JP2020109411A - エレクトロウェッティング流体操作を用いた、サンプル調製・反応に関する閉止システムにおいて、アッセイを実行するための装置及びカートリッジ - Google Patents
エレクトロウェッティング流体操作を用いた、サンプル調製・反応に関する閉止システムにおいて、アッセイを実行するための装置及びカートリッジ Download PDFInfo
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Abstract
Description
ed silicon)、炭素、無機ガラス、及び、それらの組み合わせからなるグループから選択される材料から形成される。
この出願は、米国特許出願第14/062,860号(米国特許出願公開第2014−0322706号)及び米国特許出願第14/062,865号(米国特許出願公開第2014−0194305号)に関連し、それぞれの開示は、本明細書に参照によって組み込まれる。
一般に、システムは、2つのコンポーネント、つまり、その中にサンプルが搭載され、
様々な試薬、緩衝剤、及び、望ましいアッセイ又は他のプロシジャーを実行するための他の処理材料を含む複合カートリッジと、サンプル処理および目標分析物の最終検出を実行するためにカートリッジが挿入される処理装置と、を含む。
本発明の側面は、病気や病原体による感染(例えば、バクテリア、ウイルス、菌類など)を診断するための、サンプル内の目標の分析物の検出のためのシステム及び方法を提供する。当業者によって理解されるように、サンプル溶液は、これらには限定されないが、体液(これらには限定されないが、哺乳類のサンプルが好ましく、人間のサンプルが特に好ましいが、実質的に任意の有機体の血液、尿、血清、血しょう、脳脊髄液、リンパ液、唾液、鼻咽頭サンプル、肛門・膣分泌物、糞、がん細胞を含んでいると疑われる組織を含む組織サンプル、汗、及び、精液を含む);環境サンプル(これらには限定されないが、空気、農業、水、及び、土壌のサンプル、環境スワブ(environmental swab)、及び他の収集キットを含む);生物兵器剤サンプル;食物及び飲料サンプル、研究サンプル(つまり、核酸の場合、サンプルは、おおむねWO/1999/037819に記載されているように、PCR増幅反応のように目標増幅及び信号増幅の両方を含む増幅反応の生成物であることができ、この開示は、本明細書に参照によって組み込まれる);純化されたゲノムDNA、RNA、タンパク質などの純化サンプル;生のサンプル(バクテリア、ウイルス、ゲノムDNAなど);を含む多くの物を含むことができ;当業者によって理解されるように、サンプルには、実質的に任意の実験的操作が行われたかもしれない。
本発明の側面を具現化する複合カートリッジが、図1〜4に示される。図4に示されるように、複合カートリッジは、サンプル調製モジュール70を含むアセンブリを備える。サンプル調製モジュール70は、様々なウェル、入り口・出口ポート、流体チャネル、混合機構、バルブ、及び、流体サンプル材料を受け入れ、輸送し、混ぜ合わせ、混合し、当該流体サンプル材料に他のプロセスを実行するための他のコンポーネントを含み、以下に更に詳細に記述するような方法で、試薬及び緩衝剤などの流体を処理する。サンプル調製モジュール70は、上部面に固定される上部シール56と、下部面に固定される下部シール230を有する基板72を備える。基板72は、上部面及び下部面に形成された複数の溝又は開口チャネルを含む。各溝は、基板72の上部面に形成されたブラインドホールを備える1以上の入り口ポート及び/又は基板72の下部面に形成されたブラインドホールを備える1以上の出口ポートへ接続されることができる。上部シール56及び下部シール230は、それぞれ、基板72の上部と下部をカバーし、基板72に形成された入り口と出口に整列された開口部を有し、従って、導管又は封止チャネルのネットワークを形成し、これを通って、流体、例えば、液体、ガス、溶液、乳剤、液体固体懸濁液などが、サンプル調製モジュール70のある部分から他の部分へ流れることができ、入り口ポートと出口ポートを有し、流体は、入り口ポートを通ってサンプル調製モジュール70に流入したり、出口ポートを通ってサンプル調製モジュール70から流出したりすることができる。様々な実施形態においては、サンプル調製モジュール70は、透明又は半透明であり、例えば、ポリカーボネート、ポリプロピレン、アクリル、マイラー(Mylar)、アクリロニトリル、ブタジエンスチレン(「ABS」)、又は、他の適切なポリマーから作られる。
