JP2006096760A - マイクロチップ薬物送達デバイス - Google Patents
マイクロチップ薬物送達デバイス Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0009—Galenical forms characterised by the drug release technique; Application systems commanded by energy involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0097—Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips
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- C—CHEMISTRY; METALLURGY
- C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
- C25F—PROCESSES FOR THE ELECTROLYTIC REMOVAL OF MATERIALS FROM OBJECTS; APPARATUS THEREFOR
- C25F7/00—Constructional parts, or assemblies thereof, of cells for electrolytic removal of material from objects; Servicing or operating
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0244—Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
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- Public Health (AREA)
- Dermatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Electrochemistry (AREA)
- Materials Engineering (AREA)
- Metallurgy (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Automatic Analysis And Handling Materials Therefor (AREA)
- Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
【解決手段】分子の放出のためのデバイスを製造する方法であって、基板を提供する工程;エッチマスクとして使用するために、基板上に絶縁性材料を堆積させ、そしてパターニングする工程;基板中に複数のリザーバをエッチングする工程;リザーバに放出システムおよびキャップ材料を充填する工程;および放出システムおよびキャップ材料をエッチングする工程を包含する、方法。
【選択図】なし
Description
本発明は、小型化薬物送達デバイスに関し、そしてより詳細には、制御された時間および速度放出マルチウェル化薬物送達デバイスに関する。
本発明により、以下が提供される。
(項目1)分子の放出のためのマイクロチップデバイスであって、
基板および
該基板中の複数のリザーバを備え、ここで該リザーバがその中に組み込まれている分子を制御可能に放出する、マイクロチップデバイス。
(項目2)前記リザーバが、異なるタイプの分子、異なる量の分子、またはそれらの組合せを含む、項目1に記載のデバイス。
(項目3)前記分子の放出が、前記リザーバ中に分子を組み込む放出システムにより制御される、項目1に記載のデバイス。
(項目4)前記放出システムの上の前記リザーバ上に位置した分解性リザーバキャップをさらに備え、ここで前記キャップの分解速度が分子が該リザーバから放出される時間を決定する、項目3に記載のデバイス。
(項目5)前記リザーバキャップが異なる厚さを有する、項目4に記載のデバイス。
(項目6)前記リザーバキャップが分解または溶解された後、リザーバ中の前記放出システムが分解または溶解し、前記分子を放出する、項目4に記載のデバイス。
(項目7)脈動放出が、1つのリザーバ中に異なる放出システムおよびリザーバキャップ材料を重層することにより、該リザーバから得られる、項目4に記載のデバイス。
(項目8)前記放出システムが非分解性であり、そして前記分子の該放出システムからの拡散が、前記リザーバキャップの分解後に該分子の脈動放出を提供する、項目4に記載のデバイス。
