TW201934992A - A biological test strip and a biological test strip reader for the biological test strip - Google Patents
A biological test strip and a biological test strip reader for the biological test strip Download PDFInfo
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本發明係關於一種生物試片，特別的是，係有關一種其組成結構以對稱方式設計之生物試片以及適用該生物試片之生物試片讀取機。The present invention relates to a biological test strip, and in particular, to a biological test strip whose composition structure is designed in a symmetrical manner and a biological test strip reader adapted to the biological test strip.
隨著身體健康受到人們重視，許多生理量測儀器也普及於日常生活中，除了常見溫度、血壓量測外，為了方便病患可隨時知悉身體狀態，部分侵入性生理量測也被製成輕易儀器，方便病患可隨時檢測或居家檢測，像是血糖量測，可提供糖尿病患者監控自己血糖情況，糖尿病若未能有效控制，當血液中葡萄糖含量長期持續維持在過高的狀態 時，恐傷害身體各器官，故患者必須血糖監控以達到預防或儘早發現血糖變化。As people's health is valued, many physiological measurement instruments are also popular in daily life. In addition to common temperature and blood pressure measurements, in order to facilitate the patient's awareness of physical conditions, some invasive physiological measurements are also made easy. The device is convenient for patients to test at any time or at home, such as blood glucose measurement, which can provide diabetes patients to monitor their own blood glucose. If diabetes is not effectively controlled, when the glucose content in the blood continues to remain too high for a long time, Injury to various organs of the body, so patients must monitor blood glucose to prevent or detect blood glucose changes as soon as possible.
目前常見血糖量測方式，還是以侵入式為主，依據試片(試紙)化學原理不同，可被分為比色法及電化學法，其中， 比色法主要是透過試片上酵素與葡萄糖之化學反應，判斷試片反射光強度以取得葡萄糖濃度，另外電化學法則是以電化學反應，即氧化還原反應以量測血糖濃度，亦屬目前較常被使用的方式。由於葡萄糖無法被直接量測，故透過血糖經氧化反應後之成分來達到量測目的，酵素可例如葡萄糖氧化酶(GOD)或葡萄糖去氫酶(GDH)酵素，血液在試片上經酵素催化，將使試片內電極之導電性產生變化，亦即當血滴中葡萄糖與試片上化學酶反應後， 會產生微小電流，經放大、轉換電壓、類比/數位轉換後，即可得到血糖量測。目前試片製造時，電極設置於乘載片(例如PET薄膜)時並非對稱設計，導致乘載片會因溫度改變而有尺寸改變，進而使其上電極尺寸受到影響，於此情況下，電極阻抗也會產生變化，此將導致量測結果有誤差，因而試片設計時也須預先考量因形體變化下可能帶來的阻抗改變問題，不僅提升設計困難度，也難以完整防範各種形體變化。另外，目前血糖試片的電極接點會佈設於一特定側，使用上將有方向性問題。At present, the common blood glucose measurement methods are mainly invasive, which can be divided into colorimetry and electrochemical methods based on different chemical principles of test strips (test strips). Among them, the colorimetric method mainly uses enzymes and glucose on the test strips. The chemical reaction is to judge the intensity of the reflected light of the test piece to obtain the glucose concentration. In addition, the electrochemical method is an electrochemical reaction, that is, a redox reaction to measure the blood glucose concentration, which is also a currently used method. Because grape pupa cannot be directly measured, the measurement purpose is achieved through the oxidation reaction of blood pupa components. Enzymes can be grape pupa oxidase (GOD) or grape pupa dehydrogenase (GDH) enzymes. Blood is catalyzed by enzymes on the test strips. The conductivity of the electrode in the test strip will be changed, that is, when glucose in the blood drop reacts with the chemical enzyme on the test strip, a small current will be generated. After amplification, conversion voltage, analog / digital conversion, blood glucose measurement can be obtained. . At present, in the manufacture of test strips, the electrodes are not symmetrically designed when they are placed on a carrier film (such as a PET film), which causes the size of the carrier film to change due to temperature changes, thereby affecting the size of the upper electrode. In this case, the electrode The impedance will also change, which will lead to errors in the measurement results. Therefore, the design of the test strip must also consider the possible impedance change problems caused by physical changes, which not only increases the difficulty of design, but also prevents complete physical changes. In addition, at present, the electrode contacts of the blood glucose test strip will be arranged on a specific side, and there will be directional problems in use.
由上可知，如何找出一種生物試片，可適用於血糖量測等多種生物數值感測上，特別的是，需考量承載部分可能因溫度變化而有尺寸改變，進而導致試片整體變形而令阻抗有非預期變化，最終導致量測結果受影響，此將成為本技術領域人員努力追求之目標。It can be known from the above that how to find a biological test strip can be applied to various biological numerical sensing such as blood glucose measurement. In particular, it is necessary to consider that the bearing part may have a size change due to temperature changes, which may cause the overall test strip to deform. Unexpected changes in impedance will eventually affect the measurement results, which will become the goal pursued by those skilled in the art.
鑒於上述先前技術之缺點，本發明提出一種生物試片，主要透過對稱設計，避免因承載部變形而導致阻抗變化之問題，藉此提供一種能快速安裝且可適用於多種生物偵測功能之試片。另外，針對上述生物試片，本發明亦提出一種適用本發明生物試片之生物試片讀取機，可處理和分析生物試片感測結果，生物試片讀取機針對本發明生物試片之結構，提供特殊夾具設計及防呆設計。In view of the shortcomings of the foregoing prior art, the present invention proposes a biological test strip, which mainly adopts a symmetrical design to avoid the problem of impedance change caused by deformation of the bearing portion, thereby providing a test that can be quickly installed and applicable to a variety of biological detection functions. sheet. In addition, for the above-mentioned biological test strips, the present invention also proposes a biological test strip reader adapted to the biological test strips of the present invention, which can process and analyze the sensing results of the biological test strips. Structure, providing special fixture design and foolproof design.
