JP2014166558A - 高い強度および柔軟性を有するバルーンカテーテルシャフトおよびその製造方法 - Google Patents
高い強度および柔軟性を有するバルーンカテーテルシャフトおよびその製造方法 Download PDFInfo
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- JP2014166558A JP2014166558A JP2014086565A JP2014086565A JP2014166558A JP 2014166558 A JP2014166558 A JP 2014166558A JP 2014086565 A JP2014086565 A JP 2014086565A JP 2014086565 A JP2014086565 A JP 2014086565A JP 2014166558 A JP2014166558 A JP 2014166558A
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- tubular member
- tube
- catheter
- biaxially oriented
- tapered
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Abstract
【解決手段】バルーンカテーテル10は、a)近位端12と、遠位端13と、内部に延びる膨張用管腔20と、2軸配向されたショアデュロメータ硬さが75D以下で63D以上の非多孔性熱可塑性高分子から形成されてその内部に膨張用管腔を有する管状部材23と、を有している細長いシャフト11と、b)膨張用管腔と流体的に連通する内部を有する、遠位側のシャフト部分17に密封取り付けされたバルーン14と、を備える。カテーテルは、カテーテルの性能を向上させるべく、改良された低い曲げ剛性、高い破裂圧力、高い引張り強度の組み合わせを有する。
【選択図】図1
Description
伸びパーセンテージ=100×[(OD1 2−ID1 2)/(OD2 2−ID2 2)−1] …(式1)
S(全体)=a×(伸び%)2+b×(伸び%)+ c …(式2)
W =[S(全体)−(P×ID2 2)/(OD2 2−ID2 2)]×[(3.14159/4)×(OD2 2−ID2 2)] …(式3)
押出内径(ID)が約0.005インチで押出外径(OD)が約0.0217インチ〜約0.0264インチにわたる4組の複数の管材料サンプル(N=5)を押出成形するためにPEBAX63Dを用いた。テフロンライナ付きで内径が約0.034インチのステンレス鋼製の拘束チューブに押出チューブを入れて昇温し、その内部で半径方向および軸線方向に延伸させた。具体的には、縦型の温風ネッキング装置を用いて約500psiの加圧空気で管材料を加圧すると同時に管材料の一端を引っ張る軸線方向荷重により管材料を延伸させつつ、拘束チューブの外側に沿って横動する目標値が約385°F(196℃)の加熱ノズルを用いて拘束チューブの内側で管材料を加熱した。(拘束チューブの内側の温度は、典型的に目標値以下であり、かつノズル温度目標値、ノズルの速度、ノズルの空気流量、拘束チューブの材料および寸法によって左右される)。結果として得られた2軸配向させて延伸させた管状部材のサンプルは、内径が約0.0285インチで外径が0.033インチの最終寸法と、約600psiを下回らない比較的高い破裂圧力、および約102mg以下の比較的低いガーリー曲げ剛性値を有していた。0.028〜0.0285インチのマンドレル上における100℃/15分の熱安定化後において結果として得られた管状部材のサンプルの長手方向の平均伸びパーセント、平均破裂圧力、ガーリー曲げ剛性値、および引張荷重は、以下の表1に示されている。
図7のテーパー付2軸配向管状部材123のような、変化する外径および一定な内径の管状部材を製造するために必要な外部荷重値を予測するべく、式3を用いた。予測された外部荷重値(式3を用いた)は、押出したときおよび最終的に延伸させたときの所望の寸法、算出した伸びパーセント(式1を使用)、および算出し軸線方向の全体応力値(式2を使用)と共に表2に表されている。表2に記載した実施形態において、延伸させたときの外径および肉厚は、最初の20cmにおいて一定に保持され、次いで残りの長さにおいて線形に増加している。2軸配向させてテーパー付けするプロセスの間の内部圧力は475psiで一定だった。
図10のテーパー付2軸配向管状部材135のような、変化する外径、変化する内径、および肉厚が一定な管状部材を製造するために、実施形態2と同じ条件を用いたが、20cm〜40cmの軸線方向位置では外部荷重はより少ない量だけ減少させた。具体的には、実施形態2におけるように0.0838〜0.0939cmへとチューブの外径が増加するときに、0.004インチ(0.01cm)の一定の肉厚を維持するために、軸線方向の伸びパーセント、全応力、および外部荷重を表3に示したように減少させた。
