TW200523540A - Structure for multi-use electrode testing sheet - Google Patents
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- TW200523540A TW200523540A TW94110748A TW94110748A TW200523540A TW 200523540 A TW200523540 A TW 200523540A TW 94110748 A TW94110748 A TW 94110748A TW 94110748 A TW94110748 A TW 94110748A TW 200523540 A TW200523540 A TW 200523540A
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200523540 五、發明說明(1) 【發明所屬之技術領域】 本發明係有關一種個人用的生化檢測試片,尤指一種 單一片可以多次使用的血液生化檢測試片,以及可以以一 滴血同時測量兩種以上相同或不同檢驗項的生化檢測試 片。 【先前技術】 目前所有市面上的血糖檢測試片都是只能使用一次、 用完即丟的試片。這種試片對於開發中或未開發國家的糖 尿病患者來說,實在太過昂貴、負擔不起,而無法定期依 據病情作血糖檢測,甚而危及生命。他們非常需要一種更 便宜的血糖檢測試片。同時,目前市面上的血糖試片精確 度也不夠,限於他們使用的材質及方法,常常造成超過百 分之三十以上的誤差。而且,除了歐美少數品牌以外,都 需要十五到三十秒的測量時間。因此,本發明的主要目的 就是能提供一種更便宜、更準確、測量時間更短的血糖檢 測試片。 本發明的另一個主要目的就是能提供一種血糖檢測試 片,只要採一滴血、痛一次,用一滴血就能測得數種相同 或不同的檢品讀值;用一滴血就能測得數種相同的檢品讀 值的目的是為了能多做幾次血糖檢測,取得平均值以增加 準確度,但不必多採幾次血以減少採血的疼痛;而用一滴 @血就能測得數種不同的檢品讀值的目的是為了能同時做不 同項目的檢測,但不必多採幾次血以減少採血的疼痛。 到目前為止,全世界沒有任何一個專利提出在單一個200523540 V. Description of the invention (1) [Technical field to which the invention belongs] The present invention relates to a biochemical test strip for personal use, particularly a blood biochemical test strip that can be used multiple times with a single piece, and can be simultaneously used with one drop of blood. Measure two or more biochemical test strips with the same or different test items. [Prior technology] At present, all the blood glucose test strips on the market are test strips that can only be used once and thrown away after use. This kind of test strip is too expensive and unaffordable for people with diabetes in developing or undeveloped countries. It can not be regularly tested for blood glucose according to the condition, and even life-threatening. They desperately need a cheaper blood glucose test strip. At the same time, the current blood glucose test strips on the market are not accurate enough, and they are limited to the materials and methods they use, which often causes errors of more than 30%. Moreover, with the exception of a few European and American brands, it takes fifteen to thirty seconds to measure. Therefore, the main object of the present invention is to provide a blood glucose test strip which is cheaper, more accurate, and has a shorter measurement time. Another main object of the present invention is to provide a blood glucose test strip. As long as one drop of blood is taken, the pain can be measured once, and the same or different readings can be measured with one drop of blood. The purpose of reading the same sample is to be able to do more blood glucose tests and obtain an average value to increase accuracy, but it is not necessary to take more blood to reduce the pain of blood collection; and one drop of @ 血 can measure several different The purpose of reading the sample is to be able to test different items at the same time, but it is not necessary to take more blood to reduce the pain of blood collection. So far, no patent in the world has been filed in a single
第5頁 200523540 五、發明說明(2) 一次性、用完即丟的生化檢測試片上能多次使用的結構設 計及方法,以減少使用者的經濟負擔。我們前一個專利申 請案(美國發明專利申請案號N 〇 . 1 〇 / 7 0 4,7 0 1 )首次提出了 在單一試片上能多次使用的電化學試片,但内容與本申請 案不同。 3乜1]:〇1^111^1等人申請的美國專利5,120,420揭示了 一種在一片試片上有多條電極導線,以便同時為數個檢品 檢測其血糖濃度,再取其平均值,以增加準確度。但是這 種方法需要比較多的血液量,對於病患在家自我檢測者^ 言,並不可行。同時,這種方法也無助於降低使用者的檢 _測費用。 双 再者,有很多研究報告及專利提出各種方法以提高測 量的準確度或檢測速度。例如,T h 〇 m a s Y · S · S h e η的美 國專利6,4 9 1,8 0 3有提到採用奈米金屬粉以增加導電度及 減少反應時間,但仍然需要十五秒鐘的測量時間。Har t (Biosensors & Bioelectronics, 13:333-339, 1996)^ 現在電極表面加入白金粉末可以增加導電度以改善測量的 準確度,然而這些效果還不夠好。C· D· Wisley等人的美 國專利6,5 4 1,2 1 6指出利用電漿處理銀電極和碳電極的表' 面可以增加試片測量的準確度。但是,以上這些方法並不 能達到本專利所要求的更便宜、更準確、及量測速度更快 的目標,也不是本專利所採用的方法。 