JP2022503928A - カテーテル位置合わせ装置及び方法 - Google Patents
カテーテル位置合わせ装置及び方法 Download PDFInfo
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- JP2022503928A JP2022503928A JP2021517682A JP2021517682A JP2022503928A JP 2022503928 A JP2022503928 A JP 2022503928A JP 2021517682 A JP2021517682 A JP 2021517682A JP 2021517682 A JP2021517682 A JP 2021517682A JP 2022503928 A JP2022503928 A JP 2022503928A
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Abstract
Description
本願は、2018年10月9日に出願された米国仮特許出願第62/743107号、2019年3月12日に出願された米国仮特許出願第62/817217号、及び2019年8月15日に出願された米国仮特許出願第62/887274号の優先権の利益を主張する。これらの出願のそれぞれは、引用することによりその全体が本明細書の一部をなす。
本明細書に記載される方法及びシステムは、いくつかの実施形態に従って心臓血管手術において特定の有用性を示す。いくつかの態様が以下の非限定的な例によって更に示され、そこでは、システムは、冠動脈の閉塞後の心臓組織の逆行性灌流を可能にするように動脈と静脈との接続処置(PICVA)を行う臨床医によって用いられる。
米国合衆国における肢喪失者は200万人近くである。
肢喪失者のうち、主な原因は以下である:
血管疾患(54%)(糖尿病及び末梢動脈疾患(PAD))、
外傷(45%)、及び、
癌(2%未満)。
毎年、合衆国において約185000件の切断が行われている。
肢切断に伴う入院費は2007年において総計65億ドルを超えた。
切断後の生存率は多様な要因に基づき様々である。血管疾患(PAD及び糖尿病を含む)に起因する切断を受けた者は、30日での死亡率が9%~15%と報告されており、長期生存率は1年が60%、3年が42%及び5年が35%~45%である。
血行障害(dysvascular disease)で肢を喪失した者の半数近くが5年以内に死亡する。これは、結腸直腸癌、乳癌及び前立腺癌を患った者が被る5年死亡率よりも高い。
糖尿病を患った者のうち下肢切断を受けた者は、最大55%まで、2年~3年以内にもう一本の脚の切断が必要となる。
結果:
包括的な検討のために総計56の試験が選択された。特定されたランダム化比較試験(RCT)はなかった。228人の患者を含む7つの患者群が選択基準と合致した。1年全体の肢温存は71%(95% CI:64%~77%)であり、1年の二次開存率は46%(95% CI:39%~53%)であった。大切断術を回避した患者の大部分は首尾よく創傷治癒し、休息痛が現れず、深刻な合併症がなかった。
結論:
限定された証拠に基づき、静脈の動脈化は、「手術不能な」慢性重症虚血肢を患った患者に大切断術を行う前の実行可能な代案とみなすことができる。
Claims (40)
- 第1の血管から第2の血管を標的化するための発射カテーテルであって、
カテーテルであって、
近位部分と、
遠位部分と
を含み、
前記遠位部分が、
針開口と、
平坦な長方形の放射線不透過性マーカーと
を含み、
前記平坦な長方形の放射線不透過性マーカーが、回転時に蛍光透視法下で消えて、前記発射カテーテルの回転位置合わせに関する情報を提供する、カテーテルと、
前記針開口を通して延出されるように構成された針と
を備える、発射カテーテル。 - 前記カテーテルの前記遠位部分が湾曲しており、前記マーカーが前記カテーテルの前記遠位部分の湾曲に従っていない、請求項1に記載の発射カテーテル。
- 前記針開口が前記マーカーの近位にある、請求項1に記載の発射カテーテル。
- 前記針開口が前記マーカーの遠位にある、請求項1に記載の発射カテーテル。
- 前記針開口が前記カテーテルの前記遠位部分の第1の側にあり、前記マーカーが前記カテーテルの前記遠位部分の第2の側にあり、前記第1の側が前記第2の側と同じである、請求項1に記載の発射カテーテル。
- 前記針開口が前記カテーテルの前記遠位部分の第1の側にあり、前記マーカーが前記カテーテルの前記遠位部分の第2の側にあり、前記第1の側が前記第2の側の反対側にある、請求項1に記載の発射カテーテル。
- 前記針開口から延出する前記針の遠位端部が、前記放射線不透過性マーカーと長手方向に位置合わせされる、請求項1に記載の発射カテーテル。
- 前記針がプロファイルを含み、前記針が針管腔を通ってスライドし、前記針管腔が前記プロファイルに相補的な形状を含み、前記針の前進中に前記針の長手方向の動きを低減する、請求項1に記載の発射カテーテル。
