U.S. patent application number 12/646689 was filed with the patent office on 2010-06-24 for liquid infusion pump.
Invention is credited to Andreas Brand, Harvey Buck, JR., Michael J. Celentano, Joel Jeckelmann, Ulf Meiertoberens, Markus Oberli, Peter Sabol, Raymond Strickland.
Application Number | 20100156633 12/646689 |
Document ID | / |
Family ID | 39671858 |
Filed Date | 2010-06-24 |
United States Patent
Application |
20100156633 |
Kind Code |
A1 |
Buck, JR.; Harvey ; et
al. |
June 24, 2010 |
Liquid infusion pump
Abstract
A method is provided for controlling change access to a display
menu of an ambulatory liquid infusion pump. A programmed menu of
the infusion pump may be displayed and a menu lock flag may be
monitored. Changes to at least one active item of the programmed
menu may be disabled if the menu lock flag is activated.
Inventors: |
Buck, JR.; Harvey;
(Indianapolis, IN) ; Jeckelmann; Joel;
(Villars-sur-Glane, CH) ; Oberli; Markus; (US)
; Brand; Andreas; (US) ; Celentano; Michael
J.; (Fishers, IN) ; Meiertoberens; Ulf;
(US) ; Sabol; Peter; (Fishers, IN) ;
Strickland; Raymond; (Indianapolis, IN) |
Correspondence
Address: |
ROCHE DIAGNOSTICS OPERATIONS INC.
9115 Hague Road
Indianapolis
IN
46250-0457
US
|
Family ID: |
39671858 |
Appl. No.: |
12/646689 |
Filed: |
December 23, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/US2008/066267 |
Jun 9, 2008 |
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12646689 |
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60937779 |
Jun 29, 2007 |
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60937933 |
Jun 29, 2007 |
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Current U.S.
Class: |
340/540 ;
340/3.1; 707/661; 726/30 |
Current CPC
Class: |
A61M 2205/3569 20130101;
A61M 2209/01 20130101; G06F 1/1626 20130101; A61M 5/14244 20130101;
G06F 1/169 20130101; G06F 1/1698 20130101; A61M 2205/3592 20130101;
A61M 5/172 20130101; A61M 2205/502 20130101; G16H 40/67 20180101;
G16H 20/17 20180101; A61B 5/7475 20130101; A61B 5/14532
20130101 |
Class at
Publication: |
340/540 ;
340/3.1; 726/30; 707/661 |
International
Class: |
G08B 21/00 20060101
G08B021/00; G05B 23/02 20060101 G05B023/02; G06F 21/24 20060101
G06F021/24; G06F 17/30 20060101 G06F017/30 |
Claims
1. A method of controlling change access to a display menu of an
ambulatory liquid infusion pump, the method comprising: displaying
a programmed menu of the infusion pump, monitoring a menu lock
flag, and disabling changes to at least one active item of the
programmed menu if the menu lock flag is activated.
2. The method of claim 1 wherein disabling changes comprises
disabling changes to all active items of the programmed menu.
3. The method of claim 1 further comprising displaying a warning
message upon detection of attempted changes to the at least one
active item of the programmed menu if the menu lock flag is
activated.
4. The method of claim 1 further comprising enabling changes to the
at least one active item of the programmed menu if the menu lock
flag is deactivated.
5. The method of claim 1 wherein enabling changes comprises
enabling changes to all of the active items of the programmed
menu.
6. The method of claim 1 wherein the method is carried out on the
ambulatory liquid infusion pump, and wherein 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 carried out on an
electronic device that is separate and remote from the ambulatory
liquid infusion pump, and wherein 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 containing the menu is available to users of the
ambulatory liquid infusion pump and a second version of the
application software containing the menu is available only to
health care professionals, and wherein the menu lock flag is
activated in the first version of application software and is
deactivated in the second version of the application software.
9. The method of claim 1 wherein a first version of application
software containing the menu is available to users of the
ambulatory liquid infusion pump and a second version of the
application software containing the menu is available only to
health care professionals, and wherein the menu lock flag is
activated in the first version of 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 an
ambulatory liquid infusion pump, the method comprising: monitoring
a pre-programmed lifetime timer resident in the liquid infusion
pump, allowing the liquid infusion pump to continue operating after
the lifetime timer expires, and disabling operation of the liquid
infusion pump if a liquid infusion pump operating error is detected
after the lifetime timer expires.
11. The method of claim 10 further comprising 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 the lifetime of the liquid infusion pump.
13. The method of claim 10 further comprising activating at least
one of an audible indicator and a vibratory 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
in a storage location of a non-volatile memory information relating
to delivery by the pump of a commanded liquid amount throughout
delivery by the pump of the commanded liquid amount, transferring
the information relating to delivery by the pump of the commanded
liquid amount from the storage location of the non-volatile memory
to a pump history database when delivery by the pump of the
commanded liquid amount is complete, and automatically transferring
any information relating to delivery by the pump of a commanded
liquid amount that is accumulated in the storage location of the
non-volatile memory to the pump history database upon power up of
the liquid infusion pump.
15. The method of claim 14 wherein the information relating to
delivery by the pump of a commanded liquid amount includes any one
or more of a delivered liquid quantity, a percentage of a delivered
liquid quantity relative to 100%, one or more associated liquid
delivery limits, a liquid delivery type, whether the delivered
liquid was locally or remotely commanded, and the time and date of
liquid delivery.
16. The method of claim 15 wherein the one or more liquid delivery
limits includes one or more of a maximum liquid amount, a minimum
liquid amount, a maximum delivery duration and a minimum delivery
duration.
17. The method of claim 15 wherein the liquid delivery type is at
least one of a basal rate, a temporary basal rate a standard bolus,
an extended bolus, a multi-wave bolus and a quick bolus.
18. The method of claim 14 further comprising 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 periodically storing information
relating to delivery by the pump of a commanded liquid amount
throughout delivery by the pump of the commanded liquid amount
comprises storing information periodically in time.
21. The method of claim 14 wherein periodically storing information
relating to delivery by the pump of a commanded liquid amount
throughout delivery by the pump of the commanded liquid amount
comprises storing the information after each delivery of by the
pump of an incremental amount of the commanded liquid amount.
Description
REFERENCE
[0001] This application is a continuation of PCT/US2008/066267
filed Jun. 9, 2008 which is based on and claims priority to U.S.
Provisional Patent Application Ser. No. 60/937,779 and U.S.
Provisional Patent Application Ser. No. 60/937,933, both filed Jun.
29, 2007. All applications identified in this paragraph are hereby
incorporated by reference.
FIELD
[0002] This disclosure relates generally to devices for selectively
delivering liquid to a living body, and more specifically to liquid
infusion pumps for controllably delivering liquid to a living
body.
BACKGROUND
[0003] Devices for selectively and controllably delivering liquid,
such as a drug, to a living body are known. Such devices may
typically be configured to controllably deliver the drug to the
living body at different rates during different times of the day
and according to one or more user selectable drug delivery profiles
that may be programmed by the user.
SUMMARY
[0004] The present invention may comprise one or more of the
features recited in the attached claims, and/or one or more of the
following features and combinations thereof. A method of
controlling change access to a display menu of an ambulatory liquid
infusion pump may comprise displaying a programmed menu of the
infusion pump, monitoring a menu lock flag, and disabling changes
to at least one active item of the programmed menu if the menu lock
flag is activated.
[0005] Disabling changes may comprise disabling changes to all
active items of the programmed menu.
[0006] The method may further comprise displaying a warning message
upon detection of attempted changes to the at least one active item
of the programmed menu if the menu lock flag is activated.