【發明内容】 為達上述之目的,本發明係提供一種能多次使用的生Page 5 200523540 V. Description of the invention (2) The structural design and method that can be used repeatedly on the biochemical test strips that are disposable and thrown away to reduce the financial burden on users. Our previous patent application (U.S. Patent Application No. 0.10 / 704,701) first proposed an electrochemical test strip that can be used multiple times on a single test strip, but the content is the same as this application different. 3 乜 1]: US Patent No. 5,120,420 filed by 〇1 ^ 111 ^ 1 et al. Discloses a method in which a plurality of electrode leads are provided on a test strip, so as to measure the blood glucose concentration of several samples at the same time, and then take the average value. To increase accuracy. However, this method requires a relatively large amount of blood, which is not feasible for patients who self-test at home ^. At the same time, this method does not help reduce the user's inspection costs. In addition, there are many research reports and patents suggesting various methods to improve the accuracy or speed of measurement. For example, U.S. Patent No. 6, 4 91, 803 of T h mas Y · S · S he η mentions the use of nanometer metal powder to increase the conductivity and reduce the reaction time, but it still takes fifteen seconds. measure time. Har t (Biosensors & Bioelectronics, 13: 333-339, 1996) ^ Now adding platinum powder on the electrode surface can increase the conductivity to improve the measurement accuracy, but these effects are not good enough. C. D. Wisley et al., U.S. Patent No. 6,5 4 1, 2 1 6 pointed out that the use of plasma treatment of the surface of the silver electrode and the carbon electrode can increase the accuracy of the test strip measurement. However, the above methods cannot achieve the goals of cheaper, more accurate, and faster measurement speed required by this patent, nor are they the methods adopted by this patent. [Summary of the Invention] In order to achieve the above-mentioned object, the present invention provides a product that can be used multiple times.
第6頁 200523540 五、發明說明(3) 化測試試片,其主要包含一種每片能多次使用的一次性、 用完即丟式的電極試片之結構及所含之化學載體,用以配 合生物感測檢測裝置使用,並根據檢品於生化反應中所產 生的電效應,檢出該檢品的成分及測定其濃度。本發明之 結構是由四層的薄片黏貼而成,而薄片上有各種沖孔所形 成的空間可以產生三個相同的反應區,並於各反應區上置 有生化反應載體,僅需要2 # 1的血液.量,藉由虹吸的原 理,血液會被吸入反應區後隨即與其上的生化反應載體起 電化學反應,並且藉由分析該電化學反應的結果能得知該 血液檢品的血糖濃度。同時該薄片另有各種沖孔所形成的 •空間能使該試片因應力集中因素而能將用過的試片輕易折 斷,以利第二、三次再使用其他未使用的部份;在最底層 的薄片上有兩條正負極導電電極以傳導反應的電化學訊 號,且該電極導線被設計成使每個電化學反應區的正負電 極與測莖電極頭上的正負電極間具有相同電阻 > 具有相同 電阻是本發明所揭示的試片能多次使用的關鍵因素,也是 不可或缺的要素,這種方法全世界我們首次採用。每個電 化學反應區的正負電極會將其上的化學載體與血液反應所 產生的電化學反應訊號傳到測量電極頭上的正負電極,然 後可被血糖測試機判讀其血液檢品的血糖讀值。至於 我們獨家開發的化學反應物質之配方係含有氫氧丙曱 基纖維素(hydroxypropyl methyl cellulose),以使其化 學反應物質平均分佈,這與美國專利5,1 2 0,4 2 0所採用的 羧曱基纖維素(Carboxymethyl cellulose),以及中華民Page 6 200523540 V. Description of the invention (3) Chemical test strips, which mainly include the structure of a disposable, disposable electrode strip that can be used multiple times, and the chemical carrier contained in it. It is used in conjunction with a biosensor detection device, and detects the components of the sample and determines its concentration according to the electrical effect of the sample in the biochemical reaction. The structure of the present invention is formed by pasting four layers of flakes, and the space formed by various punching holes on the flakes can generate three identical reaction zones, and a biochemical reaction carrier is placed on each reaction zone. Only 2 # are required. The amount of blood in 1 is based on the principle of siphoning. After being sucked into the reaction zone, blood will electrochemically react with the biochemical reaction carrier thereon, and the blood glucose of the blood test substance can be obtained by analyzing the result of the electrochemical reaction. concentration. At the same time, the sheet is formed by various punching holes. The space can make the test piece easily break the used test piece due to the stress concentration factor, so as to reuse the other unused parts for the second or third time. There are two