HK1140029A - User interface features for an electronic device - Google Patents

Description

User interface features for electronic devices

Cross Reference to Related Applications

This patent application claims priority and benefit from united states provisional patent application serial No. 60/937,779 and united states provisional patent application serial No. 60/937,933, both of which were filed on 29/6/2007, and the disclosures of which are incorporated herein by reference.

Technical Field

The present invention relates generally to user interface features for an electronic device that may include one or more on-board (on-board) medical devices and that may be configured to wirelessly communicate with one or more remote medical devices.

Background

Electronic devices comprising on-board medical devices are known. Electronic devices configured to be wirelessly communicable with at least one medical device are also known. The following is desirable: i.e. any one of such electronic devices comprises useful user interface features.

Disclosure of Invention

The invention may comprise one or more of the features recited in the appended claims, and/or one or more of the following features and combinations thereof. A method of controlling a display device of an electronic apparatus may include displaying a data field on the display device, performing an editing process for editing the data field displayed on the display device, and enlarging the data field on the display device relative to other portions of the display device when selected for editing in accordance with the editing process.

Enlarging the data field may include generating an enlarged polygon around the enlarged data field.

The method further includes displaying a plurality of data fields on the display device and enlarging any of the plurality of data fields when selected for editing in accordance with the editing process.

When selected for editing in accordance with the editing process, the enlarged data field is populated with a plurality of selectable options.

The method may further include incrementally increasing the value displayed within the enlarged data field by an incremental value in response to a press of a first user button of the electronic device. The method may alternatively or additionally include incrementally decreasing the value displayed within the enlarged data field in response to a press of a second user button of the electronic device. In either or both cases, the method further comprises: a fast scrolling process that incrementally increases or decreases the value displayed within the magnified field at a fast rate when the corresponding first or second user button is pressed or held, respectively. Alternatively or additionally, the method may further comprise: a process of fast scrolling that increases the increment or decrement value, respectively, when the corresponding first or second user button is pressed or held.

The method may further comprise: automatically displaying a unit of measurement of data within the enlarged data field or a unit of measurement of data to be input within the enlarged data field.

An electronic device may include electronic circuitry including a transceiver configured to be wirelessly communicable with other electronic devices, and a housing including the transceiver contained therein. The transceiver may be configured to be operable at one of visible wavelengths, infrared wavelengths, and ultraviolet wavelengths. The housing may define a first integration window located above the transceiver. The first integration window may be transmissive to an operating wavelength of the transceiver so that the transceiver may send and receive wireless information through the integration window.

The electronic circuit may further comprise a display device. The housing may define a second integrated window positioned over the display device such that information displayed on the display device is visible through the second integrated window. The display device may be a liquid crystal display device.

The first and second integrated windows may be transparent. Illustratively, the housing may be transparent, and the first and second integrated windows may be formed by coating the housing with an opaque coating when the first and second integrated windows are obscured.

An electronic apparatus may include electronic circuitry including a display device configured to display information and a housing having electronic circuitry including the display device contained therein. The housing may define an integrated, transparent window over the display device such that information displayed within the display device is visible through the integrated window.

The display device may be a liquid crystal display device. The housing may be transparent and the integrated window may be formed by coating the housing with an opaque coating when the integrated window is obscured.

An electronic analyte measuring device may include a housing, an analyte measuring device located within the housing, a display device carried by the housing, and a processor. The analyte measurement device is configured to measure a concentration of an analyte within a liquid sample deposited on a sample carrier received within the analyte measurement device. The processor may include a memory having instructions stored therein that the processor may execute to automatically control the display device to display instructions to measure the concentration of the analyte in a subsequent liquid sample by the analyte measurement device if the concentration of the analyte in the liquid sample is outside a predetermined analyte concentration limit.

The instructions stored in the memory may optionally further include instructions executable by the processor to automatically control the display device to display the instructions after a programmable time period has elapsed since the measurement of the concentration of the analyte in the liquid sample. The sample may be blood, the analyte may be glucose, and the predetermined concentration may be a maximum blood glucose limit. The instructions stored in the memory may include processor-executable instructions to automatically control the display device to display instructions to measure the concentration of the analyte in a subsequent liquid sample if the concentration of the analyte in the liquid sample is greater than the maximum blood glucose limit. The electronic analyte measuring device may further comprise at least one notification device. The maximum blood glucose limit may be a glycemic limit. The instructions stored in the memory may further include processor-executable instructions to activate the at least one notification device at or near the time the display device is controlled to display the instructions to measure the concentration of glucose in a subsequent blood sample if the concentration of glucose in the blood sample exceeds the blood glucose limit.

In an alternative embodiment, the predetermined concentration may be a minimum blood glucose limit. In this embodiment, the instructions stored in the memory may include processor-executable instructions to automatically control the display device to display instructions to measure the analyte concentration in a subsequent liquid sample if the analyte concentration in the liquid sample is less than the minimum blood glucose limit. In this embodiment, the electronic analyte measuring device may further comprise at least one notification device. The minimum blood glucose limit may be a blood glucose limit. The instructions stored in the memory may further include processor-executable instructions to activate the at least one notification device at or near the time that the control display device displays the instruction to measure the concentration of glucose in a subsequent blood sample if the concentration of glucose in the blood sample is less than the blood glucose limit.

An electronic blood glucose measuring device may include a housing, a blood glucose measuring device located within the housing, a display device carried by the housing, and a processor. A blood glucose measuring device may be configured to measure a concentration of glucose within a blood sample deposited on a sample carrier received within the blood glucose measuring device. The processor may execute a bolus recommendation process that may recommend a bolus amount based on a plurality of factors including a carbohydrate value input by a user. The processor may include a memory having instructions stored therein that the processor may execute to automatically control a display device to display blood glucose for measurement of a blood sample by the blood glucose measuring device after a programmable amount of time has elapsed since the carbohydrate value was entered if the carbohydrate value entered by the user is greater than the carbohydrate limit.

The electronic blood glucose measuring device may further comprise at least one alarm device. The carbohydrate limit may be a programmable food quantity limit. The instructions stored in the memory may include processor-executable instructions to activate the at least one notification device at or near the time of controlling the display device to display the instructions to measure blood glucose if the user-entered carbohydrate value exceeds the food quantity limit.

The method of setting and managing automatic reminders within an electronic device may include starting a timer when an event causing an automatic reminder to be set occurs, resetting the timer if the event occurs again before the timer expires, and activating a notification device when the timer expires. Activating the notification device may include activating any one of an audible indication device and a vibration device. Alternatively or additionally, activating the notification means may comprise controlling the display device to display an instruction to retest the event that caused the automatic reminder to be set.

An electronic analyte measuring device may include a housing, a plurality of user buttons carried by the housing, a carrier port having an opening defined by the housing and extending from the opening into the housing, an analyte measuring device located within the housing and in communication with the carrier port, and a processor. The analyte measurement device may measure an analyte in a liquid sample deposited on a sample carrier received in the carrier port. The processor may include a memory having instructions stored therein that the processor may execute to cause the device to power up from a powered down state, disable a plurality of user buttons and measure an analyte in a liquid sample deposited on a sample carrier when the device is in the powered down state and the sample carrier is received in the carrier port, and enable the plurality of user buttons when the analyte measurement is completed.

The analyte measurement device may include a blood glucose measurement device that measures a glucose concentration within a blood sample deposited on the sample carrier.

Drawings

FIG. 1 is a block diagram of one illustrative embodiment of a wireless communication system including a medical device and a remote electronic device both configured to wirelessly communicate with each other.

FIG. 2 is a block diagram illustration of an exemplary embodiment of electronic circuitry carried by and controlling the remote electronic device of FIG. 1.

FIG. 3 is a block diagram illustration of some details of one illustrative embodiment of a memory subsystem of the remote electronic device shown in FIG. 2.

FIG. 4 is a diagram of one illustrative embodiment external to a remote electronic device.

Fig. 5 is a flow chart of one illustrative embodiment of a process performed in a remote electronic device for unlocking a user button upon detection of a carrier port into which a sample carrier is inserted.

Fig. 6A-6C depict a flow diagram of one illustrative embodiment of a bolus recommendation process performed by a remote electronic device.

Fig. 7 is a graphical representation of one exemplary embodiment of a bolus recommendation display screen generated by the process of fig. 6A-6C.

FIG. 8 is a flow chart of one illustrative embodiment of a process for displaying an enlarged user edit area when editing data on a screen with either an electronic device or a medical device.

Fig. 9A-9H are graphical representations of one exemplary embodiment of a bolus recommendation display screen demonstrating the use of an enlarged user editing area, in accordance with the process of fig. 7.

FIG. 10 is a flow chart of one illustrative embodiment of a process for automatically notifying and instructing a user to measure blood glucose.

FIG. 11 is a flow chart of another illustrative embodiment of a process for automatically notifying and instructing a user to measure blood glucose.

FIG. 12 is a flow chart of yet another illustrative embodiment of a process for automatically notifying and instructing a user to measure blood glucose.

FIG. 13 is a flow diagram of one illustrative embodiment of a process for automatically canceling an automatic event-based notification based on the reoccurrence of an event.

Fig. 14A and 14B are diagrams of a tip portion of one illustrative embodiment of a housing of a remote electronic device.

Detailed Description

For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the exemplary embodiments illustrated 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. ____, entitled APPATUS AND METHOD FOR CONVERTING CONTROL AN AMBULATORY MEDICAL DEVICE AND having attorney docket No. 5727, PCT patent application No. ____, entitled COMMUNICATION DEVICEAND MEDICAL DEVICE FOR COMMUNICATION WIRELESSLYWITH A REMOTE MEDICAL DEVICE AND having attorney docket No. 5727-205463, PCT patent application No. ____, entitled METHOD ANDAPATRATUS FOR DETERMINING AND DELIVERING A DRUGBOLUS AND having attorney docket No. 5727-205464, PCT patent application No. ____, entitled LIQUID INITION PUMP AND having attorney docket No. 5727-205465, PCT patent application No. ____, entitled METHOD FOR APPARATUS AND APPARATUS OR MEDICALDEVICES AND DEVICE 5727, AND PCT patent application No. 5,5727 copolymer 5727 AND having attorney docket No. PCT MULTIPLE 577-MULTIPLE 4627, PCT patent application No. PCT MULTIPLE 577-MULTIPLE 4627, AND PCT MULTIPLE PATENT ASSOCATION OR No. 5727 with attorney docket No. 5-MULTIPLE ____ AND MULTIPLE PATENT No. 5727, PCT patent application No. 5727, AND PCT patent application No. 4, AND PCT MULTIPLE PCT, and U.S. provisional patent application Ser. No. ____, entitled DEVICE AND METHODS for providing compatibility BETWEEN electronic devices and electronics for AND A MEDICAL DEVICE and having attorney docket No. 5727 and 204710/WP-24993 US.

Referring now to FIG. 1, a block diagram shows one illustrative embodiment of a wireless communication system 10, the wireless communication system 10 including a remote electronic device 12 and a medical device 14, wherein the remote electronic device 12 and the medical device 14 are both configured to wirelessly communicate with each other. The remote electronic device 12 has a housing through which a user button member 16 extends. In one embodiment, the user button assembly 16 defines a plurality of user buttons, keys or switches that can be manually operated by a user to provide input to the remote electronic device 12. The 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 the present disclosure contemplates the use of 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 event, 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 component 16 may be or include one or more touch-sensitive buttons. In this embodiment, the one or more touch buttons may, but are not limited to, form part of the display unit 18.

