BRPI0617361A2 - diagnostic test systems and method of determining the level of a constituent in a fluid - Google Patents

Abstract

<B> Diagnostic Test Systems and Method for Determining the Level of a Constituent in a Fluid <D> A diagnostic test system can include a meter for testing a sample applied to a test medium and a container selectively capable of being enclosure configured to house meter-compatible home test facilities. The system can also provide mechanisms to remove a meter from a test container and reconnect it to a new test container using one of several coding methods that recalibrate the meter to the new test strip container. Alternatively, the system may include a self-calibration system in which data is provided individually to each individual test medium in a way that is readable by the test meter. The carried data may include an embedded code relating to particular data for that individual strip. The data is presented in order to be read by a meter associated with the diagnostic test strip, in order to avoid entering the information manually. In addition, the system can also provide additional mechanisms to reconfigure the meter to perform a new function, when it has been determined that an activation event has occurred.

Description

"Diagnostic Test Systems and Method of Determining the Level of a Constituent in a Fluid" Descriptive ReportDescription of the Invention

Reference to Related Orders

This International Application claims the priority of prior US Patent Application 11 / 254,881, filed October 21,

2005. This International Application also claims the priority of US Patent Application 11 / 352,209, filed February 13,

2006. The full disclosure of each of the above Referenced Applications is incorporated herein by reference.

Previous Order US 11 / 352,209, filed February 13, 2006, is a continuation in part of Order US11 / 254,881, filed October 21, 2005, which is a continuation in part of Order US 10 / 857,917, filed June 2, 2004, which claims the benefit of Provisional US Patent Application 60 / 533,557, filed December 31, 2003, all of which are hereby incorporated by reference in their entirety. Previously filed Application 11 / 352,209 filed February 13, 2006 is also a continuation in part of US Application 11 / 181,778 filed July 15, 2005, which is hereby incorporated by reference in its entirety.

In addition, this Order relates to Order US11 / 144.715, filed July 6, 2005, as well as US Drawing Orders D506,832, issued June 28, 2005, and D507,657, issued December 19, 2005. July 2005, both entitled "Meter For an Integrated Diagnostic Test System", all of which are incorporated herein by reference in their entirety.

Field of the Invention The present invention relates to the field of diagnostic testing and, more particularly, to diagnostic testing systems using electronic meters.

Background of the Invention

Diagnostic testing systems are commonly used to perform various types of diagnostic testing on various sample types. The diagnostic test may be a qualitative or quantitative test to determine the presence, concentration or amount of one or more analytes in a sample. The assay product may be a medically significant assay product - for example, glucose, ketones, cholesterol, triglycerides, human choriogonadotropin (HCG), AlC hemoglobin, fructosamine, carbohydrates, tumor markers, lead, anti-epilepsy drugs, bilirubin, liver function, toxins or their metabolites, controlled substances, blood clotting factors (PT, APTT) etc. - contained in a biological sample - eg blood, urine, tissue, saliva etc. However, the diagnostic test is not limited to medical field. For example, the diagnostic test may determine the presence or amount of an analyte in a water, soil or chemical sample.

Such diagnostic test systems may include a test medium (for example, a test strip, tongue, disc etc.) configured to react to the presence of the analyte in a sample and a separate electronic meter configured to interface with the test media, In order to conduct the diagnostic test and indicate the diagnostic test results to the user.

In order to conduct the diagnostic test, the user must first obtain a sample test medium, such as a test strip, from a container, then obtain a sample using a sampling device (eg, draw blood using a lancet). ) and then apply the sample to the test medium (before or after inserting the test medium into the meter interface). The meter then performs the diagnostic test on the sample and indicates the result to the user, for example using a numeric monitor.

However, the diagnostic meter is often bulky. In addition, as the user must lift and land the test media container, the sampling device and the succeeding meter, the test media container, the sampling device and the meter are easily separated from one another. that users may find themselves without one or more of the components required to conduct the diagnostic test. In addition, it is inconvenient for the user to carry a separate test media container, meter and electronic sampling device.

Yet different brand or manufacturer batch testing media may respond differently to the presence or concentration of analyte in the sample. In order to obtain the most accurate results, the electronic meter may be calibrated against a given brand or batch of test strips by providing it with one or more batch-specific calibration parameters or parameters that correlate the response from a particular brand. or particular test batch medium with a standardized reference.

The user may be required to provide the meter with the appropriate calibration parameters in a separate coding step. For example, the test media container may display a code number from which the meter may determine the appropriate calibration information. The user can then manually enter the code number (for example, using buttons or other user input devices on the meter) to provide calibration data to the meter. Alternatively, the calibration data can be downloaded, for example, from the manufacturer's website. In another approach, the test media container may be provided with an associated code chip in which the calibration data is stored electronically. The user can provide calibration data to the meter by inserting the code chip into a corresponding port on the meter.

This coding step can be inconvenient or difficult for the user. For example, users of advanced age or failure may have difficulty downloading calibration data or entering code chips. In addition, users may forget to calibrate the meter for use with a new brand or lot of test media. Consequently, the user may enter incorrect calibration parameters or codes or the user may use a brand or lot test means with a calibrated meter for use with test media of a different brand or lot. In addition, since a meter is calibrated for a given batch of test media, use of a meter with test media from another batch may lead to erroneous results, which could have serious consequences for the user. For example, in cases where the test is a blood glucose self-test, an erroneous result may misinform the user about the blood glucose level, which may lead to the user having a diabetes attack.

One possible solution to the above coding problems is to use the universal coding method. This method uses strip batches that are controlled and classified for tight acceptance criteria, ie all strips are adjusted with a single set of calibration parameters, thus not requiring that strip coding or more than a fixed set of calibration parameters. strip lots are stored on meter 130. Universal coding saves the cost of replacing meter 130 by allowing it to be used on many different test strip containers110. In addition, the universal coded strips 120 may be closely controlled such that many batches of strips have the same code and are classified to fit the fixed code transmission of the meter. This method is not technique dependent and helps to prevent errors due to mixed strip batching. In addition, universal encoding always has the correct code in such a way that there is no mismatch between meter 130 and the strip batch code. However, the narrow limits imposed by this method make this solution expensive as large amounts of tailings are generated during current manufacturing processes.

Accordingly, there is a need for testable diagnostic systems that are convenient to carry and minimize the chance that a user will use a diagnostic meter with test means of a brand or lot for which the meter has not been calibrated. In addition, there is a need for diagnostic test systems that reduce the potential for testing a common sample improperly calibrated test meter for the particular test media used.

Summary of the Invention

Embodiments of the present invention are directed to diagnostic test methods and systems which obviate one or more of the limitations and disadvantages of the above systems and methods.

In one embodiment, a diagnostic test system includes a meter comprising a housing, an interface for accepting test means for performing the diagnostic test, and a controller configured to perform the diagnostic test. The system also includes a container having an opening operatively associated with the meter and configured to contain test means compatible with the meter. The test media is initially stored in the container and comprises at least one test strip embedded with a controller readable code for particular identifiers for the test strip.

Another embodiment of the invention is directed to a diagnostic testing system that includes a meter for performing a diagnostic test on a sample applied for testing the media. The meter comprises a housing, an interface for accepting test media for performing the diagnostic test. , and a controller, configured to perform the diagnostic test. A recipient has an opening and is operatively associated with the meter and configured to contain test means compatible with the meter. Test media initially stored in the container comprises at least one diagnostic test strip. The test strip comprises at least one electrically insulating layer; a conductive pattern formed on at least one insulating layer includes at least one electrode disposed on at least one insulating layer in a proximal region of the strip, electrical strip contacts disposed over at least one insulating layer in a distal region of the strip, and conductive traces that electrically connect the electrodes to the at least one. least any of the contacts on the electrical strips. A reactive layer contacts at least a portion of at least one electrode and each of the electrical strip contacts may be selectively covered with a discrete portion of electrical insulating material to form at least partially a distinct controller readable pattern to identify particular data for the strip. of tests.

Another embodiment of the invention is directed to a diagnostic test system that includes a meter for performing a diagnostic test on a sample applied for testing media. The meter comprises a housing, an interface for accepting test media for performing the diagnostic test, and a controller configured for performing the diagnostic test. A container has an opening and is operatively associated with the meter and configured to contain test media compatible with the meter. The test media initially stored in the container comprises at least one diagnostic test. The test strip comprises at least one electrically insulating layer; a conductive pattern formed on at least one insulating layer includes at least one electrode disposed over at least one insulating layer in a proximal region of the strip, electrical strip contacts disposed over at least one insulating layer in a distal region of the strip, and conductive traces that connect the electrodes to the at least one. least one of the electrical contacts had stopped. A reactive layer contacts at least a portion of at least one electrode. A first plurality of electrical contacts is comprised of contacts individually connected to an electrode. A second plurality of electrical strip contacts is comprised of the conductive pattern in the distal region of the strip and an electrically insulating material separates the first and second pluralities of electrical strip contacts.

Another embodiment of the invention is directed to a diagnostic testing system which includes a meter comprising a housing, an interface for accepting test means to perform the diagnostic testing, and a controller configured to perform the diagnostic testing. The system also includes a recipient having an opening and configured to contain meter compatible test means. The initially initially stored test media comprising at least one test strip is embedded with a code readable by the controller to identify particulars for the test strip. The meter housing is configured to close the container opening.

In another embodiment, the invention is directed to a method of determining the level of a constituent within a fluid. The method comprises providing a diagnostic testing system including a meter comprising a housing, an interface for accepting test means for performing the diagnostic test, and a controller configured to perform the diagnostic test. The method further comprises providing a container with an opening configured to contain meter-compatible test means and providing test means initially stored in the container comprising at least one common embedded test strip code readable by the controller. The method further comprises removing a test strip from the container; inserting a first end of the strip into the meter interface; apply a fluid sample at a second end of the strip; read the code embedded in the test strip with the controller; identify particular data for the test strip based on the code; and calculating the fluid constituent concentration of the fluid sample with the controller.

Additional aspects and advantages of the invention will be described in part in the following description and in part will be obvious from the description or may be learned by practicing the invention. The advantages of the invention will be realized and achieved by the particulars and combinations particularly noted in the appended claims.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.

Brief Description of the Drawings

The accompanying drawings, which are incorporated and form part of this Report, illustrate various embodiments of the invention and, together with the description, serve to explain the principles of the invention.

Figure 1 is a perspective view of a first embodiment of an integrated system consistent with the present invention.

Figure 2 is a perspective view of a second embodiment of an integrated system consistent with the present invention.

Figure 3 is a perspective view of a third mode of an integrated system consistent with the present invention.

Figure 4 is a block diagram illustrating the functional components of a diagnostic meter consistent with the present invention.

Figure 5 is a cross-sectional view of an integrated fourth mode of an integrated system consistent with the present invention.

Figure 6 is a perspective view of a meter housing comprising a clip configured to receive one or more devices used for diagnostic testing.

Figure 7 is a perspective view of a recipient with a light emitting diode located on the container.

Figure 8 is a perspective view of a recipient with a light emitting diode located on the meter.

Figure 9 is a perspective view of a container with an additionally positioned light emitting diode for illuminating an exterior portion of the container.

Figure 10 is a perspective view of a closed container with an illuminated housing.

Figure 11 is a perspective view of an open container with an illuminated housing.

Figure 12 is a perspective view of an upper portion of a container housing comprising a weakened video and a ring portion.

