JP6038863B2 - 治療剤の送達のためのmemsデバイス - Google Patents
治療剤の送達のためのmemsデバイス Download PDFInfo
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- F04B43/00—Machines, pumps, or pumping installations having flexible working members
- F04B43/02—Machines, pumps, or pumping installations having flexible working members having plate-like flexible members, e.g. diaphragms
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- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
- A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
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- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B81C1/00015—Manufacture or treatment of devices or systems in or on a substrate for manufacturing microsystems
- B81C1/00023—Manufacture or treatment of devices or systems in or on a substrate for manufacturing microsystems without movable or flexible elements
- B81C1/00119—Arrangement of basic structures like cavities or channels, e.g. suitable for microfluidic systems
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
- F16K99/00—Subject matter not provided for in other groups of this subclass
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- F16K99/0003—Constructional types of microvalves; Details of the cutting-off member
- F16K99/0005—Lift valves
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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- A61M2005/14204—Pressure infusion, e.g. using pumps with gas-producing electrochemical cell
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- A61M2205/00—General characteristics of the apparatus
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- 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
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- B81C2201/01—Manufacture or treatment of microstructural devices or systems in or on a substrate
- B81C2201/0174—Manufacture or treatment of microstructural devices or systems in or on a substrate for making multi-layered devices, film deposition or growing
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
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Description
本出願は、2007年3月14日に出願され「Provisional Patent Report: Implantab le MEMS Ocular Drug Delivery System(仮特許報告:埋め込み型MEMS眼薬送達システム)」と題された米国仮特許出願第60/781,969号の利益を主張するものである。該仮出願は、引用によってその全体を本明細書に組み込まれるものとする。
