US20100160759A1 - Combination communication device and medical device for communicating wirelessly with a remote medical device - Google Patents

Combination communication device and medical device for communicating wirelessly with a remote medical device Download PDF

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Publication number
US20100160759A1
US20100160759A1 US12/646,113 US64611309A US2010160759A1 US 20100160759 A1 US20100160759 A1 US 20100160759A1 US 64611309 A US64611309 A US 64611309A US 2010160759 A1 US2010160759 A1 US 2010160759A1
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United States
Prior art keywords
electronic device
step
bolus
process
value
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Abandoned
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US12/646,113
Inventor
Michael J. Celentano
Ulf Meiertoberens
Peter Sabol
Raymond Strickland
Paul J. Galley
Markus Oberli
Mathias Ehrsam
Erich Imhol
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Roche Diagnostics International AG
Roche Diabetes Care Inc
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Roche Diagnostics International AG
Roche Diagnostics Operations Inc
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Filing date
Publication date
Priority to US93793307P priority Critical
Priority to US93777907P priority
Priority to PCT/US2008/066262 priority patent/WO2009005952A2/en
Application filed by Roche Diagnostics International AG, Roche Diagnostics Operations Inc filed Critical Roche Diagnostics International AG
Priority to US12/646,113 priority patent/US20100160759A1/en
Assigned to ROCHE DIAGNOSTICS GMBH reassignment ROCHE DIAGNOSTICS GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MEIERTOBERENS, ULF
Assigned to ROCHE DIAGNOSTICS OPERATIONS, INC. reassignment ROCHE DIAGNOSTICS OPERATIONS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CELENTANO, MICHAEL J., GALLEY, PAUL J., SABOL, PETER, STRICKLAND, RAYMOND
Assigned to ROCHE DIAGNOSTICS INTERNATIONAL LTD. reassignment ROCHE DIAGNOSTICS INTERNATIONAL LTD. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: OBERLI, MARKUS, IMHOF, ERICH, EHRSAM, MATTHIAS
Assigned to ROCHE DIAGNOSTICS OPERATIONS, INC. reassignment ROCHE DIAGNOSTICS OPERATIONS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ROCHE DIAGNOSTICS GMBH
Publication of US20100160759A1 publication Critical patent/US20100160759A1/en
Assigned to ROCHE DIABETES CARE, INC. reassignment ROCHE DIABETES CARE, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ROCHE DIAGNOSTICS OPERATIONS, INC.
Application status is Abandoned legal-status Critical

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording 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
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/74Details of notification to user or communication with user or patient ; user input means
    • A61B5/7475User input or interface means, e.g. keyboard, pointing device, joystick
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F1/00Details not covered by groups G06F3/00 – G06F13/00 and G06F21/00
    • G06F1/16Constructional details or arrangements
    • G06F1/1613Constructional details or arrangements for portable computers
    • G06F1/1626Constructional details or arrangements for portable computers with a single-body enclosure integrating a flat display, e.g. Personal Digital Assistants [PDAs]
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F1/00Details not covered by groups G06F3/00 – G06F13/00 and G06F21/00
    • G06F1/16Constructional details or arrangements
    • G06F1/1613Constructional details or arrangements for portable computers
    • G06F1/1633Constructional details or arrangements of portable computers not specific to the type of enclosures covered by groups G06F1/1615 - G06F1/1626
    • G06F1/1684Constructional details or arrangements related to integrated I/O peripherals not covered by groups G06F1/1635 - G06F1/1675
    • G06F1/169Constructional details or arrangements related to integrated I/O peripherals not covered by groups G06F1/1635 - G06F1/1675 the I/O peripheral being an integrated pointing device, e.g. trackball in the palm rest area, mini-joystick integrated between keyboard keys, touch pads or touch stripes
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F1/00Details not covered by groups G06F3/00 – G06F13/00 and G06F21/00
    • G06F1/16Constructional details or arrangements
    • G06F1/1613Constructional details or arrangements for portable computers
    • G06F1/1633Constructional details or arrangements of portable computers not specific to the type of enclosures covered by groups G06F1/1615 - G06F1/1626
    • G06F1/1684Constructional details or arrangements related to integrated I/O peripherals not covered by groups G06F1/1635 - G06F1/1675
    • G06F1/1698Constructional details or arrangements related to integrated I/O peripherals not covered by groups G06F1/1635 - G06F1/1675 the I/O peripheral being a sending/receiving arrangement to establish a cordless communication link, e.g. radio or infrared link, integrated cellular phone
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F19/00Digital computing or data processing equipment or methods, specially adapted for specific applications
    • G06F19/30Medical informatics, i.e. computer-based analysis or dissemination of patient or disease data
    • G06F19/34Computer-assisted medical diagnosis or treatment, e.g. computerised prescription or delivery of medication or diets, computerised local control of medical devices, medical expert systems or telemedicine
    • G06F19/3456Computer-assisted prescription or delivery of medication, e.g. prescription filling or compliance checking
    • G06F19/3468Computer-assisted delivery of medication via infusion or injection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3546Range
    • A61M2205/3569Range sublocal, e.g. between console and disposable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3576Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502User interfaces, e.g. screens or keyboards
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00Ancillary equipment
    • A61M2209/01Remote controllers for specific apparatus

Abstract

An electronic device may selectively disable a bolus advice process according to which the electronic device recommends delivery of a bolus amount of a drug to a body of a user based on a plurality of factors including glucose concentration of the user. The electronic device may include a glucose measuring facility configured to measure glucose concentration of a body fluid sample, and a processor including a memory having instructions stored therein that comprise the bolus advice process. The memory may further have instructions stored therein that are executable by the processor to request a glucose concentration measurement by the glucose measurement facility prior to executing, or as part of, the bolus advice process, and to disable execution of the bolus advice process if a glucose concentration value resulting from the requested glucose concentration measurement is less than a threshold value.

Description

  • This application is a continuation of PCT/US2008/066262 filed Jun. 9, 2008 which is based on and claims priority to U.S. Provisional Patent Application Ser. No. 60/937,779 and U.S. Provisional Patent Application Ser. No. 60/937,933, both filed Jun. 29, 2007, all applications in this paragraph are hereby incorporated by reference.
  • FIELD
  • This disclosure relates generally to electronic devices that may include one or more on-board medical devices, and more specifically to such electronic devices configured to wirelessly communicate with at least on off-board medical device.
  • BACKGROUND
  • Remote electronic devices for wirelessly communicating with at least one medical device are known. It is desirable to include on the remote electronic device an on-board medical device, and/or to conduct wireless communications between the remote electronic device and an off-board medical device for the purpose of commanding operation of the off-board medical device with the remote electronic device.
  • SUMMARY
  • The present invention may comprise one or more of the features recited in the attached claims, and/or one or more of the following features and combinations thereof. An electronic device is provided for selectively disabling a bolus advice process according to which the electronic device recommends delivery of a bolus amount of a drug to a body of a user based on a plurality of factors including glucose concentration of the user. The electronic device may comprise a glucose measuring facility configured to measure glucose concentration of a body fluid sample, and a processor including a memory having instructions stored therein that comprise the bolus advice process, the memory further having instructions stored therein that are executable by the processor to request a glucose concentration measurement by the glucose measurement facility prior to executing, or as part of, the bolus advice process, and to disable execution of the bolus advice process if a glucose concentration value resulting from the requested glucose concentration measurement is less than a threshold value.
  • The electronic device may further comprise a display device. The memory may further include instructions stored therein that are executable by the processor to control the display device to display a message indicating that the bolus recommendation glucose concentration value.
  • The memory may further include instructions stored therein that are executable by the processor to compute a carbohydrate value based on the glucose concentration value resulting from the requested glucose concentration measurement and a target glucose concentration value. The carbohydrate value may correspond to a quantity of carbohydrates required to be taken by the user to increase glucose concentration of the user to the target glucose concentration value.
  • The memory may further include instructions stored therein that are executable by the processor to control the display device to display the carbohydrate value with instructions to consume carbohydrates in the amount of the carbohydrate value. The threshold value may correspond to a hypoglycemic threshold.
  • A method of controlling a color display of an electronic device may comprise determining a measured or computed value, determining a display color based on the measured or computed value relative to at least one limit or range, and changing a color of at least a portion of the display to the display color when displaying the measured or computed value or a message identifying the value.
  • The electronic device may include a medical device that measures an analyte concentration in a liquid sample. The medical device may be a blood glucose meter that measures glucose concentration in blood samples. In this embodiment, determining a display color based on the measured or computed value may comprise determining a display color based on a measured glucose concentration relative to at least a target blood glucose range. For example, determining a display color may comprise selecting a first color if the measured glucose concentration is within the target blood glucose range. Determining a display color may further comprise selecting a second color different from the first color if the measured glucose concentration is between the target blood glucose range and a low blood glucose value. Determining a display color may further comprise selecting a third color different from the first and second colors if the measured glucose concentration is below the low blood glucose value. The method may further comprise controlling the display to display a warning message if the measured blood glucose concentration is below the low blood glucose value. The low blood glucose value may be a hypoglycemic blood glucose threshold. Determining a display color may further comprise selecting a fourth color different from the first color if the measured glucose concentration is between the target blood glucose range and a high blood glucose value. The method may further comprise controlling the display to display a warning message along with the fourth color if the measured blood glucose concentration is below above the high blood glucose value. The high blood glucose value may be a hyperglycemic blood glucose threshold.
  • Determining a measured or computed value may alternatively or additionally comprise computing a value, or receiving a computed value, of a quantity of a drug to be delivered to a body.
  • A method of collecting, in an electronic device, time-based event data stored in a medical device may comprise wirelessly sending by the electronic device a request for the time-based event data, wirelessly sending by the medical device time-based event data stored therein since previously wirelessly sending stored time-based event data upon receiving the request for the time-based event data, wirelessly sending by the electronic device an acknowledgement signal upon receiving the time-event based data from the another electronic device, and identifying by the medical device a location in memory of the last item of the time-event based data that was sent to the electronic device upon receiving the acknowledgement signal.
  • The medical device may be a liquid infusion pump and the time-based event data may be time-based infusion pump event data.
  • A method is provided for enabling a bolus advice feature of an electronic device according to which the electronic device recommends delivery of a bolus amount of a drug to a body of a user based on a plurality of factors including glucose concentration of the user. The method may comprise disabling the bolus advice feature of the electronic device during manufacture of the electronic device, monitoring one of a flag and a memory location when the electronic device is operable after manufacture thereof, and enabling the bolus advice feature if one of the flag is activated and the memory location includes a device pairing value.
  • Monitoring one of a flag and a memory location may comprise monitoring a flag. The method may further comprise activating the flag if a predefined password is received by the electronic device. Alternatively or additionally, the method may further comprise activating the flag when the electronic device has been successfully paired with another electronic device. The another electronic device may comprises an ambulatory medical device.
  • Monitoring one of a flag and a memory location may comprise monitoring a memory location. The method may further comprise storing the device pairing value in the memory location when the electronic device has been successfully paired with another electronic device. The another electronic device may comprise an ambulatory medical device.
  • A method of maintaining a time and date in an electronic device that communicates wirelessly with an ambulatory medical device may comprise establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device, wirelessly sending by the medical device time and date information, corresponding to a calendar date and time of day maintained by the medical device, when the wireless communication link is established, and modifying by the electronic device a calendar date and time of day thereof if the time of day received from the medical device time differs from the time of day of the electronic device by more than a predefined time value.
  • The electronic device may include a “my data” feature according to which historical records stored within the electronic device may be viewed. Establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device may comprise establishing the wireless communication link, if one is not already established, when the electronic device enters the my data feature.
  • Alternatively or additionally, the electronic device may include a bolus advice feature according to which the electronic device recommends delivery of a bolus amount of a drug to a body of a user based on a plurality of factors including glucose concentration of the user. Establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device may comprise establishing the wireless communication link, if one is not already established, when the electronic device enters the bolus advice feature.
  • Alternatively or additionally, the electronic device may include an on/off switch. Establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device may comprise establishing the wireless communication link, if one is not already established, when the on/off switch is detected as transitioning from an off state to an on state.
  • Alternatively or additionally, a memory unit of the electronic device may have at least one automatic reminder stored therein. Establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device may comprise establishing the wireless communication link, if one is not already established, when the at least one automatic reminder powers on the electronic device from an off state.
  • Alternatively or additionally, the electronic device may include a remote terminal operating mode according to which the electronic device remote controls operation of the ambulatory medical device. Establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device may comprise establishing the wireless communication link, if one is not already established, when the electronic device exits the remote terminal operating mode.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 shows a block diagram of one illustrative embodiment of a wireless communication system including a medical device and a remote electronic device that are both configured to wirelessly communicate with each other.
  • FIG. 2 shows a block diagram schematic of one illustrative embodiment of an electronic circuit that is carried by, and that controls, the remote electronic device of FIG. 1.
  • FIG. 3 shows a block diagram schematic of some of the details of one illustrative embodiment of the memory subsystem of the remote electronic device of FIG. 2.
  • FIG. 4 shows a flowchart of one illustrative embodiment of a process for enabling a bolus advice feature of the remote electronic device.
  • FIG. 5 shows a flowchart of one illustrative embodiment of a process carried out in the remote electronic device for establishing wireless communications between the remote electronic device and the medical device.
  • FIG. 6 shows a flowchart of one illustrative embodiment of a process carried out in the remote electronic device for processing information after a wireless connection is established between the remote electronic device and the medical device.
  • FIG. 7 shows a diagram of one illustrative embodiment of a number of databases defined in the memory device of the remote electronic device.
  • FIG. 8 shows a diagram of a data buffer in the medical device that is configured to store time stamped medical device events.
  • FIG. 9 shows a flowchart of one illustrative embodiment of a process for transferring portions of the time stamped medical device events from the medical device to the remote electronic device.
  • FIGS. 10 and 11 show a flowchart of one illustrative embodiment of a process carried out by the remote electronic device for processing history data transferred from the medical device to the remote electronic device.
  • FIGS. 12A-12C show a flowchart of one illustrative embodiment of a bolus advice process carried out by the remote electronic device.
  • FIG. 13 shows a flowchart of one illustrative embodiment of a process for controlling the display of the remote electronic device to indicate readily perceptible warnings and/or alerts.
  • FIG. 14 shows a flowchart of one illustrative embodiment of a hypoglycemic test process.
  • FIG. 15 shows a graphic representation of one illustrative embodiment of a bolus advice display screen produced by the process of FIGS. 12A-12C.
  • FIG. 16 shows a flowchart of one illustrative sub-process carried out by the remote electronic device in the bolus advice process of FIGS. 12A-12C.
  • FIGS. 17A and 17B show a flowchart of another illustrative sub-process carried out by the remote electronic device in the bolus advice process of FIGS. 12A-12C.
  • FIG. 18 shows a flowchart of yet another illustrative sub-process carried out by the remote electronic device in the bolus advice process of FIGS. 12A-12C.
  • FIG. 19 shows a flowchart of still another illustrative sub-process carried out by the remote electronic device in the bolus advice process of FIGS. 12A-12C.
  • FIG. 20 shows a flowchart of a further illustrative sub-process carried out by the remote electronic device in the bolus advice process of FIGS. 12A-12C.
  • DETAILED DESCRIPTION
  • For the purposes of promoting an understanding of the principles of the invention, reference will now be made to a number of illustrative embodiments shown in the attached drawings and specific language will be used to describe the same.
  • The following co-pending patent applications are incorporated herein by reference: PCT Patent Application No. PCT/US2008/066288, entitled APPARATUS AND METHOD FOR REMOTELY CONTROLLING AN AMBULATORY MEDICAL DEVICE; PCT Patent Application No. PCT/US2008/066331, entitled METHOD AND APPARATUS FOR DETERMINING AND DELIVERING A DRUG BOLUS; PCT Patent Application No. PCT/US2008/066267, entitled LIQUID INFUSION PUMP; PCT Patent Application No. PCT/US2008/066299, entitled USER INTERFACE FEATURES FOR AN ELECTRONIC DEVICE; PCT Patent Application No. PCT/US2008/066247, entitled METHOD FOR PAIRING AND AUTHENTICATING ONE OR MORE MEDICAL DEVICES AND ONE OR MORE REMOTE ELECTRONIC DEVICES; PCT Patent Application No. PCT/US2008/066248, entitled DEVICE AND METHODS FOR OPTIMIZING COMMUNICATIONS BETWEEN A MEDICAL DEVICE AND A REMOTE ELECTRONIC DEVICE; and U.S. Provisional Patent Application Ser. No. 61/130,855, entitled DEVICE AND METHODS FOR OPTIMIZING COMMUNICATIONS BETWEEN AN ELECTRONIC DEVICE AND A MEDICAL DEVICE.