Figure 13 is a perspective view of an open container with an illuminated flange.

Figure 14 is a perspective view of the bank device with a replaceable meter.

Figure 15 is a straight sectional view of a test strip according to one embodiment of the present invention.

Figure 16 is a top perspective view of a test strip inserted into a meter strip connector according to one embodiment of the present invention.

Figure 17 is a cross-sectional overview of a test strip inserted in a meter strip connector according to one embodiment of the present invention.

Figure 18A is a top view of a distal portion of a test strip illustrating interruptions dividing particular regions of the connecting end of the test strip according to one embodiment of the present invention.

Figure 18B is a top view of a distal portion of a test strip illustrating conductive regions forming electrical contacts according to an embodiment of the present invention.

Figure 18C is a top view of a distal portion of a test strip illustrating a particular arrangement for a plurality of electrical contacts in accordance with an embodiment of the present invention.

Figure 18D is a top view of a distal portion of a test strip illustrating multiple insulators covering particular regions of the test strip connector end according to one embodiment of the present invention.

Figure 19 is an exploded top view of a partist of a test strip inserted into a meter strip connector according to one embodiment of the present invention.

Figure 20 is a top view of a distal portion of a test strip illustrating a plurality of electrical contacts forming a code according to one embodiment of the present invention.

Figure 21 is a simplified schematic diagram of the electrical connections between a meter and a plurality of electrical contacts of a test strip according to one embodiment of the invention.

Figure 22 is a simplified alternative schematic diagram of the electrical connections between a meter and a plurality of electrical contacts of a test strip in accordance with one embodiment of the invention.

Figure 23 is a perspective view of a strip coded earthquake and a strip ejector mechanism.

Figure 24 is a perspective view of a strip encoded remote meter USB data connector and a strip ejector mechanism.

Figure 25 is a perspective view of a strip coded remote meter and a strip ejector mechanism attached to the lancet device.

Figure 26 is a perspective view of a clip shaped clip placed around a container.

Figure 27 is a perspective view of a hole shape used to contain a container and a lancet device.

Description of Modalities

Reference will now be made in detail to exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings for reference to the same or similar parts.

1-The Integrated System

Figure 1 shows an integrated system 100 for conducting a diagnostic test according to an exemplary embodiment of the present invention. The exemplary integrated system 100 includes container 110 for holding test media, such as test strips 120, and a meter 130 for performing a diagnostic test using test strips 120 contained in container 110.

In an illustrative embodiment, the diagnostic test is determining the amount of glucose in a whole blood sample applied to a sample chamber 121 of test strip 120. For blood glucose tests, meter 130 may employ any of a variety of techniques. Preferably, the diagnostic test employs an electrochemical technique (e.g., culometry, amperometry, potentiometry, etc.). Exemplary electrochemical systems are described in US Patents 6,743,635, issued June 1, 2004, and 6,946,299, issued September 20, 2005, both entitled "System and Method for Blood Glucose Testing" and both have a common assignee. herein, which are hereby incorporated by reference in their entirety. Alternatively, meter 130 may employ a photometric technique (e.g., reflection, transmission, diffusion, absorption, fluorescence, electro-chemiluminescence, etc.) to determine the amount of glucose in the sample. Exemplary photometric systems are described in US Patents 6,201,607; 6,284,550 and 6,541,266, each having an accessory in common with the present Application, which are hereby incorporated by reference in their entirety. However, electrochemical techniques are currently preferred because, among other reasons, they require a smaller blood sample (on the order of 1 µb or less) than photometric techniques (on the order of 1 μΐ ^ or larger). In addition, instrumentation for electrochemical techniques typically requires less energy and can typically be made more compact than instrumentation for photometric techniques.

Integrated system 100 will be illustrated with reference to a diagnostic test for determining blood glucose concentration using an electrochemical technique, with the understanding that the principles of the present invention are equally applicable to other types of tests and diagnostic techniques, such as those mentioned above. In addition, while the present invention has been illustrated by using test strips in the form of test strips 120, exemplary embodiments of the present invention are not limited to a particular type of media and those of ordinary skill will recognize that the principles of the present invention are equally applicable. diagnostic testing systems which employ testing means in other forms, for example, tongues, discs, etc.

The meter 130 may be contained in a housing 131. The housing of the meter 131 is attached or otherwise includes a closing portion 140 (bottom of meter 130 in Figure 1) that connects to container 110 in order to selectively close a housing. open 111 of the container. The meter housing 131 may additionally include a fastener 144 which is configured to receive one or more containers 110 as illustrated in Figure 6. The fastener 144 is configured to be stored under lock 140 when in use and is slidably movable (as illustrated by the arrow deposition) to a lateral position of the container 110 in order to receive and secure additional containers 110. The opening 111 may be the only opening in the container 110. In an illustrative embodiment, the meter housing 131 has one side (e.g., the lower part of the housing). -to meter 131 in Figure 1) which is shaped to fit lock 140 and is attached to lock 140, for example by a mechanical fixture (clamp etc.), connection, glue, weld etc. Alternatively, the closure portion 140 may be integrally formed with the housing of the meter 131. The meter 130 and the closure 140 thus together form a lid or lid for the container 110.

Lock 140 can be configured to connect the container in various ways. In the closed position (see Figure 3), closure 140 closes opening 111 sufficiently to prevent loss or removal of the test means from container 110. Consequently, closure 140 is configured to connect container 110 to prevent test strips 120 pass through aperture 111 when closure 140 is in the closed position. Container 110 and closure 140 may also be configured to prevent light, liquid, vapor and / or air from infiltrating the container to prevent contamination or degradation of the test media. In cases where the test media is configured in such a manner As they are toxic or may present a danger of suffocation, closure 140 may optionally be configured to be child resistant to prevent children from opening container 110 and accessing the test media. For example, closure 140 and container 110 may be configured in a similar manner to well-known child resistant containers for pharmaceuticals or household chemicals.

Closure 140 may be configured as a twist cap, for example by providing interconnected (not shown) threaded threads in closure 140 and container 110. Alternatively, closure 140 may be configured to slide over the aperture, for example, into grooves. (not shown) next to the aperture. As an additional alternative, closure 140 may be provided with a catch (not shown), such as a trigger, that attaches to container 110 (or vice versa). The capture can be released by a button. However, in an illustrative embodiment, closure 140 is configured to form a snap-fit seal with the container to seal the opening against light, liquid and vapor infiltration. For example, in Figure 1, lock 140 is configured with a recess (not shown) for pressure fitting outside opening 111 so that the rim of opening 111 fits within lock 140. Alternatively, lock 140 can be configured with a projection 241 shaped to connect to the interlocking opening 111 as shown in Figure 2. However, it will be understood that the present invention is not limited to any particular container and closure configuration and that other configurations consistent with the principles of the invention may be employed. present invention.

For ease of manufacture, the opening 111 may be made in the same manner as the container 110. The housing 131 of the meter 130 also preferably has an outer shape similar to that of the container 110 so that the integrated system can be more comfortably secured and loaded, for example However, it will be understood that the container 110, meter 130 and aperture 111 need not be of the same outer shape and the container and meter may be configured in different formats without departing from the scope of the present invention.

Preferably, the container 110 is generally a straight cylindrical and the opening 111 has a circular shape as shown in Figures 1 and 2. A circular shape is a possible configuration for the opening, because it allows a tightly evenly sealed seal to be formed. pressure fitting between closure portion 140 and container 110. As shown in Figures 1-3, gauge 130 may also be generally circular and cylindrical and have a width similar to the width of the container so that the integrated gauge 100 has a generally circular-cylindrical overall shape that is comfortable to hold and carry, for example, in the pants pocket. However, the container 110, meter 130 and aperture111 may be made in any of several other ways. For example, the container may be formed as a straight oval, elliptical or rectangular cylinder to best fit the wearer's pocket.

Container 110 and closure 140 may also be provided with corresponding flanges 112 and 242, respectively, which flow against each other when the closure portion is in the closed position to further prevent liquid and vapor infiltration. The closure 140 is also preferably provided with a protrusion 143 extending sufficiently beyond the container side 110 to assist the user in opening and closing the container 110, for example by pushing up with the thumb against the protrusion 143. The protrusion 143 may be a flange distension 242 as shown in Figure 2. Alternatively, the protrusion 143 may be formed directly into the meter housing 131 as shown in Figure 3.

As shown in Figure 1, container 110 may be opened by completely removing meter 130 and closing portion 140 from container 110. Alternatively, meter 130 and / or closure 140 may be connected to container 110 in order to prevent meter 130 is separated from the container. Container 110 and meter 130 may be connected, for example, by a hinge, zipper, or other flexible connector, such as a flexible plastic strip or wire, etc. (not shown). In an illustrative embodiment, a hinge 251 connects container 110 and damp housing 131 and / or closure 140. Hinge 251 is positioned such that projection 241 fits within aperture 111 in the closed position. The connector (e.g., hinge 251) may have one end connected to container 110 and the other end connected to lock 140 and / or meter housing 131. For example, container 110 and closure 140 may be integrally connected by a hinge, for example. example, as shown in US Patent 5,723,085, entitled "Process and Apparatus for Making a LeakProof Cap and Body Assembl ', which is incorporated herein by reference in its entirety. Alternatively, one end of the connector (e.g., the hinge 251) may be connected to a ring 252 that is sized to fit over the container 110, as shown in Figure 2. Ring 252 may be configured to selectively connect. As an alternative, ring 252 may be attached to container 110, for example by welding, gluing etc. In addition, container 110 may include a light-emitting diode (LED) 253 that automatically or selectively illuminates the contents of container 110 when it is opened. The LED 253 may be positioned on the container 110 in the meter housing 131, or additionally positioned to illuminate an exterior portion of the container 110 as illustrated in Figures 7-9.

In an exemplary embodiment, container 110 and

Closures 140 are formed of polypropylene using an injection molding process. However, other materials and processes may be used without departing from the scope of the present invention.

The integrated system 100 may further include a sampling device that the user may use to obtain a sample for testing. The sampling device may be adapted to obtain a biological sample. For example, the sampling device may be a lancet device that the user may use to draw blood, for example, for a blood glucose level diagnostic test.

An exemplary integrated system incorporating the lancet device 360 is shown in Figure 3. The exemplary lancet device 360 includes a rear body 312, a finger cover 314, an outer nozzle 318, an inner nozzle 322 and a trigger 324. An exemplary lancet blade 360 further included an internal spring (not shown) that is used to propel lancet 320 past the contact surface 321 and through the skin to the user-selected depth.

As shown in Figure 3, the exemplary lancet device 360 is connected to the container 110. The lancet device 360 may be permanently connected to the container, for example, forming the rear body 312, the finger cap 314, the outer nozzle 318 or inner nozzle 322 integrally with container 110 by attaching one of these components to container 110, for example by a mechanical connection (clamp, brackets, tabs, slots), connection, glue and welding. As would be apparent to one of ordinary skill in the art, other known subjects may be used. Alternatively, the lancet device 360 may be releasably connected to the container 110 by providing corresponding releasable connectors on the lancet device 360 and the container 110. For example, the lancet device 360 may be provided with one or more slots, holes, cavities, closures, or clamps. which attach to the corresponding structures in the container 110or vice versa. As shown in Figure 18, a fastener clip 608 may be stretched over the container 110 for tight fit. The fastener clip 608 includes a releasably connectable clip to the lancet device 360 in place. Similarly, Figure 19 materializes fastener holes 610 designed to paralyze container 110 and lancet device 360 in conjunction with one attachment. One of ordinary skill in the art will appreciate that other types of fasteners may be used to receive one or more devices used for diagnostic testing, such as brackets, magnets, bayonet latches, slots, latches and hook and loop fasteners, etc. Alternatively, the lancet device 360 may be connected to the housing 131 of the meter 130 or the closing portion 140. Preferably, only one of the rear bodies 312, the finger cover 314, the outer nozzle 318 or the inner dobby 322 is attached to the housing. 110 so that lancet device 360 can be adjusted and used without disconnecting it from container 110.

