Title: Programmable insulin pump
Abstract: An apparatus for delivering a bolus of a medical agent to a patient. The apparatus comprises a pump mechanism, a data input device, and a processor in data communication with the keypad and arranged to control the pump mechanism. The processor is programmed to receive data specifying a bolus amount through the data port, receive data regarding duration through the data port, receive a percentage through the data port, the percentage defining a portion of the bolus amount to deliver immediately upon executing a deliver command and a remainder of the bolus amount to deliver over the duration upon executing a deliver command, and execute the deliver command thereby controlling the pump mechanism to deliver the bolus. Also a method of temporarily adjusting the delivery rate of an infusion pump. The infusion pump is programmed to deliver a basal rate. The method comprises prompting a user to select whether to enter the temporary rate as a percent of the current delivery rate or as a new delivery rate; entering into the pump a period of time having a beginning and an end; entering into the pump a temporary basal rate; and delivering the therapeutic agent at a delivery rate substantially equal to the temporary basal rate during the period of time.
Patent Number: 6,852,104 Issued on 02/08/2005 to Blomquist
| Inventors:
|
Blomquist; Michael L. (Andover, MN)
|
| Assignee:
|
Smiths Medical MD, Inc. (St. Paul, MN)
|
| Appl. No.:
|
086641 |
| Filed:
|
February 28, 2002 |
| Current U.S. Class: |
604/504; 604/892.1; 700/282 |
| Intern'l Class: |
A61M 031/00; A61K009/22; G05D007/00 |
| Field of Search: |
604/504,890.1,892.1
700/282
|
References Cited [Referenced By]
U.S. Patent Documents
| 4392849 | Jul., 1983 | Petre et al. | 604/66.
|
| 5745378 | Apr., 1998 | Barker et al. | 700/282.
|
| 6539250 | Mar., 2003 | Bettinger | 604/20.
|
| 6659978 | Dec., 2003 | Kasuga et al. | 604/151.
|
| 2002/0065509 | May., 2002 | Lebel et al. | 604/892.
|
| 2003/0114836 | Jun., 2003 | Estes et al. | 604/890.
|
| 2003/0199854 | Oct., 2003 | Kovach et al. | 604/890.
|
| 2003/0212364 | Nov., 2003 | Mann et al. | 604/131.
|
| 2003/0212379 | Nov., 2003 | Bylund et al. | 604/504.
|
Primary Examiner: Picard; Leo
Assistant Examiner: Frank; Elliot L.
Attorney, Agent or Firm: Merchant & Gould P.C.
Parent Case Text
REFERENCE TO CO-PENDING APPLICATIONS
This application is being filed concurrently with the following six
commonly assigned patent applications: "Cartridge and Pump with Axial
Loading," U.S. patent application Ser. No. 10/086,646, "Syringe Pump
Control Systems and Methods," U.S. patent application Ser. No. 10/086,994,
"Child Safety Cap for Syringe Pump," U.S. patent application Ser. No.
10/086,993, "Programmable Medical Infusion Pump," U.S. patent application
Ser. No. 10/087,449, "Programmable Medical Infusion Pump Displaying a
Banner," U.S. patent application Ser. No. 10/087,205, "Programmable
Insulin Pump," U.S. Patent application Ser. No. 10/086,641, The
disclosures of these six patent application are hereby incorporated herein
by reference in their entirety.
Claims
The claimed invention is:
1. A method of delivering a bolus from a pump, the pump being a
programmable medical infusion pump having a keypad, the method comprising:
programming a bolus amount into the pump;
programming a duration into the pump;
programming a percentage into the pump, the percentage defining a portion
of the bolus amount to deliver immediately upon executing a deliver
command and a remainder of the bolus amount to deliver over the duration
upon executing a deliver command; and
executing the deliver command.
2. The method of claim 1 wherein programming a percentage into the pump
includes entering into the pump the portion of the bolus amount to deliver
immediately upon executing a deliver command.
3. The method of claim 1 wherein programming a percentage into the pump
includes entering into the pump the remainder of the bolus amount to
deliver over the duration upon executing the deliver command.
4. The method of claim 1 wherein executing the deliver command causes the
pump to begin delivery of the bolus, the bolus being insulin.
5. The method of claim 4 further comprising delivering a basal, wherein
executing the deliver command causes the pump to begin delivery of the
bolus, the bolus being in addition to the basal.
6. An apparatus for delivering a bolus of a medical agent to a patient, the
apparatus comprising:
a pump mechanism;
a data input device; and
a processor in data communication with the keypad and arranged to control
the pump mechanism, the processor being programmed to receive data
specifying a bolus amount through the data port, receive data regarding
duration through the data port, receive a percentage through the data
port, the percentage defining a portion of the bolus amount to deliver
immediately upon executing a deliver command and a remainder of the bolus
amount to deliver over the duration upon executing a deliver command, and
execute the deliver command thereby controlling the pump mechanism to
deliver the bolus.
7. The apparatus of claim 6 wherein the data input device is a keypad
having one or more buttons.
8. The apparatus of claim 6 wherein the data input device is a data port
configured to communicate with a computer.
9. The apparatus of claim 6 wherein the processor is further programmed to
control the pump mechanism to simultaneously deliver a basal and the bolus
upon executing the deliver command.
10. A method of temporarily adjusting the delivery rate of an infusion
pump, the infusion pump programmed to deliver a basal rate, the method
comprising:
prompting a user to select whether to enter the temporary rate as a percent
of the current delivery rate or as a new delivery rate;
entering into the pump a period of time having a beginning and an end;
entering into the pump a temporary basal rate; and
delivering the therapeutic agent at a delivery rate substantially equal to
the temporary basal rate during the period of time.
