JP5460861B2 - エネルギーおよび生体活性物質の有向送達 - Google Patents
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Description
本出願は、米国特許法119条(e)項の下、2009年5月13日に出願された米国仮特許出願第61/177,744号(代理人整理番号021830−004200US)の恩典を主張し、この文献の開示全体は、本明細書の出発点となる。
図1は、内腔の周囲に位置する体内組織に選択的に薬物を送達するための放出可能なコーティングを有するカテーテルシステム10の一実施形態を示す。カテーテルシステム10は、近位端16および遠位端18を有するカテーテル本体14を有するバルーンカテーテル12を含む。カテーテル本体14は可撓性があり、カテーテル軸15を規定し、ガイドワイヤ内腔22および膨張内腔24などの1以上の内腔を含んでもよい。カテーテル12は、遠位端18に隣接する膨張可能バルーン20および近位端16に隣接するハウジング29を含む。ハウジング29は、ガイドワイヤ内腔22と連通する第1のコネクタ26および膨張内腔24と流体連通する第2のコネクタ28を含む。膨張内腔24は、バルーン20と第2のコネクタ28の間に延在する。第1と第2の両方のコネクタ26、28は、任意で、Luer−Loc(商標)コネクタなどの標準的なコネクタを含んでもよい。遠位先端は、ガイドワイヤなどの通過を可能にする統合先端弁を含んでもよい。
過形成性新生内膜を予防するかまたは恒久的に除去するための現在の血管内療法は、完全に有効というわけではない。そのような組織の除去は、複数のそのような療法によって達成されるが、組織の再増殖が頻繁に起こり、再狭窄および血流機能不全をもたらす。薬物溶出ステントは、再狭窄の頻度を抑えることができるが、持続的なインプラント、すなわち、ステントが存在するために、血管機能の完全回復にはほど遠くなる。
図7は、内腔の周囲に位置する体内組織に選択的に流体を送達するための流体送達チャンネルを有するカテーテルシステム100の別の実施形態を示している。カテーテルシステム100は、近位端116および遠位端118を有するカテーテル本体114を有するバルーンカテーテル112を含む。カテーテル本体114は可撓性があり、カテーテル軸115を規定し、ガイドワイヤ内腔122および膨張内腔124などの1以上の内腔を含んでもよい。カテーテル112は、遠位端118に隣接する膨張可能バルーン120および近位端116に隣接するハウジング129を含む。ハウジング129は、ガイドワイヤ内腔122と連通する第1のコネクタ126および膨張内腔124と流体連通する第2のコネクタ128を含む。膨張内腔124は、バルーン120と第2のコネクタ128の間に延在する。第1と第2の両方のコネクタ126、128は、任意で、Luer−Loc(商標)コネクタなどの標準的なコネクタを含んでもよい。遠位先端は、ガイドワイヤなどの通過を可能にする統合先端弁を含んでもよい。
いくつかの実施形態では、膜にマイクロレベルの流体送達チャンネルを有し、圧力および熱を加えることによって分子を通り抜けさせることができる、多孔性バルーンを使用してもよい。この概念では、逆浸透とほとんど同じように、流体または薬物を膜に通すことによって、流体または薬物が特定の部位に送達される。逆浸透では、圧力を用いて、水などの液体を膜に通すが、通路が非常に小さいので、適切な分子しか通過することができない。この実施形態では、膜バリアによって、パクリタキセルのような薬物は保持される。低圧では、薬物分子は膜を通過することができない。膜を通して薬物を放出するために、バルーンを用いて薬物分子に圧力をかけ、電極対または単極電極によって局所的にエネルギーを適用することによって、薬物の放出を加速させる。
エネルギーを選択的に方向付けるとき、組織シグニチャーを用いて、インピーダンス測定を利用して組織治療領域を特定してもよく、このインピーダンス測定は、図6に示すような、内腔内の間隔の開いた電極、例えば、円周方向に配置された電極を用いて、組織を解析することによって行なってもよい。隣接電極対間の(および/または分離電極対間の)インピーダンス測定は、電流路が罹患組織を通る場合と、電流路が内腔壁の健康組織を通る場合とで異なる可能性がある。したがって、罹患組織の両側の電極間のインピーダンス測定が病変を示し得る一方で、他の隣接電極対間の測定値は健康組織を示し得る。血管内超音波、光コヒーレンストモグラフィーなどの他の特徴付けを用いて、治療すべき領域を特定してもよい。
