WO2016090226A2

WO2016090226A2 - Plug connector apparatus, wireless communication modules and systems, and methods adapted for analyte meter data communication

Info

Publication number: WO2016090226A2
Application number: PCT/US2015/063949
Authority: WO
Inventors: Eugene R. Prais; Jennifer L. GASS; Igor Y. Gofman; Christopher A. DIONISIO
Original assignee: Bayer Healthcare Llc
Priority date: 2014-12-05
Filing date: 2015-12-04
Publication date: 2016-06-09
Also published as: WO2016090226A3; TW201635979A; AR102943A1

Abstract

Embodiments provide wireless communication modules, plug connector apparatus, and wireless communication systems and methods. The wireless communication module may be retrofit to an existing analyte meter wherein test data may be communicated between the analyte meter and the host device via wireless communication. Ease of transfer of test data and/or health information to a host device may be achieved so that users may utilize advanced presentations of health information based on the test data. Plug connector apparatus enabling taking analyte measurements while the wireless communication module is plugged in are provided, as are other aspects.

Description

PLUG CONNECTOR APPARATUS, WIRELESS COMMUNICATION MODULES AND SYSTEMS, AND METHODS ADAPTED FOR ANALYTE METER DATA

COMMUNICATION

RELATED APPLICATION

[ 0001 ] The present invention claims priority to U.S. Provisional Patent Application No. 62/088,331, filed December 5, 2014 and titled "PLUG CONNECTOR APPARATUS, WIRELESS COMMUNICATION MODULES AND SYSTEMS, AND METHODS ADAPTED FOR ANALYTE METER DATA COMMUNICATION," which is hereby incorporated herein by reference for all purposes .

FIELD

[ 0002 ] The present invention relates generally to apparatus, systems and methods enabling data communication between an analyte meter and a host device.

BACKGROUND

[ 0003 ] The quantitative determination of analytes in body fluids may be important in the diagnoses and maintenance of certain physiological conditions. For example, individuals with diabetes frequently check their blood glucose levels. The data results of such tests (e.g., glucose readings) may be used to regulate their diets and/or to determine whether to administer insulin or other medication.

[ 0004 ] Diagnostic systems, such as blood-analyte testing systems, may employ an analyte meter that receives a test sensor (e.g., a test strip) to calculate an analyte concentration level. For example, a blood glucose meter (BGM) may be used to determine the glucose level in a blood sample taken from an individual. Such analyte meters may operate by measuring an output, such as an electrical current or color change resulting from a reaction with the analyte contained in the blood sample. The test data are typically stored by the analyte meter, and basic programs within the analyte meter may allow the results to be displayed to the user in simple formats on the analyte meter itself. However, because of the small size of the analyte meter display, and the generally limited processing capability of the analyte meter, as well as limitations on capability of the display, the test data display may be inadequate to provide more sophisticated data analysis, if desired.

[0005] Thus, in order to manage test data according to more advanced functionalities that go beyond simple meter display and/or storage of test data, a user may wish to download the test data to a host device. For example, the test data may be downloaded to (e.g., transferred) a conventional desktop personal computer (PC) , or a hand held device, such as a cell phone, personal digital assistant (PDA) or tablet wherein a separate health data management application may be executed.

[0006] Accordingly, apparatus, systems and methods that may allow transfer of test data to a variety of host devices may be desirable.

SUMMARY

[0007] According to a first aspect, a plug connector apparatus is provided. The plug connector apparatus includes an insulating plug body, and a conductor arrangement within the insulating plug body including a plurality of internal conductors and radially-asymmetric electrical contacts exposed on a surface of the insulating plug body.

[0008] In an apparatus aspect, a wireless communication module is provided. The wireless communication module includes a module body, and a plug connector apparatus extending from the module body, including: an insulating plug body, and a conductor arrangement within the insulating plug body including a plurality of internal conductors and radially asymmetric electrical contacts exposed on a surface of the insulating plug body.

[0009] In a system aspect, a communication system is provided.

The communication system includes a host device adapted to display test data, the host device including a device wireless communication module, an analyte meter adapted to generate test data, the analyte meter including a serial port, and a wireless communication module retro-fittingly receivable in the serial port, wherein wireless communication module is adapted to wirelessly communicate test data with the device wireless communication module.

[0010] In a method aspect, a wireless communication method is provided. The wireless communication method includes providing a host device having a device wireless communication module, providing an analyte meter having a serial port, providing a wireless communication module including a plug connector apparatus, inserting the plug connector apparatus into the serial port, and carrying out wireless communication between the device wireless communication module and the wireless communication module.

[ 0011 ] Still other aspects, features and advantages of the present invention may be readily apparent from the following detailed description by illustrating a number of example embodiments and implementations, including the best mode contemplated for carrying out the present invention. The present invention may also be capable of other and different embodiments, and its several details may be modified in various respects, all without departing from the scope of the present invention. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. The invention is to cover all modifications, equivalents and alternatives falling within the scope of the invention .

