TW539546B - Microdroplet dispensing for medical diagnostic device - Google Patents

Microdroplet dispensing for medical diagnostic device Download PDF

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Publication number
TW539546B
TW539546B TW089125534A TW89125534A TW539546B TW 539546 B TW539546 B TW 539546B TW 089125534 A TW089125534 A TW 089125534A TW 89125534 A TW89125534 A TW 89125534A TW 539546 B TW539546 B TW 539546B
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Taiwan
Prior art keywords
reagent
item
sample
scope
patent application
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TW089125534A
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English (en)
Inventor
Ian A Harding
Robert Justice Shartle
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Lifescan Inc
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Publication of TW539546B publication Critical patent/TW539546B/zh

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D3/00—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502707—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by the manufacture of the container or its components
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/4905—Determining clotting time of blood
    • G—PHYSICS
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    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/521—Single-layer analytical elements
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    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
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    • G01N33/54388—Immunochromatographic test strips based on lateral flow
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    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0621—Control of the sequence of chambers filled or emptied
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/12—Specific details about manufacturing devices
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/16—Reagents, handling or storing thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0681—Filter
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
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    • B01L2300/0822—Slides
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
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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
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0861—Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/0864—Configuration of multiple channels and/or chambers in a single devices comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0861—Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/087—Multiple sequential chambers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0887—Laminated structure
    • 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
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
    • 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
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0481—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure squeezing of channels or chambers
    • 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
    • B01L2400/0688—Valves, specific forms thereof surface tension valves, capillary stop, capillary break
