Abstract:
A smart interface assembly is provided which enables convenient, instant, and discreet communication between an analytical meter and a computer, the transfer of data from the analytical system, and/or the provision of interface software for the display or analysis of data. The smart interface assembly includes first and second couplings for interfacing with the personal computer and the analytical meter. The smart interface assembly has processing and memory capabilities facilitating displaying test results from an analytical system on a computer. The interface can also function as a storage device allowing transfer, access, or syncing of data from a diagnostic system to or by the personal computer without the need for special drivers, and also can facilitate communications between the diagnostic system and the computer using standard device drivers likely to be already present on the computer.

Description:
TECHNICAL FIELD  
       [0001]     The present invention relates to the field of diagnostic testing and, more particularly, to diagnostic testing systems using electronic meters and digital communication.  
       BACKGROUND  
       [0002]     Diagnostic testing systems are commonly used to perform various types of diagnostic tests on various types of samples. 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. However, the diagnostic test is not limited to the medical field. For instance, the diagnostic test may determine the presence or quantity of an analyte in water, soil, food products or other fluid or chemical sample.  
         [0003]     Such diagnostic testing systems may include test media (e.g., a test strip, tab, 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 results of the diagnostic test to a user.  
         [0004]     In order to conduct the diagnostic test, the user must first obtain sample test media, e.g., a test strip, from a container, then obtain a sample using a sampling device (e.g., by drawing blood using a lancet), and then apply the sample to the test media (either before or after inserting the test media into the meter interface). The meter then performs the diagnostic test on the sample and indicates the result to the user, e.g., using a numerical display. Most diagnostic meters have an onboard memory for storing results over a period of time so that trends can be identified from the test data. It is also known in the art to provide for the transfer of this data to a personal computer (e.g., an IBM compatible PC, an Apple Mac, etc.) using a data cable. A user may then use software pre-installed on the personal computer to analyze the data, or transmit the results to a physician so that an appropriate assessment of the patient&#39;s condition can be made. The pre-installed software includes drivers necessary to allow the diagnostic meter, which is a specialized device, to communicate with the PC.  
         [0005]     It is well known that data, such as numerical values representing diagnostic test results, can be stored on removable media, such as floppy disks, CD-RW ROMs, flash drives, or other storage media of similar type. However, a difficulty can arise when a user desires to utilize a computer that does not have pre-installed drivers or analysis software. Further, the computer that the user wants to employ to analyze data may only permit software to be installed by system administrators, making it impossible to install the drivers or software application program for recognizing the meter, downloading and processing the user&#39;s data. Even if installation of software were permitted, valuable time would be wasted in troubleshooting or downloading additional software for reviewing the user&#39;s diagnostic test results. The practical result is that most users of diagnostics meters frequently do not submit to the inconvenience and complexity of using valuable analysis tools available through use of a computer, except perhaps, while at home.  
         [0006]     Accordingly, there is a need for a diagnostic testing system whose hardware and software can work together to automatically configure a computer, assign resources, and allow for hardware configuration without complicated setup maneuvers.  
       SUMMARY  
       [0007]     The present invention meets these and other needs by providing a diagnostic testing system having a meter for performing a diagnostic test on a sample applied to a test media and a smart, plug-and-play interface assembly capable of providing functionality including one or more of the following: i) auto-executable software for displaying test results from the meter attached to the computer; ii) a standalone storage device allowing the transfer, access or “syncing” of test data from the meter to or by a computer without the need for special drivers; and iii) an interface between a meter and a computer that allows communications therebetween using standard device drivers likely to be already present on a computer.  
         [0008]     Plug and Play in Windows® based computers, as well as analogous Apple Mac protocols, allow a user to connect a hardware device and have the operating system configure and start the hardware. However, computer hardware, device drivers, and the operating system must all be in sync to allow installation without user intervention. For example, although Windows® provides plug-and-play functionality, if no device driver compatible with detected new hardware is available, the operating system cannot automatically configure and start the device. For this reason, prior art diagnostic meters require the user to first download and install device drivers before connecting the meter to the computer.  
         [0009]     After a computer detects the connection of a new device, the operating system checks which hardware resources the device needs (such as interrupts, memory ranges, I/O ranges, and DMA channels) and assigns those resources. These requirements are derived from a hardware identification number provided by the device. The operating system then checks the availability of a driver that matches the hardware identification number of the device. The operating system will also choose among several drivers should more than one be identified.  
         [0010]     If the device is not automatically installed by the operating system, the procedure becomes increasingly complicated as the operating system will request information about the device and where to find drivers. For non-standard devices, such as diagnostics meters, specialized drivers are required. Also, for networked computers under administrative control, such as those most frequently encountered in the workplace, and those generally available for public access, restricted privileges are required for a user to install or configure a specialized, non-standard device.  
