JP2008253800A - バルーンカテーテル用高強度低コンプライアンス複合バルーン - Google Patents
バルーンカテーテル用高強度低コンプライアンス複合バルーン Download PDFInfo
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- JP2008253800A JP2008253800A JP2008163541A JP2008163541A JP2008253800A JP 2008253800 A JP2008253800 A JP 2008253800A JP 2008163541 A JP2008163541 A JP 2008163541A JP 2008163541 A JP2008163541 A JP 2008163541A JP 2008253800 A JP2008253800 A JP 2008253800A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1084—Balloon catheters with special features or adapted for special applications having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
- A61M25/0052—Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Hematology (AREA)
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- Engineering & Computer Science (AREA)
- Vascular Medicine (AREA)
- Biomedical Technology (AREA)
- Child & Adolescent Psychology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Materials For Medical Uses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Braiding, Manufacturing Of Bobbin-Net Or Lace, And Manufacturing Of Nets By Knotting (AREA)
- Woven Fabrics (AREA)
Abstract
【解決手段】バルーンは、拘束構造部材が固定されたエラストマー外皮を備えている。拘束構造部材により、萎んだときの直径であるDdeflと膨張したときの直径であるDinflとの間で、径方向に膨張する。最小膨張圧を、選択されたエラストマーのDinflとDinflに基づいて算出できる。
【選択図】図1
Description
Esec =σ(εinfl)/εinfl
で規定される正割モジュラスEsecを有し、ここで、σ(εinfl)は、εinflの関数として、エラストマーの名目の単軸応力であり、
εinfl=Dinfl/Ddefl
である。
(P・Ddefl)/(2Esec・t)≧1
で規定される。
エラストマー外皮が取付けられると、外皮が、いくらか、中立角に再配向する繊維の能力を妨害する。その結果、過去においては、バルーンが完全に膨張した時を決定すること、より詳細には、エラストマーに求められる弾性を予測し、そのようなエラストマーが、再配向している繊維にネガティブ(消極的)に衝撃を与える(作用する)ことなしに、適当に膨張させることは困難であった。
さらに、補強材は、3層の螺旋状の延びるフィラメントを含んで、内側の層と外側の層が同じ方向に巻き付けられ、中間層が、反対方向に巻き付けられるとともに二倍の厚さを有するものでもよい。
上記の複層構造のいずれの場合にも、螺旋は、層間の仮想中間面に対して釣り合うように構成されている。
J=(P・Ddefl)/(2Esec・t)≧1
ここで、Pは単位MPaで表されたの内部作動圧、Ddef1は単位mmで表された膨張していないバルーンの直径、tは単位mmで表されたバルーン外皮の厚さ、そして、Esecはエラストマーの正割モジュラス(secant modules)である。
Esec =σ(εinfl)/εinfl
ここで、σ(εinfl)は、εinflの関数として、エラストマーの通常の単軸テンションであり、そして、
εinfl=Dinfl/Ddefl
ここで、Dieflは膨張したバルーンの所定最大膨張直径であり、Ddef1は膨張していないバルーンの内径である。
もし、マトリクス材料が、2以上のエラストマー、例えばNエラストマーなら、正割モジュラスは、下記の等式に基づいて計算される:
バルーンカテーテルは、膜厚tが0.2mmであり、1.6MPaのEsec、Ddeflが1.58mm、Dinflが9.8mmのJ基準を有する。繊維は、破断伸び(elongation to break)が3%未満である。1.2MPaの作動圧が提案されている。
(P・1.58)/(2・1.6・0.2)≧1、 P=0.4MPa
したがって、提案されている作動圧1.2MPaでは、完全に膨張し且つ従順でないバルーンとなる。上記バルーンの膨張特性すなわち直径対Jを、図6に示す。0.4MPaに対応するJ≧1では、完全直径は5%内で達成されることが判る。J基準にしたがって、0.4MPaから1.2MPaの範囲の作動圧をラベル(提案)し、この範囲内での非従順性を主張(明示)することは意味がある。
12 内側チューブ
14 外側チューブ
18 ルーメン(管腔)
20 膨張ルーメン
22 バルーン
24 エラストマー外皮
26 拘束構造部材
28 維(ファイバ)
Claims (9)
- カテーテルを固定するためのバルーンであって、膜厚がtであり、内部に加えられる最小作動圧Pによって、膨張していない直径Ddeflか膨張した直径Dinflまで膨張する、中空の圧力膨張可能なエラストマー本体を備え、該エラストマー本体が、
Esec =σ(εinfl)/εinfl
正割モジュラスEsecを有し、ここで、σ(εinfl)は、εinflの関数として、エラストマー本体の名目の単軸応力であり、
εinfl=Dinfl/Ddefl
であり、且つ、
前記バルーンは、前記エラストマー本体に付けられた非伸縮性の膨張可能な拘束構造部材を備え、前記拘束構造部材は、10%未満の破断伸びと1GPaより大きい引っ張り強度を有し、アラミド、ポリエチレン、鋼、ポリエステル、ガラス、カーボン、セラミックス、及び液晶ポリマからなるグループから選択された繊維で形成され、該拘束構造部材は、前記エラストマー本体の膨張を最大直径Dinf1に制限し、前記エラストマー本体をDinf1を越えない直径まで膨張させるのに必要な前記最小作動圧Pが、等式
J=(P・Ddefl)/(2Esec・t)≧1
で規定されるバルーン。 - 前記拘束構造部材が、前記エラストマー本体内にもたらされる捩れモーメントと釣り合うように位置決めされた、複数の螺旋状に渦巻く層を備えている請求項1記載のバルーン。
- 前記螺旋状に渦巻く層が、前記層の間の仮想中間面に対して、対称に配置されている請求項2記載のバルーン。
- 前記拘束構造部材が、螺旋状に延びる内側層および外側層と、螺旋状に延びる2つの中間層を備え、前記内側層および外側層が、一の方向に巻かれ、前記中間層が反対方向に巻かれている請求項3記載のバルーン。
- 前記拘束構造部材が、螺旋状に延びる内側層、外側層、および、中間層を備え、