好ましい実施形態では、バルーンカテーテルのバルーン部(図2)は、複数の円周方向に配置された電極を含むように構成される(図3A、3B、3C、4A、4B、4C、6、8A、8B、10A、10B、11C、12、13A、13B、13C、13D、14A、14B)。電極間で、複数の生体活性物質から構成される組成物は、バルーンの表面の少なくとも一部に存在する(図3A、3B、3C、4B、9A、10A、10B、11C、12、13B、13C、14A、14B)。複数の生体活性物質を含む組成物はさらに、他の材料(例えば、ポリマー、ゲル、潤滑剤、導電性材料または非導電性材料など)から構成されてもよい。バルーンコーティングは、浸け込み、噴霧、蒸着などを用いて塗布されてもよい。例えば、生体活性物質は、約37℃のヒト血液中で安定なポリマーマトリックスであって、選択された電極にエネルギーを適用したときに、選択された電極に隣接するバルーンコーティングを局所的に加熱し、その組成物の成分を放出するポリマーマトリックスから構成されるバルーンコーティング中に担持されてもよい。
いくつかの実施形態では、絶縁コーティング(例えば、図4Aおよび図4Bに示す絶縁コーティング)を用いて、バルーンカテーテルシステムのバルーンの表面周囲に分配された複数の電極を被覆してもよい。このコーティングは、電極を周囲のインビボ環境から絶縁するために使用されてもよく、かつ絶縁特性を有する周知の生体適合性材料のいずれかから構成されてもよく、また、周知の幅広い方法のいずれかを用いて塗布されてもよく、その例としては、電極の表面の一部に対するコーティングパリレンの噴霧または電極の表面の一部に対するシリコーンバリアの形成を挙げることができる。例として、図4Cに示すように、絶縁コーティングは、内腔内の金属体(例えば、ステント内再狭窄が存在するステント)の内側または付近を治療する場合に使用されることが好ましいが、それは、電極が金属に接触することになれば、ショートして、治療を終わらせる可能性があるからである。それゆえ、いくつかの実施形態では、金属などの導電性物体(図4C)と近接したときにショートを回避し、それにより、そのような状況下で治療を継続することができるように、電極を絶縁することが好ましい。絶縁コーティングは、電極を組織から絶縁するように働くこともでき、それによって、エネルギーがバルーン表面の選択された場所に向けられると同時に、エネルギーが組織部位に直接流れるのを防ぐことができる。例えば、罹患組織部位の緩和治療において、繰返しのまたは持続的な組織加熱を回避しながら、電極に選択的に通電し、局所的なバルーン加熱を作り出し、かつ方向性のある様式で組織部位に生体活性物質を送達する能力を保持することが好ましい場合がある。絶縁コーティングは、追加のまたはバルーンの他の領域とは異なる生体活性物質をさらに含んでもよい(図4B)。いくつかの実施形態は、表面(例えば、バルーン表面またはカテーテルシステムの他の表面)に、コーティング(例えば、ポリマー、ゲル、潤滑剤、導電性材料または非導電性材料など)をさらに含んでもよい。
本発明のいくつかの実施形態は、血管形成処置中の加熱と組み合わせて、内腔に生体活性物質を送達するためのシステムおよび方法を提供する。血管形成は、狭窄病変を横断して開口させるための十分に確立された臨床的方法であり(図4C)、ここで、狭窄は、部分的または全体的、びまん性または限局性であり得る。狭窄病変を横断して開口させるために、様々な周知のおよび定評のある技術が使用され、膨張可能な血管形成バルーンはその重要な態様を含む。病変の組織を加熱すると、追加の利益が得られる可能性がある。例えば、加熱によって、病変を軟化および収縮させることができ、これはさらに、病変内のプラークをバルーンの周囲で容易に再形成させ、それにより血管の伸縮を避け、ひいては血管の損傷を避けることができる。さらなる追加の利益は、血管形成処置および加熱プロセスの間に生体活性物質を放出することによって得られる可能性がある。血管形成処置中に生体活性物質を選択的に送達するための方法は、以下の工程のいずれかから構成されてもよく、これらの工程は、種々の順番でさらに並べられてもよい。