         [0011]     The present invention provides mechanisms for coupling a meter and a computer for communication without the requirement that the user perform any special set-up steps to auto-execute program files stored on the smart interface. To implement this plug-and-play functionality, the smart interface assembly of the present invention determines which communication protocols are required at each of its ports, and selects, activates, enables, or downloads the appropriate communication protocol drivers to enable proper operation. Data can be downloaded and stored from the meter onto a personal computer or stored on the smart interface assembly for viewing at a later, more convenient time.  
         [0012]     In one exemplary embodiment of the invention, the smart interface assembly includes a first data coupling, a second data coupling, and an electrical cable connecting the first and second data couplings. The smart interface assembly can also include a circuit board, which can be mounted on a carrier. The data couplings can be connected by any known means, e.g., hard wired connections, connectors, plugs, or wireless devices (e.g., RF, IR, BlueTooth®, etc.).  
         [0013]     According to one exemplary embodiment, the present invention can further include a plurality of electrical contacts, a protocol processor, and memory for electrically connecting to the first and second apparatuses (e.g. the meter and the personal computer). The protocol processor is capable of communicating with the first apparatus via the first data coupling and the second apparatus via the second data coupling. The data coupling, if not wireless, can include a ground contact and a voltage supply contact. If both data couplings are wireless, power can be provided to the circuitry of the smart interface device via batteries, capacitor(s), solar panel(s), a power supply or other known means.  
         [0014]     In another exemplary embodiment of the invention, a user inserts a test strip into a meter to measure the amount of glucose in the blood. After an electronic meter performs one or more diagnostic tests, the data can be analyzed on a personal computer or transmitted to a physician&#39;s computer. A user first completes a connection between a computer and the first data coupling of the smart interface. This connection can be achieved via a Universal Serial Bus (“USB”) connector IEEE-1394 plug, wireless link, or other known connection methods. The computer recognizes the interface, for example through Plug-and-Play protocols, and may execute interface software contained resident on the smart interface device, instructing the user to proceed. The user then completes a connection between the second data coupling and the data communication port of a meter in similar fashion. Once connected, the circuit of the smart interface handshakes with a processor within a microcontroller of the meter to execute machine language instructions and to complete the connection of the meter to the computer through the smart interface, for instance, through a protocol processor of the smart interface assembly. The protocol processor can auto-execute application program files stored in an onboard memory of the meter. The desired data is then transmitted from the memory directly to a processor within a microcontroller of the computer. The data can be optionally encrypted with device identification information, including a serial number of the meter, a user name, or other identifying data. Alternatively, the device and patient identification data can be transmitted from the meter together or sequentially, along with diagnostic test data, such that the computer software recognizes which data belongs with which user. The incoming data from the meter can then either be displayed on the computer&#39;s monitor or stored in a memory within the computer to be analyzed at a later time.  
         [0015]     In another exemplary embodiment of the invention the user, optionally following prompts on the meter display, first completes a connection between the second data coupling with the data communication port of the meter. Once connected, the circuit of the smart interface handshakes with the electronics of the meter to complete the connection of the meter to the smart interface, for instance, through a protocol processor within the circuit board of the smart interface assembly. The meter and smart interface combination then form a composite device. Optionally, following a prompt on the meter display, the user then completes a connection between the first data coupling and the computer (e.g., USB port, IR port, BlueTooth® or RF antenna). The computer recognizes the smart interface and meter assembly, for example through. Plug-and-Play or other recognition protocols, and may execute interface software contained resident on the interface. For instance, the protocol processor can be configured to auto-execute application program files stored in a memory of the smart interface, or stored on a memory of the meter and communicated by the smart interface. As above, the desired data can then be transmitted from the meter&#39;s memory to the computer, and the data can either be displayed on the computer&#39;s monitor or otherwise stored. In this exemplary embodiment there is no need to store data in the interface device, but rather, the PC can interface with the meter&#39;s memory through the smart interface assembly.  
         [0016]     In another exemplary embodiment, the smart interface and meter combination can contain hardware identification codes that signal to a computer, after completing a connection, that the combination device is a known device, e.g., a floppy drive. Naturally, a specialized pre-installed driver can be among those correlating the hardware identification code presented to the computer. By controlling the input and output of data to and from the device in a floppy-emulated fashion, the smart interface and meter combination can be readily interfaced with a computer using standard floppy device drivers, and can permit interfacing with a computer without special privileges. Floppy technology is long established, and implementations allow auto-execution of files which can provide for a straightforward implementation of the invention. Additionally, the standard file allocation system used by floppy drives is reliable, and can be simply emulated to allow the smart interface and meter combination to access stored data as a normal file.  