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/8483—Investigating reagent band
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/745—Assays involving non-enzymic blood coagulation factors
    • G01N2333/7454—Tissue factor (tissue thromboplastin, Factor III)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90—Enzymes; Proenzymes
    • G01N2333/914—Hydrolases (3)
    • G01N2333/948—Hydrolases (3) acting on peptide bonds (3.4)
    • G01N2333/95—Proteinases, i.e. endopeptidases (3.4.21-3.4.99)
    • G01N2333/964—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue
    • G01N2333/96425—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue from mammals
    • G01N2333/96427—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue from mammals in general
    • G01N2333/9643—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue from mammals in general with EC number
    • G01N2333/96433—Serine endopeptidases (3.4.21)
    • G01N2333/96441—Serine endopeptidases (3.4.21) with definite EC number
    • G01N2333/96447—Factor VII (3.4.21.21)

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Medicinal Chemistry (AREA)
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  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
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  • Dispersion Chemistry (AREA)
  • Clinical Laboratory Science (AREA)
  • Biophysics (AREA)
  • Ecology (AREA)
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  • Medical Informatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Description

539546 A7 B7 五、發明説明（ 10 15 經濟部智慧財產局員工消費合作社印製 20 習知申請案交叉參考 ;主糸本申明案為19"年6月15日申請之09/333765號申 言月案的部分延伸案。 發明背景 i 發明範疇 本發明關於-種醫療診斷裝置，其以無衝擊印刷 —nnpact printing)方式製備；更明確地說，藉由一試劑 無衝擊印刷於該裝置之一親水性表面上製備。 2·相關技藝說明 有許多種醫療賴程序關_對生物越（例如血 液、尿液或唾液）之檢驗，且奠基在該流體或流體成份 (如血清）之物理特性變化。此種特性得為一電的、磁 的、流體的、或光學的特質。在監控_光學特質時，這些 診斷程序可用一透明或半透明裝置盛骏生物流體和一試 劑。流體之對光吸收力變化和流體内之受測物濃度或流體 特質有關。一般而言，有一光源位在該裝置之一表面附近 且有一檢測器位在相反面附近。該檢測器測量透射通過一 流體樣本之光線。另一種選擇為光源與檢測器位在裝置同 一側，此時該檢測器測量由樣本散射及/或反射之光線。 最後，可將一反射器安裝在相反面上或附近。後型裝置稱 為、、穿透反射（transflectance ) ”裝置’其中光線首先穿 過樣本區然後二次反射穿過樣本。本說明書及申請專利範 圍中所提之、、光線（light )〃 一詞應解釋為包括紅外線及 本紙張尺度適用中國國家標準（CNS ) A4規格（210X 297公釐） (請先閲讀背面之注意事項再填寫本頁) 訂 539546 A7 B7 五、發明説明（2) 紫外線光譜和所有可見光。本文所用 ''吸收力 (absolution )/7 —詞意指一光束通過一介質之強度減少 量；因此，其包含著''真實〃吸收量及散射量。 一種透明檢驗裝置揭示逾1994年2月3日公告之世 5 界專利W094/02850號〔威爾斯（Wells)等人所有〕。該 裝置包含一密封外殼，該外殼為透明或半透明，不透氣， 且為剛性或半剛性。一分析物質連同一或多種位在預定位 置之分析試劑裝在該外殼内。在進行分析之前才打開外殼 導入樣本。分析試劑與樣本内受測物之結合在分析結束時 10 造成選定試劑之光學特質如顏色改變。此結果得以目視讀 出或以一光學儀器讀出。 1971年11月16日授與大衛（Davis)之美國專利第 3620676號揭示一種液體色度指示器。該指示器包括一可 壓縮''半球形空腔〃。該球形空腔經壓縮和釋放形成一吸 15 力以將流體自一流體源抽汲通過一半管狀空腔，該半管狀 空腔之壁上壓印著一指示器。流體流入指示器之流量控制 單元僅有該球形空腔之壓縮程度及該球形空腔釋放時該指 示器入口浸入流體源内之長度。 1972年2月8日授與赫提哥（Hurtig)等人之美國專 20 利第3640267號揭示一種收集體液樣本之容器，其包括一 隔室，該隔室具有複數個彈性且可潰縮壁。該等隔室壁在 容器入口置入待收集流體内之前，先被擠壓。該等隔室壁 在釋放時恢復未潰縮狀態並透過入口抽入流體。此裝置一 如前述之大衛裝置，對進入指示器之流體流動的控制係相 -4- 本紙張尺度適用中國國家標準（CNS ) A4規格（210X297公釐） (請先閲讀背面之注意事項再填寫本頁) 、言 經濟部智慧財產局員工消費合作社印製 經濟部智慧財產局員工消費合作社印製 539546
