JP6641104B2 - 遠位アクセス吸引ガイドカテーテル - Google Patents
遠位アクセス吸引ガイドカテーテル Download PDFInfo
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- JP6641104B2 JP6641104B2 JP2015114582A JP2015114582A JP6641104B2 JP 6641104 B2 JP6641104 B2 JP 6641104B2 JP 2015114582 A JP2015114582 A JP 2015114582A JP 2015114582 A JP2015114582 A JP 2015114582A JP 6641104 B2 JP6641104 B2 JP 6641104B2
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- Prior art keywords
- catheter
- tubular member
- catheter device
- lumen
- item
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
- Y10T29/49863—Assembling or joining with prestressing of part
- Y10T29/49865—Assembling or joining with prestressing of part by temperature differential [e.g., shrink fit]
Description
本願は、2010年10月4日に出願された米国仮特許出願第61/389,688号に対して優先権を主張し、その開示全体は本明細書中において明示的に参考として援用される。
本発明は、概して医療の装置および方法に関連しており、より詳細には、脳の血管のような血管における欠損にアクセスし、診断し、または処置することに使用可能な、カテーテルを基にしたシステムおよび方法に関連している。
5454795 Samson および5,733,400 Gold)は概して頭蓋底上に位置しておらず、遠位の大脳血管系においてマイクロカテーテルを支持することにおいて、それらの有効性を制限する。早期の型よりもわずかに長く、細く、いくらか可撓性があるが、5,180,376&5,484,425 Fiscell、5,045,072 Castillo、5,279,596 Castaneda、5454795
Samonおよび5,733,400 Goldに記載されているものと同じ製造技術で組み立てられる、より新しい遠位アクセスガイドカテーテルが開発されたが、よじれる問題を解決していない。(Neuron Penumbra Recall−10/02/09)
例えば、本発明は、以下を提供する。
(項目1)
カテーテル装置であって、該カテーテル装置は、
内腔および外表面を有する管状の部材であって、該管状の部材はらせん状の間隙および該らせん状の間隙内に配置された重合材料を有する金属のらせんを含む管状の部材;
該管状の部材の該内腔を通って延び、該カテーテルの内腔を画定する内側の裏地;ならびに
該管状の部材の該外表面上の外側のカバー;
を含み、ここで該らせん状の間隙内に配置された該重合材料は該内側の裏地および該外側のカバーの材料と異なるカテーテル装置。
(項目2)
上記金属のらせんがニッケルチタン合金を含む項目1に記載の装置。
(項目3)
上記金属のらせんがニッケルチタン合金リボンを含む項目1に記載の装置。
(項目4)
上記ニッケルチタン合金リボンが約0.003インチから約0.0125インチまでの幅および約0.001インチから約0.005インチまでの厚さを有するニチノール1型を含む項目3に記載の装置。
(項目5)
上記らせん状の間隙が連続的な幅のものである項目1に記載の装置。
(項目6)
上記金属のらせんの寸法(単数もしくは複数)および/または上記らせん状の間隙の幅が変化する項目1に記載の装置。
(項目7)
上記らせん状の間隙が約0.001インチから約0.0025インチまでの幅を有する項目1に記載の装置。
