JP2009119296A - 微小針デバイスおよび製造方法ならびにそれらの使用 - Google Patents
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Abstract
【解決手段】好適な実施形態において、皮膚または他の組織障壁を介して、損傷、苦痛、または組織への刺激なしに、診断的に適切な速度で、微小針デバイスが薬剤の送達(または除去あるいは体液の検知)を可能にする。微小針を作製するための好ましい方法は、微小針の外面を規定する側壁を有する微小モールドを形成する工程、中空微小針を形成するための側壁を電気めっきする工程、そして微小針から微小モールドを除去する工程、を包含する。使用のための好ましい方法において、この微小針デバイスは、微小針の少なくとも1つと流体接続する、1つ以上のチャンバから生物学的障壁へ、または生物学的障壁を介して流体材料送達するために使用される。このデバイスは、好ましくは微小針を通して材料の流れを制御するための手段をさらに含む。これらの手段の代表的な例は、浸透可能膜、破砕可能不浸透性膜、弁およびポンプの使用を含む。
【選択図】図1
Description
本発明は、一般的に、組織障壁を通過する治療用分子または生物学的分子の輸送(例えば、薬物送達)のためのデバイスの分野である。
組織を通過する分子(薬物および生物学的分子を含む)の輸送のための微小針デバイス、およびこのデバイスを製造するための方法が提供される。この微小針デバイスは、皮膚または他の組織障壁を通過する臨床的に適切な速度で、損傷、痛み、または組織への刺激作用が最小であるか全く伴わずに、薬物の送達または体液の除去を可能にする。微小針は、種々の材料(生分解性もしくは非生分解性のポリマー材料または金属を含む)から形成され得る。1つの好ましい実施態様において、このデバイスは、この微小針デバイスを生物学的障壁に一時的に確保して、輸送を促進するための手段を備える。このデバイスは、好ましくはさらに、微小針を通る材料の流れを制御するための手段を備える。これらの手段の代表的な例としては、浸透性膜、破砕可能な非浸透性膜、弁、およびポンプ、ならびに電気的手段の使用が挙げられる。
(1.生物学的障壁)
本明細書中に開示されるデバイスは、以下を含む生物学的障壁中に、またはそれを通過して材料を輸送する際に有用である:皮膚(またはその部分);血液脳関門;粘膜組織(例えば、経口、鼻腔、眼、膣、尿道、胃腸、呼吸);血管;リンパ管;または細胞膜(例えば、細胞の内部に材料を導入するため)。生物学的障壁は、ヒトまたは他の型の動物、ならびに植物、昆虫、または他の生物(細菌、酵母、真菌、および胚子を含む)中に存在し得る。
本明細書中に開示される微小針デバイスは、以下を備える:基板;1つ以上の微小針;および必要に応じて、薬物の送達または分析物の収集のためのリザーバー、ならびに前述の相互作用を制御するためのポンプ、センサ、および/または微小プロセッサ。
デバイスの基板は、種々の材料から構築され得、この材料としては、金属、セラミック、半導体、有機物質、ポリマー、および複合体が挙げられる。この基板は、微小針が装着されるかまたは完全に形成される基部を備える。リザーバーもまた、この基板に装着され得る。
デバイスの微小針は、種々の材料から構築され得、この材料としては、金属、セラミック、半導体、有機物質、ポリマー、および複合体が挙げられる。構築の好ましい材料としては、以下が挙げられる:医薬品グレードのステンレス鋼、金、チタン、ニッケル、鉄、金、スズ、クロム、銅、これらまたは他の材料の合金、シリコン、二酸化ケイ素、およびポリマー。代表的な生分解性ポリマーとしては、以下が上げられる:ヒドロキシ酸(例えば、乳酸およびグリコール酸ポリ乳酸)のポリマー、ポリグリコリド、ポリ乳酸−co−グリコリド、ならびにPEG、ポリ無水物、ポリ(オルソ)エステル、ポリウレタン、ポリ(酪酸)、ポリ吉草酸、およびポリ(乳酸−co−カプロラクトン)との共重合体。代表的な非生分解性ポリマーとしては、以下が挙げられる:ポリカルボネート、ポリメタクリル酸、エチレンビニルアセテート、ポリテトラフルオロエチレン(TEFLONTM)、およびポリエステル。
微小針デバイスは、微小針と連絡するリザーバーを備え得る。このリザーバーは、任意の適切な手段によって基板に装着され得る。好ましい実施態様において、このリザーバーは、接着剤(例えば、グルー)を用いて、周縁部の周りの基板の後ろ(微小針の反対側)に装着される。ガスケットもまた、流体密封シールの形成を促進するために使用され得る。