[0007] The method may further comprise enabling changes to the at
least one active item of the programmed menu if the menu lock flag
is deactivated.
[0008] Enabling changes may comprise enabling changes to all of the
active items of the programmed menu.
[0009] The method may be carried out on the ambulatory liquid
infusion pump. In this embodiment, displaying may comprise
displaying the programmed menu on a display device of the
ambulatory liquid infusion pump. Alternatively or additionally, the
method may be carried out on an electronic device that is separate
and remote from the ambulatory liquid infusion pump. In this
embodiment, displaying may comprise displaying the programmed menu
on a display device of the electronic device.
[0010] A first version of application software containing the menu
may be available to users of the ambulatory liquid infusion pump,
and a second version of the application software containing the
menu may be available only to health care professionals. In one
embodiment, the menu lock flag may be activated in the first
version of application software and may be deactivated in the
second version of the application software. Alternatively, the menu
lock flag may be activated in the first version of application
software, and the second version of the application software may
not include the menu lock flag.
[0011] A method of extending a pre-programmed lifetime of an
ambulatory liquid infusion pump may comprise monitoring a
pre-programmed lifetime timer resident in the liquid infusion pump,
allowing the liquid infusion pump to continue operating after the
lifetime timer expires, and disabling operation of the liquid
infusion pump if a liquid infusion pump operating error is detected
after the lifetime timer expires.
[0012] 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 expiration of the
lifetime of the liquid infusion pump.
[0013] The method may further comprise activating at least one of
an audible indicator and a vibratory device when the lifetime timer
expires.
[0014] A method of storing information relating to operation of a
liquid infusion pump may comprise periodically storing in a storage
location of a non-volatile memory information relating to delivery
by the pump of a commanded liquid amount throughout delivery by the
pump of the commanded liquid amount, transferring the information
relating to delivery by the pump of the commanded liquid amount
from the storage location of the non-volatile memory to a pump
history database when delivery by the pump of the commanded liquid
amount is complete, and automatically transferring any information
relating to delivery by the pump of a commanded liquid amount that
is accumulated in the storage location of the non-volatile memory
to the pump history database upon power up of the liquid infusion
pump.
[0015] The information relating to delivery by the pump of a
commanded liquid amount may include any one or more of a delivered
liquid quantity, a percentage of a delivered liquid quantity
relative to 100%, one or more associated liquid delivery limits, a
liquid delivery type, whether the delivered liquid was locally or
remotely commanded, and the time and date of liquid delivery. The
one or more liquid delivery limits may illustratively include one
or more of a maximum liquid amount, a minimum liquid amount, a
maximum delivery duration and a minimum delivery duration. The
liquid delivery type may illustratively include at least one of a
basal rate, a temporary basal rate a standard bolus, an extended
bolus, a multi-wave bolus and a quick bolus.
[0016] The method may further comprise clearing the non-volatile
memory after automatically transferring information from the
non-volatile memory to the pump history database.
[0017] The commanded liquid amount may be one of a locally
commanded liquid amount and a remotely commanded liquid amount.
[0018] In one embodiment, periodically storing information relating
to delivery by the pump of a commanded liquid amount throughout
delivery by the pump of the commanded liquid amount may comprise
storing information periodically in time. Alternatively or
additionally, periodically storing information relating to delivery
by the pump of a commanded liquid amount throughout delivery by the
pump of the commanded liquid amount may comprise storing the
information after each delivery of by the pump of an incremental
amount of the commanded liquid amount.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 shows a block diagram of one illustrative embodiment
of a wireless communication system including a liquid infusion pump
and a remote electronic device that are both configured to
wirelessly communicate with each other.
[0020] FIG. 2 shows a diagram of one illustrative embodiment of the
liquid infusion pump of FIG. 1.
[0021] FIG. 3 shows a diagram of the liquid infusion pump of FIG. 2
shown with a liquid cartridge inserted therein.
[0022] FIG. 4 shows a flowchart of one illustrative embodiment of a
process for controlling change access to one or more active items
of a displayed menu.
[0023] FIG. 5 shows a flowchart of one illustrative embodiment of a
process for extending the pre-programmed lifetime of the liquid
infusion pump.
[0024] FIG. 6 shows a flowchart of one illustrative embodiment of a
process for storing current pump operating information in
non-volatile memory during and throughout delivery of a currently
commanded liquid amount.
DETAILED DESCRIPTION
[0025] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to a number
of illustrative embodiments shown in the attached drawings and
specific language will be used to describe the same.
[0026] The following co-pending patent applications are
incorporated herein by reference: PCT Patent Application No.
PCT/US2008/066288, entitled APPARATUS AND METHOD FOR REMOTELY
CONTROLLING AN AMBULATORY MEDICAL DEVICE; PCT Patent Application
No. PCT/US2008/066262, entitled COMBINATION COMMUNICATION DEVICE
AND MEDICAL DEVICE FOR COMMUNICATING WIRELESSLY WITH A REMOTE
MEDICAL DEVICE; PCT Patent Application No. PCT/US2008/066331,
entitled METHOD AND APPARATUS FOR DETERMINING AND DELIVERING A DRUG
BOLUS; PCT Patent Application No. PCT/US2008/066299, entitled USER
INTERFACE FEATURES FOR AN ELECTRONIC DEVICE; PCT Patent Application
No. PCT/US2008/066247, entitled METHOD FOR PAIRING AND
AUTHENTICATING ONE OR MORE MEDICAL DEVICES AND ONE OR MORE REMOTE
ELECTRONIC DEVICES; PCT Patent Application No. PCT/US2008/066248,
entitled DEVICE AND METHODS FOR OPTIMIZING COMMUNICATIONS BETWEEN A
MEDICAL DEVICE AND A REMOTE ELECTRONIC DEVICE; and U.S. Provisional
Patent Application Ser. No. 61/130,855, entitled DEVICE AND METHODS
FOR OPTIMIZING COMMUNICATIONS BETWEEN AN ELECTRONIC DEVICE AND A
MEDICAL DEVICE.
[0027] Referring now to FIG. 1, a block diagram is shown of one
illustrative embodiment of a wireless communication system 10
including a liquid infusion pump 14 and a remote electronic device
12 that are both configured to wirelessly communicate with each
other. The electronic device 12 has a housing through which a user
button section 16 extends. The user button section. 16 defines a
number of user buttons, keys or switches that may be manually
manipulated by a user to provide input to the remote electronic
device 12. A visual display unit 18 is also carried by the housing
of the electronic device 12. In one embodiment, the visual display
unit 18 is provided in the form of a conventional liquid crystal
display (LCD), although this disclosure contemplates using other
conventional display units. Examples include, but are not limited
to, plasma displays, light emitting diode (LED) based displays,
vacuum fluorescent (VF) displays, and the like. In any case, the
visual display unit 18 is controlled by the electronic device 12 to
display information to a user of the device 12. The user buttons 16
and the display device 18 are both electrically connected to a
conventional processor 20 that 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 that is configured to receive therein a
carrier upon which an analyte containing liquid sample may be
deposited. The remote electronic device 12 may be operable in a
conventional manner to determine the concentration of the analyte
in the liquid sample, and to display the result on the display unit
18 and/or use the result in one or more algorithms executed by the
processor 20.
