JP2001526778A - 膜を使わずに試薬を制御移動する診断デバイス及び機器 - Google Patents
膜を使わずに試薬を制御移動する診断デバイス及び機器Info
- Publication number
- JP2001526778A JP2001526778A JP54172898A JP54172898A JP2001526778A JP 2001526778 A JP2001526778 A JP 2001526778A JP 54172898 A JP54172898 A JP 54172898A JP 54172898 A JP54172898 A JP 54172898A JP 2001526778 A JP2001526778 A JP 2001526778A
- Authority
- JP
- Japan
- Prior art keywords
- fluid
- sample
- hydrophobic
- ligand
- immobilized
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B29C66/7392—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic
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- B—PERFORMING OPERATIONS; TRANSPORTING
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Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.試験サンプル中の標的リガンドの存在又は量を決定するための、以下を 含む分析用デバイス: 構造アレイであって、構造各々は表面を含み、前記表面は固定化リガン ド受容体であって;それへ共有結合的又は非共有結合的に付けられたものを含み ;前記固定化リガンド受容体は標的リガンドへ結合することができるものである 、前記構造アレイ;及び 1つ又はそれ以上のチャネルであって、前記チャネルを通って標的リガ ンドを含有する試験サンプルが流れるとき、標的リガンドはチャネルの幅に渡っ て分散して前記固定化物へ結合するものである、前記チャネル。 2.該標的リガンドが、分析物、分析物連結体、分析物類似体、分析物類似 体連結体、補助的な結合員、又は標識試薬である、請求項1に記載の分析用デバ イス。 3.該分析物が、抗原、ヌクレオチド配列、レクチン、又はアビジンであり 、前記固定化物が、抗体、相補的ヌクレオチド配列、炭水化物、又はビオチンか らなる群から選択される、請求項2に記載の分析用デバイス。 4.該構造が、以下を含む群から選択される材料上に置かれたコポリマー、 ブレンド、ラミネート、金属化箔、金属化フィルム、又は金属から作られる、請 求項1に記載の分析用デバイス: ポリオレフィン、ポリエステル、スチレン含有ポリマー、ポリカーボネ ート、アクリル酸ポリマー、塩素含有ポリマー、アセタールホモポリマー及びコ ポリマー、セルロース類及びそのエステル、硝酸セルロース、フッ素含有ポリマ ー、ポリアミド、ポリイミド、ポリメチルメタクリレート、イオウ含有ポリマー 、ポリウレタン、シリコン含有ポリマー、ガラス、シリコーン、並びにセラミッ ク材料。 5.該構造が、プラスチック、エラストマー、ラテックス、シリコンチップ 、又は金属で作られる、請求項1に記載の分析用デバイス。 6.該構造が、テフロン(登録商標)、ポリスチレン、ポリアクリレート、ポ リカーボネート、ポリエチレン、ポリプロピレン、シリコンエラストマー、ポリ スチレンラテックス、又は疎水性ポリマーで作られる、請求項5に記載の分析用 デバイス。 7.該構造が、ポリプロピレン、ポリエチレン又はポリエステルを含む疎水 性ポリマーで作られる、請求項6に記載の分析用デバイス。 8.該構造が、混練若しくは射出成形することのできるプラスチック、又は 様々な鎖長のアルケンチオールに吸着された銅、銀及び金のフィルムで作られる 、請求項1に記載の分析用デバイス。 9.