In order to extract a sample using the exemplary lancet device 360, the user may first select a desired lancet penetration depth 320 by rotating the outer nozzle 318 so that the desired depth indicator 326 on the outer nozzle 318 is aligned with the arrow 328 on the inner nozzle. 322. The user then loads the inner spring by pulling the inner nozzle 322 away from the rear body 312 and places the contact surface 321 against the surface to be lanced. The user may then move the trigger 324 to release the inner spring, which drives the lancet device 320 beyond the contact surface 321 to the indicated depth and thereby into the skin. A blood sample can then be applied to the sample chamber 121 of the test strip 120.

Additional details of exemplary lancet device 360 are shown in previous Application 10 / 757,776, entitled "LancingDeviceT, filed January 15, 2004, the assignee being in common with the present Application, which is hereby incorporated by reference in its entirety. The invention is not limited to any particular sampling device and one of ordinary skill in the art will recognize that other sampling devices may be incorporated in a similar manner to the exemplary device described above.

2. Meter Electronics

Figure 4 shows a block diagram illustrating the functional components of exemplary meter 130. As shown in Figure 4, meter 130 may include controller function 400, media interface 410, power source 420, control function of user 430, input / output function 440, indicator function 450, media release mechanism 460, voice messaging function 470, and environmental sensors 480. Although not illustrated in Figure 4, in at least one embodiment, the interface 410 may include all of the structure required for implementing a strip coding arrangement as described later in connection with Figures 15-22. For example, the media interface 410 may include the first plurality of connector contacts 738 and the second plurality of connector contacts 740 as more fully described below. Accordingly, the example follows the benefits of a strip coding system, as will be described in more detail below, and the benefits of an integrated dispenser arrangement 130 and container 110. In an illustrative embodiment, the functional components of meter 130 are contained within the housing of meter 131. However, it will be understood that some of the components of a given function may be located elsewhere in the integrated system 100.

Controller 400 controls the operation of the meter's functional components according to its instructions 402, which may be provided as software or firmware. The controller 400 may include processor 404, memory 406 and clock 408 functions. In an illustrative embodiment of the invention, processor 404, memory 406 and / or clock 408 functions may be implemented using an Application Specific Integrated Circuit (ASIC), which allows the controller to 400 is reduced in size compared to standard integrated circuit technology. However, it will be understood that the controller may be implemented using standard integrated circuit technology or other technology without departing from the scope of the present invention.

Processor function 404 executes instructions 402 used to control meter 410 functional components 410-480. In particular, processor 404 executes the instructions 402 required to perform the diagnostic test (e.g., as described in US Patents 6,743,635 and 6,946,299, incorporated by reference above). Instructions 402 for processor 404 may be stored in memory 406 or elsewhere. Memory function 406 may also store data such as calibration data and other data used in performing the diagnostic test. In exemplary embodiments of the present invention, memory 406 is used to store diagnostic test results, together with time / date data and / or associated voice message, for later review (see below).

Clock function 408 regulates execution by processing instructions 402 in time. In particular, the clock function 408 is used to regulate the step count in the diagnostic test. For example, processor 404 may use clock 408 to regulate an incubation time or other time periods necessary for the correct performance of the diagnostic test (for example, as described in US Patents 6,743,635 and 6,946,299, incorporated by reference above). The clock function 408 may be implemented by a single system clock or by multiple clocks for different purposes.

Media interface 410 accepts test media, such as test strips 120, for testing and includes a channel 411 to ensure the test media is correctly positioned when inserted by a user or media release mechanism 460. Ainterface 410 includes one or more media sensors for determining, for example, whether a test strip 120 has been correctly inserted into test port 410 (i.e., whether the interface side 122 of test strip 120 is correctly positioned with respect to the media sensors); whether a properly sized sample was applied to the sample side sample chamber 121 of the test strip; and the presence or concentration of analyte in the sample. For meters using electrochemical techniques, the media sensors may include one or more electrical contacts that correspond to electrodes on the interface side 122 of the test strip 120. For meters using photometric techniques, at least the presence or concentration of the analyte in the probe is determined. sample using an optical sensor, for example, an LED and a corresponding photodetector.

Power supply 420 provides power for meter 130 electronic components. In an illustrative embodiment, the power source is a lithium coin cell battery. However, other energy sources such as other types of batteries, solar cells or AC / DC converters may be used without departing from the scope of this invention. The output of the power source may be regulated, for example, by a voltage regulator circuit.

The user control function 430 may include, for example, one or more buttons, switches, keys or other controls for controlling the functions of meter 130. In an illustrative embodiment, the user control function 430 is implemented by one or more buttons 132 on the left side of the meter housing131 (see Figure 1). In this position, button 132 can be comfortably pressed with the thumb or right index finger, while the integrated system 100 is held in the right hand with the video 133 in a raised position. However, user control 430 may be positioned elsewhere on meter 130. For example, button 132 may be placed on the right side of meter housing 131 to make it more convenient for left-handed users, or on the upper side of the meter, for example, centered. under video 133. As another example, user control function 430 may include a switch triggered when the user opens lock 140, for example, deforms meter 130 to turn on automatically when user opens container 110 to retrieve a Test strip.

In an exemplary embodiment of the present invention, the user control function 430 is implemented using a single control, for example a single button 132, which is used to control a plurality of meter functions. For example, user control 430 can be used to control input / output function 440, indicator function 450, media release mechanism 460e, or voice message function 470 providing direct controls for these functions or via the controller. 400. User control 430 may also be used to control the diagnostic test function of controller 400. For example, when a test should be performed using a control solution (for example, as described in US Patents 6,743,635 and 6,946. 299, incorporated by reference above), button 132 may be held depressed to indicate to controller 400 that the resulting sample is from a control solution and, consequently, that the controller 400 must perform a control test on the resulting strip.

Alternatively, a plurality of user control may be provided, for example, a plurality of buttons 132, each button having different functions. For example, two buttons may be provided to allow the user to scroll through the diagnostic test results stored in memory 406 in the forward or reverse directions. As a help to the user, the function of the button or buttons 132 at the particular time may be dynamically indicated by the indicator 450 function. For example, when recapping the results of previous tests, the indicator function 450, for example, a video 133, can instruct the user to "Press Button To See Next Result". In addition, the 430 user control may have different functions at different times. For example, pressing button 132 after inserting a test strip into the media interface410 may command the controller to perform a control test on that strip, while holding down the button without inserting a test strip may command the controller video to display. the result of the previous diagnostic test.

Input / output function 440 provides low data or instructions 402 for meter 130 and / or data uploading from meter 130. Input / output function 440 can be used, for example, to gather test results. or diagnostic tests, so that they can be transferred to a memory device or to a third party, for example, a caring physician for use in treating the user. Alternatively, input / output function 440 can be used to download data (eg calibration data) or instructions 402 (eg updated software) to meter 130. Input / output function440 can be implemented using any conventional digital or analog information interface, for example a senal port, a parallel port, an optical port, an infrared interface, etc.

The indicator function 450 indicates the result of the diagnostic test to the user, for example as a numerical value in conjunction with the units of measurement. In addition to indicating the result of this diagnostic, the indicator can present other information to the user. For example, indicator 450 may indicate the average result of a plurality of tests, the time and / or date, the remaining debating life, and so on. (e.g., as described in US Patent 6,743,635 and 6,946,299, incorporated by reference above). Indicator 450 can also be used to initiate the user to perform certain diagnostic test steps, for example, to apply the test strip sample 120. In an exemplary embodiment of the present invention (examined below), indicator 450 indicates the number of test strips that remains in container 110 or the number of tests or time remaining before meter 130 becomes inoperative.

The indicator 450 function can display information in visible, audible or tactile form. For example, indicator 450 may include a video 133 for displaying information, for example using numeric values, words, and / or icons. Several different technologies can be used for video 133. For example, the video can be a liquid crystal video, a vacuum fluorescent video, an electroluminescent video, an LED video, a plasma video, and so on. In an illustrative embodiment, video 134 is a liquid crystal video. In addition, as shown in Figure 12, indicator function 450 may include a bakelite video 123 to illuminate the test insertion point 120 when it is inserted into test port 410. In addition, an upper portion of ring 124 of housing 131 can be coupled to the bakelite video 123 and constructed with a colored transparent molded part illuminating the rear light tubes or a vial light 253 (Figures 7-9) to improve visibility if the test strip 120 is inserted into a poorly located area. light up. In addition, as illustrated in Figure 13, flange 112 is also constructed with a transparent molded part that lights when container 110 is opened.

Alternatively or in addition, indicator 450 may include an audible indicator configured to indicate sound information.

For example, indicator 450 may include a speaker connected to a voice and / or sound circuit which is configured, for example, to speak the diagnostic test result or honk to indicate that an error has occurred. In addition, indicator 450 can be linked with a particular FM radio frequency to provide a user-friendly FM radio output. Similarly, the indicator 450 could be linked to any personal electronic device such as an MP3 player, a mobile phone, a handheld computer system, or a Blackberry device, etc. in order to present test information to a user. As an additional alternative, indicator 450 may be implemented as a Brailledynamic indicator for use by blind people.

In an illustrative embodiment, the indicator function 450 includes a video 133 as well as a speaker connected to a sound circuit (not shown). Video 133 may be placed on top of the meter housing 131 as shown in Figures 1 and 3. In this position, video 133 is conveniently visible when the meter is held in the hand with the thumb or index finger over button 132.

Since diagnostic test means, for example test strips 120, are typically very small, certain users may find it difficult to retrieve the test means from container 110. Accordingly, a media release mechanism may be used to provide automated release of test media from the container.

Figure 5 shows a cross section of an integrated e-exemplification system having a media release mechanism460. In this embodiment, the container is configured as a spring loaded magazine 510. A plurality of test strips 120 are stacked on top of each other in magazine 510. The maga-zine 510 may have an interior shape similar to those of the detestable means. in order to maintain stack alignment. For example, for test strips 120 shown in Figure 1, the interior of the magazine510 may generally be of rectangular straight section.

Spring 516 pushes the test strip stack against the top 518 of magazine 510, where the upper test strip 125 is operatively positioned with respect to the strip dispensing mechanism 460. The release mechanism 460 dispenses the top test strip 125 into the stack using a linear and / or rotational mechanical action. The mechanical action can be performed manually (for example by the user pulling a slide or turning a wheel) or by a motor (eg a stepper motor) powered by the user control function 430. The upper test strip 125 is slid from the stack and through slot 520. Test media used in this embodiment may be modified by applying a friction-free layer or film such as Teflon to one or both sides to ensure smooth ejection.