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] FIGS. 1A and IB illustrate plan and cross-sectional side views, respectively, of an example plug connector that is conventionally coupled to a cable used to facilitate data communication between an analyte meter and a host device according to the prior art .

[0013] FIGS. 1C illustrates a schematic side view diagram of an example communication cable including a plug connector coupled to a blood glucose meter having a plug detection circuit according to the prior art .

[0014] FIG. 2A illustrates a block diagram of a communication system including a coupled wireless communication module enabling the retrofitting of wireless communication between an analyte meter and a host device according to embodiments.

[0015] FIG. 2B illustrates an end view of an analyte meter including a coupled wireless communication module that is externally detachable enabling retrofitting the analyte meter with wireless communication capability according to embodiments .

[0016] FIGS. 2C and 2D illustrate partial perspective views of an analyte meter including a connector plug apparatus of a wireless communication module shown unconnected and connected, respectively, according to embodiments.

[0017] FIG. 3 illustrates a block diagram of components of a wireless communication system including a wireless communication module according to embodiments.

[0018] FIG. 4A illustrates a perspective view of a wireless communication module including a connector plug apparatus configured to couple with an analyte meter according to embodiments . [0019] FIG. 4B illustrates another perspective view of a wireless communication module according to embodiments.

[0020] FIG. 4C illustrates an end view of a wireless communication module according to embodiments.

[0021] FIG. 4D illustrates a side plan view of a connector plug precursor in an as-molded condition according to embodiments .

[0022] FIG. 4E illustrates a side plan view of a connector plug apparatus according to embodiments.

[0023] FIG. 4F illustrates a cross-sectioned side view of a connector plug apparatus taken along section line 4F-4F of FIG. 4E according to embodiments.

[0024] FIG. 4G illustrates a side plan view of a connector plug apparatus rotated 90 degrees from FIG. 4E according to embodiments .

[0025] FIG. 4H illustrates a cross-sectioned side view of a connector plug apparatus taken along section line 4H-4H of FIG. 4G according to embodiments.

[0026] FIG. 5 illustrates a perspective view of a conductor subcomponent according to embodiments.

[0027] FIG. 6A illustrates a cross-sectional side view of another configuration of a wireless communication module including a plug connector apparatus having a split-sleeve contact configuration according to embodiments.

[0028] FIG. 6B illustrates a cross-sectional end view of a wireless communication module taken along section line 6B-6B of FIG. 6A according to embodiments.

[0029] FIG. 7 illustrates a schematic diagram of certain electrical components enabling selective wireless communication according to embodiments. [0030] FIG. 8 illustrates a flowchart illustrating a wireless communication method according to embodiments.

DESCRIPTION

[0031] In view of the foregoing difficulties, there is a need to make downloading of test data to different host devices more readily achievable. In some analyte meters, downloading of test data is achieved by the use of a hard-wired communication cable that is plugged into both the analyte meter 108 and into a host device (e.g., PC or the like) . Typically, an audio plug connector 100 (e.g., standard 3.5 mm 3-pole jack) is included on at least the analyte-meter- connecting end of the cable, such as shown in FIGS. 1A-1C. The audio plug connector 100 includes conventional concentric metal contacts having a tip, ring and sleeve structure, as is shown. Concentric and symmetric metal contacts consist of first contact 101, second contact 102, and third contact 103 spaced along the length of the audio plug connector 100, and first and second insulator members 104, 105, which insulate between the various metal contacts 101, 102, 103. Each of the metal contacts 101, 102, 103 span the whole circumference of the audio plug connector 100 (e.g., they are radially symmetric) , so when the audio plug connector 100 is plugged into a receptacle (e.g., a serial port) of the analyte meter 108, the audio plug connector 100 can be rotated without risk of interrupting the electrical connection with the analyte meter 108.

[0032] FIG. 1C illustrates a prior art connection of a communication cable 106 including an audio plug connector 100 to an analyte meter 108 such as a blood glucose meter (BGM)

(outline shown as a dotted box) , such as a CONTOUR® or a CONTOUR® NEXT blood glucose meter commercially available from Bayer Healthcare LLC of Tarrytown, NY. However, in such an existing analyte meter 108, when the audio plug connector 100 is plugged into the serial port 110, a plug detection circuit 112 in the analyte meter 108 (e.g., a BGM) sends an interrupt signal to the processor 114 of the analyte meter 108, which automatically switches the analyte meter 108 into a communication mode. When in the communication mode, all functions related to blood glucose measurement are disabled. Thus, when data communication is taking place downloading data to the host, the analyte meter 108 according to the prior art cannot be used to take blood glucose measurements. Accordingly, communication systems that allow for insertion into the plug without being automatically switched into a communication mode are desired. Furthermore, the ability to retrofit such an analyte meter 108 with wireless capability is desired .