(項目8)
上記重合材料がエラストマーを含む項目1に記載の装置。
(項目9)
上記重合材料がキャストエラストマーを含む項目1に記載の装置。
(項目10)
上記重合材料がキャストポリウレタンを含む項目1に記載の装置。
(項目11)
上記キャストポリウレタンが熱硬化性ポリウレタン接着剤を含む項目10に記載の装置。
(項目12)
上記内側の裏地が約0.00025インチから約0.001インチまでの厚さを有する管を含む項目1に記載の装置。
(項目13)
上記内側の裏地がフルオロポリマー;PTFE;PFAおよびFEPから成る群より選択される少なくとも一つの材料を含む項目1に記載の装置。
(項目14)
上記内側の裏地が約0.0005インチの厚さを有するPTFEを含む項目1に記載の装置。
(項目15)
上記外側のカバーが約0.0005インチから約0.002インチまでの厚さを有する項目1に記載の装置。
(項目16)
上記外側のカバーがポリエステルおよびポリオレフィンから成る群より選択される少なくとも一つの材料を含む項目1に記載の装置。
(項目17)
上記外側のカバーが約0.0005インチの厚さを有するポリエステルおよびまたはポリオレフィンを含む項目1に記載の装置。
(項目18)
上記カテーテル装置が該カテーテルの長さに沿って複数の部位を有し、ここで上記金属のらせんの寸法(単数もしくは複数)および/または上記らせん状の間隙の幅が該複数の部位の間で異なる項目1に記載の装置。
(項目19)
上記カテーテル装置が近位部位、中間部位および遠位部位を有する項目18に記載の装置。
(項目20)
上記近位部位中の上記らせん状の部材が約0.008インチの幅、約0.0025インチの厚さおよび約0.002インチ幅のらせん状の間隙を有し;上記中間部位中の該らせん状の部材が約0.008インチの幅、約0.0025インチの厚さおよび約0.004インチ幅のらせん状の間隙を有しならびに上記遠位部位中の該らせん状の部材が約0.008インチの幅、約0.0025インチの厚さおよび約0.004インチ幅のらせん状の間隙を有する項目19に記載の装置。
(項目21)
上記近位部位上の上記外側のカバーが約0.001インチの厚さを有するポリエステルを含み;上記中間部位上の該外側のカバーが約0.0005インチの厚さを有するポリエステルを含みおよび上記遠位部位上の該外側のカバーが約0.0005インチの厚さを有するポリオレフィンを含む項目20に記載の装置。
(項目22)
上記遠位部位が1200°/in−lbより大きい横方向の可撓性を有する項目21に記載の装置。
(項目23)
上記遠位部位が約0.174インチ+/−0.008インチまたはそれより小さいよじれ半径を有する項目22に記載の装置。
(項目24)
上記カテーテル装置が近位部位、中間部位、第一遠位部位および第二遠位部位を有する項目1に記載の装置。
(項目25)
上記近位部位中の上記らせん状の部材が約0.008インチの幅、約0.0025インチの厚さおよび約0.002インチ幅のらせん状の間隙を有し;上記中間部位中の該らせん状の部材が約0.008インチの幅、約0.0025インチの厚さおよび約0.004インチ幅のらせん状の間隙を有しならびに上記第一遠位部位中の該らせん状の部材が約0.008インチの幅、約0.0025インチの厚さおよび約0.004インチ幅のらせん状の間隙を有しならびに上記第二遠位部位中の該らせん状の部材が約0.004インチの幅、約0.002インチの厚さおよび0.002インチのらせん状の間隙を有する項目24に記載の装置。
(項目26)
上記近位部位上の上記外側のカバーが約0.001インチの厚さを有するポリエステルを含み;上記中間部位上の該外側のカバーが約0.0005インチの厚さを有するポリエステルを含みならびに上記第一および第二遠位部位上の該外側のカバーが約0.0005インチの厚さを有するポリオレフィンを含む項目25に記載の装置。
(項目27)
上記第二遠位部位が1200°/in−lbより大きい横方向の可撓性を有する項目26に記載の装置。
(項目28)
上記第二遠位部位が約0.174インチ+/−0.008インチまたはそれより小さいよじれ半径を有する項目26に記載の装置。