[0028] The liquid infusion pump 14 has a conventional processor 28
that includes a conventional memory unit 25. In the illustrated
embodiment, the infusion pump 14 further includes conventional
non-volatile memory units 27 and 29. In one embodiment, the
non-volatile memory unit 27 is provided in the form of a
conventional ferroelectric random access memory (FRAM) and the
non-volatile memory unit 29 is provided in the form of a
conventional electrically erasable programmable read only memory
(EEPROM), although either memory unit 27, 29 may alternatively be
provided in the form of one or more other conventional non-volatile
memory units. In any case, the memory units 27 and 29 are each
external to the processor 28 and are each electrically connected to
the processor 28. As will be described in greater detail
hereinafter, the memory unit 27 is a pump delivery (PD) memory unit
in which the processor 28 stores current pump delivery information,
and the memory unit 29 is a pump history (PH) memory unit that has
stored therein pump history information in a pump history database,
e.g., in the form of event records each corresponding to an
operational event of the 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
communicate wirelessly 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
illustrated by example throughout this disclosure, the wireless
communication module 30 and the wireless communication module 22 of
the electronic device 12 are both conventional BlueTooth.RTM.
modules configured to wirelessly communicate according to a
conventional BlueTooth.RTM. communication protocol. It will be
understood, however, 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 according to one or more other conventional
communication protocols.
[0029] The processor 28 is also electrically connected to another
wireless communication circuit or module 35. The wireless
communication circuit 35 is configured to communicate wirelessly
with another remote electronic device 15 via a wireless
communication link 17 in a conventional manner. In one embodiment,
the wireless communication circuit 35 includes a conventional
infrared (IR) transceiver, and the wireless communication circuit
35 is configured to communicate with the electronic device 15 via a
conventional IR communications protocol. In this embodiment, the
electronic device 15 also includes a conventional IR transceiver,
and the wireless communication link 17 is therefore 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 data assistant (PDA) or the like. In the
illustrated embodiment, the wireless communication circuit 35 is
used by the liquid infusion pump 14 to download pump-related data
to the electronic device 15 for analysis and/or observation. The
wireless communication circuit 35 may alternatively or additionally
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 will be understood, however,
that while the wireless communication circuit 35 has been described
as including a conventional infrared transceiver, the wireless
communication circuit 35 and the electronic device 15 may
alternatively or additionally be configured to wirelessly
communicate via other conventional media including for example, but
not limited to, a radio frequency (RF) communication link, a
microwave frequency communication link, inductive coupling, or the
like.
[0030] The liquid infusion pump 14 includes a housing through which
a number 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 that is carried by the housing and that is electrically
connected to the processor 28. The visual display unit 34 may be,
for example, a conventional liquid crystal display (LCD), plasma
displays, light emitting diode (LED) based display, vacuum
fluorescent (VF) display, or the like. The visual display unit 34
is controlled by the processor 28 to display information to a user
of the liquid infusion pump 14.
[0031] The processor 28 of the liquid infusion pump 14 is further
electrically connected to a conventional audible indication device
36 and/or to a conventional vibratory device 38. The processor 28
is generally operable to control the audible indication device 36
and/or the vibratory device 38 to produce one or more audible
sounds and/or vibrations respectively to notify the user of various
operational aspects of the liquid infusion pump 14 and to also
notify the user of any alarm and/or warning conditions associated
with the liquid infusion pump 14. The memory unit 25 has one or
more sets of instructions stored therein that are executable by the
processor 28 to carry out one or more processes associated with the
liquid infusion pump 14. The liquid infusion pump 14 further
includes a power supply 42 that is configured to derive a supply
voltage from one or more chargeable or non-chargeable batteries 44,
and to provide the supply voltage to at least the processor 28 and
the wireless communication module 30. In one embodiment, the
insulin infusion pump 14 uses a single AA 1.5V rechargeable battery
or a lithium or alkaline non-rechargeable battery, having a minimum
capacity of 2500 mAh, although this disclosure contemplates other
embodiments which use more, fewer and/or different chargeable
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 produced by
the processor 28 to drive a pump motor 48. In one embodiment, the
pump motor 48 is a brushless DC motor, although the pump motor 48
may alternatively be a conventional DC motor or a stepper motor or
other conventional drive mechanism.
[0032] Referring now to FIG. 2, a diagram is shown of one
illustrative embodiment of some of the exterior and/or readily
visible features of the liquid infusion pump 14. In the illustrated
embodiment, the pump 14 has a housing 50 through which a display 34
extends. In alternative embodiments, the pump 14 may not include a
display and/or may include other visual indicators such as one or
more lamps, light emitting diodes (LEDs), or the like. The housing
50 defines a liquid cartridge chamber 52 into which a conventional
liquid drive mechanism 54 is configured to extend. In one
embodiment, the liquid drive mechanism 54 is a conventional
telescoping drive mechanism that is configured to move linearly
within the chamber 52, although this disclosure contemplates
alternative embodiments in which the liquid drive mechanism 54
rotatably advances into and out of the chamber 52 in a conventional
manner.
[0033] As shown in FIG. 3, the chamber 52 is sized to hold a
cartridge 70 of liquid, e.g., drug, to be infused by the pump 14
into a body. The drive mechanism 54 is sized to be received within
one end of the liquid cartridge 70 and to engage a plug 72 that
forms a movable liquid seal with the cartridge 70. The opposite end
of the liquid cartridge 70 is secured to the housing 50 via
releasably engageable, e.g., threaded, adapter 74 through which a
conventional Luer lock fitting 76 extends. The Luer lock fitting 76
is configured to be fluidly connected to an infusion set (not
shown) that extends into a body of a user. Under the control of the
processor 28, the pump motor 48 drives the liquid drive mechanism
54 to controllably advance into the liquid cartridge 70 and thereby
force liquid from the cartridge 70 into the body of the user via
the Luer lock fitting 76 and infusion set.
[0034] The user buttons 32 of the liquid infusion pump 14 are
distributed in groups of two buttons or keys 60, 62 and 64, 66 each
near opposite sides of the display unit 34. In the illustrated
embodiment, the key 60 is a MENU key, the key 62 is a "check" or
"OK" key, the key 64 is an up key and the key 66 is a down key. The
MENU key 60 allows the user to select and move through menus,
function screens and information screens, and may also act an
on/off key for the infusion pump 14. The check or OK key 62 allows
the user to select menus, to save changes, to exit function and
information screens and to view one or more quick information
screens. The up key 64 allows the user to move forward in the
information screens, to increase a displayed setting, to turn on a
backlight of the display device 34, to program a quick bolus, to
cancel a quick bolus and to turn off a stop warning. The stop
warning is generally activated periodically, e.g., once per minute,
when liquid delivery by the pump 14 is stopped. By pressing and
holding the up key 64 for approximately 3 seconds, this stop
warning may be turned off or disabled. The down key 66 allows the
user to move backward in the information screens, to decrease a
displayed setting, to program a quick bolus, to cancel a quick
bolus and to 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 menus,
function screens and information screens without saving changes,
and to sequentially navigate back through the previous menus. By
simultaneously pressing the menu key 60 and the down key 66, e.g.,
until 3 beeps occur, the user can unlock the user keys 32. By
simultaneously pressing the up key 64 and the down key 66, the user
can copy an hourly basal rate to the following hour.
[0035] The processor 28 is generally operable to control the
display unit 34 within various menus to allow the user to enter
information, such as an infusion amount, infusion duration, or the
like, via one or more editable menu screens. By repeatedly pressing
the up key 64 or the down key 66 when an editable menu screen is
selected on the display unit 34, the numerical value in the
editable menu screen is correspondingly incremented or decremented
respectively. The pump 14 also includes a smart scroll function
that provides for rapid scrolling through values that the user may
enter in any of the editable menu screens. For example, by pressing
and holding the up key 64 or the down key 66, the value displayed
in the editable menu screen is, in one illustrative embodiment,
automatically incremented or decremented respectively at a high
increment or decrement rate. Alternatively or additionally, the
step size of the increment or decrement may increase to a larger
incremental value, e.g., from 0.1 to 0.5, when the up key 64 or the
down key 66 is pressed and held. In either case, the desired value
in an editable menu screen may be selected or confirmed by pressing
the OK key 62.