(項目9)放出システムの上のリザーバ上に位置した非分解性リザーバキャップをさらに備え、前記分子のキャップを通じる拡散速度が、分子がリザーバから放出される速度を決定する、項目3に記載のデバイス。
(項目10)カソード、マイクロプロセッサ、タイマー、デマルチプレクサ、および電源をさらに備え、ここで該リザーバキャップがアノードであり、そしてそれぞれ該カソードの1つによって囲まれ、ここで各カソードとアノードとの間の電位の印加の際に、該リザーバキャップが酸化し、溶液中に溶解し、そして下にある放出システムを周囲液に露出する、項目4に記載のデバイス。
(項目11)前記マイクロプロセッサ機能が、特定の時間で個々のリザーバの電極を活性化させるように予めプログラムされたメモリソースにより指示される、項目10に記載のデバイス。
(項目12)前記マイクロプロセッサ機能が、各リザーバの電極を活性化させるようにリモートコントロールにより指示される、項目10に記載のデバイス。
(項目13)バイオセンサをさらに備え、ここで前記マイクロプロセッサ機能が、各リザーバの電極を活性化するように該バイオセンサにより指示される、項目10に記載のデバイス。
(項目14)前記放出システムが賦形剤または希釈剤中に薬物分子を含む、項目2に記載のデバイス。
(項目15)各リザーバ中の前記放出システムが、放出される分子で形成され、ここで該分子の溶解速度が該分子の放出速度を決定する、項目14に記載のデバイス。
(項目16)分子の放出のためのデバイスを製造する方法であって、
基板を提供する工程;
エッチマスクとして使用するために、該基板上に絶縁性材料を堆積させ、そしてパターニングする工程;
該基板中に複数のリザーバをエッチングする工程;
該リザーバに放出システムおよびキャップ材料を充填する工程;および
放出システムおよびキャップ材料をエッチングする工程
を包含する、方法。
(項目17)前記リザーバの上の絶縁性材料の薄いフィルムを取り除く工程をさらに包含する、項目16に記載の方法。
(項目18)各リザーバを、異なるタイプおよび量のキャップ材料および、送達される分子を含む放出システムで充填する工程をさらに包含する、項目16に記載の方法。
(項目19)前記リザーバが、注入、インクジェットプリント、またはスピンコーティングによって充填される、項目16に記載の方法。
(項目20)前記リザーバが、インクジェットプリントによって充填される、項目19に記載の方法。
(項目21)各リザーバの上の絶縁性材料の薄いフィルムの上に誘電性材料の薄いフィルムをを堆積させる工程をさらに包含する、項目17に記載の方法。
(項目22)アノードが各開口部を被覆し、そしてカソードが各アノードの周囲にあるように、誘電性フィルムを電極にパターニングする工程をさらに包含する、項目21に記載の方法。
(項目23)前記アノードが直に前記リザーバの上にあり、そして前記カソードが各アノードの露出された部分の周囲にあることを除いて、各電極の上に材料を堆積させる工程をさらに包含する、項目22に記載の方法。
(項目24)分子の送達のための方法であって、
分子が送達されるべき部位に、基板および該基板中の複数のリザーバを含む、分子の放出のためのマイクロチップデバイスを提供する工程であって、ここで該リザーバがその中に組み込まれている分子を制御可能に放出する、工程
を包含する、方法。
(項目25)前記分子が薬物であり、前記マイクロチップを患者に投与するか、移植するか、または注入することを包含する、項目24に記載の方法。
(項目26)前記分子が、核酸、タンパク質、アミノ酸、多糖類、および有機分子または合成分子からなる群から選択される薬物である、項目25に記載の方法。
(項目27)前記薬物が、薬学的に受容可能なキャリアと組み合わされている、項目26に記載の方法。
(項目28)前記分子が診断試薬または化学試薬である、項目24に記載の方法。
(項目29)前記分子が、脈動様式または持続様式で放出される、項目24に記載の方法。
(項目30)前記放出システムが、放出される分子により形成されている、項目24に記載の方法。
(項目31)分解性リザーバキャップが、前記放出システムの上のリザーバ上に位置し、ここで前記キャップの分解、溶解、または拡散速度が、前記分子が該リザーバから放出される時間を決定する、項目24に記載の方法。
(項目32)前記デバイスが、カソード、マイクロプロセッサ、タイマー、デマルチプレクサ、および電源をさらに備え、前記リザーバキャップがアノードであり、そしてそれぞれ該カソードの1つにより囲まれ、ここで前記方法が、各カソードとアノードとの間で電位を印加して、該リザーバキャップを酸化し、そして下にある放出システムを周囲液に露出する工程を包含する、項目24に記載の方法。