  • Referring now to FIG. 1, a block diagram is shown of one illustrative embodiment of a wireless communication system 10 including a remote electronic device 12 and medical device 14 that are both configured to wirelessly communicate with each other. The remote electronic device 12 has a housing through which a user button section 16 extends. In one embodiment, the user button section 16 defines a number of user buttons, keys or switches that may be manually manipulated by a user to provide input to the remote electronic device 12. A visual display unit 18 is carried by the housing of the electronic device 12, and in one embodiment the visual display unit 18 is provided in the form of a conventional liquid crystal display (LCD), although this disclosure contemplates using other conventional display units. Examples include, but are not limited to, plasma displays, light emitting diode (LED) based displays, vacuum fluorescent (VF) displays, and the like. In any case, the visual display unit 18 is controlled by the electronic device 12 to display information to a user of the device 12. In alternative embodiments, the user button section 16 may be or include one or more touch-sensitive buttons. In this embodiment, one or more touch-sensitive buttons may, but not, form part of the display unit 18.
  • The electronic device 12 further includes a carrier port 20 that extends into the housing from an opening defined therein. The carrier port 20 is sized to receive therein a sample carrier or strip 22 upon which a liquid sample containing an analyte has been or will be deposited. The electronic device 12 includes electrical circuitry that analyzes the liquid sample deposited on the sample carrier 22, when the sample carrier 22 is received within the carrier port 20, to determine a concentration of the analyte contained in the liquid sample. In one embodiment, the liquid sample is blood and the analyte is glucose. In this embodiment, the sample carrier 22 may is illustratively provided in the form of a glucose test strip, and the electrical circuitry of the electronic device 12 includes conventional circuitry that measures the concentration of glucose in a blood sample deposited on the test strip 22. In alternative embodiments, the liquid sample may be or include other bodily fluids, and the analyte may be any analyte that is contained in a bodily fluid.
  • In the embodiment illustrated in FIG. 1, the electronic device 12 further includes a conventional data key port 26 that extends into the housing from an opening defined therein. The data key port 26 defines an electrical interface or connector therein that is configured to electrically connect to a complementarily configured electrical interface or connector defined on a conventional data key 24. The data key 24 includes a conventional memory device (not shown) that is electrically connected to the electrical interface or connector defined on the data key 24. The memory device, e.g., ROM key, is electrically connected to the electrical circuitry of the electronic device 12 via the electrical interface defined on the data key 24 and the electrical interface defined in the data key port 26 when the data key 26 is received within the data key port 24. Generally, the memory device of the data key 24 has calibration data stored therein that is specific to a lot or batch of test strips 22, and the electrical circuitry of the electronic device 12 uses the calibration data stored in the memory device of the data key 24 to correct glucose concentration measurements when using a test strip 22 from a corresponding lot or batch of test strips as is known in the art. Typically, each lot or batch of test strips 22 purchased by a user will include a dedicated data key 24 that is to be used when measuring glucose concentration with that lot or batch of strips.
  • It will be understood that while the carrier port 20, sample carrier 22 and electrical circuitry of the electronic device 12 have been described in one embodiment as being configured to measure the glucose concentration of blood samples deposited on the sample carrier 22, this disclosure contemplates other embodiments in which the carrier port 20, sample carrier 22 and/or electrical circuitry of the electronic device 12 is/are configured to measure other analytes in other liquid samples.
  • The medical device 14 includes a conventional processor 28 that is electrically connected to a wireless communication circuit 30. The processor 28 includes a conventional memory unit 25 which has stored therein a number of processes in the form of instructions that are executable by the processor 28 to control operation of the medical device 14 and to wirelessly communicate with the electronic device 12. In the illustrated embodiment, the medical device 14 further includes conventional non-volatile memory units 27 and 29. In one embodiment, the non-volatile memory unit 27 is provided in the form of a conventional ferroelectric random access memory (FRAM) and the non-volatile memory unit 29 is provided in the form of a conventional electrically erasable programmable read only memory (EEPROM), although either memory unit 27, 29 may alternatively be provided in the form of one or more other conventional non-volatile memory units. In any case, the memory units 27 and 29 are each external to the processor 28 and are each electrically connected to the processor 28. In one illustrative embodiment in which the medical device is a drug infusion pump, as will be described in greater detail hereinafter, the memory unit 27 is a pump delivery (PD) memory unit in which the processor 28 stores current pump delivery information, and the memory unit 29 is a pump history (PH) memory unit that has stored therein pump history information, e.g., in the form of event records each corresponding to an operational event of the pump 14. The medical device 14 further includes a wireless communication circuit 30 that is configured to communicate wirelessly with a similar wireless communication module of the remote electronic device 12 via a wireless communication link 40 in a conventional manner. In one embodiment, as will be illustrated by example throughout this disclosure, the wireless communication circuit 30 and the wireless communication module of the electronic device 12 are both conventional BlueTooth® modules configured to wirelessly communicate according to a conventional BlueTooth® communication protocol. It will be understood, however, that the wireless communication circuit or module 30 and the wireless communication module of the electronic device 12 may alternatively be configured to wirelessly communicate according to one or more other communication protocols.
  • The medical device 14 illustratively includes a housing through which a number of user keys 32 extend. The user keys 32 may be provided in the form of any number of user selectable buttons, keys or switches that are electrically connected to the processor 28. The medical device 14 further includes a visual display unit 34 that is carried by the housing and that is electrically connected to the processor 28. The visual display unit 34 may be, for example, a conventional liquid crystal display (LCD), plasma displays, light emitting diode (LED) based display, vacuum fluorescent (VF) display, or the like. The visual display unit 34 is controlled by the processor 28 to display information to a user of the medical device 14. In alternative embodiments, the user keys 32 may be or include one or more touch-sensitive buttons. In this embodiment, one or more touch-sensitive buttons may, but not, form part of the display unit 34.
  • The processor 28 of the medical device 14 is further electrically connected to a conventional audible indication device 36 and to a conventional vibratory device 38. The processor 28 is generally operable to control the audible indication device 36 and the vibratory device 38 to produce one or more audible sounds and/or vibrations respectively to notify the user of various operational aspects of the medical device 14 and to also notify the user of any alarm and/or warning conditions associated with the medical device 14. In alternative embodiments, the medical device 14 may not include a display device 34 and/or user keys 32. In some such embodiments, the medical device 14 may include one or more visual indicators for conveying information to a user. Examples of such visual indicators may include, but should not be limited to, one or more lamps, one or more light emitting diodes (LEDs), or the like.
  • In one illustrative embodiment, the medical device 14 is an ambulatory medical device. Examples of ambulatory medical devices include, but are not limited to, an implantable liquid delivery pump or a non-implantable liquid delivery pump, such as a drug infusion pump, an implantable or non-implantable body condition sensor or sensor system, or the like. In embodiments in which the electronic device 14 is a medication delivery pump, the medication delivered by such a pump may be or include, but should not be limited to, insulin or other conventional blood glucose modifying drug. In alternate embodiments, the liquid delivered by any such a pump may be or include, but should not be limited to, one or a combination of drugs, saline, one or a combination of perfusion fluids, or the like. Throughout this disclosure, the medical device 14 and operations associated with the medical device 14 will be described in the context of an insulin infusion pump, although it will be understood that the medical device 14 may alternatively be or include other medical devices and the following description therefore should not be considered to be limited to an liquid delivery pump generally or to an insulin infusion pump specifically.
  • Referring now to FIG. 2, a block diagram schematic is shown of one illustrative embodiment of an electronic circuit that is carried by, and that controls, the remote electronic device 12 of FIG. 1. In the illustrated embodiment, the electronic circuit includes four modules with separate and distinct functional responsibilities. For example, the electronic circuit includes a User Interface (UI) processor 50 that is the main controller of the electronic device 12. In addition to processing all aspects of the user interfaces 16, 18, it is the origination and destination of all data communicated from and to the insulin infusion pump 14. As will be described in greater detail herein, the UI processor 50 has no control over operation of the wireless communication circuit of the remote electronic device 12. The UI processor 50 operates according to a UI clock signal that is generated internally to the UI processor 50. The UI processor 50 includes a memory unit 66 having instructions stored therein that are executable by the UI processor 50 to control operations associated with the remote electronic device 12. In one illustrative embodiment, the UI processor 50 is a UPD70F3719GC 32-bit microcontroller that is commercially available from NEC Electronics America of Santa Clara, Calif., although this disclosure contemplates other implementations of the UI processor 50.
  • The electronic circuit of FIG. 2 further includes a wireless communication circuit 52 that is exclusively responsible for the control of all wireless communications with one or more external electronic devices but that does not control any other operations associated with the electronic device 12. The wireless communication circuit 52 operates from a clock signal that is generated internally to the wireless communication circuit 52 and that is not synchronized to the UI clock signal from which the UI processor 60 operates. Operation of the wireless communication circuit 52 is therefore asynchronous with respect to the operation of the UI processor 60. In one illustrative embodiment, the wireless communication circuit 52 is provided in the form of a conventional BlueTooth® telemetry module that includes a conventional processor and a memory unit 70, and that further includes conventional wireless communication hardware such as a suitable antenna. The memory unit 70 illustratively has stored therein instructions that are executable by the processor of the wireless communication circuit 52 to exclusively control of all wireless communications with external devices, such as the insulin infusion pump 14. In one illustrative embodiment, the wireless communication circuit 52 is a BC419143B BlueCore™4-Flash Plug-n-Go™ single chip BlueTooth® radio and baseband integrated circuit for BlueTooth® 2.4 GHz systems that is commercially available from CSR of Richardson, Tex., although this disclosure contemplates other implementations of the wireless communication circuit 52. Alternatively, as described hereinabove, this disclosure contemplates embodiments in which the wireless communication module 52 is configured for wirelessly communication according to wireless communication protocols other than BlueTooth®.
  • As illustrated in FIG. 2, the UI processor 50 and the wireless communication module 52 each include debounce circuitry 64 and 68 respectively that is electrically connected to the user buttons 16. The debounce circuitry 64, 68 is conventional in that it reduces the sensitivity of the processors 50 and 52 to spurious switching events associated with the user buttons 16, thereby increasing the likelihood that only actual button presses are detected by the processors 50 and 52.
  • The electronic circuit illustrated in FIG. 2 further includes a memory subsystem 54 that is electrically connected to the UI processor 50 and also to the wireless communication circuit 52. The memory subsystem 54 is generally operable to store, at least temporarily, data moving between the UI processor 50 and the wireless communication circuit 52. Data communication between the memory subsystem 54 and the UI processor 50 is illustratively carried out via a serial peripheral interface, SPI, in which case the transfer of data between the memory subsystem 54 and the UI processor 50 is synchronous with a data transfer clock, SCLK, of the UI processor 50. Illustratively, data communication between the memory subsystem 54 and the wireless communication circuit 52 is carried out via a universal asynchronous receiver/transmitter (UART) interface, in which case the transfer of data between the memory subsystem 54 and the wireless communication circuit 52 is asynchronous. In some alternative embodiments, the data transfer interfaces may be interchanged such that data transfer between the memory subsystem 54 and the UI processor 50 is asynchronous and data transfer between the memory subsystem 54 and the wireless communication circuit 52 is synchronous.
  • The memory subsystem 54 temporarily stores data moving between the UI processor 60 and the wireless communication circuit 52. In some embodiments, the memory subsystem 54 does not control other circuitry, and in some such embodiments the memory subsystem 54 may be provided in the form of a conventional memory device. In other embodiments in which the memory subsystem 54 does or does not control other circuitry, the memory subsystem 54 may be provided in the form of a conventional processor that is configured to operate as a Dual-Port RAM (DPR) processor. In such embodiments, the DPR processor 54 operates from a clock signal that is separate from the UI clock signal from which the UI processor 60 operates. In one illustrative embodiment, such a DPR processor 54 is a MC9S08GT16A 8-bit microcontroller unit that is commercially available from Freescale Semiconductor, Inc. of Austin, Tex., although this disclosure contemplates other implementations of the memory subsystem 54 that is provided in the form of a conventional processor configured as a DPR processor 54.
  • The electronic circuit illustrated in FIG. 2 further includes a Measurement Engine (ME) processor 56 that controls analyte concentration measurements of liquid samples contained on test elements 22, e.g., blood glucose measurements, and that reports the analyte concentration measurement results to the UI processor 50. The ME processor 56 includes a memory unit 83 having instructions stored therein that are executable by the ME processor 56 to control analyte measurement operations. The ME processor 56 operates from an internally generated clock signal that is separate from the clock signal from which the UI processor 50 operates. The ME processor 56 is electrically connected to the UI processor 50 via an Event Interrupt line, TXD (data transmission) line and a Ready line. The Event Interrupt line is illustratively used by the ME processor 56 to notify the UI processor of analyte measurement events, such as a strip insert event in which a user initiates an analyte measurement. The TXD line is used by the ME processor 56 to transmit analyte measurement data to the UI processor 50 for display on the display unit 18, for storage thereof in a history database and/or for use in conducting other operations. The Ready line is used by the ME processor 56 to notify the UI processor 50 of the operational state, e.g., measuring or not measuring analyte concentration, of the ME processor. In one illustrative embodiment, the ME processor 56 is a MSP430T2AIPEG mixed-signal microcontroller unit that is commercially available from Texas Instruments, Inc. of Dallas, Tex., although this disclosure contemplates other implementations of the ME processor 56.
  • As illustrated in FIG. 2, the ME processor 56, along with other electrical components, form an analyte measuring facility 88, e.g., a glucose meter. In addition to the ME processor 56, the analyte measuring facility 88 further includes an application specific integrated circuit (ASIC) 78 that is electrically connected to the ME processor 56 and also to an electrical interface 76 within the carrier port 20. In one illustrative embodiment, when a sample carrier 22, e.g., a glucose test strip, is inserted into the carrier port 20, electrical contacts on the sample carrier 22 contact the electrical interface 76 to thereby electrically connect the sample carrier 22 to the ASIC 78. A switch 80 contained in the ASIC is triggered by insertion of the carrier 22 into the carrier port 20, and an output of the switch 80 thus notifies the ME processor 56 of insertion of a carrier 22 into the carrier port 20. The ASIC 78 further illustratively includes a clock circuit 82 that is programmable for a number of different functions. For example, the clock circuit 82 may be programmed to generate a signal to automatically turn on, e.g., power up, the device 12 at one or more programmable times. As another example, the clock circuit 82 may be programmed to generate a signal corresponding to one or more reminders. Other examples will occur to those skilled in the art, and such other examples are contemplated by this disclosure. In any case, the signal generated by the clock circuit 82 is provided to the ME processor 56, and the ME processor 56 is responsive to the receipt of this signal to power up from a sleep state if the ME processor 56 is in such a sleep state, and to produce an event interrupt signal on the Event Interrupt line. The event interrupt signal is received by the UI processor 50, which then powers up from a sleep state if the UI processor 50 is in such a sleep state, and/or generates an audible or visible reminder corresponding to any reminder time programmed in the clock circuit 82.
  • As illustrated in FIG. 2, the analyte measuring facility 88 further includes another electrical interface 84 that is positioned within the code key port 26. Illustratively, when a code key 24 is received within the code key port 26, electrical contacts on the code key 24 electrically connect with the electrical interface 84 so that the ME processor 56 may read the calibration information stored in the memory device of the code key 24. The analyte measuring facility 88 further includes a temperature sensor 86 that is electrically connected to the ME processor 56. In one illustrative embodiment, the temperature sensor 86 is provided in the form of a conventional thermistor, although this disclosure contemplates other embodiments in which the temperature sensor 88 may be or include one or more other conventional temperature sensors. In any case, the ME processor 56 is operable to receive a temperature signal from the temperature sensor 86 that corresponds to an operating temperature of the analyte measuring facility. In one illustrative embodiment, the memory 83 has instructions stored therein that are executable by the ME processor 56 to disable, i.e., not conduct, analysis of an analyte containing sample if the temperature signal produced by the temperature sensor 86 indicates that the temperature of the analyte measuring facility 88 is less than a threshold temperature. In such cases, the ME processor 56 is further operable, pursuant to the instructions stored in the memory 83, to inform the UI processor 50 that the analyte measuring facility is so disabled, and the UI processor 50 is operable, pursuant to instructions stored in the memory unit 66, to control the display device 18 to display a message indicating that the temperature is too low to conduct analyte concentration measurements.
