HK1142150A - Liquid infusion pump - Google Patents

Description

Liquid injection pump

Cross reference to related applications

This patent application claims priority and benefit of U.S. provisional patent application serial No. 60/937,933, filed on 29/6/2007, the disclosure of which is incorporated herein by reference.

Technical Field

The present invention relates generally to devices for selectively delivering liquid to a living subject, and more particularly to liquid infusion pumps for controllably delivering liquid to a living subject.

Background

Devices for selectively and controllably delivering liquids, such as drugs, to living subjects are known. Typically, such devices may be configured to controllably deliver medication to a living subject at different rates and according to one or more user-selectable medication delivery characteristics (profiles) that may be programmed by a user during different times of the day.

Disclosure of Invention

The invention may comprise one or more of the features recited in the attached claims, and/or one or more of the following features and combinations thereof. A method of controlling a change access to a displayed menu of a non-stationary liquid injection pump may include: displaying a programmed menu of the infusion pump, monitoring a menu lock flag, and invalidating a change to at least one valid item of the programmed menu if the menu lock flag is activated.

Invalidating the changes may include: invalidating changes to all valid items of the programmed menu.

The method may further comprise: if the menu lock flag is active, a warning message is displayed upon detecting an attempt to change the at least one active item of the programmed menu.

The method may further comprise: enabling a change to the at least one active item of the programmed menu if the menu lock flag is deactivated.

The step of enabling the change may comprise: enabling changes to all active items of the programmed menu.

The method may also be implemented on a non-stationary liquid infusion pump. In this embodiment, the displaying step may include: displaying the programmed menu on a display device of the ambulatory liquid infusion pump. Alternatively or additionally, the method may be implemented on an electronic device separate and remote from the non-stationary liquid injection pump. In this embodiment, the displaying step may include: displaying the programmed menu on a display device of the electronic device.

A first version of the application software including the menu is available to a user of the ambulatory liquid infusion pump and a second version of the application software including the menu is available only to a health care professional. In one embodiment, the menu lock flag may be activated in a first version of the application software and deactivated in a second version of the application software. Alternatively, the menu lock flag may be activated in a first version of the application software, and a second version of the application software may not include the menu lock flag.

A method of extending a pre-programmed lifetime of a non-stationary liquid infusion pump may comprise: monitoring a pre-programmed life time timer in the liquid infusion pump, upon expiration of the life time timer, allowing the liquid infusion pump to continue to operate, and if a liquid infusion pump operation error is detected upon expiration of the life time timer, disabling operation of the liquid infusion pump.

The method may further comprise: displaying a message on a display device of the liquid infusion pump when the lifetime timer expires. The message may illustratively identify the expiration of the lifetime of the liquid infusion pump.

The method may further comprise: activating at least one of an audible indicator and a vibration device when the lifetime timer expires.

A method of storing information related to operation of a liquid infusion pump may comprise: periodically storing information related to pump delivery of the commanded amount of liquid in a storage location of a non-volatile memory throughout pump delivery of the commanded amount of liquid, transmitting information related to pump delivery of the commanded amount of liquid from the storage location of the non-volatile memory to a pump history database upon completion of pump delivery of the commanded amount of liquid, and automatically transmitting any information accumulated in the storage location of the non-volatile memory related to pump delivery of the commanded amount of liquid to the pump history database upon power up of the liquid injection pump.

The information relating to the delivery by the pump of the commanded amount of liquid may include any one or more of the following: the amount of liquid delivered, the percentage of the amount of liquid delivered relative to 100%, one or more associated liquid delivery limits, the type of liquid delivery, whether the liquid delivered is commanded locally or remotely, and the time and date of the liquid delivery. The one or more liquid delivery limits may illustratively include one or more of: maximum liquid volume, minimum liquid volume, maximum delivery period, and minimum delivery period. The liquid delivery types may illustratively include at least one of a basal rate, a temporary basal rate, a standard bolus, an extended bolus, a multiple wave bolus, and a fast bolus.

The method may further comprise: clearing the non-volatile memory after automatically transferring information from the non-volatile memory to the pump history database.

The commanded liquid amount may be one of a locally commanded liquid amount and a remotely commanded liquid amount.

In one embodiment, the step of periodically storing information related to delivery by the pump of the commanded amount of liquid throughout delivery by the pump of the commanded amount of liquid may comprise: the information is periodically stored in a timely manner. Alternatively or additionally, the step of periodically storing information related to the pump delivery of the commanded liquid amount throughout the pump delivery of the commanded liquid amount may comprise: the information is stored after each delivery of the pump by an increment of the commanded amount of liquid.

Drawings

FIG. 1 is a block diagram of one exemplary embodiment of a wireless communication system including a liquid infusion pump and a remote electronic device, wherein the liquid infusion pump and the remote electronic device are each configured to be wirelessly communicable with each other.

FIG. 2 is a diagrammatic view of an exemplary embodiment of the liquid infusion pump of FIG. 1.

Fig. 3 is a diagrammatic view of the liquid infusion pump of fig. 2 showing a liquid cartridge (liquid cartridge) inserted therein.

FIG. 4 is a flow diagram of one exemplary embodiment of a process for controlling the change rights (change access) to one or more valid items of a displayed menu.

FIG. 5 is a flow diagram of one exemplary embodiment of a process for extending the pre-programmed lifetime of a liquid infusion pump.

FIG. 6 is a flow chart of one exemplary embodiment of a process for storing current pump operation information in non-volatile memory during and throughout the delivery of a currently commanded liquid amount.

Detailed Description

For the purposes of promoting an understanding of the principles of the invention, reference will now be made to a number of exemplary embodiments illustrated in the 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 OPERATED CONTROL AN AMBULATORY MEDICAL DEVICE" AND having attorney docket No. 5727-205462; PCT patent application No. ____ entitled "COMMUNICATION DEVICE ANDMEDICAL DEVICE FOR COMMUNICATION WIRELESSLYWITH A REMOTE MEDICAL DEVICE" and having attorney docket No. 5727-; PCT patent application No. ____ entitled "METHOD AND DAPPARUTUS FOR DETERMINGING AND DELIVERING ADRUG BOLUS" and having attorney docket No. 5727-205464; PCT patent application No. ____ entitled "USER INTERFACE FEATURES FOR ANELECTRONIC DEVICE" and having attorney docket No. 5727-205466; PCT patent application No. ____, entitled "METHOD FOR coupling and coupling ONE OR MORE DEVICES and ONE OR MORE removal ELECTRONICs DEVICES" and having attorney docket No. 5727-205470; PCT patent application No. ____ entitled "DEVICE AND METHODS FOR optical compositions BETWEEN A MEDICAL DEVICE AND EMEMOTE ELECTRONIC DEVICE" and having attorney docket No. 57an 204710/WP-24993 PCT; and U.S. provisional patent application Ser. No. ____ entitled "DEVICE AND METHODS FOR optical communications BETWEEN ELECTRONIC devices AN ELECTRONIC device DEVICEAND A MEDICAL DEVICE" and having attorney docket No. 5727- "204710/WP-24993 US.

