JP2007537827A - 多層を有する医療用デバイス - Google Patents
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Abstract
【解決手段】 該医療用デバイスは、(a)1つ以上の(通常は複数の)荷電ナノ粒子層と、(b)1つ以上の(通常は複数の)荷電高分子電解質層とを含む、1つ以上の多層領域を含む。かかる多層は、高強度、ノンコンプライアンス、及び可撓性を含め、いくつかの望ましい特質を有する。本明細書では、また、そのようなデバイスの製造方法についても説明する。
【選択図】 図1A
Description
本発明は、埋込み可能/挿入可能な医療用デバイスのための、多層領域のレイヤーバイレイヤー堆積に関し、より詳細には、かかるデバイスのための、複数のナノ粒子層を含んだ多層領域の形成に関する。
処置対象に埋め込む若しくは挿入するために構成された、様々な医療用デバイスが知られている。したがって、これらのデバイスは、そうしたものとして、付随した機械的要件を有する。
前述及び他の課題を、本発明によって対処する。
本発明の一態様によれば、処置対象に埋め込む若しくは挿入するために適合された、1つ以上の多層領域を含む医療用デバイスが提供される。該多層領域は、(a)それぞれ荷電ナノ粒子を含んだ、1つ以上の(通常は複数の)荷電ナノ粒子層と、(b)それぞれ1つ以上の荷電高分子電解質種を含んだ、1つ以上の(通常は複数の)荷電高分子電解質層とを含む、交互に並ぶ反対に荷電した複数の層を含む。ナノ粒子層及び高分子電解質層は、隣接層の電荷とは反対の電荷を有する。
本明細書で使用する「処置」は、疾病若しくは状態の予防、疾病若しくは状態に随伴した症状の軽減若しくは排除、又は疾病若しくは状態の実質的若しくは完全な排除を指す。典型的な処置対象は、哺乳類の処置対象であり、より典型的にはヒトの処置対象である。
前述のように、本発明の多層領域は、通常、(a)荷電ナノ粒子を含んだ複数の荷電ナノ粒子層と、(b)1つ以上の荷電高分子電解質種を含んだ複数の荷電高分子電解質層とを含む。
他の実施態様では、多層領域の形成後、該多層領域に治療剤がローディングされる。この点に関し、予め形成された極微の高分子電解質多層カプセルに治療剤を組み込むための様々な技術が報告されており、これらの技術は、本発明の多層コーティング構造に等しく適用可能である。
他方、一部の実施態様では、下にある基材は、単にレイヤーバイレイヤー技術を適用するためのテンプレートとして(例えば、モールド(mold)として)の役割を果たすにすぎない。多層領域は、場合によっては除去可能な基材の内側に適用され、また、場合によっては除去可能な基材の外側に適用される。
他の実施態様では、多層領域の外表面を保護し、且つ万一多層領域が損傷した場合(例えば、万一バルーンが破裂した場合)に破片を封じ込めるために、外側のポリマー層が多層領域を覆って(例えば、従来の熱可塑性物質若しくは溶媒処理技術を使用して)設けられる。そのようなポリマー層は、基材と併せて使用するために前述した様々なポリマー材料から選択することができる。
治療剤は、本発明の医療用デバイスにおいて、単独で、又は組み合わせて使用することができる。「薬物」、「治療剤」、「薬学的に活性な剤」、「薬学的に活性な物質」、及び他の関連用語は、本明細書では交換可能に使用されることがある。これらの用語には、遺伝子治療剤、非遺伝子治療剤、及び細胞が含まれる。
広範な治療剤ローディングを本発明の医療用デバイスと併せて使用することができ、治療効果のある量は、当業者には容易に決定されるが、最終的には、例えば、処置されるべき状態、患者の年齢、性別、状態、治療剤の性質、医療用デバイスの(1つ若しくは複数の)多層領域の性質を含めた該医療用デバイスの性質などに左右される。
ここで図1A〜1Cを参照して、バルーンカテーテルの構築の一実施態様について説明する。SWNTを含んだ高分子電解質多層が、220MPaの極限強さ(PETフィルムに類似)を有すると測定されているので、これらの図に記載されている本発明の実施態様は、多層領域の形成に破壊可能なモールドを使用する。他の実施態様では、言うまでもなく、2部品の解放可能なモールドなど、又はデバイスに組み込まれる既存のバルーンなど、最終的に破壊されない基材を使用してバルーンを作製することができる。
言うまでもなく、以上の主題に関して数えきれない変形形態が可能である。
例えば、以上のステップでは、多層コーティング130は、ワックスモールド140上だけでなく、ガイドワイヤルーメン110及び外側の膨張ルーメン120の一部分も覆って形成される。その結果、バルーン130をルーメン110及び120にシールする別個のステップが回避される。他方、他の実施態様では、バルーンは、独立して形成された後で、ルーメン110、120に取り付けられる。
