JP7014610B2 - 副鼻腔炎の治療のための埋込み可能な足場 - Google Patents
副鼻腔炎の治療のための埋込み可能な足場 Download PDFInfo
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- JP7014610B2 JP7014610B2 JP2017565901A JP2017565901A JP7014610B2 JP 7014610 B2 JP7014610 B2 JP 7014610B2 JP 2017565901 A JP2017565901 A JP 2017565901A JP 2017565901 A JP2017565901 A JP 2017565901A JP 7014610 B2 JP7014610 B2 JP 7014610B2
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- 0 CCC[C@@](C)C(C)C(*C(C(C1)*2CC)C2(C2)C(C)(C)C3CC3)[C@@]1(CC)C2(C)C(C)C Chemical compound CCC[C@@](C)C(C)C(*C(C(C1)*2CC)C2(C2)C(C)(C)C3CC3)[C@@]1(CC)C2(C)C(C)C 0.000 description 3
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Description
[0001]本出願は、参照によりそのそれぞれの全体が本明細書に組み込まれる、2015年6月29日に出願されたIMPLANTABLE SCAFFOLDS FOR TREATMENT OF SINUSITISという名称の米国仮出願第62/186,030号、2016年2月2日に出願されたIMPLANTABLE SCAFFOLDS FOR TREATMENT OF SINUSITISという名称の米国仮出願第62/289,982号、および2016年5月5日に出願されたIMPLANTABLE SCAFFOLDS FOR TREATMENT OF SINUSITISという名称の米国仮出願第62/332,134号の利益を主張するものである。
[0014]足場が治療薬を含む場合、足場には、様々な放出プロファイルが提供され得る。
[0021]例えば、ヒトの洞部またはウサギの洞部内でin vivoで1週間後、足場は、1%以下から45%以上に及ぶ(例えば、1%から1.5%に、2%に、3%に、5%に、10%に、15%に、20%に、25%に、30%に、35%に、40%に、45%に及ぶ)(すなわち、前述の数値のいずれか2つの間に及ぶ)、ある実施形態では、有益には1.5から35%に及ぶ、より有益には3%から20%に及ぶ、足場内の治療薬の総量に基づく治療薬の累積放出を実証することができる。
[0026]上記態様および実施形態のいずれかと併せて使用され得るいくつかの実施形態では、編み上げ構造は、対向するヘリカルストランドの組を含んでいてもよい。例えば、ヘリカルストランドの各組は、2から64個の間の部材、より典型的には8から32個の間の部材を含んでいてもよい。
[0053]本開示の潜在的な利益には、とりわけ成人および小児の処置に関連して、下記の1つまたは複数が含まれる:(a)洞の開口/小孔の安定化、(b)癒着および術後接着の低減、(c)手術の代替としての療法(例えば、経口および/または局所ステロイドの投与に基づく医学的管理ができなかった患者の治療)、術前および/または術後ケアのための、局所的かつ長期の治療薬送達、および(d)FESSに応答しない難治性患者への治療薬送達、(e)外科的拡張後の洞の小孔/開口の狭窄の予防。
[0055]本開示の、追加の列挙される態様を、以下の段落で述べる:
[0056]態様1.洞腔に埋め込むために構成された足場であって、管腔を有するほぼ管状の構造を含み、かつ足場材料と、足場材料を少なくとも部分的に被覆するコーティング材料を含む任意選択のコンフォーマルコーティングとを含む足場。
[0058]態様3.足場が、足場材料の1つまたは複数のストランドを含む編み上げ構造を含む、態様1の足場。
[0060]態様5.それぞれの組のヘリカルストランドが2から64の間の部材を含む、態様4の足場。
[0062]態様7.材料の第2のストランドが>5GPaの弾性率を有し、材料の第1のストランドの弾性率の少なくとも2倍である、態様6の足場。
[0064]態様9.編み上げ構造の一部が、異なるサイズのセルが形成されるように除去され、または編み上げ構造が、異なるサイズのセルが形成されるように編み上げられる、態様8の足場。
[0066]態様11.セルサイズのばらつきが、足場の長手方向の長さに沿って生じる、態様8の足場。