Referring now to fig. 1, a block diagram illustrates one exemplary embodiment of a wireless communication system 10 including a liquid infusion pump 14 and a remote electronic device 12, wherein the liquid infusion pump 14 and the remote electronic device 12 are each configured to be wirelessly communicable with each other. The electronic device 12 has a housing through which a user button portion 16 extends. The user button section 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 housing of the electronic device 12 also carries (carry) a visual display unit 18. 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 case, the visual display unit 18 is controlled by the electronic device 12 to display information to a user of the device 12. Both the user buttons 16 and the display device 18 are electrically connected to a conventional processor 20, which conventional processor 20 is also electrically connected to a conventional wireless communication circuit or module 22. In some embodiments, the remote electronic device 12 may further include a conventional glucose meter configured to receive a carrier (carrier) therein from which an analyte comprising a liquid sample may be precipitated. The remote electronic device 12 may operate in a conventional manner to determine the concentration of the analyte in the liquid sample and display the results on the display unit 18 and/or use the results in one or more algorithms executed by the processor 20.

The liquid infusion pump 14 has a conventional processor 28 including a conventional memory unit 25. In the illustrated embodiment, infusion pump 14 also includes conventional non-volatile memory cells 27 and 29. In one embodiment, the non-volatile memory cell 27 is provided in the form of a conventional Ferroelectric Random Access Memory (FRAM) and the non-volatile memory cell 29 is provided in the form of a conventional Electrically Erasable Programmable Read Only Memory (EEPROM), although each of the 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. As will be described in more detail below, the storage unit 27 is a Pump Delivery (PD) storage unit in which the processor 28 stores current pump delivery information, and the storage unit 29 is a Pump History (PH) storage unit in which pump history information has been stored in a pump history database, e.g., in the form of event records, each event recordCorresponding to an operational event of pump 14. The processor 28 is also electrically connected to a wireless communication circuit or module 30. The wireless communication module 30 is configured to wirelessly communicate with the wireless communication module 22 of the remote electronic device 12 via a wireless communication link 40 in a conventional manner. In one embodiment, as will be explained throughout examples of the present disclosure, both the wireless communication module 30 and the wireless communication module 22 of the electronic device 12 are configured as is conventionalConventional for wireless communication by communication protocolAnd (5) modules. However, it should be understood that the wireless communication circuit or module 30 and the wireless communication circuit or module 22 of the electronic device 12 may alternatively be configured to wirelessly communicate in accordance with one or more other conventional communication protocols.

The processor 28 is also electrically connected to another wireless communication circuit or module 35. The wireless communication circuit 35 is configured to wirelessly communicate with another remote electronic device 15 via a wireless communication link 17 in a conventional manner. In one embodiment, the wireless communication circuitry 35 includes a conventional Infrared (IR) transceiver, and the wireless communication circuitry 35 is configured to communicate with the electronic device 15 via a conventional IR communication protocol. In this embodiment, the electronic device 15 also comprises a conventional IR transceiver, and thus the wireless communication link 17 is an IR communication link. In one embodiment, the electronic device 15 is a conventional Personal Computer (PC), although the electronic device 15 may alternatively be a conventional laptop, notebook, or other computer, a Personal Digital Assistant (PDA), and the like. In the exemplary embodiment, wireless communication circuitry 35 is used by liquid infusion pump 14 to download pump-related data to electronics 15 for analysis and/or observation. Alternatively or additionally, the wireless communication circuit 35 may be used to download data or code from the electronic device 15, such as new software, software updates, software version updates, or the like, pump configuration data, language files, current time and data information, and the like. It should be understood, however, that while the wireless communication circuit 35 is described as including a conventional infrared transceiver, the wireless communication circuit 35 and the electronic device 15 may alternatively or additionally be configured to communicate wirelessly through other conventional media including, but not limited to: such as a Radio Frequency (RF) communication link, a microwave frequency communication link, inductive coupling, or the like.

The liquid infusion pump 14 includes a housing through which a plurality of user buttons 32 extend. The user buttons 32 may be provided in the form of any number of user-selectable buttons, keys or switches that are electrically connected to the processor 28. The liquid infusion pump 14 further includes a visual display unit 34 carried by the housing, and the visual display unit 34 is 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 a user of the liquid infusion pump 14.

The processor 28 of the liquid infusion pump 14 is further electrically connected to a conventional audible indicating device 36 and/or a conventional vibrating device 38. The processor 28 is generally operable to control the audible indicating device 36 and/or the vibration device 38 to generate one or more audible sounds and/or vibrations, respectively, to notify the user of various operating conditions of the liquid infusion pump 14 and also to notify the user of any alarm and/or alert conditions associated with the liquid infusion pump 14. Memory unit 25 has one or more sets of instructions stored therein that are executable by processor 28 to implement one or more processes associated with liquid infusion pump 14. The liquid infusion pump 14 also includes a power supply 42, the power supply 42 configured to obtain a supply voltage from one or more rechargeable or non-rechargeable batteries 44 and provide the supply voltage to at least the processor 28 and the wireless communication module 30. In one embodiment, the liquid injection pump 14 uses a single AA 1.5V rechargeable battery or lithium or alkaline non-rechargeable battery with a minimum capacity of 2500mAh, although the present disclosure contemplates other embodiments using more, fewer, and/or different rechargeable and/or non-rechargeable batteries. A conventional motor drive circuit 46 is electrically connected to the processor 28, and the motor drive circuit 46 is responsive to control signals generated by the processor 28 to drive a pump motor 48. In one embodiment, the pump motor 48 is a brushless (brushless) DC motor, although the pump motor 48 may alternatively be a conventional DC motor or a stepper motor or other conventional drive mechanism (mechanism).

Referring now to FIG. 2, a block diagram illustrates one exemplary embodiment of some external and/or readily visible features of the liquid infusion pump 14. In the exemplary embodiment, pump 14 has a housing 50, and display 34 extends through housing 50. In alternative embodiments, pump 14 may not include a display and/or may include other visual indicators, such as one or more lights, Light Emitting Diodes (LEDs), or the like. The housing 50 defines a liquid cartridge chamber 52(cartridge chamber), and a conventional liquid drive mechanism 54 is configured to extend into the liquid cartridge chamber 52. In one embodiment, the liquid drive mechanism 54 is a conventional telescoping drive mechanism configured to move linearly within the cavity 52, although the present disclosure contemplates alternative embodiments in which the liquid drive mechanism 54 rotationally advances into and retracts from the cavity 52 in a conventional manner.

As shown in fig. 3, the cavity 52 is formed as a cartridge 70 sized to hold a liquid, such as a drug to be infused into the body by the pump 14. The drive mechanism 54 is sized to be received within an end of the cartridge 70 and to engage a spigot 72 forming a movable fluid seal with the cartridge 70. The opposite end of the cartridge 70 is secured to the housing 50 by a releasably engageable adapter 74, such as a threaded adapter, through which a conventional Luer lock device 76 extends through the adapter 74. Luer lock device 76 is configured to be fluidly connected to an infusion device (not shown) that extends into the body of the user. Under the control of processor 28, pump motor 48 drives fluid drive mechanism 54 to controllably advance into fluid cartridge 70 and thereby push fluid from cartridge 70 through luer lock device 76 and the infusion device and into the body of the user.