[ 0033 ] To address these needs, embodiments according to aspects of the present invention provide an improved communication system for communicating test data. Improved communication system may be highly compatible with a plurality of different host devices. Furthermore, embodiments of the invention allow for analyte measurements to take place, even when the plug connector apparatus is inserted, and allows the user to then select when download is to take place. In yet another aspect, a wireless communication module that may be retrofitted to an existing analyte meter configured with a serial port for cabled communication is provided.

[ 0034 ] In particular, apparatus, systems and methods according to embodiments of the invention may include an analyte meter and a host device wherein the analyte meter and the host device are adapted to communicate data wirelessly, wherein the analyte meter retro-fittingly receives a communication module in a serial port thereof. Accordingly, the serial port is used to facilitate wireless communication with any number of host devices including wireless communication capability (e.g., BLUETOOTH® or other suitable wireless protocols) . For example, the analyte meter may be adapted and configured to include a wireless communication module that plugs into the serial port and facilitate wireless communication with the host device (e.g., desktop or laptop personal computer (PCs), handheld or pocket personal computer (HPCs), tablet, smart cell phone, Personal Digital Assistant (PDAs), or the like) .

[0035] The host device may contain the necessary processor, memory, and software to enable execution of a health data management application, which may process and/or display test data downloaded from the analyte meter. In some embodiments, the test data may include a series of measurements of an analyte in a fluid (e.g., glucose level in a blood sample) and related information such as a test date and time, a pre- prandial or post-prandial indicator, carb intake, units of medication taken, or other suitable related information.

[0036] Accordingly, embodiments of the present invention have utility for making it more convenient for a user to allow wireless communication of test data with a variety of different host devices, without having to replace an existing analyte meter, which may have been configured for cabled communication from the factory.

[0037] By downloading the test data as well as related information (test date and time, pre-prandial or post-prandial indicator, carb intake, units of medication taken, or other information, or the like) from the analyte meter to a host device, the user may then access more sophisticated presentations (displays) and/or analysis of the test data

(e.g., blood glucose test data). For example, the user may utilize a conventional health data management application operative on the host device. Furthermore, by enabling wireless communications with the host device, embodiments of the invention may also make it easier for a user to share test data with health care professionals or other such individuals because of improved compatibility with a broad number of host devices .

[0038] These and other embodiments of apparatus, systems and methods of the present invention are described below with reference to FIGs. 1A-8.

[0039] Referring now to FIGs. 2A-2D, a non-limiting embodiment of a communication system 200 adapted to communicate test data according to aspects of the invention is generally illustrated. In particular, communication system 200 may include a host device 215 and an analyte meter 108, which are configured, as shown, to communicate wirelessly with one another. The wireless communication may be used to download test data to the host device 215, for example. The wireless communication may be accomplished using any suitable wireless protocol (e.g., BLUETOOTH protocol, for example) .

[0040] In the depicted embodiment, the analyte meter 108 includes a serial port 110 (FIG. 2C) , that may be located at a side or end of the body 219 of the analyte meter 108 that is configured to receive a wireless communication module 218. Analyte meter 108 also includes a sensor port 222 configured to receive a test sensor 224 (sometimes referred to as a "test strip") . Analyte meter 108 may include keys 228 configured to control various functions of the analyte meter 108, and a display 226 configured to display analyte readings and averages, for example. In general, the analyte meter 108 may be adapted to receive the test sensor 224 and calculate and/or display an analyte concentration in a bodily fluid sample. A series of test measurements may be stored in memory of the analyte meter 108. For example, in one embodiment, a blood glucose measurement may be obtained. The analytes may be detected in, for example, whole blood, blood serum, blood plasma, interstitial fluid, urine, and the like. Other types of analytes may be measured provided a suitable reagent exists .

[ 0041 ] Analytes that may be analyzed may include glucose, lipid profiles (e.g., total cholesterol, triglycerides, low density lipoprotein (LDL) and high density lipoprotein (HDL) , microalbumin, hemoglobin AIC, fructose, lactate, keytone, bilirubin, uric acid, or the like. It is contemplated that analyte data may be determined (e.g., analyte concentration levels) by the analyte meter 108 and such analyte test data may be stored locally in memory and communicated via wireless communication to the host device 215.

[ 0042 ] The test sensor 224 may be an electrochemical test sensor or a photochromic test sensor. An electrochemical test sensor typically includes a plurality of electrodes and a fluid-receiving area that contains a reagent . Upon contact with analyte of interest (e.g., glucose) in a fluid sample

(e.g., blood) an electrical current may be produced which may be proportional to an analyte concentration level in the sample. The reagent may contain an enzyme such as, for example, glucose oxidase. However, it is contemplated that other reagents may be used to react with the analyte, depending on the analyte desired to be measured. In general, the reagent may be selected to react with the desired analyte or analytes to be tested to assist in determining an analyte concentration of a fluid sample. If the concentration of another analyte is to be determined, an appropriate enzyme may be selected to react with the analyte.

