Patent Abstract:
The disclosure is directed to biosensor monitors, test strips and activation mechanisms and methods thereof. The biosensor monitor is for verifying a test strip to be used with the biosensor monitor. The monitor includes verification components located within the monitor and accessible to a test strip to be inserted into the biosensor monitor. The verification components interact with verification portions of the test strip to allow the biosensor monitor to verify the test strip before the biosensor monitor tests biological material on the test strip. A test strip and methods are also described.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 61/877,202, filed Sep. 12, 2013, the contents of which are incorporated herein by reference. 
     
    
     FIELD 
       [0002]    Aspects of the present disclosure relate generally to the field of biosensor monitors, test strips and activation mechanisms and Methods thereof, and more particularly to an activation mechanism for a biosensor monitor to verify the identity of a test strip and to activate the biosensor monitor accordingly. 
       BACKGROUND 
       [0003]    A patient&#39;s blood glucose level may be measured by placing a small drop of blood sample onto a test strip. Then, the test strip is inserted into a glucose meter, which will detect the presence of blood glucose. If blood glucose is detected, the glucose meter will be turned on to measure the blood glucose level. 
         [0004]    Although easy to implement, this activation mechanism may not fit the needs of many modern manufacturers. First, this activation mechanism cannot prevent users from using a non-conforming test strip with a glucose meter. Using non-conforming test strips may damage the glucose meter, and may result in inaccurate readings. A non-conforming test strip may be made by a counterfeiter or a competitor. Additionally, this activation mechanism does not allow a biosensor monitor  100  to distinguish one type of test strip from another. For exemplary, a manufacturer may have one type of test strip for home tests, and another type of test strip for professional uses. Therefore, to prevent test strips produced by the same manufacture from being used on wrong glucose meter, it is important to have test strips specifically compatible with a specific glucose meter. 
         [0005]    Accordingly, there is a need for an activation mechanism for a biosensor monitor  100  to verify the identity of the inserted test strip, and to activate the biosensor monitor  100  accordingly. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0006]      FIG. 1  is a biosensor monitor and test strip according to an exemplary embodiment. 
           [0007]      FIG. 2  is a diagrammatic view of an exemplary embodiment of a biosensor monitor according to  FIG. 1 . 
           [0008]      FIG. 3  is a generic method for detecting the identity of the test strip according to an exemplary embodiment. 
           [0009]      FIGS. 4A-4B  are illustrative views of additional exemplary test strips. 
           [0010]      FIGS. 5A-5B  are illustrative views of additional exemplary test strips. 
           [0011]      FIGS. 6A-6D  are illustrative views of additional exemplary test strips. 
           [0012]      FIGS. 7-10  illustrate exemplary activation methods of a biosensor monitor. 
           [0013]      FIGS. 11-18  are illustrative views of exemplary test strips. 
           [0014]      FIGS. 19-20  are illustrative views of exemplary test strips. 
           [0015]      FIGS. 21-24  illustrate exemplary second portions of the test strip. 
           [0016]      FIG. 25  is an illustrative view of an exemplary test strip. 
           [0017]      FIGS. 26-29  illustrate exemplary embodiments of the second portion of the test strip. 
           [0018]      FIGS. 30-37  are illustrative views of exemplary embodiments of the test strip and the biosensor monitor. 
           [0019]      FIGS. 38-46  are illustrative views of exemplary embodiments of the test strip and the biosensor monitor. 
           [0020]      FIGS. 47-49  are illustrative views of exemplary embodiments of the test strip and the biosensor monitor. 
           [0021]      FIG. 50  illustrates exemplary activation method of a biosensor monitor. 
           [0022]      FIGS. 51-52  are illustrative views of exemplary embodiments of the test strip and the biosensor monitor. 
           [0023]      FIGS. 53-54  are illustrative views of exemplary embodiments of the test strip and the biosensor monitor. 
           [0024]      FIG. 55  illustrates exemplary activation method of a biosensor monitor. 
           [0025]      FIGS. 56-58  are illustrative views of exemplary embodiments of the test strip and the biosensor monitor. 
           [0026]      FIG. 59  illustrates exemplary activation method of a biosensor monitor. 
           [0027]      FIG. 60  is an illustrative views of exemplary embodiment of the test strip and the biosensor monitor. 
           [0028]      FIG. 61  illustrates exemplary activation method of a biosensor monitor. 
       
    
    
     DETAILED DESCRIPTION 
       [0029]    It will be appreciated that for simplicity and clarity of illustration, where appropriate, reference numerals have been repeated among the different figures to indicate corresponding or analogous elements. In addition, numerous specific details are set forth in order to provide a thorough understanding of the embodiments described herein. However, it will be understood by those of ordinary skill in the art that the embodiments described herein can be practiced without these specific details. In other instances, methods, procedures and components have not been described in detail so as not to obscure the related relevant feature being described. The drawings are not necessarily to scale and the proportions of certain parts may be exaggerated to better illustrate details and features. The description is not to be considered as limiting the scope of the embodiments described herein. 
         [0030]    The term “comprising” means “including, but not necessarily limited to”; it specifically indicates open-ended inclusion or membership in a so-described combination, group, series and the like. 
