M343160 八、新型說明： 【新型所屬之技術領域】 本創作係關於一種生化感測系統、量測裝置及生化感測試 片’特別是，關於一種可免除密碼卡需求之自動校正之生化感測 系統、量測裝置、及生化感測試片。 【先前技術】 隨著醫學的進步與現代人對於健康護理觀念的日益提升，定 點照護檢測(P〇int-of_Care ; POCT)的市場普及化也大增。這類的檢 測趨向快速、便宜、體積小、以及不需專業人員操作的自我檢驗 產品，例如血糖儀、電子耳溫搶、以及電子是血壓計等。而在此 貝或中生化感測试片的使用已經是一項極為純熟的技術，其中 又以分析血糖之應用最為廣泛。 豸知生化感測系統中’每一批生化感測試片在生產過程中都 ，設定獨，的變異參數。因此，在使用量測裝置對該批生化感測 j片進行$測之前需藉由一密碼卡(c〇de。虹句來對量測裝置進行 权正，如美國專利第5,366,609號以及PCT專利第WO00/33072 號所揭示。然而，密碼卡的燒錄和製備會增加人力與製造成本， =且也生使用者忘記插入或插錯密碼卡導致校正錯誤及數據 判讀上的錯誤、或是密碼卡遺失等問題。 純二了改善密碼卡使用上所造成的不便，美國專利第6,814,844 =路了—種利用條碼_ code)作為辨識方式。目丨顯示美國專 ，814,844號所揭露之習知檢測試片1〇〇，其包含具有複數個 M343160 彼此絕緣的電極之試片導電組110以及設置於試片導電組11〇間 之irv碼120。條碼120為利用雷射消熔法(iaser abiati〇n meth〇d) • 而形成於基板上的條碼圖形。詳言之，利用高能量脈衝雷射光轟 ，擊已塗覆於基板上之金靶材的表面，使得金靶材表面瞬間蒸發， 而形成條瑪圖形。然而，如美國專利第6,814,844號所揭示，條碼 120的辨識方式為光學式的檢測系統，例如使用CCD或led作為 _，其需使用㈣的光學元件製造成本較高。再者，此種辨識 •條碼120的再現性與準確度受限於乾材表面材料，不但會造 • 程上的限制亦可能增加製造成本。 、 物㈣爾製程良率 【新型内容】 ，於先前技術所存在關題，本創作提供了 卡的使用、減少择作奂雒、B 1、士，丨、杂丨 兄陈山碼 正之生 化感測系統 可減少製程不良率的自動校- 生化之-方面’提供了一種生化感測系統，其包含-生化“Μ片及-量測裝置。生 置於絕緣基板上之一電極組、以 二具有-絶緣基板、設 元。量測裝置具有-微處理單元辨識單 合辨識單元以接收辨識單元所表示之識S二搞 兀係耦合連接器以接收信號。 馬之k唬，且被處理單 6 M343160 於一實施例中，辨識單元係以絕緣基板之一預定區域是否有 至少-凹_成’並且配合至少—凹槽之位置而組合成所表示之 識別碼。舉例而言’至少—凹槽係包含貫穿絕緣基板之一槽道、 缺口或孔洞，以及未貫穿絕緣基板之一凹槽或凹穴。連接器係具 有至少-_單讀，且感測單元組之數目係減於敢區域所 能劃分之凹槽之數目。 係摩馬 ，根據本創作之另-方面，提供了一種量測裝置。此量測裝置 係用以搭配-生化感測試^{使用。生化感測試片具有—絕緣基 板、f置於絕緣基板上之—電極組、以及由絕緣基板所構成之-辨識單元，射_單元係簡緣基板之—預定區域是否有至少 2槽形成，並且配合凹槽之位置而組合成所表示之識別碼。量 、衣置包3連接器，係耦合由絕緣基板所構成之辨識單元，以 接收觸單元所表示之識別碼之信號；以及一微處理單元 合連接器以接收來自連接器之信號。 -二i創:i再一方面’提供了一種生化感測試片，其具有 由絕緣極組設置於f緣基板之上；以及—辨識單元係 否有至r、— M、’其中辨識單元係以絕緣基板之—預定區域是 的識酬形成，並且配合凹槽之位置而決定生化感測試片 測辨二卜：於:實關，連接器之感解元組細-短路方式感 片部1而言，感測單元組包含二個導電端子及二個彈 。八—個彈片部互相不接觸。然而，當試片嵌人量測裝置 7 M343160 時’二個彈片受到擠壓而接觸以形成—短 一電路系統電性連接以輪出健至微處理單元。3 W端子與 測辨 於另-實施例，連接器之感測單元 :片受到擠開而形成-斷路，並藉統:: 連接以輸出信號至微處理單元。 一 …、電 說明’部分將在後續說明中陳述，而部分可由 所特別指出之上=: 例之 用，並非用二:：般說明及下列詳細說明均僅作舉 【實施方式】 _ 別碼二種不需利用密碼卡校正亦不需額外塗佈金屬識 碼卡# 、量測裝置、及生化感職片，其可免除密 便、防止忘記插人密碼卡或插錯密碼卡等失誤、 作之妨、=造金職別碼難巾失誤發生的可能性。為了使本創 ^敘逃更加詳盡與完備’可參照下列描述並配合圖2至圖？b之 、=壯其中類似的70件符號代表類似的元件。然以下實施例中所 :二：及程序步驟’僅用以說明本創作’並非用以限制 8 M343160 圖2繪示本創作一實施例之生化感測試片2〇〇,而圖3則繪示 生化感測試片200的結構分解圖。本創作之生化感測試片2〇〇包 含一絕緣基板210、一導電層22〇、一絕緣墊高層23〇、一上蓋25〇、 及由絶緣基板210所構成之辨識單元260。 絕緣基板210具有電絕緣性，其材料可包含但不限於：聚氯 乙稀(PVC)、玻璃纖維(fr_4)、聚g旨(卩吻⑶㈣、電木板(bakeiite)、 聚對苯二甲酸二乙_(PET)、聚碳酸酯(PC)、聚丙烯(PP)、聚乙烯 • (PE)、聚苯乙烯(PS)或陶瓷等。 如圖2及圖3所示，辨識單元260係由絕緣基板210之一預 定區域A所構成。舉例而言，預定區域a係位於絕緣基板21〇之 -侧’而辨識單元26G細絕緣基板21G之預定區域A是否有至 二凹槽262开>成，並且配合凹槽262之位置而組合成所表示之 f別f °舉例而言’辨識單元260可為絕緣基板2K)之預定區域 夕箱二上Λ需額外塗佈習知作為條碼之金屬圖案，且絕緣基板210 诚，Α可^據所欲提供的識別碼數目，劃分成複數個子區 2^? ^辨識單凡細之構成元件。當辨識單元260包含凹槽 所夺二^據凹槽262之數目及位置，而組合出辨識單元260 而二2^2 _1碼。亦即’每個子區域係表示凹槽262潛在之位置， 個賴分之子區域變化，難制、於等於一 基板:的子二所7^ ’於此實施例中，作為辨識單元260之絕緣 係形成有-凹^3Α係劃分為6個子區域，且其中—個子區域 之槽ί缺。凹槽262可為貫穿絕緣基板別 次孔而，亦可為未貫穿絕緣基板21〇之-凹槽或凹 9 M343160 ，例—缺口(或胸槽道)之祕。然，本 將於後詳述。…早"篇的形狀。有關於辨識單元勘之操作 盘一二包含-電極組。電極組至少包含-工作電極 倾it ^者―Γ施例中’電板组220⑽相互絕緣之一工 >考龟極224、及一感測電極226。 導^ 220物村為任何導電物f =膠、碳銀混轉、或其_物及齡等。在 = 例中，感測電極226係設置於工作電極從 二考電極24之間’用以感測生化感測試片200與一量測裝置(如 ，3 63明的電性連接。當生化感測試片·置人量測裝置^， $电極226將與量測裝置間形成一迴路，而M343160 VIII. New Description: [New Technology Field] This creation is about a biochemical sensing system, measuring device and biochemical test piece. In particular, a biochemical sensing system that can eliminate the need for automatic correction of the password card. , measuring device, and biochemical test strips. [Prior Art] With the advancement of medicine and the increasing awareness of modern people's health care concepts, the market penetration of point-of-care testing (P〇int-of_Care; POCT) has also increased. Such tests tend to be fast, inexpensive, small, and self-testing products that do not require professional operation, such as blood glucose meters, electronic ear thermometers, and electronics are sphygmomanometers. The use of this or a biochemical test strip is already an extremely sophisticated technique, with the most widely used blood glucose analysis. In the biochemical sensing system, each batch of biochemical test strips is set in the production process, and the unique variation parameters are set. Therefore, before using the measuring device to perform the measurement on the batch of biochemical sensing j-chips, the measuring device is required to be right by a cryptographic card, such as