微小針デバイスはまた、有用な速度で障壁を通過して材料を輸送し得なければならない。例えば、この微小デバイスは、治療的に有用であるに十分な速度で、皮膚を通過して薬物を送達し得なければならない。このデバイスは、プログラムされたスケジュールに従ってか、または患者、保健医療専門者、もしくはバイオセンサとの能動的なインターフェースを通じてかのいずれかで送達速度を制御する、マイクロエレクトロニクスおよび他の微細機械加工構造を有するハウジングを備え得る。この速度は、種々の要因を操作する事によって制御され得、この要因としては、以下が挙げられる:送達される薬物処方の特徴(例えば、その粘度、電荷、および化学組成);各微小針の寸法(例えば、その外径および有孔性開口部または中空開口部の面積);デバイス中の微小針の数;駆動力の適用(例えば、濃度勾配、電圧勾配、圧力勾配);ならびに弁の使用。
有用なセンサーとしては、圧力、温度、化学物質、および/または電磁場のセンサーが挙げられ得る。バイオセンサーは、微小針の表面上、中空もしくは有孔性微小針の内側、または微小針(中実、中空、または有孔性)を介して身体組織と連絡するデバイスの内側に配置され得る。これらの微小針バイオセンサーは、4つのクラスの主な変換器(principal transducer)(電位測定、電流滴定、光学、および物理化学)を備え得る。電流滴定センサーは、電子が、生物学的系と電極との間で交換されるときに生成される電流をモニターする。血中グルコースセンサーは、このよくある型である。
襟部およびフランジはまた、このデバイスに、例えば、その基板または基部の周囲に提供され得る。これは好ましくは、デバイスに付着するが、代替的には、例えば「オーバーサイズ」基板の中心のごく近くに微小針を形成することによって、基板の一体型部分として形成され得る。襟部はまた、デバイスの他の部分から生じ得る。襟部は、デバイスの残部に対して微小針アレイを装着するための界面を提供し、そしてより小型のデバイスの操作を容易にし得る。
図1は、皮膚内に挿入された微小針デバイスの好ましい実施態様の例示の側面立面図である。デバイス10は、複数の微小針12が突出する上部または基板11を備える。上部11の高さは、約1μmと1cmとの間であり、そしてこの上部の幅は、約1mmと10cmとの間である。このデバイスの上部11は、中実または中空であり得、そして複数の区画を備え得る。薬物送達のための好ましい実施態様において、上部11は送達される1以上の薬物を含む。この上部が、薬物または他の分子の輸送を駆動(その動力を提供/指示)する1以上のセンサーおよび/または装置(例えば、ポンプまたは電極)を備えることも、または好ましい。
微小針デバイスは、微細製作プロセスによって、シリコン、金属、ポリマー、および他の材料で小型機械構造を作製することによって、作製される。これらの微細製作プロセスは、微細機械加工の分野で使用されるさらなる方法によって増強された、集積回路、エレクトロニックパッケージングおよび他のマイクロエレクトロニックデバイスを作製するために使用される十分に確立された方法に基づく。微小針デバイスは、数ナノメーター程度に小さい寸法を有し、そして低い1ユニットあたりのコストで、大量生産され得る。
本明細書中に開示される微小針を作製する際に使用され得る微細製作プロセスとしては、リソグラフィー;エッチング技術(例えば、湿式化学、ドライ、およびフォトレジスト除去);シリコンの熱酸化;電気めっきおよび非電気めっき;拡散プロセス(例えば、ボロン、リン、砒素、およびアンチモンの拡散);イオン注入;フィルム蒸着(例えば、エバポレーション(フィラメント、電子ビーム、フラッシュならびにシャドーイングおよびステップカバレッジ)、スパッタリング、化学蒸着(CVD)、エピタキシー(蒸気相、液相、および分子ビーム)、電気めっき、スクリーン印刷、ラミネーション、ステレオリソグラフィー、レーザー加工、およびレーザー切除(投射削摩を含む))が挙げられる。一般に、Jaeger,Introduction to Microelectronic Fabrication(Addison−Wesley Publishing Co.,Reading MA 1988);Runyan,ら、Semiconductor Integrated Circuit Processing Technology(Addison−Wesley Publishing Co.,Reading MA 1990);Proceedings of the IEEE Micro Electro Mechanical Systems Conference 1987−1998;Rai−Choudhury編、Handbook of Microlithography,Micromachining & Microfabrication(SSPIE Optical Engineering Press,Bellingham,WA 1997)を参照のこと。