The electronic device 12 further includes a carrier port 20 extending into the housing from an opening defined therein. The carrier port 20 is sized to perform the following functions: i.e., may receive a sample carrier or strip 22 therein, wherein a liquid sample containing the analyte has been or will be deposited on the sample carrier or strip 22. The electronics 12 include electronic circuitry that can analyze a liquid sample deposited on the sample carrier 22 when the sample carrier 22 is received within the carrier port 20 to determine the concentration of an analyte contained within the liquid sample. In one embodiment, the liquid sample is blood and the analyte is glucose. In this embodiment, the sample carrier 22 may be illustratively provided in the form of a glucose test strip, and the electronic circuitry of the electronic device 12 includes conventional circuitry for measuring the concentration of glucose within 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 contained within the bodily fluid.

In the embodiment illustrated in FIG. 1, electronic device 12 further includes a conventional data key port 26 extending into the housing from an opening defined therein. The data key port 26 defines an electronic interface or connector therein that is configured to electrically connect to a complementary configured electronic interface or connector defined on the conventional data key 24. The data key 24 includes a conventional memory device (not shown) electrically connected to an electronic interface or connector defined on the data key 24. When a data key 26 is received in the data key port 24, a memory device, such as a ROM key, is electrically connected to the electronic circuitry of the electronic device 12 through the electronic interface defined on the data key 24 and the electronic interface defined in the data key port 26. Generally, the memory device of the data key 24 has calibration data stored therein that is specific to a number or quantity of test strips 22, and when test strips 22 from a corresponding number or quantity of test strips are used, the electronic circuitry of the electronic device 12 uses the calibration data stored in the memory device of the data key 24 to correct the measurement of the glucose concentration, as will be appreciated by those of ordinary skill in the art. Typically, each of the many or large number of test strips 22 purchased by the user will include a dedicated data key 24, wherein the dedicated data key 24 will be used when measuring glucose concentrations using the many or large number of strips.

It should be understood that while the carrier port 20, sample carrier 22, and electronic circuitry of the electronic device 12 have been described in one embodiment as being configured to measure the glucose concentration of a blood sample deposited on the sample carrier 22, the present disclosure contemplates other embodiments in which the carrier port 20, sample carrier 22, and/or electronic circuitry of the electronic device 12 are configured to measure other analytes in other liquid samples.

The medical device 14 includes a conventional processor 28 electrically connected to a wireless communication circuit 30. The processor 28 includes a conventional memory unit 25, and the conventional memory unit 25 may store a number of processes for controlling the operation of the medical device 14 and for wirelessly communicating with the electronic device 12 in the form of instructions executable by the processor 28. In the illustrative embodiment, medical device 14 further includes conventional non-volatile memory units 27 and 29. In one embodiment, non-volatile memory cell 27 is provided in the form of a conventional ferroelectric memory (FRAM) and non-volatile memory cell 29 is provided in the form of a conventional Electrically Erasable Programmable Read Only Memory (EEPROM), although memory cells 27, 29 may alternatively be provided in the form of one or more other conventional non-volatile memory cells. In any case, memory units 27 and 29 are each external to processor 28 and are each electrically connected to processor 28. In an exemplary embodiment, wherein the medical device is a drug infusion pump, as will be described in greater detail below, memory unit 27 is a Pump Delivery (PD) memory unit, wherein processor 28 stores current electrical pump delivery information, and memory unit 29 is a pump history memory unit, e.g., in the form of event records, storing pump history information, wherein each event record corresponds to an operational event of one pump 14. The medical device 14 further includes wireless communication circuitry 30, the wireless communication circuitry 30 being configured to wirelessly communicate with a similar wireless communication module of the remote electronic device 12 via a wireless communication connection 40 in a conventional manner. In one embodiment, as will be illustrated by way of example throughout this disclosure, the wireless communication circuit 30 and the wireless communication module of the electronic device 12 are each conventional bluetooth (R) modules configured to wirelessly communicate in accordance with a conventional bluetooth (R) communication protocol. However, it should be understood 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 in accordance with one or more other communication protocols.

The medical device 14 illustratively includes a housing through which a plurality of user keys 32 pass. The user keys 32 may be provided in the form of any number of user-selectable buttons, keys or switches electrically connected to the processor 28. The medical device 14 further includes a visual display unit 34 carried by the housing and electrically connected to the processor 28. The visual display unit 34 may be, for example, a conventional Liquid Crystal Display (LCD), a plasma display, a Light Emitting Diode (LED) based display, a Vacuum Fluorescent (VF) display, or the like. The visual display unit 34 is controlled by the processor 28 to display information to the user of the medical device 14. In alternative embodiments, the user keys 32 may be or include one or more touch buttons. In this embodiment, the one or more touch buttons may, but are not limited to, 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 vibration device 38. The processor 28 is generally operable for controlling the audible indicating device 36 and the vibration device 38 to generate one or more audible sounds and/or vibrations, respectively, to notify the user of various operational aspects of the medical device 14 and also to notify the user of alarm and/or alert conditions associated with the medical device 14. In alternative embodiments, medical device 14 may not include display device 34 and/or user keys 32. In some such embodiments, medical device 14 may include one or more visual indicators that convey information to the user. Examples of such visual indicators may include, but should not be limited to, one or more lights, 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, implantable or non-implantable liquid delivery pumps, such as drug infusion pumps, implantable or non-implantable body condition sensors or sensor systems, or the like. In embodiments where the medical device 14 is a drug delivery pump, the drug delivered by such a pump may be or include, but should not be limited to, insulin or other conventional blood glucose regulating drugs. In alternative embodiments, the fluid delivered by any such pump may be or include, but should not be limited to, a drug or combination of drugs, saline (saline), a combination of one or more 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 thus, the following description should generally not be considered limited to liquid delivery pumps or to particular insulin infusion pumps.

Referring now to FIG. 2, a block diagram illustrates one exemplary embodiment of electronic circuitry carried by the remote electronic device 12 of FIG. 1 and that can control the remote electronic device 12. In an exemplary embodiment, the electronic circuit includes four modules with independent and well-defined functional responsibilities. For example, the electronic circuitry includes a User Interface (UI) processor 50, the User Interface (UI) processor 50 being the primary controller of the electronic device 12. Except for all aspects of processing the user interface 16, 18, it is the origin and destination of all data from and to the insulin infusion pump 14. As will be described in greater detail herein, the UI processor 50 does not control the operation of the wireless communication circuitry of the remote electronic device 12. The UI processor 50 operates according to a UI clock signal internally generated to the UI processor 50. The UI processor 50 includes a storage unit 66 having stored therein instructions that are executed by the UI processor 50 to control operations associated with the remote electronic device 12. In one illustrative example, the UI processor 50 is a UPD70F3719GC 32 bit microcontroller commercially available from NEC Electronics of Santa Clara, Calif., although the disclosure contemplates other embodiments of UI processors.

The electronic circuit of fig. 2 further comprises a wireless communication circuit 52, whichIs exclusively responsible for all control of wireless communication with one or more external electronic devices, but it does not control any other operations associated with electronic device 12. The wireless communication circuit 52 operates according to a clock signal internally generated to the wireless communication circuit 52 that is not synchronized with the UI clock signal according to which the UI processor 60 operates. Therefore, the operation of the wireless communication circuit 52 is asynchronous with 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, which includes a conventional processor and memory unit 70, and which further includes conventional wireless communication hardware, such as a suitable antenna. Illustratively, the memory unit 70 has instructions stored therein that are executable by the processor of the wireless communication circuitry 52 to exclusively control 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^TM4-Flash Plug-n-Go^TMSingle chip bluetooth radio frequency and baseband integrated circuits commercially available from CSR of Richardson (Richardson) of texas for bluetooth 2.4GHz systems, although the disclosure contemplates other embodiments of wireless communication circuitry 52. Alternatively, as described above, the present disclosure contemplates embodiments in which the wireless communication module 52 is configured for wireless communication in accordance with other wireless communication protocols other than bluetooth.

As shown in fig. 2, each of the UI processor 50 and the wireless communication module 52 includes a kickback removal circuit 64 and 68, respectively, which are electrically connected to the user buttons 16. The debounce circuits 64, 68 are conventional in that they reduce the sensitivity of the processors 50 and 52 to false switching events associated with the user buttons 16, thereby increasing the probability that only actual button presses are detected by the processors 50 and 52.

The electronic circuitry shown in fig. 2 further includes a storage subsystem 54 electrically connected to the UI processor 50 and also electrically connected to the wireless communication circuitry 52. The memory subsystem 54 is generally operable to store, at least temporarily, data that is moved between the UI processor 50 and the wireless communication circuitry 52. Illustratively, data communication between the memory subsystem 54 and the UI processor 50 is performed through a Serial Peripheral Interface (SPI), in which case data transmission between the memory subsystem 54 and the UI processor 50 is synchronized with a data transmission clock SCLK of the UI processor 50. Illustratively, data communications between the memory subsystem 54 and the wireless communication circuitry 52 are performed via a universal asynchronous receiver/transmitter (UART) interface, in which case data transfers between the memory subsystem 54 and the wireless communication circuitry 52 are asynchronous. In some alternative embodiments, the data transfer interface is interchangeable such that data transfers between memory subsystem 54 and UI processor 50 are asynchronous and data transfers between memory subsystem 54 and wireless communication circuitry 52 are synchronous.

Memory subsystem 54 temporarily stores data that is moved between UI processor 60 and wireless communication circuitry 52. In some embodiments, memory subsystem 54 does not control other circuitry, and in some such embodiments, memory subsystem 54 may be provided in the form of conventional memory devices. In other embodiments, where memory subsystem 54 controls or does not control other circuitry, memory subsystem 54 may be provided in the form of a conventional processor configured to operate as a Dual-Port RAM (DPR) processor. In such embodiments, the DPR processor 54 operates according to a clock signal that is separate from the UI clock signal according to which the UI processor 60 operates. In one illustrative embodiment, such a DPR processor 54 is an MC9S08GT16A 8 bit micro-control unit commercially available from Freescale semiconductor, Inc. (of Austin, Tex.) of Osten, although this disclosure contemplates other implementations of the memory subsystem 54 provided in the form of a conventional processor configured as the DPR processor 54.

The electronic circuitry shown in fig. 2 further includes a Measurement Engine (ME) processor 56 that controls analyte concentration measurements, e.g., blood glucose measurements, of the liquid sample contained on test element 22 and that reports the analyte concentration measurements to UI processor 50. ME processor 56 includes a memory unit 83 having instructions stored therein that are executable by ME processor 56 to control analyte measurement operations. The ME processor 56 operates according to an internally generated clock signal that is separated from the clock signal according to which the UI processor 50 operates. The ME processor 56 is electrically connected to the UI processor 50 through an event interrupt line, a TXD (data transfer) line, and a Ready line (Ready line). Illustratively, the event interrupt line is used by the ME processor 56 to notify the UI processor of an analyte measurement event, 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 in a historical database, and/or for use in performing other operations. The ready line is used by the ME processor 56 to inform the UI processor 50 of the ME processor's operational status, e.g., measured or unmeasured analyte concentration. In one illustrative embodiment, the ME processor 56 is an MSP430T2 AIPEG mixed-signal microcontroller unit, commercially available from texas instruments, inc. of dallas, texas, although other embodiments of the ME processor 56 are contemplated by the present disclosure.

