JP4369700B2 - Catheter balloon and balloon catheter - Google Patents

Catheter balloon and balloon catheter Download PDF

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JP4369700B2
JP4369700B2 JP2003277474A JP2003277474A JP4369700B2 JP 4369700 B2 JP4369700 B2 JP 4369700B2 JP 2003277474 A JP2003277474 A JP 2003277474A JP 2003277474 A JP2003277474 A JP 2003277474A JP 4369700 B2 JP4369700 B2 JP 4369700B2
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balloon
boundary
truncated cone
catheter
surface area
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JP2005040330A (en
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雅彦 眞井
健志 岩野
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Kawasumi Laboratories Inc
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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 the like, and more particularly to a balloon catheter having the balloon for the 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 is caught by 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、バルーン（１１Ｂ）は、管状の中間部（１２Ｍ）の両側に、それぞれ円錐台状の境界部（１２Ｂ）を介して、管状の細径部（１２Ｓ）を形成し、
前記境界部（１２Ｂ）は、前記中間部（１２Ｍ）から前記細径部（１２Ｓ）方向に向けて先細り状に形成され、
前記境界部（１２Ｂ）は、前記細径部（１２Ｓ）方向に向けて傾斜する傾斜部（ＳＬ）を有し、当該傾斜部（ＳＬ）は、前記中間部（１２Ｍ）の最外径を超えないように、前記境界部（１２Ｂ）の外側に向けて突出する段部（Ｄ１）を形成し、当該段部（Ｄ１）により、前記細径部（１２Ｓ）寄りに形成される第１傾斜部（ＳＬ１）と、前記中間部（１２Ｍ）寄りに形成される第２傾斜部（ＳＬ２）とに区分され、前記第１傾斜部（ＳＬ１）の勾配を、
前記第２傾斜部（ＳＬ２）の勾配よりも大きく形成し、
当該境界部（１２Ｂ）は、前記細径部（１２Ｓ）寄りに形成される第１円錐台部（Ｃ１１）と、前記中間部（１２Ｍ）寄りに配置される第２円錐台部（Ｃ１２）とを有する二段円錐台（Ｃ１）状に形成し、
前記境界部（１２Ｂ）の表面積を、前記段部（Ｄ１）を有しないストレートな円錐台状の境界部の表面積：１００に対して、１５０から１８０に形成し、
前記中間部（１２Ｍ）の肉厚：１００に対して、前記境界部（１２Ｂ）の肉厚を（最小）１００から（最大）１５０の間に形成し、かつ肉厚部分の最大値を１２０から１５０に形成した、カテーテル用バルーン（１１Ｂ）を提供する。
［２］本発明は、バルーン（１１Ｃ）は、管状の中間部（１２Ｍ）の両側に、それぞれ円錐台状の境界部（１２Ｂ）を介して、管状の細径部（１２Ｓ）を形成し、
前記境界部（１２Ｂ）は、前記中間部（１２Ｍ）から前記細径部（１２Ｓ）方向に向けて先細り状に形成され、
前記境界部（１２Ｂ）は、前記細径部（１２Ｓ）方向に向けて傾斜する傾斜部（ＳＬ）を有し、当該傾斜部（ＳＬ）は、前記境界部（１２Ｂ）の内側に向けて突出する段部（Ｄ２）を形成し、当該段部（Ｄ２）により、前記細径部（１２Ｓ）寄りに形成される第１傾斜部（ＳＬ１）と、前記中間部（１２Ｍ）寄りに形成される第２傾斜部（ＳＬ２）とに区分され、前記第２傾斜部（ＳＬ２）の勾配を、
前記第１傾斜部（ＳＬ１）の勾配よりも大きく形成し、
当該境界部（１２Ｂ）は、前記細径部（１２Ｓ）寄りに形成される
第１円錐台部（Ｃ２１）と、前記中間部（１２Ｍ）寄りに配置される第２円錐台部（Ｃ２２）とを有する二段円錐台（Ｃ２）状に形成し、
前記境界部（１２Ｂ）の表面積を、前記段部（Ｄ１）を有しないストレートな円錐台状の境界部の表面積：１００に対して、１５０から１８０に形成し、
前記中間部（１２Ｍ）の肉厚：１００に対して、前記境界部（１２Ｂ）の肉厚を（最小）１００から（最大）１５０の間に形成し、かつ肉厚部分の最大値を１２０から１５０に形成した、カテーテル用バルーン（１１Ｃ）を提供する。
［３］本発明は、［１］または［２］に記載のカテーテル用バルーン（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] In the present invention, the balloon (11B) has a tubular small diameter part (12S) formed on both sides of the tubular intermediate part (12M) via a frustoconical boundary part (12B).
The boundary part (12B) is formed in a tapered shape from the intermediate part (12M) toward the narrow diameter part (12S),
The boundary portion (12B) has an inclined portion (SL) inclined toward the narrow diameter portion (12S), and the inclined portion (SL) exceeds the outermost diameter of the intermediate portion (12M). A step portion (D1) that protrudes outward from the boundary portion (12B), and the step portion (D1) forms a first inclined portion that is formed closer to the small diameter portion (12S). (SL1) and the second inclined portion (SL2) formed closer to the intermediate portion (12M), the gradient of the first inclined portion (SL1) is
Forming larger than the gradient of the second inclined portion (SL2);
The boundary portion (12B) includes a first truncated cone portion (C11) formed closer to the narrow diameter portion (12S), and a second truncated cone portion (C12) disposed closer to the intermediate portion (12M). A two-stage truncated cone (C1) having
The surface area of the boundary part (12B) is formed from 150 to 180 with respect to the surface area of the straight frustoconical boundary part having no stepped part (D1): 100,
With respect to the thickness of the intermediate portion (12M): 100, the thickness of the boundary portion (12B) is formed between (minimum) 100 and (maximum) 150, and the maximum value of the thick portion is from 120 A catheter balloon (11B) formed in 150 is provided.
[2] In the present invention, the balloon (11C) has a tubular small diameter part (12S) formed on both sides of the tubular intermediate part (12M) via a frustoconical boundary part (12B).
The boundary part (12B) is formed in a tapered shape from the intermediate part (12M) toward the narrow diameter part (12S),
The boundary part (12B) has an inclined part (SL) inclined toward the narrow diameter part (12S), and the inclined part (SL) protrudes toward the inside of the boundary part (12B). The step portion (D2) is formed, and the step portion (D2) is formed near the first inclined portion (SL1) formed near the narrow diameter portion (12S) and the intermediate portion (12M). It is divided into the second inclined portion (SL2), the gradient of the second inclined portion (SL2),
Forming larger than the gradient of the first inclined portion (SL1);
The boundary portion (12B) is formed closer to the small diameter portion (12S).
Forming a first truncated cone (C21) and a second truncated cone (C2) having a second truncated cone (C22) disposed closer to the intermediate portion (12M),
The surface area of the boundary part (12B) is formed from 150 to 180 with respect to the surface area of the straight frustoconical boundary part having no stepped part (D1): 100,
With respect to the thickness of the intermediate portion (12M): 100, the thickness of the boundary portion (12B) is formed between (minimum) 100 and (maximum) 150, and the maximum value of the thick portion is from 120 A catheter balloon (11C) formed at 150 is provided.
[3] The present invention provides a balloon catheter having the catheter balloon (11B, 11C) according to [1] or [2] .