positive and negative conductive electrodes on the bottom sheet to conduct the electrochemical signal of the reaction, and the electrode lead is designed so that the positive and negative electrodes of each electrochemical reaction zone and the positive and negative electrodes on the stem electrode tip have the same resistance> Having the same resistance is the key factor that the test strip disclosed by the present invention can be used multiple times, and it is also an indispensable element. This method is adopted for the first time in the world. The positive and negative electrodes of each electrochemical reaction zone will transmit the electrochemical reaction signal generated by the reaction between the chemical carrier on it and the blood to the positive and negative electrodes on the measuring electrode head, and then the blood glucose reading of the blood test product can be judged by the blood glucose tester. . As for the formula of the chemically reactive substance that we have developed exclusively, it contains hydroxypropyl methyl cellulose to distribute the chemically reactive substance evenly. This is the same as that used in US Patent 5,120,420. Carboxymethyl cellulose, and the Chinese people
第7頁 200523540 五、發明說明(4) 國專利3 7 4 1 1 6號 纖維素(Microc 世界我們首次採 除此之外, single walled) 間,它可以將反 秒鐘,並可提供 固,這種方法全 揭示的試片可以 準確的結果。 § 再者,若將 同樣的四層或八 以一滴血可以被 區,做相同的或 同時測量兩種以 測量兩種以上的 確度;但如果以 時,則可以減少 據而,本發 每次使用的檢測 最短的功能要求 1【實施方式】 為使 貴審 一層的認識與了 及美國專 r y s t a 1 1 i 用。 我們也添 奈米碳管 應時間由 適當的表 世界我們 多次重複 上述 層, 虹吸 不同 上的 相同 一滴 每一 明所 成本 四層 但其 到兩 的生 相同 檢品 J&L同 次採 述之 ,同 利6,4 1 3,3 9 4 B 1所採用的超微粒 n e cellulose) 不同,這也是全 加多壁及單壁(Multi- walled 和 以增加導電速率、減少檢測時 一般的三十秒減少到四秒甚至二 面張力及表面能,以防止血液凝 首次採用。如此一來,本發明所 使用,而且可以很迅速地得到很 所形成的試片於其最上層再加貼 虹吸進血位置皆在相同位置,則 個或三個不同的、獨立的反應 化反應檢測,因此以一滴血可以 或不同檢品。如果以一滴血同時 時,可以取其平均值以增加其準 時測S兩種以上的不相同檢品 血的疼痛。 血糖測試試片,可以降低使用者 時也具有準確度最高、測試時間 查委員對 解,茲舉 本發明之構造及其特徵能有更深 其可行實施例並配合圖是詳細說Page 7 200523540 V. Description of the invention (4) National patent 3 7 4 1 1 6 cellulose (Microc world we first adopted in addition to single walled), it can reverse the seconds, and can provide solid, The test strips revealed by this method can give accurate results. § Furthermore, if the same four layers or eight drops of blood can be zoned, the same or two measurements can be taken at the same time to measure more than two kinds of accuracy; but if the time is exceeded, the data can be reduced, and each time The shortest functional requirements used for testing 1 [Implementation] In order to make your first-level understanding and use in the United States special rysta 1 1 i. We also add nano carbon tubes to the appropriate table from time to time. We repeat the above layers multiple times, the same drop on different siphons costs four layers per square meter, but the same test article J & L is the same. In other words, it is different from the ultra-fine particle cellulose used in Lili 6, 4 1 3, 3 9 4 B 1, which is also a multi-walled and single-walled (multi-walled and multi-walled) to increase the conductivity and reduce the general three Decrease ten seconds to four seconds or even two-sided tension and surface energy to prevent blood clotting from being used for the first time. In this way, the test piece used by the present invention can quickly obtain a test piece formed on the top layer and then add a siphon. The blood injection positions are all in the same position, so one or three different, independent reaction reactions are detected, so one drop of blood can be used or different samples. If one drop of blood is simultaneously, the average value can be taken to increase its on-time measurement. There are two or more different types of pain in blood. Blood glucose test strips can reduce the user's accuracy even when the test time is the highest. Characterized to have deeper and its possible embodiments are explained in detail with FIG.
