GB2509146A

GB2509146A - Hand held test meter with low-distortion signal generation

Info

Publication number: GB2509146A
Application number: GB201223262A
Authority: GB
Inventors: David Elder; Rossano Massari
Original assignee: LifeScan Scotland Ltd
Current assignee: LifeScan Scotland Ltd
Priority date: 2012-12-21
Filing date: 2012-12-21
Publication date: 2014-06-25
Anticipated expiration: 2032-12-21
Also published as: HK1198717A1; GB2509146B; GB201223262D0

Abstract

A hand-held test meter for use with an analytical test strip in the determination of analytes in a sample includes a housing, a clock module, a microcontroller, a low-distortion signal generation (LDSG) circuit block 116, and a strip port connector configured to operationally receive the analytical test strip. The LDSG circuit includes a signal summation circuit (SSC) 119 and a single operational amplifier 122. The clock module and microcontroller are configured to generate phase-shifted square wave signals A, B, and output the phase-shifted square wave signals to the SSC configured to sum the phase-shifted square wave signals to generate a resultant summed-wave signal and output the resultant signal to the amplifier to produce a low distortion signal used to analyse a test strip. The LDSG circuit includes an RC filter 120 to filter harmonics from the summed-wave signal thereby creating a reduced harmonic distortion signal.

Description

HAND-HELD TEST METER

WITH LOW-DISTORTION SIGNAL GENERATION CIRCUIT BLOCK

FIELD OF THE INVENTION

[0001] The present invention relates, in general, to medical devices and, in particular, to test meters and related methods.

BACKGROUND

[0002] The determination (e.g., detection and/or concentration measurement) of an analyte in, or characteristic of, a bodily fluid sample is of particular interest in the medical field. For example, it can be desirable to determine glucose, ketone bodies, cholesterol, lipoproteins, triglycerides, acetaminophen, hematocrit and/or HbAlc concentrations in a sample of a bodily fluid such as urine, blood, plasma or interstitial fluid. Such determinations can be achieved using a hand-held test meter in combination with analytical test strips (e.g., electrochemical-based analytical test strips).

SUMMARY OF THE INVENTION

[0003] In a first aspect, a test meter for use with an analytical test strip in the determination of an analyte in a bodily fluid sample, the test meter comprising: a housing; a clock module disposed in or on the housing; a controller disposed in the housing; a low-distortion signal generation circuit block disposed in the housing that includes: a signal summation circuit sub-block; a filter; and an operational amplifier; and a strip port connector configured or adapted to operationally receive an analytical test strip; and wherein the clock module and controller are configured or adapted to generate a plurality of phase-shifted square wave signals and output the plurality of phase-shifted square wave signals to the signal summation circuit; and wherein the signal summation circuit is configured or adapted to sum the plurality of phase-shifted square wave signals to generate a resultant summed-wave signal and output the resultant summed-wave signal to the filter; and wherein the filter is configured or adapted to filter harmonics from the resultant summed-wave signal thereby creating a reduced harmonic distortion signal; and wherein the single operational amplifier is configured or adapted to amplify the reduced harmonic distortion signal to produce an amplified reduced harmonic distortion signal that can be output to an analytical test strip received in the meter.

[0004] The test-meter may be a hand-held test meter. The test strip may be received in a test-strip port connector. The controller may be a micro-controller.

The filter may be a resistance-capacitance (R-C) filter. The meter may comprise a single operational amplifier or further may comprise only one operational amplifier.

[0005] The hand-held test meter may further include a signal phase and magnitude measurement circuit. The plurality of phase-shifted square wave signals may include a first phase-shifted square wave signal and a second phase-shifted square wave signal. The first phase-shifted square wave signal and the second phase shifted square wave signal may have a phase difference in the range of 45 degrees to 75 degrees. The first phase-shifted square wave signal and the second phase shifted square wave signal may have a phase difference of 60 degrees.

[0006] The microcontroller may include: a timer block, wherein the timer block is employed or configured to create or generate the plurality of phase-shifted square waves.

[0007] The resultant summed wave signal may approximate or be a sine wave signal and may be essentially or wholly free of 3rd order harmonics. The amplified reduced harmonic distortion signal may have a total harmonic distortion of less than 1.1%.

[0008] The analytical test strip may be an electrochemical-based analytical test strip configured or adapted for the determination of glucose and hematocrit of a bodily fluid sample.

[0009] The clock module, micro-controller and low-distortion signal generation circuit block may be configured to measure the phase shift of a bodily fluid sample in a sample cell of an analytical test strip inserted in the hand-held test meter by forcing amplified low distortion signal of through the bodily fluid sample.

[0010] The amplified reduced harmonic distortion signal may be an amplified reduced harmonic distortion sine wave signal.

[0011] In a second aspect, a method for employing a test meter and analytical test strip comprises: inserting an analytical test strip into a strip port connector of the test meter; generating, using a clock module and a controller of the hand-held test meter, a plurality of phase-shifted square wave signals and outputting the plurality of phase-shifted square wave signals to a low-distortion signal generation circuit block of the meter; employing a signal summation circuit sub-block, filter and single operational amplifier of the low-distortion signal generation to sum the plurality of phase-shifted square wave signals to generate a resultant summed-wave signal and filter harmonics from the resultant summed-wave signal to thereby create a reduced harmonic distortion signal; and amplify the reduced harmonic distortion signal to produce an amplified reduced harmonic distortion signal that is output to the analytical test strip received in the strip port connector; and determining at least one of an analyte in, and a characteristic of, a bodily fluid sample applied to the analytical test strip using the amplified reduced harmonic distortion signal.