11. The method of claim 10 further comprising:
selecting to enter the temporary basal rate as a new delivery rate; and
wherein entering into the pump a temporary basal rate includes entering
into the pump a new delivery rate, thereby changing the basal rate to the
new delivery rate for period of time.
12. The method of claim 10 further comprising:
selecting to enter the temporary basal rate as a percent; and
wherein entering into the pump a temporary basal rate includes entering
into the pump a percentage by which to adjust the basal rate for the
period of time thereby establishing the temporary basal rate.
13. The method of claim 12 wherein entering into the pump a percentage by
which to adjust the basal rate includes entering a percentage greater than
100%.
14. The method of claim 12 wherein entering into the pump a percentage by
which to adjust the basal rate includes entering a percentage less than
100%.
15. The method of claim 12 further comprising:
delivering a therapeutic agent at a delivery rate substantially equal to
the basal rate before the beginning of the period of time; and
delivering the therapeutic agent at the delivery rate substantially equal
to the basal rate after the end of the period of time.
16. The method of claim 15 further comprising calculating the temporary
delivery rate upon entering into the pump a percentage by which to adjust
the basal rate according to the equation:
##EQU5##
where Percent is the percentage by which to adjust the basal rate.
17. An apparatus for delivering a therapeutic agent at a basal rate, the
apparatus comprising:
a pump mechanism;
a data input device; and
a processor in data communication with the keypad and arranged to control
the pump mechanism, the processor being programmed to prompt a user to
select whether to enter the temporary rate as a percent of the current
delivery rate or as a new delivery rate, receive from the data input
device a period of time having a beginning and an end and a temporary
basal rate, and control the pump mechanism to deliver the therapeutic
agent at a delivery rate substantially equal to the temporary basal rate
during the period of time.
18. The apparatus of claim 17 wherein the processor is further programmed
to receive the temporary basal rate as a new basal rate and to control the
pump mechanism to deliver the therapeutic agent at the new basal rate
during the period of time.
19. The apparatus of claim 17 wherein the processor is further programmed
to receive the temporary basal rate as a percent and to control the pump
mechanism to adjust the basal rate by the percent for the period of time
thereby establishing the temporary basal rate.
20. The apparatus according to claim 17 further comprising a reservoir
arranged to be emptied by the pump mechanism, the reservoir being filled
with insulin.
21. The apparatus of claim 20 wherein the data input device is a keypad
having one or more keys.
22. The apparatus of claim 20 wherein the data input device is a data port
configured to receive data from a computer.
23. The apparatus of claim 20 further comprising a screen in data
communication with the processor, wherein the processor is programmed to
display the prompt on the screen.
Description
TECHNICAL FIELD
The present application relates to insulin pumps, and more particularly, to
programmable insulin pumps.
BACKGROUND
A large portion of the world's population suffers from diabetes. Many of
these people need to take injections of insulin to normalize the level of
sugar in their bodies to prevent complications. Such complications can
include kidney failure, loss of circulation, and blindness. The need to
manually take injections with a syringe and the process of determining the
dose for various shots can be a great inconvenience and can limit a
diabetic's activities and restrict their movements. Furthermore, it can be
difficult to maintain a consistent level of blood glucose because there is
a practical limit to the number of injections that most patients can
receive.
One solution to reduce some of the problems associated with the manual
injection of insulin is an ambulatory pump that delivers insulin to the
diabetic user. Such insulin pumps can provide a more consistently normal
level of blood glucose, which reduces the risk of complications from
diabetes. However, current pumps still have practical limits to their
programming that make them cumbersome to program and that limits the
potential of the pump to provide even greater control over blood glucose
levels.
SUMMARY
One aspect of the present invention is a method of delivering a bolus from
a pump. The pump is a programmable medical infusion pump having a keypad.
The method comprises programming a bolus amount into the pump; programming
a duration into the pump; programming a percentage into the pump, the
percentage defining a portion of the bolus amount to deliver immediately
upon executing a deliver command and a remainder of the bolus amount to
deliver over the duration upon executing a deliver command; and executing
the deliver command.
Another aspect of the present invention is an apparatus for delivering a
bolus of a medical agent to a patient. The apparatus comprises a pump
mechanism, a data input device, and a processor in data communication with
the keypad and arranged to control the pump mechanism. The processor is
programmed to receive data specifying a bolus amount through the data
port, receive data regarding duration through the data port, receive a
percentage through the data port, the percentage defining a portion of the
bolus amount to deliver immediately upon executing a deliver command and a
remainder of the bolus amount to deliver over the duration upon executing
a deliver command, and execute the deliver command thereby controlling the
pump mechanism to deliver the bolus.
Yet another aspect of the present invention is a method of temporarily
adjusting the delivery rate of an infusion pump. The infusion pump is
programmed to deliver a basal rate. The method comprises prompting a user
to select whether to enter the temporary rate as a percent of the current
delivery rate or as a new delivery rate; entering into the pump a period
of time having a beginning and an end; entering into the pump a temporary
basal rate; and delivering the therapeutic agent at a delivery rate
substantially equal to the temporary basal rate during the period of time.
Still another aspect of the present invention is an apparatus for
delivering a therapeutic agent at a basal rate. The apparatus comprises a
pump mechanism, a data input device, and a processor in data communication
with the keypad and arranged to control the pump mechanism. The processor
is programmed to prompt a user to select whether to enter the temporary
rate as a percent of the current delivery rate or as a new delivery rate,
receive from the data input device a period of time having a beginning and
an end and a temporary basal rate, and control the pump mechanism to
deliver the therapeutic agent at a delivery rate substantially equal to
the temporary basal rate during the period of time.
DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates the architecture of a pump that embodies the present
invention;
FIG. 2 is a top view of the pump shown in FIG. 1;
FIG. 3 illustrates a suspend operation executed by the pump shown in FIGS.
1 and 2;
FIG. 4 illustrates setting time and date operating parameters in the pump
shown in FIGS. 1 and 2;
FIG. 5 illustrates setting alert styles in the pump shown in FIGS. 1 and 2;
FIGS. 6 and 7 illustrate lock and unlock operations executed by the pump
shown in FIGS. 1 and 2;
FIG. 8 illustrates setting time and date formats in the pump shown in FIGS.
1 and 2;
FIG. 9 illustrates setting alerts and reminders in the pump shown in FIGS.
1 and 2;
FIGS. 10 and 11 illustrate setting operational parameters related to the
pump history for the pump shown in FIGS. 1 and 2;
FIGS. 12-14 illustrate setting operational parameters for the basal rate
delivery programs executed by the pump shown in FIGS. 1 and 2;
FIGS. 15-17 illustrate setting operational parameters for the temporary
rate delivery programs executed by the pump shown in FIGS. 1 and 2;
FIGS. 18 and 19 illustrate setting the operational parameters for the
correction bolus delivery programs executed by the pump shown in FIGS. 1
and 2;
FIGS. 20-27 illustrate setting the operational parameters for the meal
bolus delivery programs executed by the pump shown in FIGS. 1 and 2;
FIG. 28 illustrates the operations of setting and delivering an audio bolus
on the pump shown in FIGS. 1 and 2;
FIG. 29 illustrates the pump shown in FIGS. 1 and 2 communicating with a
computer;
FIGS. 30A-30E illustrate a user interface on the computer illustrated in
FIG. 15.
DETAILED DESCRIPTION
Various embodiments of the present invention will be described in detail
with reference to the drawings, wherein like reference numerals represent
like parts and assemblies throughout the several views. Reference to
various embodiments does not limit the scope of the invention, which is
limited only by the scope of the claims attached hereto. Additionally, any
examples set forth in this specification are not intended to be limiting
and merely set forth some of the many possible embodiments for the claimed
invention.
The logical operations of the various embodiments of the invention
described herein are implemented as: (1) a sequence of computer
implemented steps, operations, or procedures running on a programmable
circuit within a computer, (2) a sequence of computer implemented steps,
operations, or procedures running on a programmable circuit within a pump
for delivering insulin; and/or (3) interconnected machine modules or
program engines within the programmable circuits.
The various embodiments execute or utilize operating parameters, which
customize or personalize operation of the computer implemented steps,
machine modules, and programs to meet the requirements of individual pump
users. The operating parameters can be numerical values, text strings,
flags, argument names, or any other aspect of the insulin pump programming
that the user can set to control operation of the pump.
Additionally, the pump generates and presents information and fields in
user interfaces, which are also referred to as displays. The user
interfaces can include fields, alpha/numeric character strings, times, and
dates. The fields, also referred to as cells, prompt users to enter and/or
select information. Because there is not an alpha/numeric keyboard on the
pump, each of the field is associated with a spin box that includes values
the user can enter into the field. The user spins or scrolls through
values until the desired value is visible within the field. When the user
selects the visible value it is entered into the field. The user selects a
value with a Next function, Edit function, or Select function as
identified herein. When the pump displays a field and the field has focus,
it is said to prompt the user to select a value. Additionally, selecting a
value in a field causes the pump to index focus to the next field as
defined by the programmed operations or to display the next user interface
as defined by the programmed operations. In an alternative embodiment, the
pump has an alpha/numeric keyboard from which operating parameters can be
typed directly into the pump.
The description set forth herein discusses pumping insulin. One skilled in
the art will realize that many of the features, structures, and methods
disclosed herein can be used with medical infusion pumps for delivering
agents other than insulin. The term "user" generally applies to the person
who is receiving insulin from the pump. In many contexts, however, the
user could also refer to any other person such as a caregiver that is
operating the pump.
A. Pump Architecture
FIG. 1 is a functional block diagram illustrating one of many possible
embodiments of an insulin pump, generally identified as 100. A
microprocessor 102 is in electrical communication with and controls a pump
motor 104, a screen 106, an audible alarm 108, and a vibratory alarm 110.
Other embodiments can use a microcomputer, or any other type of
programmable circuit, in place of the microprocessor.
The pump motor 104 drives a drive mechanism 112 that pushes a plunger
mechanism 114. The plunger mechanism 114 ejects insulin from an insulin
cartridge (not shown). The insulin cartridge contains a supply of insulin
for delivery to a patient. These mechanical components are illustrated and
discussed in commonly assigned U.S. patent application Ser. 10/086,646,
entitled Cartridge and Pump With Axial Loading, the disclosure of which
was hereby incorporated by reference above.
The screen 106 can have many different configurations such as an LCD
screen. As explained in more detail herein, the screen 106 displays a user
interface that presents various items of information useful to a patient
or caregiver. The audible alarm 108 is a beeper, and an alarm provides
actual alarms, warnings, and reminders. Similar to other portable
electronic devices such as a cellular telephone, the vibratory alarm 110
provides an alarm to either supplement the audio alarms or replace the
audio alarm when an audible beep would be disruptive or not heard. A user
can selectively enable or disable the audible 108 and vibratory 110
alarms. In one possible embodiment, however, both the audible 108 and
vibratory 110 alarms cannot be disabled at the same time.
The microprocessor 102 is in electrical communication with both a random
access memory (RAM) 116 and a read only memory (ROM) 118, which are
onboard the pump 100 but external to the microprocessor 102 itself. In one
possible embodiment, the microprocessor 102 includes internal memory as
well. The RAM 116 is a static RAM that stores data that can change over
time such as pump settings and a historical log of events experienced by
the insulin pump 100. The ROM 118 stores code for the operating system and
the application programs. The ROM 118 can be any type of programmable ROM
such as an EPROM. In one possible embodiment, the RAM 116 has 500
kilobytes of memory capacity and the ROM 118 has 2 megabytes of memory
capacity.