この方法において、固体のシリコンの有孔性シリコンへの電気化学的エッチングを使用して、穿孔構造として使用され得る極微細な(0.01μmオーダーの)シリコン網を作製する。この方法は、フッ化水素酸水溶液中での、強力に光と組合せたシリコンの電解アノード酸化を使用して、チャネルをシリコン内にエッチングする。エッチングさせるシリコンウェーハのドーピング濃度、エッチング中の電解電位、入射光強度、および電解質濃度を変化させることによって、最終的な細孔構造の制御が達成され得る。エッチングされない材料(すなわち、残ったシリコン)は、微小針を形成する。この方法は、数十ナノメーター幅のを計測する不規則な針型構造を作製するために使用されている。
この処理は、シリコンの深いプラズマエッチングを使用して、0.1μm以上のオーダーの直径を有する微小針を作製する。針は、電圧(電気化学的エッチングの場合のような)を制御することによって間接的にパターン形成するよりむしろ、リソグラフィーを使用して直接的にパターン形成して、従って、最終的な微小針形状のさらなる制御を提供する。
この処理において、金属層を、最初に平面構造上にエバポレートする。次いで、フォトレジストの層をこの金属上に堆積させて、針の形状において露出された金属領域を残すようにパターン形成したモールドを形成する。金属シード層の露出された領域上への電気めっきによって、フォトレジストによって区画されたモールドは、電気めっき材料で満たされ得る。最終的に、基板およびフォトレジストモールドを取り除き、最終的な微小針アレイを残す。この処理によって作製された微小針はほぼ、1μm以上のオーダーの直径を有する。例えば、Frazier,ら、「Two Dimensional metallic microelectrode arrays for extracellular stimulation and recording of neurons」IEEE Proceeding of the Micro Electro Mechanical Systems Conference 195−200頁(1993)を参照のこと。
シリコンまたは他の材料から作製される微小針を形成するための別の方法は、成形フォームを作製するためのリソグラフィー、プラズマエッチング、またはレーザー切除のような微細製作技術の使用(A)、エンボスまたは射出成形のような標準的な移送成形技術を使用する、この成形フォームの他の材料への移送(B)、および最終的な微小針を作製するための新しく作製されたモールド(B)を使用する、元の成形フォーム(A)の形状の再生(C)である。あるいは、成形フォームの作製(A)を省略し得、そしてモールド(B)を直接的に微細製作し得、次いで、これを最終的な微小針(C)を作製するために使用し得る。
好ましい実施態様において、材料が輸送され得る、細孔または他の経路を有する微小針が、作製される。以下の記載は、有孔性または中空の微小針のいずれかを製作するための代表的な方法を概略する。
針の長さにわたって単一の、厳密に規定された穴を有するよりむしろ、有孔性の針は、針のシャフトを通って流体またはエネルギーの伝達を可能にする、チャネルまたは孔の網で満たされる。シリコンの適切な電気化学的酸化によって、高いアスペクト比および異なる孔サイズレジームの範囲を有する孔アレイが形成され得;これらの孔レジームは、(1)2nm未満の平均の孔寸法を有する細孔性レジーム、(2)2nm〜50nmの間の平均の孔サイズを有する中間細孔性レジーム、および50nmより大きい細孔を有するマクロ孔性レジーム(3)として定義されることが示されている。中間細孔性およびマクロ孔性レジームは、薬物送達に最も有用であると予想される。有孔性の針に対して2つのアプローチが、一般的に利用可能であり、これらは、(a)シリコンウェーハを最初に有孔性にして、次いで針を形成するために上記のようにエッチングするか、または(b)中実の微小針をエッチングして、次いで例えば、電気化学的酸化(例えば、フッ化水素酸電解質中でのシリコン基板のアノード酸化による)によって有孔性にするかのいずれかである。エッチングされた有孔構造のサイズ分布は、いくつかの変因(ドーピングの種類および照明条件を含む)に高度に依存し、これはLehmann、「Porous Silicon−−A New Material for MEMS」、IEEE Proceeding of Micro Electro Mechanical Systems Conference 1−6(1996)に詳述される。有孔性のポリマー性または金属性微小針は、例えば、そのポリマーまたは金属中に分散された揮発性または浸出性材料(例えば、揮発性塩)を含むポリマーの微小モールディング、次いで、この分散された材料の揮発または浸出、微小針の形状中へのこの有孔性ポリマーマトリックスの残存によって形成され得る。