         [0017]     Additionally, present and future-developed implementations of various plug-and-play protocols and standard driver libraries can allow other input/output device drivers to be used without floppy emulation, such as flash drive drivers, PDA drivers, or even digital camera and media player drivers, etc., and this configuration is explained herein by means of example. Advantageously, operating systems choose an optimal driver from among various candidate drivers. Accordingly, the present invention enables various drivers to optimize the possibility of a successful interface.  
         [0018]     In yet another exemplary embodiment, after an electronic meter performs one or more diagnostic tests, the test results can be transferred directly to a memory of the smart interface assembly. Although modern diagnostic meters can store weeks&#39; or months&#39; worth of data, storing some or all of the data on the memory of the smart interface assembly allows for outboard storage of test results. Furthermore, the user has an option of transporting the smart interface assembly, rather than the actual meter itself, to a computer for viewing results, providing a more discrete and convenient means for uploading and viewing results. For instance, a user can employ a computer in the workplace to view and analyze the test results, without having to directly interface the test meter with the computer. With the meter not connected, for example, the smart interface can be configured to provide a device identification code to the computer, identifying it as a mass storage device such as a flash drive, or other portable data carrier and behave accordingly. For example, software can run directly from the interface to analyze data resident thereon.  
         [0019]     Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.  
         [0020]     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  
       [0021]     The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the invention and together with the description, serve to explain the principles of the invention.  
         [0022]      FIG. 1  is perspective view of a diagnostic testing system, in accordance with a preferred embodiment of the present invention;  
         [0023]      FIG. 2  is a perspective view of a smart interface assembly of  FIG. 1 , in accordance with the present invention;  
         [0024]      FIG. 3  illustrates a perspective view of a circuit board of  FIG. 2 , in accordance with a preferred embodiment of the present invention;  
         [0025]      FIG. 4  is a flow chart illustrating a method of storing and auto-executing program files from a meter to a personal computer, in accordance with a preferred embodiment of the present invention;  
         [0026]      FIG. 5  is a flow chart illustrating an alternate method of storing and auto-executing program files from a meter to a personal computer, in accordance with a preferred embodiment of the present invention;  
         [0027]      FIG. 6  is a flow chart illustrating a method of storing and auto-executing program files from a meter to a smart interface assembly, in accordance with a preferred embodiment of the present invention;  
         [0028]      FIG. 7  illustrates an exemplary block diagram of an electronic meter, in accordance with a preferred embodiment of the present invention;  
         [0029]      FIG. 8  is an exemplary block diagram of a computer, in accordance with a preferred embodiment of the present invention;  
         [0030]      FIG. 9  illustrates a smart interface assembly with two wireless connections, in accordance with a preferred embodiment of the present invention;  
         [0031]      FIG. 10  illustrates a smart interface assembly hardwired into a meter and connected wirelessly to a computer, in accordance with a preferred embodiment of the present invention;  
         [0032]      FIG. 11  is a smart interface assembly plugged into a computer and connected wirelessly to an electronic meter, in accordance with a preferred embodiment of the present invention; and  
         [0033]      FIG. 12  illustrates a smart interface assembly plugged into a meter and connected wirelessly to a computer, in accordance with a preferred embodiment of the present invention. 
     
    
     DESCRIPTION OF EXEMPLARY EMBODIMENTS  
       [0034]     Reference will now be made in detail to exemplary embodiments of the present invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. While the description includes exemplary embodiments, other embodiments are possible, and changes may be made to the embodiments described without departing from the spirit and scope of the invention. The following detailed description does not limit the invention. Instead, the scope of the invention is defined by the appended claims and their equivalents.  
         [0035]     1. Smart Interface Assembly  
         [0036]      FIG. 1  shows a diagnostic testing system  100  for conducting a diagnostic test in accordance with an exemplary embodiment of the present invention. Exemplary diagnostic testing system  100  includes a medical device  102 , such as an electronic meter, configured to interface with test media to measure glucose levels in blood samples and indicate the results of the test to a user. Attached to the medical device  102  is a smart interface assembly  104 , which includes an electric interface  120  with a first data coupling  106  and a second data coupling  116  attached at each end. The first data coupling  106  further comprises of a first plurality of pins  108 , which can be inserted into a first port  110  of a computer  112 . The second data coupling  116  can be inserted into a second port  128  of the medical device  102 . Computer  112  processes and stores data received from the first data coupling  106  and further comprises a monitor  114  or any other output device for displaying the data, such as test results.  