An infrared (IR) port 120 is in electrical communication with the
microprocessor. As explained in more detail below, the IR port 120
provides data communication with an external device such as a computer for
programming an application program, programming pump settings, and
downloading historical data logs. The insulin pump 100 can include other
types of communication ports in place of or in addition to the IR port
120. Examples of other possible communication ports include a radio
frequency (RF) port or a port that provides a hard-wired data
communication link such as an RS-232 port, a USB port, or the like.
A real-time clock 122 provides a clock signal to the microprocessor 102. An
advantage of having a real-time clock 122 is that it provides the program
with the actual time in real-time so that the programs executed by the
insulin pump can track and control the actual time of day that insulin
delivery and other events occur. Various durations described here are used
for alerts, alarms, reminders, and other functions. In one possible
embodiment, the timers are formed by the real-time clock 122 and software
executed by the microprocessor 102.
A keypad 124 also provides input to the microprocessor 102. Although other
possible types of keypads are possible, one type of keypad has four
buttons and is a membrane-type of keypad, which provides resistance to
water and other environmental conditions. The keypad 124 contains soft
keys for which the function of the keys can change as a user executes
different menu selections and commands.
Other inputs into the microprocessor 102 include a pressure sensor 126,
which is sensitive to the pressure within a reservoir of insulin; a
cartridge sensor 128, which is sensitive to the presence of an insulin
cartridge; and a motion detector 130, which detects motion of a gear (not
shown) in the drive mechanism 112. The pressure sensor 126, cartridge
sensor 128, and motion detector 130 are described in more detail in U.S.
patent application Ser. No. 10/086,646, which is entitled Cartridge and
Pump With Axial Loading, the disclosure of which was incorporated by
reference above.
Referring to FIG. 2, the pump 100 is packaged in a housing 132. The keypad
124 is positioned on a first portion of the housing 132, and the screen
106 is positioned on a second portion of the housing 132. Additionally,
the screen 106 has two portions, a display portion 134 and a template
portion 136. A user interface is presented in the display portion 134 of
the screen 106.
The template portion 136 provides a template that indicates the function
assigned to each of the keys on the keypad. In the embodiment illustrated
in the drawings, the keypad 124 has a first function key 138 and a second
function key 140, and an up key 142 and a down key 144. The up and down
keys 142 and 144 are for scrolling or spinning through operating
parameters that are presented in a spin box associated with a field or
between pages present within a user interface such as the home pages as
described below. Additionally, a first portion 146 in the template
identifies the function assigned to the first function key 138, and a
second portion 148 identifies the function assigned to the second function
key 140. A center portion 150 of the template presents an up arrow
corresponding to the scroll direction of the up key 142, and a down arrow
corresponding to the scroll direction of the down key 144.
B. Home Page
In one possible embodiment, the insulin pump 100 is controlled by a
menu-driven application program that is stored in the ROM 118 and executed
by the processor 102. The application program also is parameter-driven in
that the outcome or steps executed by the various application programs
depend on the operating parameters set by the user. Examples of outcomes
and steps that depend on the operating parameters include delivery rates,
delivery schedules, delivery amounts, the generation and presentation of
menus, and the like.
The application program presents a home page 152 in the display portion 134
of the screen 106. The home page 152 includes a first icon 154 that
illustrates the amount of insulin remaining in the insulin cartridge. This
first icon 154 has the shape of a syringe and a bar 156 arranged relative
to the syringe shape to illustrate the amount of remaining insulin. The
amount of remaining insulin also is quantified and listed below the first
icon 154. A second icon 158 has the shape of a battery and has a bar 160
arranged relative to the battery-shape to illustrate the amount of
remaining battery life. The percentage of remaining life on the battery is
positioned below the second icon 158.
In one possible embodiment, the home page 152 presents the current status
162 of the insulin pump's 100 operation. In the example set forth in the
illustration, the insulin pump 100 is delivering insulin at a rate of 1.15
units per hour according to a first basal schedule. The home page 152 also
presents the name 166 of the active delivery program it is executing and
personal information 168 as programmed by the user. In the illustrated
example, the personal information it displays is a banner "Mary's Pump,"
which identifies the owner of the insulin pump 100. Other examples of
information that might be included in the personal field includes medical
information about the pump user similar to that information included on a
medical alert bracelet such as allergies and the fact that the patient is
diabetic, more detailed information about the patient including the
patient's full name, telephone number, and address, detailed information
about the user's caregiver such as the name and telephone number of the
user's physician, and a warning that the pump 100 is an insulin pump and
should not be removed from the user.
Furthermore, the pump 100 can be configured to present more than one home
page. In this embodiment, the user scrolls through the home pages using
the up and down keys 142 and 144. For example, other home pages might
include the date, time, and amount of the last bolus delivered by the
insulin pump; contact information about the patient's caregiver; medical
information about the patient such as a list of the user's allergies, a
warning that the user is a diabetic, and a warning that the pump is an
insulin pump and should not be removed.
The pump 100 displays an icon 170 in the home page 152 to identify the
displayed page as the home page. Additionally, the icon 170 can include a
page number to indicate which home page is currently being displayed. One
possible shape for the home page icon is an icon having the shape of a
house.