當有限。 1978年5月9日授與力加（Lilja)等人之美國專利 第4088448號揭示一種小杯（cuvette)，其能對與一試劑 混合之樣本進行光學分析。該試劑塗佈在一空腔之壁面 5上，然後在該空腔内裝滿液態樣本。該樣本與試劑混合後 產生一種可偵測光學變化。 以上所述之數項專利揭示的檢驗裝置通常包含一乾 條帶有一試劑塗佈在一或多個預定位置上。將試劑施加於 大量此等裝置之預期位置原則上能藉由標準印刷方式完 10成，不過無衝擊印刷提供一些與眾不同的優點。舉例來 說，無衝擊印刷機能為較小、較輕且較便宜，因為其無須 忍受印字頭對基質之重複衝擊。其亦許可如涉及透光率變 化之光學裝置所需使用透明基質。無衝擊印刷之各類資訊 參見加州Irvine之Palatino出版社出版之J L J〇hns〇n著 15 作：扃鸯# 伊翁次理（principies of Nonimpact Pdnting )，1998年第三版〔亦參見1998年2月5曰之 Machine Design 第 52 至 55 頁，Η丄· Berger 所撰、'無濺喷 製作出更好的晶圓（Non-splatter spray makes better wafers) 〕。在各種無衝擊印刷方式中，喷墨印刷經證 20 明適合搭配試劑流體使用。 1978年9月27日公告之英國專利1526708號揭示一 種試劑檢驗裝置包含一載體，二種不同物質以一、、預定空 隙"相隔印在該載體上。噴墨印刷為其所揭示之印刷技術 的其中之一。 本紙張尺度適用中國國家標準（CNS ) Α4規格（210Χ297公釐） (請先閲讀背面之注意事項再填寫本頁)
539546 —— A7 B7 五、發明説明（4 ) 1989年10月31曰授與Hayes等人之美國專利第 4877745號揭示一種在印刷介質上印刷試劑之系統，其中 自一喷管推出液滴並重複此步驟直到在該介質上印出期望 之試劑構造。使用一種壓電式印字頭。 5 1992年4月28日授與Klebe之美國專利第5108926 號揭示一種將細胞精確定位於基質上之裝置，其使用一喷 墨印刷機使細胞直接沈積在基質上或沈積細胞黏著材料。 所用喷墨印刷機為惠普公司（Hewlett-Packard )之 Thinkjet™印刷機，其為一熱感喷墨印刷機（參見1985年 10 5月之惠普期刊）。 1995年1月3日授與Deeg等人之美國專利第 5378638號揭示一種判定液態樣本内受測物之分析元件。 該元件之製造方式為利用一熱感喷墨印字頭將試劑噴墨印 刷於一系列、'隔間内。 15 上述每一參考案明白或含蓄地涉及印刷介質上之影 像擴散，因為一影像的清晰度降低至液態 '墨水〃在乾燥 前遍及表面的程度。對診斷應用而言，通常要求清晰v'影 像〃，因為不同試劑密集在一裝置表面上但必須在裝置未 受一外加樣本弄濕之前不接觸（例如不反應）。 20 發明概述 本發明提出一種製備醫療診斷試劑裝置之方法，其 包含以下步驟·· a)提供一非吸收性基質，在其表面上具有至少一親水性 -6- 本紙張尺度適用中國國家標準（CNS ) A4規格（210 X 297公釐） (請先閲讀背面之注意事項再填寫本頁)
、T 經濟部智慧財產局員工消費合作社印製 、發明説明（ 目標區； 10 I 9 液之微液滴脈衝喷流，該喷流自一無衝 抑字頭被提供至該目標區内之一點上；0使該·相對於該基質運動；及 d) f複步驟b)#Q e)至少足夠的次數以在該目標區上提供 大致均勻試液層。 %本务明之診斷試劑裝置測量一生物流體之一受測物 展度或特性且包含： Θ添加樣本區，其用來接受-分析用生物流體樣本； 及 (請先閲讀背面之注意事項再填寫本頁) b) 15 經濟部智慧財產局員工消費合作社印製 20 預疋親水性試劑區，其上已藉由無衝擊印刷方式施 加六^斷试液與該樣本交互作用使樣本内造成一能與 ”L體之义測物遭度或特性產生關聯之物理可測量變 化。 5亥添加樣本區與試劑區可為重合或以一輸送樣本之 了間通路開。測量通常（但非必然）是在樣本處於試劑 區内t日守進行’且在以下說明中，+人感興趣的測量是在 樣本處於試劑區内之時進行。 «玄方法特別適於製備一測量凝血時間（prothroinbin time，PT time)之裝置，其中目標區塗佈一試劑成份催化 血液梯級凝固（blood clotting cascade)。相似地，本發明之 診斷試劑條帶特別適於測量一全血樣本之凝血時間。 本說明書及申請專利範圍中所提之、、微液滴 (microdroplet) ” 一詞意指體積為約1微微公升至1微公 、^1- - 7- 本紙張尺度適用中國國家標準（CNS ) A4規格（210X297公釐） 539546 A7 B7 五、發明説明（< ) 6 升之液滴。 令人驚奇的是目標區之親水性提供優異成果，因為 親水表面被視為會使沈積於其上之試劑擴散，此被認為是 不好的。 5 圖式簡單說明 圖1為一本發明裝置之平面圖。 圖2為圖1裝置之分解圖。 圖3為圖1裝置之透視圖。 10 圖4為與本發明裝置一同使用之計量器簡圖。 圖5為用以決定凝血時間之資料圖表。 圖6為本發明裝置他種實施例之平面圖。 圖7為一依據本發明方法製備之塗層平面圖。 圖8為一本發明無衝擊印刷程序之簡圖。 15 圖9為展現一本發明優點之圖表。 發明詳細說明 本發明醫療診斷試劑裝置之製備方式為利用一無衝 擊印刷程序在一非吸收性基質之一親水性 ''反應區〃上沈 20 積一試劑。該裝置為使一生物流體物理參數或一流體成份 與該流體内一受測物濃度或流體特質產生關聯之類型。雖 然有多種物理參數如電的、磁的、流體的或光學的參數能 構成測量之基準，但光學參數之變化為一較佳基準，且以 下詳細說明均將此裝置稱為一光學裝置。該裝置之一較佳 本紙張尺度適用中國國家標準（CNS ) A4規格（210X297公釐） (請先閱讀背面之注意事項再填寫本頁) 訂 經濟部智慧財產局員工消費合作社印製 10 15 經濟部智慧財產局員工消費合作社印製 (1 ) 20 (2) (3) 、發明説明（ / ，例如—熱塑性薄片。該基質在其 學參：二：及試劑區，樣本在該區内經歷-光 =及—止動接糊以在填滿試劑區之後精確止住流 处為較k來1 4衣置在試劑區為實質透明，如此該區 =在側上之光顧射且在相反細彳量透射光線。無 刷試劑使樣本經歷-變化，且在透射光線内之變化 為々人感興趣之受測物或流體特質之量度。另一種選擇 是，能以和光源於處於同-側之—檢測器制自一流體樣 錢射之光線或通職樣本然後反射（藉由位在相反侧之 一反射器反射）而二次通過樣本之光線。 此型裝置適用於多種生物流體分析測試，例如決定 生化特性或血液學特性，或是測量此種流體内蛋白質、荷 爾篆、^1水化合物、脂質、藥物、毒物、氣體、電解質等
之濃度。文獻中已說明進行這些測試之程序。文獻中曾提 及之測試如以下所述I 產色因子Xlla分析（及其他血凝塊因子）：尺抓山 M.D.等人，血液，88,3432 ( 1996 )。 因子X分析· Bick，R.L·检塞及止血障礙：臨床 及實驗室操作。芝加哥，ASCP出版社，1"2年。 稀釋勒塞耳氏蛇毒測試（DRVVT) : Exner，T.等 人，血凝固，纖維蛋白，1，259 ( 1990 )。 9- 本紙張尺度適用中國國家檩準（CNS ) A4規格（210X297公釐） 539546 經濟部智慧財產局員工消費合作社印製 A7 B7 五、發明説明（） 8 (4) 蛋白質之免疫比濁及免疫濁度測定分析：Whicher， J.T.，CRC Crit· Rev. Clin Lab Sci· 18:213 (1983 )。 (5 ) TPA 分析：Mann，K.G·等人，血液，76,755, 5 ( 1990 );以及 Hartshorn，J.N·等人，血液， 78,833,（ 1991 )。 (6) APTT (活性化局部血栓形成時間分析）：Proctor， R.R.和 Rapaport，S.I. Amer. J· Clin. Path，36,212 (1961 ) ; Brandt，J.T·和 Triplett，D.A· Amer. J. l〇 Clin. Path，76,530 ( 1981 );及 Kelsey，P.R.