Claims (13)
- エネルギーおよび/または生体活性材料を有向送達することによって標的組織を治療するためのシステムであって、
近位端および遠位端を有し、近位端と遠位端の間に軸を有し、前記遠位端の近くの放射状に拡張可能なバルーンおよび前記バルーン表面のエネルギー送達表面を有する細長いカテーテルであって、前記エネルギー送達表面が複数の電極を備える、細長いカテーテルと、
放出可能な生体活性材料を有し、前記バルーンに連結され、前記バルーンが拡張しかつ該複数の電極が通電されて熱が発生されたときに、前記標的組織に働きかけるように配向されている、熱的に変化しやすいコーティングと、
前記熱的に変化しやすいコーティングを選択的に加熱し、前記標的組織に前記生体活性材料を選択的に放出するよう、前記エネルギー送達表面の前記複数の電極に選択的に通電するように、前記カテーテルに動作可能に連結されているエネルギー源と、
を含む、システム。 - 前記エネルギー送達表面は、前記拡張可能なバルーンの周囲に位置する複数の間隔の開いた電極を含み、前記エネルギー源は、前記電極対間の前記熱的に変化しやすいコーティングの部分を加熱し、前記標的組織に前記生体活性材料を放出するよう、電極対に選択的に通電するように、前記複数の電極に動作可能に連結されている、請求項1に記載のシステム。
- 前記バルーンは、複数の円周方向に配置された電極で覆われた選択的に透過可能な膜で被包され、かつ生体活性材料を含む膨張媒体を受容するように構成されている、請求項1に記載のシステム。
- 体内組織を特徴付けるように構成された組織分析装置をさらに含み、ここで、電極送達部は、前記熱的に変化しやすいコーティングを加熱し、特徴付けられた体内組織に応答して前記生体活性材料を放出するよう、通電される、請求項1に記載のシステム。
- 前記熱的に変化しやすいコーティングが2以上の放出可能な生体活性材料を含み、ここで、前記生体活性材料は、少なくとも1つの相変化温度を有し得る、請求項1に記載のシステム。
- 前記生体活性材料は、抗増殖剤、抗トロンビン、免疫抑制剤、脂質、抗脂質、リポソーム、抗炎症薬、抗新生物薬、抗血小板薬、血管形成剤、抗血管形成剤、ビタミン、アプタマー、抗有糸分裂薬、メタロプロテイナーゼ阻害剤、NO供与体、エストラジオール、抗硬化剤、血管作用薬、増殖因子、β遮断薬、AZ遮断薬、ホルモン、スタチン、抗酸化剤、膜安定化剤、カルシウム拮抗薬、レチノイド、ペプチド、リポタンパク質、ポリペプチド、ポリペプチドをコードするポリヌクレオチド、タンパク質、タンパク質薬、酵素、遺伝物質、細胞、化学溶媒、エネルギー活性化剤、抗リンパ球、抗マクロファージ物質または上記のいずれかの組合せのうちの少なくとも1つから選択される、請求項1に記載のシステム。
- 前記熱的に変化しやすいコーティングは、ポリ乳酸、ポリグリコール酸、ポリビニルアセテート、ポリビニルプロピレン、ヒドロキシプロピルメチルセルロース、メタクリレートまたは上記のいずれかの組合せのうちの少なくとも1つから選択される、請求項1に記載のシステム。
- 内腔の周囲に位置する体内組織に選択的に流体を送達するためのカテーテルシステムであって、
近位端および遠位端を有する細長い可撓性カテーテル本体と、
前記カテーテル本体の遠位端の近くにある放射状に拡張可能な構造と、
前記拡張可能な構造により拡張可能な、熱的に変化しやすい材料で最初に遮断される複数の流体送達チャンネルと、
前記熱的に変化しやすい材料を加熱し、液化して、前記流体送達チャンネルのうちの1つまたは複数を開口させ、流体を放出するよう、前記流体送達チャンネルに動作可能に連結されているエネルギー源と、
を含み、前記複数の流体送達チャネルが複数の電極により構成され、この流体送達チャネルの開口が前記電極への通電によって行われる請求項1に記載のシステム。 - 前記複数の流体送達チャンネルは、前記拡張可能な構造から突き出て、前記内腔の体内組織に入り込んでいる、請求項8に記載のシステム。
- 前記体内組織を特徴付けるように構成された組織分析装置をさらに含み、ここで、前記流体送達チャンネルは、特徴付けられた体内組織に応答して1以上の流体送達チャンネルを選択的に開口させるよう、選択的に通電されることができ、また、ここで、前記内腔の体内組織は罹患部を含み、セレクト電極は、前記罹患部に近接した1以上の流体送達チャンネルを選択的に開口させるよう、通電される、請求項8に記載のシステム。
