JP2022023893A - 操向自在な腔内医療機器 - Google Patents
操向自在な腔内医療機器 Download PDFInfo
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Abstract
Description
[0001] 本願は、2016年2月7日に出願された米国仮特許出願第62/292,064号に従属し、かつ優先権を主張するもので、その全内容は参照により本願に組み込まれる。
連邦政府資金による研究又は開発の記載
[0002] 該当なし
[0003] 本発明は操縦可能な腔内医療機器に関し、より具体的には、身体の内腔に導入され、制御可能に動かされる可撓性のある細い医療機器(マイクロカテーテル又はガイドワイヤなど)に関する。この医療機器は、遠位の電気駆動式の屈曲可能な部分と、体内の標的とする解剖学的部位まで医療機器を操縦するための選択的に操作可能な先端部分とを含みうる。
[0004] 腔内医療機器は、体内の部位と機器を用いた治療方法に応じて、様々な構造を有する。腔内機器は一般的に、動脈又は静脈などの管腔、或いは咽頭、尿道などの体内経路(bodily passageway)、身体開口部、或いはその他の解剖学的経路に挿入され、誘導されることが可能な極めて細く可撓性のある管を含む。このような医療機器の例には、注射器、内視鏡、カテーテル及びマイクロカテーテル、ガイドワイヤ、並びにその他の手術器具が含まれる。
また、マスターコントローラ500とローカル通信部材501は電話システム、ブルートゥース、802.11無線通信、及び/又はインターネットを介して通信しうることを示している。
Claims (36)
- 遠位端と近位端を有する細長い可撓性部分と、
少なくとも1つのイオン導電性高分子アクチュエータとを含む医療機器であって、前記アクチュエータは、
前記細長い可撓性部分の遠位端に隣接して固定された少なくとも1つの高分子電解質層と、
前記少なくとも1つの高分子電解質層の周囲で円周上に分散配置された複数の電極と、
近位端と前記複数の電極の少なくとも1つに連結された遠位端をそれぞれ有する複数の導電性導管とを備え、
前記少なくとも1つの高分子電解質層は、前記複数の導電性導管の少なくとも1つを通って、前記複数の電極の少なくとも1つに加えられる電気信号に応答して非対称に変形する、医療機器。 - 前記少なくとも1つの高分子電解質層は、電解質と、フッ素高分子及び本質的導電性高分子からなる群から選択された高分子とを含む、請求項1に記載の医療機器。
- 前記フッ素高分子は、パーフルオロ化イオノマー、ポリビニリデンジフルオライド(PVDF)、或いはこれらのコポリマーである、請求項2に記載の医療機器。
- 前記本質的導電性高分子は、ポリアニリン(PANI)、ポリピロール(Ppy)、ポリ(3,4-エチレンジオキシチオフェン)(PEDOT)、ポリ(p-フェニレンスルフィド)(PPS)、或いはこれらの組み合わせを含む、請求項2に記載の医療機器。
- 前記複数の電極の各々は、プラチナ、金、カーボン、並びに、プラチナ、金及びカーボンのうちの2つ以上の組み合わせを含む、請求項1に記載の医療機器。
- 前記複数の電極の各々は、炭化物由来カーボン、カーボンナノチューブ、グラフェン、炭化物由来カーボンとイオノマーの複合材料、及びカーボンナノチューブとイオノマーの複合材料のうちの1つを含む、請求項5に記載の医療機器。
- 前記複数の電極は、前記少なくとも1つの高分子電解質層の周囲で円周上に等しい角度で分散配置されている、請求項1に記載の医療機器。
- 前記細長い可撓性部分は更に、
近位端と前記少なくとも1つの高分子電解質層と連結するように配置された遠位端を有する細長い可撓性内部部材と、
前記内部部材と前記複数の導電性導管を取り囲む外部部材と
を備える、請求項1に記載の医療機器。 - 前記内部部材と前記少なくとも1つの高分子電解質層は更にボアを形成し、前記高分子電解質層は、前記高分子電解質層の前記ボアが前記内部部材の前記ボアに揃えられた状態で、前記遠位端に隣接して固定される、請求項8に記載の医療機器。