該構造が、混練又は射出成形することのできるプラスチックを含む、請 求項8に記載の分析用デバイス。 10.該構造各々が、類似に形状づけられ、形状が、菱形、六角形、八角形、 長方形、正方形、円形、半円形、三角形、及び楕円形からなる群から選択される 、請求項1に記載の分析用デバイス。 11.該構造アレイが、試験サンプルフローの方向に対してジグザグ配列であ る、請求項10に記載の分析用デバイス。 12.該構造アレイが、前記試験サンプル中の多数のリガンドを試験すること ができる多数の固定化リガンド受容体を有する、請求項1に記載の分析用デバイ ス。 13.試験サンプルを追加するためのリザーバであって、前記リザーバは構造 アレイへ各々つながる複数の通路を含み、前記通路は前記リザーバから前記アレ イへ試験サンプルを輸送することができるものをさらに含む、請求項1に記載の 分析用デバイス。 14.試験サンプル中のリガンドの存在又は量を決定するための、以下を含む 分析用デバイス: 入口孔及び通気孔; 構造アレイであって、構造各々は、共有結合的又は非共有結合的に表面 に付けられた固定化リガンド受容体を供給する表面を有し、前記受容体は標的リ ガンドへ結合することができるものである、前記構造アレイ; 1つ又はそれ以上のチャネルであって、前記チャネルを通って標的リガ ンドを含有する試験サンプルが流れるとき、前記標的リガンドは前記チャネルの 幅に渡って分散して前記固定化物へ結合する、前記チャネル;及び 検出可能な標識へ連結された特定の結合員を含む標識化試薬であって、 前記標識は前記固定化受容体においてシグナルを発生し、試験サンプル中のリガ ンドの存在又は量を示すことができる前記標識化試薬。 15.該リガンドが、分析物、分析物連結体、分析物類似体、分析物類似体連 結体、又は補助的な結合員である、請求項14に記載のデバイス。 16.試験サンプル中の分析物の存在又は量を決定するための、以下を含む方 法: 入口孔、通気孔、1つ又はそれ以上のチャネル、及び構造アレイを含み 、前記構造各々は、構造の少なくとも1つの表面上に固定化受容体を有し、前記 受容体はリガンドと結合することができる前記構造アレイ含む分析用デバイスを 提供し; 前記試験サンプルを前記入口孔に入れ、前記チャネルが前記試験サンプ ルを前記入口孔から前記構造アレイへ運搬し; 前記試験サンプルが前記チャネルに入り、前記分析物が前記チャネルの 幅に渡って拡散し、そこで前記サンプルが固定化受容体を含む構造アレイと接触 し、そこで前記サンプル中の分析物が前記固定化受容体と結合し;そして、 検出可能な標識に連結された特定の結合員を含む分析物検出システムを 介して前記分析物を検出し、前記検出可能な標識は前記受容体−分析物結合物に おいてシグナルを発生することができ、前記サンプル中の前記分析物の存在又は 量を決定する。 17.該リガンドが、分析物、分析物類似体、補助的な結合員、又は標識試薬 である、請求項16に記載のデバイス。 18.試験サンプル中のリガンドの存在又は量を決定するための、以下を含む 方法: 入口孔、通気孔、及び複数のチャネルを有する構造アレイを含む分析用 デバイスであって、前記構造アレイがその表面にリガンド又はリガンド類似体に 結合することのできる固定化受容体を含む、前記分析用デバイスを提供し; 前記試験サンプルを前記構造アレイに接触するように置き、それによっ て前記受容体がサンプル中のリガンドの存在に対応する量の前記リガンド又はリ ガンド類似体と結合し;そして 受容体と結合したリガンド又はリガンド類似体の量を決定することによ って前記試験サンプル中のリガンドの存在を検出する。 19.該置くステップが、前記アレイ構造と接触するように前記試験サンプル を置き、そこで前記受容体がサンプル中のリガンドの存在に対応する量の前記リ ガンド又はリガンド類似体と結合することを含む、請求項18に記載の方法。 20.構造間に1つ又はそれ以上のチャネルを有する構造アレイを有するマス タを提供し;そして マスタのコピーを製造することを含む、マスタから分析用デバイスを製 造する方法。 21.断面で見たときに少なくとも1つの直線で挟まれた角を含むルーメンを 含み、前記キャピラリースペースは、そのルーメン表面上に疎水性のゾーンを含 むキャピラリースペース。 22.