一般に、ブリスタは、適切な圧力が印加されると、好ましくは破裂する、変形可能な材料でできている;つまり、ブリスタを形成するために用いられる材料は、圧力が除去されたとき、その元の形状に戻らない。というのも、これは、添加された試薬の逆流を起こすからである。更に、ブリスタは、一回(圧力の一回の印加がアッセイ中になされる)又は、何回か(例えば、複数の一定分量の試薬が、アッセイの間、単一の場所又は複数の場所のいずれかに与えられる)用いられることができる。各ブリスタは、固有のプロセス材料(例えば、緩衝剤、試薬、不混和性液体など)を含むことができ、又は、2以上のブリスタは、同一のプロセス材料を含むことができる。この冗長性は、残りの使い捨て製品において、同一のプロセス材料を複数の場所に与えるために用いられることができる。
サンプル調製モジュール70の様々な詳細が図6〜15に示される。
反応モジュール240の詳細、特に上部プレート241が、図24〜31に示されている。上部プレート241の、それぞれ上部斜視図と上部平面図を示す、図24と26を参照すると、上部プレート241は、上部プレート241の上部面242上に突出し、上部プレート241の外部エッジから内部にずらされた位置で上部面240の周囲を少なくとも部分的に囲む上部周囲壁256を含む。上部周囲壁256は、反応モジュール240をサンプル調製モジュール70に固定する接着ガスケット232の取り付け位置を提供する上部エッジに沿って形成される、途切れのない開口チャネル又は溝258を有する。図4参照。上部周囲壁256は、上部面242上の上部周囲壁256によって囲まれる凹部領域260を形成する。図28及び29も参照のこと。
図58、59を参照すると、様々な実施形態においては、複合カートリッジ10の反応モジュール240は、上部プレート241の下部に固定された、流体処理パネル354を含む。流体処理パネル354は、周囲壁290によって周囲が囲まれ、例えば、耐油性及び耐熱性の接着剤によって、パネルサポート292に支持され、固定される。流体処理パネル354は、流体の移動及び分析物の検出など、複合カートリッジ10の複数の機能を促進する。そのような流体の移動は、流体輸送経路に沿って、流体の1以上の液滴を輸送すること、振動するように1以上の液滴を移動することによって流体を混合すること(例えば、線形的に往復させて、又は、途切れのない(例えば、円形、楕円形、四角形の)経路上で)、異なる材料を含むことができる流体液滴を組み合わせる、2以上の小さな液滴に液滴を分裂すること、などを含むことができる。
複合カートリッジ10を処理し、本発明の側面を具現化するように構成された装置が、図32の参照番号400によって示されている。この装置は、制御コンソール402、制御コンソール402に動作可能に結合された1以上の処理モジュール410、各処理モジュール410内の複数の処理ベイであって、それぞれが、複合カートリッジを受け入れ、他のベイとは独立に複合カートリッジを処理するように構成された複数の処理ベイ、及び装置ソフトウェア(ISW)を備える。様々な実施形態においては、この装置は、1つの制御コンソール402と4つまでの処理モジュール410を備え、各処理モジュールは、6つの処理ベイを含む。各処理モジュール410は、例えば、電力、入出力データを交換し、制御コンソール402との信号伝送を制御するために、制御コンソール402に動作可能なように結合され、その上、制御コンソール402に物理的に接続されることができる。処理モジュール410と一体になった各処理ベイは、一度に一つの複合カートリッジ10を受け入れるように構成され、他の複合カートリッジを処理する他の処理ベイとは独立にカートリッジを処理するように構成される。様々な実施形態においては、この装置は、各処理ベイが、60分以内でカートリッジの処理を完了するように構成される。