[0068]態様13.編み上げ構造の2つ以上の節に機械的に連結された縦エラストマー繊維をさらに含む、態様3~12のいずれかの足場。
[0070]態様15.足場が、コーティング材料を含む前記コンフォーマルコーティングを含む、態様3~14のいずれかの足場。
[0072]態様17.エラストマーがウレタン架橋を含む、態様16の足場。
[0073]態様18.コーティング材料が編み上げ構造のいくつかの節を覆いながらその他の節は覆われないままにする、態様15~17のいずれかの足場。
[0075]態様20.コーティング材料が、編み上げ構造の端部を覆うが編み上げ構造の端部の間の領域は覆わない、態様15~18のいずれかの足場。
[0080]態様25.足場が、50から99.9wt%のポリ(L-ラクチド-co-カプロラクトン)および0.1から50wt%のフロ酸モメタゾンを含む追加のコーティング材料でさらに被覆される、態様15~21、23、および24のいずれかの足場。
[0083]態様28.足場が、スパイラル管状構造に巻かれた細長い部材を含む、態様1の足場。
[0085]態様30.開放フープがリボン形状の開放フープである、態様29の足場。
[0086]態様31.リボン形状の開放フープが複数のアパーチャを有する、態様30の足場。
[0088]態様33.ほぼ管状の構造が、編み込み構造である、態様1の足場。
[0089]態様34.編み込み構造が、足場を解き除去するよう引っ張ることができる単一ストランドを含む、態様33の足場。
[0091]態様36.放射状に拡張可能な挿入物が、ハブと、複数の半径報告に拡張可能なアームとを含み、または放射状に拡張可能な挿入物が編み上げフープを含む、態様35の足場。
[0095]態様40.(a)態様1~37のいずれかによる足場、(b)送達カテーテル、および(c)任意選択の投入補助具を含むキット。
[0098]態様43.送達カテーテルが、膨張管腔を有するカテーテルシャフトと、カテーテルシャフトの遠位端にまたはこの遠位端近くに配置された1つまたは複数の可膨張性バルーンとを含む、バルーンカテーテルである態様40のキット。
[00100]態様45.(a)態様1~37のいずれかによる足場と、(b)送達カテーテルとを含み、足場が、放射状に拘束された形状で送達カテーテル内に位置決めされている、送達システム。
[00104]態様49.送達カテーテルが、膨張管腔を有するカテーテルシャフトと、カテーテルシャフトの遠位端にまたはこの遠位端近くに配置された1つまたは複数の可膨張性バルーンとを含む、バルーンカテーテルである態様47の送達システム。
[00106]態様51.(a)足場を患者の洞腔内に導入して、足場が洞腔内の送達部位に位置決めされるようにするステップと、(b)拡張可能なデバイスが足場の管腔内に位置決めされている間に拡張可能なデバイスを拡張するステップとを含む、態様47の送達システムを使用する治療方法。
[00108]態様53.(a)第1の溶媒、分枝状生分解性ポリマー、およびジイソシアネート架橋剤を含む第1のコーティング溶液を、足場に付着させるステップと、(b)付着された第1のコーティング溶液を高温で硬化させるステップとを含み、足場が、洞腔内での埋込み用に構成されており、足場が、管腔を有しかつ足場材料を含むほぼ管状の構造を有する、被覆された足場を形成する方法。
[00110]態様55.足場材料がポリ(ラクチド-co-グリコリド)を含む、態様53~54のいずれかの方法。
[00112]態様57.ジイソシアネート架橋剤がヘキサメチレンジイソシアネートであり、連鎖停止剤が1-ドデカノールであり、または両方の組合せである、態様56の方法。
[00114]態様59.第1の溶媒がアニソールをさらに含む、態様58の方法。
[00118]態様63.治療薬が、ステロイド系抗炎症薬である、態様61~62のいずれかの方法。
[00120]態様65.第2の溶媒が、ギ酸エチルおよびアニソールを含む、態様64の方法。
[00122]態様67.態様53~66のいずれかの方法によって形成された足場。
[00124]態様69.治療薬がステロイド系抗炎症薬である、態様68の足場。
[00125]態様70.コーティング材料が治療薬を含む、態様15~26のいずれかの足場。
[00127]態様72.追加のコーティング材料および治療薬を含む追加のコンフォーマルコーティングをさらに含む、態様15~26のいずれかの足場。
[00129]本開示の追加の態様および実施形態について、以下に述べる詳細な説明で論じる。
[00185]他に指示しない限り、本明細書で与えられる足場の直径および足場の長さは、拘束されていない(製造された)直径および長さを指す。