         [0037]      FIG. 2  is a perspective view of the smart interface assembly  104 , as shown in  FIG. 1 . Smart interface assembly  104  includes a first data coupling  106  having a first plurality of pins  108 , a second data coupling  116  having a second plurality of pins  118 , and an electrical interface  120  coupling the first data coupling  106  to the second data coupling  116 . The electrical interface  120  can further include a number of conductors  122  for power, ground, and signals. The first data coupling  106  further comprises a carrier  124  with a circuit board  126  mounted within. Circuit board  126  is coupled to at least some of the wires of the electrical interface  120  at points between the free ends of the first plurality of pins  108  and the free ends of the second plurality of pins  118 . The circuit board  126  can be formed as part of the smart interface assembly  104  rather than as a separate component, as described further below.  
         [0038]     In the illustration of  FIG. 2 , the first data coupling  106  is a USB data coupling which connects to the first port  110 , a USB port, within the computer  112 . The second data coupling  116  is a data coupling which connects to the second port  128 , a data port, within the medical device  102 . Alternatively or in addition, there are several types of data couplings that are applicable to the method and apparatus of the present invention. In addition to USB and data couplings, there are Ethernet, Fire Wire, SCSI, modem, wireless, video, printer, serial data couplings, and several more. However, it will be understood that the present invention is not limited to any particular type of data coupling and that other data couplings may be employed consistent with the principles of the present invention.  
         [0039]     As illustrated In  FIGS. 9-12 , the first and second data couplings  106 ,  116  may be connected by any known means, e.g., hard wired connections, connectors, plugs, or wireless devices. In one exemplary embodiment,  FIG. 9  illustrates the smart interface assembly  104  with two wireless connections, one to the meter  102  and one to the computer  112 . The wireless communications devices may be RF, IR, BlueTooth®, or other similar devices consistent with the principles of the present invention. The RF device can operate in a range of about 2.4 GHz to about 2.48 GHz and has an output in a range of about −30 to +20 dBm (100 mW). Furthermore, the RF device may be enabled for spread spectrum, frequency hopping, and full-duplex operation. In the frequency hopping operation, the RF device may be enabled for operation up to 1600 hops/sec, where a signal hops among 79 frequencies at 1 MHz intervals. Alternatively, the wireless communications device may be an IR device which operates on a wavelength in a range of about 850 nm to about 1050 nm.  
         [0040]     Alternatively,  FIG. 10  illustrates the smart interface assembly  104  wherein a connection is hard wired between the data communication port  128  of the meter  102  and the second data coupling  116 , and the first data coupling  106  is wirelessly connected to the computer  112 .  
         [0041]     With reference to  FIG. 11 , in the smart interface assembly  104  a connection is plugged in between the computer  112  and the first data coupling  106 , and the second data coupling  116  is wirelessly connected to the meter  102 . Alternatively,  FIG. 12  illustrates the smart interface assembly  104  wherein a connection is plugged in between the data communication port  128  of the meter  102  and the second data coupling  116 , and the first data coupling  106  is wirelessly connected to the computer  112 . The plug may be a USB connector, IEEE 1394 connector, a serial connector, or another similar connector consistent with the principles of the present invention.  
         [0042]     With reference to  FIG. 3 , the circuit board  126  of smart interface assembly  104  comprises a protocol processor  174  which houses the program logic of the interface assembly  104 . Circuit board  126  is housed within the carrier  124  of the first data coupling  106 . Carrier  124  includes a distal end  130  and a proximal end  132  and can be made out of a material such as plastics or resins, as known in the art. Further extending from the distal end  130  are the first plurality of pins  108  that are inserted into the first port  110  of the computer  112 . Proximal end  132  may include a flange or knurl  134  to allow a user&#39;s fingers to grip the carrier  124  for either insertion into or removal from the first port  110 . Carrier  124  can also include an opening  136  through which electrical contacts  138 - 144  are accessible.  
         [0043]     Carrier  124  can further have a “key” type configuration such that carrier  124  can be inserted into the first port  110  in only one orientation. For example, carrier  124  can include a wedge-shaped corner  146  such that the carrier  124  can only fit into the first port  110  when the wedge-shaped corner  146  mates with the opening of the first port  110  in a certain orientation. This “key” type configuration may prompt the user as to the proper insertion orientation of the carrier and can prevent damage to the circuit board  126  caused by improper insertion.  
         [0044]     Circuit board  126  includes a protocol processor  174 , a memory chip  148 , and a plurality of electrical contacts  138 - 144 . These electrical contacts can include a voltage supply contact  138 , a ground contact  140 , a data input/output contact  142 , and a clock contact  144 . To enhance its reliability, ground contact  140  is of greater length. The circuit board  126  is mounted to the carrier  124  such that the ground contact  140  extends closer to distal end  130  than the other electrical contacts  138 ,  142 , and  144 . As a result, ground contact  140  is the first electrical contact on circuit board  126  to make electrical contact with the computer  112  when first data coupling  106  is inserted into first port  110  and the last electrical contact to break electrical contact with the computer  112  when first data coupling  106  is removed. This prevents the memory chip  148  from being powered in an unintended operating mode that may not be reliable.  