C. Suspending Delivery
Referring to FIG. 3, when the pump 100 is displaying the home page it
assigns a suspend function 172 to the first function key 138 and a menu
function 174 to the second function key 140. Accordingly, pressing the
first function key 138 initiates a suspend pumping operation. If the pump
100 has an active delivery program in addition to the standard basal
delivery program, the pump 100 displays a list of options that prompts 173
the user to select whether to suspend all active delivery programs or just
one of the active delivery programs other than the standard delivery
program. In one embodiment of the pump 100, there are three possible ways
to deliver additional amounts of insulin over an extended period--an
extended bolus, a combination bolus, and a temporary rate, all of which
are described in more detail herein.
In the example set forth in FIG. 3, the pump 100 has an active temporary
rate delivery program so the pump 100 prompts the user to select whether
to suspend all active delivery programs or just the temporary rate
delivery program by scrolling to the desired delivery program to suspend.
The user then activates a Select function 194, which is assigned to the
second function key 140.
After the user activates the Select function 194, the insulin pump 100
prompts 176 the user to confirm suspension of the selected delivery,
whether it is all delivery, the extended bolus, the combination bolus, or
the temporary rate. The user can confirm the suspend operation by
activating the yes function 178 by pressing the second function key 140 or
cancel the suspend operation by activating the no function 180 by pressing
the first function key 138. If there is no insulin being delivered in
addition to the standard basal rate, the insulin pump will automatically
skip from the home page 152 to the prompt 176 asking the user to confirm
suspension of the delivery.
When the user activates the yes function 178, the pump 100 displays a
warning 182 that the insulin pump 100 is stopping delivery. The user then
activates an o.k. function 184 and the pump 100 stops delivery, returns to
the home page 152 and displays a banner 186 stating the pump 100 is
stopped. On the home page 152, the pump 100 assigns a Resume function 188
in place of the suspend function 172. In one possible alternative
embodiment, the insulin pump 100 merely displays the warning that the pump
100 is stopping delivery for a predetermined period of time (e.g., 5
seconds) and then stops the pump 100 and returns to the home page 152.
To resume pumping, the user activates the Resume function. The insulin pump
100 then prompts 189 the user to either confirm or cancel the resume
function by activating either a yes function 178 or a no function 180.
Alternatively, at the list that prompts 173 the user to select whether to
suspend all active delivery programs or just one of the active delivery
programs other than the standard delivery program, the user can return to
the previous display (i.e., the home page 152) by activating a Back
function 170, which is assigned to the first function key 138. Activating
the Back function, whenever it is assigned to the first function key 138,
always returns the pump 100 back to the previous display.
D. Main Menu and Time/Date
Referring to FIG. 4, the user accesses a main menu 190 by activating a menu
function 192 assigned to the second function key 140. The insulin pump 100
then displays the main menu 190, which includes a plurality of menu items
that the user can select for setting operation parameters and performing
various tasks as described herein. In one possible embodiment, the menu
items in the main menu are Basal Programs, New Cartridge, History, and
Pump Settings. In other possible embodiments, the main menu 190 can be
customized to include other menu items such as Correction Bolus, Temporary
Rate, Meal Bolus, and others. Furthermore, the user can customize at least
some of the labels for various menu items in both the main menu 190 and
submenus.
The New Cartridge menu item is selected to access the cartridge or syringe
of insulin loaded in the pump 100. In one possible embodiment, selecting
the New Cartridge menu item automatically sequences the user through the
steps of loading the new cartridge, priming the tubing for the infusion
set, priming the cannula, and setting the display site reminder, if the
display site reminder is enabled. The display site reminder is discussed
below in more detail. In yet another embodiment the user must
affirmatively acknowledge each of these steps by pressing a predetermined
key, either the first or second function keys 138 or 140 on the keypad
124, at the conclusion of each step, which causes the pump to index to the
next step. After sequencing through each of these steps, the pump 100
prompts the user to enter an instruction whether to resume delivery of
insulin.
Accessing the cartridge is discussed in more detail in U.S. patent
application Ser. No. 10/086,646, entitled Cartridge and Pump With Axial
Loading, the disclosure of which was incorporated by reference above.
The user selects the desired menu item by using the up and down keys 142
and 144 until the desired menu item is highlighted or otherwise marked.
The user then activates the highlighted menu item by activating a select
function 194 assigned to the second function key 140.
By selecting the Pump Settings menu item, the pump brings up a Pump
Settings submenu 196 of several submenu items, including Time and Date,
Beep/Vibrate, Program Lock, and Personalize. The Time and Date menu option
is selected to set the time and date of the clock. This time and date is
set in real time. When the Time and Date menu option is selected, the
screen displays the time and date, and focus is placed on the hour field
198. The user scrolls through values for the hour until the desired value
is set. The user then activates a next function 200 assigned to the second
function key 140 to index through the remaining fields for the time and
date (e.g., the minute field 202, the am/pm field 204, the month field
206, the day field 208, and the year field 210) and set the desired values
for each of these fields. The user exits the Time and Date function at any
time by activating the Done function 212 assigned to the first function
key 138. Activating the Done function 212 saves the current time and date
settings and returns the pump to the Pump Settings submenu 196.
E. Beep/Vibrate
Referring to FIG. 5, to configure an alarm function to generate either an
audible or vibratory signal, the user selects the Beep/Vibrate menu option
within the Pump Settings submenu 196. The pump 100 then indexes to the
next user interface and places focus on a choose-alert field 214. The user
scrolls to the desired beep setting or vibrate setting and selects that
setting by activating the Next function 200 to select the desired setting.
If the Beep setting is selected, focus changes to a beep-volume field 216
and the user scrolls to and selects the desired volume level. In one
possible embodiment, the volume levels from which the user can select are
low, medium, and high. Other embodiments use a numbered volume scale,
labels such as indoor and outdoor, and the like. Upon selecting the
desired volume level, the alert and volume settings are saved and the Pump
Setting submenu 196 is displayed on the screen 106. If the user selects
vibrate in the choose-alert field 214, the pump 100 will return directly
to the Pump Setting submenu 196.