中空微小針の三次元アレイは、例えば、乾燥エッチング処理(Laermerら、「Bosch Deep Silicon Etching:Improving Uniformity and Etch Rate for Advanced MEMS Applications,」Micro Electro Mechanical Systems,Orland,Fl,USA(Jan,17−21,1999);Despontら、「High−Aspect−Ratio,Ultrathick,Negative−Tone Near−UV Photoresist for MEMS」Proc.of IEEE 10th Annual International Workshop on MEMS,Nagoya,Japan,、518−522頁(Jan.26−30,1997));リソグラフィー規定および/またはレーザー切除されたポリマーにおける微小モールドの作製および選択的な側壁電気めっき;またはエポキシ移送成形を使用する直接的な微小モールディング技術を使用して、製作される。
中空の針の製作のための1つの方法は、中実の針の形成において使用された中実のマスクの、除去された中実形状の1以上のその内部領域を有する中実形状を含むマスクによる置換である。1つの例は、「ドーナツ形状」マスクである。この型のマスクを使用して、針の内部領域を、その側壁と同時にエッチングする。針の内側壁の側面のエッチングに起因して、これは、十分にシャープな壁を作製しないかもしれない。この場合において、2つのプラズマエッチングが利用され得、一方は微小針の外壁を形成し(すなわち、「標準的」エッチング)、そして一方は内部の中空のコアを形成する(これは、極めて異方性のエッチングである(例えば、誘導結合プラズマ「ICP」エッチング))。例えば、ICPエッチングを使用して、針の内部領域を形成し、次いで、第二のリソグラフィー工程および標準的エッチングによって針の外壁を形成し得る。図2aは、シリコンウェーハ82を示し、これは、このウェーハ82の頂部にパターン形成されたフォトレジスト層84を有する。ウェーハ82は、異方的にエッチングされ(図2b)、その厚さ全体を通る空洞86を形成する(図2c)。次いで、ウェーハ82は、クロム層88で被覆され、次いで第二のフォトレジスト層90が、空洞86を覆い、そして引き続くエッチングのための円形マスクを形成するようにパターン形成される(図2d)。次いで、ウェーハ82は、標準的エッチングによってエッチングされ、微小針のテーパー状外壁92を形成する(図2e)。
金属針は、中実の針形態上に適切な金属層の物理的蒸着によって形成され得る。この針形態は、上記の技術を使用してシリコンから作製され得るか、またはエンボスまたは射出成形のような他の標準的な成形技術を使用して形成され得る。金属は、電気的研磨技術を使用して針の先端から選択的に除去され、この技術において、電解質溶液中で印加されたアノード電位は、先鋭点での電場線の濃度に起因して、その先鋭点でより迅速な金属の溶解を生じる。一旦基本となるシリコン針形態がその先端で露出されると、シリコンが選択的にエッチングされて、中空の金属針構造を形成する。この処理をまた使用して、針形態上の金属以外の材料の堆積、および上記の手順に従って、他の材料から形成される中空の針を作製し得る。
二酸化ケイ素から形成された中空の微小針は、金属を堆積させるよりはむしろ、シリコン微小針形態(上記のような)の表面を酸化して、次いで中実の針形態をエッチングして中空の二酸化ケイ素構造を形成することによって作製され得る。この方法を、図4a〜4dに例示する。図4aは、先端にマスク28を有する針形態26のアレイ24を示す。図4bにおいて、この針形態26は、金属、二酸化ケイ素または他の材料の層30で被覆されている。図4cは、マスク28が除去された被覆された針形態26を示す。最後に、図4dにおいて、針形態26はエッチングされ、金属、二酸化ケイ素または他の材料から作製された、中空の層30を生じる。