本發明係提出一種生物試片，係包括：一塑膠基材層、一包括量測電極和參考電極之電流導電層、一導電碳墨層、一絕緣隔離層以及一親水膜層，其中，該量測電極與該參考電極位於該塑膠基材層上且兩者係隔離且對稱設置，該導電碳墨層包括位於該量測電極上之第一碳墨層及位於該參考電極上之第二碳墨層，其中，該第一碳墨層與該第二碳墨層上分別具有血道區，且該第一碳墨層上之血道區塗佈有試藥層，該絕緣隔離層位於該導電碳墨層上且暴露出該第一碳墨層與該第二碳墨層上之血道區，該親水膜層位於該絕緣隔離層上，其中，該電流導電層、該導電碳墨層、該絕緣隔離層以該血道區為中心作左右及上下之對稱設計。The present invention provides a biological test strip, which includes: a plastic substrate layer, a current conductive layer including a measuring electrode and a reference electrode, a conductive carbon ink layer, an insulating and isolating layer, and a hydrophilic film layer. The measuring electrode and the reference electrode are located on the plastic substrate layer and the two are isolated and symmetrically arranged. The conductive carbon ink layer includes a first carbon ink layer on the measuring electrode and a second carbon ink layer on the reference electrode. A carbon ink layer, wherein the first carbon ink layer and the second carbon ink layer each have a blood channel region, and the blood channel region on the first carbon ink layer is coated with a reagent layer, and the insulating isolation layer is located on the conductive layer. The blood channel region on the carbon ink layer and the first carbon ink layer and the second carbon ink layer are exposed, and the hydrophilic film layer is located on the insulating and isolating layer, wherein the current conductive layer, the conductive carbon ink layer, the The insulation isolation layer is symmetrically designed with the left and right and up and down with the blood channel area as the center.
可選擇性地，該量測電極包括分隔的第一部件和第二部件，該第一碳墨層位於該第一部件和該第二部件之間且局部覆蓋該第一部件及該第二部件，且該參考電極包括分隔的第三部件和第四部件，該第二碳墨層位於該第三部件和該第四部件之間且局部覆蓋該第三部件及該第四部件。Optionally, the measuring electrode includes a first component and a second component separated, and the first carbon ink layer is located between the first component and the second component and partially covers the first component and the second component. The reference electrode includes a third component and a fourth component separated, and the second carbon ink layer is located between the third component and the fourth component and partially covers the third component and the fourth component.
可選擇性地，該絕緣隔離層包括未相連之第一隔離層和第二隔離層，該第一隔離層和該第二隔離層係暴露該血道區。Optionally, the insulating isolation layer includes a first isolation layer and a second isolation layer that are not connected, and the first isolation layer and the second isolation layer expose the blood channel area.
可選擇性地，該塑膠基材層其兩端分別具有一凹陷部。另外，該塑膠基材層為PET薄膜。Optionally, the plastic substrate layer has a recessed portion at each end thereof. In addition, the plastic substrate layer is a PET film.
於一實施態樣中，該第一碳墨層包括第一碳墨部和第二碳墨部，該第二碳墨層包括第三碳墨部和第四碳墨部，該血道區於血液進入時，該第一碳墨部與該第二碳墨部以及該第三碳墨部與該第四碳墨部分別電導通。In an embodiment, the first carbon ink layer includes a first carbon ink portion and a second carbon ink portion, the second carbon ink layer includes a third carbon ink portion and a fourth carbon ink portion, and the blood channel region is in the blood. When entering, the first carbon ink portion and the second carbon ink portion and the third carbon ink portion and the fourth carbon ink portion are electrically connected to each other.
於一實施態樣中，該試藥層上之試藥為酵素、類固醇酶、膽固醇酶、異氰酸酯、醣蛋白、抗體、血清製劑、酮體(keton)鑑別劑或高錳酸鉀之其中一者。In one embodiment, the reagent on the reagent layer is one of an enzyme, a steroidase, a cholesterolase, an isocyanate, a glycoprotein, an antibody, a serum preparation, a keton discriminator, or potassium permanganate. .
本發明係提出一種生物試片讀取機，具有由該生物試片讀取機延伸出之夾具結構，該夾具結構包括用以夾置對稱設計之生物試片之兩桿件，其中，各桿件包括：一桿體；一承載部，係連接至該桿體之側邊，且包括水平設置之一承載面；以及一搭接部，係連接至該桿體之側邊且位於該承載面之上，其中，該承載部與該搭接部之間的間隙提供該生物試片放置其中，藉以限位該生物試片。The present invention proposes a biological test strip reader with a clamp structure extending from the biological test strip reader. The clamp structure includes two rods for clamping a symmetrically designed biological test strip, wherein each rod The components include: a rod body; a load-bearing portion connected to the side of the rod body and including a load-bearing surface disposed horizontally; and an overlap portion connected to the side of the rod body and located on the load-bearing surface Above, the gap between the bearing portion and the overlapped portion provides the biological test piece to be placed therein, thereby limiting the biological test piece.
可選擇性地，該生物試片讀取機之夾具結構更包括一卡接部，其連接至該桿體之側邊，以於該生物試片夾置該間隙時卡合該生物試片之凹陷部。Optionally, the fixture structure of the biological test strip reader further includes a clamping portion connected to the side of the rod body to engage the biological test strip when the biological test strip is clamped in the gap. Depression.
於一實施態樣中，該搭接部為彈性元件。另外，該搭接部包括第一搭接部和第二搭接部，以分別夾置該生物試片之量測電極和參考電極。In one embodiment, the overlapping portion is an elastic element. In addition, the overlapped portion includes a first overlapped portion and a second overlapped portion to sandwich the measurement electrode and the reference electrode of the biological test piece, respectively.