(項目33)前記マイクロプロセッサ機能が、特定の時間で個々のリザーバの電極を活性化させるようにプログラムされたメモリソースにより指示され、ここで前記方法が該メモリをプログラムする工程を包含する、項目32に記載の方法。
(項目34)前記マイクロプロセッサ機能が、各リザーバの電極を活性化させるようにリモートコントロールにより指示される、項目32に記載の方法。
(項目35)前記デバイスがバイオセンサをさらに備え、ここで前記マイクロプロセッサ機能が、各リザーバの電極を活性化するように該バイオセンサにより指示される、項目32に記載の方法。
患者または他の実験システムの必要性に従って規定された速度および時間で薬物および他の分子を正確に送達し得るマイクロチップデバイスが、提供される。本明細書中で使用される「マイクロチップ」は、例えば以下によって記載されるような、紫外線(UV)、フォトリソグラフィー、リアクティブイオンエッチング、および電子ビームエバポレーションのような集積回路の製造に一般的に適用される方法を使用して構成された小型化デバイスである:例えば、S.WolfおよびR.N.Tauber,Silicon Processing for the VLSI Era, 第1巻−Process Technology,Lattice Press, Sunset Beach,CA,1986;およびR.C.Jaeger,Introduction to Microelectronic Fabrication,第V巻,Modular Series on Solid State Devices,Addison−Wesley,Reading,MA,1988。マイクロチップは、分子が放出される速度および放出が開始する時間の制御を提供する。放出時間は、受動的または能動的に制御され得る。マイクロチップの製造の手順は、数ミリメートルから数センチメートルまでの範囲の基本的な寸法(四角形もしくは方形である場合は側部の長さ、または円形である場合は直径)を有するデバイスの製造を可能にする。代表的なデバイスの厚さは、300μmである。しかし、デバイスの厚さは、約10μmから数ミリメートルまでで変化し得る。デバイスの厚さの変化は、マイクロチップに組み込まれ得るリザーバの最大数、および各リザーバの容積に影響を与える。デバイスのインビボの適用は、代表的には、2cm以下の一次元の寸法を有するデバイスを必要とする。インビボの適用のためのデバイスは、最小の侵襲手順を使用して飲み込まれるか、または移植されるに十分に小さい。より小さいインビボのデバイスが(およそ1ミリメートル)が、カテーテルまたは他の注射可能な手段を使用して移植され得る。インビトロの適用のためのデバイスは、より少ない大きさの制限を有し、そして必要であれば、インビボのデバイスの寸法の範囲よりもはるかに大きく作製され得る。
各デバイスは、基板、リザーバ、および送達される分子を含む、囲む、または層状にされた放出システムから構成される。分子の放出時間を制御するデバイスは、リザーバキャップを含み得る。能動なデバイスは、制御回路および電源を含み得る。
基板は、エッチングされたか(etched)または機械加工されたリザーバを含み、これはマイクロチップの支持体として作用する。支持体として作用し得るエッチングまたは機械加工に適切であり、そして送達される分子および周辺を取りまく液体(例えば、水、血液、電解質、または他の溶液)に対して不浸透性である任意の材料が基板として使用され得る。基板の材料の生体適合性が好ましいが、必要ではない。インビボの適用について、使用の前に、非生体適合性材料が生体適合性材料(例えば、ポリ(エチレングリコール)またはポリテトラフルオロエチレン様材料)中にカプセル化され得る。送達される分子に不浸透性であり、そして液体で取り囲まれている、強力な、非分解性の、容易にエッチングされる基板の一例は、シリコンである。別の実施態様において、基板は、生体適合性成分中でのある期間を超えると分解するかまたは溶解する頑丈な材料から作製される。この実施態様は、デバイスが移植され、そして後の時点でのデバイスの物理的な除去が不可能であるかまたは薦められないインビボでの適用(例えば、脳の移植)に好ましい。頑丈な生体適合性の材料のクラスの例は、K.E.Uhrichら、「Synthesis and characterization of degradable poly(anhydride−co−imides)」、Macromolecules,1995,28,2184−93によって議論されるポリ(無水物−co−イミド)である。
