JP5400569B2 - 組織を熱的切除するためのポア化デバイス - Google Patents
組織を熱的切除するためのポア化デバイス Download PDFInfo
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Description
(発明の分野)
本発明は、組織の熱的な切除のために(例えば、マイクロポアの作製のため)有用である光熱的構造物に関する。
従来のグルコースモニタリングデバイスは、種々の方法(例えば、針またはランセット)によって個体から血液を採取するという原理に基づいて作動する。個体は、血液と相互作用する化学物質を備えるストリップへ、血液の小滴を注ぐ。このストリップは、ストリップの反射率の変化に基づいてグルコース濃度を測定するための、血液−グルコースメーター中へと挿入される。
簡単に言うと、本発明は、組織の光熱的処置の目的のための、組織(例えば、角質層)に対する光熱的または光熱的材料(例えば、染料または色素)の均一な適用のための、方法および構造物に関する。1つの実施態様において、光熱的構造物は、キャリア(例えば、接着剤またはインク)と混合した光熱的材料を備え、そして生じた組合せ物は、基板(例えば、不活性ポリマー基板)に塗布されて、光熱的構造物を形成する。キャリアにこの光熱的材料を適用する手段には、プリント、噴霧、および鋳造が挙げられるが、これらに限定されない。光熱的構造物の別の実施態様において、この光熱的材料を、フィルム形成ポリマー材料に組み込み得、次いで得られた混合物を加工してフィルムを形成し得る。いずれの実施態様の光熱的構造物も、組織(例えば、角質層)と接触して配置され、そして光供給源(例えば、レーザー)により照射される。
(項目1) 組織を処置するための光熱的構造物であって、以下:
(a)多量の光熱的材料;
(b)該光熱的材料と混合されているキャリアであって、該光熱的材料が該キャリア中に実質的に均一に溶解または懸濁されている、キャリア;および
(c)該キャリア−光熱的材料混合物を塗布される基板
を備える、光熱的構造物。
(項目2) 項目1に記載の光熱的構造物であって、かつ前記基板と前記キャリアとの間に下地材料の層をさらに備える、光熱的構造物。
(項目3) 前記光熱的材料が染料または色素である、項目1に記載の光熱的構造物。
(項目4) 前記キャリアが、固体ポリマー、接着剤、ゲルおよびインクのうちの1つである、項目1に記載の光熱的構造物。
(項目5) 組織を処置するための光熱的構造物であって、以下:
(a)多量の光熱的材料;および
(b)該光熱的材料の実質的に均一な懸濁液を含むフィルム材料
を備える、光熱的構造物。
(項目6) 項目5に記載の光熱的構造物であって、かつ前記フィルム材料が、ポリエステル、ポリイミド、ポリエチレン、ポリプロピレン、アクリル性材料、セルロースおよびセルロースの誘導体のうちの1つからなる、光熱的構造物。
(項目7) 前記光熱的材料が染料または色素である、項目6に記載の光熱的構造物。
(項目8) 組織を処置するための方法であって、以下の工程:
(a)多量の光熱的材料を含む光熱的構造物を該組織に適用する工程;および
(b)該光熱的構造物を電磁放射に供する工程
を包含する、方法。
(項目9) 前記適用する工程が、前記多量の光熱的材料が実質的に均一に溶解または懸濁されているキャリアを、塗布される基板を適用する工程を包含する、項目8に記載の方法。
(項目10) 前記適用する工程が、前記基板を前記組織に接着する工程を包含する、項目9に記載の方法。
(項目11) 前記適用する工程が、前記光熱的材料の実質的に均一な懸濁液を混合しているフィルムを適用する工程を包含する、項目8に記載の方法。
(項目12) 前記電磁放射が、約10nm〜約50,000nmの波長範囲である、項目8に記載の方法。
(項目13) 前記供する工程が、多色光供給源から電磁放射を放射する工程を包含する、項目8に記載の方法。
(項目14) 前記供する工程が、レーザーから電磁放射を放射する工程を包含する、項目8に記載の方法。
(項目15) 項目8に記載の方法であって、かつ前記組織の熱的切除によって作製される開口部から体液を回収する工程をさらに包含する、方法。
(項目16) 項目15に記載の方法であって、かつ前記体液中の少なくとも1つの分析物の濃度を決定する工程をさらに包含する、方法。
(項目17) 前記決定する工程が、グルコースの濃度を決定する工程を包含する、項目16に記載の方法。