In cases where the particular diagnostic test requires the test strip to be inserted into the media interface 410 before the sample is applied, the media release mechanism 460 may position the interface side 122 of the ejected test strip 125 within the media interface. 410, for example, with the test interface interface side 122 connecting the media sensors and the test strip sample chamber121 projected outwardly from the meter 130, to allow the application of a sample as shown in Figure 5. Alternatively, the media release mechanism 460 may simply display one end of the upper test strip 125 to the user, who may then manually insert the test strip125 into the media interface 410 (before or after the sample is loaded). (depending on the requirements of the particular diagnostic test). The controller 400 may be instructed to count the number of test strips 120 dispensed by the media release mechanism 460 and to have the indicator function 450 indicate, for example, the number of test strips remaining 120 in magazine 510.

Voice message function 470 can be used to record a voice message associated with a given diagnostic test result. For self-testing of blood glucose level, for example, a user can use voice message function 470 to record information related to their diet during the time of the diagnostic test. The voice message may be recorded in memory 406 together with a pointer associating it with a particular test result. The use of voice message function 470 is more fully explained in previous Application 10 / 764.974, entitled "Medical Diagnostic Testing Device with Voice Message" Capability ", filed January 26, 2004, having a transferee in common with this Application, which is hereby incorporated by reference in its entirety. At the end of the meter 130's life, the meter 130 itself may receive or send to the user's healthcare assistant. The healthcare assistant can then review the results of diagnostic tests and / or associated voice messages for use in treating the user.

The environmental sensing function 480 may include one or more environmental sensors used to gather data used for performing the diagnostic test. Such environmental sensors may include, for example, a temperature sensor and / or a humidity sensor. For example, meter 130 may use a temperature reading to correct the diagnostic test result for temperature dependence (for example, as described in US6,743,635 and 6,946,299, incorporated by reference above). As an additional example, meter 130 may use a humidity reading to determine if the humidity level is too high to proceed with the diagnostic test.

3 - Preventing the Use of Incorrect Test Strips

Meter 130 may be calibrated for use with a particular test media manufacturer or lot by customizing the diagnostic test performed by meter 130 with respect to the mark or particular lot using one or more calibration parameters. These calibration parameters may include environmental corrections (eg temperature corrections), time counting period corrections (eg with respect to incubation time), voltage corrections (eg for use in electrochemical testing). ), color variations (for example, for use in photometric tests), etc., which customize the diagnostic test function of controller 400 to the particular brand or lot of test media. See, for example, US Patent 6,743,635 and 6,946,299, incorporated by reference above.

In an illustrative embodiment of the present invention, integrated system 100 includes one or more test strip containers 110 or magazines510 packaged together with a meter 130. Test strips 120 in the package are from the same manufacturing batch or otherwise the same characteristic reaction for blood glucose so that meter 130 can be calibrated once used thereafter with any of the test strips 120 in the non-recalibration package.

The diagnostic test function of the packaged meter 130 may be pre-calibrated by the manufacturer or distributor, for example by providing 402 instructions and / or custom data for the associated test media. Alternatively, the meter 130 may be user level calibrated by requiring the user to calibrate the meter against a particular brand or batch of test media before using the meter to conduct diagnostic tests. For example, the user may use user control functions 430 or input / output440 to enter or download calibration data or a code from which the controller 400 can derive calibration data. In another approach, each test media container 110 (or a group of co-packed containers from the same batch) can be provided with a data storage device that electronically stores calibration data. See, for example, U.S. Patent Nos. 6,743,635 and 6,946,299, incorporated by reference above.

In the event that the test strips 120 in the package are not the same batch or otherwise do not have the same blood glucose reaction, users may forget to calibrate meter 130 for use with a new brand or batch of test media. . Accordingly, the present invention allows meter 130 to be removed from the IlOe test strip container and transferred to another container using various different coding techniques that prevent erroneous results that could have serious consequences for the user if meter 130 were incorrectly calibrated. . Since the meter is correctly associated with a strip coding container from a combined batch, the user does not need to take any additional steps to program the meter.

3a - Strip Coding Example

In an illustrative embodiment, coding errors commonly associated with forgetting to change a code chip or a button code are prevented by the over coding method. This method is performed on test strip 120 supplied to meter 130. An established batch code parameter that corresponds to the specific test strip lot is selected from memory 406 of the meter. Strip coding is similar to universal coding in that this method is also not technically dependent and saves the cost of arranging meter 130 with each strip vial 120. With respect to strip coding, the individual test medium, such as, for example, a single test strip 120 may include a meter readable code 130 relating to data associated with a batch of test strips or particular data for that individual strip 120. The embedded information displays meter readable data that signals the domed microprocessor to access and use a particular particular set of stored calibration parameters to test means / means of a manufacturing lot to which the individual strip belongs or for an individual test strip. In this approach, the same calibration parameters noted above (eg parameters related to environmental corrections, time period corrections, voltage corrections and / or color variations etc.) can be individually provided in a test medium. (rather than a code associated with container 110) and read directly by controller 400 without danger of human error.

In one approach, each test strip 120 is embedded in a unique individual code that corresponds to an electrical contact pattern formed on the interface side 122 of test strip 120. After operative connection of the individual test strip 120 with meter 130, the meter is displayed and reads from the contact blocks on the interface side 122, a particular code representing the information signaling the meter 130 to access data related to the underlying test strip 120. The encoded information may signal the meter to access data, including, but without limitation, parameters indicating the particular test to be performed, parameters indicating connection to a test probe, parameters indicating connection to a confirmation strip, calibration coefficients, temperature correction coefficients, level correction coefficients. pH, moisture correction, hematocrit and data correction data to recognize a a particular brand of test strips.

Incorporating individualized code data into individual test strips provides numerous advantages beyond those associated with measurement accuracy. For example, with individual strip coding, a user no longer needs to manually enter the meter batch code, thus removing the possibility of user error for this critical step. Strip delote codes stored directly on the individual test strips will also provide a means for shipping mixed batches of strips into a single strip vial. In contrast, current technologies such as button / key coding require that all strips (typically packaged in one vial including 50 strips from the same batch) in one vial be of the same batch code.

Individual strip layers representing particular codes also provide bulk packaging benefits. For example, batch test strips and mixed vials including different number of strips will be possible. Strips from multiple lots could be stored centrally and packaged for sale without the time and expense of stripping from a single batch. Individual batch calibration codes stored on the strips can also provide a means of varying a code across a single batch if a batch of strips has variation from start to finish anywhere in the middle. Predetermined variations in manufacture within a strip batch can be corrected by applying a continuously variable code across the batch, thereby solving yield problems and improving strip to strip variation. In addition, individual strip-embedded batch codes can be used to distinguish different types of test strips (eg glucose versus ketone), confirmation strips or different manufacturing procedures, provide data for improved meter versions, correlate particular test strips for use. only with a specific meter or type of meter or, as will be described in more detail below, provide data relating to a particular preventative measure. The following disclosure provides an example of a particular strip coding configuration for use in a system employing an electrochemical technique. In addition, the following example combines the benefits of a strip coding system with the benefits of an integrated meter 130 and container 110 configuration as previously described. As noted above, although the present invention has been illustrated as using test strip test means 120, exemplary embodiments of the present invention are not limited to a particular type of media.

Those skilled in the art will recognize that the principles of the present invention, including examples of over coding, are equally applicable to diagnostic test systems using alternative techniques and those employing test means in other forms, for example tongues, discs etc.

The test means may be manufactured to include a sample chamber for receiving a fluid sample from the user, such as, for example, a blood sample. The sample chamber and test strip of this Report can be formed using materials and methods described in commonly owned US Patent 6,743,635, incorporated by reference above. Accordingly, the sample chamber may include a first opening at the proximal end of the test strip and a second opening for venting the sample chamber. The sample chamber may be sized to be capable of withdrawing the blood sample through the first aperture and holding the blood sample in the sample chamber by capillary action. The test strip may include a tapered section that is narrower at the proximal end or may include other indications to make it easier for the user to locate the first opening and apply the blood sample.

An operating electrode and a counter electrode may be arranged in the sample chamber optionally together with the fill detection electrodes. A reactive layer is disposed in the sample chamber and preferably contacts at least the operating electrode. The reactive layer may include an enzyme, such as glucose oxidase, and a mediator such as depotassium ferricyanide or ruthenium hexamine. The test strip has, near its distal end, a first plurality of detecting electrical contacts that are electrically connected to the electrodes via conductive traces. In addition, the test strip may also include a second plurality of strip electrical contacts near the distal end of the strip. The second plurality of electrical contacts may be arranged such that it provides, when the strip is inserted into the meter, a distinctly discernible lot code readable by the meter. As noted above, the readable code can be read as a signal for accessors, such as calibration coefficients, from an onboard memory unit on the meter related to test strips from deselot or even information corresponding to individual test strips.

The meter can be battery powered and can be of low power dormant when not in use in order to save energy. When the test strip is inserted into the meter, the first and second pluralities of electrical contacts on the test strip contacts the corresponding electrical contacts on the meter. The second plurality of electrical contacts may connect a pair of electrical contacts to the meter, causing a current to flow through a second plurality of electrical contacts. Current flow through the second plurality of electrical contacts causes the meter to wake up and enter an active mode. The meter also reads the code information provided by the second plurality and can then identify, for example, the particular test to be performed or a suitable operational state confirmation. In addition, the meter may also identify the inserted strip as a test strip or a confirmation strip based on the particular code information. If the meter detects a confirmation strip, it performs a confirmation strip sequence. If the meter detects a test strip, it performs a test strip sequence.

Following the test strip, the meter validates the operating electrode, counter electrode and, if included, fill detection electrodes, confirming that there are no low impedance paths between any of these electrodes. If the electrodes are valid, the meter indicates to the user that the sample can be applied to the test strip. The meter then applies a drop-sensing voltage between the operating and counter electrodes and detects a fluid sample, for example, a blood sample, detecting a current flow between the operating and counter electrodes (ie, a current flow through the blood sample as you connect the operating electrodes and counter). To detect that a suitable sample is present in the sample chamber and that the blood sample has run through the reactive layer and mixed with the chemical components in the reactive layer, the meter may apply a fill detection loop between the electrodes. fill sensor and measures any resulting current flowing between the fill detection electrodes. If this resultant current reaches a sufficient level within a predetermined period of time, the meter indicates to the user that a suitable sample is present and mixed with the reactive layer.

The meter may be programmed to wait a certain period of time after initially detecting the blood sample, to allow the blood sample to react with the reactive layer or to immediately start taking sequential readings. During a period of fluid measurement, the The meter applies a test voltage between the operating and counter electrodes and takes one or more measurements of the resulting current flowing between the operating and counter electrodes. The test voltage is close to the redox potential of chemistry in the reactive layer and the resulting current is related to the concentration of the particular component measured, such as the glucose level in a blood sample. In one example, the reactive layer may react with glucose in the blood sample to determine the particular concentration of glucose. In one example, glucose oxidase is used in the reactive layer. Reference to glucose oxidase is given as an example only and other materials may be used without departing from the scope of the invention. Other possible mediators include, but are not limited to, ruthenium and osmium. During a sample test, glucose oxidase initiates a reaction that oxidizes glucose to gluconic acid and reduces offerricyanide to ferrocyanide. When an appropriate voltage is applied to an operating electrode relative to a counter electrode, the offer cyanide is oxidized to ferricyanide, thus generating a current that is related to the glucose concentration in the blood sample. The meter then calculates the glucose level based on the measured current and calibration data with which the meter has been signaled to access code data read from the second plurality of electrical contacts associated with the test strip. The meter then displays the calculated glucose level to the user. Each of the above described components and their interconnection will now be described.

