JP2015513102A - バイオセンサーのデバイス及びシステム - Google Patents
バイオセンサーのデバイス及びシステム Download PDFInfo
- Publication number
- JP2015513102A JP2015513102A JP2015502455A JP2015502455A JP2015513102A JP 2015513102 A JP2015513102 A JP 2015513102A JP 2015502455 A JP2015502455 A JP 2015502455A JP 2015502455 A JP2015502455 A JP 2015502455A JP 2015513102 A JP2015513102 A JP 2015513102A
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- JP
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- fluid
- sample
- swab
- biological
- cartridge
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- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2400/00—Moving or stopping fluids
- B01L2400/06—Valves, specific forms thereof
- B01L2400/0633—Valves, specific forms thereof with moving parts
- B01L2400/0638—Valves, specific forms thereof with moving parts membrane valves, flap valves
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2400/00—Moving or stopping fluids
- B01L2400/06—Valves, specific forms thereof
- B01L2400/0677—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
Abstract
Description
本発明は、バイオセンサーにより試験される流体サンプルの取り扱いのための方法、デバイス、及びシステムに関するものである。本発明は特に、核酸の試験及び診断に使用するための、動物の体液及び植物のサンプルに関する。
ハウジング;ハウジング内にある複数の流体ディスペンサー;ハウジングに繋げられ且つハウジングに対して移動可能な、ユーザーにより作動された部材;及び、サンプルと試薬を混合するために、部材の動きを、流体ディスペンサーの連続且つ同時の動きの現在の組み合わせに変換するための機構、を含む。
生体サンプルを採取するためのシステムは図1に示される。この典型的なシステムは、動物(例えば、病原体を包含するサンプルを含む、ヒト及び他の哺乳動物)からサンプルを採取するための綿棒(1);使用可能なフォーマットでサンプルを提供するためのサンプル調製デバイス(70);サンプルの特性を検知するためのセンサーカートリッジ(80);及び、ユーザー又は更に接続されたデバイスに出力を提供するためのセンサーのシグナルを処理するためのアナライザー(110)を含む。
唾液、血液、及び尿を含むサンプルは、調製及びコンディショニングのためにデバイスに直接加えられ得る。代替的に、綿棒は、細胞を捕捉するために使用され得る。綿棒は、未加工で又は最小に調製されて使用される、頬側綿棒、鼻咽頭綿棒、咽頭綿棒、耳綿棒、生殖器綿棒、創傷綿棒、汚染された表面の綿棒、又はその他の綿棒でもよい。綿棒の材料は、連続気泡フォーム、独立気泡フォーム、編み込まれたポリエステル、又は凝集繊維(flocked fibre)でもよい。宿主動物における核酸検出の適用に好ましい実施形態において、サンプルは、ハンドルとして作用する棒の端部に付けられる独立気泡フォームから作られる材料を有する綿棒によって採取される、唾液である。有利に、独立気泡フォームの綿棒の材料は生体細胞を捕捉せず、故に、このシステムは、それらを放つための機械的又はユーザーによる撹拌を必要としない。
ドナーから集めた唾液流体は、後の遺伝子の及び/又はタンパク質の診断アッセイ(例えば、核酸増幅反応、DNAシーケンス解析)に干渉する物質を包含し得る。例えば、核酸増幅反応において、干渉物質は核酸増幅を阻害し、増幅効率を減少し、及び/又は非特異的な増幅を増加することができる。唾液流体中の望まれない物質を最小化する、又は幾つかの例において排除するための追加の手段として、口内洗浄液洗浄手順が、唾液の収集前に行なわれ得る。口内洗浄液洗浄手順は、唾液サンプルの収集前の更なる待機期間を要することなく、ブラッシング、飲食等の直後に行なわれ得る。口内洗浄液洗浄手順において、個人は、口から口内洗浄液を吐き出す前に、特定の時間、好ましくは10秒と2分の間、より好ましくは20秒と50秒の間で、口内洗浄液で自身の口をすすぐ。次に、唾液流体の収集前に唾液中の残りの口内洗浄液を除去又は減らすために、口は水で少なくとも2回、好ましくは少なくとも5回すすがれる。唾液流体は綿棒によって集められ得る。
1)20−30秒間、10−30mlのListerine Zero(商標)(例えば、満杯のListerineのボトルキャップに対して半分)で口をすすぐ;
2)口から口内洗浄液を吐き出す;
