Patent Grant
8505819
The present invention relates to biosensors and test strips for same; in particular, the present invention relates to methods of increasing coding information for biosensors and devices for same.
Electrochemical measuring devices have been commonly used to determine the concentration of analytes in body fluids. For example, in blood-glucose testing, the test strip may be inserted into a glucose meter, and then a blood sample may be dropped at a measuring end of a test strip that is applied with an enzyme to determine the concentration of glucose in the blood sample.
In the conventional art, the test strip is provided with a working electrode and a reference electrode to form a reaction region. The reaction region is applied with the enzyme so that when a test sample reacts with the enzyme, a chemical response is generated. When in use, the test strip is inserted in the glucose meter so that the glucose meter can read the chemical response in order to calculate the concentration of glucose in the blood sample.
However, as a result of variances in manufacturing of the test strips, calibration is needed before a particular batch of the test strips may be used with the glucose meter to obtain accurate test results. In the conventional art, the test strips are provided with a number of contact pads. These contact pads are used to couple with metal pins provided on a semiconductor chip within the glucose meters to generate electrical current, which in turn produces electrical responses readable by the glucose meters. To compensate for the manufacturing variations, the contact pads on the test strips are encoded with calibration information that may be assigned for use in computing the test results.
One common problem in the conventional art is the amount of coding information that can be encoded in the contact pads for calibration purpose. As an example, a chip with eight pins provided within the conventional glucose meter can correspond to a test strip with eight contact pads. A common arrangement of the eight contact pads may be 2 rows of 4 contact pads at one end of any given test strip. In the conventional art, there are at least a working electrode and a reference electrode to connect with contact pads. Then, depending on the status of electrical conductivity between any contact pads and common pad well know by the art, a logic value of 1 or 0 is assigned, thereby yielding a maximum of 32 (=25) codes to be used for auto-calibration purpose. Such limitation hinders the optimal use of the glucose meter and test strips.
Therefore, what is needed is a method of increasing the number of auto-calibration codes without changing the existing structure and configuration of the glucose meter and the test strip and device for same.
What is also needed is a method of verifying the auto-calibration codes to increase the accuracy when using the glucose meter in combination with the test strip.
In light of the drawbacks of the current art, one aspect of the present invention is to provide a biological measuring device with auto coding capabilities. In accordance with one embodiment of the present invention, the biological measuring device with auto coding capabilities may include a test strip having a substrate and at least a first contact pad and a second contact pad provided on the substrate; and a code reader having at least a first metal pin and a second metal pin to couple to the first contact pad and the second contact pad to obtain coding information associated with the test strip, wherein the code reader may be capable of reading the coding information based on a movement of the test strip before the test strip is placed still in relation to the code reader for a proper reading of a sample.
Another aspect of the present invention is to provide a biological measuring device adapted for use with a test strip. In one embodiment of the present invention, the test strip may have at least a first contact pad and a second contact pad. The biological measuring device of the present invention may include a code reader having at least a first metal pin and a second metal pin, wherein the code reader may be capable of reading coding information associated with the test strip based on a movement of the test strip before the test strip is placed still in relation to the code reader for a proper reading of a sample.
Yet another aspect of the present invention is to provide a test strip adapted for use with a biological measuring device. The biological measuring device of the present invention may include a code reader having at least a first metal pin and a second metal pin. The test strip of the present invention may include a substrate and a reaction region formed by at least a first electrode and a second electrode, such as a working electrode, a counter electrode, and a reference electrode provided on the substrate at one end. The reaction region may be applied with an enzyme so that an electrical response is generated when the enzyme and a test sample form a chemical reaction. The test strip of the present invention may include at least a first contact pad and a second contact pad provided on the substrate at the other end to couple to the first and second metal pins to output coding information associated with the test strip, wherein a length of the first or second contact pad may determine a movement of the test strip before the test strip is placed still in relation to the code reader for a proper reading of the test sample.
