JP2005040330A - Balloon for catheter and balloon catheter - Google Patents

Balloon for catheter and balloon catheter Download PDF

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JP2005040330A
JP2005040330A JP2003277474A JP2003277474A JP2005040330A JP 2005040330 A JP2005040330 A JP 2005040330A JP 2003277474 A JP2003277474 A JP 2003277474A JP 2003277474 A JP2003277474 A JP 2003277474A JP 2005040330 A JP2005040330 A JP 2005040330A
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balloon
catheter
boundary
small diameter
conical
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JP4369700B2 (en
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Masahiko Mai
雅彦 眞井
Kenji Iwano
健志 岩野
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SB Kawasumi Laboratories Inc
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Kawasumi Laboratories Inc
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a balloon and a balloon catheter having an enhanced passing performance through a blood vessel or a blood vessel stenosis part by enhancing foldability. <P>SOLUTION: In the balloon 11 for the catheter in which border portions 12B between a middle portion 12M and narrow small diameter portions 12S is formed in the R portions (RI) bent in an inner side direction of the balloon. The surface area of the above border portion 12B R portions (RI) is formed to 110 to 180 relative to the surface 100 of the simple straight conical-shaped border portions. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

本発明は、例えば経皮的冠状動脈血管形成術(PTCA)等に使用するバルーンカテーテルを構成するカテーテル用バルーン及び該カテーテル用バルーンを有するバルーンカテーテルに関するもので、特にバルーンの形態を改良したカテーテル用バルーンの発明に関する。本発明のカテーテル用バルーンは、本発明の目的を達成できるものであればバルーンを有する全てのカテーテルに適用することができる。   The present invention relates to a balloon for a catheter constituting a balloon catheter used for, for example, percutaneous coronary artery angioplasty (PTCA), and a balloon catheter having the balloon for a catheter. The present invention relates to a balloon invention. The catheter balloon of the present invention can be applied to all catheters having a balloon as long as the object of the present invention can be achieved.

図5は従来のカテーテル用バルーン61(以下、バルーン61と略記する)の概略図((A)正面図、(B)(A)の一部拡大断面図)である。
図5のバルーン61は中間部62Mと細径部62S間の境界部62Bを、円錐部62Cに形成している。通常、これらのバルーン61はブロー成形により加工を行うため、図5(B)の様に、中間部62Mから境界部62B(円錐部62C)を経て細径部62Sへ向けて、その先端及び末端が肉厚となるように形成されている。
バルーン61はラッピング(三つ折もしくは四つ折)を行う為、バルーン61の先端及び末端(境界部62Bと細径部62S)の肉厚が厚くなるとラッピングがしずらい。さらにリラップ性も悪くなる。
さらにバルーン61をラッピングするとき、単なるストレートな円錐形状(円錐部62C)では、折りたたみ性が悪く、血管内にバルーンを折りたたんで挿入したとき、円錐部62Cよりバルーンの一部が若干膨らんでしまう傾向があった。この膨張部が血管内を通過するときに血管内壁面に引っかかってしまうため、バルーンの血管通過性が悪かった。また血管が完全に狭窄している場合、バルーン61を膨らませながら、狭窄部の通過させるが、前記円錐部62Cが通過時の抵抗になるため、狭窄部通過性も悪かった。
FIG. 5 is a schematic view ((A) front view, (B) (A) partially enlarged cross-sectional view) of a conventional catheter balloon 61 (hereinafter abbreviated as balloon 61).
In the balloon 61 of FIG. 5, a boundary portion 62B between the intermediate portion 62M and the small diameter portion 62S is formed in the conical portion 62C. Usually, since these balloons 61 are processed by blow molding, as shown in FIG. 5B, from the intermediate part 62M to the small diameter part 62S through the boundary part 62B (conical part 62C), the tip and end thereof Is formed to be thick.
Since the balloon 61 is lapped (three folds or four folds), it is difficult to wrap the balloon 61 when the tip and end (boundary portion 62B and small diameter portion 62S) of the balloon 61 are thick. In addition, the rewrap property is also deteriorated.
Further, when wrapping the balloon 61, the mere straight conical shape (the conical portion 62C) is not foldable, and when the balloon is folded and inserted into the blood vessel, a part of the balloon tends to be slightly inflated from the conical portion 62C. was there. When this inflated part passes through the inside of the blood vessel, it catches on the inner wall surface of the blood vessel, so that the blood vessel passing through the balloon is bad. Further, when the blood vessel is completely stenotic, the balloon 61 is allowed to pass through the stenotic part while inflating, but the conical part 62C becomes resistance when passing, so that the stenotic part passing property is poor.