- 前記マーカーが、第1の放射線透過性材料と、前記第1の放射線透過性材料に結合された第2の放射線不透過性材料とを含む、請求項1に記載の発射カテーテル。
- 前記第2の放射線不透過性材料が、クラッディング、めっき、化学蒸着、原子層堆積、スクリーン印刷、コーティング、接着、又はスパッタリングのうちの1つ以上によって、前記第1の放射線透過性材料に結合される、請求項9に記載の発射カテーテル。
- 前記第2の放射線不透過性材料が、前記第1の放射線透過性材料に結合された後に、研磨又は平坦化される、請求項9に記載の発射カテーテル。
- 前記マーカーの幅に対する前記マーカーの長さの比が、1/1~5/1である、請求項1に記載の発射カテーテル。
- 前記マーカーが0.001mm~1mmの厚さを有する、請求項1から12のいずれか一項に記載の発射カテーテル。
- 前記マーカーが1nm~10μmの厚さを有する、請求項1から12のいずれか一項に記載の発射カテーテル。
- キットであって、
請求項1に記載の発射カテーテルと、
標的カテーテルと
を含む、キット。 - 前記標的カテーテルが拡張可能部材を含む、請求項15に記載のキット。
- 前記拡張可能部材がスネアを含む、請求項16に記載のキット。
- 前記拡張可能部材がメッシュを含む、請求項16に記載のキット。
- 前記拡張可能部材が放射線不透過性材料を含む、請求項16に記載のキット。
- 前記標的カテーテルが第1の放射線不透過性マーカーを含む、請求項15に記載のキット。
- 前記標的カテーテルが、前記第1の放射線不透過性マーカーから長手方向に離間した第2の放射線不透過性マーカーを含む、請求項20に記載のキット。
- カテーテルを位置合わせする方法であって、
前記マーカーが蛍光透視法下で厚さを有するまで、請求項1に記載のカテーテルを第1の血管内で回転させることを含み、前記厚さが、前記カテーテルの回転位置合わせを示す、方法。 - 前記マーカーが蛍光透視法下で前記厚さを有し且つ前記カテーテルの側面に当たるまで、前記第1の血管内で前記カテーテルを回転させることを含む、請求項22に記載の方法。
- 前記マーカーが第2の血管内の第2のカテーテルに近接するまで前記カテーテルを長手方向に前進させることを更に含む、請求項22に記載の方法。
- 前記第2のカテーテルが、蛍光透視法下で見える放射線不透過性特徴を含む、請求項24に記載の方法。
- 蛍光透視法下で見える前記第2のカテーテルの前記放射線不透過性特徴が、拡張可能部材を含む、請求項25に記載の方法。
- 前記拡張可能部材がスネアを含む、請求項26に記載の方法。
- 前記拡張可能部材がメッシュを含む、請求項26に記載の方法。
- 前記カテーテルを回転させた後、針を前記カテーテルから延出させることを更に含み、前記針を前記カテーテルから延出させることが、前記第1の血管を出て、前記第1の血管とは異なる第2の血管に入ることを含み、前記カテーテルを位置合わせすることが、前記針を位置合わせすることを含む、請求項22から28のいずれか一項に記載の方法。
- 前記針を前記カテーテルから延出させることが、前記第1の血管と前記第2の血管との間の間質組織を横断することを含む、請求項29に記載の方法。
- 前記針を通って前記第2の血管内にガイドワイヤを延出させることを更に含む、請求項29に記載の方法。
- 前記第2の血管内の第2のカテーテルに前記ガイドワイヤを絡ませることを更に含む、請求項31に記載の方法。
- 前記ガイドワイヤを絡ませることが、前記第2のカテーテルの拡張可能部材を閉塞することを含む、請求項32に記載の方法。
- 前記ガイドワイヤの対応する動きを検出するために前記第2のカテーテルを移動させることを更に含む、請求項31に記載の方法。
- 前記ガイドワイヤを前記第2の血管を通して移動させるために前記第2のカテーテルを移動させることを更に含む、請求項31に記載の方法。
- カテーテルを位置合わせする方法であって、
放射線不透過性材料を含む第1のカテーテルを第1の血管に配置することと、
平坦な長方形の放射線不透過性マーカーを含む前記カテーテルを第2の血管に配置することと、
前記第1のカテーテル及び前記カテーテルが画像化平面内に入るまで画像化システムを回転させることであって、前記画像化システムを回転させることが、
前記第1のカテーテル上に第1の中心線を描画することと、
前記カテーテル上に第2の中心線を描画することと、
前記第1の中心線と前記第2の中心線との間の距離を最大化することと、
前記第1のカテーテル及び前記カテーテルが前記画像化平面内にあるという信号を作成することと、を含む、回転させることと、
前記平坦な長方形の放射線不透過性マーカーの厚さが最小になるまで前記カテーテルを回転させることであって、前記カテーテルを回転させることが、
前記平坦な長方形の放射線不透過性マーカーの第1の長い縁に沿って第1の線を描画することと、
前記第1の長い縁の反対側にある前記平坦な長方形の放射線不透過性マーカーの第2の長い縁に沿って第2の線を描画することと、
前記第1の長い線と前記第2の線との間の距離を最小化することと、
前記厚さが最小であるという信号を作成することと、を含む、回転させることと、