[0012] The test-meter may be a hand-held test meter. The test strip may be connected to the meter by being received in a test-strip port connector. The controller may be a micro-controller. The filter may be a resistance-capacitance (R-C) filter. The meter may comprise a single operational amplifier or further may comprise only one operational amplifier.

[0013] The step of employing may include employing the amplified reduced harmonic distortion signal to determine hematocrit of a whole blood sample applied to the analytical test strip.

[0014] The plurality of phase-shifted square waves may be a first phase-shifted square wave and a second phase-shifted square wave. The amplified reduced harmonic distortion signal may be a sine wave.

[0015] The first phase-shifted square wave signal and the second phase shifted square wave signal may have a phase difference in the range of 45 degrees to degrees. The first phase-shifted square wave signal and the second phase shifted square wave signal may have a phase difference of 60 degrees.

[0016] The first phase-shifted square wave signal and the second phase shifted square wave signal may be digital signals. The amplified reduced harmonic distortion signal may be a sine wave signal.

[0017] The amplified reduced harmonic distortion signal may be a sine wave signal with a total harmonic distortion of less than 1.1%. The amplified reduced harmonic distortion signal may be a sine wave signal essentially free of 3rd order harmonics.

[0018] In a third aspect, a test meter may comprise: a housing; a clock module disposed in the housing; a controller disposed in the housing; a low-distortion signal generation circuit block disposed in the housing that includes: a signal summation circuit sub-block; and a single operational amplifier; and a strip port connector configured or adapted to operationally receive an analytical test strip; and wherein the clock module and/or controller are each or together configured or adapted to generate a plurality of phase-shifted square wave signals and output the plurality of phase-shifted square wave signals to the signal summation circuit; and wherein the signal summation circuit is configured or adapted to sum the plurality of phase-shifted square wave signals to generate a resultant summed-wave signal and can output the resultant summed-wave signal to the single operational amplifier; and wherein the single operational amplifier is configured or adapted to amplify the resultant summed wave signal to produce an amplified low-distortion signal that can be output to an analytical test strip connected to the meter.

[0019] The test-meter may be a hand-held test meter. The test strip may be connected to the meter by being received in a test-strip port connector. The controller may be a micro-controller. The filter may be a resistance-capacitance (R-C) filter. The meter may comprise a single operational amplifier or further may comprise only one operational amplifier.

[0020] The amplified low-distortion signal may be an amplified low-distortion triangular signal. The amplified low-distortion signal may be an amplified low-distortion trapezoidal signal.

[0021] In a fourth aspect, a method for employing a test meter and analytical test strip comprises: inserting an analytical test strip into a strip port connector of the test meter; generating, using a clock module and a controller of the hand-held test meter, a plurality of phase-shifted square wave signals and outputting the plurality of phase-shifted square wave signals to a low-distortion signal generation circuit block of the hand-held test meter; employing a signal summation circuit sub-block and single operational amplifier of the low-distortion signal generation to sum the plurality of phase-shifted square wave signals to generate a resultant summed-wave signal and to amplify the resultant summed-wave signal to produce an amplified low-distortion signal that is output to the analytical test strip received in the strip port connector; and determining at least one of an analyte in, and a characteristic of, a bodily fluid sample applied to the analytical test strip using the amplified low-distortion signal.

[0022] The test-meter may be a hand-held test meter. The test strip may be connected to the meter by being received in the test-strip port connector. The controller may be a micro-controller. The filter may be a resistance-capacitance (R-C) filter. The meter may comprise a single operational amplifier or further may comprise only one operational amplitier.

[0023] The amplified low-distortion signal may be an amplified low-distortion triangular signal. The amplified low-distortion signal may be an amplified low-distortion trapezoidal signal.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings, in which like numerals indicate like elements, of which: FIG. 1 is a simplified depiction of a hand-held test meter according to an embodiment of the present invention; FIG. 2 is a simplified block diagram of various blocks of the hand-held test meter of FIG. 1; FIG. 3 is a simplified schematic diagram of a low-distortion signal generation circuit block as can be employed in embodiments of the present invention; FIG. 4 is a more simplified (i.e., reduced to one active component) schematic of the low distortion signal generation circuit block of FIG. 3; FIG. 5 is a simplified stacked depiction of two phase-shifted square wave signals and a resultant summed-wave signal that employs a stacked y-axis format; FIG. 6 is a simplified electrical schematic of an electrical circuit block used for various simulations, including a simulation of (i) a low-distortion signal generation circuit block as can be employed in various embodiments of the present invention and (H) an alternative signal generation circuit block; FIG. 7 is a simplified graph of a 1st harmonic simulation amplitude results versus phase separation generated using the electrical circuit block of FIG. 6; FIG. 8 is a simplified graph of 2nd 3rd 4th and 5th harmonic simulation amplitude results versus phase separation generated using the electrical circuit block of FIG. 6; FIG. 9 is a simplified graph of Total Harmonic Distortion (THD) results versus phase separation generated using the electrical circuit block of FIG. 6; FIG. 10 is a bar chart (with the y-axis representing relative strength) comparing harmonic simulation amplitude results for a low-distortion signal generation block employing 2nd order filtration and -i-f-60-degree square wave phase separation as can be employed in embodiments of the present invention and an alternative signal generation block employing a 4th order filter; and FIG. 11 is a flow diagram depicting stages in a method for employing a hand-held test meter according to an embodiment of the present invention.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0025] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered.