As illustrated in fig. 2, the ME processor 56, together with other electronic components, forms an analyte measuring device 88, e.g., a glucose meter. In addition to the ME processor 56, the analyte measurement device 88 further includes an Application Specific Integrated Circuit (ASIC)78 electrically connected to the ME processor 56 and also electrically connected to the electronic interface 76 within the carrier port 20. In an exemplary embodiment, when a sample carrier 22, such as a glucose test strip, is inserted into carrier port 20, electrical contacts on sample carrier 22 contact electrical interface 76, thereby electrically connecting sample carrier 22 to ASIC 78. The switch 80 contained in the ASIC is triggered by the insertion of the carrier 22 into the carrier port 20 and so the output of the switch 80 informs the ME processor 56 that the carrier 22 is inserted into the carrier port 20. ASIC78 further illustratively includes a programmable clock circuit 82 for a plurality of different functions. For example, clock circuit 82 may be programmed to generate a signal to automatically turn on, e.g., power up, device 12 at one or more programmable times. As another example, clock circuit 82 may be programmed to generate signals corresponding to one or more reminders. Other examples will be apparent to those of ordinary skill in the art, and such additional examples are also contemplated by the present disclosure. In any case, a signal generated by the clock circuit 82 is provided to the ME processor 56, and the ME processor 56 powers up from a sleep state (if the ME processor 56 is in such a sleep state) in response to receipt of this signal, and generates an event interrupt signal on the interrupt line. The event interrupt signal is received by the UI processor 50, which UI processor 50 then powers up from a sleep state (if the UI processor 50 is in such a sleep state), and/or generates an audible or visual alert corresponding to any alert time programmed in the clock circuit 82.

As illustrated in fig. 2, analyte measurement device 88 further includes other electronic interfaces 84 disposed within code key port 26. Illustratively, when a combination key 24 is received within combination key port 26, electrical contacts on combination key 24 are electrically connected to electrical port 84 so that ME processor 56 can read calibration information stored within the memory device of combination key 24. The analyte measurement device 88 further includes a temperature sensor 86 electrically connected to the ME processor 56. In an exemplary embodiment, temperature sensor 86 is provided in the form of a conventional thermistor (thermistor), although the present disclosure contemplates other embodiments in which 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 the operating temperature of the analyte measuring device. In an exemplary embodiment, the memory 83 has instructions stored therein that are executable by the ME processor to disable (disable), i.e., not perform, an analysis containing a sampled analyte if the temperature signal generated by the temperature sensor 86 indicates that the temperature of the analyte measuring device 88 is less than the temperature threshold. In this case, according to instructions stored in memory 83, ME processor 56 is further operable to notify UI processor 50 that the analyte measurement device is so disabled (so disabled), and according to instructions stored in memory unit 66, UI processor 50 is operable to control display device 18 to display a message indicating that the temperature is too low to perform an analyte concentration measurement.

The electronic circuit illustrated in fig. 2 further includes a general power supply 58 that continuously supplies a power supply voltage to ASIC78, ME processor 56, UI processor 50, and storage subsystem 54 (ona connecting basis). The supply voltage is derived from one or a parallel or series combination of rechargeable or non-rechargeable batteries (batteries) 60 by a common power supply circuit 58.

A dedicated power supply 62 provides a supply voltage to wireless communication module 52 that is also derived from one or a parallel or series combination of rechargeable or non-rechargeable batteries (batteries) 60. The power supply 62 receives a control input from the user button 16, and in an exemplary embodiment, the power supply 62 may be disconnected or powered up by a user button or combination of user buttons 16 and by a control input. The power supply 62 also receives another control input from the wireless communication circuit 52, and in an exemplary 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 pointing device 72 and also to a conventional vibration device 74. The UI processor 50 is generally operable for controlling the audible indication device 72 and the vibration device 74 to produce one or more audible sounds and/or vibrations, respectively, to provide the device 12 with the ability to produce a corresponding audible and/or tactile notification (i.e., alarm or the like). In one embodiment, the audible indicating means 72 is a tone generator that generates a beep (beep) or other tone when activated, although alternatively or additionally, the audible indicating means 72 may be or include one or more other conventional audible indicating means.

In an exemplary embodiment, the UI processor 50 is also electrically connected to a conventional Infrared (IR) transceiver 65, which is configured to operate at infrared wavelengths. The UI processor 50 is configured to control the IR transceiver 65 to transmit wireless signals to off-board electronics in a conventional manner, such as a Personal Computer (PC), laptop or notebook computer, Personal Data Assistant (PDA) or other computer-based system. The ion-pad electronics include an IR transceiver, as well as other circuitry and/or software, by which the ion-pad electronics are capable of wirelessly communicating with the UI processor 50 via the IR transceiver 65. The wireless signals transmitted by the IR transceiver of such an off-board electronics are received by the UI processor 50 through the IR transceiver 65. In an exemplary embodiment, the UI processor 50 is operable to communicate with the ion-pad electronics via the IR transceiver 65 to upload information to the ion-pad electronics for subsequent analysis, e.g., measured analyte information and/or delivered drug information, and/or download control software or the like from the ion-pad electronics. In alternative embodiments, the transceiver 65 may be configured to be operable at visible or infrared wavelengths.

In general, storage subsystem 54 acts as a separate repository (repository) for data packets that are moved between UI processor 50 and wireless communications circuitry 52. Referring to fig. 3, a block diagram of some details of the memory subsystem 54 is shown, as well as electrical connections to the UI processor 50 and the wireless communication circuitry 52. In the illustrative embodiment, the storage subsystem 54 is provided in the form of a DPR processor, as described above, and FIG. 3 is described in this context, although it is understood that the storage subsystem 54 may alternatively be provided in other forms, as described above.

In the embodiment shown in FIG. 3, one of the dual ports of DPR processor 54 is a Serial Peripheral Interface (SPI) port 92 electrically connected to a serial peripheral interface port 90 of UI processor 50 through a conventional serial communication interface. The serial communication interface operates according to a serial clock signal SCLK (e.g., 125kHz) derived from the UI clock signal. The UI processor 50 uses the serial clock signal SCLK to control the 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 so that the data transfer between the two processors 50, 54 is synchronized.

The other of the two ports of DPR processor 54 is a universal asynchronous receiver/transmitter (UART) port 96 that is electrically connected to a UART port 94 of wireless communication circuit 52 through a conventional asynchronous interface. Wireless communication circuitry 52 controls the transfer of inbound and outbound data packets between UART port 94 of wireless communication circuitry 52 and UART port 96 (e.g., at 150kbps) of DPR processor 54, and occurs asynchronously with respect to the transfer of inbound and outbound data between the SPI port of UI processor 50 and the DPR processor.

The DPR processor 54 has an inbound data buffer 98 and an outbound data buffer 100, each of the inbound data buffer 98 and the outbound data buffer 100 being accessible through the SPI port and the 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. Whenever the inbound data buffer 100 is full, the DPR processor 54 deactivates the UART RTS line 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 requests data, and otherwise deactivates the UART CTS line.

When data is transmitted by the UI processor 50 to an external device or system, such as the insulin infusion pump 14, the UI processor 50 first requests the status of the outbound data buffer 100 of the DPR processor 54. If the DPR processor 54 acknowledges that its outbound data buffer 100 is "not full," the UI processor 50 transmits data, or as much data as possible, to the outbound data buffer 100 of the DPR processor 54 over the data-out (DO) line of the SPI port 90 and at a rate determined by SCLK. If instead the DPR processor 54 acknowledges that the outbound data buffer 100 is "full", the UI processor 50 waits for a time interval, then repeats the process of requesting the status of the outbound data buffer 100, and so on.

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 to the DPR processor 54 by activating the UART CTS line of the DPR processor 54. The wireless communication circuit 52 continues to periodically activate the UART CTS line as long as the outbound data buffer 100 of the DPR processor 54 is empty. If the UART CTS line is active and the outbound data buffer 100 of the DPR processor 54 is not empty, the wireless communication circuitry 52 retrieves data from the outbound data buffer 100 of the DPR processor 54 via the RX line of the UART port 96. Illustratively, the DPR processor 54 transmits the data stored in its outbound data buffer 100 to its UART port 96 in the order it was received first and then received until the outbound data buffer 100 has been emptied or until the wireless communication circuit 52 deactivates the UART CTS line. Then, the wireless communication circuit 52 merges the data retrieved from the outbound data buffer 100 of the DPR processor 54 into a wireless communication protocol structure through a data UART, and wirelessly transmits the merged data through a conventional wireless signal transmitting circuit included in the wireless communication module 52. The wireless communication circuitry 52 does not process, interpret, or change the contents of the data retrieved from the outbound data buffer 100 of the DPR processor 54, nor does it make any decisions or perform any steps based on the contents of the data. Rather, the wireless communication circuit 52 treats all of this data identically regardless of its contents, i.e., merges this data into a predefined wireless communication protocol structure, such as a Bluetooth protocol structure, and then wirelessly transmits the merged data using the predefined wireless communication protocol. Information that is communicated by UI processor 50 to storage subsystem 54 and then from storage subsystem 54 to wireless communication circuitry 52 for wireless communication to other electronic devices is referred to as outbound information or data.

Inbound wireless signals transmitted from an external device or system (e.g., the insulin infusion pump 14) are received by the wireless communication circuit 52 through conventional wireless signal receiving circuitry of the wireless communication circuit 52. The wireless communication circuit 52 first separates 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 split data, or as much 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 status of the UART RTS line.

With respect to the operation of wireless communication circuitry 52, UI processor 50 periodically and asynchronously requests the status of inbound data buffer 98 of DPR processor 54 over the data-in (DI) line of SPI port 90. The UI processor 50 continuously periodically requests the status of the inbound data buffer 98 as long as the DPR processor acknowledges that the inbound data buffer 98 is empty. If the DPR processor 54 acknowledges that the inbound data buffer 98 contains data, the UI processor 50 uses the SCLK signal to retrieve the data from the inbound data buffer 98 of the DPR processor 52 over the data-in (DI) line of the SPI port 90 and then processes the data according to its contents. The inbound and/or outbound data buffers 98, 100 of the DPR processor 54 are "checked" by the wireless communication circuit 52 and/or the UI processor 50, which "checks" generally relate to the process described in the immediately preceding paragraphs, as this term may be used hereinafter. While fig. 2 and 3 illustrate embodiments in which the interface between the UI processor 50 and the storage subsystem 54 is a synchronous interface and the interface between the wireless communication circuitry 52 and the storage subsystem 54 is an asynchronous interface, the present disclosure contemplates embodiments in which the interface between the UI processor 50 and the storage subsystem 54 is an asynchronous interface and the interface between the wireless communication circuitry 52 and the storage subsystem 54 is a synchronous interface, or in which both interfaces are asynchronous or synchronous interfaces. In any case, it should be clear that the UI processor 50 always operates independently and asynchronously with respect to the operation of the wireless communication circuit 52, and that the wireless communication circuit 52 operates independently and asynchronously with respect to the operation of the UI processor 50 and 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 associated with the wireless telemetry system of the insulin infusion pump 14. Once the electronic device 12 is powered up, followed by activation of the power supply 62 upon deactivation via the user button 16 and under certain other operating circumstances as will be described in greater detail below, the UI processor 50 attempts to establish a wireless connection with the insulin infusion pump 14. When the wireless connection between the electronic device 12 and the insulin injection pump 14 is not established, the UI processor 50 controls the display 18 to display an flashing (or fixed) icon to indicate that no wireless connection exists between the electronic device 12 and the insulin injection 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 the 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 storage subsystem 54, as described above. In such a case, the message includes the wireless connection request, for example, 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 including an acknowledgement response. If the transmitted message is received by the electronic device 12, the wireless communication circuitry 52 is operable to separate the message from the wireless communication protocol structure and place the message in the data buffer 98 of the ingress port of the storage subsystem 54, as described above. The UI processor 50 then retrieves the message from the inbound port of the storage subsystem 54, processes the message to determine whether it contains an acknowledgement response. If the message contains a confirmation response, the UI processor 50 interprets the message as indicating that a wireless connection has now been established between the electronic device 12 and the insulin injection pump 14 and controls the display device 18 to display a fixed (or flashing) icon to indicate that a wireless connection has been established between the electronic device 12 and the insulin injection pump 14. Periodically, at regular intervals, the electronics 12 transmit wireless connection status messages to the insulin infusion pump 14 in the manner described above. As long as the insulin infusion pump 14 responds as just described, the UI processor 50 controls the display 18 to display a 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 an acknowledgement response after storing such response in the memory system 52 within a predetermined period of time, the UI processor 50 controls the display 18 to display an flashing (or fixed) icon indicating that the wireless connection between the electronic device 12 and the insulin infusion pump 14 is not present or no longer present.