I =(3.14159/64)×(OD2 4−ID2 4)
目下のところ好ましい実施形態においては、押出チューブの少なくとも一端に負荷される外部荷重を加熱ノズルの位置の関数として変化させることにより、チューブを2軸配向する間にテーパー部分が形成される(すなわち、2軸配向のための延伸の間に加熱ノズルが押出チューブの長手方向に沿って横動するに連れて、軸線方向の外部荷重を変化させて軸線方向の延伸量を変更する)。2軸配向管状部材に結果として得られたテーパー部分は、外部負荷を変化させる量や拘束部材がテーパー付けされた内径を有しているかどうかといったファクターに応じて、様々に異なる構造とすることができる。目下のところ好ましい実施形態において、2軸配向管状部材に結果として得られるテーパー部分は、より小さな外径および肉厚へと遠位側に向けてテーパーが付けられているが、その内径は実質的に一定である。しかしながら、テーパー付けされた外径および肉厚を有するかあるいは有しないテーパー付けされた内径を具備するテーパー付けされた部分を含む、様々に適切な構造を用いることができる。
しかしながら、一つの実施形態においては、それに加えてあるいはそれに代えて、チューブ管腔内の加圧媒体の圧力を変化させることにより全軸線方向荷重を変化させる。
さらに、テーパーが付けられた拘束部材(例えば部材132)なしでは、完成したテーパー付2軸配向管状部材における可能な寸法の組合せの範囲は相対的に制限される。
伸びパーセンテージ=100×[(OD1 2−ID1 2)/(OD2 2−ID2 2)−1] …(式1)
S(全体)=a×(伸び%)2+b×(伸び%)+ c …(式2)
W =[S(全体)−(P×ID2 2)/(OD2 2−ID2 2)]×[(3.14159/4)×(OD2 2−ID2 2)] …(式3)
押出内径(ID)が約0.013cm(約0.005インチ)で押出外径(OD)が約0.055〜0.067cm(約0.0217インチ〜約0.0264インチ)にわたる4組の複数の管材料サンプル(N=5)を押出成形するためにPEBAX63Dを用いた。テフロンライナ付きで内径が約0.086cm(約0.034インチ)のステンレス鋼製の拘束チューブに押出チューブを入れて昇温し、その内部で半径方向および軸線方向に延伸させた。具体的には、縦型の温風ネッキング装置を用いて約3447kPa(約500psi)の加圧空気で管材料を加圧すると同時に管材料の一端を引っ張る軸線方向荷重により管材料を延伸させつつ、拘束チューブの外側に沿って横動する目標値が約385°F(196℃)の加熱ノズルを用いて拘束チューブの内側で管材料を加熱した。(拘束チューブの内側の温度は、典型的に目標値以下であり、かつノズル温度目標値、ノズルの速度、ノズルの空気流量、拘束チューブの材料および寸法によって左右される)。結果として得られた2軸配向させて延伸させた管状部材のサンプルは、内径が約0.072cm(約0.0285インチ)で外径が0.084cm(0.033インチ)の最終寸法と、約4137kPa(約600psi)を下回らない比較的高い破裂圧力、および約102mg以下の比較的低いガーリー曲げ剛性値を有していた。0.071〜0.072cm(0.028〜0.0285インチ)のマンドレル上における100℃/15分の熱安定化後において結果として得られた管状部材のサンプルの長手方向の平均伸びパーセント、平均破裂圧力、ガーリー曲げ剛性値、および引張荷重は、以下の表1に示されている。
図7のテーパー付2軸配向管状部材123のような、変化する外径および一定な内径の管状部材を製造するために必要な外部荷重値を予測するべく、式3を用いた。予測された外部荷重値(式3を用いた)は、押出したときおよび最終的に延伸させたときの所望の寸法、算出した伸びパーセント(式1を使用)、および算出し軸線方向の全体応力値(式2を使用)と共に表2に表されている。表2に記載した実施例において、延伸させたときの外径および肉厚は、最初の20cmにおいて一定に保持され、次いで残りの長さにおいて線形に増加している。2軸配向させてテーパー付けするプロセスの間の内部圧力は3275kPa(475psi)で一定だった。
図10のテーパー付2軸配向管状部材135のような、変化する外径、変化する内径、および肉厚が一定な管状部材を製造するために、実施例2と同じ条件を用いたが、20cm〜40cmの軸線方向位置では外部荷重はより少ない量だけ減少させた。具体的には、実施例2におけるように0.0838〜0.0939(0.084〜0.094)cmへとチューブの外径が増加するときに、0.004インチ(0.010cm)の一定の肉厚を維持するために、軸線方向の伸びパーセント、全応力、および外部荷重を表3に示したように減少させた。