U.S. Patent No. 5,366,609 and PCT patents. No. WO00/33072. However, the burning and preparation of the cryptographic card increases labor and manufacturing costs, and also causes the user to forget to insert or insert the wrong cryptographic card, resulting in correction errors and errors in data interpretation, or passwords. The problem of card loss, etc. Pure two has improved the inconvenience caused by the use of the password card, U.S. Patent No. 6,814,844 = way - using bar code _ code) as the identification method. A conventional test strip disclosed in U.S. Patent No. 814,844, which comprises a test strip conductive group 110 having a plurality of M343160 insulated electrodes and an irv code 120 disposed between the test strip conductive groups 11 is shown. . The bar code 120 is a bar code pattern formed on a substrate by a laser ablation method (iaser abiati〇n meth〇d). In detail, high-energy pulsed laser light is used to strike the surface of the gold target that has been coated on the substrate, so that the surface of the gold target instantaneously evaporates to form a bar graph. However, as disclosed in U.S. Patent No. 6,814,844, the identification of the bar code 120 is an optical inspection system, for example, using CCD or LED as the _, and the optical component to be used (4) is relatively expensive to manufacture. Moreover, such recognition • The reproducibility and accuracy of the bar code 120 is limited by the dry material surface material, which not only imposes limitations on the process but may also increase manufacturing costs. , (four) Seoul process yield [new content], in the previous technology issues, this creation provides the use of cards, reduce the choice of 奂雒, B 1, 士, 丨, 丨 丨 陈 陈 陈 陈 陈 陈 生化The measurement system can reduce the process defect rate of the automatic calibration - biochemical - aspect 'provides a biochemical sensing system, including - biochemical "slice and - measuring device. One of the electrode groups placed on the insulating substrate, with two The utility model has an insulating substrate and a component. The measuring device has a micro-processing unit for identifying the single-component identification unit to receive the identification signal represented by the identification unit to receive the signal. The horse is k唬, and is processed. 6 M343160 In one embodiment, the identification unit is combined with the identified identification code by a predetermined area of one of the insulating substrates and at least the position of the groove. For example, at least the concave The slot system includes a channel, a notch or a hole penetrating through the insulating substrate, and a groove or a recess that does not penetrate through the insulating substrate. The connector has at least -_ single read, and the number of sensing unit groups is reduced to the dare area Can According to another aspect of the present invention, a measuring device is provided. The measuring device is used in conjunction with a biochemical test. The biochemical test piece has an insulating substrate. , the electrode group disposed on the insulating substrate, and the identification unit composed of the insulating substrate, the unit of the unit is a simple substrate, and the predetermined area is formed by at least two grooves, and is combined with the position of the groove. The identification code, the clothing package 3 connector, is coupled with an identification unit composed of an insulating substrate to receive the signal of the identification code represented by the touch unit; and a micro processing unit connector for receiving the connection Signal of the device. -Second i: a further aspect provides a biochemical test piece with an insulating pole set on the f-edge substrate; and - the identification unit has no r, - M, ' The identification unit is formed by the compensation of the predetermined area of the insulating substrate, and the position of the groove is used to determine the biochemical test piece. 