送達される分子は、それらの純粋な形態で(液体の溶液、またはゲルとして)リザーバに挿入され得るか、またはそれらは、放出システム内または放出システムによってカプセル化され得る。本明細書中で使用される「放出システム」は、分子が固体もしくは液体のいずれかとして純粋な形態で存在するか、あるいは分解性材料またはマトリックスの拡散もしくはマトリックスの崩壊によって取り込まれた分子を放出する材料で形成されるマトリックス中に存在する両方の状況を含む。分子は、放出システムにしばしば含まれ得る。なぜなら、放出システムの分解、溶解、分散特性が分子の放出速度を制御するための方法を提供するからである。分子は、放出システム内に均一または不均一に分布し得る。放出システムの選択は、所望される分子の放出速度に依存する。非分解性放出システムおよび分解性放出システムの両方が、分子の送達に使用され得る。適切な放出システムとして、ポリマーおよびポリマー性マトリックス、非ポリマー性マトリックス、または無機および有機の賦形剤ならびに希釈物(例えば、炭酸カルシウム、およびショ糖、しかし、これらに限定されない)が挙げられる。放出システムは、天然または合成であり得るが、放出プロフィールの良好な特徴のために合成の放出システムが好ましい。放出システムは、放出が所望される期間に基づいて選択される。対照的に、数秒のように短い放出時間が、いくつかのインビボの適用に所望され得る。いくつかの場合において、リザーバからの持続(一定)放出が最も有用であり得る。他の場合において、リザーバからのパルス(バルク)放出がより有効な結果を提供し得る。1つのリザーバからの1回のパルスが複数のリザーバを使用することによる脈動放出に転換され得ることに留意すること。放出システムのいくつかの層および他の材料を単一のリザーバに組み込んで単一のリザーバからの脈動送達を達成することもまた可能である。持続放出は、分解するか、溶解するか、または長時間にわたってそれを通って分子の分散を可能にする放出システムを組み込むことによって達成され得る。さらに、持続放出は、迅速に連続する数回の分子のパルスを放出することによって、刺激され得る。
任意の天然もしくは合成の、有機分子もしくは無機分子、またはその混合物が送達され得る。1つの実施態様において、マイクロチップが薬物をそれを必要とする患者に全身的に送達するために用いられる。別の実施態様において、患者におけるマイクロチップの構築および配置は、全身的な送達には強力すぎ得る薬物の局在化した放出を可能にする。本明細書中で使用される場合、薬物は、生物活性効果を有する有機または無機分子(タンパク質、核酸および合成有機分子を包含する)であり、例えば、麻酔薬、ワクチン、化学療法剤、ホルモン、代謝物、糖、免疫調節因子、抗酸化剤、イオンチャンネル調節因子、および抗生物質を含む。薬物は、単一の薬物または薬物の混合物の形態であり得、そして薬学的に受容可能なキャリアを含み得る。別の実施態様において、分子は、例えば、分析化学または医学的診断の分野において少量(ミリグラム〜ナノグラム)の1つ以上の分子の制御された放出が必要とされる任意のシステムにおいて、インビトロで放出される。分子は、pH緩衝剤、診断剤、およびポリメラーゼ連鎖反応または他の核酸増幅手順のような複雑な反応における試薬として有効であり得る。
受動的な定時放出薬物送達デバイスにおいて、リザーバキャップは、経時的に分解もしくは溶解する材料、または分解や溶解はしないが送達される分子に対して透過性である材料から形成される。これらの材料は、好ましくはポリマー材料である。材料は、異なるリザーバから異なる時間に、いくつかの場合には、異なる速度で分子を放出し得るように、種々の分解速度または溶解速度または透過性を与えるためのリザーバキャップとしての使用のために選択され得る。異なる放出時間(放出時間遅延の量)を得るために、キャップが異なるポリマー、異なる架橋の程度を有する同じポリマー、またはUV重合可能ポリマーで形成され得る。後者の場合、このポリマーのUV光への露出を変えることによって、種々の程度の架橋を生じ、そしてキャップ材料に異なる拡散特性または分解もしくは溶解速度を与える。異なる放出時間を得るための別の方法は、1つのポリマーを用いてではあるが、そのポリマーの厚さを変える。いくつかのポリマーのより厚いフィルムは、遅延した放出時間を生じる。ポリマーの任意の組合せ、架橋の程度、またはポリマーの厚さは、特定の放出時間または速度を得るために改変し得る。1つの実施態様において、送達されるべき分子を含有する放出システムは、分子にとってほとんど不透過性である分解可能なキャップ材料によって覆われる。リザーバからの分子の放出時間は、キャップ材料が分解または溶解するために必要な時間によって制限される。別の実施態様において、キャップ材料は、非分解性であり、そして送達される分子に対して透過性である。使用される材料の物理的な特性、その架橋の程度、およびその厚さは、キャップ材料を通して拡散する分子に必要とされる時間を決定する。放出システムからの拡散が制限される場合、キャップ材料は、放出の開始を遅延させる。キャップ材料からの拡散が制限される場合、キャップ材料は、分子の放出速度ならびに放出の開始の遅延を決定する。