(項目29)
さらにバルーンを含む項目1に記載の装置。
(項目30)
上記バルーンが特定の規格で作られたバルーンを含む項目29に記載の装置。項目の数を数えること
(項目25)
ヒトまたは動物の被験体内の障害を処置または診断するための方法であって、該方法は、A)該被験体の血管系内に項目1−30のいずれか一項に記載のカテーテル装置を挿入する工程;および
B)物質または装置を該カテーテル装置の該内腔を通して送達し、該物質または装置を使用し該障害を処置または診断する工程
を含む方法。
(項目26)
上記工程Aが上記カテーテル装置を上記被験体の頭蓋内の位置にある血管内へと進める工程を含む項目25に記載の方法。
(項目27)
上記カテーテル装置が内へと進められる上記血管が頸動脈、大脳動脈、前大脳動脈、中大脳動脈および後大脳動脈から成る群より選択される項目26に記載の方法。
(項目28)
カテーテルを製造する方法であって、該方法は、
A)らせん状の間隙を有する金属のらせんを形成または得る工程;
B)重合材料を該重合材料および該金属のらせんの組み合わせで外表面および内腔を有する管状の部材を形成するように該らせん状の間隙内に配置させる工程;
C)内側の裏地を該管状の部材の該内腔内に配置させる工程;ならびに
D)外側のカバーを該管状の部材の該外表面上に配置させる工程
を含む方法。
(項目29)
上記らせん状の間隙の幅が連続的である項目28に記載の方法。
(項目30)
上記らせん状の間隙の幅が変化する項目28に記載の方法。
(項目31)
上記内側の裏地が心棒上に配置され、それから上記金属のらせんが該内側の裏地の表面上に位置を定められる項目28に記載の方法。
(項目32)
上記金属のらせんが上記内側の裏地の周囲にらせん状に巻かれ、それから熱硬化されるニッケルチタン合金を含む項目31に記載の方法。
(項目33)
流動可能な重合体が上記らせん状の間隙内にキャストされ固まることを可能にされ、その結果上記管状の部材を該管状の部材の中に配置された上記内腔とともに形成する項目31に記載の方法。
(項目34)
上記重合体が重合体接着剤を含む項目28に記載の方法。
(項目35)
放出剤または障壁を上記金属のらせんの一つまたはそれより多くの選択される領域に適用し(apply)、上記重合体が該金属のらせんの該選択される領域に付着することを防ぐまたは妨害することをさらに含む項目34に記載の方法。
(項目36)
上記重合体接着剤が上記管状の部材と上記内側の裏地との間に付着をもたらす項目34に記載の方法。
(項目37)
上記管状の部材と上記外側のカバーとの間に付着をもたらすためにある量の重合体接着剤を該管状の部材の上記外表面と該外側のカバーの内表面との間に配置させる工程をさらに含む項目34に記載の方法。
(項目38)
上記外側のカバーが上記管状の部材の外径よりも大きな内径を初めに有する管を含み、ここで該外側のカバーは該管状の部材を覆って進ませると、該管状の部材の上記外表面上にぴったりと合うように接触する項目28に記載の方法。
(項目39)
上記外側のカバーが上記管状の部材の上記外表面上に熱収縮される項目38に記載の方法。
(項目40)
上記カテーテル装置上または内に放射線撮影マーカーを配置させる工程をさらに含む項目28に記載の方法。
(項目41)
親水性の被覆を上記外側のカバーの外表面に適用することをさらに含む項目28に記載の方法。
(項目42)
ガイドカテーテルセクションであって、該ガイドカテーテルセクションは:
近位端および遠位端を有する細長い管状のカテーテル本体ならびに該近位端と該遠位端との間に延びることで内腔を画定する通路を含み;
該細長い管状のカテーテル本体は第一裏地材料の内側の管状の裏地を含み、該内側の管状の裏地は外側の管状のカバーおよび該内側の裏地と該外側のカバーとの間の管状の部材と同軸の関係であり、該管状の部材は同じ左右像を有する金属のよじれ耐性部材および熱硬化した重合体のよじれ耐性部材を少なくとも含み、ならびに該カテーテルセクションは該遠位端の部位に16:1より大きい壁厚と内径との間の比および1200°/in−lbより大きい横方向の可撓性、および15Nよりも大きい最大抗張力を有するガイドカテーテルセクション。
