Method and system for transferring analyte test data

A system for transferring data includes an analyte test instrument (ATI) adapted to store data, a wirelessly enabled data management device (DMD) for comprehensively analyzing data, and an adaptor removably connected to the ATI for transferring data stored on the ATI to the DMD. The adaptor includes a data communication device capable of removable connection with the ATI, a microprocessor electrically connected to the data communication device, a wireless controller electrically connected to the microprocessor and a wireless transceiver electrically connected to the wireless controller. In use, data transfer is executed between the ATI and the DMD by electrically and mechanically connecting the adaptor to the ATI. Data stored on the ATI is then automatically downloaded into adaptor memory. Upon completion of the download, the user activates an externally accessible input device on the adaptor which, in turn, wirelessly transmits data from the adaptor memory to the DMD.

BACKGROUND OF THE INVENTION

The present invention relates generally to the field of analyte test instrument systems which can be used to perform electrochemical assays on biological samples. More particularly, the present invention relates to analyte test instrument systems which include an adaptor for transferring data stored on an analyte test instrument (e.g., a blood glucose monitor) to a data management device (e.g., a computer).

For many patients, the concentration of a particular analyte in blood must be routinely measured. The results of an analyte concentration measurement may, in turn, necessitate the patient to undertake a particular course of action in response thereto (e.g., requiring the patient to partake in a particular drug treatment).

Diabetes is a disease which typically requires a patient to routinely monitor the concentration of glucose in his/her blood. In particular, a patient suffering from diabetes is often required to measure the concentration of glucose in his/her blood multiple times each day. Based upon the results of each blood glucose measurement, the patient may require a particular drug treatment (e.g., an injection of insulin) in order to regulate that the blood glucose level of the patient remains within a specified range. Exceeding the upper limit of said range (hyperglycemia) or dropping beneath the lower limit of said range (hypoglycemia) should be avoided with as much diligence as possible to prevent the patient from experiencing serious medical complications which include, inter alia, retinopathy, nephropathy, and neuropathy.

Analyte test instrument systems are well known and are widely used in the art to perform routine electrochemical assays on biological samples. A blood glucose monitoring system is one well-known type of analyte test instrument system which is used to perform routine glucose concentration tests on blood samples.

One type of blood glucose monitoring system which is well known and widely used in the art comprises at least one disposable test strip which electrochemically reacts in response to the deposition of a blood sample thereon. The test strip is designed for use with a corresponding blood glucose monitor which calculates the concentration of blood glucose in the blood sample based upon the electrochemical reaction between the test strip and the blood sample. Examples of blood glucose monitoring systems of the type described above are manufactured and sold by Abbott Laboratories, Medisense Products of Bedford, Mass. under the PRECISION line of blood glucose monitoring systems.

A disposable, blood glucose monitoring test strip typically comprises a thin base, or substrate, layer which is generally rectangular in shape. A plurality of electrical contacts, or strips, are deposited along substantially the entire length of the base layer in a spaced apart, parallel relationship. One end of the electrical contacts is positioned within the reaction area of the test strip. In the reaction area of the test strip, an enzyme is deposited which is capable of reacting with the glucose in a blood sample to produce a measurable electrical response. The other end of the electrical contacts is disposed to electrically contact associated conductors located in the blood glucose monitor, as will be described further below.

A blood glucose monitor is typically modular and portable in construction to facilitate its frequent handling by the patient. A blood glucose monitor often comprises a multi-function test port which is adapted to receive the test strip in such a manner so that an electrical communication path is established therebetween. As such, an electrical reaction created by depositing a blood sample onto the reaction area of the test strip travels along at least one of the conductors of the test strip and into the test port of the blood glucose monitor. Within the housing of the monitor, the test port is electrically connected to a microprocessor which controls the basic operations of the monitor. The microprocessor, in turn, is electrically connected to a memory device which is capable of storing a multiplicity of blood glucose test results.

In use, a blood glucose monitor of the type described above can be used in the following manner to measure the glucose level of a blood sample and, in turn, store the result of said measurement into memory as test data. Specifically, a disposable test strip is inserted into the test port of the monitor. With the test strip properly inserted into the monitor, there is established a direct electrical contact between the conductors on the test strip and the conductors contained within the test port, thereby establishing an electrical communication path between the test strip and the monitor through which electrical signals can travel. Having properly disposed the test strip into the test port, the monitor typically displays a “ready” indication on its display.