マイクロエレクトロニックデバイスパッケージは、代表的には、酸化アルミニウムまたは窒化シリコンのような絶縁性材料または誘電性材料から作製される。これらの目的は、デバイスの全ての構成要素が密接に配置されることを可能にし、そして電源および互いへの構成要素の相互連結を容易にすることである。送達デバイスのインビボ適用のために、全パッケージング(全ての構成要素(すなわち、デバイス、マイクロプロセッサ、および電源)を含む)が、ポリ(エチレングリコール)またはポリテトラフルオロエチレン様材料のような生体適合性材料中にコートまたはカプセル化される。インビトロ適用のために必要とされる材料は、それほどストリンジェントでなくてもよく、そして特定の状況に依存する。
(リザーバの製造)
デバイスは、当業者に公知の方法を用いて製造され、例えばWolfら(1986);およびJaeger (1988);Kwonら(1991)によって総説される。
受動定時放出マイクロチップの製造において、リザーバキャップ材料は、微量注射器36aで注入されるか、インクジェットプリンターカートリッジでプリントされるか、またはリザーバの小さな開口上になお存在する絶縁性マスク材料の薄いフィルムを有するリザーバ中にスピンコーティング36bされる。注入またはインクジェットプリント方法が使用される場合、キャップ形成は、材料がリザーバ38a中に注入されるかまたはプリントされた後、完全であり、そしてさらなる処理を必要としない。スピンコーティングが使用される場合、キャップ材料は、複数のスピンコーティング36bによってプラナライズ(planarize)される。次いで、フィルムの表面は、プラズマ、イオンビーム、または化学的エッチング液によって、所望のキャップ厚さが得られるまで38bエッチングされる。好ましい実施態様において、使用される絶縁性材料は、窒化シリコンであり、そしてキャップ材料は、キャップ材料の溶液で充填されるインクジェットカートリッジで、リザーバ中にプリントされる。
好ましい実施態様では、フォトレジストが、絶縁性材料または誘電性材料の薄膜により被覆されたリザーバを有する基板の表面上で電極の形態でパターニングされる。フォトレジストは、リザーバの被覆された開口部の直上領域がフォトレジストによって被覆されていないままであり、そしてアノードの形状にあるように現像される。溶液中に溶解し得るか、または電位の印加の際に可溶性イオンまたは酸化化合物を形成し得る誘電性材料の薄いフィルムが、堆積技術(例えば、化学蒸着、電子ビームまたはイオンビームエバポレーション、スパッタリング、スピンコーティング、および当該分野で公知の他の技術)を用いて全表面の上に堆積される。例示の材料は、Kwonら(1991)およびBaeら(1994)により開示されるような、金属(例えば、銅、金、銀、および亜鉛)およびいくつかのポリマーを含む。フィルム堆積後、フォトレジストは、基板から剥がされる。これにより、フォトレジストにより被覆されていない領域を除いて、堆積されたフィルムが除かれる(リフトオフ技術)。これにより、電極360の形態で基板の表面上に誘電性材料が残される。代替的な方法は、デバイスの全表面上に誘電性材料を堆積させる工程、UVまたは赤外線(IR)フォトリソグラフィーを用いて誘電性フィルムの頂上部に、フォトレジストがアノードの形状でリザーバ上に位置するように、フォトレジストをパターニングする工程、およびプラズマ、イオンビーム、または化学エッチング技術を用いて、マスクされていない誘電性材料をエッチングする工程を包含する。次いで、フォトレジストを剥がし、リザーバを被覆する誘電性フィルムアノードを残す。誘電性材料の代表的なフィルム厚は、0.05〜数ミクロンまでの範囲であり得る。アノードは、リザーバキャップとして働き、そしてデバイス上のカソードの配置は、デバイスの用途および電位制御の方法に依存する。
リザーバ製造の間にマスクおよびエッチストップとして使用されるリザーバを被覆する絶縁性材料または誘電性材料の薄膜は、リザーバ400の充填前に能動定時放出デバイスから、そして(リザーバが基板を完全に通している場合)リザーバ44の充填後に受動定時放出デバイスから除去されなければならない。フィルムは2つの方法で除去され得る。第一には、フィルムは、イオンビームまたはリアクティブイオンプラズマによって除去され得る。好ましい実施態様では、絶縁性材料として用いられる窒化シリコンは、CHF3またはCF4のような酸素およびフッ素含有気体で構成されたリアクティブイオンプラズマによって除去され得る。第二には、フィルムは、化学エッチングにより除去され得る。例えば、緩衝化フッ化水素酸(BHFまたはBOE)が、シリコンジオキシドをエッチングするために用いられ得、そして熱リン酸が、窒化シリコンをエッチングするために用いられ得る。
