JP2016516463A - 植込固定具 - Google Patents
植込固定具 Download PDFInfo
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- JP2016516463A JP2016516463A JP2015562347A JP2015562347A JP2016516463A JP 2016516463 A JP2016516463 A JP 2016516463A JP 2015562347 A JP2015562347 A JP 2015562347A JP 2015562347 A JP2015562347 A JP 2015562347A JP 2016516463 A JP2016516463 A JP 2016516463A
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Abstract
Description
本発明は、一般に、固定具システム、展開システム、そして小型植込部品を持つ固定具を経皮的に体内に植込むための方法に関する。このシステムおよび方法は、体内の標的組織の壁に植込まれる、たとえば体積が0.005〜100mm3の特に小型の固定具に関するものである。固定具のサイズの範囲は、標的組織の壁の厚みによって規定される。もっとも、固定具は、0.01〜10mmの範囲の外径と、好ましくは20mm以下の高さを有するものとすることができ、好ましくは、直径が0.01〜10mmの範囲で高さが0.01〜20mmの範囲の小型植込部品の組み込みが可能となるよう構成されていてもよい。部品は、固定具のポジショニングアームに完全に組み込まれるのが望ましいかもしれない。固定具は、血栓を生じさせることがなく、生物分解性がなく、生物付着しない材料、好ましくは、たとえば、ニチノール、ステンレス鋼などの好適な合金またはポリマーのような形状記憶材料からなる。一実施形態において、固定具は、外径が1mmで、0.4mmより低い高さを有し、直径が0.8mmで高さが0.3mmの小型植込部品の組み込みが可能である。固定具を埋め込むための好ましい標的エリアは、標的部位における血管の厚みに基づいて決まるものとしてもよく、0.5mm以上50mm以下としてもよい。脈管ではない標的構造の標的エリアとしては、たとえば、厚みが0.5〜10mmの範囲となるような、心臓の隔壁や肝実質などが挙げられる。
は、ストリップにより形成されている。図1Aにおいて、固定具110は、デリバリーシステム内にある場合のように展開前の状態であり、第1のスタビライザー125と第2のスタビライザー120とポジショニングアーム130とは、クリンプされた状態にある。一実施形態において、プッシュロッドの構成によって、ポジショニングアームに対応付けられたリングをもう一方のリングよりも大きくしてもよく、その逆にしてもよい。
Claims (24)
- 近位側スタビライザーと、遠位側スタビライザーと、それらの間のブリッジと、ポジショニングアームとを有し、前記第1および第2のスタビライザーは、クリンプされた形態を有し、展開された形態をとり得る、植込固定具。
- 前記ポジショニングアームは、クリンプされた状態と展開された状態とを有することを特徴とする請求項1の固定具。
- 小型植込部品が前記ポジショニングアームに取り付けられていることを特徴とする請求項1の固定具。
- 前記小型植込部品がセンサーであることを特徴とする請求項3の固定具。
- 前記センサーが、血圧を監視するよう構成されていることを特徴とする請求項4の固定具。
- 前記センサーが化学特性を監視するよう構成されていることを特徴とする請求項4の固定具。
- 第1のリングおよび第2のリングをさらに有する、請求項1〜6のいずれかの固定具。
- 前記第1のスタビライザーおよび前記ポジショニングアームが前記第1のリングから延び、前記第2のスタビライザーが前記第2のリングから延びていることを特徴とする請求項7の固定具。
- 前記第1のリングが前記第2のリングよりも大きいことを特徴とする請求項7または8の固定具。
- クリンプされた形態を有し、展開された形態をとり得る、第1のスタビライザーと、第2のスタビライザーと、それらの間のブリッジとを備える固定具を経皮的にデリバリーして植込むための展開システムであって、挿管カニューレと、プッシュロッドと、シースとを有する展開システム。
- 前記固定具は、第1のリングおよび第2のリングを有するブリッジを備え、前記第1のスタビライザーおよびポジショニングアームが前記第1のリングから延び、前記第2のスタビライザーが前記第2のリングから延びていることを特徴とする請求項10の展開システム。
- 前記シースが、展開に先立ち、前記第1のスタビライザー、第2のスタビライザーおよびポジショニングアームをクリンプされた状態に維持することを特徴とする請求項10の展開システム。