本発明のバルーン１１Ｂ、１１Ｃは、中間部１２Ｍと細径部との間の境界部１２Ｂ（傾斜部ＳＬ、円錐台部Ｃ１、Ｃ２）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。
The balloons 11B and 11C of the present invention form a large surface area of the boundary portion 12B (inclined portion SL, truncated cone portion C1, C2) between the intermediate portion 12M and the small diameter portion, and form the boundary portion 12B thinly. Therefore, 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２は参考例、図３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、バルーンの外側方向に湾曲するＲ部ＲＯ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 2 are reference examples, and FIGS. 3 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. 1A is a front view, and FIG. 1B is a partially enlarged sectional view of FIG.
Balloon 11 illustrated in Figure 1, the boundary portion 12B between the intermediate portion 12M and the thin portion 12S, a balloon 11 formed in R portion R O curved outside side 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、バルーンの内側方向に湾曲するＲ部ＲＩ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台部Ｃ１、Ｃ２に形成した、バルーン１１Ｂ、１１Ｃである。
図３に示すように、バルーン１１Ｂの境界部１２Ｂは、細径部１２Ｓ方向に向けて傾斜する傾斜部ＳＬを有し、当該傾斜部ＳＬは、中間部１２Ｍの最外径を超えないように、境界部１２Ｂの外側に向けて突出する段部Ｄ１を形成している。
当該段部Ｄ１により、細径部１２Ｓ寄りに形成される第１傾斜部ＳＬ１と、中間部１２Ｍ寄りに形成される第２傾斜部ＳＬ２とに区分され、第１傾斜部ＳＬ１の勾配を、第２傾斜部ＳＬ２の勾配よりも大きく形成している。
二つの円錐台部とは、さらに詳述すれば、図３に示すように細径部１２Ｓ寄りに形成される第１円錐台部Ｃ１１と、中間部１２Ｍ寄りに配置される第２円錐台部Ｃ１２である。
図４に示すように、バルーン１１Ｃの境界部１２Ｂは、細径部１２Ｓ方向に向けて傾斜する傾斜部ＳＬを有し、当該傾斜部ＳＬは、境界部１２Ｂの内側に向けて突出する段部Ｄ２を形成している。
当該段部Ｄ２により、細径部１２Ｓ寄りに形成される第１傾斜部ＳＬ１と、中間部１２Ｍ寄りに形成される第２傾斜部ＳＬ２とに区分され、第２傾斜部ＳＬ２の勾配を、第１傾斜部ＳＬ１の勾配よりも大きく形成している。
二つの円錐台部とは、さらに詳述すれば、図４に示すように細径部１２Ｓ寄りに形成される第１円錐台部Ｃ２１と、中間部１２Ｍ寄りに配置される第２円錐台部Ｃ２２である。
Balloon 11A illustrated in Figure 2, a boundary portion 12B between the intermediate portion 12M and the thin portion 12S, a balloon 11A formed in the R portion R I which is curved in the inner side direction of the balloon.
3, illustrated balloon 11B in FIG. 4, 11C is a boundary portion 12B between the intermediate portion 12M and the thin portion 12S, the two-stage frustum tapering shape toward the middle portion 12M to the small diameter portion 12S direction The balloons 11B and 11C are formed in the parts C1 and C2.
As shown in FIG. 3, the boundary portion 12B of the balloon 11B has an inclined portion SL that is inclined toward the narrow diameter portion 12S, and the inclined portion SL does not exceed the outermost diameter of the intermediate portion 12M. A step portion D1 is formed that protrudes toward the outside of the boundary portion 12B.
The step portion D1 is divided into a first inclined portion SL1 formed closer to the small diameter portion 12S and a second inclined portion SL2 formed closer to the intermediate portion 12M, and the gradient of the first inclined portion SL1 is changed to the first inclined portion SL1. It is formed larger than the gradient of the two inclined portions SL2.
More specifically, the two truncated cone parts are a first truncated cone part C11 formed near the small diameter part 12S and a second truncated cone part arranged near the intermediate part 12M as shown in FIG. C12.
As shown in FIG. 4, the boundary portion 12B of the balloon 11C has an inclined portion SL that is inclined toward the narrow diameter portion 12S, and the inclined portion SL protrudes toward the inside of the boundary portion 12B. D2 is formed.
The step portion D2 is divided into a first inclined portion SL1 formed closer to the small diameter portion 12S and a second inclined portion SL2 formed closer to the intermediate portion 12M, and the gradient of the second inclined portion SL2 is changed to the first inclined portion SL2. 1 slope part SL1 is formed larger than the gradient.
More specifically, the two truncated cone parts are, as shown in FIG. 4, a first truncated cone part C21 formed near the small diameter part 12S and a second truncated cone part arranged near the intermediate part 12M. C22.