相較於先前技術，本發明所提出之生物試片，透過令量測電極、參考電極以及兩個電極上之導電碳墨層採用對稱設計，如此無需考量因電極形體改變而使阻抗產生差異，進而有量測誤差問題，亦可避免在試片製作過程要預先考量因阻抗問題的電極設計方案，且在對稱設計下，試片使用上則無方向性問題，也可降低因放置方向錯誤導致無法量測的情況。另外，本發明還提出適用於此生物試片之生物試片讀取機，其夾具結構透過彈性功能之搭接部來夾置生物試片，讓生物試片可在穩固狀態下被生物試片讀取機擷取資料，此將有利於量測數據精確性以及具有量測穩定度提昇之效益。Compared with the prior art, the biological test strip proposed by the present invention adopts a symmetrical design of the conductive carbon ink layer on the measurement electrode, the reference electrode, and the two electrodes, so there is no need to consider the difference in impedance caused by the change of the electrode shape. In addition, there is a measurement error problem, which can avoid the electrode design scheme due to impedance problems in the test strip production process. Under the symmetrical design, there is no directivity problem in the use of the test strip, which can also reduce the problem caused by the wrong placement direction. Conditions that cannot be measured. In addition, the present invention also proposes a biological test strip reader suitable for the biological test strip. The fixture structure clamps the biological test strip through the overlapping part of the elastic function, so that the biological test strip can be biologically tested in a stable state. The reader captures the data, which will help the accuracy of the measurement data and the benefit of improved measurement stability.
以下內容將搭配圖式，藉由特定的具體實施例說明本發明之技術內容，熟悉此技術之人士可由本說明書所揭示之內容輕易地了解本發明之其他優點與功效。本發明亦可藉由其他不同的具體實施例加以施行或應用。本說明書中的各項細節亦可基於不同觀點與應用，在不背離本發明之精神下，進行各種修飾與變更。尤其是，於圖式中各個元件的比例關係及相對位置僅具示範性用途，並非代表本發明實施的實際狀況。The following content will be combined with drawings to illustrate the technical content of the present invention through specific embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The invention can also be implemented or applied by other different specific embodiments. Various details in this specification can also be modified and changed based on different viewpoints and applications without departing from the spirit of the invention. In particular, the proportional relationships and relative positions of the various elements in the drawings are only exemplary, and do not represent the actual status of the implementation of the present invention.
請參照圖1和圖2，係分別為本發明之生物試片的外觀視圖和結構分解圖。如圖所示，本發明之生物試片1可用於生物參數量測，舉裡來說，若應用在血糖量測上，使用者將血液滴於生物試片1上，透過血液與試藥層間的反應，進而令血液阻抗值改變，藉此達到血糖量測之目的，然血糖量測僅為本發明其中一種應用，可依據試藥層上之試藥種類而提供不同生物參數量測。本發明之生物試片1包括塑膠基材層11、包含量測電極12和參考電極13之電流導電層、導電碳墨層14、絕緣隔離層15以及親水膜層16。Please refer to FIG. 1 and FIG. 2, which are respectively an external view and an exploded view of a biological test strip of the present invention. As shown in the figure, the biological test strip 1 of the present invention can be used for biological parameter measurement. For example, if applied to blood glucose measurement, the user drops blood on the biological test strip 1 and passes between the blood and the reagent layer. The response of the blood pressure changes the blood impedance value, thereby achieving the purpose of blood glucose measurement. However, the blood glucose measurement is only one application of the present invention, and different biological parameter measurements can be provided according to the type of the reagent on the reagent layer. The biological test strip 1 of the present invention includes a plastic substrate layer 11, a current conductive layer including a measurement electrode 12 and a reference electrode 13, a conductive carbon ink layer 14, an insulating isolation layer 15, and a hydrophilic film layer 16.
生物試片1是以塑膠基材層11為其他元件之承載體，亦即，上述各元件皆設置於塑膠基材層11上，其中，塑膠基材層11可為PET薄膜。The biological test strip 1 uses the plastic substrate layer 11 as a carrier for other components, that is, each of the above components is disposed on the plastic substrate layer 11, wherein the plastic substrate layer 11 may be a PET film.
量測電極12和參考電極13都位於塑膠基材層11上，其中，參考電極13與量測電極12為隔離不相接觸，且參考電極13與量測電極12為對稱設置。為了避免塑膠基材層11因溫度改變而有變形之問題，本發明之量測電極12和參考電極13採用對稱設計，其好處為縱使塑膠基材層11發生膨脹，基於電極為對稱設計，故會等比例膨脹，亦即，對稱的兩個電極也是等比例膨脹，如此，設計時將無需考量電極形體改變所導致之阻抗問題。於一實施例中，有關量測電極12和參考電極13之電阻量測，可採用惠斯登電橋(Wheatstone bridge)理論來達成。The measurement electrode 12 and the reference electrode 13 are both located on the plastic substrate layer 11, wherein the reference electrode 13 and the measurement electrode 12 are separated and not in contact with each other, and the reference electrode 13 and the measurement electrode 12 are symmetrically disposed. In order to avoid the deformation problem of the plastic substrate layer 11 due to temperature changes, the measuring electrode 12 and the reference electrode 13 of the present invention adopt a symmetrical design. The advantage is that even if the plastic substrate layer 11 expands, the electrode is symmetrically designed. It will expand in equal proportion, that is, symmetrical two electrodes will expand in equal proportion. In this way, it is not necessary to consider the impedance problem caused by the electrode shape change during design. In one embodiment, the resistance measurement of the measurement electrode 12 and the reference electrode 13 can be achieved by using the Wheatstone bridge theory.