- 前記導電性導管の各々は、互いに電気絶縁されている、請求項1に記載の医療機器。
- 前記外部部材は、前記外部部材内に埋め込まれた複数の内腔を備え、各内腔は、前記複数の導電性導管の各々を通過するため、前記外部部材に沿って長手方向に内部空間を有する、請求項8に記載の医療機器。
- 前記複数の導電性導管の各々は更に、その上に覆われた絶縁被覆を含む、請求項1に記載の医療機器。
- 剛性と強度を高めるため、近位端と遠位端との間に介在する、前記内部部材の周囲にらせん状に又は編み込まれた状態で巻きつけられた少なくとも1つのワイヤを更に備える、請求項8に記載の医療機器。
- 前記少なくとも1つのワイヤを取り囲む絶縁部材を更に備える、請求項13に記載の医療機器。
- 前記細長い可撓性部分の近位端に設けられ、前記導電性導管によって運ばれ、前記複数の電極に付与される電荷を、選択的に制御して、前記医療機器の前記少なくとも1つのイオン導電性高分子アクチュエータを操作するように、前記導電性導管に電気的に接続された電気コントローラを更に備える、請求項1に記載の医療機器。
- 前記電気コントローラを介して屈曲の2つの自由度を提供するように、屈曲制御信号を前記少なくとも1つのイオン導電性高分子アクチュエータに入力するための操作可能な制御部材を有するマスターコントローラを更に備える、請求項15に記載の医療機器。
- 前記医療機器を長さ方向に移動するように構成された駆動アセンブリを更に備え、前記駆動アセンブリは、
グリップ面を有する第1の回転式駆動部材と、
前記第1の回転式駆動部材の前記グリップ面に近接して配置されたグリップ面を有し隣接する第2の回転式駆動部材と、
前記第1の回転式駆動部材と前記第2の回転式駆動部材のうちの少なくとも1つを、制御可能に回転するように連結された少なくとも1つの電動モーターとを含み、
前記第1の回転式駆動部材と前記第2の回転式駆動部のうちの1つの回転が前記医療機器を軸方向に動かすように、前記医療機器は中間に配置され、前記第1の回転式駆動部材の前記グリップ面と前記隣接する第2の回転式駆動部材の前記グリップ面によって係合される、請求項15に記載の医療機器。 - 前記第1の回転式駆動部材の時計回りの回転及び隣接する前記第2の回転式駆動部材の反時計回りの回転は、前記医療機器を第1の方向に動かし、前記第1の回転式駆動部材の反時計回りの回転及び隣接する前記第2の回転式駆動部材の時計回りの回転は、前記医療機器を前記第1の方向とは反対の第2の方向に動かす、請求項17に記載の医療機器。
- 前記電気コントローラを介して屈曲の2つの自由度を提供するように、屈曲制御信号を前記少なくとも1つのイオン導電性高分子アクチュエータに入力するため、及び/又は、並進の1つの自由度を提供するように、前進後退制御信号を前記駆動アセンブリに入力するため、操作可能な制御部材を有するマスターコントローラを更に備える、請求項17に記載の医療機器。
- 前記第1の回転式駆動部材、前記第2の回転式駆動部材、前記医療機器が通過する近位ポート、前記医療機器が通過する遠位ポート、及び前記医療機器の巻線を保存するための内部空洞を含む密閉された内部部分を有する第1の部分と、
モーターを支持する第2の部分と
を含むケースを更に備える、請求項17に記載の医療機器。 - 前記ケースの前記第2の部分と前記ケースの前記第1の部分は、前記モーターと前記第1の回転式部材及び前記第2の回転式部材のうちの少なくとも1つとが動作可能に係合するように、一方が他方に連結されるように適合されている、請求項20に記載の医療機器。
- 前記複数の電極の各々で前記電気信号の変化を検知するため、前記複数の電極に電気的に接続された検知部材を更に備える、請求項1に記載の医療機器。
- 前記マスターコントローラの操作に対応する信号を送信するため前記マスターコントローラに連結された送信器と、