[ 0043 ] Alternatively, the test sensor 224 may be a photochromic test sensor. Photochromic test sensors may use techniques such as, for example, transmission spectroscopy, diffuse reflectance, or fluorescence spectroscopy for measuring an analyte concentration. An indicator reagent and an analyte in a sample of body fluid may be reacted to produce a chromatic reaction, wherein the reaction between the reagent and analyte causes a color change. The degree of color change is indicative of the analyte concentration in the body fluid. The color change may be evaluated to measure the absorbance level of the transmitted light.

[0044] Some commercially available test sensors that may be used by the embodiments described herein include those that are available commercially from Bayer Healthcare LLC

(Tarrytown, New York) . These test sensors include, but are not limited to, those used in the CONTOUR® blood glucose monitoring system, the BREEZE® and BREEZE®2 blood glucose monitoring system, and CONTOUR® NEXT and CONTOUR® NEXT EZ blood glucose monitoring system. It is contemplated that other test sensors, in addition to the ones listed above, may be incorporated into the methods and systems of embodiments of the present invention.

[0045] As best shown in FIGs. 2B-2D, wireless communication module 218 is configured to couple to the serial port 110

(FIG. 2C) of the analyte meter 108 in an externally detachable manner. In this way, the wireless communication module 218 may be added (e.g., retrofitted) to an existing analyte meter 108 that a user owns, and may facilitate wireless communication capability with the host device 215 that already includes a wireless communication unit (e.g., a smart phone, PC, tablet, or the like) .

[0046] As shown in FIG. 2C, the wireless communication module 218 includes a module body 230 and a plug connector apparatus 232 extending from the module body 230. The plug connector apparatus 232 includes a plurality of contacts that electrically engage with contacts in the serial port 110 (e.g., Tx, Rx, Jl, and GND shown in FIG. 6A) , as will be explained further herein. However, as will be apparent, the plug connector apparatus 232 includes at least some electrical contacts that are radially asymmetric. As such, one or more alignment features configured to rotationally align the plug connector apparatus 232 with the contacts (e.g., Tx, Rx, Jl, and J2 ) of the serial port 110 are provided.

[0047] In the depicted embodiment, the one or more alignment features comprise one or more shelves 234 formed on the module body 230. The one or more shelves 234 may be configured to interface and engage with an inclined surface 236 of the body 219 of the analyte meter 108. As should be apparent, full insertion of the plug connector apparatus 232 may only be achieved when the module body 230 of the wireless communication module 218 is properly aligned with the inclined surface 236. Any rotational alignment other than the configuration shown will cause the one or more shelves 234 to ride up on the inclined surface 236, which will pull the plug connector apparatus 232 from the serial port 110 and disconnect the electrical connection. In the depicted embodiment, the inclined surface 236 includes a gentle radius; however, a flat inclined surface 236 may work equally well. Other suitable means for alignment and preventing rotation may be employed, such as a tang or lip that engages with a bottom of the analyte meter 108.

[0048] Referring now to FIG. 3, further details of the communication system 200 are provided. The host device 215 may be selected from a variety of processing devices, such as desktop or laptop personal computers (PCs), handheld or pocket personal computers (HPCs), tablets, compatible personal digital assistants (PDAs), and cellular phones, for example. Other types of smart devices, e.g., those including a digital processor, memory, and a suitable graphical display, may be used. To operate, the host device 215 may employ a variety of operating systems and/or configurations. For example, if the host device 215 is a desktop or laptop personal computer, the operating system may be a version of Microsoft® Windows®. Alternatively, if the host device 215 is a PDA, the operating system may correspond with those of PALM® handhelds from Palm, Inc., or Blackberry® devices from Research in Motion Limited. If the host device 215 is an APPLE® device, such as an iPhone, iPod Touch, iPad, iPad Mini, the operating system may be iOS available from Apple, Inc. Any suitable operating system may be used on the host device 215.

[0049] As best illustrated in FIG. 3, in general, the host device 215 may include a host digital processor 338 that is adapted to, and capable of, receiving data in digital form and executing any number of programmed instructions thereon. In addition, the host device 215 may be typically operated with a user interface 340, which may include a graphical display and/or a keyboard, mouse, touch screen, or other input device, which may be external to, or integrated with, other components of the host device 215.

[0050] The host device 215 may also include a memory 341, such as a Random Access Memory (RAM) including Ended Data-Out Dynamic Random-Access Memory (EDO DRAM) , synchronous dynamic random-access memory (SDRAM) , Double Data Rate Synchronous Dynamic Random-access Memory (DDR SDRAM) , Single In-line Memory Module (SIMM), Dual In-line Memory Module (DIMM), and/or nonvolatile memory such as Read-Only Memory (ROM) including Programmable Read-Only Memory (PROM) , and Electrically Erasable Programmable Read-Only Memory (EEPROM) . The memory 341 may also include storage technologies, such as one or more storage devices such as a hard drive, floppy disk or optical disc such as Compact Disc (CD), Digital Video Disc (DVD), Blu-ray disc, and the like. It is contemplated the memory 341 may be configured to include any combination and form of RAM, ROM, and/or storage technologies. The memory 341 may be provided as a separate unit or incorporated as part of and resident on the host digital processor 338.