         [0031]      FIG. 1  is a biosensor monitor  100  and a test strip  300  according to an exemplary embodiment. Exemplary biosensor monitor  100  allows the biosensor monitor  100  to verify the source and type of the inserted test strip  300 . If the source and type of the test strip  300  are acceptable, the biosensor monitor  100  may be activated to analyze or test the blood. The exemplary activation mechanisms and methods allow a biosensor  100  to distinguish among different types of test strips  300 . With this activation mechanism, a biosensor monitor  100  provided by a supplier can be activated only when used with a test strip configured to conform to the specific glucose meter. Any other test strip not properly configured will be unable to turn on the biosensor monitor  100 . 
         [0032]    In more detail, biosensor monitor  100  comprises a body  105  for containing circuitry (see  FIG. 2 ) associated with the biosensor monitor  100 , a display  110 , and a test strip receiving hole or slot  120 . Within test strip receiving hole  120  is/are one or more verification components  125 . As used herein and in the claims, the term “verification components” means the various features described herein and used to interact with the verification portion features of the test strip. Verification components  125  can comprise features, such as, but not limited to: conductive pins, light sensors and detectors, color detectors, bar code detectors, signal receivers, and sensor modules for interacting with the verification portions of the test strip, as described below. Accordingly, in  FIG. 1 , verification component  125  is shown as a generic “black box” structure. 
         [0033]    Test strip  300  is shown in  FIG. 1  as for being inserted into receiving hole  120  of the biosensor monitor  100  in insertion direction  17 . Test strip  300  includes a verification portion  310 . As used herein and in the claims, the term “verification portion” means the various test features provided on the test strip, such as, but not limited to: conductive pads, reflective pads, light through holes, barcodes, color patterns of different colored or different shaped printed blocks, and a signal transmitter that are for interacting with the verification component  125  of the biosensor monitor  100 . Accordingly, in  FIG. 1 , verification portions  310  are shown as a generic “black box” structure. 
         [0034]      FIG. 2  is a diagrammatic view of an exemplary biosensor monitor  100 . Biosensor monitor  100  includes display  110 , verification components  125 , controller  130 , comparator  135 , and a blood analyzer  140 . In its most generic form and operation, comparator  135  determines whether verification portion  125  detect the appropriate verification portions  310  of test strip  300 . Depending upon that comparison, controller  130  sends a message to display  110  and a signal for activating or not activating the blood analyzer  140  within biosensor  100 . This generic form and operation is explained in much more detail below. 
         [0035]      FIG. 3  is a generic method for detecting the identity of the test strip according to an exemplary embodiment. 
         [0036]    In its most generic and simplified form and as shown in  FIG. 3 , the method  400  includes sensing a presence of a test strip in a biosensor monitor, in step  401 ; receiving a signal at one or more verification components of the biosensor monitor from one or more verification portions of the test strip, in step  402 ; and verifying the identity of the test strip, in step  403 . 
         [0037]      FIGS. 4A-4B  are illustrative views of exemplary test strips. In these exemplary embodiments the verification portion  310  of the test strip  300  can be conductive pads  21 ,  22 ,  23 , and  24  that allow the biosensor monitor  100  to determine whether the test strip  300  has been inserted into the biosensor monitor  100 . For exemplary, in  FIG. 4A , the verification components  125  of the biosensor monitor  100  can be contact pins  1 ,  2 ,  3  and  4 . For clarity, the housing of the biosensor monitor  100  and the structure of the contact pins have been omitted. 
         [0038]    According to this first exemplary embodiment, in  FIG. 4A , before the test strip  300  is inserted into the biosensor monitor  100  in direction  17 , the contact pins  1 ,  2 ,  3 , and  4  are not electrically connected to each other. This allows the biosensor monitor  100  to know the test strip  300  is not inserted therein. 
         [0039]    In  FIG. 4B , when the test strip  300  is inserted into the biosensor monitor  100 , the pins  1 ,  2 ,  3  and  4  may be in contact with the conductive pads  21 ,  22 ,  23 , and  24  respectively. The conductive pad  21  electrically connects to conductive pad  22  and further connects to the electrode  302 , which may either be a working or reference electrode. The conductive pad  24  electrically connects to the electrode  301 . The electrodes  301  and  302  form a pair of working and reference electrodes, forming a reaction zone. As shown in  FIG. 4A  and  FIG. 4B , because the conductive pads  21  and  22  are electrically connected to each other, after the insertion of the test strip  300  into the biosensor monitor  100 , the pins  1  and  2  are electrically connected to each other within the biosensor monitor  100 . When comparator circuit  135  and conventional controller  130  within the biosensor monitor  100  detect the electrical connection between the pins  1  and  2 , the biosensor monitor  100  knows if a test strip  300  has been inserted into the biosensor monitor  100 . 
         [0040]    After the detected insertion of the test strip  300 , the biosensor monitor  100  may be activated, for exemplary, waking up from the sleep mode, e.g., the biosensor monitor  100  may now turn on a display, or brighten part of the display. Additionally, the blood analyzer  140  will analyze the blood sample. The biosensor monitor  100  may also display a symbol indicating that a test strip has been inserted. To attract a user&#39;s attention, the symbol may be text with a different font or size, or may be a flashing graph or text. 