  • The electronic circuit illustrated in FIG. 2 further includes a general power supply 58 that provides a supply voltage to the ASIC 78, the ME processor 56, the UI processor 50 and the memory subsystem 54 on a continuous basis. The supply voltage is derived by the general power supply circuit 58 from one or a series or parallel combination of rechargeable or non-rechargeable batteries (BATTERY) 60.
  • A dedicated power supply 62 provides a supply voltage, which is also derived from the one or series or parallel combination of rechargeable or non-rechargeable batteries (BATTERY) 60, to the wireless communication module 52. The power supply 62 receives one control input from the user buttons 16, and in the illustrated embodiment the power supply 62 may be powered on and off via one or a combination of the user buttons 16 via the one control input. The power supply 62 also receives another control input from the wireless communication circuit 52, and in the illustrated embodiment the power supply 62 may be turned off by the wireless communication circuit 52 via the other control input.
  • In addition to the display 18, the UI processor 50 is electrically connected to a conventional audible indication device 72 and also to a conventional vibratory device 74. The UI processor 50 is generally operable to control the audible indication device 72 and the vibratory device 74 to produce one or more audible sounds and/or vibrations respectively to provide for the capability of the device 12 to produce corresponding audible and/or tactile notifications, i.e., alarms or the like. In one embodiment, the audible indication device 72 is a tone generator that produces a beep or other tone when activated, although the audible indication device 72 may alternatively or additionally be or include one or more other conventional audible indication devices.
  • Generally, the memory subsystem 54 acts as an independent repository of data packets moving between the UI processor 50 and the wireless communication circuit 52. Referring to FIG. 3, a block diagram of some of the details of the memory subsystem 54 is shown along with electrical connections to the UI processor 50 and to the wireless communication circuit 52. In the illustrated embodiment, the memory subsystem 54 is provided in the form of a DPR processor as described above, and FIG. 3 will be described in this context, although it will be understood that the memory subsystem 54 may alternatively be provided in other forms as described above.
  • In the embodiment illustrated in FIG. 3, one of the dual ports of the DPR processor 54 is a serial peripheral interface (SPI) port 92 that is electrically connected to a serial peripheral interface port 90 of the UI processor 50 via a conventional serial communications interface. The serial communications interface operates from a serial clock signal, SCLK, (e.g., 125 kHz) that is derived from the UI clock signal. Transfer of inbound and outbound data between the SPI port 90 of the UI processor 50 and the SPI port 92 of the DPR processor 54 is controlled by the UI processor 50 using the serial clock signal, SCLK, so that data transfer between the two processors 50, 54 is synchronized.
  • The other of the dual ports of the DPR processor 54 is a universal asynchronous receiver/transmitter (UART) port 96 that is electrically connected to a UART port 94 of the wireless communication circuit 52 via a conventional asynchronous interface. Transfer of inbound and outbound data packets between the UART port 94 of the wireless communication circuit 52 and the UART port 96 of the DPR processor 54 (e.g., at 150 kbps) is controlled by the wireless communication circuit 52, and takes place asynchronously with respect to the transfer of inbound and outbound data between the SPI port of the UI processor 50 and the DRP processor 54.
  • The DPR processor 54 has an inbound data buffer 98 and an outbound data buffer 100 that are each accessible by the SPI and UART ports 92 and 96 respectively of the DPR processor 54. The UART port 96 of the DPR processor 54 includes conventional clear to send (CTS) and ready to send (RTS) lines. The CTS line is monitored by the DPR processor 54 and the RTS line is monitored by the wireless communication circuit 52. The DPR processor 54 deactivates the UART RTS line whenever the inbound data buffer 100 is full, and otherwise activates the UART RTS line. The wireless communication circuit 52 activates the UART CTS line whenever the UART port of the wireless communication circuit 52 is requesting data, and otherwise deactivates the UART CTS line.
  • When data is to be sent by the UI processor 50 to an external device or system, e.g., the insulin infusion pump 14, the UI processor 50 first requests the state of the outbound data buffer 100 of the DPR processor 54. If the DPR processor 54 answers that its outbound data buffer 100 is “not full,” the UI processor 50 transfers the data, or as much of the data as possible, to the outbound data buffer 100 of the DPR processor 54 via the data out (DO) line of the SPI port 90 at a rate determined by SCLK. If the DPR processor 54 instead answers that the outbound data buffer 100 is “full,” the UI processor 50 waits for a time interval and then repeats the process of requesting the state of the outbound data buffer 100, etc.
  • Periodically with respect to the clock signal of the wireless communication circuit 52 and asynchronously with respect to the SCLK signal, the wireless communication circuit 52 requests data from the DPR processor 54 by activating the UART CTS line of the DPR processor 54. As long as the outbound data buffer 100 of the DPR processor 54 is empty, the wireless communication circuit 52 continues to periodically activate the UART CTS line. If the UART CTS line is active and the outbound data buffer 100 of the DPR processor 54 is not empty, the wireless communication circuit 52 retrieves the data from the outbound data buffer 100 of the DPR processor 54 via the RX line of the UART port 96. The DPR processor 54 illustratively transfers the data stored in its outbound data buffer 100 to its UART port 96 in a first received to last received order until the outbound data buffer 100 has been emptied or until the wireless communication circuit 52 deactivates the UART CTS line. The wireless communication circuit 52 then incorporates the data retrieved from the outbound data buffer 100 of the DPR processor 52, via the data UART, into to the wireless communication protocol structure, and wirelessly transmits the incorporated data via conventional wireless signal transmission circuitry contained within the wireless communication module 52. The wireless communication circuit 52 does not process, interpret or alter the contents of the data retrieved from the outbound data buffer 100 of the DPR processor 54, nor does it make any decisions or execute any steps based on the contents of the data. Rather, the wireless communication circuit 52 treats all such data the same, regardless of its contents, by incorporating the data into a predefined wireless communication protocol structure, e.g., BlueTooth® protocol structure, and then wirelessly transmitting the incorporated data using the predefined wireless communication protocol. Information transferred by the UI processor 50 to the memory subsystem 54, and then from the memory subsystem 54 to the wireless communication circuit 52 for wireless transmission to another electronic device is thus referred to as outbound information or data.
  • Inbound wireless signal transmissions from external devices or systems, e.g., the insulin infusion pump 14, are received by the wireless communication circuit 52 via conventional wireless signal receiving circuitry of the wireless communication circuit 52. The wireless communication circuit 52 first isolates the inbound data from the wireless communication protocol structure, and then checks the status of the UART RTS line of the DPR processor 54. If the RTS line is activated, indicating that the inbound data buffer 98 of the DPR processor 54 is not full, the wireless communication circuit 52 sends the isolated data, or as much if the data as possible, to the UART port 96 of the DPR processor 54. The DPR processor 54 then places the data received at the UART port 96 into the inbound data buffer 98 of the DPR processor 54. If the UART RTS line is deactivated, indicating that the inbound data buffer 98 of the DPR processor 54 is full, the wireless communication circuit 52 waits for a time interval before rechecking the state of the UART RTS line.
  • Periodically, and asynchronously with respect to the operation of the wireless communication circuit 52, the UI processor 50 requests the state of the inbound data buffer 98 of the DPR processor 54 via the data in (DI) line of the SPI port 90. As long as the DPR processor 54 answers that the inbound data buffer 98 is empty, the UI processor 50 continues to periodically request the state of the inbound data buffer 98. If the DPR processor 54 answers that the inbound data buffer 98 of the DPR processor 54 contains data, the UI processor 50 retrieves the data from the inbound data buffer 98 of the DPR processor 52 via the data in (DI) line of the SPI port 90 using the SCLK signal, and then processes the data according to its contents. “Checking” the inbound and/or outbound data buffer 98, 100 of the DPR processor 54 by the wireless communication circuit 52 and/or UI processor 50, as this term may be used hereinafter, will generally refer to the process just described in the preceding several paragraphs. While FIGS. 2 and 3 illustrate an embodiment in which the interface between the UI processor 50 and the memory subsystem 54 is a synchronous interface and the interface between the wireless communication circuit 52 and the memory subsystem 54 is an asynchronous interface, this disclosure contemplates alternative embodiments in which the interface between the UI processor 50 and the memory subsystem 54 is an asynchronous interface and the interface between the wireless communication circuit 52 and the memory subsystem 54 is an synchronous interface or in which both interfaces are asynchronous or synchronous interfaces. In any case, it should be apparent that the UI processor 50 at all times operates independently and asynchronously with respect to the operation of the wireless communication circuit 52, and the wireless communication circuit 52 operates independently and asynchronously with respect to the operation of the UI processor 50 and also with respect to the operation of the DPR processor 54.
  • The UI processor 50 controls the display 18 of the electronic device 12 to indicate the connection status of the wireless communication module 52 relative to the wireless telemetry system of the insulin infusion pump 14. Upon power up of the electronic device 12, following activation of the power supply 62 via the user buttons 16 after being deactivated and under certain other operating conditions that will be described in greater detail hereinafter, the UI processor 50 attempts to establish a wireless connection with the insulin infusion pump 14. While a wireless connection is not established between the electronic device 12 and the insulin infusion pump 14, the UI processor 50 controls the display 18 to display a flashing (or fixed) icon to indicate that no wireless connection exists between the electronic device 12 and the insulin infusion pump 14. The UI processor 50 independently controls the display 18 in this manner without any information provided by the wireless communication module 52. The UI processor 50 then initiates establishment of a wireless connection between the remote electronic device 12 and the insulin infusion pump 14 by placing a message into the data buffer 100 of the outbound port of the memory subsystem 54, as described above. In this case, the message includes a wireless connection request, e.g., in the form of a command to transmit an acknowledgement response back to the electronic device 12. The wireless communication circuit 52 then transmits this message as described above. If the insulin infusion pump 14 is within range, the insulin infusion pump 14 receives the message and responds to the wireless connection request by wirelessly transmitting a message that includes an acknowledgement response. If the transmitted message is received by the electronic device 12, the wireless communication circuit 52 is operable as described above to isolate the message from the wireless communication protocol structure and to place the message in the data buffer 98 of the inbound port of the memory subsystem 54. The UI processor 50 then retrieves the message from the inbound port of the memory subsystem 54, processes the message to determine whether it contains an acknowledgement response. If the message contains an acknowledgement response, the UI processor 50 interprets this as indicating that a wireless connection is now established between the electronic device 12 and the insulin infusion pump 14, and controls the display device 18 to display a fixed (or flashing) icon to indicate that a wireless connection is established between the electronic device 12 and the insulin infusion pump 14. The electronic device 12 periodically transmits a wireless connection status message to the infusion pump 14 in the above fashion at regular intervals. As long as the insulin infusion pump 14 responds as just described, the UI processor 50 controls the display 18 to display the fixed (or flashing) icon to indicate that a wireless connection exists between the electronic device 12 and the insulin infusion pump 14. If the UI processor 50 does not receive such a response within a predefined time period following storage of the acknowledgement response in the memory subsystem 52, the UI processor 50 controls the display 18 to display a flashing (or fixed) icon indicating that the wireless connection between the electronic device 12 and the insulin infusion pump 14 does not exist or no longer exists.
  • In the illustrated embodiment the power supply 62 is generally powered on as long as the wireless communication circuit 52 is communicating with either or both of the UI processor 50 or the insulin infusion pump 14, unless otherwise powered off manually by a user via the user buttons 16 or automatically by the wireless communication circuit 52. For example, the power supply 62 may be completely powered down, i.e., turned off, from any state via a simultaneous or sequential user press of a number of the user buttons 16. The power supply 62 remains in the completely powered down state until the user again presses the simultaneous or sequential number of the user buttons 16 or a different simultaneous or sequential user press of a number of the user buttons, or if the user powers down the electronic device 12 and then powers back up the electronic device 12.
  • While the power supply 62 is on and supplying the supply voltage to the wireless communication circuit 52, the wireless communication circuit 52 is responsive to a number of different events to transition itself into, and out of, any of a plurality of different low power states, and to also turn off the power supply 62 after being in a lowest power sleep state for a predefined time period of inactivity. For example, when in a fully powered “awake” state, the wireless communication circuit 52 is operable to periodically, e.g., every 100-200 milliseconds, check the outbound data buffer 100 of the memory subsystem 54 as described above. As another example, each time the wireless communication circuit 52 finds data to be sent in the outbound data buffer 100 of the memory subsystem 54, the wireless communication circuit 52 incorporates the data into the predetermined wireless communication protocol structure, and wirelessly transmits corresponding signals to the insulin infusion pump 14 as described above. The wireless communication circuit 52 transitions to a first low power state if it fails to find data in the outbound data buffer 100 of the memory subsystem 54 when a predefined time period elapses since last finding data in the outbound data buffer 100. Thereafter, the wireless communication circuit 52 transitions to successively lower power states as successively longer time periods elapse since last finding data in the outbound data buffer 100. The number of different power states generally range between full (100%) power and a lowest power “deep sleep” state, and may include any number of reduced power states between these two extremes. When in the lowest power “deep sleep” state, the wireless communication circuit 52 periodically, e.g., every 400 milliseconds, wakes up to a “UART only” state, in which the wireless communication circuit 52 has sufficient power to check the status of the outbound data buffer 100 of the memory subsystem 54 via the data UART line. If the outbound data buffer 100 of the memory subsystem 54 has data stored therein, the wireless communication circuit 52 wakes up to a full power state to service the data. If the outbound data buffer 100 of the memory subsystem 54 has no data stored therein, the wireless communication circuit 52 transitions back to the lowest power “deep sleep” state. After being in the lowest power sleep state for a predefined period of time of inactivity, the wireless communication circuit 52 sends a control signal to the power supply 62 that causes the power supply 62 to turn off. As a further example, the wireless communication circuit 52 directly monitors activity of the user buttons 16 via the debounce circuitry 68, and when the wireless communication circuit 52 detects user press of the ON button, the wireless communication processor transitions itself from any of the lower power states to the full power state. Thus, in the lowest power “deep sleep” state, the wireless communication circuit 52 must be capable of monitoring at least the ON button of the user buttons 16. Similarly, when the wireless communication circuit 52 detects user press of the OFF button, the wireless communication circuit 52 transitions itself from any of the power states to the lowest power “deep sleep” state.
  • When a wireless connection is established between the electronic device 12 and the insulin infusion pump 14, and the UI processor 50 determines that the wireless connection should be terminated, the UI processor 50 stores a message in the outbound data buffer 100 of the memory subsystem 54 that contains a connection termination request. When the wireless communication circuit 52 thereafter finds the message in the outbound data buffer 100 of the memory subsystem 54, the wireless communication circuit 52 incorporates the message into the predetermined wireless communication protocol and then transmits the message via its wireless communication circuitry to the insulin infusion pump 14. The insulin infusion pump 14 then wirelessly sends a signal containing a predefined connection termination response back to the remote electronic device 12. Subsequently the processor 28 instructs the wireless communication circuit 30 to orderly terminate communications or connections with the wireless communications circuit 52′ that may be specific to the predetermined wireless communications protocol. When the wireless connection is terminated in this manner, the wireless communication circuit 52 is operable to periodically, but asynchronously with respect to operation of the UI processor 50, check the outbound data buffer 100 of the memory subsystem 54. If no data resides in the outbound data buffer 100, the wireless communication circuit 52 successively enters lower power sleep states or modes as described above. If, however, the wireless communication circuit 52 finds data in the outbound data buffer 100 of the memory subsystem 54, the wireless communication circuit 52 attempts to establish (or re-establish) a wireless connection with the wireless communication circuit 30 of the insulin infusion pump 14 as described above.
  • If, after a predefined or programmed number of attempts and/or elapsed time, no wireless connection can be established between the wireless communication circuit 52 and the wireless communication circuit 30, the wireless communication circuit 52 illustratively clears the outbound data buffer 100 of the memory subsystem 54. Alternatively, the UI processor 50 may clear the outbound data buffer 100 if it determines that data exists in the outbound data buffer 100 after some time period has elapsed since storing the wireless communication message in the outbound data buffer 100 or after some time period has elapsed after determining, based on failure to receive acknowledgements from the insulin infusion pump 14, that a wireless connection between the remote electronic device 12 and the insulin infusion pump 14 no longer exists. In any case, with the outbound data buffer 100 of the memory subsystem 54 empty, the wireless communication circuit 52 successively enters lower power sleep states or modes as described above.