2. In: Guan Guan, the sensory solution of the connector is fine-short-circuited. sense In section 1, the sensing unit group includes two conductive terminals and two springs. The eight elastic pieces are not in contact with each other. However, when the test piece is embedded in the measuring device 7 M343160, the two elastic pieces are pressed and contacted. To form a short-circuit system electrically connected to rotate to the micro-processing unit. 3 W terminal and the other embodiment, the sensing unit of the connector: the piece is squeezed open to form an open circuit, and by: : Connect to output the signal to the microprocessor unit. The ... part of the 'Electric Description' will be stated in the following instructions, and the part can be specified by the above =: for example, not for the second:: general description and the following detailed description Only for the implementation of the [Embodiment] _ different types of code do not need to use the password card correction and do not need to apply additional metal identification card #, measuring device, and biochemical sensory film, which can avoid the secret, prevent forgetting to insert Mistakes such as password card or wrong password card, and the possibility of making a mistake in the gold medal. In order to make this innovation more detailed and complete, please refer to the following description and cooperate with Figure 2 to Figure? b, = strong, 70 similar symbols represent similar components. However, in the following embodiments: 2: and the procedure step 'only for explaining the present creation' is not intended to limit 8 M343160. FIG. 2 illustrates the biochemical test piece 2 of the present embodiment, and FIG. 3 shows A structural exploded view of the biochemical test strip 200. The biochemical sensing test piece 2 of the present invention comprises an insulating substrate 210, a conductive layer 22, an insulating layer upper layer 23A, an upper cover 25A, and an identification unit 260 composed of an insulating substrate 210. The insulating substrate 210 has electrical insulation, and the material thereof may include, but is not limited to, polyvinyl chloride (PVC), glass fiber (fr_4), poly g (卩 kiss (3) (four), bakeiite, polyterephthalic acid B_(PET), polycarbonate (PC), polypropylene (PP), polyethylene (PE), polystyrene (PS) or ceramic, etc. As shown in Fig. 2 and Fig. 3, the identification unit 260 is composed of One of the insulating substrates 210 is formed by a predetermined area A. For example, the predetermined area a is located on the side of the insulating substrate 21 and the predetermined area A of the thin insulating substrate 21G of the identification unit 26G is provided to the second recess 262. And, in combination with the position of the groove 262, the combination of the indicated f, f, for example, the 'identification unit 260 can be the insulating substrate 2K, the predetermined area, the upper case, the upper part of the case requires additional coating as a bar code metal. The pattern and the insulating substrate 210 can be divided into a plurality of sub-areas according to the number of identification codes to be provided, and the constituent elements are identified. When the identification unit 260 includes the number and position of the groove 262, the identification unit 260 is combined with the identification unit 260 and two 2^2 _1 codes. That is, 'each sub-region indicates the potential position of the groove 262, and the sub-region of the sub-division changes, which is difficult to manufacture, and is equal to a sub-base of the substrate: in this embodiment, as the insulation system of the identification unit 260 The formation of the concave-concave system is divided into six sub-regions, and one of the sub-regions is lacking. The recess 262 may be a through hole of the insulating substrate or may be a recess or a recess 9 M343160 which is not penetrated through the insulating substrate 21, for example, a gap (or a chest channel). However, this will be detailed later. ...early" the shape of the article. The operation panel for the identification unit is included with the electrode group. The electrode group includes at least a working electrode and a working electrode. In the embodiment, the electric board group 220 (10) is insulated from each other > the turtle pole 224 and a sensing electrode 226. The guide 220 is a conductive material f = glue, carbon-silver mixed, or its age and age. In the example, the sensing electrode 226 is disposed between the working electrode from the second test electrode 24 to sense the biochemical test piece 200 and a measuring device (eg, 3 63 Ming electrical connection. When the biochemical sense The test piece and the measuring device ^, the electrode 226 will form a loop with the measuring device, and