In the illustrated embodiment, generally, the power supply 62 turns on power (powered on) whenever the wireless communication circuit 52 is in communication with the UI processor 50 or the insulin infusion pump 14, or both the UI processor 50 and the insulin infusion pump 14, unless otherwise powered off manually by the 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 by a user pressing the plurality of user buttons 16 simultaneously or sequentially. Power supply 62 remains in the fully powered down state until the user presses, either simultaneously or sequentially, multiple user buttons 16 or different simultaneous or sequential multiple user buttons again, or if the user powers down electronic device 12 and then returns electronic device 12 to the powered up state.

When the power supply 62 is on and supplies supply voltage to the wireless communication circuit 52, the wireless communication circuit 52 transitions itself to, and out of, any of a plurality of different low power states in response to a plurality of different events, and also turns off the power supply 62 after reaching the lowest power sleep state for a predefined period of inactivity. For example, when in the fully powered "awake" state, the wireless communication circuitry 52 is operable to periodically, e.g., every 100-. As another example, each time the wireless communication circuit 52 discovers data to be sent into the outbound data buffer 100 of the storage subsystem 54, the wireless communication circuit 52 incorporates the data into a predefined wireless communication protocol structure and wirelessly transmits a corresponding signal to the insulin infusion pump 14 as described above. When a predefined time period elapses since the last discovery of data in the outbound data buffer 100, the wireless communication circuitry 52 transitions to a first low power state if the wireless communication circuitry 52 does not discover data in the outbound data buffer 100 of the storage subsystem 54. Thereafter, wireless communication circuitry 52 transitions to a subsequent lower power state when a subsequent longer period of time has elapsed since the last discovery of data in outbound data buffer 100. Generally, the number of different power states is within the full (100%) power and lowest power "deep sleep" state ranges, and may include any number of reduced power states between these two extremes. While in the lowest power "deep sleep" state, the wireless communication circuitry 52 periodically, e.g., every 400 milliseconds, wakes up to a "UART only" state in which the wireless communication circuitry 52 has sufficient power to check the status of the outbound data buffer 100 of the storage subsystem 54 over the data UART lines. If the outbound data buffer 100 of the storage subsystem 54 has data stored therein, the wireless communication circuitry 52 wakes up to a full power state to service the data. If the outbound data buffer 100 of the storage subsystem 54 does not have data stored therein, the wireless communication circuitry 52 transitions back to the lowest power "deep sleep" state. After entering the lowest power sleep state during the predefined period of inactivity, the wireless communication circuit 52 sends a control signal to the power supply 62 that causes the power supply 62 to shut down. As a further example, the wireless communication circuit 52 directly monitors the activity of the user button 16 through the debounce circuit 68, and when the wireless communication circuit 52 detects that the user presses 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 able to monitor at least the ON button of the user buttons 16. Similarly, when the wireless communication circuit 52 detects that the user presses the OFF button, the wireless communication circuit 52 transitions itself from any one 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 containing a connection termination request in the outbound data buffer 100 of the storage subsystem 54. When the wireless communication circuit 52 subsequently discovers the message in the outbound data buffer 100 of the storage subsystem 54, the wireless communication circuit 52 incorporates the message into a predefined wireless communication protocol, which is then transmitted to the insulin infusion pump 14 through its wireless communication circuit. The insulin infusion pump 14 then wirelessly sends back a signal containing a predefined connection end response to the remote electronic device 12. Processor 28 then instructs wireless communication circuitry 30 to sequentially end communication or connection with wireless communication circuitry 52 ', which wireless communication circuitry 52' may be specific to the predefined wireless communication protocol. When the wireless connection is terminated in this manner, the wireless communication circuitry 52 is operable to check the outbound data buffer 100 of the storage subsystem 54 periodically, but asynchronously with respect to the operation of the UI processor. If no data is present in the outbound data buffer 100, the wireless communication circuitry 52 then enters a lower power sleep state or mode, as described above. However, if the wireless communication circuit 52 finds data in the outbound data buffer 100 of the storage 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 programmable number of attempts and/or elapsed time, no communication 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 storage subsystem 54. Alternatively, the UI processor 50 may empty the outbound data buffer 100 if it determines that data is present in the outbound data buffer 100 after some period of time has elapsed since the wireless communication message was stored in the outbound data buffer 100, or after determining that the wireless connection between the remote electronic device 12 and the insulin injection pump 14 is no longer present based on not receiving an acknowledgement from the insulin injection pump 14. In any event, the outbound data buffer 100 accompanying the storage subsystem 54 is empty, and as described above, the wireless communication circuitry 52 then enters a lower power sleep state or mode.

If the wireless connection between the remote electronic device 12 and the insulin infusion pump 14 is lost, in one embodiment, the wireless communication circuitry 52 is operable to shut down its wireless transmission circuitry and transition to a low power state if data is not found in the outbound data buffer 100 of the storage subsystem 54 since the last data found in the outbound data buffer 100. Because the wireless connection is lost, the UI processor will no longer receive an acknowledgement from the insulin infusion pump 14 and will therefore no longer store the message in the outbound data buffer 100 of the storage subsystem 54. However, when the wireless connection is lost, a message, or at least a portion of a message, may be present within the outbound data buffer 100. In this case, the wireless connection with the insulin infusion pump 14 cannot be established after a predefined or programmable number of attempts and/or after a predefined or programmable time has elapsed, the wireless communication circuit 52 illustratively empties the outbound data buffer 100 of the storage subsystem 54. Alternatively, the UI processor 50 may empty the outbound data buffer 100 if it determines that data is present in the outbound data buffer 100 after some time period has elapsed since the last message was stored in the outbound data buffer 100, some time period has elapsed, or after determining that the wireless connection between the devices 12 and 14 is no longer present based on no acknowledgement received from the insulin infusion pump 14, some time period has elapsed. In any event, the outbound data buffer 100 accompanying the storage subsystem 54 is empty, and as described above, the wireless communication circuitry 52 then enters a lower power sleep state or mode.

In one exemplary embodiment, the UI processor 50 and the processor 28 of the insulin injection pump 14 may use predetermined messages and internal timers to control the determination by each of the presence or absence of a wireless connection between the remote electronic device 50 and the insulin injection pump 14. For example, the UI processor 50 is operable to transmit messages to the outbound data buffer 100 of the storage subsystem 54 and reset the internal timer circuit periodically, e.g., every 100 milliseconds, during an exchange of information between the electronic device 12 and the insulin infusion pump 14. The wireless communication circuit 52 asynchronously retrieves the message from the outbound data buffer 100 of the storage subsystem 54 and sends the message to the insulin infusion pump 14 as described above. The insulin infusion pump 14 immediately sends a message containing an acknowledgement back to the electronic device 12 in response to receipt of the message. The message sent by the insulin infusion pump 14 is received by the wireless communication circuit 52 and unpacked (unpacked) according to the wireless communication protocol and then stored by the wireless communication circuit 52 in the inbound data buffer 98 of the storage subsystem 54. The UI processor 50 then retrieves the message from the inbound data buffer 98 of the storage 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 message is transmitted to the outbound data buffer 100 of the storage subsystem 54, the UI processor 50 resets its internal timer circuitry when the next message is transmitted to the storage subsystem 54. However, if an acknowledgement is not received by the UI processor 50 before the next scheduled message is transferred to the outbound data buffer 100 of the storage subsystem 54, the UI processor 50 transfers the message to the outbound data buffer 100 of the storage subsystem 54 without resetting its internal timer circuitry. If no acknowledgement is received by the UI processor 50 within a predefined or programmable time period, e.g., 1-2 minutes, the internal timer circuit of the UI processor 50 times out and the UI processor 50 stops transmitting messages to the outbound data buffer 100 of the storage subsystem 54. The insulin infusion pump 14, in this embodiment, stops sending back an acknowledgement to the remote electronic device 12 after a predefined or programmable period of time, such as 2 minutes, has elapsed without receiving the message sent by the electronic device 12.

Illustratively, as described above, the UI processor 50 may be operable to stop storing messages in the outbound data buffer 100 of the storage subsystem 54 upon detecting insertion of a sample carrier 22 into the carrier port 20. After a predefined period of time, wherein wireless communication circuitry 52 does not thereafter find such messages in outbound data buffer 100 of storage subsystem 54, wireless communication circuitry 52 begins transitioning to a lower power state as described above. After the analyte measurement is complete, when UI processor 50 subsequently resumes storing messages in outbound data buffer 100 of storage subsystem 54, wireless communication circuitry 52 wakes up to full power to service it. When the first message is stored in outbound data buffer 100 of storage subsystem 54 after the analyte measurement is completed, if wireless communication circuitry 52 has just entered the lowest power "deep sleep" state, this may take at least one wake-up time period, e.g., as many as 400 milliseconds.

The wireless communication circuit 52 is typically in one of the lower power sleep states or modes unless the remote electronic device 12 and the insulin infusion pump 14 are in information communication. Upon detecting insertion of the sample carrier 22 into the carrier port 20, the electronics 12 perform an analyte determination test as described above. Generally, the electronics 12 do not wirelessly communicate with the insulin infusion pump 14 during the analyte determination test, and typically, the wireless communication circuit 52 is therefore in one of the lower power sleep states when insertion of the sample carrier 22 into the carrier port 20 is detected. Wireless communication circuit 52 thus typically enters a continuous lower power sleep state upon detection of insertion of a sample carrier 22 into carrier port 20 because UI processor 50 stops storing messages in outbound data buffer 100 of storage subsystem 54 when insertion of a sample carrier 22 into carrier port 20 is detected.

As shown and described above with respect to fig. 1-3, when the electronic device 12 includes an analyte measurement device 88, in alternative embodiments, such an analyte measurement device may be omitted. In any case, the electronics 12 and the insulin injection pump 14 may be schematically paired according to a pairing process that establishes secure communication between the electronics 12 and the insulin injection pump 14. Illustratively, this process may be performed to initially establish secure wireless communication between the electronic device 12 and a particular insulin injection pump 14, and then proceed again if the electronic device 12 is to be paired with a different insulin injection pump 14, or vice versa. In one illustrative embodiment, the electronic device 12 may be paired with only a single insulin infusion pump 14 at a time, although the present disclosure contemplates other embodiments in which the electronic device 12 may be paired with any number of medical devices 14 and/or other electronic devices in general, and/or in which the medical device 14 may be paired with any number of electronic devices 12 or other medical devices. In any event, further details regarding an exemplary pairing and authentication process are provided in co-pending (co-pending) application No. ____, entitled "METHOD DFOR PAIRING AND AUTONTENING ONE OR MORE MEDICAL DEVICES ANDONE OR MORE REMOTE ELECTRONIC DEVICES", having attorney docket No. 5727 and 205470, the disclosure of which is incorporated herein by reference.