         [0041]    In  FIGS. 4A ,  4 B, although the conductive pads  21  and  22  are both connected to the electrode  302 , the principle disclosure is not so limited. For exemplary, as illustrated in the exemplary embodiment of  FIG. 5A ,  5 B, the conductive pads  22  and  23  may be connected to each other and the electrode  303 . Thus, the biosensor monitor  100  may determine whether a test strip  300  has been inserted by checking the electrical connection between the pins  2  and  3 . 
         [0042]    In  FIG. 6A-6D , according to another exemplary embodiment, additional conductive pads located on the test strip  300  can provide source information for test strip  300 . For exemplary, in  FIG. 6A , when the test strip  300  is being inserted into the biosensor monitor  100 , at time t1, the pins  1  and  2  may be in contact with a conductive pad  25  and therefore pins  1  and  2  may be electrically connected. The biosensor monitor  100  may detect such electrical connection and compare it against a first predetermined condition, for exemplary, whether there exists an electrical connection between the pins  1  and  2 . If the electrical connection does not satisfy the first predetermined condition, the biosensor monitor  100  may reject the test strip  300  by displaying an error message. Otherwise, the biosensor monitor  100  may proceed with the activation process. 
         [0043]    In  FIG. 6B , at time t2, the pins  1  and  2  may be in contact with a conductive pad  26 , and the pins  3  and  4  may be in contact with a conductive pad  27 . Therefore, the pins  1  and  2  may be electrically connected, and the pins  3  and  4  may be electrically connected. The biosensor monitor  100  may detect such electrical connections and compare them against a second predetermined condition, for exemplary, whether there exist electrical connections between the pins  1  and  2 , and between the pins  3  and  4 . If the electrical connections do not satisfy the second predetermined condition, the biosensor monitor  100  may again reject the test strip  300  by displaying an error message. Otherwise the biosensor monitor  100  may further proceed with the activation process. 
         [0044]    In  FIG. 6C , at time t3, the pins  2 ,  3  and  4  may be in contact with a conductive pad  28 . Therefore, the pins  2 ,  3  and  4  are electrically connected. The biosensor monitor  100  may detect such electrical connection and compare it with a third predetermined condition, for exemplary, whether there exists an electrical connection between the pins  2  and  3 , or between the pins  3  and  4 , or between the pins  2  and  4 . If the electrical connection does not satisfy the third predetermined condition, the biosensor monitor  100  may again reject the test strip  300  by displaying an error message. Otherwise, the biosensor monitor  100  may further proceed with the activation process. 
         [0045]    In  FIG. 6D , at time t4, the pins  1 ,  2 ,  3  and  4  may be in contact with the conductive pads  21 ,  22 ,  23  and  24 , respectively. The conductive pads  21  and  22  may be connected to the electrode  302 . The conductive pad  23  may be connected to the electrode  303 . The conductive pad  24  may be connected to the electrode  301 . The electrodes  301 ,  302  and  303  may be used to measure the voltage or current across the reaction region (defined above). If the first, second and third predetermined conditions have all been satisfied, the source of the test strip  300  has been verified, and the biosensor monitor  100  may wake up from the sleep mode or power saving mode. 
         [0046]    Furthermore,  FIGS. 6A-6C  show the pins  1  and  2  are electrically connected at time t1, the pins  3  and  4  are electrically connected at time t2, and the pins  2 ,  3  and  4  are electrically connected at time t3. If such connections satisfy all predetermined conditions, the source of the test strip  300  may be verified. 
         [0047]    Instead of sequentially detecting the electrical connections among the pins, according to some exemplary embodiments, the biosensor monitor  100  may sequentially detect the electric resistance values among them. For exemplary, in  FIG. 6A , at time t1, when the test strip  300  is being inserted into the biosensor monitor  100 , the pins  1  and  2  may be in contact with a conductive pad  25 , and so the pins  1  and  2  may be electrically connected. The biosensor monitor  100  may then check whether the electric resistance value between the pins  1  and  2  conforms to a first predetermined value. If not, the biosensor monitor  100  may reject the test strip  300  by displaying an error message. Otherwise, the biosensor monitor  100  may proceed with the activation mechanism to perform further checks at time t2 and time t3. If the electric resistance values of the pins at time t1, t2, and t3 all conform to the predetermined values, the source of the test strip  300  may be considered verified. 
         [0048]      FIGS. 7-10  illustrate exemplary activation methods for a biosensor monitor  100 . As previously described, the method may sequentially detect the electrical connections or the electric resistance values among its pins. Once the entire detection sequence is completed, the biosensor monitor  100  may reject the nonconforming test strip  300  or accept a conforming test strip  300 . Alternatively, the biosensor monitor  100  may accept the conforming strip  300  or reject a test strip  300  immediately if any the sensed value or connection at that time is deemed unacceptable. 
