JP6054751B2 - 有益な薬剤を搬送するための拡張可能な医療器具及びこの医療器具を形成する方法 - Google Patents
有益な薬剤を搬送するための拡張可能な医療器具及びこの医療器具を形成する方法 Download PDFInfo
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Description
本発明は、組織を支持する医療器具に関するもので、より詳細には、臓器を支持して開存性を維持するために、生きている動物またはヒトの体腔内に埋め込まれ、有益な薬剤を介入部位に搬送でき、体腔内で拡張可能であり、体腔内に埋め込む器具に関するものである。
これまで、身体通路の開存性を維持するために身体通路内に埋め込まれる、永久的または生分解性の器具が開発されてきた。これらの器具は、通常、経皮的に導入され、所望の場所に位置決めされるまで経腔輸送される。次いで、これらの器具は、機械的に、例えば装置内側に位置決めされたマンドレル(mandrel)またはバルーン(balloon)の拡張によって拡張し、あるいは体内で作動して蓄積したエネルギーを放出することによって単独で拡張する。ステント(stents)と呼ばれるこれらの器具は、管腔内で拡張した後、体組織内でカプセル化し、永久的に埋め込まれたまま残る。
従来技術の欠点に鑑みて、本発明は、ステントの有効壁厚を増加せず、ステントの機械的拡張特性に悪影響を及ぼさずに、比較的体積の大きい有益な薬剤を、血管腔内の外傷を負った部位に搬送できるステントを提供することが有利な点である。
(b)有益な薬剤、ポリマー・キャリアーおよび溶剤の溶液を作る工程と、
(c)前記溶液を前記開口部に与える工程と、
(d)前記有益な薬剤およびキャリアーの固体層を形成するために前記溶剤を蒸発させる工程と、
(e)前記(c)及び(d)の工程を繰り返す工程と
を備える。
図1および図2を参照すると、本発明の好ましい一実施形態による組織支持器具が、参照番号10で示されている。組織支持器具10は、S字形の架橋要素14によって接続された複数の円筒管12を含む。架橋要素14は、脈管構造の曲がりくねった経路内を通過して展開部位に到達させるときには、組織支持器具を軸方向に曲げ、支持すべき管腔の曲率に合致させるのに必要なときには、装置を曲げる。各円筒管12は、円筒管の端面から反対側の端面に向かって延びる、複数の軸方向スロット16を備える。
他の有益な薬剤を含めてもよく、微小球状体(microspheres)、微小気泡体(microbubbles)、リポソーム(liposomes)、放射性同位体(radioactive isotopes)、あるいは光か超音波のエネルギー、あるいは体系的に処理することができる循環分子によって活性化された薬剤のような物理的な薬剤に制限されるものではない。
拡張した器具の表面に面するルーメン(lumen)として知られている放射状の方向の最も内側である、内向きの表面に放出される有益な薬剤は、急速に血流によって目標とされたエリアから運び去られるかもしれない。そのような状況では装填した薬剤の合計の半分まで、血流によって運び去られることにより治療の効果は得られないことになる。恐らく、これは図9の貫通した開口部の器具と同様にすべての表面コーティングを施したステントにあてはまることであろう。
図14の実施形態では、有益な薬剤が、微小球状体(ミクロスフェア:microspheres)、粒子あるいはその他同種のものの形により開口部24に設けられている。これらの粒子を含んでいる個々の層70を生成することができ、更に、粒子のサイズは、各層ごとに変えることができる。与えられた層のボリュームに関しては、より小さな粒子サイズが、その層内の粒子表面積の合計を増加させ、各層ごとに有益な薬剤の表面積の合計を変化させる効果を有する。薬剤の分子の流出が表面積に比例するので、薬剤の流出の合計は粒子サイズの変化によって調整され、ネット効果(net effect)は、層内において変化する粒子サイズの変化により放出動力学を制御する。
Claims (17)
- 拡張可能な医療器具を形成する方法であって、
(a)複数開口部を有する複数の支柱が形成された略円筒形状の拡張可能な医療用のデバイス本体を形成する工程と、
(b)第1の有益な薬剤、第1のポリマー・キャリアーおよび溶剤の第1の溶液を作る工程と、
(c)前記第1の溶液を前記開口部に与える工程と、
(d)前記第1の有益な薬剤および第1のポリマー・キャリアーの固体層を形成するために前記第1の溶剤を蒸発させる工程と、
(e)前記(c)及び(d)の工程を繰り返す工程と、
(f)前記第1の有益な薬剤と異なる第2の有益な薬剤、第2のポリマー・キャリアー、および第2の溶剤の第2の溶液を作る工程と、
(g)前記拡張可能な医療器具の内向き表面側から当該第2の溶液を前記第1の有益な薬剤の層に接するように前記開口部に与える工程と、
(h)前記第2の有益な薬剤および前記第2のポリマー・キャリアーの第2の固体層を形成するために前記第2の溶剤を蒸発させる工程と、
(i)バリア材料を前記第2の固体層に接するように前記開口部に与えて該開口部にバリア層を形成する工程と
を順次行うことを特徴とする拡張可能な医療器具を形成する方法。 - 前記有益な薬剤は、活性薬剤であることを特徴とする、請求項1に記載の方法。
- 前記有益な薬剤は、抗増殖性部物質であることを特徴とする、請求項1に記載の方法。
- 前記有益な薬剤は、抗炎症剤であることを特徴とする、請求項1に記載の方法。
- 前記有益な薬剤は、閉塞性動脈硬化症剤であることを特徴とする、請求項1に記載の方法。
- 前記有益な薬剤は、蛋白質薬であることを特徴とする、請求項1に記載の方法。
- 前記第1の有益な薬剤は血小板凝集阻害薬である、請求項1に記載の方法。
- 前記第1の有益な薬剤はパクリタキセルである、請求項1に記載の方法。
- 前記第1の有益な薬剤はラパマイシンである、請求項1に記載の方法。
- 前記第1の有益な薬剤はヘパリンである、請求項1に記載の方法。
- 前記第1の有益な薬剤は抗血栓症剤であり、前記第2の有益な薬剤は抗豚増殖性腸炎剤である、請求項1に記載の方法。
- 前記第1の有益な薬剤は抗豚増殖性腸炎剤であり、前記第2の有益な薬剤は抗炎症剤である、請求項1に記載の方法。
- 前記第1の有益な薬剤及び前記第2の有益な薬剤は、前記デバイス本体の第1の面に与えられるように配置されている、請求項1に記載の方法。
- 前記第1の有益な薬剤が前記開口部内に配置されて第1の放出プロファイルを達成し、前記第2の有益な薬剤が前記開口部内に配置されて、前記第1の放出プロファイルとは異なる第2の放出プロファイルを達成する、請求項1に記載の方法。
- 前記層の全ての厚さは2μmから50μmである、請求項1に記載の方法。
- 前記開口部の面積は、少なくとも0.0032mm2である、請求項1に記載の方法。
- 前記開口部の深さの合計は、125μmから140μmである、請求項1に記載の方法。
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