該疎水性ゾーンが該角に接する、請求項21に記載のキャピラリースペ ース。 23.該疎水性ゾーンが、該角に近接した表面を実質的にカバーする、請求項 21に記載のキャピラリースペース。 24.該疎水性ゾーンが、該角に近接した表面の1%〜90%をカバーする、 請求項21に記載のキャピラリースペース。 25.該疎水性ゾーンが、親水性の表面に隣接している、請求項21に記載の キャピラリースペース。 26.請求項21のキャピラリースペースを含むデバイス。 27.キャピラリースペースに適合するように配置され、その表面上に疎水性 ゾーンを含む材料。 28.該疎水性表面が、該材料の表面の1%〜90%をカバーする、請求項2 7に記載の材料。 29.該材料が、フィルター、膜又はメッシュを含む、請求項27に記載の材 料。 30.該材料が少なくとも1つの直線で挟まれた角を含むキャピラリースペー スに適合することができ、該材料の該疎水性表面が該キャピラリースペースの該 角に隣接して置かれることのできる、請求項27に記載の材料。 31.疎水性ゾーンを含む材料であって、該材料に液体を加えると該疎水性ゾ ーンが該材料表面上に又は該材料内部に、液体の別個のエリアを定めることがで きる材料。 32.該材料が膜を含む、請求項31に記載の材料。 33.該材料が表面を含む、請求項31に記載の材料。 34.該表面がキャピラリーフローを促進する手段を含む、請求項33に記載 の材料。 35.ゾーンであって: その上に置かれた流体を有することができる領域、及びその上に置かれ た流体を含有することのできる該領域に接する疎水性領域であってそれにより該 疎水性の領域が該流体フローが該疎水性の領域入ることを妨げるものを含む前記 ゾーン。 36.その上に置かれた流体を有することのできる該領域が断面で見たときに 少なくとも1つの直線で挟まれた角を含むチャンバの表面であり、及び該疎水性 の領域が該チャンバのコーナーに近接した該チャンバ内に含まれる、請求項35 に記載のゾーン。 37.その上に置かれた流体をすることのできる該領域が、該領域の床面に実 質的に垂直なポストをさらに含み;前記ポストは、該ポスト表面と該床面のと間 に直線で挟まれた角を規定し、前記ポストはこの直線で挟まれた角に近接した疎 水性の表面を含む、請求項35に記載のゾーン。 38.流体の均一な乾燥を促進する方法であって、以下を含む前記方法: 請求項35のゾーンを提供すること; 流体を置くことができる該領域へ流体を導入すること;そして 前記流体を乾燥させること。 39.以下を含む請求項38に記載の方法: 断面で見たときに少なくとも1つの直線で挟まれた角を含み、コーナー に近接した疎水性領域を含むチャンバの表面を提供すること; 前記チャンバへ流体を導入すること;そして 前記流体を乾燥させること(ここで前記チャンバの疎水性領域は、均一 な乾燥を妨害し得る流体メニスカスのコーナーにおける形成を防ぐことに役立つ )。 40.疎水性の表面及び親水性の表面を含むキャピラリースペースを製造する ための方法であって、以下を含む前記方法: キャピラリースペースのルーメン表面を形成し得る親水性の表面に疎水 性の材料を適用すること;又は キャピラリースペースのルーメン表面を形成し得る疎水性表面の領域を マスクし、疎水性表面へ親水性の表面を産生するための手段を適用し、マスクさ れていない疎水性の表面をそれによって親水性のエリアとし、マスキングを除去 して親水性エリアに近接した疎水性領域を露出させること。 41.以下を含むアッセイデバイス: サンプル追加リザーバ; 前記サンプル追加リザーバと流体でつながったサンプル反応バリア; 反応チャンバであって、前記サンプル反応バリアと流体でつながって、 その壁に少なくとも2つのフィンガを有し、前記バリアが前記反応チャンバより 高いキャピラリー作用を有する前記反応チャンバ; 前記反応チャンバと流体でつながって、流体を所望の流速で通過させる ことが可能であるタイムゲート; 前記タイムゲートと流体でつながって、少なくとも1つの連結体を少な くとも1つのゾーンに固定化し得る診断エレメント;及び 前記診断エレメントと流体でつながって、前記サンプル追加リザーバか ら前記バリア、前記反応チャンバ、前記タイムゲート、前記診断エレメントと連 続的に流れる流体が次に流れてくる使用済み試薬リザーバ。 