JP5095635B2 - 分岐カテーテル用マーカ配置 - Google Patents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1045—Balloon catheters with special features or adapted for special applications for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
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Description
この出願は、米国を除く全ての国を指定する出願人である米国籍の会社ボストン・サイエンティフィック・サイメッド・インコーポレイテッド(Boston Scientific Scimed,Inc.)、及び米国のみを指定する出願人であるポーランド市民アンジェイ・マレーヴィチ(Andrzej Malewicz)及び米国市民リチャード・シー・ガンダーソン(Richard C.Gunderson)の名義のPCT国際特許出願として2007年2月22日に出願されており、2006年2月22日出願の米国仮出願第60/776149号、及び2007年2月21日出願の米国通常出願第11/677337号に対する優先権を主張する。
本開示はマルチ・ガイドワイヤで使用するように構成されたカテーテルアセンブリに関する。マーカバンド及び他のマーカ特徴部は、例えば血管分岐部の治療中に種々のカテーテル分岐とカテーテル分岐の相対的位置とを視覚的に識別するために使用できる。開示されたカテーテルアセンブリと関連方法は主カテーテル分岐と副カテーテル分岐を含む。主バルーンは典型的には主カテーテル分岐の遠端部に配置される。カテーテルアセンブリをステントの供給のために使用するときは、ステントはまた主カテーテル分岐の遠端部にある主バルーン上に配置される。副カテーテル分岐は血管分岐部において分岐血管に対してステントを方向づけるのを助けるために使用できる。
ステント供給システム10の一つの実施例の概念図が図1〜4を参照して示される。ステント供給装置10はカテーテル軸11、主カテーテル分岐12及び副カテーテル分岐14を含む。主カテーテル分岐12は主ガイドワイヤ36を通じて進行するように構成される。主カテーテル12は先端16と少なくとも第1と第2のマーカ18、19を含む。マーカ18、19は主カテーテル分岐12に沿って長さL1だけ軸方向に離間される。副カテーテル分岐14は副ガイドワイヤ38を通じて進行するような大きさの副分岐内腔(「SBL」)を定める。副カテーテル分岐14は遠端20と少なくとも第1と第2のマーカ22、23を含む。マーカ22、23は副カテーテル分岐14に沿って長さL2だけ軸方向に離間される。長さL1はマーカ18、19間の最小長さ測定値として示される。長さL2はマーカ22、23間の最小長さ測定値として示される。
図5は、マーカが互いに画像的に区別される代替的マーカ構成を図解する。「画像的に区別される」は、体腔内部のカテーテル・マーカを観察する状況において、画像形成システム、例えばステント供給手順を観察するために一般的に使用される画像形成システムにより観察可能であると定義することができる。画像形成システム例は、蛍光透視法を用いて血管を結像し、画面上に血管及びその場でのステント供給特徴部の画像を提供するCアームX線撮影装置である。マーカの構造と組成は、マーカ間を区別する観察者の能力に影響を与え得る。例えば、マーカの長さは画像を区別できる一つの構造的相違である。マーカの直径、断面形状及び材料厚は画像を区別する他の構造的相違例である。マーカにおける放射線不透性材料のタイプと濃度は画像を区別する組成相違例である。図1〜4に示される実施例と比較した主及び副カテーテル分岐12、14上の異なる位置にあるマーカの相対的位置は、単独でも、マーカ間の構造及び組成相違と組み合わせても、やはり有用である。