本発明の側面を具現化し、上記した複合カートリッジ10を処理するように構成された処理装置は、図32の参照番号400で示されている。上記したように、装置400は、制御コンソール402と、制御コンソール402に動作可能なように結びつけられた1以上の処理モジュール410を含む。制御コンソール402は、一実施形態においては、グラフィカルユーザインタフェースを呈し、ユーザが制御コンソール402に情報を入力することができ、及び/又は、情報がユーザに提示されることができるタッチスクリーンを備えるディスプレイパネル404を含む。様々な実施形態においては、制御コンソール402は、キーボード、マイク、スイッチ、手動スキャナ、音声感応入力などの、データを入力するための追加の又は別の手段を備えることができる。更に上記したように、この装置は、例えば、1次元又は2次元バーコードなどのバーコードを読み取るためのバーコードスキャナ、又は、RFIDスキャナなどの、マシン読み取り可能なコードを読み取るための他の種類のスキャナを含むことができる。様々な実施形態においては、制御コンソール402は、ハードドライブ又は他のストレージ媒体、モニタ、プリンタ、インジケータライト、又は、音響信号素子(例えば、ブザー、ホーン、ベルなど)、電子メール、テキストメッセージなどを含む、データ(つまり、情報及び/又は結果)を出力する追加の、又は、別の手段を備えることができる。
図32及び34に示されるように、各処理モジュール410は、1以上のカートリッジドア412を含み、各カートリッジドア412は、その中でカートリッジ10が処理される、処理ベイ(以下に記述される)と結びつけられている。図示された実施形態においては、各処理モジュール410は、6つのカートリッジドア412と結びつけられた処理ベイを含む。各カートリッジドア412は、複合カートリッジ10を、好ましくは、単一の好適な方向で受け入れるように構成されている。各カートリッジドアは、また、好ましくは、閉止位置では、例えば、バネなどにより、付勢されているが、カートリッジが挿入されたときには押されて開くことができる、閉止可能なドア(例えば、旋回ドアパネル)を含む。
処理ベイ440が、図38、39、40、及び41の様々な図に示される。図38〜41のそれぞれにおいて、処理ベイ440のフレーム418は、図から省略されている。図38は、複合カートリッジ10が挿入された処理モジュール440の正面、右側斜視図である。図39は、複合カートリッジ10が挿入された処理モジュール440の正面、左側斜視図である。図40は、処理モジュール440の背面、右側斜視図である。図41は、複合カートリッジ10が挿入された処理モジュール440の正面、右側分解斜視図である。
カートリッジ処理アセンブリ470の側面が図41及び42に示されている。上記したように、カートリッジ処理アセンブリ470の殆どのフィーチャは、モータマウント642のブリスタプレート644の下に配置されている。カートリッジ処理アセンブリ470は、複合カートリッジ10を受け入れ、保持し、後に排出するように構成されたカートリッジキャリッジアセンブリ650を含む。カートリッジキャリッジアセンブリ650は、搭載プレート640のブリスタプレート644の下部面に固定される。
カートリッジキャリッジアセンブリ650の更なる詳細が図46に示され、この図は、カートリッジ処理アセンブリ470の他のコンポーネントが省略された、カートリッジキャリッジアセンブリ650の分解斜視図である。カートリッジキャリッジアセンブリ650は、搭載プレート640のブリスタプレート644の下部に固定される略四角形のフレームを備えるキャリッジホルダ652を含む。検出器は、複合カートリッジ10(図46には示されていない)がカートリッジホルダ652に挿入されたときを検出するために提供されることができる。様々な実施形態において、検出器は、カートリッジホルダ652の対抗する側のそれぞれのポケット内にそれぞれが配置される、発光器686と検出器688を備える光検出器を備える。発光器686から検出器688への光ビームは、複合カートリッジがカートリッジホルダ652に挿入されたとき、遮蔽され、したがって、カートリッジの存在を示す信号を生成する。
加熱・制御アセンブリ500の詳細が、図43に示され、これは、カートリッジ処理アセンブリ470の他のコンポーネントを省略した、加熱・制御アセンブリ500の分解斜視図である。