The user is then required to deposit a blood sample onto the reaction area of the test strip, the acquisition of the blood sample typically being accomplished by pricking the fingertip of the patient with a lancing device. When a sufficient quantity of blood is deposited on the reaction area of the test strip, an electrochemical reaction occurs between the blood sample and the enzyme present in the reaction area which, in turn, produces an electrical current which decays exponentially over time.

The decaying electrical current created through the chemical reaction between the enzyme and the glucose molecules in the blood sample, in turn, travels along the electrically conductive path established between the test strip and the monitor and is measured by the microprocessor of the monitor. The microprocessor of the monitor, in turn, correlates the declining current to a standard numerical glucose value. The numerical glucose value calculated by the monitor is then shown on the monitor display for the patient to observe. In addition, the data associated with the particular blood glucose measurement is stored into the memory for the monitor.

It should be noted that blood glucose monitors of the type described above often include a memory device which is capable of storing a number of different events, wherein examples of some possible events include, but are not limited to, a blood glucose measurement, a calibration function, and a date/time change for the monitor. In fact, some blood glucose monitors are capable of storing in memory as many as 400 events at a single time.

In order to effectively monitor the blood glucose level patterns of a patient, a clinician and/or physician for a diabetes patient often downloads a series of blood glucose monitoring events onto a data management device, such as a computer, which is loaded with comprehensive data management system (DMS) software (e.g., the PRECISION LINK data management system software which is manufactured and sold by Abbott Laboratories, MediSense Products of Bedford, Mass.) capable of retrieving, managing and analyzing the data stored on the monitor. In particular, a clinical analyst and/or a physician for a diabetes patient is often interested in tracking the blood glucose levels of a patient over a fixed period of time (e.g., 1 month).

In order to effectively track the blood glucose levels of a patient over a fixed time, a clinical analyst and/or a physician is required to periodically meet with the patient and download all of the data stored in the blood glucose monitor into the data management device for comprehensive analysis. Analyzing the test results in this manner, the clinician and/or physician is able to assess how effectively the patient is able to regulate his/her blood glucose level.

Traditionally, the data stored on a blood glucose monitor is downloaded onto a data management device using a hardwire communication link. A hardwire communication link typically comprises a communication cable which, at one end, is provided with a test strip-shaped communication interface which can be removably inserted into the strip port of the blood glucose monitor and, at the other end, is provided with a connector which is adapted to removably connect with the serial port of a conventional computer.

As can be appreciated, a diabetes patient is somewhat limited in the frequency in which he/she can visit a clinician and/or physician to track glucose test results. As a result, diabetes patients are encouraged to frequently download the data stored on the blood glucose monitor onto his/her own computer for comprehensive analysis. In this manner, a diabetes patient can monitor his/her test results as frequently as desired (e.g., daily, weekly, etc.).

However, the process of electrically connecting a blood glucose monitor to a computer using a hardwire communication link has been found by some diabetes patients to be cumbersome, complicated, and time consuming. Overwhelmed by the connection process, some patients download their blood glucose levels onto a computer for further analysis less frequently than is desired, thereby increasing the patient's risk of experiencing a serious diabetes related medical complication, which is highly undesirable.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a method and system for wirelessly transferring analyte test data stored on an analyte test instrument, such as a blood glucose monitor, to a data management device, such as a computer.

It is another object of the present invention to provide a method and system for transferring analyte test data stored on an analyte test instrument to a data management device via an adaptor.

It is yet another object of the present invention to provide a method and system as described above wherein the adaptor can be removably connected to the analyte test instrument.

It is yet still another object of the present invention to provide a method and system as described above which has a limited number of parts, which is inexpensive to manufacture and which is easy to use.

Therefore, according to one feature of the present invention, there is provided a system for transferring data comprising an analyte test instrument which is adapted to store data, an adaptor removably connected to said analyte test instrument, said adaptor being in data communication with said analyte test instrument through a first data communication channel, and a data management device in data communication with said adaptor through a second data communication channel, said second communication channel being a wireless data communication channel.

According to another feature of the present invention, there is provided an adaptor for transferring data stored on an analyte test instrument to a wirelessly enabled data management device, said analyte test instrument comprising a data communication device, said adaptor comprising a data communication device, said data communication device for said adaptor being adapted to removably connect with the data communication device of said analyte test instrument so as to establish a first data communication channel between said adaptor and said analyte test instrument, a microcontroller in electrical connection with said data communication device for said adaptor, a wireless controller in electrical connection with said microcontroller; and a wireless transceiver in electrical connection with said wireless controller, said wireless transceiver being adapted to wirelessly communicate with said data management device through a second data communication channel.