I =(3.14159/64)×(OD2 4−ID2 4)
Claims (20)
- a)細長いシャフトであって、近位端と、遠位端と、該シャフトの内部に延びる膨張用管腔と、2軸配向された非多孔性熱可塑性高分子から形成されてその内部に前記膨張用管腔を有する管状部材と、を有している細長いシャフトと、
b)その内部が前記膨張用管腔と流体的に連通するとともに、その破裂圧力が前記シャフトの管状部材の破裂圧力より大幅に低い、遠位側のシャフト部分に密封取り付けされたバルーンと、
を備えたバルーンカテーテル。 - 前記2軸配向された熱可塑性高分子は、55D〜75Dより大きくないショアデュロメータ硬さを有しており、前記管状部材は、50〜150mgより大きくないガーリー曲げ剛性値と、少なくとも20〜50気圧の破裂圧力と、少なくとも1〜5lbfの引張り破断荷重とを有している、請求項1に記載のカテーテル。
- 前記シャフトの2軸配向された管状部材が外側管状部材であり、
前記シャフトが、その内部にガイドワイヤ管腔を有するとともに前記膨張用管腔内にある内側管状部材を含んでおり、
前記バルーンが、前記外側管状部材の遠位端に密封取付された近位側スカート部分と、前記内側管状部材の遠位端に密封取付された遠位側スカート部分とを有している、請求項1に記載のカテーテル。 - 前記管状部材は、内径が0.071〜0.074センチメートル(約0.028〜約0.029インチ)であり、少なくともにその一部分に沿った外径が0.0825〜0.0851センチメートル(約0.0325〜約0.0335インチ)である、請求項1に記載のカテーテル。
- 前記管状部材が前記管状部材の全長にわたって一様な外径を有する、請求項1に記載のカテーテル。
- 前記管状部材の高分子材料の2軸配向が、前記管状部材全長に沿って実質的に一様である、請求項5に記載のカテーテル。
- 前記管状部材の破裂圧力が20〜50気圧であり、前記バルーンの定格破裂圧力が14〜25気圧である、請求項1に記載のカテーテル。
- 前記管状部材は、前記管状部材の長さの少なくとも2%の長さにわたって遠位側に向けてテーパー付けされた外径を有する部分を少なくとも有し、このテーパー付けされた部分の曲げ剛性がそれに沿って20%〜80%遠位側に向けて減少する、請求項1に記載のカテーテル。
- 前記2軸配向された管状部材のテーパー付けされた部分は、遠位側に向けて減少する肉厚を有しており、かつ、近位側に少なくとも65%、より好ましくはこのテーパー付けされた部分に沿って200〜350%増加する前記の曲げ剛性を有している特徴とする請求項8に記載のカテーテル。
- 前記2軸配向された管状部材は、前記テーパー付けされた部分に沿って遠位側に向けて増加する軸線方向の配向と、少なくともその半径方向内側の表面の範囲で前記2軸配向された管状部材の全長にわたって実質的に一様な円周方向の配向とを有している、請求項9に記載のカテーテル。
- 前記シャフトの2軸配向された管状部材は遠位側の外側部材であり、この遠位側の外側部材は、前記バルーンに密封取付けされる遠位端と近位側の管状部材に密封取付けされる近位端とを有するとともに、その前記曲げ剛性が前記テーパー付けされた部分の長さに沿って2〜4.5倍減少する、請求項8に記載のカテーテル。
- 細長いシャフトと遠位側シャフト部分上のバルーンと備えるバルーンカテーテルの製造方法であって、
a)比較的低いショアデュロメータ硬さの熱可塑性高分子材料を溶融押出しして、管腔と第1の内径および第1の外径とを有するチューブを形成し、前記押出したチューブを前記溶融押出の昇温状態より低い温度に冷却し、
b)前記押出したチューブを拘束部材の内側に配置し、前記押出したチューブを昇温させ、前記拘束部材の内径にほぼ等しい第2の外径および前記押出したチューブの前記第1の内径より大きい第2の内径へと、前記チューブの管腔内の加圧媒体によって前記押出したチューブを半径方向に延伸させるとともに、それと同時にあるいはそれに続けて前記チューブの少なくとも一端上に負荷される荷重によって前記押出したチューブを軸線方向に延伸させて、前記押出したチューブの高分子材料を2軸配向し、
c)前記延伸させたチューブを室温に冷却して、前記冷却された延伸チューブを2軸配向された非多孔性熱可塑性高分子の管状部材とするとともに、前記管状部材が前記カテーテルシャフトの少なくとも一部を形成し、かつ前記バルーンの内部が前記管状部材の管腔と流体的に連通するように、前記管状部材の遠位端にバルーンを密封取り付けする、
ことを特徴とする方法。 - 前記押出チューブは、前記押出チューブの前記第1の内径の少なくとも約5倍大きい第2の内径に延伸される、請求項12に記載の方法。
- 前記拘束部材は、潤滑性の高分子材料製の内側ライナを有した金属製の管から構成され、前記加圧媒体は、前記拘束部材の外径を増加させることなく前記押出チューブを半径方向に延伸させて前記拘束部材の内側表面に接触させるのに十分な高い圧力のガスである、請求項12に記載の方法。