［バルーンの表面積と肉厚の関係］
本発明のバルーン１１Ｂ、１１Ｃの境界部１２Ｂ（傾斜部ＳＬ、円錐台部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台部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台部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（傾斜部ＳＬ、円錐台部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、円錐台部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（円錐台部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１１Ａ、Ｂでは、中間部１２Ｍの肉厚：１００に対し、境界部１２Ｂ（傾斜部ＳＬ、円錐台部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]
Balloon 11B of the present invention, 11C of the boundary portion 12B (inclined portion SL, frustoconical portion C1, C2) is the surface area of the surface area of the boundary portion 62B of the balloon 61 of FIG. 5 (simply straight frustoconical portion 62C): 100 On the other hand, it may be formed from 110 to 180, preferably from 150 to 180. Unfavorably not much improvement in folding of the balloon is less than 110 (as compared to the balloon 61 with a straight truncated cone portion 62C of FIG. 5, foldability hardly changes).
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 boundary portion 12B (inclined portion SL, frustoconical portion C1, C2) the surface area of, by increasing formation, the intermediate portion 12M and the boundary portion 12B (R part RO, R unit RI, frustoconical portion C1 , C2) can be made thin.
In balloon 61 in FIG. 5, the thickness of the intermediate portion 62M: to 100, the thickness of the boundary portion 62B (truncated cone portion 62C), which had been formed between the (minimum) 100 from (up to) 250, balloon 11A of the present invention, the B, the thickness of the intermediate portion 12M: to 100, the thickness of the boundary portion 12B (inclined portion SL, frustoconical portion C1, C2) from 120 (minimum) to 100 (maximum) It can be formed as thin as 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).