According to another feature of the present invention, there is provided a method for transferring data stored on an analyte test instrument to a data management device via an adaptor, said adaptor being independent from said analyte test instrument, said method comprising the steps of removably connecting said adaptor to said analyte test instrument so as to establish a first data communication channel between said adaptor and said analyte test instrument, transferring data stored on said analyte test instrument to said adaptor through the first data communication channel, and transmitting the transferred data from said adaptor to said data management device through a second data communication channel, the second data communication channel being a wireless data communication channel.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now toFIGS. 1 and 2, there is shown a first embodiment of a system for transferring data, said system being constructed according to the teachings of the present invention and identified generally by reference numeral11.

System11comprises an analyte test instrument (ATI)13, a data management device (DMD)15, and an adaptor17. As will be described further in detail below, analyte test data stored in ATI13can be wirelessly transmitted to DMD15via adaptor17.

Analyte test instrument13represents a monitor which can be used to measure the concentration of an analyte in a test sample. As is shown herein, ATI13is in the form of a conventional blood glucose monitor (e.g., an electrochemical or photometric blood glucose monitor). As such, ATI13is capable of measuring glucose concentrations of a blood sample and, in turn, storing the results of each blood glucose measurement as data in memory. As an example, ATI13may be of the type disclosed in U.S. Pat. No. 6,377,894 to Deweese et al, which is incorporated herein by reference.

ATI13is a communication enabled device. In this respect, ATI13is capable of serial data transfer with another device (e.g., adaptor17), as will be described further in detail below.

Referring now toFIGS. 2-4, ATI13is a modular, self-contained, and portable unit which comprises a protective housing19constructed of a durable and inexpensive material, such as plastic. Housing19includes a front casing21and a rear casing23which are secured together by means of a snap-fit interconnection. With front casing21and rear casing23affixed together, housing19is a substantially enclosed device which is shaped to include an interior cavity25into which the electrical and electronic components of ATI13are disposed, as will be described further below.

ATI13comprises a data communication device27which is disposed within interior cavity25of housing19and which is accessible through a slot29formed into the top of housing19. Data communication device27is a current source sensing device which is capable of transmitting and receiving serial data. In the present embodiment, data communication device27is in the form of a conventional multi-purpose test port which includes a slot shaped to matingly receive and electrically connect with, inter alia, a test strip, a calibration strip, or the interface connector of a hardwire communication link. Data communication device27comprises six metal contact strips, which are identified as contact strips Cont1through Cont6inFIG. 2.

It should be noted that data communication device27is not limited to a conventional multi-purpose test port. Rather, it is to be understood that data communication device27could be in the form of any conventional communication device which is capable of transmitting and receiving serial data without departing from the spirit of the present invention. As one example, data communication device27could alternatively be in the form of a wireless transceiver without departing from the spirit of the present invention. As another example, data communication device27could alternatively be in the form of a phone jack receptacle without departing from the spirit of the present invention, which will be described further in detail below.

ATI13also comprises a user input device31which is disposed within interior cavity25and which at least partially projects through an opening formed in front casing21of housing19. User input device31is shown herein as being in the form of a button capable of being manually depressed. In use, input device31is for the manual regulation of a switch which, in turn, controls operative functions for ATI13. In particular, input device31enables the user to regulate the power state of ATI13, to recall information stored in memory, to respond to messages provided in the display, to provide access to menus generated by software contained within ATI13, and to set some of the configuration control parameters.

ATI13further comprises a display33which is disposed within interior cavity25and which is viewable through a transparent window formed in front casing21of housing19. Display33is shown herein as being in the form of a screen designed to provide the user with information in a visual form. As can be seen most clearly inFIG. 5, display33is in the form of a liquid crystal display (LCD) which is used to display, inter alia, test results, user messages, and recalled information which is stored in the memory of ATI13. Display33includes a numerical display35which is capable of generating three, seven-segment digital numbers. As can be appreciated, display35provides the user with a means for visually indicating the numerical value associated with a particular test result, display35including a pair of decimal point indicators to allow for a wider range of possible output values. Display33also comprises a plurality of icons37which indicate the units of measurement of a test result (e.g., mg/dL or mmol/l) and a low battery condition. Display33further comprises a dot-matrix message line39which can be used to provide information to the user, message line39being capable of generating up to 10 numerals or up to 9 characters at the same time. The information displayed by message line39can include, among other things, time and data information, user prompts (e.g., “apply blood”), error messages (e.g., “expired strip”), and configuration control settings (e.g., setting time or selecting a operating language).