         [0049]    In  FIG. 7 , an exemplary verification method  900  with active electrical potential provision is provided. This method is implemented by the biosensor monitor  100  actively changing the electrical potential provided to the pins. With reference to  FIG. 7 , at time t1, the biosensor monitor  100  provides electrical potential to the first combination of pins, i.e., the pins  1  and  2 , in step  902 . When pins  1  and  2  are in contact with a conductive pad  25 , the biosensor monitor  100  may detect the electrical connection. Next, the biosensor monitor  100  via the comparator  135  may compare such electrical connection with a first predetermined condition, for exemplary, whether there exists an electrical connection between pins  1  and  2 , in step  904 . If the first predetermined condition is not fulfilled, the test strip  300  may be rejected and the biosensor monitor  100  may not be activated, as illustrated in step  906 . An error message may then be displayed on the screen of the biosensor monitor  100 . 
         [0050]    On the other hand, if the first predetermined condition is fulfilled, the biosensor monitor  100  ceases to provide electrical potential to the first combination of the pins  1  and  2  in step  908 . Next, the biosensor monitor  100  may provide electrical potential to the second combination of pins, i.e., the pins  3  and  4 , at time t2 in step  910 . When pins  3  and  4  are in contact with a conductive pad  27 , the biosensor monitor  100  may detect the electrical connection therebetween. Thereafter, the biosensor monitor  100  may compare such electrical connection with a second predetermined condition, for exemplary, whether there exists an electrical connection between pins  3  and  4 , in step  912 . If the second predetermined condition is not fulfilled, the test strip  300  may be rejected and the biosensor monitor  100  may not be activated, as illustrated in step  914 . An error message may be displayed on the screen of the biosensor monitor  100 . On the other hand, if the second predetermined condition is fulfilled, the biosensor monitor  100  ceases to provide electrical potential to the second combination of the pins  3  and  4  in step  916 . Next, the biosensor monitor  100  may provide electrical potential to the third combination of pins, i.e., the pins  2 ,  3  and  4 , at time t3 in step  918 . When pins  2  and  3 , or  3  and  4 , or  2  and  4  are in contact with a conductive pad  28 , the biosensor monitor  100  may detect the electrical connection between them. Next, the biosensor monitor  100  may compare such electrical connection with a third predetermined condition, for exemplary, whether there exists an electrical connection between pins  2  and  3 , or  3  and  4 , or  2  and  4 , in step  920 . If the third predetermined condition is not fulfilled, the test strip  300  may be rejected and the biosensor monitor  100  may not be activated, as illustrated in step  922 . An error message may be displayed on the screen of the biosensor monitor  100 . On the other hand, if the third predetermined condition is fulfilled, at time t4, the biosensor monitor  100  may be activated from the sleep mode or the power saving mode in step  924 . As a result, the biosensor monitor  100  may serve to measure the voltage or current across the electrodes  301 ,  302  and  303  when the blood sample is mixed or reacted with the reaction enzyme or reaction reagent. The sequential fulfillments of the first, second and third predetermined conditions represent that the source of the test strip  300  inserted is correct. Therefore, a verification method with active electrical potential provision is provided. 
         [0051]    In  FIG. 8 , an exemplary verification method  1000  with passive electrical potential provision is provided. In other words, the method in this embodiment is implemented by the biosensor monitor  100  providing unchanged electrical potential to the pins respectively. In detail, with reference to  FIG. 8 , when the biosensor monitor  100  is in the sleep mode or the power saving mode, the biosensor monitor  100  may provide electrical potential to designated pins in step  1002 . In particular, the voltage at pin  2  is lower than that at pin  1 , the voltage at pin  3  is lower than that at pin  2 , and the voltage at pin  4  is lower than that at pin  3 . For exemplary, the voltage may be 10V at pin  1 , 7V at pin  2 , 3V at pin  3 , and zero (grounded) at pin  4 . In step  1004 , when the pins  1  and  2  are in contact with one electrode, the biosensor monitor  100  may detect an electric current flowing from pin  1  to pin  2 , i.e., an electrical connection. 
         [0052]    Accordingly, the biosensor monitor  100  may compare such with a first predetermined condition, for exemplary, whether there exists an electrical connection between pins  1  and  2  in step  1004 . If the first predetermined condition is not fulfilled, the test strip  300  may be rejected and the biosensor monitor  100  may not be activated, as illustrated in step  1006 . On the other hand, if the first predetermined condition is fulfilled, the biosensor monitor  100  may proceed with the activation method. In step  1008 , when the pins  3  and  4  are in contact with one electrode, the biosensor monitor  100  may detect an electric current flowing from pin  3  to pin  4 , i.e., an electrical connection. Accordingly, the biosensor monitor  100  may compare such with a second predetermined condition, for exemplary, whether there exists an electrical connection between pins  3  and  4  in step  1008 . If the second predetermined condition is not fulfilled, the test strip  300  may be rejected and the biosensor monitor  100  may not be activated, as illustrated in step  1010 . On the other hand, if the second predetermined condition is fulfilled, the biosensor monitor  100  may proceed with the activation method. In step  1012 , when the pins  2 ,  3  and  4  are in contact with a conductive pad  28  and therefore are electrically connected, the biosensor monitor  100  may detect an electric current flowing from pin  2  to pin  3 , from pin  3  to pin  4 , or from pin  2  to pin  4 . That is, an electrical connection between pins  2  and  3 , or  3  and  4 , or  2  and  4  may be established. Accordingly, the biosensor monitor  100  may compare such with a third predetermined condition, for exemplary, whether there exists an electrical connection between pins  2  and  3 , or  3  and  4 , or  2  and  4  in step  1012 . If the third condition is not fulfilled, the test strip  300  may be rejected and the biosensor monitor  100  may not be activated, as illustrated in step  1014 . On the other hand, if the third condition is fulfilled, at time t4 the biosensor monitor  100  may be activated from the sleep mode or the power saving mode in step  1016  and may serve to measure the voltage or current across the electrodes  301 ,  302  and  303  when the blood sample is mixed or reacted with the reaction enzyme or reaction reagent. The sequential fulfillments of the first, second and third predetermined conditions represent that the source of the test strip  300  inserted is correct. Therefore, a verification method with passive electrical potential provision is provided. 
