JP2014514059A - 閉塞クロッシング用デバイス、撮像用デバイスおよびアテローム切除用デバイス - Google Patents
閉塞クロッシング用デバイス、撮像用デバイスおよびアテローム切除用デバイス Download PDFInfo
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Abstract
Description
この出願は、2011年3月28日出願に提出され、“OCCLUSION-CORRSING DEVICES, IMAGING, AND ATHERECTOMY DEVICES”と題した米国特許仮出願第61/468396号に基づく優先権を主張しており、そのすべての内容は、参照により本明細書に組み込まれる。
本明細書で言及されるすべての刊行物と特許出願は、各刊行物または特許出願が参照により組み込まれることが明確かつ個別に示されているのと同程度に、すべての内容が参照により本明細書に組み込まれる。
本明細書では、カテーテル、特に、方向性(directional)切断エレメントとOCTイメージセンサの両方を有し、回転遠位先端部(rotating distal tip)と、カテーテルの長さ方向に延在する(extend)ガイドワイヤ用の内側管腔と、遠位先端部に位置するOCTイメージセンサが回転するときにカテーテル内で巻き付き(wind)およびほどける(unwind)ように構成された光ファイバとを備えることができるカテーテルについて説明している。本明細書で説明しているカテーテルは、ガイドワイヤ支持および/または留置(placement)用カテーテル、撮像用カテーテル、アテローム切除用カテーテル、慢性完全閉塞クロッシング用カテーテル、ならびに撮像および/またはアテローム切除機能を有するハイブリッド支持/留置用カテーテルの1つまたは複数として構成できる。また、本明細書で説明しているカテーテルを使用する方法も提供される。
ガイドワイヤ留置用および/または支持用カテーテル(これらも便宜上「閉塞クロッシング用カテーテル」(occlusion crossing catheter)と呼ぶことがある)を含む、閉塞クロッシング用カテーテルなどのカテーテルを使用して、閉塞または病変をクロスすることができる。これらのカテーテルを使用して、血管の閉塞した内腔内にガイドワイヤを留置できる。本明細書で説明しているカテーテルのいずれかは、デバイス長さの全体または大部分に及ぶガイドワイヤの管腔と、(カテーテルの長手軸に対して時計周りまたは反時計回りに)回転および/または振動する遠位先端部とを含むことができる。遠位先端部は、1つまたは複数の切開(例えば切断)面を含むことができる。回転式の遠位先端領域を使用して、慢性完全閉塞の治療用を含むカテーテルを閉塞した血管内腔に通して留置させることができる。
アテローム切除用カテーテル(上記ガイドワイヤの留置後に使用できる)の一例を図20Aから図22Dに示しており、以下で説明する。概して、アテローム切除用カテーテルは、シースを用い、かつ/またはカテーテルの通路を誘導し、位置決めされたガイドワイヤを追跡する従来のカテーテル技術を用いて血管系にアクセスできる。デバイスは、血管系を通ってターゲット病変部まで追跡できる。ファイバ(例えばシングルモードファイバ)は、デバイスの遠位アセンブリまたはその付近に位置決めでき、撮像(例えば、OCT撮像)を使用して病変部の評価と治療計画を有効にすることができる。例えば、デバイスは、動脈の病変部に向けて回転するように(rotationally) 方向付けてもよく、近位の医師による制御部を使用して、刃先を病変組織へ優先的に露出させるように作動してもよい。本明細書で説明している例で、円形カッターは、ドライブシャフトの約10から10000の毎分回転数(rpm)での回転を開始することになる。デバイスは、病変部を通って移動し、OCT画像が壁と病変部の性質決定、カッターの並置および相対的な切断深さに関するリアルタイムのフィードバックを提供しながら、病変組織を平削りし(plane)、切断することができる。切断部が通過する間、組織は、円形の中空カッターを通り、カッターに対して遠位に位置する組織リザーバ内に入ってもよい。切断経路(cutting pass)が完了すると、近位の制御部を使用してデバイスを連結し、更なるデリバリと留置のために保護された位置にカッターを戻してもよい。この手順を複数回実行することにより、疾患を充分に治療できる。
Claims (37)