Thromb. Haemost. 52,172 ( 1984 )。 (7) HbAlc分析（糖基化血紅素分析）：Nicol，D.J.等 人，臨床化學，29,1694 ( 1983 )。 (8) 總血紅素：Schneck等人，臨床化學，32/33,526 15 ( 1986 );及美國專利第4088448號。 (9 ) 因子 Xa : Vinazzer，H.，Proc· Symp. Dtsch· Ges· Klin. Chem.，203 ( 1977 )，由 Witt，I·編輯。 (10)氮氧化物之比色分析：Schmidt，H.H.等人，生物化 學，2,22 ( 1995 )。 20 本裝置特別適用於測量凝血時間（prothrombin time 或PT time)，關於此裝置之細節在下文中揭示。要使本 裝置適於例如前列用途所需之修改僅須例行實驗。 圖1為本發明裝置10之平面圖。圖2為該裝置之分 解圖且圖3為該裝置之透視圖。樣本在囊袋14已壓縮後 -10- (請先閲讀背面之注意事項再填寫本頁)
539546 A7 B7 五、發明説明（ 10 15 經 濟 部 智 慧 財 產 局 員 X 消 費 人 社 印 製 20 方施加於樣本埠12。拫明顯，層26及/或層28貼近囊袋 Μ切除σ卩分之區域必須為彈性以容許囊袋μ受壓縮。約 釐厚之聚酯具有適當之彈性和彈力。較佳來說，頂 層」^厚度約” 125公釐，底層28之厚度約為〇1〇〇 a屋在釋放心袋時’吸力將樣本抽過管道μ 裝有—無衝擊印刷試劑2。。為確保_試劑内發現之膨_=成貝，其沒有通f會在冷;東乾燥 劑區二圖二2和二所示，止動接頭22鄰接囊袋η和試 _上，6可位在止動接頭22之—側或樣本到達18及/或囊袋14分隔。讓樣本到達=會停止流動。對凝，量而言， 達忒點即停止流動以容許可再生、、錢 r"^；ouleauxformation)^ — 利併===Γ於美國專利第5230866號中，此ΐ 28間t 示’所概;元件係由夾在頂層26和底層 册 曰1層24内切除部分形成。層24最好 :曰▼。止動接頭22係由層26及/或28内之又面膠膠形成’㈣分與層24狀⑽部分對準且餘 (請先閱讀背面之注意事項再填寫本頁)
539546
ίο 15 /或32密封。如圖所示，該止動接頭最好在層％和μ内 均包含切除部分，且具有密封層3G和32。止動接頭Μ所 用之每-赠部分至少與管道16 #寬。目2亦顯示一選 項性過濾器12A覆蓋在樣本埠12上。該過_可將紅血 球自全血樣本中分離出來且/或可含有—試劑與血液交互 作用以提供額外資訊。-適當過—包含1向性薄膜， 最好是加拿大多倫多市光譜診斷公司（如:-Diagnostics，Inc.)所供應之聚砜物薄膜。選項性反射哭 腸可位在層26之-表面上或附近且定位在試劑區18二 方。若有該反射器則該裝置變為一穿透反射裝置。 使用圖1、2和3所示條帶之方法可參Ϊ圖4所示計 量器元件簡圖得到了解，該圖示出一自動化計量哭。在此 之外亦有可能以手動操作。（在手動操作案例中嚢袋Μ 係在樣本施加於樣本埠12前以手動擠壓然後再釋放一 經濟部智慧財產局員工消費合作社印製 20 使用者所進行之第-步料啟動該計量器，藉此對 條帶檢測器40、樣本檢測器42、測量系、统44及選概加 熱器46供給能量。第二步係插入該條帶。該條帶最好至 少在其局部面積上並非透明’如此播人的條帶可擔住檢測 器40b的發光二極體40a之照明。（更好的方式為該中間 層以不透明材料製成，如此背景光線不會進入測量系統 44。>檢測器40b藉此感知-條帶已經插入且觸發囊袋致 動器48以壓縮囊t 14。然後，計量顯示器5〇指引使用者 將-樣本施加於樣本埠Π，此係使用|要起始測量程序所 必須進行之第三和最後之步驟。 12- 本紙張尺度適用中國國家標準（CNS ) Α4規格（210X297公釐 — (請先閱讀背面之注意事項再填寫本頁)
539546 五、發明説明（