         [0045]     Memory chip  148  is mounted on the circuit board  126  and stores the data in a predetermined format. Memory chip  148  can be a read only memory (“ROM”), random access memory (“RAM”), or both, and can store program instructions to implement various communication protocols. Preferably, memory chip  148  includes a non-volatile memory, so as to retain the stored data when un-powered. For example, memory chip  148  can be an electronically erasable programmable read only memory (“EEPROM”) chip. Such EEPROM chips can typically be written to many times (e.g., one million write cycles, or more) so that it does not wear out over the life cycle of usage.  
         [0046]     In one embodiment, a number of communication protocol drivers are stored in the read only memory of memory chip  148 . An appropriate driver is chosen from the library of available communication protocol drivers when the first data coupling  106  is inserted into the first port  110  of the computer  112  and the second data coupling  116  is inserted into the second port  128  of the medical device  102 . In another embodiment of the present invention, an appropriate communication protocol driver is downloaded from the medical device  102  connected to the smart interface assembly  104  and is stored in the random access memory.  
         [0047]     Memory chip  148  can be electrically connected to the plurality of electrical contacts  138 - 144  on the circuit board  126 . Accordingly, when the appropriate voltage is applied to voltage supply  138 , relative to ground contact  140 , data can be synchronously read from or written to the memory chip  148  using data input/output contact  142  and clock contact  144 .  
         [0048]     2. Auto-Execution Function of the Smart Interface Assembly  
         [0049]     The flowchart of  FIG. 4  illustrates an exemplary read and write sequence starting from a medical device  102  to a computer  112 . A user first inserts a test strip (not shown) into meter  102  to measure the amount of glucose in the blood, as indicated by step  150 . In step  152 , the meter  102  can then either display a message or an icon providing the user the results of the test or store the results in a memory  154 , or both. A user may then want to display the diagnostic test results on a personal computer or transmit the results to a physician&#39;s computer. Thus, step  156  provides a method of transferring test results from the meter  102  to a computer  112 .  
         [0050]     A user first plugs in the first data coupling  106  into first port  110  of the computer  112  such that the first plurality of pins  108  make contact with electrical contacts  184 - 190  of a data coupling  192  of the computer  112 , as indicated by step  168 . In step  176 , the second data coupling  116  is plugged into second port  128  of the meter  102  such that the second plurality of pins  118  make contact with electrical contacts  158 - 164  of a data coupling  166  of the meter  102 . These electrical contacts can include a voltage supply contact  158 , a ground contact  160 , a data input/output contact  162 , and a clock contact  164 . Once connected, in step  178 , a processor  170  within a microcontroller  172  of the meter  102  executes machine language instructions to a protocol processor  174  mounted on circuit board  126 . Upon receiving the instructions, in step  180 , protocol processor  174  auto-executes application program files stored within the memory  148  of the smart interface assembly  104 . The hardware and software of the medical device  102  and smart interface assembly  104  work together to automatically configure the smart interface assembly, assign resources, and allow for hardware changes and additions without complicated setup maneuvers.  
         [0051]     The smart interface assembly  104  of the present invention automatically determines which communication protocols are required at each of its ports, and selects, activates, enables, or downloads the appropriate communication protocol drivers to enable proper operation. In step  182 , electrical contacts  138 - 144  access the memory  154  within the meter  102  and transmit the desired data to a processor  198  within a microcontroller  200  of the computer  112 . As is known to one skilled in the art, a data interface can provide for the transfer of data to the computer  112 . Thus, in the present invention, smart interface assembly  104  also serves as a data interface for transferring data from the meter  102  to the computer  112 . Furthermore, it will be understood that the present invention is not limited to any particular type of data that is transferred from the medical device  102  to the computer  112 . Data such as test results, charts, graphs, trends, software application programs, etc. may be transferred consistent with the principles of the present invention. After all of data has been transferred from the memory  154  of the meter  102  to computer  112 , the incoming data from the meter can either be displayed on a monitor  114 , step  194 , or stored in a memory  206  within the computer  112  to be analyzed at a later, more convenient time, step  196 .  
         [0052]     The data transferred from the electronic meter can optionally be encrypted with identification information, including for example a serial number or name identifier of the meter, a user name, or other identifying data. Optionally, the device and patient identification data can be transmitted from the meter together or sequentially, along with the diagnostic test data, such that the computer software recognizes which data belongs with which user. Such an arrangement would be advantageous in settings such as a pharmacy, where insurance or other reimbursement for test strips is conditioned upon proof of a user&#39;s regular testing. The ability to correlate data with an identifiable user would also be useful for physicians, as well as in any setting where multiple users live, work or frequent.  