- 細長い本体と、
細長い本体の近位端から細長い本体の遠位端まで、細長い本体内に延在する中央管腔と、
細長い本体の遠位端に位置し、細長い本体に対して回転するように構成された回転式先端部と、
回転式先端部に結合され、それと共に回転するように構成された光ファイバを有するOCTイメージセンサとを備え、
光ファイバは、回転式先端部が回転するときに、細長い本体内で中央管腔の周囲に巻き付くように構成された、
閉塞クロッシング用のカテーテルデバイス。 - 回転式先端部を時計回りと反時計回りに交互に連続的に回転させるように構成された駆動機構をさらに備えた、請求項1に記載のデバイス。
- 駆動機構は、約1rpmから約100rpmで回転式先端部を回転させるように構成された、請求項2に記載のデバイス。
- 駆動機構は、約30rpmから約60rpmで回転式先端部を回転させるように構成された、請求項3に記載のデバイス。
- 各時計回りの回転は、25回転未満を含み、
各反時計回りの回転は、25回転未満を含む、請求項2に記載のデバイス。 - 光ファイバの近位端のみがカテーテルに固定された、請求項1に記載のデバイス。
- OCTイメージセンサは、カテーテルデバイスの長手軸に対して略垂直に光ビームを放射するように構成された、請求項1に記載のデバイス。
- 回転式先端部は、らせん状の刃先を有する、請求項1に記載のデバイス。
- 回転式先端部は、略滑らかで湾曲した外面であって、第1方向に回転する場合には非外傷性の組織接触面を付与し、第1方向と反対の第2方向に回転する場合には切開面を付与する外面を有する、請求項1に記載のデバイス。
- 細長い本体は、カテーテルデバイスを操縦するときに支援するように構成された、遠位端付近の固定湾曲部を含む、請求項1に記載のデバイス。
- 細長い本体は、回転式先端部の1回転ごとに少なくとも1回、OCTセンサからの撮像を妨害するように構成された少なくとも1つのマーカを含む、請求項1に記載のデバイス。
- 細長い本体は、回転式先端部付近に固定湾曲部をさらに有し、
固定湾曲部は、少なくとも1つのマーカに対して一定の方向に位置し、デバイスを操縦するときに支援するようにした、請求項11に記載のデバイス。 - OCTセンサからの撮像を妨害せず、透視法により視認される細長い本体でのマーカをさらに備えた、請求項1に記載のデバイス。
- マーカを使用した透視画像を用いて、OCTセンサから生成したOCT画像を整列させるように構成されたコントローラをさらに備えた、請求項13に記載のデバイス。
- 回転式先端部付近に開口部を有する洗浄ポートをさらに備えた、請求項1に記載のデバイス。
- 開口部は、イメージセンサから2mm未満の場所に位置する、請求項15に記載のデバイス。
- 中央管腔は、回転式先端部を回転させるように構成されたドライブシャフトを通って延在する、請求項1に記載のデバイス。
- 回転式先端部の遠位端は、イメージセンサから3mm未満の場所に位置する、請求項1に記載のデバイス。
- 細長い本体と、
細長い本体の近位端から細長い本体の遠位端まで、細長い本体内に延在する中央管腔と、
細長い本体の遠位端に位置し、細長い本体に対して回転するように構成された、らせん状のくさびを有する回転式先端部と、
回転式先端部に結合され、それと共に回転するように構成された光ファイバを有するOCTイメージセンサと、
回転式先端部を時計回りと反時計回りに交互に連続的に回転させるように構成された駆動機構とを備え、
光ファイバは、回転式先端部が回転するときに、細長い本体内で中央管腔の周囲に巻き付くように構成された、
閉塞クロッシング用のカテーテルデバイス。 - 細長い本体と、
細長い本体の近位端から細長い本体の遠位端まで、細長い本体内に延在する中央管腔と、
細長い本体の遠位端に位置し、細長い本体に対して回転するように構成された回転式先端部と、
回転式先端部に結合され、それと共に回転するように構成された光ファイバを有するOCTイメージセンサと、
カテーテルの遠位端に対して近位に位置する、細長い本体内の固定湾曲部とを備え、
細長い本体の遠位端は、OCTイメージセンサをその回転時に塞ぐように構成された1つまたは複数のマーカを有し、
固定湾曲部は、カテーテルの遠位端を、該固定湾曲部の近位に位置するカテーテルの領域に対して或る角度で位置決めする、
閉塞クロッシング用のカテーテルデバイス。 - 固定湾曲部は、約10度から約45度の角度を形成する、請求項20に記載のデバイス。