参考例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 reference example balloon ((A) front view, (B) (A) partially enlarged cross-sectional view of (A)) 参考例のバルーンの概略図（正面図）Schematic diagram of a reference example balloon (front 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 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（内側に湾曲するＲ部）
ＲＯ Ｒ部（外側に湾曲するＲ部）
Ｃ１、Ｃ２ 円錐台部（二段円錐台部）
Ｃ１１、Ｃ２１ 第１円錐台部
Ｃ２１、Ｃ２２ 第２円錐台部
Ｄ１ 段部
Ｄ２ 段部

ＳＬ 傾斜部
ＳＬ１ 第１傾斜部
ＳＬ２ 第２傾斜部
11, 11A, 11B, 11C
Catheter balloon (balloon)
12B Boundary part 12M Intermediate part 12S Small diameter part RI R part (R part curved inward )
RO R part (R part curved outward )
C1, C2 frustoconical portion (two-stage truncated cone portion)
C11, C21 first truncated cone part C21, C22 second truncated cone part D1 step part D2 step part

SL inclined part
SL1 1st inclined part
SL2 second inclined part

Claims (3)

バルーン（１１Ｂ）は、管状の中間部（１２Ｍ）の両側に、それぞれ円錐台状の境界部（１２Ｂ）を介して、管状の細径部（１２Ｓ）を形成し、The balloon (11B) forms a tubular small diameter part (12S) on both sides of the tubular intermediate part (12M) via a frustoconical boundary part (12B).
前記境界部（１２Ｂ）は、前記中間部（１２Ｍ）から前記細径部（１２Ｓ）方向に向けて先細り状に形成され、The boundary portion (12B) is formed in a tapered shape from the intermediate portion (12M) toward the narrow diameter portion (12S),
前記境界部（１２Ｂ）は、前記細径部（１２Ｓ）方向に向けて傾斜する傾斜部（ＳＬ）を有し、当該傾斜部（ＳＬ）は、前記中間部（１２Ｍ）の最外径を超えないように、前記境界部（１２Ｂ）の外側に向けて突出する段部（Ｄ１）を形成し、当該段部（Ｄ１）により、前記細径部（１２Ｓ）寄りに形成される第１傾斜部（ＳＬ１）と、前記中間部（１２Ｍ）寄りに形成される第２傾斜部（ＳＬ２）とに区分され、前記第１傾斜部（ＳＬ１）の勾配を、The boundary portion (12B) has an inclined portion (SL) inclined toward the narrow diameter portion (12S), and the inclined portion (SL) exceeds the outermost diameter of the intermediate portion (12M). A step portion (D1) that protrudes outward from the boundary portion (12B), and the step portion (D1) forms a first inclined portion that is formed closer to the small diameter portion (12S). (SL1) and the second inclined portion (SL2) formed closer to the intermediate portion (12M), the gradient of the first inclined portion (SL1) is
前記第２傾斜部（ＳＬ２）の勾配よりも大きく形成し、Forming larger than the gradient of the second inclined portion (SL2);
当該境界部（１２Ｂ）は、前記細径部（１２Ｓ）寄りに形成される第１円錐台部（Ｃ１１）と、前記中間部（１２Ｍ）寄りに配置される第２円錐台部（Ｃ１２）とを有する二段円錐台（Ｃ１）状に形成し、The boundary portion (12B) includes a first truncated cone portion (C11) formed closer to the narrow diameter portion (12S), and a second truncated cone portion (C12) disposed closer to the intermediate portion (12M). A two-stage truncated cone (C1) having
前記境界部（１２Ｂ）の表面積を、前記段部（Ｄ１）を有しないストレートな円錐台状の境界部の表面積：１００に対して、１５０から１８０に形成し、The surface area of the boundary part (12B) is formed from 150 to 180 with respect to the surface area of the straight frustoconical boundary part having no step part (D1): 100,