Gw:要=組的配置作用如上述，且各電極之間彼此絕、Ϊ =已足夠。本創作並不限制工作電極222、參考電極224、及感測 ’亦爛電極的數量，可根據實際應用所 ^墊4 230係置於導電層挪之上，且絕緣塾高層23〇 2^=^ ^暴露導電層挪之-部分岐義一反應區 層220之虛線部份所示）。開口加只要能夠暴露出部 =作祕222及部分的參考電極224即已足夠，本創作並不 限制開口 235a(亦即反應區235)的形狀。此外，絕緣塾高層23〇之 M343160 設計亦暴露出導電層220的另一部份(例如接近辨識單元26〇之部 份’圖未標示），以使導電層220可與一量測裝置(如圖6之 電性相接。絕緣墊高層230的材料可包含但不限於pVc絕緣膠 帶、PET絕緣膠帶、熱乾燥型絕緣漆或紫外光固化型絕緣漆。/Gw: The configuration of the group to be as described above, and the electrodes are absolutely independent of each other, Ϊ = is sufficient. The creation does not limit the number of the working electrode 222, the reference electrode 224, and the sensing electrode. The pad can be placed on the conductive layer according to the actual application, and the upper layer of the insulating layer is 23〇2^= ^ ^ Exposing the conductive layer is removed - the partial dotted line is shown by the dotted line portion of the reaction layer 220). It is sufficient that the opening plus the reference electrode 224 capable of exposing the portion 222 and the portion is not limited to the shape of the opening 235a (i.e., the reaction zone 235). In addition, the M343160 design of the insulating layer 23 is also exposed to another portion of the conductive layer 220 (eg, the portion adjacent to the identification unit 26 is not shown) so that the conductive layer 220 can be coupled to a measuring device (eg, The electrical connection of the insulating pad upper layer 230 may include, but is not limited to, pVc insulating tape, PET insulating tape, thermal drying insulating varnish or ultraviolet curing varnish.
上蓋250置於絕緣墊高層230之上，且覆蓋所定義之反應區 235(如開口 235a)。介於絕緣基板210與上蓋25〇之間的部份^形 成一具毛細吸引力之取樣空間，即反應區235。當取樣空間的面積 固定時，其體積可取決於絕緣墊高層230之厚度。一般而言，^ 緣墊高層230之厚度介於約_5公釐至約〇·3公釐，然不在°此限。 此外，在製造過程中，可將已裁切出用以定義反應區235之開口 235a的絕緣墊高層230放置於絕緣基板21〇與導電層22〇上，亦 了以印刷的方式避開所欲定義的反應區235及用以與量測裝置電 性相接之區域，而直接形成絕緣墊高層23G於部分的絕緣基板21〇 與導電層220之上。 鲁 本創作之生化感測试片2〇〇更包含置於反應區235中的一反 應層240 ’其具有專一性辨識生物材料或訊號之能力，其中反應層 240之材料係隨樣品不同而有所不同，例如可為一氧化還原酶，用 以2口口產生化學反應。一般而言，反應層240至少覆蓋部份的 工作電極222。 蓋250可為透明或半透明材質，以方便觀察反應 私樣品，社紅未獻神騎檢測，而導致 ❿、的、、口果。上盖250之接近反應區的下表面可塗佈—親水材料， 11 M343160 以加強反應區235内部壁面的毛細作用，用以更迅速有效地將樣 品導入反應區235中。上蓋250更包含相應於反應區235的一通 氣孔255 ’用以排出反應區235内的氣體以加強毛細作用，一般而 吕，通氣孔255係罪近反應區235末端。本創作並不限制通氣孔 255的形狀，舉例來說，通氣孔255可為圓形、橢圓形、長方形、 菱形等。 圖4及圖5為根據本創作*同實施例所繪示之生化感測試片 4〇0及5〇0 ’其為方便說明並未I會示絕緣墊高層及上蓋。生化感測 試片400包含一絕緣基板41〇、與相互絕緣之一工作電極422、一 參考電極424、-感測電極426。其中絕緣基板41〇之一部份(亦即 預定區域A)係構成-辨識單元46〇。辨識單元46〇 &含複數個由 預定區域分而紅子__成減個構成單元。在此實施 例中’辨，早兀係有6個構成單元(例如條〜4㈣，且其中 預^^:係形成為一凹槽，而其餘則為絕緣基板410之 = =====成單元^較佳為為貫魏 生化感測抑500之配置_ f 另―實施例，參考圖5， 極526。其中辨識單元56fw备 少電本524、及一感測电 凹槽，而其餘則為絕綾有轉成單元5621)、5必形成為 562d, 562f>在圖5所t \10之預定區域剩餘部份(如562a, 562c， 未貫穿、纟嶋;51G =單元562b及麻係為 緣基板51G上形成辨識罩^卩利用裁切或沖床製程於絕 份絕纖 51G，物二 12 M343160 度較原本絕緣基板510之厚度為薄。因此，當生化感測試片2〇〇、 400或500置入一量測裝置時，量測裝置將依據辨識單元26〇、 460、560中是否有凹槽形成，並配合凹槽之數目及位置而啟動連 接器上相對應的感測單元組，進而與量測裝置形成電性連接，使 量測裝置藉此而得以辨別生化感測試片4〇〇及500，進而採行相對 應校正參數或模式進行量測。 雖然圖4及圖5顯示了具有六個構成單元之辨識單元，但本 創作並不限制構成單元的數量。亦應了解到，構成單元的數量及 位置可由設計者根據實際應用自行設定，其可組合出複數個不同 的識別碼。舉例來說，當辨識單元具有N個構成單元時(即絕緣基 板之預，區域區分成N個子區域），將可組合出2^個識別碼。 亦即，每個構成單元(子區域)因應凹槽的存在與否可具有兩種狀態 (或1) ffij配合母個構成單元之位置，即可組合成多個獨特的 ，別碼。辨識單元將可藉此肋絲不同魏的生化制試片， :不同批★的生化感測試片。在其他實施例巾，觸單元之構成 為f穿或未貫穿絕緣基板之孔洞。只要量測裝置能辨識出 成單元峨如G或1}所絲之朗碼，本創作並 不限制孔洞的形狀與大小。 方塊示之—生化❹麻600的 感測試^613—量測裝置630。生化 66〇：lt™ 624 ' 如前所诚。與丄，、守辨識早兀66〇包含至少一構成單元， 牛歹'而吕，於此實施例有6個構成單元，其中之一構 13 M343160 ί^=62!形成有—凹槽。量測裝置㈣包含—連接11 640及麵 ^次接态640的一微處理單元650,其中微處理單元650内建一 位二料655，其可例如為校正參數、檢測模式、或其他資訊等。 工作电極622、參考電極624、感測電極_、及辨識單元_透 過與連接器640之間的相接而與量測裝置63〇電性相連。 。口當生化感測試片61〇與連接器64〇連接，感測電極626與連 接$ 640之間將形成—迴路，而使微處理單元㈣啟動量測裝置 630。此外，由於辨識單元_的多個構成單元分別有不同狀態(例 如有二槽或沒凹槽}，因此將與連接器_的連接產生不同的形 ，此將產生對應此觸單元_絲示之制碼的信號至微 =理單兀650。微處理單元65〇則可將根據此信舰行辨識，並自 貝料655中選擇相應此信號的參數或模式以執行。