The user buttons 32 of the liquid infusion pump 14 are distributed among two groups of buttons or keys 60, 62 and 64, 66, each group being proximate to both sides of the display unit 34. In an exemplary embodiment, key 60 is a menu key, key 62 is a "check" or "OK" key, key 64 is an up key and key 66 is a down key. The menu key 60 allows the user to select and move between menus, function screens, and information screens, and may also be used as an on/off key for the infusion pump 14. The check or OK key 62 allows the user to select menus, save changes, exit functions and information screens, and view one or more quick information screens. The up key 64 allows the user to advance in the information screen, increase the display settings, turn on the backlight of the display device 34, set the fast bolus program, cancel the fast bolus, and turn off the stop warning. When the delivery of liquid by pump 14 is stopped, a stop warning is typically activated periodically, for example, once every minute. This stop warning may be turned off or deactivated by pressing and holding the up key 64 for approximately 3 seconds. The down key 66 allows the user to move back in the information screen, to reduce the displayed settings, set the fast bolus program, cancel the fast bolus, and turn off the stop warning by pressing and holding the down key 36 for approximately 3 seconds. By simultaneously pressing the menu key 60 and the up key 64, the user can exit the menu, function screen, and information screen without saving the changes and navigate back to the previous menu in sequence. The user may unlock the user key 32 by simultaneously pressing the menu key 60 and the down key 66, for example, until 3 beeps occur. By pressing the up key 64 and the down key 66 simultaneously, the user can copy the basic rate per hour to the next hour.

Processor 28 is generally operative to control display unit 34 within various menus to allow a user to input information, such as injection volume, injection duration, or the like, through one or more editable menu screens. When the editable menu screen has been selected on the display unit 34, by repeatedly pressing the up key 64 or the down key 66, the numerical value in the editable menu screen is increased or decreased accordingly, respectively. The pump 14 also incorporates a flexible scrolling function that provides rapid scrolling of values that a user may enter in any of the editable menu screens. For example, in one exemplary embodiment, by pressing and holding the up key 64 or the down key 66, the value displayed in the editable menu screen is automatically increased or decreased at a high increase rate or a decrease rate, respectively. Alternatively or additionally, the step size of the increase or decrease may be increased to a larger incremental value, for example from 0.1 to 0.5, when either the up key 64 or the down key 66 is pressed and held. In each case, a desired value in the editable menu screen may be selected or confirmed by pressing OK key 62.

Examples of the invention

The following is a description of example features of one example embodiment of the liquid infusion pump 14 of fig. 1-3. It should be understood that these features are provided by way of example only and should not be construed in any way as limiting. In overview, the example infusion pump 14 provides three different user menu choices of varying complexity. The standard menus provide the basic functionality and programming of the pump 14, the advanced menus provide the full functionality and programming of the pump 14, and the customized menu options allow the user to define a menu structure with the desired functionality and programming options.

In general, the example infusion pump 14 provides five basic rate features and programming of three different bolus types. Illustratively, these three different bolus types include a Standard (STD) bolus, which corresponds to a specified bolus amount that is delivered all at once and at once; an extended bolus (EXT) corresponding to a specified bolus amount delivered over a specified time period; and a multi-wave bolus (MW) whose corresponding specified bolus amount is delivered in part immediately and in part during a specified time thereafter. In addition, the bolus may also be programmed without viewing the display device 34, which is a special form of standard bolus. The warning and error signals are sent using an audible tone or a combination of a beep and tactile vibration, and the volume of the beep of the audible means 36 is fully adjustable. Historical information relating to the operation of the pump 14 may be transmitted from the pump 14 to the electronics 15 via the wireless communication circuit 35. The display device 34 may be configured to display information in a default orientation or an orientation rotated 180 deg. relative to the default orientation. In addition to warnings and errors, the pump 14 may be programmed to send various alert signals. The user keys 32 may be locked to prevent accidental activation of functions, such as during sleep or certain activities, and unlocked using a combination of user keys 32 as previously described.

The screen displayed on the display device 34 relates to four general categories: 1) run, stop and fast information, 2) information, 3) functions and 4) settings. Typically, the display device 34 is deactivated by the processor 28 to conserve battery life and becomes active by pressing any of the user keys 32. When any such key is pressed, an operating screen is displayed when the pump is in the run mode, meaning that the pump 14 is delivering insulin according to the programmed basal rate. Illustratively, the run screen displays a base rate indicator icon, a current base rate per hour, a time of day, and an effective base rate characteristic. During the run mode, additional icons may be displayed on the display device 34, including but not limited to: a battery life indicator, a cartridge capacity indicator, a pump timer indicator, and a key lock indicator.

The stop screen is displayed when the pump 14 is in the stop mode, which means that insulin is no longer being delivered by the pump 14. Illustratively, the stop screen displays the current time of day, the date, and a stop symbol. The stop screen may be further configured to display any one or more of: a battery life indicator, a cartridge capacity indicator, a pump timer, and a key lock indicator. Illustratively, programming a particular function, changing a cartridge and/or infusion device, priming an infusion device, and transmitting data to and from pump 14 requires that pump 14 be in a stop mode. Additionally, illustratively, when changing the battery 44, it is recommended that the pump be in a stopped mode.

The pump 14 further includes a quick message screen that can be displayed by pressing the OK or check key 62. Typically, the quick message screen shows the remaining liquid content in the cartridge 70 in appropriate liquid units. By pressing the OK or check key 62 again, the bolus data function is displayed and the last 30 boluses can be observed by pressing the up and down keys 64 and 66, respectively.

The screen displayed on the display device 34 can typically be navigated by pressing the menu key 60 until the selected screen is reached, and then pressing the OK or check button 62. After pressing OK or check button 62, one or more function screens become available. The value displayed in each function screen can be changed by pressing the up and down keys 64 and 66, respectively, and the next function screen can be displayed by pressing the menu key 60. The user may also move backwards through the menu structure as described above. In any case, OK or check button 62 may be pressed to save the change.

Typically, information relating to the operation of the pump 14 is stored in memory by the processor 28 along with the time and date of its occurrence. Illustratively, the time may be selected as a U.S. time or a european/military time. In the embodiment shown in FIG. 1 in which the pump 14 is in wireless communication with the electronic device 12, the time and date of the pump 14 is the master time and date and is used to periodically update the time and date of the electronic device 12.

Basic rate characteristics

In this example, the pump 14 delivers the liquid every 3 minutes for 20 equal doses per hour for 24 hours per day. The fluid flow, e.g., insulin, is measured in international units per hour (U/h) and is referred to as the basal rate profile. The pump 14 can store up to 5 different base rate profiles, each consisting of 24 different base rates per hour. Each hourly base rate can be independently varied and the sum of all 24 base rates in any one base rate feature is referred to as the daily base rate sum. By pressing menu key 60, a basic rate feature programming screen is available in which the basic rate can be programmed for each hour during successive 24 hours. The base rate programming screen also allows the base rate per hour to be copied to one or more additional hours in the event that the base rate will not change over a number of consecutive hours. The change to the basic rate programming screen may be made in either run mode or stop mode. These changes may be saved by pressing the OK or check key 62. If the change is made in the run mode, the display device 34 returns to the run screen after the OK or check key 62 is pressed. If the change is made in the stop mode, the display device 34 returns to the stop screen after pressing the OK or check key 62. When attempting to make a change to the base rate, if the user does not press OK or check key 62, the screen timer will eventually time out and processor 28 will return display device 34 to run or stop the screen without effecting the change to the base rate. Generally, the change can be undone by simultaneously pressing the menu key 60 and the up key 64 when the display device 34 returns to the main menu or returns to the run or stop screen. During normal use, the pump 14 is in an operational mode and liquid, such as insulin, is continuously delivered to the user's body according to a programmed basal rate profile. The bolus amount may be programmed and delivered when deemed necessary by the user, as will be explained hereinafter.