ίο 15 1 由^ 測器 間之日寸間間隔Α内，血液充滿了試劑區。該時間間隔内 電流減少肇因於光線因紅血球而散射，因此為血球容積 大約測置值。在點2，樣本已充滿試劑區且停止流動，' 移動已為止動接頭所阻止。紅血球開始如錢幣堆集（錢 狀紅血球串聯結構）。該錢串狀紅血球串聯效應使點^ 20 3間之時間間隔内有愈來愈多光線透射穿過樣本（且較 散射）。在點3,血凝塊形成終止了錢串狀紅血球串耳二 構且通過樣本之透射量達到最大值。凝血時間能由點丄 3間之間隔B或點2和3間之間隔計算出。在二之後， 液由液態改Μ半固體凝膠’且光、線透射量亦對應縮減 Α7 Β7 11 空的樣本埠具有反射能力。在一樣本導入樣本埠内 後，其會吸收來自發光二極體42a之光線並藉此減少反射 至檢測為42b之光線。該光線之減少隨後發信通知致動器 48以釋放囊袋14。所造成之管道16内之吸力將樣本抽過 試劑區18送到止動接頭22。來自發光二極體44a之光線 通過試劑區18，檢測器44b監控樣本凝固時透射穿過樣本 之光線。當有複數試劑區時，測量系統對每一試劑區 没有一對發光二極體/檢測器（如同44a和44b )。透射光 線對時間函數之分析（下文中說明）能計算凝血時間，其 顯示在计虿顯示态50上◦樣本溫度最好以加熱器46維持 在約37°C。 圖5繪出一典型、、血凝塊徵象（cl〇t signature)"曲 線，其中來自檢測器44b之電流繪為時間之函數。血液首
539546 五、發明説明（i2) 電流C在最大值3和終點4間之減少與樣本内之纖 原有關。 、'、、、、蛋白 圖6繪出一本發明裝置之較佳實施例。发 通管道52之Hit裝置。旁通f道5 匕括旁 5區m、218和318内後之一様太〜樣本抽入試劑 川内後之樣本仃進通路 動接頭m之囊袋侧壓力減小而抽入旁通管道=止 止動接頭兩側之環境壓力均等時停止流動。試二在 有血栓形成質。試劑區2㈣318較佳含有對：;勿：含 為下文所述之對照物。試劑區218含有血检 =好 K):、及产組因子VIIa。選定的成分係為藉由抵二$ :如下丙酮香显素（Warfarm)阻凝劑之效果：二 4,本之减血時間正常化。試劑區318含有血_ 夜 洗出物以局部克服抗凝血劑之效應。因此在雜敢錢牛 15 118上測得。但該測量值僅在試劑區218和318 結果在一預定範圍内時方為有效。若該等控制測量 -者或二者均在範圍外，則表示要重新測試。 豹壬 經濟部智慧財產局員工消費合作社印製 接頭122止住這三個試劑區内的流動。 ^、動 圖1和2所示且前文說明之|置最好由熱塑 20 26和28豐合在兩側表面上均有黏著劑之熱塑性 而構成。形成圖Μ示元件之切除部分舉例來說可料 24、26和28雷射切割或沖切形成。 曰 底層28上之試劑區18由中間層24内切八— 義。頂層26面向底層28之底面最好是疏水性，至少= .14· 衣紙張尺度適用中國國家檩準（CNS ) Α4規格（210Χ297公釐） ----- 經濟部智慧財產局員工消費合作社印製 539546 A7 B7 _ ' " . _ " — 五、發明説明（） 13 7 道16和試劑區18之範圍内為如此。試劑區18之表面為 親水性。樣本埠12的表面最好也是親水性以促進填滿該 裝置；亦即使樣本自埠12移動至試劑區18。一種擁有親 水性樣本和試劑區之便利方式為讓底層28的整個表面為 5 親水性。市面上可取得具有適當親水性表面之熱塑性薄膜 包括：明尼蘇達州聖保羅市3M Health Care公司Medical Specialties 出品之 3M 9962 Antifog Film ( ''Antifog，，）； 、会面因州洛克蘭市 Bio Whittaker Molecular Applications 公司 出品之FMC GelBond Film ;聚對苯二甲酸乙酯（PET)薄 10 膜，其表面經焰冕處理（flame_corona-treated )或電漿處 理；離聚物薄膜；及其他具有親水性表面或塗層之熱塑性 薄膜。Antifog為塗佈3M專有塗層之聚對苯二甲酸乙酯薄 膜且為較佳基質材料。 就判定一基質對本裝置及方法之適用度而言，表面 15 親水性能以數種不同方式判定。 接觸角名義上為在一可濕性表面頂上之一液滴（通 常是純水）邊緣與該表面之間的角度。測量接觸角之方法 已經標準化且能利用手動或自動設備執行。（ASTM測試 方法D5946-96，利用水接觸角量測值之經電暈測試聚合 20 物薄膜標準測試方法。）在測得角度大於25。時資料可視 為是準確且可再現的，若接觸角為約60。或較小則視該等 薄膜為完全可濕性。對Antifog測得之角度為約25。。 潤濕張力之測量方式為在一受測表面喷灑已知表面 張力之溶液並觀察溶液是否、、成珠狀（bead叩）"。 _：________-15-_ 本紙張尺度適用中國國家標準（CNS ) Α4規格（210Χ297公釐Ί " 一~ ' (請先閲讀背面之注意事項再填寫本頁}