It should be noted that the information shown on display33is controlled by display driver software for ATI13. The display driver software provides display33with the ability to scroll a long message, flash a message or a portion of a message, or display alternating messages. In addition, the display driver software can provide ATI13with the ability to flash icons37. Furthermore, as ATI13is powering up, the display driver software can support a visual check of display33wherein the icons and pixels for display33are turned on for a brief period to enable the user to confirm the entire display33is functioning properly.

ATI13preferably derives power from a power source (not shown) disposed within interior cavity25. The power source may be in the form of one or more replaceable AA-type batteries which are removably mounted into an associated battery compartment in interior cavity25and which are accessible through a removable cover formed into rear casing23of housing19. However, it is to be understood that any source of power capable of providing a suitable direct (DC) voltage can be used to provide power to ATI13.

As seen most clearly inFIG. 2, user input31and display33are connected to a processing circuit41which, in turn, is connected to a microprocessor43, memory45, and instrument software47. In addition, data communication device27is connected to processing circuit41through a test strip circuit49.

Processing circuit41is an application specific integrated circuit (ASIC) which enables a test strip is inserted into direct electrical connection with data communication device27to communicate with microprocessor43. For example, processing circuit41enables microprocessor43to send signals to data communication device27to determine the identity of a strip which is disposed into electrical connection therewith (i.e., to determine whether the strip is a calibration strip, a test strip, or the strip-like interface connector for a communication link). Microprocessor43may determine the identity of a strip disposed into electrical connection with data communication device27by measuring the impedance of said strip or by detecting the location of the electrical contacts on said strip.

Microprocessor43is an application specific integrated circuit (ASIC) that functions as the central processing unit for ATI13. As such, microprocessor43performs the principal calculation and data management tasks for ATI13.

Memory45is connected to microprocessor43and serves to retain data processed by microprocessor43, said data being available for subsequent retrieval. Types of information that may be stored in memory45include measurement delay times, sample incubation times, number of measurements to be taken during an assay, thresholds against which voltage levels can be compared, values of excitation voltage levels applied to a test strip during assay, analyte value conversion factors, failsafe assay threshold values, and configurations of circuitry of analyte test instrument13. It should be noted that memory45has the capacity to store a multiplicity of assay results. Specifically, each assay result is typically stored into memory45as a data bundle referred to herein as “an event”. As can be appreciated, memory45is preferably of the type which can store in excess of 400 events.

Instrument software47is provided for microprocessor43, software47functioning in response to information received at data communication device27from a calibration strip. Specifically, instrument software47uses the information received from a calibration strip to control the operation of the ATI13. Instrument software47also controls operations of the ATI13that are independent of information introduced or generated at data communications device27. For example, instrument software47enables the user to recall assay results and assay information, can provide various warning, error, and prompting messages, can permit setting of date and time, can control transmission of data to external devices, can monitor power level or battery level or both, and can provide indications to the user if power drops below a specified level.

A test strip circuit49connects data communication device27to processing circuit41. In operation, test strip circuit49enables data to pass between data communication device27and processing circuit41.

A pair of device circuits51are also connected to processing circuit41. Device circuits51can comprise analog, digital, or mixed-signal circuits, application-specific integrated circuits (ASICs), and passive and active electrical components. Device circuits51can perform various electrical functions required by ATI13. Specifically, device circuits51carry instructions from microprocessor43to various functional components of ATI13so that these components can perform their intended functions. As one example, device circuits51may serve to drive the clock functions for microprocessor43.

In use, ATI13can be used in the following manner to measure and store analyte test data. Specifically, an analyte test strip is inserted into data communication device27so that the metal contacts on the test strip are in direct metal-to-metal contact with the contacts CONT1through CONT6of data communication device27, thereby establishing a communication channel between the test strip and ATI13. Having inserted the test strip into data communication device27, instrument software47identifies the item inserted into data communication device27as an analyte test strip. At this time, microprocessor43executes software which generates a message on display33that notifies the user to deposit a sample onto the test strip. When a sample is deposited onto the reaction area of the test strip, the sample reacts with enzymes in the reaction area which, in turn, produces an electrical response in the form of a decaying electrical current. Test strip circuit49converts the decaying current from an analog signal to a digital signal and then passes the converted signal to processing circuit41. The converted signal is then processed by microprocessor43to determine the analyte test value that corresponds to the signal. Microprocessor43then stores the analyte test data as an event in memory45and simultaneously registers the analyte test value on display33for the patient to read.

The aforementioned analyte testing process can be repeated as desired. As noted briefly above, each test performed is preferably stored into memory45as an event, memory45being capable of storing a large quantity of events which can be subsequently retrieved and analyzed by a personal computer using sophisticated data management software.