[00193]コーティングは、機械的性質の強化、分解制御、および治療薬の放出および制御を含めた様々な目的で付着されてもよい。コーティングは、足場の全てもしくは一部を覆ってもよく、または繊維ベースの技法では、足場を形成するフィラメントもしくはストランドの全てもしくは一部を覆ってもよい。本明細書で使用される「ストランド」および「フィラメント」は、同義で使用されてもよく、単繊維ストランドおよびフィラメント(モノフィラメントとも呼ぶ)と多繊維ストランドおよびフィラメントとを含む。
[00208]繊維の強さおよび/または柔軟性は、均質なまたは不均質な断面の繊維を多繊維ストランド(例えば、魚網型構造)に編み上げることによって最適化されてもよい。編み上げられる繊維は、同じ組成のものでも異なる組成のものでもよい。さらに、編み上げられる繊維は、同じ直径のものでも異なる直径のものでもよい。2つの実施形態を図1Bに示すが、これらは、(a)同じ材料の同じ直径を有するストランドから形成された多繊維ストランド11の断面と、(b)異なる組成の異なる直径を有するストランドから形成された多繊維ストランド13の断面とを示す。
[00225]より大きいセルとより小さいセルとの組合せを有する足場の潜在的な利点は、より大きいセルが柔軟性を与え得る(例えば、捲縮およびより良好な順応性を容易にするために)のに対し、より小さいセルは機械的一体性を維持し得る。
[00236]例えば、様々な実施形態では、織られたまたは編まれたストランドから形成された足場が提供される。編まれたチューブの形をした足場100を、図9に示す。そのような織られたまたは編まれた足場は、高いコンプライアンスおよび順応性も有しながら(ならびにいくつかの実施形態では治療薬送達を容易にする)、ステント留置機能をもたらすことができる。さらに、編まれた構造の場合、いくつかの実施形態では、チューブを形成するのに使用される単一ストランドの一端を引っ張ってステントを解放してもよく、足場の除去が可能になる。
[00244]治療薬の例は、とりわけ小分子剤、生物学的製剤、幹細胞を含む細胞、遺伝子治療薬、およびRNAiを含めた、所望の生物学的効果を発揮する任意の適切な薬剤である。治療薬の特定の例には、とりわけ:アスピリンおよびパラセタモールなどの単純鎮痛薬、イブプロフェン、ジクロフェナク、ナプロキセン、セレコキシブ、ケトプロフェン、ピロキシカム、およびスリンダクなどの非ステロイド系抗炎症薬、コデイントラマドール、デキストロプロポキシフェ、パラセタモール、モルホリン、オキシコドン、およびペチジン塩酸塩などのオピオイドを含めた鎮痛剤;リドカイン、ブピバカイン、およびロピバカインなどの麻酔剤;アトロバスタチン、セリバスタチン、フルバスタチン、ロバスタチン、メバスタチン、ピタバスタチン、プラバスタチン、ロスバスタチン、およびシムバスタチンなどのスタチン;グルココルチコイド、フロ酸モメタゾン、ジプロピオン酸ベクロメタゾン、ブデソニド、シクレソニド、フルニソニド、フロ酸フルチカゾン、プロピオン酸フルチカゾン、デキサメテゾン、コルチゾン、プレドニゾン、メチルプレドニゾロン、トリアムシノロンアセトニド、ベタメタゾン、デキサメタゾン、プレドニゾロン、コルチコステロン、エストロゲン、スルファサラジン、ロシグリタゾン、ミコフェノール酸、およびメサラミンなどのステロイド系抗炎症薬;ジフェンヒドラミン、ロラタジン、フェキソフェナジン、シプロヘプタジン、プロメタジン、デスロラタジン、クロルフェニラミン、ヒドロキシジン、およびピリラミンなどのH1-受容体拮抗薬、シメチジン、ファモチジン、ラフチジン、ニザチジン、ラニチジン、ロキサチジン、およびチオチジンなどのH2-受容体拮抗薬を含めた抗ヒスタミン;ムピロシン、ゲンタマイシン、およびトブラマイシンなどの抗菌剤;ペニシリン、セフォキシチン、オキサシリン、およびトブラマイシンなどの抗生剤;エンドスタチン、アンジオスタチン、およびチミジンキナーゼ阻害剤、およびその類似体または誘導体;抗ロイコトリエン剤(例えば、モンテロイカスト、ザフィルルカスト、ジロイトンなど);抗真菌剤;およびプロバイオティクスが含まれる。
[00249]例えば治療薬は、本明細書に記述されるほぼ管状の足場を形成するため後で使用される、ポリマー構築物(例えば、フィラメント、シート、固体チューブなど)内に直接埋め込まれてもよい。一実施形態では、治療薬およびポリマー(複数可)は適切な溶媒に溶解して、均質な溶液もしくは懸濁液を作製し、または治療薬およびポリマー(複数可)を加熱して、治療薬を含有するポリマー溶融体を形成する。次いで溶液、懸濁液、または溶融体を、押出し、湿式紡糸、乾式紡糸、溶融紡糸、エレクトロスピニング、またはその他のプロセスなどの適切な溶媒ベースのまたは溶融体ベースの加工に供して、埋め込まれた治療薬を含む治療薬負荷ポリマー構築物(例えば、フィラメント、シート、チューブなど)を得る。いくつかの実施形態では、治療薬を含有しないポリマー領域(例えば、ポリマーコア)は、治療薬負荷ポリマーコーティングと共押出しされて、治療薬負荷ポリマー構築物を形成する。