第8頁 200523540 五、發明說明(5) 明如下: 請參閱第一圖、第二圖及第三圖所示,本發明所述之 能多次使用的生物檢測試片1 0,係由四層薄片1 1 、1 2、 1 3、1 4所黏貼而成,並於薄片1 1、1 2之間放置有二條導線 15、16,導線15連接到三個參考電極151、152、153,而 導線1 6連接到三個工作電極1 6 1、1 6 2、1 6 3 (如第二圖 )0 薄片1 1上有兩個沖孔1 7、1 8 ,可以產生應力集中以利 試片折斷,該薄片1 1上另有一個内凹1 9 ,以標明進血位 置。 _ 薄片1 2分成三片小薄片1 2 1 、1 2 2 、1 2 3貼在導線1 5 、 1 6及薄片1 1上;該三片小薄片1 21 、1 2 2 、1 2 3中間有空隙 是為了組合後的試片好折斷(如第三圖C ),又該三片小 薄片1 2 1 、1 2 2、1 2 3上各有三個沖孔2 0 1 、2 0 2、2 0 3以放置 化學載體251、2 5 2、2 5 3於工作電極161、162、163和參考 電極151 、152、153上(如第三圖A)而成為三個不同的. 反應區,以及在該三片小薄片1 2 1、1 2 2、1 2 3端部各設有 一個内凹1 9 1 、1 9 2、1 9 3以標明進血位置。 薄片1 3分成三片小薄片1 3 1 、1 3 2 、1 3 3貼在薄片1 2 上,同理,在該三片小薄片1 3 1 、1 3 2 、1 3 3中間有空隙是 為了組合後的試片好折斷;且在其上具有三個内凹3 0 1、 0 2、3 0 3可以讓血液4 0藉由虹吸原理吸入與化學載體 251、252、253起電化學反應(如第三圖A與B)。因 此,該試片每次檢測僅需要2 // 1的血液量,藉由虹吸的原Page 8 200523540 V. Description of the invention (5) The description is as follows: Please refer to the first figure, the second figure and the third figure. The multi-use bio-assay test strip 10 according to the present invention is composed of four Layers 1 1, 1 2, 1 3, 1 4 are pasted, and two leads 15, 16 are placed between the sheets 1 1, 12, the leads 15 are connected to three reference electrodes 151, 152, 153, The lead 16 is connected to the three working electrodes 1 6 1, 1, 6 2, 1 6 3 (as shown in the second picture). 0 There are two punch holes 1 7 and 1 8 on the sheet 1 1, which can generate stress concentration to facilitate testing. The sheet is broken, and another indentation 19 is formed on the sheet 11 to indicate the blood inlet position. _ Sheet 1 2 is divided into three small sheets 1 2 1, 1 2 2, 1 2 3 attached to the wires 1 5, 16 and sheet 1 1; the three small sheets 1 21, 1 2 2, 1 2 3 are in the middle The gap is to allow the combined test piece to be broken (such as the third figure C), and the three small sheets 1 2 1, 1 2 2, 1 2 3 each have three punching holes 2 0 1, 2 0 2 2 0 3 to place the chemical carrier 251, 2 5 2, 2 5 3 on the working electrodes 161, 162, 163 and the reference electrodes 151, 152, 153 (as shown in the third figure A) to become three different. The reaction zone, And at the ends of the three small sheets 1 2 1, 1 2 2, 1 2 3, an indentation 1 9 1, 1 9 2, 1 9 3 is provided to mark the blood inlet position. The sheet 1 3 is divided into three small sheets 1 3 1, 1 3 2, 1 3 3 and affixed to the sheet 1 2. Similarly, there is a gap between the three small sheets 1 3 1, 1 3 2, and 1 3 3. In order to break the combined test piece well, and it has three indentations 3 0 1, 0, 3 0 3 to allow blood 40 to inhale electrochemical reactions with chemical carriers 251, 252, and 253 through the principle of siphon. (As in the third picture A and B). Therefore, the test strip only requires 2 // 1 blood volume per test.
第9頁 200523540 五、發明說明(6) 理,血液會被吸入反應區後隨即與其上的生化載體起電化 學反應,並且藉由分析該電化學反應的結果能得知該血液 檢品的血糖濃度。 薄片1 4分成三片小薄片1 4 1 、1 4 2 、1 4 3貼在薄片1 3 上,其上有三個内凹194、195、196,是為了標明進血位 置;其上另有沖孔4 0 1 、4 0 2、4 0 3作為虹吸原理血液的出 氣口。 而導電電極1 5、1 6則被設計為參考電極1 5 1 、1 5 2、 1 5 3到電極頭5 1需有相同的導線長度,亦即相同電阻,而 且工作電極1 6 1 、1 6 2、1 6 3到電極頭5 2需有相同的導線長 ,度,亦即相同電阻,如此,在這三個不同反應區的生化反 應結果才會一致。如上述,各導電電極15與16具有相同電 阻是本發明所揭示的試片能多次使用的關鍵因素,也是不 可或缺的要素,這種方法全世界我們首次採用。 如上述之結構中,薄片1 1 、1 2、1 3、1 4可以為塑膠、 陶質基板、紙板或F R P (玻璃纖維強化塑膠)材質;而導電 電極1 5、1 6可以為以網版印刷製程的銀膠或碳膠導線,也 可以是以加成法(Additive Process),以化學反應的方 法產生所須導電電路;也可以以減乘法(S u b t r a c t i v e process),以化學反應的方法將表面局部無用的導體去 除;然後再以化學浸鍍法(俗稱化金)將貴金屬如金、白 •金等貴金屬,以化學置換反應將貴金屬置換在底材上,以 這種方法在一次生產一百多片的大量生產時,貴金屬的厚 度才能平均,也就是每片試片上的三個反應區的電阻都能Page 9 200523540 V. Explanation of the invention (6) The blood will be sucked into the reaction zone and then it will electrochemically react with the biochemical carrier on it, and the blood glucose of the blood test substance can be obtained by analyzing the result of the electrochemical reaction. concentration. The sheet 14 is divided into three small sheets 1 