[ 0051 ] In some embodiments, the memory 341 may store software 342 associated with a health data management system

(hereinafter "health data management software") . The software 342 may be a program or collection of programs or computer codes that receive and process test data (e.g., measured analyte data, date and time, pre-prandial indicator, post^¬ prandial indicator, units of medication, and/or other related information input by the user) . The software 342 may process and/or display this input, test data, and/or related information in a manner that is desired by the user. This collective health information may be used by, for example, a user, Home Care Provider (HCP), hospital, and/or a physician.

[ 0052 ] As discussed above, the test data may be from testing of an analyte. At least some of the test data may be provided by a downloaded from the analyte meter 108. For example, the test data may include a concentration of glucose and/or other analyte concentrations in a person' s blood or other bodily fluid, as well as other date, time, and related information. Advantageously, the software 342 may provide advanced displays and data processing that may be desired by a user who may test multiple times a day (e.g., from about six to about ten times a day) . For example, the software 342 may include a product similar to GLUCOFACTS™ DELUXE Diabetes Management Software available from Bayer Healthcare LLC (Tarrytown, New York) . As such, the software 342 may provide a complete tool kit that may :

- receive and store test data from a blood glucose measurement system,

- receive and store other testing data such as test times and meal markers,

- track test data in an electronic logbook,

- calculate averages and provide a statistical analysis of outlier test data,

- summarize and provide feedback on the test data,

- provide a customizable graphical user interface,

- display user-friendly charts and graphs of the test data,

- track test data against user-specific target ranges,

- provide a predictive analysis, and/or

- send test data to healthcare professionals via fax, email, text message, or the like.

[ 0053 ] The software 342 may include any combination of software programs or components. For example, the software 342 may include a start-up or initialization program that initiates the health data management application. In some embodiments, the start-up program may identify relevant capabilities and/or the model of the analyte meter 108 so that a platform-compatible application may be selected and launched for execution on the host device 215. As such, the memory 341 of the host device 215 may store different versions of the software 342, so that the application may accept test data from any applicable analyte meter 108, which may be recognized by the software 342. [0054] In addition, the software 342 and/or memory 341 may include an embedded database 343 for receiving and storing test data. Furthermore, the software 342 may also include programs or components, such as user authentication routines, that protect data integrity and security. For example, when the software 342 launches, it may prompt the user for a user ID and/or password, personal identification number (PIN), and/or other authentication information. The user may only be allowed access to test data stored in the memory 341 if the response to the security prompt corresponds with authentication information previously entered into the software 342. A user authentication routine may also be employed to permit test data to be transferred (e.g., downloaded) to the memory 341 from the analyte meter 108. A suitable power source 344 may be employed, which may include AC power, battery power, and/or combinations and power management and/or charging. The host device 215 may include a device wireless communication module 352, such as a BLUETOOTH module. Other suitable wireless modules may be used. Wireless module as used herein means a wireless device including a transmitter, receiver and processor adapted to facilitate wireless communication.

[0055] In some embodiments, the analyte meter 108 may include a meter digital processor 345 and meter memory 346 for storage of test data, and for carrying out measurements and calculations of analyte concentration levels, and carrying out processing of acquired test data, for example. The meter digital processor 345 and meter memory 346 may include any suitable digital processor, microprocessor, and memory articles such as those described above. As illustrated, the analyte meter 108 may engage and receive the test sensor 224.

Analyte meter 108 is adapted to measure a concentration of analyte for the bodily fluid sample collected by the test sensor 224. The calculation of the concentration of analyte from the reaction measured by the analyte meter 108 may be accomplished by the meter digital processor 345, which may execute programmed instructions according to a suitable measurement algorithm contained in meter software 347. Data processed by the meter digital processor 345 may be stored in a meter memory 346. Such measurements and calculations are well known and will not be described further.

[0056] The analyte meter 108 may include a meter user interface 348, which may include any suitable display 226 for displaying test data and results to the user, such as a display (e.g., liquid-crystal display), one or more keys 228, or any combination thereof, for providing user input to the analyte meter 108. Analyte meter 108 may include a sensor port for receiving the test sensor 224 that may be inserted by a user or otherwise loaded from within the analyte meter 108 wherein suitable interface with the analyte meter 108 is achieved .

[0057] In most embodiments, the meter memory 346 and processing capability of the meter digital processor 345 of the analyte meter 108 may be intentionally limited to keep the overall cost of the analyte meter 108 relatively low. In these cases, further processing and/or more sophisticated displays of the test data may be achieved via downloading the test data to the host device 215 via wireless communication, as heretofore described.