Yet another aspect of the present invention is to provide a method of reading coding information associated with a test strip adapted for use with a biological measuring device. The test strip of the present invention may have a substrate and at least a first contact pad and a second contact pad provided on the substrate. The biological measuring device of the present invention may include a code reader having at least a first metal pin and second metal pin. The method of the present invention may include inserting the test strip into the code reader; and reading the coding information based on a movement of the test strip before the test strip is placed still in relation to the code reader for a proper reading of a sample, wherein the movement may include an open circuit movement and a closed circuit movement.
Yet another aspect of the present invention is to provide a method of verifying coding information associated with a test strip adapted for use with a biological measuring device. The test strip of the present invention may have a substrate and a plurality of contact pads provided on the substrate. The biological measuring device of the present invention may include a code reader having a plurality of metal pins corresponding to the plurality of contact pads. The method of the present invention may include assigning a parity bit to one of the plurality of contact pads; determining the coding information by counting the number of a logical value generated when the plurality of contact pads are electrically coupled to the plurality of corresponding metal pins; comparing the number of the logical value against a predetermined number for the logical value, and if the number of the logical value matches the predetermined number for the logical value, then the coding information is correct.
Yet another aspect of the present invention is to provide a test strip adapted for use with a biological measuring device. The biological measuring device of the present invention may include a code reader having a plurality of metal pins. The test strip of the present invention may include a substrate; a reaction region formed by at least a first electrode and a second electrode, such as a working electrode, a counter electrode, and a reference electrode provided on the substrate at one end. The reaction region may be applied with an enzyme so that an electrical response is generated when the enzyme and a test sample form a chemical reaction. The test strip of the present invention may also include a plurality of contact pads provided on the substrate, wherein a first and second contact pads of the plurality of contact pads are provided on the substrate at the other end to couple to a respective metal pin to output coding information associated with the test strip, and wherein a third contact pad of the plurality of contact pads is assigned with a parity bit to verify the coding information.
Yet another aspect of the present invention is to provide a biological measuring device adapted for use with a test strip, wherein the test strip may have at least a first, a second and a third contact pads. The device of the present invention may include a code reader having at least a first metal pin and a second metal pin, wherein the code reader may be capable of reading coding information associated with the test strip based on a movement of the test strip before the test strip is placed still in relation to the code reader for a proper reading of a sample, and wherein the code reader may verify the coding information using a parity bit assigned to the third contact pad provided on the test strip.
a and 2b illustrate schematic diagrams of exemplary test strips in accordance with the first and second embodiments of the present invention;
c illustrates schematic diagrams of exemplary test strips encoded with a variety of different information on the contact pads in accordance with one embodiment of the present invention;
d illustrates schematic diagrams of exemplary test strips encoded with a variety of different information on the contact pads in accordance with another embodiment of the present invention;
a and 3b illustrate schematic diagrams of exemplary biological measuring devices in operations in accordance with the first and second embodiments of the present invention; and
Reference will now be made in detail to the embodiments of the present invention. Examples of embodiments are illustrated in the accompanying drawings, wherein like reference numbers refer to like elements throughout the specification.
The present invention discloses methods of increasing coding information associated with a test strip adapted for use with a biological measuring device as well as devices and test strips for same. In accordance with one embodiment of the present invention, the biological measuring device may be capable of reading coding information associated with the test strip based on a movement of the test strip before the test strip is placed still in relation to the code reader provided within the biological measuring device for a proper reading of a sample. That is, the biological measuring device of the present invention may be capable of reading coding information associated with the test strip based on a movement of the test strip as it enters into the biological measuring device and becomes electrically coupled with a code reader provided with in the biological measuring device. As such, in addition to reading the coding information associated with the test strip when the test strip is properly set still within the code reader, the biological measuring device of the present invention may read further coding information associated with the test strip as the test strip is pushed into the code reader, thereby increasing the auto-coding capabilities of the biological measuring device.