導電碳墨層14包括位於量測電極12上之第一碳墨層141及於位於參考電極13上之第二碳墨層142，其中，第一碳墨層141與第二碳墨層142上分別設有血道區143，且第一碳墨層141上之血道區143上塗佈有試藥層2。具體來說，試藥層2可能對金屬材質之電極有腐蝕影響，故上面設置可導電之導電碳墨層14，不僅可降低試藥層2會對金屬材質之電極的影響，且試藥層2也不受導電碳墨層14影響。The conductive carbon ink layer 14 includes a first carbon ink layer 141 on the measurement electrode 12 and a second carbon ink layer 142 on the reference electrode 13, wherein the first carbon ink layer 141 and the second carbon ink layer 142 are Blood channel regions 143 are respectively provided, and a blood test region 2 on the first carbon ink layer 141 is coated with a reagent layer 2. Specifically, the reagent layer 2 may have a corrosive effect on the electrode of the metal material, so the conductive carbon ink layer 14 provided on the conductive layer can not only reduce the effect of the reagent layer 2 on the electrode of the metal material, but also the reagent layer 2 is not affected by the conductive carbon ink layer 14 either.
具體來說，為避免試藥(例如酵素)接觸到金屬電極造成腐蝕現象，因而製造過程中，在導電碳墨層14之印刷手指部分，其CD方向(横向排列)靠血道區部分需完全覆蓋到金屬電極(量測電極12、參考電極13)，接著，絕緣隔離層15其CD方向也覆蓋導電碳墨層14之印刷手指底部邊緣部分，故可形成雙重封裝方可阻止酵素的腐蝕。Specifically, in order to avoid the corrosion phenomenon caused by the contact of the reagent (such as enzyme) with the metal electrode, during the manufacturing process, the printed finger portion of the conductive carbon ink layer 14 needs to be completely covered by the bloodstream region in the CD direction (horizontal arrangement). To the metal electrode (measurement electrode 12, reference electrode 13), and then, the CD direction of the insulating isolation layer 15 also covers the bottom edge portion of the printed finger of the conductive carbon ink layer 14, so a double package can be formed to prevent enzyme corrosion.
第一碳墨層141可包括第一碳墨部和第二碳墨部，第二碳墨層142包括第三碳墨部和第四碳墨部，可參酌圖5B，第一碳墨部和第二碳墨部組合後兩者間會有溝槽，血液可進入該溝槽，同理，第三碳墨部和第四碳墨部組合後兩者間會有溝槽，血液可進入該溝槽，當血道區143有血液進入時，第一碳墨部與第二碳墨部會電導通，第三碳墨部與第四碳墨部也會電導通。The first carbon ink layer 141 may include a first carbon ink portion and a second carbon ink portion, and the second carbon ink layer 142 includes a third carbon ink portion and a fourth carbon ink portion. See FIG. 5B, the first carbon ink portion and After the second carbon ink part is combined, there will be a groove between the two, and blood can enter the groove. Similarly, after the third carbon ink part and the fourth carbon ink part are combined, there will be a groove between the two, and blood can enter the In the groove, when blood enters the blood channel region 143, the first carbon ink portion and the second carbon ink portion are electrically connected, and the third carbon ink portion and the fourth carbon ink portion are also electrically connected.
於一實施例中，量測電極12可包括分隔的第一部件121和第二部件122，第一碳墨層141位於第一部件121和第二部件122之間且局部覆蓋第一部件121及第二部件122，也就是說，第一部件121和第二部件122透過第一碳墨層141達到兩端連接的效果。另外，參考電極13可包括分隔的第三部件131和第四部件132，第二碳墨層142位於第三部件131和第四部件132之間且局部覆蓋第三部件131及第四部件132，亦即第三部件131和第四部件132透過第二碳墨層142達到兩端連接的效果。In an embodiment, the measurement electrode 12 may include a first member 121 and a second member 122 that are separated. The first carbon ink layer 141 is located between the first member 121 and the second member 122 and partially covers the first member 121 and The second member 122, that is, the first member 121 and the second member 122 are connected to each other through the first carbon ink layer 141. In addition, the reference electrode 13 may include a separated third member 131 and a fourth member 132, and the second carbon ink layer 142 is located between the third member 131 and the fourth member 132 and partially covers the third member 131 and the fourth member 132. That is, the third component 131 and the fourth component 132 are connected to each other through the second carbon ink layer 142.
由上可知，第一碳墨層141和第二碳墨層142上分別具有血道區143，血液是液體且可導電，當血液滴至血道區143時，透過第一碳墨層141兩端以及第二碳墨層142兩端的分別搭接，可使得量測電極12之第一部件121和第二部件122兩端導通以及第三部件131和第四部件132兩端導通，而第一碳墨層141上之血道區143上塗佈有試藥層2，當試藥層2與血液產生反應後，會使量測電極12上流經的電流，其阻抗值有所改變，依據兩個電極的阻抗值以得到生物量測結果。It can be known from the above that the first carbon ink layer 141 and the second carbon ink layer 142 have blood channel regions 143, respectively. Blood is liquid and can conduct electricity. When blood drops to the blood channel region 143, it passes through both ends of the first carbon ink layer 141 and The two ends of the second carbon ink layer 142 are overlapped, so that both ends of the first member 121 and the second member 122 of the measurement electrode 12 are conductive and both ends of the third member 131 and the fourth member 132 are conductive. A reagent layer 2 is coated on the blood channel region 143 on the layer 141. When the reagent layer 2 reacts with the blood, the resistance value of the current flowing on the measurement electrode 12 changes. Impedance value to get biomass measurement results.
試藥層2上之試藥可為酵素(葡萄氧化酶、葡萄去氫酶判別糖尿病)、類固醇酶、膽固醇酶、異氰酸酯、醣蛋白、抗體、血清製劑、酮體(keton)鑑別劑或高錳酸鉀之任何一者，不同試藥可輔助病症的判別。The reagent on reagent layer 2 can be enzymes (grape oxidase, grape dehydrogenase to identify diabetes), steroidase, cholesterolase, isocyanate, glycoprotein, antibody, serum preparation, keton discriminator or high manganese For any one of potassium acid, different test drugs can help identify the disease.