量測裝置_ 更包含用以顯不各種量測結果之顯示器67〇，以及用以提供所需電 源的-電源665。在另一實施例中，顯示器—及電源665可為外 接裝置，而不包含於量測裝置63〇中。 ^於一實施例’連接器640係具有複數個偵測單元組與至少— 感測單兀組。如圖7A所例示，連接器中64〇之偵測單元組742 係用以偵、測試片上各f極間的電性變化，進而傳輸至相關的電路 系統。舉例而言，偵測單元組742包含一接觸部742a及一導電端 子742b。接觸部742a係與試片電性接觸以债測各電極間的電性變 化，進而藉由導電端子742b將所偵測之電性變化傳輸至電路系 統，以進行後繽的信號處理而得到量測結果。感測單元組744之 數目係相應於辨硪單元之構成單元之數目，亦即絕緣基板之預定 14 M343160 區域所欲劃分之潛在凹槽之數目。換言之，感測單元組744於連 接态640之設置係對應於生化感測試片上之辨識單元之位置，用 以耦合各個構成單元。感測單元組744可以斷路方式或短路方式 感測辨識單元來形成信號。如圖7B所示，於—實^ 組744包含二個彈片部准、744b及二個導電端子7=^* 其中二個糾部744a、744b係設計成互相不接觸。然*，當試 嵌入量測錢630時，二個彈片744a、744b因應辨識單元:設 受到相應的讎(修綠簡形狀構成單元龍㈣接觸形 二短路，並產生-信號藉由導電端子准、期與電路系統電性 連接以輸出信號’以利微處理單元㈣進行後續的處理。亦 因應辨識單元是时凹_及配合凹槽之位置，使得連接器_ 相應的感測單元組744產生特定短路狀態，而將此狀態傳送至 路糸統以繼處理單元㈣進行_歧。換言之，只要 元;預定區域，具有可辨識的機構性幾何圖案化(二 t牙透紐或不牙透基板之凹槽圖案），使得感測單元組744能依 开Π的狀態(例如是否有凹槽)產生對應信號 讀伽依據接收之識 俜一十只轭例，感測單70組744之彈片部744a、744b tr 7tf目，此，#試片嵌人量測裝置時，二個彈片部 進〜# ζ路纽紐連接以輪出錢，㈣微處理單元650 進仃後、，的處理。舯卩’因應辨識單元是 之位置，使得連接器_相應的感測單元組心 15 M343160 悲，而將此狀態傳送至電路系統以利微處理單元65〇進行後續處 理。換言之，只要絕緣基板作為辨識單元之預定區域，具有可辨 識的機構性幾何圖案化(例如穿透基板或不穿透基板之凹槽圖 案），使得感測單元組744能依據個別構成單元的狀態(例如是^有 凹槽)產生對應信號(例如是否形成斷路），即能使得微處理器依據 ^收之識別碼信號採_應的模式進行處理。在此需注意，偵測 單元組與感測單元組之形狀並不限於實施例所示，只要能達到上 述作用之摘測單元組與感測單元組皆適用。 在此需注意，由絕緣基板之預定區域所劃分之子區域較佳係 ，寸相同’她合連接H之制單元組之·，或依據不同之設 計需求，每個子區域亦可為不同尺寸。亦即，辨識單元之每個構 成元件’、要A與感測單元細&合，其潛在欲形成之凹槽可以 同尺寸、形狀、深度。The upper cover 250 is placed over the upper layer 230 of the insulating mat and covers the defined reaction zone 235 (e.g., opening 235a). A portion between the insulating substrate 210 and the upper cover 25A forms a sampling space having a capillary attraction, that is, a reaction zone 235. When the area of the sampling space is fixed, its volume may depend on the thickness of the upper layer 230 of the insulating mat. In general, the thickness of the upper layer 230 of the edge pad is between about _5 mm and about 〇3 mm, but not the limit. In addition, during the manufacturing process, the upper layer 230 of the insulating pad which has been cut out to define the opening 235a of the reaction zone 235 can be placed on the insulating substrate 21 and the conductive layer 22, and the printed surface can be avoided. The defined reaction region 235 and the region for electrically contacting the measuring device directly form the insulating pad upper layer 23G over the portion of the insulating substrate 21 and the conductive layer 220. The biochemical test piece 2 created by Ruben further includes a reaction layer 240' disposed in the reaction zone 235, which has the ability to uniquely identify the biological material or signal, wherein the material of the reaction layer 240 varies from sample to sample. The difference, for example, may be a oxidoreductase, which is used to generate a chemical reaction at 2 mouths. In general, the reactive layer 240 covers at least a portion of the working electrode 222. The cover 250 can be made of a transparent or translucent material to facilitate observation of the reaction of the private sample, and the social red is not dedicated to the detection of the ride, resulting in sputum, and, and fruit. The lower surface of the upper cover 250 adjacent to the reaction zone may be coated with a hydrophilic material, 11 M343160, to enhance the capillary action of the inner wall of the reaction zone 235 for more rapid and efficient introduction of the sample into the reaction zone 235. The upper cover 250 further includes a vent 255' corresponding to the reaction zone 235 for venting the gas in the reaction zone 235 to enhance capillary action. Generally, the vent 255 is adjacent to the end of the reaction zone 235. This creation does not limit the shape of the vent 255. For example, the vent 255 may be circular, elliptical, rectangular, diamond-shaped, or the like. 4 and FIG. 5 show the biochemical test strips 4〇0 and 5〇0' according to the present embodiment and the same embodiment. For convenience of explanation, the upper and upper covers of the insulating mat are not shown. The biochemical sensing test strip 400 includes an insulating substrate 41A, a working electrode 422 insulated from each other, a reference electrode 424, and a sensing electrode 426. One of the portions of the insulating substrate 41 (i.e., the