送達用分子を含む放出システムは、注入、インクジェットプリント、またはスピンコーティングによって、リザーバの大きな開口部に挿入される(40a/40b/400)。各リザーバは、異なる分子および投与量を含み得る。同様に、各リザーバ中の分子の放出速度論は、放出システムおよびキャップ材料の選択により変動され得る。さらに、各リザーバにおける放出システムおよびキャップ材料の混合または重層が、特定の適用の必要性に放出速度論を適合させるように用いられ得る。
受動リザーバおよび能動リザーバが充填されている開口部は、ウェハー結合または防水性エポキシまたは周囲液44/440に不透性の他の適切な材料によって密封されている。インビトロの適用については、全体のユニット、リザーバおよび電極を含むデバイスの正面を除いて、システムに適切な材料中に入れられる。インビボの適用については、ユニットは生体適合性材料(例えば、ポリ(エチレングリコール)またはポリテトラフルオロエチレン)中にカプセル化されている。
活性型デバイスリザーバキャップはアノードであり、これは電位がアノードとカソードとの間に適用される場合、酸化して可溶性化合物およびイオンを形成する。所定の電極材料および電解質について、これらの酸化反応が熱力学的および動力学的に好ましい電位の範囲が存在する。デバイスのリザーバキャップを再現性よく酸化し、そして開けるために、アノード電位は、この電位の範囲に維持されなければならない。
受動および能動のマイクロチップデバイスは、多数のインビトロおよびインビボの適用を有する。マイクロチップは、正確に制御された時間および速度で溶液または反応混合物へインビトロで小さな制御された量の化学試薬または他の分子を送達するために使用され得る。分析化学およっび医学的診断は、マイクロチップ送達デバイスが使用され得る分野の例である。マイクロチップは、インビボで薬物送達デバイスとして使用され得る。マイクロチップは、外科技術または注射のいずれかにより患者に移植され得るか、あるいは嚥下され得る。マイクロチップは、医薬品を飲むことを覚えられないかまたは十分に移動し得ない動物またはヒトへの薬物の送達を提供する。マイクロチップは、異なる送達速度および異なる回数での多くの異なる薬物の送達をさらに提供する。
受動定時放出デバイス、マイクロチップ10を図4に示す。マイクロチップ10は、基板14から形成される。リザーバ16は、基板14にエッチングされている。リザーバ16に配置されているのは送達のための分子18を含有する放出システムである。リザーバはリザーバキャップ12で蓋がされている。放出システムおよび送達のための分子18は、列20a、20b,,20cの間、および各々の列のリザーバ内で変化し得る。
能動定時放出を提供する薬物送達デバイスを図5のマイクロチップ100に示す。マイクロチップ100は、マイクロチップ100は、能動定時放出を提供する電極を含むことを除いて、マイクロチップ10に類似する。マイクロチップ100は、基板160、送達のための分子180を含有する放出システム、アノードリザーバキャップ120、およびカソード140から形成される。好ましくは、マイクロチップ100は、インプット源、マイクロプロセッサ、タイマー、デマルチプレクサ、および電源(示していない)をさらに含む。電源は、反応を選択したアノードとカソードとの間の反応を駆動するためのエネルギーを提供する。アノードとカソードとの間小さな電位の適用の際に、電子はアノードからカソードへ外部回路を通って通過して、アノード材料を酸化し、そして可溶性の化合物またはイオンを形成し、周囲液に溶解し、送達のための分子180を含有する放出システムを周囲液へ露出する。マイクロプロセッサはPROM、リモートコントロール、またはバイオセンサによって指示されるようにデマルチプレクサを通って特定の電極対へと電力を指向させる。
Claims (8)
- 分子の放出のためのデバイスを製造する方法であって、
基板を提供する工程;
エッチマスクとして使用するために、該基板上に絶縁性材料を堆積させ、そしてパターニングする工程;
該基板中に複数のリザーバをエッチングする工程;
該リザーバに放出システムおよびキャップ材料を充填する工程;および
放出システムおよびキャップ材料をエッチングする工程
を包含する、方法。 - 前記リザーバの上の絶縁性材料の薄いフィルムを取り除く工程をさらに包含する、請求項1に記載の方法。
- 各リザーバを、異なるタイプおよび量のキャップ材料および、送達される分子を含む放出システムで充填する工程をさらに包含する、請求項1に記載の方法。