[0058] For example, the meter memory 346 may include the types of memory mentioned above for the host device 215, but may include a flash memory device, such as a universal serial bus (USB) flash drive, or a memory card. USB flash drives are also known as thumb drives, handy drives, flash sticks, or jump drives. Memory cards may have a variety of formats, including PC Card (PCMCIA), CompactFlash (CF) , SmartMedia (SM/SMC), Memory Stick (MS), Multimedia Card (MMC) , Secure Digital Card (SD) , xD-Picture Card (xD) , Intelligent Stick (iStick) , ExpressCard, or some variation thereof. Flash memory devices may employ nonvolatile memory so that the meter software 347 stored therein may be retained in the meter memory 346 even when no power is received thereby. It is also contemplated that the meter memory 346 may employ other storage media, such as a floppy disk or an optical disc (CD, DVD, Blu-ray disc, or the like) .

[0059] The analyte meter 108 may also include suitable meter power source 349. For example, the analyte meter 108 may include a battery or other power components. The meter power source 349 may include power management, which may distribute power from a meter power source 349 to the meter digital processor 345 as well as to other system components that do not have their own power source. The power management may be configured to enter a standby mode to minimize power use when the analyte meter 108 is idle. Additionally, if a

rechargeable battery is employed, the power management may also handle the recharging of the battery. In the depicted embodiment, the wireless communication module 218 may include its own power source, such as a 2.7 V lithium coin cell battery .

[0060] In the described embodiment, the communication system 200 including the host device 215 and analyte meter 108 may include a wireless communication system 350. In particular, each of the host device 215 and analyte meter 108 may include a wireless communication module (e.g., device wireless communication module 352, and wireless communication module 218), respectively, which communicate wirelessly (e.g., at radio frequency (RF)) as indicated by wiggly arrow 354. [ 0061 ] In some embodiments, the device wireless communication module 352 of the host device 215 may include electronic components to carry out paired communication with the wireless communication module 218. For example, the wireless communication may be using a BLUETOOTH® communication protocol and the device wireless communication module 352 may include electronic circuits enabling such communication, including at least a BLUETOOTH chip or a BLUETOOTH module. Other suitable wireless devices and protocols may be used in each of the device wireless communication module 352 and the wireless communication module 218.

[ 0062 ] As discussed before, a plug connector apparatus 232 of the wireless communication module 218 may couple mechanically and electrically with a serial port 110 of the analyte meter 108. The serial port 110 may be electrically connected to a communication device interface 355 which may include a plug detection circuit (e.g., plug detection circuit 112) . Because of the usage of the serial port 110 to establish wireless communication, the need for carrying/obtaining an amount of adapters and cables to enable connection to various host devices 215 is eliminated. Advantageously, wireless communication capability may be provided with most conventional PCs and HPCs, as well as other smart devices such as PDAs, tablets, and smart cellular phones, which may be used for more sophisticated processing of the test data.

[ 0063 ] Accordingly, by the addition of a wireless communication module 218 retro-fittable with the serial port 110, wireless communication may be enabled with the host device 215. Different wireless communication devices may be included in the wireless communication module 218 to enable wireless communication with various types of the device wireless communication module 352 that may be present in the host device 215. For example, the wireless communication module 218 and the device wireless communication module 352 may include a radio frequency (RF) module or circuit including transmitter and receiver. The wireless communication module 218 and the device wireless communication module 352 may communicate at a communication frequency or band, such as at 433.92 MHz, 315 MHz , 868 MHz , 915 MHz, 2400 MHz, or the like. The RF modules may comply with any suitable communication protocol for RF communications, such as ZIGBEE®, BLUETOOTH®, or the like. The data communication protocols may include any form of error checking and/or handshaking (e.g., initialization procedures). The protocols may be implemented in software, or, optionally, in hardware.

[0064] One advantage of using wireless communication, rather than having a cable (wired) connection, is that the problem of Electro-Static Discharge (ESD) protection is no longer a primary consideration. ESD protection for the host device 215 and the analyte meter 108 may be substantially different from one another. For example, some host devices 215 may be only ESD protected up to about 8kV, whereas, some analyte meters 108 may be ESD protected up to 30kV. Given that ESD may be one of the major causes of device failures, it has been generally desirable to build ESD compatibility into the overall system design with the use of controls and/or sophisticated grounding systems. This, of course, may add to system cost and complexity. Accordingly, the use of wireless RF communication according to embodiments of the invention may allow communication even where ESD incompatibility may exist between the host device 215 and the analyte meter 108.

[0065] FIGS. 4A-4C and FIGS. 4E-4H illustrates an embodiment of a wireless communication module 218 and components thereof. Wireless communication module 218 includes a module body 230, which may be a suitable molded plastic, and a plug connector apparatus 232 extending from the module body 230, such as the first embodiment of a plug connector apparatus 232 shown in FIGS. 4E-4H.