Referring to FIG. 4, one exemplary embodiment of the exterior of the remote electronics 12 is illustrated. In the illustrative embodiment, remote electronic device 12 includes a housing 120, wherein display 18 and user buttons 26 are mounted to housing 120. In the embodiment shown in FIG. 5, user buttons 26 include an ENTER key 122, an UP key 124, a down key 126, a left key 128, and a right key 130, wherein keys 124, 126, 128, and 130 are configured to provide UP, down, left, and right navigation, respectively, through an application screen (screen) displayed on display device 18. The user buttons 26 further include two so-called "soft" keys 132 and 134 that can be programmed to provide the desired function, and an on/off button 136 and a display backlight activation button 138. In the illustrated embodiment, the carrier port 20 is positioned substantially centrally on one end of the device 12 such that the opening of the carrier port 20 is positioned in line with the up and down buttons 120 and 124, although the present disclosure contemplates embodiments in which the carrier port 20 may alternatively be positioned on the device 12.

Referring to FIG. 5, a flow diagram of one illustrative embodiment of a process 150 is shown that is performed in the remote electronic device 12 to unlock the user button 26 upon detecting insertion of the sample carrier 22 into the carrier port 20. Illustratively, this process is stored in the memory unit 66 of the remote electronic device 12 in the form of instructions that the UI processor 50 can execute to implement the process 150. The process 150 begins at step 152, wherein the UI processor 50 is operable to monitor the electrical interface 76 of the carrier port 20. Thereafter, at step 154, the UI processor 50 is operable to determine whether a sample carrier 22 has been inserted into the carrier port 20. If not, step 154 jumps back to the beginning of step 152.

In one embodiment, the UI processor 50 is operable to monitor the electrical interface 76 through the ME processor 56 and the ASIC78 at steps 152 and 154. As described above, the switch 80 of the ASIC is operable to provide a strip insertion signal to the ME processor 56 based on detecting that the electrical interface of the sample carrier 22 is engaged with the electrical interface 76 when the sample carrier 22 is inserted into the carrier port 20 of the remote electronic device 12. The ME processor 56, in turn, is responsive to a strip insert signal generated by the switch 80 of the ASIC78 to notify the UI processor 50 of the event, for example, via an event interrupt line. In some alternative embodiments, the UI processor 50 may be configured to directly monitor the electrical interface 76, and in other alternative embodiments, the UI processor 50 may be configured to determine whether the sample carrier 22 has been inserted into the carrier port 20 by monitoring one or more conventional position or proximity sensors or the like.

From the "YES" branch of step 154, process 150 advances to step 156 where UI processor 50 is operable to determine whether remote electronic device 12 is currently powered down. Illustratively, the UI processor 50 is operable to perform step 156 by monitoring internal operating state indicators, although alternatively, the UI processor 50 may be operable to determine the operating state of the remote electronic device at step 156 according to other conventional techniques. In any case, if the UI processor 50 determines at step 156 that the remote electronic device 12 is powered down, the UI processor 50 is operable to power up the remote electronic device in a conventional manner. From the "NO" branch of step 156 and from step 158, process 50 proceeds to step 160, wherein UI processor 50 is operable to unlock and disable user button 26. In one embodiment, the UI processor is operable to unlock the user buttons 26 at step 160 regardless of whether they were previously manually locked by the user. Alternatively, at step 160, the UI processor 50 is operable to unlock the user button 26 only if the user button 26 has been previously manually locked by the user. In another case, at step 160, the UI processor 50 is operable to disable the user button 26 so that any successive presses of the user button 26 will not be acknowledged or acted upon by the UI processor 60 (activated up).

Process 150 advances from step 160 to step 162 where UI processor 50 is operable to determine whether the analyte measurement test is complete. Illustratively, the UI processor 50 is operable to determine that the analyte measurement test is complete when the ME processor 56 provides the measured glucose value to the UI processor 50 for display on the display unit 18, and/or when the ME processor 56 otherwise signals the UI processor 50 through a ready line or event interrupt line to notify that the analyte measurement test is complete, step 162. For purposes of process 150, UI processor 50 may be further operable to determine that the analyte measurement test is complete if the user removes sample carrier 22 from carrier port 20 before the analyte measurement test is complete, at step 162. In such a case, the UI processor 50 is operable to determine whether the sample carrier 22 has been removed from the carrier port 20 prior to completion of the analyte measurement test using any of the techniques just described to determine whether the sample carrier 22 has been inserted into the carrier port 20. In any case, if UI processor 50 determines at step 162 that the analyte measurement test is not complete, processor 150 proceeds to step 164 where at step 164 UI processor 50 is operable to maintain disabling user buttons 26, i.e., continue to ignore the user pressing any of user buttons 26.

If, at step 162, UI processor 50 determines that the analyte measurement test is complete, process 150 proceeds to step 166, and at step 166, UI processor 50 is operable to validate user buttons 26 so that when remote electronic device 12 is powered up, the user presses any of user buttons 26 with its normal effect. Process 150 ends after step 166. Thus, following completion of the analyte measurement test following the detection of insertion of the sample carrier 22 into the sample port 20, as defined herein, the process 150 results in unlocking the user button 26.

Referring now to fig. 6A-6C, a flow diagram of one illustrative embodiment of a bolus recommendation process 200 executed by the remote electronic device 12 is shown. In the context of the flow charts of fig. 6A-6C, the medical device 14 is illustratively embodied in the form of an insulin infusion pump, and will be described as such throughout the entire illustration of the process 200. However, it will be understood that the present disclosure contemplates alternative embodiments in which medical device 14 is or includes other conventional medical devices.

Illustratively, the process 200 is stored in the memory device 66 of the UI processor 50 in the form of instructions that the UI processor 50 can execute to perform the bolus recommendation process 200. The process 200 assumes that the remote electronic device 12 is powered up and that the current UI processor 50 is controlling the display device 18 to display a main menu 202, which is typically displayed upon power up of the remote electronic device 12. Illustratively, the main menu 202 provides a number of selectable options including, but not limited to, a Blood Glucose (BG) test, a bolus recommendation process, a pump remote control process 204, a "my data" process 206, and a setup or device setup process.

The pump remote control process 204 provides a menu-drive (menu-drive) process by which the remote electronics 12 can control the operation of the insulin infusion pump 14. An exemplary embodiment of such a process is described in co-pending U.S. patent application serial No. ____, having attorney docket No. 5727-205462, which is hereby incorporated by reference.

In an exemplary embodiment, the "My data" process 206 available through the main menu 202 provides for the observation and editing of daily records (e.g., specific BG test records and pump history records), and also provides for the analysis of records during daily and/or weekly time periods. Illustratively, the UI processor 50 stores up to 1000 daily records in the memory 66, while up to 250 records may be checked using the remote electronic device. Daily records may also be downloaded to a PC or other computer and, using compatible software, all records may be observed and/or analyzed. Each daily record may contain data and time, BG test results, mealtime events, carbohydrate values, health events, bolus type, and bolus quantity. The UI processor can filter and/or sort data from these data records.

The "my data" process may also provide for analysis of data records in a manner defined by time slots, both daily and weekly averages, and standard deviations, and provide for trend analysis of any of the collected data. Standard day and standard week tables or charts may be generated to observe averages and/or trends. Different chart and table options are available for presenting the data in the desired format.

Referring again to fig. 6A, the BG test procedure that may be selected from main menu 202 begins at step 208, and in step 208, UI processor 50 determines whether the user has selected the BG test procedure from main menu 202. If not, the "NO" branch of step 208 returns to the beginning of step 208. If, at step 208, UI processor 50 determines that the user has selected the BG process from main menu 202, process 200 proceeds to step 210 where UI processor 50 controls display device 18 to prompt the user to perform a BG test at step 210. In one embodiment, UI processor 50 controls display device 18 to visually guide the user through a blood glucose measurement sequence in which the user inserts carrier 20 into glucose measurement apparatus 20 of remote electronic device 12 and deposits a blood sample on carrier 22, after which blood glucose meter 88 analyzes the blood sample in a conventional manner to generate a Blood Glucose (BG) value corresponding to the glucose concentration in the deposited blood sample. The blood glucose value, BG, is provided to the UI processor 50 by a blood glucose meter 88 on board the remote electronic device 12, as described above. From step 210, process 300 advances to step 212 where, illustratively, UI processor 50 is operable to control display device 18 to display BG values along with an on-screen color indicator based on BG values associated with one or more reference BG values.

In an exemplary embodiment, the BG value display screen provides a bolus option that the user can select to enter the bolus recommendation process directly from the BG measurement process. Accordingly, after step 210, the UI processor 50 is operable to determine whether the user has selected the bolus key from the BG measurement screen at step 213. If not, the process 200 proceeds to step 214 where the user has pressed an additional key or has selected an additional option, or alternatively has done nothing and caused the BG values screen to time out, at step 214. Generally, the UI processor 50 is operable to store BG values along with measurement time and data information in the memory unit 66. Illustratively, the user may also store additional information along with the time and data stamp BG values, examples of which include, but are not limited to, time of BG measurement, bedtime and/or wake time information related to food, amount of carbohydrates taken at the time of BG measurement, health information such as exercise (excerise) level, illness or stress, and the like. In any case, if at step 213 the UI processor 50 determines that the user has selected the bolus key option from the BG value display screen, the process 200 proceeds to step 218.

From the main menu 202, the user may alternatively select a bolus recommendation process, and accordingly, at step 216, the UI processor 50 may be operable to determine whether the user has selected a bolus recommendation process. If not, the "NO" branch step 216 branches back to the beginning of step 216, and otherwise, the process 200 proceeds to step 218, where in step 218 the UI processor 50 is operable to calculate an effective insulin value, AI, corresponding to the amount of currently effective insulin ingested by the user. Thereafter, at step 220, UI processor 50 is used to calculate a first bolus value, B1, illustratively based on the most recent blood glucose value and also based on pump operation history data. In an embodiment where blood glucose has not been measured recently, B1 ═ 0. At step 220, the UI processor 50 is further operable to calculate a second bolus value, B2, illustratively based on a CARB value input by the user corresponding to carbohydrates that the user has ingested or is scheduled to ingest. Further at step 220, the UI processor 50 is operable to calculate a third bolus value, B3, illustratively based on health information entered by the user corresponding to the user's current health condition. As an illustrative example, the health condition of the user may correspond to exercise, stress, illness, or the like. Further illustrative details concerning the techniques for calculating A1 and B1-B3 are provided in co-pending application No. ____, PCT patent application with attorney docket No. 5727 and 205464, the disclosure of which is incorporated herein by reference.

From step 220, the process 200 proceeds to step 222, where the UI processor 50 is operable to calculate a total recommended bolus, TRB, as the sum of B1-B3 at step 222. Thereafter, at step 224, the UI processor 50 is operable for controlling the display unit 18 to display a bolus recommendation screen showing the effective insulin value, AI, any recent blood glucose values, BG color indicator as described with respect to step 212, B1-B3, TRB and bolus types, such as Standard (STD), Multiwave (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 performed within a predetermined time period before performing step 224, UI processor 50 is operable to display a bolus recommendation screen showing the measured blood glucose value, BG, at step 224. Otherwise, illustratively, the UI processor 50 may be operable to display a "bG test" on the screen at step 224, where the BG value will be shown if the current BG value is available. From step 224, the process 200 proceeds to sub-process B. In summary, any value measured by or entered into the remote electronic device 12 or medical device 14 by the remote electronic device 12 or medical device 14 may be schematically displayed when a screen including such a value is displayed if the value is measured or entered within a predefined time period from when the value is measured or entered.