3)10−30mlの水で口をすすぐ;
4)さらに5回、工程3を繰り返す;
5)唾液収集前に1〜2分待つ;
6)収集管に唾液を吐き出すことにより唾液を集める。
サンプル調製デバイス(70)は、流体を含む及び/又は混合するための様々な流体ディスペンサー及びレセプタクルであるハウジングを含む。ディスペンサー及び/又はレセプタクルは、シリンダー(25、50、46、52、26)、及びプランジャー(29、33、30、35、36)によって設けられ得る。図4は初期位置にあるディスペンサーを示す。プランジャーは、最終的な分配された位置に達するように下降する。栓(23)に接続されるプランジャー(29)は、出口ポート(27)を通って流体を分配するためにシリンダー(25)内でストロークする(strokes)。栓(24)に接続されるプランジャー(30)は、出口ポート(28)を通って流体を分配するためにシリンダー(26)内でストロークする。
一旦流体サンプルが調製されると、それは、ハウジング内にあるセンサーチップ(100)を有するセンサーカートリッジ(80)に運ばれる。最終的な混合流体は、チャンネルに沿って流れ、ノズル(59)を介してセンサーカートリッジハウジングに侵入する(図9を参照)。
複数の微小流体容器(101)は流体を受け取るように設けられ、各々が1以上のセンサーに暴露される。容器の頂部は最初に、流体が流れるために開き、センサーによって監視する前に密閉されるようになる。流体の均一且つ十分な分配を保証するために、流量のギャップを作るためのセンサー表面上に表面が存在する。ギャップの高さは、チップの表面に沿って吸い上げ動作を提供するように設計される。ギャップは、流体吸い上げの力が重力よりも大きくなるように設計されねばならない。ギャップは十分に一定であり、又は、(流体が壁へと取り上げられるように連続的な吸い上げ動作を提供するために)侵入ポートから遠位にある端部の方へと少なくされ得る。最適な高さは、使用される材料、流体粘度、及び流体の体積などの様々な要因に依存する。好ましい実施形態において、ギャップの高さは、100umより高い、300umより高い、又は700umより高く、及び、3mm未満、2mm未満、又は1mm未満である。好ましい実施形態において、Triton、Siloxane、BSA、CHAPSなどの界面活性剤は、流れを改善するためにウェル及び/又はチップの表面を覆う。
微小流体チャンバ(101)は、半導体チップ上のセンサーの上で除去される部分を有する薄い膜によって設けられ得る。膜は、チャンバの側面を設けるように孔が作られる、低コストの層を設ける。チャンバの底部はセンサー表面によって設けられる。膜は、シーリングを設けるためにセンサー表面に順応する表面を含む。孔は、レーザー切断、水噴射、ルーティング、掘削、又は打抜きによって作られ得る。商用プロセスは、マイクロリットルの体積を提供する膜を切断するために存在する。好ましい実施形態において、体積は、10ul未満、5ul未満、1ul未満、又は0.2ul未満である。膜は、粘着テープ接着剤、柔軟なPCB、強剛なPCB、接着剤を有するガスケット、アンダーフィルエポキシ(underfil epoxy)、又は、加熱時に粘着性層を提供するアクリル樹脂の層である1枚のBondPlyでもよい。膜は、図12に示されるラミネート構造(116)を設けるためにPCBを含み得る。
・ポリイミドで作られる柔軟構造体であるコア材料(125)(100−150umの厚み);
・付近の層の間の絶縁を提供するカバー層(121、123、127)(20−50umの厚み);
・回路トラックを提供するためにエッチングされる、伝導性メッキ(124、126)(20−50umの厚み)。半導体チップ(112)は、チップ及びメッキ層(126)上に並んだボンドパッド(129)によってPCBに電気的に接続される;
・電極を提供するために印刷される銀−塩化銀インク(122)(1−10umの厚み);及び
・チャンバ間のシーリングにより半導体チップに機械的な接続を提供する粘着テープ接着剤(128)(30−80umの厚み)。
・これらの層の一部は、所望の電気的経路を提供するために、又は前の層へのアクセスを許容するために選択的に除去され得る。
センサーチップは、各チャンバに露出された電極を含む。使用時、電極は、検出システムがトランジスターの閾電圧を設定することを可能にするために流体に基準電圧を提供する。電極(92、93、122)は、例えば銀−塩化銀、金、又は白金でもよい。
Claims (14)
- 流体混合デバイスであって、該デバイスは:
a)開口側部を有するチャンネル(62)及びb)流体ポート(27、53)を画成する土台であって、ポートは、ダム(67、61)によりチャンネルから分離される、土台;及び
チャンネルの開口側部及びポートを覆う土台に付けられる膜
を含むことを特徴とする流体混合デバイス。 - 膜の一部は、ポートからの流体がダムをわたってチャンネルに流れるのを可能にするためにポートに対する水圧下で、土台から離れて動くように配置される、ことを特徴とする請求項1に記載の流体混合デバイス。
- ダムはポートを囲み、空隙(66)はダムを囲む、ことを特徴とする請求項1に記載の流体混合デバイス。
- ポートとチャンネルの間で流体連通下にあるリザーバを更に含み、ここで、リザーバ、及びリザーバからチャンネルまでの出口は、出る前にリザーバの中に空気ポケットを作ることなく流体がリザーバを満たすように構成される、ことを特徴とする請求項1又は2に記載の流体混合デバイス。
- 土台に統合され、一端で流体ポートに接続され、且つもう一端でプランジャー(29、33、30、35、36)に適用される、シリンダー(25、50、46、52、26)を更に含む、ことを特徴とする請求項1乃至4の何れか1つに記載の流体混合デバイス。
