Patent Publication Number: US-2015072404-A1

Title: Examining test paper

Description:
The current application claims a foreign priority to the patent application of Taiwan No. 102217160 filed on Sep. 12, 2013. 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to a test paper, especially to a test paper used for sampling blood and examining blood glucose concentration. 
     2. Description of the Prior Art 
     A blood glucose meter sold on markets is used for examining the blood glucose concentration in human blood. An examining test of the blood glucose concentration requires a drop of blood of the individual to be examined on a specific site of a test paper, as an input to a blood glucose meter which reads and indicate the blood glucose concentration of the individual. The test paper comprises an electrode layer and a reaction area. The reaction area is defined on a surface of the test paper. A front of the electrode layer is located in the reaction area, whereas an end of the electrode layer is to be connected to the blood glucose meter. The reaction area of the test paper comprises a superficial enzyme layer. The enzyme layer comprises at least one enzyme that reacts with the blood sample to generate signals which the blood glucose meter detects through the electrode layer. 
     A conventional test paper is of a single-layer structure and capable of performing merely one single test. A duplication of tests for increasing accuracy or an extra test of different categories for broader knowledge of the individual demands an additional test paper, as well as an additional drop of blood sample, and thus is significantly inconvenient to perform. 
     To overcome the shortcomings, the present invention provides a test paper comprising a double-layer structure to enhance examining accuracy or to simultaneously perform two different kinds of biochemical examination. 
     SUMMARY OF THE INVENTION 
     The examining test paper in accordance with the present invention comprises an upper substrate, a lower substrate, an upper insulation sheet, a lower insulation sheet and a separator. Each of the upper and lower substrates comprises surface, a notch, a connection area, a reaction area, and an electrode layer. The notch is recessed on a proximal end. The connection area is adjacent to the notch. The reaction area and the electrode layer are defined on the surface. The upper and lower insulation sheets are respectively connected to the upper and lower substrates, and each comprises an upper surface, a lower surface, and a permeation portion. The separator is connected to the upper and lower insulation sheets and comprises two permeation portions corresponding to the permeation portions of the upper and lower insulation sheets, respectively. 
     The present invention at least provides the following improvements. Setting the electrode layer and the reaction area on the upper and lower substrate, and further setting an enzyme layer on the reaction areas help to examine blood glucose. Structures of the notches recessed on the upper and lower substrates are helpful for combination of the upper and lower substrate and corresponding to a circumscribed convert connector. Connecting the upper and lower insulation sheets respectively to the surfaces of the upper and lower substrates, helps to avoid examining errors caused by contact of the electrode layers of the upper and lower substrates. Using a separator connected to the upper insulation sheet and the lower insulation sheet allows the examining test paper to perform multiple examinations simultaneously. Two examining results can be obtained with one single drop of blood on the examining test paper once, and users can confirm the accuracy of blood glucose examination from the two examining results. 
     Furthermore, a GOD/GDH enzyme layer is applied to the reaction area of the upper substrate and an impedance membrane is formed on the reaction area of the lower substrate to enhance the accuracy of blood glucose examination. 
     Furthermore, the GOD/GDH enzyme layer and another enzyme layer are applied to the reaction areas of the upper substrate and the lower substrate, respectively, to examine different blood compositions. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a three-dimensional view of the decomposed components in accordance with the present invention. 
         FIG. 2  is an allocated figure in accordance with the present invention. 
         FIG. 3  is a usage stage figure in accordance with the present invention. 
         FIG. 4  is a decomposition chart of the second embodiment in accordance with the present invention. 
         FIG. 5  is a decomposition chart of the third embodiment in accordance with the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     With reference to  FIG. 1 , in the first embodiment, an examining test paper in accordance with the present invention comprises an upper substrate  10 , a lower substrate  20 , an upper insulation sheet  30 , a lower insulation sheet  40  and a separator  50 . 