好ましい方法において、ポリマー微小針は、微細製作モールドを使用して作製される。例えば、エポキシモールドは、上記のように作製され得、そして射出成形技術を適用して、そのモールドの微小針を形成し得る(Weberら、「Micromolding−a powerful tool for the large scale production of precise microstructures」,Proc.SPIE−International Soc.Optical Engineer.2879,156−167(1996);Schiftら、「Fabrication of replicated high precision insert elements for micro−optical bench arrangements」Proc.SPIE−International Soc.Optical Engineer.3513,122−134(1998))。これらの微小モールディング技術は、本明細書に記載の他の技術を超えて好ましい。なぜなら、これらは、それほど高価でない複製(すなわち、低コストの大量生産)を提供するからである。好ましい実施態様において、ポリマーは生分解性である。
このデバイスは、生物学的障壁を横切って迅速に輸送するための、単一または複数の用途のために使用され得るか、または分子の長期間輸送のために長時間(例えば、数時間または数日)設置され得る。デバイスの寸法、適用部位、およびデバイスが生物学的障壁中(またはその上に)導入される経路に依存して、デバイスが使用されて、特定の位置で分子を導入または取り除き得る。
本質的に任意の薬物または他の生物活性薬剤を、これらのデバイスを使用して送達し得る。薬物は、タンパク質、酵素、ポリサッカライド、ポリヌクレオドの分子および合成の有機または無機の化合物であり得る。代表的な薬剤には、抗感染性薬剤、ホルモン(例えば、インスリン)、増殖調節因子、心臓の機能または血流を調節する薬物、ならびに痛みを制御する薬物があげられる。この薬物は、局所的処置または領域性もしくは全身性治療のためであり得る。以下は、代表的な例および処置に使用される障害である: カルシトニン、骨粗鬆症;エノキサプリン(Enoxaprin)、抗凝固薬;エタネルセプト(Etanercept)、慢性関節リウマチ;エリトロポイエチン、貧血;フェンタニール、術後痛および慢性痛;フィルグラスティン(Filgrastin)、化学療法からの低白血球;ヘパリン、抗凝固薬;インスリン、ヒト糖尿病;インターフェロン β 1a、多発性硬化症;リドカイン、局所麻酔;ソマトロピン、成長ホルモン;ならびにスマトリプタン、片頭痛。
本明細書中に記載のデバイスの1つの実施態様を使用して、生物学的障壁を横切って身体から物質を取り除き得る(すなわち、最小侵襲性診断検知)。例えば、体液を組織の間質液からデバイス上部のリザーバ中へ輸送し得る。次いで、体液をリザーバ中でアッセイし得るか、または体液をリザーバから取りだし、診断または他の目的のためにアッセイし得る。例えば、間質液を、角質層を横切って表皮から取り出し、糖尿病の補助において、それらの必要とされるインスリン用量の決定の際に有用であるはずであるグルコース濃度についてアッセイし得る。検出に望ましい他の物質または特性は、乳酸(運動に重要である)、酸素、pH、アルコール、タバコ代謝産物および不法な薬物(医学的診断および法的執行の両方に重要である)を含む。
クロムマスキング材料を、シリコンウェーハー上に堆積させ、そして所望の微小針の基部にほぼ等しい直径を有するドットにパターン化される。次いで、ウェーハーを反応性のイオンエッチング機(etcher)上に装填し、そしてフルオリン(fluorine)/酸素化学に基づく、注意深く制御されたプラズマに供され、シリコン中に非常に深い、高いアスペクト比の溝をエッチングする。金属マスクにより保護されたこれらの領域が残り、そして微小針を形成する。
、10〜15Ω−cmシリコンウェーハー(Nova Electronic Materials Inc.、Richardson、TX)を開始物質として使用した。ウェーハーを、5部の容量の脱イオン水、1部の30%過酸化水素水、および1部の30%のアンモニウムヒドロオキシド(J.T.Baker、Phillipsburg、NJ)の溶液において約80℃にて15分間洗浄し、次いで炉(Blue M Electric,Watertown、WI)にて、150℃で10分間乾燥させた。約1000Åのクロム(Mat−Vac Technology、Flagler Beach、FL)を、DCスパッター(601Sputtering System、CVC Products、Rochester、NY)を使用してウェーハー上に堆積させた。クロム層を、以下に記載するリソグラフィーック処置を使用して、150μmの中心間間隔を有する直径80μmのドットの20×20のアレイにパターン化した。
微細製作された微小針を使用して、経皮薬物送達を増強し得るかどうかを決定するために、微小針のアレイを、深いプラズマエッチング技術を使用して作製した。それらの破壊することなくヒトの皮膚を貫く能力を試験し、そして経皮輸送において生じた変化を測定した。