F. Lock
Referring to FIG. 6, to lock out the pump 100 and prevent anyone from
entering the main menu 190, the user selects the Program Lock menu item in
the Pump Settings submenu 196. Focus then indexes to a lockout user
interface having a lock-out field 218, which is placed in focus. The user
scrolls and selects to the desired yes or no value. If the user selects
no, the pump 100 continues operating and the pump 100 is not locked out.
If the user selects yes, the pump 100 is locked and must be unlocked to
access the main 190 menu from the home page 152. In one possible
embodiment, if there are multiple home pages, the user can still scroll
through all of the home pages without unlocking the main menu 190. In
another possible embodiment, the user can still troubleshoot alarms
without unlocking the pump 100.
Referring to FIG. 7, to unlock the pump 100 the user activates the menu
function 174 and the pump 100 indexes to a user interface having a
lockout-code field 220, which is placed in focus. The user scrolls to and
selects the lockout code. In one possible embodiment, the lockout code is
a number and the user enters the lockout code by scrolling through
possible codes. Upon selecting the proper lock-out code, the main menu 190
is unlocked and the main menu is displayed.
In alternative embodiments, there are separate fields for each digit in the
lockout code. In this embodiment, the user indexes through the digits
using the Next function 200 until the last digit is set at which time the
pump 100 either unlocks the main menu or admonishes the user that the
wrong code was entered.
Yet another embodiment of the pump 100 has lock levels in which the
different codes can be entered into the pump 100, each code permitting
access to a different set of commands and functions. Lock levels are
described in more detail in commonly assigned U.S. Pat. No. 5,935,099,
which is entitled DRUG PUMP SYSTEMS AND METHODS and issued on Aug. 10,
1999, the complete disclosure of which is hereby incorporated by
reference.
G. Customizing Time and Date Formats
Referring to FIG. 8, to customize the time and date formats, the user
selects a Personalize menu item in the Pump Settings submenu 196. The pump
100 then indexes to a Personalize submenu 222 in which the user selects a
Localization menu item. The pump then indexes to a time-format field 224,
which is placed in focus. The user scrolls to and selects the desired time
format (e.g., 12-hour or 24-hour). The pump 100 then indexes focus to a
date-format field 226. The user scrolls to and selects the desired date
format (e.g., mm/dd/yy or dd/mm/yy). The pump 100 then indexes focus to a
numeric-format field 228. The user scrolls to and selects the desired
numeric format (e.g., xx.xx or xx,xx). The pump 100 then returns to the
Personalize submenu 222. In an alternative embodiment, the user can also
set a flag that causes the pump to automatically change time at the
beginning and end of daylight savings time.
H. Customizing and Setting Alerts and Reminders
Referring to FIG. 9, to customize and set various alerts and reminders the
user selects the Alerts item from the Personalize submenu 222. When the
user selects the Alert menu item, the pump 100 indexes to a
low-cartridge-alert field 230, which is placed into focus. The user
scrolls to and selects the desired volume (i.e., remaining volume within
the cartridge) at which the pump 100 will generate a low cartridge alert.
In one possible embodiment, the user can select whether to set the
threshold for the low volume alert in the range from 5 units to 50 units.
Upon selecting the desired volume, focus indexes to a delivery-limit field
232. The user scrolls to and selects the desired delivery limit at which
an alarm is generated when there is an attempt to deliver more insulin
than is allowed in a one-hour period of time. In one possible embodiment,
the user can select whether to set the threshold for the delivery limit
alarm in the range from 2 units to 100 units.
The insulin pump 100 then indexes focus to a glucose-reminder field 234,
which is an alert that reminds the pump user to check their blood glucose
level, based on a triggering event such as when the user last loaded a new
insulin cartridge into the pump 100 or administered a meal bolus. The user
scrolls to the desired yes and no values or settings. The yes value
enables the glucose reminder and the no value disables the glucose
reminder.
The pump 100 then indexes focus to a duration field 236 in which the user
sets the duration between the triggering event and when the glucose
reminder signals an alert. The user scrolls to and selects the desired
duration. In one possible embodiment, the user scrolls through values in
the range from 1 hour to 5 hours in a predetermined increment, such as 15
minute, half hour, or one hour increments. The pump 100 then indexes focus
to an automatic-off field 238. If the user selects no in the
glucose-reminder field 234, the pump 100 will skip over the duration field
236 and index focus directly to the automatic-off field 238.
In this embodiment occurrence of the triggering event will begin a timer
running, which will time out and generate an alarm when the duration
lapses. When the alert is signaled, the pump displays a message reminding
the user to check their blood glucose levels. The user activates a
predetermined key, either the first or second function key 138 or 140 on
the keypad 124, to clear the alert and the message.
Within the automatic-off field 238, the user sets an automatic-off alarm
that is generated when no keys or buttons on the insulin pump or a remote
control unit associated with the pump 100 are pressed within a
predetermined period of time. The pump 100 also suspends delivery when the
automatic off alarm is generated and generates an alarm display. In one
possible embodiment, when the automatic off alarm is generated, the user
must acknowledge the alarm while the alarm display is presented and then
must reinitialize the pump 100 to resume delivery. Another embodiment, the
alarm display includes a message stating that the pump is an insulin pump.
When the automatic-off field 238 is in focus, the user scrolls to and
selects the desired yes or no value. If the user selects the yes value,
the pump 100 enables the automatic-off alarm, and the pump 100 indexes
focus to a duration field 240 in which the user scrolls to the desired
duration corresponding to the delay before the automatic-off alarm is
sounded and delivery is suspended. After the delay is set, the pump 100
indexes focus to a display-site-reminder field 242. If the user selects
the no value in the automatic-off field 238, the pump 100 disables the
automatic-off alarm, and indexes focus to the display-site-reminder field
242 and skips the duration field 240.
