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

Plug connector apparatus, wireless communication modules and systems, and methods adapted for analyte meter data communication Download PDF

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Publication number
WO2016090226A2
WO2016090226A2 PCT/US2015/063949 US2015063949W WO2016090226A2 WO 2016090226 A2 WO2016090226 A2 WO 2016090226A2 US 2015063949 W US2015063949 W US 2015063949W WO 2016090226 A2 WO2016090226 A2 WO 2016090226A2
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WO
WIPO (PCT)
Prior art keywords
wireless communication
communication module
plug connector
connector apparatus
analyte
Prior art date
Application number
PCT/US2015/063949
Other languages
English (en)
French (fr)
Other versions
WO2016090226A3 (en
Inventor
Eugene R. Prais
Jennifer L. GASS
Igor Y. Gofman
Christopher A. DIONISIO
Original Assignee
Bayer Healthcare Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bayer Healthcare Llc filed Critical Bayer Healthcare Llc
Publication of WO2016090226A2 publication Critical patent/WO2016090226A2/en
Publication of WO2016090226A3 publication Critical patent/WO2016090226A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002Monitoring the patient using a local or closed circuit, e.g. in a room or building
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04Constructional details of apparatus
    • A61B2560/0443Modular apparatus
    • A61B2560/045Modular apparatus with a separable interface unit, e.g. for communication
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/22Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
    • A61B2562/225Connectors or couplings
    • A61B2562/227Sensors with electrical connectors
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • HELECTRICITY
    • H01ELECTRIC ELEMENTS
    • H01RELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
    • H01R24/00Two-part coupling devices, or either of their cooperating parts, characterised by their overall structure
    • H01R24/58Contacts spaced along longitudinal axis of engagement