The display screens of the pump 14 include start and stop screens that can be accessed by successively pressing the menu key 60. The run screen is then displayed after the user has started the pump 14 by entering the start menu and pressing the OK or check key 62. Likewise, by entering the stop screen by successively pressing menu key 60, the stop function may be activated by pressing OK or check button 62, after which the stop screen is displayed on display device 34.

The fluid infusion pump 14 also provides for temporary increases or decreases to the programmed base rate. For example, the base rate initially set to 100% may be increased to 250% and maintained for 24 hours or decreased to 0% and maintained for 24 hours, although other percentage and/or time values may be used. In an alternative embodiment, for example, the base rate initially set to 100% may be increased to 500% and maintained for 50 hours or decreased to 0% and maintained for 50 hours. By increasing or decreasing the base rate using the temporary base rate amount, the base rate per hour during the increase or decrease period is also increased or decreased. The characteristic shape of the existing basic rate feature is not affected by the temporary basic rate. The temporary base rate can be programmed only when the pump is in the run mode and is achieved by continuously pressing the menu key 60 to the temporary base rate screen. By pressing the OK or check key 62, the temporary base rate percentage value may be changed by pressing the up and down keys 64 or 66, respectively. The period of the temporary basic rate can be set by similarly entering the temporary basic rate period screen and setting the period value to the desired temporary basic rate period.

The temporary base rate may be cancelled during programming in one of three ways. First, not pressing any of the user keys 32 for 20 seconds will cause the pump 14 to return to the run screen. In addition, the temporary basic rate screen can be exited by simultaneously pressing the menu key 60 and the up key 64. Finally, the temporary base rate percentage may be set to a default value of 100%, after which the temporary base rate percentage may be saved by pressing the OK or check key 62. There are two ways to cancel the temporary base rate during transport. For example, a temporary base rate programming screen may be entered and the temporary base rate value may be changed to 100% as described above. Alternatively, as described above, the pump 14 may be put into a stop mode, which automatically cancels the temporary basal rate being delivered. A temporary basic rate cancellation warning is displayed in each case, which may or may not be accompanied by an audible and/or vibratory indication.

Programmed bolus

A bolus is generally considered to be the amount of insulin delivered to compensate for ingestion of food and/or to correct high blood glucose levels. The liquid infusion pump 14 can be programmed to deliver the three different types of boluses described above. Illustratively, these three different bolus types include a Standard (STD) bolus, which corresponds to a specified bolus amount that is delivered all at once and at once; an extended bolus (EXT) corresponding to a specified bolus amount delivered over a specified time period; and a multi-wave bolus (MW) whose corresponding specified bolus amount is delivered in part immediately and in part during a specified time thereafter. In addition, a bolus, which is a special form of a standard bolus, may also be programmed without viewing the display device 34.

As just described, the liquid infusion pump 14 provides two different types of standard boluses. When the pump 14 is operating in the run mode, a bolus can be programmed by pressing and holding the up key 64 or the down key 66 for several seconds until a beep sequence and vibration occurs. Thereafter, a fast bolus screen appears on the display device 34, and the user may press the up key 64 or the down key 66 to increase the displayed bolus amount until the desired bolus value is reached. Generally, if the up key 64 is used to enter the fast bolus screen, the down key 66 must be used to increment the desired bolus value, and vice versa. In another instance, each depression of either the up key 64 or the down key 66 may cause the pump 14 to beep and vibrate simultaneously to indicate an incremental increase in the bolus amount. After the last 5 seconds of depression of either the up key 64 or the down key 66, the pump 14 confirms the total bolus volume by activating a beep and vibration once for each bolus increment programmed. The standard bolus symbol in display 34 then blinks for approximately 5 seconds, after which pump 14 begins to deliver the programmed bolus. After the delay period, the pump 14 beeps and vibrates three times and then begins to deliver the programmed total bolus, and the display 34 simultaneously counts down the remaining boluses to be delivered until all of the programmed bolus quantities are delivered. Since the pump 14 beeps and vibrates to guide the user through the programming steps, the quick bolus amount can be programmed without viewing the pump display 34.

During programming, the bolus amount may be cancelled by reducing the bolus amount to 0.0 units using the opposite one of the up or down keys 64, 66 used to increase the bolus amount. If the display remains at 0.0 units for about 5 seconds, no new bolus will be delivered and the pump display 34 returns to the run screen, which may or may not be accompanied by an audible and/or vibratory indication. The fast bolus may also be cancelled during confirmation of the bolus amount (when a beep and vibration occurs once for each programmed bolus increment) or during the start delay (when the standard bolus symbol blinks for approximately 5 seconds) by pressing one of the up or down keys 64 and 66, respectively. When this occurs, the display device 34 returns to the run screen and a bolus cancellation warning then appears on the screen, which may or may not be accompanied by an audible and/or vibratory indication. The user may press OK or check key 62 twice to confirm and turn off the alarm. The fast bolus may also be cancelled during bolus delivery by pressing one of the up or down keys 64 and 66 for about 3 seconds, after which the display 34 will display a bolus cancellation warning that may or may not be accompanied by an audible and/or vibratory indication. The OK or check key 62 may be pressed twice to acknowledge and turn off the alarm. The actual bolus amount delivered before being cancelled can be observed by accessing a bolus history as will be described below.

A standard bolus may be programmed by continuously pressing menu key 60 into the standard bolus menu. When the standard bolus menu is displayed, pressing OK or check key 62 may cause the standard bolus amount to be displayed on display device 34. The user may press the up key 64 to increase or the down key 66 to decrease the amount of the bet and the OK or check key 62 to confirm the amount of the bet. After pressing OK or check key 62, display device 34 may be controlled to indicate the change, for example, by flashing the standard bolus symbol in display 34 for a period of time (e.g., about 5 seconds), after which delivery of the standard bolus amount will begin. When a programmed bolus amount is being delivered, pump 14 may illustratively generate an audible and/or vibratory indication, and display 34 counts down the remaining bolus to be delivered.