         [0053]    Furthermore, with reference to  FIG. 9 , the verification method  1100  with active electrical potential provision may be implemented by the biosensor monitor  100  detecting the electric resistance of the conductive pads that the pins are contacting. That is, the biosensor monitor  100  may verify the electric resistances of the conductive pads to ensure that the test strip  300  is a genuine one. Referring to  FIG. 9 , steps  1102  to  1106  are identical to steps  902 - 906  in the exemplary method in  FIG. 7  and therefore will not be repeated. Thereafter, instead of ceasing to provide electrical potential to the first combination of pins, in step  1108 , the biosensor monitor  100  may detect the electric resistance of the conductive pad connecting to pins  1  and  2  according to the value of the electric current received by pin  2 . The biosensor monitor  100  may then compare whether such electric resistance conforms to a first predetermined value. If not conforming, the test strip  300  may be rejected and the biosensor monitor  100  may not be activated, as illustrated in step  1110 . On the other hand, if the first predetermined condition is fulfilled and the electric resistance conforms to the first predetermined value, the biosensor monitor  100  may cease to provide electrical potential to the first combination of pins in step  1112 . Next, the biosensor monitor  100  may provide electrical potential to the second combination of pins, i.e., the pins  3  and  4 , at time t2, as in step  1114 . Thereafter, the biosensor monitor  100  continues the electrical connection verification and the electric resistance verification. The methods implemented in steps  1116 - 1122  are identical to those steps  1104 - 1110  and thus will not be repeated herein. In step  1124 , after the biosensor monitor  100  verifies that all the conditions are fulfilled in sequence and the electric resistances detected satisfy the predetermined values in sequence, the biosensor monitor  100  will be activated from the sleep mode or the power saving mode. Accordingly, a verification method with active electrical potential provision designed to detect electric resistance is provided. Alternatively, steps  1104 ,  1106 ,  1116  and  1118  in the present method of this embodiment may be omitted. That is, the electrical connection verification feature may be omitted. Consequently, the verification method may be implemented by only sequentially verifying the electric resistance of the conductive pads contacting the pins. Therefore, a verification method by detecting the electric resistance of the conductive pads with active electrical potential provision is provided. 
         [0054]    Similarly, as shown in  FIG. 10 , the verification method  1200  with passive electrical potential provision may be implemented by the biosensor monitor  100  detecting the electric resistance of the conductive pads that the pins are contacting. That is, the biosensor monitor  100  may verify the electric resistances of the electrodes to ensure that the test strip  300  is a genuine one. In detail, with reference to  FIG. 10 , when the biosensor monitor  100  is in the sleep mode or the power saving mode, the biosensor monitor  100  provides electrical potential to designated pins in step  1202 . In particular, the voltage at pin  2  may be lower than that at pin  1 , the voltage at pin  3  may be lower than that at pin  2 , and the voltage at pin  4  may be lower than that at pin  3 . For exemplary, the voltage may be 10V at pin  1 , 7V at pin  2 , 3V at pin  3 , and zero (grounded) at pin  4 . In step  1204 , when the pins  1  and  2  are in contact with a conductive pad  25 , the biosensor monitor  100  may detect an electric current flowing from pin  1  to pin  2 . The biosensor monitor  100  may then detect the electric resistance of the electrode connecting to pins  1  and  2  according to the value of the electric current received by pin  2 . Next, the biosensor monitor  100  may compare whether such electric resistance conforms to a first predetermined value. If not conforming, the test strip  300  may be rejected and the biosensor monitor  100  will not be activated, as illustrated in step  1206 . On the other hand, if the electric resistance conforms to the first predetermined value, the biosensor monitor  100  may continue to perform the activation method. In step  1208 , when the pins  3  and  4  are in contact with one electrode, the biosensor monitor  100  may detect an electric current flowing from pin  3  to pin  4 . The biosensor monitor  100  may then detect the electric resistance of the electrode connecting to pins  3  and  4  according to the value of the electric current received by pin  4 . Next, the biosensor monitor  100  may then compare whether such electric resistance conforms to a second predetermined value. If not conforming, the test strip  300  may be rejected and the biosensor monitor  100  may not be activated, as illustrated in step  1210 . On the other hand, if the electric resistance conforms to the second predetermined value, the biosensor monitor  100  may continue to perform the activation method. In step  1212 , when the pins  2 ,  3  and  4  are in contact with a conductive pad  28 , the biosensor monitor  100  may detect an electric current flowing from pin  2  to pin  3 , from pin  3  to pin  4 , or from pin  2  to pin  4 . The biosensor monitor  100  may then detect the electric resistance of the conductive pad  28  connecting to pins  2 ,  3  and  4  according to the value of the electric current received by pin  3  from pin  2 , by pin  4  from pin  3 , or by pin  4  from pin  2 . Next, the biosensor monitor  100  may compare whether such electric resistance conforms to a third predetermined value. If not conforming, the test strip  300  may be rejected and the biosensor monitor  100  may not be activated, as illustrated in step  1214 . On the other hand, if the electric resistance conforms to the third predetermined value, the biosensor monitor  100  may be activated from the sleep mode or the power saving mode in step  1216  and serves to measure the voltage or current across the electrodes  301 ,  302  and  303  when the blood sample is mixed or reacted with the reaction enzyme or reaction reagent. The sequential fulfillments of the first, second and third predetermined values represent that the source of the test strip  300  inserted is correct. 