Figure 15 illustrates a cross-sectional overview of one embodiment of a test strip 710. Test strip 710 includes a proximal connecting end 712, a distal end 714 and is formed with a base layer 716 extending over the entire length. The base layer 716 is preferably composed of an electrically insulating material and is of sufficient thickness to provide structural support for the test strip 710. For purposes of this Application, an insulating material (e.g., an insulating layer, coating, ink or substrate, etc.) comprises any material in which electrons or ions cannot easily displace, thereby impeding the flow of electric current. Therefore, an element may be said to be isolated when it is separated from other conductive surfaces by a dielectric substance or air space that permanently offers a high resistance to current flow and rupture discharge through the substance or space. In contrast, for purposes of this Application, a resistive element is one that introduces an increased level of impedance into a circuit that reduces (but does not necessarily prevent) the flow of electric current. The base layer 16, for example, may be polyester which is about 0.36 millimeters thick, although other sizes may be used depending on the particular method of application and manufacture. Arranged on the base layer 716 is a conductive pattern (not shown).

The conductive pattern includes a plurality of electrodes disposed on the base layer 716 near the proximal end 712, a plurality of strip electrical contacts disposed on a base bed 716 near the distal end 714 and a plurality of conductive traces that connect electrodes electrically to the plurality of strip electrical contacts. For purposes of this Order, the name "contact" denotes an area intended for mechanical connection with another corresponding "contact" regardless of whether it is a completed electrical circuit or passing through the particular area.

In one embodiment, the plurality of electrodes may include an operating electrode, a counter electrode and fill detection electrodes. The conductive pattern may be applied by applying a conductive material to the base layer 716. The conductive pattern may be applied to the upper side of the strip, the underside side to date or a combination of both. The electrode material may be provided by thin-film vacuum sputtenng of a conductive material (eg gold) and a semiconductor material (eg indium oxide oxide) on the base layer 716. The resulting electrode layer may be then be more standardized according to the specific application forming particular conducting regions / paths through a laser separation process. Alternative materials and methods for providing a conductive pattern in addition to screen printing may be employed without departing from the scope of the invention. A dielectric insulating layer 718 may be formed over the conductive pattern along a portion of the test strip. between the measuring electrodes and the plurality of strip electrical contacts to prevent scratching and other damage to the electrical connection.

As seen in Figure 15, the proximal end 712 of the test strip 710 includes a sample receiving location, such as a sample chamber 720 configured to receive a patient fluid sample as described above. The sample chamber 720 may be formed in part through a slit formed between a cover 722 and the underlying measuring electrodes formed on the base layer 716. The relative position of the measuring electrodes and strip electrical contacts form a proximal electrode region 724 at one end. 710 and a distal region of strip contacts 726 at the other end.

Referring to Figure 16, a top perspective view of a test strip 710 inserted into a meter portion 730 (representing only a portion of the meter 130 of Figure 1) is illustrated. As seen in Figure 16, strip 710 includes a proximal electrode region 724, which contains the sample chamber and measurement electrodes described above. The proximal electrode region 724 may be shaped to be particularly shaped to distinguish for the user the fluid receiving end from the distal region of strip contacts 726. Meter connector 730 includes channel 411 , also shown in Figure 4, extending outwardly into a flared opening for receiving the test strip710. Connector 730 may further include spikes 736 extending a predetermined height above channel base 732. The predetermined height of spikes 736 is selected to limit extension, such as through a raised layer corresponding to test strip 710, wherein a Test strip 710 can be inserted into channel 732.

The connector portion 730 further includes a first plurality of connector contacts 738 disposed closest to the proximal end of connector portion 730 and a second plurality of connector contacts 740 disposed closer to the distal end connector portion 730. As shown, the test strip 710 is inserted into the flared opening with the distal region of strip contacts 726 extending first through the connector channel 411. Referring to Figure 17, a straight sectional overview of a test strip inserted into a 730 meter strip connector part. Channel 411 represents a proximal row of connectors comprising a first plurality of connector contacts 738. In addition, channel 411 houses a distal row of connectors comprising a second plurality of connector contacts 740. Connector contacts 738 and 740 make contact with distinct parts of the distal region of strip contacts 726, as will be described more fully below.

Figure 18A is a top view of a distal portion of a test strip 710 illustrating the distal region of strip contacts 726. The conductive pattern formed on the base layer 716 extends along the strip 710 to include the distal strip contact region 726. As illustrated in Figure 18A, the distal strip contact region 726 is divided to form two distinct conductive regions, 742 and 744 respectively. The conductive region 744 is divided into four columns forming a first plurality of electrical strip contacts, labeled 746, 748, 750, and 752, respectively. The first plurality of electrical strip contacts are electrically connected to the plurality of electrodes. measurement at the distal end test strip 710 as explained above. It should be understood that the four contacts 746-752 are merely exemplary and the system could include less or more strip electrical contacts corresponding to the number of metering electrodes included in the system.

The first plurality of strip electrical contacts 746-752 is divided, for example, through interrupts 754 formed by the underlying conductive pattern on the test strip 710. These interruptions could be formed in the conductive pattern during printing by a process of scratching, laser ablation or through a chemical cauterization / photocauterization process. In addition, other conductive interruption forming processes may be used by removing a conductor on the test strip 710, as would be apparent to a person of ordinary skill in the art. An additional interruption 754 divides the conductive region 744 from the conductive region 742 within the distal region. of strip contacts 726 and an additional interrupt 754 separates the upper right of the distal strip contact region 726 to form notch region 756, as will be described more fully in detail below.

Figure 18B illustrates a further view of the distal region of strip contacts 726. In Figure 18B, the conductive region 742, described above with respect to Figure 18A, is divided into five distinct regions delineating a second plurality of strip electrical contacts forming blocks. 758, 760, 762, 764 and 766 respectively. The second plurality of strip electrical contacts that form contact blocks 758, 760, 762, 764, and 766 may be divided by the same process used to split the first plurality of strip electrical contacts, 746, 748, 750, and 752, described above. . As noted above, the conductive pattern on the base layer 716, which at least in part forms the electrical strip contacts, may be applied to the upper strip of the strip, next to the bottom of the strip or to a combination of both. The contact blocks 758, 760, 762, 764, and 766 are configured to be operably connected to the second plurality of connector contacts 740 within the meter connector730. Through this operative connection, the meter is presented and reads, from the contact blocks, a particular code representing the information signaling the meter to access data related to the underlying test strip 710. In addition, Figure 18B represents a standard 768 by isolating an external distal end of connection 770 from the distal region of strip contacts 726.

Figure 18C illustrates a further view of the distal strip contact region 726. In Figure 18C, the distal strip contact region 726 is shown to include the first plurality of electrical strip contacts 746-752, the second plurality of strip electrical contacts forming contact blocks 758, 760, 762, 764, and 766 and separate notch region 756. As noted, the above-described conduit regions may all be formed as a result of interruptions 754 within the underlying conductive pattern. of the detest strip 710.

Figure 18D illustrates additional features of the distal strip contact region 726. A nonconductive insulating ink strip772 may provide additional separation between the conductive region 744 and conductive region 742 within the distal region of strip contacts 726.The edges between the two regions can be printed with the 772 dye to maintain distinct areas of conductivity (limited by a distinct area of insulation) and prevent scratching by contact of the meter connector during the strip insertion process, which may adversely affect the intended conductivity of one of the strip contacts. Nonconductive insulating ink 772 may be administered, for example, through a printing screen process. This screen printing of a dielectric insulation layer is advantageous in that it can be applied later in the strip fabrication process and in an easily programmable / reproducible pattern. The extra step of adding such an insulating layer may be less expensive and time consuming than methods that somehow require substrate ablation. For example, ablation of a substrate surface by laser or chemical ablation process involves a lengthy process. just remove a particular pattern of pre-existing material.

Figure 18D illustrates that test strip 710 may include another nonconductive insulating paint strip 773 formed at the distal end of test strip 710. Nonconductive insulating paint strip 773 provides a nonconductive region at the distal end of strip 710. The strip 773 thus prevents any source connector contacts from creating an active conductive connection with any part of the contact blocks 758, 760, 762, 764, and 766 before the strip is fully inserted into the meter. Consequently, the 773 strip provides an additional feature to ensure a proper connection between the 710 test strip and the corresponding meter.

Referring to Figure 19, the connector portion of meter 730 receiving a distal strip contact region 726 from test 710 is shown. Figure 19 represents a first plurality of connector contacts 738, labeled 1-4 respectively, and a second plurality. Connector contacts 740, labeled 5-9. Connector contacts 738 and 740 contact distinct parts of the distal contact region of the 726 strip. In particular, after properly inserting the test strip 710 into the connector part of the meter 730 , the strip contacts 746-752, which form the first plurality of strip contacts, are respectively electrically connected to the connector contacts 1-4, which form the first plurality of connector contacts 738. Similarly, the contact blocks 758, 760, 762, 764 and 766, which form the second plurality of strip electrical contacts, are respectively electrically connected to the 5-9 connector contacts. , which form the second plurality of connector contacts 740.

As seen in Figure 19, the first plurality of connector contacts 738 are laterally zigzagged or offset relative to the second plurality of connector contacts740. Although the first and second pluralities are illustrated as being in separate rows and offset from each other, they need not be in separate rows and may instead be offset in additional ways, such as in separate groups. test strip 710 is inserted into the meter connector connector 730, the conductive signal provided by the 758-766 contact blocks is unimpeded by any scratches or wear that would otherwise result from the first sliding contact blocks 758-766 under the connector contacts 1 -4 in order to reach their destination connection at connector contacts 5-9. Therefore, the zigzag arrangement of connector contacts 738 relative to connector contacts 740 provides a more reliable connection. In addition, applying the nonconductive insulating paint strip 772 (Figure 18D) also helps prevent the conductive layer of one of the 758-766 contact blocks from being scratched and peeled off by friction and interaction from the contacts of the 738 meter connector. As a result, the 772 nonconductive insulating paint strip 7 provides increased connector reliability and contact handling.

In one embodiment, the connection between the contact block 766 and the connector contact 9 establishes a common ground connection (or a voltage source where the polarity is reversed), thus completing an electrical circuit including the and at least a portion of the conductive region 742. The completion of this circuit may perform a wake-up function by providing a meter signal to activate from low power sleep mode. Therefore, as shown in Figure 5, Connector 9 can be positioned proximal to other contacts 5-8 to ensure that connectors 5-8 are in proper disconnect position before final closing / wiring of the circuit through contact block 766 connection and connector contacts 9. In addition, as the nonconductive insulating paint strip 773 (see Figure 18D) can be formed at the distal end of the test strip 710 and also because a conductive substance a can be removed from the notch region 756 (see Figure 18C), premature waking of the meter will be prevented. In other words, during distal movement of the test strip 710 within the connector channel 411 (see Figures 4, 16 and 17 ), the common connection will not be established at the point connector the contact 9 connects to the extreme distal end of the test strip 710. Instead, the common connection will be established only when the connector contact passes the notch 756 and the ink strip 773. , if applied, connects to a conductive part of contact block 766. Consequently, the combination of a proximally positioned connector contact 9 and a nonconductive notch region 756 provides a more reliable connection between strip 710 and the meter.