  • In the event of a lost wireless connection between the remote electronic device 12 and the insulin infusion pump 14, the wireless communication circuit 52 is operable in one embodiment to turn off its wireless transmission circuitry and to transition to a low power state if it fails to find data in the outbound data buffer 100 of the memory subsystem 54 since last finding data in the outbound data buffer 100. Because the wireless connection is lost, the UI processor 50 will no longer receive acknowledgements from the insulin infusion pump 14 and will therefore cease to store messages in the outbound data buffer 100 of the memory subsystem 54. However, a message, or at least part of a message, may reside within the outbound data buffer 100 when the wireless connection is lost. In this case, after a predefined or programmed number of attempts and/or after a predefined or programmed elapsed time, no wireless connection can be established with the insulin infusion pump 14, the wireless communication circuit 52 illustratively clears the outbound data buffer 100 of the memory subsystem 54. Alternatively, the UI processor 50 may clear the outbound data buffer 100 if it determines that data exists in the outbound data buffer 100 after some time period has elapsed since last storing a message in the outbound data buffer 100 or after some time period has elapsed after determining, based on failure to receive acknowledgements from the insulin infusion pump 14, that a wireless connection between the devices 12 and 14 no longer exists. In any case, with the outbound data buffer 100 of the memory subsystem 54 empty, the wireless communication circuit 52 successively enters lower power sleep states or modes as described above.
  • In one illustrative embodiment, the UI processor 50 and the processor 28 of the insulin infusion pump 14 may use scheduled messages and internal timers to control determinations by each of whether a wireless connection between the remote electronic device 50 and the insulin infusion pump 14 exists. For example, during information exchange between the electronic device 12 and the insulin infusion pump 14, the UI processor 50 is operable to periodically, e.g., every 100 milliseconds, transfer a message to the outbound data buffer 100 of the memory subsystem 54 and to reset an internal timer circuit. The wireless communication circuit 52 asynchronously retrieves the message from the outbound data buffer 100 of the memory subsystem 54 and transmits the message to the insulin infusion pump 14 as described above. The insulin infusion pump 14 is responsive to receipt of the message to immediately transmit a message back to the electronic device 12 that contains an acknowledgement. The message transmitted by the insulin infusion pump 14 is received and unpacked from the wireless communication protocol by the wireless communication circuit 52, and then stored by the wireless communication circuit 52 in the inbound data buffer 98 of the memory subsystem 54. The UI processor 50 then retrieves the message from the inbound data buffer 98 of the memory subsystem 54 and processes the message to determine whether it contains an acknowledgement. As long as an acknowledgement is received by the UI processor 50 in this manner before the next scheduled transfer of a message to the outbound data buffer 100 of the memory subsystem 54, the UI processor 50 resets its internal timer circuit when transferring the next message to the memory subsystem 54. However, if an acknowledgement is not received by the UI processor 50 before the next scheduled transfer of a message to the outbound data buffer 100 of the memory subsystem 54, the UI processor 50 transfers the message to the outbound data buffer 100 of the memory subsystem 54 without resetting its internal timer circuit. If no acknowledgement is received by the UI processor 50 within a predefined or programmed time period, e.g., 1-2 minutes, the internal timer circuit of the UI processor 50 times out and the UI processor 50 stops transferring messages to the outbound data buffer 100 of the memory subsystem 54. The insulin infusion pump 14, in this embodiment, ceases to send acknowledgements back to the remote electronic device 12 after a predefined or programmed time period, e.g., 2 minutes, has passed without receiving a message transmitted by the electronic device 12.
  • Illustratively, the UI processor 50 is operable to cease storing messages in the outbound data buffer 100 of the memory subsystem 54 upon detection of insertion of a sample carrier 22 into the carrier port 20 as described above. After a predefined time period in which the wireless communication circuit 52 thereafter fails to find such messages in the outbound data buffer 100 of the memory subsystem 54, the wireless communication circuit 52 begins transitioning to lower power states as described above. When the UI processor 50 then resumes storing messages in the outbound data buffer 100 of the memory subsystem 54 after the analyte measurement is complete, the wireless communication circuit 52 wakes up to full power to service it. This may take at least a wake up time period, e.g., as much as 400 milliseconds, if the wireless communication circuit 52 has just entered the lowest power “deep sleep” state when the first message is stored in the outbound data buffer 100 of the memory subsystem 54 after the analyte measurement is complete.
  • Unless the remote electronic devices 12 and the insulin infusion pump 14 are communicating information, the wireless communication circuit 52 is generally in one of the lower power sleep states or modes. When insertion of a sample carrier 22 into the carrier port 20 is detected, the electronic device 12 performs an analyte determination test as described above. The electronic device 12 generally does not wirelessly communicate with the insulin infusion pump 14 during the analyte determination test, and the wireless communication circuit 52 is thus typically in one of the lower power sleep states when insertion of the sample carrier 22 into the carrier port 20 is detected. Because the UI processor 50 stops storing messages in the outbound data buffer 100 of the memory subsystem 54 when insertion of the sample carrier 22 into the carrier port 20 is detected, the wireless communication circuit 52 therefore typically enters successively lower power sleep states after insertion of the sample carrier 22 into the carrier port 20 is detected.
  • While the electronic device 12 is illustrated and described above with respect to FIGS. 1-3 as including an analyte measuring facility 88, such an analyte measuring facility may be omitted in alternative embodiments. In any case, the electronic device 12 and the insulin infusion pump 14 may illustratively be paired according to a pairing process that establishes secure communications between the electronic device 12 and the insulin infusion pump 14. Illustratively, this process may be carried out to initially establish secure wireless communications between the electronic device 12 and a particular insulin infusion pump 14, and then again if the electronic device 12 is to be paired with a different insulin infusion pump 14 or vice versa. In one illustrative embodiment, the electronic device 12 may only be paired with a single insulin infusion pump 14 at a time, although this disclosure contemplates other embodiments in which the electronic device 12 may be paired with any number of medical devices 14 generally and/or other electronic devices, and/or in which the medical device 14 may be paired with any number of electronic devices 12 or other medical devices. In any case, further details relating to one illustrative pairing and authentication process are provided in co-pending PCT Patent Application No. PCT/US2008/066247, entitled METHOD FOR PAIRING AND AUTHENTICATING ONE OR MORE MEDICAL DEVICES AND ONE OR MORE REMOTE ELECTRONIC DEVICES, the disclosure of which has been incorporated herein by reference.
  • Referring now to FIG. 4, a flow chart is shown of one illustrative embodiment of a process 110 for enabling a bolus advice feature of the remote electronic device 12. Illustratively, the process 110 is stored in the memory unit 66 of the UI processor 50 in the form of instructions that are executable by the UI processor 50 to enable the bolus advice feature. The process 110 begins at step 112 where the bolus advice feature of the remote electronic device 12 is disabled during manufacture of the remote electronic device 12.
  • In one embodiment, the process 110 advances from step 112 to step 114 where the UI processor 50 is operable to monitor a predefined password flag. Thereafter at step 116, the UI processor 50 is operable to determine whether the predefined password flag is active. If not, execution of the process 110 loops back to step 114. If; at step 116, the UI processor 50 determines that the predefined password flag is active, the process 110 advances to step 118 where the UI processor 50 is operable to enable the bolus advice feature of the remote electronic device 12. Following step 118, the process 110 ends.
  • In an alternate embodiment, as illustrated in FIG. 4, the process 110 may advance from step 112 to step 120 where the UI processor is operable to monitor a pairing value storage location or flag. Thereafter at step 122, the UI processor 50 is operable to determine whether the pairing value storage location or flag indicate that a pairing process, in which the remote electronic device 12 is paired with the medical device 14 as described above, is complete. If not, the process 110 loops back to step 120. If, at step 122, the UI processor 50 determines that the pairing value storage location or flag indicates that the pairing process is complete, the process 110 advances to step 124 where the UI processor 50 is operable to enable the bolus advice feature of the remote electronic device 12. Following step 124, the process 110 ends.
  • In the embodiment illustrated in FIG. 4, the remote electronic device 12 is illustratively manufactured with the bolus advice feature disabled. In one embodiment the feature may be selectively enabled by entering a predefined password into the remote electronic device 12, such as via the user buttons 16. In one embodiment, such a password will be known or available only to a suitable healthcare professional, although this disclosure contemplates other embodiments in which others may have access to the predefined password. In the alternate embodiment, the bolus advice feature may be automatically enabled upon pairing of the remote electronic device 12 with a suitable medical device 14 according to a pairing process. Illustratively, the pairing process may be as described hereinabove with respect to FIGS. 1 through 3, although this disclosure contemplates that the pairing process between the remote electronic device 12 and the medical device 14 may alternatively be or include one or more other processes that are executed by the remote electronic device 12 and/or medical device 14 that allows the remote electronic device 12 and the medical device 14 to communicate with each other. In another alternative embodiment, the process 110 may include the combination of steps 114-118 and 120-124 such that the bolus advice feature is enabled only after successful pairing of the remote electronic device 12 with the medical device 14 and receiving of the predefined password as described above. In this embodiment, successful pairing of the remote electronic device 12 with the medical device 14 is illustratively required prior to receipt of the predefined password, although the order of these two events may alternatively be reversed.
  • Referring now to FIG. 5, a flow chart of one illustrative embodiment of a process 130 is shown that is carried out in the remote electronic device 12 for establishing wireless communications between the remote electronic device 12 and the medical device 14 under various operating conditions of the remote electronic device 12 in which the remote electronic device 12 and the medical device 14 may not already be connected via a wireless communication link 40. Illustratively, the process 130 is stored in the memory device 66 of the UI processor 50 in the form of instructions that are executable by the UI processor 50 to automatically establish wireless communications between the remote electronic device 12 and the medical device 14 under certain operating conditions. At the beginning of the process 130, the UI processor 50 is operable to simultaneously to execute steps at 132, 136, 140 and 142. At step 132, the UI processor 50 is operable to monitor the on/off switch of the remote electronic device 12. Thereafter at step 134, the UI processor 50 is operable to determine whether the on/off switch of the remote electronic device 12 has been turned on. If not, the process 130 loops back to step 132. If, at step 134, the UI processor 50 determines that the on/off switch has been turned on, the UI processor 50 is operable at step 144 to establish wireless communications with the medical device 14 as described hereinabove with respect to FIGS. 1-3.
  • The UI processor 50 is operable at step 136 of the process 130 to monitor a number of automatic reminders programmed therein. Thereafter at step 138, the UI processor 50 is operable to determine whether any of the programmed automatic reminders has triggered the power up of the remote electronic device 12 from a powered down state. Alternatively, the UI processor 50 may be operable at steps 136 and 138 to monitor the on/off state of the remote electronic device 12, and to determine whether and when the remote electronic device 12 powers up from a powered down state in response to the occurrence of an automatic reminder. In either case, the “NO” branch of step 138 loops back to step 136, and the “YES” branch of step 138 advances to step 144 where the UI processor 50 is operable to establish a wireless connection with the medical device 14 as described above.
  • The UI processor 50 is operable at step 140 to monitor the main menu to determine whether the user has selected the bolus advice feature from the main menu (or alternatively from a blood glucose determination menu). If not, the process 130 loops back to the beginning of step 140, and if the UI processor 50 determines at step 140 that a user has selected the bolus advice feature, the process 130 advances to step 144 where the UI processor 50 is operable to establish a wireless connection with the medical device 14 as described above.
  • The UI processor 50 is operable at 142 to monitor the main menu display on the display device 18 of the remote electronic device 12 to determine whether a user has selected the “my data” feature from the main menu. Illustratively, the “my data” feature corresponds to a data viewing, editing and reporting feature via which a user may view current, historical and trend data relating to operation of the on-board glucose meter and/or the medical device 14. In any case, the “NO” branch at step 142 loops back to the beginning of step 142, and the “YES” branch advances to step 144 where the UI processor 50 is operable to establish wireless connection with the medical device 14 as described above.
  • Referring now to FIG. 6, a flow chart is shown of one illustrative embodiment of a process 145 that is carried out in the remote electronic device 12 for processing information at certain times when a wireless connection is established between the remote electronic device 12 and the medical device 14. Illustratively, the process 145 is stored in the memory device 66 of the UI processor 50 in the form of instructions that are executable by the UI processor 50 to carry out the process 145. The process 145 begins at step 146 where the UI processor 50 is operable to determine whether a wireless communication link has just been established between the remote electronic device 12 and the medical device 14, such as via one or more of the operations illustrated and described with respect to FIG. 5. If not, the process 145 loops back to the beginning of step 146. Illustratively, the UI processor 50 is operable while executing step 146 to also execute step 148 where the UI processor 50 is operable to determine whether the remote electronic device 12 has just exited a remote terminal operating mode in which the remote electronic device 12 is configured to control operation of the medical device 14 in substantially real time over a wireless connection established between the two devices 12, 14. If, at step 148, the UI processor 50 determines that the remote electronic device 12 has not just exited the remote terminal operating mode with the wireless connection still established, the process 145 loops back to the beginning of steps 146 and 148. If, at step 148, the UI processor 50 determines that the remote electronic device has just exited the remote terminal operating mode with the wireless connection still established between the devices 12, 14 or if, at step 146, the UI processor 50 determines that a wireless communication link has just been established between the remote electronic device 12 and the medical device 14, the UI processor 50 is operable to execute each of steps 150, 156 and 168.
  • At step 150, the UI processor 50 is operable to transfer operating data, e.g., event history information, from the medical device 14 to the remote electronic device 12 via the wireless communication link. In one embodiment, the remote electronic device 12 includes four separate databases that hold history information for computing boluses and for reviewing and/or further analyzing. Referring to FIG. 7, a diagram is shown of one illustrative embodiment of four such databases that are included in the remote electronic device 12, and that are illustratively located in the memory device 66. The four databases include a BG/Diary database 65, a pump records (PR) database 67, a meal correction (MC) database 69 and a correction records (CR) database 71. The BG/Diary database 65 acts as the main database, and the PR database 67, MC database 69 and CR database 71 are support databases which hold data used to calculate active insulin and bolus advice. The BG/Diary database 65 holds the overall resulting bolus advice data long with interim and input data used in determining the bolus advice. As illustrated in FIG. 7, the BG/Diary database 65 is in data communication with each of the other three databases 67, 69 and 71.
  • In one illustrative embodiment, the BG/Diary database 65 can hold 1000 records and operates as a circular queue that will over-write the records, oldest first, after the first 1000 records have been accumulated. The BG/Diary database 65 contains the bolus advice calculations and input parameters used in the bolus calculations.
  • In one embodiment, the correction records (CR) database 71 can hold 150 records and also operates as a circular queue that will over-write the records, oldest first, after the first 150 records have been accumulated. In this embodiment, the CR database 71 is intended to hold 8 hours of prior bolus information. The correction records database 71 is monitored over time by the UI processor 50 to determine which of the records are active and which are inactive. The correction records database 71 is used to determine the amount of active insulin in the body, and uses only the active records to determine this parameter. Each record in the CR database 71 is associated with a specific record in the BG/Diary database, and this association is determined by the BG/Diary date and time stamp and a record counter value of the specific BG/Diary database record. In this example embodiment, the BG/Diary results are stored with a resolution of one minute, and multiple BG/Diary records can be created each minute. Accordingly, the record counter is useful in this embodiment to distinguish between multiple BG/Diary records that may have the same date and time stamp.
  • In the illustrated embodiment, the meal correction database 69 is a single record database that is updated each time a BG/Diary record with a carbohydrate amount that exceeds a programmable snack size or meal excursion limit is added to the BG/Diary database 65. This update occurs whether the current meal correction record is active or not. Like the correction records database 71, the meal correction database is monitored over time to determine whether the sole record in the meal correction database 69 is or is not currently active. The meal correction record is used when determining the upper BG level that is, in turn, used during the calculation of a correction bolus. The sole record in the meal correction database 69 is also associated with a specific record in the BG/Diary database 65, and this association is determined by the BG/Diary date and time stamp and a record counter value for the specific BG/Diary record.
  • In the example embodiment, the pump records database 67, like the BG/Diary database 65, can hold 1000 records and also operates as a circular queue that will over-write the records, oldest first, after the first 1000 records have been accumulated. The pump records are received by the pump records database 68 when the operating data from the pump, e.g., the pump history records, are transferred to the remote electronic device 12 according to step 154 of the process 150 of FIG. 6. The pump history records are synchronized with specific records in the BG/Diary database 65 with the intent of matching up actual pump delivery amounts from the pump history records with bolus amounts in the BG/Diary database 65. As will be described in greater detail hereinafter with respect to FIGS. 10 and 11, pump history records that match corresponding BG/Diary records are used to confirm the bolus amounts in the BG/Diary database 65 as part of the synchronization process. When a pump record cannot be matched with a specific record in the BG/Diary database 65, a new record containing the pump information is added to the BG/Diary database 65. The PR database 67, in the illustrated embodiment, is used strictly as a scratch pad area for holding pump records that are transferred from the pump 14 to the remote electronic device pursuant to step 154 of the process 150 of FIG. 6.