他の例として、図1Aのモールドを集成装置(図示せず)の近位側まで延ばし、それによって外側のルーメンの一部を、レイヤーバイレイヤー技術を使用して構築できるようにすることができる。実際、外側のルーメン全体をこの方式で構築することができる。また、同様に、内側のルーメンの先端を同じ方式で造り出すことも可能である。
次いで、交互に並ぶ多数の高分子電解質層及びナノ粒子層を含んだ多層コーティング330が、図3Bに示したように集成装置を覆って適用される。
本発明に従って形成されるステントグラフトは、ステントデリバリー用の様々なバルーンカテーテルを含め、公知の様々なステントデリバリーシステムによって処置対象にデリバリーすることができる。一部の実施態様では、ステントグラフトを、やはり本発明に従って形成された多層バルーンを含むカテーテルを使用してデリバリーすることができる。
直径3mmのポリビニルアルコール(PVOH)のモールド、シリーズC−5(ロンドンのAdept Polymers Limitedから購入)を、190℃でインサート成形する。金属コアピンを、モールドの中心を通じて埋め込む。
層の堆積後、金属コアピンをモールドから引き抜き、コアピンによって残された開口部内に温度60℃の水を2時間にわたって流して、PVOHコアを溶解させる。
次の点を変更して、実施例1の手順に従う:コア及び第1のポリウレタン層の代わりに、既存のPEBAX7233単層バルーン(Boston Scientific Corp.)を除去不可能な基材として使用する。初めに、PEIの層をバルーン上に堆積させる。この後、次の順序:PAA−PEI−CNT−PEI−CNT−PEI−CNT−PEI−CNT−PEI−CNT−PEIに8回従うことによって、96層を堆積させる。前述のように、PAA層は、層間の静電気引力を強くする。
Claims (56)
- (a)荷電ナノ粒子を含む荷電ナノ粒子層と、
(b)荷電高分子電解質種を含む複数の荷電高分子電解質層とを含み、
処置対象に埋め込む、又は挿入するために構成された、多層領域を含む医療用デバイス。 - バルーンカテーテル、グラフト、ステント、及びフィルタから選択される、請求項1記載の医療用デバイス。
- 前記多層領域が、複数の荷電ナノ粒子層を含む、請求項1記載の医療用デバイス。
- 前記多層領域が、カーボンナノ粒子、ケイ酸塩ナノ粒子、及びセラミックナノ粒子から選択されるナノ粒子を含む複数の荷電ナノ粒子層を含む、請求項1記載の医療用デバイス。
- 前記多層領域が、カーボンナノチューブ、カーボンナノ繊維、フラーレン、セラミックナノチューブ、セラミックナノ繊維、フィロケイ酸塩、モノマーケイ酸塩、及びデンドリマーから選択されるナノ粒子を含む複数の荷電ナノ粒子層を含む、請求項1記載の医療用デバイス。
- 前記多層領域が、単層カーボンナノチューブを含む複数の荷電ナノ粒子層を含む、請求項1記載の医療用デバイス。
- 前記多層領域が、最小寸法0.5〜100nmにわたるナノ粒子を含む複数の荷電ナノ粒子層を含む、請求項1記載の医療用デバイス。
- 前記多層領域が、ポリアリルアミン、ポリエチレンイミン、ポリ(塩化ジメチルジアリルアンモニウム)、硫酸プロタミン、キトサン、ゼラチン、スペルミジン、及びアルブミンから選択されるポリカチオンを含む複数の荷電高分子電解質層と、ポリ(スチレンスルホン酸)、ポリ(アニリンスルホン酸)、ポリアクリル酸、アルギン酸ナトリウム、ポリスチレンスルホン酸塩、ユードラギット、ゼラチン、ヒアルロン酸、カラギーナン、コンドロイチン硫酸、カルボキシメチルセルロースから選択されるポリアニオンを含む複数の荷電高分子電解質層とを含む、請求項1記載の医療用デバイス。
- 前記多層領域が、10〜200の荷電高分子電解質及びナノ粒子層を含む、請求項1記載の医療用デバイス。
- 前記多層領域が治療剤を含む、請求項1記載の医療用デバイス。
- 保護ポリマーコーティング層が、前記多層領域の少なくとも一部分を覆って設けられる、請求項1記載の医療用デバイス。
- 前記複数の荷電高分子電解質層が、生分解性の荷電高分子電解質層を含む、請求項1記載の医療用デバイス。
- 治療剤が、前記生分解性の高分子電解質層の下、又は前記生分解性の高分子電解質層内に与えられる、請求項12記載の医療用デバイス。
- 前記医療用デバイスが前記多層領域を複数含む、請求項1記載の医療用デバイス。
- 前記多層領域の少なくとも一部分が自立型である、請求項1記載の医療用デバイス。
- 前記多層領域の少なくとも一部分が、その下にある構造又は上にある構造上に配置される、請求項1記載の医療用デバイス。
- 前記下にある構造又は上にある構造が、前記医療用デバイスとともに埋め込まれない若しくは挿入されない一時的構造である、請求項16記載の医療用デバイス。
- 前記下にある構造又は上にある構造が、前記医療用デバイスの一部を成す永久的構造である、請求項16記載の医療用デバイス。
- 前記下にある構造がバルーンである、請求項16記載の医療用デバイス。