As noted above, the contact blocks 758, 760, 762,764, and 766 are configured to be operatively connected to the second plurality of connector contacts 740 within the meter connector 730. Through this operative connection, the meter is displayed and reads, from contact blocks, a particular code that signals the meter to access information related to a particular underlying test strip 710. The encoded information may signal the meter to access data, including, but not limited to, parameters indicating the particular test to be accessed. be performed, parameters indicating the connection to a test probe, parameters indicating the connection to a confirmation strip, calibration coefficients, temperature correction coefficients, pH level correction coefficients, hematocrit correction data, and data for recognize a particular brand of test strip.

One such code is illustrated in Figure 20, where the conductive contact blocks 760 and 764 are overprinted on an electrical insulating material, such as, for example, a conductive (insulating) dye layer 775. A nonconductive paint layer 775 significantly increases the impedance ( and may even prevent the flow of electric current therethrough) between the corresponding connector contacts (in this example, connector contacts 6 and 8) and the underlying strip part in several predetermined contact blocks within the conductive region 742 of the distal contact contacts. In the manner described above, with respect to Figure 18D, the use of nonconductive insulating paint 775 is particularly advantageous over other methods of changing the conductivity of a strip.

Depending on the arrangement of the strip electrical contacts, the discrete parts of the electrical insulating material forming each layer 775 may be applied to the top side of the strip, the underside of the strip or a combination of both.

After connecting the contact blocks 758, 760, 762, 764 and

766 in Figure 6 with corresponding connector contacts 740, the meter will read a particular code based on the number and pattern of overprinted contact blocks in a nonconducting ink layer 775. In other words, the use of nonconductive ink layer 775 provides a switching network to be read by the meter. When an insulator is printed on one of the conductive surfaces of the contact blocks 758, 760, 762, 764 and 766, this prevents the flow of electric current along it and alters the conductive path. between the contact block and the connector contact (for example, where no current flows). When no insulator is printed on the conductor, the current flow is relatively unimpeded (a low impedance path).

After reading a particular code, an internal memory inside the meter can access, through a stored microprocessor algorithm, specific calibration information (such as calibration coefficients) in relation to the particular test range. The meter can read the code by an analog or digital method. In analog mode, a prefixed resistive ladder is interconnected within the meter with the second plurality of connector contacts 740 (labeled 5-9 in Figure 19) such that printed nonconductive ink permutations can be correlated with a batch code. distinguished by using a drop-back voltage, resistance or current measurement. The analog method can also be used simultaneously as the auto-wake / wake feature as each code has at least one nonconductive ink block that can make a low-impedance connection wake up the meter by closing an open circuit. Analog voltage, resistance, or current level could be used to signal the meter to access any of the particular data referenced above with the underlying test strip.

Figure 21 is a schematic diagram of the electrical connections between a meter and the contact blocks 758, 760,762, 764, and 766 of a test strip according to one embodiment of the invention. Switch S5 of Figure 21 provides the connection to a single V voltage source. Therefore, switch S5 represents the required connection of contact block 766 and disconnect contact 9 in the process of reading the analog code. Switches S4-S1 schematically represent the connection between disconnector contacts 5-8 and contact blocks 758-764 of Figure 19, respectively. When a nonconductive ink layer 775 is provided over one of the contact blocks 758, 760, 762, and 764, the corresponding switch S4, S3, S2, or SI will prevent long electric current flow thereafter upon physical connection with the connector contacts. corresponding 5-8. Consequently, a particular code will correspond to a particular switching configuration in the switching network of Figure 21.

As best seen in Figure 21, each switch S4-S1 is close to adding a distinct value of additional impedance to the closed circuit by bridging the connection to a particular resistor. Therefore, by applying the Ohm and Kirchhoff laws, a circuit measurement in V0ut provides distinct values based on the particular code presented by test strip 710. In an alternative embodiment, the direction of current flow may be reversed, if desired. by connecting switch S5 to common ground and instead connecting resistor R to the single voltage source.

In digital mode, as schematically represented in Figure 22, each contact block 758-766 would be read as an individual input, unlike the single input used by the analog method. For the digital method to be used simultaneously as a self-wake / wake feature, the inputs would need to be wired together or connected to the interrupt controller of a microcontroller. Each code must have at least one non-conductive ink-free block 775 such that a low impedance connection can be made to wake up the microcontroller meter.

Nonconductive paint 775 with high and low impedance levels produces a binary code that generates a code index based on the number of blocks (P) implemented, where the number of codes is N = 2P. It is possible, however, that a code comprises an arrangement in which none of the strip electrical contacts is covered with electrical insulating material (a code with all logic "1", ie all conductors). The number of codes possible when integrated with a self-wake / wake up feature, however, is reduced to N = 2P-1. In a system with a self-wake / wake feature, a code with all zeros (all isolators) is not an active code, as this will not wake up the meter.

When a strip 710 is inserted into the connector portion 730, a contact is closed and the meter wakes up by pulling the high or low microcontroller switch. The meter will then check the output voltage (Vout) to determine the test type and then read the code bits (SI, S2, S3, S4) to determine the decode value. The selected code value may, for example, be associated with a stored set of coefficients in the meter memory for use in a glucose mapping algorithm that is particularly correlated with the reagent applied in the measuring electrode region. This code may also be associated with other types of strip parameter information, such as those referenced above. You could also select different meter setup options. Voltage drop across the V series R resistor in Figure 22 can be sensed to determine if the code values are within a predetermined range for use as a confirmation signal. This can also be used to determine the identification of the strip (confirming strip, probe of manufacture and different test type).

In addition to providing a high or low impedance level (by applying or missing an insulating non-conductive paint layer 775 over one of the contact blocks), a particulate resistive element may be applied over a particular contact block. The resistive element introduces an increased level of impedance in the circuit that reduces (but does not necessarily prevent) the resulting electrical flow. Consequently, the use of a specific resistive element over a particular contact block provides an intermediate level of resistance directly in the test strip contact block. When this intermediate level of resistance is connected to the meter by bonding with a corresponding meter connector contact, the meter can detect this "intermediate" level (for example, by a voltage drop circuit measurement applying Ohm and Kirchhoff laws).

Detection of this intermediate level can be used by the meter processor to access a new complete set of code data for the particular test strip. In other words, the provision of a resistive element layer can be used to expand the number of codes available with an adjusted number of contact blocks. For example, a strip may be formed with a particular code through a particular nonconductive dyeing pattern 775. When one of the conductive contact blocks is formed to include a particular resistive element, the same code represented by Non-conductive ink pattern can now be read by the meter to access a completely different set of data. As an example, the contact block 766 of Figure 20 (or any of the available contact blocks) could be formed to include a resistive element. By way of limitation, the resistive element could be provided in the form of a printed conductive ink. The thickness of the printed ink forming the resistive element and the resistivity of the ink composition may be varied to achieve the intended resistance for a particular contact block. Additional information made available through this code expansion may include, but is not limited to, information related to hematocrit correction, information related to improved meter versions, and information related to the particular strip type. Consequently, the use of this resistive element can be done to expand the number of code configurations available with adjusted number of contact blocks.

It should be noted that the particular configurations described of the test strip 710 and, in particular, the deconector contact configuration 738, 740 and the corresponding first and second pluralities of strip electrical contacts are merely exemplary and different configurations could be formed without leaving the scope of the invention. For example, the underside of strip 710 may be formed to incorporate an additional number of contact blocks in order to increase the size (and thus the amount of information) in the code index. Additional contact blocks on the underside of strip 710 could represent a third plurality of electrical strip contacts, thereby increasing the number of codes available. The number of codes available could thus be expanded by applying an insulating layer to particular blocks on the lower side of strip 710 in addition to the block layer on the opposite side of the strip.

While the foregoing description provides an example of a code formed by a nonconductive ink pattern and / or resistive elements on the test strip, consideration is given to alternative coding provisions on the strip. Alternative code arrangements include, but are not limited to, a code formed by a circuit element pattern on the test strip that changes capacitance or inductance of a circuit, a bar code pattern that represents the code readable by the controller, a color pattern that represents the code readable by the controller, a code based on transmission / relative reflection (eg opacity) of an element on the test strip, a code based on fluorescence or relative luminescence (including electroluminescence) of an element on the strip. a code based on a particular electrochemical property of an element on the test strip, a code based on a particular pH level of an element on a test strip, a code based on the particular spatial distribution of elements on a test strip, a code based on magnetic particles provided on the test strip (eg a such as those provided on credit / ATM cards), a code based on a particular radio frequency signal issued from an element on the test strip (eg passive resonators such as those used on anti-theft tags). to prevent shoplifting) and a code based on a particular optical character pattern on the test strip readable through optical character recognition by the controller.

Referring to the above examples, a portion of the test strip may be provided with a particular element that can be detected by the meter after insertion of the test strip into the measuring interface. For example, with respect to the color pattern example, the meter could be equipped with a photodetector element that detects the particular color. Based on the particular color detected, the meter then accesses specific data corresponding to the particular test strip readable by the controller. 3b - Examples of Separate Encoding Device

As illustrated in Figures 23 and 24, the reduced size of the previously described test strips 120 and / or 710 may require a meter 130 with a strip ejector mechanism 602 in order to discard strip 120 without touching it. In addition, the lancet device 360 can be integrated with the meter 130 as shown in Figure 14.

Another coding method that allows the measuring device 130 to be removed from the test strip container 110 and transferred to another container is button coding. A user selects a code number on meter 130 each time meter 130 is interconnected to a different container. The user then enters a code that is visually read by the user based on a value printed on the test strip container 110. At least one advantage of using button coding is that it does not require a secondary manufacturing operation to add a code to a test strip. 120 after the code is determined for that batch you hold. However, this encoding method may be less desirable than universal and strip encoding due to the possibility of encoding input errors by the user.

In an alternative embodiment, the chip code coding may also be used as an effective means for calibrating meter 130. The code chip coding method requires the user to insert a code chip with batch-specific information included in each strip pack 120 in meter 130. Code dechip coding is advantageous in that it provides a better data storage. However, there is a possibility that the user may confuse old code chips with new porengano, thus causing coding errors. Also it is not always efficient to use code chips due to the packaging and size of the connector. In addition, code chip coding requires the user to handle an additional system component for testing compared to other coding techniques. Nevertheless, code chip coding is a viable coding alternative.

Alternatively, meter 130 may be calibrated via a Universal Serial Bus (USB) 600 device. Each test media container 110 (or a co-packaged group of the same lot) may be provided with a data storage device. 600 that electronically stores the calibration data. To calibrate meter 130 to the norient container 110 or particular package, the user simply plugs the corresponding data storage device 600 into a connector (not shown) on meter 130. Controller 400 then gets the necessary instructions 402 or data to In addition, remote USB meters 600 can transfer data to a personal computer (PC) (not shown) directly from the integral USB data connector 604 (for example, as described in the Commonly Ordered Order). 11 / 118,494, filed May 2, 2005, which is incorporated herein by reference in its entirety). The data connector 604 may also be connected to the test strip container 110 via a holster-type receptacle 606 formed on the side of the test strip container 110 (as shown in Figure 23), providing a convenient form of data transfer directly. to the PC. In addition, this device can be used as an "electronic log" to transfer data stored on meter 130 to the PC. The video shows basic results, but the date and time can be set via PC and the time and date information sent to the PC with each result. In addition, the PC application may launch after detecting the USB connection to the PC. The alternative embodiment provides a remote coded strip meter 600 and an ejector button 602 attached to the lancet device 360 which may be used together or separately, as illustrated in Figures 23-25.