(項目18) 項目8に記載の方法であって、かつ前記開口部中へ浸透体を導入する工程をさらに包含する、方法。
本明細書中で使用される場合、語句「生物学的流体」とは、血清または全血ならびに間質液を含むことが、意図される。「間質液」とは、身体において、細胞間の空隙を占める透明な流体である。用語「角質層」とは、皮膚の最も外部の層を意味し、これは、種々の乾燥状態において、約15〜約20の細胞層からなる。角質層は、身体の内側から外部環境への水分の損失に対する障壁、および外部環境から身体の内部への攻撃からの障壁を提供する。用語「表皮」とは、皮膚の代謝的に活性な領域を意味する。表皮は、角質層の直下にあり、そして角質層の約10倍の厚さである。表皮は、血液を含まない。用語「真皮」とは、表皮の約10倍の厚さでありそして表皮の直下に見出される、皮膚の領域を意味する。真皮は多量のコラーゲンを含み、このことは皮膚の構造的一体性を提供する。真皮は、皮膚の残りの層に酸素および栄養分を供給する、小さい毛細血管の層を含む。
カーボンブラック(20nm)を、アクリルベースの圧力感受性接着剤(Aroset A 1081、Ashland Chemical)中に均一に懸濁して、20gカーボンブラック/リットルの濃度を有する懸濁液を提供した。次いで、得られた懸濁液をポリエステルフィルム(厚さ25μm)上へ型とりをした。次いで、この接着剤を加熱により硬化させた。硬化後、接着剤層は、厚さ約50μmであった。カーボンブラック−接着剤とフィルム基板の組合せが、光熱的構造物を構成した。直径0.4インチの円形の光熱的構造物を調製し、そして被験体の前腕手掌上に配置した。1ワットのCWレーザーダイオード(810nm)(Coherent Inc.、Santa Clara CA、部品番号#S−81−100C−100T)からの光を平行にし、そして皮膚の表面の平面で直径約80μmのサイズのスポットへ焦点を合わせた。皮膚で250mWのピーク出力で、各50ミリ秒の30パルスを送達した。パルス間で各々80ミリ秒の遅延を伴った。このパルス系列を反復して、1.0mmの円の円周上に間隔を置かれた光熱的処置部位を6つ生成した。光熱的構造物の除去後、角質層において、得られた小さい孔が存在することを、検出または観察し得た。
カーボンブラック(<1μm)を、アクリルベースのインク(例えば、透明なマニキュア)中に懸濁して、10g/lの濃度を有する懸濁液を提供した。次いで、この懸濁液を、ポリエステル基板(厚さ0.050mm)上に型をとるかまたはプリントした。この懸濁液を硬化させた。次いで、得られたコーティングされた基板を、皮膚に直接(フィルムとして)かまたは間接的(デバイスの一部として)かのいずれかで局所的に適用した。レーザーからの光または多色光供給源からの光を、光熱的処置のために、フィルム、および着色料と皮膚との間の界面上に焦点を合わせた。光熱的処置後、フィルムを除去し、そして廃棄した。
カーボンブラック(<1μm)をポリエステルに混合して、最終濃度10g/lを有する混合物を提供した。この混合物は、商標名「MELINEX 427/200」として市販されていた。この混合物を融解し、次いで融解した混合物を押し出し形成してフィルム(厚さ0.050mm)を形成した。次いで、このフィルムを硬化させた。次いで、得られたフィルムを、直接(フィルムとして)かまたは間接的(デバイスの一部として)のいずれかで、皮膚に局所的に適用した。レーザーからの光または多色光供給源からの光を、光熱的処置のために、フィルム、および着色料と皮膚との間の界面上に焦点を合わせた。光熱的処置後、フィルムを除去し、そして廃棄した。
金属チタンをポリカーボネートフィルム基板上へスパッターコーティングした。この基板は、2mil(0.05mm)の厚さを有する。チタン/チタン酸化物層の厚さは、約50nmであった。このフィルムを皮膚上に配置し、金属層を皮膚と接触させた。このフィルムを、標的領域を囲む接着環により、適切な位置に維持した。レーザーからの光または多色光供給源からの光を、光熱的処置のために、フィルム、および着色料と皮膚との間の界面上に焦点を合わせた。光熱的処置後、フィルムを除去し、そして廃棄した。
実施例1の光熱構造物を、処置すべき領域にわたる皮膚上に配置した。レーザーからの光を、アセンブリー上に焦点を合わせて、熱的に処置される角質層の小さい領域を作製した。処置される領域を、下にある細胞の癒着の損失により特徴付けた。この領域は、ゆるんだ皮膚の領域に囲まれた小さい孔としてか、または表皮層における細胞の癒着が破壊された小さい水疱に似ている領域に囲まれた小さい孔として現れる。この処置を、個々に処置された領域が重複するまで反復した。接着剤を除去した時に、処置された角質層および角質層の下にある表皮のいくらかが除去された。残りの表皮を、滅菌した綿棒を用いた穏やかに剥離することにより除去し得る。この処置は、一般的に、出血を生じない。