During programming of a standard bolus, cancellation of the bolus can occur in one of three ways. If no key is pressed during the programming period, which is about 20 seconds, no bolus will be delivered and the display 34 returns to the previous screen. Additionally, if menu key 60 and up key 64 are simultaneously pressed during programming of the standard bolus amount, pump 14 exits the standard bolus menu and returns to the previous screen. Finally, if the bolus amount is set to 0.0 units, pressing OK or check key 62 will return display 34 to the previous screen and no bolus amount is delivered. In either of these cases, the user may then press the up key 64 three times to display the run screen or wait until the screen timer expires, after which the processor 28 will automatically display the run screen. During the start delay (when the standard bolus symbol blinks for approximately 5 seconds), the programmed standard bolus amount may be cancelled by pressing up key 64 or down key 66 until a beep sequence is heard, after which the display 34 displays a bolus cancellation warning. Pressing OK or check key 62 twice may confirm and turn off this alarm. During delivery of the programmed standard bolus amount, the user may press and hold the up key 64 or the down key 66 for approximately 3 seconds until a beep sequence is heard. The bolus cancellation warning will again appear and the OK or check key 62 may be pressed twice to acknowledge and turn off the alarm. The actual bolus amount delivered before cancellation can be observed by accessing a bolus history as will be described below.

The extended bolus may be programmed in time intervals, e.g., 15, 30 or 60 minute intervals, until some number of time units, e.g., 50 hours, and will begin immediately after the programmed bolus amount is confirmed. Throughout the delivery of the extended bolus, the time remaining and the bolus amount to be delivered will be displayed in the run screen on the display 34 along with the current basal rate per hour. The extended bolus may be programmed by continuously pressing menu key 60 into the extended bolus screen and then pressing OK or check key 62 when the extended bolus appears. The bolus amount may be selected by increasing the bolus amount by pressing the up key 64 or by decreasing the bolus amount by selecting the down key 66. The duration of the last extended bolus delivered appears on the screen and by pressing the menu key 60, the display 34 displays the bolus duration screen. By pressing the up key 64 and the down key 66, respectively, the bolus time period may be increased or decreased. Continued depression of menu key 60 will cause display 34 to toggle between the programmed bolus amount and the programmed bolus period. When the extended bolus amount and the extended bolus period are selected, the OK or check key 62 is pressed to confirm the bolus amount and period. When the OK or check key 62 is pressed, a sequence of beeps and/or vibrations may occur. Thereafter, bolus delivery is initiated, e.g., within the next 3 minutes. If the temporary basal rate is active at the same time as the extended bolus, the remaining time and the bolus amount will be displayed on the run screen along with the amount of the basal rate that is increased or decreased per hour. A standard bolus may be added to an ongoing extended bolus and if the standard bolus is cancelled, the extended bolus will continue to run. However, during delivery of the extended bolus, programming of another extended bolus or a multiple wave bolus will be prevented and an error message will appear on display 34 indicating that a bolus is currently being administered. To program a different extended bolus when an extended bolus is ongoing, it is necessary to put the pump 14 in a stop mode to cancel the current extended bolus and then reprogram a new extended bolus.

As described above with respect to the standard bolus, the extended bolus may be cancelled during programming. After the start of the delivery of the bolus, the extended bolus can be cancelled simply by leaving the pump 14 in a stopped state. This cancels the delivery of the standard bolus and a bolus cancellation warning is displayed on the display 34. The OK or check key 62 may be pressed twice to confirm and turn off the alarm. As will be described below, the extended bolus amount delivered prior to cancellation may be observed in the bolus history screen.

The multiple bolus injections may be programmed in intervals, such as 15, 30 or 60 minute intervals, up to some number of time units, such as 50 hours. As will be described in greater detail hereinafter, programming of a multiple wave bolus is only available in advanced or custom user menus, and in these menus, successive presses of menu key 60 will display a multiple wave bolus screen. Subsequently, pressing OK or check key 62 causes a bolus screen to appear, and the user can select a bolus amount by increasing or decreasing the total bolus amount by pressing up key 64 and down key 66, respectively. Illustratively, a first depression of the up key 64 will cause the bolus of the last multiple-wave bolus to appear on the screen during the bolus. When the total bolus amount is programmed, menu key 60 may be pressed to move to an instant bolus screen that displays the instant portion (immediateposition) of the multiple wave bolus. Illustratively, pressing the up key 64 a first time will cause the last instant portion of the multiple wave bolus to appear on the screen. The user may press the up key 64 and the down key 66 to increase and decrease the amount of instant boluses. The user may then press the menu key 60 again to move to the bolus period screen by pressing the up key 64 and the down key 66. The duration of the extended portion of the multiple wave bolus may be set in increments, for example, in 15, 30, or 60 minute increments, up to some number of time units, for example, 50 hours. Again, menu key 60 may be repeatedly pressed to toggle display device 34 between bolus amounts, instant boluses, and screens during boluses. When these three values are selected, the user may press OK or check key 62 to confirm the multiple bolus parameter, and display device 34 may then be controlled to indicate confirmation, for example by flashing a multiple bolus symbol on display 34 for a period of time (e.g., about 5 seconds). At the end of the delay (e.g., a 5 second delay), an immediate portion of the multi-wave bolus will be delivered by the pump 14. This may or may not be accompanied by an audible and/or vibratory indication. The display 34 may then be controlled to display the countdown of the remaining portion of the bolus.

As with the programming of the standard bolus and the extended bolus described above, the multiple wave bolus may be cancelled during the programming mode. During the start delay period (during which the multiple bolus symbol illustratively blinks), the multiple bolus may be cancelled as described above with respect to the standard bolus. Likewise, as described above with respect to a standard bolus, the instant portion of the multiple wave bolus may be cancelled during delivery of the instant portion of the multiple wave bolus. Finally, as described above with respect to delivery of the extended bolus, cancellation of the multiple wave bolus may be cancelled during delivery of the extended portion of the multiple wave bolus.

During a conventional automated system check, insulin delivery may be stopped if a mechanical or electrical error is found. Inserting a new battery will also cause a power interruption error to occur if the pump 14 is operating in run mode. The user may turn off the beep or vibration for the initial alarm indication, but not both. Typically, if the warning or error is not confirmed by the user within 60 seconds, the warning or error will reappear. The OK or check key 62 will typically be pressed twice to confirm the warning or error. The first press answers the warning or error and the second press acknowledges the warning or error. If a warning or error is answered but not confirmed, for example by pressing OK or check key 62 only once, it will not be cleared and will generally appear again. If the warning or error is answered and confirmed, for example, by pressing OK or check key 62 twice, the warning or error will be cleared and will not reappear unless circumstances causing the warning or error later occur.

By pressing the OK or check key 62, the user can turn off the beep and vibration, after which warnings or errors continue to be displayed on the display device 34. By pressing OK or check key 62 again, a warning or error will disappear from display 34. If more than one warning and/or error occurs at the same time, the user will be required to press OK or check key 62 twice for each warning and error to confirm and close. However, after a plurality of warnings or errors are confirmed, they are continuously displayed in the running screen or the stopping screen. Examples of such warnings or errors that will be continually displayed in the run screen or stop screen include, but are not limited to: a cartridge low (cartridge low) warning, a cartridge empty error, a battery low (battery low) warning, a battery drain error, a pump timer warning, and an end of run error.

The following is a list of warnings and errors that will be recognized and displayed by the pump 14, each followed by a brief description thereof.

When the content of the cartridge 70 drops to approximately 20 units of insulin, a cartridge low warning will occur.