本明細書に記載された発明に通じる研究は、米国政府の支援を受けており、ゆえに、米国政府は、本発明に対して一定の権利を有する。
眼の前部および後部の両方の組織への標的化送達を可能にする軟性のパリレン経強膜カニューレを有するデバイスが、以下において説明される。眼の薬物療法に適した流量(pL/分からμL/分)を提供するために、電気化学駆動式の薬物送達デバイスの実演が行われた。標的量250nLの正確な送達を実現するために、連続薬物送達モードおよびボーラス薬物送達モードの両方が実施された。緊急手術の研究のためにカプセル化パッケージング技術が開発され、ブタの眼において予備の生体外薬物送達実験が実施された。
1.治療剤を患者に送達するための埋め込み型デバイスであって、
前記治療剤を含む液体を含有するように構成されたリザーバと、
前記リザーバと流体連通するカニューレであって、前記患者と流体連通するように構成された出口を有するカニューレと、
第1の位置と第2の位置との間で移動可能な可動要素を含む弁であって、前記可動要素は、オリフィスを穿たれ、前記液体は、前記可動要素が前記第1の位置にあるときは前記オリフィスを通って前記出口へ流れ、前記可動要素が前記第2の位置にあるときは前記オリフィスを通って前記出口へ流れない、弁と、
を備えるデバイス。
2.上記1に記載のデバイスであって、
前記リザーバは、針によって一般に穿刺可能な第1の壁を含み、それによって、前記針を通した前記リザーバの詰め替えを可能にする、デバイス。
3.上記2に記載のデバイスであって、
前記第1の壁は、前記針の除去に際して自身を再封する、デバイス。
4.上記2に記載のデバイスであって、
前記リザーバは、さらに、前記針によって一般に穿刺不可能な第2の壁を含む、デバイス。
5.上記1に記載のデバイスであって、
前記カニューレは、前記患者に挿入可能でなおかつ前記出口を含む端を含む、デバイス。
6.上記5に記載のデバイスであって、
前記カニューレの前記端は、先細にされている、デバイス。
7.上記5に記載のデバイスであって、
前記弁は、前記カニューレの前記端にある、デバイス。
8.上記1に記載のデバイスであって、
前記可動要素は、前記カニューレの壁の軟性部分を含む、デバイス。
9.上記8に記載のデバイスであって、
前記弁は、弁座を含み、前記壁の前記部分は、前記可動要素が前記第1の位置にあるときは前記弁座と接触せず、前記壁の前記部分は、前記可動要素が前記第2の位置にあるときは前記弁座と接触する、デバイス。
10.上記1に記載のデバイスであって、
前記弁は、前記カニューレ内に弁座を含み、前記弁座は、前記カニューレの内側表面から前記可動要素に向かって伸びる突起を含む、デバイス。
11.上記1に記載のデバイスであって、
前記可動要素は、前記カニューレ内の流体によって前記可動要素に印加される圧力に応答し、前記第2の位置から前記第1の位置へ移動する、デバイス。
12.治療剤を患者に送達するための埋め込み型デバイスであって、
前記治療剤を含む液体を含有するように構成されたリザーバと、
前記リザーバと流体連通するカニューレであって、前記患者と流体連通するように構成された出口を有するカニューレと、
第1の電極および第2の電極であって、前記第1の電極および前記第2の電極の少なくとも1つは平面状である第1の電極および第2の電極と、
前記第1および第2の電極を通電させる材料であって、前記第1の電極と前記第2の電極との間に印加される電圧は、前記材料からガスを生成し、前記ガスは、前記リザーバから前記出口へ前記液体を流れさせる、材料と、
を備えるデバイス。
13.上記12に記載のデバイスであって、
前記第1の電極および前記第2の電極は、ともに平面状である、デバイス。
14.上記13に記載のデバイスであって、
前記第1の電極および前記第2の電極は、互いに同一平面上にある、デバイス。
15.上記14に記載のデバイスであって、
前記第1の電極および前記第2の電極は、互いに噛み合わされている、デバイス。
16.上記12に記載のデバイスであって、
前記第1の電極および前記第2の電極は、金、パラジウム、またはプラチナを含む、デバイス。
17.上記12に記載のデバイスであって、
前記材料は、水を含み、前記ガスは、水素ガスおよび酸素ガスを含む、デバイス。
18.患者に治療剤を送達するための埋め込み型デバイスを製造する方法であって、
複数の構造層を形成することと、
液体を含有するように構成されたリザーバと、前記リザーバと流体連通するカニューレとを形成するために、前記複数の構造層を接合することであって、前記カニューレは、前記患者と流体連通するように構成された出口を有する、ことと、
を備える方法。
19.上記18に記載の方法であって、
前記複数の構造層を形成することは、リソグラフィプロセスを使用して少なくとも1枚の構造層を形成することを含む、方法。
20.上記19に記載の方法であって、
前記リソグラフィプロセスは、
基板を用意することと、
前記基板上にパターン形成フォトレジスト層を形成することであって、前記フォトレジスト層は、前記基板の第1の部分を覆い、前記基板の第2の部分を覆わない、ことと、
前記基板の前記第2の部分をエッチングすることと、