実施例5に記載の方法を、接着剤のない光熱構造物を用いて実施した。光熱処置後、作用された組織を、綿棒を用いて穏やかにこすることによるか、または滅菌した接着フィルム(これは、テープを除去することにより組織を除去し得る)を適用することによって除去した。
直径9mmのオリフィスを備える小さい真空チャンバーを、実施例1の手順に従って形成された6つのマイクロポアを覆うように、皮膚上に配置した。このチャンバーを、2分間約6.00psiまで排気した。真空を解放後、得られた透明な流体を、微小毛細管を使用して収集した。このプロトコルの使用を通じて、恒常的に容量0.25〜0.75μlを得た。流体の存在は、光熱的に生成された孔が、角質層を貫通して下にある表皮内に至り、角質層の障壁特性を破っていることを示した。非処置の皮膚に対して真空を適用して、測定可能な流体は全く得られなかった。
間質液のサンプルを、実施例7に記載したように得た。透明な流体を、1.0mlの、5mMリン酸塩、0.02%アジ化ナトリウム(pH7.0)中に希釈した。間質液をサンプリングしたのと同時に、血漿サンプルを、同じ被検体から得た。被験体の指を、ランセットデバイスで刺し、そして血液をヘパリンを有する毛細管中に収集した。血液サンプルを遠心分離して、細胞画分から血漿画分を分離した。1.0μlの血漿サンプルを、毛細管を使用して1.0mlのリン酸緩衝希釈液に移した。間質液および血漿の希釈サンプルを、パルスアンペロメトリー検出器を備えた高圧液体クロマトグラフィー(HPLC−PAD)を使用してグルコース含量について分析した。HPLC−PAD分析を、Dionex PA−1カラム(4.0×250mm)を使用して、150mM水酸化ナトリウムの流速1.0ml/分で作動させて実行した。注入容量10μlを作製した。グルコースは、ピーク保持時間4.0±0.3分を示した。サンプルを、グルコースを含む既知の水性スタンダードおよび血清スタンダードと比較した。そして、濃度を、グルコースピークの領域から決定した。6人の健康な、糖尿病でない被験体から得た結果を、以下の表に示す。グルコースの単位はmg/dlである。
角質層を通じて物質を送達する能力を示すために、フルオレセインナトリウムをモデルトレーサーとして使用した。試験被験体の前腕手掌を、実施例1におけるように処置し、直径約1.1mmの円型を備える6つの孔の組を調製した。ポア化後、滅菌食塩水中10%フルオレセインナトリウム1.0μlを、これらの孔を覆うように皮膚上に配置した。皮膚のコントロール領域(形成された孔がない)を、同様に、1.0μlのフルオレセインナトリウム溶液で覆った。2分後、過剰の溶液を吸い取りによって除去し、その後、穏やかな洗剤で洗浄し、すすぎ、そして吸い取り乾燥した。孔を形成した場合、皮膚は、組織中のフルオレセインの存在に起因する目に見える色素沈着を示した。黄色に染色した領域は、直径約1.4mmであった。コントロール領域については、全く染色が明らかでなかった。紫外照射下で、孔が形成された皮膚の領域は、フルオレセインナトリウムの存在に起因して、直径約1.5mmの領域にわたって強力な黄色−緑色蛍光を示した。6つの孔各々を縁取る隣接領域は、より強力に蛍光性であった。さらに、外側角質層中のいくらかの残余の蛍光に起因すると思われる、直径約2.0mmの領域にわたるわずかな蛍光が存在した。
Claims (7)
- 組織を熱的切除するためのポア化デバイスであって、当該ポア化デバイスは:
(a)可撓性の基板を含む組織接触層を有し、;
(b)光熱的構造物を有し、該光熱的構造物は、該組織接触層の少なくとも一部を占め、電磁エネルギーを吸収し、そして該電磁エネルギーを組織を熱的切除するための熱エネルギーに変換するものであり、かつ、該光熱的構造物は、可溶性光熱的染料または不溶性光熱的色素である光熱的材料と、光熱的材料を均一に懸濁させるキャリアである圧力感受性接着剤とを含んでおり;
前記可撓性の基板の材料は、ポリエステル、ポリイミド、ポリエチレン、ポリプロピレン、ポリカーボネート、アクリル性材料、セルロース、またはセルロース誘導体であり、
前記組織接触層の厚さは、0.05mm〜2.0mmである、
ポア化デバイス。 - 請求項1に記載の組織を熱的切除するためのポア化デバイスであって、ここで、
