偏りが生じているものでもよい。また、バルーン形状について、絵では両端部がコーン形状、中央がストレート形状からなるバルーンが記載されているが特に限定はせず、バルーンの一部にブレード部が配置されているものや、バルーン中央部に拡大抑制部が配置されているなど、複数のバルーンが軸方向につながった形状のものでもよい。また、バルーンの折り畳み形状についても特に限定せず２枚折りでも３枚折り、あるいは４枚折り以上の複数枚折りでもよい。
<First embodiment>
In the drawing, the balloon catheter is arranged in a tube so as to be concentric in the figure, but the balloon catheter is not particularly limited, and the center of the balloon and the tube may be shifted. For example, the balloon may have a biased shape in which only a part of the tube in the circumferential direction is arranged, or the balloon itself may have a biased shape with respect to the circumferential direction. As for the balloon shape, in the picture, a balloon having a cone shape at both ends and a straight shape at the center is described, but there is no particular limitation. It may have a shape in which a plurality of balloons are connected in the axial direction, for example, an expansion suppressing part is disposed in the part. Further, the folded shape of the balloon is not particularly limited, and it may be folded in two, three, or four or more.
保護管について、保護管でバルーンを保護するのが目的であるが、その後にカテーテル全体を保護するチューブなどに収納するため、バルーンより硬度をもつ樹脂製が好ましい。樹脂についてはポリエチレン、ポリプロピレン、ナイロンやフッ素樹脂など特に限定しない。保護管の形状であるが、特に限定せず単純円筒形でも螺旋形状に膨らむ形状でも、ボーン形状でもよい。保護管の長さは、２０ｍｍ以上、３５０ｍｍ以下が好ましく、５０ｍｍ以上、２５０ｍｍ以下がより好ましい。保護管はバルーンよりも５ｍｍ以上長いことが好ましく、十分にバルーンを覆うため１０ｍｍ以上長いことがより好ましい。
棒状芯材の形状については特に限定せず、長手方向に全て径が一定のものでもよく、先端側へ伴い径が減少する構造でもよい。また、棒状芯材の材質については、変形が少なく、変質がない金属が好ましい。また、棒状芯材の径は０．３ミリ以上１ミリ以下のものである。棒状芯材の長さは、１００ｍｍ以上が好ましい。棒状芯材の径は０．２ミリ以上１ミリ以下のものである。棒状芯材の径は、ガイドワイヤールーメンの径よりも、０．１ｍｍ以上小さいのが好ましい。
The purpose of the protective tube is to protect the balloon with the protective tube. However, since the protective tube is then housed in a tube or the like that protects the entire catheter, it is preferably made of a resin having higher hardness than the balloon. The resin is not particularly limited, such as polyethylene, polypropylene, nylon or fluororesin. The shape of the protective tube is not particularly limited, and may be a simple cylindrical shape, a shape that swells in a spiral shape, or a bone shape. The length of the protective tube is preferably 20 mm or more and 350 mm or less, and more preferably 50 mm or more and 250 mm or less. The protective tube is preferably 5 mm or longer than the balloon, and more preferably 10 mm or longer in order to sufficiently cover the balloon.
The shape of the rod-shaped core member is not particularly limited, and may have a constant diameter in the longitudinal direction or may have a structure in which the diameter decreases toward the tip side. Moreover, about the material of a rod-shaped core material, a metal with few deformation | transformation and a quality change is preferable. The diameter of the rod-shaped core material is not less than 0.3 mm and not more than 1 mm. The length of the rod-shaped core material is preferably 100 mm or more. The diameter of the rod-shaped core material is 0.2 mm or more and 1 mm or less. The diameter of the rod-shaped core material is preferably smaller by 0.1 mm or more than the diameter of the guide wire lumen.
棒状芯材の頭部の形状は、丸みを帯びていることが好ましく、Ｒ０．５ｍｍ以上が好ましい。 The shape of the head portion of the rod-shaped core material is preferably rounded, and preferably R0.5 mm or more.
