JP4216073B2 - 改善された薬物配給および診断用サンプリングのための組織電気穿孔法 - Google Patents
改善された薬物配給および診断用サンプリングのための組織電気穿孔法 Download PDFInfo
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Description
本発明は治療の目的のための薬物配給および診断の目的のための生物学的な各種物質の可能なサンプリングを共に改善するために電流を用いるバリア膜の融除のための方法および装置に関連している。
経皮的および局所的な薬物投与形態が各種器官系の病気および皮膚および下層組織に関連する組織等のような局所的な状況の治療においてここ数十年にわたり広く処方されている。これらの薬物は一定の高い効力を伴って皮膚または粘膜を自由に浸透するので、一般的に「配給が容易な(easy-to-deliver)」薬物である。皮膚または粘膜の中を通過する薬物の浸透はその膜を跨ぐ一定の化学的な濃度勾配を生じる。「配給が容易な」薬物の例はニトログリセリン、スコポラミン、ニコチン、ヒドロコルチゾン、ベタメタゾン、ベンゾカイン、およびリドカインを含む。
一例の態様において、本発明は少なくとも一層の細胞のバリア膜(例えば、人間等の哺乳類動物の皮膚)を通して一定の分子を輸送するための方法を特徴としており、一定の治療用の電極からの一定の電流により上記膜を融除する(例えば、その膜の各細胞を破壊する)工程、およびその孔あけした膜を通して上記分子を移動するための一定の駆動力を利用する(例えば、上記膜を通してその哺乳類動物の体内または体外に移動する)工程を含む。上記膜の例は(例えば、一定の人間の)皮膚、頬、膣、および直腸の膜を含むがこれらに限らない。
当該技術分野における熟練者であれば、本明細書における説明に基づいて、本発明をその完全な程度にまで利用することが可能であると考えられる。以下の特定の実施形態は単なる例示として解釈すべきであり、本発明の開示の残りの部分を何ら限定していない。
電気穿孔処理により皮膚の角質層を通して形成した細孔の輸送経路を評価するために、一定の電気外科装置(サージトロン(Surgitron)(商標)、エルマン・インターナショナル社(Ellman International)、ヒューレット、ニューヨーク州)を用いてヨークシャー・ブタ(メス、約12kg)の背中の皮膚について一定の生体内実験を行なった。これらのブタを適当な麻酔薬および鎮痛薬により固定した。一定の細線電極(直径0.26mm)および3乃至10のスケールにおける電力出力設定による電気高周波療法用の電流を採用した。この電極の先端部分が皮膚にほとんど触れる程度まで電極を皮膚に向けて注意深く移動することによりその皮膚の表面に一定の小さい細孔を形成した。この電極の先端部分と皮膚表面との間の隙間に一定の電気的なアークが見えた直後に電極を皮膚から速やかに除去した。
上記実施例1において記載されている電気穿孔処理を皮膚において39個細孔/cm2 の細孔密度を伴う2頭のブタにおいて行なった後に、受動的な拡散による経皮的なインスリン配給を行なった。一定のインスリン収容チャンバーを電気穿孔処理した皮膚の上に速やかに置いた。このチャンバーは0.5mlのインスリン注射溶液(ポーク・インスリン、分子量≒6000ダルトン、100単位/ml、レギュラー・イレチン(Regular Iletin)(登録商標)II、エリ・リリー社(Eli Lilly)、インディアナポリス、インディアナ州)を入れた柔軟なポリエチレンにより作成されている。このチャンバー内のインスリン溶液の電気穿孔処理した皮膚に対する接触面積は2.3cm2 であった。このチャンバーは当該チャンバーの縁における一定の家畜用シリコーン接着剤によりブタの皮膚に固定されている。耳の静脈の血液サンプルを入手することにより各ブタの血液グルコースをモニターして、これらのサンプルをその精度を確認するために別々に2台の血液グルコース分析装置(ワン・タッチ(One Touch)(登録商標)ベーシック(Basic)、ライフスキャン社(LifeScan, Inc.)、ミルピタス、カリフォルニア州)により分析した。この結果、上記のインスリン配給実験の開始からかなり速やかに両方のブタにおける血液グルコース量が低下した。このような有意差のある血液グルコースの減少(その基準量の50%を超える)は上記薬物収容チャンバーからのインスリンが実際に角質層における各細孔を通過して体内に入り、全身系の血液循環の中に入ってこれらのブタにおける深刻な低血糖症を生じていることを示している。