4 1, 1 4 2, and 1 4 3 attached to the sheet 1 3 with three indentations 194, 195, and 196 on it to indicate the location of blood infusion; The holes 401, 402, and 403 are used as the air outlets for the blood of the siphon principle. The conductive electrodes 15 and 16 are designed as reference electrodes 1 5 1, 1 5 2, 1 5 3 and electrode head 5 1 with the same wire length, that is, the same resistance, and the working electrodes 1 6 1, 1 6 2, 1 6 3 to the electrode tip 5 2 need to have the same lead length, degree, that is, the same resistance, so that the biochemical reaction results in these three different reaction areas will be consistent. As mentioned above, the same resistance of each of the conductive electrodes 15 and 16 is the key factor that the test strip disclosed by the present invention can be used multiple times, and it is also an indispensable element. This method is used for the first time in the world. In the structure described above, the sheets 1 1, 1 2, 1 3, 1 4 can be made of plastic, ceramic substrate, cardboard or FRP (glass fiber reinforced plastic); and the conductive electrodes 1 5 and 16 can be screen-printed. The silver or carbon glue wire of the printing process can also be used to generate the required conductive circuit by the Additive Process and the chemical reaction method; it can also be used the Subtractive Process and the chemical reaction method to Locally useless conductors are removed on the surface; then precious metals such as gold, platinum and other precious metals are replaced by chemical immersion plating (commonly known as gold), and the precious metals are replaced on the substrate with a chemical substitution reaction. In the mass production of more than 100 pieces, the thickness of the precious metal can be averaged, that is, the resistance of the three reaction zones on each piece can be
第10頁 200523540 五、發明說明(7) 維持在百分之一以内的誤差。我們的方法與美國專利 5, 437, 999不同,也與華民國專利496110不同,因為後者 是利用電鍍法鍍上貴金屬,所有試片都需連到同一電極 (我們的方法不需要),會造成試片上的貴金屬電鍍厚度不 均,而在三個反應區的電阻都超過百分之三十以上的誤 差,因此誤差太大,不能適用。 如上述之構造使用時,請在參閱第三圖A〜D所示顯 示了本發明於血液4 0進入試片1 0的使用過程。當血液4 0由 試片1 0右側端部的内凹3 0 1經虹吸作用進入並充滿沖孔2 0 1 内之反應區後(第三圖A到B ),經過數秒鐘等血糖讀值 B出現後,該使用過的第一反應區之試片即可折斷(如第三 圖C ),而露出中間那個未使用的第二反應區(如第三圖 D ),隨即可再進行下一次的血液檢測。以此類推,等到 第二反應區用完後,可再將該第二反應區的試片折斷,使 其露出第三個未反應的反應區,隨即可該一試片1 0上再進 行第三次的血液檢測,達到在同一試片可多次使用之目 的。 再請參閱第圖四及圖五所示,其中顯示了將構造相同 而長度不同的三組如第一圖所示的試片1 0重疊組合成一片 使用的實施例圖,其讓進血的沖孔3 0 1的入口位置相同, 且其中作為出氣口的沖孔4 0 4、4 0 5、4 0 6係至少由上貫穿 •至最底層薄片,則可以以一滴血液同時做三個相同或不同 項目的檢測。本實施例使用時如第五圖所示,當一滴血液 4 0被吸入而充滿其右側端重疊設置的三個反應區a、b、Page 10 200523540 V. Description of the invention (7) The error maintained within 1%. Our method is different from U.S. Patent 5,437,999 and Republic of China Patent 496110, because the latter is plated with precious metals by electroplating. All test pieces need to be connected to the same electrode (our method does not need), which will cause The thickness of the noble metal plating on the test piece is uneven, and the resistance in the three reaction zones exceeds an error of more than 30%, so the error is too large to be applicable. When the structure is used as described above, please refer to the third figures A to D to show the use process of the present invention when the blood 40 enters the test strip 10. After the blood 40 enters the recessed area 3 0 1 on the right end of the test strip 1 10 through the siphon effect and fills the reaction area in the punching hole 2 0 (third picture A to B), wait for a few seconds for the blood glucose reading After B appears, the test piece of the used first reaction zone can be broken (such as the third picture C), and the unused second reaction zone (such as the third picture D) is exposed, and then the next step can be performed. A blood test. By analogy, after the second reaction zone is used up, the test