42.該サンプル追加リザーバが、流体サンプルから粒子状の物質を分離し得 るフィルターを含む、請求項41に記載のデバイス。 43.該サンプル反応バリアが、その表面に複数のテクスチャー構造を含み、 前記テクスチャー構造が高さ0.01〜0.02mm、幅0.10〜0.20m mであり、隣接するテクスチャー構造間の距離が0.08〜0.10mmである 、請求項41に記載のデバイス。 44.該反応チャンバが約0.03〜0.07mmの高さを有するキャピラリ ースペースを含む、請求項41に記載のデバイス。 45.該反応バリアが、コーナーを有し、かつ前記コーナーにおいて疎水性ゾ ーンを含む、請求項41に記載のデバイス。 46.該反応バリアが、10の垂直な溝を含み、各々の前記溝が高さ約0.0 2〜0.03mmであり、各々の前記溝が約0.5〜1.5mm離れて隔てられ ている、請求項41に記載のデバイス。 47.該反応チャンバが、高さ約0.03〜1.0mmのキャピラリースペー ス及び約0.2〜6μlの容積を含む、請求項41に記載のデバイス。 48.該反応チャンバが複数のテクスチャー構造を含み、前記テクスチャー構 造の各々が高さ約0.015〜0.03mm、直径約0.05〜0.1mmのポ ストであり、かつ近接したポストが約0.015〜0.025mm離れて隔てら れている、請求項41に記載のデバイス。 49.該反応チャンバが流体フローの主方向に対して垂直に配向されている複 数の溝を含み、前記溝の各々が高さ約0.03〜0.07mmであり、かつ近接 した溝が約0.08〜0.12mm離れている、請求項41に記載のデバイス。 50.該反応チャンバがエッジ又はコーナーを含み、前記エッジ又はコーナー に疎水性ゾーンを含む、請求項41に記載のデバイス。 51.該タイムゲートが約0.02〜0.12mmの高さで、流体フローの主 方向に対して垂直に配向されている複数の溝を含み、前記溝の各々が高さ約0. 03〜0.07mmであり、かつ近接した溝が約0.08〜0.12mm離れて いる、請求項41に記載のデバイス。 52.該診断エレメントが約0.01〜0.05mmの高さで、かつ約0.5 〜3μlの容積を含む、請求項41に記載のデバイス。 53.該診断エレメントが複数のテクスチャー構造を含み、前記テクスチャー 構造のそれぞれが高さ約0.01〜0.02mm、直径約0.03〜0.07m mであり、かつ近接したテクスチャー構造が約0.04〜0.09mm離れてい る、請求項41に記載のデバイス。 54.該診断エレメントがエッジ又はコーナーを含み、かつ前記エッジ又はコ ーナーに疎水性ゾーンを含む、請求項41に記載のデバイス。 55.該使用済み試薬リザーバが約0.01〜0.05mmの高さで、かつ約 1μlより多い容積を含む、請求項41に記載のデバイス。 56.該使用済み試薬リザーバが複数のテクスチャー構造を含み、前記テクス チャー構造の各々が高さ約0.01〜0.02mm、直径0.03〜0.07m mであり、かつ近接したテクスチャー構造が約0.04〜0.09mm離れてい る、請求項41に記載のデバイス。 57.該診断エレメントの表面と前記使用済み試薬リザーバの表面との間に位 置付けられるデッドスペース領域をさらに含む、請求項41に記載のデバイス。 58.アッセイを実施することが可能なデバイスであり、前記デバイスはアッ セイを実施している間流体と接触している2つ又はそれ以上の表面を含み、第一 の流体接触デバイス表面がその上に固定化された第一の免疫アッセイ試薬を含み かつ第二の流体接触デバイス表面がその上に固定化された第二の免疫アッセイ試 薬を含むものである、前記デバイス。 59.アッセイされるべき流体がアッセイの間流れるキャピラリースペースを 含み、前記キャピラリースペースが2つ又はそれ以上の流体接触表面を含み、前 記キャピラリースペースの第一の流体接触表面がその上に固定化された第一の免 疫アッセイ試薬を含み、前記キャピラリースペースの第二の流体接触表面がその 上に固定化された第二の免疫アッセイ試薬を含む、請求項58に記載のデバイス 。 60.