特許文献1には、図面中に単に、バルーンの両端部をR状に形成したバルーンカテーテルの発明が記載されているが、バルーンの表面積、肉厚及びこれらとラッピングの関係については、何ら記載ないし示唆されていない。
特許文献2には、バルーンの境界部(円錐部)の表面積を、従来よりも小さくして、折りたたみ性、血管内の通過性を改良した発明が記載されているが、
バルーンの肉厚及びラッピングとの関係については、何ら記載ないし示唆されていない。
Patent Document 1 describes an invention of a balloon catheter in which both ends of a balloon are simply formed in an R shape in the drawing. However, there is no description about the surface area of the balloon, the wall thickness, and the relationship between the balloon and the wrapping. Not suggested.
Patent Document 2 describes an invention in which the surface area of the boundary portion (conical portion) of the balloon is made smaller than before, and the folding property and the passage through the blood vessel are improved.
There is no description or suggestion regarding the relationship between balloon thickness and wrapping.

特開平11−262527号公報(図1、3から5)JP-A-11-262527 (FIGS. 1, 3 to 5) 特開2002−263193号公報(図1、3、4)JP 2002-263193 (FIGS. 1, 3, and 4)

解決しようとする問題点は、バルーンの折りたたみ性が悪いため、ラッピングがしずらく、リラップ性が悪い点、さらに血管通過性、狭窄部通過性が悪い点である。   The problem to be solved is that the balloon is poorly folded, so that it is difficult to wrap, the rewrap property is poor, and the blood vessel passage property and the stenosis portion passage property are bad.

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、中間部(12M)と細径部(12S)間の境界部(12B)を、バルーンの内側方向に湾曲するR部(RI)に形成したカテーテル用バルーン(11)を提供する。
[2]本発明は、中間部(12M)と細径部(12S)間の境界部(12B)を、バルーンの外側方向に湾曲するR部(RO)に形成したカテーテル用バルーン(11A)を提供する。
[3]本発明は、中間部(12M)と細径部(12S)間の境界部(12B)を、中間部(12M)から細径部(12S)方向に向けて先細り状になった二段円錐部(C1、C2)に形成したカテーテル用バルーン(11B、11C)を提供する。
[4]本発明は、前記境界部(12B)(R部(RO)、R部(RI)、円錐部(C1、C2))の表面積を、単にストレートな円錐状の境界部の表面積:100に対して、110から180に形成した[1]ないし[3]に記載のカテーテル用バルーン(11、11A、11B、11C)を提供する。
[5]本発明は、前記中間部(12M)の肉厚:100に対して、境界部(12B)(R部(RO)、R部(RI)、円錐部(C1、C2))の肉厚を(最小)100から(最大)150の間に形成した[1]ないし[4]に記載のカテーテル用バルーン(11、11A、11B、11C)を提供する。
[6]本発明は、[1]ないし[5]に記載のカテーテル用バルーン(11、11A、11B、11C)を有するバルーンカテーテルを提供する。
Therefore, as a result of intensive studies to solve the above problems, the present inventor has reached the following invention.
[1] The present invention provides a catheter balloon (11) in which a boundary portion (12B) between an intermediate portion (12M) and a small diameter portion (12S) is formed in an R portion (RI) that curves inward of the balloon. provide.
[2] The present invention provides a catheter balloon (11A) in which a boundary part (12B) between the intermediate part (12M) and the small diameter part (12S) is formed in an R part (RO) that curves outward of the balloon. provide.
[3] In the present invention, the boundary portion (12B) between the intermediate portion (12M) and the small diameter portion (12S) is tapered from the intermediate portion (12M) toward the small diameter portion (12S). Provided are balloons for catheters (11B, 11C) formed in stepped cones (C1, C2).
[4] In the present invention, the surface area of the boundary part (12B) (R part (RO), R part (RI), conical part (C1, C2)) is simply the surface area of the straight conical boundary part: 100. In contrast, the catheter balloons (11, 11A, 11B, 11C) according to [1] to [3] formed from 110 to 180 are provided.
[5] In the present invention, the thickness of the intermediate part (12M) is 100, and the boundary part (12B) (R part (RO), R part (RI), conical part (C1, C2)) The catheter balloon (11, 11A, 11B, 11C) according to [1] to [4], having a thickness between (minimum) 100 and (maximum) 150, is provided.
[6] The present invention provides a balloon catheter having the catheter balloon (11, 11A, 11B, 11C) according to [1] to [5].