  • Referring now to FIGS. 8 and 9, one illustrative embodiment of the process carried out at step 154 of the process 150 illustrated in FIG. 6 is shown. Referring specifically to FIG. 8, a diagram is shown of a data buffer 170 that resides in the pump history (PH) memory device 29 of the medical device 14. The data buffer 170 is configured to store time stamped medical device event records, and in the embodiment illustrated in FIG. 7 the data buffer 170 is a first-in-first-out (FIFO) buffer that is sized to store a predefined number, e.g., 4500, medical device event records. Also in the illustrated embodiment, a history position pointer, HP, points to the last medical device event record that was transferred from the medical device 14 to the remote electronic device 12 during the most recent download of the medical device event records from the medical device 14 to the remote electronic device 12. However, when the medical device 14 is re-paired with a new remote electronic device 12 or re-paired with an existing remote electronic device 12, the history position pointer, HP, is illustratively set to point to the first record in the data buffer.
  • In any case, the medical device event records are illustratively stored in the data buffer 170 in the order of time of occurrence such that the oldest medical device event record is at the output of the data buffer 170 and the newest medical device event record is at the input of the data buffer 170.
  • Referring now to FIG. 9, a flow chart is shown of one illustrative embodiment of a process for carrying out step 154 of the process 150 of FIG. 6 to transfer portions of the time stamped medical device event records from the medical device 14 to the remote electronic device 12. The flow chart of FIG. 9 is partitioned into portions that are carried out by the remote electronic device 12 and other portions that are carried out by the medical device 14. Thus, the remote electronic device will carry out some of the steps of the illustrative process while the medical device 14 will carry out others. The data transfer process begins at step 172 where the UI processor 50 of the remote electronic device 12 is operable to determine whether a wireless connection between the remote electronic device 12 and the medical device 14 has just been established. If not, the process loops back to the beginning of step 172, otherwise the process advances to step 174 where the UI processor 50 of the remote electronic device 12 is operable to send a read pump history command to the medical device 14 via the wireless communication circuit 54. Thereafter at step 176, the processor 28 of the medical device 14 is operable to receive, via the wireless communication circuit 30, the read pump history command sent by the remote electronic device 12. Thereafter at step 178, the processor 28 of the medical device 14 is operable to scan the pump history records that have been saved in the memory device 29 since storage therein of the pump history record to which the history position pointer, HP, points. If, at step 180, the processor 28 determines that enough records have been found in the scan to form a block of records, or if a response time for responding to the read pump history command sent by the remote electronic device 12 is about to expire, the process advances from step 180 to step 182. Otherwise, step 180 loops back to step 178 to continue to scan and search for pump history records that have been stored in the data buffer 170 since the storage therein of the pump history record to which HP points.
  • At step 182, the processor 28 of the medical device 14 is operable to determine whether a history gap flag has been set. If so, the process advances to step 184 where the processor 28 includes a history gap indicator in the response to be sent to the remote electronic device 12. The processor 28 is further operable at step 184 to determine from the data buffer 170 whether additional pump history data is available after detecting the history gap from the history gap flag. Illustratively, the processor 28 further includes information in the response to be sent to the remote electronic device 12 that indicates whether any such additional pump history data is available after the detected history gap. From step 184, and from the “NO” branch of step 182, the process advances to step 186 where the processor 28 is operable to send, via the wireless communication circuit 30, a block or partial block of pump history event records to the remote electronic device 12. Thereafter at step 188, the UI processor 50 of the remote electronic device 12 is operable to receive, via the wireless communication circuit 54, the block or partial block of pump history event records from the medical device 14. Thereafter at step 190, the UI processor 50 is operable to determine whether the processing of the block or partial block of pump history event records, e.g., transferring of the pump history event records to the PR database 67, was successful. If not, the process loops back to step 174 where the pump history request, search and transfer process just described is repeated. If, at step 190, the UI processor 50 determines that the processing of the block or partial block of pump history event records at step 188 was successful, the process advances to step 192 where the UI processor 50 is operable to send the wireless communication circuit 54, a successful transfer message to the medical device 14. Thereafter at step 194, the processor 28 of the medical device 14 is operable to receive, via the wireless communication circuit 30, the successful transfer message, and to deactivate or render inactive the history gap flag and set the history position pointer, HP, to a new location in the data buffer 170 that corresponds the oldest pump history event record that was sent to, and successfully processed by, the remote electronic device 12. From step 194, the process loops back to step 176 to again scan pump history event records that were saved in the pump history memory device 29 since storing the pump history event record to which the newly positioned history position pointer, HP, now points.
  • Step 192 of the illustrated process additionally advances to step 196 where the UI processor 50 is operable to determine whether all pump history event records since the previous execution of the illustrative process have been transferred from the medical device 14 to the remote electronic device 12. Illustratively, the processor 28 of the medical device 14 is operable to include a last record indicator in the block or partial block of pump history event records transferred from the medical device 14 to the remote electronic device 12 at step 184. If, at step 196, the UI processor 50 determines that the last record information was received and processed in the most recent block or partial block of the pump history event records sent from the medical device 14 to the remote electronic device 12, the process advances to step 198 where the process ends. Otherwise, the process loops from step 196 back to step 174 where the process continues as described until all pump history event records that were stored in the memory device 29 of the processor 28 since the previous execution of the illustrated process are transferred.
  • At step 200, the processor 28 of the medical device 14 is operable to monitor the data in the pump history event record to which the history position pointer, HP, points. Thereafter at step 202, the processor 28 is operable to determine whether the data in the pump history event record to which HP points has changed since the previous transfer of information from the medical device 14 to the remote electronic device 12. If so, this means that at least some of the pump history event records stored in the data buffer 170 have been overwritten since the last transfer of information from the medical device 14 to the remote electronic device 12, and that a gap in the time line of pump history event records therefore exists. In this case, the process advances from step 202 to step 204 where the processor 28 is operable to activate the history gap flag described above. Otherwise, step 202 loops back to step 200.
  • Referring again to FIG. 6, the process 145 advances from step 150 to step 152 where the UI processor 50 is operable to process the medical device operating data that was transferred from the medical device 14 to the remote electronic device 12 at step 150. Referring now to FIGS. 10 and 11, a flowchart is shown of one illustrative process for carrying out step 152 of the process 145 of FIG. 6 to process the pump history records and synchronize the pump history records with the BG/Diary records in the BG/Diary database 65. Illustratively, the process of FIG. 10 is stored in the memory unit 66 in the form of instructions that are executable by the UI processor 50 to carry out the illustrated process.
  • The pump history records transferred from the pump 14 to the remote electronic device 12 may include commanded and non-commanded pump events. Commanded events are generally those in which the remote electronic device 12 commands the liquid infusion pump 14, via the wireless communication circuits 52 and 30 respectively, to deliver a desired bolus amount and type, except when the remote electronic device 12 and the pump 14 are operating in a remote terminal operating mode as briefly described above. In such cases, the commanded events are treated as being locally commanded, i.e., commanded by pressing appropriate ones of the keys 32 of the pump 14. Non-commanded events, in contrast, are those that were performed manually by the user and not commanded by the remote electronic device 12. Non-commanded events may include manually programming the liquid infusion pump 14 to deliver desired bolus amounts and types, and also manually delivering bolus amounts via a syringe or drug delivery pen. In the process illustrated in FIG. 10, both commanded and non-commanded events are read from the pump history records transferred from the pump 14 to the remote electronic device 12 and synchronized with the BG/Diary database 65. Non-commanded events may or may not be synchronized or associated with an existing BG result. If non-commanded events are not synchronized, they are in effect orphaned but nevertheless considered part of the overall history of the user.
  • Illustratively, the UI processor 50 is operable pursuant to the process illustrated in FIGS. 10 and 11 to synchronize the pump event records with the BG/Diary database 65 immediately after the records are transferred from the pump 14 to the remote electronic device 12. Generally, this process entails attempting to match the bolus type, bolus amount, date and time stamp of each pump event record to an existing BG/Diary record that does not yet have an associated programmed or delivered bolus amount. If a pump event record cannot be matched with such an existing BG/Diary record, a new BG/Diary record is created and added to the BG/Diary database 65. Each such new addition of a BG/Diary record will require a corresponding update of the correction records database 71.
  • If a pump event record is matched with an existing BG/Diary record, the delivered bolus amount is checked for confirmation. If the delivered amount in the pump event record matches the bolus amount in the matched BG/Diary record, the bolus amount is confirmed and the BG/Diary record is updated to reflect this result. If, on the other hand, the delivered amount in the pump event record is different from the bolus amount in the matched BG/Diary record, the actual delivered amount is confirmed and the BG/Diary record is updated to reflect this result. In this latter case, however, the correction records database 71 is updated to reflect the actual delivered bolus amount. Illustratively, the correction records database 71 is updated in this manner to ensure accuracy of the active insulin value that can be determined from the data.
  • The process illustrated in FIGS. 10 and 11 is executed once for each pump event record that is transferred from the pump 14 to the remote electronic device 12. The illustrated process begins at step 210 where the UI processor 50 is operable to search the BG/Diary database for all records with non-confirmed bolus amounts. Thereafter at step 212, the UI processor 50 is operable to determine whether the present pump event record corresponds to a commanded event. Generally, the pump event records will contain a field that defines whether the pump event was a commanded or non-commanded event. If the UI processor 50 determines at step 212 that the current pump event is not a commanded event, the process advances to step A (FIG. 11). If the UI processor 50 instead determines at step 212 that the current pump event record corresponds to a commanded pump event, the process advances to step 214 where the UI processor 50 is operable to determine the event type of the current pump record, i.e., whether the current pump record corresponds to a programmed bolus amount or a delivered bolus amount. Again, the pump event records illustratively contain a field that defines whether the pump event was a programmed or a delivered bolus amount.
  • If the UI processor 50 determines at step 214 that the current pump event corresponds to a programmed bolus amount, the illustrated process advances to step 216 where the UI processor 50 searches through the non-confirmed and non-programmed Standard, Extended and Multi-wave bolus type records in the BG/Diary database 65 for a record having a date/time stamp and bolus delivery type (DTD) that matches that of the current pump event record. If the UI microprocessor 50 finds such a match at step 216, the illustrated process advances to step 218 where the UI processor 50 determines whether the time stamp (T) of the matched BG/Diary record is within a predefined time value, e.g., 6 minutes, of that of the current pump event record. If so, the illustrated process advances to step 220 where the UI processor 50 is operable to determine whether the programmed bolus amount in the BG/Diary record is equal to a user selected amount. If so, the illustrated process therefore advances to step 222 where the UI processor 50 is operable to set a bolus advice flag in the current BG/Diary record to PROG. If at step 218 the UI processor 50 determines that the time stamps (T) of the matched BG/Diary record is not within the predefined time value of that of the current pump event record, the illustrated process advances to step 224. Likewise, if the UI processor 50 determines at step 220 that the programmed bolus amount in the BG/Diary record is not equal to a user selected amount, the illustrated process advances to step 224. Also, if the UI processor 50 does not find a match at step 216, the illustrated process advances to step 224. At step 224, the UI processor 50 is operable to create and add a new record to the BG/Diary database 65 using the date/time stamp and data from the current pump event record, and to set a bolus advice flag of this new record to PROG.
  • If, at step 214, the UI processor 50 determines that the current pump event corresponds to a delivered bolus amount, the illustrated process advances to step 226 were the UI processor 50 is operable to determine whether the bolus delivery type was a standard bolus or either of an extended bolus and a multi-wave bolus. If the UI processor 50 determines at step 226 that the delivered bolus type is a standard bolus (STD), the illustrated process advances to step 228 where the UI processor 50 searches through the non-confirmed and programmed Standard bolus type records in the BG/Diary database 65 for a record having a date/time stamp and bolus delivery type (DTD) that matches that of the current pump event record. If the UI microprocessor 50 finds such a match at step 228, the illustrated process advances to step 230 where the UI processor 50 determines whether the time stamp (T) of the matched BG/Diary record is within a predefined time value, e.g., 6 minutes, of that of the current pump event record. If so, the illustrated process advances to step 232 where the UI processor 50 is operable to update the confirmed bolus amount with the delivered bolus amount from the pump event record and to then set the bolus advice flag to DELIV. If at step 230 the UI processor 50 instead determines that the time stamps (T) of the matched BG/Diary record is not within the predefined time value of that of the current pump event record, or the UI processor 50 does not find a match at step 228, the illustrated process advances to step 234 where the UI processor 50 is operable to create and add a new record to the BG/Diary database 65 using the date/time stamp and data from the current pump event record, and to set a bolus advice flag of this new record to DELIV.
  • If, at step 226, the UI processor 50 determines from the pump event record that the delivered bolus type is not a standard bolus (STD), the illustrated process advances to step 236 where the UI processor 50 searches through the non-confirmed and programmed Extended (EXT) and Multi-wave (MW) bolus type records in the BG/Diary database 65 for a record having a date/time stamp and bolus delivery type (DTD) that matches that of the current pump event record. If the UI microprocessor 50 finds such a match at step 236, the illustrated process advances to step 238 where the UI processor 50 determines whether the time stamp (T) of the matched BG/Diary record is within a predefined time value, e.g., 6 minutes, of that of the current pump event record. If so, the illustrated process advances to step 240 where the UI processor 50 is operable to update the confirmed bolus amount with the delivered bolus amount from the pump event record and to then set the bolus advice flag to DELIV. If at step 238 the UI processor 50 instead determines that the time stamp (T) of the matched BG/Diary record is not within the predefined time value of that of the current pump event record, or the UI processor 50 does not find a match at step 236, the illustrated process advances to step 242 where the UI processor 50 is operable to create and add a new record to the BG/Diary database 65 using the date/time stamp and data from the current pump event record, and to set a bolus advice flag of this new record to DELIV.
  • Referring now to FIG. 11, the “A” branch of step 212 of the process illustrated in FIG. 10 advances to step 250 where the UI processor 50 is operable to determine the event type of the current pump record, i.e., whether the current pump record corresponds to a programmed bolus amount or a delivered bolus amount. If the UI processor 50 determines the event type to be a programmed bolus event, the process advances to step 252 where the UI processor 50 is operable to search through the non-confirmed and non-programmed manual and pen/syringe type bolus records in the BG/Diary database 65 for a record having a date/time stamp that is closest to that of the current pump event record. Thereafter at step 254 the UI microprocessor 50 is operable to determine whether the time stamp (T) of the BG/Diary record selected at step 252 is within a predefined time value, e.g., 5 minutes, of that of the current pump event record. If so, the illustrated process advances to step 256 where the UI processor 50 is operable to determine whether the programmed bolus amount in the BG/Diary record is equal to a user selected amount. If so, the illustrated process advances to step 260 where the UI processor 50 is operable to set the bolus advice flag in the current BG/Diary record to PROG and to set the delivery type of the BG/Diary record to MANUAL. From the “NO” branch of either of steps 254 and 256, the illustrated process advances to step 258 where the UI processor 50 is operable to create and add a new record to the BG/Diary database 65 using the date/time stamp and data from the current pump event record, to set a bolus advice flag of this new record to PROG and to set the delivery type of the record to MANUAL.
  • If, at step 250, the UI processor 50 determines from the current pump history record that the pump event type corresponds to a delivered bolus event, the illustrated process advances to step 262 where the UI processor 50 is operable to search through the Manual and Pen/Syringe type, non-confirmed and programmed records in the BG/Diary database 65 for a record having a date/time stamp that matches that of the current pump event record. If the UI microprocessor 50 finds such a match at step 262, the illustrated process advances to step 264 where the UI processor 50 determines whether the time stamp (T) of the matched BG/Diary record is within a predefined time value, e.g., 5 minutes, of that of the current pump event record. If so, the illustrated process advances to step 266 where the UI processor 50 is operable to update the confirmed bolus amount with the delivered bolus amount from the pump event record and to then set the bolus advice flag to DELIV. If at step 262 the UI processor 50 does not find a match, and also from the “NO” branch of step 264, the illustrated process advances to step 268 where the UI processor 50 is operable to create and add a new record to the BG/Diary database 65 using the date/time stamp and data from the current pump event record. Thereafter at step 270, the UI processor 50 is operable to set the bolus advice flag of this new record to DELIV and to set the delivery type to MANUAL.