The drawings, which are not necessarily to scale, depict exemplary embodiments for the purpose of explanation only and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.

[0026] As used herein, the terms "about" or "approximately" for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein.

[0027] In general, hand-held test meters for use with an analytical test strip in the determination of an analyte in, and/or a characteristic of, a bodily fluid sample according to embodiments of the present invention include a housing, a clock module disposed in the housing, a micro-controller disposed in the housing, a low-distortion signal generation circuit block disposed in the housing, and a strip port connector configured to operationally receive an analytical test strip. The low-distortion signal generation circuit block includes a signal summation circuit sub-block, a resistance-capacitance (RC) filter, and a single operational amplifier.

[0028] The clock module and micro-controller are configured to generate a plurality of phase-shifted square wave signals and output the plurality of phase-shifted square wave signals to the signal summation circuit. The signal summation circuit is configured to sum the phase-shifted square wave signals to generate a resultant summed-wave signal and output the resultant summed-wave signal to the RC filter. Furthermore, the RC filter is configured to filter harmonics from the resultant summed-wave signal, thereby creating a reduced harmonic distortion signal. The single operational amplifier is configured to amplify the reduced harmonic distortion signal to produce an amplified reduced harmonic distortion signal that is output to an analytical test strip received in the strip port connector.

[0029] Hand-held test meters according to embodiments of the present invention are beneficial in that they provide improved accuracy of determination using an inexpensive low-distortion signal generation circuit block. In addition, since the low-distortion signal generation circuit block includes only a single operational amplifier, it requires relatively little space in the hand-held test meter housing.

The low-distortion signal generation circuit block is low cost since, for example, it includes only a single active component, namely the single operational amplifier with the remainder of the circuit being composed of passive components such as batteries (or other suitable power rail source), resistors and capacitors. Despite including only a single operational amplifier, the low-distortion signal generation circuit block generates a reduced harmonic distortion signal that is beneficially low in distortion (e.g., having a Total Harmonic Distortion (THC) of less than, for example, 1.1% and 0.8% for 2nd and 4th order harmonics respectively) and, therefore, particularly suitable for the use in high accuracy determinations.

[0030] Once one skilled in the art is apprised of the present disclosure, he or she will recognize that an example of a hand-held test meter that can be readily modified as a hand-hand test meter according to the present invention is the commercially available OneTouch® Ultra® 2 glucose meter from LifeScan Inc. (Milpitas, California). Additional examples of hand-held test meters that can also be modified are found in U.S. Patent Application Publications No's.

2007/0084734 (published on April 19, 2007) and 2007/0087397 (published on April 19, 2007) and in International Publication Number W02010/049669 (published on May 6,2010), each of which is hereby incorporated herein in full by reference. In addition, the use other circuit configurations for the determination of hematocrit is described in U.S. Patent Application No. 13/008405, which is also hereby incorporated in full by reference.

[0031] FIG. 1 is a simplified depiction of a hand-held test meter 100 for the determination of an analyte in a bodily fluid sample according to an embodiment of the present invention. FIG. 2 is a simplified block diagram of various blocks of hand-held test meter 100. FIG. 3 is a simplified schematic diagram of a low-distortion signal generation circuit block as can be employed in embodiments of the present invention including hand-held test meter 100. FIG. 4 is a more simplified (i.e., reduced to one active component) schematic of the low distortion signal generation circuit block of FIG. 3. FIG. 5 is a simplified stacked depiction of two phase-shifted square wave signals and a resultant summed-wave signal.

[0032] FIG. 6 is a simplified electrical schematic of an electrical circuit block 200 used for various simulations, including (i) a simulation of a low-distortion signal generation circuit block as can be employed in various embodiments of the present invention and (H) an alternative signal generation circuit block. FIG. 7 is a simplified graph of a 1st harmonic simulation amplitude results versus phase separation generated using electrical circuit block 200. FIG. 8 is a simplified graph of 2nd 3rd 4th and 5ti harmonic simulation amplitude results versus phase separation generated using electrical circuit block 200. FIG. 9 is a simplified graph of Total Harmonic Distortion (THD) versus phase separation generated using electrical circuit block 200. FIG. 10 is a bar chart comparing harmonic simulation amplitude results for a low-distortion signal generation block employing 2nd order filtration and ±60-degree square wave phase separation as can be employed in embodiments of the present invention and an alternative signal generation block employing a 4th order filter.