Although ATI13is represented herein as being in the form of a communication enabled, blood glucose monitor, it is to be understood that ATI13represents any conventional communication enabled device which can be used to measure the concentration of an analyte in a sample. As an example, ATI13may represent any of the PRECISION line of blood glucose monitors which are manufactured and sold by Abbott Laboratories, MediSense Products of Bedford, Mass.

Data management device (DMD)15is represented herein as being in the form of a wirelessly enabled, laptop computer. As such, DMD15is capable of serial data transfer with another device (e.g., adaptor17) through a wireless communication channel.

Preferably, DMD15is provided with comprehensive data analysis software (e.g., the PRECISION LINK software manufactured and sold by Abbott Laboratories, MediSense Products of Bedford, Mass.) which allows for analyte test data stored on an analyte testing device (e.g., ATI13) to be downloaded, managed, and analyzed (e.g., charted) by DMD15, thereby providing the patient with sophisticated analyte test data monitoring and tracking capabilities, which is highly desirable.

Although DMD15is represented herein as being in the form of a wirelessly enabled, laptop computer, it is to be understood that DMD15is not limited to a wirelessly enabled laptop computer. Rather, DMD15could be in the form of other types of conventional, wirelessly enabled data management devices (e.g., desktop computer, personal data assistant (PDA), printer, etc.) without departing from the spirit of the present invention.

Adaptor17is a modular, self-contained and portable unit which can be removably connected to ATI13, as seen most clearly inFIGS. 3(a)-(c). As will be described further in detail below, adaptor17is adapted to communicate with ATI13by means of a first communication channel53and wirelessly communicate with DMD15by means of a second communication channel55. In this capacity, adaptor17can be used to retrieve data (e.g., analyte test data) stored in memory45via first communication channel53and, in turn, wirelessly transmit said data to DMD15via second communication channel55.

As seen most clearly inFIGS. 2 and 6(a)-(d), adaptor17comprises a protective housing57constructed of a durable and inexpensive material, such as plastic. Housing57is a substantially enclosed device which is shaped to define an interior cavity59which is shaped to substantially receive the electrical and electronic components of adaptor17, as will be described further below.

Adaptor17comprises a data communication device61disposed within interior cavity59and which partially and fittingly protrudes out through a narrow slot formed in the bottom of housing57. Data communication device61is a communication device which is capable of electrically connecting with data connection device27of ATI13, so as to establish communication channel53between ATI13and adaptor17through which data can be transmitted and received.

In the present embodiment, the portion of data communication device61which extends out from housing57is in is in the form of a rectangular strip63having the same approximate width and thickness as a test strip used in conjunction with data communication device27. Six metal contact strips, which are identified as contact strips Cont1through Cont6inFIGS. 2 and 6(a)-(c), are deposited along substantially the entire length of strip63in a spaced apart, parallel relationship. As such, when strip63of data communication device61is inserted into the test port configuration of data communication device27, each of the contact strips, or leads, on data communication device61is disposed in direct conductive contact with an associated contact strip within the test port. In this manner, with data communication device61properly inserted into the test port slot for data communication device27, communication channel53is established between ATI13and adaptor17through which serial data is capable of being transferred.

It should be noted that the particular construction of data communication device61enables adaptor17to be removably connected to ATI13. As a result, adaptor17can be manufactured and stored separately from ATI13, adaptor17being connected to ATI13to form communication channel53only when the user desires to send data from ATI13to DMD15.

As can be appreciated, the ability to removably connect adaptor17to ATI13provides the user with a number of significant advantages. As a first advantage, when the user only desires to store data onto ATI13and is not interested in wirelessly transmitting said data to DMD15, adaptor17can be separated from ATI13, thereby reducing the overall size and weight of the unit, which is highly desirable. As a second advantage, the particular construction of data communication device61enables adaptor17to be used in conjunction with many types of pre-existing types of analyte test instruments. As a result, a patient who owns a pre-existing ATI which is compatible with adaptor17can wirelessly transmit data stored on said pre-existing ATI to a data management device, such as a computer, simply by purchasing adaptor17, which is highly desirable.

It should be noted that data communication device61is not limited to the test strip-type configuration shown herein. Rather, it is to be understood that data communication device61could be in the form of alternative types of conventional communication devices which are capable of transmitting and receiving serial data without departing from the spirit of the present invention. Specifically, data communication device27and data communication device61represent any compatible means for establishing a communication channel (e.g., wireless, hardwire) therebetween. As will be described further in detail below, data communication device61may be in the form of a male, phone jack and data communication device27may be in the form of a female, phone jack receptacle without departing from the spirit of the present invention.