  • Further details relating to the processing of information in one or more of the databases 65, 67, 69 and 71 are provided in co-pending PCT Patent Application No. PCT/US2008/066331 and which is assigned to the assignee of this disclosure, and the disclosure of which has been incorporated herein by reference.
  • Referring again to FIG. 6, the “YES” branch of step 146 also advances to step 156 where the UI processor 50 is operable to send a time request message to the medical device 14 via the wireless communication link. Thereafter at step 158, the medical device receives the time request and sends a current medical device time (MDT) to the remote electronic device 12 via the wireless communication link. Thereafter at step 160, the remote electronic device 12 receives MDT and compares the medical device time to the current remote electronic device time (RDT). Following step 160, the UI processor 50 is operable at step 162 to determine whether a difference between MDT and RDT is greater than 60 seconds. If so, the UI processor 50 is operable to set the current remote electronic device time, RDT, equal to the medical device time, MDT that was wirelessly sent by the medical device 14 to the remote electronic device 12 at steps 158 and 160. Following step 164, the process 145 advances to step 166 where the UI processor 50 is operable to update the correction records database 71 and the meal correction database 69 with the new remote device time, RDT. More specifically, when the remote electronic device time, RDT, changes, the active records in the correction records database 71 and the meal correction database 69 are updated based on the new RDT.
  • The “YES” branch of step 146 also advances to step 168 where the UI processor 50 is operable to check and act on any warnings, alarms or errors that are associated with the medical device 14 and the occurrence of which is communicated wirelessly to the remote electronic device 12 when the wireless communication link is established. Following steps 152, 166 and 168 and the “NO” branch of step 162, the process 145 ends.
  • Referring now to FIGS. 12A-12C, a flow chart is shown of one illustrative embodiment of a bolus advice process 300 that is carried out by the remote electronic device 12. In the context of the flowchart of FIGS. 12A and 12B, the medical device 14 is illustratively implemented in the form of an insulin infusion pump, and will be described as such throughout the description of the process 300. It will be understood, however, that this disclosure contemplates alternate embodiments in which the medical device 14 is or includes one or more other conventional medical devices.
  • Illustratively, the process 300 is stored in the memory device 66 of the UI processor 50 in the form of instructions that are executable by the UI processor 50 to carry out the bolus advice process 300. The process 300 presumes that the remote electronic device 12 is powered up and that the UI processor 50 is currently controlling the display device 18 to display a main menu 302 that is generally displayed upon power up of the remote electronic device 12. Illustratively, the main menu 302 provides for a number of selectable user options that include, but that should not be limited to, a blood glucose (BG) test, a bolus advice process, a pump remote control process 304, a “my data” process 306 and a settings or device set up process. The pump remote control process 304, or remote terminal operational mode as referred to above, illustratively provides a menu-driven process by which the remote electronic device 12 may control operation of the insulin infusion pump 14 substantially in real time. One illustrative embodiment of such a process is described in co-pending PCT Patent Application No. PCT/US2008/066288, which is assigned to the assignee of this disclosure, and the disclosure of which has been incorporated herein by reference.
  • The “my data” process 306 illustratively provides for the viewing and editing of diary records, e.g., specific BG test records and pump history records, and also for the analysis of the records over daily and/or weekly time periods. Illustratively, the UI processor 50 stores in the memory 66 up to 1,000 diary records, and up to 250 records may be reviewed using the remote electronic device. The diary records may also be downloaded to a PC or other computer, and using compatible software all records may be viewed and/or analyzed. Each diary record may contain date and time, BG test result, meal time events, carbohydrate value, health event, bolus type, bolus amount and duration. The UI processor can filter and/or sort data from these data records.
  • The “my data” process also provides for the analysis of the data records in the form of daily and weekly averages, and standard deviations, defined by time slot, and for trend analysis of any of the collected data. Standard day and standard week tables or graphs may be generated to view averages and/or trends. Various charting and table options are also available for presenting data in desired formats.
  • The BG test process that may be selected from the main menu 302 begins at step 308 where the UI processor 50 determines whether the user has selected the BG test process from the main menu 302. If not, the “NO” branch of step 308 loops back to the beginning of step 308. If, at step 308, the UI processor 50 determines that the user has selected the BG process from the main menu 302, the process 300 advances to step 310 where the UI processor 50 controls the display device 18 to prompt a user to conduct a BG test. In one embodiment, the UI processor 50 controls the display device 18 to visually guide a user through a blood glucose measurement sequence in which a user inserts a carrier 22 into the glucose measurement facility 20 of the remote electronic device 12 and deposits a sample of blood on the carrier 22, after which the blood glucose meter 88 analyzes the blood sample in a conventional manner to produce a blood glucose (BG) value that corresponds to a concentration of glucose in the deposited blood sample. The blood glucose value, BG, is provided by the blood glucose meter 88 that is on-board the remote electronic device 12 to the UI processor 50 as describe hereinabove. From step 310, the process 300 advances to step 312 where the UI processor 50 is operable to control the display device 18 to display the BG value along with an on-screen color indicator that is based on the BG value relative to one or more reference BG values.
  • Referring now to FIG. 13, a flow chart is shown of one illustrative embodiment of a process 350 for controlling the display device 18 of the remote electronic device 12 to indicate readily perceptible warnings and/or alerts. The process 350 may illustratively be used to carry out step 312 of the process 300 illustrated in FIG. 12A, although the process 350 is broader than briefly described with respect to step 312 and may alternatively or additionally be used to control a display device of the remote electronic device 12 and/or the medical device 14 generally to display any analyte or drug related value with an on-screen color indicator that is based on the value of the analyte or drug related value relative to one or more reference values. In the illustrated embodiment, the process 350 may be stored in the memory device 66 of the UI processor 50 and/or in the memory device 25 of the processor 28 of the insulin infusion pump 14 in the form of instructions that are executable by the processor 50, 28 to display the analyte or drug related value on a corresponding display device with on-screen color indicator that is based on the value of the analyte or drug related value relative to one or more reference values.
  • The process 350 begins at step 352 where the processor 50, 28 is operable to determine whether an analyte or drug related value has just been measured or computed. If not, the “NO” branch of step 352 loops back to the beginning of step 352. Otherwise, the process 350 advances to step 354 where the processor 50, 28 is operable to determine a display color based on the measured or computed value relative to one or more reference values. Thereafter at step 356, the processor 50, 28 is operable to control the display device 18, 34 to change the color of the display or a portion thereof to the display color determined at step 354 when displaying the measured or computed value and/or a warning message related to the measured or computed value. From step 356, the process 350 ends.
  • The process 350 of FIG. 13 may illustratively be used at step 312 of the process 300 to display the measured BG value with an on-screen color indicator. In one example embodiment, the UI processor 50 may be operable at step 356 of the process 350 to display a green bar next to measured and displayed BG values that are within a target range, to display a yellow bar next to measured and displayed BG values that are between the target range and a hypoglycemic limit value, to display a red bar with the text HYPO within the red bar next to measured and displayed BG values that are less than the hypoglycemic limit value, to display a light blue bar next to measured and displayed BG values when the measured BG values are between the target range and a hyperglycemic limit value, and to display the text HYPER within the light blue color bar next to measured and displayed BG values that are greater than the hyperglycemic limit value. In some alternative embodiments, more, fewer and/or different colors may be displayed based on more, fewer and/or different BG value comparisons with BG limits or ranges. In other alternative embodiments, one or more portions of the display, or the entire display, may be changed in color based on the measured or computed value relative to one or more reference values. Any such color change may be implemented as a solid or transparent color, flashing or otherwise patterned in time, and/or accompanied by one or more explanatory messages.
  • Also following step 310, the process 300 advances to step 314 where the UI processor 50 is operable to execute a hypoglycemic test process in relation to the blood glucose value, BG, measured at step 310. Referring now to FIG. 14, a flowchart is shown of one illustrative embodiment of the hypoglycemic test process 314. Illustratively, the process 314 is stored in the memory 66 of the UI processor 50 in the form of instructions that are executable by the UI processor 50 to conduct the hypoglycemic test. The process 314 begins at step 360 where the UI processor 50 is operable to determine whether the measured BG value, BG, is less than a hypoglycemic limit value, BGHYPO. If so, the process 314 advances to step 362 where the UI processor 50 is operable to control the display device 18 to display a message indicating that the measured BG value is too low for a bolus to be delivered. Thereafter at step 364, the UI processor 50 is illustratively operable to compute a number of carbohydrates, e.g., fast-acting carbohydrates, which will be suggested to be taken by the user to get the user's blood glucose value back to a target blood glucose value, BGTARGET. In one embodiment, for example, the UI processor 50 is operable at step 364 to compute the required carbohydrates according to the formula CARBS=(BGTARGET−BG)*IS*CR, wherein IS corresponds to a programmable insulin sensitivity value and CR corresponds to a programmable carbohydrate ratio. In any case, the process 314 advances from step 364 to step 366 where the UI processor 50 is operable to control the display device 18 to display a message recommending intake of the computed amount of carbohydrates. In one embodiment, the CARBS value has a lower limit, e.g., 12 grams, which is substituted for the computed CARBS value when the computed GARBS value is less than the lower limit. Following step 366, the process 314 returns the value RETURN to the process 300 of FIG. 12A, and following the “NO” branch of step 360 the process 314 returns the value ADVANCE to the process 300 of FIG. 12A. Thus, if the blood glucose measurement taken at step 310 is less than BGHYPO, the process 300 follows the RETURN path from step 314 and loops back to display the main menu. If the blood glucose measurement taken at step 310 is not less than BGHYPO, the process 300 follows the ADVANCE path to step 316. In alternate embodiments, the hypoglycemic limit value, BGHYPO, may be replaced at step 360 by another suitable lower BG limit.
  • If the process 300 reaches step 316, the BG value display screen illustratively provides a bolus option that a user may select to enter the bolus advice process directly from the BG measurement process. The UI processor 50 is accordingly operable following the ADVANCE path from step 314 to step 316 to determine whether the user has selected the bolus option from the BG display. If not, the process 300 advances to step 318 where the user has pressed another key or has selected another option, or alternatively has done nothing and caused the BG value screen to time out. Generally, the UI processor 50 is operable to store the BG value in the memory unit 66 along with measurement time and date information. Illustratively, the user may also store additional information along with the time and date stamp BG value, examples of which may include, but should not be limited to, the timing of the BG measurement relative to meal, bedtime and/or awake time information, amount of carbohydrates taken at the time of the BG measurement, health information such as exercise level, illness or stress, and the like. In any case, if the UI processor 50 determines at step 316 that the user has selected the bolus key option from the BG value display screen, the process 300 advances to step 322.
  • From the main menu 302, the user may alternatively select the bolus advice process, and the UI processor 50 is accordingly operable at step 320 to determine if the user has selected the bolus advice process. If not, the “NO” branch step 320 loops back at the beginning of step 320, and otherwise the process 300 advances to step 322 where the UI processor 50 is operable to determine whether the pump history and/or bolus threshold and/or pump status information was updated when the bolus advice process 300 was entered either via step 316 or step 322. If not, the process 300 advances to step 324 where the processor 50 is operable to control the display device 18 to display a warning message on the bolus advice screen that one or more bolus advice values and/or an active insulin may not be based on current drug pump operating history. From step 324, and from the “YES” branch of step 322, the process 300 advances to step 326 where the processor 50 is operable to compute the active insulin value, AI. Thereafter at step 328, the UI processor 50 is operable to compute a first bolus value, B1, which is illustratively based on a recent blood glucose value and also on pump operating history data. In embodiments in which blood glucose has not recently been measured, B1=0. Also at step 328, the UI processor 50 is operable to compute a second bolus value, B2, that is illustratively based on CARB values entered by the user that correspond to carbohydrates that the user has taken or is planning to take. Further at step 328, the UI processor 50 is operable to compute a third bolus value, B3, which is illustratively based on health information entered by the user that corresponds to a current health state of the user. As one illustrative example, the health state of the user may correspond to exercise, stress, illness, or the like. Further details relating to illustrative techniques for computing AI and B1-B3 are provided in co-pending PCT patent application Ser No PCT/US2008/066331, the disclosure of which has been incorporated herein by reference.
  • The process 300 advances from step 328 to step 330 where the UI processor 50 is operable to compute a total recommended bolus, TRB, as a sum of B1-B3. Thereafter at step 332, the UI processor 50 is operable to control the display unit 18 to display a bolus advice screen that shows the active insulin value, AI, any recent blood glucose value, BG, a BG color indicator as described with respect to step 312, B1-B3, TRB and a bolus type, e.g., standard (STD), multi-wave (MW), extended (EXT), each of which may be used to automatically program the pump 14 from the remote electronic device 12, and two manual types. In one embodiment, if a blood glucose measurement, BG, has been conducted within a predefined time period prior to executing step 332, the UI processor 50 is operable at step 332 to display the bolus advice screen showing the measured blood glucose value, BG. Otherwise, the UI processor 50 may be illustratively operable at step 332 to display “bG Test” on the screen where a BG value would be shown if a current BG value was available. From step 332, the process 300 advances to a sub-process B. In general, any value that was measured by or entered into the remote electronic device 12 or medical device 14 may illustratively be displayed when a screen that includes such a value is displayed if the value was measured or entered within a predefined time period since measuring or entering the value.
  • Referring now to FIG. 15, a graphic example is shown of one illustrative embodiment of a bolus advice display screen 386 produced by the process 300 of FIG. 12A at the point just prior to executing sub-process B, i.e., after step 324 or step 330. In the illustrated example, a Bolus Advice label 370 appears at the top of the screen 368 to indicate that the user is executing the bolus advice feature. A blood drop symbol appears next to the displayed blood glucose value 372, e.g., 120 mg/dl, and a color bar 374, providing a visual indication of the blood glucose value 372 relative to an acceptable blood glucose range and/or a number of blood glucose limits, is positioned next to the blood glucose value 372. The active insulin value 378, e.g., −2 U, is positioned under the blood glucose value 372, and a bolus value 376, corresponding to the bolus value B1, is displayed adjacent to the active insulin value 378. As described above, if the bolus advice screen 368 was generated via step 330 and a recently measured blood glucose value, BG, was not available, the value 120 mg/dL would illustratively be replace by the phrase bG Test.
  • An apple symbol is used to identify a carbohydrates field 380, and a heart symbol is used to identify a health field 382. A bolus type indicator 386 appears below the health field 382 and the total recommended bolus value 382, e.g., 3 U, is displayed adjacent to the bolus type indicator 386. A bolus type 388, e.g., Standard, is displayed below the total recommended bolus 384. At the bottom of the screen between Cancel and Confirm inputs, a BlueTooth® symbol 390 is provided to indicate the connection status of the wireless communication link with the insulin infusion pump 14, e.g., solid when a wireless connection exists and otherwise flashing.
  • Referring now to FIGS. 12B and 12C, the sub-process B identified after step 332 of FIG. 12A, is shown, wherein the sub-process B forms part of the bolus advice process 300. It will be observed that the sub-process B includes a number of processes that may each be accessed independently any number of times. For example, the sub-process B includes a process 400 for measuring a blood glucose value and computing a bolus amount, B1, which corresponds to the BG measurement. In the illustrated embodiment, the process 400 begins at step 402 where the UI processor 50 is operable to determine whether a strip insert, e.g., insertion of a blood glucose strip into the carrier port 20 of the remote electronic device 12, has been detected or if the user has selected the bG Test field if this field is displayed in place of a blood glucose value as described above. If not, the process 400 loops back to the beginning of step 402. If, at step 402, the UI processor 50 determines that a strip insert or user selection of the bG Test field has been detected, the process 400 advances to step 404 where the UI processor 50 is operable to conduct a blood glucose test, e.g., by prompting and guiding a user through such a BG test as described above, which returns a measured blood glucose value, BG. Thereafter at step 406, the UI processor 50 is operable to execute the hypoglycemic test process 314 illustrated in FIG. 14 and described above. If the hypoglycemic test process 314 returns a value RETURN, this indicates that the blood glucose value is too low to recommend a bolus value and the process 400 advances to step 414 where the UI processor 50 is operable to exit the bolus advice feature and display the main menu 302. If the hypoglycemic test process 314 instead returns the value ADVANCE, the process 400 advances to step 408 where the UI processor 50 is operable to compute all of the bolus values, B1-B3. In the illustrated embodiment, measured and/or user entered value may have an effect on one or more of the bolus values, B1-B3, and the UI processor 50 is accordingly operable in sub-process B to re-compute each bolus value, B1-B3, after each BG measurement, Carbohydrate entry or health entry. In any case, following step 408 the UI processor 50 is operable at step 410 to compute a total recommended bolus value, TRB, as a sum of B1 and two other bolus values, B2 and B3. Thereafter at step 412, the UI processor 50 is operable to update the bolus advice screen with BG; a BG color indicator as described above, B1-B3 and TRB. From step 412, the process 400 loops back to the beginning of the sub-process B.