539546 A7 ---^___ B7 五、發明説明（1 '~" ^ 14 ； (AST=娜試方法D2578_94，聚乙烯和聚丙烯薄膜之潤 心、、張力軚準冽试方法。）成珠狀代表内部液體吸引力壓倒 表面之吸收弓丨力。此等溶液以達因/公分為單位校準，且 稱為達因溶液（dyne s〇luti〇ns)。市面上供應的是川至 5 6〇>達因。/公分。表面在測試開始時用最低值溶液然後逐漸 k问到隶T%值。對表面指派對應於灑出約2秒仍留下之溶 液的達因/公分值。由於Antifog讓所有溶液潤濕，其特徵 為表面潤屬張力大於60達因/公分。 3M 公司的 Medical Specialties Department 開發出一 10種潤濕測試对薄膜之水潤濕能力定出特性。 (3M SMD # 6122，潤濕測試，1998年12月4日-由明尼蘇達州55144-1000聖保羅市3M中心提供。）此測試涉及將一染料水溶 液小心放置在一表面上，讓其乾燥，並測量乾燥斑塊的直 徑。收集通常在3「至40 WMWWWW1 -ϊΏΠ 15 一非常可濕表面。 基於上述測量結果，吾人斷定Antifog表面為極度親 水性。當一表面具有充分親水性時，試劑液滴會擴散於表 面上且在期望區域形成一大致均勻試劑層（前提為沈積充 分液滴）。本說明書及申請專利範圍中所提之、、大致均勻 20 ( substantiaUy unif〇rm ) ” 一詞不應解釋為必然使人認為 在整個目標區上之表面塗層厚度為相同，亦不應解釋為整 個表面都受塗佈。 圖7繪出一典型有塗層目標區之局部平面圖。在此 註明雖然表面（B)之大部分經塗佈，但表面（a)之部 -16- 本紙張尺度適用中國國家標準（CNS )八4規格（210X297公釐） (請先閲讀背面之注意事項再填寫本頁)
、1T 經濟部智慧財產局員工消費合作社印製 15539546 A7 五、發明説明（ 10 15 經濟部智慧財產局員工消費合作社印製 20 分仍未文塗佈。目標區最好至少約8〇%經塗佈。有塗層區 或、、内之厚度差異最好減至最小；例如最厚區的厚度 比有塗層區域之平均厚度的三倍小。有塗層區域内之平均 塗層厚度通常約為G.1微米·約1微米，視試劑本質和特定 用途而定。 、、 、囷8、、、w出一種將試劑無衝擊印刷在一本發明基質之 忒d區上的裝置簡圖。印字頭6〇重複地對織物喷上一 "式J液滴噴流，該織物以圖中箭頭所示方向運動。選項性 遮罩64和66確保液滴喷流僅到達織物62之試劑區18。 為控制印刷效果，遮罩66 (亦即最接近印字頭60的 遮罩）或者有一疏水性表面68面向印字頭。來自印字頭 ⑼之複數個施㈣嘴_齡料表面μ上形成複數個 .式劑圓點=由於該表面為疏水性，這些圓點保持孤立且能 該表面的液滴擴散且/或聯合，使得光學系統70更難以直 接從試劑區上偵測到獨立圓點。 光學系統70能偵測出有缺陷產品且在必要時予以退 件。舉例來祝，少了一些圓點可能代表一或多個施配喷嘴 故障。在適當光學制方法巾為暗域冑術（滅fi仙 microscopy )，陰影成像法（shad〇wing )，提花術 (patterning )，雷射照明法（laser uluminati〇n )等。得 視需要對試劑添加一著色劑或螢光染料使光學系統7〇更 易於看見試劑。舉例來說，對一試劑添加約〇1%最終濃 度之亞甲監染料使一光學系統可看見該試劑而不會實質改 2 訂 17- 本紙張又度適用中國國家標準（CNS )八4規格（210X297公蹇） 10 15 經濟部智慧財產局員工消費合作社印製 539546 五、發明説明（
變對該試劑做出之測量結果。 超立、m6G可為習知之任何無衝擊印字頭，其中包括 ^式、電子圖式、離子投影式等。印字頭6 1墨印字頭’最好是熱感喷墨印字頭。 以 何限^下義實例示範本發明之各個實施例，但並不具有任 製備二個上述凝血測量型條帶（參見圖丨至））。 -W間之差別為條帶A有—未經處理具對苯二甲 底層二，而條帶b有一 FMC GdB〇nd —底層28。對： 施加-血液樣本且在圖4所示類型裝置内做凝血 f。圖9繪出所得血凝塊曲線。條帶a之曲線有一比較平 之尖峰 果凝血計算之精確度。相較之下，條帶Β之曲線有一較^ 出的尖峰，其許可較大精確度。（在此註明以此二條 量之樣本的凝血時間為不同。） 實例二 20 本發明裝置之做法如下··首先使一失在兩釋放襯墊 間之雙面膠膠帶〔康乃迪克州溫莎市司加帕膠帶公司 (Scapa Tapes)出品之RX 675SLT〕通過一疊合及旋轉沖 切加工系統。將頂部釋放襯墊及膠帶切穿出如圖2所示圖 案（止動接頭除外），但不切穿底部釋放襯墊，該底部釋 ____ -18- 本紙張尺度適用中國國家標準（CNS ) A4規格（210X297公釐）