Data communication device61is electrically connected to a microcontroller65via universal asynchronous receiver transmitter (UART) communication bus67, microcontroller65being disposed within interior cavity59of housing57. Microcontroller65is an application specific integrated circuit (ASIC) which functions as the central processing unit for adaptor17. As such, microcontroller65is responsible for, inter alia, the processing and managing of data which is retrieved from ATI13and wirelessly transmitted to DMD15, as will be described further in detail below.

For purposes of the present specification and claims, the term microcontroller shall mean microcontroller or microprocessor unless otherwise specified.

Memory69is disposed within interior cavity59of housing57and is electrically connected to microcontroller65through a communication bus71. As will be described further below, memory69serves two principal functions. As a first function, memory69stores the application code software for adaptor17. As a second function, memory69temporarily stores (i.e., buffers) the data retrieved from ATI13prior to its transmission to DMD15. It should be noted that memory69preferably includes two separate memory devices, one of said memory devices being responsible for storing the application code software for adaptor17and the other of said memory device being responsible for temporarily storing the data retrieved from ATI13prior to its transmission to DMD15.

A wireless controller73is disposed within interior cavity59of housing57and is electrically connected to microcontroller65via universal asynchronous receiver transmitter (UART) communication bus75. As will be described further in detail below, in response to commands sent by microncontroller65, wireless controller73serves to regulate the operation of a wireless transceiver75.

For purposes of the present specification and claims, wireless controller73represents both a component which is physically separate from microcontroller65as well as a component which is physically incorporated into microcontroller65to form an integrated device unless otherwise specified.

Wireless transceiver75is disposed within interior cavity59of housing57and is electrically is connected to wireless controller73via a transmitter line TxD and a receiver line RxD, electrical signals passing from controller73to transceiver75traveling via transmitter line TxD and electrical signals passing from transceiver75to controller73traveling via receiver line RxD. As will be described further in detail below, wireless transceiver75serves to transmit electrical signals to DMD15and receive electrical signals from DMD15. Preferably, wireless transceiver75is disposed within interior cavity59in close proximity to a window77formed into the top of housing17through which signals are capable of traveling.

It should be noted that wireless transceiver75represents any conventional transceiver which is capable of two-way communication with a communication enabled device. As a result, wireless communication channel55represents any conventional two-way wireless communication channel (e.g., infrared (IR), such as infrared data (IrDA), or radio frequency (RF), such as Bluetooth, 802.11, Zigbee).

A power source79is disposed within interior cavity59of housing57and is electrically connected to microcontroller65, memory69, wireless controller73and wireless transceiver75. Power source79is preferably in the form of a replaceable 3 volt, coin cell lithium battery which is accessible through a door81which is slidably mounted onto housing57. However, it is to be understood that power source79is not limited to a 3 volt, coin cell lithium battery. Rather, it is to be understood that power source79could be in the form of additional types of conventional power sources (e.g., a solar battery cell) without departing from the spirit of the present invention. In addition, it is to be understood that power source79could be eliminated entirely from adaptor17without departing from the spirit of the present invention. Specifically, if power source79were to be removed from adaptor17, power could alternatively be supplied to adaptor17from the power source of ATI13.

A user input device83is disposed within interior cavity59and is sized and shaped to fittingly project through a corresponding opening formed in the front of housing57. User input device83is preferably in the form of a circular button which can be manually depressed so as to selectively close a switch which is electrically connected to microcontroller65. As will be described further below, input device83serves as a finger actuable means for triggering the execution of the data transfer from adaptor17to DMD15.

An indicator85is disposed within interior cavity59and is sized and shaped to fittingly project through a corresponding opening formed in the front of housing57. Indicator85is preferably in is in the form of a green light emitting diode (LED) which is electrically connected to microcontroller65. As will be described further in detail below, indicator85serves as a means for providing the user with a visual indication of the operating state of indicator (e.g., whether indicator85is transferring data to DMD15).

As noted above, system11is capable of transferring data stored in memory45of ATI13to DMD15via adaptor17. As will be described further below, system11transfers data stored on ATI13to DMD15via adaptor17by means of a two-step process. In the first step of the two step process, data stored in memory45of ATI13is transferred into buffer memory69of adaptor17. In the second step of the two step process, data transferred into buffer memory69of adaptor17is, in turn, wirelessly transmitted to DMD15. Each of the two aforementioned steps will be discussed further in detail below.