(項目43)
ガイドカテーテルであって、該ガイドカテーテルは、
近位端および遠位端を有する細長い管状の部材ならびに該近位端と該遠位端との間に延びることで内腔を画定する通路を含み、該細長い管状の部材は:
a)相対的に硬い近位区画を有し、該近位区画は内側の近位の管状の裏地から構成され、該内側の近位の管状の裏地は外側の近位の管状のカバーと同軸の関係である近位の裏地材料を含み、該外側の近位の管状のカバーは近位のカバー材料を含み、該近位のカバー材料は該外側の近位の管状のカバーによって覆われる該内側の近位の管状の裏地上を編まれる1インチ当たり80ピックより多いピック数の金属の編みひも構造であり、ならびに
b)相対的に可撓性のある遠位区画を有し、遠位の該細長い管状の部材は外側の管状のカバーと同軸の関係である第一裏地材料からなる内側の管状の裏地を含み、該外側の管状のカバーは第一カバー材料ならびに金属のおよび熱硬化性重合体のよじれ耐性部材構造を少なくとも含み、該よじれ耐性部材構造は同じ左右像を有し該内側の管状の裏地の外側を巻かれ、該外側の管状のカバーに覆われ、ならびにカテーテルセクションの該遠位端の部位に16:1より大きい壁厚と内径との間の比および1200°/in−lbより大きい横方向の可撓性、および15Nよりも大きい最大抗張力を有し
;ならびに
c)少なくとも一つの中間区画を有し、該中間区画は該相対的に硬い近位区画と該相対的に可撓性のある遠位区画との間の通路を画定し、編まれた補剛構造から金属および熱硬化性重合体のよじれ耐性部材構造への移行部を有する装置。
本仮特許出願に付け加えられたおよび一部を形成しているものは以下の資料である:
以下の詳細な説明および参照する添付の図面はいくつかの、しかし必ずしもすべてではない、本発明の実施例または実施形態を説明する意図がある。説明される実施形態はすべての点で例示としてのみ考慮され制限するものではないものとして考慮されるべきである。本詳細な説明および添付の図面の内容はいかなる様式でも本発明の範囲を限定するものではない。
Claims (21)
- カテーテル本体を含むカテーテル装置であって、
前記カテーテル本体は、
内腔および外表面を画定している管状部材であって、前記管状部材は、らせん状の間隙を画定している金属のらせんと、前記らせん状の間隙内に配置された熱硬化性重合材料とを含む、管状部材と、
前記管状部材の前記内腔を通って延在しており前記カテーテル本体の内腔を画定している内側裏地と、
前記管状部材の前記外表面上の外側カバーと
を含み、
前記らせん状の間隙内に配置された前記熱硬化性重合材料は、前記内側裏地および前記外側カバーの材料とは異なる、カテーテル装置。 - 前記金属のらせんは、ニッケルチタンを含む、請求項1に記載のカテーテル装置。
- 前記らせん状の間隙は、前記金属のらせんの長さに沿った連続した幅のものである、請求項1に記載のカテーテル装置。
- 前記カテーテル装置は、その長さに沿って複数の部位を有し、前記金属のらせんの幅または前記らせん状の間隙の幅のうちの少なくとも1つは、前記複数の部位の間で異なる、請求項1に記載のカテーテル装置。
- 前記熱硬化性重合材料は、エラストマーを含む、請求項1に記載のカテーテル装置。
- 前記熱硬化性重合材料は、熱硬化性ウレタン樹脂を含む、請求項1に記載のカテーテル装置。
- 前記内側裏地は、フルオロポリマー、PTFE、PFA、およびFEPから成る群から選択される少なくとも1つの材料を含む、請求項1に記載のカテーテル装置。
- 前記外側カバーは、ポリエステルおよびポリオレフィンから成る群から選択される少なくとも1つの材料を含む、請求項1に記載のカテーテル装置。
- 前記カテーテル本体の遠位の部位は、内径対壁厚の比を有し、前記内径対壁厚の前記比は、16よりも大きいかそれと等しい値:1である、請求項1に記載のカテーテル装置。
- 前記内径対壁厚の比は、16:1〜24:1である、請求項9に記載のカテーテル装置。
- 前記カテーテル本体の前記遠位の部位は、22ニュートンの最大抗張力を有する、請求項9に記載のカテーテル装置。