カムフレームアセンブリ600の詳細が、図47に示され、これは、カートリッジ処理アセンブリ470の他のコンポーネントを省略した、カムフレームアセンブリ600の分解斜視図である。カムフレームアセンブリ600は、線形アクチュエータ604を駆動するカムフレームモータ602を含む。カムフレーム606は、対向する、略平行で、長尺方向の円材608、610と、長尺方向の円材608、610のそれぞれの対応する端部の間に延伸するクロス円材614を含む。線形アクチュエータ604は、クロス円材614から上方に突出するモータコネクタ618において、カムフレーム606に結合する。フォロワスロット又はチャネル612は、長尺方向の円材608、610のそれぞれの上部面の下の外部側に沿って形成される。側壁472、474のそれぞれから延伸するフォロワ素子480a、480b(図42参照)は、フォロワスロット612に延伸する。
混合モータアセンブリ700の詳細が、図50A及び50Bに示される。図50Aは、混合モータアセンブリ700の斜視図であり、図50Bは、混合モータアセンブリ700の分解斜視図である。
ブリスタ圧縮機構アセンブリ750の詳細が図51に示されており、この図は、ブリスタ圧縮機構アセンブリ750の分解斜視図である。アセンブリ750は、カムアームプレート752と、カムアームプレート752内に動作可能なように搭載されたカムアーム動作圧縮機構のアレイ754を備える。カムアームプレート752は、搭載プレート640のブリスタプレート644の上部に搭載される。アレイ754の圧縮機構は、複合カートリッジ10の破裂可能な流体コンパートメント又はブリスタを圧縮するように構成された圧縮機構、カートリッジのランスブリスタを圧縮するように構成された圧縮機構、及び、カートリッジの能動バルブアセンブリを押し下げ、閉止するように構成された圧縮機構、を備える。アレイ754の様々な圧縮機構は、ブリスタプレート644に形成されたブリスタ穴646に整列され、アレイ754の圧縮機構が、ブリスタと、処理ベイ440内のブリスタプレート644の下に配置された複合カートリッジ10の能動バルブにアクセス可能となる。
圧縮機構の詳細が図52、53、及び54に示される。図52は、圧縮機構のアレイ754の圧縮パッドを示すカムアームプレート752の下部部分平面図である。図53は、カムアームプレート752から隔離されたアレイ754の圧縮機構の上部斜視図である。図54は、カムアームプレート752から隔離されたアレイ754の圧縮機構の下部斜視図である。
大まかに、及び、具体的に上記したように、開示の側面は、制御及びコンピューティングハードウェアコンポーネント、ユーザ生成ソフトウェア、データ入力コンポーネント、及びデータ出力コンポーネントによって実装される。ハードウェアコンポーネントは、1以上の入力値を受信し、入力値の操作、又はそうでなければ入力値への作用のための命令を提供する非一時的マシン読み取り可能な媒体に格納された1以上のアルゴリズム(例えば、ソフトウェア)を実行することにより、計算及び/又は制御ステップを実施し、1以上の出力値を出力するように構成された、マイクロプロセッサ及びコンピュータなどの、コンピューティング及び制御モジュール(例えば、システムコントローラ)を含む。そのような出力は、ユーザに、例えば、装置の状態に関する情報、又は、実行中のプロセスなどの情報を提供するために、ユーザに表示され、又はそうでなければ示されることができ、又は、そのような出力は、他のプロセス及び/又は制御アルゴリズムへの入力を含むことができる。データ入力コンポーネントは、データが、制御及びコンピューティングハードウェアコンポーネントによる使用のために入力される素子を備える。そのようなデータは、グラフィックユーザインタフェース、キーボード、タッチスクリーン、マイク、スイッチ、手動スキャナ、音声感応入力などの手動入力素子と共に、位置センサ、モータエンコーダを備えることができる。データ出力コンポーネントは、ハードドライブ、又は、他のストレージ媒体、グラフィックユーザインタフェース、モニタ、プリンタ、インジケータライト、又は、音声信号素子(例えば、ブザー、ホーン、ベルなど)を備えることができる。
サンプル調製モジュール70において実行されることができる例示的サンプル調製プロセスが、図16〜23に記述され、図示される。当業者は、本明細書で記述していないサンプル調製プロセス−例えば、本明細書で記述したものからのステップの並べ替え、本明細書で記述したあるステップの省略、及び/又は、あるステップの追加−は、サンプル調製モジュール又は、サンプル調製モジュールの改変バージョンによって実行されうることを認識するだろう。