predetermined area A) constitutes an identification unit 46A. The identification unit 46 〇 & contains a plurality of predetermined regions and the red __ is divided into constituent units. In this embodiment, it is known that there are six constituent units (for example, strips ~4 (four), and wherein the pre-forms are formed as a groove, and the rest is the insulating substrate 410 ====== The unit ^ is preferably a configuration of the Wei Wei biosensitivity 500. _ Another embodiment, refer to FIG. 5, the pole 526. The identification unit 56fw is provided with a power 524 and a sensing electrical recess, and the rest For the absolute conversion unit 5621), 5 must be formed as 562d, 562f> in the remaining part of the predetermined area of t \10 in Figure 5 (such as 562a, 562c, not penetrating, 纟嶋; 51G = unit 562b and hemp The identification mask is formed on the edge substrate 51G. The cutting or punching process is used for the absolute fiber 51G, and the thickness of the material 12 M343160 is thinner than the thickness of the original insulating substrate 510. Therefore, when the biochemical test piece is 2, 400 Or 500 is placed into a measuring device, the measuring device will be formed according to whether there is a groove in the identification unit 26〇, 460, 560, and the corresponding sensing unit group on the connector is activated according to the number and position of the groove. And further forming an electrical connection with the measuring device, so that the measuring device can distinguish the biochemical test pieces 4 and 500 And then the corresponding correction parameters or modes are used for measurement. Although Figures 4 and 5 show the identification unit with six constituent units, the creation does not limit the number of constituent units. It should also be understood that the constituent units are The number and position can be set by the designer according to the actual application, and a plurality of different identification codes can be combined. For example, when the identification unit has N constituent units (that is, the pre-induction of the insulating substrate, the region is divided into N sub-regions) 2, each identification code can be combined. That is, each constituent unit (sub-region) can have two states (or 1) depending on the presence or absence of the groove, and can be combined with the position of the parent constituent unit. Into a number of unique, different code. Identification unit will be able to use this rib silk different Wei biochemical test strips: different batches of biochemical test strips. In other embodiments, the touch unit is composed of f wear or not The hole penetrates through the insulating substrate. As long as the measuring device can recognize the metric code of a unit such as G or 1}, the creation does not limit the shape and size of the hole. The square shows that the sensory test of biochemical ramie 600 613 Measuring device 630. Biochemical 66 〇: ltTM 624 ' As before, 丄, 守 兀 兀 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 , , , , , , , , , , , , One of the structures 13 M343160 ί^=62! is formed with a groove. The measuring device (4) comprises a micro processing unit 650 connecting the 11 640 and the surface 640, wherein the micro processing unit 650 has one built in two The material 655 can be, for example, a calibration parameter, a detection mode, or other information, etc. The working electrode 622, the reference electrode 624, the sensing electrode _, and the identification unit _ are connected to the connector 640 and are measured. The device 63 is electrically connected. . The biosensor test piece 61 is connected to the connector 64A, and the sensing electrode 626 is connected to the connection $640 to form a loop, and the microprocessing unit (4) activates the measuring device 630. In addition, since the plurality of constituent units of the identification unit _ have different states (for example, there are two slots or no grooves), the connection with the connector _ is generated in a different shape, which will generate corresponding to the contact unit _ The coded signal is sent to the micro=processing