piece of the second reaction zone can be broken to expose the third unreacted reaction zone, and then the test piece 10 can be subjected to the first Three blood tests are used to achieve the purpose of multiple use in the same test strip. Please refer to FIG. 4 and FIG. 5 again, which shows three embodiments of the same structure but different lengths of the test strips 10 shown in FIG. The entrance position of the punching hole 3 0 1 is the same, and the punching holes 4 0 4, 4 0 5 and 4 0 6 which are the air outlets are at least penetrated from the top to the bottom sheet, and three identical ones can be made with one drop of blood at the same time. Or detection of different items. When this embodiment is used, as shown in the fifth figure, when a drop of blood 40 is inhaled and fills the three reaction zones a, b, and
第11頁 200523540 五、發明說明(8) c,各反應區裡的化學載體251會同時與吸入各反應區内的 血液40起電化學反應。而其中在三個反應區a、b、c中的 化學載體251可以是同一種,以產生相同的讀值,再取其 平均值以得到較佳的準確度;也可以是不同種類,以一滴 血得到三種不同讀值。同樣的,這種試片一樣的在第一次 測試用完後可以折斷再使用。 以上所述的試片構造亦可變化實施如第六及第七圖所 示,如第六圖所顯示的實施例,該試片1 0係設計成由三層 薄片1 1 、1 2、1 3黏貼而成,其中内凹的血液入口 7 1 、7 2、 73設於第二層薄片12,且都設計在延長度方向電極頭51、 2的另一側,致血液得由側面之血液入口 7 1 、7 2、7 3進 入,而沖孔404、405、406 (至少貫穿至最底層的薄片) 為血液虹吸的出氣口 ,又為因應不同的血液入口位置可改 變其導電電極1 5、1 6的設計形式(如圖七所示),並將化 學載體251塗佈於第一層薄片11的工作電極161 、162、163 和參考電極1 5 1 、1 5 2、1 5 3所形成的反應區上;據而即可 達到如第一圖之實施例所示,可以同一試片1 0作多次檢測 使用之目的。又,這種血液由側面進入的試片另可設計成 多重堆疊之實施方式(如第八圖),其中的血液進入口 71 、7 2 、7 3 、7 4 、7 5 、7 6 、7 7 、7 8 、7 9 得、設於該言式片 1 0 的 側邊,而沖孔4 0 4、4 0 5、4 0 6為血液虹吸的出氣口 ,據而 >同樣可達到如第四圖之實施例所述,以一滴血可作多種測 試的試片功效。如上述,同樣的在每一段的試片上可作進 一步的堆疊至四組或五組以上的反應區。Page 11 200523540 V. Description of the invention (8) c. The chemical carrier 251 in each reaction zone will electrochemically react with the blood 40 drawn into each reaction zone at the same time. Among them, the chemical carriers 251 in the three reaction zones a, b, and c may be the same type to generate the same reading value, and then take the average value to obtain better accuracy; it may also be a different type with one drop Blood gets three different readings. In the same way, this kind of test piece can be broken and used again after the first test. The structure of the test piece described above can also be changed. As shown in the sixth and seventh figures, the test piece 10 is designed as a three-layer sheet 1 1, 1 2, 1 as shown in the sixth figure. 3 Adhesive, in which the recessed blood inlets 7 1, 7 2, 73 are provided on the second sheet 12 and are all designed on the other side of the electrode heads 51, 2 in the extension direction, so that the blood must be from the side blood The inlets 7 1, 7 2, 7 3 enter, and the punching holes 404, 405, 406 (at least through the bottommost slice) are the air outlet for blood siphon, and the conductive electrodes can be changed according to different blood inlet positions 1 5 And 16 design patterns (as shown in Figure 7), and the chemical carrier 251 is applied to the working electrodes 161, 162, 163 and reference electrodes 1 5 1, 1 5 2, 1 5 3 of the first layer 11 According to the formed reaction zone, as shown in the embodiment of the first figure, the purpose of using the same test strip 10 for multiple tests can be achieved. In addition, this type of test piece with blood entering from the side can also be designed as a multi-stacked embodiment (such as the eighth figure), in which the blood inlets 71, 7 2, 7 3, 7 4, 7 5, 7 6, 7 7, 7 8 and 7 9 are obtained and set on the side of the speech sheet 1 0, and the punching holes 4 0 4, 4 5 5 and 4 0 6 are the outlets of blood siphon. According to > the same can be achieved as As shown in the example of the fourth figure, a single drop of blood can be used for a variety of tests. As mentioned above, the test pieces in each section can be further stacked into four or more groups of reaction zones.