         [0053]     In another exemplary embodiment of the invention, the flowchart of  FIG. 5  illustrates an additional method where the PC  112  can interface directly with the meter&#39;s memory  154  through the smart interface assembly  104 .  
         [0054]     A user can optionally follow prompts on the meter display  234  after the results of the diagnostic test are complete, as indicated by step  264 . The user first plugs in the second data coupling  116  into the second port  128  of the meter  102  such that the second plurality of pins  118  make contact with electrical contacts  158 - 164  of the data coupling  166  of the meter  102 , step  266 . In step  268 , once connected, the circuit  126  of the smart interface  104  handshakes with a processor  170  within a microcontroller  172  of the meter  102  to execute machine language instructions and to complete the connection of the meter  102  to the interface  104 , for instance through a protocol processor  174  within the circuit board  126  of the smart interface assembly  104 . The meter  102  and interface  104  combination then form a composite device. In step  270 , optionally following a prompt on the meter display  234 , the user can then plug in the first USB data coupling  106  into the first port  110  of a computer  112  such that the first plurality of pins  108  make contact with electrical contacts  184 - 190  of a data coupling  192  of the computer  112 . The computer  112  recognizes the interface  104  and meter  102  assembly, for example through Plug-and-Play protocols, and can execute interface software contained resident on the interface  104 . For example, the protocol processor  174  can be configured to auto-execute application program files stored in the smart interface memory  148 , and electrical contacts  138 - 144  on the circuit board  126  access a memory  154  within the meter  102 , step  272 . As above, the desired data can then be transmitted from the meter&#39;s memory— 154  directly to a processor  198  within a microcontroller  200  of the computer  112 , step  274 , or in step  276 , the data can either be displayed on the computer&#39;s monitor  114  or stored in the memory  206 , step  278 .  
         [0055]     In yet another embodiment of the present invention, a user can transport the lightweight, smart interface assembly  104  to a computer for viewing data and analysis without having to bring meter  102  along. The flowchart of  FIG. 6  illustrates an exemplary read and write sequence starting from a meter  102  to the smart interface assembly  104 , where data can be stored on the interface assembly  104 .  
         [0056]     Similar to the process described above, in step  202 , a user plugs in the second data coupling  116  into the second port  128  of the meter  102  such that the second plurality of pins  118  make contact with electrical contacts  158 - 164  of a data coupling  166  of the meter  102 . Once connected, a processor  170  within a microcontroller  172  of the meter  102  executes machine language instructions to a protocol processor  174  mounted on circuit board  126 , as indicated by step  204 . Upon receiving the instructions, in step  236 , protocol processor  174  auto-executes application program files stored within the smart interface memory  148  and electrical contacts  138 - 144  start transferring data from the memory  154  of the meter  102  to the memory chip  148  of the smart interface assembly  104 , step  252 . After all of the desired data has been downloaded to the memory chip  148  of the smart interface assembly  104 , the user is now able to take the lightweight, smart interface  104  to a physician&#39;s office or a computer in a remote location, as indicated by step  254 . It should be noted that after data is transferred from the memory  154  of the meter  102  to the memory chip  148  of the smart interface assembly  104 , a user has an option of erasing some or all of the data stored in the meter&#39;s memory  154  such that more storage space is available for diagnostic tests in the future.  
         [0057]     Next, at a physician&#39;s office, for example, the user can plug in the first USB data coupling  106  of the smart interface assembly  104  into the first port  110  of computer  112 , such that the first plurality of pins  108  make contact with electrical contacts  184 - 190  of a data coupling  192  of the computer  112 , step  256 . Once connected, the smart interface assembly  104  serves as a well known jump drive, memory key, or any other memory device of similar type. In step  258 , a physician can open up the desired data file from the memory  148  of the smart interface assembly  104  and either display the test results on the monitor  114 , step  260 , or store the data in the computer&#39;s memory  206 , such that the results can be reviewed at a later time, as indicated by step  262 .  
         [0058]     3. Meter Electronics  
         [0059]     As described above, to measure the glucose level in a blood sample, a test strip (not shown) is preferably used with an electronic meter  102 , as shown in  FIGS. 1 and 7 .  FIG. 7  shows, in simplified form, a block diagram illustrating functional components of exemplary electronic meter  102 . Meter  102  can include a second port  128 , a data coupling  166 , an indicator function  216 , a microcontroller function  172 , an external memory  226 , a media interface  208 , a user control function  212 , a media dispensing mechanism  218 , environmental sensors  220 , and a power source  210 . In an illustrative embodiment, the functional components of meter  102  are contained within meter housing  222 .  