- 前記リザーバが、注入、インクジェットプリント、またはスピンコーティングによって充填される、請求項1に記載の方法。
- 前記リザーバが、インクジェットプリントによって充填される、請求項4に記載の方法。
- 各リザーバの上の絶縁性材料の薄いフィルムの上に誘電性材料の薄いフィルムを堆積させる工程をさらに包含する、請求項2に記載の方法。
- アノードが各リザーバーの開口部を被覆し、そしてカソードが各アノードの周囲にあるように、誘電性フィルムを電極にパターニングする工程をさらに包含する、請求項6に記載の方法。
- 前記アノードが直に前記リザーバの上にあり、そして前記カソードが該アノードの露出された部分の周囲にあることを除いて、各電極の上に材料を堆積させる工程をさらに包含する、請求項7に記載の方法。
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US5490962A (en) * | 1993-10-18 | 1996-02-13 | Massachusetts Institute Of Technology | Preparation of medical devices by solid free-form fabrication methods |
US5518680A (en) * | 1993-10-18 | 1996-05-21 | Massachusetts Institute Of Technology | Tissue regeneration matrices by solid free form fabrication techniques |
US5770076A (en) * | 1994-03-07 | 1998-06-23 | The Regents Of The University Of California | Micromachined capsules having porous membranes and bulk supports |
US5651900A (en) * | 1994-03-07 | 1997-07-29 | The Regents Of The University Of California | Microfabricated particle filter |
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US5893974A (en) * | 1994-03-07 | 1999-04-13 | Regents Of University Of California | Microfabricated capsules for immunological isolation of cell transplants |
US5985328A (en) * | 1994-03-07 | 1999-11-16 | Regents Of The University Of California | Micromachined porous membranes with bulk support |
US5660680A (en) * | 1994-03-07 | 1997-08-26 | The Regents Of The University Of California | Method for fabrication of high vertical aspect ratio thin film structures |
US5992769A (en) * | 1995-06-09 | 1999-11-30 | The Regents Of The University Of Michigan | Microchannel system for fluid delivery |
SE9502258D0 (sv) * | 1995-06-21 | 1995-06-21 | Pharmacia Biotech Ab | Method for the manufacture of a membrane-containing microstructure |
US5830659A (en) * | 1996-09-13 | 1998-11-03 | University Of Utah Research Foundation | Active microtubule-based separations by kinesins |
US5938923A (en) * | 1997-04-15 | 1999-08-17 | The Regents Of The University Of California | Microfabricated filter and capsule using a substrate sandwich |