EXAMPLE
[0036] The following is a description of example features of one
illustrative embodiment of the liquid infusion pump 14 of FIGS.
1-3. It will be understood that such features are provided only by
way of example, and should not be considered limiting in any way.
By way of overview, the example infusion pump 14 provides for the
choice of three different user menus of varying complexity. A
standard menu provides for basic functionality and programming of
the pump 14, an advanced menu provides for full functionality and
programming of the pump 14 and a custom menu option allows the user
to define a menu structure having desired functionality and
programming options.
[0037] Generally, the example infusion pump 14 provides for five
basal rate profiles, and for the programming of three different
bolus types. Illustratively, the three different bolus types
include a standard (STD) bolus, corresponding to a specified bolus
quantity that is delivered immediately and all at once, an extended
bolus (EXT), corresponding to a specified bolus quantity that is
delivered over a specified period of time, and a multi-wave bolus
(MW), corresponding to a specified bolus quantity of which a
portion is delivered immediately and another portion of which is
thereafter delivered over a specified time period. Additionally, a
quick bolus, which is a specific form of a standard bolus, may also
be programmed without having to view the display device 34.
Warnings and errors are signaled using the combination of audible
tones or beeps and tactile vibrations, and the beep tones of the
audible device 36 are fully adjustable in volume. Historical
information relating to operation of the pump 14 may be transferred
from the pump 14 to the electronic device 15 via the wireless
communication circuit 35. The display device 34 may be configured
to display information in a default orientation or in an
orientation that is rotated 180.degree. relative to the default
rotation. In addition to the warnings and errors, the pump 14 may
be programmed to signal various reminders. The user keys 32 may be
locked to prevent accidental activation of functions, such as
during sleep or certain activities, and may be unlocked using a
combination of the user keys 32 as described above.
[0038] The screen displayed on the display device 34 relate to four
general categories: 1) run, stop and quick information, 2)
information, 3) function and 4) setup. Generally, 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, the RUN screen is displayed when the pump
14 is in the RUN mode, meaning that insulin is being delivered by
the pump 14 according to the programmed basal rate. Illustratively,
the RUN screen displays a basal rate indication icon, the current
hourly basal rate, the time of day and the active basal rate
profile. Additional icons that may be displayed on the display
device 34 during the RUN mode include, but should not be limited
to, a battery life indicator, a cartridge volume indicator, a pump
timer indicator and a key lock indicator.
[0039] A STOP screen is displayed when the pump 14 is in the STOP
mode, meaning 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 further be
configured to display any one or more of a battery life indicator,
a cartridge volume indicator, a pump timer, and a key lock
indicator. Illustratively, programming specific functions, changing
the cartridge and/or the infusion set, priming the infusion set,
and transferring data to and from the pump 14 all require the pump
14 to be in the STOP mode. Additionally, it is illustratively
recommended for the pump to be in the STOP mode when changing the
battery 44.
[0040] The pump 14 further includes a quick information screen,
which may be displayed by pressing the OK or check key 62.
Generally, the quick information screen shows the remaining liquid
content in the cartridge 70 in suitable liquid units. By again
pressing the OK or check key 62, the bolus data function is
displayed, and the most recent 30 boluses may be viewed by pressing
the up and down keys 64 and 66 respectively.
[0041] The screens displayed on the display device 34 may generally
be navigated by pressing the menu key 60 until reaching a screen of
choice, and then pressing the OK or check button 62. After pressing
the OK or check button 62, one or more function screens become
available. The value displayed within each function screen may be
changed by pressing the up and down keys 64 and 66 respectively,
and the next function screen may be displayed by pressing the menu
key 60. A user may also move backwards through the menu structure
as described hereinabove. In any case, the OK or check button 62
may be pressed to save changes.
[0042] Information relating to operation of the pump 14 is
generally stored in memory by the processor 28 along with the time
and date of occurrence thereof. Illustratively, the time may be
selected to be American time or European/military time. In
embodiments in which the pump 14 communicates wirelessly with the
electronic device 12 as illustrated in FIG. 1, 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.
[0043] Basal Rate Profile
[0044] In this example, the pump 14 delivers liquid every three
minutes, in 20 equal doses each hour, 24 hours per day. The flow of
liquid, e.g., insulin, is measured in international units per hour
(U/h), and is called the basal rate profile. The pump 14 can store
up to five different basal rate profiles each consisting of 24
different hourly basal rates. Each hourly basal rate may be changed
independently, and the total of all 24 basal rates in any one basal
rate profile is referred to as the daily basal rate total. By
pressing the menu key 60, basal rate profile programming screens
are available in which basal rates may be programmed for each hour
of consecutive 24 hour periods. The basal rate programming screens
further allow for the copying of hourly basal rates to one or more
additional hours for situations in which the basal rate will be
unchanged for multiple consecutive hours. Changes to the basal rate
programming screens may be made in either the RUN mode or the STOP
mode. These changes are saved by pressing the OK or check key 62.
If changes are made in the RUN mode, the display device 34 returns
to the RUN screen after pressing the OK or check key 62. If changes
are made in the STOP mode, the display device 34 returns to the
STOP screen after pressing the OK or check key 62. If the user does
not press the OK or check key 62 when attempting to make changes to
a basal rate, the screen timer will eventually time out and the
processor 28 will return the display device 34 to the RUN or STOP
screen without implementing the change to the basal rate.
Generally, changes may 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 to the RUN or STOP screen. During normal use, the
pump 14 is in the RUN mode, and liquid, e.g., insulin, is
continually delivered to the user's body according to the
programmed basal rate profile. Bolus amounts may be programmed and
delivered as deemed necessary by the user, as will be described
hereinafter.
[0045] The display screens of the pump 14 include a START and a
STOP screen that may be accessed by successively pressing the menu
key 60. After the user starts the pump 14 by accessing the START
menu and pressing the OK or check key 62, the RUN screen is
thereafter displayed. Likewise, by accessing the STOP screen via
successively presses of the menu key 60, the STOP function may be
activated by pressing the OK or check button 62, after which the
STOP screen is displayed on the display device 34.
[0046] The liquid infusion pump 14 further provides for the
temporary increase or decrease of the programmed basal rate. For
example, a basal rate initially set to 100% can be increased up to
250% for up to 24 hours or decreased down to 0% for up to 24 hours,
although other percentage and/or time values may be used. In one
alternative embodiment, for example, a basal rate initially set to
100% may be increased up to 500% for up to 50 hours or decreased
down to 0% for up to 50 hours. By increasing or decreasing the
basal rate by the temporary basal rate amount, each hourly basal
rate for the duration of the increase or decrease is likewise
increased or decreased. The characteristic shape of the existing
basal rate profile remains intact with the temporary basal rate. A
temporary basal rate may be programmed only when the pump is in the
RUN mode, and is implemented by successively pressing the menu key
60 to a temporary basal rate screen. By pressing the OK or check
key 62, the temporary basal rate percentage value may be changed by
pressing the up or down key 64 or 66 respectively. The duration of
the temporary basal rate may be set by similarly accessing a
temporary basal rate duration screen, and setting the duration
value to a desired temporary basal rate duration.
[0047] The temporary basal rate may be canceled during programming
in one of three ways. First, failure to press any of the user keys
32 for 20 seconds will cause the pump 14 to return to the RUN
screen. Additionally, the temporary basal rate screen may be exited
by simultaneously pressing the menu key 60 and the up key 64.