前記パターン形成フォトレジスト層を除去することと、
前記基板上に離型層を形成することと、
前記離型層上に前記構造層を形成することと、
前記基板から前記構造層を除去することと、
を含む、方法。
21.上記20に記載の方法であって、
前記離型層は、パリレン(登録商標)を含む、方法。
22.上記20に記載の方法であって、
前記構造層は、ポリジメチルシロキサンを含む、方法。
23.上記18に記載の方法であって、
少なくとも1枚の構造層は、第1の電極および第2の電極を含み、前記少なくとも1枚の構造層を形成することは、
基板を用意することと、
前記基板の上に誘電体層を形成することと、
前記誘電体層の上に前記第1の電極および前記第2の電極を形成することと、
前記基板の一部を露出させるために前記誘電体層の一部を除去することと、
前記基板の前記露出した一部の上に第1の犠牲層を形成することと、
前記第1の犠牲層の上に、前記カニューレの底壁として機能する第1の構造層を形成することと、
前記第1の構造層の上に第2の犠牲層を形成することと、
前記第2の犠牲層の上に、前記カニューレの頂壁および側壁として機能する第2の構造層を形成することと、
前記第1の構造層および前記第2の構造層をパターン形成することと、
前記誘電体層の上に、前記リザーバの一部として機能する第3の構造層を形成することと、
前記第1および第2の犠牲層を除去することと、
前記第1および第2の構造層の下の前記基板の一部を除去することと、
を含む、方法。
24.上記23に記載の方法であって、
前記第1の構造層および前記第2の構造層は、パリレン(登録商標)を含む、方法。
25.患者に治療剤を送達する方法であって、
前記患者の中または上に埋め込まれるデバイスを提供することであって、前記デバイスは、
前記治療剤を含む液体を含有するリザーバと、
前記リザーバと流体連通するカニューレであって、前記患者と流体連通する出口を有するカニューレと、
第1の電極、第2の電極、ならびに前記第1および第2の電極を通電させる材料と、
を含む、ことと、
前記材料からガスを生成するために、前記第1の電極と前記第2の電極との間に第1の電圧を印加することであって、前記ガスは、前記リザーバから前記出口へ前記液体を流れさせる、ことと、
前記ガスから前記材料を生成するために、前記第1の電極と前記第2の電極との間に第2の電圧を印加することと、
を備える方法。
26.上記25に記載の方法であって、
前記材料は、水を含み、前記ガスは、水素ガスおよび酸素ガスを含む、方法。
27.上記25に記載の方法であって、
前記第1の電圧と前記第2の電圧は、符号が反対である、方法。
Claims (9)
- 患者の眼に埋め込まれることになる埋め込み型デバイスであって、
前記患者の眼に投与されるべき液体を収容するための薬物チャンバと、
前記チャンバと流体連通するカニューレと、
前記薬物チャンバに隣接した電解チャンバであって、その中に第1および第2の電極が配された電解チャンバと、
前記第1および第2の電極に電流を印加し、該第1および第2の電極と通電可能な作動流体からガスを生成する回路構成と、
前記薬物チャンバと前記電解チャンバとの間に配された柔軟性の波形膜であって、圧力の増減とともに伸縮するように構成され、前記電解チャンバ内での前記ガスの発生により、前記膜が伸張されて液体が前記薬物チャンバから前記カニューレ内へ流されるようにし、且つ前記電解チャンバ内の前記ガスの再結合により前記膜が収縮して液体が前記薬物チャンバから前記カニューレ内へ流されることを停止する、膜とを備え、
前記膜が、一連の、半径方向に同心の波形状を有し、その半径方向に同心の波形状が、(a)圧力の増加により、実質的に平らな形状から膨張した形状への前記膜の膨張、及び(b)圧力の減少により、前記膨張した形状から前記実質的に平らな形状への前記膜の収縮を促進する、埋め込み型デバイス。 - 請求項1に記載の埋め込み型デバイスであって、
前記膜はパリレン(登録商標)である、埋め込み型デバイス。 - 請求項1又は2に記載の埋め込み型デバイスであって、
前記第1の電極および前記第2の電極は、ともに平面状である、埋め込み型デバイス。 - 請求項3に記載の埋め込み型デバイスであって、
前記第1の電極および前記第2の電極は、互いに噛み合わされている、埋め込み型デバイス。 - 請求項1〜4の何れかに記載の埋め込み型デバイスであって、さらに、
電流を印加することで前記一対の電解電極を動作させるためのワイヤレス動作式回路構成を備える、埋め込み型デバイス。 - 請求項5に記載の埋め込み型デバイスであって、さらに、
前記回路構成に電力供給するためのワイヤレス充電式電池を備える、埋め込み型デバイス。 - 請求項5又は6に記載の埋め込み型デバイスであって、
前記回路構成は、前記一対の電解電極に印加される電流を制御し、それにより圧力生成の時間的なパターンを制御し、投与量および放出を制御する、埋め込み型デバイス。 - 請求項5〜7の何れかに記載の埋め込み型デバイスであって、さらに、
フィードバック制御のためのセンサを備える埋め込み型デバイス。 - 請求項1〜8の何れかに記載の埋め込み型デバイスであって、
前記液体は薬物を含む、埋め込み型デバイス。
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