本発明のバルーン11、11A、11B、11Cは、中間部12Mと細径部12S間の境界部12Bを、(1)バルーンの内側方向に湾曲するR部RIに形成するかまたは、(2)バルーンの外側方向に湾曲するR部ROに形成するかまたは、(3)中間部12Mから細径部12S方向に向けて先細り状になった二段円錐部C1、C2に形成することにより、境界部12Bの表面積を大きく形成し、境界部12Bを肉薄に形成することができるので、折りたたみ性が良くなり、血管内または血管狭窄部の通過性が向上する。   In the balloons 11, 11A, 11B, and 11C of the present invention, the boundary portion 12B between the intermediate portion 12M and the small diameter portion 12S is either (1) formed in the R portion RI that is curved in the balloon inner direction, or (2) By forming it in the R portion RO that curves in the outward direction of the balloon, or (3) by forming it in the two-stage conical portions C1 and C2 that are tapered from the intermediate portion 12M toward the small diameter portion 12S. Since the surface area of the portion 12B can be formed large and the boundary portion 12B can be formed thin, the foldability is improved and the passage through the blood vessel or the blood vessel stenosis is improved.

[バルーンの形状]
図1から図4は本発明の一例を示すカテーテル用バルーン11、11A、11B、11C(以下、バルーン11、11A、11B、11Cと略記する)の概略図(図1の(A)は正面図、(B)は(A)の一部拡大断面図)である。
図1に例示したバルーン11は、中間部12Mと細径部12S間の境界部12Bを、バルーンの内側方向に湾曲するR部RIに形成したバルーン11である。
以上のように境界部12BをR部に形成することにより、境界部12Bの表面積を大きくでき、境界部12Bの肉厚も薄くできる。このためバルーン11が折りたたみやすくなり、折りたたみ性が向上する。
また図2から4に例示したバルーン11A、11B、11Cも図1に例示したバルーン11と同様に、境界部12Bの表面積を大きくし、境界部12Bの肉厚を薄くすることにより、バルーン11A、11B、11Cを折りたたみやすくし、折りたたみ性を向上させたものである。
[Balloon shape]
1 to 4 are schematic views of catheter balloons 11, 11A, 11B, and 11C (hereinafter abbreviated as balloons 11, 11A, 11B, and 11C) showing an example of the present invention (FIG. 1A is a front view). , (B) is a partially enlarged sectional view of (A).
The balloon 11 illustrated in FIG. 1 is a balloon 11 in which a boundary portion 12B between the intermediate portion 12M and the small diameter portion 12S is formed in an R portion RI that curves in the inner direction of the balloon.
By forming the boundary portion 12B in the R portion as described above, the surface area of the boundary portion 12B can be increased, and the wall thickness of the boundary portion 12B can be reduced. For this reason, the balloon 11 becomes easy to fold and the foldability is improved.
In addition, the balloons 11A, 11B, and 11C illustrated in FIGS. 2 to 4 have the same surface area as that of the balloon 11 illustrated in FIG. 11B and 11C are made easy to fold and the foldability is improved.

図2に例示したバルーン11Aは、中間部12Mと細径部12S間の境界部12Bを、バルーンの外側方向に湾曲するR部ROに形成したバルーン11Aである。
図3、図4に例示したバルーン11B、11Cは、中間部12Mと細径部12S間の境界部12Bを、中間部12Mから細径部12S方向に向けて先細り状になった二段円錐部C1、C2に形成した、バルーン11B、11Cである。
バルーン11Bの二段円錐部C1は、図1のバルーン11の内側方向に湾曲するR部RIに段部D1を形成し、二つの円錐部より形成したものである。このため段部D1はバルーン11Bの外側方向に突出している。
バルーン11Cの二段円錐部C2は、図2のバルーン11Aの外側方向に湾曲するR部ROに段部D2を形成し、二つの円錐部より形成したものである。このため段部D2はバルーン11Cの内側方向に窪んでいる。
The balloon 11A illustrated in FIG. 2 is a balloon 11A in which a boundary portion 12B between the intermediate portion 12M and the small diameter portion 12S is formed in an R portion RO that curves in the outward direction of the balloon.
The balloons 11B and 11C illustrated in FIGS. 3 and 4 have a two-stage conical portion in which a boundary portion 12B between the intermediate portion 12M and the small diameter portion 12S is tapered from the intermediate portion 12M toward the small diameter portion 12S. Balloons 11B and 11C formed on C1 and C2.
The two-stage conical portion C1 of the balloon 11B is formed by forming a step portion D1 in the R portion RI curved in the inner direction of the balloon 11 in FIG. For this reason, the step part D1 protrudes in the outward direction of the balloon 11B.
The two-stage conical portion C2 of the balloon 11C is formed by forming a step portion D2 in the R portion RO that curves in the outward direction of the balloon 11A in FIG. Therefore, the step portion D2 is recessed in the inner direction of the balloon 11C.