前記組織接触層が、さらに、該ポア化デバイスを該組織に接着させるための接着剤を備える、ポア化デバイス。 - 請求項1に記載の組織を熱的切除するためのポア化デバイスであって、ここで、前記光熱的材料が、前記光熱的構造物が加熱された場合に蒸発し、放出されるフラックスエンハンサ化合物とともに懸濁されている、ポア化デバイス。
- 請求項1に記載の組織を熱的切除するためのポア化デバイスであって、ここで、前記光熱的材料が、さらに、可塑剤、界面活性剤、結合剤、および架橋剤のうちの少なくとも1つを含む、ポア化デバイス。
- 請求項1に記載の組織を熱的切除するためのポア化デバイスであって、
さらに、
生物学的流体を輸送する、流体輸送層;および
該電磁エネルギーに対して透過性のメーター−インターフェース層、
を備える、
前記ポア化デバイス。 - 請求項5に記載の組織を熱的切除するためのポア化デバイスであって、
前記流体輸送層が、化学的補助された灯心によって生物学的流体を輸送する、
前記ポア化デバイス。 - 請求項5に記載の組織を熱的切除するためのポア化デバイスであって、さらに、以下:
前記生物学的流体の分析のための、該生物学的流体と接触するように前記メーター−インターフェース層によって支持されるセンサー、
を備える、ポア化デバイス。
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- 1999-03-05 DE DE69937338T patent/DE69937338T2/de not_active Revoked
- 1999-03-05 DE DE69938100T patent/DE69938100D1/de not_active Expired - Lifetime
- 1999-03-05 EP EP99911191A patent/EP1059883B1/en not_active Expired - Lifetime
- 1999-03-05 EP EP99911184A patent/EP1059882B1/en not_active Revoked
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- 2003-09-25 US US10/671,006 patent/US6922578B2/en not_active Expired - Fee Related
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Also Published As
Publication number | Publication date |
---|---|
EP1059883B1 (en) | 2008-02-06 |
JP5314231B2 (ja) | 2013-10-16 |
EP1059938A1 (en) | 2000-12-20 |
AU2989399A (en) | 1999-09-20 |
WO1999044638A1 (en) | 1999-09-10 |
AU2898699A (en) | 1999-09-20 |
US20040158137A1 (en) | 2004-08-12 |
AU2988899A (en) | 1999-09-20 |
JP2002505305A (ja) | 2002-02-19 |
EP1059883A1 (en) | 2000-12-20 |
US6922578B2 (en) | 2005-07-26 |
DE69937338T2 (de) | 2008-07-24 |
ATE385405T1 (de) | 2008-02-15 |
CA2323160A1 (en) | 1999-09-10 |
DE69937338D1 (de) | 2007-11-29 |
EP1059882A1 (en) | 2000-12-20 |
EP1059882B1 (en) | 2007-10-17 |
ATE375752T1 (de) | 2007-11-15 |
JP2010158510A (ja) | 2010-07-22 |
DE69938100D1 (de) | 2008-03-20 |
WO1999044508A1 (en) | 1999-09-10 |
WO1999044507A1 (en) | 1999-09-10 |
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