         [0060]     Microcontroller  172  controls the operation of the functional components of the meter in accordance with its instructions, which can be provided as software or firmware. Microcontroller  172  can include the processor  170 , memory  154 , clock functions  224 , and input/output ports  214 . In an illustrative embodiment of the invention, the processor  170 , memory  154 , clock  224  functions, and/or input/output ports  214  can be implemented using an Application Specific Integrated Circuit (ASIC), which allows microcontroller  172  to be reduced in size in comparison to standard integrated circuit technology. However, it will be understood that the microcontroller  172  can be implemented using standard integrated circuit technology, or other technology, without departing from the scope of the present invention.  
         [0061]     Processor function  170  executes instructions used to control the functional components of meter  102 . In particular, processor  170  executes instructions necessary to perform the diagnostic test. A plurality of machine language instructions for the processor  170  can be stored in the memory  154 , an external memory  226 , or the memory chip  148  of the smart interface assembly  104 . The memory  154  can also store data, such as calibration data and other data, used in the performance of the diagnostic tests.  
         [0062]     Clock function  224  regulates the processor&#39;s execution of the instructions in time. In particular, clock function  224  is used to regulate the timing of steps in the diagnostic test. For instance, processor  170  can use clock  224  to regulate an incubation time period, or other time periods, necessary for the correct performance of the diagnostic test. Clock function  224  can be implemented by a single system clock or by multiple clocks for different purposes.  
         [0063]     Media interface  208  accepts test media, such as test strips (not shown), and includes a channel  228  to ensure that the test media is correctly positioned when inserted by a user or media dispensing mechanism  218 . Interface  208  includes one or more media sensors  230  for determining, e.g., whether a test strip has been correctly inserted in the channel  228 . For meters using electrochemical techniques, the media sensors  230  can include one or more electrical contacts corresponding to electrodes on an interface side of the test strip. For meters using photometric techniques, at least the presence or concentration of analyte in the sample is determined using an optical sensor, e.g., a light emitting diode and corresponding photo-detector.  
         [0064]     Power source  210  provides power to the electronic components of meter  102 . In an illustrative embodiment, the power source is a lithium coin cell battery. However, other power sources, such as other types of batteries, solar cells, or AC/DC converters may be used without departing from the scope of the present invention.  
         [0065]     User control function  212  can include, for example, one or more buttons, switches, keys or other controls for controlling the functions of meter  102 . In an illustrative embodiment, user control function  212  is implemented by one or more buttons  232  placed on the left side of meter housing  222 . However, user control  212  may be positioned elsewhere on meter  102 . For example, button  232  can be placed on right hand side of the meter housing  222  in order to be more convenient for left handed users, or on the top of the meter.  
         [0066]     In an exemplary embodiment of the present invention, user control function  212  is implemented using a single control, e.g., a single button  232 , that is used to control a plurality of meter functions. For example, user control  212  can be used to control the input/output  214  function, indicator function  216 , and/or media dispensing mechanism  218  by providing commands to these functions directly or through microcontroller  172 . User control  212  can also be used to control the diagnostic test function of microcontroller  172 . For example, when a test is to be performed using a control solution, button  232  may be held down to indicate to microcontroller  172  that the current sample is of a control solution and, consequently, that microcontroller  172  should perform a control test on the current strip.  
         [0067]     Alternatively, a plurality of user controls  212 , e.g., a plurality of buttons  232 , can be provided, with each button having different functions. For example, two buttons may be provided to allow a user to scroll through diagnostic test results stored in the memory  154  in either forward or reverse directions. As an aid to the user, the function of the button or buttons  232  at the particular time can be dynamically indicated by indicator function  216 . Further, user controls  212  can have different functions at different times. For example, holding button  232  down upon the insertion of a test strip into media interface  208  can command the microcontroller  172  to perform a control test on that strip, while holding the button  232  down without inserting a test strip can command the microcontroller  172  to display the result of the previous diagnostic test.  
         [0068]     Input/output function  214  provides for the downloading of data or instructions to meter  102 , and/or the uploading of data from meter  102 . Input/output function  214  can be used, for example, to upload the results of a diagnostic test or tests so that they may be transferred to the smart interface assembly  104  or to a third party, e.g., a medical care provider for use in treating the user. Alternatively, input/output function  214  can be used to download data (e.g., calibration data) or instructions (e.g., updated software) to the meter  102 . Input/output function  214  can be implemented using any conventional digital or analog information interface, e.g., a serial port, a parallel port, an optical port, an infrared interface, etc.  
