JP2022009501A - 閉塞を横断する及び治療するためのシステム及び方法 - Google Patents
閉塞を横断する及び治療するためのシステム及び方法 Download PDFInfo
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Abstract
【解決手段】完全閉塞または近完全閉塞を有する患者を治療するためのデバイス及び方法を提供する。デバイスは、治療部位において血管内に位置付けられ得る。治療部位での閉塞をカテーテルによって広げる。閉塞内へガイドワイヤ上でカテーテルを前進させる。1以上の、[a]ガイドワイヤに掛けた圧縮もしくは捻れ、または、[b]カテーテル本体に掛けた圧縮もしくは捻れ、は、閉塞を通る経路を拡大させるまたは形成する。アクセス経路の拡大または形成は、閉塞を切除するもしくは研削することによって、または、靴ベラ効果によって、なされ得る。
【選択図】図2A
Description
シース54は、カテーテルデバイス58よりも約10cmから約20cm短くなり得る。細長い本体65は、細長い本体84よりも10cmから20cm短くなり得る。より一般的には、シース54及び細長い本体65は、作業長さを提供するのに十分な量だけ、カテーテルデバイス58または細長い本体84よりも短くなり得る。
潤滑性-外面は、より滑りやすい材料で形成され得、または、カテーテル本体よりも滑りやすく形成され得、そのため、カテーテルの追従及びトルク付与を容易にする;
支持-スリーブは、カテーテルの遠位部分の長手方向剛性を増大させるように構成されており、その結果、切除先端部は、直線状に案内される;及び/または、
保護-スリーブは、切除先端部の後縁部を被覆し、追従及びトルク付与中に後縁部が取り外されることから保護する。
除去デバイス100と同様の除去デバイス及びシステム50を実際に使用することを図7Aから図7Fで示す。図7Aは、慢性完全閉塞を有する患者の透視下での画像を示している。暗色領域は、注入された造影剤が閉塞の上流側で閉じ込められていることを示す。図7Bは、システムを透視下で撮像したデバイスを示す。除去デバイス100は、ガイドワイヤ上に配設されている。除去デバイスは、閉塞を通って(図7Bで記録されている時点後に)前進されるように位置付けられる。図7Cは、ガイドワイヤ上にかつ閉塞を横切るように配設されたバルーンカテーテルの透視下での画像を示している。図7Dは、閉塞においてかつ閉塞の両側において膨張されたバルーンの透視下での画像を示している。矢印は、閉塞の部位でバルーンが狭くされていることを示しており、閉塞の残りの部分がバルーンよりも硬質であることを示している。図7Eは、図7Aに示すものと同一の血管セグメントを示しており、閉塞を開いて、流動を復旧した。
実例1-ステント内再狭窄
54歳男性は、4年前に右総腸骨動脈に配置されたステントの狭窄に起因するステージIIbの抹消動脈障害(PAD)を示した。0.035インチ(0.889mm)径のPTFE血管内ガイドワイヤを患者内に挿入し、狭窄領域を横切るように前進させた。その後、バルーンカテーテルをオーバーザワイヤ(OTW)構造のガイドワイヤ上に備え付け、狭窄領域へ前進させた。バルーンカテーテルは、対象狭窄を横断できなかった。バルーンカテーテルを患者から引き抜き、一実施形態にかかる除去デバイス100をOTW構造にあるガイドワイヤに備え付けた。この及び以降の例において、実施形態にかかる除去デバイス100を使用した。この患者を治療するために使用したこの実施形態にかかる除去デバイス100は、0.035インチ(0.889mm)内径及び0.071インチ(1.8034mm)外径の先端縁を有していた。上述のように、鋸を使用して木片を切断するのとほぼ同一方法で、血管狭窄の内腔縁を通して研削または切除することによって、鋸歯状先端部を使用して抵抗性のある病変内でカテーテルを前進させた。より靴ベラ状の鈍っているまたは傾斜した先端部を使用するが、いくらかの研削能力を有し得る。