- 前記下にある構造がカテーテルである、請求項16記載の医療用デバイス。
- 前記下にある構造がステントである、請求項16記載の医療用デバイス。
- 前記下にある構造がグラフトである、請求項16記載の医療用デバイス。
- パターン多層領域が、前記下にある構造を覆って設けられる、請求項16記載の医療用デバイス。
- 前記下にある構造が、セラミック、金属、又はポリマー構造である、請求項16記載の医療用デバイス。
- 1つ以上の補強部材が、前記多層領域に隣接して、又は前記多層領域内に設けられる、請求項1記載の医療用デバイス。
- 前記1つ以上の補強部材が、繊維メッシュ、繊維ブレード、又は繊維巻線の形態である、請求項1記載の医療用デバイス。
- 前記多層領域に隣接した除去可能な基材からの残留物をさらに含む、請求項1記載の医療用デバイス。
- 複数の荷電高分子電解質封入層を含む荷電ナノカプセルが、前記多層領域に組み込まれる、請求項1記載の医療用デバイス。
- 前記荷電ナノカプセルが治療剤を含む、請求項28記載の医療用デバイス。
- 前記治療剤が、抗血栓剤、抗増殖剤、抗炎症剤、抗遊走剤、細胞外マトリックス産生及び形成に影響を及ぼす剤、抗悪性腫瘍剤、抗有糸分裂剤、麻酔剤、抗凝固剤、血管細胞成長促進因子、血管細胞成長阻害剤、コレステロール降下剤、血管拡張剤、並びに内在性血管作動性機構に干渉する剤から選択される、請求項10記載の医療用デバイス。
- 基材を提供するステップと、前記基材を覆って一連の荷電層を適用するステップとを含み、各連続層が、直前に適用された層とは反対の電荷であり、前記一連の荷電層が、(a)荷電ナノ粒子を含む荷電ナノ粒子層と、(b)荷電高分子電解質種を含む複数の前記荷電高分子電解質層とを含む、請求項1記載の医療用デバイスを提供する方法。
- 前記一連の荷電層が、荷電ナノ粒子を含む複数のナノ粒子層を含む、請求項31記載の方法。
- 交互に並ぶ一連の、負に荷電したナノ粒子層と正に荷電した高分子電解質層とを適用するステップを含む、請求項32記載の方法。
- 交互に並ぶ一連の、正に荷電したナノ粒子層と負に荷電した高分子電解質層とを適用するステップを含む、請求項32記載の方法。
- 基材を補強するために一連の荷電層を含む、請求項31記載の方法。
- 前記荷電ナノ粒子及び高分子電解質層が、スプレー噴霧によって前記基材を覆って適用される、請求項32記載の方法。
- 前記荷電ナノ粒子及び高分子電解質層が、ディッピングによって前記基材を覆って適用される、請求項32記載の方法。
- 前記基材が完成医療用デバイスの一部となる、請求項32記載の方法。
- 前記基材が除去される、請求項32記載の方法。
- バルーンが前記基材を覆って形成される、請求項39記載の方法。
- 前記基材がステントの表面を被覆するために使用される、請求項39記載の方法。
- 前記多層領域が前記基材の内表面を覆って堆積される、請求項39記載の方法。
- 前記基材がステントの外表面を被覆し、前記多層領域が前記ステントの内表面及び前記基材を覆って堆積される、請求項42記載の方法。
- バルーンが前記基材の内表面を覆って形成される、請求42に記載の方法。
- 前記多層領域が前記基材の外表面を覆って堆積される、請求項39記載の方法。
- 前記基材がステントの内表面を被覆し、前記多層領域が前記ステントの外表面及び前記基材を覆って堆積される、請求項45記載の方法。
- バルーンが前記基材の外表面を覆って形成される、請求項45記載の方法。
- 前記基材が2部品モールドである、請求項39記載の方法。
- 前記基材が、可融解性、可昇華性、可燃焼性、又は可溶解性材料で形成される、請求項39記載の方法。
- 前記基材がワックスで形成される、請求項39記載の方法。
- 前記荷電層を適用する前に、潅流チューブが前記基材内に位置決めされる、請求項47記載の方法。
- 前記荷電層を適用する前に、ガイドワイヤルーメンが前記基材内に位置決めされる、請求項47記載の方法。
- 処置対象の身体の管腔に挿入されて該管腔内で膨張されるように構成されたバルーンを含んでおり、前記バルーンが、(a)荷電カーボンナノチューブを含む少なくとも5層の荷電ナノ粒子層と、(b)荷電高分子電解質種を含む少なくとも5層の荷電高分子電解質層とをさらに含む多層領域を含む、請求項1記載の医療用デバイス。
- 前記荷電高分子電解質層が、ポリアクリル酸、ポリエチレンイミン、又はそれら両方の組合せから選択される、請求項53記載の医療用デバイス。
- 前記多層領域の下にある膨張可能なバルーンをさらに含む、請求項53記載の医療用デバイス。
- 繊維性の補強部材をさらに含む、請求項53記載の医療用デバイス。
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US10/849,742 US7758892B1 (en) | 2004-05-20 | 2004-05-20 | Medical devices having multiple layers |