絕緣隔離層15位於導電碳墨層14上且暴露出第一碳墨層141與第二碳墨層142上之血道區143，最後，親水膜層16則位於並覆蓋絕緣隔離層15上。於一實施例中，絕緣隔離層15可包括未相連之第一隔離層151和第二隔離層152，該第一隔離層151和該第二隔離層152可暴露出血道區143。The insulating isolation layer 15 is located on the conductive carbon ink layer 14 and exposes the blood channel region 143 on the first carbon ink layer 141 and the second carbon ink layer 142. Finally, the hydrophilic film layer 16 is located on and covers the insulating isolation layer 15. In an embodiment, the insulating isolation layer 15 may include a first isolation layer 151 and a second isolation layer 152 that are not connected, and the first isolation layer 151 and the second isolation layer 152 may expose the bleeding channel region 143.
具體來說，絕緣隔離層15覆蓋部分導電碳墨層14，以使血液僅能進入特定範圍，即血道區143，如此可避免血液影響到電極，絕緣隔離層15覆蓋部分導電碳墨層14時會露出血道區143，而親水膜層16可供血液滴於其上，因此，血液會滲透到下面導電碳墨層14上的血道區143，據此，血道區143於血液進入時，將使第一碳墨層141其血道區143之兩端以及第二碳墨層142其血道區143之兩端分別電導通。Specifically, the insulating isolation layer 15 covers a portion of the conductive carbon ink layer 14 so that blood can only enter a specific range, that is, the blood channel region 143, so that the blood does not affect the electrodes. When the insulating isolation layer 15 covers a portion of the conductive carbon ink layer 14 The blood channel area 143 will be exposed, and the hydrophilic membrane layer 16 can be used for blood dripping thereon. Therefore, the blood will penetrate the blood channel area 143 on the conductive carbon ink layer 14 below. According to this, when the blood enters, the blood channel area 143 will cause Both ends of the blood channel region 143 of the first carbon ink layer 141 and both ends of the blood channel region 143 of the second carbon ink layer 142 are electrically conducted.
由上可知，透過塑膠基材層11、包含量測電極12和參考電極13之電流導電層、導電碳墨層14、絕緣隔離層15及親水膜層16組成本發明之生物試片1，其中，量測電極12、參考電極13以及兩者其上的第一碳墨層141和第二碳墨層142採取對稱設計，有助於避免因塑膠基材層11變形所導致之阻抗偏差問題。具體來說，電流導電層(量測電極12、參考電極13)、導電碳墨層14、絕緣隔離層15以血道區143為中心作左右及上下之對稱設計，因而導電四點對整個試片中心距離或是血道區143中心距離幾乎是一樣的，總而言之，電流導電層(例如金屬箔)、碳墨導電層14每一層被區分為四區塊，四區塊即以血道區143為中心兩兩相對。It can be known from the above that the biological test strip 1 of the present invention is composed of the plastic substrate layer 11, the current conductive layer including the measuring electrode 12 and the reference electrode 13, the conductive carbon ink layer 14, the insulating and isolating layer 15 and the hydrophilic film layer 16, wherein The measurement electrode 12, the reference electrode 13, and the first carbon ink layer 141 and the second carbon ink layer 142 thereon are symmetrically designed to help avoid the problem of impedance deviation caused by the deformation of the plastic substrate layer 11. Specifically, the current conductive layer (measurement electrode 12, reference electrode 13), conductive carbon ink layer 14, and insulating isolation layer 15 are symmetrically designed on the left and right and up and down with the blood channel area 143 as the center. The center distance or the center distance of the blood channel area 143 is almost the same. In short, each layer of the current conductive layer (such as metal foil) and the carbon ink conductive layer 14 is divided into four blocks, and the four blocks are centered on the blood channel region 143. Two opposites.
前述對稱設計係指以惠斯登電橋為原理，生物試片1以血道區143中心，經貼合、刮除、印刷(或轉印)、滴入及堆疊等程序而製成，以期望能以誤差最小的距離，較精準的電流，得到最精準的量測數據。The aforementioned symmetrical design refers to the principle of Wheatstone bridge. The biological test strip 1 is made by applying, scraping, printing (or transferring), dripping and stacking in the center of the blood channel area 143. Can get the most accurate measurement data with the distance with the smallest error and more accurate current.
請參照圖3A和3B，係分別為本發明之生物試片使用前的外觀視圖和上視圖。如圖3A和3B所示， 其為將生物試片1之塑膠基材層11、包含量測電極12和參考電極13之電流導電層、導電碳墨層14和絕緣隔離層15疊合，而未包含圖2之親水膜層16，之後，將針對血液滴於生物試片1前後做進一步說明。另外，於圖3B中，塑膠基材層11兩端可包括凹陷部111，此為將生物試片1放置於例如血糖測試機之生物試片讀取機時用於對準之設計，其應用後續將有更詳細說明。Please refer to FIGS. 3A and 3B, which are respectively an external view and a top view of the biological test strip before use. As shown in FIG. 3A and FIG. 3B, it is a superposition of the plastic substrate layer 11 of the biological test strip 1, the current conductive layer including the measuring electrode 12 and the reference electrode 13, the conductive carbon ink layer 14 and the insulating isolation layer 15, and The hydrophilic membrane layer 16 of FIG. 2 is not included, and the blood dripping on the biological test strip 1 before and after will be further explained. In addition, in FIG. 3B, both ends of the plastic substrate layer 11 may include recessed portions 111. This is a design for alignment when the biological test strip 1 is placed in a biological test strip reader such as a blood glucose tester, and its application This will be explained in more detail later.
由圖3A和3B可知，為生物試片未滴入血液之狀態，其中，絕緣隔離層15之第一隔離層151和第二隔離層152之間所暴露出的區塊即為血道區143，且於量測電極12部分之血道區143上塗佈有試藥層2(於圖中以點狀表示)，因而在圖3A和3B中，當血液未滴至生物試片1 前，可看到量測電極12上的血道區143有試藥層，而參考電極13上的血道區143則無任何東西。It can be known from FIGS. 3A and 3B that the biological test strip is not dripped with blood. The block exposed between the first isolation layer 151 and the second isolation layer 152 of the insulating isolation layer 15 is the blood channel region 143. And the reagent layer 2 (shown as a dot in the figure) is coated on the blood channel area 143 of the measuring electrode 12 portion, so in Figs. 3A and 3B, when the blood does not drip onto the biological test strip 1, it can be seen The blood channel area 143 on the measurement electrode 12 has a reagent layer, and the blood channel area 143 on the reference electrode 13 has nothing.