FIG. 7is a flow chart illustrating the method in which system11transfers data from ATI13to adaptor17, said method being represented generally by reference numeral101. Method101commences once data communication channel53is established between ATI13and adaptor17, said step being represented by reference numeral103. It should be noted that, for system11, data communication channel53is established between ATI13and adaptor17by inserting strip63of data communication device61into the corresponding test port slot of data communication device27, wherein the electrical conductors on data communication device61are disposed in direct electrical contact against the electrical conductors within data communication device27.

Having established data communication channel53between ATI13and adaptor17in step103, adaptor microcontroller65becomes active, or “wakes up”, in anticipation of the transfer of data between ATI and adaptor17, said step being represented by reference numeral105. Specifically, once data communication channel53has been established between ATI13and adaptor17, the protocol for ATI13is to send out a signal to determine the type of device (e.g., adaptor, analyte test strip, calibration test strip) connected to data communication device27. It is this signal sent by ATI13to determine the type of device connected to data communication device27which, in turn, serves to activate adaptor microcontroller65. Once adaptor microcontroller65becomes active, adaptor microcontroller65then sends a signal to activate, or “wake up”, microprocessor43for ATI13in anticipation of data transfer between ATI13and adaptor17, said step being represented by reference numeral107.

With adaptor microcontroller65and ATI microprocessor43having been activated in steps105and107, adaptor microcontroller65receives a first bundle of data stored in memory45of ATI13, said step being represented by reference numeral109. It should be noted that adaptor microcontroller65is programmed to understand the protocol of ATI13(e.g., ASTM1381protocol) and, as a result, can recognize the particular bundles, or packets, of data stored in memory45of ATI13. Having received the first bundle of data in step109, adaptor microcontroller65processes (i.e., reformats and sorts) the first bundle of data in order to render said bundle in compliance with the data receiving protocol for DMD15, said step being represented by reference numeral111. In step113, the first bundle of processed data in microcontroller65is then buffered into memory69.

Having completed the transfer of the first bundle of data from memory45of ATI13to buffer memory69of adaptor17, microcontroller65then sends a signal to microprocessor43to determine whether additional bundles of data remain in memory45for ATI13that need to be retrieved by adaptor17, said step being represented by reference numeral115. If there are no additional bundles of data located in memory45of ATI13, the data transfer process between ATI13and adaptor17ends, as represented by reference numeral117.

However, if additional bundles of data are located in memory45of ATI13, adaptor microcontroller65receives the next sequential bundle of data stored in memory45of ATI13, said step being represented by reference numeral119. Having received the next sequential bundle of data in step119, adaptor microcontroller65processes said bundle of data in step121. In step123, said bundle of processed data in microcontroller65is then buffered into memory69.

Having completed the transfer of the next sequential bundle of data from ATI13to adaptor17, microcontroller65then sends an additional signal to microprocessor43to determine whether more bundles of data remain in memory45of ATI13that need to be retrieved by adaptor17, said step being represented by reference numeral125. If there are no additional bundles of data located in memory45, method101proceeds to step117. However, if additional bundles of data are located in memory45of ATI13, method101returns to step119. As such, method101continues until all the bundles of data in memory45for ATI13are properly transferred into memory69for adaptor17.

Having completed the first step of the two-step process for transferring data from ATI to DMD15via adaptor17, system11is now prepared to execute the second step of the two-step process for transferring data from ATI13to DMD15via adaptor17. More specifically, system11is now prepared to wirelessly transmit the data buffered into memory69of adaptor17to wirelessly enabled DMD15.FIG. 8is a flow chart illustrating the method by which system11transfers data from memory69of adaptor17to DMD15, said method being represented generally by reference numeral201.

Method201commences once user input device83on adaptor17is activated (i.e., depressed), said step being represented by reference numeral203. The activation of user input device83in step203, causes adaptor microcontroller65to become active, or “wake up”, in anticipation of data transfer between adaptor17and DMD15, said step being represented by reference numeral205.

Once activated, adaptor microcontroller65instructs wireless controller73to have wireless transceiver75send out a signal through window77in order to establish a data communication channel55between adaptor17and DMD15, said step being represented by reference numeral207. It should be noted that during step207, adaptor microcontroller65simultaneously instructs indicator85to provide a signal (e.g., a flashing green light) to notify the user of the attempt by adaptor17to establish a data communication channel55with DMD15. If compatible, adaptor17and DMD15will be able to establish data communication channel55, said step being represented by reference numeral209. It should be noted that, upon establishing data communication channel55between adaptor17and DMD15, adaptor microcontroller65simultaneously instructs indicator85to provide a signal (e.g., a solid, non-flashing green light) to notify the user of the established data communication channel.