A low battery warning will occur when the voltage provided by the battery 44 is below a threshold voltage. Failure to replace the battery will typically result in additional error messages.

When the pump 14 is powered off for more than 1 hour, a check time warning will occur. With this warning, the user is prompted to check and correct the current date and time, if necessary.

A lifetime error will occur when the pump 14 is about to reach the end of its predetermined lifetime. This associated pump life timer warning will occur when the operating time of the pump 14 is about to expire soon. When this error occurs, the display 34 may or may not be activated to show the approximate number of days remaining in the operation of the pump 14. In this embodiment, when the pump life timer reaches 0, the pump 14 will change to the stop mode and no longer operate. Alternatively, the pump 14 may be configured to run after the pump life timer reaches 0, as will be described later with respect to fig. 5.

A temporary basic rate cancellation warning will occur when the temporarily increased or decreased basic rate has been cancelled. Similarly, when the temporary base rate has been terminated, a temporary base rate end warning will occur and the original base rate (100%) will be automatically resumed.

A bolus cancellation warning will occur when a bolus has been cancelled during the start delay or after delivery has begun.

If the data authentication associated with the pairing and the authentication of the electronic device 12 are bad or bad, or if the wireless communication module 30 (illustratively, toThe form of the module is provided) is damaged, operation of the pump 14 will thereafter result in a communication failure warning. Such an alert will typically not occur after the pump 14 has been re-paired with the electronic device 12 with which it was previously paired, or after the pump 14 has been paired with a new electronic device.

When the insulin cartridge 70 is empty, a cartridge empty error will occur. Similarly, if the battery 44 is depleted, a battery depletion error will occur.

If no key is pressed during a specified period of time in the run mode, an auto-off error will occur if the auto-off error feature of the pump 14 has been activated.

In some cases, a blocked infusion device, a damaged cartridge 70, and/or a contaminated or damaged piston rod will result in insulin that may not be delivered by the pump 14. In this case, an occlusion error will occur. Similarly, a cartridge change function that is not performed correctly, a cartridge error will occur, and if the cartridge has been changed but the injection device is not primed, a device non-priming error will occur.

If the data transmission via the wireless communication circuit 35 has been interrupted, a data interruption error will occur.

Additionally, a number of different alarm clock functions may be programmed into the pump 14, and an alarm error will occur when any of the programmed alarm clock functions expire.

In general, it should be understood that the occurrence of any error or warning shown by way of example herein may or may not be accompanied by any type of message, any one, more or series of audible indications and/or any one, more or series of vibratory indications displayed on the display device 34.

Observing pump data

An external Pump History (PH) storage unit 29 of the pump 14 stores history information related to the operation of the pump 14. Pump history information may include, for example, but is not limited to: all events related to the operation of the pump 14, such as warnings and errors, programmed operations, and insulin delivery records. Up to about 4500 events can be stored, which corresponds to about 90 days of prior use. Such data may be downloaded to the electronic device 15 via the wireless communication circuit 35 as described above. While still present in the PH storage unit 29, the following data categories may be viewed directly on the display device 34: 1) bolus history (last 30 boluses), 2) warning history (last 30 warnings and errors), 3) history of daily insulin amounts (daily amounts of insulin delivered for the last 30 times), and 4) temporary basal rate history (last 30 increases and decreases in basal rate). Additionally, pump timer (the number of hours remaining until the pump timer expires) information may be viewed via the display 34 if the pump 14 is configured to do so. Typically, the menu key 60 may be continuously pressed to display a "My data" screen from which previous pump data classifications may be accessed. In the bolus history screen, for example, the bolus amount and type, bolus time, date, and number of entries may be displayed. In the warning history screen, the number and type of warnings or errors may be displayed along with a textual description of the warning or error, the time, date, and number of entries for the warning or error. In the daily insulin total amount history screen, the total amount of daily insulin delivered by date and the number of entries may be displayed, and in the temporary basic rate history screen, an increase or decrease (by percentage) of the temporary basic rate, the period, time, and date of the total basic rate may be displayed. In the pump timer screen, the total number of remaining days the pump was running is displayed.

The pump 14 additionally has a data transfer menu that can be accessed by repeatedly pressing the menu key 60, and when the data transfer menu is selected, the user can press the OK or check key 62 to cause information to be downloadable to the electronic device 15. Typically, the electronic device 15 will include one or more software applications configured to request download of pump data from the PH storage unit 29 to the electronic device 15 via the wireless communication circuit 35.

Available menus

More or fewer of the previous menus are available on the pump screen depending on which of the three menus is selected for use. These three options are standard, advanced and customized. If the standard menu is selected, all of the menus required for the basic function of the pump 14 are available to the user via the display 34. If the advanced menu option is selected, the full range of functions of the pump 14 are provided in a menu that is available to the user via the display 34, and in the custom menu option, the user may select which menu is available from the full menu. By successively pressing menu key 60 to the menu settings display, the user can select standard, advanced or custom menu settings. If a standard user menu is selected, the following menu settings are available: treatment settings, pump settings, time and date settings, and my data. In run mode, programmed basal rate, stop command, standard bolus, extended infusion, temporary basal rate, and basal rate programming displays are available. In the stop mode, stop display, start pump, cartridge change, infusion set priming, data transfer, and base rate one to five selection screens are available. In the advanced user menu settings, the following menu settings are available: bluetooth settings, therapy settings, pump settings, time and date settings, reminder settings, and my data. In the run mode, one to five programming screens are available for basal rate display, stop command, standard bolus, extended bolus, multiple wave bolus, temporary basal rate programming, and basal rate features. In the stop mode, stop display, start command, cartridge change, infusion set priming, data transfer and base rate one to five selection screens are available. In the customized menu setting, a desired menu setting of the advanced menu settings may be selected for display.

Referring now to fig. 4, a flow chart of one exemplary embodiment or process for controlling the right to change one or more active items of a menu display to the display device 34 of the insulin infusion pump 14 is shown. In one embodiment, process 80 is illustratively stored in the form of instructions within storage unit 25 of processor 28 or one of storage units 27 and 29, which instructions are executable by processor 28 to implement the features of process 80. In alternative embodiments, the process 80 is illustratively stored in the form of instructions in a memory unit of the electronic device 15 that are executable by a processor of the electronic device 15 to implement the features of the process 80. In the latter embodiment, the electronic device 15 is illustratively a PC, laptop or notebook computer, although the electronic device 15 may alternatively be any conventional computer, handheld electronic device, or other conventional electronic device. While process 80 is described with respect to fig. 4 as being implemented on liquid infusion pump 14 (i.e., as being executed by processor 28), it should be understood that process 80 may alternatively be implemented on electronic device 15, i.e., as being executed by a processor included in electronic device 15.

In the illustrated embodiment, process 80 assumes that the menu for display on display 34 of liquid infusion pump 14 has been programmed and stored in memory unit 25. At step 82 of process 80, processor 28 is operable to control display device 34 to display a program menu thereon. Following step 82, processor 28 is operable at step 84 to monitor the menu lock flag stored in memory unit 25 or alternatively in memory units 27 or 29. Processor 28 is then operable at step 86 to determine the state, e.g., locked (activated) or unlocked (deactivated), of the menu lock flag stored in memory unit 25.