近位のマーカ(例えばマーカ19、23)と遠位のマーカ(例えばマーカ18、22)の対間の軸方向間隔は、調整可能なもう一つの変数である。
本願に開示されるシステム例はオーバーザワイヤ又はラピッドエクスチェンジ・システムに使用されてもよい。いくつかのラピッドエクスチェンジ・システムの例はバルディ(Vardi)他の米国特許出願公開第2003/0181923号に開示されており、参照により本願に援用される。
本開示の一つの態様は、第1のカテーテル分岐、第2のカテーテル分岐、第1の遠位及び近位マーカ、及び第2の遠位及び近位マーカを含むカテーテルアセンブリに関する。第1のカテーテル分岐は第1の方向に延びる遠端部を含む。第2のカテーテル分岐は、おおむね第1の方向と同じ方向である第2の方向に延びる遠端部を含む。第1の遠位マーカ及び第1の近位マーカは第1のカテーテル分岐上に配置される。第2の遠位マーカ及び第2の近位マーカは第2のカテーテル分岐上に配置される。第1の遠位マーカ、第1の近位マーカ、第2の遠位マーカ及び第2の近位マーカはそれぞれ遠位部と近位部を含む。第1の遠位マーカの近位部は第2の遠位マーカの遠位部の遠位に配置され、第1の近位マーカの遠位部は第2の近位マーカの近位部の近位に配置される。
11 カテーテル軸
12 主カテーテル分岐
14 副カテーテル分岐
16 主カテーテル先端
17 第3のマーカ
18 第1のマーカ
19 第2のマーカ
20 副カテーテルの遠端
21 第3のマーカ
22 第1のマーカ
23 第2のマーカ
24 螺旋コイル
26 分岐されたバルーン
28 主バルーン
30 副バルーン
32 副バルーンの近位部
34 副バルーンの遠位部
36 主ガイドワイヤ
38 分岐ガイドワイヤ
40 血管分岐部
42 主血管
44 分岐血管
46A〜C 閉塞
50 ステント
52 ステント側方開口
54 ステントの延長可能な構造
64 カテーテル分岐の外層
200 カテーテルアセンブリ
Claims (16)
- 第1の方向に延びる遠端部を有する第1のカテーテル分岐と、
遠端部を有する第2のカテーテル分岐であって、前記第2のカテーテル分岐の前記遠端部が前記第1の方向と略同一方向である第2の方向に延びる第2のカテーテル分岐と、
それぞれが遠位部と近位部を有し、前記第1のカテーテル分岐上に配置された第1の遠位マーカ及び第1の近位マーカと、
それぞれが遠位部と近位部を有し、前記第2のカテーテル分岐上に配置された第2の遠位マーカ及び第2の近位マーカであって、前記第1カテーテル分岐と前記第2カテーテル分岐とが捩れ状態でない場合、前記第1の近位マーカの前記遠位部が前記第2の近位マーカの前記近位部の近位に配置され、且つ前記第1の遠位マーカの前記近位部が前記第2遠位マーカの前記遠位部の遠位に配置される、第2の遠位マーカ及び第2の近位マーカと、を備え、
前記第1カテーテル分岐と前記第2カテーテル分岐とが捩れ状態である場合、前記第1の遠位マーカの前記近位部が前記第2の遠位マーカの前記遠位部の近位に配置される
カテーテルアセンブリ。 - 前記第2のカテーテル分岐が、ガイドワイヤ内腔を定めるガイドワイヤ軸と、膨張内腔を定める膨張軸と、前記膨張内腔と流体連通して結合されたバルーン部材と、を含み、前記第2の近位及び遠位マーカが前記ガイドワイヤ軸上に配置されることを特徴とする請求項1に記載のカテーテルアセンブリ。
- 前記第1のカテーテル分岐が、ガイドワイヤ内腔を定めるガイドワイヤ軸と、膨張内腔を定める膨張軸と、前記膨張内腔と流体連通して結合されたバルーン部材と、を含み、前記第1の近位及び遠位マーカが前記ガイドワイヤ軸上に配置されることを特徴とする請求項1に記載のカテーテルアセンブリ。
- 近位開放端と、遠位開放端と、前記近位及び遠位開放端の間の位置において側壁内に定められた側方開口と、を有するステントと、
前記ステントの側方開口を通る第1の方向に延びる遠端部を有する第1のカテーテル分岐と、