Finally, the temporary basal rate percentage may be set to the
default value of 100%, after which the temporary basal rate value
may be saved by pressing the OK or check key 62. During delivery,
there are two ways to cancel a temporary basal rate. For example,
the temporary basal rate programming screen may be accessed, and
the temporary basal rate value may be changed to 100% as described
above. Alternatively, the pump 14 may be put into the STOP mode as
described above, which automatically cancels the temporary basal
rate being delivered. A temporary basal rate cancel warning is
displayed in each case, which may or may not be accompanied by an
audible and/or vibratory indication.
[0048] Programming Boluses
[0049] It is generally understood that a bolus is an amount of
insulin delivered to compensate for the intake of food and/or to
correct high blood glucose levels. The liquid infusion pump 14 is
capable of being programmed to deliver three different types of
bolus as described above. Illustratively, the three different bolus
types include a standard (STD) bolus, corresponding to a specified
bolus quantity that is delivered immediately and all at once, an
extended bolus (EXT), corresponding to a specified bolus quantity
that is delivered over a specified period of time, and a multi-wave
bolus (MW), corresponding to a specified bolus quantity of which a
portion is delivered immediately and another portion of which is
thereafter delivered over a specified time period. Additionally, a
quick bolus, which is a specific form of a standard bolus, may also
be programmed without having to view the display device 34.
[0050] The liquid infusion pump 14 provides for two different types
of standard bolus as just described. A quick bolus may be
programmed when the pump 14 is operating in the RUN mode by
pressing and holding the up key 64 or the down key 66 for several
seconds until a beep sequence and vibration occur. Thereafter, a
quick bolus screen appears on the display device 34, and the user
may press the up key 64 or the down key 66 to increment the
displayed bolus amount until the desired bolus value is reached.
Generally, if the up key 64 was used to enter the quick bolus
screen, the down key 66 must be used to increment the desired bolus
value, and vice versa. In either case, each press of the up key 64
or the down key 66 causes the pump 14 to simultaneously beep and
vibrate to indicate the incremental increase in the bolus amount.
Five seconds after the last press of the up key 64 or the down key
66, the pump 14 confirms the total quick bolus amount by activating
one beep and vibration for each bolus increment that was
programmed. The standard bolus symbol in the display 34 then blinks
for approximately five seconds, after which the pump 14 begins to
deliver the programmed quick bolus. After the delay period, the
pump 14 beeps and vibrates three times and then begins to deliver
the total quick bolus that was programmed, and the display 34
simultaneously counts down the remaining bolus to be delivered
until the full programmed quick bolus amount is delivered. Because
the pump 14 beeps and vibrates to guide the user through the
programming steps, the quick bolus amounts may be programmed
without viewing the pump display 34.
[0051] During programming, the quick bolus amount may be canceled
by decrementing the quick bolus amount to 0.0 units using the
opposite one of the up or down key 64, 66 that was used to
increment the quick bolus amount. If the display remains at 0.0
units for approximately five 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 quick bolus may also be canceled during
confirmation of the total bolus amount (when one beep and vibration
occurs for each bolus increment programmed) or during start delay
(when the standard bolus symbol blinks for approximately five
seconds), by pressing either 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 cancel warning then appears on the
screen which may or may not be accompanied by an audible and/or
vibratory indication. The user may press the OK or check key 62
twice to confirm and turn off the alert. The quick bolus may also
be canceled during bolus delivery by pressing either the up key 64
or the down key 66 for approximately three seconds, after which the
display 34 will display a bolus cancel warning which may or may not
be accompanied by an audible and/or vibratory indication. The OK or
check key 62 may be pressed twice to confirm and turn off the
alert. The actual bolus amount delivered prior to being canceled
may be viewed by accessing the bolus history as will be described
hereinafter.
[0052] A standard bolus may be programmed by accessing the standard
bolus menu via successive presses of the menu key 60. Pressing the
OK or check key 62 when the standard bolus menu is displayed causes
a standard bolus amount to be displayed on the display device 34.
The user may press the up key 64 to increase or the down key 66 to
decrease the bolus amount, and the OK or check key 62 is pressed to
confirm the bolus amount. After pressing the OK or check key 62,
the display device 34 may be controlled to indicate the change, for
example by flashing the standard bolus symbol in the display 34 for
some time period, e.g., for approximately five seconds, after which
the delivery of the standard bolus amount will begin. The pump 14
may illustratively produce an audible and/or vibratory indication
when the programmed bolus amount is being delivered, and the
display 34 counts down the remaining bolus yet to be delivered.
[0053] During programming of the standard bolus, cancellation of
the bolus may occur in one of three ways. If no key is pressed for
approximately 20 seconds during programming, no bolus amount will
be delivered and the display 34 returns to the previous screen.
Also, if during programming of the standard bolus amount, the menu
key 60 and the up key 64 are simultaneously pressed, the 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 the OK
or check key 62, will return the display 34 to the previous screen
with no bolus amount being delivered. In any 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 times out after which the
processor 28 will automatically display the RUN screen. During the
start delay (when the standard bolus symbol blinks for
approximately five seconds) the programmed standard bolus amount
may be canceled by pressing the up key 64 or the down key 66 until
a beep sequence is heard, after which the display 34 displays a
bolus cancel warning. Pressing the OK or check key 62 twice
confirms and turns off this alert. 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 three seconds until
a beep sequence is heard. A bolus cancel warning will again appear,
and the OK or check key 62 may be pressed twice to confirm and turn
off this alert. The actual bolus amount delivered prior to
cancellation can be viewed by accessing the bolus history as will
be described hereinafter.
[0054] Extended boluses may be programmed in intervals, e.g., 15,
30 or 60 minute intervals, up to some number of time units, e.g.,
50 hours, and will begin immediately after confirmation of the
programmed bolus amount. Throughout delivery of an extended bolus,
the remaining time and bolus amount yet to be delivered will be
displayed, along with the current hourly basal rate, on the display
34 in the RUN screen. An extended bolus may be programmed by
accessing an extended bolus screen via successive presses of the
menu key 60, and then by pressing the OK or check key 62 when the
extended bolus appears. The bolus amount may be selected by
pressing the up key 64 to increase the bolus amount or by selecting
the down key 66 to decrease the bolus amount. The duration of the
last extended bolus that was delivered appears on the screen, and
by pressing the menu key 60 the display 34 displays the bolus
duration screen. The bolus duration may be increased or decreased
by pressing the up key 64 and the down key 66 respectively.
Successive pressing the menu key 60 will switch the display 34
between the programmed bolus amount and programmed bolus duration.
When the extended bolus amount and extended bolus duration are
selected, the OK or check key 62 is pressed to confirm the bolus
amount and duration. A beep sequence and/or vibration may occur
when the OK or check key 62 is pressed. Bolus delivery thereafter
begins, e.g., within the next three minutes. If a temporary basal
rate is active at the same time as an extended bolus, the remaining
time and amount of the bolus as well as the amount of the increased
or decreased hourly basal rate will be displayed together on the
RUN screen. A standard bolus can be added to an ongoing extended
bolus, and if the standard bolus is canceled, the extended bolus
will continue to run. However, during the delivery of an extended
bolus, the programming of another extended bolus or of a multi-wave
bolus will be blocked, and an error message indicating that a bolus
is currently running will appear on the display 34. To program a
different extended bolus when an extended bolus is currently
running, the pump 14 must be put into the STOP mode to cancel the
current extended bolus and then to reprogram a new extended
bolus.