     With reference to  FIGS. 1 to 3 , the upper substrate  10  is a thin film and comprises a surface, a proximal end, a distal end, a notch  12 , a connection area  101 , a reaction area  11 , and an electrode layer  13 . The distal end is opposite to the proximal end. The notch  12  is recessed on the proximal end of the upper substrate  10 . The connection area  101  is formed on the upper substrate  10  adjacent to the notch  12 . The reaction area  11  is defined on the surface near the distal end of the upper substrate  10  and comprises a hydrophilic layer. The electrode layer  13  is defined on the surface of the upper substrate  10 , and comprises a transmitting electrode  131  and a reference electrode  132 . The transmitting electrode  131  which is a transmitting end and arranged in accordance with a shape of the upper substrate  10  comprises a distal portion overlapped with the reaction area  11  of the upper substrate  10 , and a proximal portion located at the connection area  101  of the upper substrate  10 . The reference electrode  132  which is a grounding terminal and arranged separately from the transmitting electrode  131  in accordance with a shape of the upper substrate  10  comprises a distal portion overlapped with the reaction area  11  of the upper substrate  10 , and a proximal portion located at the connection area  101  of the upper substrate  10 . The lower substrate  20  is a thin film and comprises a surface, a proximal end, a distal end, a notch  22 , a connection area  201 , a reaction area  21 , and an electrode layer  23 . The distal end is opposite to the proximal end. The notch  22  is recessed on the proximal end of the lower substrate  20 . The connection area  201  is formed on the lower substrate  20  adjacent to the notch  22 . The reaction area  21  is defined on the surface near the distal end of the lower substrate  20  and comprises a hydrophilic layer. The electrode layer  23  is defined on the surface of the lower substrate  20 , and comprises a transmitting electrode  231  and a reference electrode  232 . The transmitting electrode  231  which is a transmitting end and arranged in accordance with a shape of the lower substrate  20  comprises a distal portion overlapped with the reaction area  21  of the lower substrate  20 , and a proximal portion located at the connection area  201  of the lower substrate  20 . The reference electrode  232  which is a grounding terminal and arranged separately from the transmitting electrode  231  in accordance with a shape of the lower substrate  20  comprises a distal portion overlapped with the reaction area  21  of the lower substrate  20 , and a proximal portion located at the connection area  201  of the lower substrate  20 . 
     The notch  12  recessed from the upper substrate  10  is corresponding to the connection area  201  of the lower substrate  20 , and allows the connection area  201  to be positioned on the notch  12 . The notch  22  recessed from the lower substrate  20  is corresponding to the connection area  101  of the upper substrate  10 , and allows the connection area  101  to be positioned on the notch  22 . The connection area  101  of the upper substrate  10  and the connection area  201  of the lower substrate  20  are positioned side by side. 
     The upper insulation sheet  30  connected to the surface of the upper substrate  10 , but excluded from the connection area  101  comprises an upper surface, a lower surface, and a permeation portion  31 . The permeation portion  31  is exposed on the upper surface of the upper insulation sheet  30  and on the lower surface of the upper insulation sheet  30  and corresponding to the reaction area  11  of the upper substrate  10 . The lower insulation sheet  40  connected to the surface of the lower substrate  20 , but excluded from the connection area  201  comprises an upper surface, a lower surface, a permeation portion  41  and a venting air duct  42 . The permeation portion  41  is formed on the upper surface of the lower insulation sheet  40  and the lower surface of the lower insulation sheet  40 , and corresponding to the reaction area  21  of the lower substrate  20 . The venting duct hole  42  is formed across the lower insulation sheet  40  and adjacent to the permeation portion  41  thereof to enhance fluid speed of blood. 
     The separator  50  connected to the upper insulation sheet  30  and the lower insulation sheet  40  comprises an upper surface, a lower surface, an adhesive layer  51  and a permeation portion  52 . The adhesive layer  51  is formed on the upper surface of the separator  50  and on the lower surface thereof, but excluded from the venting air duct  42  and the permeation portion  52 . The permeation portion is exposed on the upper surface of the separator  50  and the lower surface of the separator  50  and corresponding to the permeation portion  31  of the upper insulation sheet  30  and permeation portion  41  of the lower insulation sheet  40 , respectively. 
     As performing the invention, connection of the upper substrate  10  and the lower substrate  20  is performed by overlapping the distal portion of the electrode layer  13  with the reaction area  11  of the upper substrate  10  and overlapping the distal portion of the electrode layer  23  with the reaction area  21  of the lower substrate  20 , respectively. As dropping the blood on the reaction area  11  or on the reaction area  21 , an electron cycle e is formed, and transferring signals to the proximal portion of the connection area  101  of the upper substrate  10  or the connection area  201  of the lower substrate  20 . Furthermore, apply an enzyme layer to the reaction area  11  and to the reaction area  21 , respectively to examine blood glucose. Connect the upper insulation sheet  30  and the lower insulation sheet  40  to the surface of the upper substrate  10  and the surface of the lower substrate  20 , respectively to avoid examining errors caused by contacting the electrode layer  13  of the upper substrate  10  with the electrode layer  23  of the lower substrate  20 , so as to make the examining test paper have twice examining function by combining the upper substrate  10  with the lower substrate  20 . During the process of blood examination, dropping the blood once on the reaction area  11  of the upper substrate  10  and completing the first examination; furthermore, the blood is permeating at the same time by function of the hydrophilic layer on the reaction area  11 , and passing through the permeation portion  31 , the permeation portion  41  and the permeation portion  52  to the reaction area  21  of the lower substrate  20 . Twice blood glucose examination will be done as the blood distributes completely, and we can confirm the accuracy of blood glucose concentration from the two examining results. 