図２ａには、保護管が被さったバルーンカテーテルの遠位端４と保護管２の内部にニードル状器具１１を挿入している形態を図示している。 FIG. 2 a shows a configuration in which the needle-like instrument 11 is inserted into the distal end 4 of the balloon catheter covered with the protective tube and the inside of the protective tube 2.
図２ａでは、ニードル状器具１１の先端が単純直線テーパー形状のものを図示しているが、先端形状については特に限定せず、一様の断面形状でもよいが、バルーンカテーテルの遠位端４を持ち上げやすいよう直線、あるいは曲線テーパー形状であることが好ましい。テーパーの角度は、１°以上、が好ましい。また、ニードル状器具１１の断面形状については、円形、楕円形、四角形、三日月形あるいは馬蹄形など特に限定しないが、ニードル状器具１１の挿入時に保護管２およびバルーンカテーテル１を傷つけないよう丸みを帯びた形状であることが好ましい。ニードル状器具１１の材質については、金属や樹脂など特に限定せず、表面状態についてはニードル状器具１１挿入時に保護管２およびバルーンカテーテル１に傷が入らないよう表面は鏡面仕上げ程度が好ましい。ニードル状器具１１の外径については特に限定しないが、バルーンカテーテル遠位端４の外面と保護管２の内面がなす空隙に入る必要があり、０．２ミリ以上１．０ミリ以下であることが好ましい。ニードル状器具１１の長さは、１００ｍｍ以上、が好ましい。 In FIG. 2a, the tip of the needle-like instrument 11 is illustrated as having a simple linear taper shape, but the tip shape is not particularly limited and may be a uniform cross-sectional shape. A straight or curved taper shape is preferable for easy lifting. The taper angle is preferably 1 ° or more. Further, the cross-sectional shape of the needle-like instrument 11 is not particularly limited, such as a circle, an ellipse, a quadrangle, a crescent shape, or a horseshoe shape. It is preferable that the shape is different. The material of the needle-like instrument 11 is not particularly limited, such as metal or resin, and the surface is preferably mirror-finished so that the protective tube 2 and the balloon catheter 1 are not damaged when the needle-like instrument 11 is inserted. The outer diameter of the needle-like instrument 11 is not particularly limited, but it is necessary to enter the gap formed by the outer surface of the balloon catheter distal end 4 and the inner surface of the protective tube 2 and is 0.2 mm or more and 1.0 mm or less. Is preferred. The length of the needle-like instrument 11 is preferably 100 mm or more.
図２ａの配置後、図２ｂに示すように、ニードル状器具１１をバルーンカテーテル１の近位側へさらに挿入することにより、バルーンカテーテル遠位端４が上側へ持ち上げられ保護管２内壁と接触する。バルーンカテーテル１、保護管２およびニードル状器具１１の状態、例えばニードル状器具１１断面が小さな楕円形状の場合、図２ｂで示すようにニードル状器具１１を単純に挿入するだけでは空隙が発生しバルーンカテーテル遠位端４が保護管２の内壁に接触しない場合もあるため、図２ｃに示すようにニードル状器具１１の先端を、バルーンカテーテル遠位端４を持ち上げるよう径方向内側に傾かせることにより、図２ｄに示すようにカテーテル遠位端４を保護管２の内壁に接触させることができる。 After the arrangement of FIG. 2a, as shown in FIG. 2b, the needle-like instrument 11 is further inserted into the proximal side of the balloon catheter 1, so that the distal end 4 of the balloon catheter is lifted upward and comes into contact with the inner wall of the protective tube 2 . In the state of the balloon catheter 1, the protective tube 2, and the needle-like instrument 11, for example, when the needle-like instrument 11 has a small elliptical cross section, a gap is generated by simply inserting the needle-like instrument 11 as shown in FIG. Since the catheter distal end 4 may not contact the inner wall of the protective tube 2, the tip of the needle-like instrument 11 is tilted radially inward to lift the balloon catheter distal end 4 as shown in FIG. As shown in FIG. 2 d, the catheter distal end 4 can be brought into contact with the inner wall of the protective tube 2.