  • The sub-process B of FIG. 12B further includes a process 420 for entering a carbohydrate value of a meal or snack that has just been, or is planned to be taken, and determining a bolus value based on the entered carbohydrate value. The process 420 begins at step 422 where the UI processor 50 is operable to determine whether a user has selected the CARB field of the displayed bolus advice screen, e.g., item 380 illustrated in FIG. 15. If not, the process 420 loops back to the beginning of step 422. If user selection of the CARBS field is detected at step 422, the process 420 advances to step 424 where the processor 50 is operable to determine whether a carbohydrate value relating to a meal or snack that was just, or is planned to be, taken, has been entered by the user. If not, the process 420 loops back to the beginning of step 424. In one embodiment, the user at step 424 may manually enter a carbohydrate value into the remote electronic device 12, e.g., via the user buttons 16, that corresponds to a carbohydrate content of the meal or snack that was just taken or is planned to be taken. In an alternative embodiment, selection by the user of the carbohydrate value field displayed by the UI processor 50 on the display device 18 at step 422 may take the user to a menu-driven food database via which the user may select the various food items that comprise the meal or snack. In this embodiment, the menu-driven food database is operable to compute a total carbohydrate value based on the individual carbohydrate values of the food items selected by the user from the food database, and the UI processor 50 is operable at step 424 to automatically enter the total carbohydrate value determined by the menu-driven food database process into the carbohydrate value field displayed on the display device 18 at step 424. In any case, if the user has entered a carbohydrate value that is detected by the UI processor 50 at step 424, the process 420 advances to step 426 where the UI processor 50 is operable to re-compute each of the bolus values B1-B3. Thereafter at step 428, the UI processor 50 is operable to compute the total recommended bolus, TRB, as the sum of B1-B3. Thereafter at step 430, the UI processor 50 is operable to control the display device 18 to update the bolus advice display screen to include the carbohydrate value provided by the user at step 424 to display the computed bolus values, B1-B3, determined at step 426 and to display the updated total recommended bolus value, TRB. The process 420 loops from step 430 back to the beginning of the sub-process B.
  • The sub-process B of FIG. 12B further includes a process 440 for entering a health information, and determining a bolus value based on the entered health information. The process 440 begins at step 442 where the UI processor 50 is operable to determine whether a user has selected the Health field of the displayed bolus advice screen, e.g., item 382 illustrated in FIG. 15. If not, the process 440 loops back to the beginning of step 442. If user selection of the Health field is detected at step 442, the process 440 advances to step 444 where the processor 50 is operable to determine whether a Health value has been entered by the user. If not, the process 440 loops back to the beginning of step 444. In one embodiment, when the user manually selects at step 442 the health event field displayed on the display device 18 by the UI processor 50, the UI processor 50 is operable to control the display device 18 to display a plurality of health event choices. The health event choices may include, for example, but should not be limited to, no entry, one or more exercise options, an illness option and a sickness option, although more, fewer and/or different options may alternatively be available. In this embodiment, the user may define percentage values associated with each of the health event options during the device set up process such that when the user manually selects one of the health event options at step 444, the UI processor 50 is operable thereafter at step 446 to re-compute the bolus values B1-B3. Thereafter at step 448, the UI processor 50 is operable to again compute the total recommended bolus, TRB, e.g., as a sum of the individual bolus values, B1-B3. The process 440 advances from step 448 to step 450 where the UI processor 50 is operable to control the display device 18 to update the bolus advice display to include the health event, the bolus values, B1-B3, and the total recommended bolus value, TRB. The process 440 loops from step 450 back to the beginning of the sub-process B.
  • The sub-process B of FIG. 12B further includes a process 460 that allows the user to manually modify the total recommended bolus value, TRB. The process 460 begins at step 462 where the UI processor 50 is operable to determine whether a user has selected the TRB field of the displayed bolus advice screen, e.g., item 384 illustrated in FIG. 15. If not, the process 460 loops back to the beginning of step 462. If user selection of the TRB field is detected at step 462, the process 460 advances to step 464 where the processor 50 is operable to determine whether the user has modified the TRB value. If not, the process 460 loops back to the beginning of step 464. If the processor 50 determines that the user has, at step 464, modified the TRB value, the process 460 advances to step 466 where the UI processor 50 is operable to control the display device 18 to update the bolus advice display to include the modified total recommended bolus value, TRB. The process 460 loops from step 466 back to the beginning of the sub-process B.
  • Referring now to FIG. 12C, the sub-process B further includes a process 470 for selecting a bolus type. The process 470 begins at step 472 where the UI processor 50 is operable to determine whether a user has selected the bolus type field of the displayed bolus advice screen, e.g., item 388 illustrated in FIG. 15. If not, the process 470 loops back to the beginning of step 472. If user selection of the bolus type field is detected at step 472, the process 470 advances to step 474 where the processor 50 is illustratively operable to display available bolus types on the bolus advice screen. In one illustrative embodiment, the available bolus types may include, but should not be limited to, a standard bolus (STD), a multi-wave (MW) bolus, an extended (EXT) bolus, a manually programmable bolus and a manually administered bolus via an insulin pen or syringe or the like. In cases were a wireless connection between the remote electronic device 12 and 14 is or can be established, the available bolus types may illustratively include all bolus types that the pump 14 is currently capable of delivering. In other cases where a wireless connection could not be established when first entering the bolus advice process, and cannot currently be established, the available bolus types may illustratively include only manually programmable and/or manual delivery via insulin pen/syringe. Those skilled in the art will recognize more, fewer and/or different bolus types that may be made available to the user at step 474, and any such alternative or additional bolus types are contemplated by this disclosure.
  • Following step 474, the process 470 advances to step 476 where the UI processor 50 is operable to determine whether the user has selected a bolus type. If not, the process 470 loops back to step 474. If the processor 50 determines that the user has, at step 476, selected a bolus type, the process 470 advances to step 476 where the UI processor 50 is operable to control the display device 18 to update the bolus advice display to include the selected bolus type. The process 470 loops from step 478 back to the beginning of the sub-process B.
  • The sub-process B of FIG. 12C further includes a process 480 that allows the user to cancel and exit the bolus advice process. The process 480 begins at step 482 where the UI processor 50 is operable to determine whether a user has selected the Cancel function displayed on the bolus advice screen, e.g., see FIG. 15, such as via one of the user buttons 16. If not, the process 480 loops back to the beginning of step 482. If user selection of the Cancel function is detected at step 482, the process 480 advances to step 484 where the processor 50 is illustratively operable to exit the bolus advice process and display the main menu 302.
  • The sub-process B of FIG. 12C further includes a process 490 that allows the user to confirm the diary entry including the total recommended bolus, TRB, for delivery. The process 490 begins at step 492 where the UI processor 50 is operable to determine whether a user has selected the Confirm function displayed on the bolus advice screen, e.g., see FIG. 15, such as via one of the user buttons 16. If not, the process 490 loops back to the beginning of step 492. If user selection of the Confirm function is detected at step 492, the process 490 advances to step 494 where the UI processor 50 is illustratively operable to determine whether the current value of TRB is less than or equal to zero, i.e., whether the user has confirmed a null or negative bolus. If so, the process 490 advances to step 496 where the UI processor 50 is illustratively operable to store the bolus advice record, and to exit the bolus advice process and display the main menu 302.
  • It at step 494, the UI processor 50 determines that TRB is not less than or equal to zero, the process 490 advances to step 498 where the UI processor 50 is operable to determine whether the user confirmation detected at step 492 is of a manual, e.g., manual pump or pen/syringe, or commanded, e.g., STD, MW or EXT, bolus. If the user confirmation is of a commanded bolus, the process 490 advances to step 500 where the UI processor 50 is operable to determine whether the remote electronic device 12 and the pump 14 are still wirelessly connected via a wireless communication link 40 (see FIG. 1). If not, the process 490 advances to step 502 where the UI processor 50 sets as the currently available bolus types only the manual bolus types, i.e., manual pump and pen/syringe, and the process 490 thereafter loops back to the beginning of the sub-process B. Thus, if the UI processor 50 determines after user confirmation of a commanded bolus, e.g., STD, MW or EXT, that a wireless connection does not or no longer exists between the remote electronic device 12 and the infusion pump 14, the process 490 returns to the bolus advice process of sub-process B where the UI processor 50 makes available as user selectable bolus types, e.g., at step 474 of the process 470, only manually deliverable bolus types, e.g., via manual programming of an infusion pump or via manual delivery via a drug pen or syringe.
  • If, at step 500, the UI processor 50 determines that the remote electronic device 12 and the pump 14 are still wirelessly connected, the process 490 advances to step 504 the UI processor 50 determines whether the user selected bolus type, i.e., the bolus type selected by the user at step 476, is a Standard bolus, STD. If so, the process 490 advances to a process C. If not, the process 490 advances to step 506 where the UI processor 50 is operable to determine whether the user selected bolus type, i.e., the bolus type selected by the user at step 476, is a multi-wave bolus, MW. If so, the process 490 advances to a process D. If not, the process 490 advances to a process E.
  • If, at step 498, the UI Processor 50 determines that the user confirmation detected at step 492 is of a manual bolus, the process 490 advances to step 508 where the UI processor 50 is operable to determine whether the confirmed bolus type is a manual pump (MP), corresponding to manually programming an infusion pump to deliver the bolus, or a pen/syringe (PS), corresponding to manual delivery of the bolus via a conventional drug pen or syringe. If the confirmed bolus is a manual pump (MP), the process 490 advances to a process F, and if the confirmed bolus is a pen/syringe (PS), the process 490 advances to a process G.
  • As described hereinabove with respect to FIGS. 5-11, the remote electronic device 12 and the pump 14 illustratively cooperate to transfer pump operating history and bolus threshold/status from the pump 14 to the remote electronic device when a user accesses the bolus advice process 300. The remote electronic device is further operable to compute B1 based, at least in part, on recent bolus delivery history, and utilize the wireless communication link to wirelessly program the pump 14 to deliver boluses. However, in situations in which a wireless connection cannot be established when the bolus advice process 300 is accessed or thereafter, neither recent pump history nor bolus threshold/status information is transferred from the pump 14 to the remote electronic device 12, and the remote electronic device 12 cannot remotely program the pump 14 to deliver a recommended bolus from the bolus advice process if a wireless connection between the devices 12, 14 cannot be established and/or is lost during the bolus advice process. Such situations may occur, for example, when the pump 14 is turned off and/or when wireless communication between the remote electronic device 12 and the pump 14 are disabled or otherwise compromised. During such situations, however, the bolus advice process 300 continues to be accessible, and the bolus advice process 300 illustrated and described herein is illustratively operable under such conditions to compute active insulin, AI, and a total recommended bolus, TRB, based on current BG measurements and pump history and that was previously collected and processed by the remote electronic device 12, and recent values of Carbs and/or health information.
  • In such cases, the UI processor 50 is operable at step 522 of the process 300 of FIG. 12A to determine if pump history and/or bolus threshold and pump status information was not updated at the start of the current bolus advice session. If a wireless connection cannot be established between the remote electronic device 12 and the pump 14, the remote electronic device 12 will not display the Standard, Extended or Multi-wave boluses as available bolus types at step 476, and the user will in such cases be able to deliver the drug only by manually, e.g., locally, programming the pump 14, by manually administering the drug via conventional drug pen or syringe, or via other conventional manual drug delivery techniques. The remote electronic device 12 thus prompts the user to manually program or manually deliver the bolus amount under conditions where a wireless communications link is not established between the devices 12 and 14, and the UI processor 50 accordingly notifies the user when a wireless connection cannot be established when the bolus advice process is begun and when the wireless connection is lost during the bolus advice process. When wireless communications is lost during a bolus advice session, the remote electronic device 12 does not attempt to establish wireless communications during the current bolus advice session.
  • Referring now to FIG. 16, a flowchart is shown of one illustrative embodiment 550 of the process C referred to in the process 490 of FIG. 12C. The process 550 is executed when the user has confirmed a Standard bolus of an amount TRB. The process 550 begins at step 556 where the UI processor 50 is operable to display a standard bolus confirmation screen with the total recommended bolus amount. Thereafter at step 558, the UI processor 50 is operable to determine whether the user has selected a back, i.e., go back, function that is available on the confirmation screen. If so, the process 550 advances to step 560 where the UI processor 50 returns to the bolus advice screen. If not, the process 550 advances to step 562 where the UI processor 50 is operable to determine whether the user has selected a deliver function that is available on the confirmation screen. If not, the process 550 loops back to step 560. If, at step 562, the UI processor 50 determines that the user has selected deliver on the confirmation screen, the UI processor 50 sends a deliver command to the pump 14 to which the pump is responsive to begin delivering the standard bolus in the amount of the total programmed bolus.
  • The process 550 advances from the “YES” branch of step 562 to step 564 where the UI processor 50 is operable to send a deliver command to the pump 14 and to store the entire record in memory. Thereafter at step 566, the processor 50 is operable to receive a wireless message from the pump 14 corresponding to an amount of the total programmed bolus that is currently being delivered. The UI processor 50 is, in turn, operable to control the display device 18 to update the total recommended bolus value, TRB, to reflect delivery by the pump 14 of the bolus amount so far delivered. For example, if at step 566 the UI processor 50 receives a message from the pump 14 that the pump 14 has delivered 1/10 U of insulin, the UI processor 50 is operable to control the display device 18 to update the displayed TRB value by subtracting 1/10 U from the displayed value of TRB. Thereafter at step 568, the UI processor 50 is operable to determine whether a user has manually stopped the insulin delivery process by manually selecting a suitable one or more of the user buttons 16 of the remote electronic device 12. If the UI processor 50 determines that the user has manually stopped the delivery of insulin by the pump 14, the process 550 advances to step 570 where UI processor 50 controls the display device 18 to display a bolus canceled message. Otherwise, the process 550 advances to step 572 where the UI processor 50 is operable to determine, based on messages wirelessly provided by the pump 14, whether delivery of the standard bolus is complete. If not, the process 550 loops back up to step 566. Thus, steps 566-572 illustratively result in a count down on the display device 18 of bolus delivery from the total recommended bolus value, TRB. When delivery of the standard bolus is complete, step 572 advances to step 574 where the UI processor 50 is operable to control the display device 18 to display a delivery complete message. From step 574, and also from step 570, the process 550 advances to step 576 where the UI processor 50 stores the bolus delivery record in memory.
  • Referring now to FIGS. 17A and 17B, a flowchart is shown of one illustrative embodiment 580 of the process D referred to in the process 490 of FIG. 12C. The process 580 is executed when the user has confirmed a multi-wave bolus of an amount TRB. The process 580 begins at step 582 where the UI processor 50 is operable to send a MW immediate portion (IMD) and a duration (DUR) request to the pump 14 along with the total recommended bolus value, TRB. Thereafter at step 584, the UI processor 50 is operable to determine whether a multi-wave bolus program command acknowledgement and accompanying multi-wave bolus data have been received from the pump 14. Illustratively, the pump 14 is responsive to the MW bolus program command to automatically program a multi-wave bolus in the amount of TRB using previous or default values of the immediate portion, IMD, and of the duration, DUR, of the extended portion of the multi-wave bolus, and to send an acknowledgement back to the remote electronic device 12 that a multi-wave bolus in the amount of TRB has been programmed having an immediate amount of IMD and a duration of DUR, and to await further instructions. If the UI processor 50 determines at step 584 that such an acknowledgement has not been received, the process 580 advances to step 586 where the UI processor 50 is operable to determine whether an acknowledgement timer has timed out since sending the command at step 582. If not, the process 580 loops back to step 584. If the acknowledgement timer has timed out, the process 580 advances to step 588 where the UI processor returns to the previous bolus advice screen.