The display-site reminder is an alert that reminds the user to change their
infusion set and access site (i.e., where on their body the insulin is
injected). Within the display-site-reminder field 242, the user scrolls to
and selects the desired yes and no values. If the user selects the yes
function the pump 100 enables the display-site reminder, and if the user
selects the no value, the user will disable the display-site reminder. In
one possible embodiment, the display-site reminder will generate an alarm
at a predetermined interval after the last time that the user changed
their infusion set and access site. Upon selecting the yes or no value,
focus indexes to a review/edit-meal-bolus-alarm field 246.
If the user enables the display site reminder, the pump 100 prompts the
user to enter the interval (i.e., the number of days) after which to
generate a reminder or alarm and the time of day at which to generate the
reminder. For example, setting an interval of 2 days and a time of 4:00
pm, would cause the pump 100 to generate a display-site reminder at 4:00
pm on the second day after the interval starts to run. When the pump 100
generates the display-site reminder to change the user's infusion set and
access site, it generates an audio and/or vibratory alarm and displays a
banner or other visual reminder that the user acknowledges by pressing a
designated function key 138 or 140 on the key pad 124. The pump 100
includes a display-site reminder menu item that the user selects to reset
the display site reminder and to adjust the interval and time of day if so
desired. The user would access this menu item and reset the display-site
reminder when changing his or her infusion set and access site.
In one possible embodiment, the pump automatically takes the user through
the process of setting the interval and time of day for the display site
reminder when going through the sequence of loading the new cartridge or
syringe into the pump 100 and priming the infusion set.
A meal bolus alarm is an alarm that reminds the user to deliver a meal
bolus during a predetermined time interval. For example, if the user eats
breakfast every day between 7:00 am and 8:00 am every day, the user may
set a missed-meal-bolus alarm for an interval between 6:15 am and 8 am. In
this example, an alarm sounds if a meal bolus is not delivered within this
interval. In one possible embodiment, the user can set up to four separate
missed-meal-bolus alarms.
Within the review/edit-meal-bolus-alarm field 246, the user scrolls to and
selects the desired yes or no value. If the user selects the no value, the
pump 100 returns to the Personalize submenu 222. If the user selects the
yes value, the pump 100 presents a user interface 248 entitled "Meal Bolus
Alarm," which lists the names 250 of the available alarms (Alarms 1-4 in
the illustrated embodiment) and a check box 252 next to the name of each
alarm. If a missed-meal-bolus alarm is enabled, the check box 252 is set.
If a missed-meal-bolus alarm is not enabled, the check box 252 is cleared.
To set an alarm, the user scrolls to the name 250 of the desired alarm and
activates an edit function 254, which is assigned to the second function
key 140. The pump 100 then displays a user interface 256 entitled "Meal
Bolus Alarm: Alarm X", where X identifies the alarm to which the screen
relates. In the illustrated embodiment, the display 256 relates to Alarm
1. There is one Meal Bolus Alarm: Alarm X display 256 associated with each
of the alarms 250. Within the Meal Bolus Alarm: Alarm X display 256, there
are three fields, a give-alert field 258, an interval-start field 260, and
an interval-end field 262.
The give-alert field 258 is the first field placed in focus. The user
scrolls to and selects the desired yes or no value. The yes value enables
the meal bolus alarm, and the no value disables the meal bolus alarm. If
the user selects the no value, the pump 100 returns to the "Meal Bolus
Alarm" user interface 248. If the user selects the yes value, the pump
indexes focus to the interval-start field 260. The user then scrolls to
and selects the desired start time for the interval. The pump 100 then
indexes focus to the interval-end field 262. The user scrolls to and
selects the desired end time for the interval. In one possible embodiment,
the time values through which the use scrolls are set at 15 minute
increments, although other embodiments will have other time increments.
The pump 100 then saves interval start and stop times for that meal bolus
alarm and returns to the Meal Bolus Alarm display 248. The user can then
select another meal bolus alarm to enable and set or to disable using the
procedures discussed above. Alternatively, the user can activate the Done
function 212 and the pump 100 will save the settings for all of the meal
bolus alarms and return to the Personalize submenu 222.
I. Pump History
Referring to FIG. 10, one possible embodiment of the insulin pump 100
tracks historical information related to the pump 100 such as delivery
information and other events related to the pump 100. Historical
information can be viewed on the screen 106 of the pump 100 or uploaded to
a computer as discussed in more detail herein. The pump 100 can be
customized to view historical delivery and event information in individual
history screens or under the History item of the main menu 190.
Additionally, the pump 100 can display delivery information either as
individual events or as averages. These alternatives are only some of the
possible embodiments.
The pump 100 can be programmed to track many different types of historical
information, to present the historical information in many different ways,
and to provide different ways to access historical information. In one
possible embodiment, the historical information that the pump 100 tracks
includes:
(1) The aggregate insulin delivered by the pump 100 as well as the amount
of insulin broken down by insulin delivered as a meal bolus, insulin
delivered to counteract estimated carbohydrates consumed by the user (if
the carbohydrate estimator is used), delivered as a correction bolus, and
delivered according to basal delivery protocols. In various embodiments,
the pump 100 will record delivery according to basal delivery protocols as
a total for all basal delivery protocols, or if the pump 100 is programmed
with multiple delivery basal protocols, the delivered insulin can be
broken down by each basal protocol used by the pump 100. In one possible
embodiment, this data is stored as a daily total and an average daily
total for a predetermined number of days. Additionally, in various
embodiments, the average data can be recorded as actual average values or
the average data can be calculated from the daily totals when requested
for display or upon other requests.