[0033] In FIGs. 3, 4 and 6, "A" represents a first phase-shifted square wave signal, "B" represents a second phase-shifted square wave signal, and "C" represents an amplified reduced harmonic distortion signal (for example, an amplified reduced harmonic distortion sine wave signal) that is output to an analytical test strip received in the strip port connector. Signal "A" can be, for example, a 250 kHz digital square wave at 1V peak-to-peak and phase-shifted by +30 degrees. Signal "B" can be, for example, a 250 kHz digital square wave at 1V peak-to-peak and phase-shifted by -30 degrees. Signal "C" can be, for example, a 250 KHz digital sine wave at 10 my peak-to-peak.

[0034] Referring to FIGs. I through 10, hand-held test meter 100 includes a display 102, a plurality of user interface buttons 104, a strip port connector 106, a USB interface 108, and a housing 110 (see FIG. 1). Referring to FIG. 2 in particular, hand-held test meter 100 also includes a clock module 112, a micro-controller 114, a low-distortion signal generation circuit block 116, a phase-shift-based hematocrit measurement block 118 and other electronic components (not shown) for applying a test voltage to analytical test strip (labeled TS in FIGs. 1 and 2), and also for measuring an electrochemical response (e.g., plurality of test current values) and determining an analyte or characteristic based on the electrochemical response. To simplify the current descriptions, the figures do not depict all such electronic circuitry.

[0035] Low-distortion signal generation circuit block 116 includes a signal summation circuit sub-block 119; a resistance-capacitance (RC) filter 120, and a single operational amplifier 122 (see FIG. 3 in particular). Signal summation circuit sub-block 119 includes resistors Ri 0 and R7 of FIG. 3. RC filter 120 includes a first stage (i.e., capacitor C6 and resistor R9 of Fig. 3) and a second stage (i.e., capacitor C7 and resistor R8 of FIG. 3). In FIG. 3, single operational amplifier 122 is labeled U3.

[0036] Clock module 112 and micro-controller 114 are configured to generate a plurality of phase-shifted square wave signals (such as signals A and B depicted in FIG. 4) and output the plurality of phase-shifted square wave signals to signal summation circuit sub-block 119 (see FIG. 3). Signal summation circuit sub-block 119 is configured to sum the plurality of phase-shifted square wave signals to generate a resultant summed-wave signal and output the resultant summed-wave signal to RC filter 120. RC filter 120 is configured to filter harmonics from the resultant summed-wave signal, thereby creating a reduced harmonic distortion signal. Single operational amplifier 122 is configured to amplify the reduced harmonic distortion signal to produce an amplified reduced harmonic distortion signal (e.g., signal C) that is output to an analytical test strip IS received in strip port connector 106.

[0037] To illustrate the operation of clock module 112, micro-controller 114 and signal summation circuit sub-block 119, FIG. 5 depicts first and second phase-shifted square waves and the resultant summed-wave signal. In FIG. 5, the uppermost signal is a -30 degree phase-shifted square wave signal while the center signal is a +30 degree phase-shifted square wave signal. The two square wave signals are, therefore, phase-shifted by a total of 60 degrees. The lowermost signal is the resultant summed-wave signal, which is a closer approximation to a sine wave than either of the first or second phase-shifted square wave signals. It has been determined that using two square waves signals that are phase-shifted by 60 degrees to create a resultant summed-wave signal essentially completely eliminates any 3 order harmonics. However, other phase-shifts, such as phase-shifts in the range of 45 degrees to 75 degrees, can also substantially reduce 3 order harmonics.

[0038] The effect of phase separation on 1st through 5th harmonics was studied using the simulation schematic depicted in FIG. 6. The results are shown in FIGs. 7, 8, 9 and 10. In this regard, it is noted that the upper portion of the simulation schematic if FIG. 6 is a 4th order filter employing two operational amplifiers while the lower portion is essentially equivalent to the schematic of FIG. 3.

[0039] FIGs. 7, 8, 9 and 10 indicate that pt order harmonics are at a maximum for a phase separation of zero degrees and a minimum at a phase separation of degrees. FIG. 8 indicates that 2nd and 4th order harmonics are minimal due to the input square waves being composed of only odd harmonics. The 3rd order harmonic has the largest contribution to Total Harmon Distortion (THD) and has a minimum at phase separations of 60, 180 and 300 degrees (see FIG. 8). The lowest THD is at 60 degrees and 300 degrees (see FIG. 9). FIG. 10 illustrates that the 2nd 3rd and 4th order harmonic THD for low-distortion signal generation circuit block 116 gives similar performance to a 4th order RC filter with two operational amplifiers for the circumstance of two square waves shifted by 60 degrees.

[0040] In hand-held test meters according to embodiments of the present invention, it has been determined that there is a relationship between the "knee" frequency of an RC filter and a resultant sine wave in that varying the knee frequency varies the attenuation of the ft harmonic and, therefore, controls the amplitude of a resultant sine wave. For example, for a second order RC filter, reducing the amplitude of a generated square wave from 2V peak-to-peak to 2OmV peak-to-peak requires 40dB of attenuation. This requires the knee frequency to be predetermined at a level one decade (i.e., one order of -14-magnitude) below the desired frequency. Thus, for an exemplary but non-limiting desired frequency of 250KHz, an RC filter with a knee frequency of 25kHz is required.