前記中間部（１２Ｍ）の肉厚：１００に対して、前記境界部（１２Ｂ）の肉厚を（最小）１００から（最大）１５０の間に形成し、かつ肉厚部分の最大値を１２０から１５０に形成した、ことを特徴とするカテーテル用バルーン（１１Ｂ）。With respect to the thickness of the intermediate portion (12M): 100, the thickness of the boundary portion (12B) is formed between (minimum) 100 and (maximum) 150, and the maximum value of the thick portion is from 120 150, a balloon for catheter (11B). バルーン（１１Ｃ）は、管状の中間部（１２Ｍ）の両側に、それぞれ円錐台状の境界部（１２Ｂ）を介して、管状の細径部（１２Ｓ）を形成し、The balloon (11C) forms a tubular small diameter portion (12S) on both sides of the tubular intermediate portion (12M) via a frustoconical boundary portion (12B).
前記境界部（１２Ｂ）は、前記中間部（１２Ｍ）から前記細径部（１２Ｓ）方向に向けて先細り状に形成され、The boundary portion (12B) is formed in a tapered shape from the intermediate portion (12M) toward the narrow diameter portion (12S),
前記境界部（１２Ｂ）は、前記細径部（１２Ｓ）方向に向けて傾斜する傾斜部（ＳＬ）を有し、当該傾斜部（ＳＬ）は、前記境界部（１２Ｂ）の内側に向けて突出する段部（Ｄ２）を形成し、当該段部（Ｄ２）により、前記細径部（１２Ｓ）寄りに形成される第１傾斜部（ＳＬ１）と、前記中間部（１２Ｍ）寄りに形成される第２傾斜部（ＳＬ２）とに区分され、前記第２傾斜部（ＳＬ２）の勾配を、The boundary part (12B) has an inclined part (SL) inclined toward the narrow diameter part (12S), and the inclined part (SL) protrudes toward the inside of the boundary part (12B). The step portion (D2) is formed, and the step portion (D2) is formed near the first inclined portion (SL1) formed near the narrow diameter portion (12S) and the intermediate portion (12M). It is divided into the second inclined portion (SL2), the gradient of the second inclined portion (SL2),
前記第１傾斜部（ＳＬ１）の勾配よりも大きく形成し、Forming larger than the gradient of the first inclined portion (SL1);
当該境界部（１２Ｂ）は、前記細径部（１２Ｓ）寄りに形成されるThe boundary portion (12B) is formed closer to the small diameter portion (12S).
第１円錐台部（Ｃ２１）と、前記中間部（１２Ｍ）寄りに配置される第２円錐台部（Ｃ２２）とを有する二段円錐台（Ｃ２）状に形成し、Forming a first truncated cone (C21) and a second truncated cone (C2) having a second truncated cone (C22) disposed near the intermediate portion (12M);
前記境界部（１２Ｂ）の表面積を、前記段部（Ｄ１）を有しないストレートな円錐台状の境界部の表面積：１００に対して、１５０から１８０に形成し、The surface area of the boundary part (12B) is formed from 150 to 180 with respect to the surface area of the straight frustoconical boundary part having no stepped part (D1): 100,
前記中間部（１２Ｍ）の肉厚：１００に対して、前記境界部（１２Ｂ）の肉厚を（最小）１００から（最大）１５０の間に形成し、かつ肉厚部分の最大値を１２０から１５０に形成した、With respect to the thickness of the intermediate portion (12M): 100, the thickness of the boundary portion (12B) is formed between (minimum) 100 and (maximum) 150, and the maximum value of the thick portion is from 120 150,
ことを特徴とするカテーテル用バルーン（１１Ｃ）。A catheter balloon (11C) characterized by the above. 請求項１または請求項２に記載のカテーテル用バルーン（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 (11B, 11C) according to claim 1 or 2.
JP2003277474A 2003-07-22 2003-07-22 Catheter balloon and balloon catheter Expired - Fee Related JP4369700B2 (en)

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US5254091A (en) * 1991-01-08 1993-10-19 Applied Medical Resources Corporation Low profile balloon catheter and method for making same
US5733301A (en) * 1996-01-11 1998-03-31 Schneider (Usa) Inc. Laser ablation of angioplasty catheters and balloons
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