[0055] An extended bolus may be canceled during programming
identically as described hereinabove with respect to the standard
bolus. After delivery of the bolus has begun, the extended bolus
may be canceled only by putting the pump 14 in the STOP mode. This
cancels delivery of the standard bolus, and displays a bolus cancel
warning in the display 34. The OK or check key 62 may be pressed
twice to confirm and turn off the alert. The amount of extended
bolus delivered prior to the cancellation may be viewed in the
bolus history screen as will be described hereinafter.
[0056] A multi-wave bolus may be programmed in intervals, e.g., 15,
30 or 60 minute intervals, for up to some number of time units,
e.g., 50 hours. Programming of a multi-wave bolus is only available
in the advanced or custom user menus, as will be described in
greater detail hereinafter, and in these menus successive presses
of the menu key 60 will display the multi-wave bolus screen.
Pressing the OK or check key 62 then causes a bolus amount screen
to appear, and the user may select the bolus amount by pressing the
up key 64 and down key 66 to increase or decrease respectively the
total bolus amount. Illustratively, the first press of the up key
64 will cause the bolus duration of the last multi-wave bolus to
appear on the screen. When the total bolus amount is programmed,
the menu key 60 may be pressed to move to the immediate bolus
screen which displays the immediate portion of the multi-wave
bolus. Illustratively, the first press of the up key 64 will cause
the amount of the last immediate portion of a multi-wave bolus to
appear on the screen. The user may press the up key 64 and the down
key 66 to increment and decrement the immediate bolus amount. The
user may then press the menu key 60 again to move to the bolus
duration screen by pressing the up key 64 and the down key 66. The
duration of the extended portion of the multi-wave bolus may be set
in increments, e.g., in increments of 15, 30 or 60 minutes, up to
some number of time units, e.g., 50 hours. Again, the menu key 60
may be pressed repeatedly to switch the display device 34 between
the bolus amount, immediate bolus and bolus duration screens. When
these three values have been selected, the user may press the OK or
check key 62 to confirm the multi-wave bolus parameters, and the
display device 34 may then be controlled to indicate the
confirmation, for example by flashing the multi-wave bolus symbol
on the display 34 for some time period, e.g., approximately five
seconds. At the end of the delay, e.g., a five second delay, the
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 will then be controlled to
display a count down of the remaining portion of the bolus.
[0057] The multi-wave bolus may be canceled during the programming
mode identically as described with respect to the programming of
the standard and extended bolus. During the START delay (in which
the multi-wave bolus symbol illustratively flashes), the multi-wave
bolus may be canceled identically as described above with respect
to the standard bolus. Likewise, the immediate portion of the
multi-wave bolus may be canceled during delivery thereof
identically as described above with respect to the standard bolus.
Finally, cancellation of the multi-wave bolus during delivery of
the extended portion of the multi-wave bolus may be canceled
identically as described above with respect to delivery of the
extended bolus.
[0058] Insulin delivery may stop if a mechanical or an electrical
error is discovered during the routine automatic system check.
Insertion of a new battery will also cause a power interrupt error
to occur if the pump 14 is operating in the RUN mode. A user may
turn off either the beeps or vibrations for the initial alarm
indication, but not both. Generally, if a warning or error is not
confirmed by the user in 60 seconds, it will occur again. The OK or
check key 62 will generally be pressed twice to confirm a warning
or an error. The first press acknowledges the warning or error, and
the second press confirms the warning or error. If the warning or
error is acknowledged but not confirmed, e.g., by pressing the OK
or check key 62 only once, the warning or error will not be cleared
and it will generally occur again. If the warning or error is
acknowledged and confirmed, e.g., by pressing the OK or check key
62 twice, the warning or error will be cleared and will not occur
again unless the condition that caused the warning or error
thereafter occurs.
[0059] The user may turn off the beeps and vibrations by pressing
the OK or check key 62, after which the warning or error continues
to be displayed on the display device 34. By pressing the OK or
check key 62 again, the warning or error will disappear from the
display 34. If more than one warning and/or error occurs
simultaneously, the user will be required to press the OK or check
key 62 twice for each warning or error to confirm and turn off.
However, a number of warnings or errors will continue to be
displayed in the RUN screen or the STOP screen after they have been
confirmed. Examples of such warnings or errors that will be
continued to be displayed in the RUN screen or STOP screen include,
but may not be limited to, a cartridge low warning, a cartridge
empty error, a battery low warning, a battery depleted error, a
pump timer warning, and an end of operation error.
[0060] The following is a list of warnings and errors that will be
identified and displayed by the pump 14, each followed by a short
description thereof.
[0061] A cartridge low warning will occur when the contents of the
cartridge 70 have dropped to approximately 20 units of insulin.
[0062] A battery low warning will occur when the voltage supplied
by the battery 44 is less than a threshold voltage. Failure to
replace the battery will generally result in additional error
messages.
[0063] When the pump 14 has been without power for more than one
hour, a review time warning will occur. With this warning, the user
is prompted to check and correct if necessary, the current date and
time.
[0064] When the pump 14 is coming to the end of its predetermined
lifetime, a lifetime error will occur. Related to this is a pump
lifetime timer warning that will occur when the operating time of
the pump 14 will soon expire. When this error occurs, the display
34 may or may not be activated to display an approximate number of
days remaining in the operation of the pump 14. In this embodiment,
when the pump lifetime timer reaches zero, the pump 14 will change
to the STOP mode and no longer operate. Alternatively, the pump 14
may be configured to operate after the pump lifetime timer reaches
zero as will be described hereinafter with respect to FIG. 5.
[0065] When a temporarily increased or decreased basal rate has
been canceled, a temporary basal rate cancellation warning will
occur. Similarly, when a temporary basal rate has ended, a
temporary basal rate over warning will occur, and the original
basal rate (100%) will resume automatically.
[0066] When a bolus has been canceled during the start delay or
after delivery has begun, as described hereinabove, a bolus
cancellation warning will occur.
[0067] If authentication data associated with the pairing and
authentication of an electronic device 12 is or becomes corrupt, or
if operation of the wireless communication module 30,
illustratively provided in the form of a BlueTooth.RTM. module, is
compromised, operation of the pump 14 thereafter will result in a
wireless communication fault warning. This warning generally will
not occur after pump 14 is either re-paired with the electronic
device 12 to which it was previously paired, or after the pump 14
is paired with a new electronic device.
[0068] When the insulin cartridge 70 is empty, a cartridge empty
error will occur. Similarly, if the battery 44 is depleted, a
battery depleted error will occur.
[0069] If no keys are pressed within a specified time period in the
RUN mode, an automatic off error will occur if this feature of the
pump 14 is activated.
[0070] On some occasions, insulin may not be delivered by the pump
14 as a result of a blocked infusion set, a damaged cartridge 70,
and/or a dirty or damaged piston rod. In this case, an occlusion
error will occur. Similarly, cartridge change function was not
correctly performed, a cartridge error will occur, and if the
cartridge has been changed but the infusion set has not been
primed, a set not primed error will occur.
[0071] If data transfer via the wireless communication circuit 35
has been interrupted, a data interruption error will occur.
[0072] Additionally, a number of different alarm clock functions
may be programmed in the pump 14, and an alarm error will occur
when any of the programmed alarm clock functions expires.
[0073] Generally, it will be understood that the occurrence of any
of the errors or warnings described herein by example, may or may
not be accompanied by any type of message displayed on the display
device 34, any single one of, plurality of or sequence of an
audible indication and/or any single one of, plurality of or
sequence of a vibratory indication.