請參照圖4A和4B，係分別為本發明之生物試片滴入血液的外觀視圖和上視圖。圖4A和4B為圖3A和3B滴入血液後的示意圖，如圖所示，相關構件與圖2、圖3A和3B所述相同，故不在贅述，於滴入血液3(於圖中以斜線表示)後，可發現血液3是散佈於量測電極12之血道區143以及參考電極13之血道區143上，而血液3會使量測電極12之第一部件121和第二部件122以及參考電極13之第三部件131和第四部件132分別導通。Please refer to FIGS. 4A and 4B, which are respectively an external view and a top view of a biological test strip dripping blood into the present invention. Figures 4A and 4B are schematic diagrams after dripping blood in Figures 3A and 3B. As shown in the figure, the relevant components are the same as those described in Figures 2, 3A and 3B, so they will not be described in detail. (Shown), it can be found that blood 3 is scattered on the blood channel region 143 of the measurement electrode 12 and the blood electrode region 143 of the reference electrode 13, and the blood 3 causes the first part 121 and the second part 122 of the measurement electrode 12 and the reference The third member 131 and the fourth member 132 of the electrode 13 are respectively turned on.
另外，基於量測電極12上鋪佈有試藥層2，兩者會產生化學反應， 故此處阻抗值會改變，因而基於量測電極12和參考電極13兩者之阻抗差異，可據此推算生物參數，例如血糖數值。In addition, since the reagent layer 2 is spread on the measuring electrode 12, the two will produce a chemical reaction, so the impedance value will change here. Based on the difference in impedance between the measuring electrode 12 and the reference electrode 13, it can be calculated based on this Biological parameters, such as blood glucose levels.
請參照圖5A和5B，係分別為本發明之生物試片之血道區與試藥層塗佈的示意圖。如圖所示，親水膜層16會覆蓋於絕緣隔離層15之第一隔離層151和第二隔離層152上，第一隔離層151和第二隔離層152僅暴露出量測電極12和參考電極13上的血道區，血液也會經親水膜層16滲透至血道區處。另外，圖5B為圖5A中G處的局部放大圖，由圖5可知，血道區143包含一微細溝槽，即第一碳墨部和第二碳墨部兩端結合處以及第三碳墨部和第四碳墨部兩端結合處，當血液滲入後填滿該些微細溝槽，則可令量測電極12兩端以及參考電極13兩端產生電導通，另外，試藥層2則塗佈於量測電極12其血道區143處，可以是表面或是內層。Please refer to FIG. 5A and FIG. 5B, which are schematic diagrams of the blood channel area and the reagent layer coating of the biological test strip of the present invention, respectively. As shown in the figure, the hydrophilic film layer 16 covers the first isolation layer 151 and the second isolation layer 152 of the insulating isolation layer 15, and the first isolation layer 151 and the second isolation layer 152 only expose the measuring electrode 12 and the reference In the blood channel area on the electrode 13, blood will also penetrate the blood channel area through the hydrophilic membrane layer 16. In addition, FIG. 5B is a partial enlarged view at G in FIG. 5A. It can be seen from FIG. 5 that the blood channel region 143 includes a fine groove, that is, the junction of the two ends of the first carbon ink portion and the second carbon ink portion, and the third carbon ink. The junction of the two ends of the carbon black part and the fourth carbon ink part. When blood penetrates and fills these fine grooves, the two ends of the measuring electrode 12 and the reference electrode 13 can be electrically connected. In addition, the reagent layer 2 is The blood electrode region 143 coated on the measuring electrode 12 may be a surface or an inner layer.
另外，基於生物試片為經貼合、印刷等堆疊方式施作製作，因此有極高的辨識度，例如可設計正面有凸起效果，此面朝上，而背面為光滑平面，如此不論在低光源下或盲人都可經觸摸而得知正確使用方向。In addition, the biological test strips are made by stacking, printing and other stacking methods, so they have a high degree of recognition. For example, the front side can be designed with a convex effect, this side is facing up, and the back side is a smooth flat surface. Under low light or blind people, you can know the correct use direction by touching.
請參照圖6，係本發明之生物試片讀取機之夾具結構與生物試片的使用示意圖。如圖所示，夾具結構係指由生物試片讀取機延伸出之兩桿件4，用於夾置為對稱設計之生物試片1，其中，每一個桿件4可包括桿體41、承載部42及搭接部43。本發明的生物試片讀取機可用於讀取例如血糖試紙的生物試片，但不以此為限，本發明的生物試片讀取機可用於各式生物試片的資料擷取。Please refer to FIG. 6, which is a schematic diagram of the fixture structure of the biological test strip reader and the use of the biological test strip of the present invention. As shown in the figure, the fixture structure refers to two rods 4 extending from the biological test strip reader for clamping the biological test strip 1 having a symmetrical design. Each of the rods 4 may include a rod body 41, Bearing portion 42 and the overlapping portion 43. The biological test strip reader of the present invention can be used to read biological test strips such as blood glucose test strips, but is not limited thereto. The biological test strip reader of the present invention can be used for data retrieval of various biological test strips.
承載部42連接至桿體41之側邊，且承載部42包括水平設置之承載面421，搭接部43也連接至桿體41之側邊，而搭接部43位於承載面421之上，據此，承載部42與搭接部43之間的間隙可提供生物試片1放置其中，亦即透過夾置方式使生物試片1緊固於兩者之間。The bearing portion 42 is connected to the side of the rod body 41, and the bearing portion 42 includes a horizontally disposed bearing surface 421. The overlap portion 43 is also connected to the side of the rod body 41. According to this, the gap between the bearing portion 42 and the overlap portion 43 can be provided for the biological test strip 1 to be placed therein, that is, the biological test strip 1 is fastened between the two by a sandwiching method.