If processor 28 determines at step 86 that the menu lock flag is locked or activated, processor 28 is operable at step 88 to invalidate changes to any one or more active menu items of the currently displayed menu. In an exemplary embodiment, upon detecting an attempt to change one or more active menu items of a currently displayed window while the menu lock flag is locked or activated, step 88 may further include the act of displaying a warning message via display device 34, which may or may not be accompanied by an audible and/or vibratory indication. If, at step 86, processor 28 determines that the state of the menu lock flag is unlocked or deactivated, processor 28 is thereafter operable at step 90 to effect a change to one or more active items in the currently displayed menu. At either step 88 or 90, the process 80 ends.

Illustratively, there is a different menu lock flag for each pre-programmed menu of the liquid infusion pump 14. Alternatively, there may be a single menu lock flag for all preprogrammed menus of the liquid infusion pump. In one embodiment, all of the one or more menu lock flags are initially locked or activated so that a user cannot change one or more active menu items of any displayable menu. In one embodiment, the menu lock flag of any one or more displayable menus may be unlocked or deactivated by entering an appropriate code or password into processor 28 via one or more user keys 32. Such a password may be known, for example, by a healthcare provider or other limited personnel who may unlock or deactivate menu lock flags of one or more menus so that one or more such menus may be customized for the user. For example, unlocking or deactivating any such menu lock flag may allow a healthcare professional or other limited person to modify one of one or more active menu items of any displayed menu, or may alternatively unlock or deactivate all active menu items of a selected display so that the healthcare professional or other limited person may modify any active display items.

In an alternative embodiment, there may be two different versions of application software containing one or more menus; one available to the user and the other available only to the healthcare professional. In this embodiment, the menu lock flag is illustratively activated in the version available to the user so that the user has no rights to change one or more active menu items in one or more menus, and is illustratively deactivated or absent in the version available to the healthcare professional so that the healthcare professional has rights to change one or more active menu items in one or more menus. In this embodiment, the versions available to the user may, but need not, provide menu change rights by entering an appropriate password or other access code.

Referring now to fig. 5, a flow diagram of one exemplary embodiment of a process 100 for extending the pre-programmed lifetime of the liquid infusion pump 14 is shown. In one embodiment, as described above, the pump 14 includes a pump life timer that allows the pump 14 to operate for a predetermined time (e.g., 4 years), after which the operation of the pump 14 is deactivated. In the embodiment illustrated in fig. 5, instead, operation of the pump 14 may be extended beyond the expiration of the pump life timer. Illustratively, process 100 is stored in storage unit 25 or in storage units 27 or 29 in the form of instructions that are executable by processor 28 to implement various features of process 100.

Process 100 begins at step 102, where processor 28 monitors a pump lifetime timer. Thereafter at step 104, processor 28 is operable to determine whether the lifetime timer has expired. If not, process 100 jumps back to step 102. If, at step 104, processor 28 determines that the pump life cycle timer has expired, process 100 advances to step 106 where processor 28 is operable to control display device 34 to display a message indicating that pump 14 has passed its life cycle. Thereafter, at step 108, when the lifetime timer expires, the processor 28 is operable for controlling the audible indicator 36 and/or the vibration device 38 to provide a corresponding audible and/or vibratory indication. Step 108 is shown in fig. 5 as a dashed step to indicate that this step is optional. In any event, process 100 advances to step 110 where processor 28 is operable to determine whether an operational error associated with operation of pump 14 has been detected. Illustratively, the operational error monitored at step 110 may be or include any one or more of the pump errors described above. If no such error is detected, process 100 jumps back to the beginning of step 110. If, at step 110, processor 28 determines that an operational error has been detected, process 100 proceeds from step 110 to step 112, at step 112, processor 28 is operable to disable (e.g., permanently) operation of pump 14. After step 112, the process 100 ends.

Referring now to fig. 6, a flowchart of one exemplary embodiment of a process 120 for periodically storing pump operation information in non-volatile PD storage unit 27 during delivery of liquid by liquid infusion pump 14 is shown. Illustratively, process 120 is stored in memory unit 25 or memory unit 27 or 29 in the form of instructions that are executable by processor 28 to implement process 120. The process 120 begins at step 122 where the processor 28 is operable to determine whether the liquid injection pump 14 is currently delivering liquid, is delivering liquid as a result of a local command, or is delivering liquid as a result of a remote command. In each case, if processor 28 determines at step 122 that liquid infusion pump 14 is not currently delivering liquid, process 120 jumps back to the beginning of step 122. Otherwise, if at step 122, processor 28 determines that liquid infusion pump 14 is currently delivering liquid, process 120 proceeds to step 124, at step 124, processor 28 is operable to periodically store pump operation information at a predefined storage location of non-volatile Pump Delivery (PD) storage unit 27. Alternatively, processor 28 is operable at step 124 to periodically store pump operation information at predefined storage locations of non-volatile Pump History (PH) storage unit 29. Illustratively, the term "periodically" may be based on time and may be any time value between a few microseconds and one or more seconds. Alternatively or additionally, the term "periodically" may correspond to a unit or sub-unit of liquid delivered by the liquid infusion pump 14. A particular example of the former case may be 1-10 microseconds and a particular example of the latter case may be 1/10-1/2 liquid units, such as IU, although these examples should not be construed as limiting in any way. In any case, the term "pump operation information" may be or include, but is not limited to: the amount of liquid delivered, e.g., in IU, as a percentage of the amount of liquid delivered relative to 100%, one or more associated liquid delivery limits, e.g., maximum and/or minimum amount and/or duration, the type (or characteristics) of delivery, e.g., basal, bolus, standard bolus, extended bolus, multiple wave bolus, fast bolus, or the like, whether the liquid delivered is commanded locally or remotely, the time and date of liquid delivery, and the like.

Following step 124, processor 28 is operable at step 126 to determine whether the current liquid delivery characteristic is complete, i.e., whether delivery of the currently commanded liquid delivery type is complete. If not, the process 120 jumps back to the beginning of step 124. If, at step 126, the processor 28 determines that the current liquid delivery characteristic is complete, the process 120 proceeds to step 128 where the processor 28 transfers all pump operation information associated with the currently commanded liquid delivery characteristic from the predefined location of the non-volatile PH storage unit 27 to the pump history database residing in the non-volatile PH storage unit 29 at step 128. Alternatively, the pump history database may be located in the non-volatile storage unit 27 at a location different from the location of the current pump operation information. In any case, process 120 advances from step 128 to step 132 where processor 28 is operable to clear the predefined location of non-volatile memory unit 27 to remove pump operation information from non-volatile memory unit 27 regarding the currently commanded liquid delivery characteristic at step 132. After completion of step 132, process 100 ends.