[0074] Viewing Pump Data
[0075] The external pump history (PH) memory unit 29 of the pump 14
stores historical information associated with the operation of the
pump 14. The pump history information may include, for example, but
should not be limited to, all events relating to the operation of
the pump 14, e.g., warnings and errors, programming operations and
insulin delivery records. Up to approximately 4500 events may be
stored, which corresponds to approximately the previous 90 days of
use. This data may be downloaded to the electronic device 15 via
the wireless communication circuit 35 as described hereinabove.
While still present within the PH memory unit 29, the following
data categories can be reviewed directly on the display device 34:
1) bolus history (last 30 boluses), 2) alarm history (last thirty
warnings and errors), 3) history of daily insulin totals (last 30
daily totals of insulin delivered), and 4) temporary basal rate
history (last 30 increases and decreases in basal rate).
Additionally, if the pump 14 is configured to do so, the pump timer
(remaining timing days until the pump timer expires) information
may be reviewed via the display device 34. Generally, the menu key
60 may be successively pressed to display a "my data" screen from
which the foregoing pump data categories may be accessed. In the
bolus history screen, for example, the bolus amount and type, bolus
time, date and entry number may be displayed. In the alarm history
screen, the number and type of the warning or error may be
displayed along with a text description of the warning or error,
the time, date and entry number of the warning or error. In the
daily insulin total history screen, total daily insulin delivered
by date and entry number may be displayed, and in the temporary
basal rate history screen, the temporary basal rate increase or
decrease (in percentage), total basal rate duration, time and date
may be displayed. In the pump timer screen, the total number of
days remaining of pump operation are displayed.
[0076] The pump 14 additionally has a data transfer menu that may
be accessed through repeated presses of the menu key 60 and when
the data transfer menu is selected, the user may press the OK or
check key 62 to enabled downloading of information to the
electronic device 15. Generally, the electronic device 15 will
include one or more software applications configured to request the
downloading of pump data from the PH memory unit 29 to the
electronic device 15 via the wireless communication circuit 35.
[0077] Available Menus
[0078] More or fewer of the foregoing menus are available on the
pump screen depending upon which of three menus are selected for
use. The three choices are standard, advanced and custom. If the
standard menu is selected, all menus required for the basic
functions for the pump 14 will be available to the user via the
display 34. If the advanced menu option is selected, the complete
range of functions of the pump 14 are provided in menus 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 range of
menus. The user may select the standard, advanced or custom menu
settings by successively pressing the menu key 60 to a menu
settings display. If the standard user menu is selected, the
following menu settings are available; therapy settings, pump
settings, time and date settings, and my data. In the RUN mode, the
programmed basal rate, stop command, standard bolus, extended
bolus, temporary basal rate and basal rate programming displays are
available. In the STOP mode, the STOP display, start pump,
cartridge change, infusion set priming, data transfer and basal
rate one through five selection screens are available. In the
advanced user menu setting, 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, the basal rate display, stop command, standard bolus,
extended bolus, multi-wave bolus, temporary basal rate programming
and basal rate profiles one through five programming screens are
available. In the STOP mode, the stop display, start command,
cartridge change, infusion set priming, data transfer and basal
rate one through five selection screens are available. In the
custom menu setting, the desired ones of the advanced menu settings
may be selected for display.
[0079] Referring now to FIG. 4, a flowchart is shown of one
illustrative embodiment or process for controlling change access to
one or more active items of a menu display of the display device 34
of the insulin infusion pump 14. In one embodiment, the process 80
is illustratively stored within the memory unit 25 of the processor
28, or in either of the memory units 27 and 29, in the form of
instructions that are executable by the processor 28 to carry out
the features of the process 80. In an alternate embodiment, the
process 80 is illustratively stored in a memory unit of the
electronic device 15 in the form of instructions that are
executable by a processor of the electronic device 15 to carry out
the features of the process 80. In this 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, hand-held electronic device or other
conventional electronic device. While the process 80 will be
described with respect to FIG. 4 as being carried out on the liquid
infusion pump 14, i.e., executed by the processor 28, it will be
understood that the process 80 may alternatively be carried out on
the electronic device 15, i.e., executed by a processor included in
the electronic device 15.
[0080] In the illustrated embodiment, the process 80 presumes that
a menu for display on the display device 34 of the liquid infusion
pump 14 has been programmed and stored in the memory unit 25. At
step 82 of the process 80, the processor 28 is operable to control
the display device 34 to display the program menu thereon.
Following step 82, the processor 28 is operable at step 84 to
monitor a menu lock flag that is stored in the memory unit 25, or
alternatively in the memory unit 27 or 29. Thereafter at step 86,
the processor 28 is operable to determine the status, e.g., locked
(activated) or unlocked (deactivated), of the menu lock flag stored
in the memory unit 25.
[0081] If the processor 28 determines at step 86 that the menu lock
flag is locked or activated, the processor 28 is operable at step
88 to disable changes to any one or more of the active menu items
of the currently displayed menu. In one illustrative embodiment,
step 88 may further include the act of displaying via the display
device 34 a warning message, that may or may not be accompanied by
an audible or vibratory indication, upon detection of attempted
changes to the one or more active menu items of the currently
displayed window when the menu lock flag is locked or activated.
If, at step 86, the processor 28 determines that the menu lock flag
status is unlocked or deactivated, the processor 28 is thereafter
operable at step 90 to enable changes to one or more active menu
items in the currently displayed menu. At either of steps 88 or 90,
the process 80 ends.
[0082] Illustratively, a different menu lock flag exists for each
pre-programmed menu of the liquid infusion pump 14. Alternatively,
a single menu lock flag may exist for all of the pre-programmed
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 may not change one or more active menu items of any of
the displayable menus. In one embodiment, the menu lock flag for
any one or more of the displayable menus may be unlocked or
deactivated by entering a suitable code or password into processor
28 via one or more of the user keys 32. Such a password may, for
example, be known to a healthcare provider or other restricted
person who may unlock or deactivate the menu lock flag for one or
more menus so that one or more such menus may be customized for the
user. Unlocking or deactivating any such menu lock flag may
illustratively allow the healthcare professional or other
restricted person to modify one of a certain one or more active
menu items of any displayed menu, or may alternatively unlock or
deactivate all active menu items of the selected display so that
the healthcare professional or other restricted person may modify
any active display item.
[0083] In an alternative embodiment, two different versions of
application software containing the menu or menus may exist; one
that is available to users and another that is available only to
health care professionals. In this embodiment, the menu lock flag
is illustratively activated in the version that is available to
users so that users do not have change access to one or more active
menu items in one or more menus, and illustratively deactivated or
non-existent in the version that is available to health care
professionals so that health care professionals do have change
access to the one or more active menu items in one or more menus.
In this embodiment, the version that is available to users may, but
need not, provide for menu change access by entering a suitable
password or other access code.
[0084] Referring now to FIG. 5, a flow chart is shown of one
illustrative embodiment of a process 100 for extending the
preprogrammed lifetime of the liquid infusion pump 14. In one
embodiment, as described hereinabove, the pump 14 includes a pump
lifetime timer that allows the pump 14 to operate for a
predetermined time, e.g., four years, after which operation of the
pump 14 is disabled. In the embodiment illustrated in FIG. 5, in
contrast, operation of the pump 14 may be extended beyond
expiration of the pump lifetime timer. The process 100 is
illustratively stored in the memory unit 25, or in the memory unit
27 or 29, in the form of instructions that are executable by the
processor 28 to carry out the various features of the process
100.