unit 650. The micro processing unit 65〇 can identify the parameters according to the letter and select the parameter or mode corresponding to the signal from the batten 655. The measuring device _ further includes A display 67 for displaying various measurement results, and a power supply 665 for providing a required power supply. In another embodiment, the display and the power source 665 may be external devices and not included in the measuring device 63. In one embodiment, the connector 640 has a plurality of detection unit groups and at least a sensing unit group. As illustrated in FIG. 7A, the 64-inch detection unit group 742 in the connector is used to detect The electrical variation between the f-poles on the test chip is transmitted to the relevant circuit system. For example, the detecting unit group 742 includes a contact portion 742a and a conductive terminal 742b. The contact portion 742a is in electrical contact with the test strip. Measuring the electrical changes between the electrodes by debt, The detected electrical changes are transmitted to the circuitry by the conductive terminals 742b to perform signal processing to obtain a measurement result. The number of sensing unit groups 744 is corresponding to the number of constituent units of the identification unit. That is, the number of potential grooves to be divided by the predetermined 14 M343160 region of the insulating substrate. In other words, the setting of the sensing unit group 744 in the connected state 640 corresponds to the position of the identification unit on the biochemical test strip for coupling the respective components. The sensing unit group 744 can form a signal by means of an open circuit or a short circuit sensing component. As shown in FIG. 7B, the virtual group 744 includes two shrapnel portions, 744b and two conductive terminals 7=^*. The two correcting portions 744a and 744b are designed not to be in contact with each other. However, when the trial inserts the measuring amount 630, the two elastic pieces 744a and 744b are corresponding to the identification unit: the corresponding 雠 is set (the green shape is formed into a unit dragon) (4) The contact form is short-circuited, and the -signal is electrically connected to the circuit system by the conductive terminal to output the signal 'to facilitate the subsequent processing of the micro-processing unit (4). The position of the recess _ and the matching groove is such that the corresponding sensing unit group 744 of the connector _ generates a specific short-circuit state, and the state is transmitted to the routing system to perform the _discrimination of the processing unit (four). In other words, as long as the unit; The region has an identifiable structural geometric patterning (a two-toothed or non-toothed substrate groove pattern), so that the sensing unit group 744 can generate a corresponding signal according to the state of the opening (for example, whether there is a groove) According to the receiving tens of ten yoke cases, the sensing unit 70 sets 744 shrapnel parts 744a, 744b tr 7tf mesh, this, # test piece embedded measuring device, two shrapnel parts into ~ #ζ路New Zealand is connected to take out the money, and (4) the processing of the microprocessor unit 650.舯卩' Depending on the location of the identification unit, the corresponding _ sensing unit core 15 M343160 is sad, and this state is transmitted to the circuitry for subsequent processing by the microprocessor unit 65. In other words, as long as the insulating substrate serves as a predetermined area of the identification unit, it has an identifiable mechanical geometric patterning (for example, a groove pattern penetrating the substrate or not penetrating the substrate), so that the sensing unit group 744 can be based on the state of the individual constituent units. (For example, there is a groove) to generate a corresponding signal (for example, whether or not an open circuit is formed), that is, the microprocessor can process according to the mode in which the identification code signal is received. It should be noted that the shapes of the detecting unit group and the sensing unit group are not limited to those shown in the embodiment, as long as the sensing unit group and the sensing unit group capable of achieving the above functions are applicable. It should be noted here that the sub-areas divided by the predetermined area of the insulating substrate are preferably the same size, and the sub-areas may be of different sizes depending on the design requirements. That is, each of the constituent elements of the identification unit ', A and the sensing unit are thin & the potential grooves to be formed may be the same size, shape, and depth.