- 前記流体は、セラミド、スラミン、ラパマイシン、パクリタキセル、シロリムス、ゾタロリムス、エベロリムス、治療的流体、麻酔薬、治療薬、小分子、遺伝子治療化合物、抗血栓溶解剤、(固着することなくより高い温度を可能にするための)潤滑剤、電極におけるインピーダンスを低下させるための導電性化合物、治療する必要がない組織の治療を防ぐための電気絶縁化合物、組織の内皮層を通って移動して、間質層にエネルギーを運ぶことを意図した導電性化合物、または上記の組合せのうちの少なくとも1つから選択される、請求項8に記載のシステム。
- 内腔の周囲に位置する体内組織に選択的に流体を送達するためのカテーテルシステムであって、
近位端および遠位端を有する細長い可撓性カテーテル本体と、
前記カテーテル本体の遠位端の近くにある放射状に拡張可能な構造と、
前記拡張可能な構造が拡張したときに、前記内腔の体内組織に働きかけるように配向されている複数の流体送達チャンネルと、
1以上の流体送達チャンネルを選択的に開口させ、前記内腔に流体を放出するよう、前記流体送達チャンネルに連結されている複数の微小電気機械システム(MEMS)と、
を含み、前記複数の流体送達チャネルが複数の電極により構成され、この流体送達チャネルの開口が前記電極への通電によって行われる請求項1に記載のシステム。 - 内腔の周囲に位置する体内組織に薬物を送達するためのカテーテルアセンブリであって、
近位端および遠位端を有し、近位端と遠位端の間に軸を有する細長いカテーテルと、
内面および外面を有する放射状に拡張可能な多孔性バルーンであって、エネルギーを伝達するための前記バルーンに近接したエネルギー送達表面を有するカテーテルの遠位端の近くに位置している、前記バルーンと、
内面および外面を有する選択的多孔性膜であって、前記バルーン表面を覆っている、前記膜と、
前記バルーンを膨張させるための膨張媒体であって、前記バルーンを膨張媒体で膨張させたときに、前記薬物が前記多孔性バルーンの外面と前記膜の内面の間に導入されるように薬物を含む、前記媒体と、
前記エネルギー送達表面にエネルギーを送達すると同時に、前記バルーンの外面から前記膜を通して前記体内組織に前記薬物を送達するために、前記バルーンが前記内腔の内側で拡張するよう、前記カテーテルの近位端に連結されているエネルギー源と、
を含み、前記エネルギー送達表面に複数の電極が設けられており、前記薬物の送達が前記電極への通電による局所的加熱によって行われる請求項1に記載のカテーテルシステムのアセンブリ。
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WO2017023036A1 (ko) * | 2015-07-31 | 2017-02-09 | 재단법인 오송첨단의료산업진흥재단 | 복합신경 자극용 이식형 리드 및 그 제조방법 |
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AU2010248955B2 (en) | 2013-10-31 |
US20110130708A1 (en) | 2011-06-02 |
KR20120029415A (ko) | 2012-03-26 |
CN102458566A (zh) | 2012-05-16 |
US8551096B2 (en) | 2013-10-08 |
EP2429641A1 (en) | 2012-03-21 |
EP2429641B1 (en) | 2016-04-20 |
EP2429641A4 (en) | 2012-12-05 |
AU2010248955A1 (en) | 2011-12-22 |
CN102458566B (zh) | 2014-08-20 |
WO2010132703A1 (en) | 2010-11-18 |
JP2012526635A (ja) | 2012-11-01 |
KR101337187B1 (ko) | 2013-12-05 |
CA2761669A1 (en) | 2010-11-18 |
CA2761669C (en) | 2015-11-24 |
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