3c - Examples of Preventive Measures

Although the coding methods described above are designed to prevent meter calibration errors, the integrated diagnostic test system still employs additional protections (in addition to the "coding" strip approach described in Figures 15-22) to minimize the likelihood that a user misuse meter 130 with test means of a brand or lot so meter 130 has not been calibrated.

Illustrative embodiments of the present invention provide one or more preventative measures that may disable one or more meter functions in the event of certain activation events.

For example, the preventive measure may render meter 130 completely inoperative after meter 130 has been used for a certain period of time or amount of testing or with a certain amount of test media. The meter 130 can then simply be discarded or returned to the manufacturer for remanufacturing.

Alternatively, the precautionary measure may render the controller 400 diagnostic test function inoperative only or simply prevent the meter from displaying the result of a diagnostic test. The user can then hold meter 130 in order to use its remaining functions.

A given preventive measure may be activated by the occurrence of an activation event, such as the expiration of a certain period of time. The time period may be related to particular test means, for example, a particular container 110 or a test strip lot 120 for which meter 130 has been calibrated or otherwise associated. For example, a preventive measure may be activated if the current date is after a test media deadline associated with meter 130, for example, where the manufacturer indicates that particular test media should no longer be used after two years from its date. of manufacture. Alternatively, the datalimite may be determined relative to a date when a particular container was opened, for example, when the manufacturer indicates that the test media should not be used more than 2 months after its container 110 has been opened by the container. first time.

The date on which a particular test media container 110 was first opened can be estimated or determined in various ways. For example, a detector 412 monitors the pull current of LED 253 and transmits the information to meter 130, detailing how meter 130 can certify when vial 110 has been opened. This function does not need to be performed by a separate component, but can be performed by the 400 controller. In addition, where the meter 130 is pre-calibrated for use with a single container or batch of test strips, the date the The first open container can be estimated by determining the date the meter was first turned on, for example, instructing the controller 400 to record the date or start a timer when the meter 130 was first turned on or otherwise activated for use. However, since the user can turn on the meter (for example, to become familiar with the meter's functions or to calibrate the meter) indefinitely before actually using the meter to conduct a diagnostic test, the date of first use of the meter may will be overestimated by instructing controller 400 to record the date or start a timer when meter 130 is first used to perform a diagnostic test. Similarly, in cases where meter 130 is user calibrated, the date a particular container is opened can be estimated by instructing controller 400a to record the date or start a timer when meter 130 is first used to drive a diagnostic test is then calibrated or otherwise associated with a given plurality of test strips. Alternatively, where meter 130 is connected to a particular container 110, user control function 430 may include a switch actuated when user opens lock 140, for example, so that the controller is informed when container 110 is first opened. One of ordinary skill in the art will understand that other ways of determining first use of container 110 are possible.

In addition, an optical sensor, an electrical measurement, a mechanical switch or an acoustic sensor can also be used to determine how long and the accumulated time the container 110 has been open. This information can be valuable in determining the viability of test strip 120 or, in the case of a moisture sensitive test strip 120, for example, if a test strip 120 can be recovered by placing it in a dissecting container 110 for a period of time. longer time.

Further, when the test media container 110 is opened, the meter 130 can selectively automatically turn on the video 133. In other embodiments, the controller 400 may be initiated or awakened to a sleep state when the container 110 is first opened.

Detector 412 can also monitor LED 253 withdrawal current and transmit the information to meter 130, such that meter 130 can ascertain when LED 253 has been illuminated. This function does not need to be performed by a separate component, but can be performed by controller 400. Controller 400 is configured to start a timer to determine that light source 253 has been illuminated. Similar to the method described above, the timer is designed to track a time elapsed since the first time a container 110 is opened by the user. In addition, the timer is also configured to signal controller 400 to extinguish light source 253 and alert the user after a predetermined time. The alert may be, for example, an alarm, visual, audio, kinetic or combination.

The time period need not be related to a particular lot or container of test media. A particular preventive measure may be activated at a predetermined time after manufacture or first use of meter 130 or first use of a particular meter function (e.g., performing a diagnostic test), without regard to any characteristics of the test means. For example, a given preventative measure may be activated three months after the first use of the meter to conduct a diagnostic test. In any case, indicator function 450 can be used to indicate the time remaining until preventive measures are activated.

Alternatively or in addition, the controller 400 may maintain a current count of the amount of test media used or the amount of diagnostic tests performed by the meter using the current calibration data. The amount of test media used can be estimated by the number of times the test media has been inserted into the media interface 410 or, preferably, the number of times a sample has been detected, for example by media sensors. The current count can be compared to a quantity of tests or test means allowed before activating a preventative measure. The allowable amount may relate to a quantity of test media that was originally packaged with the meter 130 by the manufacturer or distributor, for example, the amount of test media originally contained in an associated recipient 110. Alternatively, the allowable amount may exceed the number of test strips contained in the associated container 110 in a small amount, for example 10%. If the current count exceeds the operating quantity then a preventative measure may be activated. Indicator function 450 can be used to indicate the amount of diagnostic tests or test media left before a preventative measure is activated. Information related to the trigger for preventive measure (for example, the time allowed, associated test media, the amount of diagnostic tests, the number of diagnostic test strips, etc.) can be obtained in a similar manner to the calibration data. In an illustrative embodiment, controller 400 is distributed with drive information, for example, encoded in memory 406 elsewhere in controller 400. Alternatively, drive information may be entered by the user. For example, drive information may be added to the calibration data that is entered or downloaded by the user. Alternatively, the user can enter or download drive information (or a code from which controller 400 can derive drive information) separately from the calibration data. As an additional example, drive information may be directly "encoded" over the particular test medium in conjunction with the calibration data previously described with respect to the approach of Figures 15-22. For example, the encoded information read by controller 400 from the test means could signal memory 406 to access the particular data corresponding to the specific code.

Controller 400 may be instructed to periodically determine whether a particular preventative measure is activated. For example, controller 400 may determine whether a preventative measure is activated on a daily or weekly basis. Alternatively or additionally, controller 400 may be instructed to determine whether a given preventive measure is activated whenever a certain event occurs. For example, controller 400 may be instructed to determine whether a preventive measure is activated whenever a test strip 120 is inserted into the interface of the test strip 110 whenever a sample is detected by the media sensors whenever a diagnostic test is performed. -co by the controller whenever the result of a diagnostic test is displayed or whenever a certain user control 430 is triggered or another meter function 130 etc.

Preventive measures can take many forms. In cases where the meter power source 420 is finite (e.g., a battery), the preventive measure may manipulate the life of the power supply 420 so that the power source, for example, a battery within housing 131, becomes inoperative. then the preventive measure is activated. For example, controller 400 may increase the load on the power source when the preventive measure is activated. The charge can be increased, for example, by raising the clock frequency of system 408 so that the rate energy is consumed by controller 400 and other electronic functions are increased. Power source 420 and thus meter 130 will then become inoperable. in a relatively short period of time. Alternatively, or additionally, controller 400 may be instructed to cause meter 130 to remain in an "on" state once the preventive measure is activated, thereby draining the power source. As an additional alternative, the controller may be instructed to open a switch or blow a fuse to disconnect power supply 420 from the electronic functions of meter 130. For this mode, meter housing 131 may be constructed such that power supply 420 is not replaceable. Indicator function 450 may indicate an estimate of the time remaining before power supply 420 and thus meter 130 becomes inoperative.

Another preventive measure may prevent a diagnostic test from being performed. For example, where meter 130 includes a self-ligating function to initiate a diagnostic test upon insertion of a test strip 120 at interface 410 (for example, as described in US Patents 6,743,635 and 6,946,299, incorporated by reference above) ), controller 400 may be instructed to deactivate the self-on function when the preventive measure is activated. The controller 400 may, however, allow the user to turn on the meter using the 430 user control function to allow access to other meter functions. For example, controller 400 may allow the user to turn on the meter and review previous test results and / or associated voice messages stored in memory406.

Alternatively, the preventive measure may allow a diagnostic test to be performed but prevent the indicator function from indicating the result. Instead, the meter may display a message indicating that the meter is not calibrated and / or that the meter needs to be replaced. As before, the 400 controller may also allow the user to review previous test results and any associated voice messages stored in memory 406.

The meter 130 itself may then be given or sent to the user's healthcare assistant. The medical care assistant can then review the results of diagnostic tests and / or associated voice messages for use in treating the user.

As an additional preventive measure, controller 400 may be instructed to reconfigure the function of meter 130. For example, controller 400 may instruct to reconfigure indicator function 450 to indicate other information instead of a diagnostic test result. For example, indicator function 450 may be reset again to indicate the time and / or date. Alternatively, indicator function 450 may be reconfigured to indicate environmental sensors 480. For example, meter 130 may indicate temperature and / or humidity, together with appropriate units, in video 133. As another alternative, controller 400 may be instructed to reconfigure the voice message function 470 to allow voice messages to be logged for purposes other than to indicate the results of a diagnostic test.

User control function 430 can be configured new according to the indicator function reset. For example, indicator function 450 may be set back to act as a timer, for example, a kitchen timer. User control 430 may be correspondingly configured as new to control the timer. For example, user control 430 can be set again to start and stop the timer. Alternatively, the 430 user control can be reconfigured to toggle between or to adjust time, date, temperature and / or humidity displays.

The meter may be provided with a clip (for example, a magnet, a velcro hook and loop clip, an insulating tape, etc.) on its back to allow the user to place the meter 130 where its new function will be useful. For example, the user may place the meter in their refrigerator. In this manner, the user may be reminded of the name of the meter manufacturer or distributor and / or logo (which may be placed next to the video 133) in a context outside the use of diagnostic tester 130.

Other embodiments of the invention will be apparent to those skilled in the art from consideration of the disclosure and practice of the invention described herein. It is intended that the Descriptive Report and the Examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following Claims.