サンプル処理モジュール70から反応モジュール268のサンプルコンパートメント266に送られるサンプル材料に対して、反応モジュール240での反応プロセスが実施される。一例示的実施形態においては、その反応プロセスは、PCR増幅及び分析物検出を含む。
以下の実施形態は、前述の開示に含まれる。
i)基板と、
ii)基板に形成され、ある体積の流体サンプルを受けるように構成されたサンプルウェルと、
iii)サンプルウェルに選択的に配置されるように構成されたクロージャと、
iv)基板上に支持され、変形されていない状態では、流体を内部に保持し、外部圧縮力の印加の際に破裂して流体チャンバから流体の少なくとも一部を排出するように構成され、基板に形成されたチャネルを介して、サンプルウェルと流体を通じる変形可能な流体チャンバと、
v)基板に形成され、基板に形成されたチャネルを介してサンプルウェルと流体を通じる混合ウェルと、
vi)基板に形成され、基板に形成されたチャネルを介して混合ウェルと流体を通じる流体出射ポートと、を備えるa)サンプル調製モジュールと、
サンプル調製モジュールに取り付けられ、サンプル調製モジュールに形成された流体出射ポートを介して、サンプル調製モジュールから流体を受けるように構成された(b)反応モジュールであって、
1)上部面と、
2)上部面の周囲を少なくとも部分的に囲み、サンプル調製モジュールの面と流体シールによって接触し、上部面とサンプル調製モジュールの面との間に、介在空間を形成する上昇壁と、
3)サンプル調製モジュールの流体出射ポートと流体結合するサンプルチャンバと、
4)試薬チャンバと、
5)検出チャンバと、
を備えるi)上部プレートと、
上部プレートの下部面に結合し、流体処理パネルと上部プレートとの間に反応・処理空間を規定し、反応・処理空間は、サンプルチャンバ、反応チャンバ、及び検出チャンバに開いている、又は、開くことが可能で、
1)その上に形成され、少なくとも反応・処理空間の少なくとも一部内の流体液滴の操作を行うように構成されたエレクトロウェッティンググリッド、
を備えるii)流体処理パネルと、
を備える(b)反応モジュールと、
を備える流体サンプル処理カートリッジ。
乾燥検出緩衝剤を含む検出緩衝剤チャンバと、
サンプル調製モジュールから送られる再水和緩衝剤を受けるように構成された再水和緩衝剤チャンバと、
乾燥PCR試薬を含むPCR試薬チャンバと、
乾燥エキソヌクレアーゼ試薬を含むエキソヌクレアーゼチャンバと、
を備える、実施形態1又は2に記載の流体サンプル処理カートリッジ。
a)装置に挿入された流体サンプル処理カートリッジを受け入れ、保持するように構成されたカートリッジキャリッジアセンブリと、
b)カートリッジキャリッジアセンブリに隣接し、カートリッジキャリッジアセンブリ内に保持されるカートリッジと動作可能に接触しない第1の位置と、カートリッジキャリッジアセンブリ内に保持されるカートリッジと動作可能に接触する第2の位置との間のカートリッジキャリッジアセンブリに対する移動を行うように構成される制御アセンブリと、
c)電力が与えられた移動を行うように構成され、カムブロックアセンブリの電力を与えられた移動を、制御アセンブリの第1の位置と制御アセンブリの第2の位置との間のカートリッジキャリッジアセンブリに対する制御アセンブリの移動に変換するための制御アセンブリに動作可能なように結合されたカムブロックアセンブリと、
e)変形可能な流体チャンバを破裂させ、その流体チャンバから流体の少なくとも一部を排出するために、変形可能なチャンバに外部圧縮力を選択的に印加するように構成された変形可能なチャンバ圧縮アセンブリと、
を備える装置。
i)基板の平面と略平行な第1の方向への、電力が与えられた移動を行うように構成されたカムフォロワプレートと、
ii)カートリッジの変形可能なチャンバと関連付けられ、基板の平面と略垂直な成分を有する第2の方向への移動により、基板に対しチャンバを圧縮する力を印加するように構成された圧縮機構と、を備え、
iii)カムフォロワプレートは、カムフォロワプレートの第1の方向の移動を第2の方向の圧縮機構の移動に変換し、したがって、チャンバに外部圧縮力を印加するために、圧縮機構に動作可能に結合される、
実施形態16又は17に記載の装置。
Claims (5)