-
1996
- 1996-07-02 US US08/675,375 patent/US5797898A/en not_active Expired - Lifetime
-
1997
- 1997-07-02 WO PCT/US1997/011589 patent/WO1998000107A2/en active IP Right Grant
- 1997-07-02 CA CA002258898A patent/CA2258898C/en not_active Expired - Lifetime
- 1997-07-02 JP JP10504460A patent/JP2000513725A/ja not_active Withdrawn
- 1997-07-02 AT AT97936950T patent/ATE216219T1/de not_active IP Right Cessation
- 1997-07-02 ES ES97936950T patent/ES2176768T3/es not_active Expired - Lifetime
- 1997-07-02 PT PT97936950T patent/PT914092E/pt unknown
- 1997-07-02 EP EP97936950A patent/EP0914092B1/en not_active Expired - Lifetime
- 1997-07-02 DK DK97936950T patent/DK0914092T3/da active
- 1997-07-02 DE DE69712063T patent/DE69712063T2/de not_active Expired - Lifetime
-
1998
- 1998-02-11 US US09/022,322 patent/US6123861A/en not_active Expired - Lifetime
-
2005
- 2005-11-09 JP JP2005325452A patent/JP2006096760A/ja not_active Withdrawn
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2013520422A (ja) * | 2010-02-18 | 2013-06-06 | アンパック バイオ−メディカル サイエンス カンパニー リミテッド | マイクロデバイスの製造方法 |
JP2013524275A (ja) * | 2010-04-03 | 2013-06-17 | ドシ,プラフル | 薬剤を含む医療機器、その製造方法とその使用方法 |
JP2015232707A (ja) * | 2010-04-03 | 2015-12-24 | ドシ,プラフル | 薬剤を含む医療機器、その製造方法とその使用方法 |
JP2017107216A (ja) * | 2010-04-03 | 2017-06-15 | ドシ,プラフル | 薬剤を含む医療機器、その製造方法とその使用方法 |
JP2019034153A (ja) * | 2010-04-03 | 2019-03-07 | ドシ,プラフル | 薬剤を含む医療機器、その製造方法とその使用方法 |
Also Published As
Publication number | Publication date |
---|---|
CA2258898C (en) | 2005-01-11 |
EP0914092A2 (en) | 1999-05-12 |
ES2176768T3 (es) | 2002-12-01 |
JP2000513725A (ja) | 2000-10-17 |
DE69712063D1 (de) | 2002-05-23 |
DK0914092T3 (da) | 2002-08-12 |
PT914092E (pt) | 2002-09-30 |
CA2258898A1 (en) | 1998-01-08 |
WO1998000107A2 (en) | 1998-01-08 |
EP0914092B1 (en) | 2002-04-17 |
DE69712063T2 (de) | 2002-10-24 |
US6123861A (en) | 2000-09-26 |
ATE216219T1 (de) | 2002-05-15 |
WO1998000107A3 (en) | 1998-06-11 |
US5797898A (en) | 1998-08-25 |
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