[バルーンの表面積と肉厚の関係]
本発明のバルーン11、11A、B、Cの境界部12B(R部RO、R部RI、円錐部C1、C2)の表面積は、図5のバルーン61の境界部62B(単にストレートな円錐部62C)の表面積:100に対し、110から180、好ましくは150から180に形成するのが良い。110未満ではバルーンの折りたたみ性の改善効果があまりないので好ましくない(図5のストレートな円錐部62Cを有するバルーン61と比較して、折りたたみ性はほとんど変わらない)。
他方、180を超えると表面積が多くなりすぎでバルーンの加工性が低下するので好ましくない。
以上のように、境界部12B(R部RO、R部RI、円錐部C1、C2)の表面積を、大きく形成することにより、中間部12Mと境界部12B(R部RO、R部RI、円錐部C1、C2)の肉厚を、薄肉にすることができる。
図5のバルーン61では、中間部62Mの肉厚:100に対し、境界部62B(円錐部62C)の肉厚は、(最小)100から(最大)250の間に形成されていたが、本発明のバルーン11、11A、B、Cでは、中間部12Mの肉厚:100に対し、境界部12B(R部RO、R部RI、円錐部C1、C2)の肉厚は、(最小)100から(最大)120から150の間とかなり薄く形成することができる。特に肉厚の最大値を、従来のバルーン61(最大値:250)に対して、120から150と大幅に小さく形成することができる。
[Relationship between balloon surface area and wall thickness]
The surface area of the boundary portion 12B (R portion RO, R portion RI, conical portion C1, C2) of the balloons 11, 11A, B, C of the present invention is equal to the boundary portion 62B (simply straight conical portion 62C) of the balloon 61 of FIG. ) Surface area: 100 to 110, preferably 150 to 180. If it is less than 110, there is not much improvement effect of the foldability of the balloon, which is not preferable (the foldability is hardly changed as compared with the balloon 61 having the straight conical portion 62C in FIG. 5).
On the other hand, if it exceeds 180, the surface area becomes too large and the workability of the balloon is lowered, which is not preferable.
As described above, the intermediate portion 12M and the boundary portion 12B (R portion RO, R portion RI, cone) are formed by increasing the surface area of the boundary portion 12B (R portion RO, R portion RI, cone portion C1, C2). The thickness of the parts C1, C2) can be reduced.
In the balloon 61 of FIG. 5, the thickness of the boundary 62B (cone 62C) is formed between (minimum) 100 and (maximum) 250, whereas the thickness of the intermediate portion 62M is 100. In the balloons 11, 11A, B, and C of the invention, the thickness of the boundary portion 12B (R portion RO, R portion RI, conical portion C1, C2) is (minimum) 100 while the thickness of the intermediate portion 12M is 100. To (maximum) between 120 and 150. In particular, the maximum value of the wall thickness can be significantly reduced from 120 to 150 with respect to the conventional balloon 61 (maximum value: 250).