於一實施例中，搭接部43為彈性元件，且搭接部43可包括第一搭接部431和第二搭接部432，以分別夾置生物試片1之量測電極12和參考電極13。具體來說，兩個桿件可夾置一個生物試片1，各桿件之搭接部43可分別包括第一搭接部431和第二搭接部432，據此，兩個桿件之第一搭接部431可夾置量測電極12，亦即，夾置量測電極12之第一部件121和第二部件122，同理，兩個桿件之第二搭接部432可夾置參考電極13，也就是說，夾置參考電極13之第三部件131和第四部件132。夾具結構整體亦為對稱設計，材質可為塑膠彈性材質，因而夾具結構兩端施力大小幾乎一致。In an embodiment, the overlap portion 43 is an elastic element, and the overlap portion 43 may include a first overlap portion 431 and a second overlap portion 432 to sandwich the measurement electrode 12 and the reference of the biological test strip 1 respectively. Electrode 13. Specifically, one biological test piece 1 can be sandwiched between two members, and the overlapping portion 43 of each member can include a first overlapping portion 431 and a second overlapping portion 432, respectively. The first overlapping portion 431 can sandwich the measuring electrode 12, that is, the first member 121 and the second member 122 of the measuring electrode 12 can be sandwiched. Similarly, the second overlapping portion 432 of the two rods can be sandwiched. The reference electrode 13 is placed, that is, the third member 131 and the fourth member 132 of the reference electrode 13 are sandwiched. The overall structure of the fixture structure is also symmetrical, and the material can be plastic elastic material, so the force applied at both ends of the fixture structure is almost the same.
於另一實施例中，前述夾具結構之桿件4更包括一卡接部44，其連接至桿體41之側邊，以於生物試片1夾置承載部42與搭接部43之間的間隙時，卡合生物試片1之凹陷部111，而凹陷部111與卡接部44之卡合，可避免生物試片1水平位移。In another embodiment, the rod member 4 of the aforementioned clamp structure further includes a latching portion 44 connected to the side of the rod body 41 to sandwich the carrier portion 42 and the overlap portion 43 between the biological test strip 1. During the gap, the recessed portion 111 of the biological test strip 1 is engaged, and the engagement of the recessed portion 111 and the engaging portion 44 prevents the biological test strip 1 from being displaced horizontally.
請參照圖7，係本發明之生物試片讀取機之夾具結構夾置生物試片的示意圖。如圖所示，生物試片1夾置承載部42之承載面421與搭接部43之間，透過第一搭接部431和第二搭接部432來固定生物試片1，卡接部44可將生物試片1卡合以避免位移，此時生物試片1即可被固定並供生物試片讀取機進行資料擷取。Please refer to FIG. 7, which is a schematic diagram of a biological test strip clamped by the fixture structure of the biological test strip reader of the present invention. As shown in the figure, the biological test strip 1 is sandwiched between the bearing surface 421 of the bearing portion 42 and the overlap portion 43, and the biological test strip 1 and the clip portion are fixed through the first overlap portion 431 and the second overlap portion 432. 44 The biological test strip 1 can be locked to avoid displacement. At this time, the biological test strip 1 can be fixed and used for data acquisition by the biological test strip reader.
請參照圖8，係本發明之生物試片讀取機之夾具結構夾置生物試片的俯視圖。如圖所示，兩個桿件4可夾置生物試片1，其中，第一搭接部431夾置量測電極12之第一部件121和第二部件122，第二搭接部432夾置參考電極13之第三部件131和第四部件132，量測電極12與參考電極13為對稱設計且隔離，且透過卡接部44卡合生物試片1之凹陷部111(如圖6所示)，將可更穩固生物試片1。Please refer to FIG. 8, which is a top view of a biological test strip clamped by the fixture structure of the biological test strip reader of the present invention. As shown in the figure, the two rod members 4 can sandwich the biological test strip 1, wherein the first overlap portion 431 sandwiches the first member 121 and the second member 122 of the measurement electrode 12, and the second overlap portion 432 clamps The third part 131 and the fourth part 132 of the reference electrode 13 are set, the measurement electrode 12 and the reference electrode 13 are symmetrically designed and isolated, and the recessed portion 111 of the biological test strip 1 is engaged through the clamping portion 44 (as shown in FIG. 6). (Shown), will make the biological test strip 1 more stable.
另外，圖9為本發明圖8所示生物試片讀取機之夾具結構其中A-A剖面線的剖面圖。如圖所示，生物試片1可透過第一搭接部431與承載部42之承載面421夾置固定，由於第一搭接部431為彈性元件，透過令第一搭接部431朝遠離承載面421方向拉扯，以騰出空隙供生物試片1置入，並且於生物試片1置入後，在無拉扯下，第一搭接部431基於彈性朝承載面421復原而產生壓制效果。In addition, FIG. 9 is a cross-sectional view taken along the line A-A of the fixture structure of the biological test strip reader shown in FIG. 8 of the present invention. As shown in the figure, the biological test strip 1 can be clamped and fixed through the first overlapping portion 431 and the bearing surface 421 of the bearing portion 42. Since the first overlapping portion 431 is an elastic element, the first overlapping portion 431 is directed away from The bearing surface 421 is pulled in the direction to make a gap for the biological test piece 1 to be inserted. After the biological test piece 1 is inserted, without pulling, the first overlapping portion 431 is restored toward the bearing surface 421 based on the elasticity to produce a pressing effect. .