[0041] Display 102 can be, for example, a liquid crystal display or a bi-stable display configured to show a screen image. An example of a screen image may include a glucose concentration, a date and time, an error message, and a user interface for instructing an end user how to perform a test.

[0042] Strip port connector 106 is configured to operatively interface with an analytical test strip TS, such as an electrochemical-based analytical test strip configured for the determination of hematocrit and/or glucose in a whole blood sample. Therefore, the analytical test strip is configured for operative insertion into strip port connector 106 and to operatively interface with low-distortion signal generation circuit block 116 and phase-shift-based hematocrit measurement block 118 via, for example, suitable electrical contacts.

[0043] USB Interface 108 can be any suitable interface known to one skilled in the art. USB Interface 108 is essentially a passive component that is configured to power and provide a data line to hand-held test meter 100.

[0044] Once an analytical test strip is interfaced with hand-held test meter 100, or prior thereto, a bodily fluid sample (e.g., a whole blood sample) is introduced into a sample chamber of the analytical test strip. The analytical test strip can include enzymatic reagents that selectively and quantitatively transform an analyte into another predetermined chemical form. For example, the analytical test strip can include an enzymatic reagent with ferricyanide and glucose oxidase so that glucose can be physically transformed into an oxidized form.

[0045] Micro-controller 114 also includes a memory sub-block that stores suitable algorithms for the determination of an analyte based on the electrochemical response of analytical test strip and to also determine hematocritof the introduced sample. Micro-controller 114 is disposed within housing 110 and can include any suitable micro-controller and/or micro-processer known to those of skill in the art. Suitable micro-controllers include, but are not limited to, a micro-controller commercially available from Texas Instruments (Dallas, Texas, USA) as part number M5P430F5636 and a micro-controller commercially available from STMicroelectronics, (Geneva, Switzerland) as part number 5TM8L152. Micro-controller 114 can, if desired, include a timer block that is employed in the creation of the plurality of phase-shifted square waves.

[0046] As described further below, phase-shift-based hematocrit measurement block 118 and micro-controller 114 are configured to measure the phase shift of a bodily fluid sample in a sample cell of an analytical test strip inserted in the hand-held test meter by, for example, measuring the phase shift of one or more high frequency electrical signals driven through the bodily fluid sample. In addition, micro-controller 114 is configured to compute the hematocrit of the bodily fluid based on the measured phase shift.

[0047] The amplified reduced harmonic distortion signal produced by low-distortion signal generation circuit block 116 is communicated to strip port connector 106 where it is driven across a sample cell of analytical test strip TS and the resultant signal detected by phase-shift-based hematocrit measurement block 118. Further details regarding the use of sine wave signals for the determination of hematocrit in bodily fluid samples are available in U.S. Patent Application No. 13/008405, which is hereby incorporated in full by reference.

[0048] In the embodiment described with respect to FIGs. 1-11, the amplified reduced harmonic distortion signal is a sine wave. However, hand-held test meters according to alternative embodiments of the present invention can be employed to generate other amplified low-distortion signals from a plurality of phase-shifted square wave signals including, for example, an amplified low-distortion trapezoidal wave signal and an amplified low-distortion triangular wave signal. Such trapezoidal and triangular wave signals can be created without the use of a RC filter and the distortion of the amplified signal is reduced as the number of summed phase-shifted square wave signals is increased.

[0049] Therefore and in general, alternative embodiments of a hand-held test meter for use with an analytical test strip in the determination of an analyte in, and/or a characteristic of, a bodily fluid sample according to embodiments of the present invention include a housing, a clock module disposed in the housing, a micro-controller disposed in the housing, a low-distortion signal generation circuit block disposed in the housing, and a strip port connector configured to operationally receive an analytical test strip. The low-distortion signal generation circuit block includes a signal summation circuit sub-block and a single operational amplifier.

[0050] The clock module and micro-controller are configured to generate a plurality of phase-shifted square wave signals and output the plurality of phase-shifted square wave signals to the signal summation circuit. The signal summation circuit is configured to sum the phase-shifted square wave signals to generate a resultant summed-wave signal and output the resultant summed-wave signal to single operational amplifier. The single operational amplifier is configured to amplify the resultant summed-wave signal to produce a low-distortion amplified signal (such as an amplified low-distortion triangular signal or an amplified low-distortion trapezoidal signal) that is output to an analytical test strip received in the strip port connector.

[0051] FIG. 11 is a flow diagram depicting stages in a method 300 for employing a hand-held test meter (e.g., hand-held test meter 100 of FIG. 1)according to an embodiment of the present invention.

[0052] Method 300 includes inserting an analytical test strip into a strip port connector of a hand-held test meter (see step 310 of FIG. 11). The analytical test strip can be any suitable analytical test strip including, for example, an electrochemical-based analytical test strip configured for the determination of glucose and/or hematocrit in a whole blood sample.

[0053] At step 320 of method 300, a clock module and a micro-controller of the hand-held test meter are used to generate a plurality of phase-shifted square wave signals and to output the plurality of phase-shifted square wave signals to a low-distortion signal generation circuit block of the hand-held test meter. The plurality of phase-shifted square waves can be phase shifted in a range, for example, between 45 degrees and 75 degrees.