Referring now to FIG. 7, a diagram of an exemplary embodiment of a bolus recommendation display screen 320 generated by the process 200 of FIG. 6A at a point just prior to the performance of sub-process B, i.e., after step 224. In the illustrative example, a bolus recommendation tab 322 appears at the top of the screen 320 to indicate that the user is performing the bolus recommendation feature. A blood drop symbol appears next to the displayed blood glucose value 324, e.g., 120mg/dl, and a colored bar 326, which provides a visual indication of the blood glucose value 324 relative to an acceptable blood glucose range and/or a plurality of blood glucose limits, is placed next to the blood glucose value 324. An effective insulin value 328, e.g., -2U, is placed below the blood glucose value 324 and a bolus value 330, corresponding to bolus value B1, is displayed adjacent to the effective insulin value 328.

The apple symbol is used to identify the carbohydrate field 332 and the heart symbol is used to identify the health field 334. The bolus type indicator 338 appears below the health field 334 and an overall recommended bolus value 3336, e.g., 3U, is displayed adjacent to the bolus indicator 338. A bolus type 340, for example, standard, is displayed below the total recommended bolus 336. At the bottom of the screen, between cancel and confirm (confirmation) inputs, a bluetooth symbol 342 is provided to indicate the connection status of the wireless communication link with the insulin infusion pump 14, e.g., fixed when a wireless connection exists and flashing otherwise.

Referring now to fig. 6B and 6C, a sub-process B identified after step 224 of fig. 6A is shown, wherein sub-process B forms part of the bolus recommendation process. It will be observed that sub-process B includes multiple processes, each of which may be independently accessed any number of times. For example, sub-process B includes process 230 for measuring a blood glucose value and calculating a bolus amount B1 based at least in part on BG measurements. In the illustrative embodiment, the process 230 begins at step 232, and at step 232 the UI processor 50 is operable to determine whether a strip insertion, e.g., a blood glucose strip, into the carrier port 20 of the remote electronic device 12 has been detected or whether the user has selected the bG test field (field) if this field is displayed in place of a blood glucose value as described above. If not, process 230 jumps back to the beginning of step 232. If, at step 232, the UI processor 50 determines that a strip insertion or user selection of a bG test field has been detected, then the process 400 proceeds to step 234, at step 234, the UI processor 50 is operable to perform a blood glucose test, for example, by prompting and instructing the user through a BG test as described above, which returns a measured blood glucose value, BG. Thereafter, the UI processor 50 is operable to calculate all bolus values, B1-B3, at step 236. In an exemplary embodiment, the measured and/or user-entered values may act on one or more of the bolus values B1-B3, and accordingly, the UI processor 50 is operable to recalculate each bolus value, B1-B3, in sub-process B after each BG measurement, carbohydrate input (entry), or health input. In any case, after step 236, the UI processor 50 is operable to calculate the total recommended bolus value, TRB, as the sum of B1 and two other bolus values (B2 and B3) at step 238. Thereafter, at step 240, the UI processor 50 is operable to update the bolus recommendation screen with BG, BG color indicator as described above, B1-B3, and TRB. From step 240, process 200 jumps back to the beginning of sub-process B.

The sub-process B of fig. 6B further includes a process 250 for inputting a carbohydrate value for the food or snack that has just been ingested or is scheduled to be ingested, and determining a bolus value based on the input carbohydrate value. The process 250 begins at step 252 and at step 252 the UI processor 50 is operable to determine whether the user has selected the CARB field of the displayed bolus recommendation screen, e.g., item 332 shown in fig. 7. If not, the process 250 jumps back to the beginning of step 252. If the user selection of the CARBS field is detected at step 252, the process 250 advances to step 254 where the processor 50 is operable to determine whether a just ingested or projected ingested carbohydrate value associated with the food or snack has been entered by the user at step 254. If not, the process 250 jumps back to the beginning of step 254. In one embodiment, at step 254, the user may manually enter into the remote electronic device 12, e.g., via the user button 16, a value for carbohydrate corresponding to the carbohydrate content of the food or snack that has just been ingested or is scheduled to be ingested. If, at step 254, the user has entered the value of carbohydrate detected by the UI processor 50, the process 250 proceeds to step 256, and at step 256, the UI processor 50 is operable to again calculate each of the bolus values B1-B3. Thereafter, at step 258, the UI processor 50 is operable to calculate a total recommended bolus, TRB, as the sum of B1-B3. Thereafter, at step 260, the UI processor is operable to control the display device 18 to update the bolus recommendation display screen to include the value of carbohydrate provided by the user at step 224, to display the calculated bolus value B1-B3 determined at step 256, and to display the updated total recommended bolus value, TRB. Process 250 jumps from step 260 back to the beginning of sub-process B.

Sub-process B of FIG. 6B further includes a process 270 for inputting health information and determining a bolus value based on the input health information. Process 270 begins at step 272 where UI processor 50 is operable to determine whether the user has selected a health field of a displayed bolus recommendation screen, e.g., item 334 shown in fig. 7. If not, process 270 jumps back to the beginning of step 272. If the user selection of a health field is detected at step 272, the process 270 proceeds to step 274, and at step 274, the processor 50 is operable to determine whether a health value has been entered by the user. If not, the processor 270 jumps back to the beginning of step 274. In one embodiment, when the user manually selects the health event field displayed on the display device 18 via the UI processor 50 at step 272, the UI processor 50 is operable to control the display device 18 to display a plurality of health event selections. The health event selections may include, for example, without limitation, no input, one or more exercise options, a disease option, and an unhealthy 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 setup process so that when the user manually selects one of the health event options at step 274, the UI processor 50 is operable to recalculate the bolus values B1-B3 at a subsequent step 276. Thereafter, at step 278, the UI processor 50 is operable to calculate a total recommended bolus value, TRB, for example, as the sum of the individual bolus values B1-B3. From step 278, the process 270 advances to step 280, where the UI processor 50 is operable for controlling the display device 18 to update the bolus recommendation display to include the health event, the bolus value B1-B3, and the total recommended bolus value TRB at step 280. The process 270 jumps from step 270 back to the beginning of sub-process B.

The sub-process B of FIG. 6B further includes a process 290 that allows the user to manually modify the total recommended bolus value, TRB. The process 290 begins at step 292 where the UI processor 50 is operable to determine whether the user has selected the TRB field of the displayed bolus recommendation screen, e.g., item 336 shown in fig. 7, at step 292. If not, process 290 jumps back to the beginning of step 292. If a user selection of the TRB field is detected at step 292, the process 290 proceeds to step 294 where the processor 50 is operable to determine whether the user has modified the TRB value at step 294. If not, process 290 jumps back to the beginning of step 294. If the processor 50 determines that the user has modified the TRB value at step 294, the process 290 advances to step 296 where the UI processor 50 is operable to control the display device 18 to update the bolus recommendation display to include the modified total recommended bolus value, TRB at step 296. The process 290 jumps from step 296 back to the beginning of sub-process B.

Referring now to fig. 6C, sub-process B further includes a process 300 for selecting a bolus type. Process 300 begins at step 302 where UI processor 50 is operable to determine whether the user has selected a bolus type field of a displayed bolus recommendation screen, e.g., item 340 shown in fig. 7, at step 302. If not, the process 300 jumps back to the beginning of step 302. If a user selection of a bolus type field has been detected at step 302, process 300 proceeds to step 304 where, illustratively, processor 50 is operable to display the available bolus type on a bolus recommendation screen at step 304. In one illustrative embodiment, the types of bolus that may be used may include, but are not limited to, standard bolus (STD), Multiple Wave (MW) bolus, Extended (EXT) bolus, manually programmable bolus by insulin pen (insulin pen) or syringe (syring) or the like, and manually supplied (administered) bolus. If a wireless connection has been established or can be established between the remote electronic devices 12 and 14, illustratively, the available bolus types may include all bolus types that the pump 14 is currently capable of delivering. In other cases where wireless communication cannot be established, and cannot currently be established, when a bolus recommendation procedure is first entered, illustratively, the available bolus types may include bolus types that are only manually programmable and/or that are manually deliverable via an insulin pen/syringe. Those of ordinary skill in the art will recognize that more, fewer, and/or different bolus types made available to the user at step 304, as well as any such alternative or additional bolus types, are contemplated by the present disclosure.

After step 304, process 300 proceeds to step 306 where UI processor 50 is operable to determine whether the user has selected a bolus type at step 306. If not, the process 300 jumps back to step 304. If processor 50 determines in step 306 that the user has selected a bolus type, process 300 proceeds to step 306 where UI processor 50 is operable to control display device 18 to update the bolus recommendation display to include the selected bolus type in step 306. Process 300 jumps from step 300 back to the beginning of sub-process B.

Illustratively, the UI processor 50 may be configured to provide an extended editing screen in any situation, such as, for example, but not limited to, the processes 250 and 270 of FIG. 6B, in which a user is requested to enter information into the remote electronic device 12 or in which a user enters information into the remote electronic device according to a device setup process. Referring to fig. 8, which shows a flow diagram of one illustrative embodiment of a process 350 by which UI processor 50 may control display device 18 to provide such an extended editing screen. Illustratively, the process 350 is stored within the storage unit 66 in the form of instructions that can be executed by the UI processor 50 to implement the process 350. It will be appreciated that the process 350 may alternatively or additionally be stored in the memory 29 of the processor 28 of the insulin infusion pump 14 in the form of instructions that are executable by the processor 28 to provide an expanded editing screen when data, commands or the like are entered into the insulin infusion pump 14.

The process 350 begins at step 352 where the UI processor 50 determines whether an on-screen item has been selected for editing. Illustratively, the user selects an on-screen item for editing, typically by navigating to the desired on-screen item using the up, down, left and right buttons 124, 126, 128 and 130, respectively, and then selecting the desired on-screen item by pressing the enter button 122. When an on-screen item is so selected, process 350 proceeds to step 354 where UI processor 50 is operable to control display device 18 to enlarge the selected on-screen item to appear in larger text and/or numbers than the previous selection at step 354. Optionally, at step 356, the UI processor 50 may be further operable to determine a boundary, e.g., an edit box or other polygon, around or near the magnified item. Thereafter, at step 358, the UI processor 50 is operable to determine whether a value within the enlarged item has been selected, for example, by the user pressing the enter button 122. If not, process 350 jumps back to step 354 and, at step 354, UI processor 50 continues to control display device 18 to zoom in on the selected on-screen item. If instead, at step 358, the UI processor 50 determines that a value for an enlarged item has been selected, the process 350 proceeds to step 360, at step 360 the UI processor 50 is operable to reduce the enlarged on-screen item to a normal size, e.g., the size of the item selected prior to step 354. Following step 360, process 350 ends.

9A-9H, a graphical representation of one illustrative embodiment of a bolus recommendation display screen 380 illustrating the use of an expanded user editing area on display device 18 according to process 350 of FIG. 8 is shown. FIG. 9A schematically shows an example state of a display screen 380 at the beginning of step 252 in process 250 shown in FIG. 6B. Here, the user has navigated to the carbohydrate field 382, as indicated by the thick line bounding the carbohydrate field 382, and the carbohydrate field 382 is monitored by the UI processor 50 to determine whether the user selected the carbohydrate field 382 for editing. The rough outline for the carbohydrate fields in fig. 9A may schematically represent the actual rough outline of the CARBS data item or field 382 on the screen, or may alternatively represent some other conventional highlighting technique for attracting the user's attention to the CARBS item or field. In any event, FIG. 9B shows an example state of the display screen 380 when the user selects CARB item or field 382, for example, by pressing enter button 122 when CARBS item or field 282 is highlighted.