Illustratively, processor 28 is operable to store pump operation information relating to the fluid delivery characteristics currently being delivered by pump 14 in a predefined location of non-volatile memory unit 27 in accordance with process 120 just described. After the feature delivery is complete, processor 28 transmits pump operation information relating to the completed delivery feature, illustratively from a predefined location in non-volatile storage unit 27 to a pump history database in non-volatile storage unit 29. The purpose of periodically storing pump operation information when a commanded amount of liquid is delivered is to retain pump operation information in the event of a power outage or power failure of the pump 14. Illustratively, the on/off function (e.g., menu key 60) is deactivated so that the pump 14 cannot be turned off during delivery of the fluid. However, the occurrence of a power outage may involve one or more batteries 44 and/or power supply circuitry 42 and result in an interruption of the power supplied by power supply circuitry 42 to processor 28. Likewise, if one or more batteries 44 are removed, the power supplied by the power supply circuit 42 to the processor 28 will be interrupted. In each case, the current liquid delivery information may be saved by periodically storing pump operation information in the non-volatile storage unit 27 as the commanded amount of liquid is delivered.

Since such a power outage or loss of power may occur at any time, process 120 also includes an additional step 130 that is repeatedly performed by processor 28. At step 130, processor 28 is operable to determine whether pump 14 has just been powered up. If processor 28 determines that pump 14 has not just been powered up, process 120 jumps back to the beginning of step 130. If, at step 130, processor 28 determines that pump 14 has just been powered up, step 130 proceeds to step 128 where, at step 128, processor 28 is operable to transfer any pump operation information corresponding to the current fluid delivery from the predefined location of non-volatile memory unit 27 to the pump history database residing in non-volatile memory unit 29. During normal operation of pump 14, immediately after pump 14 is powered up, the predefined location of non-volatile memory unit 27 will not normally have any information stored therein relating to the fluid currently being delivered by pump 14, and in such a case, execution of step 128 will not result in any current fluid delivery information being transferred from the predefined location of non-volatile memory unit 27 to the pump history database residing in non-volatile memory unit 29 after pump 14 is powered up. However, in the event of a power outage or power outage as described above, if pump 14 is delivering fluid at the time of the power outage or power outage, performing step 128 following subsequent powering up of pump 14 will typically result in current fluid delivery information being transferred from the predefined location of non-volatile memory unit 27 to the pump history database residing in non-volatile memory unit 29. In this case, the current fluid delivery information transmitted at step 128 will correspond to fluid delivery information accumulated at the predefined location of non-volatile memory unit 27 prior to the power outage or outage.

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 have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected. For example, while various operations of the various fluid infusion pumps 14 have been described herein with general or special displays, general or special audible indications, and/or general or special vibratory indications on the display device 34, it should be understood that any input of information into the pump 14, any wireless communication with the pump 14, and/or any operation, delay, or otherwise effected by the pump, includes, but is not limited to: a basal or bolus delivery, error condition, warning condition, or the like, may or may not be accompanied by any type of information, any one, more, or series of audible indications, and/or any one, more, or series of vibratory indications displayed on the display device 34.

Claims (21)

1. A method of controlling change access to a displayed menu of a non-stationary liquid injection pump, the method comprising:

displaying a menu of programming of the infusion pump,

monitoring menu lock flags, and

if the menu lock flag is activated, then changes to at least one valid item of the programmed menu are invalidated.

2. The method of claim 1, wherein the step of invalidating changes comprises invalidating changes to all valid items of the programmed menu.

3. The method of claim 1, wherein the method further comprises: if the menu lock flag is active, a warning message is displayed upon detecting an attempt to change the at least one active item of the programmed menu.

4. The method of claim 1, wherein the method further comprises: if the menu lock flag is deactivated, then the change to the at least one valid item of the programmed menu is made valid.

5. The method of claim 1, wherein the step of validating the change comprises: making changes to all of the active items of the programmed menu active.

6. The method of claim 1, wherein the method is performed on a non-stationary liquid infusion pump,

and wherein the step of displaying comprises: displaying the programmed menu on a display device of the ambulatory liquid infusion pump.

7. The method of claim 1, wherein the method is performed on an electronic device separate and remote from the ambulatory liquid infusion pump,

and wherein the step of displaying comprises: displaying the programmed menu on a display device of the electronic device.

8. The method of claim 1, wherein a first version of application software including the menu is available to a user of the ambulatory liquid infusion pump and a second version of application software including the menu is available only to a healthcare professional,

and wherein the menu lock flag is activated in a first version of the application software and deactivated in a second version of the application software.

9. The method of claim 1, wherein a first version of application software including the menu is available to a user of a non-stationary liquid infusion pump and a second version of application software including the menu is available only to a health care professional,

and wherein the menu lock flag is activated in the first version of the application software,

and wherein the second version of the application software does not include the menu lock flag.

10. A method of extending a pre-programmed lifetime of a non-stationary liquid infusion pump, the method comprising:

monitoring a pre-programmed life timer in the liquid infusion pump,

allowing the liquid infusion pump to continue operating after expiration of the lifetime timer, an

And after the life time timer expires, if the liquid injection pump is detected to be in error in operation, stopping the operation of the liquid injection pump.

11. The method of claim 10, wherein the method further comprises: displaying a message on a display device of the liquid infusion pump when the lifetime timer expires.

12. The method of claim 11, wherein the message identifies expiration of a lifetime of the liquid infusion pump.

13. The method of claim 10, wherein the method further comprises: activating at least one of an audible indicator and a vibration device when the lifetime timer expires.

14. A method of storing information relating to operation of a liquid infusion pump, the method comprising:

periodically storing information in a storage location of a non-volatile memory related to the delivery of the commanded amount of liquid by the pump throughout the delivery of the commanded amount of liquid by the pump,

transmitting information related to the delivery of the commanded amount of liquid by the pump from the storage location of the non-volatile memory to a pump history database upon completion of the delivery of the commanded amount of liquid by the pump, an

Upon power-up of the liquid infusion pump, automatically transferring any information accumulated in the storage location of the non-volatile memory associated with delivery of the commanded amount of liquid by the pump to the pump history database.

15. The method of claim 14, wherein the information related to the delivery of the commanded amount of liquid by the pump comprises any one or more of: the amount of liquid delivered, the percentage of the amount of liquid delivered relative to 100%, one or more associated liquid delivery limits, the type of liquid delivery, whether the liquid delivered is commanded locally or remotely, and the time and date of the liquid delivery.

16. The method of claim 15, wherein the one or more liquid delivery limits comprise one or more of: maximum liquid volume, minimum liquid volume, maximum delivery period, and minimum delivery period.

17. The method of claim 15, wherein the liquid delivery type is at least one of basal rate, temporal basal rate, standard bolus, extended bolus, multi-wave bolus, and bolus.

18. The method of claim 14, wherein the method further comprises: clearing the non-volatile memory after automatically transferring information from the non-volatile memory to the pump history database.

19. The method of claim 14, wherein the commanded liquid amount is one of a locally commanded liquid amount and a remotely commanded liquid amount.

20. The method of claim 14, wherein the step of periodically storing information related to the delivery of the commanded amount of liquid by the pump throughout the delivery of the commanded amount of liquid by the pump comprises: the information is periodically stored in a timely manner.

21. The method of claim 14, wherein the step of periodically storing information related to the delivery of the commanded amount of liquid by the pump throughout the delivery of the commanded amount of liquid by the pump comprises: the information is stored after each delivery of an increased amount of the commanded liquid amount by the pump.