図２ｂ或いは図２ｃにてバルーンカテーテル遠位端４を保護管２の内壁に接触させた状態だとガイドワイヤールーメンの位置が一意に決まる。そのため、図２ｅにて示すように棒状芯材３をニードル状器具１１に沿わせて進めることにより、図２ｆのように棒状芯材３をガイドワイヤールーメン５に容易に挿入することができる。
棒状芯材３の先端が、一旦ガイドワイヤールーメン５に入ってしまえば挿入方向へ棒状芯材３を進めることが可能となる。ニードル状器具１１によりバルーンカテーテル遠位端４を持ち上げたままではガイドワイヤールーメン内の形状の変形により棒状芯材３の挿入に対して抵抗が生じる可能性がある。そのため、挿入抵抗を下げるべく棒状芯材３の挿入を進める前にニードル状器具１１を一旦外す。
When the balloon catheter distal end 4 is in contact with the inner wall of the protective tube 2 in FIG. 2b or 2c, the position of the guide wire lumen is uniquely determined. Therefore, the rod-shaped core 3 can be easily inserted into the guide wire lumen 5 as shown in FIG. 2f by advancing the rod-shaped core 3 along the needle-shaped instrument 11 as shown in FIG. 2e.
Once the tip of the rod-shaped core 3 enters the guide wire lumen 5, the rod-shaped core 3 can be advanced in the insertion direction. If the balloon catheter distal end 4 is lifted by the needle-like instrument 11, there is a possibility that resistance to the insertion of the rod-shaped core member 3 may occur due to deformation of the shape in the guide wire lumen. Therefore, the needle-like instrument 11 is temporarily removed before the insertion of the rod-shaped core member 3 is advanced in order to reduce the insertion resistance.
１ バルーンカテーテル
２ 保護管
３ 棒状芯材
４ バルーンカテーテル遠位端
５ ガイドワイヤールーメン
１１ ニードル状器具
DESCRIPTION OF SYMBOLS 1 Balloon catheter 2 Protective tube 3 Rod-shaped core material 4 Balloon catheter distal end 5 Guide wire lumen 11 Needle-shaped instrument
Claims (4)
バルーンカテーテルの遠位端もしくは遠位部と、保護管との間に、ニードル状器具を挿入することによってバルーンカテーテルの遠位端を保護管の内壁に接触させ、接触させた状態で棒状芯材をガイドワイヤールーメンに挿入する、棒状芯材が挿入されたバルーンカテーテルの製造方法。 A balloon catheter is covered with a protective tube, and a rod-shaped core material is inserted into a guide wire lumen.
By inserting a needle-like instrument between the distal end or distal portion of the balloon catheter and the protective tube, the distal end of the balloon catheter is brought into contact with the inner wall of the protective tube, and the rod-shaped core material is in contact with the distal end. A method for manufacturing a balloon catheter in which a rod-shaped core material is inserted, into which a guide wire lumen is inserted.
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| JP2018092264A JP6985208B2 (en) | 2018-05-11 | 2018-05-11 | How to manufacture a balloon catheter with a rod-shaped core inserted |
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| JP2016055165A (en) * | 2014-09-04 | 2016-04-21 | アボット カーディオバスキュラー システムズ インコーポレイテッド | Balloon catheter |
| JP2018015833A (en) * | 2016-07-27 | 2018-02-01 | 株式会社カネカ | Core material insertion jig |
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| JP2008104657A (en) * | 2006-10-25 | 2008-05-08 | Kaneka Corp | Medical balloon catheter |
| JP2016055165A (en) * | 2014-09-04 | 2016-04-21 | アボット カーディオバスキュラー システムズ インコーポレイテッド | Balloon catheter |
| JP2018015833A (en) * | 2016-07-27 | 2018-02-01 | 株式会社カネカ | Core material insertion jig |
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| JP6985208B2 (en) | 2021-12-22 |
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