         [0055]    Therefore, a verification method by detecting the electric resistance of the electrodes with passive electrical potential provision is provided. 
         [0056]    It is to be noted that the test strips or the biosensor monitor  100  implementing the activation mechanism is not so limited. Below are further exemplary embodiments of the test strips or the biosensor monitor  100  capable of implementing the activation mechanism disclosed herein. 
         [0057]      FIGS. 11-18  are illustrative views of exemplary test strips. For clarity, the left portions of  FIGS. 11 and 12  and the right portions of  FIGS. 13-18  are omitted.  FIG. 11  illustrates a first portion of the test strip  300  having electrodes  301  and  302 . The electrodes  301  and  302  may be used to measure the voltage or current across them when the blood sample is applied to the test strip and mixed or reacted with the reaction enzyme or reagent. The electrodes  301  and  302  can have other shapes or configurations, as illustrated in  FIG. 12 . 
         [0058]      FIGS. 13-18  illustrate exemplary embodiments of the second portion of the test strip  300 . The second portion may be combined with the first portion previously described to form a complete test strip. As illustrated, the second portions may comprise conductive pads  21  and  22 , and other conductive pads to implement the activation mechanism previously discussed. For exemplary, in  FIG. 13 , the source of the test strip may be identified as (1) an electrical connection between the pins  1  and  2  at time t1, (2) no electrical connection between the pins  1  and  2  at time t2, and (3) an electrical connection between the pins  1  and  2  at time t3. If the biosensor monitor  100  finds this source acceptable, it may be activated and wakes up from the sleep mode or power saving mode. 
         [0059]    It should be noted that other arrangements of conductive pads may also be employed by the activation mechanism, as illustrated in  FIGS. 14-16 , as long as such arrangements may enable the first, second, and third conditions to be satisfied. Moreover, in  FIGS. 17 and 18 , the test strips  300  may comprise additional conductive pads to allow the biosensor monitor  100  to check an additional condition at time t4. A person of ordinary skill in the art would appreciate that these additional conductive pads may allow the biosensor monitor  100  to perform a more complex verification process. 
         [0060]      FIGS. 19-20  are illustrative views of exemplary test strips.  FIG. 19  illustrates a first portion of the test strip  300  having electrodes  301 ,  302  and  303 . The electrodes  301  and  302  may be used to measure the voltage or current across them when the blood sample is applied to the test strip and mixed or reacted with the reaction enzyme or reaction reagent. In addition, electrode  303  may be used to detect the amount of the blood sample. For exemplary, when the amount of the blood sample is insufficient, the blood sample may not contact electrode  303 . If this happens, the biosensor monitor  100  may display a warning message. 
         [0061]    A person of ordinary skill in the art would appreciate that the shapes of the electrode  301 ,  302  and  303  may have various shapes. For exemplary,  FIG. 20  demonstrates another exemplary embodiment of the first portion of the test strip  300 . 
         [0062]      FIGS. 21-24  illustrate exemplary second portions of the test strip  300 . These second portions may comprise conductive pads  21 ,  22  and  23 , and other conductive pads to implement the activation mechanism. Accordingly, the biosensor monitor  100  may utilize the activation mechanism previously discussed to verify the source of the inserted test strip  300 . For exemplary, in  FIG. 21 , the source of the test strip  300  may be identified as (1) an electrical connection between the pins  1  and  2  at time t1, (2) an electrical connection between the pins  2  and  3  at time t2, and (3) an electrical connection between the pins  1  and  2  at time t3. Other arrangements, as illustrated in  FIGS. 22-24 , may be similarly implemented. In addition, as illustrated in  FIGS. 23 and 24 , a person of ordinary skill in the art would appreciate that additional conductive pads may be employed to allow the biosensor monitor  100  to perform a more complex verification process. 
         [0063]      FIG. 25  is an illustrative view of an exemplary test strip.  FIG. 25  illustrates a first portion of the test strip  300  having electrodes  301 ,  302  and  303 . These electrodes may serve similar functions as previously discussed. 