[0054] As depicted in step 330 of FIG. 11, a signal summation circuit sub-block, resistance-capacitance (RC) filter and single operational amplifier of the low-distortion signal generation circuit block are employed to (i) sum the plurality of phase-shifted square wave signals to generate a resultant summed-wave signal, (ii) filter harmonics from the resultant summed-wave signal thereby creating a reduced harmonic distortion signal, and (Hi) amplify the reduced harmonic distortion signal to produce an amplified reduced harmonic distortion signal that is output to the analytical test strip received in the strip port connector.

Alternatively, when an amplified low-distortion triangular or trapezoidal wave signal is to be produced, the RC-filter need not be employed and the resultant summed-wave signal can be amplified to create an amplified low-distortion signal.

[0055] In step 340 of method 300, at least one of an analyte in (such as glucose) and a characteristic of (e.g., hematocrit) a bodily fluid sample applied to the analytical test strip is determined using the amplified reduced harmonic distortion signal or, alternatively, an amplified low-distortion signal.

[0056] Once apprised of the present disclosure, one skilled in the art will recognize that methods according to embodiments of the present invention, including method 300, can be readily modified to incorporate any of the techniques, benefits and characteristics of hand-held test meters according to embodiments of the present invention and described herein. For example, if desired, an analyte in the introduced bodily fluid sample can be determined using the analytical test strip, hand-held test meter and computed hematocrit.

[0057] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that devices and methods within the scope of these claims and their equivalents be covered thereby.

Claims

CLAIMS1. A hand-held test meter for use with an analytical test strip in the determination of an analyte in a bodily fluid sample, the hand-held test meter comprising: a housing; a clock module disposed in the housing; a micro-controller disposed in the housing; a low-distortion signal generation circuit block disposed in the housing that includes: a signal summation circuit sub-block; a resistance-capacitance (RC) filter; and a single operational amplifier; and a strip port connector configured to operationally receive an analytical test strip; and wherein the clock module and micro-controller are configured to generate a plurality of phase-shifted square wave signals and output the plurality of phase-shifted square wave signals to the signal summation circuit; and wherein the signal summation circuit is configured to sum the plurality of phase-shifted square wave signals to generate a resultant summed-wave signal and output the resultant summed-wave signal to the RC filter; and wherein the RC filter is configured to filter harmonics from the resultant summed-wave signal thereby creating a reduced harmonic distortion signal; and wherein the single operational amplifier is configured to amplify the reduced harmonic distortion signal to produce an amplified reduced harmonic distortion signal that is output to an analytical test strip received in the strip port connector.
2. The hand-held test meter of claim 1 further including a signal phase and magnitude measurement circuit.

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3. The hand-held test meter of claim 1 wherein the plurality of phase-shifted square wave signals includes a first phase-shifted square wave signal and a second phase-shifted square wave signal.
4. The hand-held test meter of claim 3 wherein the first phase-shifted square wave signal and the second phase shifted square wave signal have a phase difference in the range of 45 degrees to 75 degrees.
5. The hand-held test meter of claim 4 wherein the first phase-shifted square wave signal and the second phase shifted square wave signal have a phase difference of 60 degrees.
6. The hand-held test meter of any one of the preceding claims wherein the microcontroller includes: a timer block, wherein the timer block is employed to create the plurality of phase-shifted square waves.
7. The hand-held test meter of any one of the preceding claims wherein the resultant summed wave signal approximates a sine wave signal and is essentially-free of 3d order harmonics.
8. The hand-held test meter of any one of the preceding claims wherein the amplified reduced harmonic distortion signal has a total harmonic distortion of less than 1.1%.
9. The hand-held test meter of any one of the preceding claims wherein the analytical test strip is an electrochemical-based analytical test strip configured for the determination of glucose and hematocrit of a bodily fluid sample.

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10. The hand-held test meter of any one of the preceding claims wherein the clock module, micro-controller and low-distortion signal generation circuit block are configured to measure the phase shift of a bodily fluid sample in a sample cell of an analytical test strip inserted in the hand-held test meter by forcing amplified low distortion signal of through the bodily fluid sample.
11. The hand-held test meter of any one of the preceding claims wherein the amplified reduced harmonic distortion signal is an amplified reduced harmonic distortion sine wave signal.
12. A method for employing a hand-held test meter and analytical test strip, the method comprising: inserting an analytical test strip into a strip port connector of a hand-held test meter; generating, using a clock module and a micro-controller of the hand-held test meter, a plurality of phase-shifted square wave signals and outputting the plurality of phase-shifted square wave signals to a low-distortion signal generation circuit block of the hand-held test meter; employing a signal summation circuit sub-block, resistance-capacitance (RC) filter and single operational amplifier of the low-distortion signal generation to sum the plurality of phase-shifted square wave signals to generate a resultant summed-wave signal and filter harmonics from the resultant summed-wave signal to thereby create a reduced harmonic distortion signal; and amplify the reduced harmonic distortion signal to produce an amplified reduced harmonic distortion signal that is output to the analytical test strip received in the strip port connector; and determining at least one of an analyte in, and a characteristic of, a bodily fluid sample applied to the analytical test strip using the amplified reduced harmonic distortion signal.