Definitions

  • the present invention relates generally to apparatus, systems and methods enabling data communication between an analyte meter and a host device.
  • 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.
  • glucose readings e.g., glucose readings
  • Diagnostic systems may employ an analyte meter that receives a test sensor (e.g., a test strip) to calculate an analyte concentration level.
  • a test sensor e.g., a test strip
  • BGM blood glucose meter
  • 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.
  • the test data display may be inadequate to provide more sophisticated data analysis, if desired.
  • 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.
  • PC personal computer
  • PDA personal digital assistant
  • a 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.
  • a 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.
  • 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.
  • a 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.
  • 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 .
  • 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 .
  • 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.
  • 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 .
  • 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.
  • FIG. 3 illustrates a block diagram of components of a wireless communication system including a wireless communication module according to embodiments.
  • 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 .
  • FIG. 4B illustrates another perspective view of a wireless communication module according to embodiments.
  • FIG. 4C illustrates an end view of a wireless communication module according to embodiments.
  • FIG. 4D illustrates a side plan view of a connector plug precursor in an as-molded condition according to embodiments .
  • FIG. 4E illustrates a side plan view of a connector plug apparatus according to embodiments.
  • 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.
  • FIG. 4G illustrates a side plan view of a connector plug apparatus rotated 90 degrees from FIG. 4E according to embodiments .
  • 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.
  • FIG. 5 illustrates a perspective view of a conductor subcomponent according to embodiments.
  • 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.
  • 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.
  • FIG. 7 illustrates a schematic diagram of certain electrical components enabling selective wireless communication according to embodiments.
  • FIG. 8 illustrates a flowchart illustrating a wireless communication method according to embodiments.
  • an audio plug connector 100 e.g., standard 3.5 mm 3-pole jack
  • 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.
  • 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)
  • BGM blood glucose meter
  • a plug detection circuit 112 in the analyte meter 108 e.g., a BGM
  • the processor 114 of the analyte meter 108 When in the communication mode, all functions related to blood glucose measurement are disabled.
  • the analyte meter 108 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 .
  • 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.
  • 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.
  • a wireless communication module that may be retrofitted to an existing analyte meter configured with a serial port for cabled communication is provided.
  • 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.
  • 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) .
  • 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) .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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 .
  • 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) .
  • 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.
  • 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.
  • 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 .
  • 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.
  • lipid profiles e.g., total cholesterol, triglycerides, low density lipoprotein (LDL) and high density lipoprotein (HDL)
  • microalbumin e.g., hemoglobin AIC
  • fructose lactate
  • keytone e.g., bilirubin
  • uric acid uric acid
  • 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
  • analyte of interest e.g., glucose
  • 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.
  • an enzyme such as, for example, glucose oxidase.
  • other reagents may be used to react with the analyte, depending on the analyte desired to be measured.
  • 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.
  • 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.
  • test sensors that may be used by the embodiments described herein include those that are available commercially from Bayer Healthcare LLC
  • 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.
  • wireless communication module 218 is configured to couple to the serial port 110
  • 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) .
  • a wireless communication unit e.g., a smart phone, PC, tablet, or the like
  • 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.
  • the plug connector apparatus 232 includes at least some electrical contacts that are radially asymmetric.
  • 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.
  • 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.
  • an inclined surface 236 of the body 219 of the analyte meter 108.
  • 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.
  • 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.
  • 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.
  • 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®.
  • 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.
  • 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.
  • 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.
  • 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) .
  • RAM Random Access Memory
  • EDO DRAM synchronous dynamic random-access memory
  • DDR SDRAM Double Data Rate Synchronous Dynamic Random-access Memory
  • SIMM Single In-line Memory Module
  • DIMM Dual In-line Memory Module
  • nonvolatile memory such as Read-Only Memory (ROM) including Programmable Read-Only Memory (PROM) , and Electrically Erasable Programmable Read-Only Memory (EEP
  • 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.
  • the memory 341 may store software 342 associated with a health data management system
  • 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.
  • HCP Home Care Provider
  • 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.
  • 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.
  • 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) .
  • the software 342 may include a product similar to GLUCOFACTSTM DELUXE Diabetes Management Software available from Bayer Healthcare LLC (Tarrytown, New York) .
  • the software 342 may provide a complete tool kit that may :
  • test data to healthcare professionals via fax, email, text message, or the like.
  • the software 342 may include any combination of software programs or components.
  • the software 342 may include a start-up or initialization program that initiates the health data management application.
  • 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.
  • 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.
  • the software 342 and/or memory 341 may include an embedded database 343 for receiving and storing test data.
  • 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.
  • 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.
  • 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 .
  • 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.
  • 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) .
  • the analyte meter 108 may also include suitable meter power source 349.
  • 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
  • the power management may also handle the recharging of the battery.
  • the wireless communication module 218 may include its own power source, such as a 2.7 V lithium coin cell battery .
  • the communication system 200 including the host device 215 and analyte meter 108 may include a wireless communication system 350.
  • 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.
  • RF radio frequency
  • 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.
  • 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.
  • 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) .
  • a plug detection circuit e.g., plug detection circuit 112
  • the need for carrying/obtaining an amount of adapters and cables to enable connection to various host devices 215 is eliminated.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • FIG. 4D 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.
  • 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.
  • FIGS. 6A-6B schematic diagrams of an embodiment of wireless communication module 218 including a wireless communication unit 658 are shown.
  • the wireless communication module 218 may include a power source
  • a battery e.g., a 2.7 V lithium coin cell battery
  • the wireless communication unit 658 such as a switch
  • 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.
  • 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
  • first contact 662 and second contact 664 are radially-symmetric electrical contacts
  • second and third contacts 665, 667 are radially-asymmetric electrical contacts
  • 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.
  • 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.
  • FIG. 7 illustrates a schematic diagram of an electrical connection between the analyte meter 108 and the wireless communication module 618.
  • 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.
  • controllable switch 772 Normally, the default position of controllable switch 772 is open (high impedance) .
  • 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
  • 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.
  • FIG. 8 illustrates, according to one or more
  • a wireless communication method 800 is useful to enable wireless communication of test data between an analyte meter 108 and a host device 215.
  • 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
  • wireless communication module e.g., wireless communication module 218 or 618, .
  • test data transmission may take place.
  • 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.
  • wireless communication module e.g., wireless communication module 218 or 618
  • 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.
  • 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) .
  • 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) .
  • 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.
  • a data transfer routine in software 342 may be launched to receive the test data to the host device 215.

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PCT/US2015/063949 2014-12-05 2015-12-04 Plug connector apparatus, wireless communication modules and systems, and methods adapted for analyte meter data communication WO2016090226A2 (en)

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GB1274621A (en) * 1971-01-27 1972-05-17 Sealectro Corp Jack plugs
US3826986A (en) * 1972-08-17 1974-07-30 Scope Inc Remote control adapter
US6976958B2 (en) * 2000-12-15 2005-12-20 Q-Tec Systems Llc Method and apparatus for health and disease management combining patient data monitoring with wireless internet connectivity
DE202004006906U1 (de) * 2004-04-29 2004-10-21 Schmitz, Martin Netzstecker und Netzsteckdose mit Schutzkontakt
US20070255126A1 (en) * 2006-04-28 2007-11-01 Moberg Sheldon B Data communication in networked fluid infusion systems
US20130066644A1 (en) * 2007-10-22 2013-03-14 Kent Dicks Methods for personal emergency intervention
US8475732B2 (en) * 2010-10-26 2013-07-02 Abbott Diabetes Care Inc. Analyte measurement devices and systems, and components and methods related thereto
NL2010294C2 (en) * 2013-02-13 2014-08-14 Boudewijn John Sambeek Connection device, assembly thereof and assembly method therefor.

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