[0085] The process 100 begins at step 102 where the processor 28
monitors the pump lifetime timer. Thereafter at step 104, the
processor 28 is operable to determine whether the lifetime timer
has expired. If not, the process 100 loops back to step 102. If, at
step 104, the processor 28 determines that the pump lifetime timer
has expired the process 100 advances to step 106 where the
processor 28 is operable to control the display device 34 to
display a message indicating that the pump 14 has passed its
lifetime. Thereafter at step 108, the processor 28 is operable to
control the audible indicator 36 and/or the vibratory device 38 to
provide a corresponding audible and/or vibratory indication when
the lifetime timer expires. Step 108 is illustrated in FIG. 5 as a
dashed-line step to indicate that this step is optional. In any
case, the process 100 advances to step 110, where the processor 28
is operable to determine whether an operating error associated with
the operation of the pump 14 has been detected. Illustratively, the
operating error monitored at step 110 may be or include any one or
more of the pump errors described hereinabove. If such an error is
not detected, the process 100 loop back to the beginning of step
110. If, at step 110, the processor 28 determines that an operating
error has been detected, the process 100 advances from step 110 to
step 112, where processor 28 is operable to disable, e.g.,
permanently, operation of the pump 14. Following step 112, the
process 100 ends.
[0086] Referring now to FIG. 6, a flowchart is shown of one
illustrative embodiment of a process 120 for periodically storing
pump operating information in the non-volatile PD memory unit 27
during delivery of liquid by the liquid infusion pump 14. The
process 120 is illustratively stored in the memory unit 25, or in
the memory unit 27 or 29, in the form of instructions that are
executable by the processor 28 to carry out the process 120. The
process 120 begins at step 122 where the processor 28 is operable
to determine whether the liquid infusion pump 14 is currently
delivering liquid, either as a result of being locally commanded to
deliver liquid or of being remotely commanded to do so. In either
case, if the processor 28 determines at step 122 that the liquid
infusion pump 14 is not currently delivering liquid, the process
120 loops back to the beginning of step 122. If, at step 122, the
processor 28 otherwise determines that the liquid infusion pump 14
is currently delivering liquid, the process 120 advances to step
124 where the processor 28 is operable to periodically store pump
operating information in a predefined storage location of the
non-volatile pump delivery (PD) memory unit 27. Alternatively, the
processor 28 may be operable at step 124 to periodically store the
pump operating information in a predefined storage location of the
non-volatile pump history (PH) memory unit 29. Illustratively, the
term "periodically" may be time-based and may be any time value
between a few microseconds and one or more seconds. Alternatively
or additionally, the term "periodically" may correspond to units or
sub-units of liquid that is delivered by the liquid infusion pump
14. One specific example of the former case may be 1-10
milliseconds, and one specific example of the latter case may be
1/10-1/2 units of liquid, e.g., IU, although neither of these
examples should be considered to be limiting in any way. In any
case, the term "pump operating information" may be or include, but
should not be limited to, delivered liquid quantity, e.g., in IU, a
percentage of a delivered liquid quantity relative to 100%, one or
more associated liquid delivery limits, e.g., maximum and/or
minimum quantity and/or duration, delivery type (or profile), e.g.,
basal, temporary basal, standard bolus, extended bolus, multi-wave
bolus, quick bolus or the like, whether the delivered liquid was
locally or remotely commanded, time and date of liquid delivery,
and the like.
[0087] Following step 124, the processor 28 is operable at step 126
to determine whether the current liquid delivery profile is
complete, i.e., whether delivery of the currently commanded liquid
delivery type is complete. If not, the process 120 loops back to
the beginning of step 124. If, at step 126, the processor 28
determines that the current liquid delivery profile is complete,
the process 120 advances to step 128 where the processor 28
transfers all of the pump operating information relating to the
currently commanded liquid delivery profile from the predefined
location of the non-volatile memory unit 27 to a pump history
database resident in the non-volatile PH memory unit 29.
Alternatively, the pump history database may be resident in the
non-volatile memory unit 27 at a location that is different from
that of the current pump operating information. In any case, the
process 120 advances from step 128 to step 132 where the processor
28 is operable to clear the predefined location of the non-volatile
memory unit 27 to thereby remove the pump operating information
relating to the currently commanded liquid delivery profile from
the non-volatile memory unit 27. The process 100 ends after the
completion of step 132.
[0088] The processor 28 is operable according to the process 120
just described to illustratively store in a predefined location of
the non-volatile memory unit 27 pump operating information that
relates to a liquid delivery profile that is currently being
delivered by the pump 14. After delivery of the profile is
complete, the processor 28 illustratively transfers the pump
operating information relating the completed delivery profile from
the predefined location of the non-volatile memory unit 27 to the
pump history database in the non-volatile memory unit 29. One
purpose for periodically storing the pump operating information as
the commanded liquid amount is being delivered is to retain pump
operating information in the event of a power down or power failure
of the pump 14. Illustratively, the on/off function (e.g., the menu
key 60) is disabled so that the pump 14 cannot be turned off during
delivery of liquid. However, a power failure may occur that relates
to the one more batteries 44 and/or power supply circuit 42 and
that causes disruption of electrical power supplied by the power
supply circuit 42 to the processor 28. Likewise, power supplied by
the power supply circuit 42 to the processor 28 will be disrupted
if the one or more batteries 44 is/are removed. In either case,
current liquid delivery information is retained by periodically
storing the pump operating information in the non-volatile memory
unit 27 as the commanded liquid amount is being delivered.
[0089] Because such a power failure or power disruption may occur
at any time, the process 120 further includes an additional step
130 that is repeatedly executed by the processor 28. At step 130,
the processor 28 is operable to determine whether the pump 14 has
just powered up. If the processor 28 determines that the pump 14
has not just powered up, the process 120 loops back to the
beginning of step 130. If, at step 130, the processor 28 determines
that the pump 14 has just powered up, step 130 advances to step 128
where the processor 28 is operable to transfer any pump operating
information that corresponds to current delivery of liquid from the
predefined location of the non-volatile memory unit 27 to the pump
history database resident within the non-volatile memory unit 29.
During normal operation of the pump 14, the predefined location of
the non-volatile memory unit 27 generally will not have any
information stored therein upon power up of the pump 14 that
relates to liquid currently being delivered by the pump 14, and in
such cases the execution of step 128 after power up of the pump 14
will not result in the transfer of any current liquid delivery
information from the predefined location of the non-volatile memory
unit 27 to the pump history database resident within the
non-volatile memory unit 29. However, in cases where a power
failure or disruption occurs as described above, execution of step
128 following subsequent power up of the pump 14 will typically
result in the transfer of current liquid delivery information from
the predefined location of the non-volatile memory unit 27 to the
pump history database resident within the non-volatile memory unit
29 if the pump 14 was delivering liquid at the time of the power
failure or disruption. The current liquid delivery information that
is transferred at step 128 will, in such cases, correspond to the
liquid delivery information that was accumulated in the predefined
location of the non-volatile memory unit 27 prior to the power
failure or disruption.
[0090] While the invention has been illustrated and described in
detail in the foregoing drawings and description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only illustrative embodiments thereof have
been shown and described and that all changes and modifications
that come within the spirit of the invention are desired to be
protected. For example, while various operations of the liquid
infusion pump 14 have been described herein as being accompanied by
a general or specific display on the display device 34, a general
or specific audible indication and/or a general or specific
vibratory indication, it will be understood that the entering of
any information into the pump 14, any wireless communication with
the pump 14 and/or any operation carried out by the pump, delayed
or otherwise, including but not limited to basal or bolus delivery,
error conditions, warning conditions, or the like, may or may not
be accompanied by any type of message displayed on the display
device 34, any single one of, plurality of or sequence of an
audible indication and/or any single one of, plurality of or
sequence of a vibratory indication.
* * * * *