[00256]いくつかの実施形態では、本明細書に記述されるデバイスを、sinuplastyと併せて使用することができる。例えば、本明細書に記述されるような足場は、数ある可能性の中でも拡張可能なフレーム(例えば、拡張可能なワイヤフレーム)またはバルーンなどの拡張可能なデバイスの支援を得て、洞腔内に展開することができる。そのような実施形態では、本開示による足場は、製造現場でまたはヘルスケアの専門化により送達時点で、拡張可能なデバイスの上、中、下、近位、または遠位に位置決めされてもよい。拡張可能なデバイスは、薬物溶出デバイス(例えば、拡張可能なデバイス上に配置された薬物含有コーティングを介して)または非薬物溶出デバイスであってもよい。薬物溶出デバイスにより放出される治療薬の例は、上述の通りである。
Claims (13)
- (a)ポリマー材料を含む、複数のポリマーストランドを含む足場と、
(b)架橋型エラストマーを含む、前記足場上のコーティングと、
(c)フロ酸モメタゾンを含む層であって、当該層上には、足場を中鼻道に配置した後に前記フロ酸モメタゾンが12週間以上時間と量が線形となる関係で放出されるように構成された厚さを有するトップコートが設けられている層と、
を含み、中鼻道空間の形状に合わせられている足場。 - 前記ポリマー材料が、ポリ(ラクチド-co-グリコリド)を含む、請求項1に記載の足場。
- 前記架橋型エラストマーが、ポリ(ラクチド-co-カプロラクトン)を含む、請求項1または2に記載の足場。
- 前記架橋型エラストマーが、30%以上50%以下のラクチドのモルパーセンテージと50%以上70%以下のカプロラクトンのモルパーセンテージとを有するポリ(ラクチド-co-カプロラクトン)を含む、請求項3に記載の足場。
- 前記架橋型エラストマーが、分枝状ポリ(ラクチド-co-カプロラクトン)ポリオールとジイソシアネート架橋剤とを反応させることによって形成される、請求項1から4のいずれか1項に記載の足場。
- 分枝状ポリ(ラクチド-co-カプロラクトン)ポリオールは、1-置換C8~C18アルコールの存在下、ジイソシアネート架橋剤と反応させられる、請求項5に記載の足場。
- 前記足場の軸が2枚の平行な平板と平行になるように、かつ前記平行な平板の間の第1の距離を初期の非拘束状態の直径の17%にすることによって、軸に垂直に測定され前記第1の距離に等しい第1の最小幅を前記足場が有する点まで、前記足場が前記平行な平板の間で圧縮されるように、34℃、80%の相対湿度環境で10週間、前記平行な平板の間で前記足場を圧縮状態で保持した後に、および前記足場を圧縮状態から6時間にわたって解放した後に、前記足場の最小幅が、前記軸に垂直に測定され前記第1の最小幅の少なくとも250%である第2の最小幅まで回復する、請求項1から6のいずれか1項に記載の足場。
- 前記足場の軸が2枚の平行な平板と平行になるように、かつ前記平行な平板の間の第1の距離を初期の非拘束状態の直径の8.5%にすることによって、軸に垂直に測定され前記第1の距離に等しい第1の最小幅を前記足場が有する点まで、前記足場が前記平行な平板の間で圧縮されるように、34℃、80%の相対湿度環境で10週間、前記平行な平板の間で前記足場を圧縮状態で保持した後に、および前記足場を6時間にわたる圧縮状態から解放した後に、前記足場の最小幅が、前記軸に垂直に測定され前記第1の最小幅の少なくとも450%である第2の最小幅まで回復する、請求項1から6のいずれか1項に記載の足場。
- 送達カテーテル内に載置される、請求項1から8のいずれか1項に記載の足場。
- (a)生分解性ポリマー材料を含む管状足場と、
(b)架橋型エラストマーを含む、前記管状足場上のコーティングと、
(c)フロ酸モメタゾンを含む層であって、当該層上には、足場を中鼻道に配置した後に前記フロ酸モメタゾンが12週間以上時間と量が線形となる関係で放出されるように構成された厚さを有するトップコートが設けられている層と、
を含み、中鼻道空間の形状に合わせられている足場。 - 前記生分解性ポリマー材料が、ポリ(ラクチド-co-グリコリド)を含む、請求項10に記載の足場。
- 前記管状足場が、複数の編み上げポリマーストランドを含む、請求項10または11に記載の足場。
- 前記足場は、(a)10~15mmの範囲の拘束されていない直径、(b)15~20mmの範囲の拘束されていない直径、および(c)20~60mmの範囲の拘束されていない直径から選択される拘束されていない直径を有する、請求項1に記載の足場。
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EP3313325A1 (en) | 2018-05-02 |
CN113633434A (zh) | 2021-11-12 |
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