該第一の免疫アッセイ試薬が前記第一の流体接触表面上に分散し得るほ どに固定化され、該第二の免疫アッセイ試薬が前記第二の流体接触表面上に分散 し得るほどに固定化され、又はいずれの免疫アッセイ試薬もいずれの流体接触表 面に分散し得るほどに固定化されていることをさらに含む、請求項58に記載の デバイス。 61.該第一の免疫アッセイ試薬が前記第一の流体接触表面上に分散し得ない ほどに固定化され、前記第二の免疫アッセイ試薬が前記第二の流体接触表面上に 分散し得ないほどに固定化され、又はいずれの免疫アッセイ試薬もいずれの流体 接触表面に分散し得ないほどに固定化されている、請求項58に記載のデバイス 。 62.該キャピラリースペースが第三の流体接触表面を含み、このとき前記第 三のキャピラリースペースの表面がそこに固定化されている第三の免疫アッセイ 試薬を含む、請求項58に記載のデバイス。 63.該第三の免疫アッセイ試薬が該第三の流体接触表面に分散し得るほどに 固定化されているか、又は前記第三の免疫アッセイ試薬が前記第三の流体接触表 面に分散し得ないほどに固定化されている、請求項62に記載のデバイス。 64.該キャピラリースペースが、固定化された免疫アッセイ試薬を含む粒子 をさらに含む、請求項58に記載のデバイス。 65.アッセイを実施することが可能であるデバイスであって、前記デバイス がストップ及びエネルギー・ディレクタを含み、 このとき、デバイスの製造の間に、該エネルギー・ディレクタは第一の デバイス部品を第二のデバイス部品に封止してデバイス内にキャピラリースペー スを規定することに役立ち、かつ該ストップは均一な大きさを有するデバイスチ ャンバの製造を可能にすることに役立つものである、前記デバイス。 66.該ストップ及び該エネルギー・ディレクタが、単一の構造を含む、請求 項65に記載のデバイス。 67.該ストップ及び該エネルギー・ディレクタが、流体の流入し得ないデバ イスのデッドスペース領域を定める、請求項65に記載のデバイス。 68.該ストップが、ポスト又はリッジを含む、請求項65に記載のデバイス 。 69.該エネルギー・ディレクタが、ポスト又はリッジを含む請求項65に記 載のデバイス。 70.乾燥された試薬の均一な層の配置を促進するように配置された表面であ って、前記表面が液体が接触して置かれるときに複数のメニスカスが形成される ことを可能にする複数のテクスチャー構造を含む、前記表面。 71.請求項70の表面を含む、アッセイを実施することが可能であるデバイ ス。 72.乾燥された試薬の均一な層を表面に配置するための方法であって、以下 を含む前記方法: 請求項70の表面を提供すること; 前記表面に接触して流体を置くこと;そして 前記流体を乾燥させること。 73.該乾燥工程が、蒸発の起こる時間待つこと又は蒸発を促進するために外 部のエネルギー源を適用することを含む、請求項72に記載の方法。
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Also Published As
Publication number | Publication date |
---|---|
EP1019193A2 (en) | 2000-07-19 |
US6271040B1 (en) | 2001-08-07 |
DE69815365D1 (de) | 2003-07-10 |
WO1998043739A3 (en) | 2001-06-07 |
CA2284801C (en) | 2007-02-13 |
WO1998043739A2 (en) | 1998-10-08 |
ATE242054T1 (de) | 2003-06-15 |
EP1019193A4 (en) | 2000-04-27 |
CA2284801A1 (en) | 1998-10-08 |
EP1019193B1 (en) | 2003-06-04 |
DE69815365T2 (de) | 2004-08-19 |
AU6579098A (en) | 1998-10-22 |
JP3531941B2 (ja) | 2004-05-31 |
US6156270A (en) | 2000-12-05 |
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