         [0069]     Indicator function  216  indicates the result of the diagnostic test to the user. In addition to indicating the result of the diagnostic test, the indicator can present other information to the user. For example, the indicator  216  may indicate the average result of a plurality of tests, the time and/or date, remaining battery life, etc. Indicator  216  can also be used to prompt the user to perform certain steps of the diagnostic test, e.g., to apply the sample to the test strip. In an exemplary embodiment of the present invention, indicator  216  indicates the number of tests or the time remaining before meter  102  becomes inoperative.  
         [0070]     Indicator function  216  can present information in visible, audible or tactile form. For example, indicator  216  may include a display  234  for displaying information, e.g., using numerical values, words and/or icons. A number of different technologies may be used for display  234 . For example, the display can be a liquid crystal display, a vacuum fluorescent display, an electroluminescent display, a light emitting diode display, a plasma display, etc. In an illustrative embodiment, display  234  is a liquid crystal display. Alternatively or in addition, indicator  216  can include an audible indicator configured to indicate information by sound. For example, indicator  216  may include a speaker connected to a voice and/or sound circuit  238  that is configured to, e.g., speak the result of the diagnostic test or to beep to indicate that an error has occurred. As a further alternative, indicator  216  can be implemented as a dynamic Braille indicator for use by the blind.  
         [0071]     Because the diagnostic test media, e.g., test strips, are typically very small, certain users may find it difficult to retrieve the test media from a container. Accordingly, a media dispensing mechanism  218  may be used to provide for the automated dispensing of test media from the container.  
         [0072]     4. Computer Electronics  
         [0073]     As described above, the computer  112  of diagnostic system  100  is a general-purpose computing system.  FIG. 8  illustrates, in simplified form, a block diagram illustrating functional components of the computer  112 . Computer  112  can include a power source  246 , an input device  248 , a microcontroller  200 , an output device  250 , a monitor  114 , a data coupling  192 , and a first port  110 . Possible input devices  248  include network interfaces, keyboards, mice, speech recognition devices, or document, video, or image input devices. Additionally, possible output devices include network interfaces, printers, or sound or speech output devices. In an illustrative embodiment, the functional components of the computer  112  are contained within computer housing  240 .  
         [0074]     As illustrated in  FIG. 8 , the computer system  112  can also include at least one microcontroller or central processing unit (“CPU”)  200 . CPU  200  can execute software programs for implementing some of the processes described above with respect to  FIGS. 4-6 . Software programs for the computer system can reside in the third memory  206  of the CPU  200 . Third memory  206  can include graphs, charts, etc., and software for manipulating the data.  
         [0075]     Microcontroller  200  controls the operation of the functional components of the computer in accordance with its instructions, which can be provided as software or firmware. Microcontroller  200  can include a processor  198 , third memory  206 , input/output ports  242 , and clock functions  244 . These functional components operate similarly to the functional components of microcontroller  172  of meter  102 , as described above.  
         [0076]     The foregoing description of possible implementations consistent with the present invention does not represent a comprehensive list of all such implementations or all variations of the implementations described. The description of only some implementations should not be construed as an intent to exclude other implementations. One of ordinary skill in the art will understand how to implement the invention in the appended claims in many other ways, using equivalents and alternatives that do not depart from the scope of the following claims.  
         [0077]     The systems and methods disclosed herein can be embodied in various forms. Moreover, the above-noted features and other aspects and principles of the present invention can be implemented in various environments. Such environments and related applications can be specially constructed for performing the various processes and operations according to the invention or they can include a general-purpose computer selectively activated or reconfigured by code to provide the necessary functionality. The processes disclosed herein are not inherently related to any particular computer or other apparatus, and can be implemented by a suitable combination of hardware, software, and/or firmware. For example, various general-purpose machines can be used with programs written in accordance with teachings of the invention, or it may be more convenient to construct a specialized apparatus or system to perform the required methods and techniques.  
         [0078]     Additional benefits are possible through use of the smart interface of the present invention. For instance, when connected to a computer, software or firmware updates for the meter can be obtained and installed automatically from a manufacturer&#39;s web site, using, for instance, simple HTTP protocols.  
         [0079]     Of course, it should be appreciated that while discussion of exemplary embodiments places certain functionalities and memory storage locations either within the interface or in the meter, placement of these functions in one or the other location is not always critical to the invention. For the interface to serve as a standalone device, one having ordinary skill in the art would appreciate that certain functionality would need to be located on the interface, but the functionality of the composite interface and meter combination described hereinabove could be enabled where all functionality is provided on the meter, and the interface is employed essentially for data connectivity between the computer and the meter, similar to a digital camera or digital media player.  
         [0080]     Systems and methods consistent with the present invention also include computer readable media that include program instruction or code for performing various computer-implemented operations based on the methods and processes of the invention. The media and program instructions can be those specially designed and constructed for the purposes of the invention, or they can be of the kind well known and available to those having skill in the computer software arts.