皮膚において9個細孔/cm2 の一定の細孔密度を伴う2頭のブタにおいて一定の電気穿孔処理を行なった後に、経皮的なインスリン配給を行なった。この実験において一定の低い細孔密度を採用した目的は経皮的なインスリン配給に対する細孔の数の作用効果(例えば、利用可能な輸送経路の程度)を調べることである。実施例2における構成と同一のインスリン収容チャンバーおよび薬物供給処置をこの実験において採用した。しかしながら、一定のスチール線をイオン導入用の配給電極として作用させるために上記のインスリン収容チャンバーの中に配置した。このイオン導入の電力供給源は一定の市販のイオン導入装置(フォレサーII(Phoresor II)(商標)、PM700、モーション・コントロール社(Motion Control Inc.)、ソルト・レーク・シティ、ユタ州)であった。この配給実験の最初の1.5時間はインスリンの受動的拡散のみであった。その後、インスリンのイオン導入を、図10において各矢印により示されているように、それぞれ1.5時間目および3時間目において4mAの直流電流により30分間の部分で2回行なった。さらに、上記チャンバーの中の薬物溶液のpHチャンバーの変動を防止するために5分ごとに電導性の電極の電気的な極性を逆にした。
実施例3における処置と同様に一定の電気穿孔処理を2頭のブタにおいて行なった後に、その処理部位にエリスロポイエチン(20kU/ml、プロクリット(Procrit)(登録商標)、オルソ・バイオテック社(Ortho Biotech, Inc.)、ラリタン、ニュージャージー州)の受動的な拡散を行なった。各ブタにおいて電気穿孔処理により作成した25個細孔/cm2 が存在していた。この電気穿孔処理した皮膚の上に設置した薬物チャンバーは0.5mlのエリスロポイエチン溶液を収容していた。さらに、血液サンプルを一定のELISA法によるエリスロポイエチン分析のために収集した。上記エリスロポイエチンの配給処置は7時間にわたり行ない、配給処置の終了時に薬物収容チャンバーは除去したが、血液のサンプリングはこの実験の開始後から30時間まで続けた。この結果、上記薬物収容チャンバーを各ブタの皮膚から除去するまで血漿のエリスロポイエチン濃度における漸進的な増加が見られることが分かった。さらに、この配給実験の1日後において、各ブタにおける血漿のエリスロポイエチン濃度はその内因性の基準量よりも依然として高かった。
12 電流制御装置
14 電流発生装置
16 治療(用)電極
50 小孔
52 角質層
54 表皮
56 真皮
100 装置
Claims (31)
- 少なくとも1個の細胞層から成る哺乳類動物のバリア膜を通して分子を輸送するための装置において、
治療用電極のアレイにして、該治療用電極のアレイは該アレイと前記膜との間に空隙を形成するように位置決めされ、該膜を融除する電流を供給でき、該電流が前記治療用電極と前記膜との間に電気的なアークを形成する、治療用電極のアレイと、
前記孔あけ処理した膜を通して前記分子を移動するための駆動力とを備え、前記膜が皮膚である、装置。 - 前記分子が前記膜を通して前記哺乳類動物の中に輸送される薬剤である請求項1に記載の装置。
- 前記薬剤が多糖類、ペプチド、タンパク質、およびポリヌクレオチドから成る群から選択される請求項2に記載の装置。
- 前記装置が前記融除の前に前記膜に供給される導電性の物質と共に使用される請求項1に記載の装置。
- 前記導電性の物質が各種の電解質、金属粒子、および炭素粒子から成る群から選択される請求項4に記載の装置。
- 前記電流の電圧が約5乃至約2,000mVである請求項1に記載の装置。
- 前記装置が基準電極をさらに備え、前記電流が前記治療用電極から前記基準電極に流れる請求項1に記載の装置。
- 前記電流が直流電流を含む請求項1に記載の装置。
- 前記電流が交流電流を含む請求項1に記載の装置。
- 前記電流が約60kHz乃至約5,000kHzの周波数を有する請求項1に記載の装置。
- 前記電流の波形が減衰正弦波、被変調正弦波、純正正弦波、減衰方形波、被変調方形波、純正方形波、直流電流およびこれらの混合波形から成る群から選択される請求項 1 に記載の装置。
- 前記膜が人間の角質層である請求項 1 に記載の装置。
- 前記駆動力がイオン導入、電気浸透、逆イオン導入、電気穿孔、フォノフォレーシス、圧力勾配、熱および濃度勾配から成る群から選択される請求項1に記載の装置。
- 前記分子が前記哺乳類動物の体内から前記膜を通して輸送される請求項1に記載の装置。
- 各種の針またはブレードから成る群から選択される前記膜を孔あけする部材をさらに備える請求項1に記載の装置。
- 前記融除の前または融除の間に前記膜を冷却する手段をさらに備える請求項1に記載の装置。
- 前記装置が前記融除の前または融除の間に前記膜に供給される鎮痛薬と共に使用される請求項1に記載の装置。
- 前記膜における融除の存在を決定するために電気抵抗またはインピーダンスをモニターする手段をさらに備える請求項1に記載の装置。
- 少なくとも1個の細胞層から成る哺乳類動物のバリア膜を通して分子を輸送するための装置において、
治療用電極のアレイにして、該治療用電極のアレイは該アレイと前記膜との間に空隙を形成するように位置決めされ、該治療用電極のアレイにおける少なくとも1個の電極は前記膜を融除できるように電流により選択的にエネルギー供給され、前記治療用電極と前記膜との間には空隙が形成され、前記電流が前記治療用電極と前記膜との間に電気的なアークを形成する、治療用電極のアレイと、
前記膜における融除の侵入の深さを所定の閾値と比較するために前記融除の侵入の深さを感知するセンサーと、
前記孔あけ処理した膜を通して前記分子を移動するための駆動力とを備える、装置。 - 前記センサーが前記膜のインピーダンスを測定して前記侵入の深さを感知する請求項19に記載の装置。