     With reference to  FIG. 4 , the second embodiment in accordance with the present invention is similar to the first embodiment, and comprises an upper substrate  10 A, a lower substrate  20 A, an upper insulation sheet  30 , a lower insulation sheet  40  and a separator  50 . The structure of examining test paper used in the second embodiment different from the first embodiment comprises a notch  12 , a notch  22 A, and an secondary notch  22 AB, and a connection area  201 A. The notch  12 A of the upper substrate  10 A is recessed on a central portion of the proximal end of the upper surface of the upper substrate  10 A, and the connection area  101 A of the upper substrate  10 A bilaterally flanks the notch  12 A of the upper substrate  10 A. The notch  22 A of the lower substrate  20 A is recessed on a lateral portion of the proximal end of a lower substrate  20 A, and the secondary notch  22 AB is further recessed on an opposite portion of the proximal end of the lower substrate  20 A. The connection area  201 A is formed between the notch  22 A and the secondary notch  22 AB of the lower substrate  20 A. The notch  12 A of the upper substrate  10 A is corresponding to the connection area  201 A of the lower substrate  20 A, and the connection area  101 A of the upper substrate  10 A and the connection area  201 A of the lower substrate  20 A are positioned side by side. 
     With reference to  FIG. 5 , the third embodiment in accordance with the present invention is similar to the second embodiment, and comprises an upper substrate  10 B, a lower substrate  20 B, an upper insulation sheet  30 , a lower insulation sheet  40  and a separator  50 . The structure of examining test paper used in the third embodiment different from the second embodiment comprises a notch  12 B, a notch  22 B, a secondary notch  22 BC, and a connection are  201 B. The notch  12 B of the upper substrate  10 B is defined through a central region of the upper substrate  10 B adjacent to the proximal end, and the connection area  101 B of the upper substrate  10 B bilaterally flanks the notch  12 B of the upper substrate  10 B. The notch  22 B of the lower substrate  20 B is recessed on a lateral portion of the proximal end of a lower substrate  20 B, and the secondary notch  22 BC is further recessed on an opposite portion of the proximal end of the lower substrate  20 B. The connection area  201 B is formed between the notch  22 B and the secondary notch  22 BC of the lower substrate  20 B. The notch  12 B of the upper substrate  10 B is corresponding to the connection area  201 B of the lower substrate  20 B. 
     The connection area  101 ,  101 A and  101 B formed on the upper substrate  10 ,  10 A and  10 B, respectively, in accordance with the present invention are not connected with the connection area  201 ,  201 A and  201 B formed on the lower substrate  20 ,  20 A and  20 B, but are arranged in alignment separately. During the process of examination, users can separate the two connectors of the two examining test papers at different position for providing connecting points of the blood glucose meter by using a mutual converter. 
     In a preferable embodiment, a GOD/GDH enzyme layer is applied to the reaction area  11  of the upper substrate  10  and to the reaction area  21  of the lower substrate  20 , respectively, and then the reaction area  11  of the upper substrate  10  is set as a capacitive recognition suite, and the reaction area  11  of the upper substrate  10  and the reaction area  21  of the lower substrate  20  are set as an examining electrode suite to enhance the accuracy of blood glucose measurement. 
     In a preferable embodiment, the GOD/GDH enzyme layer is applied to the reaction area  11  of the upper substrate  10 , and an impedance membrane is applied on the reaction area  21  of the lower substrate  20  to enhance the capacitive accuracy of the reaction area  11  and reaction area  21 . The reaction  11  of the upper substrate  10  is a DC examining electrode suite, and the reaction  21  of the lower substrate  20  is a AC capacitive recognition suite, and the DC examining electrode suite and the AC capacitive recognition suite are reacting at the same time. 
     In a more preferable embodiment, the GOD/GDH enzyme layer is applied to the reaction area  11  of the upper substrate  10  to examine blood glucose, and another enzyme is applied to the reaction area  21  of the lower substrate  20  to examine other biochemical substrates (such as cholesterol, blood lactate and uric acid), so that different blood compositions can be examined at the same time in a single examining test paper, and the combination of the enzyme can be chosen by need. 
     Sentences described above are just preferable examples, but not restricted to the invention; although the preferable examples of the invention had been shown as above, not restricted to the invention; any general knowledge belongs to the technical field, some technical contents described above can be altered or modified slightly to get the same effect of the experimental examples based on specification of the technical program of the invention; however, any technical content described above simple altered or modified to get the same effect of the experimental examples based on specification of the technical program of the invention, belong to the specification of the technical program of the invention.