微小管の三次元アレイを、従来のリアクティブイオンエッチング剤における改変された黒シリコンプロセスと組み合わせた深いリアクティブイオンエッチングを使用して、シリコンから製作した。この製作プロセスを図5a〜dに例示する。初めに、40μmの直径の環状穴32のアレイを、フォトレジスト34を通じて、2インチのシリコンウェーハ38上の1μm厚のSiO2層36中にパターン化した(図5a)。次いで、このウェーハ38を、深い垂直穴40をエッチングする誘導結合プラズマ(ICP)リアクターにおいて、深いリアクティブイオンエッチング(DRIE)(Laermerら、「Bosch Deep Silicon Etching:Improving Uniformity and Etch Rate for Advanced MEMS Applications」Micro Electro Mechanical Systems、Orlando、Florida、USA(1999年1月17〜21日)を使用してエッチングした。深いシリコンエッチングを、穴40がシリコン基板38中におよそ200μmの深さにした後に停止し(図5b)、そしてフォトレジスト34を除去した。第2のフォトリソグラフィー工程は、その穴に同心性の丸中に残っているSIO2層36をパターン化し、それによってこの穴の周囲の環形状酸化マスク34を残した(図5c)。次いで、このフォトレジスト34を、除去し、そしてウェーハ38を再度深くシリコンエッチングし、一方同時に穴40を、ウェーハ38(SiO2リング内部)を通して完全にエッチングし、このシリコンをシリンダー42を残すSIO2環38の回りにエッチングした(図5d)。得られた管は、150μmの高さであり、80μmの外部直径、40μmの内部直径、および300μmの管の中心間の空間であった。
中空金属微小管を、エポキシの厚い光規定したモールドを使用して、ドライシリコンエッチングなしに調製した。この順序を図6a〜eに例示する。初めに、SU−8エポキシ44の厚層を、30nmのチタン48(犠牲層)でコーティングされたシリコンまたはガラス基板46上に回転鋳造した。次いで、円柱穴49のアレイを、エポキシ層44を通じて、代表的には150μmの厚さで光リソグラフィーで規定した(図6a)。次いで、犠牲層を、SU−8フォトレジスト46中の円柱穴の底にフッ化水素酸および水を含む湿式エッチング溶液を使用して部分的に取り外した(図6b)。次いで、Ti/Cu/Ti(30nm/200nm/30nm)39のシード層を、エポキシモールドの上方表面上に、および円柱穴49の側壁上に、一致してDCスパッター堆積した(図6c)。図6cに示されるように、このシード層39を、基板から電気的に単離した。引き続いて、NiFeを、シード層39上に電気めっきし(図6d)、エポキシ44を基板から除去し、そして周囲のエポキシ44が除去された(図6e)。得られた微小管は、200μmの高さで、80μmの外部直径、60μmの内部直径、および150μmの管の中心管の空間である。微小管の内側の穴は、この管を支持する基部金属を通じて押し出す。
テーパ状の壁を有する微小モールドを、既存の3−Dアレイ(すなわち、モールド挿入物)を鋳造すること、および続いてモールド挿入物を除去することによって製作した。次いで、この微小モールドを、実施例4に記載される微小管についての様式と同様の様式にて、表面めっきした。この製作の順序を図7a〜7dに例示する。
テーパ状の壁を有する微小モールドを、レーザー切除技術の使用によって、図8a〜dに示されるように製作した。レーザーで切除可能なポリマーシート60(例えば、KAPTON登録商標ポリイミド、およそ150ミクロン厚)を、必要に応じて薄い(10〜30ミクロン)金属シート62(例えば、チタン)に積層した(図8a)。テーパ状の穴64を、レーザー技術(例えば、エキシマーレーザー切除)を使用して、金属/ポリマー積層60/62中に形成した(図8b)。レーザースポットのエントリー穴は、金属側部62上であり、そして貫通穴を、金属シートおよびポリマーフィルムの両方を通して作製した。この貫通穴64は、テーパを生成する集束しないまたは適切な基板動作のいずれかと組み合せてテーパ状であり、その結果、穴64の広い端(代表的には40〜50ミクロン)は、金属側62上であり、そして穴64の狭い端(代表的には10〜20)は、ポリマー60側上であった。次いで、厚さ0.1ミクロンの金属66(例えば、チタン)の薄層を、例えば、スパッター堆積技術を使用して、金属66が金属フィルム側面上に堆積し、そしてポリマー側壁をコーティングするが、積層のポリマー6側面をコーティングしないような方法において、堆積した(図8c)。次いで、1〜5ミクロンの厚さでの金属68(例えば、金)の電着を、チタンでコーティングした金属表面66、および64の隣の60のポリマー側壁湾曲セクション上で実行した。最後に、ポリマー60を、例えば、酸素プラズマを使用して除去し、完成した微小針を形成した(図8d)。