US10/849,742 | 2004-05-20 | ||
PCT/US2005/016542 WO2005115496A1 (en) | 2004-05-20 | 2005-05-12 | Medical devices having multiple layers |
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2004
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2005
- 2005-05-12 WO PCT/US2005/016542 patent/WO2005115496A1/en active Application Filing
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- 2005-05-12 JP JP2007527298A patent/JP5139060B2/ja not_active Expired - Fee Related
- 2005-05-12 US US11/127,968 patent/US20050261760A1/en not_active Abandoned
- 2005-05-12 CA CA002590543A patent/CA2590543A1/en not_active Abandoned
- 2005-05-12 DE DE602005023726T patent/DE602005023726D1/de active Active
- 2005-05-12 EP EP05747738A patent/EP1750784B1/en not_active Not-in-force
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JP2010517044A (ja) * | 2007-01-29 | 2010-05-20 | ホリスター・インコーポレイテッド | 尿サンプルを採取する装置及び方法 |
US9186439B2 (en) | 2008-03-12 | 2015-11-17 | Anges Mg, Inc. | Drug-eluting catheter and method of manufacturing the same |
JP2012501712A (ja) * | 2008-09-08 | 2012-01-26 | ラボラトリオス ファルマセウティコス ロビ,ソシエダッド アノニマ | ポリマー材料 |
JP2014508560A (ja) * | 2010-12-29 | 2014-04-10 | セント・ジュード・メディカル・エイトリアル・フィブリレーション・ディヴィジョン・インコーポレーテッド | 疎水性カテーテルおよび組成物 |
US10238776B2 (en) | 2010-12-29 | 2019-03-26 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Hydrophobic catheter and composition |
JP2015181486A (ja) * | 2014-03-20 | 2015-10-22 | テルモ株式会社 | カテーテル |
JP2021522961A (ja) * | 2018-05-03 | 2021-09-02 | バイオナット ラブス リミテッド | 生体組織における機能的な小粒子の展開および引戻しのための方法および装置 |
Also Published As
Publication number | Publication date |
---|---|
EP1750784A1 (en) | 2007-02-14 |
DE602005023726D1 (de) | 2010-11-04 |
US20050261760A1 (en) | 2005-11-24 |
EP1750784B1 (en) | 2010-09-22 |
US20100280452A1 (en) | 2010-11-04 |
US20100179645A1 (en) | 2010-07-15 |
WO2005115496A1 (en) | 2005-12-08 |
ATE481993T1 (de) | 2010-10-15 |
CA2590543A1 (en) | 2005-12-08 |
US8293262B2 (en) | 2012-10-23 |
US7758892B1 (en) | 2010-07-20 |
JP5139060B2 (ja) | 2013-02-06 |
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