前記遠位及び近位開放端の間で前記ステントを通って延びる遠端部を有する第2のカテーテル分岐であって、前記第1のカテーテル分岐の前記遠端部が、カテーテルアセンブリの体腔への挿入に先立ち前記第1の方向と略同一方向である第2の方向に延び、前記第2のカテーテル分岐は、前記ステントを配置するための主バルーン及び副バルーンを備え、前記副バルーンは、前記主バルーンに対して半径方向外側に延びるように構成される、第2のカテーテル分岐と、
前記第1のカテーテル分岐上に配置された第1の遠位マーカ及び第1の近位マーカであって、前記第1の遠位マーカが前記ステントの前記側方開口の遠位に配置され、前記第1の近位マーカが前記第1の遠位マーカの近位に配置される第1の遠位マーカ及び第1の近位マーカと、
前記第2のカテーテル分岐上に配置された第2の遠位マーカ及び第2の近位マーカであって、前記第1カテーテル分岐と前記第2カテーテル分岐とが捩れ状態でない場合、前記第2の遠位マーカが前記第1の遠位マーカの近位、且つ前記第1の近位マーカの遠位に配置され、前記第2の近位マーカが前記第1の近位マーカの近位に配置され、前記第1カテーテル分岐と前記第2カテーテル分岐とが捩れ状態である場合、前記第2の遠位マーカが前記第1の遠位マーカ及び前記第1の近位マーカの双方の遠位に配置される、第2の遠位マーカ及び第2の近位マーカと、を備えるカテーテルアセンブリ。 - 前記第1の遠位マーカの少なくとも一部が前記ステントの遠端の遠位に配置され、前記第1の近位マーカの少なくとも一部が前記ステントの近端の近位に配置されることを特徴とする請求項4に記載のカテーテルアセンブリ。
- 前記第2の遠位マーカの少なくとも一部が前記ステントの遠端の遠位に配置され、前記第2の近位マーカの少なくとも一部が前記ステントの近端の近位に配置されることを特徴とする請求項5に記載のカテーテルアセンブリ。
- 前記第1の遠位マーカと前記第1の近位マーカがそれぞれ遠位部と近位部を有し、前記第2の遠位マーカと前記第2の近位マーカがそれぞれ遠位部と近位部を有し、前記第1の遠位マーカの前記近位部が前記第2の遠位マーカの前記遠位部の遠位に配置され、前記第1の近位マーカの前記近位部が前記第2の近位マーカの前記遠位部の遠位に配置されることを特徴とする請求項4に記載のカテーテルアセンブリ。
- 前記第1の遠位マーカと前記第1の近位マーカが、前記第2の遠位マーカと前記第2の近位マーカとそれぞれ画像的に区別されることを特徴とする請求項7に記載のカテーテルアセンブリ。
- 前記第1のカテーテル分岐の、前記第1の遠位マーカと前記第1の近位マーカの間の位置に配置された第1の中間マーカをさらに備える請求項4に記載のカテーテルアセンブリ。
- 前記第2のカテーテル分岐の、前記第2の遠位マーカと前記第2の近位マーカの間の位置に配置された第2の中間マーカをさらに備える請求項4に記載のカテーテルアセンブリ。
- ステントを通って延びる遠端部を有する第1のカテーテル分岐と、
前記ステントを通って延びる遠端部を有する第2のカテーテル分岐であって、前記第1のカテーテル分岐の前記遠端部が、前記カテーテルアセンブリの体腔への挿入に先立ち前記第2のカテーテル分岐の前記遠端部に隣接して延びる第2のカテーテル分岐と、
軸方向に離間された位置において前記第1のカテーテル分岐上に配置された第1の遠位マーカ及び第1の近位マーカと、
軸方向に離間された位置において前記第2のカテーテル分岐上に配置された第2の遠位マーカ及び第2の近位マーカであって、前記第1の遠位マーカ及び前記第1の近位マーカが前記第2の遠位マーカ及び前記第2の近位マーカの長さのそれぞれと画像的に区別される長さを有する第2の遠位マーカ及び第2の近位マーカと、を備え
前記第1カテーテル分岐と前記第2カテーテル分岐とが捩れ状態でない場合、前記第1の遠位マーカと前記第2の遠位マーカとは第1の縦配置であり、前記第1カテーテル分岐と前記第2カテーテル分岐とが捩れ状態である場合、前記第1の遠位マーカと前記第2の遠位マーカとは別の第2の縦配置である、カテーテルアセンブリ。 - 前記第1の遠位マーカ及び前記第1の近位マーカの長さが前記第2の遠位マーカ及び前記第2の近位マーカの長さより少なくとも25%大きいことを特徴とする請求項11に記載のカテーテルアセンブリ。