With data communication channel55having been established between adaptor17and DMD15, adaptor microcontroller65retrieves a first bundle of data from adaptor memory69and, in turn, sends said first bundle of data to wireless controller73, as represented by reference numeral211. It should be noted that the size of the first data bundle retrieved from adaptor memory69is dependent upon the transfer protocol established between adaptor17and DMD15. In step213, wireless controller73coverts the first bundle of received data into a format suitable for wireless transmission. The converted first bundle of data is then sent from wireless controller73to wireless transceiver75through transmission line TxD, said step being represented by reference numeral215. In step217, the converted first bundle of data is wirelessly transmitted from wireless transceiver75to DMD15.

Having completed the transfer of the first bundle of data from adaptor17to DMD15, microcontroller65then sends out a signal to determine whether additional data bundles remain in adaptor memory69, said step being represented by reference numeral219. If there are no additional bundles of data located in memory69, the data transfer process between adaptor17and DMD15terminates, as represented by reference numeral221. It should be noted that once method201reaches step221, adaptor microcontroller65simultaneously turns off indicator85to notify the user that the transfer of data between adaptor17and DMD15has completed.

However, if additional bundles of data are located in memory69, adaptor microcontroller65retrieves the next sequential bundle of data from adaptor memory69and, in turn, forwards said bundle to wireless controller73, as represented by reference numeral223. In step225, wireless controller73coverts the next sequential bundle of received data into a format suitable for wireless transmission. The converted bundle of data is then sent from wireless controller73to wireless transceiver75through transmission line TxD, said step being represented by reference numeral227. In step229, the converted bundle of data is wirelessly transmitted from wireless transceiver75to wireless enabled DMD15.

Having completed the transfer of the next sequential bundle of data from adaptor17to DMD15, microcontroller65then sends an additional signal to determine whether more bundles of data remain in memory69for adaptor17, said step being represented by reference numeral231. If there are no additional bundles located in adaptor memory69, method201proceeds to step221. However, if additional bundles of data are located in adaptor memory69, method201returns to step223. As such, method201continues until all of the bundles of data stored in adaptor memory69are wirelessly transmitted to DMD15.

As noted above, data communication device61of adaptor17is preferably in the form of a strip-type connective interface which includes multiple metal contacts and communication device27is preferably in the form of a slotted, multi-purpose test port which includes multiple metal contacts. Preferably, the strip-type connective interface of device27is sized and shaped to be fittingly inserted into the slot of the multi-purpose test port of device61so that the metal contacts of device61are disposed in direct electrical contact with the metal contacts within device27. In this manner, data communication channel53is established between ATI13and adaptor17.

However, it is to be understood that system11is not limited to the particular type of electrical interconnection between ATI13and adaptor17as described above. In particular, system11is not limited to data communication device61being in the form of a strip-type connective interface with multiple metal contacts and data communication device27being in the form of a multi-purpose test port with multiple metal contacts. Rather, it is to be understood that data communication devices27and61are meant to represent any complementary pair of connectors which can be removably interconnected so as to establish a serial data communication channel therebetween.

As an example, referring now toFIG. 9, there is shown a second embodiment of a system for transferring data, said system being constructed according to the teachings of the present invention and identified generally by reference numeral311.

System311is similar to system11in that system311comprises an analyte test instrument (ATI)313, a data management device (DMD)315and an adaptor317, wherein analyte test data stored in ATI313can be wirelessly transmitted to DMD315via adaptor317.

The principal distinction between system311and system11lies in the fact that adaptor317releasably interconnects with ATI313in a different manner in which adaptor17releasably interconnects with ATI13. Specifically, ATI313comprises a data communication device327which is in the form of a conventional, female-type, conductive phone jack receptacle and adaptor317comprises a data communication device361which is in the form of conventional, male-type, conductive phone jack. Preferably, the phone jack receptacle of device327is sized and shaped to fittingly and releasably receive the phone jack of device361, with device361being disposed in direct electrical contact with device327. As such, a serial data communication path can be established between adaptor317and ATI313, which is highly desirable.

It should be noted that the adaptors of the present invention which were described in detail above can be used in conjunction with various types of analyte test instruments. By providing adaptors which can be used with different types of analyte test instruments, the present invention serves to create a standardized means for wirelessly transmitting data of any format from any type of analyte test instrument to a common data management device, which is highly desirable.