         [0064]      FIGS. 26-29  illustrate exemplary embodiments of the second portion of the test strip  300 . These second portions may comprise conductive pads  21 ,  22 ,  23 ,  24  and  25 , and other conductive pads to implement the activation mechanism previously discussed (refer to pins  1 - 4  above). For exemplary, in  FIG. 26 , the source of the test strip  300  may be identified as (1) an electrical connection between the pins  1  and  2  at time t1, (2) an electrical connection between the pins  2  and  3  at time t2, and (3) an electrical connection between the pins  1  and  5  at time t3.  FIGS. 27-29  are embodiments illustrating different arrangements of conductive pads according to embodiments. 
         [0065]      FIGS. 30-37  are illustrative views of exemplary embodiments of the test strip and the biosensor monitor  100 . In  FIG. 30 , a second portion of the test strip  300  may comprise conductive pads  21 ,  22 ,  23  and  24 , and two other conductive pads (not numbered). In  FIG. 31 , a sectional side view of the biosensor monitor  100  with the test strip  300  fully inserted is provided. In this embodiment, the biosensor monitor  100  may have as previously described four pins; though, in these figures only pin  1  is illustrated. The pins may be L-shaped so that only their tips may contact with the test strip  300 . However, the pins may also have other shapes. 
         [0066]      FIG. 32  is a sectional side view of the pin  1  and the test strip when the test strip is being inserted into the biosensor monitor  100  at time t1.  FIG. 33  is the corresponding perspective top view of the pins and the test strip. Similarly,  FIG. 34  is a sectional side view of the pin  1  and the test strip when the test strip is being inserted into the biosensor monitor  100  at time t2, and  FIG. 35  is the corresponding perspective top view. In addition,  FIG. 36  is a sectional side view of the pin  1  and the test strip when the test strip is being inserted into the biosensor monitor  100  at time t3, and  FIG. 37  is the corresponding perspective top view. 
         [0067]    In  FIG. 33 , at time t1, the pins  1  and  3  may be in contact with one conductive pad, thereby establishing an electrical connection between the pins  1  and  3 . The biosensor monitor  100  may check such electrical connection with the first predetermined condition. At time t2, as illustrated in  FIG. 35 , the pins  1  and  3  may be in contact with one conductive pad, and the pins  2  and  4  may be in contact with another conductive pad. Therefore, electrical connections may be established between the pins  1  and  3 , and between the pins  2  and  4 . The biosensor monitor  100  may check such electrical connections with the second predetermined condition. At time t3, as illustrated in  FIG. 37 , the pins  1 ,  2 ,  3  and  4  may be in contact with the conductive pads  21 ,  22 ,  23 , and  24  respectively. If the first and second predetermined conditions have been satisfied, the biosensor monitor  100  may be activated and wake up from the sleep mode or power saving mode. A person of ordinary skill in the art would appreciate that the configurations of pins and conductive pads may be adjusted to accommodate the desired complexity of the activation mechanism. 
         [0068]      FIGS. 38-45  are illustrative views of exemplary embodiments of the test strip and the biosensor monitor  100 . In these exemplary embodiments, conductive pads used by the activation mechanism may be formed on both sides of a test strip. For exemplary, a conductive pad formed on one side of the test strip can penetrate through the test strip and be exposed on the other side. 
         [0069]    In  FIG. 38 , the test strip is placed between the pins  1  and  101 . Similarly, in  FIGS. 39-40 , the biosensor monitor  100  may be placed between the pins  2  and  102 , and between the pins  3  and  103 . According to an embodiment, the pins  1  and  101  may have similar shapes. For the purpose of clarity, in  FIG. 38 , only the pins  1  and  101  are illustrated. 
         [0070]    As illustrated in  FIG. 38 , at time t1, when the test strip  300  is being inserted in to the biosensor monitor  100 , the pin  1  contacts a first surface  306  of the test strip  300  and the pin  101  contacts a second surface  308  of the test strip  300 . At this time, as illustrated in  FIG. 39 , the pins  1  and  2  are electrically connected. Similarly, as illustrated in  FIG. 40 , no electrical connection is formed among the pins  101 ,  102  and  103 . The biosensor monitor  100  may check such electrical connection with the first predetermined condition 
         [0071]    At time t2, as illustrated in  FIG. 42 , the test strip  300  is further inserted into the biosensor monitor  100 . At this time, as illustrated in  FIGS. 43 and 44 , because the pins  2  and  102  are in contact with the same conductive pad, an electrical connection is established between the pins  2  and  102 . The biosensor monitor  100  may check such electrical connection with the second predetermined condition. 
         [0072]    At time t3, as illustrated in  FIG. 44 , the test strip  300  is yet further inserted into the biosensor monitor  100 . At this time, as illustrated in  FIGS. 45-46 , because the pins  3  and  103  are in contact with the same conductive pad, an electrical connection is established between the pins  3  and  103 . The biosensor monitor  100  may check such electrical connection with the third predetermined condition. Finally, if the first, second, and third predetermined conditions have been satisfied, the biosensor monitor  100  may be activated. 