- 遠位開放端と、近位開放端と、前記近位及び遠位開放端間の位置において側壁内に定められた側方開口とを有するステントと、
主バルーン部材及び副バルーン部材を含む主カテーテル分岐であって、前記主バルーン部材は前記近位開放端から前記遠位開放端まで前記ステントを通って延び、前記副バルーン部材は膨張したときに前記主バルーンに対して半径方向外側に延びるように構成され、
血管分岐部の主血管まで第1のガイドワイヤを通じて進行するように構成される主カテーテル分岐と、
前記ステントの前記近位開放端の中に延び、前記側方開口から外に延びる副カテーテル分岐であって、前記血管分岐部の分岐血管に第2のガイドワイヤを通じて進行するように構成された副カテーテル分岐と、
前記主カテーテル分岐上に配置された主遠位マーカ及び主近位マーカと、
前記副カテーテル分岐上に配置された副遠位マーカ及び副近位マーカであって、前記主及び副近位マーカの少なくとも一方が前記ステントの外部に配置され、前記主及び副遠位マーカの少なくとも一方が前記ステントの外部に配置され、前記主及び副遠位マーカと前記主及び副近位マーカは、前記主カテーテル分岐と前記副カテーテル分岐とが捩れ状態でない場合には第1の相対位置を有し、前記主カテーテル分岐と前記副カテーテル分岐とが捩れ状態である場合には別の第2の相対位置を有する、副遠位マーカ及び副近位マーカと、を備えるステント供給システム。 - 前記第1の相対位置において前記副遠位マーカの少なくとも一部が前記主遠位マーカの遠位部の遠位に配置され、前記第2の相対位置において前記副遠位マーカの少なくとも一部が前記主遠位マーカの遠位部の近位に配置されることを特徴とする請求項13に記載のステント供給システム。
- 前記副近位マーカの少なくとも一部が前記主近位マーカの近位部よりさらに近位に配置されることを特徴とする請求項14に記載のステント供給システム。
- 相対的捩れが、少なくとも主遠位マーカ及び主近位マーカ間の位置における主及び副カテーテル分岐の互いに対する捩れを含むことを特徴とする請求項14に記載のステント供給システム。
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-
2007
- 2007-02-21 US US11/677,337 patent/US8821561B2/en not_active Expired - Fee Related
- 2007-02-22 CA CA2641154A patent/CA2641154C/en not_active Expired - Fee Related
- 2007-02-22 JP JP2008556444A patent/JP5095635B2/ja not_active Expired - Fee Related
- 2007-02-22 EP EP07751504A patent/EP1993478A2/en not_active Withdrawn
- 2007-02-22 WO PCT/US2007/004748 patent/WO2007100672A2/en active Application Filing
Also Published As
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WO2007100672A2 (en) | 2007-09-07 |
WO2007100672A3 (en) | 2008-01-10 |
JP2009527332A (ja) | 2009-07-30 |
CA2641154C (en) | 2016-04-12 |
US8821561B2 (en) | 2014-09-02 |
EP1993478A2 (en) | 2008-11-26 |
US20070203562A1 (en) | 2007-08-30 |
CA2641154A1 (en) | 2007-09-07 |
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