- 固定湾曲部は、細長い本体の1つまたは複数のマーカと一列に並んだ、請求項20に記載のデバイス。
- 閉塞クロッシング用カテーテルを身体内腔内へ前進させる工程と、
閉塞クロッシング用カテーテルの細長い本体の遠位端に位置する回転式遠位先端部を回転させる工程と、
回転式遠位先端部に結合されたOCTセンサを使用して、カテーテルを包囲する身体内腔の領域を撮像する工程と、
回転式遠位先端部に、身体内腔内の閉塞を通過させる工程とを含む、
閉塞または病変部のクロッシング方法。 - 身体内腔内でカテーテルを回転させる工程をさらに含む、請求項23に記載の方法。
- 閉塞クロッシング用カテーテルの細長い本体内の中央管腔をガイドワイヤに通過させることにより、ガイドワイヤを前進させて閉塞を通過させる工程をさらに含む、請求項23に記載の方法。
- 撮像領域を画面上に表示する工程をさらに含む、請求項23に記載の方法。
- 回転式先端部を回転させる工程は、閉塞クロッシング用カテーテルの中央管腔の周囲に、OCTセンサを形成する光ファイバを巻き付けることを含む、請求項23に記載の方法。
- 回転させる工程は、回転式先端部を時計回りと反時計回りに交互に回転させることを含む、請求項23に記載の方法。
- 回転式先端部を回転させて内腔内の組織を分離しつつカテーテルを前進させる工程をさらに含む、請求項23に記載の方法。
- OCTセンサ付近の流体ポートを通じて流体を流す工程をさらに含む、請求項23に記載の方法。
- ポートを通じて1mL未満の流体を流す、請求項30に記載の方法。
- OCTセンサを用いて収集した画像データを表示する前に、該画像データを補正して検出器に対するイメージセンサの遅延を考慮するようにした工程をさらに含む、請求項23に記載の方法。
- OCTセンサを用いて収集した画像データを表示する前に、該画像データを補正して画像の一部をマスクするようにした工程をさらに含む、請求項23に記載の方法。
- OCTセンサを用いて取得した画像データを方向付けし、透視画像と一列に並べる工程をさらに含む、請求項23に記載の方法。
- 閉塞クロッシング用カテーテルを、患者の閉塞した身体内腔内へ前進させる工程と、
カテーテルの細長い本体に対して、少なくとも1つのらせん刃とOCTイメージセンサとを含むカテーテルの回転式遠位先端部を回転させる工程と、
回転式先端部でOCTセンサを使用して、カテーテルを包囲する身体内腔の領域を撮像する工程と、
回転式先端部の1回転ごとに少なくとも1回OCTセンサからの撮像を妨害するように構成された少なくとも1つのマーカを含むカテーテルを、身体内腔のOCT画像とマーカとに基づいて患者の身体内腔内で操縦する工程とを含む、
慢性完全閉塞のクロッシング方法。 - カテーテルは、少なくとも1つのマーカに対して一定の方向を有する回転式先端部付近の固定湾曲部を有し、
操縦する工程は、カテーテルの細長い本体を回転させて固定湾曲部を方向付ける工程を含む、請求項35に記載の方法。 - 操縦する工程は、カテーテルの遠位端を、OCTセンサが撮像する非正常な組織に対して向けることを含む、請求項35に記載の方法。
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US11903677B2 (en) | 2024-02-20 |
EP3135232B1 (en) | 2018-05-02 |
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JP6205344B2 (ja) | 2017-09-27 |
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CA2831306A1 (en) | 2012-10-26 |
EP2691038A2 (en) | 2014-02-05 |
EP2691038A4 (en) | 2015-01-07 |
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EP3135232A1 (en) | 2017-03-01 |
US20120253186A1 (en) | 2012-10-04 |
US11134849B2 (en) | 2021-10-05 |
WO2012145133A2 (en) | 2012-10-26 |
CA2831306C (en) | 2018-11-20 |
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