- 生体サンプル調製デバイスであって、該デバイスは:
ハウジング;
ハウジング内にある複数の流体ディスペンサー(25、50、46、52、26、29、33、30、35、36);
ハウジングに繋げられ且つハウジングに対して移動可能な、ユーザーにより作動された部材(10);及び
サンプルと試薬を混合するために、部材の動きを、流体ディスペンサーの連続且つ同時の動きの現在の組み合わせに変換するための機構(41、45)
を含むことを特徴とする生体サンプル調製デバイス。 - 生体サンプル調製デバイスであって、該デバイスは:
少なくとも2つの流体ディスペンサー(25、50、46、52、26、29、33、30、35、36);
流体ディスペンサーを受け取りチャンバに接続する微小流体チャンネル(62)であって、流体ディスペンサーは、流体チャンネルをほぼ同時に通って受け取りチャンバへ流すために流体を分配するように配置される、微小流体チャンネル(62)
を含むことを特徴とする生体サンプル調製デバイス。 - 生体液サンプルを抽出するためのデバイスであって、該デバイスは:
第1構成部品(1)であって、該部品は、ハンドル(2)と、圧縮されていない状態で流体を吸収するためにハンドルの端部にある綿棒(5)とを有する、第1構成部品(1);及び
第2構成部品であって、該部品は、綿棒を受け取るための開口部と、圧縮状態で綿棒を圧縮するために綿棒に干渉するよう配置されるチャンバ(12)とを有する、第2構成部品
を含むことを特徴とする、生体液サンプルを抽出するためのデバイス。 - 生体液サンプルを抽出するためのデバイスであって、該デバイスは:
ハンドル(2);
流体を吸収又は吸着するためのハンドルの端部にある綿棒(5);及び
綿棒を圧縮するためハンドルに沿って摺動するよう配置されるカラー(3)
を含むことを特徴とする、生体液サンプルを抽出するためのデバイス。 - サンプルの生物学的特性を感知する方法であって、該方法は:
サンプルを含む流体を微小流体容器に提供する工程であって、各容器は、センサーと、物質により覆われる又は物質の中に固定されるセンサーを有する、工程;
サンプルと反応させるために試薬を制御自在に放出するため物質を溶かす工程;
サンプルの特性を決定するために、試薬と、各容器におけるセンサーからの出力シグナルを相互に関連付ける工程
を含むことを特徴とする、サンプルの生物学的特性を感知する方法。 - サンプルの生物学的特性を感知するためのカートリッジであって、該カートリッジは:
ハウジング(80);
センサーのアレイを中に統合する半導体チップ(100、112);
サンプルを受け取るための微小流体ウェルのアレイ(101);
各ウェルにある物質によって覆われる又はその中に固定される試薬;及び
物質に熱を提供するように構成されるヒーター
を含むことを特徴とする、サンプルの生物学的特性を感知するためのカートリッジ。 - 生体サンプルを感知するためのカートリッジであって、該カートリッジは:
ハウジング(80);
センサーのアレイを中に統合する半導体チップ(100、112);
間にギャップを形成するためにチップから離れて配置されるシーリングブロック(87);
サンプルを受け取るため一面で開放するウェルのアレイ
を含み、
ここで、シーリングブロックとチップは、非シーリング位置と、互いからウェルを分離するようギャップを閉じるためのシーリング位置との間を互いに対して動くように配置される
ことを特徴とする、生体サンプルを感知するためのカートリッジ。 - 生体反応のための微小流体デバイスであって、該デバイスはラミネート構造(116)を有し、且つ:
平面基板(125、124);
平面基板の主要表面に堆積された伝導性トラック(122);
伝導性トラック及び平面基板を覆う絶縁層(121);及び
1以上の微小流体容器を提供するためのラミネート構造を通過する1以上の開口部(101)
を含み、
ここで、トラックは、電極を提供するために、端部のみにて各微小流体容器へと露出される
ことを特徴とする、生体反応のための微小流体デバイス。 - 微小流体デバイスを製造する方法であって、該方法は:
a.平面基板を提供する工程;
b.基板に伝導性トラックの第1セットを置く工程;
c.等角の絶縁層でトラックと基板を覆う工程;
d.伝導性トラックの縁部にのみ露出される開口部を形成するための工程(i)乃至(iii)によって提供される層により切断する工程
を含むことを特徴とする、微小流体デバイスを製造する方法。
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CN104203411A (zh) | 2014-12-10 |
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WO2013144643A2 (en) | 2013-10-03 |
JP2017163993A (ja) | 2017-09-21 |
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US20170106371A1 (en) | 2017-04-20 |
GB2501179B (en) | 2016-11-23 |
EP3323511B1 (en) | 2021-10-27 |
GB2501179A (en) | 2013-10-16 |
CN106501327B (zh) | 2019-06-28 |
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