[0066] The plug connector apparatus 232 includes an insulating plug body 437, and a conductor arrangement 439 provided (e.g., molded) within the insulating plug body 437 including a plurality of conductors 439A-439D extending within the

insulating plug body 437 and electrical contacts 451A-451D, which may be terminal portions of the plurality of conductors 439A-439D, exposed on a surface 453 of the insulating plug body 437. At least two of the electrical contacts 451A-451D are radially asymmetric, with all four electrical contacts 451A-451D shown as being radially asymmetric in the depicted embodiment. As such, the plug connector apparatus 232 is rotationally aligned with the serial port 110 via the one or more alignment features (e.g., one or more shelves 234. The electrical contacts 451A-451D may be positioned radially oriented to line up with existing electrical contacts in the serial port 110 of the analyte meter 108. Connector portions 456 of the conductors 439A-439D extend out of the insulating plug body 437 and are configured to connect to wires or other conductors that electrically connect to a wireless

communication unit 658 (FIG. 6A) , which may be provided in the module body 230.

[0067] An as-molded precursor 432P of the plug connector apparatus 232 is shown in the depicted embodiment of FIG. 4D. A conductor subcomponent 560, as shown in FIG. 5, including a support connection 561 between the various conductors 439A- 439D may be inserted in a suitable mold and the insulating plug body 437 formed around the conductor subcomponent 560 by injection or other suitable plastic molding process to form the as-molded precursor 432P. After molding, the support connection 561 between the various conductors 439A-439D may be severed to form the plug connector apparatus 232. Severing may be by any suitable sawing, cutting or grinding method along dotted line 462.

[0068] Now referring to FIGS. 6A-6B, schematic diagrams of an embodiment of wireless communication module 218 including a wireless communication unit 658 are shown. As depicted, the wireless communication module 218 may include a power source

659 such as a battery (e.g., a 2.7 V lithium coin cell battery), and the wireless communication unit 658. A switch

660 may be activated by the user to power the wireless communication unit 658 and commence pairing between the wireless communication unit 658 and the device wireless communication module 352. Wireless communication unit 658 may be BLUETOOTH® module, a communication circuit including a BLUETOOTH® chip, or the like, and may be connected to the various conductors 669A-669D by wires shown.

[0069] In FIGS. 6A and 6B, another embodiment of a plug connector apparatus 632 is shown. This embodiment of plug connector apparatus 632 includes a combination of radially- symmetric electrical contacts and radially-asymmetric

electrical contacts. The first contact 662 and second contact 664 are radially-symmetric electrical contacts, whereas the second and third contacts 665, 667 are radially-asymmetric electrical contacts. In particular, the second and third contacts 665, 667 are radially-asymmetric electrical contacts and may be made from a split sleeve 639S (see FIG. 6B) . Halves of the split sleeve 639S comprising the conductors 639C and 639D may be formed by either bending plates or slotting a tube along its length. First, second, third and fourth contacts 662, 664, 665, 667 may be made of any suitably conductive metal, such as copper, aluminum, steel, or the like. As shown first insulation 668 may be provided as a sleeve to insulate between the first contact 662 and the second contact 664.

Second insulation 670 may be provided between the second contact 664 and third and fourth contacts 665, 667 as well as between the third and fourth contacts 665, 667 themselves. Accordingly, all contacts 662, 664, 665, 667 are insulated relative to one another.

[ 0070 ] FIG. 7 illustrates a schematic diagram of an electrical connection between the analyte meter 108 and the wireless communication module 618. In this embodiment, the plug

connector apparatus 632 includes a combination of symmetric electrical contacts (first and second contacts 662, 664) and asymmetric electrical contacts (third and fourth contacts 665, 667) as shown in FIG. 6A-6B. The plug connector apparatus 632 may be inserted into the serial port 110 of the analyte meter 108 and the analyte meter 108 may still undertake analyte testing in accordance with one aspect.

[ 0071 ] Normally, the default position of controllable switch 772 is open (high impedance) . When a switch 660 is activated

(e.g., depressed), a closed signal (low impedance) from the General Purpose Input/Output (GPIO) pin is provided. This initiates an interrupt signal to the processor 114 and

initiates the start of wireless communication from

communication circuit 775. Communication may start with pairing followed by data transmission. Communication circuit 775 may include a BLUETOOTH® low energy chip and other common electrical components to achieve RF communications with the host device 215. Battery 777 may be a 2.7 V lithium coin cell battery, for example.

[ 0072 ] FIG. 8 illustrates, according to one or more

embodiments of the invention, a wireless communication method 800. The wireless communication method 800 is useful to enable wireless communication of test data between an analyte meter 108 and a host device 215. In some embodiments, the wireless communication method 800 includes, in 802, providing a host device (e.g., host device 215) having a device wireless communication module (e.g., device wireless communication module 352), and, in 804, providing an analyte meter (e.g., analyte meter 108) having a serial port (e.g., serial port 110) . The wireless communication method 800 includes, in 806, providing a wireless communication module (e.g., wireless communication module 218 or 618) including a plug connector apparatus (e.g., plug connector apparatus 232 or 632), and, in 808, inserting the plug connector apparatus into the serial port. The wireless communication method 800 includes, in 810, carrying out wireless communications (e.g., RF communications) between the device wireless communication module (e.g., device wireless communication module 352) and the wireless

communication module (e.g., wireless communication module 218 or 618) .