前記画像化平面において前記第2の血管内の前記カテーテルから前記第2の血管を出て、前記第1の血管内に針を延出させることと、
を含む、方法。 - カテーテルを位置合わせする方法であって、
第1の血管に造影剤を注入することと、
第2の血管に造影剤を注入することと、
前記第1の血管及び前記第2の血管が画像化平面内にあるまで前記画像化システムを回転させることであって、前記画像化システムを回転させることが、
前記第1の血管に沿って第1の線を描画することと、
前記第2の血管に沿って第2の線を描画することと、
前記第1の線と前記第2の線との間の領域を最大化することと、
前記第1の血管及び前記第2の血管が前記画像化平面内にあるという信号を作成することと、を含む、回転させることと、
平坦な長方形の放射線不透過性マーカーを含む前記カテーテルを前記第2の血管に配置することと、
前記平坦な長方形の放射線不透過性マーカーの厚さが最小になるまで前記カテーテルを回転させることであって、前記第2のカテーテルを回転させることが、
前記平坦な長方形の放射線不透過性マーカーの第1の長い縁に沿って第1の線を描画することと、
前記第1の長い縁の反対側にある前記平坦な長方形の放射線不透過性マーカーの第2の長い縁に沿って第2の線を描画することと、
前記第1の長い線と前記第2の線との間の距離を最小化することと、
前記厚さが最小であるという信号を作成することと、を含む、回転させることと、
前記画像化平面において前記第2の血管内の前記カテーテルから前記第2の血管を出て、前記第1の血管内に針を延出させることと
を含む、方法。 - カテーテルを位置合わせする方法であって、
第1の血管に第1のカテーテルを配置することと、
放射線不透過性マーカーを含むカテーテルを第2の血管に配置することと、
前記放射線不透過性マーカーの厚さがある値よりも小さくなるまで前記カテーテルを回転させることと、
前記厚さが前記値よりも小さいという信号を作成することと
を含む、方法。 - 対象の脛骨静脈にアクセスする方法であって、
第1の止血帯を脚の膝上方に配置することと、
第2の止血帯を前記脚の足首上方に配置することであって、前記第1の止血帯が前記第2の止血帯とは異なるタイプであることと、
中足静脈を介して一定量の造影剤を注入することと、
蛍光透視法を使用して前記脚の足の静脈を画像化するために静脈造影図を作成することと、
前記静脈造影図を使用して脛骨静脈を選択することと、
前記選択された脛骨静脈にガイドワイヤを前進させることと、
前記第2の止血帯を取り外すことと、
前記ガイドワイヤ上で機能的カテーテルを追跡することと
を含む、方法。 - カッティングスネアシステムであって、
ガイドワイヤを受け入れるように構成された複数のセルを含むスネア構造と、
2つの近位に面するブレードと8つの近位に面するブレードとの間を含む弁膜切開刀構造であって、前記スネア構造とモノリシックな弁膜切開刀構造と、
外側シースであって、前記スネア構造及び前記弁膜切開刀構造が前記外側シースから拡張可能である、外側シースと
を含む、カッティングスネアシステム。
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2019
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- 2019-10-08 JP JP2021517682A patent/JP7466531B2/ja active Active
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SG11202102500UA (en) | 2021-04-29 |
CN112955207A (zh) | 2021-06-11 |
AU2019359268A1 (en) | 2021-04-08 |
US11116943B2 (en) | 2021-09-14 |
US20220008693A1 (en) | 2022-01-13 |
US20210220623A1 (en) | 2021-07-22 |
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US11129965B2 (en) | 2021-09-28 |
US20210322728A1 (en) | 2021-10-21 |
US11478614B2 (en) | 2022-10-25 |
US20210220616A1 (en) | 2021-07-22 |
EP3863707A4 (en) | 2022-07-13 |
US11850379B2 (en) | 2023-12-26 |
JP7466531B2 (ja) | 2024-04-12 |
US11311700B2 (en) | 2022-04-26 |
US20220152358A1 (en) | 2022-05-19 |
WO2020076833A1 (en) | 2020-04-16 |
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