第12頁 200523540 五、發明說明(9) 如上所述之一個試片可多次使用的試片結構,我們也 提出另一種適合市面上少數以光學方法檢測血糖濃度的血 糖測試儀(如:R 0 C Η E )使用之設計的實施例,如圖九所 示,其可在一試片90上可設有三個具有化學栽體91、92、 9 3之反應區,並在每二反應區之間的二側邊對應的設有二 缺口 9 4,以能輕易的將已用過的反應區折斷。 至於本發明中所採用的化學載體配方,詳述如下。 該反應區内的化學載體,其組成包含: 1· 氫氧丙曱基纖維素(Hydroxypropyl methyl cellulose),含量:0·4°/〇 _ ·擰檬酸(Citric acid),含量:0.096% 3·磷酸氫二卸(Dibasic potassium phosphate),含量: 0·453% 4 · 非離子性介面活性劑T r i t ο η X - 1 0 0,含量:〇 · 〇 4 % 5·葡萄糖氧化酵素(Glucose oxidase),含量:〇·7% 6·赤血鹽(Ρ o t a s s i u m f e r r i c y a n i d e ),含量:3 · 5 % 7·去離子水(Deionized water),含量:94.81% ^ ·奈米碳管(Nanotube carbon),含量:0.05% 其中氫氧丙曱基纖維素是我們首次採用,用以使化學 栽體在乾燥於試片上時能均勻地分佈;檸檬酸是用來調整 酸鹼值,同時它也有抗凝血的作用;磷酸氫二鉀是用來調 整酸驗值;非離子性介面活性劑T r i t ο η X - 1 0 〇是用來降低 水的表面張力,有助於添加物的溶解;葡萄糖氧化酵素則 會與血液產生電化學反應;赤血鹽則作為導電介質;奈米Page 12 200523540 V. Description of the invention (9) As mentioned above, a test strip structure can be used multiple times. We also propose another blood glucose tester (such as: R 0 C Η E) An embodiment of the design used, as shown in FIG. 9, it can be provided on a test piece 90 with three reaction zones with chemical plants 91, 92, 93, and in every two reaction zones Two gaps 9 4 are provided correspondingly between the two sides to easily break the used reaction zone. As for the chemical carrier formulation used in the present invention, the details are as follows. The chemical carrier in the reaction zone has a composition of: 1. Hydroxypropyl methyl cellulose, content: 0.4 ° / 〇_, Citric acid, content: 0.096% 3 · Dibasic potassium phosphate, content: 0.453% 4 · Non-ionic surfactant T rit ο η X-1 0 0, content: 〇 · 〇4% 5 · Glucose oxidase (Glucose oxidase ), Content: 0.7% 6. Red blood salt (Potassiumferricyanide), content: 3.5% 7. Deionized water, content: 94.81% ^ Nanotube carbon, content : 0.05% Among them, we used hypromellose cellulose for the first time to make the chemical plant evenly distributed when dried on the test strip; citric acid is used to adjust the pH value, and it also has anticoagulant Role; dipotassium hydrogen phosphate is used to adjust the acid test value; non-ionic surfactant T rit ο η X-1 0 〇 is used to reduce the surface tension of water and help the dissolution of additives; glucose oxidase is Will react electrochemically with the blood Potassium ferricyanide is used as a conductive medium; nm
第13頁 200523540 五、發明說明(10) 碳管也是我們首次採用,用以增加反應速率、減少反應時 間,如圖十所示。奈米碳管可以用,也可以不用;用了可 以減少反應時間,不是絕對必要的元素。 前述的化學載體(25 1〜2 5 3 )是以武藏牌(Musashi)精密 點膠機點在沖孔(201〜2 0 3 )内的工作電極(161〜163)及參考 電極(1 5 1〜1 5 3 )上,用以吸附載體的生物活性物質及導電 介質,並且使該電極部份由疏水性變為親水性,以利檢品 之附著,更進而可以保護該生物活性物質於較高溫的乾燥 過程不致受損;而前述的生物活性物質則是只包括經固定 化或甚至未經固定化之酵素(如葡萄糖氧化酵素GiUCC)se X i d a s e )、抗原、抗體、微生物細胞、動植物細胞、動植 物組織具有生物性辨識能力的成分,用以與之捿觸的檢品 (如血液等生物組織)產生生化或化學反應;而前述之導電 介質(如Potassium ferricyanide ,quinones)含量3 5 % , 乃用以接收酵素與檢品反應後所產生的電子,並再將此電 子經由電極導線傳給感測器轉換為檢品濃度。Page 13 200523540 V. Description of the invention (10) The carbon tube is also our first use to increase the reaction rate and reduce the reaction time, as shown in Figure 10. Nano carbon tubes can be used or not; the use of them can reduce the reaction time and is not an absolutely necessary element. The aforementioned chemical carrier (25 1 to 2 5 3) is a working electrode (161 to 163) and a reference electrode (1 5 1) that are placed in a punching hole (201 to 2 0 3) by a Musashi precision dispenser. ~ 1 5 3), to adsorb the bioactive substance and conductive medium of the carrier, and change the electrode part from hydrophobic to hydrophilic to facilitate the adhesion of the test product, and further protect the bioactive substance from The high-temperature drying process will not be damaged; the aforementioned bioactive substances only include immobilized or even unimmobilized enzymes (such as glucose oxidase GiUCC) se X idase), antigens, antibodies, microbial cells, animal and plant cells 2. The components of animal and plant tissues with biological identification ability, which are used to produce biochemical or chemical reactions with the test objects (such as blood and other biological tissues) in contact with it; and the aforementioned conductive medium (such as Potassium ferricyanide, quinones) content is 35%, It is used to receive the electrons generated after the enzyme reacts with the sample, and then pass this electron to the sensor via the electrode wire to convert it into the sample concentration.