(2) The amount of insulin delivered by the pump 100 according to a basal
protocol as a percent of the total insulin delivered by the pump 100. In
one possible embodiment, this data is stored as a daily percentage and an
average daily percentage for a predetermined number of days. Additionally,
in various embodiments, the average data can be recorded as actual average
values or the average data can be calculated from the daily totals when
requested for display or upon other requests.
(3) The date, time, and amount of each bolus delivered.
(4) The 500-Rule factor, which is used to estimate the grams of
carbohydrates that are covered by each unit of insulin. To determine the
grams of carbohydrates that are covered by each unit of insulin, the
500-Rule factor is divided by the total daily dose of insulin required to
maintain the user blood sugar level in an acceptable range. The typical
500-Rule factor is 500, and hence the ratio is called the 500 Rule.
However, the factor may vary for different types of insulin and from user
to user and the value for the 500-Rule factor is calculated and stored. In
one possible embodiment, the 500-Rule factor is stored as a daily value
depending on the total delivery dose and an average value for a
predetermined number of days. In an alternative embodiment, the 500-Rule
factor is not stored but is calculated as the 500-Rule factor is required
for a display, calculation, or other function.
(5) The 1800-Rule factor, which is used to estimate the number of units of
insulin is required for each mg/dL (or mmol/L) drop in blood glucose. To
determine the drop in blood glucose for each unit of insulin delivered to
the user, the 1800-Rule factor is divided by the total daily dose of
insulin required to maintain the user blood sugar level in an acceptable
range. The typical 1800-Rule factor is 1800, and hence the ratio is called
the 1800 Rule. However, the factor may vary for different types of insulin
and from user to user and the value for the 1800-Rule factor is calculated
and stored. In one possible embodiment, the 1800-Rule factor is stored as
a daily value depending on the total delivery dose and an average value
for a predetermined number of days. In an alternative embodiment, the
1800-Rule factor is not stored but is calculated as the 1800-Rule factor
is required for a display, calculation, or other function.
(6) The complete history, which in one possible embodiment is the last 2000
events that are experienced by the pump, including all daily delivery
totals, all alerts, all errors, all battery changes, all insulin cartridge
changes, all changes to the pump program, and the like. Each record of an
event includes the date and time that the event occurred. In other
embodiments, a predetermined number of events other than 2000 are
recorded. In yet another possible embodiment, the pump 100 records the
events for a predetermined number of days rather than an absolute
quantity, although there might be a limit to the total number of events
that are recorded depending on available memory and other factors.
In one possible embodiment, as used herein total daily dose, also referred
to as Total Daily Dose or TDD, refers to the total amount of insulin
delivered during a single day excluding the amount of insulin delivered as
a correction bolus. Other embodiments might includes the amount of insulin
delivered as a correction bolus in the total daily dose of insulin.
To customize how the historical information is displayed on the pump 100,
the user selects the History menu item from the Personalize submenu 222.
The pump 100 indexes to a delivery-summary field 246, which is placed in
focus. The user scrolls to and selects the desired yes or no value. The
yes value enables the Delivery Summary menu item in the History submenu
290 (FIG. 11), and the no value disables the Delivery Summary menu item in
the History submenu 290. Disabled menu items are not displayed as part of
the menu. In one possible embodiment, the delivery summary displayed under
this menu item includes the total daily dose of insulin delivered by the
pump 100 as well as the amount of insulin broken down by insulin delivered
as a meal bolus, insulin delivered to counteract estimated carbohydrates
consumed by the user (if the carbohydrate estimator is used), delivered as
a correction bolus, and delivered according to basal delivery protocols.
In an alternative embodiment, the delivery summary includes the total or
aggregate amount of insulin, including insulin delivered as a correction
bolus.
Upon selecting the yes or no value in the delivery-summary field 246, focus
indexes to an average-delivery-summary field 266, in which the user
scrolls to and selects either a yes value or a no value. The yes value
enables the Average Delivery Summary menu item in the History submenu 290,
and the no value disables the Average Delivery Summary menu item in the
History submenu 290. In one possible embodiment, the Average Delivery
Summary displayed under this menu item includes the average daily total
for a predetermined number of days for the aggregate insulin delivered by
the pump as well as the amount of insulin broken down by insulin delivered
as a meal bolus, insulin delivered to counteract estimated carbohydrates
consumed by the user (if the carbohydrate estimator is used), delivered as
a correction bolus, and delivered according to basal delivery protocols.
Upon selecting the yes or no value in the average-delivery-summary field
266, focus indexes to basal-as-percent-of-TDD field 268. In one possible
embodiment, basal as a percent of TDD is the amount of insulin delivered
by the pump 100 according to a basal protocol as a daily percent of the
total insulin delivered by the pump 100. The user selects whether to
display the Basal as a Percent of TDD menu item in the History submenu 290
using a procedure similar to that described for the Delivery Summary.
Under this menu item, the pump 100 lists the total daily amount of insulin
delivered as a basal as a percent of the total daily dose of insulin In an
alternative embodiment, the pump 100 lists the total daily amount of
insulin delivered as a bolus as a percent of the total daily dose of
insulin delivered. In various embodiments, the bolus as a percent can be
listed as the meal bolus as a percent of the total daily dose of insulin
delivered, correction bolus as a percent of the total daily dose of
insulin delivered, or total bolus as a percent of the total daily dose of
insulin delivered. The pump 100 then indexes focus to an
average-basal-as-percent-of-TDD field 270. In one possible embodiment,
average basal as a percent of total daily delivery (TDD) is the amount of
insulin delivered by