- 前記電流の電圧が約5乃至約2,000mVである請求項19に記載の装置。
- 前記装置が基準電極をさらに備え、前記電流が前記治療用電極から前記基準電極に流れる請求項19に記載の装置。
- 前記電流が直流電流を含む請求項19に記載の装置。
- 前記電流が交流電流を含む請求項19に記載の装置。
- 前記電流が約60kHz乃至約5,000kHzの周波数を有する請求項19に記載の装置。
- 前記膜が人間の角質層である請求項 1 9に記載の装置。
- 前記駆動力がイオン導入、電気浸透、逆イオン導入、電気穿孔、フォノフォレーシス、圧力勾配、熱および濃度勾配から成る群から選択される請求項19に記載の装置。
- 前記分子が前記膜を通して前記哺乳類動物の中に輸送される薬剤である請求項19に記載の装置。
- 前記分子が前記哺乳類動物の体内から前記膜を通して輸送される請求項19に記載の装置。
- 前記装置が前記融除の前に前記膜に供給される導電性の物質と共に使用される請求項19に記載の装置。
- 哺乳類動物におけるバリア膜を通して分子を輸送するための装置において、
バリア膜接触用の表面部分を有するハウジングと、
前記皮膚接触用の表面部分に連絡しているオリフィスを有する貯蔵器と、
複数の電極にして、各電極が前記バリア膜と当該各電極の先端部分との間に空隙を定め、前記複数の電極が前記バリア膜を融除する電流を供給し、前記電流が前記電極と前記膜との間に電気的なアークを形成する、複数の電極と、
RFエネルギーを電子制御回路に供給するための電力供給源を備えており、この制御回路が、
前記複数の電極の1個以上にRFエネルギーを選択的に供給するための変調回路を含み、
前記皮膚接触用の表面部分が前記膜に接触する時に、前記装置が前記電流により前記膜を融除すること、および前記貯蔵器から前記膜を通して前記哺乳類動物の体内に、あるいは、当該哺乳類動物から、前記膜を通して、前記貯蔵器の中に前記分子を輸送することの両方を行なうことができる装置。
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US09/795,908 US7133717B2 (en) | 1999-08-25 | 2001-02-28 | Tissue electroperforation for enhanced drug delivery and diagnostic sampling |
PCT/US2002/006101 WO2002068044A2 (en) | 2001-02-28 | 2002-02-28 | Tissue electroperforation for enhanced drug delivery and sampling |
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JP2004523308A JP2004523308A (ja) | 2004-08-05 |
JP4216073B2 true JP4216073B2 (ja) | 2009-01-28 |
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EP (1) | EP1365834A2 (ja) |
JP (1) | JP4216073B2 (ja) |
AU (1) | AU2002252152A1 (ja) |
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US8480580B2 (en) * | 1998-04-30 | 2013-07-09 | Abbott Diabetes Care Inc. | Analyte monitoring device and methods of use |
US9066695B2 (en) | 1998-04-30 | 2015-06-30 | Abbott Diabetes Care Inc. | Analyte monitoring device and methods of use |
US6949816B2 (en) | 2003-04-21 | 2005-09-27 | Motorola, Inc. | Semiconductor component having first surface area for electrically coupling to a semiconductor chip and second surface area for electrically coupling to a substrate, and method of manufacturing same |
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AU2002252152A1 (en) | 2002-09-12 |
US7133717B2 (en) | 2006-11-07 |
WO2002068044A2 (en) | 2002-09-06 |
US20020010414A1 (en) | 2002-01-24 |
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