  • If, at step 584, the UI processor 50 determines that the multi-wave bolus program acknowledgement and accompanying programmed bolus data was received, the process 580 advances to step 590 where the UI processor 50 is operable to display a multi-wave bolus confirmation screen with the immediate portion, IMD, the bolus duration, DUR, and the total programmed bolus amount. Thereafter at step 592, the UI processor 50 is operable to determine whether the user has selected a back, i.e., go back, function that is available on the confirmation screen. If so, the process 580 advances to step 594 where the UI processor 50 is operable to return to the previous bolus advice screen. If not, the process 580 advances to step 596 where the UI processor 50 is operable to determine whether the user has selected the IMD field of the multi-wave bolus screen for editing. If so, the process 580 advances to step 598 where the UI processor 50 is operable to determine whether the user has entered a new IMD value in the IMD field of the multi-wave bolus screen. If not, the process 580 loops back to the beginning of step 598. If so, the process 580 loops back to step 590. If, at step 596, the UI processor 50 determines that the user has not selected the IMD field for editing, the process 580 advances to step 600 where the UI processor 50 is operable to determine whether the user has selected the DUR field of the multi-wave bolus screen for editing. If so, the process 580 advances to step 602 where the UI processor 50 is operable to determine whether the user has entered a new DUR value in the DUR field of the multi-wave bolus screen. If not, the process 580 loops back to the beginning of step 602. If so, the process 580 loops back to step 590. If, at step 600, the UI processor 50 determines that the user has not selected the IMD field for editing, the process 580 advances to step 604 where the UI processor 50 is operable to determine whether the user has selected the deliver function of the multi-wave bolus screen. If, at step 606, the UI processor 50 has determined that the user has selected deliver on the multi-wave bolus confirmation screen, the UI processor 50 sends a deliver command to the pump 14 to which the pump is responsive to begin delivering the multi-wave bolus in the amount of the total programmed bolus having an immediate portion, IMD, and a duration, DUR.
  • The process 580 advances from the “YES” branch of step 604 to step 606 where the UI processor 50 is operable to send a deliver command to the pump 14 and to store the entire bolus advice record in memory. Thereafter at step 608, the UI processor 50 is operable to receive a wireless message from the pump 14 corresponding to an amount of the immediate portion, IMD, of the multi-wave bolus that is currently being delivered. The UI processor 50 is, in turn, operable to control the display device 18 to update the immediate bolus value, IMD, to reflect delivery by the pump 14 of the immediate bolus amount so far delivered. For example, if at step 608 the UI processor 50 receives a message from the pump 14 that the pump 14 has delivered 1/10 U of insulin, the UI processor 50 is operable to control the display device 18 to update the displayed IMD value by subtracting 1/10 U from the displayed value of IMD. Thereafter at step 610, the UI processor 50 is operable to determine whether a user has manually stopped the insulin delivery process by manually selecting a suitable one or more of the user buttons 16 of the remote electronic device 12. If the UI processor 50 determines that the user has manually stopped the delivery of insulin by the pump 14, the process 580 advances to step 612 where UI processor 50 controls the display device 18 to display a bolus canceled message. Otherwise, the process 580 advances to step 614 where the UI processor 50 is operable to determine, based on messages wirelessly provided by the pump 14, whether delivery of the immediate portion of the multi-wave bolus is complete. If not, the process 580 loops back up to step 608. Thus, steps 608-614 illustratively result in a count down on the display device 18 of delivery of the immediate portion of the multi-wave bolus. When delivery of the immediate portion of the multi-wave bolus is complete, step 614 advances to step 616 where the UI processor 50 is operable to control the display device 18 to display an immediate bolus delivery complete message that is followed by or that includes a message that the multi-wave bolus delivery is continuing.
  • Referring now to FIG. 18, a flowchart is shown of one illustrative embodiment 620 of the process E referred to in the process 490 of FIG. 12C. The process 620 is executed when the user has confirmed an extended bolus of an amount TRB. The process 620 begins at step 622 where the UI processor 50 is operable to send an extended bolus duration (DUR) request to the pump 14 along with the total recommended bolus value, TRB. Thereafter at step 624, the UI processor 50 is operable to determine whether an extended bolus program command acknowledgement and accompanying extended bolus data have been received from the pump 14. Illustratively, the pump 14 is responsive to the extended bolus program command to automatically program an extended bolus in the amount of TRB using a previous or default value of the duration, DUR, of the extended bolus, and to send an acknowledgement back to the remote electronic device 12 that an extended bolus in the amount of TRB has been programmed, and to await further instructions. If the UI processor 50 determines at step 624 that such an acknowledgement has not been received, the process 620 advances to step 626 where the UI processor 50 is operable to determine whether an acknowledgement timer has timed out since sending the command at step 622. If not, the process 580 loops back to step 624. If the acknowledgement timer has timed out, the process 620 advances to step 628 where the UI processor returns to the previous bolus advice screen.
  • If, at step 624, the UI processor 50 determines that the extended bolus program acknowledgement and accompanying programmed bolus data was received, the process 620 advances to step 630 where the UI processor 50 is operable to display an extended bolus confirmation screen with the bolus duration, DUR, and the total programmed bolus amount. Thereafter at step 632, the UI processor 50 is operable to determine whether the user has selected a back, i.e., go back, function that is available on the confirmation screen. If so, the process 620 advances to step 634 where the UI processor 50 is operable to return to the previous bolus advice screen. If not, the process 620 advances to step 636 where the UI processor 50 is operable to determine whether the user has selected the DUR field of the multi-wave bolus screen for editing. If so, the process 620 advances to step 638 where the UI processor 50 is operable to determine whether the user has entered a new DUR value in the DUR field of the extended bolus screen. If not, the process 620 loops back to the beginning of step 638. If so, the process 620 loops back to step 630. If, at step 636, the UI processor 50 determines that the user has not selected the DUR field for editing, the process 620 advances to step 640 where the UI processor 50 is operable to determine whether the user has selected the deliver function of the multi-wave bolus screen. If, at step 406, the UI processor 50 has determined that the user has selected deliver on the extended bolus confirmation screen, the UI processor 50 sends a deliver command to the pump 14 to which the pump is responsive to begin delivering the extended bolus in the amount of the total programmed bolus having a duration, DUR.
  • The process 620 advances from the “YES” branch of step 640 to step 642 where the UI processor 50 is operable to send a deliver command to the pump 14 and to store the entire bolus advice record in memory. Thereafter at step 644, the UI processor 50 is operable to receive a wireless message from the pump 14 that the pump is currently delivering the extended bolus. Thereafter at step 646, the UI processor 50 is operable to control the display unit 18 to display a message indicating that delivery of the extended bolus is continuing.
  • Referring now to FIG. 19, a flowchart is shown of one illustrative embodiment 650 of the process F referred to in the process 490 of FIG. 12C. The process 650 is executed when the user has confirmed that the bolus amount TRB will be manually programmed on the pump 14. The process 650 begins at step 652 where the UI processor 50 is operable to display a manual program screen with instructions to manually program the bolus amount TRB on the pump 14. Thereafter at step 654, the UI processor 50 is operable to determine whether the user has selected a back, i.e., go back, function that is available on the confirmation screen. If so, the process 650 advances to step 656 where the UI processor 50 is operable to return to the previous bolus advice screen. If not, the process 650 advances to step 658 where the UI processor 50 is operable to determine whether the user has selected OK on the manual program bolus screen. If not, the process 650 loops back to step 654. If, at step 658, the UI processor 50 has determined that the user has selected OK on the bolus confirmation screen, the UI processor 50 stores the entire record in memory at step 660.
  • Referring now to FIG. 20, a flowchart is shown of one illustrative embodiment 670 of the process G referred to in the process 490 of FIG. 12C. The process 670 is executed when the user has confirmed that the bolus amount TRB will be manually delivered via a drug pen or syringe or the like. The process 670 begins at step 672 where the UI processor 50 is operable to display a pen/syringe screen with instructions to manually deliver the bolus amount TRB via a drug pen or syringe. Thereafter at step 674, the UI processor 50 is operable to determine whether the user has selected a back, i.e., go back, function that is available on the confirmation screen. If so, the process 670 advances to step 676 where the UI processor 50 is operable to return to the previous bolus advice screen. If not, the process 670 advances to step 678 where the UI processor 50 is operable to determine whether the user has selected OK on the manual program bolus screen. If not, the process 670 loops back to step 674. If, at step 678, the UI processor 50 has determined that the user has selected OK on the bolus confirmation screen, the UI processor 50 stores the entire record in memory at step 680.
  • Further details relating to the bolus advice process illustrated in FIGS. 12A and 12B are provided in co-pending PCT Patent Application No. PCT/US2008/066331, the disclosure of which has been incorporated by reference.
  • While the invention has been illustrated and described in detail in the foregoing drawings and description, the same is to be considered as illustrative and not restrictive in character, it being understood that only illustrative embodiments thereof have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected. For example, the UI processor 50 and/or the processor 28 of the medical device may be configured to determine a display color based on a computed and/or delivered bolus value, relative to one or more reference bolus values and to change the color of the display device 18 and/or 34, or portion thereof, to the determined display color, as described above with respect to FIG. 13.

Claims (30)

1. An electronic device for selectively disabling a bolus advice process according to which the electronic device recommends delivery of a bolus amount of a drug to a body of a user based on a plurality of factors including glucose concentration of the user, the electronic device comprising:
a glucose measuring facility configured to measure glucose concentration of a body fluid sample, and
a processor including a memory having instructions stored therein that comprise the bolus advice process, the memory further having instructions stored therein that are executable by the processor to request a glucose concentration measurement by the glucose measurement facility prior to executing, or as part of, the bolus advice process, and to disable execution of the bolus advice process if a glucose concentration value resulting from the requested glucose concentration measurement is less than a threshold value.
2. The electronic device of claim 1 further comprising a display device,
and wherein the memory further includes instructions that are executable by the processor to control the display device to display a message indicating that the bolus recommendation glucose concentration value.
3. The electronic device of claim 2 wherein the memory further includes instructions stored therein that are executable by the processor to compute a carbohydrate value based on the glucose concentration value resulting from the requested glucose concentration measurement and a target glucose concentration value, the carbohydrate value corresponding to a quantity of carbohydrates required to be taken by the user to increase glucose concentration of the user to the target glucose concentration value.
4. The electronic device of claim 3 wherein the memory further includes instructions stored therein that are executable by the processor to control the display device to display the carbohydrate value with instructions to consume carbohydrates in the amount of the carbohydrate value,
and wherein the threshold value corresponds to a hypoglycemic threshold.
5. A method of controlling a color display of an electronic device, the method comprising:
determining a measured or computed value,
determining a display color based on the measured or computed value relative to at least one limit or range, and
changing a color of at least a portion of the display to the display color when displaying the measured or computed value or a message identifying the value.
6. The method of claim 5 wherein the electronic device includes a medical device that measures an analyte concentration in a liquid sample.
7. The method of claim 6 wherein the medical device is a blood glucose meter that measures glucose concentration in blood samples,
and wherein determining a display color based on the measured or computed value comprises determining a display color based on a measured glucose concentration relative to at least a target blood glucose range.
8. The method of claim 7 wherein determining a display color comprises selecting a first color if the measured glucose concentration is within the target blood glucose range.
9. The method of claim 8 wherein determining a display color comprises selecting a second color different from the first color if the measured glucose concentration is between the target blood glucose range and a low blood glucose value.
10. The method of claim 9 wherein determining a display color comprises selecting a third color different from the first and second colors if the measured glucose concentration is below the low blood glucose value.
11. The method of claim 10 further comprising controlling the display to display a warning message if the measured blood glucose concentration is below the low blood glucose value.
12. The method of claim 10 wherein the low blood glucose value is a hypoglycemic blood glucose threshold.
13. The method of claim 8 wherein determining a display color comprises selecting a fourth color different from the first color if the measured glucose concentration is between the target blood glucose range and a high blood glucose value.
14. The method of claim 13 further comprising controlling the display to display a warning message along with the fourth color if the measured blood glucose concentration is below above the high blood glucose value.
15. The method of claim 14 wherein the high blood glucose value is a hyperglycemic blood glucose threshold.
16. The method of claim 5 wherein determining a measured or computed value comprises computing a value, or receiving a computed value, of a quantity of a drug to be delivered to a body.
17. A method of collecting in an electronic device time-based event data stored in a medical device, the method comprising:
wirelessly sending by the electronic device a request for the time-based event data,
wirelessly sending by the medical device time-based event data stored therein since previously wirelessly sending stored time-based event data upon receiving the request for the time-based event data,
wirelessly sending by the electronic device an acknowledgement signal upon receiving the time-event based data from the another electronic device, and
identifying by the medical device a location in memory of the last item of the time-event based data that was sent to the electronic device upon receiving the acknowledgement signal.
18. The method of claim 17 wherein the medical device is a liquid infusion pump and the time-based event data is time-based infusion pump event data.
19. A method for enabling a bolus advice feature of an electronic device according to which the electronic device recommends delivery of a bolus amount of a drug to a body of a user based on a plurality of factors including glucose concentration of the user, the method comprising:
disabling the bolus advice feature of the electronic device during manufacture of the electronic device,
monitoring one of a flag and a memory location when the electronic device is operable after manufacture thereof, and
enabling the bolus advice feature if one of the flag is activated and the memory location includes a device pairing value.
20. The method of claim 19 wherein monitoring one of a flag and a memory location comprises monitoring a flag,
and further comprising activating the flag if a predefined password is received by the electronic device.
21. The method of claim 19 wherein monitoring one of a flag and a memory location comprises monitoring a flag,
and further comprising activating the flag when the electronic device has been successfully paired with another electronic device.
22. The method of claim 21 wherein the another electronic device comprises an ambulatory medical device.
23. The method of claim 19 wherein monitoring one of a flag and a memory location comprises monitoring a memory location,
and further comprising storing the device pairing value in the memory location when the electronic device has been successfully paired with another electronic device.
24. The method of claim 23 wherein the another electronic device comprises an ambulatory medical device.
25. A method of maintaining a time and date in an electronic device that communicates wirelessly with an ambulatory medical device, the method comprising:
establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device,
wirelessly sending by the medical device time and date information, corresponding to a calendar date and time of day maintained by the medical device, when the wireless communication link is established, and
modifying by the electronic device a calendar date and time of day thereof if the time of day received from the medical device time differs from the time of day of the electronic device by more than a predefined time value.
26. The method of claim 25 wherein the electronic device includes a my data feature according to which historical records stored within the electronic device may be viewed,
and wherein establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device comprises establishing the wireless communication link, if one is not already established, when the electronic device enters the my data feature.
27. The method of claim 25 wherein the electronic device includes a bolus advice feature according to which the electronic device recommends delivery of a bolus amount of a drug to a body of a user based on a plurality of factors including glucose concentration of the user,
and wherein establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device comprises establishing the wireless communication link, if one is not already established, when the electronic device enters the bolus advice feature.
28. The method of claim 25 wherein the electronic device includes an on/off switch,
and wherein establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device comprises establishing the wireless communication link, if one is not already established, when the on/off switch is detected as transitioning from an off state to an on state.
29. The method of claim 25 wherein a memory unit of the electronic device has at least one automatic reminder stored therein,
and wherein establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device comprises establishing the wireless communication link, if one is not already established, when the at least one automatic reminder powers on the electronic device from an off state.
30. The method of claim 25 wherein the electronic device includes a remote terminal operating mode according to which the electronic device remote controls operation of the ambulatory medical device,
and wherein establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device comprises establishing the wireless communication link, if one is not already established, when the electronic device exits the remote terminal operating mode.
US12/646,113 2007-06-29 2009-12-23 Combination communication device and medical device for communicating wirelessly with a remote medical device Abandoned US20100160759A1 (en)

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US93793307P true 2007-06-29 2007-06-29
US93777907P true 2007-06-29 2007-06-29
PCT/US2008/066262 WO2009005952A2 (en) 2007-06-29 2008-06-09 Combination communication device and medical device for communicating wirelessly with a remote medical device
US12/646,113 US20100160759A1 (en) 2007-06-29 2009-12-23 Combination communication device and medical device for communicating wirelessly with a remote medical device

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US12/646,113 Abandoned US20100160759A1 (en) 2007-06-29 2009-12-23 Combination communication device and medical device for communicating wirelessly with a remote medical device
US12/646,564 Abandoned US20100167385A1 (en) 2007-06-29 2009-12-23 User interface features for an electronic device
US12/646,336 Active US8118770B2 (en) 2007-06-29 2009-12-23 Reconciling multiple medical device bolus records for improved accuracy
US12/646,471 Active 2030-06-04 US8451230B2 (en) 2007-06-29 2009-12-23 Apparatus and method for remotely controlling an ambulatory medical device

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US12/646,336 Active US8118770B2 (en) 2007-06-29 2009-12-23 Reconciling multiple medical device bolus records for improved accuracy
US12/646,471 Active 2030-06-04 US8451230B2 (en) 2007-06-29 2009-12-23 Apparatus and method for remotely controlling an ambulatory medical device

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EP2186035B1 (en) 2018-12-26
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