エンボスによる微小針の形成を、図9a〜9fに示す。ポリマー層70(図9a)を、中実微小針または微小針アレイ72によって打ち出す。アレイ72を、除去し(図9c)、そして層70を、打ち出しされた空洞76を露出するまで、打ち出しされない側面74からエッチングする(図9d)。次いで、金属層78を、打ち出しされた側面および側壁上に堆積させるが、打ち出しされない側面74上に堆積させない(図9e)。この層78を、必要に応じて、金属層78の上にさらなる金属層80を電着させることによって厚くする(図9e)。次いで、ポリマー層70を、取り外し、微小針78/80を形成する(図9f)。
中空微小針の孔は、例えば、経皮薬物送達において、物質を輸送するために適切であるために、最小の詰まりで流体の流れを提供しなければならない。従って、微小針および微小管を、これらの機能にそれらが適切なことを決定するために評価した。
研究を、中実微小針および中空微小針を用いて実行し、分子および流体の輸送を実証した。表1に示されるように、皮膚を横切る、多数の異なる化合物の輸送は、微小針を使用して可能である。これらの研究を、本特許に記載される方法によってなされた中実シリコン微小針を使用してか、または中空シリコン微小針を使用して実行した。ヒトの死体の表皮を横切る輸送を、Franz拡散チャンバーを37℃で使用して、S.Henry、D.McAllister、M.G.Allen、およびM.R.Prausnitz「Microfabricated Microneedles:A novel method to increase transdermal drug delivery」J.Pharm.Sci.87:922〜25(1998)に記載の方法を使用してインビトロで測定した。
Claims (1)
- 生物学的障壁を横切る分子またはエネルギーの輸送のためのデバイスであって、該デバイスは、
(a)100μmと1mmとの間の長さを有する、複数の中空微小針または有孔微小針であって、該微小針のシャフトの少なくとも一部が約1μmと200μmとの間の幅を有する、複数の中空微小針または有孔微小針と、
(b)該微小針が付着されるかまたは一体化形成される基板であって、該微小針が該基板の表面からある角度で延びる、基板とを含み、
前記基板および/または微小針は可撓性の材料から形成され、これにより該デバイスが前記生物学的障壁の輪郭に適合することを可能にするデバイス。
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US09/095,221 US6503231B1 (en) | 1998-06-10 | 1998-06-10 | Microneedle device for transport of molecules across tissue |
US09/316,229 US6334856B1 (en) | 1998-06-10 | 1999-05-21 | Microneedle devices and methods of manufacture and use thereof |
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JP2000553570A Division JP2002517300A (ja) | 1998-06-10 | 1999-06-10 | 微小針デバイスおよび製造方法ならびにそれらの使用 |
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CN108237211A (zh) * | 2017-12-29 | 2018-07-03 | 广东工业大学 | 一种非晶合金微针的制造方法 |
Also Published As
Publication number | Publication date |
---|---|
ES2356337T3 (es) | 2011-04-07 |
US6334856B1 (en) | 2002-01-01 |
DE69941696D1 (de) | 2010-01-07 |
US20100312191A1 (en) | 2010-12-09 |
US20090131905A1 (en) | 2009-05-21 |
US6503231B1 (en) | 2003-01-07 |
US8708966B2 (en) | 2014-04-29 |
ATE449841T1 (de) | 2009-12-15 |
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