[ 0073 ] In 810, once wireless communication has been established between the respective host device 215 and analyte meter 108, such as by performing an initialization and pairing, an optional security sequence, or otherwise establishing readiness to transmit wireless signal communications, the test data transmission may take place. In 810, the wireless data transmission may occur between the analyte meter 108 and the host device 215 according to a pre- established communication protocol, which is recognized by both the host device 215 and the analyte meter 108. Of course, to be able to facilitate the data communication between the host device 215 and the wireless communication module (e.g., wireless communication module 218 or 618) inserted in the analyte meter 108, software components necessary to carry out the communication protocol may be preinstalled in the respective memories of the host device 215 and the wireless communication module (e.g., wireless communication module 218 or 618) to ensure compatibility.

[0074] Once the test data has been communicated to the host device 215, the test data may undergo processing to produce information, which may be displayed on the host device 215 to provide the user with enhanced analysis and/or display of the test data. The test data may be test data generated over time, such as a series of test data measurements of analyte concentration levels and/or associated information (e.g., average glucose readings, date and time stamp information, pre- or post-prandial indicators, log information, or the like) .

[0075] In some embodiments, the analyte meter may detect, through a suitable plug detection circuit within the communication device interface 355 (FIG. 3), an electrical connection to the wireless communication module (e.g., wireless communication module 218 or 618) only upon activation of a switch (e.g., switch 660) . In some embodiments, a prompt enabling and initiating wireless communication may be input to the host device 215 by an input via the user interface 340 to the software 342. Once the wireless connection has been readied via suitable pairing via initialization, a data transfer routine in software 342, may be launched to receive the test data to the host device 215.

[0076] While the invention is susceptible to various modifications and alternative forms, specific embodiments and methods thereof have been shown by way of example in the drawings and are described in detail herein. It should be understood, however, that it is not intended to limit the invention to the particular systems or methods disclosed, but, to the contrary, the intention is to cover all modifications, equivalents and alternatives falling within the scope of the invention .

Claims

CLAIMS WHAT IS CLAIMED IS:

1. A plug connector apparatus, comprising:

an insulating plug body; and

a conductor arrangement within the insulating plug body including a plurality of internal conductors and radially- asymmetric electrical contacts exposed on a surface of the insulating plug body.

2. The plug connector apparatus of claim 1 comprising a plug anti-rotation feature configured to engage with a body of an analyte meter.

3. A communication module including the plug connector apparatus of claim 1, comprising at least two radially- asymmetric electrical contacts .

4. The plug connector apparatus of claim 1, comprising at least two radially-asymmetric electrical contacts.

5. The plug connector apparatus of claim 1, comprising four radially-asymmetric electrical contacts.

6. The plug connector apparatus of claim 1, comprising a combination of axisymmetric electrical contacts and radially- asymmetric electrical contacts.

7. The plug connector apparatus of claim 1, comprising a combination of two axisymmetric electrical contacts and two radially-asymmetric electrical contacts.

8. The plug connector apparatus of claim 1, comprising a split sleeve.

9. A wireless communication module, comprising:

a module body; and

a plug connector apparatus extending from the module body, including:

an insulating plug body, and

a conductor arrangement within the insulating plug body including a plurality of internal conductors and radially-asymmetric electrical contacts exposed on a surface of the insulating plug body.

10. The wireless communication module of claim 9, wherein the module body includes a wireless communication circuit.

11. The wireless communication module of claim 9, wherein the module body includes a switch.

12. The wireless communication module of claim 9, comprising at least two radially-asymmetric electrical contacts.

13. The wireless communication module of claim 9, comprising a combination of radially-symmetric electrical contacts and radially-asymmetric electrical contacts.

14. A communication system, comprising:

a host device adapted to display test data, the host device including a device wireless communication module;

an analyte meter adapted to generate test data, the analyte meter including a serial port; and

a wireless communication module retro-fittingly receivable in the serial port, wherein wireless communication module is adapted to wirelessly communicate test data with the device wireless communication module.

15. The communication system of claim 14, wherein the host device includes software for processing the test data and displaying the test data on the host device.

16. The system of claim 14, wherein the analyte meter comprises a blood glucose meter.

17. The system of claim 14, wherein the host device is a personal computer, a laptop computer, a personal digital assistant, tablet, or a cellular phone.

18. The system of claim 14, wherein the test data includes analyte data.

19. A wireless communication method, comprising:

providing a host device having a device wireless communication module;

providing an analyte meter having a serial port;

providing a wireless communication module including a plug connector apparatus;

inserting the plug connector apparatus into the serial port; and

carrying out wireless communication between the device wireless communication module and the wireless communication module .

20. The wireless communication method according to claim 19, further comprising transmitting analyte test data from the analyte meter to the host device.