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13. The method of claim 12 wherein the step of employing includes employing the amplified reduced harmonic distortion signal to determine hematocrit of a whole blood sample applied to the analytical test strip.
14. The method of claim 12 or claim 13 wherein the plurality of phase-shifted square waves are a first phase-shifted square wave and a second phase-shifted square wave.
15. The method of claim 14 wherein the amplified reduced harmonic distortion signal is a sine wave.
16. The method of claim 14 or claim 15 wherein the first phase-shifted square wave signal and the second phase shifted square wave signal have a phase difference in the range of 45 degrees to 60 degrees.
17. The method of claim 16 wherein the first phase-shifted square wave signal and the second phase shifted square wave signal have a phase difference of 60 degrees.
18. The method of any one of claims 12 to 17 wherein the first phase-shifted square wave signal and the second phase shifted square wave signal are digital signals.
19. The method of any one of claims 12 to 18 wherein the amplified reduced harmonic distortion signal is a sine wave signal.
20. The method of claim 19 wherein the amplified reduced harmonic distortion signal is a sine wave signal with a total harmonic distortion of less than 1.1% -23 -
21. The method of claim 19 or claim 20 wherein the amplified reduced harmonic distortion signal is a sine wave signal essentially free of 3rd order harmonics.
22. A hand-held test meter for use with an analytical test strip in the determination of an analyte in a bodily fluid sample, the hand-held test meter comprising: a housing; a clock module disposed in the housing; a micro-controller disposed in the housing; a low-distortion signal generation circuit block disposed in the housing that includes: a signal summation circuit sub-block; and a single operational amplifier; and a strip pod connector configured to operationally receive an analytical test strip; and wherein the clock module and micro-controller are configured to generate a plurality of phase-shifted square wave signals and output the plurality of phase-shifted square wave signals to the signal summation circuit; and wherein the signal summation circuit is configured to sum the plurality of phase-shifted square wave signals to generate a resultant summed-wave signal and output the resultant summed-wave signal to the single operational amplifier; and wherein the single operational amplifier is configured to amplify the resultant summed wave signal to produce an amplified low-distortion signal that is output to an analytical test strip received in the strip port connector.
23. The hand-held test meter of claim 22 wherein the amplified low-distortion signal is an amplified low-distortion triangular signal.-24 - 24. The hand-held test meter of claim 22 wherein the amplified low-distortion signal is an amplified low-distortion trapezoidal signal.25. A method for employing a hand-held test meter and analytical test strip, the method comprising: inserting an analytical test strip into a strip port connector of a hand-held test meter; generating, using a clock module and a micro-controller of the hand-held test meter, a plurality of phase-shifted square wave signals and outputting the plurality of phase-shifted square wave signals to a low-distortion signal generation circuit block of the hand-held test meter; employing a signal summation circuit sub-block and single operational amplifier of the low-distortion signal generation to sum the plurality of phase-shifted square wave signals to generate a resultant summed-wave signal and to amplify the resultant summed-wave signal to produce an amplified low-distortion signal that is output to the analytical test strip received in the strip port connector; and determining at least one of an analyte in, and a characteristic of, a bodily fluid sample applied to the analytical test strip using the amplified low-distortion signal.26. The method of claim 25 wherein the amplified low-distortion signal is an amplified low-distortion triangular signal.27. The method of claim 25 wherein the amplified low-distortion signal is an amplified low-distortion trapezoidal signal.-25 -Amendments to the claims have been made as follows:CLAIMS1. A hand-held test meter for use with an analytical test strip in the determination of an analyte in a bodily fluid sample, the hand-held test meter comprising: a housing; a clock module disposed in the housing; a micro-controller disposed in the housing; a low-distortion signal generation circuit block disposed in the housing that includes: a signal summation circuit sub-block; a resistance-capacitance (RC) filter; and a single operational amplifier; and a strip port connector configured to operationally receive an analytical test strip; and C') wherein the clock module and micro-controller are configured to generate a plurality of phase-shifted square wave signals and output the plurality of phase-o shifted square wave signals to the signal summation circuit; and wherein the signal summation circuit is configured to sum the plurality of phase-shifted square wave signals to generate a resultant summed-wave signal and output the resultant summed-wave signal to the RC filter; and wherein the RC filter is configured to filter harmonics from the resultant summed-wave signal thereby creating a reduced harmonic distortion signal; and wherein the single operational amplifier is configured to amplify the reduced harmonic distortion signal to produce an amplified reduced harmonic distortion signal that is output to an analytical test strip received in the strip port connector.2. The hand-held test meter of claim 1 further including a signal phase and magnitude measurement circuit.3. The hand-held test meter of claim 1 wherein the plurality of phase-shifted square wave signals includes a first phase-shifted square wave signal and a second phase-shifted square wave signal.4. The hand-held test meter of claim 3 wherein the first phase-shifted square wave signal and the second phase shifted square wave signal have a phase difference in the range of 45 degrees to 75 degrees.5. The hand-held test meter of claim 4 wherein the first phase-shifted square wave signal and the second phase shifted square wave signal have a phase difference of 60 degrees.6. The hand-held test meter of any one of the preceding claims wherein the microcontroller includes: a timer block, wherein the timer block is employed to create the plurality of phase-shifted square