前記駆動アセンブリ、並びに、前記送信器によって前記駆動アセンブリに送信される前記信号を受信するための前記電気コントローラ、及び/又は前記マスターコントローラの操作に応答する前記電気コントローラに、電気的に接続された受信器と
を更に備える、請求項19に記載の医療機器。 - 高分子電解質層を管状に調製する方法であって、
平坦な表面を有する基板を提供すること、
前記高分子電解質層用に所望のサイズの直径を有するマンドレルを提供すること、
フッ素高分子と本質的導電性高分子からなる群から選択されたベース材料の大量の分散液を提供すること、
前記基板上に前記分散液を塗布すること、
前記基板上に10ミクロンから50ミクロンまでの厚みを有する硬化高分子膜を形成するため、前記選択されたベース材料の分散液を硬化すること、
前記高分子の複数の被覆からなる全体的に管状のスリーブを提供するため、前記マンドレルの一部に前記高分子膜を巻き付けること、
熱収縮管を提供すること、
前記マンドレルの一部とその上の全体的に管状の前記スリーブを前記熱収縮管で覆うこと、及び、
均質な管状の高分子電解質層を形成するため、前記高分子膜のリフローを引き起こすように前記熱収縮管を加熱すること
を含む方法。 - 前記フッ素高分子はパーフルオロ化イオノマー、ポリビニリデンジフルオライド(PVDF)或いはこれらのコポリマーを含む、請求項24に記載の方法。
- 前記本質的導電性高分子は、ポリアニリン(PANI)、ポリピロール(Ppy)、ポリ(3,4-エチレンジオキシチオフェン)(PEDOT)、ポリ(p-フェニレンスルフィド)(PPS)、ポリビニリデンフルオライド、ポリビニリデンジフルオライド、又はプロピレンカーボネートのうちの一又は複数を含む、請求項24に記載の方法。
- 前記熱収縮管はフッ化エチレンプロピレン(FEP)管である、請求項24に記載の方法。
- 前記熱収縮管は、200°Cから230°Cまでの温度で加熱される、請求項24に記載の方法。
- 医療機器のイオン導電性高分子アクチュエータを管状に調製する方法であって、
外壁を有する高分子電解質層を提供すること、
揮発性溶剤にカーボンベース導電性粉末を加えた混合物を提供すること、
各々が近位端と遠位端を有する複数の導電性導管を提供すること、
カーボン電極層を形成するため、前記高分子電解質層の前記外壁の上に前記混合物を塗布すること、
各導電性導管の前記遠位端を前記カーボン電極層に接触させること、
熱収縮管を提供すること、
前記高分子電解質層とその上の前記カーボン電極層を前記熱収縮管で覆うこと、及び
前記イオン導電性高分子アクチュエータを形成するため、前記高分子電解質層のリフローを引き起こすように前記熱収縮管を加熱すること
を含む方法。 - 前記高分子電解質層は更に電解質に含浸される、請求項29に記載の方法。
- 前記電解質は、1-エチル-3-メチルイミダゾリウムテトラフルオロボラート(EMI-BF4)、1-エチル-3-メチルイミダゾリウムビス(トリフルオロメチルスルホニル)イミド(EMI-TFSI)、或いはこれらの組み合わせのうちの一又は複数を含むイオン液体を備える、請求項29に記載の方法。
- 前記カーボン電極層の一部は更に、一又は複数の金属層で覆われている、請求項29に記載の方法。
- 前記熱収縮管の加熱後、複数の電極を形成するため、前記カーボン電極層は更に微細加工される、請求項29に記載の方法。
- 前記カーボンベース導電性粉末は、炭化物由来カーボン、カーボンナノチューブ、カーボンエアロゲル、グラフェン、或いはこれらの組み合わせを含む、請求項29に記載の方法。
- 前記カーボンベース導電性粉末は更に、遷移金属酸化物粉末、金属粉末、或いはこれらの組み合わせを含む、請求項29に記載の方法。
- 前記混合物は、ブラシ塗装又はスプレー塗装を用いて、前記高分子電解質層の前記外壁の上に塗布される、請求項29に記載の方法。
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