綜上所述，本發明之生物試片，藉由使量測電極、參考電極以及兩個電極上之導電碳墨層對稱設計，故無需考量因電極形體改變所導致之阻抗差異問題，另外，本發明還提出適用於此生物試片之生物試片讀取機的夾具結構，透過彈性功能之搭接部來夾置生物試片，可令生物試片可在穩固狀態下被生物試片讀取機擷取資料，此將有利於量測數據精確性以及具有量測穩定度提昇之效益。In summary, the biological test strip of the present invention has a symmetrical design of the conductive carbon ink layer on the measurement electrode, the reference electrode, and the two electrodes, so there is no need to consider the impedance difference caused by the electrode shape change. In addition, The invention also proposes a fixture structure of a biological test strip reader suitable for the biological test strip. The elastic test function is used to sandwich the biological test strip, so that the biological test strip can be read by the biological test strip in a stable state. Take the machine to retrieve the data, which will help the accuracy of the measurement data and the benefit of improved measurement stability.
上述實施例僅例示性說明本發明之原理及功效，而非用於限制本發明。任何熟習此項技術之人士均可在不違背本發明之精神及範疇下，對上述實施例進行修飾與改變。因此，本發明之權利保護範圍，應如本發明的申請專利範圍所列。The above-mentioned embodiments only exemplify the principles and effects of the present invention, and are not intended to limit the present invention. Anyone skilled in the art can modify and change the above embodiments without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the rights of the present invention should be as listed in the patent application scope of the present invention.
1‧‧‧生物試片1‧‧‧ biological test strip
11‧‧‧塑膠基材層11‧‧‧Plastic substrate layer
111‧‧‧凹陷部111‧‧‧ Depression
12‧‧‧量測電極12‧‧‧ measuring electrode
121‧‧‧第一部件121‧‧‧ the first part
122‧‧‧第二部件122‧‧‧Second Part
13‧‧‧參考電極13‧‧‧Reference electrode
131‧‧‧第三部件131‧‧‧Third component
132‧‧‧第四部件132‧‧‧Fourth Part
14‧‧‧導電碳墨層14‧‧‧ conductive carbon ink layer
141‧‧‧第一碳墨層141‧‧‧The first carbon ink layer
142‧‧‧第二碳墨層142‧‧‧Second carbon ink layer
143‧‧‧血道區143‧‧‧Blood channel area
15‧‧‧絕緣隔離層15‧‧‧Insulation
151‧‧‧第一隔離層151‧‧‧The first isolation layer
152‧‧‧第二隔離層152‧‧‧Second isolation layer
16‧‧‧親水膜層16‧‧‧ hydrophilic film
2‧‧‧試藥層2‧‧‧ reagent layer
3‧‧‧血液3‧‧‧ blood
4‧‧‧桿件4‧‧‧ lever
41‧‧‧桿體41‧‧‧ shaft
42‧‧‧承載部42‧‧‧bearing department
421‧‧‧承載面421‧‧‧bearing surface
43‧‧‧搭接部43‧‧‧ Overlap
431‧‧‧第一搭接部431‧‧‧First overlap
432‧‧‧第二搭接部432‧‧‧Second Lap Section
44‧‧‧卡接部44‧‧‧Card Connection Department
圖1，係本發明之生物試片的外觀視圖。FIG. 1 is an external view of a biological test strip of the present invention.
圖2，係本發明之生物試片的結構分解圖。FIG. 2 is a structural exploded view of a biological test strip of the present invention.
圖3A和3B，係本發明之生物試片使用前的外觀視圖和上視圖。3A and 3B are an external view and a top view of the biological test strip of the present invention before use.
圖4A和4B，係本發明之生物試片滴入血液的外觀視圖和上視圖。4A and 4B are an external view and a top view of a biological test strip dripped into blood according to the present invention.
圖5A和5B，係本發明之生物試片之血道區與試藥層塗佈的示意圖。5A and 5B are schematic diagrams of coating of a blood channel region and a reagent layer of a biological test strip of the present invention.
圖6，係本發明之生物試片讀取機之夾具結構與生物試片的使用示意圖。FIG. 6 is a schematic diagram of a fixture structure of the biological test strip reading machine and the use of the biological test strip of the present invention.
圖7，係本發明之生物試片讀取機之夾具結構夾置生物試片的示意圖。FIG. 7 is a schematic diagram of a biological test strip clamped by a fixture structure of the biological test strip reader of the present invention.
圖8，係本發明之生物試片讀取機之夾具結構夾置生物試片的俯視圖。FIG. 8 is a top view of a biological test strip clamped by the fixture structure of the biological test strip reader of the present invention.
圖9，係本發明圖8所示生物試片讀取機之夾具結構其中A-A剖面線的剖面圖。FIG. 9 is a cross-sectional view taken along the line A-A of the fixture structure of the biological test strip reader shown in FIG. 8 according to the present invention.
Claims (12)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ??107103905 | 2018-02-02 | ||
| TW107103905 | 2018-02-02 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| TW201934992A true TW201934992A (en) | 2019-09-01 |
Family
ID=63961918
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW107203106U TWM565301U (en) | 2018-02-02 | 2018-03-09 | A biological test strip and a biological test strip reader for the biological test strip |
| TW107108131A TW201934992A (en) | 2018-02-02 | 2018-03-09 | A biological test strip and a biological test strip reader for the biological test strip |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW107203106U TWM565301U (en) | 2018-02-02 | 2018-03-09 | A biological test strip and a biological test strip reader for the biological test strip |
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| Country | Link |
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| TW (2) | TWM565301U (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113109577A (en) * | 2021-04-01 | 2021-07-13 | 广州南雪医疗器械有限公司 | Test paper for detecting total cholesterol |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112312692B (en) * | 2019-08-02 | 2022-06-21 | 华广生技股份有限公司 | Physiological signal sensing device |
| US11896804B2 (en) | 2019-08-02 | 2024-02-13 | Bionime Corporation | Insertion device for a biosensor and insertion method thereof |
-
2018
- 2018-03-09 TW TW107203106U patent/TWM565301U/en not_active IP Right Cessation
- 2018-03-09 TW TW107108131A patent/TW201934992A/en unknown
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113109577A (en) * | 2021-04-01 | 2021-07-13 | 广州南雪医疗器械有限公司 | Test paper for detecting total cholesterol |
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| Publication number | Publication date |
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| TWM565301U (en) | 2018-08-11 |
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