Claims (58)

"Diagnostic Test Systems and Level Determination Method of a Constituent in a Fluid" Claims Diagnostic Testing System, characterized in that it comprises: a meter for performing a diagnostic test on a sample applied to test means, the meter having a housing comprising the meter, an interface for accepting test means from in order to perform the diagnostic test; a controller, configured to perform the diagnostic test: a container operatively associated with the meter and configured to contain test means compatible with the meter, the container having an aperture; test media initially stored in the container and comprising at least one test strip embedded with a controller-readable code to identify particular data to the test strip. Diagnostic Testing System according to Claim 1, characterized in that it further comprises a light source positioned to illuminate an interior of the container. Diagnostic Testing System according to Claim-1, characterized in that at least one test strip includes a conductive pattern including electrical contacts arranged in a distal region of the strip forming a distinct pattern representing the controller code readable to identify particular data. for the tirade tests. Diagnostic Testing System according to Claim 1, characterized in that at least one test strip includes a code pattern representing the code readable by the controller to identify particular data for the test strip. Diagnostic Testing System according to Claim 1, characterized in that at least one test strip includes a colored pattern representing the code readable by the controller to identify particular data for the test strip. Diagnostic Testing System according to Claim 3, characterized in that at least one test strip comprises: at least one electrically insulating layer in which the conductive pattern is formed; and wherein each of the electrical contacts is capable of being selectively covered with a discrete piece of electrical insulating material to produce a binary code based on the number of electrical contacts, the resulting binary code representing the controller code readable to identify particular data for the test range. Diagnostic Testing System according to Claim 3, characterized in that the electrical contacts are configured for contact when inserted into the meter interface with a plurality of contacts within the meter interface. 8. A diagnostic test system according to claim 7 wherein at least one of the electrical contact contacts includes a resistive element disposed thereon to form the distinct standard part readable by the meter upon insertion of the test strip into the test strip. Meter interface. Diagnostic Testing System according to Claim 1, characterized in that the code is used by the meter to access particular calibration parameters stored therein related to the particular test strip. Diagnostic Testing System according to Claim 1, characterized in that the code is used by the meter to perform a particular measurement corresponding to the particular date type of tests. Diagnostic Testing System according to Claim 1, characterized in that the code is used by the meter to access particular calibration parameters stored therein relating to a particular entire batch of test strips. Diagnostic Testing System, characterized in that the system comprises: a meter for performing a diagnostic test on a sample applied to test media, the meter having a housing, the meter comprising: an interface for accepting test media in order to perform the diagnostic test; a controller configured to perform the diagnostic test; a container operably associated with the meter and configured to contain meter-compatible test means, the container having an aperture; test means initially stored in the container, comprising test means by at least one diagnostic test strip comprising: at least one electrically insulating layer, a conductive pattern formed on at least one insulating layer comprising at least one electrode disposed in at least one insulating layer in a proximal region of the strip, strip contacts disposed at least one insulating layer in a distal strip region, and conductive traces that electrically connect the electrodes to at least one of the electrical strip contacts: a reactive layer that contacts at least one of the at least one electrode; and wherein each of the strip electrical contacts is capable of being selectively covered with a discrete portion of electrical insulating material to at least partially form a distinct pattern readable by the controller to identify particular data for the test strip. Diagnostic Testing System according to Claim 12, characterized in that at least one test strip includes a bar code pattern representing the code readable by the controller to identify particular data for the test strip. tests. Diagnostic Testing System according to Claim 12, characterized in that at least one test strip includes a color pattern representing the code readable by the controller to identify particular data for the test strip. Diagnostic Testing System according to Claim 12, characterized in that it further comprises at least one discrete part of electrical insulating material disposed on at least one of the strip electrical contacts to at least partially form a distinct pattern readable by the controller. to identify particular data for the test strip. Diagnostic Testing System according to Claim 12, characterized in that the distinct readable pattern for particular test strip identifiers comprises an arrangement in which none of the strip electrical contacts are covered with electrical insulating material. Diagnostic Testing System according to Claim 15, characterized in that a resistive element is disposed over at least one of the strip electrical contacts to form part of the distinct readable pattern to identify particular data for the test strip. Diagnostic Testing System according to Claim 12, characterized in that each of at least one electrode is individually connected to a contact in a first plurality of electrical strip contacts. Diagnostic Testing System according to Claim 18, characterized in that the conductive pattern in the distal region includes a second plurality of electrical strip contacts. Diagnostic Testing System according to Claim 19, characterized in that the first and second pluralities of electrical strip contacts are positioned to form distinct groups of electrical contacts, the groups being spaced apart. Diagnostic Testing System according to Claim 19, characterized in that the second plurality of electrical strip contacts form a discrete set of contact blocks. Diagnostic Testing System according to Claim 15, characterized in that the insulating material comprises a nonconductive insulating paint. Diagnostic Testing System according to Claim 21, characterized in that the contact blocks are configured for contact when inserted into a compatible meter with a plurality of contacts in a corresponding meter connector. 24. Diagnostic Testing System, characterized in that the system comprises: a meter for performing a diagnostic test on a sample applied to test media, the meter comprising: a housing, an interface for accepting test media for performing the test. diagnostic; a controller configured to perform the diagnostic test; a container operably associated with the meter and configured to contain meter compatible test means, the container having an aperture; test means initially stored in the container, the test means comprising at least one test strip; diagnostic tests comprising: at least one electrically insulating layer, a conductive pattern formed of at least one insulating layer including at least one electrode disposed in at least one insulating layer in a proximal region of the strip, electrical contacts disposed of at least one insulating layer in a region distal and conductive traces that electrically connect the electrodes to at least one of the strip electrical contacts, a reactive layer contacting at least one of at least one electrode, a first plurality of comprised strip electrical contacts of contacts individually connected to one electrode; a second plurality of electrical contacts of the comprised strip of the conductive pattern in the distal region of the strip; wherein an electrically insulating material separates the first and second plurality of strip electrical contacts. Diagnostic Testing System according to Claim 24, characterized in that each of the electrical contact contacts comprises the second plurality is capable of being selectively covered with a discrete part of electrical insulating material so as to partially form a single component. distinct pattern readable by the controller to identify particular data for the test strip. Diagnostic Testing System according to Claim 25, further comprising at least one discrete portion of electrical insulating material disposed on at least one of the strip electrical contacts to at least partially form a distinct legible pattern for identifying particular data for the tirade tests. Diagnostic Testing System according to Claim 25, characterized in that the distinct readable pattern for particular test strip identifiers comprises a configuration in which none of the strip electrical contacts are covered with electrical insulating material. Diagnostic Testing System according to Claim 26, characterized in that a resistive element is disposed over at least one of the strip electrical contacts to form part of the distinct readable pattern to identify particular data for the test strip. Diagnostic Testing System according to Claim 24, characterized in that the second plurality of electrical strip contacts form a discrete set of contact blocks. 30. A diagnostic test system according to claim 24 wherein the insulating material comprises a nonconductive insulating paint. 31. Diagnostic Testing System, characterized in that the system comprises: a meter for performing a diagnostic test on a sample applied to test media, the meter comprising: a housing, an interface for accepting test media for performing the test. diagnostic; a controller configured to perform the diagnostic test; a container configured to contain meter-compatible test means, the container having an aperture; the test device initially stored in the container and comprising at least one test strip embedded with a code-readable controller to identify particular data for test tirade; and wherein the meter housing is configured to close the aperture. Diagnostic testing system according to Claim 31, characterized in that it further comprises a light source positioned to illuminate an interior of the container. Diagnostic Testing System according to Claim 31, characterized in that at least one test strip includes a conductive pattern including electrical contacts disposed in a distal region of the strip forming a distinct pattern representing the code readable by the controller to identify data. particular for the tirade tests. Diagnostic test system according to Claim 31, characterized in that at least one test strip includes a bar code pattern representing the code readable by the controller to identify particular data for the test strip. . Diagnostic Testing System according to Claim 31, characterized in that at least one test strip includes a color pattern representing the code readable by the controller to identify particular data for the test strip. Diagnostic Test System according to Claim 33, characterized in that at least one test strip comprises: at least one electrically insulating layer in which the conductive pattern is formed; and wherein each of the electrical contacts is capable of being selectively covered with a discrete piece of electrical insulating material to produce a binary code based on the number of electrical contacts, the resulting binary code representing the controller code readable to identify particular data for the test range. Diagnostic test system according to Claim 33, characterized in that at least one test strip comprises: at least one electrically insulating layer in which the conductive pattern is formed; and wherein each of the electrical contacts is capable of being selectively covered with a discrete piece of electrical insulating material to produce a binary code based on the number of electrical contacts, the resulting binary code representing the controller code readable to identify particular data for the test range. Diagnostic Testing System according to Claim 33, characterized in that the electrical contacts are configured for contact when inserted into the meter interface with a plurality of contacts within the meter interface. Diagnostic Testing System according to Claim 38, characterized in that at least one of the electrical contacts it has includes a resistive element arranged therein to form part of the distinct meter readable pattern after insertion of the test strip into the interface of the meter. meter. Diagnostic Testing System according to Claim 31, characterized in that the code is used by the meter to access particular calibration parameters stored therein relating to the particular test strip. Diagnostic Testing System according to Claim 31, characterized in that the code is used by the meter to perform a particular measurement that corresponds to the particular date type of tests. 42. A diagnostic test system according to Claim 31 wherein the code is used by the meter to access particular calibration parameters stored therein relating to a particular entire batch of test strips. 43. The diagnostic test system of Claim 31 wherein the container comprises a fastener configured to receive one or more devices used for diagnostic testing and that the opening is accessible to a user of the system. 44. The diagnostic test system of claim 43 wherein the clip attaches to the meter. A diagnostic test system according to Claim 43, characterized in that the clip attaches to a lancet. 46. A Fluid Constituent Level Determination Method, comprising: providing a diagnostic test system comprising: a meter for performing a diagnostic test, the meter comprising: a housing, an interface for accepting detest means in order to perform the diagnostic test; a controller configured to perform diagnostic testing, a container configured to contain meter-compatible test means, the container having an opening, initially stored test means and comprising at least one embedded test strip with a code readable by the controller; and wherein the meter housing is configured to close the aperture; remove a test strip from the container; insert a first end of the strip into the measuring interface; apply a fluid sample to a second second end; read the code embedded in the test strip with the controller. identify the particular data for the code-based test strip; and calculate the fluid constituent concentration of the fluid sample with the controller. 47. A Fluid Constituent Level Determination Method according to Claim 46, further comprising closing the container with the meter housing. 48. The method of determining the level of a constituent in a fluid according to claim 46, further comprising illuminating an interior of the container with a light source. 49. The method of determining the level of a fluid constituent according to claim 46, further comprising providing at least one test strip with a conductive pattern including electrical contacts disposed in a distal region forming a distinct pattern representing the driver-readable code to identify particular data for the test strip. 50. A Fluid Constituent Level Determination Method according to Claim 46 further comprising providing at least one test strip with a bar code pattern representing the controller readable code for identifying particular data for the strip. of tests. Method of Determining the Level of a Fluid Constituent according to Claim 46, further comprising providing at least one test strip with a color pattern representing the controller readable code for identifying particular data for the test strip. tests. Method for determining the level of a fluid constituent according to Claim 49, wherein providing a diagnostic test system includes providing at least one electrically insulating layer on the test strip after which the conductive pattern is formed; and each of the electrical contacts is capable of being selectively covered with a discrete piece of electrical insulating material to produce a binary code based on the number of electrical contacts, the resulting binary code representing the controller code readable to identify particular data for the test range. Method of Determining the Level of a Fluid Constituent according to Claim 49, characterized in that inserting a first end of the strip into the meter interface includes connecting each of the electrical contacts on the strip to a plurality of corresponding contacts within the meter interface. . A Fluid Constituent Level Determination Method according to Claim 46, wherein identifying particular data for the test strip includes accessing particular calibration parameters stored in the meter with respect to the particular test strip. Method of Determining the Level of a Fluid Constituent according to Claim 46, characterized in that the code is used by the meter to perform a particular measurement that corresponds to the particular type of test strip. A Fluid Constituent Level Determination Method according to Claim 46, wherein identifying particular data for the test strip includes accessing particular calibration parameters stored in the meter with respect to a particular entire batch of test strips. Method of Determining the Level of a Fluid Constituent according to Claim 46, characterized in that the code is read by the controller by an analogous method. Method of Determining the Level of a Fluid Constituent according to Claim 46, characterized in that the code is read by the controller by a digital method.