前記内側層および外側層の巻き方向が、前記中間層の巻き方向とは、反対方向であり、前記中間層の厚さが、前記内側層および前記外側層の厚さの2倍である請求項2記載のバルーン。 - 前記拘束構造部材が、繊維を組み、編み、又は織ることにより形成された単一層を備えている請求項1記載のバルーン。
- 前記拘束構造部材が、前記繊維を組むことによって形成された単一層である請求項4記載のバルーン。
- ASTM D412−87に従って測定したとき、500%伸びで、Esecが7MPaである請求項1記載のバルーン。
- 前記繊維が液晶ポリマから形成されている請求項1記載のバルーン。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/487,177 US5647848A (en) | 1995-06-07 | 1995-06-07 | High strength low compliance composite balloon for balloon catheters |
US08/487,177 | 1995-06-07 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP9501711A Division JPH11507257A (ja) | 1995-06-07 | 1996-06-07 | バルーンカテーテル用高強度低コンプライアンス複合バルーン |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2008253800A true JP2008253800A (ja) | 2008-10-23 |
JP5149711B2 JP5149711B2 (ja) | 2013-02-20 |
Family
ID=23934718
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP9501711A Pending JPH11507257A (ja) | 1995-06-07 | 1996-06-07 | バルーンカテーテル用高強度低コンプライアンス複合バルーン |
JP2008163541A Expired - Lifetime JP5149711B2 (ja) | 1995-06-07 | 2008-06-23 | バルーンカテーテル用高強度低コンプライアンス複合バルーンの製造方法 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP9501711A Pending JPH11507257A (ja) | 1995-06-07 | 1996-06-07 | バルーンカテーテル用高強度低コンプライアンス複合バルーン |
Country Status (8)
Country | Link |
---|---|
US (1) | US5647848A (ja) |
EP (1) | EP0836503B1 (ja) |
JP (2) | JPH11507257A (ja) |
AT (1) | ATE216905T1 (ja) |
AU (1) | AU697793B2 (ja) |
CA (1) | CA2221452C (ja) |
DE (1) | DE69621018T2 (ja) |
WO (1) | WO1996040350A1 (ja) |
Cited By (7)
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WO2016035739A1 (ja) * | 2014-09-04 | 2016-03-10 | テルモ株式会社 | カテーテル |
WO2016035740A1 (ja) * | 2014-09-04 | 2016-03-10 | テルモ株式会社 | カテーテル |
WO2016035741A1 (ja) * | 2014-09-04 | 2016-03-10 | テルモ株式会社 | カテーテル及びその製造方法 |
JP2016052448A (ja) * | 2014-09-04 | 2016-04-14 | テルモ株式会社 | カテーテル及びその製造方法 |
JP2016052449A (ja) * | 2014-09-04 | 2016-04-14 | テルモ株式会社 | カテーテル |
JP2016052447A (ja) * | 2014-09-04 | 2016-04-14 | テルモ株式会社 | カテーテル |
JP6296580B1 (ja) * | 2016-09-21 | 2018-03-20 | 朝日インテック株式会社 | カテーテル及びバルーンカテーテル |
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JP2016052449A (ja) * | 2014-09-04 | 2016-04-14 | テルモ株式会社 | カテーテル |
JP2016052447A (ja) * | 2014-09-04 | 2016-04-14 | テルモ株式会社 | カテーテル |
WO2016035739A1 (ja) * | 2014-09-04 | 2016-03-10 | テルモ株式会社 | カテーテル |
JPWO2016035740A1 (ja) * | 2014-09-04 | 2017-06-22 | テルモ株式会社 | カテーテル |
US10449338B2 (en) | 2014-09-04 | 2019-10-22 | Terumo Kabushiki Kaisha | Catheter and method of manufacturing the same |
US10532191B2 (en) | 2014-09-04 | 2020-01-14 | Terumo Kabushiki Kaisha | Catheter |
US10561819B2 (en) | 2014-09-04 | 2020-02-18 | Terumo Kabushiki Kaisha | Catheter |
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US10722682B2 (en) | 2016-09-21 | 2020-07-28 | Asahi Intecc Co., Ltd. | Catheter and balloon catheter |
Also Published As
Publication number | Publication date |
---|---|
WO1996040350A1 (en) | 1996-12-19 |
EP0836503B1 (en) | 2002-05-02 |
EP0836503A1 (en) | 1998-04-22 |
US5647848A (en) | 1997-07-15 |
JP5149711B2 (ja) | 2013-02-20 |
DE69621018D1 (de) | 2002-06-06 |
ATE216905T1 (de) | 2002-05-15 |
AU6098096A (en) | 1996-12-30 |
AU697793B2 (en) | 1998-10-15 |
CA2221452C (en) | 2008-03-18 |
CA2221452A1 (en) | 1996-12-19 |
DE69621018T2 (de) | 2002-12-05 |
JPH11507257A (ja) | 1999-06-29 |
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