- 前記拘束部材は、前記延伸された押出しチューブを前記第2の外径で半径方向に拘束するように構成された一様な内径を有しており、前記第2の外径が前記延伸させたチューブの長手方向に沿って一様である、請求項12に記載の方法。
- 前記c)の前に、前記押出チューブの高分子材料を安定させるのに十分な昇温状態へと前記押出チューブをマンドレル上で加熱することによって前記押出チューブを熱的に安定化させることをさらに含む、請求項12に記載の方法。
- 前記押出チューブの高分子材料を2軸配向させることは、前記拘束部材の内側にある前記押出チューブの第1の端部から第2の端部へと長手方向に移動する外部熱供給源によって少なくともその一部分を加熱するときに、前記チューブの全軸線方向荷重を制御可能に変化させることによって、前記押出チューブの少なくとも一部を同時にテーパー付けすることを含む、請求項12に記載の方法。、
- 前記全軸線方向荷重を変化させることは、前記外部熱供給源を前記チューブに沿って移動させながら、前記チューブの端部に負荷される外部負荷を変化させることを含む、請求項17に記載の方法。
- 前記全軸線方向荷重を変化させることは、前記外部熱供給源を前記チューブに沿って移動させながら、前記チューブの管腔内の加圧媒体の圧力を変化させることを含む、請求項17に記載の方法。
- 前記拘束部材は、その少なくとも一部分に沿って小さな内径から大きな内径へとテーパー付けされており、前記拘束部材のテーパー付けされた部分に沿って小さな内径から大きな内径へと加熱ノズルが移動するにつれて前記全軸線方向荷重を減少させる、請求項17に記載の方法。
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2007
- 2007-06-15 US US11/763,623 patent/US8382738B2/en active Active
- 2007-06-22 EP EP07798928.3A patent/EP2043722B1/en not_active Not-in-force
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- 2007-06-22 JP JP2009518471A patent/JP2009542363A/ja active Pending
- 2007-06-22 WO PCT/US2007/071873 patent/WO2008005706A2/en active Application Filing
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JPH09164191A (ja) * | 1995-10-11 | 1997-06-24 | Terumo Corp | カテーテル用バルーンおよびバルーンカテーテルならびに血管拡張用カテーテル |
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US10245352B2 (en) | 2019-04-02 |
EP2474336A1 (en) | 2012-07-11 |
WO2008005706A2 (en) | 2008-01-10 |
US8721624B2 (en) | 2014-05-13 |
JP5895017B2 (ja) | 2016-03-30 |
WO2008005706A3 (en) | 2008-06-19 |
US8382738B2 (en) | 2013-02-26 |
US8388602B2 (en) | 2013-03-05 |
JP2009542363A (ja) | 2009-12-03 |
EP2043722A2 (en) | 2009-04-08 |
US20160067384A1 (en) | 2016-03-10 |
US20140213967A1 (en) | 2014-07-31 |
US20130178795A1 (en) | 2013-07-11 |
US9205223B2 (en) | 2015-12-08 |
US20150238737A1 (en) | 2015-08-27 |
US9968713B2 (en) | 2018-05-15 |
EP2474336B1 (en) | 2019-04-03 |
EP2043722B1 (en) | 2019-04-17 |
US20080045928A1 (en) | 2008-02-21 |
US20120143129A1 (en) | 2012-06-07 |
US9056190B2 (en) | 2015-06-16 |
US20130160932A1 (en) | 2013-06-27 |
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