Refer to
As shown in
Furthermore, the code reader 104 of the present invention may be electrically coupled to the memory 106 so that information gathered from the test strip 102 by the code reader 104 may be stored in the memory 106. Additionally, the code reader 104 of the present invention may retrieve information from the memory 106 to work with the information collected from the test strip 102. Although
Refer to
In one embodiment of the present invention, the other end of the substrate 202 may be provided with a plurality of contact pads. As shown in
In accordance with another embodiment of the present invention, the test strip 250 may include a substrate 252. The substrate 252 of the present invention may be made of an insulating material, such as polyethylene terephthalate (PET) or the like. In accordance with one embodiment of the present invention, at least two electrodes, such as any combination of a working electrode 256, a counter electrode (not shown), or a reference electrode 258, may be provided on the substrate 252. The working electrode 256 and the reference electrode 258 may be made of a conductive material, such as gold, palladium, silver, or carbon, as well known in the art, to form a reaction region 254 at one end of the substrate 252. In another embodiment of the present invention, an additional counter electrode (not shown) may also be provided on the substrate 252 to form the reaction region 254. In accordance with the present invention, the reaction region 254 may be applied with an enzyme so that when a test sample performs a chemical reaction with the enzyme at the reaction region 254, an electrical response may be generated from the test strip 250.
In one embodiment of the present invention, the other end of the substrate 252 may be provided with a plurality of contact pads. As shown in
As can be seen from
Additionally, as shown in
Refer now to
In one embodiment of the present invention, the physical connectivity between any two contact pads on the substrate may affect the conductivity between them. Take the test strip on the top left corner of
In accordance with the present invention, P may be a parity bit assigned to one of the contact pads on the test strip so as to verify the correctness of the coding information associated with the test strip. As shown in
In another embodiment of the present invention, the code reader that is used in combination with the test strip assigned with a parity bit may be configured to perform an even parity check That is, if the coding information associated with the test strip outputs an even number of logic 1, then the coding information is correct. On the other hand, if the coding information associated with the test strip outputs an odd number of logic 1, then the coding information is incorrect. For example, the conductivity for bits 0, 1, 2, 3 and P with G or C shown in
In accordance with the present invention, assigning an odd or even parity bit to the contact pads on the test strip provides a way to verify the correctness of the reading of the coding information associated with the strip, thereby reducing the risk of reading wrong coding information associated with the test strip due to manufacturing defects, such as scratches or dusts. However, without the parity bit, information can still be made with the contact pads through the different conductivity among the contact pads to distinguish one test strip from another, and thus to calibrate the biological measuring device in accordance with the present invention. Those skilled in the art should understand that the parity bit is not limited to be assigned to only the contact pad shown in
Refer now to
In one embodiment of the present invention, as shown in position 1.1 of
In accordance with the present invention, the contact pad 322 being in contact with both the metal pins 332 and 334 at the same time, as shown in position 1.3 of
Then, as shown in position 1.4 of
In accordance with one embodiment of the present invention, as shown in
In accordance with one embodiment of the present invention, when the metal pins 332 and 334 both move onto the same contact pad, such as contact pad 322, the metal pins 332 and 334 as well as the contact pad 322 are electrically coupled to one another. At this time, an electrical conductivity exists between the metal pins 332 and 334 through the contact pad 322. Consequently, the circuit formed by the metal pins 332 and 334 as well as the contact pad 322 is known as a closed circuit by those ordinarily skilled in the art. As such, the test strip 300 may be referred to as being in a closed circuit movement. On the other hand, when the metal pins 332 and 334 move on different contact pads, such as contact pads 322 and 314, respectively, the metal pins 332 and 334 are not electrically coupled to each other. At this time, no conductivity exists between the metal pins 332 and 334 through either the contact pad 322 or the contact pad 314. Consequently, the circuit formed by the metal pins 332 and 334 as well as the contact pad 322 is known as an open circuit by those ordinarily skilled in the art. Additionally, the circuit formed by the metal pins 332 and 334 as well as the contact pad 314 is also known as an open circuit by those ordinarily skilled in the art. As such, the test strip 300 may be referred to as being in an open circuit movement. In other words,
More specifically,
In another embodiment of the present invention, as shown in position 3.1 of
In accordance with one embodiment of the present invention, as shown in
In accordance with the present invention, the code reader 380 may be capable of reading the coding information associated with the test strip 350 based on the sequence of the movement of the test strip 350, or lack of sequence as is the case in
Refer to
Then, at step 404, for example, the code reader of the present invention may determine the coding information associated with the test strip inserted based on a movement of the test strip. In one embodiment of the present invention, the movement of the test strip may include, for example, a sequence of an open circuit movement, a closed circuit movement and back to an open circuit movement, as described in details in
Then, optionally, at step 406, the code reader of the present invention may determine the coding information associated with the test strip when the test strip is placed still in the code reader. That is, for example, when the contact pads 322 and 314 are electrically coupled to the metal pins 332 and 334, respectively, in
At step 408, the coding information obtained from the test strip is used to calibrate the biological measuring device before a user uses it to obtain a test result. The present method ends at step 410.