When the user selects a CARB item or field, such as illustrated in fig. 9B, UI processor 50 controls display device 18 to generate an enlarged edit region 386 that enlarges the selected CARB item or field 382 relative to other portions of display device 18 while also providing an enlarged field that the user can edit. In one embodiment, as shown in fig. 9A-9H, schematically, the units of measurement are accompanied by an expanded edit field, e.g., carbohydrates are illustrated in units of grams. In the illustrative embodiment, enlarged edit area 386 is surrounded by a border in the form of, for example, a solid color rectangle. When the user presses the up button 124, as indicated by the upward arrow within the enlarged editing area 386, the UI processor 50 modifies the display device 18 to generate 0 along the upward and downward arrows within the enlarged editing area 386, as shown in fig. 9C. The user may then select up button 124 or down button 126 to increase and decrease the displayed value. Illustratively, when the up button 124 or the down button 126 is pressed and held, the UI processor may execute a fast scroll algorithm that allows the CARBS value to change rapidly and/or increase by an incremental value (e.g., an entire 5, 10, or other number). As shown in fig. 9D, the user has repeatedly pressed the up button 124 to indicate that the food or snack includes 16 grams of carbohydrate. The user then presses enter button 122 to enter the 16 gram selection in the CARBS field, and when this is done, UI processor 50 is operable for controlling display device 18 to reduce the enlarged on-screen CARBS field 389 back to its default size shown in FIG. 9E.

As also shown in FIG. 9E, based on the entered CARBS value, the processor 50 has calculated the bolus, (1.6U) and has updated the bolus recommendation display 380 in accordance with steps 256 and 260 of the process 250 of FIG. 6B. In this example, B2 is calculated according to the equation B2 CARBS CR, where CR is the carbohydrate ratio value that the user has defined as 1U/10g within the setting screen, so that B2 is 1.6. The UI processor 50 has also updated the total recommended bolus field to automatically increase the B1 bolus value and the B2 bolus value for a total of 4.6U of insulin.

As further shown in fig. 9E, when the user enters a carbohydrate value into the CARBS field 382, the UI processor 50 automatically prompts the user to enter health event information, as represented in fig. 9E by the thick outline of the health field 384 surrounding the example bolus recommendation screen 380. The rough outline may schematically represent the actual rough outline of the on-screen health item or field 384, or may alternatively represent some other conventional highlighting technique for attracting the user's attention to the health item or field 384. In any case, FIG. 9F represents an example state of the display screen 380 when the user selects the health item or field 384, for example, by pressing the enter button 122 when the health item or field 384 is highlighted.

When the user selects a health item or data field, the UI processor 50 controls the display device 18 to generate an enlarged edit area 388 that enlarges the selected health item or data field 384 while also providing a plurality of selectable health options. In the illustrative embodiment, the selectable fitness options include no input, workout 1, workout 2, stress, and illness, although this list may alternatively include more, fewer, and/or different fitness-related options. Illustratively, the no-input item is the default item in the health list 388, and is therefore highlighted, as represented by the outline surrounding the no-input. The user may navigate the list displayed within the enlarged editing area 388 using the up and down buttons 124, 126, respectively, and when the desired health item is highlighted, the user may select one of the desired health items on the list by pressing the enter button 122. In the example shown in fig. 9G and 9H, the user has chosen and selected pressure as a health item within the enlarged edit area 388. When the user presses the enter button 122 to enter a pressure item into the health field, the UI processor 50 is operable, as shown in fig. 9H, to control the display device 18 to reduce the enlarged on-screen item 384 back to its default size.

In one embodiment, the UI processor 50 may be operable to deactivate the confirmation function shown in FIGS. 9A-9H at the lower right-hand corner of the screen 380. In this embodiment, a bolus cannot be confirmed when the user is editing certain functions of the bolus recommendation process. In an alternative embodiment, the UI processor 50 may control the display 18 to confirm that the function is removed, i.e. not visible, during the illustrated editing process. In other alternative embodiments, the confirmation function may be run in its entirety during the editing process shown.

As also shown in FIG. 9H, based on the entered health item, the UI processor 50 has calculated a bolus, B3, and has updated the bolus recommendation display 380 in accordance with steps 276 and 280 of the process 270 of FIG. 6B. In this example, B3 is calculated according to the equation B3 ═ Stress% (B1+ B2), where Stress% is the percentage value that the user has defined as 5% in the setting screen, so that B3 ═ 0.23 ═ 0.2. The UI processor 50 also updates the total recommended bolus field to automatically increase the B1 bolus value and the B2 bolus value and the B3 bolus value for a total of 4.8U of insulin, per step 278 of the process 270 of fig. 6B.

Illustratively, if certain measured and/or user-entered parameters fall outside of one or more ranges or limits, the UI processor 50 is programmed to automatically notify the user through the audible indicator 72 and/or vibration device 74 and display a message to the user through the display device 18 to measure blood glucose. Referring now to FIG. 10, a flow diagram of one exemplary embodiment of one such process 400 for automatically notifying and instructing a user to measure blood glucose is shown. Illustratively, the process 400 is stored in the memory unit 66 in the form of instructions executable by the UI processor 50 to automatically notify and instruct the user to measure blood glucose. The process 400 begins at step 402 and at step 402 the UI processor 50 is operable to determine whether a BG measurement has just been made by the glucose meter 88 on the plate. Typically, when the ME processor provides the measured blood glucose value to the UI processor 50 via the TXD line, the UI processor 50 will be notified when the ME processor 56 has made a BG measurement. If the UI processor 50 determines at step 402 that a BG measurement has not been taken, the process 400 jumps back to the beginning of step 402. Otherwise, process 400 proceeds to step 404 where UI processor 50 is operable to determine whether the BG value (BG) just measured is greater than a high BG value, BG_H. Schematically, BG_HMay be a hyperglycemic (hyperglycemic) threshold, although BG_HAlternatively, may be a different high blood glucose value.

If, at step 404, UI processor 50 determines that the BG measurement just taken is greater than the BG_HThe process 400 proceeds to step 406 where the UI processor 50 is operable to reset and start an internal timer at step 406. Thereafter, at step 408, the UI processor 50 is operable for determining whether the count value of the internal timer has reached a time value, T1, e.g., greater than or equal to T1. In one embodiment, the time value T1 may be selected by a user in a settings menu. Alternatively, the time value T1 may be set by a health care (health care) professional or may be set during manufacture and in either case not modifiable by the user. If, at step 408, the UI processor 50 determines that the count value of the timer is not greater than or equal to T1, the process 400 jumps back to the beginning of step 408. When the count value of the timer reaches T1, the process 400 proceeds to step 410, and at step 410, the UI processor 50 is operable to notify the user with an audible and/or vibratory signal or pattern of signals (pattern of signals). Thereafter, at step 412, UI processor 50 is operable to control display device 18 to display instructions to the user to re-measure blood glucose. From step 412, and from the "NO" branch of step 404, the process 400 ends.

Referring now to FIG. 11, a flow diagram of another illustrative embodiment of a process 420 for automatically notifying and instructing a user to measure blood glucose is shown. Illustratively, the process 420 is stored in the memory unit 66 in the form of instructions that are executable by the UI processor 50 to automatically notify and instruct the user to measure blood glucose. Process 420 begins at step 422, and at step 422 UI processor 50 is operable to determine (e.g., as described above) whether a BG measurement has just been made by glucose meter 88 on the plate. If the UI processor 50 determines at step 422 that a BG measurement has not been taken, the process 420 jumps back to the beginning of step 422. Otherwise, process 420 proceeds to step 424, where UI processing is performed at step 424The device 50 is operable to determine whether the just measured BG value (BG) is less than a Low BG value, BG_L. Schematically, BG_LMay be a hyperglycemic (hyperglycemic) threshold, although BG_LAlternatively may be a different low blood glucose value.

If, at step 424, UI processor 50 determines that the BG measurement just taken is less than BG_LProcess 420 advances to step 426 where UI processor 50 is operable to reset and start an internal timer at step 426. Thereafter, at step 428, the UI processor 50 is operable to determine whether the count value of the internal timer has reached, e.g., is greater than or equal to, the time value T2. In one embodiment, the time value T2 may be selected by a user in a settings menu. Alternatively, the time value T2 is set by the health care professional or may be set during manufacture and, in either case, cannot be modified by the user. If, at step 428, the UI processor 50 determines that the count value of the timer is not greater than or equal to T2, the process 420 jumps back to the beginning of step 428. When the count value of the timer reaches T2, the process 420 proceeds to step 430 where the UI processor 50 is operable to notify the user with an audible and/or vibratory signal or pattern of signals at step 430. Thereafter, at step 432, UI processor 50 is operable to control display device 18 to display instructions to the user to re-measure blood glucose. From step 432, and from the "NO" branch of step 424, process 420 ends.

Referring now to FIG. 12, a flow diagram of another illustrative embodiment of a process 440 for automatically notifying and instructing a user to measure blood glucose is shown. Illustratively, the process 440 is stored in the memory unit 66 in the form of instructions that are executable by the UI processor 50 to automatically notify and instruct the user to measure blood glucose. The process 440 begins at step 442, and at step 442 the UI processor 50 is operable to determine whether the user has entered a carbohydrate value, for example, using a bolus recommendation process. If so, the process 440 proceeds to step 444, where the UI processor 50 is operable to determine whether the carbohydrate value input at step 442 is greater than a predetermined, e.g., programmable, food quantity at step 444. If so, process 440 proceeds to step 446, and at step 446, UI processor 50 is operable to reset and start an internal timer. Thereafter, at step 448, the UI processor 50 is operable to determine whether the count value of the internal counter has reached a time value, T3. In one embodiment, the time value T3 may be selected by a user in a settings menu. Alternatively, the time value T3 may be set by the health care professional or may be set during manufacture and, in either case, cannot be modified by the user. If, at step 448, the UI processor 50 determines that the count value of the timer is not greater than or equal to T3, the process 440 jumps back to the beginning of step 442. When the count value of the timer reaches T2, the process 440 proceeds to step 450, where the UI processor 50 is operable to notify the user with an audible and/or vibratory signal or pattern of signals at step 450. Thereafter, at step 452, UI processor 50 is operable to control display device 18 to display instructions to the user to measure blood glucose. From step 452, and from the "NO" branch of step 444, the process 440 ends.

Referring now to FIG. 13, a flowchart is shown of one illustrative embodiment of a process 460 for canceling an automatic notification when an event causing a notification to be programmed occurs again. Illustratively, the process 460 is stored in the storage unit 66 in the form of instructions that are executable by the UI processor 50 to selectively cancel the automatic notification in certain cases. Process 460 begins at step 462, and at step 462, UI process 50 is operable to determine whether an event has occurred that has caused an automatic reminder (e.g., a programmable notification) to be set (i.e., to be programmed within the UI). If so, process 460 advances to step 464 where UI processor 50 is operable to reset and start an internal timer in step 464. Thereafter, at step 466, the UI processor 50 is operable to determine whether the count value of the internal counter has exceeded a time value, T. If not, step 460 proceeds to step 468 where the UI processor 50 is operable at step 468 to determine if an event has occurred that would result in the same automatic reminder (e.g., programmed notification) having been set or pending. If so, process 460 proceeds to step 464, where in step 464 the timer is reset and started again, thereby canceling the earlier programmed notification in favor of the later occurring notification. If, at step 468, the UI processor determines that an event has not occurred that will result in the same automatic reminder (e.g., programmed notification) being set, process 460 proceeds to step 466. When the count value of the counter reaches T, the process 460 proceeds to step 470 where the UI processor 50 is operable to notify the user with an audible and/or vibratory signal or pattern of signals at step 470. Thereafter, at step 472, the UI processor 50 is operable to control the display device 18 to display instructions to the user to retest the event that caused the automatic reminder to be set. From step 472, process 460 ends.