539546 A7 B7 五、發明説明（ 17 10 放襯墊隨後連同自膠帶切除部分當作廢料清除。將3M Antifog Film疊合於膠帶之外露底側。然後將試劑〔紐約 州納瑞塔市正臨床診斷公司（〇rth〇 clinical Diagnostics ) 出品之血栓形成質〕以熱感噴墨印刷方式〔利用俄勒岡州 科閥力市惠普公司出品之印字頭51612A〕印在該薄膜之 試劑區（18 )上。自未處理過的聚酯膜〔賓州峽谷岩市黏 著劑研究公司（Adhesives Research)出品之AR1235〕切 出樣本埠，然後對齊並疊合於雙面膠膠帶之頂部（膠帶已 去除釋放襯墊之後）。然後一沖頭沖切此疊合之三層而切 出止動接頭。最後，將單面黏性膠帶〔明尼蘇達州聖保羅 市3M公司出品之目錄編號9843 ( MSX4841 )〕施加於該 等聚酯層外側以密封該止動接頭。 請 先 閱 讀 背 面 之 注 意 事 項
訂 15 經濟部智慧財產局員工消費合作社印製 20 在此依循類似於前述實例二之程序做出圖6所繪類 型條帶。其中分別熱感喷墨印刷於區118、218和318上 之試劑為：血栓形成質；血栓形成質，牛洗出物及重組因 子Vila ;血栓形成質及牛洗出物。該牛洗出物（血漿擰檬 酸鋇牛洗出物）可由佛蒙特州柏林頓市之血液學科技中心 (Haemotologic Technologies)取得；而重組因子 VIIa 可 由康乃迪克州格林威治市之美國醫療診斷中心（American Diagnostica )取得。 對一全血樣本利用此實例條帶所做測量對每一試劑 區均產生如圖5所示類型之曲線。來自對照區（試劑區 -19- 本紙張尺度適用中國國家標準（CNS ) A4規格（210X29?公釐） 539546 A7 ____^B7_______ 五、發明說明（18) 218和318)曲線之資料係用以核驗試劑區U8p曲線之資 料。因此，能較僅有單一試劑區之條帶得到更土 血時間。 ’、、、可靠之凝 經濟部智慧財產局員工消費合作社印製 ο 2 坡---- (請先閱讀背面之注意事項再填寫本頁) 訂----才----#· 本紙張尺度適用中國國家標準（CNS)A4規格（210 χ 297公釐） 539546 A7 B7 經濟部智慧財產局員工消費合作社印製 (請先閱讀背面之注意事項再填寫本頁) 五、發明說明（19) 圖示之代號說明： 代表符號 A B C 1 2 3 4 10 12 12A 14 16 18 18A 20 22 24 26 28 30 32 名稱 時間點1和2間之時間間隔 時間點1和3間之時間間隔 電流 時間點 時間點 時間點 時間點 醫療診斷裝置 樣本埠 過滤器 囊袋 管道 試劑區 反射器 無衝擊印刷試劑 止動接頭 中間層 頂層 底層 密封層 密封層 -21- 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） 539546 A7 B7 五、發明説明（2()) 經濟部智慧財產局員工消費合作社印製 40 條帶檢測器 40a 發光二極體 40b 檢測Is 42 樣本檢測Is 42a 發光二極體 42b 檢測器 44 測量系統 44a 發光二極體 44b 檢測器 46 加熱器 48 囊袋致動器 50 計量顯示器 52 旁通管道 60 印字頭 62 織物 64 遮罩 66 遮罩 68 疏水性表面 70 光學系統 118 試劑區 122 止動接頭 218 試劑區 318 試劑區 -22- (請先閲讀背面之注意事項再填寫本頁) 本紙張尺度適用中國國家標準（CNS ) A4規格（210X297公釐）

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  1. 539546