Refer now to
At step 506, in one embodiment of the present invention, the code reader may count the number of logical value of one generated by the test strip. Then, at step 508, the code reader may compare the number of logical value of one generated by the test strip against a predetermined number set for the logical value. For example, the predetermined number may be any even number. That is, the code reader may perform an even parity check at step 508. Therefore, if the number of logical value of one generated by the test strip is two, then, at step 510, there is a match. As a result, the coding information obtained is deemed correct at step 510.
However, if the number of logical value of one generated by the test strip is one, then at step 510, there is no match. As a result, the coding information obtained is deemed in incorrect. In such case, the biological measuring device of the present invention may alert the user and/or request the user to insert the test strip again before the biological measuring device may be used properly.
In another embodiment of the present invention, at step 508, the code reader may compare the number of logical value of one generated by the test strip against a predetermined number set for the logical value. For example, the predetermined number may be any odd number. That is, the code reader may perform an odd parity check at step 508. Therefore, if the number of logical value of one generated by the test strip is three, then, at step 510, there is a match. As a result, the coding information obtained is deemed correct at step 510.
However, if the number of logical value of one generated by the test strip is two, then at step 510, there is no match. As a result, the coding information obtained is deemed incorrect. In such case, the biological measuring device of the present invention may alert the user and/or request the user to insert the test strip again before the biological measuring device may be used properly. The present invention ends at step 516.
In accordance with the present invention, the code reader's capability to read the coding information associated with the test strip as the test strip moves into the code reader increases the amount of information that may be encoded on the test strip without changing the existing structure and configuration of the biological measuring device and the test strip. For example, an arrangement of the eight contact pads with 2 rows of 4 contact pads provided on the substrate may exhibit 16 (=24) codes in any given test strip originally. By reading the code information based on the movement of the test strip before the test strip is placed still in relation to the code reader of the present invention, the code information carried by the test strip may increase to, for example, 81 (=1×20+4×21+6×22+4×23+1×24) codes without increasing the number of contact pads on the substrate. Furthermore, by assigning a parity bit to one of the contact pads on the test strip, the correctness of the coding information associated with the test strip read by the cod ready may be improved.
While the invention has been described in conjunction with exemplary preferred embodiments, it is to be understood that many alternatives, modifications, and variations will be apparent to those skilled in the art in light of the foregoing description. Accordingly, the present invention embraces all such alternatives, modifications, and variations. All matters set forth herein or shown in the accompanying drawings are to be interpreted in an illustrative and non-limiting sense.
This application is related to and claims priority to U.S. provisional patent application, U.S. Provisional Application No. 61/408,569, filed on Oct. 29, 2010, by the applicants Cheng-Che Lee, Wen-Hai Tsai, Keng-Hao Chang, Chiu-Chin Yang, Waken Chen, and Jih-Hsin Yeh, entitled “Biosensor and Test Strip and Methods of Manufacturing Same.”
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