- 平坦な基板上に支持された変形可能な流体チャンバであって、変形されていない状態においては、その中に流体を保持するように、外部圧縮力が印加されたときには、破裂して、前記流体チャンバから流体の少なくとも一部を排出するように構成される変形可能な流体チャンバを少なくとも一つと、自身の上に形成されたエレクトロウェッティンググリッドを含む反応モジュールと、を含む流体サンプル処理カートリッジを処理するように構成された装置において、前記エレクトロウェッティンググリッドは、前記流体サンプル処理カートリッジの少なくとも一部内の流体液滴の操作を行うように構成された装置であって、
a)前記装置に挿入される流体サンプル処理カートリッジを受け入れ、保持するように構成されたカートリッジキャリッジアセンブリと、
b)カートリッジキャリッジアセンブリに隣接し、カートリッジキャリッジアセンブリ内に保持されたカートリッジと動作可能に接触していない第1の位置と、カートリッジキャリッジアセンブリ内に保持されるカートリッジと動作可能に接触する第2の位置との間のカートリッジキャリッジアセンブリに対する移動を行うように構成される制御アセンブリと、
c)電力を与えられた移動を行うように構成され、カムブロックアセンブリの電力を与えられた移動を、制御アセンブリの第1の位置と制御アセンブリの第2の位置との間のカートリッジキャリッジアセンブリに対する制御アセンブリの移動に変換する制御アセンブリに動作可能に結合されるカムブロックアセンブリと、
e)変形可能な流体チャンバを破裂させ、その流体チャンバから流体の少なくとも一部を排出するために、変形可能な流体チャンバへ外部圧縮力を選択的に印加するように構成された変形可能なチャンバ圧縮アセンブリと、
を備える装置。 - 前記制御アセンブリは、制御アセンブリが第2の位置にあるとき、前記装置と、カートリッジのエレクトロウェッティンググリッドとの間で、電力を供給し、電気接続を制御するように構成される電気コネクタ素子を含むコネクタボードを備える、請求項1に記載の装置。
- 前記変形可能なチャンバ圧縮アセンブリは、
i)基板の平面に略平行な第1の方向への、電力を与えられた移動を行うように構成されたカムフォロワプレートと、
ii)カートリッジの変形可能なチャンバに関連づけられ、基板の平面に略垂直な成分を有する第2の方向への移動により、基板に対してチャンバを圧縮する力を印加するように構成される圧縮機構と、を備え、
iii)カムフォロワプレートは、第1の方向へのカムフォロワプレートの移動を、第2への方向の圧縮機構の移動に変換し、したがって、チャンバへ外部圧縮力を印加するために、圧縮機構に動作可能に結合される、請求項1又は請求項2に記載の装置。 - 流体サンプル処理カートリッジは、電子センサアレイを含み、制御アセンブリのコネクタボードの電気コネクタ素子は、制御アセンブリが第2の位置にあるとき、装置と前記電子センサとの間で、電力を供給し、データ伝送を行うように構成される、請求項2又は請求項3に記載の装置。
- 制御アセンブリのコネクタボードの電気コネクタ素子は、複数のコネクタピンアレイを備え、各コネクタピンアレイは、複数のポゴピンを備える、請求項2〜4のいずれか1項に記載の装置。
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EP3218109A2 (en) | 2017-09-20 |
EP3218109B1 (en) | 2021-09-29 |
US20180161769A1 (en) | 2018-06-14 |
JP7079278B2 (ja) | 2022-06-01 |
EP3218109B8 (en) | 2021-11-03 |
US20160129437A1 (en) | 2016-05-12 |
JP6762646B2 (ja) | 2020-09-30 |
AU2015346505A1 (en) | 2017-06-29 |
WO2016077341A2 (en) | 2016-05-19 |
JP2018503831A (ja) | 2018-02-08 |
US10005080B2 (en) | 2018-06-26 |
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ES2896098T3 (es) | 2022-02-23 |
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