This should be evident: process 460 provides only one type of valid alert at a time. As an example, a user measures low blood glucose and an automatic reminder is automatically set by the low glucose value to notify the user to test blood glucose within thirty minutes. Then, if the user retests blood glucose twenty minutes later and again finds the same low blood glucose value, the process 460 can cancel the first automatic reminder in favor of the second.

Referring now to fig. 14A and 14B, there is shown a top portion 120 of a housing 120 of a remote electronic device (see fig. 1-4)₁Is described herein. In the illustrated embodiment, the top 120 of the housing 120₁Is a single, unitary piece illustratively formed from a conventional polymeric material, such as by a conventional injection molding process, although the present disclosure contemplates using other conventional materials and/or other conventional processes to form the housing top 120₁. In the embodiment shown in fig. 14A and 14B, illustratively, the housing top 120₁Is formed to define through the housing top 120₁An opening to the carrier port 20, an opening 480 cut and shaped to receive the user button 16, an opening 482 cut and shaped to receive the on/off button 136, and an opening 484 cut and shaped to receive the backlight button 138. Although not atAs particularly shown in fig. 14A and 14B, when the user button 16 is disposed within the housing 120, the user button 16 extends into and at least partially through the opening 480, and when the buttons 136 and 138 are received within the housing 120, the buttons 136 and 138 similarly extend into and at least partially through the openings 482 and 484, respectively.

Housing top 120 shown in FIG. 14A₁Illustratively formed from a light-transmissive polymer. In one embodiment, the housing top 120₁Formed of a transparent polymer, i.e. such that it transmits light without perceptibly dispersing it so that the object spread (object beyond) is clearly visible. In this embodiment, the housing top 120₁May be clear or may alternatively be colored, e.g., tinted. In an alternative embodiment, the housing top 120₁May be at least partially translucent. In any event, in the top portion 120 of the housing₁After initial formation, it is further processed to define a plurality of through housing tops 120₁Integrated windows of (a).

In the example embodiment shown in FIG. 14B, the housing top 120₁Is further processed to define two such integrated windows 490 and 496. In this example, the housing top 120₁The defined integrated window 490 is approximately D-shaped, although the window 490 may alternatively be formed in any desired shape. In any case, the window 490 is positioned relative to the housing 120 and relative to the electronic circuitry carried by the housing 120 to extend over and adjacent to the IR transceiver 65 so that the transceiver 65 has a straight line of sight through the housing 120. Another is formed by the top of the housing 120₁The defined integration window 496 is generally rectangular in shape, although the window 496 may alternatively be formed in any desired shape. Illustratively, the integrated window 496 is disposed relative to the housing 120 and relative to electronic circuitry carried by the housing 120 to extend over a viewable area of the display unit 18 so that the display unit 18 can be viewed through the integrated window 496.

In the illustrative embodimentsBy coating the top housing 120 with an opaque or other coating that does not transmit light₁While appropriately masking the window areas 490 and 496 from the coating, integrated windows 490 and 496 are defined. In an example embodiment, the top housing 120₁Except for windows 490 and 496, are coated with a suitable acrylic or oil-based coating, although the present disclosure contemplates alternative and/or additional coatings or coating types. In the example embodiment shown in fig. 14B, three different coating regions are defined. The first coated region 492 is defined to surround the housing top 120₁A second coating region 494 is defined at the housing top 120₁And the third coating region 498 is defined in the form of stripes separating coating regions 492 and 494. In the illustrated embodiment, the coating regions 492, 494, and 498 represent different colors, although the coating regions 492, 494, and 498 may alternatively or additionally define different shading and/or texturing.

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.

Claims (32)

1. A method of controlling a display device of an electronic apparatus, the method comprising:

displaying a data field (field) on the display device,

performing an editing process for providing editing of the data field displayed on the display device, an

When selected for editing according to the editing process, the data field is enlarged on the display device relative to other portions of the display device.

2. The method of claim 1, wherein the step of enlarging the data field comprises: generating an enlarged polygon around the enlarged data field.

3. The method of claim 1, further comprising:

displaying a plurality of data fields on said display device, an

Any of the plurality of data fields is enlarged when selected for editing according to the editing process.

4. The method of claim 1, wherein the enlarged data field is populated with a plurality of selectable options when selected for editing according to the editing process.

5. The method of claim 1, further comprising: incrementally (incrementally) increasing a value displayed within the enlarged data field according to an incremental value in response to a press of a user button of the electronic device.

6. The method of claim 5, further comprising: a fast scrolling process that incrementally increases the value displayed within the enlarged data field at a fast rate as the user button is pressed and held.

7. The method of claim 5, further comprising: a fast scrolling process that increases the incremental value when the user button is pressed and held.

8. The method of claim 1, further comprising: incrementally decreasing the value displayed within the enlarged data field in response to a press of a user button of the electronic device.

9. The method of claim 8, further comprising: a fast scrolling process that incrementally decreases the value displayed within the enlarged field at a fast rate when the user button is pressed and held.

10. The method of claim 8, further comprising: a fast scrolling process that increases the decrement value when the user button is pressed and held.

11. The method of claim 1, further comprising automatically displaying a unit of measure of data within the enlarged data field or to be entered into the enlarged data field.

12. An electronic device, the electronic device comprising:

electronic circuitry comprising a transceiver configured to wirelessly communicate with other electronic devices, the transceiver configured to operate at one of a visible wavelength, an infrared wavelength, and an ultraviolet wavelength, an

A housing having the electronic circuitry including the transceiver contained therein, the housing defining a first integrated window (integrated window) positioned over the transceiver, the first integrated window transmitting an operating wavelength of the transceiver for the transceiver to transmit and receive wireless information through the integrated window.

13. The electronic device of claim 12, wherein the electronic circuit further comprises a display device,

and wherein the housing defines a second integrated window located on the display device such that information displayed on the display device is visible through the second integrated window.

14. The electronic device according to claim 13, wherein the display device is a liquid crystal display device.

15. The electronic device of claim 12, wherein the first and second integrated windows are transparent.

16. The electronic device of claim 15, wherein the housing is transparent,

and wherein the first and second integrated windows are formed by coating the housing with an opaque coating while the first and second integrated windows are covered.

17. An electronic device, the electronic device comprising:

an electronic circuit comprising a display device configured to display information, an

A housing having electronic circuitry including the display device contained therein, the housing defining an integrated, transparent window over the display device such that the information displayed within the display device is visible through the integrated window.

18. The electronic device according to claim 17, wherein the display device is a liquid crystal display device.

19. The electronic device of claim 17, wherein the housing is transparent,

and wherein the integrated window is formed by coating the housing with an opaque coating when the integrated window is obscured.

20. An electronic analyte measurement device comprising:

the outer shell is provided with a plurality of grooves,

an analyte measurement device located within the housing, the analyte measurement device configured to measure a concentration of an analyte within a liquid sample deposited on a sample carrier received within the analyte measurement device,

a display device carried by the housing, an

A processor comprising a memory having instructions stored therein, the instructions being executable by the processor to automatically control the display device to display instructions to measure a concentration of the analyte in a subsequent liquid sample by the analyte measurement device if the concentration of the analyte in the liquid sample is outside a predefined analyte concentration limit.

21. The electronic analyte measuring device of claim 20 wherein the instructions stored in the memory further comprise instructions executable by the processor to automatically control the display device to display the instructions after a programmable period of time has elapsed since the concentration of the analyte in the liquid sample was measured.

22. The electronic analyte measuring device of claim 21 wherein the sample is blood, the analyte is glucose and the predefined concentration is a maximum blood glucose limit,

and wherein the instructions stored in the memory include instructions executable by the processor to automatically control the display device to display instructions to measure the concentration of the analyte in a subsequent liquid sample if the concentration of the analyte in the liquid sample is greater than the maximum blood glucose limit.

23. The electronic analyte measurement device of claim 22 further comprising at least one notification device,

wherein the maximum blood glucose limit is a hyperglycemic limit,

and wherein the instructions stored in the memory further include instructions executable by the processor to activate the at least one notification device at or near the time when the display device is controlled to display instructions to measure the concentration of glucose in a subsequent blood sample if the concentration of the glucose in the blood sample exceeds the hyperglycemic limit.

24. The electronic analyte measuring device of claim 21 wherein the sample is blood, the analyte is glucose and the predefined concentration is a minimum blood glucose limit,

and wherein the instructions stored in the memory include instructions executable by the processor to automatically control the display device to display instructions to measure the concentration of the analyte in a subsequent liquid sample if the concentration of the analyte in the liquid sample is less than the minimum blood glucose limit.

25. The electronic analyte measurement device of claim 24 further comprising at least one notification device,

wherein the minimum blood glucose limit is a hypoglycemic limit,

and wherein the instructions stored in the memory further include instructions executable by the processor to activate the at least one notification device at or near the time when the display device is controlled to display instructions to measure the concentration of glucose in a subsequent blood sample if the concentration of the glucose in the blood sample is less than the hypoglycemic limit.

26. An electronic blood glucose measurement device comprising:

the outer shell is provided with a plurality of grooves,

a blood glucose measuring device located on the housing, the blood glucose measuring device configured to measure a concentration of glucose in a blood sample deposited on a sample carrier received within the blood glucose measuring device,

a display device carried by the housing, an

A processor that executes a bolus recommendation process that recommends a bolus amount based on a plurality of factors including a value of carbohydrate input by a user, the processor including a memory having instructions stored therein that are executable by the processor to automatically control the display device to display instructions to measure blood glucose of a blood sample by the blood glucose measurement device after some programmable time has elapsed since the value of carbohydrate was input if the value of carbohydrate input by the user is greater than a carbohydrate limit.

27. The electronic blood glucose measuring device of claim 26, further comprising at least one warning device,

wherein the carbohydrate limit is a programmable food quantity limit and wherein the instructions stored in the memory device include instructions executable by the processor to activate the at least one notification device at or near the time of controlling the display device to display instructions to measure blood glucose if the user-entered carbohydrate value exceeds the food quantity limit.

28. A method of setting and managing automatic alerts within an electronic device, the method comprising:

starting a timer when an event causing automatic reminding to be set occurs;

resetting the timer if the event occurs again before the timer times out, an

Activating a notification device when the timer times out.

29. The method of claim 28, wherein the step of activating the notification device comprises: activating either of the audible indicating means and the vibrating means.

30. The method of claim 28, wherein the step of activating the notification device comprises: controlling a display device to display instructions to retest the event that caused the automatic reminder to be set.

31. An electronic analyte measurement device comprising:

the outer shell is provided with a plurality of grooves,

a plurality of user buttons carried by the housing,

a carrier port having an opening defined by the housing, the carrier port extending from the opening into the housing,

an analyte measurement device located within the housing and in communication with the carrier port, the analyte measurement device measuring an analyte within a liquid sample deposited on a sample carrier received within the carrier port,

a processor comprising a memory having instructions stored therein, the instructions being executable by the processor to cause the device to power up from a powered down state, disable the plurality of user buttons and measure an analyte within a liquid sample deposited on a sample carrier when the device is in the powered down state and the sample carrier is received within the carrier port, and cause the plurality of user buttons to be active when the analyte measurement is complete.

32. The electronic device of claim 31, wherein the analyte measuring device comprises a blood glucose measuring device that measures a glucose concentration within a blood sample deposited on the sample carrier.