- 前記カテーテル本体の前記遠位の部位は、4.42ミリメートル+/−0.2032ミリメートルまたはそれより小さいよじれ半径を有する、請求項9に記載のカテーテル装置。
- 前記カテーテル本体の前記遠位の部位は、0.113ニュートン−メートル当たり1200°のたわみよりも大きい横方向の可撓性を有する、請求項9に記載のカテーテル装置。
- 前記カテーテル本体に取り付けられたバルーンをさらに含む、請求項1に記載のカテーテル装置。
- 前記カテーテル本体は、軸方向に延びる補剛ワイヤをさらに含む、請求項1に記載のカテーテル装置。
- らせん状の間隙を画定している金属のらせんを形成するかまたは得ることと、
前記らせん状の間隙内に熱硬化性重合材料を配置し、その結果、前記熱硬化性重合材料および前記金属のらせんが、組み合わせで、外表面および内腔を有する管状部材を形成するようにすることと、
前記管状部材の前記内腔内に内側裏地を配置することと、
前記管状部材の前記外表面上に外側カバーを配置することと
を含む、方法。 - 前記熱硬化性重合材料を前記金属のらせんの前記らせん状の間隙内に配置する前に、前記金属のらせんを心棒上に巻き付けることをさらに含む、請求項16に記載の方法。
- 前記内側裏地を前記管状部材の前記内腔内に配置することは、前記内側裏地を心棒上に配置し、かつ、前記金属のらせんを前記内側裏地の表面上に位置付けることを含む、請求項16に記載の方法。
- 前記内側裏地を前記管状部材の前記内腔内に配置することは、流動可能な重合体を前記金属のらせんの前記らせん状の間隙内にキャストし、前記流動可能な重合体を固め、これにより、前記管状部材を前記管状部材の中に配置された前記内側裏地と共に形成することを含む、請求項16に記載の方法。
- 放射線不透過マーカーを前記管状部材上に配置することをさらに含む、請求項16に記載の方法。
- 前記外側カバーを前記管状部材の前記外表面上に配置することは、前記外側カバーを前記管状部材上に熱収縮させることを含む、請求項16に記載の方法。
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2011
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JP5795376B2 (ja) | 2015-10-14 |
JP2015180296A (ja) | 2015-10-15 |
CN106110469A (zh) | 2016-11-16 |
JP2020022803A (ja) | 2020-02-13 |
WO2012047803A2 (en) | 2012-04-12 |
EP2624905A4 (en) | 2014-11-19 |
EP2624905A2 (en) | 2013-08-14 |
CA2813067C (en) | 2017-01-24 |
CN103648574B (zh) | 2016-08-10 |
RU2013112656A (ru) | 2014-11-20 |
CA2813067A1 (en) | 2012-04-12 |
EP2624905B1 (en) | 2023-09-06 |
WO2012047803A3 (en) | 2013-12-27 |
JP2018118102A (ja) | 2018-08-02 |
KR101588097B1 (ko) | 2016-01-22 |
BR112013008157A2 (pt) | 2016-07-12 |
JP2014509201A (ja) | 2014-04-17 |
US20190175871A1 (en) | 2019-06-13 |
KR20130061740A (ko) | 2013-06-11 |
US10245413B2 (en) | 2019-04-02 |
US11160953B2 (en) | 2021-11-02 |
CN106110469B (zh) | 2019-07-30 |
CN103648574A (zh) | 2014-03-19 |
US20140046297A1 (en) | 2014-02-13 |
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