waves.7. The hand-held test meter of any one of the preceding claims wherein the resultant summed wave signal approximates a sine wave signal and is essentially-free of 3rd order harmonics.8. The hand-held test meter of any one of the preceding claims wherein (\J the amplified reduced harmonic distortion signal has a total harmonic distortion of less than 1.1%.9. The hand-held test meter of any one of the preceding claims wherein the analytical test strip is an electrochemical-based analytical test strip configured for the determination of glucose and hematocrit of a bodily fluid sample.10. The hand-held test meter of any one of the preceding claims wherein the clock module, micro-controller and low-distortion signal generation circuit block are configured to measure the phase shift of a bodily fluid sample in a sample cell of an analytical test strip inserted in the hand-held test meter by forcing amplified low distortion signal through the bodily fluid sample.11. The hand-held test meter of any one of the preceding claims wherein the amplified reduced harmonic distortion signal is an amplified reduced harmonic distortion sine wave signal.12. A method for employing a hand-held test meter and analytical test strip, the method comprising: inserting an analytical test strip into a strip port connector of a hand-held test meter; generating, using a clock module and a micro-controller of the hand-held test meter, a plurality of phase-shifted square wave signals and outputting the plurality of phase-shifted square wave signals to a low-distortion signal generation circuit block of the hand-held test meter; employing a signal summation circuit sub-block, resistance-capacitance (RC) filter and single operational amplifier of the low-distortion signal generation circuit to sum the plurality of phase-shifted square wave signals to generate a resultant summed-wave signal and filter harmonics from the resultant summed-wave signal to thereby create a reduced harmonic distortion signal; and ¶2 amplify the reduced harmonic distortion signal to produce an amplified reduced harmonic distortion signal that is output to the analytical test strip received in the strip o port connector; and determining at least one of an analyte in, and a characteristic of, a (\J bodily fluid sample applied to the analytical test strip using the amplified reduced harmonic distortion signal.13. The method of claim 12 wherein the step of employing includes employing the amplified reduced harmonic distortion signal to determine hematocrit of a whole blood sample applied to the analytical test strip.14. The method of claim 12 or claim 13 wherein the plurality of phase- shifted square waves are a first phase-shifted square wave and a second phase-shifted square wave.15. The method of claim 14 wherein the amplified reduced harmonic distortion signal is a sine wave.16. The method of claim 14 or claim 15 wherein the first phase-shifted square wave signal and the second phase shifted square wave signal have a phase difference in the range of 45 degrees to 75degrees.17. The method of claim 16 wherein the first phase-shifted square wave signal and the second phase shifted square wave signal have a phase difference of degrees.18. The method of any one of claims 12 to 17 wherein the first phase-shifted square wave signal and the second phase shifted square wave signal are digital signals.19. The method of any one of claims 12 to 18 wherein the amplified reduced harmonic distortion signal is a sine wave signal.20. The method of claim 19 wherein the amplified reduced harmonic distortion signal is a sine wave signal with a total harmonic distortion of less than 1.1% 21. The method of claim 19 or claim 20 wherein the amplified reduced (\J harmonic distortion signal is a sine wave signal essentially free of 3rd order harmonics.22. A hand-held test meter for use with an analytical test strip in the determination of an analyte in a bodily fluid sample, the hand-held test meter comprising: a housing; a clock module disposed in the housing; a micro-controller disposed in the housing; a low-distortion signal generation circuit block disposed in the housing that includes: a signal summation circuit sub-block; and a single operational amplifier; and a strip port connector configured to operationally receive an analytical test strip; and wherein the clock module and micro-controller are configured to generate a plurality of phase-shifted square wave signals and output the plurality of phase-shifted square wave signals to the signal summation circuit; and wherein the signal summation circuit is configured to sum the plurality of phase-shifted square wave signals to generate a resultant summed-wave signal and output the resultant summed-wave signal to the single operational amplifier; and wherein the single operational amplifier is configured to amplify the resultant summed wave signal to produce an amplified low-distortion signal that is output to an analytical test strip received in the strip port connector.23. The hand-held test meter of claim 22 wherein the amplified low-distortion signal is an amplified low-distortion triangular signal.
24. The hand-held test meter of claim 22 wherein the amplified low-distortion signal is an amplified low-distortion trapezoidal signal.
25. A method for employing a hand-held test meter and analytical test strip, o the method comprising: inserting an analytical test strip into a strip port connector of a hand-held test meter; generating, using a clock module and a micro-controller of the hand-held test meter, a plurality of phase-shifted square wave signals and outputting the plurality of phase-shifted square wave signals to a low-distortion signal generation circuit block of the hand-held test meter; employing a signal summation circuit sub-block and single operational amplifier of the low-distortion signal generation circuit to sum the plurality of phase-shifted square wave signals to generate a resultant summed-wave signal and to amplify the resultant summed-wave signal to produce an amplified low-distortion signal that is output to the analytical test strip received in the strip port connector; and determining at least one of an analyte in, and a characteristic of, a bodily fluid sample applied to the analytical test strip using the amplified low-distortion signal.
26. The method of claim 25 wherein the amplified low-distortion signal is an amplified low-distortion triangular signal.
27. The method of claim 25 wherein the amplified low-distortion signal is an amplified low-distortion trapezoidal signal. C') a,