第14頁 200523540 圖式簡單說明 【圖示簡單說明】 第一圖為本發明能多次使用的生物檢測試片的立體組合圖 第二圖為本發明能多次使用的生物檢測試片的立體分解圖 第三圖為本發明能多次使用的生物檢測試片的剖面圖 第四圖為本發明的一片可多次使用、且一滴血可檢驗三種 相同或不相同檢測項目的生物檢測試片的立體組合圖 第五圖為本發明的一片可多次使用、且一滴血可檢驗三種 相同或不相同檢測項目的生物檢測試片的剖面圖 第六圖為本發明的一片可多次使用、且血液入口在側面的 生物檢測試片的立體組合圖 _第七圖為本發明的一片可多次使用、且血液入口在側面的 生物檢測試片中的導電電極貫施例不意圖 第八圖為本發明的一片可多次使用、血液入口在側面、且 一滴血可檢驗三種相同或不相同檢測項目的生物檢測 試片的立體組合圖 第九圖為本發明的另一種實施例的示意圖 第十圖為有加奈米碳管與沒加奈米碳管的化學載體與寫意 的電化學反應圖 【主要元件符號說明】 試片 1 0 、9 0 ⑩薄片 1 1 、1 2 、1 3 、14 小薄片 1 2 1 、1 2 2 、1 2 3 、1 3 1 、1 3 2 、1 3 3 、1 4 1 、1 4 2 、1 4 3 沖孔 2 0 1、2 0 2、2 0 3Page 14 200523540 Brief description of the drawings [Simplified illustration of the diagram] The first picture is a three-dimensional combination diagram of the bio-detection test strip that can be used multiple times according to the present invention. Exploded view. The third figure is a cross-sectional view of a bio-assay test strip that can be used multiple times according to the present invention. The fourth picture is a bio-test strip that can be used multiple times and one drop of blood can test three same or different test items. The fifth figure is a cross-sectional view of a bio-test strip that can be used multiple times and one drop of blood can test three same or different detection items. A three-dimensional combined view of a biological test strip with a blood inlet on the side _ The seventh figure is a conductive electrode in a biological test strip with a blood inlet on the side that can be used multiple times in the present invention This is a three-dimensional combination diagram of a biological test strip that can be used multiple times, the blood inlet is on the side, and one drop of blood can test three same or different detection items. The ninth figure is The schematic diagram of another embodiment of the invention. The tenth figure is a chemical carrier with and without a carbon nanotube and a free electrochemical reaction chart. [Description of the main component symbols] Test piece 1 0, 9 0 ⑩ sheet 1 1 , 1 2, 1 3, 14 Small sheet 1 2 1, 1 2 2, 1 2 3, 1 3 1, 1 3 2, 1 3 3, 1 4 1, 1 4 2, 1 4 3 Punching 2 0 1 , 2 0 2, 2 0 3
第15頁 200523540 圖式簡單說明 内凹 19 、 191 、 192 、 193 、 194 、 195 、 196 内凹 301、 302、 303 沖子L 4 0 1 、4 0 2 、4 0 3 、4 0 4 、4 0 5 、4 0 6 4 匕學載體 251 > 2 5 2 > 2 5 3 、91 、92 、93 血液 4 0 血液進入口 71、72、73、74、75、76、77、78、79 電極頭 51、52、53、54、55、56 電極導線1 5、1 6 工作電極161 、 162 、 163 參考電極151 、 152 、 153 _沖孔 1 7、1 8Page 15 200523540 Schematic description of recessed 19, 191, 192, 193, 194, 195, 196 recessed 301, 302, 303 Punch L 4 0 1, 4 0 2, 4 0 3, 4 0 4, 4 0 5, 4 0 6 4 Carrier 251 > 2 5 2 > 2 5 3, 91, 92, 93 Blood 4 0 Blood inlets 71, 72, 73, 74, 75, 76, 77, 78, 79 Electrode heads 51, 52, 53, 54, 55, 56 Electrode leads 1 5, 1 6 Working electrodes 161, 162, 163 Reference electrodes 151, 152, 153 _ punched holes 1 7, 1 8
第16頁Page 16
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