本発明のバルーンの概略図((A)正面図、(B)(A)の一部拡大断面図)Schematic of the balloon of the present invention ((A) front view, (B) (A) partially enlarged sectional view) 本発明のバルーンの概略図(正面図)Schematic (front view) of the balloon of the present invention 本発明のバルーンの概略図(正面図)Schematic (front view) of the balloon of the present invention 本発明のバルーンの概略図(正面図)Schematic (front view) of the balloon of the present invention 従来のバルーンの概略図((A)正面図、(B)(A)の一部拡大断面図)Schematic diagram of a conventional balloon ((A) front view, (B) (A) partially enlarged cross-sectional view of (A))

符号の説明Explanation of symbols

11、11A、11B、11C カテーテル用バルーン(バルーン)
12B 境界部
12M 中間部
12S 細径部
RI R部(内側湾曲)
RO R部(外側湾曲)
C1、C2 円錐部(二段円錐部)
D1 段部
D2 段部
11, 11A, 11B, 11C Balloon for catheter (balloon)
12B Boundary part 12M Intermediate part 12S Small diameter part RI R part (inner curve)
RO R (curved outside)
C1, C2 Conical part (two-stage conical part)
D1 Step D2 Step

Claims (6)

中間部(12M)と細径部(12S)間の境界部(12B)を、バルーンの内側方向に湾曲するR部(RI)に形成した、ことを特徴とするカテーテル用バルーン(11)。   A catheter balloon (11) characterized in that a boundary portion (12B) between the intermediate portion (12M) and the small diameter portion (12S) is formed in an R portion (RI) that is curved inward of the balloon. 中間部(12M)と細径部(12S)間の境界部(12B)を、バルーンの外側方向に湾曲するR部(RO)に形成した、ことを特徴とするカテーテル用バルーン(11A)。   A balloon for catheter (11A), characterized in that a boundary portion (12B) between the intermediate portion (12M) and the small diameter portion (12S) is formed in an R portion (RO) that is curved outward of the balloon. 中間部(12M)と細径部(12S)間の境界部(12B)を、中間部(12M)から細径部(12S)方向に向けて先細り状になった二段円錐部(C1、C2)に形成した、ことを特徴とするカテーテル用バルーン(11B、11C)。   A two-stage conical portion (C1, C2) in which a boundary portion (12B) between the intermediate portion (12M) and the small diameter portion (12S) is tapered from the intermediate portion (12M) toward the small diameter portion (12S). The catheter balloon (11B, 11C), characterized in that it is formed in a). 前記境界部(12B)(R部(RO)、R部(RI)、円錐部(C1、C2))の表面積を、単にストレートな円錐状の境界部の表面積:100に対して、110から180に形成した、ことを特徴とする請求項1ないし請求項3に記載のカテーテル用バルーン(11、11A、11B、11C)。   The surface area of the boundary part (12B) (R part (RO), R part (RI), conical part (C1, C2)) is 110 to 180 with respect to the surface area of the straight conical boundary part: 100. The catheter balloon (11, 11A, 11B, 11C) according to any one of claims 1 to 3, wherein the balloon is used. 前記中間部(12M)の肉厚:100に対して、境界部(12B)(R部(RO)、R部(RI)、円錐部(C1、C2))の肉厚を(最小)100から(最大)150の間に形成した、ことを特徴とする請求項1ないし請求項4に記載のカテーテル用バルーン(11、11A、11B、11C)。   The thickness of the intermediate part (12M): 100, and the thickness of the boundary part (12B) (R part (RO), R part (RI), conical part (C1, C2)) from (minimum) 100 The catheter balloon (11, 11 A, 11 B, 11 C) according to claim 1, wherein the balloon is formed between (maximum) 150. 請求項1ないし請求項5に記載のカテーテル用バルーン(11、11A、11B、11C)を有する、ことを特徴とするバルーンカテーテル。   A balloon catheter comprising the catheter balloon (11, 11A, 11B, 11C) according to any one of claims 1 to 5.
JP2003277474A 2003-07-22 2003-07-22 Catheter balloon and balloon catheter Expired - Fee Related JP4369700B2 (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107847719A (en) * 2015-07-28 2018-03-27 奥林巴斯株式会社 Treatment instrument for endoscope
CN112203712A (en) * 2018-07-09 2021-01-08 株式会社戈德曼 Balloon catheter

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JPH06508532A (en) * 1991-01-08 1994-09-29 アプライド メディカル リソーセス コーポレイション Low profile balloon catheter and its manufacturing method
JPH09192227A (en) * 1996-01-11 1997-07-29 Schneider Usa Inc Catheter for forming blood vessel, and removing and shaping balloon using laser
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CN107847719A (en) * 2015-07-28 2018-03-27 奥林巴斯株式会社 Treatment instrument for endoscope
CN112203712A (en) * 2018-07-09 2021-01-08 株式会社戈德曼 Balloon catheter
CN112203712B (en) * 2018-07-09 2023-11-07 株式会社戈德曼 balloon catheter

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