         [0073]    As previously described, the source of the inserted test strip may be verified by checking whether the electrical characteristics of the pins satisfy a default condition. For exemplary, the biosensor monitor  100  may check the electrical connections among a set of designated pins, as depicted in the methods of  FIGS. 7 and 10 . It may also check the electrical resistance values between two designated pins, as depicted in  FIGS. 9 and 10 . It may also apply a voltage on a designated pin, and then measure an electrical characteristic between the designated pin and another designated pin, as depicted in  FIG. 8 . Moreover, it may further conduct the test at a subsequent time on another pair of designated pins, as depicted in  FIG. 7 . 
         [0074]    Alternatively, the source of the inserted test strip may be verified by checking whether the optical characteristics of the test strip satisfy a default condition. For example, as illustrated in  FIGS. 47-49 , the source of the test strip may be represented by the locations of the holes  710  on the test strip  300 . These locations may be determined by the light sources  702  and sensor modules  704 . For example, in  FIGS. 47-49 , it is determined if light projected by the light source  702  can be sensed by the sensor module  704  (such as infrared sensor module). Thus, when the test strip is inserted, the sensor modules  704  in  FIGS. 47-48  will provide the information needed to determine the hole configuration. For exemplary, as illustrated in  FIGS. 49 and 50 , in the exemplary method  1500 , at time t1, the first sensor module and the second sensor module may transmit the “ON” signals to represent the existence of the top two holes  710  (the first signal combination, as shown in steps  1501  and  1502 ). At time t2, the second sensor module and the fourth sensor module may transmit the “ON” signals to represent the existence of the third hole  711  and the fourth hole  712  (the second signal combination, as shown in steps  1504  and  1505 ). Then, if the first and second signal combinations are deemed acceptable, the biosensor monitor  100  may be activated (as shown in step  1507 ). 
         [0075]    Accordingly to another embodiment, as illustrated in  FIGS. 51-52 , the source of the test strip  300  may be represented by the configuration of the reflective pads, whose locations may similarly be determined by the light source  702  and the sensor module  704 . 
         [0076]    Accordingly to another exemplary embodiment, as shown in  FIGS. 53-54 , the verification portions  310  of the test strip  300  may be represented by the barcode printed thereon. The verification components  125  of the biosensor  100  may comprise barcode readers. This barcode ( 910  in  FIGS. 53 and 920  in  FIG. 54 ) may be read by the method  1600  of  FIG. 55 . In step  1601 , using detector module  902  (such as barcode detector module), the barcode can be decoded. If the decoded information is acceptable, the biosensor monitor  100  will be activated (as shown in steps  1602  and  1604  of  FIG. 55 ). If the decoded information is unacceptable, the biosensor monitor  100  will not be activated (as shown in step  1603 ) and the strip rejected. The barcode may, for exemplary, be a one-dimensional barcode  910  in  FIG. 52 , or a two-dimensional barcode  920  in  FIG. 53 . 
         [0077]    Accordingly to another exemplary embodiment, the source of the test strip may be represented by the color pattern printed thereon. This color pattern may be read by the sensor modules  1002  (such as CMOS/CCD sensor module) in  FIGS. 56-57 , and be subsequently used to determine if the biosensor monitor  100  shall be activated. The color pattern may comprise the colors of the blocks (such as red, blue, or yellow) ( FIG. 58 ), or the shape and size associated with each block. As illustrated in exemplary method  1700  shown in  FIG. 59 , in step  1701 , when the test strip is inserted, the sensor module  1002  may capture the images and recognize the associated colors (color  1 , color  2 , and color  3 ). Then, the biosensor monitor  100  may check whether the recognized colors are acceptable ( 1702 ). If so, the biosensor monitor  100  may be activated  1704 . Otherwise, the strip will be rejected ( 1705 ). 
         [0078]    Accordingly to another embodiment, as shown in  FIGS. 60-61 , the verification portions  310  of the test strip  300  may be represented by at least one signal transmitter  1010  thereon and the verification components  125  of biosensor  100  can be a signal detector  1003 . According to method  1800 , in step  1810 , the at least one signal transmitter would send out at least one signal and the at least one signal is then received by the signal detector module  1003  of biosensor  100  and is subsequently decoded. If the decoded information is unacceptable, the strip will be rejected and biosensor monitor  100  will not be activated (as shown in step  1830  of  FIG. 61 ). If the decoded information is acceptable, the biosensor monitor  100  will be activated (as shown in step  1840  of  FIG. 61 ). The signal described here can be passively and/or actively generated. The signal transmission described here can involve, but not limited to, a near-field communication (NFC), BLUETOOTH™, ZigBee and/or radio frequency identification (RFID). 
         [0079]    The embodiments shown and described above are only exemplarys. Even though numerous characteristics and advantages of the present technology have been set forth in the foregoing description, together with details of the structure and function of the present disclosure, the disclosure is illustrative only, and changes may be made in the detail, including in matters of shape, size and arrangement of the parts, order of method steps, all within the principles of the present disclosure up to, and including, the full extent established by the broad general meaning of the terms used in the claims.

Technology Classification (CPC): 6