70歳老男性は、浅大腿動脈の閉塞に起因するステージIIbの抹消動脈障害(PAD)を示した。X線写真画像は、閉塞が動脈の25cmを越える長さに影響を及ぼしていることを示し、患者は、95%脛腓幹狭窄(truncus tibiofibularis stenosis)を有していた。0.035インチ(0.889mm)径のPTFE血管内ガイドワイヤを患者内に挿入し、狭窄領域を横切るように前進させた。バルーンカテーテルをオーバーザワイヤ(OTW)構造のガイドワイヤ上に備え付け、狭窄領域へ前進させた。バルーンカテーテルは、対象狭窄を横断できなかった。バルーンカテーテルを患者から引き抜き、一実施形態にかかる除去デバイス100をOTW構造にあるガイドワイヤに備え付けた。この患者を治療するために使用したこの実施形態にかかる除去デバイス100は、0.035インチ(0.889mm)内径及び0.071インチ(1.8034mm)外径の先端縁を有していた。
86歳老男性は、浅大腿動脈の閉塞に起因するステージIIbの抹消動脈障害(PAD)を示した。X線写真画像は、閉塞が動脈の6cm未満の長さに影響を及ぼしていることを示した。0.035インチ(0.889mm)径のPTFE血管内ガイドワイヤを患者内に挿入し、狭窄領域を横切るように前進させた。バルーンカテーテルをオーバーザワイヤ(OTW)構造のガイドワイヤ上に備え付け、狭窄領域へ前進させた。バルーンカテーテルは、対象狭窄を横断できなかった。バルーンカテーテルを患者から引き抜き、一実施形態にかかる除去デバイス100をOTW構造にあるガイドワイヤに備え付けた。この患者を治療するために使用したこの実施形態にかかる除去デバイス100は、0.035インチ(0.889mm)内径及び0.071インチ(1.8034mm)外径の先端縁を有していた。
72歳老男性は、石灰化膝下(BTK)99%脛腓幹狭窄に起因するステージIVのの抹消動脈障害(PAD)を示した。0.014インチ(0.3556mm)径のガイドワイヤによる成功裏の狭窄のワイヤ横断の後、1.5mm径のプッシュカテーテルを用いて、1.2mm外径のオーバーワイヤーバルーンカテーテルをガイドワイヤに沿って前進させた。バルーンカテーテルは、狭窄を横断できなかった。バルーンカテーテルを患者から引き抜き、一実施形態にかかる除去デバイス100をOTW構造にあるガイドワイヤに備え付けた。この実例のために使用したこの実施形態にかかる先端部140は、0.018インチ(0.4572mm)の内径と外径0.063インチ(1.6002mm)の先端縁とを有していた。ハンドル130をガイドワイヤに沿って遠位側に移動させて先端部140を対象病変まで前進させた。いったん先端部140の遠位面142が対象病変と接触すると、除去デバイス100のハンドル130を遠位方向で穏やかに押してガイドワイヤ回りに往復回転させ、遠位面142が対象病変を研削させた。
Claims (1)
- 明細書及び添付図面に関連付けて実質的に説明されたカテーテル。
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US9826995B2 (en) | 2017-11-28 |
WO2015042190A3 (en) | 2015-06-18 |
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US20220378464A1 (en) | 2022-12-01 |
JP2020022878A (ja) | 2020-02-13 |
US20150209057A1 (en) | 2015-07-30 |
US10278715B2 (en) | 2019-05-07 |
EP3035876A2 (en) | 2016-06-29 |
CN105873530A (zh) | 2016-08-17 |
US20150209066A1 (en) | 2015-07-30 |
CN105873530B (zh) | 2019-11-08 |
US10499934B2 (en) | 2019-12-10 |
EP3035876B1 (en) | 2018-11-14 |
JP2016533861A (ja) | 2016-11-04 |
JP6968861B2 (ja) | 2021-11-17 |
US20150209064A1 (en) | 2015-07-30 |
WO2015042190A2 (en) | 2015-03-26 |
EP3035876A4 (en) | 2017-03-22 |
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