    申請專利範圍 經濟部智慧財產局員工消費合作社印製 h —種製備醫療診斷試劑裝置之方法，其包含以下步 驟： a) 提供-非吸收性基質，在其表面上具有至少一親水 性目標區； b) 提供-診斷試液之微液_衝喷流，該喷流自一益 衝擊印字頭被提供至該目標區内之一點上； ‘“、 C)使該喷流相對於該基質運動；及 d)重複步驟b)和c)至少足夠的次數以在該目標區上提 供一大致均勻試液層。 2. 如申請專利範圍第i項之方法，其中該基質包含 致平坦薄片。 3. 如申請專利範圍第1項之方法，其中該基質包含-故 塑性薄片。 …、 4. =申請專利範圍第"頁之方法，其中至少—目標區各 有一約不超過60。之水接觸角。 & =申請專利範圍第μ之方法，其中該印字頭為一妖 感喷墨印字頭。 、 6·如申請專利範圍第"員之方法，其中該試液包含蛛 形成質。 % 7·如申請專利範圍第2項之方法，其中該喷流以一大致 垂直於該基質之方向行進，且該噴流藉由該基質以- 大致垂直於噴流行進方向之方向運動而相對於該基質 運動。 、 10 15 8.如申請專利範圍第i項之方法，其中該喷流通過 個 I -------^訂--------- (請先閱讀背面之注意事項再填寫本頁) 23 - 本紙張尺度適肝關家標準（CNS：)A4規4咖x 297公复了 89623B(9LFS) ^546 六 、申請專利範 圍 5 10 15 經濟部智慧財產局員工消費合作社印製 20 位於施配器與基質間之薄片之一孔。 9.=請專職圍第8項之方法，其中該薄片有一疏水 性表面面向該施配器。1〇·^請專利範圍第9項之方法，其中該試劑包含一著 ㈣量生物流體之受測物濃度或特性的診斷試 別裝置，其包括一非吸收性基質且包含： a) -添加樣本區，其用來接受—分析用生本；及 b) -預定親水性試躯，其上已藉由無衝擊印刷方式 施加-診斷舰與該樣本交互作用使樣本内造成一 能與該流體之受測物濃度或触產生關聯之物理可 測量變化。 I2·如申請專利範圍第11項之裝置 試劑區實質重合。 13.如申請專利範圍第11項之裝置 该添加區輸送至試劑區之機構。 1令如申請專利範圍第11項之裝置 親水性。 15·如申睛專利範圍第11項之裝置 質透明平坦薄片。 16.如申请專利範圍第11項之裝置 質透明熱塑性薄片。 如中請相範圍第ii項之裝置，其中該試液包含血检 樣 ’其中該添加樣本區與 其更包含將該樣本自 其中該添加樣本區為 其中該基質包含一實 其中該基質包含一實 -24 本紙張尺度適用巾關家鮮（CNS)A4規格⑽; 297公釐） 以:>46
    形成質。 18·如申請專利範圍第u項之裝置，其中該試液包含 色劑。 5 19_ ^申請專利範圍第13項之袭置，其中將該樣本自添加 區輸送至试劑區之機構包含一頂層與該基質以一中間 層相隔，該中間層内有一穿透孔且鄰接管道切入其 内°亥頂層、中間層及基質形成一囊袋經壓縮再釋放 以在該管道内造成一減小的壓力而將血液抽入試劑區 内。 10 20.如申請專利範圍第19項之裝置，其中該頂層有一疏水 性表面面向基質，至少在該管道和試劑區内為如此。 --------訂· -------- (請先閱讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合作社印製 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐）
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DE60027677D1 (de) 2006-06-08
RU2256167C2 (ru) 2005-07-10
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US6830934B1 (en) 2004-12-14
US20020098114A1 (en) 2002-07-25
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US20030210287A1 (en) 2003-11-13
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NO20006106D0 (no) 2000-12-01
CN1301965A (zh) 2001-07-04
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CN1213302C (zh) 2005-08-03
ATE325342T1 (de) 2006-06-15
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