=上所述，本創作之辨識單元係由機構性圖案化絕緣基板的 、疋區域所構成，無需額外塗覆昂貴的金屬材料，可節省製造成 此外，本創作之辨識單元係結合於生化感測試片之絕緣基板， 於贴疋，里測裝置中所内建之資料，例如内建複數組相應 因:片上韻單元組合數之校正錄、檢繼式、或其他資訊。 ” u夂本創作所揭示的生化感測系統不但達到無需密碼卡之目的 亚牛低了試片的製造成本，且避免人為操作的疏失。 作本創作之較佳實施例而已，並非用以限定本創 6月專利乾圍；凡其它未脫離本創作所揭示之精神下所完成 16 M343160 之等效改變或修飾’均應包含在下述之申請專利範圍内。 【圖式簡單說明】 圖1繪示一習知的生化感測試片； 圖2繪示本創作一實施例之生化感測試片； 圖3繪示圖2之生化感測試片的結構分解圖； 圖4及圖5為根據本創作不同實施例所綠示之生化感測試片； 圖6為根據本創作一實施例所繪示之一生化感測系統的方塊 示意圖； 圖7A及7B為根據本創作一實施例所繪示之一連接器之偵測 單元組與感測單元組的示意圖。 【主要元件符號說明】 100 110 120 200 210 220 222 224 226 習知檢測試片 試片導電組 -條碼 生化感測試片 絕緣基板 導電層 工作電極 參考電極 感測電極 絕緣墊高層 17 230 M343160= As mentioned above, the identification unit of this creation is composed of the 图案 area of the structurally patterned insulating substrate, and no need to apply extra expensive metal materials, which can save manufacturing. In addition, the identification unit of the creation is combined with biochemical sensation. The insulating substrate of the test piece, the material built in the measuring device, such as the built-in complex array corresponding to: the correction record, the successor, or other information of the number of elements on the chip. The biochemical sensing system disclosed by the present invention not only achieves the purpose of eliminating the need for a cryptographic card, but also reduces the manufacturing cost of the test piece and avoids the omission of human operation. The preferred embodiment of the present invention is not limited to The creation of the patents in June; the equivalent changes or modifications of 16 M343160 that are not removed from the spirit of this creation shall be included in the scope of the following patent application. [Simplified illustration] Figure 1 A biochemical test piece is shown in FIG. 2; FIG. 2 is a biochemical test piece according to an embodiment of the present invention; FIG. 3 is a structural exploded view of the biochemical test piece of FIG. 2; FIG. 4 and FIG. FIG. 6 is a block diagram showing a biochemical sensing system according to an embodiment of the present invention; FIGS. 7A and 7B are diagrams showing one embodiment according to an embodiment of the present invention; Schematic diagram of the detection unit group and the sensing unit group of the connector. [Main component symbol description] 100 110 120 200 210 220 222 224 226 Conventional test strip test strip conductive group - barcode biochemical test strip insulating substrate conductive layer Working electrode Reference electrode Sensing electrode Insulation pad high-rise 17 230 M343160
235a 開口 235 反應區 240 反應層 250 上蓋 255 通氣孔 260 辨識單元 262 凹槽 400 生化感測試片 410 絕緣基板 422 工作電極 424 參考電極 426 感測電極 460 辨識單元 462a〜462f 構成單元 500 * 生化感測試片 510 絕緣基板 522 工作電極 524 參考電極 526 感測電極 560 辨識單元 562a〜562f 構成早元 600 生化感測系統 610 生化感測試片 M343160 622 624 626 660 662 630 640 650 655 665 工作電極 爹考電極 感測電極 辨識單元 凹槽 量測裝置 連接器 微處理單元 數位資料 電源 顯示器 670235a opening 235 reaction zone 240 reaction layer 250 upper cover 255 vent 260 identification unit 262 groove 400 biochemical test piece 410 insulating substrate 422 working electrode 424 reference electrode 426 sensing electrode 460 identification unit 462a to 462f constituent unit 500 * biochemical test Sheet 510 Insulating Substrate 522 Working Electrode 524 Reference Electrode 526 Sensing Electrode 560 Identification Units 562a to 562f constituting Early Element 600 Biochemical Sensing System 610 Biochemical Sense Test Strip M343160 622 624 626 660 662 630 640 650 655 665 Working Electrode Sense Electrode Electrode identification unit groove measuring device connector micro processing unit digital data power display 670