- さらに針を有する請求項10の展開システム。
- カニューレとシースと固定具とを有する展開システムであって、前記固定具が、ポジショニングアームと、第1のリングから延びる第1のスタビライザーと、第2のリングから延びる第2のスタビライザーとを配向させて備え、前記シースが、前記第1のスタビライザーおよび前記第2のスタビライザーをクリンプされた状態に維持するよう構成された展開システムを使用する方法であって、
前記カニューレを標的部位に進めるステップと、
前記固定具を前記標的部位に位置決めするステップと、
前記第1のスタビライザーをクリンプされた状態からリリースするために制御された量の力を与えるステップと、
前記第2のスタビライザーをクリンプされた状態からリリースするために制御された量の力を与えるステップと、
前記カニューレを引っ込めるステップと
を有する方法。 - 前記標的部位が肝門脈内の場所である、請求項14の方法。
- 前記シースが、前記第1のスタビライザーと、前記第2のスタビライザーと、前記ポジショニングアームとを、前記クリンプされた状態から制御可能にリリースする機械的手段を有することを特徴とする請求項14または15のいずれかの方法。
- 前記展開システムがさらにプッシュロッドを有し、
前記固定具を前記標的部位に進めるために前記プッシュロッドを前記カニューレを通して挿入するステップと、
前記固定具の展開に続けて前記プッシュロッドを引っ込めるステップと
を有する請求項14〜16のいずれかの方法。 - 前記ポジショニングアームが前記第1のリングから延びていることを特徴とする請求項14〜16のいずれかの方法。
- 前記ポジショニングアームが前記第2のリングから延びていることを特徴とする請求項14〜16のいずれかの方法。
- 前記展開システムがさらに針を有し、前記カニューレを標的部位に進める前に、前記方法が、さらに、
前記針で外部体組織を穿孔すること、および
前記針を覆うように前記カニューレを進めること
をさらに有する請求項14の方法。 - 固定具を製造する方法であって、
マンドレル上に材料を配置するステップと、
前記マンドレルをマンドレルカバーで覆うステップと、
前記材料に熱処理を施して前記固定具を形成するステップと
を有する方法。 - 第1のディスクと第2のディスクとアクセルとを有するマンドレルをさらに有し、前記第1のディスクおよび第2のディスクがそれぞれ螺旋状の溝を有することを特徴とする請求項21の方法。
- 拡張可能な第1および第2のスタビライザーを有する固定具を製造するためのマンドレルであって、第1のディスクと第2のディスクとそれらの間のアクセルとを有し、前記第1のディスクが前記第2のディスクに向かう凸面を有し、前記第2のディスクが前記第1のディスクに向かう凸面を有し、各ディスクが、前記アクセルから螺旋状に延びる溝を有することを特徴とするマンドレル。
- 複数の部分が一緒になって前記マンドレルを包むようになっているマンドレルカバーをさらに有する請求項23に記載のマンドレル。
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CN108354589A (zh) | 2018-08-03 |
AU2013382051A1 (en) | 2015-09-03 |
JP6350833B2 (ja) | 2018-07-04 |
HK1212579A1 (zh) | 2016-06-17 |
US20140275865A1 (en) | 2014-09-18 |
CN105050489A (zh) | 2015-11-11 |
WO2014140684A1 (en) | 2014-09-18 |
RU2632524C2 (ru) | 2017-10-05 |
IL240995A0 (en) | 2015-11-30 |
AU2013382051B2 (en) | 2017-05-18 |
EP2967328A1 (en) | 2016-01-20 |
CN105050489B (zh) | 2018-02-13 |
JP2018153670A (ja) | 2018-10-04 |
WO2014140684A9 (en) | 2014-11-27 |
RU2015135240A (ru) | 2017-04-21 |
JP6519827B2 (ja) | 2019-05-29 |
CA2907009A1 (en) | 2014-09-18 |
AU2013382051C1 (en) | 2017-11-16 |
RU2017132469A (ru) | 2019-02-06 |
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RU2684841C2 (ru) | 2019-04-15 |
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